Mammography Screening Preferences Among Screening-Eligible Women in Their 40s : A National U.S. Survey.

BACKGROUND: The U.S. Preventive Services Task Force (USPSTF) recently changed its recommendation for mammography screening from informed decision making to biennial screening for women aged 40 to 49 years. Although many women welcome this change, some may prefer not to be screened at age 40 years. OBJECTIVE: To conduct a national probability-based U.S. survey to investigate breast cancer screening preferences among women aged 39 to 49 years. DESIGN: Pre-post survey with a breast cancer screening decision aid (DA) intervention. (ClinicalTrials.gov: NCT05376241). SETTING: Online national U.S. survey. PARTICIPANTS: 495 women aged 39 to 49 years without a history of breast cancer or a known BRCA1/2 gene mutation. INTERVENTION: A mammography screening DA providing information about screening benefits and harms and a personalized breast cancer risk estimate. MEASUREMENTS: Screening preferences (assessed before and after the DA), 10-year Gail model risk estimate, and whether the information was surprising and different from past messages. RESULTS: Before viewing the DA, 27.0% of participants preferred to delay screening (vs. having mammography at their current age), compared with 38.5% after the DA. There was no increase in the number never wanting mammography (5.4% before the DA vs. 4.3% after the DA). Participants who preferred to delay screening had lower breast cancer risk than those who preferred not to delay. The information about overdiagnosis was surprising for 37.4% of participants versus 27.2% and 22.9% for information about false-positive results and screening benefits, respectively. LIMITATION: Respondent preferences may have been influenced by the then-current USPSTF guideline. CONCLUSION: There are women in their 40s who would prefer to have mammography at an older age, especially after being informed of the benefits and harms of screening. Women who wanted to delay screening were at lower breast cancer risk than women who wanted screening at their current age. Many found information about the benefits and harms of mammography surprising. PRIMARY FUNDING SOURCE: National Cancer Institute.

Using the Behaviour Change Wheel to identify barriers and targeted strategies to improve adherence in randomised clinical trials: The example of MEL-SELF trial of patient-led surveillance for melanoma.

BACKGROUND: Adherence to self-management interventions is critical in both clinical settings and trials to ensure maximal effectiveness. This study reports how the Behaviour Change Wheel may be used to assess barriers to self-management behaviours and develop strategies to maximise adherence in a trial setting (the MEL-SELF trial of patient-led melanoma surveillance). METHODS: The Behaviour Change Wheel was applied by (i) using the Capability, Opportunity, Motivation-Behaviour (COMB) model informed by empirical and review data to identify adherence barriers, (ii) mapping identified barriers to corresponding intervention functions, and (iii) identifying appropriate behaviour change techniques and developing potential solutions using the APEASE (Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects and safety, Equity) criteria. RESULTS: The target adherence behaviour was defined as conducting a thorough skin self-examination and submitting images for teledermatology review. Key barriers identified included: non-engaged skin check partners, inadequate planning, time constraints, low self-efficacy, and technological difficulties. Participants' motivation was positively influenced by perceived health benefits and negatively impacted by emotional states such as anxiety and depression. We identified the following feasible interventions to support adherence: education, training, environmental restructuring, enablement, persuasion, and incentivisation. Proposed solutions included action planning, calendar scheduling, alternative dermatoscopes, optimised communication, educational resources in various formats to boost self-efficacy and motivation and optimised reminders (which will be evaluated in a Study Within A Trial (SWAT)). CONCLUSION: The Behaviour Change Wheel may be used to improve adherence in clinical trials by identifying barriers to self-management behaviours and guiding development of targeted strategies.

Health benefits and harms of mammography screening in older women (75+ years)-a systematic review.

