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Dr Nicola Lindson-Hawley and Dr Rachna Begh led the recent UK Centre for Tobacco and Alcohol Studies (UKCTAS) early-career researcher conference in Leeds this month.
Associations between burnout and career disengagement factors among general practitioners: a path analysis
Background: Burnout is associated with career disengagement among general practitioners (GPs), but the underlying mechanisms of this association remain poorly understood. Objective: This study examined the pathways linking burnout to career disengagement factors among GPs. Methods: An 11-item online questionnaire, including validated abbreviated measures of burnout outcomes (single items on emotional exhaustion (EE) and depersonalisation), career disengagement factors (intention to quit patient care, work–life balance, presenteeism and job satisfaction), and demographic information, was distributed to a random sample of GPs in England between December 2019 and April 2020. Correlations between burnout outcomes and disengagement factors were assessed, followed by a path analysis using a generalized structural equation model, to examine directional relationships between burnout outcomes and survey variables. Results: A total of 351 GPs from 57 different medical practices completed the questionnaire. Up to one in four GPs (22.5%) experienced emotional exhaustion, while up to one in three (27.4%) experienced depersonalisation on a weekly basis. In addition, one in three GPs (33.3%) expressed a moderate-to-high intention to quit patient care within the next 5 years. Moreover, one in five GPs (18.8%) reported job dissatisfaction, two in five GPs (40.7%) indicated poor work–life balance, and up to one in two GPs (27.4%) reported presenteeism in the past year. In the path analysis, intention to quit patient care had significant direct associations with both job satisfaction and burnout and significant indirect associations (via burnout) with work–life balance and presenteeism. GP demographics were excluded from the path analysis because they exhibited very weak correlations with dimensions of burnout and work engagement factors. Conclusion: These findings highlight the urgent need for interventions and policies aimed at addressing burnout and improving job satisfaction to retain GPs. In addition, improving work–life balance and reducing presenteeism could serve as effective early preventative measures to reduce burnout and job dissatisfaction and, in turn, retain GPs.
Comparing thermal imaging and non-contact infrared thermometers for monitoring skin temperature in a prospective cohort with lower limb cellulitis.
OBJECTIVE: Skin temperature assessment is essential for the diagnosis of cellulitis and monitoring treatment response, but is currently subjective and can contribute to overdiagnosis. We aimed to characterise skin temperature changes over time in cellulitis and compare two objective measurement approaches, a thermal imaging camera (TIC) and a non-contact infrared thermometer (NCIT). DESIGN: A device comparison study nested within a prospective cohort. We measured limb temperatures daily for 4 days using a TIC and two NCITs. SETTING: Two acute hospitals in the UK's National Health Service. PARTICIPANTS: 202 adults (age ≥18 years) diagnosed with lower limb cellulitis who attended hospital for antibiotic treatment. OUTCOME MEASURES: We used linear mixed-effects models to quantify changes in temperature over time and intraclass correlation coefficients (ICC) to assess reliability. We compared temperature measurements between devices using Lin's concordance coefficients and Bland-Altman plots with estimated 95% limits of agreement. RESULTS: 202 patients were included: 95% white ethnicity. Baseline limb temperature differences varied between 2.4°C and 3.4°C, depending on the device. All devices showed significant reductions in affected limb temperature per day, with the largest decrease recorded by the TIC (-0.34°C per day, 95% CI -0.48°C to -0.19°C, p<0.001). Only the TIC and NCIT-1 showed significant reductions in limb temperature difference per day. All devices had excellent reliability (ICCs ≥0.98). However, the magnitude of daily temperature change estimates was small relative to the repeatability coefficients of each device. The NCIT-2 consistently recorded the smallest differences in limb temperatures and demonstrated evidence of proportional bias. CONCLUSIONS: Daily temperature changes may be too small for reliable monitoring at the individual patient level, but cumulative changes from day 0 to day 3 may be sufficient for clinical interpretation, despite limitations in the precision of device measurements. NCITs' measurement capabilities differ widely, so these devices cannot be used interchangeably. Due to this and the potential benefits of advanced thermal image analysis, TICs should be prioritised for further study in cellulitis. Future research should confirm our findings in different skin tones and explore the clinical utility of thermal imaging in enabling earlier diagnosis or detecting signs of therapeutic failure.
