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Information-processing biases such as attentional, interpretation, and memory biases are believed to play a role in exacerbating and maintaining chronic pain (CP). Evidence suggests that individuals with CP show attentional bias toward pain-related information. However, the selective attentional processes that underpin this bias are not always well outlined in the literature. To improve current understanding, a systematic review was performed using a descriptive synthesis of reaction time-based studies. A random-effects meta-analysis was added to explore whether the results of previous meta-analyses would be confirmed using studies with a larger sample size. For this review, 2008 studies were screened from 4 databases, of which 34 (participant n = 3154) were included in the review and a subset of 15 (participant n = 1339) were included in the meta-analysis. Review results were summarised by producing a descriptive synthesis for all studies. Meta-analysis results indicated a mild significant attentional bias toward sensory pain-related information (k = 15, g = 0.28, 95% CI [0.16, 0.39], I2 = 43.2%, P = 0.038), and preliminary evidence of significant moderate bias towards affective pain-related information (k = 3, g = 0.48, 95% CI [0.23, 0.72], I2 = 7.1%, P = 0.341) for CP groups compared with control groups. We explored the main tasks, stimuli, and CP subtypes used to address attentional biases and related processes. However, variation across studies did not allow for a decisive conclusion about the role of stimulus, task type, or related attentional processes. In addition, a table of CP attention-related models was produced and tested for reliability. Finally, other results and recommendations are discussed.

Peer reviewed: True, OBJECTIVE: To examine the association of physician burnout with the career engagement and the quality of patient care globally. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, PsycINFO, Embase, and CINAHL were searched from database inception until May 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Observational studies assessing the association of physician burnout (including a feeling of overwhelming emotional exhaustion, feelings of cynicism and detachment from job defined as depersonalisation, and a sense of ineffectiveness and little personal accomplishment) with career engagement (job satisfaction, career choice regret, turnover intention, career development, and productivity loss) and the quality of patient care (patient safety incidents, low professionalism, and patient satisfaction). Data were double extracted by independent reviewers and checked through contacting all authors, 84 (49%) of 170 of whom confirmed their data. Random-effect models were used to calculate the pooled odds ratio, prediction intervals expressed the amount of heterogeneity, and meta-regressions assessed for potential moderators with significance set using a conservative level of P

BackgroundIndividuals with vitamin B12 deficiency (including pernicious anaemia) often report being ‘let down’ or stigmatised by general practice systems and policy, and choose instead to self-medicate via injection; the association between this and perceptions of safe primary care in this group of people is unknown.AimTo examine the association between self-medication for vitamin B12 deficiency and patient-reported safety in primary care.Design and settingA UK cross-sectional online survey.MethodThe survey consisted of the three components: demographics; the validated Primary Care Patient Measure of Safety; and questions about self-medication for vitamin B12 deficiency. Multivariable logistic regression analyses and thematic synthesis were undertaken.ResultsResponses from 1297 participants indicated 508 (39.2%) self-medicated via injection. Perceived primary care safety was low. Those who self-medicated via injection reported a significantly lower level of patient safety in primary care including adverse patient-related factors (odds ratio 0.82, 95% confidence interval = 0.73 to 0.92), and patients >34 years of age were significantly more likely to self-medicate via injection. Many reported that treatment under the guidance of a clinician was preferable to self-medication, but felt they had no other choice to regain quality of life. Almost half felt that the doctor did not always consider what they wanted for their care.ConclusionTo the authors’ knowledge, this is the largest study to date examining patient safety and vitamin B12 deficiency. It found that four out of 10 patients with B12 deficiency self-medicate via injection. Patients who self-medicated perceived primary care as less safe. Providing patient-centred care and treating these patients with dignity and respect is a policy priority to reduce unsafe health behaviours.

BACKGROUND: In the United States (US), 61% of all suicide cases may involve firearms, and some evidence suggests that mental disorders may play a role in suicide by firearm. We performed the first systematic review and meta-analyses to investigate: (i) whether mental disorders are associated with suicide by firearm, and (ii) whether the risk of using a firearm compared with alternative means is associated with higher levels of suicide in individuals with a mental disorder\ud \ud METHODS AND FINDINGS: We searched twelve databases from inception to the 24th of May 2020. We retrieved 22 observational studies conducted in the US. Random-effects meta-analyses showed individuals who had a diagnosis of a mental disorder had lower odds (odds ratios (OR)= 0.50, 95% CI: 0.36 to 0.69; I2=100 (95% CI: 87 to 100%), of dying by suicide with a firearm than those who did not have a diagnosis of a mental disorder. Secondary analysis showed that decedents who had a mental health diagnosis resulted in lower odds of dying by suicide by using firearms than using other means\ud \ud LIMITATIONS: Risk of bias revealed a heterogeneous and poor definition of mental disorders as well as lack of control for potential demographic confounding factors. In the meta-analyses, studies were combined in the same analytic sample as 77% of these studies did not specify the type of mental disorder\ud \ud CONCLUSION: While our results seem to suggest that having a mental disorder may not be consistently associated with the odds of dying by suicide using a firearm, the presence of substantial heterogeneity and high risk of bias precludes any firm conclusions.

