RESUMEN

OBJECTIVES: Pragmatic randomised controlled trials (pRCTs) are essential for determining the real-world safety and effectiveness of healthcare interventions. However, both laypeople and clinicians often demonstrate experiment aversion: preferring to implement either of two interventions for everyone rather than comparing them to determine which is best. We studied whether clinician and layperson views of pRCTs for COVID-19, as well as non-COVID-19, interventions became more positive during the pandemic, which increased both the urgency and public discussion of pRCTs. DESIGN: Randomised survey experiments. SETTING: Geisinger, a network of hospitals and clinics in central and northeastern Pennsylvania, USA; Amazon Mechanical Turk, a research participant platform used to recruit online participants residing across the USA. Data were collected between August 2020 and February 2021. PARTICIPANTS: 2149 clinicians (the types of people who conduct or make decisions about conducting pRCTs) and 2909 laypeople (the types of people who are included in pRCTs as patients). The clinician sample was primarily female (81%), comprised doctors (15%), physician assistants (9%), registered nurses (54%) and other medical professionals, including other nurses, genetic counsellors and medical students (23%), and the majority of clinicians (62%) had more than 10 years of experience. The layperson sample ranges in age from 18 to 88 years old (mean=38, SD=13) and the majority were white (75%) and female (56%). OUTCOME MEASURES: Participants read vignettes in which a hypothetical decision-maker who sought to improve health could choose to implement intervention A for all, implement intervention B for all, or experimentally compare A and B and implement the superior intervention. Participants rated and ranked the appropriateness of each decision. Experiment aversion was defined as the degree to which a participant rated the experiment below their lowest-rated intervention. RESULTS: In a survey of laypeople administered during the pandemic, we found significant aversion to experiments involving catheterisation checklists and hypertension drugs unrelated to the treatment of COVID-19 (Cohen's d=0.25-0.46, p<0.001). Similarly, among both laypeople and clinicians, we found significant aversion to most (comparing different checklist, proning and mask protocols; Cohen's d=0.17-0.56, p<0.001) but not all (comparing school reopening protocols; Cohen's d=0.03, p=0.64) non-pharmaceutical COVID-19 experiments. Interestingly, we found the lowest experiment aversion to pharmaceutical COVID-19 experiments (comparing new drugs and new vaccine protocols for treating the novel coronavirus; Cohen's d=0.04-0.12, p=0.12-0.55). Across all vignettes and samples, 28%-57% of participants expressed experiment aversion, whereas only 6%-35% expressed experiment appreciation by rating the trial higher than their highest-rated intervention. CONCLUSIONS: Advancing evidence-based medicine through pRCTs will require anticipating and addressing experiment aversion among patients and healthcare professionals. STUDY REGISTRATION: http://osf.io/6p5c7/.

Asunto(s)

RESUMEN

OBJECTIVE: To assess the level of bioethics awareness among healthcare professionals in Pakistan, focusing on the associations with sociodemographic characteristics, training and teaching of ethics, medical ethics practice and specific ethical issues. DESIGN: Cross-sectional study. SETTING: Public and private hospitals in Haripur, Pakistan. PARTICIPANTS: A total of 647 healthcare professionals participated in this study. METHODS: This study was conducted between March and May 2023, following Strengthening the Reporting of Observational Studies in Epidemiology checklist criterion, involving healthcare professionals with at least 6 months of experience in patient care practice. Providers under close supervision are advised not to respond to the bioethics knowledge, attitudes and practices survey form due to potential ethical dilemmas. RESULTS: Both physicians and non-physicians need to know more about bioethics. There was a significant difference (p<0.05) in ethical training and teaching based on job categories/designations, with ethical views differing greatly by job designation. Specific ethical issues, such as accepting gifts from patients and pharmaceutical companies, referral fees, advising specific products, disclosure of medical errors, patient confidentiality, not informing patients fully about treatment and performing tasks for financial gain, showed significant associations (p<0.05) with healthcare professional's designation. Ethical awareness scores also showed significant differences (p<0.05) based on age, ethnicity, place of posting, professional experience and the organisation's ethical guidelines. CONCLUSION: This study highlighted a notable gap in the understanding of certain ethical concerns among healthcare professionals, with nurses showing relatively lower awareness of healthcare practice compared with other professionals. Addressing these issues through targeted training and robust ethical guidelines is critical to improving patient care in Pakistan's healthcare system.

