UNASSIGNED: There is a policy drive in NHS maternity services to improve open disclosure with harmed families and limited information on how better practice can be achieved.
UNASSIGNED: To identify critical factors for improving open disclosure from the perspectives of families, doctors, midwives and services and to produce actionable evidence for service improvement.
UNASSIGNED: A three-phased, qualitative study using realist methodology. Phase 1: two literature reviews: scoping review of post-2013 NHS policy and realist synthesis of initial programme theories for improvement; an interview study with national stakeholders in NHS maternity safety and families. Phase 2: in-depth ethnographic case studies within three NHS maternity services in England. Phase 3: interpretive forums with study participants. A patient and public involvement strategy underpinned all study phases.
UNASSIGNED: National recruitment (study phases 1 and 3); three English maternity services (study phase 2).
UNASSIGNED: We completed n = 142 interviews, including 27 with families; 93 hours of ethnographic observations, including 52 service and family meetings over 9 months; and interpretive forums with approximately 69 people, including 11 families.
UNASSIGNED: The policy review identified a shift from viewing injured families as passive recipients to active contributors of post-incident learning, but a lack of actionable guidance for improving family involvement. The realist synthesis found weak evidence of the effectiveness of open disclosure interventions in the international maternity literature, but some improvements with organisation-wide interventions. Recent evidence was predominantly from the United Kingdom. The research identified and explored five key mechanisms for open disclosure: meaningful acknowledgement of harm; involvement of those affected in reviews/investigations; support for families\' own sense-making; psychological safely of skilled clinicians (doctors and midwives); and knowing that improvements to care have happened. The need for each family to make sense of the incident in their own terms is noted. The selective initiatives of some clinicians to be more open with some families is identified. The challenges of an adversarial medicolegal landscape and limited support for meeting incentivised targets is evidenced.
UNASSIGNED: Research was conducted after the pandemic, with exceptional pressure on services. Case-study ethnography was of three higher performing services: generalisation from case-study findings is limited. No observations of Health Safety Investigation Branch investigations were possible without researcher access. Family recruitment did not reflect population diversity with limited representation of non-white families, families with disabilities and other socially marginalised groups and disadvantaged groups.
UNASSIGNED: We identify the need for service-wide systems to ensure that injured families are positioned at the centre of post-incident events, ensure appropriate training and post-incident care of clinicians, and foster ongoing engagement with families beyond the individual efforts made by some clinicians for some families. The need for legislative revisions to promote openness with families across NHS organisations, and wider changes in organisational family engagement practices, is indicated. Examination of how far the study\'s findings apply to different English maternity services, and a wider rethinking of how family diversity can be encouraged in maternity services research.
UNASSIGNED: This study is registered as PROSPERO CRD42020164061. The study has been assessed following RAMESES realist guidelines.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research Programme (NIHR award ref: 17/99/85) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 22. See the NIHR Funding and Awards website for further award information.
This study describes the experiences of families and healthcare professionals involved in incidents in NHS maternity care. The incidents caused harm-like injury or death to the baby or woman. We wanted to know whether services involved families in investigations and reviews and how this was done, what worked well, what did not work well and why. To do this, we first looked at what had already been written about ‘open disclosure’ or OD. Open disclosure is when the NHS admits to families that the care they provided has directly caused harm. After open disclosure occurs, families should be involved in making sure that the NHS learns so it can deliver better care for families in the future. In our reading, we found that families want a meaningful apology, to be involved in reviews or investigations, to know what happened to their loved one, to be cared for by knowledgeable doctors and midwives who are supported in providing open disclosure and to know things have changed because of what happened. Recommendations for involving families in open disclosure have improved, but there is still work to be done to make sure families are involved. Next, we talked to over 100 healthcare professionals involved in government policy for open disclosure in maternity services and 27 families who experienced harm. We spent 9 months observing the work of clinicians at three maternity services to watch open disclosure. We shared early findings with families, doctors, midwives and managers, and included their views. We found that services need to provide dedicated time, education and emotional support for staff who provide open disclosure. Services need to ensure that families have ongoing support and better communication about incidents. Finally, families must be involved in the review process if they want to be with their experiences reflected in reports and kept informed of ongoing improvements.

