Monthly Archives: June 2023

Errors during the Night Shift: An Age Management Policy is Needed for Nurses Over 55

DOI: 10.31038/IJNM.2023431

 
 

In the study “Relation between sleep deprivation and nursing errors during the night shift,” conducted on a sample of 3358 nurses, 94.7% of the respondents stated that they perform regular activities during the night shift. 16.8% of the respondents made errors in the last two night shifts, with 59.5% of the cases involving a single error. Sleep deprivation (3-5 hours of sleep within the 24 hours preceding the interview) appears to contribute to a higher frequency of errors. This tendency is particularly pronounced among nurses working in critical care units (23.9%). The number of nights worked also influences the likelihood of making errors, with an error frequency of 20.5%. The propensity to make errors is relatively high among the younger age group (17.2%), decreases in the middle age group (15.8%), and then increases again in the older age group (17.6%). We have concluded that night-time care is exhausting and demanding and can have negative effects on the quality of care provided. Therefore, healthcare organizations should support nurses in the organization of night-time care by investing in strategies for safe and quality night-time care that minimizes the negative impact on nurses’ quality of life and psycho-physical well-being. This includes increasing the number of nursing staff during the night shift. Furthermore, the authors conclude that precise age management strategies supported at the management level are needed to minimize the negative effects of the current situation and to enhance the skills that increase in quantity and quality with work experience, utilizing them as valuable resources within the system.

A significant portion of the global and Italian nursing workforce is represented by those over 55. According to the “Health Profile 2019” for Italy published by the OECD and the European Commission in 2020, available on the FNOPI website, the majority of nurses are concentrated in the age group between 36 and 55 years: 268,914. There are also 15,552 nurses between 20 and 25 years old and 13,259 nurses over 65. The “younger” nurses (up to 58 years old with over 30 years of professional experience) number over 30,000. Nurses over 60 (with over 30 years of professional experience) amount to just over 13,000, and nurses up to 28 years old, at risk of underemployment/unemployment, are 39,000. Finally, nurses over 60 without more than 30 years of professional experience amount to approximately 25,000. Nurses over 55 are an important segment of the nursing profession who, along with advancing age and years of service, face a range of psychophysical issues that make it difficult to ensure efficient work performance. Despite this, healthcare companies do not pay attention to this age group of nurses. What would nurses want for their careers in the years leading up to retirement?

A survey conducted at the Modena Local Health Authority investigated the organizational health status of workers over 50, their perceptions, motivations, health issues, and proposed measures to raise awareness of the phenomenon of aging in the profession and suggest improvement actions to be tested within the company. Nurses who participated in the survey listed some self-strategies to mitigate the impact of aging and strategies to suggest to the organizational system.

Self-strategies:

  • Invest in personal professional development and participate in individual training courses.
  • Maintain a part-time employment contract.
  • Have more hours of rest.
  • Achieve a balanced use of absences from work for psycho-physical recovery by reviewing the threshold for illness and the use of contractually defined leaves.
  • Request authorization for extended ordinary leave of at least 4-5 consecutive days for rest and better vacation planning.
  • Strategies to suggest to the organizational system:
  • Value the experience gained by older nurses by combining the energy and vitality of younger nurses with the knowledge and experience of older ones. The value of older nurses should be measured by recognizing their wealth of skills and field experience, different culture, and being the key to the company’s historical memory, as older nurses are loyal to their work due to cultural and generational factors.
  • Identify older nurses who can facilitate the integration of newly hired nurses.
  • Mentoring, the process of knowledge transfer through the support of newly hired or nursing students, can play a significant role in work organization.
  • Motivate older nurses by bridging their technological training gaps. Older nurses today face greater difficulty in adapting to new technologies.
  • Employ older nurses in less stressful services with lower workloads, services that require experience and good relational skills more than physical endurance.
  • Exempt employees over 55, upon request, from night shifts and on-call shifts, and ensure a regular schedule to allow for psycho-physical recovery.

Grandparents’ Family Functions in Grandchildrearing in Japan, and Its Effect Factors

DOI: 10.31038/IJNM.2023424

Abstract

Midwives have the role of helping grandparents enhance their family functions as they welcome new family members. However, their specific functions and effect factors remain unclear. Therefore, we conducted a survey with the aim of clarifying the family function of grandparents in raising grandchildren. We conducted an online survey of 2,000 Japanese grandparents and analyzed the data using factor analysis and multiple regression.

Four functions of the grandparents were revealed: daily care and healthcare, emotional support for parents, grandchildren’s character development, and own well-being. Raising grandchildren exerts a great influence on family dynamics. Grandparents who did not feel burdened reported that grandchild-rearing was one of their lives’ passions and helped them maintain their strength and youth. To enhance their family functions grandparents, it is necessary to assess the four functions of grandparents, support them in maintaining an appropriate distance from their grandchildren and parents, and set up a forum for discussion between grandparents and parents.

Keywords

Childcare, Family function, Grandchildren, Grandparents

Contribution to the Field

  • The family function of grandparents in raising Japanese grandchildren was clarified. Therefore, in the future, the viewpoints of the four family functions mentioned above will be used as an assessment tool, which may lead to the implementation of midwives’ care that enhances the family functions of grandparents.
  • To improve the quality of life of grandparents, the need to maintain a moderate distance from grandchildren was revealed. New grandparents of both sexes can be educated in advance about the role of grandparents.

Introduction

Against the backdrop of declining family functions, problems such as depression, suicide among pregnant women [1], and infant abuse continue to persist [2]. The birth of a new child represents a developmental crisis because the family roles of both parents and grandparents change considerably. The main purpose of family support is to enable families welcoming new children to smoothly fulfill their roles and functions and enhance family functions. In Japan, for grandparents, the birth of a grandchild is the achievement of family succession, and the involvement of grandparents in childcare improves the grandparents’ own quality of life [3,4]. For mothers, the influence of grandparents has the merits of physical recovery after childbirth, elimination of anxiety about childcare, and passing on childcare skills [5]. In recent years, the employment rate of Japanese mothers has increased [6]. Mothers need access to formal childcare schemes [7] and informal family support to balance childcare and work. The Japanese tend to choose informal support from grandparents when they need childcare support [8,9]. Furthermore, 53% of Japanese couples receive childcare support from their mothers until their children are three years old. If wives are employed, this number rises to 58% [6]. In addition, the role of grandparents as caretakers of grandchildren is associated with an increase in the number of births [10]. All of this indicates a growing expectation that grandparents will take on a role in providing childcare for their grandchildren. However, involvement in grandchild-rearing adds a physical and emotional burden on grandparents [11,12]. Differences in childcare policies between mothers and grandparents have created issues such as burden and stress on mothers [5,13]. In the future, as the average life expectancy increases further [14] it is conceivable that as grandparents get older, the physical burden will increase, making it more difficult for them to be involved in the regular rearing of their grandchildren [15]. Midwives have a role to play in helping families, including grandparents, adapt to the birth of a new child [16]. Therefore, it is necessary to assess the family functions of grandparents and provide appropriate support. In recent years, grandparents who welcome new grandchildren have been educated about childcare and the roles of grandparents so that they can understand the role and take charge of raising their grandchildren [17]. However, these supports are not sufficient to meet the needs of grandparents because they are care plans based on an assessment of the family functions of grandparents raising grandchildren and remain ambiguous. Previous studies have cited the role of grandparents as providing basic care to their grandchildren, ensuring their safety and health [18] and identifying themselves as role models and educators [18-20]. In addition, the extent and impact of grandparents’ involvement in parenting have been clarified, but the exact family functions of grandparents remain unknown. Grandparents often refer to the ambiguity of their role within the family and the concomitant challenge of adjusting the parents’ roles, which can lead to the drawing of boundaries and severing of family ties [21]. Therefore, it is necessary to clarify the role function of grandparents responsible for raising grandchildren to support the family so that they can perform individual functions in the family without crossing boundaries. Accordingly, this study aimed to determine grandparents’ family functions in grandchild-rearing in Japan and factors that influence them.

Methods and Materials

Operational Definitions and Conceptual Framework

Grandparents

Men and women with grandchildren between 0 and 5 years of age, with the infants’ parents being over the age of 40.

Grandparents’ Family Functions

Grandparents’ family function was defined as the state in which grandparents maintain and improve their own well-being in harmony with their work, hobbies, and community activities while building relationships with their own children and their children’s families [22].

Research Design

This cross-sectional observational study used a questionnaire survey.

Participants

The sample comprised 2,000 individuals (50% women), 40–89 years of age, with preschool-aged grandchildren with whom they interacted at least once a year.

Survey Period and Methodology

In July 2021, we commissioned a Japanese internet research firm to conduct an online survey, ensuring participants’ anonymity. The sample was selected from a list of people registered with this firm. The internet research company’s monitors are registered in accordance with the rules and have 1.12 million monitors. Participants were selected from among them.

Survey Contents

Participants’ Attributes and the Burden of Raising a Grandchild

The participant attributes surveyed included gender, age, cohabitation, and employment. The respondents who indicated being “very” (scored as 4) or “somewhat” involved (scored as 3) in their grandchildren’s development, supporting the parents, and general housework, were defined as “involved.” Those who indicated being “not very involved” (scored as 2) and having “almost no involvement” (scored as 1) were defined as “not involved.” Regarding the burden of child-rearing (e.g., caring for their grandchildren, disciplining them, supporting their parents, and doing general housework), those who indicated feeling “very” (scored as 4) and “somewhat” (scored as 3) burdened, were assigned to the “burden” group, whereas those who indicated feeling “not very burdened” (scored as 2) and “almost no burden” (scored as 1) were assigned to the “no burden” group.

Grandparents’ Family Functions

In order to clarify the family function of grandparents, 15 items that assessed grandparents’ family functions were extracted from previous studies [11,23-25]. Experts examined the constructs of the extracted items. Items were scored on a five-point Likert scale, ranging from 1 (“not at all applicable”) to 5 (“very applicable”).

Analysis Method

Basic statistics were calculated for each variable, and an exploratory factor analysis was conducted for the grandparents’ family function items. After confirming multicollinearity using the correlation coefficient variance inflation factor (VIF), a linear regression analysis (i.e., forced entry method) was conducted with the grandparents’ family functions as the dependent variables and basic attributes as the independent variables. Multiple regression analysis was conducted between the grandparents’ family functions subscale and basic attributes. Gender was coded as 0=male and 1=female. Employment and cohabitation status were both coded as 0=no and 1=yes. The dummy variables for involvement in grandchild-rearing and the degree of grandchild burden were set as 0=none and 1=yes. The significance level was set at 5%. Statistical analyses were performed using IBM’s SPSS Statistics software, Ver. 27.

Ethical Considerations

A statement clearly stating the ethical considerations (e.g., guarantee of voluntary research cooperation and anonymity, confidential handling of data after completion of the research, existence of conflicts of interest, and monitoring) was displayed on the screen before the beginning of the survey. The study was approved by the Ethical Review Committee for Nursing Research of Dokkyo Medical University (approval number: Nursing 03008). Because this was an online survey, the study participants provided informed consent by checking a box to indicate that they agree with the ethical statements that appeared on the screen.

Results

Overview of the Participants

A summary of the participants’ characteristics is presented in Table 1. The participants’ age averaged 63.4 years (6.9 SD); 67 of them (3.4%) were in their 40s, 451 (22.6%) were in their 50s, 1,092 (54.6%) were in their 60s, and 390 (19.5%) were in their 70s or older. Further, 715 participants (35.8%) lived with their grandchildren, whereas 1,285 (64.3%) did not. Additionally, 1,088 (54.4%) were involved in grandchild care, 1,085 (54.3%) were involved in supporting their own children, and 1,102 (55.1%) were not involved in general housework. Of the respondents, 1,248 (62.3%) did not feel burdened by grandchild care, 1,211 (60.6%) did not feel burdened by disciplining grandchildren, 1,624 (81.2%) did not feel burdened by supporting their own children, and 1,102 (55.1%) did not feel burdened by general housework.

Table 1: Outline of eligible persons (N=2,000)

TAB 1

Notes: 1Involvement in child-rearing: Yes (very involved, somewhat involved); No (not very involved, almost no involvement).
2Burden of child-rearing: Yes (very burdened, somewhat burdened); No (not very burdened, no burden).

Grandparents’ Family Functions and Effect Factors

The 15 items of grandparents’ family functions were confirmed by calculating basic statistics; no ceiling or floor effects were found. These items were subsequently subjected to exploratory factor analysis, based on the maximum likelihood method. Judging from the possibility of interpretation, a factor analysis of Promax rotation was performed with four factors. As a result, two items, “I am troubled by the gap between my own child-rearing experience and that of my own children” and “I try to ease the strained relationship between my grandchildren and their parents,” were deleted because their factor loadings were lower than 0.4, and factor analysis was conducted again using maximum likelihood method and Promax rotation. Table 2 presents the factor loadings.

Table 2: Grandparents’ family function: exploratory factor analysis (N=2,000)

TAB 2

Notes: Maximum likelihood method: Promax method with Kaiser normalization.
Kaiser-Meyer-Olkin .93; Bartlett spherical test of: p<0.001.

The following four dimensions of grandparents’ family function were identified: Function 1 was named daily care and health care because of its high loadings in “contributing to grandchildren’s health and growth by helping them eat and bathe,” “contributing to grandchildren’s health recovery by taking care of them when they are sick,” “taking time away from work and hobbies to take care of them,” “contributing to the stability of family life for the parental couple,” and “providing relaxation time for the parental couple by taking care of the grandchildren”. Function 2 was named emotional support for parents due to the high loadings of “I respect the parenting policies of my own children and am involved in my grandchildren’s lives,” “I watch the human development of my own children through child-rearing,” and “I ask myself whether the degree to which I help my children and their spouses with child-rearing is excessive”. Function 3 was named grandchildren’s character development owing to its high loadings for “I help my grandchildren develop lifestyle habits and learn social rules”. “I help my grandchildren learn compassion and patience,” and “I am a good role model for my grandchildren”. Function 4 was named own well-being because of its high loadings for the items “raising grandchildren is one of the things that makes life worth living,” and “being involved in my grandchildren’s lives helps me maintain my own physical strength and youthfulness”. Cronbach’s α coefficients for dimensions 1–4 were 0.91, 0.86, 0.78, 0.81, and 0.86, respectively. The inter-factor correlations are depicted in Table 3.

Table 3: Grandparents’ family function: correlation between factors

TAB 3

Note: Maximum likelihood method: Promax method with Kaiser normalization.

Linear regression analysis of grandparents’ family functions and participants’ characteristics is presented in Table 4. Multiple regression analysis was performed, with grandparents’ family functions as dependent variables and basic attributes as independent variables. All variables were included because there were no variables with r>0.8. The VIFs were all lower than 10.0; therefore, there were no problems with multicollinearity.

Table 4: Comparison of grandparents’ family function and grandparents’ attributes

TAB 4

Notes: SCs: Standardized Coefficients; NSCs: Non-Standardized Coefficients.

Function 1 was significantly affected by grandchildren’s involvement in childcare: (β=0.392, p<0.000), support for the parents (β=0.189, p<0.000), general housework (β=0.181, p<0.000), co-residence (β=0.058, p<0.003), and age (β=-0.048, p<0.009) had a significant effect.

Function 2 was significantly affected by support for their own children: (β=0.203, p<0.000), involvement in raising the grandchildren (β=0.102, p<0.000), age (β=0.056, p<0.017), and the burden of support for their own children (β=-0.066, p<0.009), and gender (β=-0.096, p<0.000).

Function 3 included involvement in childcare (β=0.285, p<0.000), support for the parents (β=0.215, p<0.000), general housework (β=0.144, p<0.000), cohabitation (β=0.074, p<0.001), gender (β=0.067, p<0.002), the burden of general housework (β=0.053, p<0.018), and the burden of support for parents (β=0.048, p<0.028). The burden of general housework (β=0.053, p<0.018), burden of support for parents (β=0.048, p<0.028), and burden of disciplining grandchildren (β=-0.084, p<0.000) had significant effects.

Function 4 was significantly affected by involvement in childcare: (β=0.284, p<0.000), support for parents (β=0.151, p<0.000), general housework (β=0.099, p<0.000), gender (β=0.080, p<0.001), and the burden of childcare (β=-0.146, p<0.000).

Discussion

Characteristics of the Target Population

Over 50% of participants were involved in grandchild-rearing, which is in line with the finding that 53% of Japanese couples receive childcare support from their grandmothers by the time their children are three years old [6] half of grandparents in China [26], and 42-44% of grandparents in Europe and other countries take care of their grandchildren [27]. In the United States, 25% of children under five years of age are in the care. Thus, it can be said that the subjects of this study are a general population.

Furthermore, 64.3% of participants did not live with their grandchildren. In a survey of Japanese people’s perceptions regarding cohabitation, 22% of respondents stated that living apart from their grandparents was preferred, but that living in the same neighborhood as their parents was ideal [28]. This suggests that Japanese people prefer to maintain a moderate distance from their parents. The reason for this may be that, for the parental generation, grandparents provide childcare support when needed, which is beneficial to both the parental and grandparental generations’ psychological health.

Grandparents’ Family Functions

The four family functions of grandparents were extracted: daily care and health care, emotional support for parents, grandchildren’s character development, and own well-being. Shiraishi and Inoue (2017) categorized grandparents’ participation in grandchild care as support for grandchildren’s daily life, support for parents’ daily life, emotional support for parents, and support for grandchildren’s emotional and social needs [29]. The three functions revealed in this study: daily care and health care, emotional support for parents, and grandchildren’s character development were consistent with Shiraishi and Inoue (2017) [29]. According to a survey by the Cabinet Office (2014), 50-60% of the parents’ generation expected grandparents to talk and play with their children and pass on their experiences and wisdom to their children, whereas 40% of the parents’ generation expected grandparents to discipline them in daily life [28]. It has also been demonstrated that grandparents perceive themselves as role models and educators [18-20]. Grandparents play an essential role in the character development of grandchildren even in today’s era of nuclear families [30-36]. In this study, the family functions of grandparents were shown by daily care and healthcare and character formation of grandchildren. It was found that grandparents are involved in the child-rearing policy of the parent couple as emotional support for parents and think about whether the scope of helping the parent couple raise the child is excessive. According to Sumikawa (2016), grandparents state that it is the role of parents to raise their grandchildren and that they are involved in “not intervening too much in the childcare of their grandchildren as grandparents” [31]. Many grandparents tend to play a supportive but non-interfering role, set clear boundaries with the parents to avoid family conflict, respect parental wishes, and ensure family harmony and consistency in parenting [32-35]. The current study shows that emotional support for parents respects the child-rearing policy of parents and couples and protects their personal growth. To enhance the family function of grandparents, it is necessary to discuss in detail the division of roles between parents and grandparents, and midwives need to set up a discussion place for parents and grandparents. The role function of grandparents’ characteristics in this study was “own well-being. Grandparents expressed that raising their grandchildren was one of their purpose in life, whereas that the function of maintaining their own health was to maintain their own health. Grandparents experience a “rejuvenating effect” by being involved in childcare [37]. It was also revealed to result in better physical health [3]. Therefore, assessing the family functions related to the health balance of grandparents themselves will lead to support according to the needs of grandparents.

Factors Affecting the Family Functioning of Grandparents

The four family functions of grandparents were affected by the degree of involvement of grandchildren. Grandparents involved in raising grandchildren scored higher on four factors. Grandparents who did not feel burdened by taking care of their grandchildren recognized that raising their grandchildren helped them maintain their physical strength and youth. For grandparents, raising grandchildren has a positive impact on their health.

Regarding gender differences, grandfathers scored higher on the function of grandchildren’s character development and own well-being, whereas grandmothers scored higher on emotional support for parents. Further, grandmothers were more likely to raise their grandchildren for longer periods [38,39]. Grandparents’ employment status had no significant effect on their family functions. However, compared to those who were unemployed, grandparents working full-time perceived child-rearing as one of their reasons for living, whereas unemployed grandparents perceived that it reduced the time they could spend on work and hobbies. Grandparents who were unemployed held the belief that they respected the child-rearing policies of the parents [40] suggesting that further investigation is needed to determine whether grandparents’ employment influences their functions in the family. Grandparents’ age affected the dimensions of daily care and healthcare and emotional support for parents. Grandparents in their 40s and 50s were more involved in grandchild-rearing, recognizing that grandchild-rearing was one of their reasons for living and that grandchild-rearing was contributing to the family’s quality of life, even though it reduced their time available for work and hobbies [40]. It is assumed that grandparents, especially those who are younger, take on the role of caretakers while also having jobs and hobbies; we speculate that the balance between these two roles may affect grandparents’ family functions. It goes without saying that the closer the physical distance to the grandchildren, the more the family function of the grandparents. This study revealed that grandparents living with their grandchildren scored higher in daily care and healthcare and grandchildren’s character development than grandparents who did not live with them. Those who lived with their grandchildren had more intense parenting responsibilities and burdens, and the pressure to do a good job of raising their grandchildren often caused psychological stress, burnout, frustration, and feelings of being overwhelmed and helpless [19,41,42]. In contrast, grandparents who were only moderately involved in grandchild rearing, enjoyed the traditional laid-back grandparenting role without a sense of obligation to provide childcare [43]. The attitude of grandparents toward raising their grandchildren is that they consider it the responsibility of the parents to raise their grandchildren, but also to be involved when requested, and it is clear that they are responsible for raising their grandchildren in response to the parents’ requests [33,35,40]. Also, even if grandparents do not live with their children and grandchildren, they will watch over and adjust to them to maintain balance and live [44]. Therefore, in order to improve the quality of life of grandparents in their later years, it is necessary to provide support such as education and environment improvement so that grandparents can perform family functions, including maintaining an appropriate distance in preparation for welcoming new grandchildren.

Limitations of the Study and Future Research

This study clarified the family functions of grandparents with infant grandchildren. However, the family functions of grandfathers and grandmothers may be different in other scenarios. In some cases, grandparents responsible for grandchild rearing were at a higher risk of developing health problems and serious medical conditions, such as cardiovascular disease, arthritis, and generalized pain [45,46]. These topics should be explored in future research, as grandparents’ health status may affect their family functions. We also included grandparents with grandchildren aged 1 to 5 years and did not analyze their ages in detail. Grandparents have reported fatigue and lack of rest when caring for younger grandchildren [12,46]. In addition, differences in the choice of grandparents to assume the role of grandparents themselves or as obligations may affect the family function of grandparents [47]. Therefore, it is necessary to clarify the possibility that the burden of the role of grandparents is influenced by the recognition of whether or not they are responsible for raising their grandchildren as a duty.

Conclusions

The survey revealed grandparents’ family functions: daily care and healthcare, emotional support for parents, grandchildren’s character development, and own well-being. Grandparents who did not feel burdened reported that grandchild-rearing was one of their life passions and helped them maintain their own strength and youth. Grandparents’ involvement in raising their grandchildren affected their functions in the family. To enhance their family functions grandparents, it is necessary to assess the four functions of grandparents, support them in maintaining an appropriate distance from their grandchildren and children, and set up a forum for discussion between grandparents and parents.

Acknowledgments

We would like to thank Editage (http://www.editage.com) for English language editing.

Funding

This study was supported by Grant-in-Aid for Scientific Research Fundamental Research (C) under Grant 20K10896.

Competing Interests

The authors declare that they have no competing interests.

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Polynucleotides/Sodium Hyaluronate Ovules for Postmenopausal Vulvovaginal Atrophy and Other Vaginal Environment Disorders

DOI: 10.31038/AWHC.2023624

Abstract

Introduction: Vulvovaginal atrophy, as the most troublesome symptom complex within the more comprehensive clinical picture of Genitourinary Syndrome of Menopause, severely impacts the postmenopausal women’s quality of life, their self-respect as still attractive women, and possibly the women’s couple relationship. The same may happen at a younger age, with vaginal dryness as an occasional side effect of estro-progestin oral contraceptives, hormone-releasing vaginal rings, and other disorders leading to a deranged vaginal environment. Based on a sound rationale, a new medical device based on natural-origin polynucleotides and sodium hyaluronate formulated as vaginal ovuli may help over the long term with those frequent hassles of middle-aged and younger women.

Methods: Design: a survey investigation based on a questionnaire compiled by three investigators familiar with the new vaginal ovuli medical device in their everyday office practice. The investigators completed the survey based on outcomes in 45 ambulatory adult women (≥18 years old). All women had freely consulted the investigators to seek relief from vulvovaginal atrophy symptoms and vaginal dryness as a contraceptive side effect. The minimal inclusion and exclusion criteria helped simulate a real-world office situation. The survey followed a treatment cycle with a Class-III CE-marked medical device (Ovuli PNHA, Mastelli S.r.l., Sanremo, Italy—vaginal ovules with 0.25% polynucleotides, 0.25% non-cross-linked sodium hyaluronate, and 3% polycarbophil as functional ingredients). After the end of the self-administration cycle (one ovule intravaginally per day for two to four weeks), the survey’s goal was to assess the impressions of investigators and their patients about the safety and efficacy (symptom relief, restoration of a healthy vaginal environment) of the medical device in all conditions of vulvovaginal atrophy/vaginal dryness and dystrophic lesions/vaginal environment disorders. The device establishes a protective, moisturizing, and pH-controlled lubricating film onto the cervix and vaginal mucosa and promotes its physiological regenerative and reparative mechanisms. Assessment tools at baseline and after the end of the treatment cycle: Vaginal Health Index score (validated investigator-assessed five-item scale, with scores ranging from 5 to 25 and <15 as dryness and atrophy score threshold); subjective VVA symptom severity (vaginal dryness, vulvovaginal irritation/itching, vulvovaginal soreness, dyspareunia) assessed by the patients with the support of a series of five-point VAS scales (0=absent, 1=mild, 2=moderate, 3=severe, 4 = very severe).