Asunto(s)

RESUMEN

OBJECTIVES: To evaluate the extent and trends of personal payments from pharmaceutical companies to cardiologists board-certified by the Japanese Circulation Society. DESIGN: A retrospective analysis study using data from a publicly available database. SETTING: The study focused on payments to cardiologists in Japan. PARTICIPANTS: All 15 048 cardiologists who were board-certified by the Japanese Circulation Society as of 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the extent of personal payments to cardiologists in 2016-19. Secondary outcomes included the analysis of trends in these payments over the same period. RESULTS: Of all 15 048 board-certified cardiologists, 9858 (65.5%) received personal payments totaling $112 934 503 entailing 165 013 transactions in 2016-19. The median payment per cardiologist was $2947 (IQR, $1022-$8787), with a mean of $11 456 (SD, $35 876). The Gini Index was 0.840, indicating a high concentration of payments to a small number of cardiologists. The top 1%, 5% and 10% of cardiologists received 31.6%, 59.4% and 73.5% of all payments, respectively. There were no significant trends in the number of cardiologists receiving payments or number of payments per cardiologist during the study period. CONCLUSIONS: More than 65% of Japanese cardiologists received personal payments from pharmaceutical companies over the 4-year study period. Although the payment amount was relatively small for the majority of cardiologists, a small number of cardiologists received the vast majority of the payments.

Asunto(s)

RESUMEN

OBJECTIVE: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan. METHODS: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020. RESULTS: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs. CONCLUSIONS: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.

Asunto(s)

RESUMEN

Genome-wide association studies seek to associate an organism's genotypes with phenotypes. The goal of such research is to identify specific genetic variants that may be used to predict an individual's risk for a specific physical or mental disease. Recently, it has been recommended that policymakers in the USA should employ genomic surveillance so that it can be used for initial military personnel selection and personnel assignments. However, such a proposal highlights the necessity of subjecting such recommendations to rigorous ethical analysis, including concerns regarding recruitment, transparency and the return of genetic results.

RESUMEN

OBJECTIVE: Research cannot advance without the voluntary participation of human participants. SUMMARY OF ARGUMENTS: Full participation of research participants is often restrained by the traditional research framework, which relegates them to a predefined participant role and allows them only quasi-scripted opportunities to contribute to research processes and outcomes. Terms commonly used to refer to research participants do not reflect their significant role or send a clear message about their value. The authors propose a shift from 'patient participant' to 'participant partner.' Recognition of the true partnership between the participant and the research team, from the consent process to the trial's end, will encourage and enable fuller participation. CONCLUSION: Changing the rhetoric of research in the labelling of research participants will require dialogue. 'Respect for persons' demands it, and the research process will be better for it.

Asunto(s)

RESUMEN

OBJECTIVES: The objective of this study was to investigate associations between knowledge of health issues and healthcare satisfaction and propensity to complain including the association between knowledge and greater patient involvement. DESIGN: The present study is a secondary analysis of a larger cross-sectional case vignette survey. SETTING: Survey conducted in adult Danish men. PARTICIPANTS: Participants included 6755 men aged 45-70 years. INTERVENTIONS: Participants responded to a survey with scenarios illustrating prostate-specific antigen (PSA) testing and different information provision. PRIMARY AND SECONDARY OUTCOME MEASURES: Using Likert scales (scored 1-5), participants rated their satisfaction with the care described and their inclination to complain and responded to a short quiz (scored 0-3) assessing their knowledge about the PSA test. RESULTS: Satisfaction with healthcare increased with better quiz performance (Likert difference 0.13 (95% CI .07 to 0.20), p <0.001, totally correct vs totally incorrect responders) and correspondingly, the desire to complain significantly decreased (Likert difference -0.34 (95% CI 0.40 to -0.27), p <0.001). Respondents with higher education performed better (mean quiz score difference 0.59 (95% CI 0.50 to 0.67), p <0.001, most educated vs least educated). Responders who received information about the PSA test generally performed better (quiz score difference 0.41 (95% CI 0.35 to 0.47), p<0.001, neutral vs no information). Overestimation of PSA merits was more common than underestimation (7.9% vs 3.8%). CONCLUSIONS: Mens' knowledge of the benefits of screening varies with education, predicts satisfaction with care and the desire to complain, and may be improved through greater involvement in decision-making.

