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Today is National No Smoking Day 2023, and we're delighted to share the research happening across the Nuffield Department of Primary Care Health Sciences and the Centre for Evidence-Based Medicine, to determine the effects of e-cigarettes to help smokers achieve long‐term abstinence.
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Self-monitoring blood pressure in pregnancy: evaluation of women's experiences of the BUMP trials.
BACKGROUND: The COVID-19 pandemic accelerated the adoption of remote care, or telemedicine, in many clinical areas including maternity care. One component of remote care, the use of self-monitoring of blood pressure in pregnancy, could form a key component in post-pandemic care pathways. The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether it improved detection or control of hypertension for pregnant people at risk of hypertension or with hypertension during pregnancy. This paper reports the qualitative evaluation which aimed to understand how the intervention worked, the perspectives of participants in the trials, and, crucially, those who declined to participate. METHODS: The BUMP trials were conducted between November 2018 and May 2020. Thirty-nine in-depth qualitative interviews were carried out with a diverse sample of pregnant women invited to participate in the BUMP trials across five maternity units in England. RESULTS: Self-monitoring of blood pressure in the BUMP trials was reassuring, acceptable, and convenient and sometimes alerted women to raised BP. While empowering, taking a series of self-monitored readings also introduced uncertainty and new responsibility. Some declined to participate due to a range of concerns. In the intervention arm, the performance of the BUMP intervention may have been impacted by women's selective or delayed reporting of raised readings and repeated testing in pursuit of normal BP readings. In the usual care arm, more women were already self-monitoring their blood pressure than expected. CONCLUSIONS: The BUMP trials did not find that among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring led to significantly earlier clinic-based detection of hypertension nor improved management of blood pressure. The findings from this study help us understand the role that self-monitoring of blood pressure can play in maternity care pathways. As maternity services consider the balance between face-to-face and remote consultations in the aftermath of the COVID-19 pandemic, these findings contribute to the evidence base needed to identify optimal, effective, and equitable approaches to self-monitoring of blood pressure.
Medical school ranking and provider outpatient Medicare Part D claims for antibiotics among older patients in the USA.
BACKGROUND: Our study aimed to assess whether there was a relationship between graduating from higher-ranked medical schools and the rate of prescribing antibiotics among Medicare Part D providers in the USA. METHODS: The study obtained data from the Medicare Part D Prescribers (FY2013-2021) and the Doctor and Clinicians National repositories. A regression model was fitted to assess the relationship between provider medical school ranking and the rate of antibiotic days supplied per 100 beneficiaries at the provider level. RESULTS: A total of 197 540 providers were included. No association was found between the medical school ranking and the rate of antibiotics days supplied per 100 beneficiaries. Instead, the type of provider is associated with the prescription rates. Hospitalists and Emergency Medicine providers had fewer days supplied per 100 beneficiaries than Family Medicine providers. In contrast, students, more experienced providers (>20 years since medical school graduation) and females had more days supplied per 100 beneficiaries. CONCLUSION: Our study highlights the need for robust outpatient stewardship interventions and incorporating an outcome-based approach to antibiotic stewardship curricula in medical and mid-level provider schools.
Patient safety in remote primary care encounters: Multimethod qualitative study combining Safety i and Safety II analysis
Background Triage and clinical consultations increasingly occur remotely. We aimed to learn why safety incidents occur in remote encounters and how to prevent them. Setting and sample UK primary care. 95 safety incidents (complaints, settled indemnity claims and reports) involving remote interactions. Separately, 12 general practices followed 2021-2023. Methods Multimethod qualitative study. We explored causes of real safety incidents retrospectively ('Safety I' analysis). In a prospective longitudinal study, we used interviews and ethnographic observation to produce individual, organisational and system-level explanations for why safety and near-miss incidents (rarely) occurred and why they did not occur more often ('Safety II' analysis). Data were analysed thematically. An interpretive synthesis of why safety incidents occur, and why they do not occur more often, was refined following member checking with safety experts and lived experience experts. Results Safety incidents were characterised by inappropriate modality, poor rapport building, inadequate information gathering, limited clinical assessment, inappropriate pathway (eg, wrong algorithm) and inadequate attention to social circumstances. These resulted in missed, inaccurate or delayed diagnoses, underestimation of severity or urgency, delayed referral, incorrect or delayed treatment, poor safety netting and inadequate follow-up. Patients with complex pre-existing conditions, cardiac or abdominal emergencies, vague or generalised symptoms, safeguarding issues, failure to respond to previous treatment or difficulty communicating seemed especially vulnerable. General practices were facing resource constraints, understaffing and high demand. Triage and care pathways were complex, hard to navigate and involved multiple staff. In this context, patient safety often depended on individual staff taking initiative, speaking up or personalising solutions. Conclusion While safety incidents are extremely rare in remote primary care, deaths and serious harms have resulted. We offer suggestions for patient, staff and system-level mitigations.