BACKGROUND: Approximately 15% of women in low-and middle-income countries experience common perinatal mental disorders. Yet, many women, even if diagnosed with mental health conditions, are untreated due to poor quality care, limited accessibility, limited knowledge, and stigma. This paper describes how mental health-related stigma influences pregnant women\'s decisions not to disclose their conditions and to seek treatment in Vietnam, all of which exacerbate inequitable access to maternal mental healthcare.
METHODS: A mixed-method realist study was conducted, comprising 22 in-depth interviews, four focus group discussions (total participants n = 44), and a self-administered questionnaire completed by 639 pregnant women. A parallel convergent model for mixed methods analysis was employed. Data were analyzed using the realist logic of analysis, an iterative process aimed at refining identified theories. Survey data underwent analysis using SPSS 22 and descriptive analysis. Qualitative data were analyzed using configurations of context, mechanisms, and outcomes to elucidate causal links and provide explanations for complexity.
RESULTS: Nearly half of pregnant women (43.5%) would try to hide their mental health issues and 38.3% avoid having help from a mental health professional, highlighting the substantial extent of stigma affecting health-seeking and accessing care. Four key areas highlight the role of stigma in maternal mental health: fear and stigmatizing language contribute to the concealment of mental illness, rendering it unnoticed; unconsciousness, normalization, and low literacy of maternal mental health; shame, household structure and gender roles during pregnancy; and the interplay of regulations, referral pathways, and access to mental health support services further compounds the challenges.
CONCLUSIONS: Addressing mental health-related stigma could influence the decision of disclosure and health-seeking behaviors, which could in turn improve responsiveness of the local health system to the needs of pregnant women with mental health needs, by offering prompt attention, a wide range of choices, and improved communication. Potential interventions to decrease stigma and improve access to mental healthcare for pregnant women in Vietnam should target structural and organizational levels and may include improvements in screening and referrals for perinatal mental care screening, thus preventing complications.

UNASSIGNED: Culture and stigma-relevant issues discourage transgender individuals in China from gender identity disclosure, which may limit their access to comprehensive health care services. This study evaluates how gender identity disclosure to healthcare professionals would facilitate healthcare services in China.
UNASSIGNED: A cross-sectional study was conducted in nine cities across mainland China from December 2019 to June 2020 among transgender individuals. Participants completed questions covering socio-demographic information, Human Immuno-Deficiency Virus and Sexually Transmitted Infections (HIV/STI) testing habits, sexual risk behaviors, and access to medical and mental health services for the past 3 months.
UNASSIGNED: A total of 277 eligible transgender individuals with a mean age of 29 ± 8 years old completed the survey. Overall, 56.0% (155/277) had disclosed their gender identity to health professionals. 83.9% had ever tested for HIV (with HIV prevalence of 12.9%), 54.2% had tested for STIs, 62.6% had used hormone therapy, and 12.3% had undergone gender-affirming surgery. Multivariable logistic regression showed that participants who had ever disclosed their gender identity to healthcare professionals were more likely to have tested for STIs (aOR = 1.94, 95%CI: 1.12-3.39) and HIV (aOR = 1.72, 95% CI 0.82-3.39), received hormone intervention therapy (aOR = 2.81, 95%CI: 1.56-5.05), and used pre-exposure prophylaxis (PrEP) (aOR= 3.51, 95%CI: 1.12-10.97) compared to non-disclosers.
UNASSIGNED: Our study demonstrated strong correlations between gender identity disclosure and healthcare services usage among Chinese transgender individuals. Facilitating the gender identity disclosure of transgender individuals to healthcare professionals with caution would be useful for improving their access to care.

OBJECTIVE: The main objective of this study was twofold: to investigate what kind of information patients with heart failure (HF) tell their doctors about their medication adherence at home, and how often such information is provided in consultations where medication reconciliation is recommended. To meet these objectives, we developed an analysis to recognise, define, and count (1) patient utterances including medication adherence disclosures in clinical interactions (MADICI), (2) MADICI including red-flags for non-adherence, and (3) MADICI initiated by patients without prompts from their doctor.
METHODS: Exploratory interaction-based observational cohort study. Inductive microanalysis of authentic patient-doctor consultations, audio-recorded at three time-points for each patient: (1) first ward visit in hospital, (2) discharge visit from hospital, and (3) follow-up visit with general practitioner (GP).
METHODS: Norway (2022-2023).
METHODS: 25 patients with HF (+65 years) and their attending doctors (23 hospital doctors, 25 GPs).
RESULTS: We recognised MADICI by two criteria: (1) they are about medication prescribed for use at home, AND (2) they involve patients\' action, experience, or stance regarding medications. Using these criteria, we identified 427 MADICIs in 25 patient trajectories: 143 (34%) at first ward visit (min-max=0-35, median=3), 57 (13%) at discharge visit (min-max=0-8, median=2), 227 (53%) at GP-visit (min-max=2-24, median=7). Of 427 MADICIs, 235 (55%) included red-flags for non-adherence. Bumetanide and atorvastatin were most frequently mentioned as problematic. Patients initiated 146 (34%) of 427 MADICIs. Of 235 \'red-flag MADICIs\', 101 (43%) were initiated by patients.
CONCLUSIONS: Self-managing older patients with HF disclosed information about their use of medications at home, often including red-flags for non-adherence. Patients who disclosed information that signals adherence problems tended to do so unprompted. Such disclosures generate opportunities for doctors to assess and support patients\' medication adherence at home.

