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The Centre for Evidence-Based Medicine (CEBM) at Oxford University develops, promotes and disseminates better evidence for health care.
Transitions between smoking and vaping: Evidence (or lack thereof) on potential differences by gender and sex
Objective: To synthesize existing evidence on possible differential effects by sex and gender from two Cochrane reviews evaluating vaping and smoking transitions. Methods: We screened included studies from two Cochrane reviews for studies reporting smoking outcomes based on gender or sex. The first review examines the effects of using e-cigarettes to help people quit smoking and includes randomized controlled trials and uncontrolled intervention studies published to July 2023. The second review aims to assess the evidence on the relationship between the use and availability of e-cigarettes and subsequent smoking in young people (aged 29 and younger) and includes quasi-experimental and cohort studies published to April 2023. Due to the paucity and heterogeneity of data, we report results narratively. Results: 10 of 161 studies included in the two relevant reviews met our criteria. Only five reported analyzing whether observed effects or associations varied based on sex and/or gender. A further three provided relevant descriptive information, and two did not report overall outcomes regarding vaping and smoking transitions but did investigate whether these differed by sex/gender. Synthesized data were largely inconclusive, but there was some suggestion that vaping was more strongly associated with subsequent smoking in young males than females. No studies reported data on nonbinary participants. Conclusions: Despite plausible reasons why sex and gender may be moderators of vaping and smoking transitions, there is little evidence investigating this. Future studies of vaping and smoking transitions should conduct and report analyses investigating potential differences based on sex and gender.
PROTOCOL: The efficacy of nutritional interventions in reducing childhood/youth aggressive and antisocial behavior: A systematic review and meta-analysis
This is a protocol for a Campbell systematic review of intervention effectiveness. The goal of this systematic review is to answer the following questions based on the available empirical evidence: Are there nutritional interventions (dietary manipulation, fortification or supplementation) that can reduce excessive aggression towards others in children/youth? If yes, how strong is their effect and is there a difference among the three intervention types? Are there nutritional interventions that can reduce antisocial behaviors in children/youth? If yes, how strong is their effect and is there a difference among the intervention types? Are there nutritional interventions that can reduce violent offending in children/youth? If yes, how strong is their effect and is there a difference among the intervention types? Are there nutritional interventions that can reduce non-violent offending in children/youth? If yes, how strong is their effect and is there a difference among the intervention types? What implementation barriers and solutions to these exist in relation to the above nutritional interventions in children/youth?.
Patient-planetary health co-benefit prescribing in a circumpolar health region: a qualitative study of physician voices from the Northwest Territories, Canada
Background Despite climate change being described as a code red for humanity, health systems have been particularly slow in both climate mitigation and adaptation responses. The effects of climate change on health and health systems will not be felt equally, with underserved and marginalised communities disproportionately impacted. The circumpolar region is warming at 3-4 times the global rate, amplifying already existing socioeconomic barriers and health inequities, with particular amplified effects for the substantial Indigenous population in the area. Objectives and setting We therefore sought to explore perspectives of physicians around patient-planetary health (P-PH) co-benefit prescribing in a circumpolar region in the Northwest Territories (NWT), Canada, known to be one of the ground zero levels for climate change. Methods Thirteen semi-structured physician interviews were carried out in the NWT region between May 2022 and March 2023 using purposive sampling. Interviews were transcribed verbatim and reflexive thematic analysis was carried out to identify key themes. Results There were three main themes identified including (1) current healthcare system does not support planetary health, (2) supporting patient-planetary health is currently difficult for clinicians and (3) considering change in the NWT to support patient-planetary health. Participants noted key opportunities to move planetary health forward, with the NWT having the potential to be an innovative model for planetary health-informed change for other health systems. Conclusion The NWT health system has unique features due to its rural and remote nature and smaller population base. Despite this, our study identified some key opportunities for advancing P-PH co-benefit efforts. The identified opportunities may be considered in future intervention, organisational change and policy-making efforts with potential relevance in other settings.
