Women's interest, knowledge, and attitudes relating to anti-Mullerian hormone testing: a randomized controlled trial.

STUDY QUESTION: What is the impact of co-designed, evidence-based information regarding the anti-Mullerian hormone (AMH) test on women's interest in having the test? SUMMARY ANSWER: Women who viewed the evidence-based information about the AMH test had lower interest in having an AMH test than women who viewed information produced by an online company selling the test direct-to-consumers. WHAT IS KNOWN ALREADY: Online information about AMH testing often has unfounded claims about its ability to predict fertility and conception, and evidence suggests that women seek out and are recommended the AMH test as a measure of their fertility potential. STUDY DESIGN, SIZE, DURATION: An online randomized trial was conducted from November to December 2022. Women were randomized (double-blind, equal allocation) to view one of two types of information: co-designed, evidence-based information about the AMH test (intervention), or existing information about the AMH test from a website which markets the test direct-to-consumers (control). A total of 967 women were included in the final analysis. PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were women recruited through an online panel, who were aged 25-40 years, living in Australia or The Netherlands, had never given birth, were not currently pregnant but would like to have a child now or in the future, and had never had an AMH test. The primary outcome was interest in having an AMH test (seven-point scale; 1 = definitely NOT interested to 7 = definitely interested). Secondary outcomes included attitudes, knowledge, and psychosocial and behavioural outcomes relating to AMH testing. MAIN RESULTS AND THE ROLE OF CHANCE: Women who viewed the evidence-based information about the AMH test had lower interest in having an AMH test (MD = 1.05, 95% CI = 0.83-1.30), less positive attitudes towards (MD = 1.29, 95% CI = 4.57-5.70), and higher knowledge about the test than women who viewed the control information (MD = 0.75, 95% CI = 0.71-0.82). LIMITATIONS, REASONS FOR CAUTION: The sample was more highly educated than the broader Australian and Dutch populations and some measures (e.g. influence on family planning) were hypothetical in nature. WIDER IMPLICATIONS OF THE FINDINGS: Women have higher knowledge of and lower interest in having the AMH test when given evidence-based information about the test and its limitations. Despite previous studies suggesting women are enthusiastic about AMH testing to learn about their fertility potential, we demonstrate that this enthusiasm does not hold when they are informed about the test's limitations. STUDY FUNDING/COMPETING INTEREST(S): This project was supported by an NHMRC Emerging Leader Research Fellowship (2009419) and the Australian Health Research Alliance's Women's Health Research, Translation and Impact Network EMCR award. B.W.M. reports consultancy for ObsEva and Merck and travel support from Merck. D.L. is the Medical Director of, and holds stock in, City Fertility NSW and reports consultancy for Organon and honoraria from Ferring, Besins, and Merck. K.H. reports consultancy and travel support from Merck and Organon. K.M. is a director of Health Literacy Solutions that owns a licence of the Sydney Health Literacy Lab Health Literacy Editor. No other relevant disclosures exist. TRIAL REGISTRATION NUMBER: ACTRN12622001136796. TRIAL REGISTRATION DATE: 17 August 2022. DATE OF FIRST PATIENT'S ENROLMENT: 21 November 2022.

Main COVID-19 information sources in a culturally and linguistically diverse community in Sydney, Australia: A cross-sectional survey.

OBJECTIVE: Describe COVID-19 information-seeking experiences for culturally and linguistically diverse groups in Sydney, Australia. METHODS: Cross-sectional survey, translated into 11 languages; participants recruited from March 21 to July 9, 2021. Regression models identified factors associated with difficulty finding easy-to-understand COVID-19 information. RESULTS: Across 708 participants (88% born overseas, 31% poor English proficiency), difficulty finding easy-to-understand COVID-19 information was rated 4.13 for English (95%CI: 3.85-4.41) and 4.36 for non-English language materials (95%CI: 4.07-4.66) (1 easy to 10 hard). Participants who were older (p < 0.001), had inadequate health literacy (p < 0.001), or poor English proficiency (p < 0.001) found it harder to find easy-to-understand English-language COVID-19 information. Those who had greater difficulty finding easy-to-understand non-English COVID-19 information were younger (p = 0.004), had poor English proficiency (p < 0.001), were university-educated (p = 0.05), and had spent longer living in Australia (p = 0.001). They were more likely to rely on friends and family for COVID-19 information (p = 0.02). There was significant variation in information-seeking experiences across language groups (p's < 0.001). CONCLUSIONS: Easy-to-understand and accessible COVID-19 information is needed to meet the needs of people in culturally and linguistically diverse communities. PRACTICE IMPLICATIONS: COVID-19 communication efforts must involve working alongside these communities to leverage existing communication channels and tailor messages.

