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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
A realist review of how, why, for whom and in which contexts quality improvement in healthcare impacts inequalities
Introduction: Quality improvement (QI) is aimed at improving care. Equity is one of the six domains of healthcare quality, as defined by the Institute of Medicine. If this domain is ignored, QI projects have the potential to maintain or even worsen inequalities. Aims and objectives: We aimed to understand why, how, for whom and in which contexts QI approaches increase, or do not change health inequalities in healthcare organisations. Methods: We conducted a realist review by first developing an initial programme theory, then searching MEDLINE, Embase, CINAHL, PsychINFO, Web of Science and Scopus for QI projects that considered health inequalities. Included studies were analysed to generate context-mechanism-outcome configurations (CMOCs) and develop an overall programme theory. Results: We screened 6259 records. Thirty-six records met our inclusion criteria, the majority of which were from the USA. We developed CMOCs covering four clusters: values and understanding, resources, data, and design. Five of these described circumstances in which QI may increase inequalities and 15 where it may reduce inequalities. We found that QI projects that are values-led and incorporate diverse, patient-led data into design are more likely to address health inequalities. However, when staff and patients cannot engage fully with equity-focused projects, due to practical or technological barriers, QI projects are more likely to worsen inequalities. Conclusions: The potential for QI projects to positively impact inequalities depends on embedding equity-focused values across organisations, ensuring sufficient and appropriate resources are provided to staff delivering QI, and using diverse disaggregated data alongside considered user involvement to inform and assess the success of QI projects. Policymakers and practitioners should ensure that QI projects are used to address inequalities.
Health economic aspects of childhood excess weight
Background: Over the past four decades, the prevalence of childhood excess weight has risen significantly globally and remains high in many countries. In England, the prevalence of excess weight among Year 6 children (10–11-year-olds) increased from 31.6% in 2006/07 to 36.6% in 2022/23. Despite the increasing public health burden, substantial uncertainty persists regarding key economic parameters and outcomes necessary to guide research and inform policy for the efficient allocation of resources that target childhood excess weight. Methods: This thesis presents a structured review of economic aspects of childhood excess weight as a foundation for further analyses. A systematic review of economic evaluations of interventions targeting childhood excess weight was conducted, followed by an analysis of data from the UK Millennium Cohort Study to estimate transitions in childhood weight status. Additionally, electronic health records extracted from the Clinical Practice Research Datalink (CPRD), linked with Hospital Episode Statistics (HES), were analysed to estimate direct healthcare costs attributable to childhood excess weight. Results: The systematic review found that early prevention strategies for childhood excess weight are generally cost-effective. Analysis of data from the Millennium Cohort Study indicated that children aged 3 to 7 years had a significantly higher probability of transitioning from overweight or obesity to a healthy weight compared to older children, with more than twice the annual likelihood of such transitions. These movements between weight status categories were also influenced by child, maternal, and sociodemographic factors. My analyses of CPRD-HES data revealed that children living with overweight and obesity incurred significantly higher direct healthcare costs than their peers with a healthy weight. In comparison to children with healthy weight, those living with overweight generated additional costs of £133.93 and £66.32, on average, in the year preceding and following a BMI measurement, respectively, while children with obesity incurred additional costs of £115.47 and £154.51, on average, during the same periods. The total annual healthcare cost attributable to childhood excess weight in England was estimated at £0.3 billion. Conclusions: This thesis identifies critical areas for future economic research, offering insights for researchers and policymakers. It underscores the significance of investing early in cost-effective interventions to address childhood excess weight. The evidence presented in this thesis can serve as data inputs for future economic evaluations in this field.
Electronic cigarettes for smoking cessation.
BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices that produce an aerosol by heating an e-liquid. People who smoke, healthcare providers, and regulators want to know if ECs can help people quit smoking, and if they are safe to use for this purpose. This is a review update conducted as part of a living systematic review. OBJECTIVES: To examine the safety, tolerability, and effectiveness of using EC to help people who smoke tobacco achieve long-term smoking abstinence, in comparison to non-nicotine EC, other smoking cessation treatments, and no treatment. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 February 2024 and the Cochrane Tobacco Addiction Group's Specialized Register to 1 February 2023, reference-checked, and contacted study authors. SELECTION CRITERIA: We included trials randomizing people who smoke to an EC or control condition. We included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report an eligible outcome. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. We used the risk of bias tool (RoB 1) and GRADE to assess the certainty of evidence. Critical outcomes were abstinence from smoking after at least six months, adverse events (AEs), and serious adverse events (SAEs). Important outcomes were biomarkers, toxicants/carcinogens, and longer-term EC use. We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in pairwise and network meta-analyses (NMA). MAIN RESULTS: We included 90 completed studies (two new to this update), representing 29,044 participants, of which 49 were randomized controlled trials (RCTs). Of the included studies, we rated 10 (all but one contributing to our main comparisons) at low risk of bias overall, 61 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. Nicotine EC results in increased quit rates compared to nicotine replacement therapy (NRT) (high-certainty evidence) (RR 1.59, 95% CI 1.30 to 1.93; I2 = 0%; 7 studies, 2544 participants). In absolute terms, this might translate to an additional four quitters per 100 (95% CI 2 to 6 more). The rate of occurrence of AEs is probably similar between groups (moderate-certainty evidence (limited by imprecision)) (RR 1.03, 95% CI 0.91 to 1.17; I2 = 0%; 5 studies, 2052 participants). SAEs were rare, and there is insufficient evidence to determine whether rates differ between groups due to very serious imprecision (RR 1.20, 95% CI 0.90 to 1.60; I2 = 32%; 6 studies, 2761 participants; low-certainty evidence). Nicotine EC probably results in increased quit rates compared to non-nicotine EC (moderate-certainty evidence, limited by imprecision) (RR 1.46, 95% CI 1.09 to 1.96; I2 = 4%; 6 studies, 1613 participants). In absolute terms, this might lead to an additional three quitters per 100 (95% CI 1 to 7 more). There is probably little to no difference in the rate of AEs between these groups (moderate-certainty evidence) (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 5 studies, 840 participants). There is insufficient evidence to determine whether rates of SAEs differ between groups, due to very serious imprecision (RR 1.00, 95% CI 0.56 to 1.79; I2 = 0%; 9 studies, 1412 participants; low-certainty evidence). Compared to behavioural support only/no support, quit rates may be higher for participants randomized to nicotine EC (low-certainty evidence due to issues with risk of bias) (RR 1.96, 95% CI 1.66 to 2.32; I2 = 0%; 11 studies, 6819 participants). In absolute terms, this represents an additional four quitters per 100 (95% CI 3 to 5 more). There was some evidence that (non-serious) AEs may be more common in people randomized to nicotine EC (RR 1.18, 95% CI 1.10 to 1.27; I2 = 6%; low-certainty evidence; 6 studies, 2351 participants) and, again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 0.93, 95% CI 0.68 to 1.28; I2 = 0%; 12 studies, 4561 participants; very low-certainty evidence). Results from the NMA were consistent with those from pairwise meta-analyses for all critical outcomes. There was inconsistency in the AE network, which was explained by a single outlying study contributing the only direct evidence for one of the nodes. Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued EC use. Very few studies reported data on other outcomes or comparisons; hence, evidence for these is limited, with CIs often encompassing both clinically significant harm and benefit. AUTHORS' CONCLUSIONS: There is high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty evidence that they increase quit rates compared to ECs without nicotine. Evidence comparing nicotine EC with usual care or no treatment also suggests benefit, but is less certain due to risk of bias inherent in the study design. Confidence intervals were, for the most part, wide for data on AEs, SAEs, and other safety markers, with no evidence for a difference in AEs between nicotine and non-nicotine ECs nor between nicotine ECs and NRT, but low-certainty evidence for increased AEs compared with behavioural support/no support. Overall incidence of SAEs was low across all study arms. We did not detect evidence of serious harm from nicotine EC, but longer, larger studies are needed to fully evaluate EC safety. Our included studies tested regulated nicotine-containing EC; illicit products and/or products containing other active substances (e.g. tetrahydrocannabinol (THC)) may have different harm profiles. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information to decision-makers, this is a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
Interventions for quitting vaping
Rationale: There is limited guidance on the best ways to stop using nicotine-containing vapes (otherwise known as e-cigarettes) and ensure long-term abstinence, whilst minimising the risk of tobacco smoking and other unintended consequences. Treatments could include pharmacological interventions, behavioural interventions, or both. Objectives: To conduct a living systematic review assessing the benefits and harms of interventions to help people stop vaping compared to each other or to placebo or no intervention. To also assess how these interventions affect the use of combustible tobacco, and whether the effects vary based on participant characteristics. Search methods: We searched the following databases from 1 January 2004 to 24 April 2024: CENTRAL; MEDLINE; Embase; PsycINFO; ClinicalTrials.gov (through CENTRAL); World Health Organization International Clinical Trials Registry Platform (through CENTRAL). We also searched the references of eligible studies and abstracts from the Society for Research on Nicotine and Tobacco 2024 conference, and contacted study authors. Eligibility criteria: Randomised controlled trials (RCTs) recruiting people of any age using nicotine-containing vapes, regardless of tobacco smoking status. Studies had to test an intervention designed to support people to quit vaping, and plan to measure at least one of our outcomes. Outcomes: Critical outcomes: vaping cessation; change in combustible tobacco use at six months or longer; number of participants reporting serious adverse events (SAEs) at one week or longer. Risk of bias: We used the Cochrane RoB 1 tool to assess bias in the included studies. Synthesis methods: We followed standard Cochrane methods for screening and data extraction. We grouped studies by comparisons and outcomes reported, and calculated individual study and pooled effects, as appropriate. We used random-effects Mantel-Haenszel methods to calculate risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. We used random-effects inverse variance methods to calculate mean differences and 95% CI for continuous outcomes. We assessed the certainty of the evidence using the GRADE approach. Included studies: Nine RCTs, representing 5209 participants motivated to stop using nicotine-containing vapes at baseline, are included. In six studies, participants were abstinent from smoking tobacco cigarettes at baseline, although most studies included some participants who had previously smoked. Eight studies included participants aged 18 or older, three included only young adults (18 to 24 years), and one included 13- to 17-year-olds only. We judged three studies at low risk, three at high risk, and three at unclear risk of bias. Synthesis of results: Pharmacological interventions for quitting nicotine vaping. Studies assessed combination nicotine replacement therapy (NRT), cytisine, and varenicline as pharmacological interventions for quitting vaping in comparison to placebo or no/minimal support (control). The point estimate for combination NRT indicated possible benefit, but the CI incorporated the possibility of no benefit and a potential benefit of control (very low-certainty evidence due to imprecision and risk of bias; RR 2.57, 95% CI 0.29 to 22.93; 1 study, 16 participants). The one study investigating cytisine did not report vaping cessation rates at six months or longer. Varenicline increased vaping cessation rates at six months, but the evidence was low certainty due to imprecision (RR 2.00, 95% CI 1.09 to 3.68; 1 study, 140 participants). Zero participants reported SAEs in the studies of combination NRT versus no/minimal support (1 study, 508 participants; low-certainty evidence due to imprecision) and cytisine versus placebo (1 study, 