Challenges to quality in contemporary, hybrid general practice: a multi-site longitudinal case study.
BACKGROUND: Since 2022, general practice has shifted from responding to the acute challenges of COVID-19 to restoring full services using a hybrid of remote, digital, and in-person care. AIM: To examine how quality domains are addressed in contemporary UK general practice. DESIGN AND SETTING: Multi-site, mostly qualitative longitudinal case study, placed in UK national policy context. METHOD: Data were collected from longitudinal ethnographic case studies of 12 general practices (2021-2023), multi-stakeholder workshops, stakeholder interviews, patient surveys, official reports, and publicly accessible patient experience data. Data were coded thematically and analysed using multiple theories of quality. RESULTS: Quality efforts in UK general practice occur in the context of cumulative impacts of financial austerity, loss of resilience, increasingly complex patterns of illness and need, a diverse and fragmented workforce, material and digital infrastructure that is unfit for purpose, and physically distant and asynchronous ways of working. Providing the human elements of traditional general practice (such as relationship-based care, compassion, and support) is difficult and sometimes even impossible. Systems designed to increase efficiency have introduced new forms of inefficiency and have compromised other quality domains such as accessibility, patient-centredness, and equity. Long-term condition management varies in quality. Measures to mitigate digital exclusion (such as digital navigators) are welcome but do not compensate for extremes of structural disadvantage. Many staff are stressed and demoralised. CONCLUSION: Contemporary hybrid general practice features changes (digitalisation, physical distancing, extension of roles, and protocolisation) that have had the unintended effect of dehumanising, compromising, and fragmenting care. Policymakers and practices should urgently address the risks to patients and the traditional core values of general practice should be urgently addressed.
What is the effect of bariatric surgery on health-related quality of life in people with obesity? observational cohort analysis of the United Kingdom national bariatric surgery registry.
BACKGROUND: Previous small studies investigating health-related quality of life (HRQoL) following bariatric surgery have demonstrated heterogenous effects. This study aimed to use National Bariatric Surgery Registry (NBSR) records to investigate the relationship between weight and HRQoL in people undergoing bariatric surgery in the UK. MATERIALS AND METHODS: In this observational study using United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022, patients undergoing primary bariatric surgery with one baseline and at least one follow-up visit within one year from surgery were eligible for inclusion. Models estimated the relationship between EuroQol Five Dimension 5-level (EQ-5D) and BMI at baseline and longitudinally. Further analyses stratified by type 2 diabetes, type of operation (adjustable gastric band, sleeve, or bypass) and domain of EQ-5D. RESULTS: 5,587 observations of 2,160 patients were analysed. At baseline, mean BMI was 45.7±7.8 kg/m2 and mean EQ-5D was 0.78±0.22. A 1 kg/m2 higher BMI was associated with 0.005 (95%CI[-0.006,-0.004]) lower EQ-5D. In the month following surgery, EQ-5D increased to 0.91±0.2 while BMI decreased to 39.8±7.1 kg/m2 (P<0.001 for both); subsequently EQ-5D plateaued (0.90±0.17 at 12 months) while BMI continued to decrease (31.5±6.2 kg/m2 at 12 months, P<0.001). Each 1 kg/m2 decrease in BMI was associated with a 0.006 (95%CI [-0.007,-0.005]) increase in EQ-5D. Remission of T2D was independently associated with increase in EQ-5D (0.037, 95%CI [0.015,0.059]); type of operation was not. Decreases in BMI were associated with improvements in all five domains of EQ-5D. CONCLUSIONS: In this large dataset, greater weight loss and T2D remission were independently associated with greater improvements in HRQoL following bariatric surgery. The HRQoL-BMI relationship for people undergoing bariatric surgery differs to that which has previously been estimated following behavioural interventions. Use of the estimates generated here will be important for clinical and political decision making.
