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© Nasir Hamid
Navigating change and crisis: an ethnographic case study of the digitalisation of general practice work between 2020-2024
Since 2020, changes in the organisation and delivery of UK general practice have been extensive and far-reaching. The widespread scale-up of remote and digital forms of working in UK general practice during the COVID-19 pandemic has driven the development of new routines and working styles, affecting how work is done, and the conditions in which it is completed, with repercussions for the wellbeing of the workforce. In the work reported here, I aim to build a more nuanced understanding of the impact of digitalisation on the kinds of work performed by patients and staff in UK GP practices, the impact thereof on staff wellbeing, and ascertain what further learning could be gleaned about how change and crisis are navigated in practice teams. I conducted a narrative literature synthesis and a multi-sited ethnographic case study of UK GP practice, informed by the Eisenhardt method. To do so, I employed multiple qualitative methods to collect data from two in-depth ethnographic case study sites. I also collected and reanalysed previously collected qualitative data from eight comparative case study sites. I analysed these data at three sequential levels: inductively, thematically, and abductively, to build and extend theory in conversation with my data. In this thesis, I make several novel contributions to empirical, methodological, and theoretical literature. I split my results on the impact of digitalisation during 2020-24 across four chapters. The first outlines the work that patients must now perform to achieve digital candidacy and craft a digital facsimile to access their GP practice successfully. The second looks at the impact on the work and wellbeing of support staff, highlighting the unique translational work they perform. The third describes the impacts on the whole practice team, and identifies new risks to their wellbeing: technostress, technosuffering, and relational strain. Finally, the fourth results chapter illustrates the organisational conditions that are most protective of staff wellbeing when navigating these kinds of change and crisis events and suggests a model for how these conditions can be constructed, maintained, or slip away. I have disseminated these findings to academic, public, policy, and practice audiences.
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)
Background: Improved blood-glucose control decreases the progression of diabetic microvascular disease, but the effect on macrovascular complications is unknown. There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation. We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a randomised controlled trial. Methods: 3867 newly diagnosed patients with type 2 diabetes, median age 54 years (IQR 48-60 years), who after 3 months' diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of 6.1-15.0 mmol/L were randomly assigned intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or glipizide) or with insulin, or conventional policy with diet. The aim in the intensive group was FPG less than 6 mmol/L. In the conventional group, the aim was the best achievable FPG with diet alone; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment: any diabetes-related endpoint (sudden death, death from hyperglycaemia or hypoglycaemia, fatal or non-fatal myocardial infarction, angina, heart failure, stroke, renal failure, amputation [of at least one digit], vitreous haemorrhage, retinopathy requiring photocoagulation, blindness in one eye, or cataract extraction); diabetes-related death (death from myocardial infarction, stroke, peripheral vascular disease, renal disease, hyperglycaemia or hypoglycaemia, and sudden death); all-cause mortality. Single clinical endpoints and surrogate subclinical endpoints were also assessed. All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy. Findings: Over 10 years, haemoglobin A(1c) (HbA(1c)) was 7.0% (6.2-8.2) in the intensive group compared with 7.9% (6.9-8.8) in the conventional group - an 11% reduction. There was no difference in HbA(1c) among agents in the intensive group. Compared with the conventional group, the risk in the intensive group was 12% lower (95% CI 1-21, p = 0.029) for any diabetes-related endpoint; 10% lower (-11 to 27, p = 0.34) for any diabetes-related death; and 6% lower (-10 to 20, p = 0.44) for all-cause mortality. Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25% risk reduction (7-40, p = 0.0099) in microvascular endpoints, including the need for retinal photocoagulation. There was no difference for any of the three aggregate endpoints between the three intensive agents (chlorpropamide, glibenclamide, or insulin). Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis (both p < 0.0001). The rates of major hypoglycaemic episodes per year were 0.7% with conventional treatment, 1.0% with chlorpropamide, 1.4% with glibenclamide, and 1.8% with insulin. Weight gain was significantly higher in the intensive group (mean 2.9 kg) than in the conventional group (p < 0.001), and patients assigned insulin had a greater gain in weight (4.0 kg) than those assigned chlorpropamide (2.6 kg) or glibenclamide (1.7 kg). Interpretation: Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications, but not macrovascular disease, in patients with type 2 diabetes. None of the individual drugs had an adverse effect on cardiovascular outcomes. All intensive treatment increased the risk of hypoglycaemia.
