Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

OBJECTIVE: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. METHODS: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. RESULTS: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. CONCLUSIONS: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.

Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

OBJECTIVE: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects. METHODS: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome. RESULTS: A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice. CONCLUSIONS: We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.

Examining willingness to donate frozen oocytes among women of reproductive age.

RESEARCH QUESTION: What are the predictors of willingness to donate frozen oocytes among women of reproductive age in Australia? DESIGN: An online survey involving 303 women of reproductive age (18-49 years) in Australia who had not frozen their oocytes or planned to freeze their oocytes in the next 12 months. The survey assessed demographic variables, prototype willingness model variables (attitude, subjective norm, prototype similarity and prototype favourability) and additional variables (altruism, empathy and infertility awareness) as predictors of hypothetical scenarios of willingness to donate frozen oocytes. A multivariate repeated measures analysis of variance explored differences in willingness to donate frozen oocytes. Hierarchical multiple regression analysis examined predictors of donor willingness. RESULTS: Women's willingness to donate their frozen oocytes was higher for donating to a friend or family member and to research compared with an egg bank or fertility clinic, or a couple advertising online for an egg donor (all P < 0.001). The prototype willingness model variables were significant predictors of willingness to donate showing slightly varied patterns across four scenarios. After accounting for demographics, regression models including prototype willingness model variables and additional variables accounted for 45-64% of variance in donor willingness. CONCLUSIONS: Frozen oocyte donation may be facilitated by improving attitudes towards donation and establishing positive images of donors. Professionals requiring frozen oocytes for research could focus on creating a sense of social approval for donating in this context. Encouraging frozen oocyte donation could increase access to oocytes for IVF treatment and aid in reducing the psychological burdens associated with involuntary childlessness.

Patient and professional perspectives about using in vitro fertilisation add-ons in the UK and Australia: a qualitative study.

OBJECTIVES: In vitro fertilisation (IVF) add-ons are additional procedures offered alongside an IVF cycle with the aim of improving live birth rates. They are controversial because of the paucity of evidence to support their efficacy and safety, alongside the additional financial cost they often pose to patients. Despite this, they are popular. However, there is limited qualitative research regarding their use. The aims of the VALUE Study were to understand the decision-making process surrounding using or recommending add-ons; report sources of information for add-ons; and explore concerns for safety and effectiveness when considering their use. DESIGN: 'VALUE' is a qualitative semistructured interview study using inductive thematic analysis of anonymised transcriptions. SETTING: Participants were recruited from a broad geographical spread across the UK and Australia from public and private clinical settings. PARTICIPANTS: Patients (n=25) and health professionals (embryologists (n=25) and clinicians (n=24)) were interviewed. A purposive sampling strategy was undertaken. The sampling framework included people having state-subsidised and private cycles, professionals working in public and private sectors, geographical location and professionals of all grades. RESULTS: Patients often made decisions about add-ons based on hope, minimising considerations of safety, efficacy or cost, whereas professionals sought the best outcomes for their patients and wanted to avoid them wasting their money. The driving forces behind add-on use differed: for patients, a professional opinion was the most influential reason, whereas for professionals, it was seen as patient driven. For both groups, applying the available evidence to individual circumstances was very challenging, especially in the sphere of IVF medicine, where the stakes are high. CONCLUSIONS: There is scope to build on the quality of the discourse between patients and professionals. Patients describe valuing their autonomy with add-ons, but for professionals, undertaking informed consent will be critical, no matter where they sit on the spectrum regarding add-ons. TRIAL REGISTRATION: osf.io/vnyb9.

"It all depends on why it's red": qualitative interviews exploring patient and professional views of a traffic light system for IVF add-ons.

Background IVF add-ons are techniques, medicines or procedures used in addition to standard IVF with the aim of improving the chance of success. The United Kingdom's IVF regulator, ( the Human Fertilisation Embryology Authority (HFEA) developed a traffic light system to categorise add-ons as either green, amber, or red, based on results of randomised controlled trials. Method Qualitative interviews were undertaken to explore understanding and views of the HFEA traffic light system among IVF clinicians, embryologists and IVF patients across Australia and the United Kingdom. Results A total of 73 interviews were conducted. Overall, participants were supportive of the intention of the traffic light system, however many limitations were raised. It was widely recognized that a simple traffic light system necessarily omits information which may be important to understanding the evidence base. In particular, the red category was used in scenarios that patients viewed as having different implications for their decision-making, including 'no evidence' and 'evidence of harm'. Patients were surprised at the absence of any green add-ons and questioned the value of a traffic light system in this context. Many participants considered the website a helpful starting point, but desired more detail, including the contributing studies, results specific to patient demographics (e.g., <35 years and >35 years), and inclusion of more options (e.g. acupuncture). Overall, participants believed the website to be reliable and trustworthy, particularly due to the Government affiliation, and despite some concerns regarding transparency and an overly cautious regulator. Conclusion Participants identified many limitations with the current application of the traffic light system. These could be considered in any future updates to the HFEA website and for others developing similar decision support tools.