The impact of the COVID-19 pandemic and associated disruptions in health-care provision on clinical outcomes in people with diabetes: a systematic review
The COVID-19 pandemic triggered disruptions to health care and lifestyles that could conceivably impact diabetes management. We set out to identify the impact of disruptions caused by COVID-19 on clinical outcomes in people with diabetes. We performed a systematic review of the available literature in the MEDLINE and OVID databases from Jan 1, 2020, to June 7, 2023, and included 138 studies (n>1 000 000 people). All but five studies were judged to be at some risk of bias. All studies compared prepandemic with pandemic periods. All-cause mortality (six studies) and diabetes-related mortality (13 studies) showed consistent increases, and most studies indicated increases in sight loss (six studies). In adult and mixed samples, data generally suggested no difference in diabetic ketoacidosis frequency or severity, whereas in children and adolescents most studies showed increases with some due to new-onset diabetes (69 studies). Data suggested decreases in hospital admissions in adults but increases in diabetes-related admissions to paediatric intensive care units (35 studies). Data were equivocal on diabetic foot ulcer presentations (nine studies), emergency department admissions (nine studies), and overall amputation rates (20 studies). No studies investigated renal failure. Where reported, the impact was most pronounced for females, younger people, and racial and ethnic minority groups. Further studies are needed to investigate the longer-term impact of the pandemic and the on potential differential impacts, which risk further exacerbating existing inequalities within people with diabetes.
How has the COVID-19 pandemic affected the delivery of preventive healthcare? An interrupted time series analysis of adults in English primary care from 2018 to 2022
Objective: Offering advice and support for smoking, obesity, excess alcohol, and physical inactivity is an evidence-based component of primary care. The objective was to quantify the impact of the pandemic on the rate of advice or referral for these four risk factors. Methods: A retrospective cohort study using primary care data from 1847 practices in England and 21,191,389 patients contributing to the Oxford Clinical Informatics Digital Hub. An interrupted time series analysis was undertaken with a single change point (March 2020). Monthly trends were modelled from 1st January 2018 – 30th June 2022 using segmented linear regression. Results: There was an initial step reduction in advice and referrals for smoking, obesity, excess alcohol, and physical inactivity in March 2020. By June 2022, advice on smoking (slope change −0.02 events per hundred patient years/month (EPH/month); 95% confidence interval (CI) -0.17, 0.21), obesity (0.06 EPH/month; 95% CI 0.01, 0.12), alcohol (0.02 EPH/month; 95% CI -0.01, 0.05) and physical inactivity (0.05 EPH/month; 95% CI 0.01, 0.09) had not returned to pre-pandemic levels. Similarly, smoking cessation referral remained lower (0.01 EPH/month; 95% CI -0.01, 0.09), excess alcohol referral returned to similar levels (0.0005 EPH/month; 95% CI 0.0002, 0.0008), while referral for obesity (0.14 EPH/month; 95% CI 0.10, 0.19) and physical inactivity (0.01 EPH/month; 95% CI 0.01, 0.02) increased relative to pre-pandemic rates. Conclusion: Advice and support for smoking, and advice for weight, excess alcohol and physical inactivity have not returned to pre-pandemic levels. Clinicians and policy makers should prioritise preventive care in COVID-19 recovery plans.
Weight trends amongst adults with diabetes or hypertension during the COVID-19 pandemic: an observational study using OpenSAFELY.