BackgroundCognitive–behavioural therapy (CBT) is frequently used as an umbrella term to include a variety of psychological interventions. It remains unclear whether more complex CBT contributes to greater depression reduction.AimsTo (a) compare the effectiveness of core, complex and ultra-complex CBT against other psychological intervention, medication, treatment-as-usual and no treatment in reducing depression at post-treatment and in the long term and (b) explore important factors that could moderate the effectiveness of these interventions.MethodMEDLINE, PsycInfo, Embase, Web of Science and the Cochrane Register of Controlled Trials were searched to November 2021. Only randomised controlled trials were eligible for the subsequent network meta-analysis.ResultsWe included 107 studies based on 15 248 participants. Core (s.m.d. = −1.14, 95% credible interval (CrI) −1.72 to −0.55 [m.d. = −8.44]), complex (s.m.d. = −1.24, 95% CrI −1.85 to −0.64 [m.d. = −9.18]) and ultra-complex CBT (s.m.d. = −1.45, 95% CrI −1.88 to −1.02 [m.d. = −10.73]) were all significant in reducing depression up to 6 months from treatment onset. The significant benefits of the ultra-complex (s.m.d. = −1.09, 95% CrI −1.61 to −0.56 [m.d. = −8.07]) and complex CBT (s.m.d. = −0.73, 95% CrI −1.36 to −0.11 [m.d. = −5.40]) extended beyond 6 months. Ultra-complex CBT was most effective in individuals presenting comorbid mental health problems and when delivered by non-mental health specialists. Ultra-complex and complex CBT were more effective for people younger than 59 years.ConclusionsFor people without comorbid conditions healthcare and policy organisations should invest in core CBT. For people

Meta-analysis of clinical trials targeting rare events face particular challenges when the data lack adequate number of events and are susceptible to high levels of heterogeneity. The standard meta-analysis methods (DerSimonian Laird (DL) and Mantel–Haenszel (MH)) often lead to serious distortions because of such data sparsity. Applications of the methods suited to specific incidence and heterogeneity characteristics are lacking, thus we compared nine available methods in a simulation study. We generated 360 meta-analysis scenarios where each considered different incidences, sample sizes, between-study variance (heterogeneity) and treatment allocation. We include globally recommended methods such as inverse-variance fixed/random-effect (IV-FE/RE), classical-MH, MH-FE, MH-DL, Peto, Peto-DL and the two extensions for MH bootstrapped-DL (bDL) and Peto-bDL. Performance was assessed on mean bias, mean error, coverage and power. In the absence of heterogeneity, the coverage and power when combined revealed small differences in meta-analysis involving rare and very rare events. The Peto-bDL method performed best, but only in smaller sample sizes involving rare events. For medium-to-larger sample sizes, MH-bDL was preferred. For meta-analysis involving very rare events, Peto-bDL was the best performing method which was sustained across all sample sizes. However, in meta-analysis with 20% or more heterogeneity, the coverage and power were insufficient. Performance based on mean bias and mean error was almost identical across methods. To conclude, in meta-analysis of rare binary outcomes, our results suggest that Peto-bDL is better in both rare and very rare event settings in meta-analysis with limited sample sizes. However, when heterogeneity is large, the coverage and power to detect rare events are insufficient. Whilst this study shows that some of the less studied methods appear to have good properties under sparse data scenarios, further work is needed to assess them against the more complex distributional-based methods to understand their overall performances.