Asunto(s)

RESUMEN

OBJECTIVES: The mental health of veterinary and other animal health professionals is significantly impacted by the psychological stressors they encounter, such as euthanasia, witnessing animal suffering and moral distress. Moral distress, initially identified in nursing, arises when individuals are aware of the right action but are hindered by institutional constraints. We aimed to review existing research on moral distress scales among animal care workers by focusing on the identification and psychometric validity of its measurement. DESIGN: Two-step systematic review. First, we identified all moral distress scales used in animal care research in the eligible original studies. Second, we evaluated their psychometric validity, emphasising content validity, which is a critical aspect of patient-reported outcome measures (PROMs). This evaluation adhered to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). The results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. DATA SOURCES: PubMed, EMBASE and PsycINFO to search for eligible studies published between January 1984 and April 2023. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included original (primary) studies that (1) were conducted in animal care workers; (2) describing either the development of a moral distress scale, or validation of a moral distress scale in its original or modified version, to assess at least one of the psychometric properties mentioned in COSMIN guidelines. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers used standardised methods to search, screen and code included studies. We considered the following information relevant for extraction: study reference, name and reference of the moral distress scale used, psychometric properties assessed and methods and results of their assessments. The collected information was then summarised in a narrative synthesis. RESULTS: The review identified only one PROM specifically adapted for veterinary contexts: the Measure of Moral Distress for Animal Professionals (MMD-AP), derived from the Measure of Moral Distress for Healthcare Professionals (MMD-HP). Both MMD-HP and MMD-AP were evaluated for the quality of development and content validity. The development quality of both measures was deemed doubtful. According to COSMIN, MMD-HP's content validity was rated as sufficient, whereas MMD-AP's was inconsistent. However, the evidence quality for both PROMs was rated low. CONCLUSION: This is the first systematic review focused on moral distress measurement in animal care workers. It shows that moral distress is rarely measured using standardised and evidence-based methods and that such methods should be developed and validated in the context of animal care. PROSPERO REGISTRATION NUMBER: CRD42023422259.

Asunto(s)

RESUMEN

OBJECTIVES: Public access databases such as clinicaltrials.gov achieve dissemination of clinical trial design and aggregated study results. However, return of participant-level data is rarely done. A key barrier includes the proprietary ownership of data by the sponsor. Additionally, investigators may not have access to centralised data, and per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, must maintain the confidentiality of participants. This study piloted an approach to return both individual and aggregate clinical trial data to parents of children participating in a series of open-label clinical trials. SETTING AND DESIGN: A small biotech company obtained central ethics approval (centralised institutional review board [IRB], non-exempt). The study was advertised via parent advocacy groups. Parents of trial participants were offered the option to contact an employee (coordinator) within the company, requesting return of their child's study results. Ethics approval covered participation in six countries. The study focused on the sequential clinical trials of vamorolone VBP15-002 (NCT02760264) and VBP15-003 (NCT02760277) (post-results). INTERVENTIONS: Contact initiated by the parent enabled the coordinator to obtain informed consent (and separate General Data Protection Regulations consent), with phone translation when needed. Using date of birth and study site location provided by the parent, the data manager reported the participant number to the coordinator. The coordinator retrieved and compiled data, along with an aggregate summary, which was mailed via a password protected and encrypted memory device to the parent. Prereturn and postreturn surveys were sent to consented parents (n=19; 40% of 48 total trial participants) and investigators. RESULTS: Prereturn surveys indicated a request for as much data as offered, in all formats offered. Postreturn survey showed high satisfaction with the process and data returned. Survey of the physician site investigators (n=10; 100% participation of investigators) voiced general satisfaction with the process, with some reservations. CONCLUSIONS: This pilot study demonstrates an innovative, cost-effective, centralised and labour conservative approach to return of participant-level and aggregate data to participants in studies.

