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Senior Researcher and Departmental Lecturer, Dr Stephanie Tierney, explains how a best-fit framework synthesis was undertaken tor review papers on volunteering, as a way to support people's health and well-being.
plaTform fOr Urinary tract infection diagnostiC evAluatioN (TOUCAN): a protocol for a prospective diagnostic accuracy study of point-of-care testing in patients suspected of acute uncomplicated urinary tract infection in primary care clinics in England.
INTRODUCTION: Acute uncomplicated urinary tract infection (UTI) is a common condition with potentially serious sequelae that is mostly diagnosed and managed in primary care settings. Around half of all women have a UTI in their lifetime, and a quarter experience an infection caused by organisms resistant to more than one antibiotic. Reducing inappropriate prescribing of antibiotics is a core tenet of antimicrobial stewardship. However, current diagnostics for UTI are unfit for purpose in acute (highest prescribing) settings, being too slow to inform the required immediate decision-making and often confounded by sample contamination.Rapid point-of-care diagnostic tests (POCTs) that facilitate timely decision-making are potential solutions to this problem. Several such tests have reached advanced stages of technology readiness, but their diagnostic performance has not been evaluated in primary care with clinical users. To progress novel tests towards implementation, a diagnostic field study is required, to allow for parallel and sequential evaluation of multiple tests in a primary care population. METHODS AND ANALYSIS: We will recruit participants assigned female at birth from primary care clinics in England who contact their clinic with symptoms of acute uncomplicated UTI. Eligible participants will complete a short questionnaire to capture symptoms and symptom severity and will provide a urine sample. Samples will be split and initially tested using novel index tests (POCTs) and conventional urinalysis 'dipstick' at the primary care clinic. The second part of the sample will be processed at a National Health Service-based reference laboratory using a modified reference standard including microscopy, microbiological culture, pathogen speciation and antimicrobial susceptibility testing. The UTI reference standard culture, although based on the national methods, is modified to provide accurate bacterial counts, better to define a microbiological diagnosis of UTI. Susceptibility testing will be performed using 'gold-standard' methods, not usually performed in diagnostic laboratories. The primary outcome will be the diagnostic performance (sensitivity, specificity, positive and negative predictive values) of POCTs for detection of UTI and antimicrobial susceptibility for POCTs that include antimicrobial susceptibility testing. Secondary outcomes will include the symptom profile of patients presenting with uncomplicated UTI, a theoretical determination of how use of POCT results might change prescribing, an understanding of POCT failure rate and qualitative capture of the experiences of those using the POCT to deliver the study in primary care clinics. ETHICS AND DISSEMINATION: Ethical approval was received from the London Central Research Ethics Committee (23/LO/0371) and the UK Health Research Authority. We will publish the findings of The plaTform fOr Urinary tract infection diagnostiC evAluatioN evaluations in peer-reviewed medical journals and more broadly following a dissemination plan formulated by a communications specialist in consultation with patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN80937472.
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.
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.
Using Laboratory Test Results for Surveillance During a New Outbreak of Acute Hepatitis in 3-Week- to 5-Year-Old Children in the United Kingdom, the Netherlands, Ireland, and Curaçao: Observational Cohort Study.