BACKGROUND: COVID-19 pandemic restrictions may have influenced behaviours related to weight. AIMS: To describe patterns of weight change amongst adults living in England with Type 2 Diabetes (T2D) and/or hypertension during the COVID-19 pandemic. Design and Setting With the approval of NHS England, we conducted an observational cohort study using the routinely collected health data of approximately 40% of adults living in England, accessed through the OpenSAFELY service inside TPP. METHOD: We investigated clinical and sociodemographic characteristics associated with rapid weight gain (>0·5kg/m2/year) using multivariable logistic regression. RESULTS: We extracted data on adults with T2D (n=1,231,455, 44% female, 76% white British) or hypertension (n=3,558,405, 50% female, 84% white British). Adults with T2D lost weight overall (median δ = -0.1kg/m2/year [IQR: -0.7, 0.4]), however, rapid weight gain was common (20.7%) and associated with sex (male vs female: aOR 0.78[95%CI 0.77, 0.79]); age, older age reduced odds (e.g. 60-69-year-olds vs 18-29-year-olds: aOR 0.66[0.61, 0.71]); deprivation, (least-deprived-IMD vs most-deprived-IMD: aOR 0.87[0.85, 0.89]); white ethnicity (Black vs White: aOR 0.95[0.92, 0.98]); mental health conditions (e.g. depression: aOR 1.13 [1.12, 1.15]); and diabetes treatment (non-insulin treatment vs no pharmacological treatment: aOR 0.68[0.67, 0.69]). Adults with hypertension maintained stable weight overall (median δ = 0.0kg/m2/year [ -0.6, 0.5]), however, rapid weight gain was common (24.7%) and associated with similar characteristics as in T2D. CONCLUSION: Amongst adults living in England with T2D and/or hypertension, rapid pandemic weight gain was more common amongst females, younger adults, those living in more deprived areas, and those with mental health condition.
Lessons to be learned from test evaluations during the COVID-19 pandemic: RSS Working Group’s Report on Diagnostic Tests
The coronavirus disease (Covid-19) pandemic raised challenges for everyday life. Development of new diagnostic tests was necessary, but under such enormous pressure risking inadequate evaluation. Against a background of concern about standards applied to the evaluation of in vitro diagnostic tests (IVDs), clear statistical thinking was needed on the principles of diagnostic testing in general, and their application in a pandemic. Therefore, in July 2020, the Royal Statistical Society convened a Working Group of six biostatisticians to review the statistical evidence needed to ensure the performance of new tests, especially IVDs for infectious diseases—for regulators, decision-makers, and the public. The Working Group’s review was undertaken when the Covid-19 pandemic shone an unforgiving light on current processes for evaluating and regulating IVDs for infectious diseases. The report’s findings apply more broadly than to the pandemic and IVDs, to diagnostic test evaluations in general. A section of the report focussed on lessons learned during the pandemic and aimed to contribute to the UK Covid-19 Inquiry’s examination of the response to, and impact of, the Covid-19 pandemic to learn lessons for the future. The review made 22 recommendations on what matters for study design, transparency, and regulation.
Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial
Chronic kidney disease (CKD) is associated with a substantial risk of progression to end-stage renal disease and vascular events. The nonsteroidal mineralocorticoid receptor antagonist (MRA), finerenone, offers cardiorenal protection for people with CKD and diabetes, but there is uncertainty if the steroidal MRA, spironolactone, provides the same protection. In this prospective, randomized, open, blinded endpoint trial, we assessed the effectiveness of 25 mg spironolactone in addition to usual care or usual care alone for reducing cardiovascular outcomes in stage 3b CKD among an older community cohort (mean age = 74.8 years and s.d. = 8.1). We recruited 1,434 adults from English primary care, of whom 1,372 (96%) were included in the primary analysis. The primary outcome was time from randomization until the first occurrence of death, hospitalization for heart disease, stroke, heart failure, transient ischemic attack or peripheral arterial disease, or first onset of any condition listed not present at baseline. Across 3 years of follow-up, the primary endpoint occurred in 113 of 677 participants randomized to spironolactone (16.7%) and 111 of 695 participants randomized to usual care (16.0%) with no significant difference between groups (hazard ratio = 1.05, 95% confidence interval: 0.81–1.37). Two-thirds of participants randomized to spironolactone stopped treatment within 6 months, predominantly because they met prespecified safety stop criteria. The most common reason for stopping spironolactone was a decrease in the estimated glomerular filtration rate that met prespecified stop criteria (n = 239, 35.4%), followed by participants being withdrawn due to treatment side effects (n = 128, 18.9%) and hyperkalemia (n = 54, 8.0%). In conclusion, we found that spironolactone was frequently discontinued due to safety concerns, with no evidence that it reduced cardiovascular outcomes in people with stage 3b CKD. Spironolactone should not be used for people with stage 3b CKD without another explicit treatment indication. ClinicalTrials.gov registration: ISRCTN44522369.