Remote consulting
Remote care is a feature of contemporary general practice but brings additional challenges for GP registrars. Communication and rapport are more challenging in telephone calls. They can be enhanced through strategies such as the use of open questions, active listening, summarising and clarifying next steps. Remote clinical assessment can be complemented by using video, texted photos or home instruments such as thermometers, blood pressure machines and pulse oximeters. Decision making can be affected causing over or under investigation, referral or prescribing. If a condition is failing to resolve or to progress as expected following an initial remote consultation, subsequent encounters should be in person. Effective remote consulting needs to be supported by adequate infrastructure and practice processes. Solutions are required for patients whose needs mean that remote consulting is less appropriate. Quality of care may be compromised, particularly in long-term conditions.
Valve thrombosis and antithrombotic therapy after bioprosthetic mitral valve replacement: a systematic review and meta-analysis
Aims: Transcatheter mitral valve replacement (TMVR) has become a feasible alternative to surgical mitral valve replacement (SMVR) in selected patients at high surgical risk. The risk of valve thrombosis following SMVR and TMVR, and the optimal antithrombotic therapy following these procedures, remains uncertain. We aimed to compare the incidence of bioprosthetic mitral valve thrombosis (bMVT) after SMVR and TMVR, and the incidence of bMVT between patients on different antithrombotic regimens. Methods and results: A literature search of Medline, Embase, and Cochrane Library was performed between January 2000 and August 2024. Random-effects models were used to derive pooled estimates of the incidence of bMVT in the absence of prior or active endocarditis and valve thrombosis. A total of 47 studies (6170 patients, total follow-up 9541.8 patient-years) were eligible for inclusion. The overall incidence of bMVT was 5.05 [95% confidence interval (CI) 3.18-8.01, I2 = 82%] per 100-patient-years. Subclinical bMVT was more common than clinically significant bMVT: incidence 19.11 vs. 7.91 per 100-patient-years, adjusted incidence rate ratio (aIRR) 4.62 (95% CI 1.39-15.36), P = 0.012. bMVT was numerically more common after TMVR than SMVR, but the comparison was not statistically significant: incidence 7.03 vs. 0.58 per 100-patient-years, aIRR 2.19 (95% CI 0.72-6.72), P = 0.170. Patients on vitamin-K antagonists (VKA) had a lower incidence of bMVT than patients on direct oral anticoagulants (DOAC; incidence 5.72 vs. 17.08, aIRR 0.31, 95% CI 0.13-0.73, P = 0.007). Conclusions: bMVT is not uncommon, with numerically higher incidence in transcatheter compared to surgical valves, but the comparison was not statistically significant. VKAs are associated with a lower incidence of bMVT compared to DOACs.
Identification of undetected SARS-CoV-2 infections by clustering of Nucleocapsid antibody trajectories.
During the COVID-19 pandemic, numerous SARS-CoV-2 infections remained undetected. We combined results from routine monthly nose and throat swabs, and self-reported positive swab tests, from a UK household survey, linked to national swab testing programme data from England and Wales, together with Nucleocapsid (N-)antibody trajectories clustered using a longitudinal variation of K-means (N = 185,646) to estimate the number of infections undetected by either approach. Using N-antibody (hypothetical) infections and swab-positivity, we estimated that 7.4% (95%CI: 7.0-7.8%) of all true infections (detected and undetected) were undetected by both approaches, 25.8% (25.5-26.1%) by swab-positivity-only and 28.6% (28.4-28.9%) by trajectory-based N-antibody-classifications-only. Congruence with swab-positivity was respectively much poorer and slightly better with N-antibody classifications based on fixed thresholds or fourfold increases. Using multivariable logistic regression N-antibody seroconversion was more likely as age increased between 30-60 years, in non-white participants, those less (recently/frequently) vaccinated, for lower cycle threshold values in the range above 30, and in symptomatic and Delta (vs. BA.1) infections. Comparing swab-positivity data sources showed that routine monthly swabs were insufficient to detect infections and incorporating national testing programme/self-reported data substantially increased detection. Overall, whilst N-antibody serosurveillance can identify infections undetected by swab-positivity, optimal use requires fourfold-increase-based or trajectory-based analysis.
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.