Results: The surveyed investigators stated that the mean total VHI score significantly improved over the follow-up period, from 2.5 ± 0.94 to 3.6 ± 0.85 (p <0.001 vs. baseline). The mucosal thickness and integrity, showing severe or very severe atrophy in 13 surveyed women at baseline, presented no more than some mild atrophy in 91.1% of women, with 35.6% of surveyed women reverting to complete restitutio ad integrum. Vaginal dryness also markedly decreased from baseline, with 79% of cohort women improving to mild atrophy or symptom clearance and 21% reverting to restitutio ad integrum. Regarding the subjective symptom relief, the surveyed women reported a highly significant reduction of the mean total VAS score — cumulatively accounting for vaginal itching, vaginal burning, vaginal pain, pain/discomfort during intercourse, and vaginal dryness — from 3.5 ± 0.70 to 2.1 ± 0.73 (p <0.001 vs. baseline). The occasional mild local pain and irritation were of no clinical significance and rapidly transitory.

Conclusions: The novel formulation of polynucleotides and sodium hyaluronate as vaginal ovules efficiently counteract the symptom complex due to vulvovaginal atrophy in postmenopausal women, including younger women with contraindications for estrogen therapy and vaginal dryness as a contraceptive side effect. The study confirms that PNs, in synergy with hyaluronic acid, retain their innovative potential as non-pharmacological activators of physiological regenerative and reparative processes in vulvovaginal tissues. The study also confirms the novel device’s safety and the women’s compliance with treatment.

Keywords

Dyspareunia, Hyaluronic acid, PNHA ovules, Polynucleotides, Vaginal dryness, Vulvovaginal atrophy

Introduction

The role of 17ß-estradiol in so many cellular pathways regulating vulvovaginal cell growth, barrier functions, and cell proliferation and trophism explains why menopausal hypoestrogenism may have a grievous impact on middle-aged women [1]. Unfortunately, women in advanced countries may expect, on average, to live more than three decades in postmenopausal condition, and about 27% to 84% of them will experience the most troublesome vulvovaginal atrophy (VVA) symptoms [2]. Severe vulvar irritation and burning, compromised vaginal lubrication with discomfort or frank dyspareunia during sexual activity, vaginal discharge, dysuria, and recurrent urinary tract infections may thus be unwelcome companions for many years. The consequences for daily living activities are dire for 75% of symptomatic women, according to the outcomes of the “Vaginal Health: Insights, Views & Attitudes” (“VIVA”) online survey of 3,520 postmenopausal women in six countries [3-6].

Combined with hyaluronic acid (HA), highly purified DNA polynucleotides (PNs), purified from male salmon trout gonads, already showed to improve genital atrophy, VVA symptoms, and the disrupted sexual life and couple relationship of menopausal women [7-11]. PNs showed a powerful restructuring effect on local connective tissues after infiltration in the dermis and tonaca propria of vulvovaginal tissues [9,10]. PNs act non-pharmacologically by progressively releasing small nitrogen precursors (nitrogen bases, nucleosides, nucleotides) in vulvovaginal tissues and showing persistent moisturizing effects.7 Now, a new handy medical device formulation of natural-origin PNs and strongly hydrating HA as vaginal ovuli (formulation henceforth labeled PNHA) promises to extend their combined benefits to other troubling vaginal environment disorders. Examples are the younger women’s vaginal dryness and dyspareunia occasionally observed as adverse effects of estro-progestin oral contraceptives, birth control vaginal rings releasing hormones, and especially progesterone-only contraceptive methods [12-14].

The paper reports on the outcomes of a retrospective survey centered on a questionnaire prospectively administered by the investigators, all gynecologists, to some of their patients who spontaneously sought help and office treatment for problems of menopausal vulvovaginal atrophy (VVA). Some younger women sought relief for their vaginal dryness as a side effect of estro-progestin oral contraceptives or birth control hormone-releasing vaginal rings.

All investigators already used the investigated PNHA device as described in the approved product information leaflet (IFU)-one PNHA ovule daily [15]. The survey study, performed after two to four weeks of everyday use of the intravaginal medical device, was the first within a long-term monitoring program of the device’s persistent efficacy and profile of known side effects and contraindications. Identifying unknown side effects or emergent risks was another purpose of the study and the ongoing long-term monitoring program. Resorting to real-world data, independently from the rigid inclusion and exclusion criteria of randomized clinical studies with their highly selected patient samples, is the clue that supports the clinical value of the investigation in daily practice.

Methods

Study Design

Conceived as a single-arm ambulatory cohort investigation of adults of both genders who had spontaneously sought specialist help for postmenopausal vaginal environment problems and vaginal dryness as a side effect of estro-progestin oral contraceptives and birth control hormone-releasing vaginal rings. Before the survey, following the investigators’ prescription, all individuals had self-administered, at home in a real-world setting, the monitored Class-III CE-marked medical device (Ovuli PNHA, Mastelli S.r.l., Sanremo, Italy: vaginal ovules with 0.25% polynucleotides, 0.25% non-cross-linked sodium hyaluronate, and 3% polycarbophil as functional ingredients). Dose and self-administration period: one ovule intravaginally per day for two to four weeks as stated in the approved product information leaflet (IFU) [15].

After the last ovule domiciliary self-administration, the survey, completed by the investigators, was purely observational with no active intervention. All subjects agreed to submit to the survey after being informed about its goals. Beyond monitoring the efficacy and safety outcomes, the reasons for vaginal treatment were also registered. Questionnaires allow information collection without time constraints for the investigator to answer questions thoroughly, faithfully, and more quickly than face-to-face interviews.

The office-based survey study respected the Helsinki Declaration and Good Clinical Practice principles. All study materials, which included informed consent forms and questionnaires, were preliminarily peer-reviewed for ethical problems.

Observational Efficacy Assessments

Primary Efficacy Endpoint

Relieving objective signs and restoring the healthy vaginal state is paramount in managing vulvovaginal atrophy and disorders of the vaginal environment. The improvement of vaginal signs and symptoms from baseline, evaluated by the investigators with the help of the validated Vaginal Health Index, was the observational primary efficacy endpoint (assessment: total VHI score change from baseline after the last PNHA-based vaginal ovule). First described in 1995, the VHI is a five-point investigator-assessed scoring scale extensively used in clinical trials, which considers the lack of mucosal moisture, vaginal elasticity and volume of vaginal secretions, intravaginal pH, and the evidence of vaginal petechiae and bleeding (Table 1 [16,17]. The ranges of VHI subscale scores are 1 = none, 2 = poor, 3 = fair, 4 = good, and 5 = excellent, with the total VHI score between 5 and 25. Total VHI scores below 15 signal vaginal atrophy [15]. The unimodal symmetric distributions of outcomes on five-point Likert-like assessment tools like the VHI subscales minimize the statistical liability of skewed J- and U-shaped distributions; outcomes assessed on five-point scales also have lower means, floor, and ceiling effects. At the same time, the regression analysis shows that these scales explain a significant fraction of the variation in floor and ceiling effects while minimizing the contribution of unknown factors [16].

Table 1: Vaginal Health Index (Bachmann et al.); * Lower scores: progressively more severe atrophy [16]

Score

Overall elasticity *

Secretions type and consistency

pH

Mucosal epithelium

Moisture

1 None None 6.1 Petechiae noted before contact None; mucosa inflamed
2 Poor Scant, thin yellow 5.6−6.0 Bleeds with light contact None; mucosa not inflamed
3 Fair Superficial, thin white 5.1−5.5 Bleeds with scraping Minimal
4 Good Moderate, thin white 4.7−5.0 Not friable, thin mucosa Moderate
5 Excellent Normal (white flocculent) ≤4.6 Not friable, normal mucosa Normal

Secondary Efficacy Endpoint

Subjective assessment by patients of symptom severity (vaginal dryness, vulvovaginal irritation/itching, vulvovaginal soreness, dyspareunia) with the support of a series of impromptu five-score Visual Analog Scales (henceforth VAS, 0=absent, 1=mild, 2=moderate, 3=severe, 4 = very severe) [18].

Safety

Based on spontaneous reporting over the whole study period. The questionnaire included closed and open questions to identify known side effects, describe their clinical presentation, severity, and duration, and detect any previously unknown adverse event.

Statistics

The sample size estimation took advantage of the G*Power statistical program version 3.14 [19]. The estimate, after a literature review of the efficacy of comparable products, was based on a fictional cumulative VAS symptom score and a conservative assumption of the mean cumulative VAS symptom score at the end of the treatment course (60% improvement). Under these assumptions, the statistical power (two-tailed) to detect a significant difference in a treatment cohort of at least 42 women would have minimized the risk of false-negative type II errors (ß-risk = 0.92).

Descriptive statistics: tabulated as means ± standard errors of the mean (SEM). Inferential statistics: mean total VHI score and subscores as primary efficacy parameter and self-assessed symptom severity VAS scores as secondary efficacy parameter: non-parametric Wilcoxon test [18]. All statistical analyses, two-tailed with a 5% significance level, were performed with the StatPlus analysis program Version v7 [20].

Results

The three participating clinical investigators, all experienced gynecologists already prescribing the PNHA vaginal ovules, enrolled 45 ambulatory menopausal and non-menopausal women with VVA symptoms. All women completed the study fully compliant with the protocol and domiciliary vaginal ovule self-administration with only a few transitory and mild local adverse effects and without dropouts. Table 1 illustrates the women’s demographics, menopausal or non-menopausal conditions, and previous use of estrogens. The subgroup of menopausal women had been in menopause for a range of 2 to 30 years and had experienced VVA symptoms for periods ranging from 1 month to 20 years (Figure 1). Often together with oral or topical estrogens, 16 cohort women (35.6%) had used other topical and parenteral formulations and techniques to counter their VVA symptoms—other injectable polynucleotide and hyaluronic acid gels, hyaluronate topical formulations, vaginal moisturizers, lubricants, and electroporation and radiofrequency biostimulation procedures.

Table 1: Women’s demographics, menopausal condition, and oral and topical estrogen use. SEM: Standard Error of the Mean.

Age Mean ± SEM (years) 55.4 ± 10.29
Median (years) 56
Range (years) 25-74
Menopause Yes (%) 29 (64.4)
Years in menopause ± SEM 9.2± 6.64
Years with VVA symptoms ± SEM 6.6 ± 5.46
No (%) 16 (35.6)
Oral estrogens Yes (%) 7 (15.6)
No (%) 38 (84.4)
Topical estrogens Yes (%) 5 (11.1)
No (%) 46 (88.9)

FIG 1

Figure 1: Years with VVA atrophy symptoms in the 45-strong women’s cohort

At baseline, the VVA symptoms appeared to severely affect the women’s sexual life, with 31 menopausal and non-menopausal women (68.9%) reporting reduced sexual activity with decreased sexual interest and desire in 27 (60.0%).

The VVA signs and symptoms which most commonly induced the investigators to prescribe the PNHA intravaginal ovules were, in decreasing frequency, vaginal dryness (80% of cohort women), vaginal burning (40% of women), vaginal itching (37.8% of women), vaginal pain (31.1% of women), often during intercourse (24.4% of women), and vaginal bleeding during intercourse (15.6% of women). Symptoms co-existed very commonly. Previous genital surgery and dysuria were other significant reasons for prescribing the PNHA ovules (6.7% and 2.2% of women, respectively).

Efficacy

At baseline, the mean VHI score was 12.68, beyond the VVA threshold, while the mean total VHI score (mean of all VHI subscale scores) was 2.5 ± 0.94, once again describing a severe VVA picture. Figure 2 shows the highly significant improvement in the mean total VHI score at the study end compared with baseline, although always with some persisting atrophy signs and symptoms. Figure 3 analytically illustrates the improvements vs. baseline for each VHI subscore after treatment with the PNHA ovules.

FIG 2

Figure 2: Mean total Vaginal Health Index scores (± standard errors of the mean); **p<0.001 vs. baseline

FIG 3

Figure 3: Mean VHI subscores (± standard errors of the mean); **p<0.001 vs. baseline

Looking more in detail into the mucosal thickness and integrity (Figure 4), the ultimate basis for bleeding and other symptoms, thirteen women showed severe or very severe atrophy of the vaginal epithelium at baseline (scores: 1 or 2); after the topical PNHA treatment, 91.1% of women showed no more than a condition of mild atrophy (scores: 4 or 5), with 35.6% of them reverting to complete restitutio ad integrum (score: 5).

FIG 4

Figure 4: Percent of cohort women with compromised vaginal mucosal thickness and integrity of variable clinical severity (scores 1 to 5) at baseline and end-of-treatment assessment visits.

Regarding the clinical severity of vaginal dryness, the most bothersome and frequently reported symptom of atrophy, it also markedly decreased from baseline in all cohort women (Figure 5), with 79% of them improving to a condition of mild atrophy or symptom clearance (scores: 4 or 5), and 21% of them reverting to complete restitutio ad integrum (score: 5).

FIG 5

Figure 5: Percent of cohort women who reported vaginal dryness of variable clinical severity (scores 1 to 5) at baseline and end-of-treatment assessment visits.

Safety

The investigators and treated women invariably deemed the procedure manageable and handy without unexpected technical difficulties, troubles, and discomfort. The repeated insertion of the PNHA ovules was well tolerated, with a few transitory and mild local adverse effects—local burning in 15 cohort women (mild 31.8%, moderate 2.3%), vulvovaginal itching in 16 women (mild 31.8%, moderate 4.5%), and local discomfort in 19 women (mild 36.4%, moderate 6.8%). According to investigators, two women reported some mild vaginal blood losses, which disappeared in 6 to 10 days and were unrelated to the PNHA topical treatment. There were no unexpected technical difficulties. The few transitory and mild local adverse effects (local burning, vulvovaginal itching, and local discomfort) were of no clinical significance. They resolved spontaneously in a few hours without further therapy. There were no unexpected side events or complications (Figures 6 and 7).

FIG 6

Figure 6: Mean total symptom VAS scores (± standard errors of the mean); **p<0.001 vs. baseline

FIG 7

Figure 7: Mean VAS scores (± standard errors of the mean) for some representative symptoms; **p<0.001 vs. baseline.

Discussion

Real-world investigations aim to provide reliable insights into conditions analogous to everyday clinical practice [21]. Within a long-term monitoring program, the PNHA vaginal ovule formulation confirmed its efficacy and lack of unknown and troublesome side effects with once-daily dosing in menopausal VVA and other non-menopausal and post-surgical disorders with vaginal dryness and other symptoms, as stated in the Information for Use leaflet.

In this first step of the ongoing real-world, long-term monitoring program of the once-daily PNHA vaginal ovule medical device, the formulation proved to be effective with no intolerably bothersome side effects in vulvovaginal atrophy and other menopausal and non-menopausal or post-surgery disorders.

The phenotypic expression of postmenopausal vulvar involution — depletion of labia majora adiposity, blundering of interlabial sulci, loss of pigmentation and hair, reduced density of sweat and sebaceous production, preputial retraction with clitoral exposure and chronic irritation, and overall dysfunction of the vaginal ecosystem — and related symptoms are a burden on the woman’s self-confidence and self-image. Microscopically, the fragmentation and fusion of elastin fibers, collagen hyalinization, and extracellular matrix depletion are the markers of the VVA picture [2,22]. Moreover, vaginal dryness is a frequent side effect of estro-progestin oral contraceptives and hormone-releasing vaginal rings in up to 12.7% to 30.4% of women after three menstrual cycles, especially with preparations with the lowest synthetic estrogen content [23].

The hydrophilic polynucleotide polymers of the PNHA formulation reorganize in vulvovaginal tissues into a three-dimensional gel that binds water with a moisturizing and volume-increasing effect that synergizes with the potent HA hydrating effect [7-11]. Over the longer term, the polynucleotide component of the PNHA device passively replenishes the fibroblast pool of nitrogen bases, nucleosides, and nucleotide precursors and supports the dermal fibroblast viability, thus facilitating the production of new collagen fibers—the rationale for exploring the PNHA option to antagonize the menopausal and non-menopausal VVA and vaginal dryness [7-10].

The survey study had two main problems: compensating for the lack of a control group and the ß-risk of failing to detect a significant difference in semiquantitative scores, compared with baseline, at the end of the self-administration at home. However, the impressive efficacy outcomes reported by surveyed investigators and women are unlikely to be incidental findings and likely compensate for the first bias. Moreover, the cohort size of the enrolled women, more numerous than what was estimated to reduce to almost zero the ß-risk under the conservative assumption of a 60% efficacy, compensated for the second bias.

All surveyed clinical signs and symptoms showed highly significant improvements over the follow-up period, demonstrating that the newly introduced PNHA ovules are an effective option in all forms of vaginal atrophy, independently of cause. The clinically meaningful relief of VVA objective signs was not associated with more than some occasional undefined discomfort and mild burning of no clinical significance.

In conclusion, improving VVA-related objective signs means that the novel PNHA vaginal ovule medical device is an effective, safe, and well-tolerated non-hormonal therapeutic option in postmenopausal women with VVA and all women unwilling or unable to consider estrogen therapy. In general, the new PNHA device appears effective, independently of age, in all situations of vaginal dryness and a deranged vaginal environment for whatever cause.

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Destructive Complicated Polyonychomycosis and Nail Incarnations: Peculiarities of Interventions, Author’s Views on Complex Treatment of Patients with Comorbid Background Pathology, Diabetes Mellitus

DOI: 10.31038/JCRM.2023621

Introduction

Surgical onychopathology includes a group of nosological forms of purulent-necrotic and mycotic-associated lesions of the nail phalanx, nail and peri-nail tissues, epidermophytia of the feet occupies one of the prominent places among pathological skin lesions; poses a risk of spreading to patients with diabetes due to high contagiousness, frequency of various complications; leads to a violation of the quality of life. Onychomycotic lesions are macroscopically classified into superficial mycosis, proximal and distal-lateral onychomycosis, onychocheilosis, subungual hyperkeratosis, and onychogryphosis. Pathological changes in the nail plate of the foot in patients with diabetes are often combined: hypertrophy and onychogryphotic deformation of the nail (in the form of an eagle’s or vulture’s beak) with its secondary growth, which is combined with the presence of dermatophytes (trichophytes, onychomatrichoma), pathological layering on the nail bed (brown color with destruction, disintegration) and the formation of multiple purulent bacterial-mycotic foci with abscessation. Complex treatment of patients with severe fungal lesions, complicated destructive onychomycosis with multiple nail lesions, onychogryphosis with incarnation, in particular in patients with diabetes, determines the removal of nail plates and the use of antifungal therapy, correction of background vascular pathology and is an urgent problem of outpatient surgery and dermatology. Some aspects of epidemiology, etiology, pathogenesis of onycheal and subungual pathology, macroscopic types of lesions, risk factors and cases of nail incarnations – ingrown nail (IN), localization, frequency of occurrence and causes of purulent onychia, paronychia, other complications and recurrences. In our previous publications, the effectiveness of various methods of surgical interventions, isolated and in combination with other methods of complex treatment, features of the postoperative period in isolated and combined lesions, in particular complicated destructive polyonychomycosis (UDP), were analyzed. It has been established that conservative and orthopedic treatment of IN and other mycotic surgical lesions of nails are not very effective, while the main methods are Dupuytren’s nail removal, Emmert-Schmiden operation, etc. in 2-20% of cases (depending on the absence or presence of onychocryptosis and associated fungal lesions) cause relapses. Complicated mycotic lesions and HF in patients with diabetes are a special problem.

The goal of the work is to improve the implementation of interventions, comprehensive treatment of patients with complicated polyonychomycosis with comorbid background pathology, diabetes and to implement an original method of elimination of UDP – hyperkeratosis and onychogryphosis with nail incarnation – secondary nail growth, in particular in patients with diabetes to optimize early and long-term results.

Materials and Methods

In the 4th City Clinical Hospital of Lviv and MC “Salyutas”, the prospective material for a 10-year period was 496 cases of destructive onychomycosis complicated by secondary nail incarnation, of which 320 were men and 176 were women. The age of the operated patients is from 35 to 72 years. The main group consisted of 325 patients – 172 men and 153 women aged 43-68 years. The control group included 171 cases of onychodestruction that were treated according to “classical” schemes. All subsamples were statistically similar and comparable in terms of age and gender composition. Imperfect surgical techniques account for more than half of the causes of relapses, including cases of IN with subungual hyperkeratosis or onychogryphosis, χ2=20.13, p=0.01. The highest frequency of repeated INs among the technical reasons for recurrence was observed in unjustified refusal of partial matrixectomy – 19.8% and with traumatic mobilization/removal of nails (traumatic onychectomy). The hallux of the left foot was most often affected – in 48.85%, the right – in 33.26%, the presence of IN of both hallux was found in 17.89% of patients. In 18.8% of the sample, onychocryptosis occurred against the background of obliterating diseases of the arteries of the lower extremities: atherosclerosis in 13.76% and diabetes in 15.05%. All surgical interventions in outpatient conditions were performed under adequate anesthesia. The Mann-Whitney U-test, χ2-test (V-square), χ2-test with Yates’ correction for continuity, Fisher’s exact test (Fisher exact p). We determined the χ2 degree of influence of the studied phenomenon (etiological factor, morphogenetic mechanism) on the development of nail plate incarnation and other complications. “Classical methods” of descriptive statistics were also used, with a confidence interval of 95%, calculations were performed on licensed software. The study meets the requirements of bioethics.

Results and Discussion

We have researched clinical variants and peculiarities of the course of the pathological process, confirmed the optimal methods of surgical intervention, their phasing and the terms of complex treatment of complicated, combined mycotic processes and recurrences of reincarnations of nail plates and lesions of the nail structures. Adjuvant systemic three-day antimycotic pulse therapy with daily intake of 400 mg of itraconazole was applied for three days prior to interventional/operative treatment. The peak frequency of mycotic lesions with HF occurred in the subsamples of people aged 40-50 years and in people aged 50-60 years. Pathological incarnations of mycotically altered nail plates were characteristic of trichophytosis in elderly patients. It has been claimed that the free lateral edges of the nail with UDP due to the lifting of its central part by hyperkeratosis are “undermined”, compressing perieponycheal tissues and eponychia. We used the following methods of surgical treatment. “Classic” removal of VN (Dupuytren’s operation) was performed in 64 people (12.90%), en bloc eponychectomy (excision of pathologically changed eponycheal tissues) + nail removal through onycholised structures (low-traumatic) + dermatophytoma resection + partial matrixectomy + eponycheoplasty – in 57 others cases (11.49%), nail removal through onycholised structures (low-traumatic) – in 51 (10.28%), “classic” nail removal + excision of pathologically changed eponycheal tissues – in 43 (8.66%), en bloc eponyhectomy ( excision of pathologically changed eponycheal tissues) + nail removal through onycholated structures (low-traumatic) + resection of dermatophytoma + partial matrixectomy – in 40 (8.04%) block-like eponychectomy + nail removal through onycholised structures (less traumatic) + partial matrixectomy – in other 8 (1.61%) patients. Thus, removal of ingrown nails was used in all cases, of which 64 people (12.90%) had Dupuytren’s nail removal without anti-relapse supplements, extended ablation with excision of dermatophytoma – in other 57 cases (11.49%). In the vast majority of patients (87.1% of the sample), surgical treatment of UDP with VN with anti-recurrence components was applied – two- or three-component, supplemented by excision of pathologically changed eponycheal tissues or (and) mechanical abrasion or (and) coagulation partial matrixectomy. Patients with diabetes accounted for 17% of the sample and were adequately represented in the main and control groups and in the clinical subsamples.

In patients with type 2 diabetes, probable strong positive correlations were recorded between all indicators of carbohydrate metabolism: glucose with insulin (r=0.52; p<0.01), with the NOMA index (r=0.69; p<0.01), with glycosylated hemoglobin (r=0.76; p<0.001); insulin with NOMA index (r=0.74; p<0.01) and glycosylated hemoglobin (r=0.65; p<0.01); NOMA index with glycosylated hemoglobin (r=0.69; p<0.01). We proposed and implemented a method of removing affected nail plates in patients with UDP, in particular, in the presence of trichophytic nail hyperkeratosis, polyonychogryphosis. This method is applied and has proven itself positively in diabetic patients with purulent / incarnate lesions associated primarily with Tr. Rubrum infection.