Systematic protocol and methodology needed for pre-procedure counselling of elective egg freezing patients in Singapore.

Upon legalization of social egg freezing in Singapore from 2023 onwards, compulsory pre-procedure counselling is mandated for all prospective patients to enable informed choice about whether to undergo the procedure. Being a newly introduced medical procedure in Singapore, there are currently no clear directives on what pre-procedure counselling for elective egg freezing should entail. Due to pervasive media and internet influences, prospective egg freezing patients could be misled into believing that the procedure represents a guaranteed path to future motherhood, contrary to statements by professional bodies such as the American Society for Reproductive Medicine (ASRM) and the British Fertility Society (BFS). Hence, comprehensive counselling is recommended to provide women with evidence-based information (e.g. success rates of social egg freezing for women of their age) to ensure they make informed decisions and to avoid possible decision regret. For this purpose, a systematic protocol and methodology for pre-procedure counselling of women considering elective egg freezing was developed, incorporating flowcharts and decision trees that are specifically tailored to the unique sociocultural values and legal restrictions in Singapore. Questions relating to the why, what, how, where and when of the egg freezing procedure should be addressed, which could serve as a roadmap to facilitate informed decision-making by women considering elective egg freezing.

Elective egg freezers' disposition decisions: a qualitative study.

OBJECTIVE: To explore the factors that influence elective egg freezers' disposition decisions toward their surplus-frozen oocytes. DESIGN: Qualitative. SETTING: Not applicable. PATIENT(S): Thirty-one participants: 7 past; 6 current; and 18 future oocyte disposition decision-makers. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Qualitative thematic analysis of interview transcripts. RESULTS: Six inter-related themes were identified related to the decision-making process which are as follows: decisions are dynamic; triggers for the final decision; achieving motherhood; conceptualization of oocytes; the impacts of egg donation on others; and external factors affecting the final disposition outcome. All women reported a type of trigger event for making a final decision (e.g., completing their family). Women who achieved motherhood were more open to donating their oocytes to others but were concerned about the implications for their child and felt responsibility for potential donor children. Women who did not achieve motherhood were unlikely to donate to others due to the grief of not becoming a mother, often feeling alone, misunderstood, and unsupported. Reclaiming oocytes (e.g., taking them home) and closure ceremonies helped some women process their grief. Donating to research was viewed as an altruistic option as oocytes would not be wasted and did not have the "complication" of a genetically-linked child. There was a general lack of knowledge around disposition options at all stages of the process. CONCLUSION(S): Oocyte disposition decisions are dynamic and complex for women, exacerbated by a general lack of understanding of these options. The final decision is framed by: whether women achieved motherhood, dealing with grief if they did not achieve motherhood, and considering the complexities of donating to others. Additional decision support through counseling, decision aids, and early consideration of disposition when eggs are initially stored may help women make informed decisions.

Disposition intentions of elective egg freezers toward their surplus frozen oocytes: a systematic review and meta-analysis.

OBJECTIVE: To examine the disposition outcomes and disposition intentions of elective egg freezers (EEFs) toward their surplus frozen oocytes and the psychosocial determinants underlying these. DESIGN: A systematic review and meta-analysis. SETTING: Not applicable. PATIENT(S): Actual EEFs (women with oocytes in storage), potential EEFs (women investigating elective oocyte cryopreservation or about to freeze their oocytes), and women of reproductive age (women in the community aged ≥18 years). INTERVENTION(S): A systematic review was undertaken and electronically searched MEDLINE, Embase, and PsycINFO on the Ovid platform for conference abstracts and peer-reviewed articles, published in English after January 1, 2010. A search strategy combined synonyms for oocyte, cryopreservation, donation, disposition, elective, and attitude. Eligible studies assessed disposition outcomes (how an oocyte was disposed of) and disposition intentions (how women intend to dispose of an oocyte) and/or the psychosocial determinants underlying disposition outcomes and intentions. The Joanna Briggs Institute Prevalence Tool was used to assess the risk of bias. A meta-analysis using random effects was applied to pool proportions of women with similar disposition intentions toward their oocytes. MAIN OUTCOME MEASURE(S): Disposition outcomes and intentions toward surplus frozen oocytes: donate to research; donate to others; discard; unsure. Psychosocial determinants (beliefs, attitudes, barriers, and facilitators) of disposition outcomes and intentions. RESULT(S): A total of 3,560 records were identified, of which 22 (17 studies) met the inclusion criteria (8 studies from Europe, 7 from North America, and 2 from Asia). No studies reported on past oocyte disposition outcomes. Seventeen studies reported on the future disposition intentions of 5,446 women. Only 2 of the 17 studies reported on the psychosocial determinants of oocyte disposition intentions. There was substantial heterogeneity in the pooled results, which was likely a result of the significant variation in methodology. Actual EEFs were included in eight studies (n = 873), of whom 53% (95% confidence interval [CI], 44-63; I2, 87%) would donate surplus oocytes to research, 31% (95% CI, 23-40; I2, 72%) were unsure, 26% (95% CI, 17-38; I2, 92%) would donate to others, and 12% (95% CI, 6-21; I2, 88%) would discard their eggs. Psychosocial determinants: One study reported that 50% of these women were aware of friends and/or family having difficulty conceiving, which may have contributed to their willingness to donate to others. Potential EEFs were included in 4 studies (n = 645), of whom 38% (95% CI, 28-50; I2, 84%) would donate to research, 32% (95% CI, 17-51; I2, 91%) would donate to others, 29% (95% CI, 17-44; I2, 89%) would discard, and 7% (95% CI, 1-27; I2, 77%) were unsure. Psychosocial determinants: No studies. Women of reproductive age were included in 5 studies (n = 3,933), of whom 59% (95% CI, 48-70; I2, 97%) would donate to research and 46% (95% CI, 35-57; I2, 98%) would donate to others. "Unsure" and "discard" were not provided as response options. Psychosocial determinants: One study reported that the facilitators for donation to others included a family member or friend in need, to help others create a family, financial gain, to further science, and control or input over the selection of recipients. Barriers for donation included fear of having a biological child they do not know or who is raised by someone they know. CONCLUSION(S): No studies reported on the disposition outcomes of past EEFs. Disposition intentions varied across the three groups; however, "donating to research" was the most common disposition preference. Notably, the second disposition preference for one-third of actual EEFs was "unsure" and for one-third of potential EEFs was "donate to others." There were limited studies for actual and potential EEFs, and only two studies that explored the psychosocial determinants of oocyte disposition intentions. Additionally, these data suggest that disposition decisions change as women progress on their egg freezing journey, highlighting the importance of ongoing contact with the fertility team as intentions may change over time. More research is needed to understand the psychosocial determinants of oocyte disposition decisions so fertility clinics can provide EEFs with the support and information they need to make informed decisions about their stored eggs and reduce the level of uncertainty reported among EEFs and the potential risk of psychological distress and regret. CLINICAL TRIAL REGISTRATION NUMBER: PROSPERO 2020: CRD42020202733.