Patient buy-in to social prescribing through link workers as part of person-centred care: a realist evaluation
Background Social prescribing link workers have become part of primary health care in recent years. They help patients to recognise non-medical factors affecting their health and identify sources of support, often in the voluntary, community and social enterprise sector. They form part of wider work to strengthen person-centred care, which actively seeks to engage individuals in decision-making about their health, taking into account their medical, social, psychological, financial and spiritual circumstances. Objective To understand how buy-in to social prescribing and the link worker role is established for a patient, and how this relates to person-centred care. Design A realist evaluation. Setting Patients engaging with link workers in seven different parts of England were involved. Methods As part of data collection, we observed link workers interacting with 35 patients. We also interviewed 61 patients and re-interviewed 41 of them 9–12 months later. Data were coded and developed into context–mechanism–outcome configurations, which were used to produce a programme theory. Results Data highlighted how patients might be uncertain about the link worker role but agree to a referral as they sought assistance with their non-medical issues. Patients talked about experiencing a sense of hope through the trust they developed in a link worker. This trust was established through the communication skills and knowledge demonstrated by a link worker, and by their ability to act as an anchor point when required – a reliable, consistent source of support to whom patients could offload. The link worker role also involved connecting patients to external support, which called for sensitivity around how ready someone was to move forward; this was shaped by a patient’s motivation but also their capacity to make changes given other demands in their life. Connecting patients to external support could be affected by structural factors outside the link workers’ control (e.g. housing options or employment opportunities). Limitations We did not interview patients who had rejected the offer of social prescribing, and most had a positive view of meeting with a link worker. Conclusions Person-centred care is engendered by link workers through their skills, knowledge and ability to respond to the individual readiness of patients to engage with external support. It can be curtailed by structural factors outside link workers’ sphere of control, such as access to housing or caring responsibilities of patients. This can hinder patients’ ability to ‘connect to’, leaving link workers to continue ‘connecting with’ patients as they act as an anchor point. Future work Exploration is required of factors affecting patients who interact with a link worker but do not access external support. Longitudinal work with a cohort of patients, speaking to them on a regular basis, may provide further understanding in this respect. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR130247.
Insights into the quantification and reporting of model-related uncertainty across different disciplines
Quantifying uncertainty associated with our models is the only way we can express how much we know about any phenomenon. Incomplete consideration of model-based uncertainties can lead to overstated conclusions with real-world impacts in diverse spheres, including conservation, epidemiology, climate science, and policy. Despite these potentially damaging consequences, we still know little about how different fields quantify and report uncertainty. We introduce the “sources of uncertainty” framework, using it to conduct a systematic audit of model-related uncertainty quantification from seven scientific fields, spanning the biological, physical, and political sciences. Our interdisciplinary audit shows no field fully considers all possible sources of uncertainty, but each has its own best practices alongside shared outstanding challenges. We make ten easy-to-implement recommendations to improve the consistency, completeness, and clarity of reporting on model-related uncertainty. These recommendations serve as a guide to best practices across scientific fields and expand our toolbox for high-quality research.