159 participants; low-certainty evidence due to imprecision). Three studies investigating varenicline measured the number of participants reporting SAEs. However, only one study reported an SAE (in the intervention arm); therefore, the effect estimate was calculated based on that single study (RR 2.60, 95% CI 0.11 to 62.16; 95 participants; low-certainty evidence due to imprecision). Behavioural interventions for quitting nicotine vaping. Studies assessed reducing nicotine concentration and vaping behaviour (1 study) and text message-based interventions (3 studies) as behavioural interventions for stopping vaping in comparison to no/minimal support (control). In one study, the point estimate suggested nicotine/vaping reduction increased vaping cessation compared to minimal support at six-month follow-up, but the CI incorporated the possibility of no intervention effect and higher cessation rates in the control arm (RR 3.38, 95% CI 0.43 to 26.30; 17 participants; very low-certainty due to imprecision and risk of bias). There was low-certainty evidence (downgraded two levels due to indirectness) that text message-based interventions may have increased vaping cessation rates compared to control in 13- to 24-year-olds (RR 1.32, 95% CI 1.19 to 1.47; I2 = 0%; 2 studies, 4091 participants). The one study investigating nicotine/vaping behaviour reduction did not report on SAEs. One of the studies investigating text message-based interventions did report on SAEs; however, zero events were reported in both study arms (508 participants; low-certainty evidence due to imprecision). No studies reported change in combustible tobacco smoking at six-month follow-up or longer. Authors' conclusions: There is low-certainty evidence that text message-based interventions designed to help people stop nicotine vaping may help more youth and young adults to successfully stop than no/minimal support, and low-certainty evidence that varenicline may also help people quit vaping. Data exploring the effectiveness of combination NRT, cytisine, and nicotine/vaping behaviour reduction are inconclusive due to risk of bias and imprecision. Most studies that measured SAEs reported none; however, more data are needed to draw clear conclusions. Of note, data from studies investigating these interventions for quitting smoking have not demonstrated serious concerns about SAEs. No studies assessed the change in combustible tobacco smoking, including relapse to or uptake of tobacco smoking, at six-month follow-up or longer. It is important that future studies measure this so the complete risk profile of relevant interventions can be considered. We identified 20 ongoing RCTs. Their incorporation into the evidence base and the continued identification of new studies is imperative to inform clinical and policy guidance on the best ways to stop vaping. Therefore, we will continue to update this review as a living systematic review by running searches monthly and updating the review when relevant new evidence that will strengthen or change our conclusions emerges. Registration: Protocol available via DOI: 10.1002/14651858.CD016058.
Hearing the Silence and Silenced: Co-Producing Research on Infant-Feeding Experiences and Practices With Black Women With HIV
In the UK, up to 700 people with HIV give birth annually; the majority are Black African migrant cisgender women. Infant-feeding decisions for parents with HIV are complex, requiring parents to weigh-up the small risk of HIV transmission via breastmilk and UK guidelines recommending formula milk, against strong personal and societal expectations to breastfeed. We explored this situation in a qualitative study. In this paper, we discuss our experiences of co-producing our research on infant-feeding experiences and practices among women with HIV. In particular, we focus on how our methodology, working practices and team structure enabled us to hear and describe the ‘silences’ and ‘screaming silences’ faced by our socially marginalised study participants. For the participants, intense multidimensional anxieties regarding infant-feeding had to be managed within a wider context and with people who were largely unaware of the potentially devastating impact that decision had on their reality. Our interdisciplinary study team and advisory panel comprised women with HIV, clinicians, policymakers and academics; the majority were racially minoritised women. Through regular team meetings, respect for the varied perspectives of all contributors and diverse dissemination routes, we sustained relational ethics with a broad range of stakeholders and impacted national policy.
