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The Centre for Evidence-Based Medicine (CEBM) at Oxford University develops, promotes and disseminates better evidence for health care.
Pharmacological and electronic cigarette interventions for smoking cessation in adults: component network meta-analyses
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To conduct component network meta-analyses (cNMAs) to investigate the comparative effectiveness, safety and tolerability of different smoking cessation pharmacotherapies and electronic cigarettes (EC), singly and combined, when helping people to stop smoking tobacco. To investigate:. how the different characteristics of smoking cessation pharmacotherapies and EC interventions (e.g. intervention subtype, dose, length of intervention, whether the intervention is used prequit as well as from quit date or from quit date only) influence efficacy, safety and tolerability; whether identifiable participant characteristics and behavioural support suggest different optimal intervention strategies.
Poor quality medical research causes serious harms by misleading healthcare professionals and policymakers, decreasing trust in science and medicine, and wasting public funds. Here we outline underlying problems including insufficient transparency, dysfunctional incentives, and reporting biases. We make the following recommendations to address these problems: Journals and funders should ensure authors fulfil their obligation to share detailed study protocols, analytical code, and (as far as possible) research data. Funders and journals should incentivise uptake of registered reports and establish funding pathways which integrate evaluation of funding proposals with initial peer review of registered reports. A mandatory national register of interests for all those who are involved in medical research in the UK should be established, with an expectation that individuals maintain the accuracy of their declarations and regularly update them. Funders and institutions should stop using metrics such as citations and journal's impact factor to assess research and researchers and instead evaluate based on quality, reproducibility, and societal value. Employers and non-academic training programmes for health professionals (clinicians hired for patient care, not to do research) should not select based on number of research publications. Promotions based on publication should be restricted to those hired to do research.
The Long-Term Impact of Vaginal Surgical Mesh Devices in UK Primary Care: A Cohort Study in the Clinical Practice Research Datalink
Purpose: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) may be treated with surgical mesh devices; evidence of their long-term complications is lacking. Patients and Methods: Rates of diagnoses of depression, anxiety or self-harm (composite measure) and sexual dysfunction, and rates of prescriptions for antibiotics and opioids were estimated in women with and without mesh surgery, with a diagnostic SUI/POP code, registered in the Clinical Practice Research Datalink (CPRD) gold database. Results: There were 220,544 women eligible for inclusion; 74% (n = 162,687) had SUI, 37% (n = 82,123) had POP, and 11% (n = 24,266) had both. Women undergoing mesh surgery for SUI or POP had about 1.1 times higher rates of antibiotic use. Women with no previous history of the outcome, who underwent mesh surgery had 2.43 (95% CI 2.19–2.70) and 1.47 (95% CI 1.19–1.81) times higher rates of depression, anxiety, or self-harm, 1.88 (95% CI 1.50–2.36) and 1.64 (95% CI 1.02–2.63) times higher rates of sexual dysfunction and 1.40 (95% CI 1.26–1.56) and 1.23 (95% CI 1.01–1.49) times higher opioid use for SUI and POP, respectively. Women with a history of depression, anxiety and self-harm had 0.3 times lower rates of these outcomes with SUI or POP mesh surgery (HR for SUI 0.70 (95% CI 0.67-0.73), HR for POP 0.72 (95% CI 0.65-0.79)). Women with a history of opioid use who had POP mesh surgery had about 0.09 times lower rates (HR 0.91 (95% CI 0.86–0.96)) of prescriptions. Negative control outcome analyses showed no evidence of an association between asthma consultations and mesh surgery in women with POP, but the rate was 0.09 times lower (HR 0.91 (95% CI 0.87–0.94)) in women with SUI mesh surgery, suggesting that study results are subject to some residual confounding. Conclusion: Mesh surgery was associated with poor mental and sexual health outcomes, alongside increased opioid and antibiotic use, in women with no history of these outcomes and improved mental health, and lower opioid use, in women with a previous history of these outcomes. Although our results suggest an influence of residual confounding, careful con-sideration of the benefits and risk of mesh surgery for women with SUI or POP on an individual basis is required.