BACKGROUND: There is little evidence on the balance between potential benefits and harms of mammography screening in women 75 years and older. The aim of this systematic review was to synthesise the evidence on the outcomes of mammography screening in women aged 75 years and older. METHODS: A systematic review of mammography screening studies in women aged 75 years and over. RESULTS: Thirty-six studies were included in this review: 27 observational studies and 9 modelling studies. Many of the included studies used no or uninformative comparison groups resulting in a potential bias towards the benefits of screening. Despite this, there was mixed evidence about the benefits and harms of continuing mammography screening beyond the age of 75 years. Some studies showed a beneficial effect on breast cancer mortality, and other studies showed no effect on mortality. Some studies showed some harms (false positive tests and recalls) being comparable to those in younger age-groups, with other studies showing increase in false positive screens and biopsies in older age-group. Although reported in fewer studies, there was consistent evidence of increased overdiagnosis in older age-groups. CONCLUSION: There is limited evidence available to make a recommendation for/against continuing breast screening beyond the age of 75 years. Future studies should use more informative comparisons and should estimate overdiagnosis given potentially substantial harm in this age-group due to competing causes of death. This review was prospectively registered with PROSPERO (CRD42020203131).

Assessing and Understanding Reactance, Self-Exemption, Disbelief, Source Derogation and Information Conflict in Reaction to Overdiagnosis in Mammography Screening: Scale Development and Preliminary Validation.

PURPOSE: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet some people may react to overdiagnosis with doubt and skepticism. The present research assessed 4 related reactions to overdiagnosis: reactance, self-exemption, disbelief, and source derogation (REDS). The degree to which the concept of overdiagnosis conflicts with participants' prior beliefs and health messages (information conflict) was also assessed as a potential antecedent of REDS. We developed a scale to assess these reactions, evaluated how those reactions are related, and identified their potential implications for screening decision making. METHODS: Female participants aged 39 to 49 years read information about overdiagnosis in mammography screening and completed survey questions assessing their reactions to that information. We used a multidimensional theoretical framework to assess dimensionality and overall domain-specific internal consistency of the REDS and Information Conflict questions. Exploratory and confirmatory factor analyses were performed using data randomly split into a training set and test set. Correlations between REDS, screening intentions, and other outcomes were evaluated. RESULTS: Five-hundred twenty-five participants completed an online survey. Exploratory and confirmatory factor analyses identified that Reactance, Self Exemption, Disbelief, Source Derogation, and Information Conflict represent unique constructs. A reduced 20-item scale was created by selecting 4 items per construct, which showed good model fit. Reactance, Disbelief, and Source Derogation were associated with lower intent to use information about overdiagnosis in decision making and the belief that informing people about overdiagnosis is unimportant. CONCLUSIONS: REDS and Information Conflict are distinct but correlated constructs that are common reactions to overdiagnosis. Some of these reactions may have negative implications for making informed screening decisions. HIGHLIGHTS: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet when provided information about overdiagnosis, some people are skeptical.This research developed a measure that assessed different ways in which people might express skepticism about overdiagnosis (reactance, self-exemption, disbelief, source derogation) and also the perception that overdiagnosis conflicts with prior knowledge and health messages (information conflict).These different reactions are distinct but correlated and are common reactions when people learn about overdiagnosis.Reactance, disbelief, and source derogation are associated with lower intent to use information about overdiagnosis in decision making as well as the belief that informing people about overdiagnosis is unimportant.

Women's views about current and future management of Ductal Carcinoma in Situ (DCIS): A mixed-methods study.

Management of low-risk ductal carcinoma in situ (DCIS) is controversial, with clinical trials currently assessing the safety of active monitoring amidst concern about overtreatment. Little is known about general community views regarding DCIS and its management. We aimed to explore women's understanding and views about low-risk DCIS and current and potential future management options. This mixed-method study involved qualitative focus groups and brief quantitative questionnaires. Participants were screening-aged (50-74 years) women, with diverse socioeconomic backgrounds and no personal history of breast cancer/DCIS, recruited from across metropolitan Sydney, Australia. Sessions incorporated an informative presentation interspersed with group discussions which were audio-recorded, transcribed and analysed thematically. Fifty-six women took part in six age-stratified focus groups. Prior awareness of DCIS was limited, however women developed reasonable understanding of DCIS and the relevant issues. Overall, women expressed substantial support for active monitoring being offered as a management approach for low-risk DCIS, and many were interested in participating in a hypothetical clinical trial. Although some women expressed concern that current management may sometimes represent overtreatment, there were mixed views about personally accepting monitoring. Women noted a number of important questions and considerations that would factor into their decision making. Our findings about women's perceptions of active monitoring for DCIS are timely while results of ongoing clinical trials of monitoring are awaited, and may inform clinicians and investigators designing future, similar trials. Exploration of offering well-informed patients the choice of non-surgical management of low-risk DCIS, even outside a clinical trial setting, may be warranted.