After applying a tourniquet to the base of the finger, preparing the operating field and anesthesia, stepping back from the proximal edge of the onychogryphous nail by 2-3 mm, we perform a linear dissection of the soft tissues medially retronycheally to the nail plate, which is extended to the medialeponycheal ridge, cutting out pathologically changed medial eponycheal tissues in a block-like manner. We continue the medial dissection distally and linearly down 5 mm on the finger bundle. The remains of the medial eponycheal tissues are separated from the medial edge of the onychogryphous nail with a pedicure spatula for an ingrown onychogryphous nail, a blade of a sterile pedicure tool PE-60/1 (an inclined manicure file with a blade). We visualize the medial edge of the onychogryphous nail and conduct a visual macroscopic assessment of it for the presence of deformations, delaminations, indentations, foci of hyperkeratosis. Similarly, retreating from the edge of the onychogryphous nail by 2-3 mm, we perform a lateral retronycheal linear dissection of the soft tissues to the nail plate, which we extend tolateral eponycheal ridge, cutting out pathologically changed lateral eponycheal tissues en bloc. We continue the lateral dissection distally and linearly down 5 mm on the finger bundle. The remains of the lateral eponycheal tissues are separated from the lateral edge of the onychogryphous nail with a pedicure spatula for an ingrown onychogryphous nail, the blade of a sterile PE-60/1 pedicure tool (an inclined manicure file with a blade). We visualize the incarnated lateral edge of the onychogryphous nail and conduct a visual macroscopic assessment of it for the presence of deformations, delaminations, serrations, foci of hyperkeratosis. Under the distal corner of the onychogryphous nail, in the area of the smaller incarnation, through the onycholized structures between the nail plate and the nail bed in the proximal-lateral direction, we insert the ax-shaped tip of the sterile nail blade PE-10/2 (with a rounded pusher with an ax-shaped raspator), the sterile pedicure tool PE-60/1, with which we gradually mobilize the nail plate with pendulum-like movements to the germinal zone and the proximal edge of the onychogryphous nail, gradually removing hyperkeratoid masses by scraping with a sterile PE-10/2 manicure spatula and a small Volkmann spoon, mobilizing and lifting the nail plate. We insert the blade of a sterile PE-30/4 manicure tool (a rounded pusher with a bent blade) into the formed channel, which completes the mobilization with pendulum-like movements. We introduce the straight blade of a PE-30 sterile manicure tool (a rounded pusher with a straight blade) with which in the proximal-contralateral direction we finally separate the mycotically changed thickened incarnate nail plate en block with the main mass of hyperkeratotic masses, grab it with a sterile Kocher clamp and remove it. With the ax-shaped tip of the sterile manicure blade PE-10/2 (rounded pusher with ax-shaped rasp) and the bent blade of the sterile manicure tool PE-30/4 (rounded pusher with bent blade), we gradually isolate from the eponycheal canals and the nail bed and mobilize in the distal direction the remnants of hyperkeratoids masses and dermatophytomas, which are also captured en block with a sterile Kocher clamp and removed. We clean the nail bed and eponycheal canals from the remnants of exfoliated epidermal structures. We clean the sinuses and eponycheal canals with a Volkmann spoon and a sterile pusher. We perform a revision of the medial and lateral edges of the wound for the tactile detection of the remaining fragments of the jagged edges of the onychogryphous nail. After devulsion of the remnants of eponycheal tissues in the area of incarnation of the onychogryphous nail with the bent blade of a sterile manicure tool PE-30/4, the remaining incarnate fragments of the nail plate are captured under visual and tactile control and removed with a Mosquito-type clamp. we perform bilateral partial marginal matrixectomy with longitudinal mechanical excision and diathermocoagulation of the germ zone and matrix of the onychogryphous nail in the areas of incarnations. Coagulated detritus is cleaned by scraping with the tip of a PE-60 sterile pedicure paddle. The sinuses, eponycheal canals and nail beds are cleaned with a Volkmann spoon and a sterile pusher. We clean the wound three times with a 3% solution of hydrogen peroxide and an aqueous solution of povidone iodine. After repeated devulsion of the remains of the eponycheal tissues with the blade of the PE-60/1 sterile pedicure tool, the eponycheal channels are filled with tampons made of iodoform gauze, keeping the remains of the eponycheal tissues removed. The central part of the wound is filled with povidone-iodine liniment, tightly tamped with gauze swabs under visual control. We remove the tourniquet from the base of the finger. Apply an aseptic bandage. We clean the wound three times with a 3% solution of hydrogen peroxide and an aqueous solution of povidone iodine. After repeated devulsion of the remains of the eponycheal tissues with the blade of the PE-60/1 sterile pedicure tool, the eponycheal channels are filled with tampons made of iodoform gauze, keeping the remains of the eponycheal tissues removed. The central part of the wound is filled with povidone-iodine liniment, tightly tamped with gauze swabs under visual control. We remove the tourniquet from the base of the finger. Apply an aseptic bandage. We clean the wound three times with a 3% solution of hydrogen peroxide and an aqueous solution of povidone iodine. After repeated devulsion of the remains of the eponycheal tissues with the blade of the PE-60/1 sterile pedicure tool, the eponycheal channels are filled with tampons made of iodoform gauze, keeping the remains of the eponycheal tissues removed. The central part of the wound is filled with povidone-iodine liniment, tightly tamped with gauze swabs under visual control. We remove the tourniquet from the base of the finger. Apply an aseptic bandage. tightly tampon with gauze tampons under visual control. We remove the tourniquet from the base of the finger. Apply an aseptic bandage. tightly tampon with gauze tampons under visual control. We remove the tourniquet from the base of the finger. Apply an aseptic bandage.

In the presence of polyonychomycosis with damage to more than 4 nail plates and damage to other structures of the foot (hand), surgical rehabilitation is divided into several stages. No more than four nail plates were removed simultaneously. In the case of other mycotic-associated pathology, no more than two simultaneous interventions were performed at the same time and no more than three nail plates were removed. The sequence of surgical interventions was selected according to their urgency. Nail plates affected by subungual hyperkeratosis were mobilized from the nail bed through hyperkeratoid masses and onycholated structures by a blunt approach to the retronycheal (posterior nail) ridge with fixation by the distal edge of the secondary VN, onychectomy was performed. A bare nail bed with remnants of hyperkeratoid layers and dermatophytomas in the distal part and hyperkeratoses near the eponycheal structures was visualized, which were removed by scraping, additional sanitation with a Volkmann spoon. Antimycotic pulse therapy was continued for the next 4 days of the postoperative period with daily intake of 400 mg of itraconazole. The remaining mycotically changed areas of the nails are cleaned daily with ciclopirox-containing antimycotic varnishes in order to prevent re- or mixed infection, as well as to prevent further fragmentation of the nails. In addition, three 7-day courses of pulse therapy with daily intake of 400 mg of itraconazole with a 10-day break between them were applied. In patients with existing obliterating lesions of the arteries of the lower extremities and in patients with diabetes, planned stages of surgical rehabilitation were performed only after complete epithelization under the guise of a course of vasodilator therapy. Dressings were performed every other day with treatment of surgical wounds with povidone iodine solution (until complete epithelization of wounds) and application of terbinafine liniment (until complete regrowth of nails) with sanitation of other remaining (unremoved) nails by applying antimycotic varnish every other day for 3 months. The last anti-recurrence course of UDP pulse therapy with itraconazole was carried out after the complete surgical rehabilitation of VN and polyonychomycosis. In patients with UDP and VN of the main group, in particular, in 57 patients with diabetes, in which the nail plates were removed due to onycholised structures, the healing time (crushing) of surgical wounds was 11-20 days (the average duration of healing – 16 days), in the control group – 15-25 days (the average duration of healing – 21 days); that is, in patients with UDP who underwent onychectomy due to onycholised structures, the healing time of onychectomy wounds was shorter. Good effectiveness of complex treatment was established in 284 patients of the main group (87.38%) and in 141 cases of the control group (82.46%). In general, a positive effect from the use of combined therapy with itraconazole and staged surgical removal of mycotically affected nails was confirmed in 425 patients (85.69%). who underwent onychectomy through onycholated structures, the healing time of onychectomy wounds was shorter. Good effectiveness of complex treatment was established in 284 patients of the main group (87.38%) and in 141 cases of the control group (82.46%). In general, a positive effect from the use of combined therapy with itraconazole and staged surgical removal of mycotically affected nails was confirmed in 425 patients (85.69%). who underwent onychectomy through onycholated structures, the healing time of onychectomy wounds was shorter. Good effectiveness of complex treatment was established in 284 patients of the main group (87.38%) and in 141 cases of the control group (82.46%). In general, a positive effect from the use of combined therapy with itraconazole and staged surgical removal of mycotically affected nails was confirmed in 425 patients (85.69%). In patients on the background of adjuvant systemic antimycotic treatment with daily pulse therapy of 400 mg of itraconazole, operative treatment of UDP with VN through onycholated structures with the use of podological pedicure instruments, supplemented by excision of pathologically changed eponycheal tissues, mechanical and coagulation partial matrixectomy, was applied to patients, this method can be recommended for the elimination of affected nails in patients with diabetes and obliterating lesions of the vessels of the lower extremities, as well as in patients with other vascular and/or neurotrophic pathology, elderly patients. The applied treatment scheme made it possible to achieve clinical and mycological recovery in 83.33% of the subsample. The achieved good result of the treatment was primarily determined by the peculiarity of the surgical approach, χ2=48.25, p<0.01.

The presence of foci of onycholysis and disintegration of areas of hyperkeratosis, which leads to detachment of part of the nail plate (χ2=15.23, p=0.0211), especially in elderly patients with background endocrine pathology – diabetes, justifies the feasibility of performing a minimally traumatic onychectomy. Patients with onychomycosis associated with secondary incarnation of the nail have a total hypertrophic fungal lesion with the formation of subungual hyperkeratosis or onychogryphosis (χ2=20.41, p=0.01) and subonycheal dermatophytoma, which complicates the mobilization and surgical removal of affected nails. Good effectiveness of the proposed treatment was established in 284 patients of the main group (87.38%) and in 141 cases of the control group (82.46%). In general, a positive effect from the removal of mycotically affected nails was confirmed in 425 patients (85.69%).

The Obtained Research Data Prove That

The author’s developed methods of surgical interventions, based on low-traumatic mobilization and resection/removal of affected nails through onycholated structures, determine a decrease in intraoperative damage to the nail bed (χ2=20.13, p=0.01), reduce the risk of mycotic contamination of other adjacent structures (χ2=27.41, p=0.01); are characterized by a decrease in the intensity of pain (χ2=48.32, p=0.01), a statistically significant increase in the speed of wound healing, the Popova index (χ2=32.14, p=0.01), an improvement in the results of complex treatment and the quality of life of patients. In the postoperative period, we apply dressings with antiseptics, antifungal (antimycotic) ointments and varnishes until the nail(s) grow back completely, according to indications – adequate systemic antifungal therapy. Partial marginal matrixectomy ensures the absence of growth of the nail plate in the area of resection, narrowing the nail and preventing its re-incarnation. Adequate classification criteria of purulent-necrotic complications of onychomycosis are proposed with the selection of the main types of lesions, in each of which clinical variants are differentiated according to the severity of morphological changes, which are of practical importance for the sequence of removal of affected nails. It is claimed that the use of minimally invasive nail removal helps to accelerate the elimination of the fungus and the healing of wounds, improve the results of complex treatment and the quality of life of patients. Adequate classification criteria of purulent-necrotic complications of onychomycosis are proposed with the selection of the main types of lesions, in each of which clinical variants are differentiated according to the severity of morphological changes, which are of practical importance for the sequence of removal of affected nails. It is claimed that the use of minimally invasive nail removal helps to accelerate the elimination of the fungus and the healing of wounds, improve the results of complex treatment and the quality of life of patients. Adequate classification criteria of purulent-necrotic complications of onychomycosis are proposed with the selection of the main types of lesions, in each of which clinical variants are differentiated according to the severity of morphological changes, which are of practical importance for the sequence of removal of affected nails. It is claimed that the use of minimally invasive nail removal helps to accelerate the elimination of the fungus and the healing of wounds, improve the results of complex treatment and the quality of life of patients [1-14].

Conclusions

For patients with destructive complicated polyonychomycosis, in particular, in the presence of secondary growths against the background of comorbid pathology, in particular, background diabetes, we have developed original methods of surgical interventions based on minimally traumatic mobilization and resection/removal of affected nails through onycholated structures, which determine the reduction of intraoperative damage to the nail bed, (χ2=20.13, p=0.01), reduce the risk of mycotic contamination of other adjacent structures (χ2=27.41, p=0.01); are characterized by a decrease in the intensity of pain (χ2=48.32, p=0.01), a statistically significant increase in the speed of wound healing, the Popova index (χ2=32.14, p=0.01), an improvement in the results of complex treatment and the quality of life of patients. In patients with incarnate onychomycosis, there is the formation of subungual hyperkeratosis or onychogryphosis and dermatophytoma, which complicates the mobilization and surgical removal of affected nails. In our clinic, in the complex treatment of complicated and combined fungal onychodestructions, we use minimally traumatic removal of nail plates in their destructive onychomycotic lesions. We remove the affected nail through onycholised structures using podological pedicure instruments, if there is an ingrowth, we supplement it with other local interventions – excision of pathologically changed eponycheal tissues, mechanical and coagulation partial marginal matrixectomy. In the postoperative period, we apply bandages with antiseptics, antifungal (antimycotic) ointments and varnishes until the nail(s) grow back completely.

References

  1. Cabete J, Galhardas C, Apetato M, Lestre S (2015) Onychomycosis in patients with chronic leg ulcer and toenail abnormalities. An Bras Dermatol 90: 136-139. [crossref]
  2. Chiu HH, et al. (2016) Onychomadesis following hand-foot-and-mouth disease. Cutis 97: 20-21. [crossref]
  3. Erdogan FG, Guven M, Erdogan BD, Gurler A (2014) Previous nail surgery is a risk factor for recurrence of ingrown nails. Dermatol Surg 10: 1152-1154. [crossref]
  4. Jung DJ, Kim JH, Lee HY, Kim DC, Lee SI, et al. (2015) Anatomical characteristics and surgical treatments of pincer nail deformity. Arch Plast Surg 42: 207-213. [crossref]
  5. Kallis P, Tosti A (2016) Onychomycosis and Onychomatricoma. Skin Appendage Disord 1: 209-212. [crossref]
  6. Kim JY (2012) Matrixplasty for the treatment of severe incurved toenail with growth plate deformity. J Am Podiatr Med Assoc 102: 198-204. [crossref]
  7. Leeyaphan C, Bunyaratavej S, Prasertworanun N, Muanprasart C, Matthapan L, et al. (2016) Dermatophytoma: An under-recognized condition. Indian J Dermatol Venereol Leprol 82: 188-189. [crossref]
  8. Nadashkevitch O, et al. (2017) Complicated onychomycosis and ingrown nail: complex treatment (case series). Proc Shevchenko Sci Soc Medical sciences 2: 64-68.
  9. Tucker JR (2015) Nail Deformities and Injuries. Prim Care 42: 677-691.
  10. Vergun, et al. (2017) Chronic mycotic-assotiated surgical nail pathology complicated with ingrown nail (nail incarnation): the analyses of clinical cases and complex treatment. International Journal of Medicine and Medical Research 3: 33-40.
  11. Vergun AR, et al. (2020) Surgical Incarnated Nail Pathology, Author Views of Some Controversion in Complex Treatment. Acta Scientific Medical Sciences 4: 31-37.
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  14. Zhu X, Shi H, Zhang L, Gu Y (2012) Lateral fold and partial nail bed excision for the treatment of recurrent ingrown toenails. J Clin Exp Med 5: 257-261. [crossref]

Effects of Selected Primers and Vanishes on Open Dentine Tubules: An SEM Study

DOI: 10.31038/JDMR.2023612

Abstract

Dentine sensitivity (DS) is a common painful condition affecting teeth. The exact mechanism of transmission of an environmental stimulus across dentine is not fully understood; currently the most accepted theory is the hydrodynamic theory as proposed initially by Brannstrom. Treatment has been concentrated on either reducing the dentine fluid flow by occlusion of tubule openings, or altering the pulpal sensory nerve activity preventing transmission of pain to the central nervous system.

Aims and Methods: The aims of the present in vitro study were to examine the dentine tubule occluding and penetrating properties of selected in-office desensitizing agents (varnishes and primers) using scanning electron microscopy and a dentine disc model.

Results: Of the products examined, the fluoride varnishes, Bifluoride 12 and Duraphat, and Cervitec (a chlorhexidine containing varnish) were effective in both occluding and penetrating the dentine tubules. The results from All Bond 2, One Step and Scotchbond primers were superior to those of HEMA group primers, Gluma 3, Gluma CPS and Solobond Plus.

Conclusions: These findings suggest a mechanism for the action of these potential desensitising agents and suggest that the tubule penetrating properties may play a role in the longevity of their retention on the tooth. Investigation of surface coverage and tubule penetrating characteristics are both necessary in order to fully evaluate in vitro the desensitising potential of agents claimed to reduce Dentine Sensitivity.

Introduction

Dentine sensitivity (DS) can be defined as a pain arising from exposed dentine typically in response to chemical, thermal, tactile, or osmotic stimuli, which cannot be explained as arising from any other form of dental defect or pathology [1]. Currently, the most accepted theory of stimulus transmission across dentine is the hydrodynamic theory [2] proposed initially by Brannstrom [3]. According to this theory, minute fluid shifts across dentine in either direction in response to thermal, tactile, chemical or osmotic stimuli can stimulate mechanoreceptors in or near the pulp, which in turn excite the pulp sensory nerves to cause pain.

Pashley [4] reported that there are two approaches in the treatment of DS, 1) partial or complete occlusion of the dentine tubules and 2) alteration of pulpal sensory nerve activity (SNA) at or near the pulpo-dentinal surface. If the hydrodynamic theory of intradental nerve stimulation is accepted then the treatment of DS through tubule occlusion is a feasible and reasonable approach.

Clinically, DS has been treated by numerous agents, in-office and over the counter (OTC), which have claimed to effectively reduce pain arising from exposed dentine. Laboratory evaluation of these desensitizing agents using the dentine disc model has been reported in several studies [5,6], although, Mordan et al. [7] have modified this model to establish a more precise methodology control to evaluate potential desensitizing agents.

The aims of the present study were to investigate the degree of dentine surface coverage and the extent of tubule occlusion and penetration of selected in-office varnishes and primers. A dentine disc model and qualitative scanning electron microscopy (SEM) were used.

Methods and Materials

Surgically extracted, carious free, unerupted third molars were fixed in 3% glutaraldehyde in 0.1M sodium cacodylate buffer (CAB) solution (pH 7,4) at 4°C for up to one week. 1mm thick dentine discs were obtained from the region below the crown and above the pulp using a Testbourne diamond saw and stored in 0.1 M CAB at 4°C until required.

Before use, the dentine discs were ultrasonicated for 30 seconds in distilled water to dislodge cutting debris. The smear layer was then removed using either 6% citric acid for two minutes or the appropriate etchant provided by the manufacturer and applied according to their instructions. The discs were rinsed in distilled water and marked on either side for orientation (Figure 1) before being broken into halves using dental pliers to provide control and test sections [7].

FIG 1

Figure 1: Marking of dentine discs used in the study

The selected desensitising agents and their ingredients, according to the manufacturer’s information, are shown in Tables 1a and 1b. During the study all the products were coded and at least two discs were used for each agent. The selected desensitising agents were applied onto the test halves according to manufacturer’s instructions. The test and control halves were then allowed to dry in a desiccator for at least 24 hours.

Table 1a: Formulation and manufacturer information of test agents: Varnishes

Test agent

Manufacturer

Active ingredients

Bifluoride 12 Voco GMBH, 27457, Cuxhaven, Germany Fluoride varnish made of synthetic resin. Sodium and calcium fluoride
Cervitec Vivadent Ets. Shaan

Liechtenstein, Germany

1 g contains: 0.010 g chlorhexidine, 0.010 g thymol Polyvinyl Butyral (varnish) Ethanol, ethyl acetate
Duraphat Previously Rhone-Poulenc Rover GMBH, Nattermannallee 150829, Koln, Germany (Current Manufacturer Colgate Palmolive Company, USA) An alcoholic suspension of natural resins containing 5% NaF

Table 1b: Formulation and manufacturer information of test agents: Primers

Test agent

 Manufacturer

 Active ingredients

Hema-Seal G Germipherne Corporation

Ontario, Canada

HEMA, Glutaraldehyde, Sodium fluoride, Water
Gluma 3 Bayer Dental

Leverkusen, Germany

Aqueous solution of gluteral (Glutaraldehyde), HEMA
Gluma CPS Bayer Dental

Leverkusen, Germany

36,1% HEMA, 5,1% Glutaraldehyde, 58,8% Water
Solobond Plus

Universal Bonding Agent

Voco,

Cuxhaven, Germany

Methacrylate Acetone
All Bond 2

Universal Adhesive System

Dual cured

Bisco Inc.

Itasca, IL, 60143

Illinois, USA

N-phenylglycine-glycine methacrylate and bisphenyl dimethacrylate.
Scotchbond

Multi-purposed

Dental Adhesive System

3M Dental Products

Saint Paul, MN 55144

1000, USA

HEMA and BIS-GMA
One Step

Universal Dental Adhesive System

Bisco Inc.

Itasca, IL 60143

Illinois, USA

BPDM monomer dissolved in an acetone solution

A separate series of discs was prepared following the protocol described above, but both control and test halves were carefully fractured into quarters providing longitudinal surfaces for examination of the tubule lumen contents.

After drying in the desiccator, the discs were attached to SEM stubs and sputter coated using a Polaron E5000 sputter coater (Polaron U.K.) with a layer of gold/palladium. The specimens were viewed in a FEI/Philips XL30 FEG SEM (FEI, Eindhoven, Netherlands) at a working distance of 10 mm.

Micrographs were taken from selected fields in the central portion of each half disc on either side of the fractured edge and the test surfaces were only compared with the corresponding controls. Comparison of the test products’ ability to block and penetrate the dentinal tubules was also subjectively assessed using the micrographs.

Results

An example of a control disc with both surface and fractured profiles can be observed in Figure 2a showing open dentinal tubules in both views (surface and fractured).

FIG 2A

Figure 2a: Control Surface and Fracture

Varnishes

After application to the dentine disc, Cervitec (containing chlorhexidine) was observed to form a uniform layer that covered the whole dentine surface (Figure 2b). No tubule orifices, however were apparent. Fracturing the disc revealed the presence of a thick, textured layer, which covered the tubule orifices. There was some penetration of the product into the tubule lumen (arrows). Duraphat (containing fluoride) provided an uneven crystalline layer that covered the dentine surface and left tubule orifices visible (Figure 2c). Upon fracturing the dentine disc, a thin, amorphous surface layer was evident, although the varnish was usually present within the tubules, where penetration occurred it appeared to coat the lumen occupying the whole tubule diameter. When Bifluoride 12 (containing fluoride) was applied to the dentine disc, the surface was observed to be covered with small, irregular crystal-like structures and the tubule orifices were covered (Figure 2d). After fracturing the disc a thick, rough layer was observed which occluded the tubule orifices and occluded the tubules with plugs that occupied most of the tubule lumen (arrow).

FIG 2B

Figure 2b: Cervitec varnish Surface and Fracture views

FIG 2C

Figure 2c: Duraphat Varnish (Surface and Fractured views)

FIG 2D

Figure 2d: BiFluoride 12 Varnish (Surface and Fractured views)

Primers

The Gluma group of primers (Gluma 3 and Gluma CPS) as well as Hema-Seal G and Solobond Plus primer, whose principal active ingredients are glutaraldehyde and 2- hydroxyethylmethacrylate (HEMA), appeared to produce similar deposits on the dentine surface, partially occluding the tubule openings (Figures 3a-3f).

FIG 3A

Figure 3a: Hema-seal G Primer (Surface and Fractured views)

FIG 3B

Figure 3b: Gluma 3 Primer (Surface and Fractured views)

FIG 3C

Figure 3c: Gluma CPS Primer (Surface and Fractured views)

FIG 3D

Figure 3d: Solobond Plus (Surface and Fractured views)

FIG 3E

Figure 3e: All Bond 2 (Surface and Fractured views)

FIG 3F

Figure 3f: Scotchbond (Surface and Fractured views)

Application of a Hema-Seal G primer resulted in limited deposition on the dentine disc with small deposits partially occluding the tubule orifices (Figure 3a). After comparison with the control half of the disc, it was observed that there was some apparent further etching. When the dentine disc was fractured the tubule orifices appeared unsealed with no sign of material deposit although some tubules appeared widened (arrow). The Gluma 3 primer produced partial occlusion of some of the tubule orifices with irregularly shaped deposits, usually observed on the surface and at the edges of the tubule openings (Figure 3b arrow). When fractured, tubule lumens free of deposits were observed. After treatment with Gluma CPS there were sparse irregular deposits on the dentine surface, some of which appeared to partially occlude the tubule orifices, whereas others were observed on the tubule periphery (Figure 3c). Fracture of the disc revealed little or no tubule occlusion or penetration.

Solobond Plus Universal Adhesive System was applied on a dentine disc etched with Vococid. The dentine surface appeared rough, and the tubule orifices were patent (Figure 3d). Some particles were noticed on the dentine around, but not occluding, the tubules (arrow). When fractured the tubules, small deposits 20-30µm were observed deeper into the tubules, although the tubules were open and widened towards the dentine surface fractured compared to the control disk (example 2a).

After application of All Bond 2 to the dentine it was apparent that the surface was covered with an almost uniform layer sealing the tubule orifices (Figure 3e). Fracture of the dentine disc revealed the presence of a thin layer covering the tubule orifices which appeared to coat the inner walls of the dentine tubule to a varying depth (arrow). Treatment with Scotchbond following etching with maleic acid 10% for 15 seconds demonstrated that some of the ttubule orifices were evident, but greatly reduced in diameter (Figure 3f). The fractured view revealed a degree of product penetration within the tubule lumen which appeared coated (Figure 3f fractured view). One Step produced an even layer which covered the whole dentine surface and no tubule orifices were obvious (Figure 3g). Fracturing the dentine disc showed a thin layer covering the tubule orifices and a considerable degree of agent penetration within the tubule lumen (arrow).

FIG 3G

Figure 3g: One Step (Surface and Fractured views)

Subjective assessment of the test products’ ability to both occlude and penetrate the dentinal tubules was recorded as shown in Table 2. These results would suggest that the fluoride varnishes (Bifluoride 12 and Duraphat, and Cervitec) were effective in both occluding and penetrating the dentine tubules. It was also evident that All Bond 2, One Step and Scotchbond primers were superior to those of the HEMA group primers (Hema-Seal G, Gluma 3, Gluma CPS) and Solobond Plus

Table 2: Summary of the test products’ tubule occluding and penetrating ability

Test agents

Degree of tubule occlusion

Degree of dentine surface coverage

Degree of tubule lumen penetration

Bifluoride 12

+++

+++

+++

Cervitec

+++

+++

+++

Duraphat

+++

+++

++

Hema-Seal G

+

+

0

Gluma 3 Primer

+

+

0

Gluma CPS

+

++

0

Solobond Plus

+

+

0

All Bond 2

+++

+++

+++

Scotchbond

++

++

+++

One Step

+++

+++

+++

Key:
+++ Most tubules occluded/maximum surface coverage/good penetration
++ Some tubule occlusion/some surface coverage/some penetration
+ Few tubules occluded/little surface coverage/little penetration
0 No occlusion/coverage/penetration.