Understanding how and why quality circles improve standards of practice, enhance professional development and increase psychological well-being of general practitioners: a realist synthesis
ObjectivesTo understand how and why participation in quality circles (QCs) improves general practitioners’ (GPs) psychological well-being and the quality of their clinical practice. To provide evidence-informed and practical guidance to maintain QCs at local and policy levels.DesignA theory-driven mixed method.SettingPrimary healthcare.MethodWe collected data in four stages to develop and refine the programme theory of QCs: (1) coinquiry with Swiss and European expert stakeholders to develop a preliminary programme theory; (2) realist review with systematic searches in MEDLINE, Embase, PsycINFO and CINHAL (1980–2020) to inform the preliminary programme theory; (3) programme refinement through interviews with participants, facilitators, tutors and managers of QCs and (4) consolidation of theory through interviews with QC experts across Europe and examining existing theories.Sources of dataThe coinquiry comprised 4 interviews and 3 focus groups with 50 European experts. From the literature search, we included 108 papers to develop the literature-based programme theory. In stage 3, we used data from 40 participants gathered in 6 interviews and 2 focus groups to refine the programme theory. In stage 4, five interviewees from different healthcare systems consolidated our programme theory.ResultRequirements for successful QCs are governmental trust in GPs’ abilities to deliver quality improvement, training, access to educational material and performance data, protected time and financial resources. Group dynamics strongly influence success; facilitators should ensure participants exchange knowledge and generate new concepts in a safe environment. Peer interaction promotes professional development and psychological well-being. With repetition, participants gain confidence to put their new concepts into practice.ConclusionWith expert facilitation, clinical review and practice opportunities, QCs can improve the quality of standard practice, enhance professional development and increase psychological well-being in the context of adequate professional and administrative support.PROSPERO registration numberCRD42013004826.
OBJECTIVES: The social ties people have with one another are known to influence behaviour, and how information is accessed and interpreted. It is unclear, however, how the social networks that exist in multi-professional health care workplaces might be used to improve quality in hospitals. This paper develops explanatory theory using realist synthesis to illuminate the details and significance of the social ties between health care workers. Specifically we ask: How, why, for whom, to what extent and in what context, do the social ties of staff within a hospital influence quality of service delivery, including quality improvement? METHODS: From a total of 75 included documents identified through an extensive systematic literature search, data were extracted and analysed to identify emergent explanatory statements. RESULTS: The synthesis found that within the hospital workforce, an individual's place in the social whole can be understood across four identified domains: (1) social group, (2) hierarchy, (3) bridging distance and (4) discourse. Thirty-five context-mechanism-outcome configurations were developed across these domains. CONCLUSIONS: The relative position of individual health care workers within the overall social network in hospitals is associated with influence and agency. As such, power to bring about change is inequitably and socially situated, and subject to specific contexts. The findings of this realist synthesis offer a lens through which to understand social ties in hospitals. The findings can help identify possible strategies for intervention to improve communication and distribution of power, for individual, team and wider multi-professional behavioural change in hospitals.
Facilitating safe discharge through predicting disease progression in moderate COVID-19: a prospective cohort study to develop and validate a clinical prediction model in resource-limited settings.
BACKGROUND: In locations where few people have received COVID-19 vaccines, health systems remain vulnerable to surges in SARS-CoV-2 infections. Tools to identify patients suitable for community-based management are urgently needed. METHODS: We prospectively recruited adults presenting to two hospitals in India with moderate symptoms of laboratory-confirmed COVID-19 in order to develop and validate a clinical prediction model to rule-out progression to supplemental oxygen requirement. The primary outcome was defined as any of the following: SpO2 < 94%; respiratory rate > 30 bpm; SpO2/FiO2 < 400; or death. We specified a priori that each model would contain three clinical parameters (age, sex and SpO2) and one of seven shortlisted biochemical biomarkers measurable using commercially-available rapid tests (CRP, D-dimer, IL-6, NLR, PCT, sTREM-1 or suPAR), to ensure the models would be suitable for resource-limited settings. We evaluated discrimination, calibration and clinical utility of the models in a held-out temporal external validation cohort. RESULTS: 426 participants were recruited, of whom 89 (21.0%) met the primary outcome. 257 participants comprised the development cohort and 166 comprised the validation cohort. The three models containing NLR, suPAR or IL-6 demonstrated promising discrimination (c-statistics: 0.72 to 0.74) and calibration (calibration slopes: 1.01 to 1.05) in the validation cohort, and provided greater utility than a model containing the clinical parameters alone. CONCLUSIONS: We present three clinical prediction models that could help clinicians identify patients with moderate COVID-19 suitable for community-based management. The models are readily implementable and of particular relevance for locations with limited resources.