Strategies to Improve Adherence to Skin Self-examination and Other Self-management Practices in People at High Risk of Melanoma: A Scoping Review of Randomized Clinical Trials.

Importance: Adherence, both in research trials and in clinical practice, is crucial to the success of interventions. There is limited guidance on strategies to increase adherence and the measurement and reporting of adherence in trials of melanoma self-management practices. Objective: This scoping review aimed to describe (1) strategies to improve adherence to self-management practices in randomized clinical trials of people at high risk of melanoma and (2) measurement and reporting of adherence data in these trials. Evidence Review: Four databases, including MEDLINE, Embase, CENTRAL, and CINAHL, were searched from inception to July 2022. Eligible studies were randomized clinical trials of self-monitoring interventions for early detection of melanoma in people at increased risk due to personal history (eg, melanoma, transplant, dysplastic naevus syndrome), family history of melanoma, or as determined by a risk assessment tool or clinical judgment. Findings: From 939 records screened, 18 eligible randomized clinical trials were identified, ranging in size from 40 to 724 participants, using a range of adherence strategies but with sparse evidence on effectiveness of the strategies. Strategies were classified as trial design (n = 15); social and economic support (n = 5); intervention design (n = 18); intervention and condition support (n = 10); and participant support (n = 18). No strategies were reported for supporting underserved groups (eg, people who are socioeconomically disadvantaged, have low health literacy, non-English speakers, or older adults) to adhere to self-monitoring practices, and few trials targeted provider (referring to both clinicians and researchers) adherence (n = 5). Behavioral support tools included reminders (n = 8), priority-setting guidance (n = 5), and clinician feedback (n = 5). Measurement of adherence was usually by participant report of skin self-examination practice with some recent trials of digital interventions also directly measuring adherence to the intervention through website or application analytic data. Reporting of adherence data was limited, and fewer than half of all reports mentioned adherence in their discussion. Conclusions and Relevance: Using an adaptation of the World Health Organization framework for clinical adherence, this scoping review of randomized clinical trials identified key concepts as well as gaps in the way adherence is approached in design, conduct, and reporting of trials for skin self-examination and other self-management practices in people at high risk of melanoma. These findings may usefully guide future trials and clinical practice; evaluation of adherence strategies may be possible using a Study Within A Trial (SWAT) framework within host trials.

Do patient decision aids help people who are facing decisions about solid organ transplantation? A systematic review.

BACKGROUND: Decisions about solid organ transplantation are complex. Patient decision aids (PDAs) enhance traditional education, by improving knowledge and supporting patients to align their values with treatments. There are increasing numbers of transplantation PDAs, however, it is unclear whether these are effective. We conducted a systematic review of studies assessing the impact of PDA use in transplantation. METHODS: We searched the Cochrane Register of Controlled Trials, CINAHL, EMBASE, MEDLINE, and PsycINFO databases from database inception to October 26, 2020. We included primary studies of solid organ transplantation PDAs defined by the International Patient Decision Aids Standards. All comparators and reported outcomes were included. Mean difference in knowledge (before vs. after) was standardized on a 100-point scale. Pooled-effect for PDAs was calculated and compared to the standard of care for randomized controlled trials (RCTs) and meta-analyzed using random effects. Analysis of all other outcomes was limited due to heterogeneity (PROSPERO registration, CRD42020215940). RESULTS: Seven thousand four hundred and sixty-three studies were screened, 163 underwent full-text review, and 15 studies with 4278 participants were included. Nine studies were RCTs. Seven RCTs assessed knowledge; all demonstrated increased knowledge with PDA use (mean difference, 8.01;95%CI 4.69-11.34, p < .00001). There were many other outcomes, including behavior and acceptability, but these were too heterogenous and infrequently assessed for meaningful synthesis. CONCLUSIONS: This review found that PDAs increase knowledge compared to standard education, though the effect size is small. PDAs are mostly considered acceptable; however, it is difficult to determine whether they improve other decision-making components due to the limited evidence about non-knowledge-based outcomes.