BACKGROUND: In March 2022, a concerning rise in cases of unexplained pediatric hepatitis was reported in multiple countries. Cases were defined as acute hepatitis with serum transaminases >500 U/L (aspartate transaminase [AST] or alanine transaminase [ALT]) in children aged 16 years or younger. We explored a simple federated data analytics method to search for evidence of unreported cases using routinely held data. We conducted a pragmatic survey to analyze changes in the proportion of hospitalized children with elevated AST or ALT over time. In addition, we studied the feasibility of using routinely collected clinical laboratory results to detect or follow-up the outbreak of an infectious disease. OBJECTIVE: We explored a simple federated data analytics method to search for evidence of unreported cases using routinely held data. METHODS: We provided hospitals with a simple computational tool to enable laboratories to share nondisclosive summary-level data. Summary statistics for AST and ALT measurements were collected from the last 10 years across all age groups. Measurements were considered elevated if ALT or AST was >200 U/L. The rate of elevated AST or ALT test for 3-week- to 5-year-olds was compared between a period of interest in which cases of hepatitis were reported (December 1, 2021, to August 31, 2022) and a prepandemic baseline period (January 1, 2012, to December 31, 2019). We calculated a z score, which measures the extent to which the rate for elevated ALT or AST was higher or lower in the period of interest compared to a baseline period, for the 3-week- to 5-year-olds. RESULTS: Our approach of sharing a simple software tool for local use enabled rapid, federated data analysis. A total of 34 hospitals in the United Kingdom, the Netherlands, Ireland, and Curaçao were asked to contribute summary data, and 30 (88%) submitted their data. For all locations combined, the rate of elevated AST or ALT measurements in the period of interest was not elevated (z score=-0.46; P=.64). Results from individual regions were discordant, with a higher rate of elevated AST or ALT values in the Netherlands (z score=4.48; P
Investigating deaths of people with autistic spectrum disorder in health and social care in England and Wales
Purpose: This paper aims to examine the trends identified in inquests conducted in the Coronial system in England and Wales for individuals formally diagnosed with autism spectrum disorder (ASD), where the death occurred within a health or social care setting. Design/methodology/approach: It uses data from 42 reports to prevent future deaths (PFDs) issued by Coroners to establish where and in what contexts each death occurred. PFDs are sent to organisations that Coroners believe could act to PFDs. Findings: The research identified four key findings. Firstly, 33% of the deaths identified were not recorded as suicides, marking a clear departure from the extant literature on this issue. Secondly, data highlighted a lack of training and education of staff to understand the complexity of autism. Thirdly, this lack of understanding was often compounded by a lack of specialist provision for people with ASD. Fourthly, Coroners attributed a number of deaths to an individual’s autism, which served to some extent to mask the failures of the agencies involved in the care of the decedent. Originality/value: There is limited research available about the preventable deaths of individuals with ASD in health and social care settings. This paper makes an initial step in highlighting significant structural failures that can lead to preventable deaths.
Incentives for smoking cessation
Background: Financial incentives (money, vouchers, or self-deposits) can be used to positively reinforce smoking cessation. They may be used as one-off rewards, or in various schedules to reward steps towards sustained smoking abstinence (known as contingency management). They have been used in workplaces, clinics, hospitals, and community settings, and to target particular populations. This is a review update. The previous version was published in 2019. Objectives: Primary. To assess the long-term effects of incentives and contingency management programmes for smoking cessation in mixed and pregnant populations. Secondary. To assess the long-term effects of incentives and contingency management programmes for smoking cessation in mixed populations, considering whether incentives were offered at the final follow-up point. To assess the difference in outcomes for pregnant populations, considering whether rewards were contingent on abstinence or guaranteed. Search methods: For this update, we searched CENTRAL, MEDLINE, Embase, PsycINFO, and two trials registers on 2 November 2023, and the Cochrane Tobacco Addiction Group Specialised Register on March 2023, together with reference checking, citation searching, and contact with study authors to identify additional studies. Selection criteria: We considered only randomised controlled trials (RCTs), allocating individuals, workplaces, groups within workplaces, or communities to smoking cessation incentive schemes or control conditions. We included studies in a mixed-population setting (e.g. community-, work-, clinic- or institution-based), studies with specific populations (e.g. those with diagnosed mental health conditions), and studies in pregnant people who smoke. Data collection and analysis: We used standard Cochrane methods. The primary outcome measure in the mixed-population studies was abstinence from smoking at longest follow-up (at least six months from the start of the intervention). In the trials of pregnant people, we used abstinence from smoking measured at the longest follow-up, and at least to the end of the pregnancy. Where available, we pooled outcome data using a Mantel-Haenszel random-effects model, with results reported as risk ratios (RRs) and 95% confidence intervals (CIs), using adjusted estimates for cluster-randomised trials. We analysed studies carried out in mixed populations separately from those carried out in pregnant populations. Main results: Forty-eight mixed-population studies met our inclusion criteria, recruiting more than 21,924 participants; 15 of these are new to this version of the review. Studies were set in varying locations, including community settings, clinics or health centres, workplaces, and outpatient drug clinics. We judged eight studies to be at low risk of bias, and 16 to be at high risk of bias, with the remaining 24 studies at unclear risk. Thirty-three of the trials were run in the USA, two in