Electronic cigarettes for smoking cessation: a Cochrane review
BACKGROUND Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol by heating an e-liquid. People who smoke, healthcare providers and regulators want to know if ECs can help people quit smoking, and if they are safe to use for this purpose. This is a review update conducted as part of a living systematic review. OBJECTIVES To examine the safety, tolerability and effectiveness of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long-term smoking abstinence, in comparison to non-nicotine EC, other smoking cessation treatments and no treatment. SEARCH METHODS We searched the Cochrane Tobacco Addiction Group’s Specialized Register to 1 February 2023, and Cochrane Central Register of Controlled Trials (Central), Medline, Embase, and PsycINFO to 1 July 2023, and reference-checked and contacted study authors. SELECTION CRITERIA We included trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention as these studies have the potential to provide further information on harms and longer-term use. Studies had to report an eligible outcome. DATA COLLECTION AND ANALYSIS We followed standard Cochrane methods for screening and data extraction. Critical outcomes were abstinence from smoking after at least six months, adverse events (AEs), and serious adverse events (SAEs). We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in pairwise and network meta-analyses (NMA). MAIN RESULTS We included 88 completed studies (10 new to this update), representing 27,235 participants, of which 47 were randomized controlled trials (RCTs). Of the included studies, we rated ten (all but one contributing to our main comparisons) at low risk of bias overall, 58 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There is high certainty that nicotine EC increases quit rates compared to nicotine replacement therapy (NRT). In absolute terms, this might translate to an additional four quitters per 100. There is moderate-certainty evidence that the rate of occurrence of AEs is similar between groups. SAEs were rare, and there is insufficient evidence to determine whether rates differ between groups due to very serious imprecision. There is moderate-certainty evidence, limited by imprecision, that nicotine EC increases quit rates compared to non-nicotine EC. In absolute terms, this might lead to an additional three quitters per 100. There is moderate-certainty evidence of no difference in the rate of AEs between these groups. There is insufficient evidence to determine whether rates of SAEs differ between groups, due to very serious imprecision. Due to issues with risk of bias, there is low-certainty evidence that, compared to behavioral support only/no support, quit rates may be higher for participants randomized to nicotine EC. In absolute terms, this represents an additional four quitters per 100. There was some evidence that (non-serious) AEs may be more common in people randomized to nicotine EC and, again, insufficient evidence to determine whether rates of SAEs differed between groups. Results from the NMA were consistent with those from pairwise meta-analyses for all critical outcomes, and there was no indication of inconsistency within the networks. Data from non-randomized studies were consistent with RCT data. The unwanted effects (at medium and short term) reported most often with nicotine EC were throat or mouth irritation, headache, cough and feeling sick. These appeared similar to those people experience when using NRT. These effects were reduced over time as people continued using nicotine EC. AUTHORS’ CONCLUSIONS There is high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty evidence that they increase quit rates compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain due to risk of bias inherent in the study design. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non-nicotine ECs nor between nicotine ECs and NRT. Overall incidence of SAEs was low across all study arms. We did not detect evidence of serious harm from nicotine EC, but the longest follow-up was two years and the number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-todate information to decision-makers, this review is a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available.
Mapping the Social Organisation of Neglect in the Case of Fibromyalgia: Using Smith's Sociology for People to Inform a Systems-Focused Literature Review.
Fibromyalgia is a syndrome characterised by persistent unexplained pain and fatigue. People with fibromyalgia report receiving little support to manage symptoms, difficult interactions with healthcare practitioners and stigma associated with this contested condition. In this article, we employ Dorothy E Smith's Sociology for People to undertake a systems-focused literature review from the standpoint of people with fibromyalgia, moving beyond individual subjectivities to map how problems are socially organised. This is a novel application of a Sociology for People which, although previously used to structure research projects, has not previously been reported as a framework for literature review. Our findings highlight how, within a biomedically orientated healthcare system, practitioners' activities are organised to withdraw support from people with fibromyalgia and characterise problems as "psychological". Those looking to make service improvements for this patient group need to specifically challenge biomedical systems and ideology, in order to promote alternative models of care. We highlight a Sociology for People as a powerful lens for systems-focused literature review that links frontline experiences with dominant power relations, and provides an alternative to traditional qualitative evidence syntheses. Additionally, the theoretically-grounded and creative use of published literatures is an ethical approach adding value to extant research.
Coronavirus conspiracy beliefs, mistrust, and compliance with government guidelines in England
Background An invisible threat has visibly altered the world. Governments and key institutions have had to implement decisive responses to the danger posed by the coronavirus pandemic. Imposed change will increase the likelihood that alternative explanations take hold. In a proportion of the general population there may be strong scepticism, fear of being misled, and false conspiracy theories. Our objectives were to estimate the prevalence of conspiracy thinking about the pandemic and test associations with reduced adherence to government guidelines. Methods A non-probability online survey with 2501 adults in England, quota sampled to match the population for age, gender, income, and region. Results Approximately 50% of this population showed little evidence of conspiracy thinking, 25% showed a degree of endorsement, 15% showed a consistent pattern of endorsement, and 10% had very high levels of endorsement. Higher levels of coronavirus conspiracy thinking were associated with less adherence to all government guidelines and less willingness to take diagnostic or antibody tests or to be vaccinated. Such ideas were also associated with paranoia, general vaccination conspiracy beliefs, climate change conspiracy belief, a conspiracy mentality, and distrust in institutions and professions. Holding coronavirus conspiracy beliefs was also associated with being more likely to share opinions. Conclusions In England there is appreciable endorsement of conspiracy beliefs about coronavirus. Such ideas do not appear confined to the fringes. The conspiracy beliefs connect to other forms of mistrust and are associated with less compliance with government guidelines and greater unwillingness to take up future tests and treatment.