Australian Women's Responses to Breast Density Information: A Content Analysis.

Breast density (BD) is an independent risk factor for breast cancer and reduces mammographic sensitivity. This study explored women's responses and intentions if notified that they had dense breasts. METHODS: Content analysis was used to assess responses from a written questionnaire undertaken in conjunction with focus groups on BD involving 78 Australian women aged 40-74. RESULTS: Half the women reported that they would feel a little anxious if notified they had dense breasts, while 29.5% would not feel anxious. The most common theme (29.5%) related to anxiety was the psychosocial impact of the possibility of developing cancer, and women believed that being better informed could help with anxiety (26.9%). When asked what they would do if notified of having dense breasts, the most common response was to consult their doctor for information/advice (38.5%), followed by considering supplemental screening (23%). Consequently, when asked directly, 65.4% were interested in undergoing supplemental screening, while others (10.3%) said they "wouldn't worry about it too much". DISCUSSION: These findings have important implications for health systems with population-based breast screening programs that are currently considering widespread BD notification in terms of the impact on women, health services and primary care.

Factors associated with women's supplemental screening intentions following dense breast notification in an online randomised experimental study.

Controversy surrounding recommendations for supplemental screening (ultrasound and magnetic resonance screening) in women with dense breasts exists, as the long-term benefits from these additional modalities may not outweigh the harms. This study aimed to examine factors associated with supplemental screening intentions following a hypothetical breast density notification in a population of women who have not been routinely notified. Australian women of breast screening age participated in an online randomised experimental study where they were presented with one of two breast density notifications (with or without health literacy-sensitive information) and asked their screening intentions. After adjusting for covariates in multivariable analyses, women in both groups (n = 940) who indicated higher levels of breast cancer worry, had private health insurance, had a family history of breast cancer, and had a greater number of times previously attending mammography screening had higher intentions for supplemental screening. Understanding women's supplemental screening intentions following notification of dense breasts has important implications for health systems with breast screening considering the impacts of widespread notification. Personal, clinical and psychological factors should be considered when discussing both the benefits and harms of supplemental screening with women with dense breasts.

Australian General Practitioners' Current Knowledge, Understanding, and Feelings Regarding Breast Density Information and Notification: A Cross-Sectional Study.

BACKGROUND: There is a lack of evidence around Australian general practitioners' (GPs) views of issues surrounding breast density. The current study aimed to quantitatively assess GPs' current knowledge, understanding, and feelings around breast density information and notification. METHODS: This study involved a cross-sectional survey using an online platform to collect quantitative data from Australian GPs. Survey data were analysed with descriptive statistics. RESULTS: A total 60 responses from GPs were analysed. Most (n = 58; 97%) had heard or read about breast density and nearly 90% (n = 52; 87%) have had discussions about breast density with patients. Three-quarters (n = 45; 75%) were supportive of making breast density notification mandatory for patients with dense tissue and a similar proportion (n = 45/58; 78%) felt they need or want more education on breast density. CONCLUSIONS: There is strong support for notifying patients of breast density, and interest in further education and training among the surveyed GPs. As GPs play a central role in cancer prevention and control, their involvement in discussions related to breast density notification, evaluation and appraisal of evidence, development of communication strategies, and participation in ongoing research on the topic will be indispensable.

Effects of awareness of breast cancer overdiagnosis among women with screen-detected or incidentally found breast cancer: a qualitative interview study.