Research inefficiencies in external validation studies of the Framingham Wilson coronary heart disease risk rule: A systematic review
Background External validation studies create evidence about a clinical prediction rule's (CPR's) generalizability by evaluating and updating the CPR in populations different from those used in the derivation, and also by contributing to estimating its overall performance when metaanalysed in a systematic review. While most cardiovascular CPRs do not have any external validation, some CPRs have been externally validated repeatedly. Hence, we examined whether external validation studies of the Framingham Wilson coronary heart disease (CHD) risk rule contributed to generating evidence to their full potential. Methods A forward citation search of the Framingham Wilson CHD risk rule's derivation study was conducted to identify studies that evaluated the Framingham Wilson CHD risk rule in different populations. For external validation studies of the Framingham Wilson CHD risk rule, we examined whether authors updated the Framingham Wilson CHD risk rule when it performed poorly. We also assessed the contribution of external validation studies to understanding the Predicted/Observed (P/O) event ratio and c statistic of the Framingham Wilson CHD risk rule. Results We identified 98 studies that evaluated the Framingham Wilson CHD risk rule; 40 of which were external validation studies. Of these 40 studies, 27 (67.5%) concluded the Framingham Wilson CHD risk rule performed poorly but did not update it. Of 23 external validation studies conducted with data that could be included in meta-analyses, 13 (56.5%) could not fully contribute to the meta-analyses of P/O ratio and/or c statistic because these performance measures were neither reported nor could be calculated from provided data. Discussion Most external validation studies failed to generate evidence about the Framingham Wilson CHD risk rule's generalizability to their full potential. Researchers might increase the value of external validation studies by presenting all relevant performance measures and by updating the CPR when it performs poorly.
Outcomes for older people with screening detected versus existing chronic kidney disease: Cohort study with data linkage.
BACKGROUND: Chronic Kidney Disease (CKD) is a common health problem, associated with increased risk of cardiovascular disease (CVD), end stage kidney disease (ESKD), and premature death. A third of people aged≥70 years have CKD, many of whom are undiagnosed, but little is known about the value of screening. AIM: To compare the risk of adverse health outcomes between people with an existing diagnosis of CKD and those identified on screening. To identify factors associated with mortality in CKD. DESIGN & SETTING: Prospective cohort study of 892 primary care patients aged≥60 years with CKD (existing and screening detected) in Oxfordshire, with data linkage to civil death registry and secondary care. METHOD: Hazard Ratios (HR) and 95% Confidence Intervals (CI) were estimated using Cox proportional-hazard models to compare the risk of all-cause mortality, hospitalisation, CVD, ESKD separately, and as a composite between CKD groups, as well as to identify factors associated with mortality. RESULTS: After a median follow-up of 3-5 years, 49 people died, 493 were hospitalised, 57 had an incident CVD event, and 0 had an ESKD event. There was no difference in the composite outcome between those existing CKD and those identified on screening (HR 0.94, CI 0.67-1.33). Older age (HR 1.10, CI 1.06-1.15), male sex (HR 2.31, CI 1.26-4.24), and heart failure (HR 5.18, CI 2.45-10.97) were associated with increased risk of death. CONCLUSION: Screening older people for CKD may be of value, as their risk of short-term mortality, hospitalisation, and CVD is comparable to people routinely diagnosed. Larger studies with longer follow-up in more diverse and representative populations of older adults are needed to corroborate these findings.
Experiences of integrating social prescribing link workers into primary care in England: Bolting on, fitting in or belonging.
BACKGROUND: Following the 2019 NHS Long-Term Plan, link workers (LWs) have been employed across primary care in England to deliver social prescribing (SP). AIM: To understand and explain how the LW role is being implemented in primary care in England. DESIGN AND SETTING: Realist evaluation undertaken in England. METHOD: Focused ethnographies around seven LWs from different parts of England. As part of this, we interviewed 61 patients and 93 professionals from healthcare and the voluntary, community and social enterprise (VCSE) sector. We reinterviewed 41 patients, seven LWs and a LW manager 9-12 months after their first interview. RESULTS: We developed four concepts around how LWs are integrated (or not) within primary care: Centralising or diffusing power; Forging an identity in general practice; Demonstrating effect; Building a facilitative infrastructure. These concepts informed the development of a programme theory around a continuum of integration of LWs into primary care - from being 'bolted on' to existing provision, without much consideration, to 'fitting in', shaping what is delivered to be accommodating, through to 'belonging', whereby they are accepted as a legitimate source of support, making a valued contribution to patients' broader well-being. CONCLUSION: SP was introduced into primary care to promote greater attention to the full range of factors affecting patients' health and well-being, beyond biomedicine. For that to happen, our analysis highlights the need for a whole system approach to defining, delivering and maintaining this new part of practice.