RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures (study protocol).

INTRODUCTION: Most simple undisplaced fractures can be managed without surgery by immobilising the limb with a splint, prescribing medication for pain, and providing advice and early rehabilitation. Recent systematic reviews based on retrospective observational studies have reported that virtual fracture clinics can deliver follow-up care that is safe and cost-effective. However, no randomised controlled trial has investigated if a virtual fracture clinic can provide non-inferior physical function outcomes compared with an in-person clinic for patients with simple fractures. METHODS AND ANALYSIS: 312 participants will be recruited from 2 metropolitan hospitals located in Sydney, Australia. Adult patients will be eligible if they have an acute simple fracture that can be managed with a removable splint and is deemed appropriate for follow-up at either the virtual or in-person fracture clinic by an orthopaedic doctor. Patients will not be eligible if they have a complex fracture that requires a cast or surgery. Eligible participants will be randomised to receive their follow-up care either at the virtual or the in-person fracture clinic. Participants at the virtual fracture clinic will be reviewed within 5 days of receiving a referral through video calls with a physiotherapist. Participants at the in-person fracture clinic will be reviewed by an orthopaedic doctor within 7-10 days of receiving a referral. The primary outcome will be the patient's function measured using the Patient-Specific Functional Scale at 12 weeks. Secondary outcomes will include health-related quality of life, patient-reported experiences, pain, health cost, healthcare utilisation, medication use, adverse events, emergency department representations and surgery. ETHICS AND DISSEMINATION: The study has been approved by the Sydney Local Health District Ethics Review Committee (RPAH Zone) (X23-0200 and 2023/ETH01038). The trial results will be submitted for publication in a reputable international journal and will be presented at professional conferences. TRIAL REGISTRATION NUMBER: ACTRN12623000934640.

Fertility treatment pathways and births for women with and without polycystic ovary syndrome-a retrospective population linked data study.

OBJECTIVE: To study the fertility treatment pathways used by women with and without polycystic ovary syndrome (PCOS) and which pathways were more likely to result in a birth. DESIGN: This retrospective national community-based cohort study used longitudinal self-report survey data (collected 1996-2022; aged 18-49 years) from women born in 1973-1978 who are participants in the Australian Longitudinal Study on Women's Health. The study also used linked administrative data on fertility treatments (1996-2021). PATIENTS: Of the 8,463 eligible women, 1,109 accessed fertility treatment and were included. EXPOSURE: Polycystic ovary syndrome diagnosis was self-reported. MAIN OUTCOME MEASURE: use of ovulation induction (OI), intrauterine insemination, and/or in vitro fertilization (IVF) was established through linked administrative data. Births were self-reported. RESULTS: One in 10 of the eligible participants had PCOS (783/7,987, 10%) and 1 in 4 of the women who used fertility treatment had PCOS (274/1,109, 25%). Women with PCOS were 3 years younger on average at first fertility treatment (M = 31.4 years, SD = 4.18) than women without PCOS (M = 34.2 years, SD = 4.56). Seven treatment pathways were identified and use differed by PCOS status. Women with PCOS were more likely to start with OI (71%; odds ratio [OR] 4.20, 95% confidence interval [CI]: 2.91, 6.07) than women without PCOS (36%). Of the women with PCOS who started with OI, 46% required additional types of treatment. More women without PCOS ended up in IVF (72% vs. 51%). Overall, 63% (701/1,109) had an attributed birth, and in adjusted regressions births did not vary by last type of treatment (IVF: 67%, reference; intrauterine insemination: 67%, OR 0.94 95% CI: 0.56, 1.58; OI: 61%, OR 0.71, 95% CI: 0.52, 0.98), or by PCOS status (OR 1.27, 95% CI: 0.91, 1.77). By age, 74% of women under 35 years (471/639) and 49% of women 35 years or older had a birth. CONCLUSION: More women with PCOS used fertility treatment but births were equivalent to women without PCOS. Most women followed clinical recommendations. Births did not differ between pathways, so there was no disadvantage in starting with less invasive treatments (although there may be financial or emotional disadvantages).