Evaluating video and hybrid group consultations in general practice: mixed-methods, participatory study protocol (TOGETHER 2)
Background: General practice is facing an unprecedented challenge in managing the consequences of the pandemic. In the midst of a policy drive to balance remote and in-person service provision, substantial workload pressures remain, together with increasing prevalence of long-term conditions, and declining staff numbers and morale. To address these challenges, some practices in the UK have been delivering video and hybrid group consultations (VHGCs) providing clinical care to multiple patients at the same time. Despite positive initial findings and enthusiasm, there are still gaps in our understanding of the influence VHGCs have on patient experience, healthcare utilisation, quality, safety, equity and affordability. Objectives: To generate an in-depth understanding of VHGCs for chronic conditions in general practice, surface assumptions and sociotechnical dynamics, inform practice and extend theorisation. Methods: Mixed-methods, multi-site research study using co-design and participatory methods, from qualitative, quantitative and cost-related perspectives. WP1 includes a national, cross-sectional survey on VHGC provision across the UK. In WP2 we will engage patients and general practice staff in co-design workshops to develop VHGC models with emphasis on digital inclusion and equity. In WP3 we will carry out a mixed-methods process evaluation in up to 10 GP practices across England (5 sites already running VHGCs and 5 comparison sites). Qualitative methods will include interviews, focus groups and ethnographic observation to examine the experiences of patients, carers, clinical and non-clinical NHS staff, commissioners and policy-makers. Quantitative methods will examine the impact of VHGCs on healthcare utilisation in primary and secondary care, patient satisfaction, engagement and activation. We will also assess value for money of group and individual care models from a health economics perspective. Conclusions: We aim to develop transferable learning on sociotechnical change in healthcare delivery, using VHGCs as an exemplar of technology-supported innovation. Findings will also inform the design of a future study.
What are the unintended patient safety consequences of healthcare technologies? A qualitative study among patients, carers and healthcare providers
ObjectiveTo identify patient-safety-related unintended consequences of healthcare technologies experienced by their primary users: patients, carers and healthcare providers (HCPs).DesignQualitative study based on data collected in online focus groups. Transcripts were analysed inductively after each focus group using reflexive thematic analysis, focusing on identifying unintended consequences of healthcare technologies with implications for patient safety. Patient safety was broadly conceptualised to include a more subjective concept of ‘feeling safe’ as well as risks of actual harm.SettingPatient/public and HCP participants from the UK with experience in healthcare technologies were recruited using a mixture of purposive, convenience and snowball sampling.Participants40 participants (29 patients/public, 11 HCPs) took part in 5 focus groups between November 2021 and February 2022.ResultsWe identified five main themes of unintended consequences with implications for patient safety: inequity of access, increased end-user burden, loss of the human element of healthcare, over-reliance on technology and unclear responsibilities. Both groups of participants identified unintended consequences directly affecting patients; HCPs also described those affecting themselves. Some unintended consequences are described in previous literature, including alert fatigue, the ‘illusion of communication’, reduced opportunities for face-to-face interactions and increased end-user burden. Others are potentially novel, including patients’ psychological dependence on technologies, ‘gaming’ of data entry and incorrect interpretation of health data.ConclusionsDrawing on the perspectives of patients/public as well as HCPs, we identified five areas of patient-safety-related unintended consequences associated with healthcare technologies. These should be considered when developing tools to identify and mitigate the patient-safety-related unintended consequences of healthcare technologies.
Cost-effectiveness of C-reactive protein point of care testing for safely reducing antibiotic consumption for acute exacerbations of chronic obstructive pulmonary disease as part of the multicentre, parallel-arm, open, individually randomised, controlled PACE trial.
