Androcentric bias in surgical equipment - What challenges do women face?

BACKGROUND: Increasing diversity amongst surgeons results in a wide range of sizes and strengths. There are many types of biases affecting women surgeons. This study evaluates what challenges women surgeons may have with surgical equipment. METHODS: An online survey was distributed to Women in Surgery social media groups in North America and Australasia between April 2022-July 2022. RESULTS: There were 480 respondents across the range of specialties. 453 surgeons were included. Median glove size was 6.5. Difficulty with use of surgical instruments due to size was reported by 89% of surgeons and 71% reported difficulty due to the required grip strength. One hundred and twelve different tools were reported to be problematic. CONCLUSIONS: This study highlights a potential source of androcentric bias which could be addressed to improve equity for women surgeons.

Blowing the whistle on mixed gender hospital rooms in Australia and New Zealand: a human rights issue.

The practice of placing men and women in the same hospital room (mixed gender rooms) has been prohibited in the UK National Health Service for over a decade. However, recent research demonstrates that the practice is common and increasing in a major New Zealand public hospital. Reports and complaints show that the practice also occurs in Australia. We argue that mixed gender rooms violate the fundamental human rights of personal security and dignity. The high rates of cognitive impairment, sensory impairment and frailty in hospital wards exacerbates the risk for these violations and subsequent harm. We argue for the adoption of specific national policies prohibiting mixed gender rooms and public reporting of breaches. Importantly, these guidelines can be adopted without compromising the rights of gender minorities. In the long term, hospitals should be built with single occupancy rooms.

Public acceptability of COVID-19 control measures in Singapore, Hong Kong, and Malaysia: A cross-sectional survey.

BACKGROUND: Several countries have implemented control measures to limit SARS-CoV-2 spread, including digital contact tracing, digital monitoring of quarantined individuals, and testing of travelers. These raise ethical issues around privacy, personal freedoms, and equity. However, little is known regarding public acceptability of these measures. METHODS: In December 2020, we conducted a survey among 3635 respondents in Singapore, Hong Kong, and Malaysia to understand public perceptions on the acceptability of COVID-19 control measures. FINDINGS: Hong Kong respondents were much less supportive of digital contact tracing and monitoring devices than those in Malaysia and Singapore. Around three-quarters of Hong Kong respondents perceived digital contact tracing as an unreasonable restriction of individual freedom; <20% trusted that there were adequate local provisions preventing these data being used for other purposes. This was the opposite in Singapore, where nearly 3/4 of respondents agreed that there were adequate data protection rules locally. In contrast, only a minority of Hong Kong respondents viewed mandatory testing and vaccination for travelers as unreasonable infringements of privacy or freedom. Less than 2/3 of respondents in all territories were willing to be vaccinated against COVID-19, with a quarter of respondents undecided. However, support for differential travel restrictions for vaccinated and unvaccinated individuals was high in all settings. INTERPRETATION: Our findings highlight the importance of sociopolitical context in public perception of public health measures and emphasize the need to continually monitor public attitudes toward such measures to inform implementation and communication strategies.

Ethics of digital contact tracing wearables.

The success of digital COVID-19 contact tracing requires a strategy that successfully addresses the digital divide-inequitable access to technology such as smartphones. Lack of access both undermines the degree of social benefit achieved by the use of tracing apps, and exacerbates existing social and health inequities because those who lack access are likely to already be disadvantaged. Recently, Singapore has introduced portable tracing wearables (with the same functionality as a contact tracing app) to address the equity gap and promote public health. We argue that governments have an ethical obligation to ensure fair access to the protective benefits of contract tracing during the pandemic and that wearables are an effective way of addressing some important equity issues. The most contentious issues about contact tracing apps have been the potential infringements of privacy and individual liberty, especially where the use of apps or other technology (such as wearables or QR codes) is required for access to certain spaces. Here we argue that wearables, as opposed to apps alone, will make a digital contact tracing mandate more practical and explain some conditions under which such a mandate would be justified. We focus on Singapore as a case study that has recently deployed contact tracing wearables nationally, but also reference debate about wearables in Australia and New Zealand. Our analysis will be relevant to counties trialling similar portable tracing wearables.

Stability of maternal serum free ß-hCG following whole blood sample transit: First trimester Down's syndrome screening in Scotland.