Understanding the Relationship between Illness Perceptions and Health Behaviour among Women with Polycystic Ovary Syndrome.

This paper aims to delineate the cognitive, emotional, and behavioural responses of women with polycystic ovary syndrome (PCOS) to their illness by applying the Common-Sense Model of Self-Regulation (CSM) to their health behaviour. An online cross-sectional design was used to examine the relationship between participants' illness perceptions (illness identity, consequence, timeline, control, and cause) and emotional representations of their PCOS, and their health behaviours (diet, physical activity, and risky contraceptive behaviour). The participants were 252 women between the ages of 18 and 45 years, living in Australia, and self-reporting a diagnosis of PCOS, recruited through social media. Participants completed an online questionnaire regarding illness perceptions as well as their diet, physical activity, and risky contraceptive behaviour. Illness identity was positively associated with the number of maladaptive dietary practices (B = 0.71, 95% CI: 0.003, 0.138; p = 0.04), and perception of longer illness duration was associated with reduced physical activity (OR = 0.898, 95% CI: 0.807, 0.999; p = 0.49) and risky contraceptive behaviour (OR = 0.856, 95% CI: 0.736, 0.997; p = 0.045). The limitations of the study include all data being self-reported (including PCOS diagnosis), and the potential for analyses of physical activity and risky contraceptive use being underpowered due to reduced sample sizes. The sample was also highly educated and restricted to those who use social media. These findings suggest that illness perceptions may play a role in influencing health behaviour in women with PCOS. A better understanding of the illness perceptions of women with PCOS is needed to increase health-promoting behaviour and improve health outcomes for women with PCOS.

A systematic assessment of online international breast density information.

BACKGROUND: Breast density has become a topic of international discussion due to its associated risk of breast cancer. As online is often a primary source of women's health information it is therefore essential that breast density information it is understandable, accurate and reflects the best available evidence. This study aimed to systematically assess online international breast density information including recommendations to women. METHODS: Searches were conducted from five different English-speaking country-specific Google locations. Relevant breast density information was extracted from the identified websites. Readability was assessed using the SHeLL Editor, and understandability and actionability using the Patient Education Materials Assessment Tool (PEMAT). A content analysis of specific recommendations to women was also conducted. RESULTS: Forty-two eligible websites were identified and systematically assessed. The included informational content varied across websites. The average grade reading level across all websites was 12.4 (range 8.9-15.4). The mean understandability was 69.9% and the mean actionability was 40.1%, with 18/42 and 39/42 websites respectively scoring lower than adequate (70%). Thirty-six (85.7%) of the websites had breast density-related recommendation to women, with 'talk to your doctor' (n = 33, 78.6%) the most common. CONCLUSIONS: Online information about breast density varies widely and is not generally presented in a way that women can easily understand and act on, therefore greatly reducing the ability for informed decision-making. International organisations and groups disseminating breast density information need to ensure that women are presented with health literacy-sensitive and balanced information, and be aware of the impact that recommendations may have on practice.

The challenges with managing polycystic ovary syndrome: A qualitative study of women's and clinicians' experiences.

OBJECTIVE: To explore clinicians' and women's views and experiences with managing polycystic ovary syndrome (PCOS). METHODS: Semi-structured interviews with 36 clinicians and 26 women with PCOS. Clinicians were recruited through advertising via relevant professional organisations, snowballing and contacting clinics across Australia. Women with PCOS were recruited through social media advertising. Transcribed audio-recordings were analysed thematically using Framework analysis. RESULTS: Findings across women with PCOS and clinician interviews were organised into three themes. Both women and clinicians experienced 1) challenges with managing PCOS, often stemming from the disparate and wide spectrum of presentations, issues with current treatment options (including limited evidence) and the long-term nature of management. Both spoke about 2) online information about PCOS and alternative treatments, including lack of relevant information and widespread misinformation. 3) Follow-up and continuity of care, where we found notable differences between women's and clinicians' expectations. CONCLUSIONS: This is the first study to explore both clinicians' and women's experiences with managing PCOS, illustrating several challenges in managing this heterogeneous condition. PRACTICE IMPLICATIONS: Clarifying and addressing patient expectations, providing personalised counselling and information according to PCOS phenotype and a multidisciplinary approach may reduce uncertainty and improve patient-centred care.