OBJECTIVES: Many patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care do not benefit from antibiotics. Excessive use wastes resources, promotes antimicrobial resistance and can harm patients. DESIGN: We conducted a within-trial economic evaluation, using a UK National Health Service perspective, as part of the multicentre, parallel-arm, open, individually randomised, controlled PACE trial. SETTING: Participating general practices in primary care. PARTICIPANTS: PACE included 324 and 325 consenting participants presenting with AECOPD in the usual-care and CRP-guided groups, respectively. INTERVENTION: We assessed the cost-effectiveness (CE) of a C-reactive protein point-of-care-test (CRP-POCT) in addition to usual clinical assessment to guide antibiotic prescribing for AECOPD in primary care. PRIMARY AND SECONDARY OUTCOME MEASURES: A cost-effectiveness analysis (CEA) of incremental cost per 1% antibiotic consumption reduction at 4 weeks and a cost-utility analysis (CUA) at 6 months were performed, based on a modified intention-to-treat population. Sensitivity analyses assessed the impact of uncertainty on the results. CE acceptability curves represent the probability of CRP-POCT being cost-effective at different willingness-to-pay (WTP) thresholds. RESULTS: Both groups had similar clinical outcomes, but a 20% absolute reduction in antibiotic consumption was observed in the CRP-guided group. CRP-POCT costs of £11.31 per test were largely offset by savings in healthcare resource use related to COPD. The mean incremental CE ratios of CRP-POCT were £120 per 1% absolute reduction in antibiotic consumption at 4 weeks and £1054 per quality-adjusted life-year (QALY) gained at 6 months. Sensitivity analysis showed that the CEA results were most affected by changes in healthcare costs, while CUA was sensitive due to marginal differences in costs and outcomes. There is a 73% probability of CRP-POCT being cost-effective at WTP ≤£20 000 per QALY gained. CONCLUSION: CRP-POCT is a cost-effective intervention for safely reducing antibiotic consumption in patients with AECOPD. TRIAL REGISTRATION NUMBER: ISRCTN24346473.
Developing a data-enabled nudge intervention for childhood antibiotics in primary care: a qualitative study.
BACKGROUND: Preschool children (aged≤5 years old) have the highest antibiotic prescribing rate in general practice, mostly for self-limiting acute respiratory tract infections (RTIs). Research from over 250 000 UK children suggests that a child's antibiotic history for RTI may be a good predictor for re-consulting a health professional for the same illness episode and increase clinical workload. AIM: To develop a data-enabled nudge intervention to optimise antibiotic prescribing for acute RTI based on a child's antibiotic history in general practice DESIGN & SETTING: Two phase qualitative study with parents/carers of preschool children and primary care clinicians METHOD: In phase 1, through an initial focus group with eight parents/carers and 'think aloud' interviews with 11 clinicians, we co-designed the intervention (computer screen prompt and personalised consultation leaflet). In phase 2, 13 clinicians used the intervention, integrated into the GP computer software, and share their feedback through 'think aloud' interviews. Interviews were audio-recorded, transcribed, and analysed thematically. RESULTS: We co-created a data-driven intervention that automatically integrates a child's antibiotic history for acute RTI and personalised leaflet into the electronic medical records. We found that parents and clinicians found this intervention, in principle, acceptable and feasible to use in primary care consultations. CONCLUSION: Delivering such interventions, integrated into practice workflow, could be efficiently scaled up to promote effective antimicrobial stewardship and reduce unnecessary antibiotic use in primary care. Further research will test this intervention in a future trial.
Enhancing the trustworthiness of pain research: A call to action.
The personal, social and economic burden of chronic pain is enormous. Tremendous research efforts are being directed toward understanding, preventing, and managing chronic pain. Yet patients with chronic pain, clinicians and the public are sometimes poorly served by an evidence architecture that contains multiple structural weaknesses. These include incomplete research governance, a lack of diversity and inclusivity, inadequate stakeholder engagement, poor methodological rigour and incomplete reporting, a lack of data accessibility and transparency, and a failure to communicate findings with appropriate balance. These issues span pre-clinical research, clinical trials and systematic reviews and impact the development of clinical guidance and practice. Research misconduct and inauthentic data present a further critical risk. Combined, they increase uncertainty in this highly challenging area of study and practice, drive the provision of low value care, increase costs and impede the discovery of more effective solutions. In this focus article, we explore how we can increase trust in pain science, by examining critical challenges using contemporary examples, and describe a novel integrated conceptual framework for enhancing the trustworthiness of pain science. We end with a call for collective action to address this critical issue. Perspective: Multiple challenges can adversely impact the trustworthiness of pain research and health research more broadly. We present ENTRUST-PE, a novel, integrated framework for more trustworthy pain research with recommendations for all stakeholders in the research ecosystem, and make a call to action to the pain research community.