UNASSIGNED: Despite the recognized value of experiential knowledge, drug use and disclosure of drug use within the drug research community is rarely discussed or studied.
UNASSIGNED: We distributed a cross-sectional online survey using targeted recruitment. Researchers provided information on drug use, disclosure of use (or abstinence) professionally, and their impact via write-in text boxes. We used the general inductive approach to analyze the data.
UNASSIGNED: Of the sample (n=669, 43 countries), 52 % were cisgender women, 89 % had post-graduate education, and 79 % worked in academia. Most (86 %) reported lifetime drug use and 47 % past 3-month use. Among 557 researchers who used drugs, 59 % disclosed their use to institutional colleagues, 59 % to colleagues outside their institution, 25 % to research participants, and 11 % in their research/scholarship. Themes included frequency; context; meaning of drug use disclosure personally, professionally, and socially; and how drug use experience and disclosure informs research. Respondents connected their concerns about disclosure in research with issues of social identity, professional risk, and the role of stigma related to lived experience. Some respondents felt that such concerns reinforce a vacuum, noting that the inability to disclose drug use limits research questions and the knowledge base overall.
UNASSIGNED: Our findings support the dichotomy of thought surrounding the lived experience of drug use: \"[They\'ve] used drugs- [they\'re] biased!\" and \"[They\'re] not a drug user-what would [they] know!\" Our findings provide an opportunity to reflect upon our positionality and the impact researchers\' own drug use may have on the field.

Variants in seven genes (LRRK2, GBA1, PRKN, SNCA, PINK1, PARK7 and VPS35) have been formally adjudicated as causal contributors to Parkinson\'s disease; however, individuals with Parkinson\'s disease are often unaware of their genetic status since clinical testing is infrequently offered. As a result, genetic information is not incorporated into clinical care, and variant-targeted precision medicine trials struggle to enrol people with Parkinson\'s disease. Understanding the yield of genetic testing using an established gene panel in a large, geographically diverse North American population would help patients, clinicians, clinical researchers, laboratories and insurers better understand the importance of genetics in approaching Parkinson\'s disease. PD GENEration is an ongoing multi-centre, observational study (NCT04057794, NCT04994015) offering genetic testing with results disclosure and genetic counselling to those in the US (including Puerto Rico), Canada and the Dominican Republic, through local clinical sites or remotely through self-enrolment. DNA samples are analysed by next-generation sequencing including deletion/duplication analysis (Fulgent Genetics) with targeted testing of seven major Parkinson\'s disease-related genes. Variants classified as pathogenic/likely pathogenic/risk variants are disclosed to all tested participants by either neurologists or genetic counsellors. Demographic and clinical features are collected at baseline visits. Between September 2019 and June 2023, the study enrolled 10 510 participants across >85 centres, with 8301 having received results. Participants were: 59% male; 86% White, 2% Asian, 4% Black/African American, 9% Hispanic/Latino; mean age 67.4 ± 10.8 years. Reportable genetic variants were observed in 13% of all participants, including 18% of participants with one or more \'high risk factors\' for a genetic aetiology: early onset (<50 years), high-risk ancestry (Ashkenazi Jewish/Basque/North African Berber), an affected first-degree relative; and, importantly, in 9.1% of people with none of these risk factors. Reportable variants in GBA1 were identified in 7.7% of all participants; 2.4% in LRRK2; 2.1% in PRKN; 0.1% in SNCA; and 0.2% in PINK1, PARK7 or VPS35 combined. Variants in more than one of the seven genes were identified in 0.4% of participants. Approximately 13% of study participants had a reportable genetic variant, with a 9% yield in people with no high-risk factors. This supports the promotion of universal access to genetic testing for Parkinson\'s disease, as well as therapeutic trials for GBA1 and LRRK2-related Parkinson\'s disease.

