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© Nasir Hamid
From ‘A Rapid and Necessary Revolution’ to ‘Telemedicine Killed the PE Teacher’: Changing Representations of Remote GP Consultations in UK Media During the COVID-19 Pandemic
The abrupt shift from face-to-face general practitioner (GP) consultations to remote ones was one of the most radical changes to the UK National Health Service (NHS) since it was set up in 1948. Overnight, people were blocked from turning up at their GP’s surgery and instead offered telephone, video or email contacts. This chapter considers how the lay press interpreted and conveyed this shift. We systematically collected UK newspaper stories about remote general practice from early 2020, mid 2020 and late 2021, and analysed these for their narrative content and form. The three time periods represented three distinct ‘eras’. Early in the pandemic, newspapers depicted remote consultations positively as an essential component of the country’s war against the virus (‘technology as superhero’). By summer 2020, the incidence of COVID-19 had fallen to a low level, lockdown had ended and many aspects of life were returning to normal. But the Secretary of State for Health (a technology enthusiast) had declared that virtual consultations should continue in order to make the NHS more efficient and modern. The mainstream media made much of this misalignment through funny and tragic stories of remote consultations which were clearly inappropriate or unsafe (‘technology as farce’). In 2021, the pandemic grumbled on and a backlog of unmet needs began to surface. The NHS was busier than ever; staff were exhausted; secondary care sought to redistribute work to primary care; and many key posts were unfilled because of early retirement, long-term staff illness and Brexit. In this context—a system under extreme stress—GPs used remote triage as a tool to control their workload. The media responded aggressively, running front-page campaigns to demand a better service from ‘lazy’ GPs who were depicted as being on the golf course while making occasional calls to sick patients on their smartphones. In this period, the focus of media stories was on the perceived lack of traditional face-to-face appointments and patients who had been ‘fobbed off’ with telephone calls (‘technology as cop-out’). Over the course of 2 years, media narratives on technology-mediated consultations thus shifted from hopeful (reproducing a discourse of modernity and efficiency) to nostalgic (demanding a return to a golden era when patients could be seen ‘properly’). We discuss the implications of these depictions for the future of remote (and face-to-face) consultations.
Statin safety in prevention of cardiovascular diseases: causal inference and risk prediction
Background: The widespread concerns about statin safety have resulted in low uptake of and poor adherence to statin treatment for prevention of cardiovascular diseases. The use of statins for primary prevention has been particularly challenging due to the controversy about the balance between benefits and harms of treatment. Personalised clinical decision-making and stratified treatment strategies that take into account the risk of adverse events are potential approaches towards better use of statins. Methods: A systematic review of randomised controlled trials was conducted, with pair-wise, network, and dose-response meta-analyses, to assess the associations between statins and common adverse events and explore the variations by drug type and dose in primary prevention patients. A prognostic model (StatinMD) was derived and externally validated to predict the personalised risk of serious muscle disorders in individuals eligible for statin treatment, using a competing risk model with data from electronic healthcare records. Results: Statins were associated with a small increase in the risk of muscle symptoms, liver dysfunction, renal insufficiency, and eye conditions, but not with muscle disorders or diabetes. There was little evidence of the difference between statin drugs or the dose-response relationships of their adverse effects. The StatinMD model included 22 predictors to predict the risk of serious muscle disorders in 1, 5, and 10 years. The model showed overall good discrimination and calibration in the majority of the population. Conclusions: The overall balance between benefits and harms of statins supports their use for primary prevention of cardiovascular diseases. The StatinMD model provides a reliable predicted risk of serious muscle disorders for most individuals to assist clinical decision-making on statin treatment.
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.
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..
