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.

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.