The Association between COVID-19 Status and Economic Costs in the Early Stages of the COVID-19 Pandemic: Evidence from a UK Symptom Surveillance Digital Survey.
INTRODUCTION: In the absence of a vaccination programme, the coronavirus disease 2019 (COVID-19) pandemic had substantial impacts on population health and wellbeing and health care services. We explored the association between COVID-19 status, sociodemographic, socioeconomic and clinical factors and economic costs during the second wave of the COVID-19 pandemic. DATA: The study used patient-reported digital survey and symptom surveillance data collected between July and December 2020, in collaboration with a primary care computerised medical record system supplier, EMIS Health, in the UK. The study included 11,534 participants. METHODS: Generalised linear models (GLM) and two-part regression models were used to estimate factors associated with economic costs (£sterling, 2022 prices) estimated from two perspectives: (i) a UK National Health Service (NHS) and personal social services (PSS) perspective and (ii) a societal perspective. RESULTS: Experience of the onset of COVID-19 symptoms started more than 3 months ago was associated with significantly higher NHS and PSS costs (GLM: £319.8, two-part: £171.7) (p < 0.001) and societal costs (GLM: £776.9, two-part: £675.6) (p < 0.001) in both models. A positive test result within the previous 14 days was associated with significantly higher NHS and PSS costs (two-part: £389.1) (p < 0.05) and societal costs (GLM: £470.7, two-part: £439.2) (p < 0.01). Age between 31 and 55 years was associated with significantly higher societal costs than age between 16 and 30 years. CONCLUSION: This study identifies and quantifies factors associated with the economic costs incurred during the second wave of the COVID-19 pandemic in the UK. The results of our study can inform cross-country comparisons and other cost comparisons.
Respiratory Syncytial Virus-related Community Chronic Obstructive Pulmonary Disease Exacerbations and Novel Diagnostics: A Binational Prospective Cohort Study
Rationale: Respiratory syncytial virus (RSV) is a common global respiratory virus that is increasingly recognized as a major pathogen in frail older adults and as a cause of chronic obstructive pulmonary disease (COPD) exacerbations. There is no single test for RSV in adults that has acceptable diagnostic accuracy. Trials of RSV vaccines have recently shown excellent safety and efficacy against RSV in older adults; defining the frequency of RSV-related community infections and COPD exacerbations is important for vaccine deployment decisions. Objectives: This prospective study aimed to establish the frequency of outpatient-managed RSV-related exacerbations of COPD in two well-characterized patient cohorts using a combination of diagnostic methods. Methods: Participants were recruited at specialist clinics in London, United Kingdom, and Groningen, the Netherlands, beginning in 2017 and observed for three consecutive RSV seasons, during exacerbations, and at least twice yearly. RSV infections were detected by RT-PCR and serologic testing. Measurements and Main Results: A total of 377 patients with COPD attended 1,999 clinic visits and reported 310 exacerbations. There were 27 RSV-related exacerbations (8.7% of the total); of these, seven were detected only by PCR, 16 only by serology, and four by both methods. Increases in RSV-specific Nucleoprotein antibody were as sensitive as those in the antibody to Pre-Fusion or Post-Fusion for serodiagnosis of RSV-related exacerbations. Conclusions: RSV is associated with 8.7% of outpatientmanaged COPD exacerbations in this study. Antibodies to RSV Nucleoprotein may have diagnostic value and are potentially important in a vaccinated population. The introduction of vaccines that prevent RSV is expected to benefit patients with COPD.