How do patient information documents present dialysis and conservative kidney management? A document analysis
Background Most older people with advanced kidney disease face a decision between conservative kidney management (CKM) or dialysis and must weigh their potential benefits, risks and impacts on quality and length of life. Patient information documents are designed to supplement patients' understanding of their kidney disease and explain treatment options to support decision-making. We aimed to explore how patient information documents frame the treatment options of CKM and dialysis and consider implications for patients' treatment choice. Methods We conducted a qualitative document analysis of patient information documents collected from four UK renal outpatient departments with variation in rates of CKM for people ≥75 years of age. Data were analysed using critical discourse analysis. Results Three global themes were identified: 1) Treatment options are not presented equally: Dialysis was constructed as the assumed patient choice. CKM was often omitted as an option; when included, it was always mentioned last and was typically constructed negatively. 2) Deciding is challenging: Treatment decision-making, particularly choosing CKM, was portrayed as a challenge requiring emotional support, with clinicians the ultimate decision-maker. 3) Dialysis is living, CKM is dying: Patient information documents presented patients as living with one treatment option choice (dialysis) and dying with another (CKM). Advance care planning, palliative care and information about dying were presented only in the context of CKM, implying these were irrelevant topics for people choosing dialysis. Conclusions Patient information documents presented unbalanced explanations of dialysis and CKM. Dialysis was framed as 'treatment' and possible complications were minimized. CKM was framed as 'non-treatment' and linked to advance care planning, palliative care and death. Inaccurate framing of both CKM and dialysis may mean patients exclude treatment options that may be more concordant with their goals, values and preferences.
Patient Characteristics Associated with Repeat Antibiotic Prescribing Pre- and during the COVID-19 Pandemic: A Retrospective Nationwide Cohort Study of >19 Million Primary Care Records Using the OpenSAFELY Platform
COVID-19 pandemic-related pressures on primary care may have driven the inappropriate continuation of antibiotic prescriptions. Yet, prescribing modality (repeat/non-repeat) has not previously been investigated in a pandemic context. With the approval of NHS England, we conducted a retrospective cohort study of >19 million English primary care patient records using the OpenSAFELY-TPP analytics platform. We analysed repeat/non-repeat prescribing frequency in monthly patient cohorts between January 2020 and 2022. In-depth analysis was conducted on January 2020 (“pre-pandemic”) and January 2021 (“pandemic”) cohorts (with a particular focus on repeat prescribing). Per-patient prescribing and clinical conditions were determined by searching primary care records using clinical codelists. Prescriptions in a 6-month lookback period were used to delineate repeat prescribing (≥3 prescriptions) and non-repeat prescribing (1–2 prescriptions). Associations between demographics (e.g., age, sex, ethnicity) and prescribing were explored using unadjusted risk ratios. The frequency of clinical conditions among prescribed patients was examined. Antibiotic prescribing declined from May 2020; non-repeat prescribing declined more strongly than repeat prescribing (maximum declines −26% vs. −11%, respectively). Older patients were at a higher risk of prescribing (especially repeat prescribing). Comorbidities were more common among repeat- vs. non-repeat-prescribed patients. In the pandemic cohort, the most common clinical conditions linked to repeat prescribing were COPD comorbidity and urinary tract infection. Our findings inform the ongoing development of stewardship interventions in England, targeting patient groups wherein there is a high prevalence of repeat prescribing.
Crafting Tempo and Timeframes in Qualitative Longitudinal Research: Case Studies From Health Research
Qualitative Longitudinal Research (QLR) is a dynamic and evolving methodology using time as a lens to inform study design, data collection and analysis. A key feature of QLR is the collection of data on more than one occasion, often described as waves or time points. Thus, researchers embarking on designing a new study need to consider several key features including the study duration (timeframe) and the frequency and intensity of data collection (tempo). Yet, how to embed these features in practice is not well described. Leveraging the intensive-extensive temporal plane of time, we explore research approaches employing both shorter and longer timeframes, as well as intensive and extensive tempos. Drawing on six studies that we have conducted, we discuss four pivotal aspects including: (i) crafting intensive-extensive tempo and timeframes; (ii) defining baseline and closure points; (iii) planning for flexibility; and (iv) working ethically within a temporal lens. By examining and critically analysing these case studies through the lens of the intensive-extensive plane of time, this article aspires to offer insights for researchers interested in using the QLR design in healthcare. We thus aim to prepare researchers for embedding these features during the research process.
The PRINCIPLE randomised controlled open label platform trial of hydroxychloroquine for treating COVID19 in community based patients at high risk.