BACKGROUND: Smoking is a risk factor for most respiratory infections, but it may protect against SARS-CoV-2 infection. The objective was to assess whether smoking and e-cigarette use were associated with severe COVID-19. METHODS: This cohort ran from 24 January 2020 until 30 April 2020 at the height of the first wave of the SARS-CoV-2 epidemic in England. It comprised 7 869 534 people representative of the population of England with smoking status, demographic factors and diseases recorded by general practitioners in the medical records, which were linked to hospital and death data. The outcomes were COVID-19-associated hospitalization, intensive care unit (ICU) admission and death. The associations between smoking and the outcomes were assessed with Cox proportional hazards models, with sequential adjustment for confounding variables and indirect causal factors (body mass index and smoking-related disease). RESULTS: Compared with never smokers, people currently smoking were at lower risk of COVID-19 hospitalization, adjusted hazard ratios (HRs) were 0.64 (95% confidence intervals 0.60 to 0.69) for <10 cigarettes/day, 0.49 (0.41 to 0.59) for 10-19 cigarettes/day, and 0.61 (0.49 to 0.74) for ≥20 cigarettes/day. For ICU admission, the corresponding HRs were 0.31 (0.24 to 0.40), 0.15 (0.06 to 0.36), and 0.35 (0.17 to 0.74) and death were: 0.79 (0.70 to 0.89), 0.66 (0.48 to 0.90), and 0.77 (0.54 to 1.09) respectively. Former smokers were at higher risk of severe COVID-19: HRs: 1.07 (1.03 to 1.11) for hospitalization, 1.17 (1.04 to 1.31) for ICU admission, and 1.17 (1.10 to 1.24) for death. All-cause mortality was higher for current smoking than never smoking, HR 1.42 (1.36 to 1.48). Among e-cigarette users, the adjusted HR for e-cigarette use and hospitalization with COVID-19 was 1.06 (0.88 to 1.28), for ICU admission was 1.04 (0.57 to 1.89, and for death was 1.12 (0.81 to 1.55). CONCLUSIONS: Current smoking was associated with a reduced risk of severe COVID-19 but the association with e-cigarette use was unclear. All-cause mortality remained higher despite this possible reduction in death from COVID-19 during an epidemic of SARS-CoV-2. Findings support investigating possible protective mechanisms of smoking for SARS-CoV-2 infection, including the ongoing trials of nicotine to treat COVID-19.