An hourglass model for conceptualising stigma in infectious disease outbreaks
Stigma is widely observed during (re)emerging infectious disease outbreaks, contributing to psychological distress, social isolation, and care-seeking hesitancy. Despite this, it is often inadequately addressed in public health responses, partly due to the lack of a fit-for-purpose approach. The objective of this study was to develop a conceptual model to facilitate structured consideration of stigma during (re)emerging disease outbreaks. We conducted 34 in-depth interviews with international stakeholders across 25 outbreak-prone diseases, including emergency response leaders, frontline responders, researchers, and community advocates. We analysed transcripts using thematic analysis, integrating insights from social and behavioural theories to refine the model. We introduce the hourglass stigma model, a theory-informed conceptualisation of stigma in outbreaks. The model consists of five domains (major themes): context, thoughts, emotions, manifestations, and impact. Within each domain there are key considerations, such as the influence of response measures on concealability (context), the association of certain diseases with ‘dirtiness’ due to hygiene-dominant messaging (thoughts), the negative effects of fear-based appeals (emotions), the enactment of stigma due to unconscious bias (manifestations), and the enduring consequences of (mis)trust in institutions (impact). The hourglass model can be used to inform operational tools, ensuring stigma is adequately addressed in outbreak preparedness and response activities.
Impact of the COVID-19 pandemic on antidepressant prescribing with a focus on people with learning disability and autism: an interrupted time series analysis in England using OpenSAFELY-TPP
BACKGROUND: COVID-19 restrictions led to increased reports of depressive symptoms in the general population and impacted health and social care services. We explored whether these changes affected antidepressant prescribing trends in the general population and those with learning disability or autism. METHODS: With the approval of NHS England, we used >24 million patients' primary care data from the OpenSAFELY-TPP platform. We used interrupted time series analysis to quantify trends in those prescribed and newly prescribed an antidepressant across key demographic and clinical subgroups, comparing pre-COVID-19 (January 2018-February 2020), COVID-19 restrictions (March 2020-February 2021) and recovery (March 2021-December 2022) periods. RESULTS: Prior to COVID-19 restrictions, antidepressant prescribing was increasing in the general population and in those with learning disability or autism. We did not find evidence that the pandemic was associated with a change in antidepressant prescribing trend in the general population (relative risk (RR) 1.00 (95% CI 0.97 to 1.02)), in those with autism (RR 0.99 (95% CI 0.97 to 1.01)) or in those with learning disability (RR 0.98 (95% CI 0.96 to 1.00)).New prescribing post restrictions was 13% and 12% below expected had COVID-19 not happened in both the general population and those with autism (RR 0.87 (95% CI 0.83 to 0.93), RR 0.88 (95% CI 0.83 to 0.92)), but not learning disability (RR 0.96 (95% CI 0.87 to 1.05)). CONCLUSIONS AND IMPLICATIONS: In this England study, we did not see an impact of COVID-19 on overall antidepressant prescribing, although unique trends were noted, such as trends in new antidepressant prescriptions which increased in care homes over the pandemic and decreased in the general population and those with autism since recovery.
Integrated palliative care and oncology: a realist synthesis.
BACKGROUND: Existing evidence demonstrates the benefits of integrated palliative care for people with cancer, for improved symptom burden, quality of life for patient and caregiver, and appropriate healthcare resource use. The integration of palliative care and oncology has the potential to reduce suffering and is recommended by international guidelines. However, it is not yet consistent practice. There are many approaches to integration, but it is unclear what works, for whom, and in what contexts, to achieve the best possible outcomes for patients, families, and healthcare systems. METHODS: Realist review, conducted in accordance with RAMESES quality standards. Evidence was identified through systematic academic databases searches and stakeholder engagement. Data were extracted from included articles and synthesized using realist analysis to develop explanations of how and why integrated palliative care in oncology works, for whom, and in what contexts. RESULTS: One hundred sixty-four papers were included in the review, from 33 countries, and involving a range of inpatient, outpatient, and home-based care settings. Integrated palliative care and oncology could improve patient outcomes, increase the goal-concordance of patient care, and support workforce wellbeing. Interventions towards integration should be tailored to the context in which they are delivered. Ensuring the timely delivery of palliative care for people with cancer requires integration that overcomes siloes between oncology, specialist palliative care, and primary and community care. The motivation to prioritise the integration of palliative care relies upon all stakeholders first understanding its value. Enriched interdisciplinary collaboration involves developing staff skills and confidence, facilitating coordination between care settings, and supporting communication within and between teams. Leadership is needed at all levels to attend to the structural and social norms of care. CONCLUSIONS: The success of integration is influenced by the ways in which palliative care is understood, prioritised, operationalised, and measured within oncology. Through the synthesis of international evidence, this project draws on implementation science to contribute clarity on how integrated palliative care and cancer care can be achieved in practice.