Early on in the COVID-19 pandemic, we aimed to assess the effectiveness of hydroxychloroquine on reducing the need for hospital admission in patients in the community at higher risk of complications from COVID-19 syndromic illness (testing was largely unavailable at the time, hence not microbiologically confirmed SARS-CoV-2 infection), as part of the national open-label, multi-arm, prospective, adaptive platform, randomised clinical trial in community care in the United Kingdom (UK). People aged 65 and over, or aged 50 and over with comorbidities, and who had been unwell for up to 14 days with suspected COVID-19 were randomised to usual care with the addition of hydroxychloroquine, 200 mg twice a day for seven days, or usual care without hydroxychloroquine (control). Participants were recruited based on symptoms and approximately 5% had confirmed SARS-COV2 infection. The primary outcome while hydroxychloroquine was in the trial was hospital admission or death related to suspected COVID-19 infection within 28 days from randomisation. First recruitment was on April 2, 2020, and the hydroxychloroquine arm was suspended by the UK Medicines Regulator on May 22, 2020. 207 were randomised to hydroxychloroquine and 206 to usual care, and 190 and 194 contributed to the primary analysis results presented, respectively. There was no swab result available within 28 days of randomisation for 39% in both groups: 107 (54%) in the hydroxychloroquine group and 111 (55%) in the usual care group tested negative for SARS-Cov-2, and 13 (7%) and 11 (5%) tested positive. 13 participants, (seven (3·7%) in the usual care plus hydroxychloroquine and six (3.1%) in the usual care group were hospitalized (odds ratio 1·04 [95% BCI 0·36 to 3.00], probability of superiority 0·47). There was one serious adverse event, in the usual care group. More people receiving hydroxychloroquine reported nausea. We found no evidence from this treatment arm of the PRINCIPLE trial, stopped early and therefore under-powered for reasons external to the trial, that hydroxychloroquine reduced hospital admission or death in people with suspected, but mostly unconfirmed COVID-19.
Making it Personal - play script
Play script created as part of Making it Personal - an engagement with research project funded by the PCER Fund, University of Oxford and the Centre for Personalised Medicine, University of Oxford.
Do pregnant people have opportunities to participate in clinical trials? an exploratory survey of NIHR HTA-funded trialists
Background: Pregnant people are often excluded from clinical trials, primarily due to safety concerns. However, exclusion causes population-level harms as well as sometimes providing individual protection. Harms caused to pregnant people by exclusion from clinical trials have been clearly evidenced and highlighted during the COVID pandemic. The National Institute for Health and Care Research (NIHR) has since provided guidance on improving inclusion of under-served groups, which includes pregnant people, in clinical research. Appropriate inclusion and active facilitation to participate are required to provide equitable evidence-based healthcare during pregnancy and to comply with ethical principles for research. Methods: We carried out an exploratory, online, cross-sectional survey of trialists to assess whether, why, and how pregnant people are included or excluded from clinical trials funded by the NIHR Health Technology Assessment (HTA) Programme, with awards starting in 2022–2023. Trialists were the respondents, with trials the primary focus of this survey. Invitations were sent to trialists between October 2023 and March 2024. Summary statistics were calculated to describe the characteristics of the trials and respondents, to describe eligibility of pregnant people, reasons for this, and how this eligibility is documented and implemented. Results: We identified 120 trials of which 88 were eligible for this survey. Responses were received for 81 trials. Pregnant people are excluded from 34 of these 81 trials. Pregnant people are eligible for inclusion in 40 of the 81 trials, including four which partially exclude people during pregnancy. Eligibility is unclear for seven trials. Exclusions are mostly for safety reasons. Sponsors and regulatory authorities are unnecessary barriers to inclusion in some trials. Eight trials of 40 trials make explicit or deliberate attempts to include people during pregnancy. Conclusions: A minority of the 120 trials include people during pregnancy. Most trials for which pregnant people are eligible do not report explicitly including people during pregnancy or facilitating their inclusion. A small number of trials, different in setting, clinical area, and intervention type, are intentionally designed and conducted in a way that include people during pregnancy. There are clear opportunities to improve the inclusion of pregnant people in clinical trials in the NIHR HTA Programme.