Discussion

Currently, the most accepted mechanism of stimulus transmission across dentine is the hydrodynamic theory, which proposes that rapid shifts of fluid movement in either direction within the dentine tubules may stimulate mechano-receptors in or near the pulp to excite the pulpal nerve and cause pain. This theory leads to the concept of dentine tubule occlusion as a method of dentine desensitization [2,3].

The use of the dentine disc model has been proved to be a reliable method for the initial in vitro screening of tubule occluding properties of potential desensitizing agents [5,7,8]. The dentine disc would appear to be the method of choice since it is easy to use, reproducible, provides a flat surface for elemental analysis and may be correlated with fluid flow research [7]. Due to the differences in the size, orientation, density and diameter of the dentine tubules throughout the tooth [9], the discs were obtained from the same region of the tooth, below the crown and above the root canal. One half of each dentine disc provided the control and the other half the test portion, and only those tubules from the central region of the disc, on either side of the fractured edge, were examined and all the observations on the test side were compared with the control half of the same disc. All the tested agents were applied according to the manufacturer’s instruction in an attempt to mimic the clinical situation.

Cervitec is a chlorhexidine containing varnish, marketed in Europe, which possesses very good dentine covering and tubule occluding properties. Chlorhexidine may act as an antiseptic in the dentine tubule lumen and reduce the number of microbes penetrating the open tubules of sensitive dentine, reducing possible pulp inflammation.

Duraphat has been studied in vivo [10-18] and proved to be effective in alleviating DS short-term. The main ingredient of Duraphat is sodium fluoride (NaF), which can precipitate onto the dentine surface [19] and may contribute its tubule occluding potential, along with its fluid texture which allows penetration into the tubule lumen. Fluoride is also reported to have potential for reducing sensitivity, perhaps acting on the SNA, and the effect of the combined sensory and physical actions may account for the widespread clinical success of Duraphat.

Bifluoride12 appears to seal the dentine surface with a crystal-like deposit in an amorphous matrix that penetrates the tubule lumen. It contains sodium and calcium fluoride, which probably account for the presence of deposits. Although the plugs penetrating the tubules do not completely occupy the tubule lumen, they appear to reduce the tubule radius and this, in association with the desensitising potential of the fluoride, may contribute to a reduction in DS in the clinical environment.

The Gluma group primers (Gluma 3, Gluma CPS), Hema-Seal G and Solobond Plus primer contain mainly glutaraldehyde and HEMA. They appeared to produce similar deposits on the dentine disc surface, partially occluding the tubule orifices. Fracturing did not reveal any degree of deposit penetration. Dondi Dall’ Orologio et al. [20] reported significant reduction of DS following application of Gluma 3 attributed to a possible reaction of glutaraldehyde with the dentinal fluid proteins, precipitation and thus a partial or complete obturation of dentine tubules. The mode of action of HEMA is still unknown. Probably, the partial occlusion of tubule openings shown in the present study may explain the reduction in DS. Hema-Seal G also contains sodium fluoride. Thus any reduction in DS may be attributed either to the partial occlusion of dentine tubule orifices or to the action of sodium fluoride which forms crystals of calcium fluoride reducing the radius of dentine tubules [19]. However, a degree of ‘over etching’ was observed following application of Hema-Seal G, indicating that, when applied to the dentine surface in vivo and in conjunction with acidic dietary intake, it might result in an increase in dentine permeability.

All-Bond 2 primers formed a layer that appeared to fully cover the dentine surface and also penetrated the tubule lumen to some depth. This is in accordance with Tay et al. [21] who also showed penetration of the tubule lumen. Furthermore, Ianzano et al. [22] and Gillam et al. [23] reported that All-Bond 2 primers were effective in vivo in reducing DS, although different evaluation techniques were employed by these investigators. All-Bond 2, therefore, may be useful in the in-office treatment of DS although its effectiveness may be relatively short-lived. One Step was a relatively new product (at the time of evaluation) and so far there are no studies evaluating its desensitizing or occluding properties although it is the same as All Bond 2. As with All-Bond 2, One Step may be of some clinical value given that it’s occluding and penetrating properties are satisfactory and it is also easily applied. Scotchbond has been reported to be effective in reducing DS [24] although it is possible that the primer was subsequently covered with a light-cured resin. In the present study only, the primer was applied onto the dentine disc surface and the results showed a degree of surface coverage although some tubules with reduced diameters were also evident. This may be due to the application procedure or the etching period. It is possible that longer application period or thicker layer would completely obscure the tubule openings. However, the fracture of the disc revealed penetration of the product within the tubules rendering this agent a potential desensitiser.

This study was based on a well-established dentine disc model which has been modified to provide greater control in the preparation and analysis of surface deposits. In this respect, the method may be considered an improvement over previously reported studies. Difficulties may still arise, however, in the interpretation of the results particularly with regard to fracturing the disc halves, which is relatively technique sensitive, and the exact plane of fracture is somewhat unpredictable. Nevertheless, if the control and the test disc sections are carefully compared, the penetrating potential of the tested agents can be satisfactory evaluated as indicated in this present study. The dentine disc model although useful for the initial in vitro assessment of different agents may not reflect the in vivo situation and the results of this in vitro study should be extrapolated to the in vivo situation with caution. Factors such as pulpal pressure, the oral environment (saliva, gingival fluid) and patient’s habits (vigorous toothbrushing, acidic dietary intake) may also influence the retention of these products on the dentine surface. The presence of dentinal fluid within the tubules and its rate of movement in vivo may influence the formation of deposits on the dentine surface despite efforts to keep the exposed dentine [15]. Vongsavan and Matthews [25] reported that the penetration of different molecules into the dentine tubules may be greater in vivo than in vitro.

All the agents introduced in the present study, appear to be clinically applicable since they are easily applied, and some appear to possess both occluding and penetrating ability. Varnishes and primers, (together with sealants which were not reported on in this study), because of the relative ease of application, may provide a useful treatment option for the practicing dentist in the alleviation of DS. Attention should be paid to the mode of their application, which may be technique sensitive, e.g. All Bond 2 and Scotchbond where a vigorous air blast may remove a great amount of the agent leaving uncovered dentine tubules. Tubule penetration properties are important because even when the agent is removed from the dentine surface, plugs of the material may remain within the tubule lumen, which may either maintain the desensitizing effect of the agent or provide the patient with temporary relief until natural tubule occlusion occurs. Both short and long term clinical studies are required to determine whether the in vitro potential of these agents can be extrapolated in the clinical environment.

The majority of in vitro studies have evaluated the desensitizing properties of agents using descriptive methods of dentine surface assessment. Although some authors claimed that their methods of assessing the amount of tubule occlusion were quantitative in nature [6,26] in many cases they were semi-quantitative with no measuring involved. Quantitative studies using digital image analysis and SEM would provide a more accurate result [27] however, most of the products in this study resulted in total surface coverage, negating the need for measurement. Studies including fractures of dentine discs are of benefit in the investigation of the desensitizing potential as there may be blockage within the tubule which is not evident from the surface. Elemental analysis was not within the scope of this study, but further examination of some of the surface products would be interesting.

Conclusions

The results of this study suggest that, of the agents tested, the varnishes, All-Bond 2 primer, Scotchbond primer, and One Step appear to have both occluding and penetrating properties. However, agents which have been observed to be effective in vivo but with no significant tubule occluding or penetrating properties as demonstrated in the present study may employ other mechanism/s which cannot be simulated in this in vitro model. Moreover, the results obtained following the application of all the agents tested in the present study may be affected by the application technique(s) employed to apply them on the dentine surface, although every effort was made to follow the manufacturer’s instructions for clinical application.

References

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Faking Orgasm: Interviews with College Women about How, When, and Why They Pretend to Experience Orgasm

DOI: 10.31038/AWHC.2023623

Abstract

This study investigated the context in which young women fake orgasm, as well as their reasons. A key component of this study was to examine the way that sexual scripts and societal pressures influence young women who fake orgasm. In-depth interviews were conducted with 12 college women between the ages of 19-22 who had faked orgasms during sexual intercourse. Interview transcripts were analyzed for common themes. These college women faked orgasm for a variety of reasons and in the context of a diversity of relationships. Limitations, suggestions for future research, and recommendations for sexuality education are discussed.

Introduction

Faking orgasm, also known as feigning or pretending to orgasm, has been seen in popular media for decades. When Harry met Sally, was the first movie to highlight a woman faking orgasm. In the iconic restaurant scene, Sally claims that “at one time or another most women have faked it” [1]. Television shows, including Seinfeld [2], Parks and Recreation [3], and I Am Cait [4] have all dealt with the topic, and popular magazines, such as Cosmopolitan, have feature articles on faking orgasm including “7 Sad But True Reasons Women Fake Orgasm” [5] and “Funny Ways People Faked” [6]. These examples from popular media acknowledge that faking orgasm is something some women do, and at the same time raise important questions for researchers about how common it truly is and the reasons why women fake orgasm. It has been suggested it is one of the “least well-studied human sexual behaviors” [7].

Prevalence of Faking Orgasm

Several researchers have looked at the prevalence of women faking orgasm (e.g., Caron, 2021; Darling & Davidson, 1986; Ellison, 2000; Fahs, 2014; Hite, 1976; Muehlenhard & Shippee, 2010; Wiederman, 1997) [8-14]. Four of the earlier studies to address the prevalence of women faking orgasm provided important groundwork for more recent studies. One of these earlier studies was the research by Shere Hite published in her 1976 book, The Hite report: A nationwide study of female sexuality, which was based on the responses of 3,019 women, ages 14 to 78 [12]. The Hite Report revealed that most women experienced orgasm during clitoral stimulation rather than through vaginal penetration (a somewhat revolutionary finding for that time) and that these women felt that men’s attitudes about sex needed to expand to include the stimulation women needed. Important to the current study was her finding that more than half (57%) of women reported faking orgasm [12]. A decade later, a second study was published by Darling and Davidson specifically focused on faking orgasm (referred to as “pretending orgasm”). Their sample included 868 nurses from around the United States and revealed that, of the 745 women who had engaged in penile-vaginal intercourse, more than half (58%) had pretended to orgasm [9]. Another decade later, a third study focusing on faking orgasm involved a sample of 161 college women ages 18-27 from a Midwestern state university [14]. His findings were consistent with the two previous studies in that more than half (56%) of the women reported faking an orgasm during sexual intercourse [14]. In 2000, a fourth study discussing women faking orgasm was published by Ellison in her book, Women’s sexualities: Generations of women share intimate secrets of sexual self-acceptance. Similar to Hite, Ellison reported the results of her national survey, as well as in-depth interviews with women [10]. Of the 2,311 women between the ages of 23 and 95 who answered the questions about faking orgasm, 70% indicated they had faked an orgasm at least once with their partner [10].

More recent studies in the last two decades confirm what these earlier studies have shown: many women have faked orgasm. Muehlenhard and Shippee’s 2010 study of Kansas University college women from the ages of 18-29 found that two-thirds (67%) had faked during intercourse. Their study also looked beyond sexual intercourse and found that some college women pretended to orgasm during oral sex, manual stimulation, and phone sex [13]. Fahs’ (2014) research involving in-depth interviews with 20 women ages 18-59 found that 75% of women had faked orgasm at least once in their life [11]. Nearly half (45%) of these women reported that they faked orgasm regularly during their sexual encounters [11]. And in 2021, Caron published her book, The sex lives of college students: Three decades of attitudes and behaviors based on her annual survey of college students at the University of Maine. Her findings for the 6,654 students ages 18-22 covered a wide range of sexuality topics. In terms of faking orgasm, 70% of sexually active college women in the study said they have faked an orgasm. This is the only study to look at faking orgasm over time. When looking across the 30 years, Caron found that for college women, faking behavior has increased dramatically over time – from less than half to over three-quarters of college women today saying they have faked an orgasm [8].

Reasons Why Women Fake Orgasm

Along with research on the prevalence of women faking orgasms, there are several of studies that have examined the reasons why women fake orgasm. (i.e., Bryan, 2001; Braun et al., 2014; Fahs, 2014; Kaighobadi et al., 2010; Lafrance et al, 2017; Mialon, 2012; Muehlenhard & Shippee, 2010; Roberts et al., 1995) [11,13,15-20]. In addition, Cooper et al. (2014) developed a scale to assess women’s motives for faking orgasm, The Faking Orgasm Scale for Women [7]. These reasons have ranged from concern for their male partner’s feelings and wanting sex to end, to saving the relationship and pressure to perform in order for her to appear “normal.”

The most common reason researchers have found for why a woman might fake orgasm has been out of concern for the feelings of her male sexual partner; women reported they faked orgasm in order to preserve their partner’s feelings, or in some cases, to give him an “ego boost.” This was labeled by Cooper et al. (2014) as “altruistic deceit” and based on gendered beliefs, such as if a woman does not orgasm it will negatively impact the man’s ego. In Roberts et al.’s 1995 study, some of the 75 women interviewed explained how their partner felt he had failed in some way if she did not orgasm, so faking was a way to ensure he did not feel like a failure [20]. Ellison (2000) also found that women viewed faking orgasm as important in taking care of their partner’s feelings. One of the women interviewed stated, “he had to think he was a good lover, satisfying me. Basically, faking was me taking care of the man” [10]. In Bryan’s 2001 study, the women that she surveyed described wanting to boost their partners’ egos and not hurt his feelings. Her orgasm indicated whether or not he was sexually proficient and skilled; it emphasized that sex is a skilled activity, and a woman’s orgasm was the man’s responsibility [15]. Muehlenhard and Shippee (2010) found that 78% of women had pretended orgasm in order to avoid hurting their partner’s feelings, while 47% of women faked orgasm to make their partner feel good about themselves [13]. Mialon (2012) also found that women who care about their partner’s sexual pleasure are more likely to fake; they want to make him happy [19]. And along with protecting his feelings, a woman may want to reinforce her partner’s sexual skills. Fahs found that these were common themes in both her 2011 and 2014 research [11,21]. In Braun et al.’s 2014 research, a common reason women faked orgasm was to save the feelings of their most intimate partner [16]. Most recently, a study of 462 women ages 19 to 73 in the UK found that those who held more gendered beliefs, such as women’s orgasm is necessary for men’s gratification, were more likely to fake orgasm [22].

A second common reason some women fake orgasm is because she wants sex to end (Cooper et al. (2014) labeled this “sexual adjournment” [7]. As a woman in Ellison’s study (2000) described, “I enjoy sex even without orgasm. I fake because my partner tries too hard to get me to orgasm and that turns me off” [10]. In Bryan’s 2001 study, many women faked orgasm in order to stop intercourse [15]. Their reasons for why they wanted to end intercourse included feeling tired, bored, nervous, or in pain [15]. Muehlenhard and Shippee (2010) found that 61% of women in their sample indicated that wanting sex to end was their reason for faking orgasm. The women who wanted sex to end claimed that it was because “they were bored, not in the mood, or tired and wanting sleep” (Muehlenhard & Shippee, 2010). These researchers also found that some women faked orgasm so that their partner would orgasm, and this would lead to the end of sex [13]. In both Fahs’ 2014 study and Lafrance et al.’s 2017 study, women said they purposely faked orgasms in order to end sexual encounters [11,18].

A third common reason found in studies of why women fake an orgasm included her feeling that this keeps her partner happy and the relationship intact. Some women described feeling as though they could lose their boyfriend if they don’t fake [20]. In Ellison’s 2000 study, she describes this as a common theme. One interviewee explained the reason she fakes orgasm is because she needs to please her partner so that ‘then he won’t leave me and I’ll have a boyfriend” [10]. In Bryan’s 2001 study, the researcher found that there were a broad variety of partner-related reasons, and these included, “to maintain the relationship” [15]. In Kaighobadi et al.’s 2010 study about women faking orgasm in order to retain their mate, they found that women who were more insecure in their relationships and who perceived a higher risk of partner infidelity were more likely to fake orgasm [17].

Finally, some researchers have found that the reason a woman has faked orgasm was to convince their partner that she is normal; otherwise the feeling is that there may be something wrong with her. Bryan (2001) found that some women were motivated to fake orgasm because they felt embarrassed, ashamed, or abnormal because they were not going to have an orgasm when they thought they should [15]. Bryan’s research found that women “feared appearing inexperienced or naieve;” therefore, they felt pressure to experience an orgasm [15]. Along with feelings of abnormality come feelings of guilt or shame. In Fahs’ 2014 research, some women felt her inability to orgasm implied that there was something wrong with her, as one woman explained, “I don’t want him to know that I’m one of those women who can’t get aroused from a penis inside of her” [11].

Sexual Scripts

As these studies reveal, faking orgasm is not only common, but increasing, and women of all ages indicate a variety of reasons for faking, including concern for a partner’s feelings, wanting sex to end, to save the relationship, and pressure to appear “normal.” However, the idea that today’s young women fake orgasms seems nonsensical when viewed through a modern lens.

In a society that has seen a rise in feminism, discussions of women’s empowerment and sexual pleasure, women’s marches, empowering television shows and movies, and a myriad of information available online about sexual functioning and women’s pleasure, one would think that the number of women faking orgasm would be small or have decreased over the past few decades, not increased [23]. On the other hand, sex seems to be everywhere, but is seldom talked about honestly and openly. For example, pornography is accessible, but too often unrealistic, and sex education rarely includes discussions about female pleasure [21,24]. It is no wonder that, according to Casey et al. (2013), traditional sexual scripts for women are still in existence. These scripts include women not desiring sex, having a weak “sex drive,” resisting advances, being more highly valued if she is less sexually experienced, as well as the notion that women should prefer relational sex, want commitment and monogamy, and should seek emotional intimacy and trust with sex [25].

These traditional sexual scripts also provide ideas surrounding women’s experience with orgasm. According to Lavie-Ajayi and Joffe (2009) [26] in their article Social Representations of Female Orgasm, these scripts center on three ideas: 1) women’s orgasm as the central indicator of sexual pleasure and the goal of sex, 2) vaginal orgasms are thought of as better than clitoral orgasms, and 3) while it is common for women not to experience orgasm through intercourse, if she doesn’t, it is a sign of her deficiency. These orgasm scripts suggest reasons why women might fake during a sexual encounter. Essentially, the message for women has been that “we have been taught that orgasms are obligatory” [27]. Women, as well as men, have been socialized to believe that orgasm is the goal of sex, and without an orgasm, sex is pointless. This puts an incredible amount of pressure on both parties involved, and it may be easier to fake an orgasm than to deviate from these social norms [26].

The Purpose of this Study

While a number of studies have been done over the past several decades on the frequency of and reasons for faking orgasm, many involve women across a range of ages. Few studies have examined younger women. This qualitative study investigated the context in which today’s young women fake orgasm and examined their reasons for faking orgasm. A key component of this study was to explore the ways that traditional sexual scripts and societal pressures may continue to influence college women who fake orgasm. Specifically, this study involved in-depth interviews with younger college women who have faked orgasm during sexual intercourse. The following research questions were explored:

  1. How often and in what context do college women fake orgasm?
  2. What are college women’s reasons for faking orgasm?
  3. How do college women feel about faking and what is their sense of how their partner(s) and friends feel(s) about women faking orgasm?
  4. What do the college women’s accounts of faking orgasm reveal about their sexual scripts?

Methodology

The Sample

The criteria for inclusion in the study were college women ages 18-22 who had faked an orgasm during sexual intercourse. All 12 women described faking orgasm in the context of a sexual relationship with a man. Participants were recruited through announcements made in classes and e-mail announcements sent to several university discussion boards. The final sample included 12 women (Table 1) attending a public university in the northeastern United States. The age of the participants ranged from 19 to 22 years old, with the average being 21 years old. All 12 of the participants identified as White and cisgender. Ten of the participants identified as heterosexual, one identified as bisexual, and one identified as queer. The number of sexual partners each participant had ranged from 1 to 35 (M=11.6; SD=11). The number of sexual partners each participant faked with ranged from 1-20 (M=6.4; SD=6.8). Most women reported faking orgasm with most of their sexual partners. The percentage of partners they faked orgasm with ranged from 14% to 100% (M=65.4%; SD=26.3).

Table 1: Demographics of Participants (N=12)

Participant Pseudonyms

Age

Race

Sexual Orientation

Number of Sexual Partners*

Number of partners they faked with

Percent of Partners Faked With

Abigail

22

White

Straight

1

1

100%

Bella

21

White

Straight

6

4

66%

Charlotte

21

White

Straight

7

7

100%

Delilah

21

White

Straight

1

1

100%

Emma

22

White

Straight

27

20

74%

Faith

21

White

Straight

3

2

66%

Grace

21

White

Straight

5

3

60%

Hannah

22

White

Bisexual

9

2

22%

Irene

19

White

Straight

3

2

66%

Jasmine

22

White

Straight

22

3

14%

Kaylee

19

White

Queer

20

12

60%

Lily

22

White

Straight

35

20

57%

*All reported that their sexual partners were male

Interview Procedure

The interview was comprised of a series of questions focusing on the experience of faking orgasm. The Human Subjects Committee of the university approved the interview protocol. Interviews began with basic demographic questions (e.g., age, race, number of sex partners). The subjects were then asked a series of questions that centered on how often and the context for faking, what their reasons were for faking, how they and their sexual partner(s) and friends felt about women faking orgasm, and their sexual scripts.

College women who met the criteria (age 18-22 who had faked an orgasm during sexual intercourse) and expressed interest in participating in the study were provided with a copy of the consent form before an interview was scheduled. Consent was implied when they agreed to arrange an interview after reviewing the consent form. Consent was also verbally provided by the participants at the start of the interview. Interviews were conducted face-to-face in a private space on the university campus. Participants were assured that any and all responses would be kept confidential. No names or identifying information was included in the data report; a pseudonym was assigned to each participant, and any names of partners or friends mentioned in the interview were changed. Each interview lasted approximately ninety minutes. Interviews were tape recorded and extensive notes were taken. At the end of the interview, participants were given the opportunity to review the notes with their responses for omissions or clarifications. The taped interviews were later transcribed and afterwards the content from the taped interview was deleted.

Interview Analysis

Interview transcripts were analyzed using established methods of qualitative inquiry, including coding and categorizing processes that make use of both deductive and inductive approaches [28]. Thematic analysis was utilized to analyze and code the interviews. The first and second author read the first three interview transcripts independently, and initial coding of the transcripts involved marking comments that fit under the four research questions of focus for the study: frequency/context, reasons, feelings, and scripts. For example, a response that encompassed a woman’s reason for faking orgasm would have the initial code word “reason” added next to it. Next, coding categories or themes were created under these areas of focus through a process of open coding [28]. For something to be considered a theme, at least half of the women (six women) needed to discuss this in their responses. For instance, under the responses for “reasons,” if six or more women mentioned that the reason she faked an orgasm was because she worried about her partner’s ego and/or did not want to hurt his feelings, this was categorized under that theme. These were compared and coding categories were further developed.

The rest of the interviews were coded by the first author and reviewed by the second author as any changes or additions were made. No new coding categories emerged after approximately 10 interviews were completed, leading to assurances of content saturation. A total of 16 themes emerged from the coding. These are discussed below and presented in Table 2. In terms of frequency and context for faking orgasm, four themes were identified. For reasons for faking orgasm, five themes were determined, and for feelings about faking orgasm a total of four themes were identified. Finally, the fourth research question sought to understand what young women’s accounts of faking orgasm reveal about their sexual scripts. Three sexual scripts were identified and will be discussed.

Table 2: Themes identified for college women’s frequency and context of faking orgasm, reasons for faking orgasm, feelings about faking orgasm, and sexual scripts related to faking.

Frequency and Context of Faking Orgasm

·         How often: It depends

·         How she faked: I was a great actress and lied

·         When she faked: It was typically with intercourse

·         Who she faked with: When I didn’t know him well

Reasons for Faking Orgasm

·         I did not want to hurt his feelings

·         I was uncomfortable being with him

·         I felt I was taking too long

·         He did not know what he was doing

·         It’s expected

Feelings about Faking: Hers, Her Partner(s), and Her Friends

·         I feel it is pretty normal

·         I feel guilty, but it was necessary

·         My sexual partner would feel deceived

·         My girlfriends feel it is perfectly okay

Sexual Scripts

•         Media messages of what “normal sex” looks like

•         Her orgasm is a reflection of his competence

•         Her orgasm signals that sex is complete

Findings

Themes are reported below for each of the areas of focus for this research: frequency and context of faking orgasm, reasons for faking orgasm, feelings about faking orgasm, and sexual scripts. Direct quotations from the interview transcriptions are included to highlight the findings (Table 2).

Frequency and Context of Faking Orgasm

The first research question asked, “How often and in what context do college women fake orgasm?” The 12 college women were asked a series of questions to understand their experience of faking orgasm. Four unique themes were identified from the in-depth interviews, including how often she faked, how she faked, when she faked, and who she faked orgasm with. These are described below and are listed in Table 2.