Temporary 2-week suspension of methotrexate treatment to enhance COVID-19 vaccine response in people with immune-mediated inflammatory diseases: the VROOM RCT
Objective Methotrexate is first-line treatment for many immune-mediated inflammatory diseases. However, it inhibits vaccine-induced immunity – a major concern for this vulnerable group of patients. We evaluated if a 2-week interruption of methotrexate treatment immediately after COVID-19 booster improved antibody response against spike protein of the receptor binding domain and live virus neutralisation (ancestral Wuhan and Omicron BA.1) in patients with immune-mediated inflammatory diseases. Design Open-label, prospective, individually randomised, parallel-group, controlled superiority trial with 1 : 1 randomisation. Setting Multicentre, secondary-care rheumatology and dermatology outpatient clinics. Participants Adults with immune-mediated inflammatory diseases attending rheumatology and dermatology clinics taking methotrexate (≤ 25 mg/week) for ≥ 3 months. Intervention Suspending methotrexate treatment for 2 weeks immediately after COVID-19 booster vaccination. Main outcome(s) and measure(s) The primary outcome was spike protein of the receptor binding domain antibody level 4 weeks after COVID-19 booster vaccination. Secondary outcomes were spike protein of the receptor binding domain antibody levels 12 and 26 weeks after COVID-19 vaccine dose; live virus neutralisation (ancestral Wuhan Hu-1, Omicron BA.1) at weeks 4, 12 and 26; and self-reported inflammatory disease activity, flare-ups, quality of life, global assessment of inflammatory disease and adherence with trial allocation. Results A total of 383 participants (61% female, average age 59.0 years) were randomised to either suspend or continue methotrexate. The geometric mean (95% confidence interval) spike protein of the receptor binding domain antibody titre was 25,413 (22,227 to 29,056) and 12,326 (10,538 to 14,418) U/ml in those who suspended and continued methotrexate, respectively. The geometric mean ratio (95% confidence interval) was 2.08 (1.59 to 2.70), p < 0.0001. The intervention effect was present across prognostic subgroups, for example, age groups, methotrexate dose, methotrexate administration route, diseases and past severe acute respiratory syndrome coronavirus 2 infection. Enhanced antibody responses were sustained at 12 and 26 weeks with geometric mean ratio (95% confidence interval) 1.88 (1.44 to 2.46) and 1.50 (1.12 to 2.01), respectively. Interruption of treatment improved neutralisation of Wuhan and Omicron BA.1 at 4 weeks with geometric mean ratio (95% confidence interval) 2.56 (1.21 to 5.44) and 2.42 (1.45 to 4.05), respectively. Self-reported inflammatory disease activity initially deteriorated in the suspended methotrexate group, but the groups were comparable at week 12. Conclusion Two-week interruption of methotrexate treatment for immune-mediated inflammatory diseases enhanced antibody responses after COVID-19 vaccination that were sustained at 12 and 26 weeks. Limitations Lack of participant masking which could have affected self-reported outcomes. Condition-specific disease activity was not used as we recruited participants with a range of diseases, with many lacking validated outcome measures. We did not have data for memory B-cell and T-cell responses. Some hospitals declined to participate in the 26-week follow-up visit which was added to the study after interim analysis, due to lack of capacity, contributing to increased attrition at week 26. Future work Future research should evaluate whether interrupting other immune-suppressing treatments soon after vaccination against COVID-19 or other infectious diseases can improve immune responses. Further research should also evaluate whether a shorter hold in methotrexate would improve the immune response elicited by vaccination. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme as award number NIHR134607.
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.
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.