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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.
SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials
Importance: The protocol of a randomized 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. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. Observations: 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, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 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 enrollment, 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, policy makers, regulators, and other reviewers..
Prediction Models for Maternal and Offspring Short- and Long-Term Outcomes Following Gestational Diabetes: A Systematic Review
Objectives: Gestational diabetes mellitus (GDM), affecting one in seven pregnant women worldwide, can have short- and long-term adverse outcomes for both the mother and her baby. Despite a raft of prognostic models aiming to predict adverse GDM outcomes, very few have impacted clinical practice. This systematic review summarizes and critically evaluates prediction models for GDM outcomes, to identify promising models for further evaluation. Methods: We searched EMBASE, MEDLINE, Web of Science, CINAHL, and CENTRAL for studies that reported the development or validation of predictive models for GDM outcomes in mother or offspring (PROSPERO: CRD42023396697). Results: Sixty-four articles detailing 103 developed and 12 validated models were included in this review. Of these, 45% predicted long term, 31% birth, and 23% pregnancy outcomes. Most models (87%) had a high risk of bias, lacking sufficient outcome events, internal validation, or proper calibration. Only eight models were found at low risk of bias. Conclusions: Our findings highlight a gap in rigorously developed prediction models for adverse GDM outcomes. There is a need to further validate existing models and evaluate their clinical utility to generate risk prediction tools capable of improving clinical decision-making for women with GDM and their children.
Digitally Enabled Care in Diverse Environments (DECIDE): protocol for a programme of rapid evaluation of technology-enabled remote monitoring in health and social care
Background There is considerable interest in technology-enabled remote monitoring in the UK. The aim is to respond to system pressures and improve access, experience and quality of care. There is an urgent need for process, outcome and impact evaluations of interventions at various stages of development and implementation to address evidence gaps around adoption, spread, sustainability and inequalities. Aim DECIDE (Digitally Enabled Care in Diverse Environments) is a centre for rapid evaluation of technology-enabled remote monitoring funded by the National Institute for Health and Care Research (2023 to 2026). It aims to support service users, service commissioners and providers of remote monitoring services, to enable high quality care. Example questions include: Is the technology-enabled remote monitoring innovation needed and, if so, for whom? How are technology-enabled care pathways implemented, and what are associated outcomes and impacts? What are the opportunities and challenges for sustainability, scale-up and spread? Methods A range of qualitative, quantitative and economic methods will be used. Exact methods and questions will be dependent on the focus, scope and scale of each evaluation. Evaluations will be informed by relevant theory, including the Non-Adoption, Abandonment and the challenges to Spread, Scale-up and Sustainability of technological innovation in health and care (NASSS) framework. A User Advisory Group and External Steering Committee, both with diverse voices, will help shape evaluation design, implementation and dissemination. Project-led dissemination will ensure timely sharing of insights and support impact. Conclusion Evaluations will advance understanding of when and for whom technology-enabled remote monitoring innovation is needed; how it works and how factors related to the intervention, implementation process and wider context influence adoption; associated outcomes and impacts, whether and how these tackle inequalities; and potential challenges to scale and spread. We aim to inform decision-making by policymakers, commissioners, providers, patients/service users and researchers.
Implementation framework for AI deployment at scale in healthcare systems
Artificial intelligence (AI) and digital health technologies are increasingly used in the medical field. Despite promises of leading the future of personalized medicine and better clinical outcomes, implementation of AI faces barriers for deployment at scale. We introduce a novel implementation framework that can facilitate digital health designers, developers, patient groups, policymakers, and other stakeholders, to co-create and solve issues throughout the life cycle of designing, developing, deploying, monitoring, and maintaining algorithmic models. This framework targets health systems that integrate multiple machine learning (ML) models with various modalities. This design thinking approach promotes clinical utility beyond model prediction, combining privacy preservation with clinical parameters to establish a reward function for reinforcement learning, ranking competing models. This allows leveraging explainable AI (xAI) methods for clinical interpretability. Governance mechanisms and orchestration platforms can be integrated to monitor and manage models. The proposed framework guides users toward human-centered AI design and developing AI-enhanced health system solutions.
Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial.