How often: It depends. The first theme related to the frequency and context of faking orgasm was related to how often the women faked an orgasm. When asked how often they had faked an orgasm, the most common response was “it depends,” with responses ranging from “only a few times” to “hundreds of times.” For many women, it depended on a range of factors from how inexperienced she was or how inexperienced her partner was, to how well she knew him or how much pressure she felt. While some women said they had faked an orgasm only a few times in one relationship, others indicated they had faked “hundreds of times” in most relationships. Examples of how college women described how often they faked an orgasm are included below:

I did it more at the beginning of our relationship, and then less later into the relationship because I think that we both started learning more what we liked in the bedroom. I would say almost the majority of the time at the beginning of the relationship and then almost not at all as the relationship progressed forward. (Grace)

I would say that every one-night stand that I have had, I pretty much faked with. Like when I have a one-night stand, I would say it’s a guarantee pretty much that I am going to fake. It’s usually different than when I’m with someone that I’m emotionally close to. (Lily)

How she faked: I was a great actress and lied. The second theme related to frequency and context of faking orgasm focused on how she actually faked her orgasm. The majority of women described how faking orgasm involved good acting and included descriptions of the kinds of actions (i.e., body movements and sounds) they would engage in. They also said that when asked by their partner after sex if they had had an orgasm, they deliberately lied to him. Many not only described being good at faking, but also discussed getting better overtime with more sexual experiences. Some sample quotes describing how she faked include:

I verbalize, like moaning and getting grabbier. Definitely working myself up kind of thing and then heavy breathing afterwards. That was always a definite and I was like “Oh my God” ((panting)) kind of thing. I would say that I usually didn’t say anything though, just used my muscles and I would scratch their back too. (Kaylee)

I didn’t use just my body. He was like, ‘Did you get it?’ and I just said “Yes” even though I didn’t, so most of the time it’ll be like physical and moaning except for the two times that I straight up lied out of my mouth. (Charlotte) When she faked: It was typically with intercourse. A third theme related to frequency and context of faking focused on sexual intercourse. All 12 college women described faking orgasm during penile-vaginal intercourse. Two women added that they had also faked an orgasm during oral sex. Some women described that they began faking orgasms during sexual intercourse before they had ever had a real orgasm, but once they experienced an orgasm and knew what it felt like, they got better at faking. Some examples of women explaining when they faked include:

I fake during intercourse because I don’t even have a reason. Oral depends, I don’t know, I fake during both of them, but most commonly during intercourse because like I said, I don’t orgasm just by intercourse alone, so, uh, it is to make him feel better. (Delilah)

I emphasized more or got more convincing when I was faking when we were having sex. I think that because I knew what the orgasm was supposed to feel like because of a previous relationship, I was better at faking when I was doing stuff with other guys. (Irene)

Who she faked with: When I didn’t know him well. The fourth and final theme related to frequency and context of faking centered on how well they knew their sexual partner. All 12 college women talked about how they faked orgasm with someone they did not know well, either in the context of a one-night stand or in the very beginning of the dating relationship. It was described by many as “easier to get away with” if they faked an orgasm with someone whom they did not know and would never see again. Most described faking at the start of a relationship that eventually evolved into something long-term. As their partner got to know their sexual needs, there was no need to fake anymore. Some examples describing who women faked with include:

We were dating for less than a year, I only did it like a couple of times in the beginning ‘cause I kind of almost felt bad ‘cause it’s like obviously you’re putting a lot of effort in, you really are trying. It was just sometimes it was not going to happen and also that was one of my early relationships so I wasn’t as comfortable talking openly about it so I didn’t feel okay asking him to try something different. (Jasmine)

I only dated him for like three months, it was a stupid relationship. We didn’t have sex very many times, so this is kind of awkward, but I faked every single time with him. We only had sex like three times. This is so sad. I never even had an orgasm with him. (Bella)

Reasons for Faking Orgasm

The second research question asked, “What are college women’s reasons for faking orgasm?” A series of interview questions explored their most important reasons and what their rationale was for faking orgasm. Five themes were identified for the reasons women said they fake orgasm, including not wanting to hurt his ego, experiencing uncomfortable emotional and physical feelings with him, worrying she was taking too long, feeling like the guy wasn’t doing anything that was stimulating her, or she felt it was expected that she reach orgasm as part of sex. Each woman had many reasons for faking (not just one) and their reasons varied based on the context of the sexual experience. These five themes are described below and listed in Table 2.

I did not want to hurt his feelings. The first theme related to reasons for faking included concern for his feelings. Most of the college women described faking orgasm because they were worried about his ego and whether or not he would feel like he was a good sexual performer. Examples of things women said included:

I guess mainly I was just trying to make my partners feel better about themselves and that’s why I would never say, “Hey I’ve been faking the entire time we’ve been sleeping together” because that would take away all that validation too. Plus, I feel like it’s kind of a waste of time to be faking quite a bit and then tell the partner that you were faking. Their feelings are really going to get hurt that way. (Hannah)

I think that men get their feelings hurt easily and they’re very sensitive when it comes to sex and they always want to protect their ego and I think that there’s at least in some way pressure on women to fake orgasms so that they protect the feeling of their male partner. (Abigail)

I was uncomfortable being with him. The second theme related to reasons for faking orgasm was because they were really uncomfortable being with their sexual partner and therefore knew the sexual encounter was not going to lead to orgasm. They described being emotionally uncomfortable in terms of not being able to relax with him, not feeling a connection to him, or feeling very self-conscious. Many women also mentioned feeling physically uncomfortable (i.e., pain) and faking orgasm in order for the sex to end. For example:

I think “discomfort” would be the one-word summary of why I faked. I think with the more casual relationships, I never was emotionally close to them so I was emotionally uncomfortable with the situation. I felt like, “I don’t like that you’re seeing my boobs right now and I hardly know you.” With my first boyfriend it was probably more like, “This is my first partner ever, I don’t know what I’m doing.” I’m self-conscious, that’s why I’m uncomfortable and also when you don’t really know what you’re doing. I think physically that’s uncomfortable too. (Charlotte)

I felt like I was taking too long. The third theme related to the reason why women faked orgasm was because it was taking them too long to reach a real orgasm. They were worried that their partner would think something was wrong with them or they felt pressured by their partner continually asking, “Have you come yet?” Some examples of quotes from women describing how they felt they were taking too long included:

It’s more like I felt that I should reach an orgasm sooner, more than because he wasn’t going to give me one cause he’s doing the same things he usually does [when I have an orgasm] but sometimes it’s just not as fast. I feel like sometimes it takes me a lot longer to have an orgasm, but I don’t know why. I feel bad when it takes me a long time ‘cause then I think he feels bad too. (Delilah)

I feel like the guy is going to think that something is wrong with me if I don’t have an orgasm. I don’t want him to think that he just had sex with a weirdo after he finishes. He would ask me if I had orgasms, and I hated that. He did it all the time during sex, it made pleasure really difficult to focus on. (Bella)

He didn’t know what he was doing. The fourth theme related to reasons women gave for why they fake an orgasm was because the man they were with did not seem to know what he was doing in terms of stimulating her. Women described how they were sure they would not be reaching a real orgasm with him and therefore felt their only option was to fake an orgasm. Examples of this included:

I think with the other guys [one night stands] it was different. They didn’t really know what they were doing. If I was going to be in a long-term relationship, it would be different, but I had no confidence in the men that I slept with. I would always be like “Eh, they’re never going to get it,” so I would fake because I’m pretty sure that I just wouldn’t have ever have an orgasm in those encounters. (Emma)

I think that the majority of the time I fake because they are not doing anything and I’m not getting very stimulated throughout the whole thing, so I just don’t feel like it’s going to happen no matter how long it goes. No matter how long we like had sex, I wasn’t going to have an orgasm. (Lily)

It’s expected. The fifth theme related to reasons why women faked orgasms included an expectation and pressure to have an orgasm with intercourse. All of the college women said they believed it was what needed to happen in order for sexual intercourse to be complete. Not only should he orgasm, but she needs to orgasm as well. Women described this expectation and pressure in the following examples:

Guys just think we should have an orgasm, so that’s how it happens. I think there’s a huge amount of pressure on many women to have an orgasm, so they end up faking. I wouldn’t say anyone is happy to fake orgasms because normally the situation that you find yourself in is not ideal. (Abigail)

I feel like guys expect you to orgasm, but among girls I feel like it’s an understanding that having an orgasm during sex is not quite so common. I kind of think that’s where faking comes from because girls all understand how difficult it can be to have an orgasm, but guys just don’t seem to get it. I think that they kind of like originate the pressure, but sometimes I feel like I internalize that and then like I feel like I need to have an orgasm. (Emma).

Feelings about Faking: Hers, Her Partner(s), and Her Friends

The third research question asked, “How do college women feel about faking and what is their sense of how their partner(s) and friends feel about women faking orgasm?” The 12 college women were asked a series of questions to explore their feelings about faking, as well as the feelings of those around them. Four unique themes were identified from the in-depth interviews. Many women stated that both she and her friends feel that faking orgasm was typical or normal behavior. Most admitted feeling guilty, but recognized it was necessary, and they described how they never discussed faking with their sexual partner because they knew his response would not be good. These are described below and are listed in Table 2.

I feel it is pretty normal. The first theme related to the women’s personal feelings about having faked orgasm and centered on how normal this behavior was within a sexual encounter. Women seemed to shrug their shoulders and be unphased about having faked and orgasm. Many were okay with faking orgasm and saw it as a useful tool in many sexual encounters. Examples of women’s description of their feelings include:

I don’t think I’m doing anything bad. Just kind of like neutral. I think it’s pretty normal though, and I don’t think that many women feel bad about faking, especially because they are faking to not hurt their partner’s feelings. (Delilah)

It’s so normal, almost like, it shouldn’t be so normal, it shouldn’t be something that I have to do, I just don’t even think about it. I feel like it’s become like I’m used to it. It is what it is. No one really puts any thought into it. I don’t care that I have done it personally, but it’s probably something that I should change at some point. (Emma)

I feel guilty, but it was necessary. The second theme focused on how women feel about having faked orgasm and involved guilt. However, these women also qualified these guilty feelings by saying that faking was necessary in many situations they found themselves in order for the sexual encounter to be considered a success. Some quotes from college women about these feelings include:

I feel bad that I didn’t address it, I mean lying is really what I feel guilty about, but I didn’t want to make either of them feel bad. Going back, I would definitely talk more about it ‘cause that’s super important but going back I was just too shy at the time to discuss it. (Irene)

It is disappointing to fake cause I didn’t feel like my needs were important enough to tell the guy about. It is always hard for me to say, “That wasn’t good for me.” I am also okay that I didn’t make them feel bad, but also I was lying so then you kind of feel guilty anyway. (Faith)

My sexual partner would feel deceived. The third theme to emerge related to feelings about faking orgasm involved her thoughts on how her sexual partner would feel if he knew. All of the college women indicated they were not willing to tell their sexual partner they had faked because they were sure he would respond in a negative way. All of them were sure he would feel lied to or deceived. This reaction was confirmed by a few women who shared that they had later told a sexual partner about faking, and his response was to feel lied to and deceived. Sample responses included:

I haven’t ever talked about that with any of my sex partners. That would be so awkward and embarrassing for both of us because he would feel like he couldn’t get me off. (Bella)

I don’t want it to come out that I have faked in the past, so it’s not something that I ever bring up with my partner. I don’t want to hurt my partner’s feelings, so I would not want to talk about it. I don’t think that guys like to think that anyone has ever faked with them because that would hurt their confidence, so they probably don’t want to bring it up either. (Kaylee)

My girlfriends feel it is perfectly okay. The fourth theme related to feelings about faking orgasm centered on her friends’ reactions to finding out they fake. The overwhelming response from her girlfriends was that it is perfectly normal behavior and not surprising. Women talked only about their female friends’ response; none of the women discussed how male friends would feel about her faking orgasm with a partner. Some example of friends’ feelings about faking orgasm include:

I talked to my friends before I met you for this interview. I texted everyone. And one of my roommates responded back, “Have I faked an orgasm? Do you mean am I a woman?!” We all just laughed because it’s so regular. I feel like with my friends it’s the norm, and that’s what a lot of women unfortunately do. (Abigail)

So the only people I’ve ever talked about this with are my current roommates. We talked about it and all of us kind of joked like, “Oh girl, have I faked? Hell yes I faked, who hasn’t faked?” But it never went really beyond that. They didn’t have any specific reaction when I told them that I personally had faked. I think that most women just assume that all other women are faking, too. (Charlotte).

Sexual Scripts

An examination of the transcripts revealed three overarching sexual scripts these college women internalized to explain their faking orgasm behavior. These sexual scripts include: 1) media messages of what “normal sex” looks like, 2) her orgasm is a reflection of his competence, and 3) her orgasm signals that sex is complete. These sexual scripts are discussed below. Sample quotes are included to highlight these scripts.

Media messages of what “normal sex” looks like. The first sexual script centered on the media. Many of the women didn’t know exactly where their ideas, reasons for, or feelings about faking orgasm originated from, but they were able to cite the media as playing a very important role. Women discussed movies, television shows, and pornography. Women found these various types of media to be influential in their sex lives and to offer them an understanding of what “normal sex” should look like. Some sample quotes describing women’s experiences with media are below:

I think in my experience the way that men and women act has a lot to do with porn and when they watch it. Like the women through the whole entire thing are having orgasms, multiple orgasms. I think that porn plays such a big role in the expectations today. If you have a partner that looks at porn and always thinks it’s going to be the reality of sex, then that’s going to cause a lot of problems in the relationship. (Delilah)

I haven’t really thought about where I learned about faking orgasm before. I don’t want to say TV shows because that’s cliché, but you know how sometimes on TV you might see stuff like that, I don’t know, but I feel like the women on the TV fake it. It’s not like I’ve ever really given it thought, though I guess, I think I would say TV was a pretty big influence. (Grace)

I think that porn is a big reason why women fake, the way that sex is shown makes men think that sex in real life is going to be different than it actually is. Even in movies and stuff, sex is like this amazing thing that everyone wants to have, like in American Pie, but in real life it’s not ever really that interesting. I think sex can be really boring, especially if the guy has no idea what do to with your body. (Faith)

Her orgasm is a reflection of his competence. The second sexual script centered around her orgasm as a reflection of him. Nearly every single woman interviewed had faked orgasm because they understood that her ability to reach orgasm assured him he was competent. This sexual script suggests these women have learned that sex is about him; it’s about assuring him of his abilities, his sexual prowess, and his manhood. All women described the pressure from their partner to orgasm in order to assure him of his competency. Some examples of this can be found below:

With my boyfriend I would fake because I didn’t want to make him feel bad. And I think the other two guys, I mean, maybe it was just kind of, I guess the best reason would be like societal expectations. I don’t know, I always kind of feel like it’s something that should happen during sex. Even if they didn’t make me orgasm, they did make me feel good in at least some way, and faking was kind of my way of like showing even if they really didn’t make me orgasm, they were doing something good. (Grace)

Um, honestly I fake for him, so as not to hurt their ego because men are babies. They couldn’t handle rejection, so I would basically just fake with them because I didn’t want to hurt their feelings or anything. Men need to feel strong, needed, and important. So, I think that giving a girl an orgasm is very important to their self-esteem; if they are unable to give a girl that orgasm it hurts their self-esteem and makes them feel like they aren’t as sexually powerful as they should be. (Bella)

I think that men kind of originate the pressure to have an orgasm. Sometimes I feel like I internalize that and then like I feel I need to have one. Guys always want you to have an orgasm. I think it makes them feel better and more accomplished and then they get the added bonus that their partner is having a good time too. (Emma).

Her orgasm signals that sex is complete. The third sexual script is that women felt like sex was not complete until she experienced an orgasm. Not only did women feel this way, many also proclaimed that their male partners felt similarly. This pressure to perform in order to make the sex act complete was a recurring sentiment. Some sample quotes are below about women feeling as though their orgasm signals to the male partner that he can now orgasm and then sex is complete:

I wanted it to be over, so faking the orgasm was how I decided that I wanted to end the sexual encounter. I learned that if I wanted to end sex, then I could fake orgasm because that was a signal to him that he should be finishing up soon. (Charlotte)

At the time I felt like an orgasm was supposed to happen and then that was sort of like the mark of the end of the experience so I should basically have one to finish things up. (Irene).

Discussion

This study sought to add to our understanding of how and why women fake orgasm. There have been previous studies on women who fake orgasm, however, several are decades old and/or include a very broad age range of participants. For a behavior that appears to be extremely common in sexually active women, and one that has been increasing among college women over the past 30 years [8], there is a need for more research to understand this phenomenon. This study focused exclusively on a younger cohort of educated, college women who had faked orgasm. It involved in-depth interviews in order to understand the context, reasons, feelings, as well as to determine the sexual scripts that are influencing faking orgasm among today’s young women.

Comparison of Findings to Previous Research

Frequency and context of faking orgasm. In terms of the frequency and context of faking orgasm, there was a great variation in how often these college women reported they had faked orgasms. Some women reported that they faked every single time they had sex, while others had only faked a few times in their life. Other researchers also found that there was a wide range in frequency of faking among their study participants. For example, Bryan’s (2001) [15] found that 20% of women faked orgasm during 20% of their encounters, Fahs (2014) [11] found that 45% of women report that they faked orgasm “regularly” during their sexual encounters, and Ellison (2000) [10] found that while most had faked less than 50 times; 10% of the women claimed to have faked orgasm between “150 and 10,000 times or wrote in another answer such as ‘countless’ or ‘a bazillion’” [10].

Most of the college women in this study discussed pretending to orgasm by using their bodies and lying if their partner asked them about having an orgasm. Many women described “putting on a show” for their male partner so that they would not suspect anything. This was a finding described in other studies of women faking orgasm (e.g., Bryan, 2001) [15]. In addition, they all discussed how faking orgasm typically occurred with sexual intercourse. Few women identified faking during oral sex. Earlier studies (e.g., Darling & Davidson, 1986; Wiederman, 1997) [9,14] also specifically explored women who faked orgasm and found this to be typical.

Two findings related to frequency and context were unique to this research. First, the college women in this study reported that they got better at faking over time. Many noted that the longer they faked, the more convincing they felt they became. And related to this, once they experienced a real orgasm, they felt their ability to convincingly fake future orgasms improved considerably. The other unique finding that has not been discussed in previous research related to the context was that these college women described faking orgasm at the beginning of a relationship. All of the women faked when they were “less close” with their partners and had “less emotional attachment.” For some women (those who had only one-night stands), this pattern continued, but for those who had long-term boyfriends, they stopped faking as the relationship progressed.

Reasons for faking orgasm. In terms of the reasons why women fake, almost every woman interviewed agreed that they faked orgasm in order to save their partner’s feelings. The women were more concerned with their partner’s ego than with their own pleasure during the sexual experience. This finding was similar amongst nearly all of the previous research on reasons why women fake [7, 10, 13, 15, 16, 19, 20, 21]. For many women, it was reported that it was easier to fake and “protect his feelings” than to tell him the truth and deal with an uncomfortable conversation. Other reasons women cited for faking were similar to previous studies noted earlier including being uncomfortable, worrying she was taking too long, and feeling the pressure to orgasm.

Unique findings in this study related to reasons women fake orgasm included college women talking about experiencing physical pain, lack of concern for maintaining the relationship, and because he did not know what he was doing. In this study, many of the women cited feeling physically uncomfortable (not just emotionally uncomfortable) and cited this as a reason for faking orgasm in order to have the sexual encounter stop. Few of the previous study [15] discussed that women fake orgasm because of physical discomfort.

In addition, many of the previous studies found that a common reason why women fake was to keep the relationship intact [10, 12, 17, 20]. In the current study, not one of the college women talked about this as a reason for faking an orgasm, which raises questions about today’s college women and their focus on long-term commitments.

Another unique theme noted by college women in this study to explain their reason for faking was because their partner did not know what he was doing. The women who discussed this felt as though they would never experience an orgasm with their partner and therefore faked orgasm. These women were faking orgasm in order to end the encounter, and this is where there are similarities to the other studies [10,11,13,15,18]. These previous studies found that women would fake orgasm to end the sexual encounter, however it was for a variety of other reasons such as being tired, bored, or uncomfortable, not that the male partner didn’t know what he was doing. This reason for faking could be explained in large part because of the young age of the female respondents, who in turn may have young, sexually inexperienced partners who do not know what is involved in pleasing their partner.

Feelings about faking. Several studies have investigated how women feel about faking orgasm and women have suggested their male partner would be hurt to know [10, 11, 18], but asking about how their friends feel about their faking behavior has not been a focus of past studies. In this study, the college women were divided in their own feelings about having faked orgasm. On the one hand, many of the women felt as though their behavior was normal and nothing they were concerned about; on the other hand, many women felt guilty about faking orgasm, but they also justified their actions as necessary. These women knew that faking may not have been the right thing to do, but they could justify why it was done. In addition, most of the college women mentioned that they didn’t tell their partner about faking orgasm because they did not want him to have a negative response.

A unique finding in the study was the reaction of her friends. The college women interviewed for this study all described their female friends as having a supportive view of faking orgasm. Many of their college girlfriends shared that they do the same thing, and that they also believe faking orgasm is a very normal behavior.

Sexual scripts. The finding that many college women discussed the role of the media in defining what “normal sex” is and what female orgasm is supposed to look like was unique. Few of the previous studies [11] examined women’s sexual scripts or the variety of societal pressures that are placed on women. All the women in this study described the important role of the media in shaping their understanding of sex and orgasm. The college women participating in this study mentioned either learning about orgasms or faking orgasms through some sort of media such as pornography, movies, or television. These women mentioned having a fantasy version or unrealistic idea of what “normal sex” is “supposed” to look like due to the media influence in their younger years.

The second script that arose from the interviews with college women is the notion that her orgasm serves as a reflection of her partner. Previous studies have also described this need for women to assure her partner of his competency. [26, 27] discuss how it becomes obligatory for women to have an orgasm. A large goal of her orgasm is not about her pleasure; rather it is about making sure her male partner is happy and confident about his own sexual abilities. This belief system further ingrains the sexual double standard that the male orgasm is for pleasure while the female orgasm is for performance. Other studies [11, 15] found that many women faked because they felt that they needed to show their partner that he is doing a good job and give him the impression that they are enjoying sex as much as he is.

Finally, the third script to emerge from the interviews was the notion that female orgasm signals that sex is complete. Many of the women discussed faking orgasm in order to end the sexual experience. This is similar to other studies such as [26] in which they noted that the woman’s orgasm is the “goal of sex.” Similar to the current study, the female orgasm is seen as what needs to happen for the sex to be complete.

Limitations

As with all qualitative studies, the findings of this study cannot be generalized. There were several limitations to this study beginning with a small sample size and being limited by participants who were willing to be interviewed for the study. In-depth interviews were completed with college women who volunteered and therefore may be more open and comfortable with talking about faking orgasm. The interviews relied on the participants’ ability to recall as well as their perceptions of events, which could not be verified. This study was also limited to students who attended one public university in the northeastern U.S. and all shared the same race. A more diverse group of participants may impact the findings. Factors such as women’s race, socioeconomic status, culture, or religious orientation could all play into women’s propensity towards faking orgasm, along with their willingness to discuss such matters.

Future Research

The prevalence of faking orgasm and the reasons why women fake have been the focus of many studies, however, as noted earlier, it is one of the “least well-studied human sexual behaviors” [7]. In relation to the current study, it would be beneficial for future studies to conduct more in-depth investigations focusing on specific aspects of the current study. Future studies could focus solely on the context of faking, reasons for faking, or feelings a woman or her friends might have about faking orgasm. It would also be beneficial to look at the deeper meaning of faking orgasm in terms of the sexual scripts.

It is important to note that all of the participants in this study ranged in age from 19 to 22 years old. This sample was chosen because of the interest in examining young women’s experiences. Recognizing that faking orgasm is increasing among this age group, it is important to understand why. It is useful to examine this age group to understand how society, media, self-image, and male partners all affect their faking behavior. Other studies could compare how younger women differ from older women in their attitudes, beliefs, and influences. Future research could also compare women based on other factors such as ethnicity, race, religion, socioeconomic factors, and sexual orientation. The participants for this study were all women who shared their experiences of faking orgasm with male partners. Further research could examine how women in same sex relationships experience faking orgasm.

Suggestions and Recommendations

The frequency with which women fake orgasm, and the pressure women feel from their partners to reach orgasm provides several suggestions and recommendations for sexuality education. First and foremost, there is greater need for education of basic anatomy, as well as opportunities for discussion of what students see as the purpose of sex. It appears that for many of the women interviewed in this study, sex involves feelings of pressure, and involves an act or performance in order to prove (mostly to the male partner) that the sexual encounter was a success and that she is normal and okay. Better sexuality education is needed for both men and women in order to have a more realistic understanding of sexual function and the role of pleasure.

Second, there is a need for media literacy and a discussion of the role of pornography specifically in shaping ideas about sex. Many of the women felt their faking behavior was influenced by what has been portrayed in pornography, as well as in television shows and in movies. An opportunity to discuss the reality of sexual encounters versus the image portrayed in the media would be useful.

Third, there is a need for greater permission for couples to talk about their sexual response, their desires, motives, what feels good, and what they need. The college women interviewed for this study made it clear that sex is not something you can or should talk about with even your most intimate partner. Better role models for communicating and greater emphasis in sexuality education classes on how to approach topics of sexual pleasure are needed to give both women and men permission to talk with their partner.

Conclusion

This research looked at an understudied aspect of women’s sexuality – faking orgasm – from a qualitative perspective. It focused on young women who fake in order to understand the reasons, context, and influences for such behavior. Among these women’s circles of friends, faking orgasm is considered commonplace and normal. Faking orgasm is not new; however, it appears that more women are faking than in prior generations. For college women, faking behavior has increased dramatically over the past 30 years – from less than half to over three-quarters of college women today saying they have faked an orgasm [8]. This increase in faking seems counter-intuitive as the emergence of the third wave of feminism has worked to empower women, and women are becoming much more aware of their own pleasure and their own bodily autonomy. There are a wide variety of reasons women give for faking, and by delving into these reasons, the sexual scripts that women are raised to believe can be better understood. By deciphering these scripts that lead to faking orgasm, researchers can further understand societal pressure, self-pressure, and partner pressure, and work to change that.

This study was unique in that it used a qualitative methodology to investigate the experiences of college women who had faked orgasm in the context of heterosexual relationships. Women faking orgasm appears to be normalized amongst their peer group. Interviews with these 12 college women revealed many themes and suggested that women have similar experiences when it comes to faking orgasm and their sexual scripts. By understanding the scripts that young women who fake orgasm hold onto, along with the context and reasons for faking orgasm, we can further deconstruct the societal implications tied to what “normal sex” is “supposed” to look like and help them have a more honest and pleasurable sexual experience.