Asunto(s)

RESUMEN

OBJECTIVES: Gestational diabetes mellitus (GDM) has implications for the future health of both mother and offspring, and there is a risk that mothers are held responsible and blamed for their own and their offspring's long-term health. The media plays a significant role in shaping public perceptions of health. Therefore, our study aimed to investigate how GDM and women with GDM are portrayed in Danish written media. DESIGN: We identified written newspaper articles reporting on GDM from 2018 to 2019 and analysed them using thematic network analysis and elements from critical discourse analysis. RESULTS: In total, 130 articles were included in the analysis. Four themes emerged: (1) ways of introducing GDM, (2) descriptions of causes and prevention of GDM, (3) descriptions of consequences of GDM and (4) value-laden descriptions of GDM. GDM was often mentioned in relation to other conditions or factors and with lack of differentiation. Maternal responsibility was emphasised via oversimplified descriptions of causal relations, descriptions of individual agency and no emphasis on structural causes and preventive measures. GDM was positioned as resulting in 'bad pregnancies' using value-laden wordings. CONCLUSION: We identified various aspects of how GDM is portrayed in written media. The findings signal the importance of clear, nuanced and respectful communication on GDM, including conveying the complexity of the condition and the role of structural factors.

Asunto(s)

RESUMEN

INTRODUCTION: The hospital ethical climate refers to the ethical work environment within a hospital, which may positively or negatively impact individual nurses, nursing organisations and patient care. Most of studies investigating the hospital ethical climate among Korean nurses have been published in Korean. However, papers addressing the hospital ethical climate in Korean were excluded from the systematic review. To enhance our comprehension of the hospital ethical climate, a systematic review specifically focusing on Korean nurses is imperative. Additionally, it is crucial to ascertain the factors associated with the hospital ethical climate and their respective effect sizes through meta-analyses. METHODS AND ANALYSIS: The systematic search will be conducted for papers published in both Korean and English, encompassing the hospital ethics climate of Korean nurses from 10 database inception to May 2023. Two reviewers will independently review each article based on the inclusion and exclusion criteria, and any differences in opinion will be resolved through discussion and consensus. The study selection process will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Quality assessment will be conducted using the Checklist for Analytical Cross-Sectional Studies provided by Joanna Briggs Institute. Effect size will be analysed using Comprehensive Meta-Analysis software V.2.0. The results of this study will identify factors related to the hospital ethical climate and the effect size of these factors among nurses in Korea. ETHICS AND DISSEMINATION: Ethical approval is not required, as the data will be collected from existing literature. Findings will be disseminated through peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022379812.

Asunto(s)

RESUMEN

OBJECTIVES: The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct. DESIGN: A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS. SETTING: Fourteen UK paediatric intensive care units. PARTICIPANTS: Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire. RESULTS: Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child's participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be 'streamlined' to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends. CONCLUSION: Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions. TRIAL REGISTRATION NUMBER: ISRCTN11746266.

Asunto(s)

RESUMEN

OBJECTIVES: Kidney transplantation offers patients better quality of life and survival compared with dialysis. The risk of end stage renal disease is higher among ethnic minorities and they experience longer wait times on transplant lists. This inequality stems from a high need for kidney transplantation combined with a low rate of deceased donation among ethnic minority groups. This study aimed to explore the perspectives around living donor kidney transplantation of members of the Sikh and Muslim communities with an aim to develop a digital intervention to overcome any barriers. DESIGN: A qualitative descriptive study using in person focus groups. SETTING: University Teaching Hospital and Transplant Centre. PARTICIPANTS: Convenience sampling of participants from the transplant population. Three focus groups were held with 20 participants, all were of South Asian ethnicity belonging to the Sikh and Muslim communities. METHODS: Interviews were digitally audio-recorded and transcribed verbatim; transcripts were analysed thematically. RESULTS: Four themes were identified: (a) religious issues; (b) lack of knowledge within the community; (c) time; (d) cultural identification with transplantation. CONCLUSIONS: Not only is the information given and when it is delivered important, but also the person giving the information is crucial to enhance consideration of live donor kidney transplantation. Information should be in a first language where possible and overtly align to religious considerations. A more integrated approach to transplantation counselling should be adopted which includes healthcare professionals and credible members of the target cultural group. TRIAL REGISTRATION NUMBER: NCT04327167.

