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Nasir Hamid
Is It Cost-Effective to Induce Labour Early to Prevent Shoulder Dystocia? Evidence From the Big Baby Trial.
BACKGROUND: The cost-effectiveness of early induction of labour for suspected large-for-gestational-age foetuses to prevent shoulder dystocia is unknown. METHODS: A within-trial economic evaluation of induction at 38 + 0 to 38 + 4 weeks' gestation for suspected large-for-gestational-age foetuses. Resource use and costs were measured to 6 months postpartum. We estimated incremental cost per case of shoulder dystocia prevented and incremental cost per maternal quality-adjusted life year (QALY) gained. We collected data for planned caesarean sections in a cohort study. FINDINGS: Mean combined woman and infant costs in the induction arm were £89 (95% confidence interval (CI): -£79, £257) higher than the standard care arm, driven by increased neonatal costs. The incremental cost of preventing one case of shoulder dystocia was £11 879 and the incremental cost per maternal QALY gained was £39 518. The probability of early induction being cost-effective was 0.65 at a cost-effectiveness threshold of £20 000 per case of shoulder dystocia prevented, but 0.36 at a cost-effectiveness threshold of £20 000 per maternal QALY gained. The cohort study found the mean cost was £310 (95% CI: £74, £545) higher in the induction arm than in the planned caesarean group. INTERPRETATION: Early induction of labour increased neonatal care costs. It is not a cost-effective approach when effects are restricted to maternal QALYs. Planned caesarean section might be cost-saving when compared to early induction, although we did not assess longer-term effects such as an increased risk of repeat caesarean sections. Assessments of long-term effects on the mother and infant should be incorporated into future studies. TRIAL REGISTRATION: ISRCTN18229892.
Primary Care EHR data on Social Determinants of Health: Quality and Fitness for Purpose in Precision/Personalised Medicine
INTRODUCTION: Precision and personalised medicine requires comprehensive genetic, epigenetic, lifestyle, social, community and environmental knowledge of the patient. This approach highlights the importance of the social determinants of health (SDoH), described by the World Health Organization (WHO) as 'the non-medical factors that influence health outcomes, the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life such as economic policies and systems, development agendas, social norms, social policies and political systems'. METHODS: This study examined if countries collect SDoH indicators and, if they do, the quality of the data and whether they are fit for clinical and population health purposes. The sources of data were EHR networks and, where not available, national data collections. RESULTS: While demographic details (age, gender) and rurality were well documented in most countries, we found that data availability and quality for education, occupation, income, socio-economic status, and residential care varied considerably between countries. Data for smoking, obesity, alcohol use, mental health, and substance use were generally poorly recorded. CONCLUSION: Recommendations include a universal set of indicators and taxonomy for SDoH; common data model and metadata standards for national and global harmonisation and monitoring; benchmarks for data quality and fitness-for-purpose; capacity building at national and subnational levels in data collection, data analysis, communication and dissemination of results; ethical and transparent data stewardship; and governance, leadership and diplomacy across multiple sectors to co-create an enabling policy and regulatory environment.
Social factors, health policy, and environment: implications for cardiovascular disease across the globe
Abstract Cardiovascular disease (CVD) is the leading cause of deaths worldwide, with 80% occurring in low- and middle-income countries. These countries are characterized by rapid urbanization, poorly funded health systems, poor access to prevention and treatment strategies, and increasing age and a higher prevalence of chronic disease. Rapid urbanization has contributed to the significant environmental and societal changes affecting daily life habits and cardiovascular health. There is growing awareness that environmental and social exposures and policies can influence CVD directly or through behavioural risk factors. However, much of this knowledge comes from studies in high-income countries and is applied to low- and middle-income countries without evidence to indicate this is appropriate. This state-of-the-art review will present and synthesize key findings from the Prospective Urban Rural Epidemiology study and related studies that have aimed to understand the environmental, social, and policy determinants of cardiovascular health in countries across varying levels of economic development through an urban/rural lens. Emerging from these findings are future policy and research recommendations to accelerate the reduction of the global burden of CVD.
Community resilience to health emergencies: A scoping review
Background There is recognition of the importance of community resilience in mitigating long-term effects of health emergencies on communities. To guide policy and practice, conceptual clarity is needed on what community resilience involves and how it can be operationalised for community protection in ways that empower and strengthen local agency. Objectives To identify the core components of community resilience to health emergencies using a scoping review methodology. Search methods PubMed, EMCARE, Scopus, Web of Science, PTSDpubs, APO and ProQuest Dissertations were systematically searched to identify review studies published from 2014. Selection criteria Studies were included if they reported a review of original research papers investigating community resilience in the context of a health emergency. Data collection and analysis Data were extracted from included studies using a specially developed data extraction form. Qualitative data were subjected to a meta-synthesis consisting of three levels of analysis. Main results 38 evidence reviews were included. Analysis identified recurring characteristics of community resilience. Six studies reported 10 abilities required for community resilience including: Adapt, transform, absorb, anticipate, prepare, prevent, self-organise, include, connect and cope. 25 studies reported 11 types of resources: social, economic, environmental, governance, physical infrastructure, institutional, communication, human capital, health, emergency management and socioeconomic. Conclusions 21 components have been identified that can be used as a basis for operationalising and measuring community resilience. In contexts of disaster management, community resilience is a fairly mature concept that reflects a community's inherent capacity/abilities to withstand and recover from shocks. There is a need to incorporate a 'resource' perspective that speaks to a wider enabling environment. There is scope to investigate whether the same set of components identified here has relevance in public health emergencies emanating from disease or human acts of aggression and to articulate resilience logics to critical endpoints for health emergency management.