Implementing a text message-based intervention to support type 2 diabetes medication adherence in primary care: a qualitative study with general practice staff
Background: The Support through Mobile Messaging and digital health Technology for Diabetes (SuMMiT-D) project has developed, and is evaluating, a mobile phone-based intervention delivering brief messages targeting identified behaviour change techniques promoting medication use to people with type 2 diabetes in general practice. The present study aimed to inform refinement and future implementation of the SuMMiT-D intervention by investigating general practice staff perceptions of how a text message-based intervention to support medication adherence should be implemented within current and future diabetes care. Methods: Seven focus groups and five interviews were conducted with 46 general practice staff (including GPs, nurses, healthcare assistants, receptionists and linked pharmacists) with a potential role in the implementation of a text message-based intervention for people with type 2 diabetes. Interviews and focus groups were audio-recorded, transcribed and analysed using an inductive thematic analysis approach. Results: Five themes were developed. One theme ‘The potential of technology as a patient ally’ described a need for diabetes support and the potential of technology to support medication use. Two themes outlined challenges to implementation, ‘Limited resources and assigning responsibility’ and ‘Treating the patient; more than diabetes medication adherence’. The final two themes described recommendations to support implementation, ‘Selling the intervention: what do general practice staff need to see?’ and ‘Fitting the mould; complementing current service delivery’. Conclusions: Staff see the potential for a text message-based support intervention to address unmet needs and to enhance care for people with diabetes. Digital interventions, such as SuMMiT-D, need to be compatible with existing systems, demonstrate measurable benefits, be incentivised and be quick and easy for staff to engage with. Interventions also need to be perceived to address general practice priorities, such as taking a holistic approach to care and having multi-cultural reach and relevance. Findings from this study are being combined with parallel work with people with type 2 diabetes to ensure stakeholder views inform further refinement and implementation of the SuMMiT-D intervention.
Development of START-EDI guidelines for reporting equality, diversity and inclusion in research: a study protocol.
INTRODUCTION: Acknowledging equality, diversity and inclusion (EDI) in research is not only a moral imperative but also an important step in avoiding bias and ensuring generalisability of results. This protocol describes the development of STAndards for ReporTing EDI (START-EDI) in research, which will provide a set of minimum standards to help researchers improve their consistency, completeness and transparency in EDI reporting. We anticipate that these guidelines will benefit authors, reviewers, editors, funding organisations, healthcare providers, patients and the public. METHODS AND ANALYSIS: To create START-EDI reporting guidelines, the following five stages are proposed: (i) establish a diverse, multidisciplinary Steering Committee that will lead and coordinate guideline development; (ii) a systematic review to identify the essential principles and methodological approaches for EDI to generate preliminary checklist items; (iii) conduct an international Delphi process to reach a consensus on the checklist items; (iv) finalise the reporting guidelines and create a separate explanation and elaboration document; and (v) broad dissemination and implementation of START-EDI guidelines. We will work with patient and public involvement representatives and under-served groups in research throughout the project stages. ETHICS AND DISSEMINATION: The study has received ethical approval from the Imperial College London Research Ethics Committee (study ID: 7592283). The reporting guidelines will be published in open access peer-reviewed publications and presented in international conferences, and disseminated through community networks and forums. TRIAL REGISTRATION NUMBER: The project is pre-registered within the Open Science Framework (https://osf.io/8udbq/) and the Enhancing the Quality and Transparency of Health Research Network.
Exploring the variation in muscle response testing accuracy through repeatability and reproducibility
Research Objectives To explore the variation in mean muscle response testing (MRT) accuracy and whether this variation can be attributable to participant characteristics. Methods A prospective study of diagnostic test accuracy was carried out in a round-robin format. Sixteen practitioners tested each of 7 test patients (TPs) using 20 MRTs broken into 2 blocks of 10 which alternated with 2 blocks of 10 intuitive guessing. Mean MRT accuracies (as overall percent correct) were calculated for each unique pair. Reproducibility and repeatability were assessed using analyses of variance (ANOVA) and scatter and Bland-Altman plots. Results The mean MRT accuracy (95% CI) was 0.616 (0.578–0.654), which was significantly different from both the mean intuitive guessing accuracy, 0.507 (95% CI 0.484–0.530; p<0.01) and chance (p<0.01). Visual inspection of scatterplots of mean MRT accuracies by practitioner and by TP suggest large variances among both subsets, and regression analysis revealed that MRT accuracy could not be predicted by TP (r = ‒0.14; p = 0.19), nor by Practitioner (r = 0.01; p = 0.90). A significant effect imposed by both practitioners and TPs individually and together was found at the p<0.05 level; however, together they account for only 57.0% of the variance, with 43.0% of the variance unexplained by this model. From a statistical perspective, Bland-Altman Plots of mean MRT accuracy by practitioner do show adequate repeatability since all scores fell within 2 SDs of the mean; however, the wide range of scores also suggests insufficient repeatability from a clinical perspective. Finally, ANOVA demonstrated that an insignificant amount of variance could be explained by block [F(1,21) = 0.02, p=0.90].
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