Clinicians' perspectives on diagnosing polycystic ovary syndrome in Australia: a qualitative study.

STUDY QUESTION: What are clinicians' views about the diagnosis of polycystic ovary syndrome (PCOS), and how do they handle any complexities and uncertainties in practice? SUMMARY ANSWER: Clinicians have to navigate many areas of complexity and uncertainty regarding the diagnosis of PCOS, related to the diagnostic criteria, limitations in current evidence and misconceptions surrounding diagnosis, and expressed concern about the risk and consequences of both under- and overdiagnosis. WHAT IS KNOWN ALREADY: PCOS is a complex, heterogeneous condition with many areas of uncertainty, raising concerns about both underdiagnosis and overdiagnosis. Quantitative studies with clinicians have found considerable variation in diagnostic criteria used and care provided, as well as a lack of awareness around the breadth of PCOS features and poor uptake of recommended screening for metabolic complications. Clinicians' views about the uncertainties and complexities of diagnosing PCOS have not been explored. STUDY DESIGN, SIZE, DURATION: Semi-structured telephone interviews were conducted with clinicians from September 2017 to July 2018 to explore their perceptions about the diagnosis of PCOS, including how they handle any complexities and uncertainties in practice. PARTICIPANTS/MATERIALS, SETTING, METHODS: A group of 36 clinicians (15 general practitioners, 10 gynaecologists and 11 endocrinologists) currently practicing in Australia, were recruited through advertising via professional organisations, contacting a random sample of endocrine and gynaecology teams across Australia and snowballing. Transcribed audio-recordings were analysed thematically using Framework analysis. MAIN RESULTS AND THE ROLE OF CHANCE: Clinicians expressed a range of uncertainties and complexities regarding the diagnosis of PCOS, which were organised into three areas: (i) establishing diagnosis (e.g. lack of standardisation regarding diagnostic cut-offs, risk of misdiagnosis), (ii) factors influencing the diagnostic process (e.g. awareness of limitations in evidence and consideration of the benefits and harms) and (iii) strategies for handling challenges and uncertainties (e.g. using caution and communication of uncertainties). Clinicians also varied in their concerns regarding under- and overdiagnosis. Overall, most felt the diagnosis was beneficial for women provided that it was the correct diagnosis and time was taken to assess patient expectations and dispel misconceptions, particularly concerning fertility. LIMITATIONS, REASONS FOR CAUTION: There is possible selection bias, as clinicians who are more knowledgeable about PCOS may have been more likely to participate. Clinicians' views may also differ in other countries. WIDER IMPLICATIONS OF THE FINDINGS: These findings underscore the vital need to first consider PCOS a diagnosis of exclusion and use caution before giving a diagnosis in order to reduce misdiagnosis, as suggested by clinicians in our study. Until there is greater standardisation of diagnostic criteria, more transparent conversations with women may help them understand the uncertainties surrounding the criteria and limitations in the evidence. Additionally, clinicians emphasised the importance of education and reassurance to minimise the potential harmful impact of the diagnosis and improve patient-centred outcomes. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the University of Sydney Lifespan Research Network and an NHMRC Program Grant (APP1113532). T.C. is supported by an Australian Government Research Training Program (RTP) Scholarship and a Sydney Medical School Foundation Scholarship, from the The University of Sydney, Australia. B.W.M. reports consultancy for ObsEva, Merck, Merck KGaA and Guerbet. No further competing interests exist. TRIAL REGISTRATION NUMBER: N/A.

'Your hopes can run away with your realistic expectations': a qualitative study of women and men's decision-making when undergoing multiple cycles of IVF.