Developing a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice and subsequently change antibiotic use
OBJECTIVES: To develop a behavioural intervention package to support clinicians and patients to amend incorrect penicillin allergy records in general practice. The intervention aimed to: (1) support clinicians to refer patients for penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin, when indicated, following a negative PAT result. METHODS: Theory-based, evidence-based and person-based approaches were used in the intervention development. We used evidence from a rapid review, two qualitative studies, and expert consultations with the clinical research team to identify the intervention 'guiding principles' and develop an intervention plan. Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change. In the final stage, think-aloud interviews were conducted to optimise intervention materials. RESULTS: The collated evidence showed that the key barriers to referral of patients by clinicians were limited experience of referral and limited knowledge of referral criteria and PAT. Barriers for patients attending PAT were lack of knowledge of the benefits of testing and lack of motivation to get tested. The key barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Intervention materials were designed and developed to address these barriers. CONCLUSIONS: We present a novel behavioural intervention package designed to address the multiple barriers to uptake of PAT in general practice by clinicians and patients. The intervention development details how behaviour change techniques have been incorporated to hypothesise how the intervention is likely to work to help amend incorrect penicillin allergy records. The intervention will go on to be tested in a feasibility trial and randomised controlled trial in England.
Mixed-methods evaluation of a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice
OBJECTIVES: About 6% of the UK general practice population has a record of a penicillin allergy but fewer than 10% of these are likely to be truly allergic. In the ALABAMA (Allergy Antibiotics and Microbial resistance) feasibility trial, primary care patients with penicillin allergy were randomised to penicillin allergy assessment pathway or usual care to assess the effect on health outcomes. A behavioural intervention package was developed to aid delabelling. This study aimed to investigate patients' and clinicians' views of penicillin allergy testing (PAT). DESIGN: We conducted a mixed-methods process evaluation embedded within the ALABAMA trial, which included a clinician survey, a patient survey (at baseline and follow-up) and semistructured interviews with patients and clinicians. SETTINGS: The study was conducted in primary care, as part of the feasibility stage of the ALABAMA trial. PARTICIPANTS: Patients and primary care clinicians. RESULTS: Clinicians (N=53; 52.2%) were positive about PAT and its potential value but did not have previous experience of referring patients for a PAT and were unsure whether patients would take penicillin after a negative allergy test. Patients (N=36; 46%) were unsure whether they were severely allergic to penicillin and did not fear a severe allergic reaction to penicillin. Clinician interviews showed that they were already aware of the benefit of PAT. Interviews with patients suggested the importance of safety as patients valued having numerous opportunities to address their concerns about safety of the test. CONCLUSIONS: This study highlights the positive effects of the ALABAMA behavioural intervention for both patients and clinicians. TRIAL REGISTRATION NUMBER: NCT04108637; ISRCTN20579216; Pre-results.
Environmental sustainability and the limits of healthcare resource allocation.
Recent literature has drawn attention to the complex relationship between health care and the environmental crisis. Healthcare systems are significant contributors to climate change and environmental degradation, and the environmental crisis is making our health worse and thus putting more pressure on healthcare systems; our health and the environment are intricately linked. In light of this relationship, we might think that there are no trade-offs between health and the environment; that healthcare decision-makers have special responsibilities to the environment; and that environmental values should be included in healthcare resource-allocation decisions. However, we argue that these claims are mistaken. The environmental crisis involves a wider range of considerations than just health. There is a plurality of reasons to act on the environment; we might do so to protect the natural world, to prevent catastrophes in other parts of the world, or to avert climate war and displacement. Trading-off between health care and environmental sustainability is thus unavoidable and requires sensitivity to all these reasons. Healthcare decision-makers are not well placed to be sensitive to these reasons, nor do they have the democratic authority to make such value judgements. Therefore, decisions about environmental sustainability interventions should be made at a 'higher level' of resource allocation. Importantly, hospitals have environmental duties but not environmental responsibilities; their job is to provide the best healthcare possible within the constraints given to them, not to choose between health care and other goods.