BACKGROUND: Preterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce preterm birth and adverse neonatal outcomes.METHODS: We did a systematic review of randomised trials comparing vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate (17-OHPC), or oral progesterone with control, or with each other, in asymptomatic women at risk of preterm birth. We identified published and unpublished trials that completed primary data collection before July 30, 2016, (12 months before data collection began), by searching MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers between inception and July 30, 2019. Trials of progestogen to prevent early miscarriage or immediately-threatened preterm birth were excluded. Individual participant data were requested from investigators of eligible trials. Outcomes included preterm birth, early preterm birth, and mid-trimester birth. Adverse neonatal sequelae associated with early births were assessed using a composite of serious neonatal complications, and individually. Adverse maternal outcomes were investigated as a composite and individually. Individual participant data were checked and risk of bias assessed independently by two researchers. Primary meta-analyses used one-stage generalised linear mixed models that incorporated random effects to allow for heterogeneity across trials. This meta-analysis is registered with PROSPERO, CRD42017068299.FINDINGS: Initial searches identified 47 eligible trials. Individual participant data were available for 30 of these trials. An additional trial was later included in a targeted update. Data were therefore available from a total of 31 trials (11 644 women and 16185 offspring). Trials in singleton pregnancies included mostly women with previous spontaneous preterm birth or short cervix. Preterm birth before 34 weeks was reduced in such women who received vaginal progesterone (nine trials, 3769 women; relative risk [RR] 0·78, 95% CI 0·68-0·90), 17-OHPC (five trials, 3053 women; 0·83, 0·68-1·01), and oral progesterone (two trials, 181 women; 0·60, 0·40-0·90). Results for other birth and neonatal outcomes were consistently favourable, but less certain. A possible increase in maternal complications was suggested, but this was uncertain. We identified no consistent evidence of treatment interaction with any participant characteristics examined, although analyses within subpopulations questioned efficacy in women who did not have a short cervix. Trials in multifetal pregnancies mostly included women without additional risk factors. For twins, vaginal progesterone did not reduce preterm birth before 34 weeks (eight trials, 2046 women: RR 1·01, 95% CI 0·84-1·20) nor did 17-OHPC for twins or triplets (eight trials, 2253 women: 1·04, 0·92-1·18). Preterm premature rupture of membranes was increased with 17-OHPC exposure in multifetal gestations (rupture INTERPRETATION: Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks' gestation in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Evidence for oral progesterone is insufficient to support its use. Shared decision making with woman with high-risk singleton pregnancies should discuss an individual's risk, potential benefits, harms and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.FUNDING: Patient-Centered Outcomes Research Institute.

Importance: Residents of long-term care facilities (LTCFs) experience high hospitalization rates, yet little is known about the effects of transitional care interventions for these residents.Objective: To assess the association of transitional care interventions with readmission rates and other outcomes for residents of LTCFs who are 65 years and older and LTCF staff and to explore factors that potentially mitigate the association.Data Sources: MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature were searched for English-language studies published until July 21, 2021. Associated qualitative studies were identified using aspects of the CLUSTER (citations, lead authors, unpublished materials, searched Google Scholar, tracked theories, ancestry search for early examples, and follow-up of related projects) methodology.Study Selection: Controlled design studies evaluating transitional care interventions for residents of LTCFs 65 years and older were included. Records were independently screened by 2 reviewers; disagreements were resolved through discussion and involvement of a third reviewer. From 14 538 records identified, 15 quantitative and 4 qualitative studies met the eligibility criteria.Data Extraction and Synthesis: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data were extracted by one reviewer and checked by a second reviewer. Fixed-effect and random-effects models were used according to the number of studies reporting the outcomes of interest.Main Outcomes and Measures: The primary outcome consisted of 30-, 60-, and 90-day readmission rates (hospital and emergency department [ED]). Other outcomes included length of stay, functional independence (Barthel score), and quality of life. The I2 statistic was used to quantify heterogeneity.Results: Of 14 538 records identified from searches, 15 quantitative studies (totaling 32 722 participants or records) and 4 qualitative studies were included. People allocated to transitional care interventions were 1.7 times less likely to be readmitted to the hospital or ED compared with those in control groups (14 studies; odds ratio, 1.66 [95% CI, 1.18-2.35]; I2 = 81% [95% CI, 70%-88%]). Length of stay in the ED was significantly decreased for intervention groups (3 studies; standardized mean difference, -3.00 [95% CI, -3.61 to -2.39]; I2 = 99% [95% CI, 98%-99%]). There were no significant differences for other outcomes. Factors associated with outcomes included communication and referral processes between health care professionals.Conclusions and Relevance: Emerging evidence suggests that transitional care interventions are associated with lower readmissions for residents of LTCFs 65 years and older. Despite this and with aging populations, investment in such interventions has been remarkably low across most countries.