BACKGROUND: Maternal serum free beta human chorionic gonadotrophin (free ß-hCG) is used as a biomarker in first trimester screening for fetal Down's syndrome. Production of free ß-hCG can occur in vitro in a time- and temperature-dependent manner; thus, the current Scottish screening protocol states samples must be received by the laboratory within 72 h. To assess the validity of the protocol, an audit was conducted to determine the impact of transit time on maternal serum free ß-hCG multiple of median (MoM) values in the Scottish screened population. METHODS: Corrected MoM values from antenatal screening carried out over one year (April 2017 to March 2018) were stratified according to sample transit time and compared. To investigate possible environmental temperature effects, the data were split according to season and maternal serum free ß-hCG concentrations from summer and winter compared. RESULTS: Of the 28,368 samples included in the study, 24,368 were received on the day of phlebotomy or after one day in transit. Only 1.5% of samples were received after 3 days in transit. The difference in maternal serum free ß-hCG MoM values due to transit time was not significant. No statistical difference was found between maternal serum free ß-hCG concentrations from samples collected in summer and winter months. CONCLUSION: The current sample receipt protocol in use by the Scottish Down's syndrome screening programme is fit for purpose.

Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials.

Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m2, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any 'health' screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities.

Religious Perspectives on Precision Medicine in Singapore.

Precision medicine (PM) aims to revolutionise healthcare, but little is known about the role religion and spirituality might play in the ethical discourse about PM. This Perspective reports the outcomes of a knowledge exchange fora with religious authorities in Singapore about data sharing for PM. While the exchange did not identify any foundational religious objections to PM, ethical concerns were raised about the possibility for private industry to profiteer from social resources and the potential for genetic discrimination by private health insurers. According to religious authorities in Singapore, sharing PM data with private industry will require a clear public benefit and robust data governance that incorporates principles of transparency, accountability and oversight. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s41649-021-00180-4.

Trust and Trade-Offs in Sharing Data for Precision Medicine: A National Survey of Singapore.

BACKGROUND: Precision medicine (PM) programs typically use broad consent. This approach requires maintenance of the social license and public trust. The ultimate success of PM programs will thus likely be contingent upon understanding public expectations about data sharing and establishing appropriate governance structures. There is a lack of data on public attitudes towards PM in Asia. METHODS: The aim of the research was to measure the priorities and preferences of Singaporeans for sharing health-related data for PM. We used adaptive choice-based conjoint analysis (ACBC) with four attributes: uses, users, data sensitivity and consent. We recruited a representative sample of n = 1000 respondents for an in-person household survey. RESULTS: Of the 1000 respondents, 52% were female and majority were in the age range of 40-59 years (40%), followed by 21-39 years (33%) and 60 years and above (27%). A total of 64% were generally willing to share de-identified health data for IRB-approved research without re-consent for each study. Government agencies and public institutions were the most trusted users of data. The importance of the four attributes on respondents' willingness to share data were: users (39.5%), uses (28.5%), data sensitivity (19.5%), consent (12.6%). Most respondents found it acceptable for government agencies and hospitals to use de-identified data for health research with broad consent. Our sample was consistent with official government data on the target population with 52% being female and majority in the age range of 40-59 years (40%), followed by 21-39 years (33%) and 60 years and above (27%). CONCLUSIONS: While a significant body of prior research focuses on preferences for consent, our conjoint analysis found consent was the least important attribute for sharing data. Our findings suggest the social license for PM data sharing in Singapore currently supports linking health and genomic data, sharing with public institutions for health research and quality improvement; but does not support sharing with private health insurers or for private commercial use.

Perceptions of 'Precision' and 'Personalised' Medicine in Singapore and Associated Ethical Issues.

Governments are investing in precision medicine (PM) with the aim of improving healthcare through the use of genomic analyses and data analytics to develop tailored treatment approaches for individual patients. The success of PM is contingent upon clear public communications that engender trust and secure the social licence to collect and share large population-wide data sets because specific consent for each data re-use is impractical. Variation in the terminology used by different programmes used to describe PM may hinder clear communication and threaten trust. Language is used to create common understanding and expectations regarding precision medicine between researchers, clinicians and the volunteers. There is a need to better understand public interpretations of PM-related terminology. This paper reports on a qualitative study involving 24 focus group participants in the multi-lingual context of Singapore. The study explored how Singaporeans interpret and understand the terms 'precision medicine' and 'personalised medicine', and which term they felt more aptly communicates the concept and goals of PM. Results suggest that participants were unable to readily link the terms with this area of medicine and initially displayed preferences for the more familiar term of 'personalised'. The use of visual aids to convey key concepts resonated with participants, some of whom then indicated preferences for the term 'precision' as being a more accurate description of PM research. These aids helped to facilitate dialogue around the ethical and social value, as well as the risks, of PM. Implications for programme developers and policy makers are discussed.