STUDY QUESTION: What are the factors that contribute to the decision to continue or stop IVF treatment after multiple unsuccessful cycles? SUMMARY ANSWER: Factors contributing to the decision included external factors, such as their doctor's guidance, success rates, the outcomes of previous cycles and anecdotal stories of success, as well as emotional and cognitive drivers, including perception of success, hope and fear of regret. WHAT IS KNOWN ALREADY: Infertility affects about one in six Australian couples of reproductive age. Regarding IVF, some couples with a good prognosis drop out of treatment prematurely, whilst others continue for multiple cycles, despite limited chances of success. Little is known about what factors contribute to the decision to continue IVF after multiple failed cycles. STUDY DESIGN SIZE DURATION: Semi-structured face-to-face and telephone interviews were conducted with 22 participants. Interviews were audio-recorded, transcribed and analysed thematically using Framework analysis. PARTICIPANTS/MATERIALS SETTING METHODS: Doctors and nurses at an Australian private fertility clinic recruited individuals and/or couples who had undergone three or more complete unsuccessful cycles of IVF. MAIN RESULTS AND THE ROLE OF CHANCE: The majority of participants had decided to or were leaning towards continuing treatment. Participants expressed a range of common factors important in their decision-making, which were evident both within and across couples. For most, their doctor's advice and hope were key factors influencing their decision. Most participants expressed they would continue as long as there was a chance of success and until their doctor advised otherwise. Other factors included participants' perception of their likelihood of success, hearing anecdotal stories of success after multiple cycles, positive outcomes of previous cycles and fear of regret. LIMITATIONS REASONS FOR CAUTION: The sample was highly educated and recruited from one private Australian fertility clinic only. Many participants were also couples, which may have resulted in more homogenous data as they shared the same diagnosis for infertility and outcomes of previous cycles. Factors influencing the decision to continue or stop may differ in different sociodemographic populations and in other healthcare systems. WIDER IMPLICATIONS OF THE FINDINGS: Given the important role of the doctor's guidance and patients' own perceptions of their likelihood of success, which they tended to overestimate, it is vital that fertility specialists give accurate and transparent information regarding their likelihood of success and continue to regularly communicate this throughout the IVF journey. Anecdotal stories of success against the odds appeared to be influential in the decision to continue and underpinned unrealistic perceptions of possible success. More personalized, cumulative estimates of likelihood of success may help couples with their decision-making as well as with discussions about ending treatment or setting a limit before commencing IVF. STUDY FUNDING/COMPETING INTERESTS: The study was funded by the National Health and Medical Research Council (NHMRC) Program Grant (APP1113532). No further competing interests exist.

The benefits and harms of receiving a polycystic ovary syndrome diagnosis: a qualitative study of women's experiences.

STUDY QUESTION: What are the benefits and harms of receiving a polycystic ovary syndrome (PCOS) diagnosis in a community sample of women, including impact on psychosocial wellbeing, lifestyle choices and behaviour? SUMMARY ANSWER: Although some women benefit considerably from the diagnosis, such as through increased awareness and reassurance, women with minimal symptoms may experience more harm than benefit, including long-lasting anxiety and altered life plans. WHAT IS KNOWN ALREADY: Disease labels can validate symptoms and play a vital role in understanding and coping with illness; however, they can also cause harm by evoking illness schemas about severity and permanence. Regarding PCOS, the diagnostic criteria have expanded over time to include women with milder phenotypes (such as those without signs of androgen excess). This has occurred despite limited investigation of the benefits and harms of the diagnosis and has increased the number of women diagnosed. STUDY DESIGN SIZE DURATION: Semi-structured interviews were conducted face-to-face or by telephone with 26 participants from April-July 2018 to explore women's experiences with the diagnosis, including the benefits and harms of receiving the diagnosis and the impact on their life. PARTICIPANTS/MATERIALS SETTING METHODS: In total, 26 women in the community self-reporting a diagnosis of PCOS (reporting mild to severe symptoms) made by a medical doctor, aged 18-45 years and living in Australia were recruited through social media. Data were analysed thematically using Framework analysis. MAIN RESULTS AND THE ROLE OF CHANCE: The study identified a range of both positive and negative effects of a PCOS diagnosis in the immediate, short and long-term, which were influenced by symptom severity, expectations and experience. For women with previously unexplained and bothersome symptoms, it was a relief to receive a diagnosis, and this resulted in an increased understanding about the importance of a healthy lifestyle. By contrast, women with milder symptoms often reported feeling shocked and overwhelmed by the diagnosis, consequently experiencing anxiety about the associated long-term risks. The majority of women, regardless of symptom severity, experienced prolonged worry and anxiety about infertility, resulting for some in risk taking with contraception, unintended pregnancies, pressure to conceive early or altered life plans. With time, many women developed positive coping strategies and perceived the diagnosis to be valuable, including those who felt they had experienced minimal benefit or even harm. LIMITATIONS REASONS FOR CAUTION: PCOS diagnosis was self-reported and the sample was highly educated. WIDER IMPLICATIONS OF THE FINDINGS: Fear of infertility was salient for many women, underscoring the need for accurate information, counselling and reassurance of fertility potential. Given the risk of significant consequences, health professionals should use a tailored approach to PCOS diagnosis to increase the benefits of appropriate and timely diagnosis for women affected by significant symptoms, while reducing the harms of unnecessarily labelling healthy women for whom the benefits of a diagnosis are small. STUDY FUNDING/COMPETING INTERESTS: The study was funded by the University of Sydney Lifespan Research Network and an NHMRC Program Grant (APP1113532). B.W.M. reports consultancy for ObsEva, Merck, Merck KGaA and Guerbet. No further competing interests exist. TRIAL REGISTRATION NUMBER: N/A.