Background Stressful life events are a risk factor for suicidal ideation and behaviour, but the strength and nature of this association is unclear. This review examined the prospective relationship between stressful life events and subsequent suicidal ideation and behaviours. Methods Five databases were searched from inception to April 2019. Eligible studies included observational, quantitative longitudinal cohort studies with adult or adolescent samples. A random-effects meta-analysis model was used to examine the prospective relationship between stressful life events and subsequent suicidal ideation and behaviours. Sub-group analyses examined moderating factors. Results Eight studies were identified in the systematic review, and seven studies comprising 2,639 participants were included in the meta-analysis. Six studies investigated suicidal ideation and one investigated suicidal behaviours. Stressful life events were associated with a 37% higher odds of subsequently reported suicidal ideation and behaviours combined (Odds Ratio (OR): 1.37, 95% CI: 1.10 to 1.70), and a 45% increased risk for suicidal ideation (OR: 1.45, 95% CI: 1.20 to 1.75). This association was stronger in males, young adults, and studies with shorter term follow-up. Limitations The analyses indicated statistical heterogeneity was high (I2 = 76. 48, 95% CI: 55.0 to 87.7%) and there was evidence of publication bias. Conclusions Stressful life events were shown to increase the risk of subsequently reported suicidal ideation and behaviours. These findings suggest that the experience of stressful life events should be incorporated into clinical suicide risk assessments and suicide interventions could include a component on developing resilience and adaptive coping to stressful life events.

Background: Excessive blood glucose promotes neuropathological cognitive decline in individuals with type 2 diabetes mellitus and the metabolic syndrome, but no systematic synthesis of the evidence for the same association exists in individuals without these conditions. Objectives: To systematically review studies exploring therole of glucose on cognition, dementia risk, and related biomarkers in adults without diabetes or metabolic syndrome. Data sources: We searched databases from inception until July 2021 and manually searched the reference lists of included studies. Risk of bias was assessed using the Joanna Briggs Institute tool. ]Results : We found 46 observational studies including approximately 98,216 participants. Substantial heterogeneity in study results precluded drawing definitive conclusion whether blood glucose levels are associated with cognition or dementia risk. Higher blood glucose, however, was associated with greater amyloid burden, brain atrophy, and reduced cortical thickness. Conclusions and Implications: High glucose concentrations in blood may exacerbate dementia-related neuropathology but whether this translates into pathological cognitive decline or elevate dementia risk later in life remains unclear.

BackgroundPrescribing of strong opioids and antibiotics impacts patient safety, yet little is known about the effects GP wellness has on overprescribing of both medications in primary care.AimTo examine associations between strong opioid and antibiotic prescribing and practice- weighted GP burnout and wellness.Design and settingA retrospective cross-sectional study was undertaken using prescription data on strong opioids and antibiotics from the Oxford- Royal College of General Practitioners Research and Surveillance Centre linking to a GP wellbeing survey overlaying the same 4-month period from December 2019 to April 2020.MethodPatients prescribed strong opioids and antibiotics were the outcomes of interest.ResultsData for 40 227 patients (13 483 strong opioids and 26 744 antibiotics) were linked to 57 practices and 351 GPs. Greater strong opioid prescribing was associated with increased emotional exhaustion (incidence risk ratio [IRR] 1.19, 95% confidence interval [CI] = 1.10 to 1.24), depersonalisation (IRR 1.10, 95% CI = 1.01 to 1.16), job dissatisfaction (IRR 1.25, 95% CI = 1.19 to 1.32), diagnostic uncertainty (IRR 1.12, 95% CI = 1.08 to 1.19), and turnover intention (IRR 1.32, 95% CI = 1.27 to 1.37) in GPs. Greater antibiotic prescribing was associated with increased emotional exhaustion (IRR 1.19, 95% CI = 1.05 to 1.37), depersonalisation (IRR 1.24, 95% CI = 1.08 to 1.49), job dissatisfaction (IRR 1.11, 95% CI = 1.04 to 1.19), sickness–presenteeism (IRR 1.18, 95% CI = 1.11 to 1.25), and turnover intention (IRR 1.38, 95% CI = 1.31 to 1.45) in GPs. Increased strong opioid and antibiotic prescribing was also found in GPs working longer hours (IRR 3.95, 95% CI = 3.39 to 4.61; IRR 5.02, 95% CI = 4.07 to 6.19, respectively) and in practices in the north of England (1.96, 95% CI = 1.61 to 2.33; 1.56, 95% CI = 1.12 to 3.70, respectively).ConclusionThis study found higher rates of prescribing of strong opioids and antibiotics in practices with GPs with more burnout symptoms, greater job dissatisfaction, and turnover intentions; working longer hours; and in practices in the north of England serving more deprived populations.

BackgroundPatients recovering from an episode in an intensive care unit (ICU) frequently experience medication errors on transition to the hospital ward. Structured handover recommendations often underestimate the challenges and complexity of ICU patient transitions. For adult ICU patients transitioning to a hospital ward, it is currently unclear what interventions reduce the risks of medication errors.The aims were to examine the impact of medication-related interventions on medication and patient outcomes on transition from adult ICU settings and identify barriers and facilitators to implementation.MethodsThe systematic review protocol was preregistered on PROSPERO. Six electronic databases were searched until October 2020 for controlled and uncontrolled study designs that reported medication-related (ie, de-prescribing; medication errors) or patient-related outcomes (ie, mortality; length of stay). Risk of bias (RoB) assessment used V.2.0 and ROBINS-I Cochrane tools. Where feasible, random-effects meta-analysis was used for pooling the OR across studies. The quality of evidence was assessed by Grading of Recommendations, Assessment, Development and Evaluations.ResultsSeventeen studies were eligible, 15 (88%) were uncontrolled before-after studies. The intervention components included education of staff (n=8 studies), medication review (n=7), guidelines (n=6), electronic transfer/handover tool or letter (n=4) and medicines reconciliation (n=4). Overall, pooled analysis of all interventions reduced risk of inappropriate medication continuation at ICU discharge (OR=0.45 (95% CI 0.31 to 0.63), I2=55%, n=9) and hospital discharge (OR=0.39 (95% CI 0.2 to 0.76), I2=75%, n=9). Multicomponent interventions, based on education of staff and guidelines, demonstrated no significant difference in inappropriate medication continuation at the ICU discharge point (OR 0.5 (95% CI 0.22 to 1.11), I2=62%, n=4), but were very effective in increasing de-prescribing outcomes on hospital discharge (OR 0.26 (95% CI 0.13 to 0.55), I2=67%, n=6)). Facilitators to intervention delivery included ICU clinical pharmacist availability and participation in multiprofessional ward rounds, while barriers included increased workload associated with the discharge intervention process.ConclusionsMulticomponent interventions based on education of staff and guidelines were effective at achieving almost four times more de-prescribing of inappropriate medication by the time of patient hospital discharge. Based on the findings, practice and policy recommendations are made and guidance is provided on the need for, and design of theory informed interventions in this area, including the requirement for process and economic evaluations.

This short report aims to investigate the association between teamwork and burnout among general practitioners (GPs). A two-stage survey was conducted. In stage one, validated self-report measures of burnout and teamwork were completed by 50 GPs across 12 general practices in Greater Manchester, UK. In stage two, staff members across 3 of the 12 general practices (GPs, nursing staff, managers and admin staff) responded to free text questions about teamwork (n = 20). The results of the stage one survey showed that teamwork in GPs was significantly negatively associated with the emotional exhaustion (r = −0.326, P

Importance - Wearable physical activity (PA) trackers, such as accelerometers, fitness trackers, and pedometers, are accessible technologies that may encourage increased PA levels in line with current recommendations. However, whether their use is associated with improvements in PA levels in participants who experience 1 or more cardiometabolic conditions, such as diabetes, prediabetes, obesity, and cardiovascular disease, is unknown.\ud \ud Objective - To assess the association of interventions using wearable PA trackers (accelerometers, fitness trackers, and pedometers) with PA levels and other health outcomes in adults with cardiometabolic conditions.\ud \ud Data Sources - For this systematic review and meta-analysis, searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and PsycINFO were performed from January 1, 2000, until December 31, 2020, with no language restriction. A combination of Medical Subject Heading terms and text words of diabetes, obesity, cardiovascular disease, pedometers, accelerometers, and Fitbits were used.\ud \ud Study Selection - Randomized clinical trials or cluster randomized clinical trials that evaluated the use of wearable PA trackers, such as pedometers, accelerometers, or fitness trackers, were included. Trials were excluded if they assessed the trackers only as measuring tools of PA before and after another intervention, they required participants to be hospitalized, assessors were not blinded to the trackers, or they used a tracker to measure the effect of a pharmacological treatment on PA among individuals.\ud \ud Data Extraction and Synthesis - The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. A random-effects model was used for the meta-analysis.\ud \ud Main Outcomes and Measures - The primary outcome was mean difference in PA levels. When the scale was different across studies, standardized mean differences were calculated. Heterogeneity was quantified using the I2 statistic and explored using mixed-effects metaregression.\ud \ud Results - A total of 38 randomized clinical trials with 4203 participants were eligible in the systematic review; 29 trials evaluated pedometers, and 9 evaluated accelerometers or fitness trackers. Four studies did not provide amenable outcome data, leaving 34 trials (3793 participants) for the meta-analysis. Intervention vs comparator analysis showed a significant association of wearable tracker use with increased PA levels overall (standardized mean difference, 0.72; 95% CI, 0.46-0.97; I2 = 88%; 95% CI, 84.3%-90.8%; P