How to read a paper involving artificial intelligence (AI)
This paper guides readers through the critical appraisal of a paper that includes the use of artificial intelligence (AI) in clinical settings for healthcare delivery. A brief introduction to the different types of AI used in healthcare is given, along with some ethical principles to guide the introduction of AI systems into healthcare. Existing publication guidelines for AI studies are highlighted. Ten preliminary questions to ask about a paper describing an AI based decision support algorithm are suggested.
The implementation of a Nationally Enhanced Service incentive for weight management: A longitudinal qualitative study of the perceptions and experiences of UK primary care staff on weight management using normalisation process theory
SummaryIn 2021 a Nationally Enhanced Service (NES) incentive for weight management in primary care was rolled out in England. This paid general practices £11.50 for every eligible referral they made to a weight management programme. We explored primary care staff's perceptions, experiences and attitudes toward the NES by conducting 37 semi‐structured interviews with General Practitioners (GPs), administrative staff and nurses preceding the introduction of the NES (May to September 2021) and 1 year later following its introduction (September to December 2022). Data were analysed using normalisation process theory. The NES for weight management solidified the position of staff already supportive of referring patients to weight management programmes. For staff less supportive of weight management services, the dissonance between the perceived lack of benefit of services and making referrals to services was reduced with referrals becoming more habitual. Facilitators to implementation included the presence of a coherent national policy; having a ‘champion’ explain key aspects; and a financial incentive if framed as benefiting the practice at large. Barriers included a perception that primary care has been shouldered with a complex and difficult health crisis; a worry over workload burdens; and inefficient and unclear referral systems. The implementation of the NES was broadly welcomed and accepted by primary care staff. Interviewees expressed concerns around the acceptance of weight management policies in primary care, the provision of training to raise the topic of weight and whether the responsibility of weight management fell with primary care, public health or with the patient.
The potential of programme theory in bridging the evidence into practice gap in implementation science: a worked example of integrating palliative care into heart failure management
Abstract Implementation science has been defined as the scientific study of methods focused on promoting the systematic uptake of research findings into routine practice in order to improve the quality and effectiveness of healthcare services. However, a recent critique of the science has highlighted a research to practice gap paradox suggesting that rather than closing the gap, implementation science may be reinventing it. Others have more recently provided a further critique focusing on the promises and pitfalls of implementation science, arguing that the field needs to further develop and grow. Our paper aims to contribute to this call by suggesting one possible way forward. To do this we first explore the ideas and assumptions underpinning implementation science, before we introduce the benefits of realist approaches - which are increasingly recognised as crucial for addressing the research to practice gap paradox as they deal with real world complexity. Whilst realist approaches may help move the field of implementation science forward, we also point out that the theories within this field can also help to improve understanding in realist research. In summary, our paper challenges the growing reliance on implementation theories, models and frameworks as the only starting point for research in this field, and we argue that realist programme theory may be equally useful.
The impact of patient enrolment in primary care on continuity and quality of care around the world, 2014-2024, and lessons for Australia: a scoping review.
OBJECTIVES: To identify publications examining the enablers of and barriers to patient enrolment in primary care and its impact on continuity and quality of care; to assess the likely effectiveness of voluntary patient enrolment (MyMedicare) in Australia with regard to improving continuity of care and supporting other health care reforms. STUDY DESIGN: Scoping review of peer-reviewed journal article published in English during 1 January 2014 - 12 July 2024 that evaluated primary care enrolment models, including patient enrolment enablers and barriers. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, Embase, CINAHL (Cumulated Index in Nursing and Allied Health Literature), PsycINFO, PAIS (Public Affairs Information Service), Web of Science, Scopus. The bibliographies of included articles were checked for further relevant publications. DATA SYNTHESIS: The database searches and bibliography checks identified 508 potentially relevant articles; we reviewed the full text of 66 articles after title and abstract screening, of which 24 publications met our inclusion criteria. Twenty-two of the included studies were undertaken in fifteen countries, including eleven in Canada, four in Australia, and two each in the United Kingdom and New Zealand; one publication compared schemes in twelve countries, one was a rapid review. The characteristics of patient enrolment models differ greatly between countries in both form and implementation, including the mandatory and voluntary components. We found little evidence that enrolment improved continuity of care. However, existing patient engagement with usual general practitioners was high among participants in many studies, and some studies involved patients who may already have had high levels of continuity of care. There is evidence that enrolment can support primary care reforms, including preventive care and the management of chronic conditions, and that other reforms, such as incentives and increased access to services can affect the enrolment of patients and practices. People in marginalised groups or with complex care needs are less likely to enrol with practices or practitioners. CONCLUSIONS: The Australian voluntary patient enrolment scheme should be continuously evaluated to assess levels of engagement by patients and general practices, drawing on the experiences of other countries in which similar schemes operate. Further assessment of overseas enrolment systems could identify reasons for the different experiences reported, as well as enablers of and barriers to successful implementation and better health outcomes.
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.