Digging for Literature on Tailoring Cultural Offers With and for Older People From Ethnic Minority Groups: A Scoping Review
ABSTRACTIntroductionSocial prescribing addresses non‐medical issues (e.g., loneliness, financial worries, housing problems) affecting physical and/or mental health. It involves connecting people to external support or services, including ‘cultural offers’–events, groups and activities run within or by cultural organisations. Such offers need to be acceptable and accessible to diverse populations if forming part of a social prescription.MethodsA scoping review was conducted to identify what existing literature, conducted in the United Kingdom, tells us about tailoring cultural offers for older people (aged 60+ years) from ethnic minority groups. Relevant literature was searched for on electronic databases, through Google, via a questionnaire to cultural organisations and by contacting the study's advisory group.ResultsScreening of 906 references–59 of which were read as full documents–resulted in six sources being included in the review. Some cultural activities described within them were run in traditional cultural spaces (e.g., museums, art galleries). Others were held in community centres. Data suggested that attending with others could reduce concerns about belonging. Barriers to engagement included low energy, language, poor confidence, accessing transport and unfamiliarity with a setting and/or activities. Provision of familiar food could help make people feel welcomed.ConclusionsReviewed papers showed that consulting with target groups is important to ensure that activities are inclusive and sympathetically delivered. The review also highlighted a paucity of published research on the topic; this means that cultural providers have little evidence to draw on when developing cultural offers for older people from ethnic minority groups.
Methodological literature on the reporting of systematic reviews of health economic evaluations: a scoping review protocol
Systematic reviews of health economic evaluations play a crucial role in informing evidence-based healthcare decisions, yet they lack standardized reporting guidelines. A project has been initiated that aims to extend the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline for systematic reviews of health economic evaluations (PRISMA-EconEval). This scoping review forms a foundation for the PRISMA-EconEval project, aiming to identify, map, and extract candidate reporting items from the methodological literature. The scoping review will follow the PRISMA Extension for Scoping Reviews (PRISMA-ScR) Checklist and involve comprehensive searches in databases such as PubMed MEDLINE, Embase, and Web of Science, covering the period from 2015 to 2024. Supplementary searching, reference checking and citation searching will target grey literature, overlooked studies and evidence prior to 2015. Inclusion criteria will focus on methodological papers that provide frameworks or recommendations for reporting systematic reviews of health economic evaluations and enhanced case studies that critically discuss methods and reporting structures. The extracted data will be coded and analyzed to produce an initial list of candidate reporting items, structured according to conventional sections of a systematic review (e.g., title, abstract, methods, results). This initial list will be used in the subsequent stages of the project and disseminated through a peer-reviewed publication and presentations at international conferences. The outcome of this scoping review will significantly contribute to the development of a comprehensive PRISMA-EconEval reporting guideline, aimed at enhancing the transparency, consistency, and quality of systematic reviews of health economic evaluations, and provide an essential tool for authors, editors, peer-reviewers, and stakeholders.
Evaluating the efficacy and mechanisms of a ketogenic diet as adjunctive treatment for people with treatment-resistant depression: A protocol for a randomised controlled trial
Background: One-third of people with depression do not respond to antidepressants, and, after two adequate courses of antidepressants, are classified as having treatment-resistant depression (TRD). Some case reports suggest that ketogenic diets (KDs) may improve some mental illnesses, and preclinical data indicate that KDs can influence brain reward signalling, anhedonia, cortisol, and gut microbiome which are associated with depression. To date, no trials have examined the clinical effect of a KD on TRD. Methods: This is a proof-of-concept randomised controlled trial to investigate the efficacy of a six-week programme of weekly dietitian counselling plus provision of KD meals, compared with an intervention involving similar dietetic contact time and promoting a healthy diet with increased vegetable consumption and reduction in saturated fat, plus food vouchers to purchase healthier items. At 12 weeks we will assess whether participants have continued to follow the assigned diet. The primary outcome is the difference between groups in the change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 weeks. PHQ-9 will be measured at weeks 2, 4, 6 and 12. The secondary outcomes are the differences between groups in the change in remission of depression, change in anxiety score, functioning ability, quality of life, cognitive performance, reward sensitivity, and anhedonia from baseline to 6 and 12 weeks. We will also assess whether changes in reward sensitivity, anhedonia, cortisol awakening response and gut microbiome may explain any changes in depression severity. Discussion: This study will test whether a ketogenic diet is an effective intervention to reduce the severity of depression, anxiety and improve quality of life and functioning ability for people with treatment-resistant depression.