Beyond the treatment effect: Evaluating the effects of patient preferences in randomised trials.

The treatments under comparison in a randomised trial should ideally have equal value and acceptability - a position of equipoise - to study participants. However, it is unlikely that true equipoise exists in practice, because at least some participants may have preferences for one treatment or the other, for a variety of reasons. These preferences may be related to study outcomes, and hence affect the estimation of the treatment effect. Furthermore, the effects of preferences can sometimes be substantial, and may even be larger than the direct effect of treatment. Preference effects are of interest in their own right, but they cannot be assessed in the standard parallel group design for a randomised trial. In this paper, we describe a model to represent the impact of preferences on trial outcomes, in addition to the usual treatment effect. In particular, we describe how outcomes might differ between participants who would choose one treatment or the other, if they were free to do so. Additionally, we investigate the difference in outcomes depending on whether or not a participant receives his or her preferred treatment, which we characterise through a so-called preference effect. We then discuss several study designs that have been proposed to measure and exploit data on preferences, and which constitute alternatives to the conventional parallel group design. Based on the model framework, we determine which of the various preference effects can or cannot be estimated with each design. We also illustrate these ideas with some examples of preference designs from the literature.

Physician-patient-companion communication and decision-making: a systematic review of triadic medical consultations.

OBJECTIVE: To systematically review quantitative and qualitative studies exploring physician-adult patient-adult companion (triadic) communication and/or decision-making within all medical encounters. METHODS: Studies were identified via database searches and reference lists. One author assessed eligibility of studies, verified by two co-authors. Data were extracted by one author and cross-checked for accuracy. Two authors assessed the quality of included articles using standardized criteria. RESULTS: Of the 8409 titles identified, 52 studies were included. Summary statements and tables were developed for each of five identified themes. Results indicated companions regularly attended consultations, were frequently perceived as helpful, and assumed a variety of roles. However, their involvement often raised challenges. Patients with increased need were more often accompanied. Some companion behaviours were felt to be more helpful (e.g. informational support) and less helpful (e.g. dominating/demanding behaviours), and preferences for involvement varied widely. CONCLUSION: Triadic communication in medical encounters can be helpful but challenging. Based on analysis of included studies, preliminary strategies for health professionals are proposed. PRACTICE IMPLICATIONS: Preliminary strategies for health professionals include (i) encourage/involve companions, (ii) highlight helpful companion behaviours, (iii) clarify and agree upon role preferences of patient/companions. Future studies should develop and evaluate specific strategies for optimizing triadic consultations.

Optimal allocation of participants for the estimation of selection, preference and treatment effects in the two-stage randomised trial design.

Outcomes in clinical trials may be affected by the choice of treatment that participants might make, if they were indeed allowed to choose (a so-called selection effect), and by whether they actually receive their preferred treatment (a preference effect). Selection and preference effects can be important, but they cannot be estimated in the conventional trial design. An alternative approach is the two-stage randomised trial, in which participants are first randomly divided into two subgroups. In one subgroup, participants are randomly assigned to treatments, while in the other, participants are allowed to choose their own treatment. This approach yields estimates of the direct treatment effect, and of the preference and selection effects. The latter two provide insight that goes considerably beyond what is possible in the standard randomised trial. In this paper, we determine the optimal proportion of participants who should be allocated to the choice subgroup. The precision of the estimated selection, preference and treatment effects are functions of: the total sample size; the proportion of participants allocated to choose their treatment; the variances of the outcome; the proportions of participants who select each treatment in the choice group; and the selection, preference and treatment effects themselves. We develop general expressions for the optimum proportion of participants in the choice group, depending on which effects are of primary interest. We illustrate the results with trial data comparing alternative clinical management strategies for women with abnormal results on cervical screening.