Psychosocial determinants of women's intentions and willingness to freeze their eggs.

OBJECTIVE: To examine the psychosocial factors that influence Australian women's intentions to freeze their eggs. DESIGN: Initially, a qualitative elicitation study followed by a larger-scale quantitative study. SETTING: Both studies were conducted online. PATIENTS: A total of 234 Australian women 25-43 years of age, who identifed as heterosexual, had no children, were open to the idea of having children, were currently not pregnant, and did not have a diagnosis of medical infertility. INTERVENTION: None. MAIN OUTCOME MEASURE(S): Intentions and willingness of women to freeze their eggs. RESULT(S): Hierarchical multiple regression analyses showed that after accounting for demographic variables, there was strong support for the psychosocial predictors of attitude, pressure from others, and control perceptions as predictors of women's intentions to freeze their eggs. Of the additional variables, cognitive bias (influence of the media) was significant, and the final model accounted for 52.7% of variance in women's intentions to freeze their eggs. CONCLUSION(S): This study was the first to predict women's intentions to freeze their eggs using a well-established decision-making model, the theory of planned behavior. Messages designed to develop a positive attitude toward egg freezing, and to encourage an increased perception of personal control of the egg freezing process, as well as approval from others, could support women to investigate egg freezing, in consultation with appropriate medical advice, as an option when faced with possible future infertility. Effective strategies broaden fertility options for women faced with age-related fertility decline, maximize women's chances of a successful pregnancy, and, critically, prevent the often substantial psychological distress associated with involuntary childlessness.

The use of CAM products, practices, and practitioners by long-term endometrial cancer survivors in Australia.

BACKGROUND: The use of complementary and alternative medicines (CAM) has been reported to be frequent and increasing in the general population and among cancer survivors. Very few studies have investigated the use of CAM among long-term endometrial cancer survivors. To address this gap in evidence, this qualitative study aimed to understand the use of CAM and factors motivating the use among long-term survivors of endometrial cancer. METHODS: Semi-structured qualitative interviews were conducted with 17 women diagnosed with endometrial cancer 7-10 years previously, to understand their CAM use and its impact on their wellbeing. Thematic analysis was performed by two researchers to extract the most relevant quotes related to CAM products, practices, and practitioners. RESULTS: All 17 women interviewed used some type of CAM practices, practitioners, or products, specifically 94% concentrated on their diet, 88% focused on their exercise, 59% used a CAM product, 53% visited a CAM practitioner, and 18% used a CAM psychological approach. The main motivators for CAM use included to reduce physical and psychological symptoms, and to stop or reduce medications. Women reported a lack of lifestyle advice from their traditional medical healthcare team which they therefore tried to obtain from other sources. CONCLUSIONS: Our findings suggest CAM practices, practitioners, or products form an important part of women's healthcare options and are commonly used by long-term endometrial cancer survivors. Our data can be of importance to health care professionals and hospitals, as it reflects an unfulfilled need among cancer survivors that does not currently appear to be met by their traditional healthcare team.