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Reflections on Women’s Medical Autonomy in the 21st Century

DOI: 10.31038/AWHC.2023622

Editorial

One of the fiercest and most pragmatic of women’s battle was their right of medical autonomy vis-a- vis full information and right of acceptance/ refusal of any treatment offered. One of the most celebrated of these medico-legal battles and one which proved a page-turner was the case of Montgomery (Appellant) v Lanarkshire Health Board (Respondent) [2015] UKSC 11. It is time to take a reality check on the situation arising in this case, for it is becoming amply clear that in daily obstetric practice, women’s rights are far from being respected for one reason or another.

Montgomery (Appellant) v Lanarkshire Health Board (Respondent) [2015] UKSC 11 revolved about a pregnant mother’s request for an elective caesarean section was completely rejected by the obstetrician. The mother, a PhD graduate, repeatedly and persistently informed her obstetrician about her fears of a vaginal delivery. Her request for a CS was not unreasonable, for she, a primigravida, would be delivering a baby presenting by the breech. In addition,

(i)She was of a short stature.
(ii)She was a diabetic.
(ii)She was carrying a clinically large baby (4.25kg).

Subsequently, at birth the baby experienced severe shoulder dystocia and developed cerebral palsy of the spastic quadriplegic dyskinetic form consistent with underlying Hypoxic-Ischaemic Encephalopathy. At the Appeals Court, the defendant obstetrician was deemed negligent and the Appellant was awarded the sum of £5.25 million in damages. The ruling is widely held to have displaced the previous “Bolam test” in matters of consent.

There is no doubt that the hefty sum awarded in Montgomery was impressive as was indeed the now doubly underlined warning that that the doctor does not know all and the patient must be informed of all that has to happen to him/her and has the right to accept or reject any medical treatment proposed. This principle of disclosure in itself had been long a-brewing, but Montgomery pushed it to the fore not only in the Anglo-Saxon world but also across the ocean. Not that, anyone needed to be advised to explain managements to patients and listen to their side of the coin.

There was and is a danger with Montgomery that the medical practitioner just listens to what the patient wants and simply concedes. This is not a rare occurrence especially with caesarean sections in private practice. That is not the spirit of the Montgomery judgement which, above all, requires that the physician explains the suggested treatment and any alternatives to it, the pros and the cons, what potential complications may be entailed etc. This is Montgomery and it seeks to elicit the charity, the compassion and the ‘loving father image’ rather than the now rejected paternal aspect of “I know best”. A loving father explains to a child and helps in the right choice. In the great majority of cases, medical practitioners across all disciplines are cut of the “loving father” cloth, but, by no means, does this apply universally so.

I have recently been greatly disturbed by a patient of mine, whose daughter in Germany had had a breech presentation and was repeatedly and forcefully refused a caesarean section. The obstetrician could not be a person well versed with recent obstetric developments nor with modern medical ethics in general. Having confirmed all the details, I was both much amazed and greatly pained at such dictatorial remnant behaviour in 2023. Perhaps this is even commoner than I thought. And in this case, we speak of a woman who was tertiary educated – a PhD, in fact. Imagine what an uneducated woman, a non-English speaker or a refugee goes would to through, at this obstetrician’s hands and his ilk.

The battle for woman’s rights is by no means over. I firmly believe that before such rights can be fought for, their existence must surface, be noted and registered. Taking obstetric care as one example, the mode of delivery, especially and particularly in complicated cases, must be actively discussed with the parents, with an end scope of truly answering their questions. If the mother’s choice is for a particular mode of delivery, the only solid element to bring out and defend against would be maternal and child safety. In a breech delivery, for example, the greatest potential danger in a vaginal delivery, would be fetal intra-partum obstruction with subsequent intra-partum hypoxia and its resultant damage such as cerebral palsy. The inherent surgical and anaesthetic risks in a modern-day caesarean section especially with regional anaesthesia would be far less than the previous situation as discussed.

In Medicine, where one must practice secundum artis, depending on challenge and circumstance, no one can write a book of magical solutions. However, as modern medicine broadens its scientific horizons and new legal and ethical reins regulate behaviour, it is now clear that just as important as the tenets of science that we must be informed about, are the obligations of behaviour, imposed by the continuously evolving principles of law and medical ethics.

Repeated Traumatic Brain Injury is Associated with Neurotoxic Plasma Autoantibodies Directed against the Serotonin 2A and Alpha 1 Adrenergic Receptors

DOI: 10.31038/EDMJ.2023722

Abstract

Objectives: Traumatic brain injury (TBI) was associated with increased plasma agonist autoantibodies targeting the serotonin 2A receptor. Repeated TBI exposure is associated with high risk for neurodegenerative and neuropsychiatric complications. Here we tested a hypothesis that repeated TBI is associated with plasma agonist autoantibodies targeting more than one kind of catecholamine G-protein coupled receptor.

Methods: Protein-A affinity chromatography was used to isolate the IgG fraction of plasma in forty-two middle-aged and older adults who had experienced one or more TBI exposures. The Ig (1/40th dilution=7.5 ug/mL) were tested for neurotoxicity in mouse neuroblastoma cells using an acute neurite retraction assay indicative of Gq11/IP3/Ca2+ and RhoA/Rho kinase signaling pathways’ activation. Three different linear synthetic peptides corresponding to the second extracellular loop of the alpha 1A, alpha 2A or serotonin 2A receptors were used as target antigen in different enzyme-linked immunoassays. The second extracellular loop receptor peptides themselves (alpha 1A, alpha 2A) or a fragment (serotonin 2A) were tested for ability to prevent Ig-induced neurite retraction.

Results: Patients who had experienced either repeated TBI (N=10) or a single TBI with a co-morbid autoimmune disease (N=5) were significantly more likely to harbor neurotoxic plasma autoantibodies targeting both alpha 1 adrenergic and serotonin 2A receptors vs. patients having only a single TBI. Ig-induced neurotoxicity was significantly prevented by co-incubation with either 850 nM prazosin (alpha 1 adrenergic receptor) and/or 500 nM M100907 (serotonin 2A receptor) antagonists. Alpha 1 adrenergic receptor and serotonin 2A receptor Ig immunoreactive level and titer were significantly increased in repeated TBI and single TBI/autoimmune patients (N=7-8) compared to age-matched TBI patients without neurotoxic plasma Ig (N=4). SN.8, a linear synthetic peptide corresponding to a conserved region of the second extracellular loop (ECL) of the serotonin 2A receptor completely prevented neurite retraction induced by repeated TBI plasma Ig. A repeated TBI patient harboring alpha adrenergic receptor AAB alone experienced prospective steep decline in cognitive function over two years.

Conclusions: Repeated TBI and TBI with associated autoimmunity harbored more than one kind of neurotoxic catecholaminergic agonist GPCR autoantibody each associated with high risk for steep rate of cognitive decline. Specific immunoassays using the second extracellular receptor loop as target antigen are needed to detect each specific different GPCR autoantibody. A fragment of the second ECL of the serotonin 2A receptor (SN.8) neutralized Ig-induced neurotoxicity in repeated TBI or TBI with associated systemic autoimmunity.

Introduction

Traumatic brain injury (TBI) contributes to substantially increased global disability including the increased risk for later occurrence of major depressive disorder, Parkinson’s disease or dementia [1]. United States military veterans of the conflicts in Afghanistan and Iraq who sustained repeated TBI exposures are also likely to suffer with chronic post- traumatic stress disorder (PTSD). Certain symptoms of chronic PTSD overlap significantly with those of TBI including mood changes (anxiety, depression, suicidal ideation), and altered cognition (attention deficits, memory impairment). A distinct subset of chronic PTSD symptoms (nightmares, panic attacks) involving hyperarousal suggest dysregulated norepineprhine and epinephrine signaling on alpha 1-adrenergic receptors expressed in the brain and sympathetic nervous systems [2].

G-protein coupled receptors are highly druggable treatment targets, and prazosin, a selective alpha1 adrenergic receptor antagonist is effective for the treatment of nightmare disorder in chronic PTSD [3]. Traumatic brain injury and its later neurodegenerative sequelae (major depression, Parkinson’s disease, dementia) was previously associated with increased plasma agonist autoantibodies targeting the serotonin 2A receptor [4,5]. Here we tested a hypothesis that repeated exposures to traumatic brain injury promotes persistent neuroinflammation leading to the development of humoral autoantibodies targeting two, related catecholaminergic GPCRs, i.e. the serotonin 2A and the alpha 1A adrenergic receptors. We used immunoassays specific for the second extracellular loop regions of the alpha1 A receptor and serotonin 2A receptors to test for co-occurrence of these catecholaminergic receptor- targeting autoantibodies (AAB) and its association with clinical outcomes in 42 middle-age and older adult TBI-sufferers.

Methods

TBI Patients

Informed consent for the local Institutional Review Board-approved studies was obtained from all participants prior to blood drawing or cognitive testing. The participants belonged to two different cohorts, A and B. Cohort A included patients age 50 years or older (N=35) among whom approximately two-thirds of patients were previously reported to harbor plasma autoantibodies targeting a second extracellular loop region of the serotonin 2A receptor [4]. Here we report additional bioassay results in thirty of thirty-five consecutively-enrolled patients from cohort A, i.e. neurite retraction in mouse neuroblastoma cells induced by plasma IgG fraction; and whether plasma IgG-induced neurite retraction was significantly reduced (70% or greater) by the presence of either a highly selective serotonin 2A receptor antagonist (M100907) or a selective alpha 1 adrenergic receptor (prazosin) antagonist. Cohort B is comprised of younger patients age 40-60 years who suffered either a single or repeated TBI exposures. In Cohort B we not only tested Ig for bio-assayable 5-HT2AR-like and alpha 1AR-like neurite retraction, but also for immunoreactivity targeting the second extracellular loop of the alpha 1AR (and/or 5HT2AR).

TBI Exposure

All participants in Cohort A experienced direct force traumatic brain injury. Cohort B participants included patients who had experienced either direct force (n=6), blast TBI (n=5) or both types of TBI (n=1). In nearly all cases, the TBI exposure was judged to have been mild.

Peptides

QN.18, PP.15 (PAPEDETICQINEEP), and RT.18 (RQPDAGAAYPQCGLNDET) are linear synthetic peptides corresponding to the second extracellular loop of the human 5HT2AR, alpha1a AR or alpha 2a AR, respectively. SN.8 (SCLLADDN) is comprised of a subregion of the human 5HT2AR involved in mediating receptor activation All peptides were synthesized at Lifetein, Inc (Hillsborough, NJ). The peptides had purity ≥ 95% and were stored under desiccated conditions at -40 degrees C prior to use. On the day of an experiment an aliquot of lyophilized peptide was dissolved in sterile, phosphate buffered saline or deionized water prior to immunoassay or bioassay.

Protein-A Affinity Chromatography

Protein-A Affinity Chromatography was carried out as previously reported [4]. The resulting IgG fraction obtained from TBI patient plasma was stored at 0-4 degrees C prior to bioassay and immunoassay.

Mouse N2A Neuroblastoma Cells

Mouse N2A Neuroblastoma Cells were obtained from the American Type Culture Collection (Rockville, MD).

N2A Neurite Retraction Bioassay for 5HT2AR-like and Alpha 1AR-like Neurotoxicity

We used a previously reported acute neurite retraction assay in cultured mouse N2A neuroblastoma cells [6] to test the IgG fraction of plasma from adult TBI patients for autoantibodies (AAB) causing significant acute neurite retraction. A selective serotonin 2AR (M100907) and alpha 1AR (prazosin) antagonists was each incubated (separately) with TBI patient IgG to test for significant inhibition (>/=70%) of the AAB-induced N2A neurite retraction.

Enzyme Linked Immunoassay

Enzyme Linked Immunoassay were performed as previously described using the QN..18 second extracellular loop of the 5HT2AR [5] as the target peptide antigen. For the alpha 1AR and alpha 2AR immunoassays, the respective specific second extracellular loop peptide for each receptor PP.15 (alpha 1AR) or RT.18 (alpha 2AR) was substituted in place of QN 18.

Rat Plasma, Protein-G Affinity Chromatography, Enzyme Linked Immunoassays

Rat Plasma, Protein-G Affinity Chromatography, Enzyme Linked Immunoassays plasma was obtained from 25-week-old male spontaneously hypertensive rats (SHR) as previously reported [7]. The IgG fraction was isolated using protein-G affinity chromatography as previously reported [8]. Enzyme linked immunoassay was performed as previously described [7] using either the 5HT2AR second extracellular loop peptide QN.18 or the alpha 1A adrenergic receptor second extracellular loop peptide PP.15 as target antigen.

Statistics

Statistical analysis was performed using unpaired Students’ t-test and Fischer’s exact test.

Results

Co-occurrence of Plasma Alpha 1 Adrenergic- and Serotonin 2A-receptor Autoantibodies in TBI

Table 1 shows the clinical characteristics in a subset of 7/30 TBI patients (from Cohort A) whose plasma IgG had the properties of both alpha1AR targeting and serotonin 2AR target AAB. All seven patients had experienced either recurrent TBI or a single TBI exposure in the setting of having an underlying autoimmune disorder. The dose-response curves of IgG-induced N2A neurite retraction in these seven patients was compared to that of twenty additional patients who had experienced a single TBI and harbored either serotonin 2AR-targeting AAB alone or a lower level of uncharacterized AAB activity (Figure 1). Mean potency (neurotoxicity) in a 1/80th dilution from repeated TBI or autoimmune + single TBI plasma IgG significantly exceeded (P < 0.05) potency in an identical concentration of IgG from single uncomplicated TBI (Figure 1).

Table 1: Clinical characteristics in a subset of older adult TBI patients (Cohort A) who harbored both 5HT2AR-like and Alpha 1 AR- like bioactive Ig or Alpha 1 AR-like Ig alone.

tab 1

rTBI: Repeated Traumatic Brain Injury; Sys: Systemic; PTSD: Post Traumatic Stress Disorder; cognitive dysfunction.

fig 1

Figure 1: The indicated dilution of protein-A eluate fraction of plasma was incubated with mouse neuroblastoma cells and acute neurite retraction was determined as previously reported [ ]. Results are the mean ± SE of two or more measurements. *P<0.05: mean N2A neurite retraction in Ig from seven repeated or autoimmune TBI plasma significantly exceeded level in Ig from twenty patients who suffered a single TBI, not complicated by an autoimmune disorder.

Younger TBI patients many of whom are US military combat veterans having served in Afghanistan or Iraq they had a high rate of repeated TBI exposure and also suffer from post-traumatic stress disorder, whose symptoms overlap with those of TBI (e.g. anxiety and depression). The clinical characteristics in a subset of younger TBI patients (Cohort B) is shown in Table 2 with comparison to Cohort A. Cohort B patients had significantly lower mean age compared to Cohort B patients (Table 2). Six of twelve Cohort B patients tested had (N2A neurite retraction bioassay) evidence for both plasma 5HT2AR and alpha 1AR-like AAB (Table 2) including four patients who experienced repeat mild TBI and two patients who had a single TBI and a coexisting autoimmune disorder (not show in Table 2). The prevalence of chronic PTSD was quite high in Cohort B (75%) but it did not differ significantly from the PTSD prevalence in Cohort A (42%).

Table 2: Clinical characteristics in nested cohort of twelve younger TBI patients (Cohort B): comparison to subset of Cohort A patients harboring 5HT2A and/or alpha 1A receptor AAB.

tab 2

*Four patients had repeated TBI exposures, two patients had single TBI and an autoimmune disorder; ^ six patients harboring both 5HT2A and alpha1- receptor autoantibodies, one patient with only alpha1- receptor autoantibodies. AAB- autoantibodies, PTSD- post traumatic stress disorder. Alpha 1AR- alpha 1 adrenergic receptor.

When the results from Cohort A (N=30) and B (N=12) were combined, a striking association was evident between the presence of 5HT2AR and/or alpha 1AR-targeting bioactive Ig (vs. 5HT2AR Ig alone vs. neither AAB) and either recurrent TBI (7/12 vs 0/15 vs. 0/15; P=0.0016) or single TBI patients having a comorbid systemic autoimmune disorder (P=0.003) (Table 3). These data suggest that repeated TBI exposure carries an equivalent high risk as systemic autoimmunity for development of agonist autoantibodies targeting both 5HT2A and alpha 1A receptors (Table 4).

Table 3: Risk factors associated with combined presence of 5HT2AR and/or Alpha 1AR agonist Ig neurotoxic bioactivity in mouse N2A neuroblastoma cells.

tab 3

^ N=1 patient with recurrent TBI had alpha 1 AR AAB alone

Table 4: PTSD symptoms in Cohort B TBI patients: relation to AAB status

tab 4

^excluding obstructive sleep apnea

Agonist autoantibodies targeting each kind of receptor have been previously reported to be associated with an increased risk for dementia [9,10]. Neurodegenerative disease (dementia, cognitive dysfunction and/or Parkinson’s disease) was highly prevalent (5/7) among older Cohort A patients harboring both 5-HT2AR and/or alpha 1AR AAB (Table 1). In two such patients with recurrent TBI and chronic PTSD (Pt 4 and 6; Table 1) a 7.5 mg/mL (50 nanomolar) concentration of the plasma Ig caused potent 70-75% neurite retraction after 5 mins exposure in N2A cells (Figure 2A). Neurite retraction was substantially prevented by co-incubation with an 850 nanomolar concentration of prazosin (Figure 2A). Plasma Ig in two patients having Parkinsons’ disease (PD) and/or dementia (Pt 1 and 4; Table 1) mediated dose-dependent potent N2A neurotoxicity (i.e. neurite retraction) (Figure 2B). One of the patients (Patient 4, Table 1) who was observed prospectively (over two years) progressed from near normal baseline cognition to clinical dementia, in serial St. Louis University Mental Status testing (Figure 2c). The Patient 4 plasma alpha 1AR-targeting AAB was not detected in an enzyme-linked immunoassay specific for the second extracellular loop of the 5HT2AR (data not shown in Figure 2).

fig 2

Figure 2: A) Protein A- eluate (7.5 mg/mL) from two patients suffering with recurrent TBI, PTSD (Pts 4&6, Table 1) induced acute neurite retraction in N2A mouse neuroblastoma cells. The Ig- induced neurotoxicity (neurite retraction) was substantially prevented by co-incubating cells together with 850 nM concentration of the alpha 1 AR antagonist prazosin. B) Dose-response curves of neurotoxicity in the protein-A eluate fraction of plasma from TBI/PTSD (Pt 4) or TBI/Parkinson disease (Pt 1, Table 1). C) Pt 4 (TBI/chronic PTSD) harboring alpha1AR agonist Ig tested negative in 5HT2AR enzyme linked immunoassay, but experienced substantial 2-year decline in St. Louis University Mental Status (SLUMS) examination score. Dashed line indicates the cutoff score below which the score is indicative of dementia.

Taken together, these data suggested that younger recurrent TBI patients (including those in Cohort B) may be at substantially increased risk for the future development of clinically significant decline in cognitive function. An immunoassay specific for 5HT2AR Ig alone may not suffice to identify all such high- risk TBI patients.

The bioassay (N2A neurite retraction) data in all 42 Cohort A and B patients is summarized here. Twenty-one of 42 patients (50%) had IgG neurotoxicity which was significantly prevented by co-incubation of N2A cells with 200-500 nanomolar concentration of the highly selective 5HT2AR antagonist M100907 (Figure 3A). Fourteen of 42 patients (33%) had IgG neurotoxicity which was incompletely neutralized by M100907 and was not further characterized (Figure 3B). Eleven of 42 patients (26%) had IgG which was (blocked by M100907) and by co-incubation with 850 nanomolar concentration of the selective alpha 1 adrenergic receptor antagonist prazosin. Six patients (14%) demonstrated a low level of neurotoxicity in plasma which was not further characterized. One of 42 patients (2%) tested had an IgG which was solely inhibited by prazosin (alpha 1AR-like), but not by M100907 (5-HT2AR-like). The total exceeds 100% because patients (26%) harboring more than one Ig were counted twice. In an immunoassay specific for the second extracellular loop of the 5HT2AR, patients having 5HT2AR and/or alpha 1AR agonist-like neurotoxic bioactivity (N=12) had significantly higher level of 5HT2AR immunoreactivity compared to TBI patients (N=14) in whom 5HT2AR- or alpha 1 AR-like neurotoxicity could not be confirmed in bioassays (P=0.024) (Figure 3B). These data are consistent with a prior report that human pathologies’ 5-HT2AR Ig-induced neurotoxicity was highly correlated with plasma 5HT2AR immunoreactivity [5] using an enzyme linked immunoassay having QN..18, the entire second (5HT2AR) extracellular loop peptide, as target antigen.

fig 3

Figure 3: A) Neutralization of neurotoxicity in 21 of 42 TBI protein-A eluates by 200-500 nM concentration of the highly selective 5HT2AR antagonist M10097. B) Incomplete neutralization of neurotoxicity in 14 of 42 TBI protein A eluates by 200-500 nM concentration of M100907; C) binding to 5-HT2AR second extracellular loop peptide in protein-A eluates from TBI patients displaying (N=12) or not displaying (N=12) M100907-inhibitable neurotoxicity.

Sleep disorders including trauma nightmares are common in recurrent TBI patients suffering with chronic PTSD. Neutralization of combined (5HT2AR and alpha 1AR) plasma Ig-induced neurotoxicity in a representative patient with recurrent TBI and nightmare disorder is shown in Figure 4. Prazosin, an alpha 1 adrenergic receptor antagonist, is FDA approved to treat hypertension, and was effective in lessening the symptoms in traumatic nightmare disorder in combat veterans [3]. Here we conducted an exploratory analysis of whether alpha 1 AR agonist AAB may be associated with traumatic nightmare disorder in combat veterans suffering recurrent TBI.

fig 4

Figure 4: Ninety-three percent neutralization of neurotoxicity in the protein A eluate of plasma from recurrent TBI (Pt 5, Table 1) having traumatic nightmare disorder by 200 nanomolar concentration of the highly selective 5HT2AR antagonist M100907; eight-two percent neutralization by 850 nanomolar concentration of the specific Alpha 1AR antagonist prazosin. Results are mean ± SEM.

The prevalence of sleep-disorder (excluding obstructive sleep apnea) in Cohort B patients harboring alpha 1AR AAB vs Cohort B patients not harboring plasma alpha 1 AR AAB was increased (5/8 vs 1/4), but the sample size was too small and lacked sufficient power to detect a statistically significant difference. Of interest, Patient 4 harboring plasma alpha 1AR AAB was prescribed prazosin which provided symptomatic relief from traumatic nightmares. Yet despite regularly filling the prazosin prescription, he still experienced a substantial prospective decline in cognitive function over a two-year period. This observation may be consistent (in part) with the relatively short half-life of prazosin’s action and reports that alpha 1AR Ig mediates long-lasting receptor activation.

Mouse neuroblastoma N2A neurite retraction induced by the protein A eluate from a recurrent TBI patient harboring both alpha 1AR and 5HT2AR-targeting AAB was completely neutralized by 25 micromolar concentration of Y27632, a selective RhoA/Rho kinase inhibitor or by 50 micromolar concentration of 2-APB, an IP3R antagonist. These data are consistent with known positive coupling of TBI Ig-induced 5HT2AR and alpha 1AR signaling to Gq11/IP3R/Ca2+ and RhoA/Rho kinase signaling pathways [6].

In patients suffering with Alzheimer’s or vascular dementia, alpha 1 adrenergic receptor agonist autoantibodies were previously reported to target an epitope in the second extracellular loop of the receptor [10]. We next used enzyme linked immunoassays specific for binding to the second extracellular loop of the alpha 1 AR or the 5HT2AR to test plasma Ig from repeated and/or autoimmune TBI patients.

Alpha 1AR immunoreactivity and 5HT2AR immunoreactivity were both significantly elevated (P < 0.01) in the protein-A eluates from younger Cohort B patients who suffered repeated or autoimmune TBI (N=8), compared to level in four age-matched TBI patients lacking neurotoxicity (Figure 5A and 5B). Mean binding was approx. 2-fold higher than background (0.04 Absorbance units) in plasma harboring both alpha 1AR, and 5HT2AR AAB specificities. The Ig titer was also significantly elevated in co-occurring alpha 1AR and 5HT2AR plasmas compared to plasmas from TBI patients lacking neurotoxicity (Figure 6A-6B).

fig 5

Figure 5: Binding to a linear synthetic second extracellular loop peptide of the alpha 1A adrenergic receptor(A) or of the 5HT2A receptor (B) was significantly increased in protein-A eluates (1/40th dilution) from multiple or autoimmune TBI compared to uncomplicated TBI without bioassayable neurotoxicity. Background binding = 0.04 absorbance units. Results are mean ± SEM.

fig 6

Figure 6: Titer of binding to second extracellular loop peptide of the alpha 1A adrenergic receptor (A) or the 5HT2A receptor (B) was significantly increased in the protein-A eluates from multiple or autoimmune TBI vs. uncomplicated TBI lacking bio-assayable neurotoxicity. Background = 0.04 absorbance units.

As a further test of the specificity of recurrent TBI Ig for the alpha 1 AR and 5HT2AR, we used a synthetic peptide identical to the second extracellular loop of the alpha 2A adrenergic receptor (alpha 2R) as the target antigen in an enzyme-linked immunoassay. Since the alpha 2AR couples to Gi/Go subfamily of G proteins leading to decreased intracellular cyclic AMP, its activation is not expected to cause N2A neurite retraction. Alpha 2R agonism has peripheral sympatholytic effects (decreased blood pressure) and in the CNS mediates presynaptic inhibition of neurotransmitter release (epinephrine, norepinephrine) through actions on auto-receptors. To our knowledge, there has been no reports of spontaneously-occurring alpha 2R-targeting agonist autoantibodies in human disorders.