Thailand, one in the Philippines, one in Hong Kong, and one in South Africa. The rest were European. Incentives offered included cash payments, self-deposits, or vouchers for goods and groceries, offered directly or collected and redeemable online. The pooled RR for quitting with incentives at longest follow-up (six months or more) compared with controls was 1.52 (95% CI 1.33 to 1.74; I2 = 23%; 39 studies, 18,303 participants; high-certainty evidence). Results were not sensitive to the exclusion of seven studies that offered an incentive for cessation at long-term follow-up (result excluding those studies: RR 1.46, 95% CI 1.23 to 1.73; I2 = 26%; 32 studies, 15,082 participants), suggesting the impact of incentives continues for at least some time after incentives cease (at least six months). For this update, we included an adjusted analysis incorporating three cluster-RCTs. The pooled odds ratio was 1.57 (95% CI 1.37 to 1.79; I2 = 30%; 43 studies, 23,960 participants; high-certainty evidence). Although not always clearly reported, the total financial amount of incentives varied considerably between trials, from zero (self-deposits), to a range of between 45 US dollars (USD) and USD 1185. There was no clear difference in effect between trials offering low or high total value of incentives, nor those encouraging redeemable self-deposits. We ran an updated exploratory meta-regression and found no significant association between the outcome and the total value of the financial incentive (P = 0.963). Any such indirect comparison is particularly crude in this context, due to differences in the cultural significance of financial amounts (e.g. USD 50 might have different significance in different contexts). We included 14 studies of 4314 pregnant people (11 conducted in the USA, one in France, and two in the UK). We judged four studies to be at low risk of bias, two at high risk of bias, and eight at unclear risk. When pooled, the 13 trials with usable data delivered a risk ratio at longest follow-up (up to 48 weeks postpartum) of 2.13 (95% CI 1.58 to 2.86; I2 = 31%; 13 studies, 3942 participants; high-certainty evidence), in favour of incentives. Authors' conclusions: Overall, our conclusion from this latest review update remains that there is high-certainty evidence that incentives improve smoking cessation rates at long-term follow-up in mixed population studies. The evidence demonstrates that the effectiveness of incentives is sustained even when the last follow-up occurs after the withdrawal of incentives. There is also now high-certainty evidence that incentive schemes conducted amongst pregnant people who smoke improve smoking cessation rates, both at the end of pregnancy and postpartum. This represents a change from the previous update in which we rated this evidence as moderate certainty. Current and future research might more precisely explore differences between trials offering low or high cash incentives and self-incentives (deposits), within a variety of smoking populations, focusing on low- and middle-income countries where the burden of tobacco use remains high.
Weight change, cardio-metabolic risk factors and cardiovascular incidence in people with serious mental illness: Protocol of a population-based cohort study in the UK from 1998 to 2020
Introduction People with serious mental illness (SMI), which includes people with diagnoses of schizophrenia spectrum and bipolar disorders, face significant health inequality. This includes a life expectancy reduced by 15-20 years mostly due to premature cardiovascular disease (CVD) compared with the general population. Excess weight gain and related comorbidities are preventable risk factors for CVD. To improve the understanding and management of CVD in people with SMI, we will examine the association between SMI and: (1) weight change; (2) cardio-metabolic risk factors for CVD; and (3) incidence of and mortality from CVD. We will also (4) examine the incidence of referral to weight management services for people with SMI compared with people without SMI. Methods and analysis In this retrospective cohort study, we will link general practice records from the UK Clinical Practice Research Datalink Aurum database. We will establish a cohort of patients diagnosed with SMI between 1998 and 2020 who are matched with up to four controls on age, sex, general practice and calendar year. We will use multivariable mixed-effects linear regression models and Cox proportional hazard models with sequential adjustment for potential confounders identified by separate directed acyclic graphs. Ethics and dissemination This study has been reviewed and approved by the Independent Scientific Advisory Committee for Medicines and Healthcare products Regulatory Agency database research. The results will be published in a peer-reviewed journal.
Prevalence and patterns of testing for anaemia in primary care in England.
Background Despite epidemiological data on anaemia being available on a global scale, its prevalence in the United Kingdom is not well described. Aim To investigate anaemia prevalence and testing patterns for haemoglobin and other blood parameters. Design and Setting A population-based cohort study using data drawn from the Clinical Practice Research Datalink Aurum database in 2019. Method We extracted demographic data for each person who was registered at their current practice during 2019, including linked data on Index of Multiple Deprivation. We calculated anaemia prevalence in 2019 based on World Health Organization specified age and gender thresholds for haemoglobin. We classified anaemia based on mean corpuscular volume and ferritin. We followed up people with anaemia for up to one year to investigate longitudinal testing patterns for haemoglobin. Results The cohort contained 14 million people. Anaemia prevalence in 2019 was 4.1% (5.1 % females and 3.1% males). Prevalence was higher in people aged >65 years, Black and Asian ethnicities, and people living in areas with higher social deprivation. Only half of people with anaemia and a mean corpuscular volume of ≤100 fL had an accompanying ferritin value recorded. About half of people with anaemia had a follow-up haemoglobin test within one-year, most of which still indicated anaemia. Conclusion Anaemia is prevalent in the UK with large disparities between levels of demographic variables. Investigation and follow-up of anaemia is suboptimal in many patients. Health interventions aimed at improving anaemia investigation and treatment are needed, particularly in these at-risk groups.