Asunto(s)

RESUMEN

OBJECTIVES: Intensive care unit (ICU) dying patients are the most important source of organ donation. This study explores the reasons affecting organ donation in the Chinese sociocultural context from the perspectives of coordinators and physicians, and further seeks countermeasures to alleviate the shortage of organs. DESIGN AND SETTING: Semistructured interviews conducted in a large tertiary hospital in China. PARTICIPANTS AND METHOD: 15 respondents (including 8 organ coordinators and 7 ICU physicians) were interviewed. Participants were invited to describe the factors that influence organ donation and the underlying reasons behind it. Bronfenbrenner's socioecological system model was used as theoretical support to construct a theoretical model of the factors influencing organ donation. Respondents participated in semistructured qualitative interviews that were audio-recorded and transcribed. The relevant data were analysed using thematic analysis. RESULTS: Four themes that influenced organ donation were identified including the influence of the deceased person's attributes, immediate family members, surrounding people and the environment, and the social-level factors. In addition, we obtained four strategies from the interviews to improve the organ shortage to ameliorate the current supply-demand imbalance in organ donation. These include multilevel publicity, relevant policy support, increasing other forms of supply and reducing organ demand. CONCLUSIONS: Factors affecting organ donation after the death of a Chinese citizen include the personal characteristics of the donor, the decisions of family members such as immediate family members and the indirect influence of surrounding people such as collateral family members, in addition to factors related to the humanistic environment, religious beliefs and social opinion.

Asunto(s)

RESUMEN

OBJECTIVES: Implementing ethics is crucial to prevent harm and promote widespread benefits in social experiments based on medical artificial intelligence (MAI). However, insufficient information is available concerning this within the paediatric healthcare sector. We aimed to conduct a comparative survey among paediatricians, nurses and health information technicians regarding ethics implementation knowledge of and attitude towards MAI social experiments at children's hospitals in Shanghai. DESIGN AND SETTING: A cross-sectional electronic questionnaire was administered from 1 July 2022 to 31 July 2022, at tertiary children's hospitals in Shanghai. PARTICIPANTS: All the eligible individuals were recruited. The inclusion criteria were as follows: (1) should be a paediatrician, nurse and health information technician, (2) should have been engaged in or currently participating in social experiments based on MAI, and (3) voluntary participation in the survey. PRIMARY OUTCOME: Ethics implementation knowledge of and attitude to MAI social experiments among paediatricians, nurses and health information technicians. RESULTS: There were 137 paediatricians, 135 nurses and 60 health information technicians who responded to the questionnaire at tertiary children's hospitals. 2.4-9.6% of participants were familiar with ethics implementation knowledge of MAI social experiments. 31.9-86.1% of participants held an 'agree' ethics implementation attitude. Health information technicians accounted for the highest proportion of the participants who were familiar with the knowledge of implementing ethics, and paediatricians or nurses accounted for the highest proportion among those who held 'agree' attitudes. CONCLUSIONS: There is a significant knowledge gap and variations in attitudes among paediatricians, nurses and health information technicians, which underscore the urgent need for individualised education and training programmes to enhance MAI ethics implementation in paediatric healthcare.

Asunto(s)

RESUMEN

Mass casualty events (MASCAL) do not follow the same rules as typical major incidents. In the West at least, the latter often occur in stable, networked trauma systems, whereas MASCAL are characterised by overwhelming numbers of patients, compounded by protracted scene and transport times, decompensated response systems and significant disruption to infrastructure, command and control.This paper describes the 8Ds approach being taken by the UK Defence Medical Services and the North Atlantic Treaty Organization Emergency Medicine Panel framework to approach MASCAL. The eight domains were derived from literature about management of casualties in the World Wars, and also from approaches taken by civilian health systems as they struggle to manage increasing demand. They are: distribute; decompress; delay; delegate; deliver faster and deliver better; dynamic levels of care; and de-escalate These domains will allow a structured approach to research and innovate around MASCAL, informing better guidelines for their management.

RESUMEN

INTRODUCTION: In humanitarian settings, aid agencies are constantly challenged by difficult decisions such as when and how to terminate aid without harming the aid recipients, local institutions, staff members and the organisation. Despite important efforts devoted to responsibly leaving a setting, hurtful exits are still common in contemporary relief aid. Moreover, debates on how humanitarian aid agencies exit are limited, with no previous comprehensive evidence synthesis on the concept of 'responsible exit'. The objective of this scoping review is to map evidence and knowledge gaps, to identify and describe concepts, theories and existing frameworks related to 'responsible exit' of humanitarian aid agencies. METHODS AND ANALYSIS: Our search uses searches of several bibliographic databases (CAB Direct (including Global Health), Web of Science, PubMed and Google Scholar) as well as manual searches of specific journals and retrieval of grey literature through searches of organisational websites and direct contact with experts and organisations. Reference tracking will be used to identify additional sources. Searches will cover papers available up to the dates of the searches (December 2022 to January 2023), with no date restrictions applied to the literature search. To be included, published or unpublished papers must explicitly discuss the exit of humanitarian aid agencies from humanitarian settings and be accessible. We will exclude all exits related to military, local and governmental humanitarian operations, education, development, employment, and business sectors. Only papers written in English and French will be considered. Three reviewers will conduct the selection process against the predefined criteria. Data will be extracted in an iterative process following pre-established items and the results will be presented in a Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews flow chart, tables and/or graphs, and descriptive formats. ETHICS AND DISSEMINATION: Being a review, conducted on publicly available information, no ethical approval is required. The results will be disseminated through publication in an open access journal, scientific conferences, workshops, and via humanitarian aid agencies to facilitate further research and possible practical translations of generated knowledge.

