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CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials
Importance: Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Herein, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. Observations: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication [TIDieR]), and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, 3-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added 7 new checklist items, revised 3 items, deleted 1 item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. Conclusions and Relevance: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.
Clinical Study Reports-a systematic review with thematic synthesis: Part 2. Studying benefits, harms, and the benefit to harm balance of pharmacological interventions.
BACKGROUND: We define clinical study reports (CSRs) as standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities when they apply for marketing authorization. METHODS: In this systematic review we searched various databases (Clarivate Web of Science, EMBASE and Ovid Medline, Google Scholar, and PubMed) for publications containing the term "clinical study report/s", without restrictions. THEMATIC SYNTHESIS: In the first part of this review we discussed the history of CSRs, their contents and structure, definitions, and relevant terminology. In this second part we discuss the uses of CSRs, concentrating on the individual benefits and harms of pharmacological interventions, and thus the benefit to harm balance. We also discuss adherence to interventions, prepublication of protocols of clinical trials, and how CSRs are written, factors that can all affect estimation of the benefit-harm balance. CONCLUSIONS: When clinical trial data from CSRs are compared with the data in published trial reports, the apparent benefits of pharmacological interventions are less impressive, and more information emerges about harms they can cause. Both of these effects change how the benefit-harm balance of a pharmacological intervention is estimated, generally making it less favourable than was otherwise thought. For more accurate assessment of the benefit-harm balance of an intervention, full, not abbreviated or synoptic, clinical study reports should continue to be made publicly available by regulatory authorities and manufacturers. Authorities that do not currently make them available should do so. CSRs should be introduced for assessment of surgical operations, therapeutic devices, and other non-pharmacological interventions in clinical trials.
Clinical Study Reports-a systematic review with thematic synthesis: Part 1. History, contents and structure, definitions, and terminology.
BACKGROUND: Clinical study reports (CSRs) are standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities, as part of the drug approval process. Their recommended contents and structure were described in 1995 in a document of the International Conference on Harmonisation, ICH E3, although companies can choose how to present the data. Until 2015, such reports were not readily available to the public, but since then some regulatory authorities have made them available, as have some pharmaceutical companies, albeit often in abbreviated or redacted versions. The apparent benefits of pharmacological interventions are not as impressive when they are calculated using data from clinical study reports compared with published trial reports, and more information emerges about harms the interventions can cause. RESULTS: Our methods are described in Part 2 of this systematic review with thematic synthesis, in which we have summarized the uses of CSRs, as described in 349 publications of various sorts, including analyses of clinical trials, data analyses, commentaries, and official documents. We have specifically concentrated on how CSRs affect assessments of benefits, harms, and the benefit-to-harm balance, and other factors that affect it. In Part 1, we discuss the history of the development of CSRs, their contents and structure, definitions of CSRs and qualifying terms, and relevant terminology (including the availability of CSRs, data sharing systems, and transparency and confidentiality). CONCLUSIONS: Our conclusions are listed in Part 2 of this review.
Investigating the association between recorded smoking cessation interventions and smoking cessation in people living with cardiovascular disease using UK general practice data.