Consultations for clinical features of possible cancer and associated urgent referrals before and during the COVID-19 pandemic: an observational cohort study from English primary care
Background: It remains unclear to what extent reductions in urgent referrals for suspected cancer during the COVID-19 pandemic were the result of fewer patients attending primary care compared to GPs referring fewer patients. Methods: Cohort study including electronic health records data from 8,192,069 patients from 663 English practices. Weekly consultation rates, cumulative consultations and referrals were calculated for 28 clinical features from the NICE suspected cancer guidelines. Clinical feature consultation rate ratios (CRR) and urgent referral rate ratios (RRR) compared time periods in 2020 with 2019. Findings: Consultations for cancer clinical features decreased by 24.19% (95% CI: 24.04–24.34%) between 2019 and 2020, particularly in the 6–12 weeks following the first national lockdown. Urgent referrals for clinical features decreased by 10.47% (95% CI: 9.82–11.12%) between 2019 and 2020. Overall, once patients consulted with primary care, GPs urgently referred a similar or greater proportion of patients compared to previous years. Conclusion: Due to the significant fall in patients consulting with clinical features of cancer there was a lower than expected number of urgent referrals in 2020. Sustained efforts should be made throughout the pandemic to encourage the public to consult their GP with cancer clinical features.
Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status.
BACKGROUND: People from lower socioeconomic groups are more likely to smoke and less likely to succeed in achieving abstinence, making tobacco smoking a leading driver of health inequalities. Contextual factors affecting subpopulations may moderate the efficacy of individual-level smoking cessation interventions. It is not known whether any intervention performs differently across socioeconomically-diverse populations and contexts. OBJECTIVES: To assess whether the effects of individual-level smoking cessation interventions on combustible tobacco cigarette use differ by socioeconomic groups, and their potential impact on health equalities. SEARCH METHODS: We searched the Cochrane Database of Systematic Reviews from inception to 1 May 2023 for Cochrane reviews investigating individual-level smoking cessation interventions. We selected studies included in these reviews that met our criteria. We contacted study authors to identify further eligible studies. SELECTION CRITERIA: We included parallel, cluster or factorial randomised controlled trials (RCTs) investigating any individual-level smoking cessation intervention which encouraged complete cessation of combustible tobacco cigarette use compared to no intervention, placebo, or another intervention in adults. Studies must have assessed or reported smoking quit rates, split by any measure of socioeconomic status (SES) at longest follow-up (≥ six months), and been published in 2000 or later. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening, data extraction, and risk of bias assessment. We assessed the availability of smoking abstinence data by SES in lieu of selective reporting. The primary outcome was smoking cessation quit rates, split by lower and higher SES, at the longest follow-up (≥ six months). Where possible, we calculated ratios of odds ratios (ROR) with 95% confidence intervals (CIs) for each study, comparing lower to higher SES. We pooled RORs by intervention type in random-effects meta-analyses, using the generic inverse-variance method. We subgrouped by type of SES indicator and economic classification of the study country. We summarised all evidence in effect direction plots and categorised the intervention impact on health equality as: positive (evidence that the relative effect of the intervention on quit rates was greater in lower rather than higher SES groups), possibly positive, neutral, possibly neutral, possibly negative, negative, no reported statistically significant difference, or unclear. We evaluated certainty using GRADE. MAIN RESULTS: We included 77 studies (73 from high-income countries), representing 127,791 participants. We deemed 12 studies at low overall risk of bias, 13 at unclear risk, and the remaining 52 at high risk. Included studies investigated a range of pharmacological interventions, behavioural support, or combinations of these. Pharmacological interventions We found very low-certainty evidence for all the main pharmacological interventions compared to control. Evidence on cytisine (ROR 1.13, 95% CI 0.73 to 1.74; 1 study, 2472 participants) and nicotine electronic cigarettes (ROR 4.57, 95% CI 0.88 to 23.72; 1 study, 989 participants) compared to control indicated a greater relative effect of these interventions on quit rates in lower compared to higher SES groups, suggesting a possibly positive impact on health equality. CIs for both estimates included the possibility of no clinically important difference and of favouring higher SES groups. There was a lower relative effect of bupropion versus placebo on quit rates in lower compared to higher SES groups, indicating a possibly negative impact on health equality (ROR 0.05, 95% CI 0.00 to 1.00; from 1 of 2 studies, 354 participants; 1 study reported no difference); however, the CI included the possibility of no clinically important difference. We could not