OBJECTIVES: To explore experiences of women who identified themselves as having a possible breast cancer overdiagnosis. DESIGN: Qualitative interview study using key components of a grounded theory analysis. SETTING: International interviews with women diagnosed with breast cancer and aware of the concept of overdiagnosis. PARTICIPANTS: Twelve women aged 48-77 years from the UK (6), USA (4), Canada (1) and Australia (1) who had breast cancer (ductal carcinoma in situ n=9, (invasive) breast cancer n=3) diagnosed between 2004 and 2019, and who were aware of the possibility of overdiagnosis. Participants were recruited via online blogs and professional clinical networks. RESULTS: Most women (10/12) became aware of overdiagnosis after their own diagnosis. All were concerned about the possibility of overdiagnosis or overtreatment or both. Finding out about overdiagnosis/overtreatment had negative psychosocial impacts on women's sense of self, quality of interactions with medical professionals, and for some, had triggered deep remorse about past decisions and actions. Many were uncomfortable with being treated as a cancer patient when they did not feel 'diseased'. For most, the recommended treatments seemed excessive compared with the diagnosis given. Most found that their initial clinical teams were not forthcoming about the possibility of overdiagnosis and overtreatment, and many found it difficult to deal with their set management protocols. CONCLUSION: The experiences of this small and unusual group of women provide rare insight into the profound negative impact of finding out about overdiagnosis after breast cancer diagnosis. Previous studies have found that women valued information about overdiagnosis before screening and this knowledge did not reduce subsequent screening uptake. Policymakers and clinicians should recognise the diversity of women's perspectives and ensure that women are adequately informed of the possibility of overdiagnosis before screening.

Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial.

Importance: Whether the benefits of notifying women about breast density outweigh the potential harms to inform current and future mammogram screening practice remains unknown. Objective: To assess the effect of mammographic breast density notification and information provision on women's intention to seek supplemental screening and psychological outcomes. Design, Setting, and Participants: A 3-arm online randomized clinical trial was conducted from August 10 to 31, 2021. Data analysis was conducted from September 1 to October 20, 2021. Participants included Australian residents identifying as female, aged between 40 and 74 years, with no history of breast cancer who were residing in jurisdictions without existing breast density notification with screening mammograms. Interventions: Women were randomized to receive 1 of the following hypothetical breast screening test result letters: screening mammogram result letter without breast density messaging (control), screening mammogram result letter with breast density messaging and an existing density information letter taken from a screening service in Australia (intervention 1), and screening mammogram result letter with breast density messaging and a health literacy-sensitive version of the letter adapted for people with lower health literacy (intervention 2). Main Outcomes and Measures: Primary outcomes were intention to seek supplemental screening; feeling anxious (uneasy, worried, or nervous), informed, or confused; and having breast cancer worry. Results: A total of 1420 Australian women were randomized and included in the final analysis. The largest group consisted of 603 women aged 60 to 74 years (42.5%). Compared with the control cohort (n = 480), women who received density notification via intervention 1 (n = 470) and intervention 2 (n = 470) reported a significantly higher intention to seek supplemental screening (0.8% vs 15.6% and 14.2%; P < .001) and feeling anxious (14.2% vs 49.4% and 48.5%; P < .001), confusion (7.8% vs 24.0% and 23.6%; P < .001), and worry about breast cancer (quite/very worried: 6.9% vs 17.2% and 15.5%; P < .001). There were no statistically significant differences in these outcomes between the 2 intervention groups. Conclusions and Relevance: In this randomized clinical trial, breast density notification and information integrated with screening mammogram results increased women's intention to seek supplemental screening and made women feel anxious, confused, or worried about breast cancer. These findings have relevance and implications for mammogram screening services and policy makers considering whether and, if so, how best to implement widespread notification of breast density as part of mammography screening. Trial Registration: ACTRN12621000253808.

Perceptions of Conflicting Breast Cancer Screening Recommendations Among Racially/Ethnically Diverse Women: a Multimethod Study.