Importance: More deaths in the US are attributed to cigarette smoking each year than to any other preventable cause. Approximately 34 million people and an estimated 14% of adults in the US smoke cigarettes. If they stopped smoking, they could reduce their risk of tobacco-related morbidity and mortality and potentially gain up to 10 years of life. Observations: Tobacco smoking is a chronic disorder maintained by physical nicotine dependence and learned behaviors. Approximately 70% of people who smoke cigarettes want to quit smoking. However, individuals who attempt to quit smoking make an average of approximately 6 quit attempts before achieving long-term abstinence. Both behavioral counseling and pharmacotherapy while using nicotine replacement therapy (NRT) products, varenicline, or bupropion are effective treatments when used individually, but they are most effective when combined. In a meta-analysis including 19488 people who smoked cigarettes, the combination of medication and behavioral counseling was associated with a quit rate of 15.2% over 6 months compared with a quit rate of 8.6% with brief advice or usual care. The EAGLES trial, a randomized double-blind clinical trial of 8144 people who smoked, directly compared the efficacy and safety of varenicline, bupropion, nicotine patch, and placebo and found a significantly higher 6-month quit rate for varenicline (21.8%) than for bupropion (16.2%) and the nicotine patch (15.7%). Each therapy was more effective than placebo (9.4%). Combining a nicotine patch with other NRT products is more effective than use of a single NRT product. Combining drugs with different mechanisms of action, such as varenicline and NRT, has increased quit rates in some studies compared with use of a single product. Brief or intensive behavioral support can be delivered effectively in person or by telephone, text messages, or the internet. The combination of a clinician's brief advice to quit and assistance to obtain tobacco cessation treatment is effective when routinely administered to tobacco users in virtually all health care settings. Conclusions and Relevance: Approximately 34 million people in the US smoke cigarettes and could potentially gain up to a decade of life expectancy by stopping smoking. First-line therapy should include both pharmacotherapy and behavioral support, with varenicline or combination NRT as preferred initial interventions..
BACKGROUND: Rapid weight gain is common with antipsychotic medication. Lost confidence, low mood and medication non-adherence often follow. Yet, the dynamic interactions between the physical and psychological consequences of weight gain, and implications for intervention, are unknown. OBJECTIVES: We examined first-person accounts of weight gain to identify preferences for weight change interventions. DESIGN: A qualitative design was used to explore patients' experiences of weight change in the context of psychosis. METHOD: Semi-structured interviews, analysed using grounded theory, were conducted with 10 patients with psychosis. Sample validation was conducted with peer researchers with lived experience of psychosis. RESULTS: Patients described that initially the extent and speed of weight gain was overshadowed by psychotic experiences and their treatment. This led to a shocking realisation of weight gain. The psychological impact of weight gain, most strikingly on the self-concept, was profound. Loss of self-worth and changed appearance amplified a sense of vulnerability. There were further consequences on mood, activity and psychotic experiences, such as voices commenting on appearance, that were additional obstacles in the challenging process of weight loss. Sedative effects of medication also contributed. Unsuccessful weight loss left little hope and few preferences for interventions. Early information about common weight gain trajectories and working with experts-by-experience were valued. Rebuilding self-confidence, efficacy and worth may be a necessary first step. CONCLUSIONS: The journey of weight gain in patients with psychosis is characterised by loss of self-worth, agency and hope. There are multiple stages in the journey, each with different psychological reactions, that may need different treatment responses.
Background: Heated tobacco products (HTPs) are designed to heat tobacco to a high enough temperature to release aerosol, without burning it or producing smoke. They differ from e-cigarettes because they heat tobacco leaf/sheet rather than a liquid. Companies who make HTPs claim they produce fewer harmful chemicals than conventional cigarettes. Some people report stopping smoking cigarettes entirely by switching to using HTPs, so clinicians need to know whether they are effective for this purpose and relatively safe. Also, to regulate HTPs appropriately, policymakers should understand their impact on health and on cigarette smoking prevalence. Objectives: To evaluate the effectiveness and safety of HTPs for smoking cessation and the impact of HTPs on smoking prevalence. Search methods: We searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, and six other databases for relevant records to January 2021, together with reference-checking and contact with study authors and relevant groups. Selection criteria: We included randomised controlled trials (RCTs) in which people who smoked cigarettes were randomised to switch to exclusive HTP use or a control