determine the intervention impact of combination or single-form nicotine replacement therapy on relative quit rates by SES. No studies on varenicline versus control were included. Behavioural interventions We found low-certainty evidence of lower quit rates in lower compared to higher SES groups for print-based self-help (ROR 0.85, 95% CI 0.52 to 1.38; 3 studies, 4440 participants) and text-messaging (ROR 0.76, 95% CI 0.47 to 1.23; from 3 of 4 studies, 5339 participants; 1 study reported no difference) versus control, indicating a possibly negative impact on health equality. CIs for both estimates included the possibility of no clinically important difference and of favouring lower SES groups. There was very low-certainty evidence of quit rates favouring higher SES groups for financial incentives compared to balanced intervention components. However, the CI included the possibility of no clinically important difference and of favouring lower SES groups (ROR 0.91, 95% CI 0.45 to 1.85; from 5 of 6 studies, 3018 participants; 1 study reported no difference). This indicates a possibly negative impact on health equality. There was very low-certainty evidence of no difference in quit rates by SES for face-to-face counselling compared to less intensive counselling, balanced components, or usual care. However, the CI included the possibility of favouring lower and higher SES groups (ROR 1.26, 95% CI 0.18 to 8.93; from 1 of 6 studies, 294 participants; 5 studies reported no difference), indicating a possibly neutral impact. We found very low-certainty evidence of a greater relative effect of telephone counselling (ROR 4.31, 95% CI 1.28 to 14.51; from 1 of 7 studies, 903 participants; 5 studies reported no difference, 1 unclear) and internet interventions (ROR 1.49, 95% CI 0.99 to 2.25; from 1 of 5 studies, 4613 participants; 4 studies reported no difference) versus control on quit rates in lower versus higher SES groups, suggesting a possibly positive impact on health equality. The CI for the internet intervention estimate included the possibility of no difference. Although the CI for the telephone counselling estimate only favoured lower SES groups, most studies narratively reported no clear evidence of interaction effects. AUTHORS' CONCLUSIONS: Currently, there is no clear evidence to support the use of differential individual-level smoking cessation interventions for people from lower or higher SES groups, or that any one intervention would have an effect on health inequalities. This conclusion may change as further data become available. Many studies did not report sufficient data to be included in a meta-analysis, despite having tested the association of interest. Further RCTs should collect, analyse, and report quit rates by measures of SES, to inform intervention development and ensure recommended interventions do not exacerbate but help reduce health inequalities caused by smoking.
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.
Longitudinal patterns in smoking abstinence in trials of e-cigarettes for smoking cessation: secondary analysis of data from a systematic review, with meta-analyses.
INTRODUCTION: We set out to better understand patterns of smoking abstinence and relapse in trials of e-cigarettes for smoking cessation. METHODS: Secondary analysis of studies from a Cochrane review. Studies had to test any type of e-cigarette intervention for smoking cessation. They had to follow-up for at least 6 months and report either: abstinence at multiple time points; abstinence using multiple definitions; relapse. We narratively synthesized data and conducted meta-analyses. RESULTS: We included 15 studies (n=7,233 participants). Using the Cochrane risk of bias tool v1, 5 were judged to be at high risk of bias, 8 were at low risk, and 2 at unclear risk. Absolute continuous abstinence rates tended to decline over time, but varying slopes. For absolute point prevalence abstinence, three studies demonstrated a shallow decline over time, two a steep decline, and three the opposite - an increase in abstinence over time. Data on relative abstinence rates (e-cigarettes versus control) were mixed. There were multiple instances of differences between point prevalence and continuous/sustained abstinence rates, both in trajectories over time and in terms of relative abstinence. The few studies addressing relapse highlighted mixed demographic and behavioural characteristics associated with relapse rates. CONCLUSIONS: Smoking trajectories vary between trials of e-cigarettes for smoking cessation. Risk ratios may not be stable over time and may increase or decrease in favor of e-cigarettes depending on the study. Further data are needed, especially on relapse rates in early quitters who use e-cigarettes versus those who use other or no stop-smoking aids. IMPLICATIONS: While some have posited e-cigarettes might increase smoking relapse when used as a cessation tool, others have posited that combustible cigarette quit rates may increase over time in the same studies due to 'accidental quitting'. We set out to investigate this empirically and found considerable variation in smoking trajectories in e-cigarette trials. Data suggest risk ratios may not be stable over time and may increase or decrease in favor of e-cigarettes depending on the study. Further data are needed, especially on relapse rates in early quitters who use e-cigarettes versus those who use other or no stop-smoking aids.