BACKGROUND: Smoking significantly increases the risk of cardiovascular diseases (CVD), yet quitting smoking after diagnosis of CVD can mitigate further negative impacts. However, encouraging smoking cessation remains a challenge for General Practitioners (GPs) with concerns regarding mental health. Since 2004, the UK's Quality and Outcomes Framework (QOF) incentivises GP smoking cessation support. Despite this, a significant proportion of individuals diagnosed with CVD continue to smoke after diagnosis. This study aims to investigate the frequencies and types of smoking cessation interventions offered to people with CVD (defined as coronary heart disease (CHD) and stroke), with and without mental illness, and assess their association with successful cessation. METHODS: This retrospective cohort study examined adults diagnosed with CHD or stroke using the QResearch general practice records database (1996-2019). We evaluated the frequency and types of smoking cessation interventions documented in patients' records, including education, brief interventions, pharmacological support, referrals, and counselling. Logistic regression assessed the relationship between recorded interventions and smoking abstinence rates within the one-year post-index event, considering QOF incentives and mental illness presence. RESULTS: While smoking cessation education was common in general practice settings, prescriptions for nicotine replacement therapy or other evidence-based interventions were comparatively low. CHD and stroke populations showed a significant association between any intervention and smoking cessation within one year (CHD: OR 1.41, 95% CI 1.36-1.45; stroke: OR 1.49, 95% CI 1.43-1.55). Education consistently correlated with higher cessation likelihoods, while other interventions were linked to lower rates. Individuals with common and serious mental illness were less likely to quit, irrespective of intervention. QOF implementation led to increased documentation of advice but not intensive support or treatment, with pre-QOF interventions associated with significantly increased abstinence likelihoods (CHD: OR 5.09, 95% CI 4.84-5.35; stroke: OR 4.44, 95% CI 4.07-4.86). CONCLUSIONS: Financial incentives for GP smoking cessation support outlined in QOF may not suffice to enhance methods that are more efficacious or improve cessation rates, especially among people with mental illness. Practical strategies that provide tangible support and treatment are needed for CVD patients, including those with mental illness, to facilitate successful cessation.
Mangroves support an estimated annual abundance of over 700 billion juvenile fish and invertebrates
Mangroves are a critical habitat that provide a suite of ecosystem services and support livelihoods. Here we undertook a global analysis to model the density and abundance of 37 commercially important juvenile fish and juvenile and resident invertebrates that are known to extensively use mangroves, by fitting expert-identified drivers of density to fish and invertebrate density data from published field studies. The numerical model predicted high densities throughout parts of Southeast and South Asia, the northern coast of South America, the Red Sea, and the Caribbean and Central America. Application of our model globally estimates that mangroves support an annual abundance of over 700 billion juvenile fish and invertebrates. While abundance at the early life-history stage does not directly equate to potential economic or biomass gains, this estimate indicates the critical role of mangroves globally in supporting fish and fisheries, and further builds the case for their conservation and restoration.
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.
Managing obstetric bleeding in Wales: A qualitative evaluation of the OBS Cymru care bundle using Normalisation Process Theory.
BACKGROUND: Post-partum haemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity worldwide. The Obstetric Bleeding Strategy (OBS) care bundle for PPH management was adopted into Welsh national guidelines in 2019 (as OBS Cymru), and is currently being implemented across 36 sites in the rest of the UK through the OBS UK stepped-wedge cluster randomised controlled trial. We conducted a qualitative evaluation of the OBS care bundle five years after its adoption to inform plans for optimising its implementation across the UK. METHODS: We conducted ethnographic observations, informal conversations and qualitative interviews with multidisciplinary teams (MDT) in four maternity units in Wales. Data were analysed thematically and using Normalisation Process Theory. RESULTS: The OBS Cymru protocol was used daily and MDT members believe it improves the quality and safety of PPH management. The paper proforma supporting OBS Cymru was the 'boundary object' that kept the care bundle in view while clarifying individualised roles across the MDT during a PPH and prompting improved and continuous communication as bleeding progressed. The standardisation of processes through the care bundle was seen as enabling all staff with an overall knowledge of PPH care, while situating the prominence of their particular roles within a greater whole. Enacting the bundle in practice varied slightly across different settings, according to staffing structures (e.g., in delivery rooms versus theatre births) and caseload, and some residual tensions remained regarding expectations from different staff members and levels of support provided regarding OBS Cymru. CONCLUSIONS: Despite some small-scale variations, OBS care bundle has become normalised as standard PPH care in Wales. Insights from this evaluation, such as the centrality of the proforma in holding the bundle together, and need for greater clarity in staff role expectations, have informed implementation plans for the OBS UK trial.
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.