Breast Density Notification: A Systematic Review of the Impact on Primary Care Practitioners.

Background: In the last decade, there has been an unprecedented amount of advocacy and attention surrounding the issue of breast density (BD) in relation to mammography screening. It is largely unknown what impact notifying women of their BD has had on clinical practice for PCPs. This systematic review aimed to synthesize evidence from existing studies to understand the impact of BD notification on primary care practitioners' (PCPs) knowledge, attitudes, and practice implications. Methods: Empirical studies were identified through relevant database searches (database inception to May 2020). Two authors evaluated the eligibility of studies, extracted and crosschecked data, and assessed the risk of bias. Results were synthesized in a narrative form. Results: Six studies of the 232 titles identified and screened were included. All studies were undertaken in the United States, with five conducted postlegislation in their respective states, and one study conducted in states that were both prelegislation and postlegislation. Five studies were quantitative, including four cross-sectional surveys, and one study was qualitative. Findings consistently demonstrated PCPs' overall lack of knowledge about BD, low level of comfort in discussing and managing patients in relation to dense breasts, and limited consensus on the most appropriate approach for managing women with dense breasts, particularly in relation to supplemental screening. Conclusions: This review highlights important gaps in PCPs' understanding of BD and confidence in having discussions with women about the implications of dense breasts. It identifies the need for high-quality research and the development of evidence-based guidelines to better support PCPs.

The Impact of Breast Density Information or Notification on Women's Cognitive, Psychological, and Behavioral Outcomes: A Systematic Review.

BACKGROUND: Breast density (BD) is an independent risk factor for breast cancer and reduces the sensitivity of mammography. This systematic review aims to synthesize evidence from existing studies to understand the impact of BD information and/or notification on women's cognitive, psychological, and behavioral outcomes. METHODS: Studies were identified via relevant database searches up to March 2020. Two authors evaluated the eligibility of studies with verification from the study team, extracted and crosschecked data, and assessed the risk of bias. RESULTS: Of the 1134 titles identified, 29 studies were included. Twenty-three studies were quantitative, including only 1 randomized controlled trial of women receiving BD information, and 6 were qualitative. Twenty-seven studies were conducted in the United States, with 19 conducted post-BD legislation. The overall results in terms of BD awareness, knowledge, attitudes, perceptions, and intentions were heterogeneous across included studies, with the strongest consistency demonstrated regarding the importance of communication with and involvement of health-care professionals. Together, the studies did, however, highlight that there is still limited awareness of BD in the community, especially in more socioeconomic disadvantaged communities, and limited knowledge about what BD means and the implications for women. Importantly, BD information in the context of overall breast cancer risk has not yet been studied. CONCLUSIONS: There are important gaps in the understanding of the impact of BD information or notification on women and how best to communicate BD information to women. More high-quality evidence to inform both current and future practice related to BD is still needed.

Impact of a diagnosis of polycystic ovary syndrome on diet, physical activity and contraceptive use in young women: findings from the Australian Longitudinal Study of Women's Health.