BACKGROUND: Understanding attitudes toward participation among diverse preclinical Alzheimer\'s disease (AD) trial participants could yield insights to instruct future recruitment.
METHODS: Using data from the Anti-Amyloid Treatment in Asymptomatic AD (A4) Study, we examined differences among mutually exclusive racial and ethnic groups in views and perceptions of amyloid imaging (VPAI), a measure of motivations to undergo amyloid biomarker testing in the setting of preclinical AD. We used linear regression to quantify differences at baseline.
RESULTS: Compared to non-Hispanic or Latino (NH) White participants, Hispanic or Latino (3.52 points, 95% confidence interval [CI]: [2.61, 4.42]); NH Asian (2.97 points, 95% CI: [1.71, 4.22]); and NH Black participants (2.79 points, 95% CI: [1.96, 3.63]) participants demonstrated higher levels of endorsement of the VPAI items at baseline.
CONCLUSIONS: Differences may exist among participants from differing ethnic and racial groups in motivations to undergo biomarker testing in the setting of a preclinical AD trial.
CONCLUSIONS: Representative samples in AD clinical trials are vital to result in generalizability. We assessed motivations to undergo amyloid imaging in a preclinical AD trial. Racial and ethnic minority groups showed higher endorsement of VPAI items. Differences were driven by perceived risk, plan/prepare, and curiosity domains. Few observations among racial and ethnic groups changed after biomarker disclosure.

BACKGROUND: The International Committee of Medical Journal Editors (ICMJE) has published Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. These provide a global standard for writing and editing medical articles, including research integrity. However, no study has examined the research integrity-related content of Japanese medical journals\' Instructions for Authors. We therefore compared research integrity content in ICMJE member journals with those in the English- and Japanese-language journals of the Japanese Association of Medical Sciences (JAMS).
METHODS: This was a descriptive literature study. We obtained Instructions for Authors from English- and Japanese-language journals listed on the JAMS website and the ICMJE member journals listed on the ICMJE website as of September 1, 2021. We compared the presence of 20 topics (19 in the ICMJE Recommendations plus compliance with ICMJE) in the Instructions for Authors, and analyzed the content of the conflict of interest disclosure.
RESULTS: We evaluated 12 ICMJE member journals, and 82 English-language and 99 Japanese-language subcommittee journals. The median number of topics covered was 10.5 for ICMJE member journals, 10 for English-language journals, and three for Japanese-language journals. Compliance with ICMJE was mentioned by 10 (83%) ICMJE member journals, 75 (91%) English-language journals, and 29 (29%) Japanese-language journals. The ICMJE Conflicts of Interest Disclosure Form was requested by seven (64%) ICMJE member journals, 15 (18%) English-language journals, and one (1%) Japanese-language journal.
CONCLUSIONS: Although the topics in the JAMS English-language journals resembled those in the ICMJE member journals, the median value of ICMJE-related topic inclusion was approximately one-third lower in JAMS Japanese-language journals than in ICMJE member journals. It is hoped that Japanese-language journals whose conflict of interest disclosure policies differ from ICMJE standards will adopt international standards to deter misconduct and ensure publication quality.

Workplace mental health challenges have emerged as a significant concern post-pandemic. Despite this, the pervasive stigma surrounding mental illness leads to the concealment of symptoms and reluctance to seek professional help among employees. This study aims to explore the perception of different stakeholders towards the \'Detection and disclosure\' of workplace mental health challenges in the Indian context. Fifteen semi-structured interviews were conducted with human resource professionals, counselors, and employees who had previously experienced mental health challenge(s). Thematic analysis was done to identify recurring themes and sub-themes. Three critical pathways were identified: minimizing the inhibitory factors, including lack of awareness, denial, low self-efficacy, stigma, and underestimating organizational capability; maximizing the encouraging factors, including psychological safety, perceived social support, and communicating success stories; and implementing supportive organizational practices, including generating awareness and literacy, build the organizational capability, strengthen the role of managers, leadership advocacy, policies, and processes. By fostering a culture of support and prioritizing employee well-being, organizations in India can create healthier and more resilient work environments, benefiting both individuals and the larger society.

OBJECTIVE: We compared the rate of errors in genome sequencing (GS) result disclosures by genetic counselors (GC) and trained non-genetics healthcare professionals (NGHPs) in SouthSeq, a randomized trial utilizing GS in critically ill infants.
METHODS: Over 400 recorded GS result disclosures were analyzed for major and minor errors. We used Fisher\'s exact test to compare error rates between GCs and NGHPs and performed a qualitative content analysis to characterize error themes.
RESULTS: Major errors were identified in 7.5% of disclosures by NGHPs and in no disclosures by GCs. Minor errors were identified in 32.1% of disclosures by NGHPs and in 11.4% of disclosures by GCs. Although most disclosures lacked errors, NGHPs were significantly more likely to make any error than GCs for all result types (positive, negative, or uncertain). Common major error themes include omission of critical information, overstating a negative result, and overinterpreting an uncertain result. The most common minor error was failing to disclose negative secondary findings.
CONCLUSIONS: Trained NGHPs made clinically significant errors in GS result disclosures. Characterizing common errors in result disclosure can illuminate gaps in education to inform the development of future genomics training and alternative service delivery models.