BACKGROUND: Conflicting breast cancer screening recommendations have the potential to diminish informed decision making about screening. OBJECTIVE: We examined the knowledge, attitudes, and intentions related to divergent recommendations for breast cancer screening among racially/ethnically diverse women. DESIGN: We used a multimethod study design employing focus groups and questionnaires. Focus groups included: (1) two 10-min presentations on the national screening recommendations and the potential benefits and harms of screening and (2) an interactive discussion. Data were collected: 8/3/2017 to 11/19/2019. Analysis occurred from 1/21/2019 to 7/24/2020. PARTICIPANTS: Participants were (1) women 40-75 years; (2) English or Spanish speaking; (3)self-identified as Latina, Black, or non-Latina White; and (4) no known increased risk for breast cancer. MAIN MEASURES: Main outcomes were participants' knowledge and perceptions of benefits and harms of screening mammography and their screening intentions. Focus groups were transcribed and analyzed using a qualitative descriptive approach. Quantitative data were summarized using descriptive statistics. KEY RESULTS: One hundred thirty-four women (n=52, 40-49 years; n=82, 50-75 years) participated in 28 focus groups. Participants were Latina (n=44); Black (n=51); and non-Latina White (n=39). Approximately one-quarter (n=32) had limited health literacy and almost one-fifth (n=23) had limited numeracy. In the context of differing national screening recommendations, participants questioned the motives of the recommendation-making agencies, including the role of costs and how costs were considered when making screening recommendations. Participants expressed concern that they were not represented (e.g., race/ethnicity) in the data informing the recommendations. Immediately following the focus groups, most participants expressed intention to screen within the upcoming year (pre n=100 vs. post n=107). CONCLUSIONS: Divergent breast cancer screening recommendations may lead to mistrust and paradoxically reinforce high overall enthusiasm for screening.

Experiences of Patient-Led Surveillance, Including Patient-Performed Teledermoscopy, in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: Current clinician-led melanoma surveillance models require frequent routinely scheduled clinic visits, with associated travel, cost, and time burden for patients. Patient-led surveillance is a new model of follow-up care that could reduce health care use such as clinic visits and medical procedures and their associated costs, increase access to care, and promote early diagnosis of a subsequent new melanoma after treatment of a primary melanoma. Understanding patient experiences may allow improvements in implementation. OBJECTIVE: This study aims to explore patients' experiences and perceptions of patient-led surveillance during the 6 months of participation in the MEL-SELF pilot randomized controlled trial. Patient-led surveillance comprised regular skin self-examination, use of a mobile dermatoscope to image lesions of concern, and a smartphone app to track and send images to a teledermatologist for review, in addition to usual care. METHODS: Semistructured interviews were conducted with patients previously treated for melanoma localized to the skin in New South Wales, Australia, who were randomized to the patient-led surveillance (intervention group) in the trial. Thematic analysis was used to analyze the data with reference to the technology acceptance model. RESULTS: We interviewed 20 patients (n=8, 40% women and n=12, 60% men; median age 62 years). Patients who were more adherent experienced benefits such as increased awareness of their skin and improved skin self-examination practice, early detection of melanomas, and opportunities to be proactive in managing their clinical follow-up. Most participants experienced difficulty in obtaining clear images and technical problems with the app. These barriers were overcome or persevered by participants with previous experience with digital technology and with effective help from a skin check partner (such as a spouse, sibling, or friend). Having too many or too few moles decreased perceived usefulness. CONCLUSIONS: Patients with melanoma are receptive to and experience benefits from patient-led surveillance using teledermoscopy. Increased provision of training and technical support to patients and their skin check partners may help to realize the full potential benefits of this new model of melanoma surveillance.

