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Nasir Hamid
Interventions for smokeless tobacco use cessation
Rationale: While combustible tobacco has been the subject of a very large amount of research, smokeless tobacco products receive less attention. Most smokeless tobacco products are very harmful and cause global health inequality. It is therefore important to identify evidence-based cessation aids. Objectives: To assess the effects of behavioural and pharmacological interventions for smokeless tobacco use cessation. Search methods: We searched the following databases from inception to 16 February 2024: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; PsycINFO; ClinicalTrials.gov (through CENTRAL); World Health Organisation International Clinical Trials Registry Platform (through CENTRAL). We also searched references of eligible studies. Eligibility criteria: We included randomised controlled trials (RCTs) recruiting people of any age using smokeless tobacco, regardless of tobacco smoking status. Eligible studies could test any intervention designed to support people to quit smokeless tobacco use, and had to measure abstinence from either all tobacco use or smokeless tobacco use at six months or longer. Outcomes: The outcome of interest was abstinence from all tobacco use or from smokeless tobacco use at six months or longer. Risk of bias: We used the Cochrane RoB 1 tool to assess bias in included studies. Synthesis methods: We followed standard Cochrane methods for screening and data extraction. We grouped studies by comparisons of eligible interventions and comparators, reporting individual study and pooled effects as appropriate. We used a random-effects Mantel-Haenszel model for analyses of behavioural interventions and a fixed effect Mantel-Haenszel model for analyses of pharmacotherapies to calculate risk ratios (RR) with 95% confidence intervals (CI). We assessed the certainty of evidence using GRADE. Included studies: We included 43 trials of 20,346 people. Thirty-three trials were conducted in North America, five in India, two in Scandinavia, one in Pakistan and one in Turkey. One study was conducted across multiple sites in Bangladesh, India and Pakistan. Studies tested behavioural interventions (e.g. cessation counselling and brief advice) and pharmacotherapies (e.g. nicotine replacement therapy (NRT), varenicline, and bupropion). We judged five studies to be at low risk of bias overall, 22 at high risk of bias, and the remaining 16 at unclear risk of bias. Synthesis of results: We found moderate-certainty evidence of increased quit rates from counselling compared with minimal support (RR 1.76, 95% CI 1.44 to 2.16; I2 = 69%; 21 studies, n = 7417; downgraded because of heterogeneity), brief advice compared with no support (RR 1.24, 95% CI 1.03 to 1.48; I2 = 49%; 7 studies, n = 6271; downgraded because of imprecision), and varenicline compared with placebo (RR 1.35, 95% CI 1.08 to 1.68; I2 = 0%; 2 studies, n = 508; downgraded because of imprecision). We found low-certainty evidence (downgraded because of imprecision and risk of bias) of increased quit rates from NRT compared with placebo or no medication (RR 1.18, 95% CI 1.05 to 1.33; I2 = 39%; 11 studies, n = 2826). Low-certainty evidence (downgraded because of imprecision) did not show benefit from bupropion compared with placebo (RR 0.89, 95% CI 0.54 to 1.44; I2 = 0%; 2 studies, n = 293). We planned subgroup analyses to explore whether smokeless tobacco type affects intervention efficacy, but found insufficient data. Authors' conclusions: Cessation counselling, brief advice, and varenicline each probably help more people to quit smokeless tobacco use than minimal or no support, or placebo. NRT may help more people to quit smokeless tobacco use than placebo or no medication. Low-certainty evidence does not currently support bupropion as a smokeless tobacco cessation intervention. Despite the majority of smokeless tobacco users living in South and Southeast Asia, only a minority of trials are conducted in those regions. Future trials should address this imbalance. Registration: Protocol available via DOI: 10.1002/14651858.CD015314.
The DESTINIES Study: an online Delphi study to build international consensus on the medical conditions and procedures that confer immunosuppression and their respective COVID-19 risk profiles
Background: The lack of international consensus on defining and categorising immunosuppression has undermined disease surveillance and patient care, particularly during the COVID-19 pandemic. To address this, a global expert panel was recruited to join the eDElphi STudy to fully defiINe and COVID-risk stratify ImmunosupprESsion (DESTINIES) and develop a COVID risk-stratified digital phenotype for ‘adult immunosuppression’ (the DESTINIES phenotype). Methods: Panellists were presented with all medical diagnoses and procedures cited in prevailing immunosuppressed definitions; they evaluated their appropriateness for the DESTINIES phenotype and their risks for severe COVID-19 outcomes through anonymous online questionnaires and discussion. Panel agreement with a series of clinical statements were also assessed; statements incorporated longstanding disputes, including variables that could reverse immunosuppression. Each round of data collection informed and refined a draft phenotype until final ratification. This study was active between May and September 2024. Findings: Sixty-four experts from four continents and 12 international agencies completed two rounds of consensus questionnaire, a discussion group and ratifying vote. Panellists identified candidates posing higher (e.g. Transplantation, Primary Immunodeficiency) and lower COVID-19 risk (e.g. Anorexia nervosa, Cerebral spinal fluid leak) but disagreed on the categorisation of others (e.g. Asplenia, Immune-mediated Inflammatory Disease). Consensus was reached on ten clinical statements, notably removing Drug-managed HIV and Cancer remission from consideration as immunosuppressed. The DESTINIES phenotype was ratified with near unanimous support (94%) for implementation in surveillance. Interpretation: Pending validation, the DESTINIES phenotype provides a clinically meaningful, internationally ratified and digitally practical method for identifying and COVID-19 risk-stratifying adult immunosuppressed patients in healthcare data. Funding: This work was funded by the UK Medical Research Council and EMIS Health.
Recognition and management of acute functional decline in older people living in care homes: a qualitative interview study with UK care home staff.
BACKGROUND: Older people living in care homes who experience acute functional decline pose a diagnostic challenge to GPs. AIM: We aimed to explore beliefs, practices and experiences of UK care home staff who first recognise and respond to acute functional decline, including in the context of the COVID-19 pandemic. DESIGN & SETTING: Qualitative interview study with 25 UK care home staff. METHOD: Semi- structured interviews were conducted over the phone between January 2021 and April 2022. Thematic analysis was facilitated by NVivo software. RESULTS: Care home staff recognised acute functional decline as subtle changes from normal, which required knowing a resident well. However, it could be difficult to differentiate between an 'off day' and a more significant deviation, particularly for residents with a variable baseline. Acute functional decline caused anxiety to care home staff, in part due the uncertainty about illness trajectory and outcome. They commonly considered UTI a likely underlying cause. Some participants described a watch and wait approach or trying simple interventions, whilst others preferred escalating directly to outside clinical support. Triggers for escalation included perceived severity of illness, gut feeling or failure to respond to initial supportive management. CONCLUSION: This study has highlighted the complexities around the identification and management of a care home resident experiencing acute functional decline. There was variation in interpretation and responding to these episodes within the care home. More work is needed to understand the physiology and risk profiles of acute functional decline, as well as any relationship to UTI.
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.