Equity in vaccine trials for higher weight people? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19.

INTRODUCTION: Vaccination is a public health strategy that aims to reduce the burden of viral illness, especially important for populations known or likely to be at increased risk for inequitable outcomes due to the disease itself or disparities in care accessed and received. The role of weight status in COVID-19 susceptibility and disease burden remains unclear. Despite this, higher weight is frequently described as a definitive risk factor for both susceptibility and disease severity. Therefore, COVID-19 vaccine trials should recruit a study group representative of the full weight spectrum, and undertake appropriate subgroup analysis by weight status to evaluate response and titrate dose regimes where indicated to ensure equitable outcomes for higher weight people. METHODS AND ANALYSIS: We aim to review inclusion and exclusion criteria of clinical trial protocols registered with ClinicalTrials.gov, ISRCTN Register, the WHO official vaccine trial register, and 'The COVID-19 Vaccine Tracker'. To determine the number of trials including higher weight (body mass index >30 kg/m2) individuals and the number of trials conducting efficacy subgroup analyses by weight status. Screening, data extraction and quality appraisal of trial protocols will be completed independently by a minimum of two reviewers. Clinical trials will be assessed for risk of bias using the Risk of Bias-2 tool. We will conduct a descriptive analysis of extracted data. The following subsets are proposed: participation of higher weight people in COVID-19 vaccine trials by trial phase, country and vaccine platform. ETHICS AND DISSEMINATION: Ethical approval was not required for this review. The results of this rapid review will be presented at appropriate conferences and published in a suitable peer reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020226573.

Young people with a variation in sex characteristics in Aotearoa/New Zealand: identity, activism and healthcare decision-making.

Young people born with variations in sex characteristics (VSC) or disorders of sex development (DSD) face numerous challenges in navigating issues relating to identity and to their lived and embodied experience. There is limited published research amplifying the voices of young people with a VSC, especially from Aotearoa/New Zealand. This qualitative study provides an up-to-date picture of the lived experience of 10 young people with a VSC in Aotearoa/New Zealand. The research was conducted in collaboration with the advocacy group, Intersex Youth Aotearoa, and explored the level of support provided by health services, peers and advocacy groups in relation to the ways the participants viewed themselves and their bodies, and their health related decision-making. Findings reveal the pressure on young people with a VSC to conform to cultural and societal norms, specifically, heteronormative and traditional constructs of how male and female bodies should look in Aotearoa/NZ society. Such views, often held and perpetuated by health professionals and parents, contributed to complexities surrounding identity, agency and acceptance of difference experienced by these young people. The implications of these findings are discussed, including the need for better psychological and peer support for young people.

In defence of a broad approach to public interest in health data research.

In their response to 'Public interest in health data research: laying out the conceptual groundwork', Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees (IRBs/RECs), we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current frameworks such as that found in the guidelines approved under Australia's Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies.

Digital contact tracing and exposure notification: ethical guidance for trustworthy pandemic management.

There is growing interest in contact tracing apps (CT apps) for pandemic management. It is crucial to consider ethical requirements before, while, and after implementing such apps. In this paper, we illustrate the complexity and multiplicity of the ethical considerations by presenting an ethical framework for a responsible design and implementation of CT apps. Using this framework as a starting point, we briefly highlight the interconnection of social and political contexts, available measures of pandemic management, and a multi-layer assessment of CT apps. We will discuss some trade-offs that arise from this perspective. We then suggest that public trust is of major importance for population uptake of contact tracing apps. Hasty, ill-prepared or badly communicated implementations of CT apps will likely undermine public trust, and as such, risk impeding general effectiveness.

"Who is watching the watchdog?": ethical perspectives of sharing health-related data for precision medicine in Singapore.

BACKGROUND: We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine (PM) and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. METHODS: We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages (English, Mandarin and Malay) and analysed with qualitative content and thematic analysis. RESULTS: Four key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust (and distrust) in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. CONCLUSION: Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective.

Points of contention: Qualitative research identifying where researchers and research ethics committees disagree about consent waivers for secondary research with tissue and data.

BACKGROUND: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. METHODS: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. RESULTS: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical. CONCLUSION: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.