Introduction\ud Caregivers who live with a person with dementia who receives care, compared with those who live elsewhere, are often considered to experience greater levels of psychological and affective burden. The evidence for this is, however, only limited to studies employing small sample sizes and that failed to examine caregivers’ psychological wellbeing. We address these issues in a large cohort of dementia caregivers.\ud \ud Methods\ud We conducted a cross-sectional study comparing caregivers living with a dementia care recipient (n = 240) to caregivers living elsewhere (n = 255) on caregivers’ burden, anxiety, and depression.\ud \ud Results\ud We found that caregivers living with the care recipient relative to those living elsewhere showed significantly greater burden and depression, but we found no group difference in anxiety.\ud \ud Conclusions\ud Our study adds to the evidence by showing that cohabiting with a care recipient with dementia is associated with greater burden and poorer psychological wellbeing. Strategies aiming to improve caregivers’ burden and psychological wellbeing should take account of caregivers’ living arrangements.

To assess whether CC is more effective at reducing suicidal ideation in people with depression compared with usual care, and whether study and patient factors moderate treatment effects. We searched Medline, Embase, PubMed, PsycINFO, CINAHL, CENTRAL from inception to March 2020 for Randomised Controlled Trials (RCTs) that compared the effectiveness of CC with usual care in depressed adults, and reported changes in suicidal ideation at 4 to 6 months post-randomisation. Mixed-effects models accounted for clustering of participants within trials and heterogeneity across trials. This study is registered with PROSPERO, CRD42020201747. We extracted data from 28 RCTs (11,165 patients) of 83 eligible studies. We observed a small significant clinical improvement of CC on suicidal ideation, compared with usual care (SMD, -0.11 [95%CI, -0.15 to -0.08]; I , 0·47% [95%CI 0.04% to 4.90%]). CC interventions with a recognised psychological treatment were associated with small reductions in suicidal ideation (SMD, -0.15 [95%CI -0.19 to -0.11]). CC was more effective for reducing suicidal ideation among patients aged over 65 years (SMD, - 0.18 [95%CI -0.25 to -0.11]). Primary care based CC with an embedded psychological intervention is the most effective CC framework for reducing suicidal ideation and older patients may benefit the most. [Abstract copyright: Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.]

Key Points Question Is the use of accelerometers and/or pedometers associated with increased physical activity in people with cardiometabolic conditions? Findings This systematic review and meta-analysis of 32 randomized clinical trials (4856 participants) found that accelerometer- and pedometer-based interventions were associated with small to medium short-term improvements in physical activity and that consultations with health professionals and pedometers were associated with improved physical activity. Meaning Accelerometer- and pedometer-based interventions for people with cardiometabolic conditions have demonstrated encouraging results, but levels of physical activity remain below the targets set by clinical recommendations., This systematic review and meta-analysis examines the association of accelerometer- and pedometer-based interventions with increases in physical activity among participants with cardiometabolic conditions., Importance Accelerometers and pedometers are accessible technologies that could have a role in encouraging physical activity (PA) in line with current recommendations. However, there is no solid evidence of their association with PA in participants with 1 or more cardiometabolic conditions such as diabetes, prediabetes, obesity, and cardiovascular disease. Objectives To assess the association of accelerometer- and pedometer-based interventions with increased activity and other improved health outcomes in adults with cardiometabolic conditions and to examine characteristics of the studies that could influence the association of both interventions in improving PA. Data Sources Records from MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and PsycINFO were searched from inception until August 2018 with no language restriction. Study Selection Randomized clinical trials or cluster randomized clinical trials evaluating the use of wearable technology devices such as pedometers and accelerometers as motivating and monitoring tools for increasing PA were included. After removing duplicates, the searches retrieved 5762 references. Following abstract and title screening of 1439 references and full-text screening of 107 studies, 36 studies met inclusion criteria. Data Extraction and Synthesis Mean difference in PA was assessed by random-effects meta-analysis. Where the scale was different across studies, the standardized mean difference was used instead. Heterogeneity was quantified using the I2 statistic and explored using mixed-effects metaregression. This study was registered with PROSPERO and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Main Outcomes and Measures The primary outcome was objectively measured PA in the short to medium term (postintervention to 8 months’ follow-up). Results Thirty-six randomized clinical trials (20 using accelerometers and 16 using pedometers) involving 5208 participants were eligible for review. Meta-analysis involving 32 of these trials (4856 participants) showed medium improvements in PA: accelerometers and pedometers combined vs comparator showed a small significant increase in PA overall (standardized mean difference, 0.39 [95% CI, 0.28-0.51]; I2 = 60% [95% CI, 41%-73%]) in studies of short to medium follow-up over a mean (SD) of 32 (28.6) weeks. Multivariable metaregression showed improved association with PA for complex interventions that involved face-to-face consultation sessions with facilitators (β = 0.36; 95% CI, 0.17-0.55; P