STUDY QUESTION: Do diet, physical activity and contraceptive use change after receiving a diagnosis of polycystic ovary syndrome (PCOS)? SUMMARY ANSWER: Using longitudinal data 12 months apart, young women newly diagnosed with PCOS were more likely to stop using contraception but did not change their physical activity or vegetable intake. WHAT IS KNOWN ALREADY: Diagnostic criteria for PCOS have widened to capture more women, despite limited evidence of the benefits and harms. Possible benefits of a PCOS diagnosis are that it may help women with family planning and motivate them to implement healthy lifestyle changes to reduce the reproductive, metabolic and cardiovascular risks associated with PCOS. However, there are no empirical studies investigating how women respond to a diagnosis of PCOS with respect to their health behaviour, and longitudinal population-based studies are lacking. STUDY DESIGN, SIZE, DURATION: This is a longitudinal analysis of two waves of data collected 12 months apart from the cohort born 1989-1995 in the Australian Longitudinal Survey on Women's Health, a population-based cohort study. Women in this cohort were first surveyed in 2012-2013, aged 18-23 years. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women who responded to the 2014 survey (aged 19-24, n = 11 344) and 2015 survey (aged 20-25, n = 8961) were included. Using logistic regression, multinomial logistic regression and linear regression, change in vegetable intake, physical activity and contraceptive use were compared for women newly diagnosed with PCOS to women not reporting a diagnosis of PCOS. Changes in psychological distress and BMI were also examined. MAIN RESULTS AND THE ROLE OF CHANCE: Young women reporting a new diagnosis of PCOS were no more likely to increase their vegetable intake or physical activity than women not reporting a PCOS diagnosis. Women newly diagnosed with PCOS were 3.4 times more likely to stop using contraception during the 12-month study period than women without PCOS (14% versus 4%, 95% CI = 2.3 to 5.1, P < 0.001). This difference remained significant after controlling for demographics, chronic conditions associated with PCOS, endometriosis, BMI and psychological distress (P < 0.001). LIMITATIONS, REASONS FOR CAUTION: All data was self-reported including PCOS diagnosis, assessment of diet quality was limited to vegetable intake only. The exact timing of diagnosis within the 12-month period and whether the women intended to conceive are unknown. The number of women reporting a new diagnosis of PCOS was also relatively small. WIDER IMPLICATIONS OF THE FINDINGS: These findings suggest that a diagnosis of PCOS may not produce short-term benefits by way of improving health behaviour. The observed reduction in contraception use suggests some women may be at increased risk of unplanned pregnancies, highlighting the importance of counselling about contraceptive needs. Both potential benefits and harms must be considered when determining the appropriateness of a PCOS diagnosis. STUDY FUNDING/COMPETING INTEREST(S): The Australian Longitudinal Study on Women's Health is funded by the Australian Government Department of Health. BWM reports consultancy for ObsEva, Merck, Merck KGaA and Guerbet. No further competing interests exist. TRIAL REGISTRATION NUMBER: N/A.

Women's Acceptance of Overdetection in Breast Cancer Screening: Can We Assess Harm-Benefit Tradeoffs?

Background. Breast cancer screening has been presented to women as mostly positive for decades, despite voices raising issues related to harms since its introduction. Public communications about breast cancer screening tended to use persuasive techniques aimed at maximizing uptake. Concern about the harm of overdetection is more recent, and awareness of overdetection among the public is limited. We aimed to assess the impact of extensive information on treatment following overdetection in breast screening on women's acceptance of screening, and to assess correlates of acceptance. Methods. We performed an online survey among women aged 45-75 from the general public in the Netherlands and Australia, asking women their maximum acceptable ratio of overdetection, per breast cancer death avoided, for four treatment scenarios (randomized order): mastectomy; lumpectomy; lumpectomy plus radiotherapy; lumpectomy plus radiotherapy and hormone therapy. The effect of treatment was assessed using General Linear Models, controlling for socio-demographics, experience, and psychological characteristics. Results. Four-hundred Australian and 403 Dutch women responded. Around half of the women would always screen, even at a 6:1 overdetection-to-death-avoided ratio. Acceptance was highest for the lumpectomy scenario, decreasing with more invasive treatment. In multivariate analyses the effect of treatment remained (p<0.001). Higher acceptance was seen for women with children (p=0.04), screening experience (p<0.001), and less understanding of overdetection (p<0.001). A learning effect was seen: acceptance was highest for the first scenario shown. Conclusions. Acceptance of overdetection was high, but decreased after the first scenario and with invasiveness of treatment. This provides a first indication that with more knowledge and understanding, women may move from uncritical acceptance of screening towards a more informed decision that involves a trade-off of the benefits and harms.

Words do matter: a systematic review on how different terminology for the same condition influences management preferences.