Mean plasma Ig binding (to the A2AR second extracellular loop peptide) in all eight younger TBI patients tested (Cohort B) was minimally elevated above background (1.25-fold) even though it was significantly higher (P < 0.05) compared to binding in four Cohort B TBI patients lacking Ig neurotoxicity (Figure  7A). The titer of A2AR peptide Ig -binding was similarly low, i.e. 1-1.25-fold vs. background (0.04 AU) in multiple TBI, autoimmune TBI, and in TBI lacking neurotoxicity (Figure 7B). Only one of twelve Cohort B patients tested (a patient with potent neurotoxicity who had suffered a single TBI) harbored alpha2R immunoreactivity at a significant level, i.e. 1.5-fold above background. The clinical significance of this finding is unknown. Taken together, these data demonstrating a much lower level of binding to the second extracellular loop of the alpha 2R, an aminergic GPCR family receptor related to the 5HT2AR [11] confirms the specificity of the results in TBI Ig for the alpha 1 AR and 5HT2AR.

fig 7

Figure 7: Absence of significant binding to a linear synthetic second extracellular loop peptide of the alpha 2A adrenergic receptor in the protein-A eluates (1/40th dilution) from multiple or autoimmune TBI compared to uncomplicated TBI lacking bio-assayable neurotoxicity. B) Non-significant, low titer of binding to alpha 2A adrenergic receptor second extracellular loop peptide in protein-A eluates from multiple or autoimmune TBI or uncomplicated TBI. Background binding = 0.04 absorbance units.

The orthosteric binding pockets of aminergic, family GPCR are conserved [9]. A novel small peptide antagonist of the 5HT2AR comprised of an epitope (SN.8) in the C-terminal region of the second ECL was previously reported to have completely neutralized the neurotoxic bioactivity in TBI and neurodegenerative disorders plasma Ig [5]. Here we tested for neutralization of N2A neurite retraction in recurrent or autoimmune TBI plasma by synthetic peptides corresponding to the entire second extracellular loop of the alpha 1A (PAPEDETICQINEEP) or the alpha 2A (RQPDAGAAYPQCGLNDET) adrenergic receptors. A twenty microgram per milliter concentration of SN.8 (SCLLADDN) completely neutralized neurotoxicity in 7.5 ug/mL concentration of autoantibodies in recurrent and single/autoimmune TBI plasma (N=4) (Figure 8A). An identical concentration of PAPEDETICQINEEP, which includes the epitope specific sequence APEDE (shown in bold text) previously reported to have blocked bioactivity in dementia plasma AAB [10] only partially prevented (52%) neurite retraction by the same four recurrent and single/autoimmune TBI plasma Igs (Figure 8B). An identical (twenty microgram per millilter) concentration of RQPDAGAAYPQCGLNDET comprising the entire second ECL of the alpha 2AR had no significant inhibitory effect on neurite retraction by two of two recurrent TBI plasma Ig tested (Figure 8C).

fig 8

Figure 8: Neurite retraction in a 1/40th dilution of the protein-A eluate from multiple or autoimmune TBI was A) nearly completely prevented by co-incubation with a 20 microgram per milliliter concentration of the SN.8 epitope-specific 5HT2AR second extracellular loop peptide, B) partially prevented by co-incubation with a 20 ug/mL concentration of a linear synthetic second extracellular loop peptide of the alpha 1A adrenergic receptor, or C) unaffected by co-incubation with a 20 ug/mL concentration of a linear synthetic peptide of the second extracellular loop of the alpha 2A adrenergic receptor. Results are mean ± SE.

A one-fourth dilution (~1 µg/mL) of the protein-G eluate of plasma in two 25-week-old male Spontaneously Hypertensive Rats (SHR) displayed two-fold increased binding to the second extracellular loop peptides of the 5HT2AR and the alpha 1A adrenergic receptors in two separate enzyme linked immunoassays (Figure 9A). The protein G eluate (1 µg/mL) from a representative twenty-five-week old male SHR caused significant N2A neurite retraction which was completely prevented by co-incubation with a twenty microgram per milliliter concentration of the SN.8 peptide (Figure 9B). Co-incubation with an identical (20 µg/mL) concentration of the PP.15 second extracellular loop peptide from the alpha1A adrenergic receptor had much less inhibitory effect on SHR Ig-induced N2A neurite retraction (Figure 9B).

fig 9

Figure 9: A) Binding to a second extracellular loop peptide of the 5HT2AR or Alpha1A AR was significantly increased in the protein-G eluate fraction of plasma in two, 25-week-old SHR rats compared to background = 0.032 AU. B) Neurite retraction in a 1/4th dilution (~1 µg/mL) of the protein-G eluate of plasma from a representative 25-week-old male SHR rat was completed prevented by co-incubation with a 20 microgram per milliliter concentration of SN..8, but was only 32% inhibited by an identical concentration of PP..15, the alpha 1A adrenergic receptor second extracellular loop peptide. Results are mean ± SEM.

Discussion

The alpha1 adrenergic receptor shares significant amino acid homology with the serotonin 2A receptor [11] in a region of the second extracellular loop involved in mediating long-lasting receptor activation. Both GPCR receptors positively couple to phospholipase C gamma/inositol triphosphate / Ca2+ release signaling pathway to promote IgG neurotoxicity in neuroblastoma cells. Repeated TBI plasma was associated with both significantly increased titer of plasma serotonin 2AR agonist IgG autoantibodies, and the appearance of additional agonist IgG having specificity for the alpha 1-adrenergic receptor based on neutralization of Ig bioactivity by a specific alpha1AR antagonist (prazosin). The striking association between multiple TBI, or single TBI/autoimmune disorder and co-occurrence of bio-assayable and immune-assayable 5HT2AR and alpha 1AR-targeting AAB suggests that specific methods for the early detection of both kinds of AAB specificities may be required to avoid missing TBI patients prone to experience rapid rate of cognitive decline. Patients with underlying systemic autoimmune disorder (e.g. autoimmune thyroid disease) who experienced only a single TBI still had the autoantibody equivalent of ‘repeated TBI exposure’ suggesting such patients may be at higher risk for future neurodegenerative complications compared to patients who experienced a single uncomplicated TBI exposure.

There are currently no medications available to slow the rate of cognitive decline in TBI patients. If future candidate drugs become available for testing, the availability of validated biomarkers (which can serve as surrogates for an increased risk of neurodegeneration) may be quite useful in identifying and monitoring high-risk TBI patients. Increased plasma 5HT2AR-immunoreactive AAB (vs lower AAB) was a significant predictor of a steep (two-year) rate of prospective cognitive decline in a cohort of older adult TBI patients from cohort A [9].

In subsets of Alzheimers’ and vascular dementia [10] autoantibodies targeted an epitope in the second ECL of the alpha 1AR (shown in bold, PAPEDETICQINEEP) located in a region N-terminal to the conserved (underlined) cysteine residue. On the other hand, 5HT2AR- targeting autoantibodies in diverse neurodegenerative pathologies were reported to target (QDDSKVFKEGSCLLADDN) a more highly conserved region of the second extracellular loop (shown in bold letters) including (underlined) amino acid residues which play a key role in mediating aminergic receptor activation [11]. For example, conserved amino acid residues leucine (L) and aspartate (D) play key roles in stabilizing hydrophobic interactions within the transmembrane core (L) and interhelical hydrogen bonding (D) important in activating GPCR signaling, respectively. Since the small hydrophobic SN.8 peptide (SCLLADDN) antagonist contains these two conserved amino acid residues it might ‘compete’ with the same amino acid residues on the native receptor for binding sites important in stabilizing and activating the receptor.

Persistent neuro-inflammation associated with repeated TBI and single/autoimmune TBI may increase the likelihood for occurrence of agonist autoantibodies directed against closely-related catecholamine receptors. Catecholamine receptors are expressed on immune cells and play a role in promoting acute and chronic inflammatory responses [12,13]. Treatment with either 5HT2AR [14] or alpha 1 AR antagonist medication [15] was previously reported to be associated with reduced mortality in severe Covid 19 infection. Plasma agonist 5HT2AR IgG autoantibodies were associated with hyperinflammation in severe Covid-19 infection and increased titer was associated with an increased risk of Covid-19 mortality [16].

Alpha 1 adrenergic receptor autoantibodies were previously reported to increase in subsets of human refractory hypertension [12], however, in the present study only two of forty-two patients (~5%) suffered with refractory hypertension. Alteration in regulatory T cells has been linked with hypertension in the genetically hypertensive male Spontaneously Hypertensive Rat (SHR) strain [17]. Male SHR rats (25-weeks-old) not subjected to TBI, spontaneously harbored both alpha 1A adrenergic and 5HT2A receptor immunoreactive autoantibodies, and the level and titer of the two kinds of plasma catecholaminergic agonist AAB were nearly indistinguishable. Acute N2A neurite retraction induced by male SHR Ig was not only prevented by the 5HT2A second extracellular loop receptor peptide SN.8 (in vitro), but systemic (in vivo) administration of SN.8 in male SHR rats was reported to mediate potent, long-lasting systolic and diastolic blood pressure-lowering [7].

Alpha 1 AR and 5HT2AR are expressed in overlapping, but distinct brain regions. Decreased expression of each receptor was reported in cerebral cortex from dementia patients [18,19] perhaps consistent with shared downstream Gq11/IP3/Ca2+ signaling pathway activation (by AAB) which is toxic in neurons. There has been no prior report of a specific association between alpha 1 AR agonist autoantibodies and TBI. A much larger study is needed to test the hypothesis that alpha 1AR autoantibodies may increase in association with specific symptoms in TBI with chronic PTSD (e.g. trauma nightmares, panic disorder, anxiety).

In summary, plasma alpha 1 adrenergic and serotonin 2A receptor agonist AAB co-occur in patients who experienced repeated TBI or single TBI in the setting of systemic autoimmunity and may contribute to higher risk for dementia. A small peptide antagonist, SN.8 comprised of a highly conserved region of the serotonin 2A receptor whose amino acid residues play key roles in stabilizing aminergic GPCR activation, prevented neurotoxicity from both 5HT2AR- and alpha 1AR-targeting autoantibodies by an unknown mechanism. These observations may have particular relevance to patients expressing both kinds of autoantibodies (without a history of TBI exposure) as the results of a recent study in the Zucker rat strain (which expressed both 5HT2AR and alpha 1AR AAB) indicated significant in vivo neuroprotection (by systemically-administered SN.8) in sham-injured, but not in TBI-injured rats [20].

Acknowledgements

Supported by a grant from the New Jersey Commission of Brain Injury Research (Trenton, New Jersey) NJCBIR22 PIL022 to MBZ.

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Social and Cultural Representation of Autism as Experienced by Mothers in Cameroon

DOI: 10.31038/PSYJ.2023554

Abstract

This study poses the problem of the socio-cultural significance of autism spectrum disorders in the Cameroonian cosmogonic universe. In doing so, we set ourselves the objective of understanding the representations and attributions given to this developmental psychopathology which occurs in the individual from early childhood. Based on work carried out in the African anthropo-sociocultural context, we can draw etiological explanations of autism more from the relationships transgenerational cosmic events that the ego undergoes. There is a generalized paranormal attribution both from the nosological and etiopathogenic point of view which always crystallizes on a fatalistic prognosis. Speeches were collected with an interview grid from four (04) mothers of autistic children living in the city of Yaoundé-Cameroon. It emerges from the analysis of the contents that these children are still considered crazy, mentally disordered or “snake children”. In many Cameroonian cultures, children with ASD are considered born to die. For some, they don’t want to stay in the world of the living. For others, they disrupt the family line by being born and dying multiple times; they are inhabited by an evil spirit which threatens the family and we cannot send them to school, because they are useless. This plunges their parents and neighbors into feelings of shame, guilt and hostility that affect their affective exchanges and their socio-cognitive development. This implies the need for better awareness of this disorder and the possibilities of care and schooling for children who present with them.

Keywords

Autism, Mother, Social representation, Child

Introduction

In each culture, mental illness is interpreted by giving it a specific meaning. We thus try to shed light on the origin of the disease for cultural management. In this work, it is about the social and cultural representations of the autistic child in Cameroon. Childhood autism is defined by Kanner [1] as an inability of children to establish normal relationships with people and to react normally to situations, accompanied by a disorder of affective contact, and appearing from the beginning of life. It is a global and early developmental disorder, which appears from the age of 3 years. The criteria that describe it, however, still pose problems due to its categorization in psychiatric disorders and on the other hand to the fact that in the majority of African cultures, it is caused by the curse and/or the presence of impure spirits. It can therefore be seen that in Africa and in Cameroon in particular, the problem does not lie in the existence of autistic disorders but rather in the mastery of its clinical description as it has been developed by the Association of American Psychiatrists [APA] [2] and by the World Health Organization [WHO] [3].

According to the traditional approach, mental illness is of the magico-religious type, divine punishment, attack by evil spirits, sorcery, transgression by the parents (especially the mother) of a prohibition, malevolence or jealousy of a co-wife are very widely spread. Thus in Mali, in the popular consciousness, the mentally retarded is considered as a person animated by evil spirits [4]. It represents the sign of a curse or a deterioration of social and family relations due to a transgression of ancestral laws. In Senegal, among the Wolofs and Lebous, psychopathological behavior stems from aggression from the outside world, either from a human enemy or from an angry spirit. According to Boyer [5], the child can be the object of alienating parental projections. According to her, in the face of relationship difficulties with a child, parents can set up this type of projection. She thus speaks of a particular psychopathological entity described by Zempleni [6] in Senegal: The “nit-ku-bon” child who could be an example of alienating parental projections.

The set of traits presented by the “nit-ku-bon” child, combining a refusal of verbal and visual communication, singular beauty, excessive wisdom, evoke early childhood autism [4]. In Africa, people with autism are sometimes perceived as idiots, victims of faults committed by their parents or other family members [7]. Some are considered as wizards, as lucky charms, or on the contrary as a curse. The Yoruba of Benin also call children with autism Akibus, which means “to be born and die”. They suspect her children of communicating with spirits and wanting to harm their families. In Cameroon, Lolo [8] had observed that autistic children are often considered as “children born to die”. According to her, they don’t want to stay in the world of the living and disrupt family dynamics by being born and dying multiple times. Parents perceive them as inhabited by an evil, and therefore threatening, spirit. These studies give a brief overview of the autistic child in Africa, but what exactly is Cameroon?

The prevalence of autism and ASD in Cameroon is not precisely known due to the lack of a national registry. This prevalence is estimated at 1/165 [9]. Autism statistics in Cameroon as given by the Ministry of Public Health in 2013, amount to 100, 000 children. According to the WHO, tens of millions of people are affected by autism in Africa [10]. This can be explained by the fact that a majority of countries on this continent are under-informed and do not have appropriate structures for the management of this syndrome. This therefore prompts us to question the social and cultural representation of autism in Cameroon. The objective of this article is to grasp the socio-cultural significance of autism in the anthropo-socio-cosmogonic context of Cameroon.

Methodology

This study is qualitative in nature. The qualitative approach is a research method that makes it possible to analyze and understand phenomena, behaviors, facts or subjects [11]. It is a question of apprehending the social and cultural representation of the autistic child in Cameroon. To fully understand this, the clinical approach was used. Its purpose is to describe the phenomena or the set of observable facts, of events as they occur to us. It therefore made it possible to explore the participants according to their perception, their feelings and their subjective reality that they each have of the autistic child. The clinical method by its singularity and its totality has made it possible to grasp the social and cultural representation of the autistic child in Cameroon. We mainly based ourselves on the case, with the aim of understanding in depth the phenomenon as experienced in a very specific context which is that of Cameroon. The study was done during a camp for parent and child with autism in Yaoundé Cameroon.

The sampling technique adopted in this work is called non-probability. Participants were chosen based on their ability to provide interesting and relevant information about how others perceive their child. They are four mothers of autistic children, of Cameroonian nationality. Data collection was done through semi-structured interviews. This made it possible to center the comments of the participants as well as the perception of the others vis-à-vis their children. These voluntary participants, after signing the informed consent, were free to end the interviews at any time. As a data analysis technique, we used content analysis based on verbatim statements.

Results

This section presents the results of the interviews.

Presentation of the Case

The characteristics of the participants are presented in the Table 1.

Table 1: The characteristics of the participants

Characteristic

Mother 1

Mother 2

Mother 3

Mother 4

Age 49 years old 31 years old 39 years old 45 years old
Ethnic group Bamiléké Yambassa Bamiléké Bamiléké
Marital status Married Married Married Bachelor
Child’s age 4 years old 7 years old 10 years old 11 years old
Age of diagnosis 3 years old 2 years old 3 years old 2 years old
Family history of disability Yes Yes No Yes

Thematic Analysis of Interview Content

Clinical interviews with each participant highlight a number of factors that explain the representation of the child’s disability.

The Autistic Child Seen as Crazy

Mother 1 addresses the issue of representation by questioning family members about the origin and condition of her child. She says: “The family was wondering what went wrong. We wondered if he was crazy; if he is mad; what have we not done and we really wanted to know what autism is”. But this mother believes that family members who call the child crazy or crazy know nothing about the issue of autism. The words of Mother 3 are in the same direction as those of Mother 1. Her child is also described as crazy or mentally disordered. “Sometimes we say he acts like a madman, we say he acts like a mental disorder”.

Child Seen as a Snake Child

As for mother 2, her verbatims on the social representation of autism are different from those of mother 1. In her environment, we speak of a snake child. “This kind of child is a snake child. It was a nurse who told me to go throw my child in the river, she is a nurse. My daughter if there is any advice I can give you, the child here, eh, it is the kind of child that should be sent back to the ancestors. You have to look for a river, you throw it there and you let it go to see the ancestors”. These words of the nurse show to what extent the Cameroonian medical profession has limits with regard to the diagnosis of autism. The representation of the disease as presented by mother 4 is similar to that of mother 2. She relates: “People always have something to say. Either the mother is a witch, or she tried to have an abortion, or she gave birth to a snake child, or she gave birth to a Mongolian child. With these words, she describes the meaning that society and culture give to the situation of her child who is autistic.

In view of the above, it can be said that autism is still poorly perceived in Cameroonian culture. Society considers children with autism to be lunatics, mentally retarded, “snake” children.

Discussion

This research was devoted to the study of the conception that Cameroonians have of autism spectrum disorders. In Africa, people with autism are sometimes perceived as idiots, victims of faults committed by their parents or other members of their family. We find that autistic children in Cameroon are perceived as crazy or “snake” children. This study is consistent with the study by Ebwel et al. [7] on social representations of autism in Africa where he refers to cultural semantics in the Democratic Republic of Congo to demonstrate that autistic children are assimilated to those with mental retardation and/or deafness. According to Lolo [8], autistic children in Cameroon are considered as “children born to die”. For her, they do not want to remain in the world of the living and disturb the family line by being born and dying several times. Parents perceive them as inhabited by an evil spirit that threatens the family. The Yoruba of Benin also call children with autism Akibus, which means “to be born and die”. They suspect them of communicating with spirits and wanting to harm their family. Children with autism are often hidden away, largely because of the stigma associated with having a child with a disability [12]. Indeed, it is shameful and unacceptable for some parents to have an autistic child. The guilt felt is amplified by the family and the neighborhood who attribute any fault to the consequence of a parental fault.

Conclusion

The aim of this study was to grasp the social and cultural representation of autism as experienced by mothers in Cameroon. Autism is a very severe developmental disorder that requires an extremely rigorous approach in the argumentation and assessment of the severity of the disorder. It is characterized by the inability of children to establish normal relationships with people and to react normally to situations. Within Cameroonian communities, children with autism are assimilated to those with mental retardation. The results of the interviews with the mothers who participated in this study show that autistic children are represented as crazy, mentally disordered, “snake” children… Therefore, it is important to raise public awareness about autism childhood in the Cameroonian context.

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Assessing Preinjury Frailty in the Elderly Hip Fracture Patient to Promote Palliative Care Referral in Those at Risk for High Morbidity and Mortality

DOI: 10.31038/IJNM.2023423

Abstract

Objective: To assess preinjury frailty in elderly hip fracture patients as a predictor for postsurgical morbidity and mortality, prompting early referral to palliative care services in patients deemed high-risk for postoperative complications. Including palliative care in the multidisciplinary care of the high-risk patient has been shown to improve quality of life (QOL), increase patient and caregiver satisfaction, and reduce healthcare costs.

Design: The design is a quality improvement initiative.

Setting: The setting is an academic medical center, serving as the region’s Level 1 Trauma Center. There is no current process for measuring frailty as a predictor of postsurgical morbidity and mortality.

Participants: The project’s participants are elderly adults aged 65 and older presenting to the emergency room for treatment following a hip fracture.

Interventions/Measurements: A frailty measurement tool using PDSA (plan-do-study-act) cycles was selected. Next, a clinical decision-making algorithm for risk assessment and palliative care referral was designed and implemented for the project participants. Pre- and post-implementation referral rates and post-implementation risk identification and compliance with the utilization of the risk assessment tool were measured. This initiative aimed to begin preoperative frailty assessment with 50% compliance in the target population, with palliative care referral occurring per recommendations based on an algorithm.

Results: Patients in the post-implementation group were more likely to have their frailty risk evaluated and to receive a palliative care referral than the pre-implementation group. Rates of risk identification and palliative care referral increased by 68% and 85%, respectively, which surpassed the goals of this initiative.

Conclusion: Identifying patients with higher preinjury frailty can predict those at risk for mortality and morbidity, thus indicating those patients for whom palliative care referral may be beneficial. Using a standardized process for preinjury frailty screening and referral increased risk assessment and palliative care referral for elderly hip fracture patients.

Keywords

Hip fracture, Frailty, Frailty screening, Elderly, Palliative care

Introduction

In the United States, there are an estimated two million bone fractures annually [1]. These fractures account for over 432,000 hospital admissions and around 180,000 nursing home admissions [1]. Hip fractures account for 14% of these bone fractures [2], accounting for over 300,000 hospital admissions annually in the United States [3]. Hip fractures represent 72% of fracture-related medical expenses [2], with the estimated cost of hip fracture in the United States being $12-15 billion annually [4]. A low-impact trauma, such as a fall from standing, can result in a fragility fracture, with one of the most common fracture sites being the hip [5]. Fragility fractures result from a force that would not ordinarily result in a fracture [6]. In elderly patients aged 65 and older, a hip fracture is associated with high mortality [7]. Approximately 8-10% of elderly hip fracture patients die within 30 days of surgery [8]. About 20% of older women and 37% of older men die in the year following injury [9]. Hip fracture in this elderly population also increases morbidity [7]. According to Johnston et al. [9], approximately 42% of elderly hip fracture patients will fail to return to their pre-fracture mobility, and 35% will become dependent on personal assistance or an assistive device for ambulation. These patients are four times more likely to need long-term care [9]. This population is more likely to suffer complications such as deep venous thrombosis (DVT), pulmonary embolism (PE), pneumonia (PNA), infection, bleeding, nonunion/malunion, and anesthesia-related complications [10]. Hip fractures are associated with high healthcare costs, with the total annual cost estimated at $50,508 per patient in the United States [2]. Pre-fracture comorbidities are associated with even higher costs [11]. These estimates correspond to $5.96 billion yearly in healthcare spending [2].

According to Alexiou et al. [8], a hip fracture in the elderly can severely impact physical, mental, and psychological health and diminish quality of life (QOL). Due to the high morbidity and mortality associated with a hip fracture in the elderly patient, as well as the economic and caregiver burdens of the injury, early referral to palliative care should be considered to meet the holistic needs of the patient, families and the healthcare system [7]. According to Archibald et al. [12], early palliative care referral is not routinely occurring, thus missing an opportunity to improve the quality of care. Frailty is a state of increased vulnerability to illnesses or health conditions following a stressor event such as a hip fracture, thus increasing the incidence of disability, hospitalization, long-term care, and premature mortality [12]. Frailty is characterized by increased deficits and decreased strength, endurance, and physiological function [13]. These frail, elderly patients are at increased risk of adverse events such as infection, anemia, delirium, and falls [5,10]. Frailty is associated with a 29% increase in hospital costs [3]. Frailty is also associated with increased postoperative mortality [14]. Frail patients who undergo an emergent surgical procedure are 23 times more likely than robust patients to expire on postoperative day one [14]. In the elderly hip fracture population, there is a positive correlation between frailty score and incidence of 1-year mortality [15].

Problem

Many elderly hip fracture patients experience a downward health trajectory despite being without a life-threatening diagnosis [13]. Others have multiple medical diagnoses and comorbidities [13]. A severe illness or injury, such as a hip fracture, can negatively affect QOL due to the burden of symptoms, treatment, or caregiver stress [16]. “Clinical vulnerability of older adults after hip fracture is a consequence of pre-existing frailty that is worsened as a consequence of fracture-fragility, exacerbating disability and driving poorer clinical outcomes over time” [17]. According to Archibald et al. [12], a higher level of frailty in the elderly patient is associated with increased intra-operative resource and postoperative care requirements, thus increasing the length of stay (LOS) and the likelihood of being institutionalized in a long-term care facility following discharge. Even in low-risk procedures, frail patients have a greater than three times incidence of serious complications, including sepsis, pneumonia, and delirium [14,18]. The American College of Surgeons and the American Geriatrics Society recommend that frailty screening be performed as a routine preoperative assessment on patients ≥65 years of age [12]. “The ability of acute care providers to adequately prepare for, recognize and respond to the needs of frail older adults is paramount to aiding prognosis and care plan optimization” [12]. In elective surgery, frailty evaluation can be utilized to optimize preoperative function in the individual [19,20]. Conversely, for emergency or non-elective surgery, such as hip fracture repair, frailty evaluation can trigger early discussion regarding “ceilings of care…and the futility of escalating interventions after complications…” [19]. Preoperative frailty assessment can also ensure appropriate resources are available pending surgical or postsurgical complications [20]. Despite these recommendations, providers often overlook this screening [12].