E-cigarette (EC) and heated tobacco product (HTP) use in the United Arab Emirates, an emerging EC and HTP market: A cross-sectional analysis of the International Tobacco Control (ITC) UAE Survey.
INTRODUCTION: E-cigarettes (ECs) and heated tobacco products (HTPs) are recent arrivals to the nicotine product market in the Middle East, which are rapidly growing in popularity in the region. There is a lack of surveillance data at the country-level on use of these products and factors associated with their use. METHODS: This study analyzed a subset of data from the UAE Healthy Future Study, a population-based cohort study of the Emirati population, to determine the factors associated with EC and HTP use among a sample of Emirati adults (≥ 18 years). The baseline assessment and supplementary questionnaires, conducted from 2016 to 2023, included data on combustible tobacco use, EC, and HTP use and sociodemographic characteristics. RESULTS: Of the 2,041 individuals who answered questions on EC use, 32% reported ever using them. Of 521 people providing data on HTP, 30% reported ever using them. After adjusting for age, sex, education, perceived harms and perceived addictiveness of EC, current EC use was associated with baseline combustible tobacco smoking (aOR = 27.63, 95% confidence interval [CI] 14.39, 53.06), users of a younger age (aOR=0.91, 95%CI 0.88, 0.95), and users of male sex (OR = 2.15, 95% CI 1.21, 3.81). Current HTP use was less common, but was also associated with baseline combustible tobacco use. CONCLUSIONS: Use of ECs and HTPs was more common among those who used combustible tobacco. Future research should examine use trajectories among those who do and do not smoke, as well as uptake of these products among youth. IMPLICATIONS: Non-combustible nicotine products are growing in popularity in the Middle East Region. Our study found that EC and HTP use is associated with baseline combustible tobacco use and that concurrent users may use them to cut down on their combustible tobacco use. Continued comprehensive population-based monitoring of all tobacco and nicotine products, especially EC and HTP use, will provide current data to aid in appropriately informing public health and harm reduction messages and programming.
Stroke incidence in heart failure and atrial fibrillation: population cohort study.
BACKGROUND: Heart failure (HF) is a risk factor for stroke among people with atrial fibrillation (AF). Prognosis following a HF diagnosis is often poor, but this is not accounted for in existing stroke risk scores. AIM: To examine stroke incidence in people with HF and AF compared to AF alone, considering the competing risk of death. DESIGN AND SETTING: Population-based cohort study. METHODS: We identified 2,381,941 people aged ≥45 years in the Clinical Practice Research Datalink (2000-2018). HF and AF were included as time-varying covariates; 69,575 had HF and AF, 141,562 had AF alone and 91,852 had HF alone. We report hazard ratios for first stroke using Cox and Fine and Gray models. RESULTS: Over median follow-up of 6.62 years, 93,665 people (3.9%) had a first stroke and 314,042 (13.2%) died. Over half (51.3%) of those with HF and AF died. In the fully-adjusted Cox model, relative stroke risk was highest among people with AF alone (HR 2.43, 95%CI: 2.38-2.48) than HF and AF (HR 2.20, 95%CI: 2.14-2.26). In a Fine and Gray model accounting for all-cause mortality, the relative risk of stroke was similar for people with AF alone (HR 2.38, 95%CI: 2.33-2.43), but there was significant attenuation among those with HF and AF (HR 1.48, 95%CI: 1.44-1.53). CONCLUSION: HF is an aetiological risk factor for stroke yet its prognostic significance is reduced by the high incidence of death. Use of the CHA2DS2VASc score may over-estimate stroke incidence in some people with HF, particularly those with a poor prognosis.