Perspectives and Experiences of Patient-Led Melanoma Surveillance Using Digital Technologies From Clinicians Involved in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: The growing number of melanoma patients who need long-term surveillance increasingly exceeds the capacity of the dermatology workforce, particularly outside of metropolitan areas. Digital technologies that enable patients to perform skin self-examination and send dermoscopic images of lesions of concern to a dermatologist (mobile teledermoscopy) are a potential solution. If these technologies and the remote delivery of melanoma surveillance are to be incorporated into routine clinical practice, they need to be accepted by clinicians providing melanoma care, such as dermatologists and general practitioners (GPs). OBJECTIVE: This study aimed to explore perceptions of potential benefits and harms of mobile teledermoscopy, as well as experiences with this technology, among clinicians participating in a pilot randomized controlled trial (RCT) of patient-led melanoma surveillance. METHODS: This qualitative study was nested within a pilot RCT conducted at dermatologist and skin specialist GP-led melanoma clinics in New South Wales, Australia. We conducted semistructured interviews with 8 of the total 11 clinicians who were involved in the trial, including 4 dermatologists (3 provided teledermatology, 2 were treating clinicians), 1 surgical oncologist, and 3 GPs with qualifications in skin cancer screening (the remaining 3 GPs declined an interview). Thematic analysis was used to analyze the data with reference to the concepts of "medical overuse" and "high-value care." RESULTS: Clinicians identified several potential benefits, including increased access to dermatology services, earlier detection of melanomas, reassurance for patients between scheduled visits, and a reduction in unnecessary clinic visits. However, they also identified some potential concerns regarding the use of the technology and remote monitoring that could result in diagnostic uncertainty. These included poor image quality, difficulty making assessments from a 2D digital image (even if good quality), insufficient clinical history provided, and concern that suspicious lesions may have been missed by the patient. Clinicians thought that uncertainty arising from these concerns, together with perceived potential medicolegal consequences from missing a diagnosis, might lead to increases in unnecessary clinic visits and procedures. Strategies suggested for achieving high-value care included managing clinical uncertainty to decrease the potential for medical overuse and ensuring optimal placement of patient-led teledermoscopy within existing clinical care pathways to increase the potential for benefits. CONCLUSIONS: Clinicians were enthusiastic about the potential and experienced benefits of mobile teledermoscopy; however, managing clinical uncertainty will be necessary to achieve these benefits in clinical care outside of trial contexts and minimize potential harms from medical overuse. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12616001716459; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371865.

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.

"It's about our bodies we have the right to know this stuff": A qualitative focus group study on Australian women's perspectives on breast density.

OBJECTIVE: This study aimed to explore Australian women's current knowledge, perspectives and attitudes about breast density (BD); and information needs to inform effective evidence-based communication strategies. METHODS: Fourteen online focus group sessions with a total of 78 women in New South Wales and Queensland, Australia aged 40-74 years without a personal diagnosis of breast cancer were conducted. Audio-recorded data was transcribed and analysed thematically. RESULTS: Women had a very limited knowledge of BD. Overall, women expressed a preference for more frequent mammograms and/or supplemental screening should they be told they had dense breasts, despite being presented with information on potential downsides of additional testing. The majority of women were supportive of the notion of BD notification, often suggesting they had a 'right to know' and they would prefer to be educated and informed about it. CONCLUSION: The potential of being informed and notified of BD is found to be of interest and importance to Australian women of breast screening age despite lacking current knowledge. PRACTICE IMPLICATIONS: This study highlights that policy makers and screening services need to consider how to weigh up these views and preferences of women with current evidence surrounding BD in deciding about implementing population-based BD notification.

Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.

IMPORTANCE: Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma. OBJECTIVE: To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance. DESIGN, SETTING, AND PARTICIPANTS: This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020. INTERVENTION: Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care). MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma). RESULTS: Of 326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age, 58.7 [12.0] years; 53 [53%] men) were randomized to patient-led (n = 49) or clinician-led (n = 51) surveillance. Data were available on patient-reported outcomes for 66 participants and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance was associated with increased SSE frequency (odds ratio [OR], 3.5; 95% CI, 0.9 to 14.0) and thoroughness (OR, 2.2; 95% CI, 0.8 to 5.7), had no detectable adverse effect on psychological outcomes (fear of cancer recurrence subscale score; mean difference, -1.3; 95% CI, -3.1 to 0.5), and increased clinic visits (risk ratio [RR], 1.5; 95% CI, 1.1 to 2.1), skin lesion excisions (RR, 1.1; 95% CI, 0.6 to 2.0), and subsequent melanoma diagnoses and subsequent melanoma diagnoses (risk difference, 10%; 95% CI, -2% to 23%). New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%). CONCLUSIONS AND RELEVANCE: This pilot of a randomized clinical trial found that patient-led surveillance after treatment of localized melanoma appears to be safe, feasible, and acceptable. Experiences from this pilot study have prompted improvements to the trial processes for the larger trial of the same intervention. TRIAL REGISTRATION: http://anzctr.org.au Identifier: ACTRN12616001716459.