Clinical Significance

The organization participating in the project is a Magnet-recognized hospital and Level 1 Trauma Center serving as the area’s academic medical center. In the project’s setting, the hospitalist group routinely admits patients who experience a hip fracture with orthopedic consultation. These patients, specifically those 65 years and older, are not routinely screened for frailty by the hospitalist or the orthopedic group. The hospitalist or orthopedic provider can assess a patient’s perioperative risk and individualized needs by incorporating routine frailty screening [14]. The Clinical Frailty Scale (CFS) is a risk stratification tool that evaluates frailty based on comorbidity, function, and cognition to assess a numerical frailty score ranging from very fit to terminally ill [21]. By incorporating a routine frailty screening, the provider can identify patients who would benefit from early palliative care consultation.

Including palliative care in the multidisciplinary care of frail, elderly hip fracture patients is appropriate as these injuries can pose a risk to QOL [22]. Palliative care providers assist with symptom management, QOL, and advanced care planning [23,24]. The palliative care team helps patients determine the best management or treatment options considering the patient’s prognosis and can assist in providing safe and effective pain management to elderly patients [23,24]. “Recent models of optimal palliative care integration emphasize referral at diagnosis, increasing presence as time progresses, and a shift in focus toward rehabilitation and survivorship care if a patient’s illness trajectory improves or toward end-of-life care and hospice referral if their trajectory declines” [24]. Palliative care is associated with lower healthcare utilization and cost savings by honoring patients’ wishes and decreasing the number of medical procedures performed [25]. Palliative care-associated savings average $2,642 per admission for patients discharged alive and $6,896 for patients who pass away during their hospitalization [26]. Despite the benefits of palliative care, this service is often underutilized in this patient population [26]. Patients not diagnosed with cancer are less likely to receive a timely referral [24]. Barriers to the utilization of palliative care occur due to a knowledge deficit on the purpose and benefits of these services [27]. Many patients and providers are uncomfortable discussing advanced directives, leaving patients open to potentially unwanted invasive procedures in an emergency [7]. Providers may be reluctant to consult palliative care to prevent loss of hope or increased fear [27]. Additionally, palliative care is frequently mistaken for end-of-life care. According to the World Health Organization (WHO), palliative care is an approach that seeks to improve the QOL of patients and their families facing life-threatening illnesses “through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial, and spiritual” [16]. Radbrudh et al. [16] state that palliative care is not intended to expedite or postpone death but rather to manage symptoms. Palliative care has been shown to reduce pain symptoms and psycho-emotional stress, which correlates to higher patient satisfaction [28]. Palliative care assessment of every hip fracture patient is unrealistic due to limited resources; however, palliative care evaluation for those elderly hip fracture patients who score higher on the risk stratification scale, such as the CFS, is a practical approach [27].

Materials and Methods

This quality improvement (QI) project focuses on the principles of patient-centered care, which includes “respect for patient values, preferences, and expressed needs, coordination and integration of care, and providing emotional support alongside the alleviation of fear and anxiety associated with clinical care” [29]. Therefore, this project aims to enhance QOL by incorporating palliative care into holistic care through symptom management and patient and caregiver satisfaction [30]. These aims are accomplished by promoting open discussions regarding the goals of care and patient preferences [7].

Development of PICOT (Patient, Intervention, Comparison, Outcomes, Time) Question

The population of interest included patients aged 65 and older who had sustained a hip fracture. The primary intervention of interest was utilizing the CFS screening tool on each of these patients on admission, with a goal of at least 50% compliance with this risk assessment by the admitting provider. This intervention was compared to the current practice of not evaluating preoperative frailty in the target population, thus missing identifying those at increased risk for poor outcomes. The desired outcome included considering palliative care referrals for those who scored moderately frail and above. This project aimed to improve QOL and patient satisfaction in the target population. The project was implemented from November to December 2022, and the results were compared to the same period in 2021.

PICOT Question

In the elderly (≥years/age) hospitalized patient who experiences an acute fragility hip fracture (P), how does the implementation of the Clinical Frailty Scale (CFS) tool on hospital admission (I) compared to no frailty screening (C), increase the incidence of palliative care referral in the target population (O)?

Evidence: Review of Literature/Literature Search

A literature search was conducted with the previously mentioned PICOT question as the focus. The databases searched included PubMed and CINAHL; the search engine Google Scholar was also utilized. A PRISMA diagram (Figure 1) is included to describe the literature search. Two studies were excluded from the databases and three from the search engine due to duplication. PubMed was searched using the keywords (hip fracture AND frailty scale) and (hip fracture AND frailty). MeSH terms included the following: aged, conservative treatment, femoral fractures/therapy, femoral fractures/psychology, femoral fractures/rehabilitation, frailty/diagnosis, frailty/psychology, life expectancy, quality of life, activities of daily living, comorbidity, mobility limitation, recovery of function, walking, hip fractures/therapy, frail elderly, hip fractures/mortality, long-term care, frail elderly/statistics and numerical data, frail elderly/statistics and numerical data, decision making, hip fractures/complications, multimorbidity, and patient acceptance of health care. Boolean connectors included “Hip fracture AND frail AND mortality” and “hip fracture AND frail AND palliative care.” When limiting to publications over the past five years, PubMed revealed thirty-four studies with abstracts reviewed. Thirty-two articles were eliminated based on abstract evaluation lacking either hip fracture diagnosis or utilization of frailty scale. Two studies were retained for appraisal after being found to meet topic relevance.

fig 1

Figure 1: 1A PRISMA diagram
From : Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372:n71.
doi: 10.1136/bmj.n71. For more information, visit: http://www.prisma-statement.org/

CINAHL search was performed using the keywords (hip fract* AND frailty scale), (femoral neck fract* AND frailty scale), and (femoral neck fract* AND frail*). Limitations included studies from the last five years and the English language. The search revealed sixteen studies with all abstracts reviewed. Fifteen articles were eliminated, not meeting topic relevance; one was retained for appraisal. A search was conducted utilizing the Google Scholar database with the keywords “hip fracture” AND “palliative care” AND “elderly” AND “frail” AND “frailty scale.” Narrowing the studies to include the last five years and review articles revealed 23 results. Three of the studies were duplicates of a previous search. Ten articles were retained for review, and four were eliminated based on a review of the abstract; five did not contain information regarding hip fracture. One study was included for appraisal.

Evidence Synthesis

The four articles were appraised using the John Hopkins Evidenced-Based Practice Model for Nursing and Healthcare Professionals. The Research Evidence Appraisal Tool, Appendix E, was utilized for article evaluation. Each article was assigned a level and grade of evaluation, as seen in the Evaluation Table (Table 1) and Study Level and Quality Table (Table 2).

Table 1: Grade of evaluation

Article Citation

Conceptual Framework and Purpose

Design/Method

Sample/Setting

Major Variables Studied (and Their Definitions)

Measurement

Data Analysis

Findings

Appraisal: Worth to Practice

Braude, P., Carter, B., Parry, F., Ibitoye, S., Rickard, F., Walton, B., Short, R., Thompson, J., & Shipway, D. (2021). Predicting 1-year mortality after traumatic injury using the clinical frailty scale. Journal of the American Geriatrics Society, 70(1), 158-167. https://doi.org/10.1111/jgs.17472 No conceptual framework described

Aim: to determine the effect of frailty on 1-year mortality in older adults admitted following trauma

Observational study Level 1 Evidence Quality Grade A High Quality Severn Major Trauma Net-work’s major trauma center based in South West England

Patients ≥ 65 years/age admitted between Nov. 2018 and Sept. 2019 with traumatic injuries (N = 585)

DV: Mortality at 1 yearIV: Level of frailty as measured by CFS Frailty was measured by the CFS included age, sex, comorbidities, injury type and injury severity score CFSNumber deceased at 1-year f/u Median age: 81 years/old55.7% female 44.3% male 50.8% living with frailty (CFS ≥ 5) At 1-year f/u 29.6% had deceased Strengths: large sample size, easily replicated Limitations: did not include hip fracture patients, CFS scores prior to March 2019 were retro-spectively assessed.

 

Conclusion: Association between increasing severity of frailty and 1- year mortality (the chance of dying increased with a higher frailty score)

Note: DV: Dependent Variable, IV: Independent Variable, CFS: Clinical Frailty Scale, f/u: Follow-Up

Article Citation

Conceptual Framework and Purpose

Design/Method

Sample/Setting

Major Variables Studied (and Their Definitions)

Measurement

Data Analysis

Findings

Appraisal: Worth to

Practice

Chan, S., Wong, E. K., Ward, S. E., Kuan, D., & Wong, C. L. (2019). The predictive value of the clinical frailty scale on discharge destination and complications in older hip fracture patients. Journal of Orthopaedic Trauma, 33(10), 497- 502. https://doi.org/10.1097 /bot.000000000000 1518 No conceptual framework described

Aim: to determine if the CFS is associated with discharge destination, in-hospital complica- tions, and length of stay following hip fracture

Retrospective cohort study

 

Level 1 Evidence Quality Grade A High Quality

Setting: Un-named academic level 1 trauma center in Canada Sample: all patients age ≥ 65 years admitted with an isolated hip fracture (N = 423) DV1: Discharge destinationDV2: in- hospital complications

DV3: Length of stay

IV: Level of frailty as measured by CFS

Frailty was measured by the CFS

DV1 measured as either death or discharge to long-term care facility DV2 measured as presence or absence of the hospital complications DV3 measured in days of hospital admission

Data was evaluated by comparing DVs to frailty score Median age: 82.5 years/old

63.3% female

36.7% male

 

15.9% died or were

d/c’d to long term facility 81.8% De-veloped at least 1 compli- cation Median LOS was 7 days

Strengths: first study to examine the use of CFS to predict adverse outcomes

Limitations: small percentage of CFS scores determined in retrospect; universal health care which may affect discharge destinationConclusion: frailty is associated with adverse d/c destination, in-hospital complications and increased LOS

Note: DV: Dependent Variable, IV: Independent Variable, CFS: Clinical Frailty Scale, d/c’d: Discharged

Article Citation

Conceptual Framework and Purpose

Design/Method

Sample/Setting

Major Variables Studied (and

Their Definitions)

Measurement

Data Analysis

Findings

Appraisal: Worth to

Practice

Chen, C., Chen, C., Wang, C., Ko, P., Chen, C., Hsieh, C., & Chiu, H. (2019). Frailty is associated with an increased risk of major adverse outcomes in elderly patients following surgical treatment of hip fracture. Scientific Reports, 9(1), 1 – 9. https://doi.org/10.1038/s41598-019-55459-2 No conceptual framework described

Aim: to determine the effect of the level of frailty on post-operative

emergency room visits, readmission, and mortality

Observational cohort study

Level 1 Evidence Quality Grade A High Quality

Setting: an orthopedic ward in a medical center and a district hospital in Changhua County, Taiwan Sample: Patients ≥ 50 years treated for a hip fracture (N=245) DV1: 1-, 3-, and 6- month emergency department visits

DV2: readmission rates

DV3: mortality ratesIV: level of frailty on CFS

Frailty was measured by the CFS

DV1 measured number of emergency department visits to participating hospitals

DV2 measured as readmissions to participating hospitals due to postoperative complications

DV3 measured in number of all cause mortalities

Data was evaluated by comparing DVs to frailty score at 3 points in time of the study Prevalence of pre-frailty and frailty were markedly higher in womenFrail patients were typically older, had lower BMI, and worse cognitive function Strengths: study examined relationships adjusted for covariates

Limitations: based on subjective data, may not represent all geographical areas

 

Conclusion: frailty is associated with more short-term mortality; pre-frailty was more strongly associated with early ED visits and hospital readmissions

Note: DV: Dependent Variable, IV: Independent Variable, CFS: Clinical Frailty Scale, BMI: Body Mass Index

Article Citation

Conceptual Framework and Purpose

Design/Method

Sample/Setting

Major Variables Studied (and Their Definitions)

Measurement

Data Analysis

Findings

Appraisal: Worth to

Practice

Thorne, G. & Hodgson, L. (2021). Performance of the Nottingham hip fracture score and clinical frailty scale as predictors of short and long-term outcomes: A dual-centre 3-year observational study of hip fracture patients. Journal of Bone and Mineral Metabolism, 39(3), 494-500. No conceptual framework described

Aim: to report outcomes for patients with a hip fracture and compare the performance of the NHFS with the CFS

Observational cohort study

Level 1 Evidence Quality Grade A

 

High Quality

Setting: two non- specialist hospitals on the South Coast of England over a 3- year period from Jan. 2016 to Dec. 2018

 

Sample: Any patient admitted during this time frame who suffered a hip fracture (N=2,422)

DV1: Inpatient mortality

DV2: 30-day mortality

DV3: LOS

IV1: NHFS score

IV2: CFS

score

30-day mortality prediction after hip fracture with NHFS

Frailty measured by CFS Inpatient mortality and 30-day mortality were measured as a percentage

LOS measured in days

Data was evaluated by comparing inpatient mortality, 30-day mortality, and LOS based on CFS scoring and NHFS Median age: 85 years 70.6% female 29.4% male

30-day mortality: 5.8%

 

1-year mortality: 23.5%

 

Average LOS: 18.0 days

Strengths: large sample population, only study to compare NHFS and CFS in predicting mortality and \ hospital stayLimitations: 28% of patients did not have NHFS; 42% did not have CFSzConclusions:

Both CFS and NHFS are useful to predict survival rates for 1 year following injury; neither score predicted LOS

Note: DV: Dependent Variable, IV: Independent Variable, LOS: Length of Stay, NHFS: Nottingham Hip Fracture Score, CFS: Clinical Frailty Scale.

Table 2: Study Level and Quality

Article 1

Article 2

Article 3

Article 4

Level I

·                     Experimental study (RCT)

·                     Systematic Review of RCT’s

·                     Explanatory mixed method design that includes level I quant study

 

 

 Xa

 

 

 

 

 Xa

 

 

 

 Xa

 

 

 

Xa

 

Level II

·                     Quasi-experimental study

·                     System Review w/combination of RCTs, Quasi-exp, or quasi-exp. Only

·                     Explanatory mixed method design that includes only Level II quant study

Level III

·                     Non-experimental

·                     Systematic Review w/combination of exp./non-exp studies

·                     Qualitative study or meta-synthesis

·                     Exploratory, convergent or multiphasic mixed methods

·                     Explanatory mixed method design that includes only a level III quant study

Level IV

Opinion of respected authorities/expert committees, or consensus panels

·                     Clinical practice guidelines

·                     Consensus panels

·                     Position statements

Level V

·                     Integrative/Scoping/Literature Review

·                     QI, program, financial evaluation

·                     Case Reports

·                     Expert opinion

Note: a: High Quality; b: Good Quality; c: Low Quality or Major Flaws; Article 1: Braude et al., (2021); Article 2: Chan et al., (2019); Article 3: Chen et al., (2019); Article 4: Thorne and Hodgkin, (2021).

Table 3 includes the Synthesis Table Outcomes for each study appraised. The synthesis reveals the relationship between frailty and 1-year mortality, short-term mortality, and adverse discharge destinations, including long-term institutionalization and death, in-hospital complications, LOS, early emergency department visits, and hospital readmissions following initial injury/hospitalization. Recommendations for practice change include evaluating acute hip fracture patients ≥65 years of age on a frailty scale as a predictor tool (Table 4), thus assisting the provider in identifying patients who may benefit from palliative care consultation.

Table 3: Table of Recommendation(s) for Practice Change

Recommendation

References in Support of Recommendation

Rationale

Level of Evidence

Quality Rating

1.                   Patients ≥ 65

years of age experiencing an acute hip fracture should be screened on a CFS as a predictor for mortality.

Braude et al., (2021)

 

Chen et al., (2019)

 

Thorne & Hodgson (2021)

To identify those at risk

for 1-year or early

mortality following a

hip fracture as there is a

positive correlation

between severity of

frailty and mortality.

 

I

 

A

2.                   Patients ≥ 65 years of age experiencing an acute hip fracture should be screened on a frailty scale as a predictor for adverse discharge destinations, in-hospital complications, and increased LOS Chan et al., (2019) To identify those at risk

for adverse discharge

destinations such as

death or long-term

institutionalization, in-

hospital complications

and prolonged LOS.

 

I

 

A

Note: CFS: Clinical Frailty Scale, LOS: Length of Stay

Table 4: Table of Strength of Recommendation(s)

Recommendation

Strength of Evidence for Recommendation

References in Support of Recommendation

1. Patients ≥ 65 years of age experiencing an acute hip fracture should be screened on a CFS as a predictor for mortality.

 

*Strong evidence = Strongly recommend

Based on the JHEBP level of evidence and

quality ratings, strong & compelling evidence

with consistent results was found to support

organizational translation (Dang et al., 2022).

 

Braude et al., (2021)

 

Chen et al., (2019)

 

Thorne & Hodgson (2021)

2. Patients ≥ 65 years of age experiencing an acute hip fracture should be screened on a frailty scale as a predictor for adverse discharge destinations, in-hospital complications, and increased LOS

 

*Strong evidence = Strongly recommend

 

Based on the JHEBP level of evidence and

quality ratings, strong & compelling evidence

with consistent results was found to support

organizational translation (Dang et al., 2022).

 

Chan et al., (2019)

 

 

Note: CFS: Clinical Frailty Scale, LOS: Length of Stay

Theoretical/Project Framework

The Model for Improvement guides this QI project using PDSA (Plan-Do-Study-Act) cycles. Initially, project planning included researching the evidence to determine the effectiveness of the proposed intervention. The literature demonstrates that frailty screening is recommended preoperatively for patients aged 65 and older [12]. The benefits of palliative care in frail, elderly patients, regardless of diagnosis, have been established, with improved QOL, patient and family satisfaction, and healthcare costs. Secondly, the plan was formulated. The instructions regarding implementation were widely disseminated among the hospitalist APRNs. This information detailed the scope of the project and project goals, the CFS, and the benefits of including palliative care in the multidisciplinary team caring for the frail, elderly hip fracture patient. SMART (specific, measurable, achievable, relevant, and time-bound) goals describe the project’s aim. The project took place at a university teaching hospital and included the hospitalist APRNs responsible for evaluating frailty in each elderly hip fracture patient utilizing the CFS. The APRNs were then prompted to consider palliative care consultation for patients identified as moderately frail or above. The initial goal for this project was 50% or greater compliance with the use of a CFS and palliative care consultation in the specified population. Measuring progress included evaluating the electronic health record (EHR) of those patients in the target population by measuring the use of a CFS followed by suggested recommendations for palliative care consultation when appropriate. Results were assessed throughout the project implementation to guide further education and project revisions to promote compliance.

Project Design

The project was initiated on a small scale with the hospitalist APRNs performing the CFS, with tentative plans to include all hospitalist providers pending project results. Data was collected and documented. The daily hospitalist patient logs were checked for the inclusion criteria. Once these patients were identified, EHRs were reviewed for the utilization of a CFS by the hospitalist APRNs and the subsequent palliative care referral in those deemed moderately frail and above. The data results were then compared to the same patient population and time frame from one year prior. Data were evaluated to determine the effectiveness of the project.

Implementation

The patients participating in the described project were identified by age and diagnosis, including those aged 65 years and older who sustained an acute hip or femoral neck fracture and who were admitted to the medical center by a hospitalist APRN. On admission, these patients were evaluated for frailty utilizing the CFS. Palliative care consultation was recommended for those scoring moderately frail (6) or above. SWOT (strengths, weaknesses, opportunities, and threats) analysis was conducted on the projected project. Strengths identified included the support of the palliative care team and the hospitalist group. An additional strength was the recommendation of the American College of Surgeons and the American Geriatrics Society to perform frailty screening routinely preoperatively on patients ≥ 65 years [12]. A project weakness included resistance to change by providers within the hospitalist group and misconceptions regarding palliative care. There was concern among providers that frailty screening would be time-consuming and burdensome. Additionally, providers often deferred/refrained from initiating palliative care referrals for fear that their patients would give up hope in their recovery [27]. Some providers misconstrued palliative care as end-of-life care [16]. These weaknesses were mitigated by incorporating education regarding the benefits of palliative care and frailty screening.

By including palliative care providers in the care planning of these patients within the target population, this project provided opportunities for improvement in the patient’s QOL, patient and caregiver satisfaction [31], and healthcare costs [25]. The interdisciplinary care promoted by this project encouraged patient-centered care through the holistic shared management of healthcare challenges [32]. The concern about eliminating potential operative cases from the orthopedic service was a potential threat. This threat was reduced by communicating with the orthopedic team the goals of care, including promoting patient-centered care with optimal surgical recovery based on the patient’s and family’s personal preferences. Barriers identified included increased time and workload, negative attitudes towards change, and the potential for ineffective communication regarding project goals and implementation. Mitigating actions included acknowledging concerns and reinforcing project goals, benefits, patient-centeredness, and cost-effectiveness. The project’s facilitators included multidisciplinary collaborations, communication, and teamwork. The project’s hospitalist group is a large medical group within a university medical center with various expert specialties and consultants. There is excellent teamwork between the hospitalist group and consulting services, such as orthopedics and palliative care, with open communication. Team leaders from the hospitalist service supported the project.

Stakeholders and Project Team

The project team included the Doctoral of Nursing Practice (DNP) student, hospitalist APRNs, palliative care providers, the medical center’s nursing and ancillary staff, the DNP project chair, the DNP project committee member, and the statistician. This multidisciplinary team worked together to provide patient-centered and cost-effective quality care. The CFS was disseminated among the hospitalist APRNs. Instructions regarding implementation were distributed via email and in person to all hospitalist APRNs detailing the project’s scope, project goals, and the benefits of including palliative care in the multidisciplinary team caring for the frail, elderly hip fracture patient. Implementation of the project began in November 2022, with data collection and evaluation from November 1, 2022 – December 31, 2022. Pre-implementation data was also obtained from November 1, 2021 – December 31, 2021. Pre- and post-implementation data included age in years, gender, race, and time of visit. Additional post-implementation data included utilization of CFS, ranking on CFS, risk identified, and referral to palliative care if appropriate. Data was collected via the hospitalist’s daily census reports and EHR chart review. No patient identifiers were required, collected, or saved; therefore, Institutional Review Board (IRB) approval was unnecessary.

Results and Discussion

The frailty assessment was evaluated on the CFS, with frailty measured numerically from 1 (very fit) to 9 (terminally ill) [21]. A study by Rockwood et al. [33] shows a high correlation between the judgment-based CFS and the mathematically based Frailty Index (FI), with a Pearson coefficient of 0.80 and p < 0.01. There is an excellent consistency of the CFS with an experienced geriatric medicine specialist’s opinion (Cohen’s K: 0.80, p < 0.0001) [34]. There is a strong inter-rater reliability (Cohen’s K: 0.811, p < 0.001) and a strong test-retest reliability utilizing the CFS (Cohen’s K: 1.0, p < 0.001) [34]. Data collected for this project included the patient’s age, gender, race, CFS score, month of admission, eligibility, CFS used (yes/no), risk identified (yes/no), and palliative care referral (yes/no) based on findings. The total palliative care referral numbers were compared to the same data from one year prior during the same period. The goal outcome was palliative care referral for those elderly frail hip fracture patients who score moderately frail or above (CFS ≥ 6). Meeting this goal outcome represents QI, with the expected results being improved patient and family satisfaction and reduced healthcare costs.

Findings

During the pre-implementation period from November – December 2021, 24 patients met the criteria with admission by the hospitalist APRNs. Of those 24 patients, only one received a palliative care referral during their hospitalization. In comparison, during project implementation from November – December 2022, 19 patients met the same specified criteria. The CFS risk assessment was performed on 13 of these 19 patients. This number equates to 68.4% compliance with the utilization of the risk assessment tool, surpassing the goal of 50%. Seven of these 13 assessed patients were deemed less than moderately frail, scoring ≤ 5 on the CFS assessment performed by the admitting APRN. Therefore, palliative care referral was not recommended for these seven low-frailty patients. Six of these 13 patients were moderately frail or above (CSF ≥ 6). Four of these six patients with a CFS score of ≥ 6 received the recommended palliative care referral. Based on this data, there was 84.6% compliance with appropriately placed palliative care referrals. Of the 13 patients assessed for frailty, the APRNs performing the assessment appropriately followed the referral recommendations for 11 patients (Table 5).

Table 5: Results

Year

Number in specified population admitted by hospitalist APRN

Number in specified population in which CFS was utilized

Number of those assessed scoring ≥ 6 (moderately frail or above) on CFS

Number in target population receiving palliative care referral

2021

24

N/A

N/A

1

2022

19

13

6

4

Note: APRN: Advanced Practice Registered Nurse, CFS: Clinical Frailty Scale

Implications for Practice/Policy

The goal of this project is to identify those patients who are considered frail by utilizing a CFS on all hip fracture patients within the target population who are admitted to the medical center by the hospitalist service as recommended by the American College of Surgeons and the American Geriatrics Society [12]. These frail patients are considered at high-risk for complications and mortality [5,7], which may affect the patient or caregiver’s QOL due to symptom burden, caregiver stress, and complex treatment options [16]. Palliative care referral is recommended for those patients in the target population who score moderately frail and above (CFS ≥ 6). This QI project is intended to improve patient and caregiver QOL and reduce healthcare costs. Palliative care assists with symptom management and advanced care planning, promoting QOL by identifying and respecting the patient’s personal goals of care [23]. Palliative care is also associated with lowered healthcare utilization and costs, saving an average of $2,642 – $6,896 per patient by respecting the individual’s wishes regarding the plan of care [26]. The study’s strengths included the excellent collaboration between the hospitalist group and the palliative care team. Numerous studies also show the superiority of the CFS over other frailty assessments and a positive correlation between a higher frailty score and morbidity and mortality. Limitations include the small sample size and provider subjectivity of the CFS scoring. Additionally, the study only evaluated elderly patients who had sustained an acute hip fracture and did not address additional types of injuries or surgical procedures. Another limitation includes a lack of evaluation of long-term outcomes, including the patient’s perceived QOL or patient and caregiver satisfaction following palliative care consultation.

References

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