ObjectiveTo compare the efficacy of different statin treatments by intensity on levels of non-high density lipoprotein cholesterol (non-HDL-C) for the prevention of cardiovascular disease in people with diabetes.DesignSystematic review and network meta-analysis.Data sourcesMedline, Cochrane Central Register of Controlled Trials, and Embase from inception to 1 December 2021.Review methodsRandomised controlled trials comparing different types and intensities of statins, including placebo, in adults with type 1 or type 2 diabetes mellitus were included. The primary outcome was changes in levels of non-HDL-C, calculated from measures of total cholesterol and HDL-C. Secondary outcomes were changes in levels of low density lipoprotein cholesterol (LDL-C) and total cholesterol, three point major cardiovascular events (non-fatal stroke, non-fatal myocardial infarction, and death related to cardiovascular disease), and discontinuations because of adverse events. A bayesian network meta-analysis of statin intensity (low, moderate, or high) with random effects evaluated the treatment effect on non-HDL-C by mean differences and 95% credible intervals. Subgroup analysis of patients at greater risk of major cardiovascular events was compared with patients at low or moderate risk. The confidence in network meta-analysis (CINeMA) framework was applied to determine the certainty of evidence.ResultsIn 42 randomised controlled trials involving 20 193 adults, 11 698 were included in the meta-analysis. Compared with placebo, the greatest reductions in levels of non-HDL-C were seen with rosuvastatin at high (−2.31 mmol/L, 95% credible interval −3.39 to −1.21) and moderate (−2.27, −3.00 to −1.49) intensities, and simvastatin (−2.26, −2.99 to −1.51) and atorvastatin (−2.20, −2.69 to −1.70) at high intensity. Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C. In 4670 patients at greater risk of a major cardiovascular events, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (−1.98, −4.16 to 0.26, surface under the cumulative ranking curve 64%). Simvastatin (−1.93, −2.63 to −1.21) and rosuvastatin (−1.76, −2.37 to −1.15) at high intensity were the most effective treatment options for reducing LDL-C. Significant reductions in non-fatal myocardial infarction were found for atorvastatin at moderate intensity compared with placebo (relative risk=0.57, confidence interval 0.43 to 0.76, n=4 studies). No significant differences were found for discontinuations, non-fatal stroke, and cardiovascular deaths.ConclusionsThis network meta-analysis indicated that rosuvastatin, at moderate and high intensity doses, and simvastatin and atorvastatin, at high intensity doses, were most effective at moderately reducing levels of non-HDL-C in patients with diabetes. Given the potential improvement in accuracy in predicting cardiovascular disease when reduction in levels of non-HDL-C is used as the primary target, these findings provide guidance on which statin types and intensities are most effective by reducing non-HDL-C in patients with diabetes.Systematic review registrationPROSPERO CRD42021258819.