Asunto(s)

RESUMEN

INTRODUCTION: Transgender women experience disparities in sport participation that are exacerbated by policies from sport organisations and legislation in the USA regulating the participation of transgender women in the category that best aligns with their gender identity. Both transgender and cisgender women are affected by these policies because sport organisations do not have a clear understanding of the effects of gender-affirming hormone therapy on transgender women and the unfair advantage they may have over cisgender women athletes. This article describes a review protocol to understand disparities in sport participation of transgender women. METHODS AND ANALYSIS: A systematic and scoping review is being conducted. Studies are included if they explore disparities in sport participation (ie, participation rates, real and/or perceived barriers to participation) of transgender women of any age. A search strategy has been developed for PubMed, EMBASE, Web of Science, Cochrane Library and CINAHL. Relevant grey literature will also be scanned. The planned search dates are July and August 2023. ETHICS AND DISSEMINATION: This review does not directly involve human subjects, so ethical approval is not required. Findings from the systematic review will be disseminated via publications in peer-reviewed journals and conferences.

Asunto(s)

RESUMEN

INTRODUCTION: Linking healthcare data sets can create valuable resources for research, particularly when investigating rare exposures or outcomes. However, across Europe, the permissions processes required to access data can be complex. This paper documents the processes required by the EUROlinkCAT study investigators to research the health and survival of children with congenital anomalies in Europe. METHODS: Eighteen congenital anomaly registries in 14 countries provided information on all the permissions required to perform surveillance of congenital anomalies and to link their data on live births with available vital statistics and healthcare databases for research. Small number restrictions imposed by data providers were also documented. RESULTS: The permissions requirements varied substantially, with certain registries able to conduct congenital anomaly surveillance as part of national or regional healthcare provision, while others were required to obtain ethics approvals or informed consent. Data linkage and analysis for research purposes added additional layers of complexity for registries, with some required to obtain several permissions, including ethics approvals to link the data. Restrictions relating to small numbers often resulted in a registry's data on specific congenital anomalies being unusable. CONCLUSION: The permissions required to obtain and link data on children with congenital anomalies varied greatly across Europe. The variation and complexity present a significant obstacle to the use of such data, especially in large data linkage projects. Furthermore, small number restrictions severely limited the research that could be performed for children with specific rare congenital anomalies.

Asunto(s)

RESUMEN

OBJECTIVES: We assess different approaches to seeking consent in research in secondary schools. DESIGN: We review evidence on seeking active versus passive parent/carer consent on participant response rates and profiles. We explore the legal and regulatory requirements governing student and parent/carer consent in the UK. RESULTS: Evidence demonstrates that requiring parent/carer active consent reduces response rates and introduces selection biases, which impact the rigour of research and hence its usefulness for assessing young people's needs. There is no evidence on the impacts of seeking active versus passive student consent but this is likely to be marginal when researchers are directly in communication with students in schools. There is no legal requirement to seek active parent/carer consent for children's involvement in research on non-medicinal intervention or observational studies. Such research is instead covered by common law, which indicates that it is acceptable to seek students' own active consent when they are judged competent. General data protection regulation legislation does not change this. It is generally accepted that most secondary school students age 11+ are competent to provide their own consent for interventions though this should be assessed individually. CONCLUSION: Allowing parent/carer opt-out rights recognises their autonomy while giving primacy to student autonomy. In the case of intervention research, most interventions are delivered at the level of the school so consent can only practically be sought from head teachers. Where interventions are individually targeted, seeking student active consent for these should be considered where feasible.

Asunto(s)