condition. Eligible outcomes were smoking cessation, adverse events, and selected biomarkers. RCTs conducted in clinic or in an ambulatory setting were deemed eligible when assessing safety, including those randomising participants to exclusively use HTPs, smoke cigarettes, or attempt abstinence from all tobacco. Time-series studies were also eligible for inclusion if they examined the population-level impact of heated tobacco on smoking prevalence or cigarette sales as an indirect measure. Data collection and analysis: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking at the longest follow-up point available, adverse events, serious adverse events, and changes in smoking prevalence or cigarette sales. Other outcomes included biomarkers of harm and exposure to toxicants/carcinogens (e.g. NNAL and carboxyhaemoglobin (COHb)). We used a random-effects Mantel-Haenszel model to calculate risk ratios (RR) with 95% confidence intervals (CIs) for dichotomous outcomes. For continuous outcomes, we calculated mean differences on the log-transformed scale (LMD) with 95% CIs. We pooled data across studies using meta-analysis where possible. Main results: We included 13 completed studies, of which 11 were RCTs assessing safety (2666 participants) and two were time-series studies. We judged eight RCTs to be at unclear risk of bias and three at high risk. All RCTs were funded by tobacco companies. Median length of follow-up was 13 weeks. No studies reported smoking cessation outcomes. There was insufficient evidence for a difference in risk of adverse events between smokers randomised to switch to heated tobacco or continue smoking cigarettes, limited by imprecision and risk of bias (RR 1.03, 95% CI 0.92 to 1.15; I2 = 0%; 6 studies, 1713 participants). There was insufficient evidence to determine whether risk of serious adverse events differed between groups due to very serious imprecision and risk of bias (RR 0.79, 95% CI 0.33 to 1.94; I2 = 0%; 4 studies, 1472 participants). There was moderate-certainty evidence for lower NNAL and COHb at follow-up in heated tobacco than cigarette smoking groups, limited by risk of bias (NNAL: LMD −0.81, 95% CI −1.07 to −0.55; I2 = 92%; 10 studies, 1959 participants; COHb: LMD −0.74, 95% CI −0.92 to −0.52; I2 = 96%; 9 studies, 1807 participants). Evidence for additional biomarkers of exposure are reported in the main body of the review. There was insufficient evidence for a difference in risk of adverse events in smokers randomised to switch to heated tobacco or attempt abstinence from all tobacco, limited by risk of bias and imprecision (RR 1.12, 95% CI 0.86 to 1.46; I2 = 0%; 2 studies, 237 participants). Five studies reported that no serious adverse events occurred in either group (533 participants). There was moderate-certainty evidence, limited by risk of bias, that urine concentrations of NNAL at follow-up were higher in the heated tobacco use compared with abstinence group (LMD 0.50, 95% CI 0.34 to 0.66; I2 = 0%; 5 studies, 382 participants). In addition, there was very low-certainty evidence, limited by risk of bias, inconsistency, and imprecision, for higher COHb in the heated tobacco use compared with abstinence group for intention-to-treat analyses (LMD 0.69, 95% CI 0.07 to 1.31; 3 studies, 212 participants), but lower COHb in per-protocol analyses (LMD −0.32, 95% CI −1.04 to 0.39; 2 studies, 170 participants). Evidence concerning additional biomarkers is reported in the main body of the review. Data from two time-series studies showed that the rate of decline in cigarette sales accelerated following the introduction of heated tobacco to market in Japan. This evidence was of very low-certainty as there was risk of bias, including possible confounding, and cigarette sales are an indirect measure of smoking prevalence. Authors' conclusions: No studies reported on cigarette smoking cessation, so the effectiveness of heated tobacco for this purpose remains uncertain. There was insufficient evidence for differences in risk of adverse or serious adverse events between people randomised to switch to heated tobacco, smoke cigarettes, or attempt tobacco abstinence in the short-term. There was moderate-certainty evidence that heated tobacco users have lower exposure to toxicants/carcinogens than cigarette smokers and very low- to moderate-certainty evidence of higher exposure than those attempting abstinence from all tobacco. Independently funded research on the effectiveness and safety of HTPs is needed. The rate of decline in cigarette sales accelerated after the introduction of heated tobacco to market in Japan but, as data were observational, it is possible other factors caused these changes. Moreover, falls in cigarette sales may not translate to declining smoking prevalence, and changes in Japan may not generalise elsewhere. To clarify the impact of rising heated tobacco use on smoking prevalence, there is a need for time-series studies that examine this association.
BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 20112012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. ARTICLE DESIGN AND SETTING: Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. RESULTS AND CONCLUSION: This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports. SOURCE: This article is a translation of the original paper CARE guidelines for case reports: explanation and elaboration document in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia).