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A blog by Dr Gurpreet Singh Kalra and Shawn D. Mathis, members of cohort 1 of the MSc in Global Healthcare Leadership
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 and 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.
Inclusion in trials during pregnancy
Presentation
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. FUNDING: None REGISTRATION: Protocol available via DOI: 10.1002/14651858.CD015314.
Antibiotics for common infections in primary care before, during and after the COVID-19 pandemic: cohort study of extent of prescribing based on risks of infection-related hospital admissions
Objectives: Antibiotics are effective in treating bacterial infections, but they carry the risks of antimicrobial resistance and effectiveness loss. This study aimed to assess whether antibiotics for common infections are prescribed in a risk-based manner and how this changed during the COVID-19 pandemic. Design: Cohort study of common infections and antibiotic prescribing. Setting: With the approval of NHS England, we accessed pseudonymised patient-level electronic health records of primary care data from The Phoenix Partnership through OpenSAFELY. Participants: We included adults registered at general practices in England with a record of common infection, including lower respiratory tract infection (LRTI), upper respiratory tract infections (URTI) and lower urinary tract infection (UTI), from January 2019 to March 2023. Patients with a record of COVID-19 were excluded. Main outcome measures: Patient-specific risks of infection-related hospital admission were estimated for each infection using risk prediction scores for patients who were not prescribed an antibiotic. The infection cohorts were then grouped into risk deciles, and probabilities of being prescribed an antibiotic were assessed. Results: We found 15,719,750 diagnoses of common infections. Of them, 450,215 (2.86%) were hospitalised in the 30 days after the diagnosis and 10,429,060 (66.34%) were prescribed an antibiotic. There were substantial differences in observed rates of hospital admissions between the lowest and highest risk deciles (25-fold difference in URTI). The probability of being prescribed an antibiotic for LRTI or UTI was unrelated to hospital admission risk, and that for URTI was weakly related to hospital admission risk. During the COVID-19 pandemic, the level of risk-based antibiotic prescribing reduced. Conclusions: There is a need to better target antibiotics in primary care to patients with worse prognosis and strengthen treatment guidelines in personalisation of prescribing.
Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer
Background: Although currently most widely used in mechanical ventilation and cardiopulmonary resuscitation, features of the carbon dioxide (CO2) waveform produced through capnometry have been shown to correlate with V/Q mismatch, dead space volume, type of breathing pattern, and small airway obstruction. This study applied feature engineering and machine learning techniques to capnography data collected by the N-Tidal™ device across four clinical studies to build a classifier that could distinguish CO2 recordings (capnograms) of patients with COPD from those without COPD. Methods: Capnography data from four longitudinal observational studies (CBRS, GBRS, CBRS2 and ABRS) was analysed from 295 patients, generating a total of 88,186 capnograms. CO2 sensor data was processed using TidalSense’s regulated cloud platform, performing real-time geometric analysis on CO2 waveforms to generate 82 physiologic features per capnogram. These features were used to train machine learning classifiers to discriminate COPD from ‘non-COPD’ (a group that included healthy participants and those with other cardiorespiratory conditions); model performance was validated on independent test sets. Results: The best machine learning model (XGBoost) performance provided a class-balanced AUROC of 0.985 ± 0.013, positive predictive value (PPV) of 0.914 ± 0.039 and sensitivity of 0.915 ± 0.066 for a diagnosis of COPD. The waveform features that are most important for driving classification are related to the alpha angle and expiratory plateau regions. These features correlated with spirometry readings, supporting their proposed properties as markers of COPD. Conclusion: The N-Tidal™ device can be used to accurately diagnose COPD in near-real-time, lending support to future use in a clinical setting. Trial registration: Please see NCT03615365, NCT02814253, NCT04504838 and NCT03356288.
Intervention design and adherence to Mediterranean diet in the Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat (CADIMED) randomized trial
Effective interventions targeting modifiable cardiovascular disease (CVD) risk factors, such as diet, are urgently needed. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat study hypothesizes that eliminating red and processed meat in the context of a Mediterranean diet (MD) will significantly modify circulating low-density lipoprotein cholesterol concentration and the fatty acid profile compared to general CVD prevention advice. Here we describe the intervention design and summarize baseline dietary intakes (mean ± standard deviation) related to MD adherence and red/processed meat intakes in a sample of 81 participants. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat study is a two-arm, 8-week parallel randomized controlled intervention trial involving a final sample of 156 adults (≥18 years) with dyslipidemia (not undergoing pharmacological treatment) recruited from healthcare and community settings in Granada (Spain). The primary outcome will assess changes in circulating low-density lipoprotein cholesterol and the fatty acid profile, whilst secondary outcomes will measure changes in CVD-related metabolites/biomarkers, gut microbiome, diet/lifestyle, and intervention feasibility/acceptability. Preliminary findings indicate low MD adherence (Mediterranean Diet Adherence Screener score 7.6 ± 1.9), and high consumption of red and processed meat (1.04 ± 0.90) servings/d). These results underscore the need for targeted dietary interventions to address the growing burden of dyslipidemia and CVD. If successful, this intervention holds potential for scalability and significant impact on public health, dietary guidelines, and advancements in nutrition science by improving MD adherence and reducing CVD risk factors in adults with dyslipidemia.
CONSORT 2025 statement: Updated guideline for reporting randomised trials.
BACKGROUND: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare 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 randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. METHODS: 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, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. RESULTS: We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one 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 randomised 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: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.
CONSORT 2025 statement: updated guideline for reporting randomized trials.
Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of healthcare 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. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. 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, Non-Pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (such as personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one 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. 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.
CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.
Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.
CONSORT 2025 statement: updated guideline for reporting randomised trials.
BACKGROUND: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare 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 randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. METHODS: 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, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. RESULTS: We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one 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 randomised 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. CONCLUSION: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.
Investigating the conditions in which women GPs thrive: a realist review protocol.
BACKGROUND: Women now make up approximately half of the GP workforce. However, many are leaving the profession. This could be because they experience higher rates of burnout, stress and anxiety, suicide, and lower rates of career progression. They also take on a greater load of emotional labour. Retaining this staff group is one of five priorities for future policy and research. AIM: This research aims to synthesise the available evidence on how general practice workplaces can best support women GPs to thrive at work. DESIGN & SETTING: We propose to undertake a realist review, which seeks to understand why an approach may work in specific contexts. This involves building an understanding of how contextual factors affect the activation of mechanisms (ie, changes in participant reasoning or behaviours) to produce their outcomes. METHOD: We will locate available evidence on the topic, and, using a realist logic of analysis develop an understanding as to how, why, for whom and in what contexts women GPs thrive at work. Evidence will include: academic literature, policy documents, media items and guidelines. RESULTS: Findings will be co-disseminated with PPI and stakeholder members to all key groups including policymakers, employers, the public, and academic audiences by a wide variety of means. CONCLUSION: This review is intended to improve understanding of how working environments affect women GPs. It is anticipated that findings will support the implementation of strategies to better support this group to thrive at work.
Socio-sexual norms and young people's sexual health in urban Bangladesh, India, Nepal and Pakistan: A qualitative scoping review.
In South Asia, young people face myriad challenges and opportunities regarding their sexual lives relating to varied experiences of norms and restrictions; gender norms and socio-sexual taboos limit communication around sexual health which in turn can affect sexual health outcomes. In this article we focus on norms affecting young people's sexual health experiences in urban settings in Bangladesh, India, Nepal, and Pakistan. We conducted a scoping review of peer reviewed empirical studies based on qualitative data pertaining to young people's experiences of sexuality and sexual health in Bangladesh, India, Nepal, and Pakistan. We searched four electronic databases for articles published (2010-2022), using terms relating to sexual health, young people, and South Asia. Sixteen articles met the inclusion criteria with sample size ranging from 9 to 180. The authors followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines for the design and analysis of this study. We synthesised the included articles using thematic analysis. The studies covered topics such as sexual health services and contraceptive use; sexuality education and communication; and gender and sexual violence. Recurring findings included: parental and societal expectations around premarital 'sexual purity' through abstinence; limited communication around sexuality between young people and parents/adults; gender norms limiting young women's sexual and reproductive decision making; and an absence of research on experiences of sexual and gender minorities. We identified common themes as well as prominent gaps which must be addressed if we are to capture diverse experiences and build a better evidence base to improve sexual health services for young people in the region. The body of research fails to include experiences of young people with diverse gender, sexual orientation, and sex characteristics.
Community-led responses to COVID-19 within Gypsy and Traveller communities in England: A participatory qualitative research study.
Individuals were asked to play an active role in infection control in the COVID-19 pandemic. Yet while government messages emphasised taking responsibility for the public good (e.g. to protect the National Health Service), they appeared to overlook social, economic and political factors affecting the ways that people were able to respond. We co-produced participatory qualitative research with members of Gypsy and Traveller communities in England between October 2021 and February 2022 to explore how they had responded to COVID-19, its containment (test, trace, isolate) and the contextual factors affecting COVID-19 risks and responses within the communities. Gypsies and Travellers reported experiencing poor treatment from health services, police harassment, surveillance, and constrained living conditions. For these communities, claiming the right to health in an emergency required them to rely on community networks and resources. They organised collective actions to contain COVID-19 in the face of this ongoing marginalisation, such as using free government COVID-19 tests to support self-designed protective measures including community-facilitated testing and community-led contact tracing. This helped keep families and others safe while minimising engagement with formal institutions. In future emergencies, communities must be given better material, political and technical support to help them to design and implement effective community-led solutions, particularly where government institutions are untrusted or untrustworthy.
Provision of cervical screening for transmasculine patients: a review of clinical and programmatic guidelines.
BackgroundMost cervical cancer can be prevented through routine screening. Disparities in uptake of routine screening therefore translate into disparities in cervical cancer incidence and outcomes. Transmasculine people including transgender men experience multiple barriers to cervical screening and their uptake of screening is low compared with cisgender women. Comprehensive evidence-based guidelines are needed to improve cervical screening for this group.MethodsWe searched for and synthesised clinical and programmatic guidelines for the provision of cervical screening for transmasculine patients.FindingsThe guidelines offer recommendations addressing: (1) reception, check-in and clinic facilities; (2) patient data and invitation to screening; (3) improving inclusion in screening programmes; and (4) sexual history taking, language and identity. Guidelines offer strategies for alleviating physical and psychological discomfort during cervical screening and recommendations on what to do if the screening procedure cannot be completed. Most of the guidelines were from and for high-income countries.DiscussionThe evidence base is limited, but existing guidelines provide recommendations to ensure life-saving screening services are available to all who need them. We were only able to identify one set of guidelines for a middle-income country, and none for low-income countries. We encourage the involvement of transmasculine people in the development of future guidelines.
Reimagining authorship guidelines to promote equity in co-produced academic collaborations.
Authorship of academic papers is a currency that can bring career advantages in academia and other industries. How authorship should be decided is not always clear, particularly in co-produced research with non-academic collaborators, for which existing authorship guidelines are largely silent. In this paper, we critically reflect on what constitutes written authorship in the context of co-produced health research. We present examples from our own work to illustrate the argument we make, including publishing a co-authored paper with non-academic partners. We consider questions of what constitutes authorship and how it is mutually understood. We discuss some of the opportunities and limits to participation and how these might translate into academic authorship as a collaborative research output. Finally, we explore the potential of authorship guidelines as a resource for critical reflection on what we mean by co-produced work and how we recognise contributions to global health research. We suggest that authorship guidelines should be adapted to encourage attribution of co-produced research to include non-academic as well as academic collaborators, and we provide a draft guideline for how this might be done.