OBJECTIVES: Changing terminology for low-risk, screen-detected conditions has now been recommended by several expert groups in order to prevent overdiagnosis and reduce the associated harms of overtreatment. However, the effect of terminology on patients' preferences for management is not well understood. This review aims to synthesise existing studies on terminology and its impact on management decision making. DESIGN: Systematic review. METHODS: Studies were included that compared two or more terminologies to describe the same condition and measured the effect on treatment or management preferences and/or choices. Studies were identified via database searches from inception to April 2017, and from reference lists. Two authors evaluated the eligibility of studies with verification from the study team, extracted and crosschecked data, and assessed the risk of bias of included studies. RESULTS: Of the 1399 titles identified, seven studies, all of which included hypothetical scenarios, met the inclusion criteria. Six studies were quantitative and one was qualitative. Six of the studies were of high quality. Studies covered a diverse range of conditions: ductal carcinoma in situ (3), gastro-oesophageal reflux disease (1), conjunctivitis (1), polycystic ovary syndrome (1) and a bony fracture (1). The terminologies compared in each study varied based on the condition assessed. Based on a narrative synthesis of the data, when a more medicalised or precise term was used to describe the condition, it generally resulted in a shift in preference towards more invasive managements, and/or higher ratings of anxiety and perceived severity of the condition. CONCLUSIONS: Different terminology given for the same condition influenced management preferences and psychological outcomes in a consistent pattern in these studies. Changing the terminology may be one strategy to reduce patient preferences for aggressive management responses to low-risk conditions. TRIAL REGISTRATION NUMBER: PROSPERO: CRD42016035643.

Influence of the disease label 'polycystic ovary syndrome' on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women.

Study question: Does the disease label 'polycystic ovary syndrome' (PCOS) have an impact on desire for medical testing and psychosocial outcomes? Summary answer: When given the disease label PCOS in a hypothetical scenario, participants had higher intention to have an ultrasound, perceived the condition to be more severe and had lower self-esteem than those not given the disease label. What is known already: Widening diagnostic criteria and improved imaging sensitivity have increased the number of reproductive-aged women diagnosed with PCOS from 4% to 8% to up to 21%. The uncertain clinical benefit of knowing this diagnosis needs to be weighed against the potential for poor psychological outcomes in women labelled with PCOS. Study design, size, duration: This experimental online study randomised 181 young women to receive one of four hypothetical scenarios of a doctor's visit in a 2 (PCOS disease label versus no disease label) x 2 (information about unreliability of ultrasounds in clarifying diagnosis versus no information) design. Participants/materials, setting, methods: Participants were university students (mean age: 19.4). After presenting the scenario, intention to have an ultrasound, negative affect, self-esteem, perceived severity of condition, credibility of the doctor and interest in a second opinion were measured. Participants were then presented with a second scenario, where the possibility of PCOS overdiagnosis was mentioned. Change in intention and perceived severity were then measured. Main results and the role of chance: Participants given the PCOS label had significantly higher intention to have an ultrasound (mean = 6.62 versus mean = 5.76, P = 0.033, 95% CI(difference) = 0.069-1.599), perceived the condition to be more severe (17.17 versus 15.82, P = 0.019, 95% CI(difference) = 0.229-2.479) and had lower self-esteem (25.86 versus 27.56, P = 0.031, 95% CI(difference) = -3.187 to -0.157). After receiving overdiagnosis information, both intention and perceived severity decreased, regardless of condition (both P < 0.001). Limitations, reasons for caution: This study used hypothetical scenarios; it is likely that for women facing a real diagnosis of PCOS, outcomes would be more affected than in the current study. The hypothetical design, however, allowed the symptoms and risks of PCOS to be held constant across conditions, the impact on intention and psychosocial outcomes directly attributable to the effect of the disease label. Wider implications of the findings: These findings demonstrate the potential negative consequences of PCOS labelling. It is crucial we consider the impact of the label before diagnosing more women with PCOS when clinical benefit of this diagnosis is uncertain. Study funding/competing interest(s): This paper was written with support from a NHMRC grant awarded to the Screening and Test Evaluation Program. J.J. is supported by an NHMRC Early Career Fellowship. K.M. is supported by an NHMRC Career Development Fellowship. The authors declare that no competing interests exist. Trial registration number: ACTRN12617000111370. Trial registration date: 20/01/2017. Date of first patient's enrolment: 01/06/2015.