BACKGROUND: The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care. METHODS: In this open-label, randomised controlled phase 3 trial, women aged ≥18 years with a suspected LGA fetus (estimated fetal weight >90th customised percentile) as identified by ultrasound scan between 35 weeks and 0 days (35+0 weeks) of gestation and 38+0 weeks' gestation, recruited from 106 hospitals across England, Scotland, and Wales in the UK, were randomly assigned (1:1) by web app to standard care or induction of labour between 38+0 weeks' gestation and 38+0 weeks' gestation using minimisation, balancing site, estimated fetal weight percentile (≤95th EFW percentile or >95th EFW percentile), and maternal age (≤35 years or >35 years). Key exclusion criteria included drug-treated diabetes, gestational diabetes, and elective caesarean section or induction already planned or indicated for any reason. Our primary outcome was incidence of shoulder dystocia, assessed by a masked independent expert adjudication panel who reviewed participants' delivery notes. Induction of labour was anticipated to result in birth 10·5 days earlier with a 300 g lower birthweight on average than standard care. We did an intention-to-treat (ITT) analysis in all participants for whom we had primary outcome data, and a per-protocol analysis in participants in the induction group who went into labour or were induced at 38+0 to 38+0 weeks' gestation versus participants in the standard care group who had not started labour, been induced, or had an elective caesarean section before 38+0 weeks' gestation. This study was registered with ISRCTN (18229892) and is no longer recruiting. FINDINGS: Between June 8, 2018, and Oct 25, 2022, 2893 women were randomly assigned to induction of labour (n=1447) or standard care (n=1446); the trial was terminated before the target of 4000 participants was reached on advice of the data monitoring committee following the lower-than-expected incidence of shoulder dystocia in the standard care group. Two participants in the induction group and seven in the standard care group had missing data for the primary outcome and were excluded from the ITT analysis. In the ITT analysis, 33 (2·3%) of 1445 babies in the induction group versus 44 (3·1%) of 1439 in the standard care group had shoulder dystocia (risk ratio [RR] 0·75 [95% CI 0·51-1·09]; p=0·14) with a mean difference of -6·0 days' (95% CI -6·3 to -5·6) gestation and -163·6 g (-190·0 to -137·1) birthweight between trial groups. 355 (24·6%) of 1446 mothers in the standard care group were induced, delivered, or went into labour at or before 38+0 weeks' gestation. In the per-protocol analysis, 27 (2·3%) of 1180 babies in the induction group versus 40 (3·7%) of 1074 in the standard care group had shoulder dystocia (RR 0·62 [0·41-0·92]; p=0·019), and there was a mean difference of -8·1 days' (-8·4 to -7·9) gestation and -213·3 g (-242·0 to -184·6) birthweight between trial groups. One neonatal death occurred from perinatal asphyxia after shoulder dystocia in the standard care group, and one neonatal death occurred following sepsis and congenital pneumonia in the induction group. 88 (6·1%) of 1447 mothers in the induction group had an adverse event versus 108 (7·5%) of 1446 in the standard care group (RR 0·81 [0·62 to 1·06]; p=0·13). Similar numbers of serious adverse events were reported in both groups. INTERPRETATION: No significant difference in incidence of shoulder dystocia was found between trial groups in the ITT analysis, probably due to the high proportion of earlier-than-expected deliveries in the standard care group reducing the intended between-group differences in gestational age and birthweight. However, in the per-protocol analysis, compared with all deliveries after 38+0 weeks' gestation, induction of labour between 38+0 weeks' gestation and 38+0 weeks' gestation did show a significant reduction in shoulder dystocia. This study provides pregnant women with suspected LGA fetuses and their clinicians important information about choices and decision making for timing and mode of birth. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.
Capacity for Care: Meta-Ethnography of Acute Care Nurses’ Experiences of the Nurse-Patient Relationship
This chapter reports findings of a meta-ethnography of published qualitative research on nurses’ experiences of nurse-patient relationships in acute settings, reported in detail in Bridges et al. (2012a). Concerns are growing that modern healthcare delivery is lacking in compassion and is failing to provide the individualized care required by, for instance, older people with complex needs (Firth-Cozens and Cornwell, 2009). Promoting meaningful connections with patients in which practitioners see each patient ‘as a person to be engaged with rather than a body to do things to’ (Nicholson et al., 2010, p. 12) requires nurses and others to be able to articulate and appreciate the nature of these connections and their impact on patient outcomes, along with an understanding of the factors that can promote or inhibit therapeutic relationships. Nurses and nursing are now often portrayed as lacking in compassion and being distracted from these aspects of care (Flatley and Bridges, 2008). A range of high-profile reports in the United Kingdom into the quality of in-patient care for older people suggest that many of the reported problems centre on a lack of humanity in hospital staff, particularly nurses. While good practice does exist, we understand little about the conditions in which high-quality, compassionate in-patient care is delivered. Insight into nurses’ experiences as they engage with patients is therefore critical to understand how best to support existing good practice and to focus service improvement initiatives. This focus is of particular importance in acute settings where patient throughput, service configuration and staffing patterns reduce contact time between staff and patients. In addition, we lack understanding about how nursepatient relationships, the act of caring and engagement in therapeutic relationships impact on nurses themselves.
The Antiviral Efficacy of HIV-Specific CD8+ T-Cells to a Conserved Epitope is Heavilydependent on the Infecting HIV-1 Isolate
A major challenge to developing a successful HIV vaccine is the vast diversity of viral sequences, yet it is generally assumed that an epitope conserved between different strains will be recognised by responding T-cells. We examined whether an invariant HLA-B8 restricted Nef90-97 epitope FL8 shared between five high titre viruses and eight recombinant vaccinia viruses expressing Nef from different viral isolates (clades A-H) could activate antiviral activity in FL8-specific cytotoxic T-lymphocytes (CTL). Surprisingly, despite epitope conservation, we found that CTL antiviral efficacy is dependent on the infecting viral isolate. Only 23% of Nef proteins, expressed by HIV-1 isolates or as recombinant vaccinia-Nef, were optimally recognised by CTL. Recognition of the HIV-1 isolates by CTL was independent of clade-grouping but correlated with virus-specific polymorphisms in the epitope flanking region, which altered immunoproteasomal cleavage resulting in enhanced or impaired epitope generation. The finding that the majority of virus isolates failed to present this conserved epitope highlights the importance of viral variance in CTL epitope flanking regions on the efficiency of antigen processing, which has been considerably underestimated previously. This has important implications for future vaccine design strategies since efficient presentation of conserved viral epitopes is necessary to promote enhanced anti-viral immune responses. © 2011 Ranasinghe et al.
Maternal Anaemia and Congenital Heart Disease in Offspring: A Case-Control Study Using Linked Electronic Health Records in the United Kingdom.
OBJECTIVE: Assessment of whether maternal anaemia in early pregnancy is associated with offspring congenital heart disease (CHD). DESIGN: Matched case-control study. SETTING: January 1998-October 2020, United Kingdom. POPULATION: Women with a haemoglobin measurement in the first 100 days of pregnancy and a CHD-diagnosed child. METHODS: Data were extracted from the United Kingdom Clinical Practice Research Datalink GOLD database of electronic health records. Cases were 2,776 women with a CHD-diagnosed child. These were compared to 13 880 matched controls, women without a CHD-diagnosed child. Anaemia was classified as
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.
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.
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.