Adiposity and risks of gastrointestinal cancers: A 10-year prospective study of 0.5 million Chinese adults
Associations of adiposity with risks of oesophageal squamous cell carcinoma (ESCC) and non-cardia stomach cancer, both prevalent in China, are still inconclusive. While adiposity is an established risk factor for colorectal cancer, the relevance of fat-free mass and early-adulthood adiposity remains to be explored. The prospective China Kadoorie Biobank study included 0.5 million adults (aged 30–79 years) from 10 areas in China. Participants' body size and composition were measured at baseline and at resurveys (amongst a subset). After >10 years of follow-up, 2350, 3345 and 3059 incident cases of oesophageal (EC), stomach (SC) and colorectal (CRC) cancers were recorded, respectively. Cox regression was used to estimate hazard ratios (HRs) for these cancers in relation to different adiposity traits. General and central adiposity were inversely associated with EC (primarily ESCC) risk, with HRs of 0.81 (95% CI 0.77–0.85), 0.76 (0.72–0.81) and 0.87 (0.83–0.92) per SD increase in usual levels of BMI, body fat percentage (BF%) and waist circumference (WC), respectively. Adiposity was also inversely associated with SC risk [HR = 0.79 (0.75–0.83) and 0.88 (0.84–0.92) per SD increase in usual BF% and WC], with heterogeneity by cardia and non-cardia subsites, and positively associated with CRC [HR = 1.09 (1.03–1.15) and 1.17 (1.12–1.22) per SD higher usual BF% and WC]. Fat-free mass was inversely associated with EC [HR = 0.93 (0.89–0.98) per SD increase] but positively associated with CRC [1.09 (1.04–1.14)], while BMI at age 25 was positively associated with all three cancers. After mutual adjustment, general adiposity remained inversely associated with EC and SC, while central adiposity remained positively associated with CRC.
Comparison of models to predict incident chronic liver disease: a systematic review and external validation in Chinese adults
Background: Risk prediction models can identify individuals at high risk of chronic liver disease (CLD), but there is limited evidence on the performance of various models in diverse populations. We aimed to systematically review CLD prediction models, meta-analyze their performance, and externally validate them in 0.5 million Chinese adults in the China Kadoorie Biobank (CKB). Methods: Models were identified through a systematic review and categorized by the target population and outcomes (hepatocellular carcinoma [HCC] and CLD). The performance of models to predict 10-year risk of CLD was assessed by discrimination (C-index) and calibration (observed vs predicted probabilies). Results: The systematic review identified 57 articles and 114 models (28.4% undergone external validation), including 13 eligible for validation in CKB. Models with high discrimination (C-index ≥ 0.70) in CKB were as follows: (1) general population: Li-2018 and Wen 1–2012 for HCC, CLivD score (non-lab and lab) and dAAR for CLD; (2) hepatitis B virus (HBV) infected individuals: Cao-2021 for HCC and CAP-B for CLD. In CKB, all models tended to overestimate the risk (O:E ratio 0.55–0.94). In meta-analysis, we further identified models with high discrimination: (1) general population (C-index ≥ 0.70): Sinn-2020, Wen 2–2012, and Wen 3–2012 for HCC, and FIB-4 and Forns for CLD; (2) HBV infected individuals (C-index ≥ 0.80): RWS-HCC and REACH-B IIa for HCC and GAG-HCC for HCC and CLD. Conclusions: Several models showed good discrimination and calibration in external validation, indicating their potential feasibility for risk stratification in population-based screening programs for CLD in Chinese adults.