BackgroundNaltrexone is an opioid antagonist used in many different conditions, both licensed and unlicensed. It is used at widely varying doses from 3 to 250 mg. The aim of this review was to extensively evaluate the safety of oral naltrexone by examining the risk of serious adverse events and adverse events in randomised controlled trials of naltrexone compared to placebo.MethodsA systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, other databases and clinical trials registries was undertaken up to May 2018. Parallel placebo-controlled randomised controlled trials longer than 4 weeks published after 1 January 2001 of oral naltrexone at any dose were selected. Any condition or age group was included, excluding only studies in opioid or ex-opioid users owing to possible opioid/opioid antagonist interactions. The systematic review used the guidance of the Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-analyses harms checklist throughout. Numerical data were independently extracted by two people and cross-checked. Risk of bias was assessed with the Cochrane risk-of-bias tool. Meta-analyses were performed in R using random effects models throughout.ResultsEighty-nine randomised controlled trials with 11,194 participants were found, studying alcohol use disorders (n = 38), various psychiatric disorders (n = 13), impulse control disorders (n = 9), other addictions including smoking (n = 18), obesity or eating disorders (n = 6), Crohn’s disease (n = 2), fibromyalgia (n = 1) and cancers (n = 2). Twenty-six studies (4,960 participants) recorded serious adverse events occurring by arm of study. There was no evidence of increased risk of serious adverse events for naltrexone compared to placebo (risk ratio 0.84, 95% confidence interval 0.66–1.06). Sensitivity analyses pooling risk differences supported this conclusion (risk difference −0.01, 95% confidence interval −0.02–0.00) and subgroup analyses showed that results were consistent across different doses and disease groups. Secondary analysis revealed only six marginally significant adverse events for naltrexone compared to placebo, which were of mild severity.ConclusionsNaltrexone does not appear to increase the risk of serious adverse events over placebo. These findings confirm the safety of oral naltrexone when used in licensed indications and encourage investments to undertake efficacy studies in unlicensed indications.

Importance - Accelerometers and pedometers are accessible technologies that could have a role in encouraging physical activity (PA) in line with current recommendations. However, there is no solid evidence of their association with PA in participants with 1 or more cardiometabolic conditions such as diabetes, prediabetes, obesity, and cardiovascular disease.\ud \ud Objectives - To assess the association of accelerometer- and pedometer-based interventions with increased activity and other improved health outcomes in adults with cardiometabolic conditions and to examine characteristics of the studies that could influence the association of both interventions in improving PA.\ud \ud Data Sources - Records from MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and PsycINFO were searched from inception until August 2018 with no language restriction.\ud \ud Study Selection - Randomized clinical trials or cluster randomized clinical trials evaluating the use of wearable technology devices such as pedometers and accelerometers as motivating and monitoring tools for increasing PA were included. After removing duplicates, the searches retrieved 5762 references. Following abstract and title screening of 1439 references and full-text screening of 107 studies, 36 studies met inclusion criteria.\ud \ud Data Extraction and Synthesis - Mean difference in PA was assessed by random-effects meta-analysis. Where the scale was different across studies, the standardized mean difference was used instead. Heterogeneity was quantified using the I2 statistic and explored using mixed-effects metaregression. This study was registered with PROSPERO and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.\ud \ud Main Outcomes and Measures - The primary outcome was objectively measured PA in the short to medium term (postintervention to 8 months’ follow-up).\ud \ud Results - Thirty-six randomized clinical trials (20 using accelerometers and 16 using pedometers) involving 5208 participants were eligible for review. Meta-analysis involving 32 of these trials (4856 participants) showed medium improvements in PA: accelerometers and pedometers combined vs comparator showed a small significant increase in PA overall (standardized mean difference, 0.39 [95% CI, 0.28-0.51]; I2 = 60% [95% CI, 41%-73%]) in studies of short to medium follow-up over a mean (SD) of 32 (28.6) weeks. Multivariable metaregression showed improved association with PA for complex interventions that involved face-to-face consultation sessions with facilitators (β = 0.36; 95% CI, 0.17-0.55; P

Objective To compare the different self-management models (multidisciplinary case management, regularly supported self-management, and minimally supported self-management) and self-monitoring models against usual care and education to determine which are most effective at reducing healthcare use and improving quality of life in asthma. Design Systematic review and network meta-analysis. Data sources Medline, the Cochrane Library, CINAHL, EconLit, Embase, Health Economics Evaluations Database, NHS Economic Evaluation Database, PsycINFO, and ClinicalTrials.gov from January 2000 to April 2019. Review methods Randomised controlled trials involving the different self-management models for asthma were included. The primary outcomes were healthcare use (hospital admission or emergency visit) and quality of life. Summary standardised mean differences (SMDs) and 95% credible intervals were estimated using bayesian network meta-analysis with random effects. Heterogeneity and publication bias were assessed. Results From 1178 citations, 105 trials comprising 27 767 participants were included. In terms of healthcare use, both multidisciplinary case management (SMD –0.18, 95% credible interval −0.32 to −0.05) and regularly supported self-management (–0.30, −0.46 to −0.15) were significantly better than usual care. For quality of life, only regularly supported self-management (SMD 0.54, 0.11 to 0.96) showed a statistically significant benefit compared with usual care. For trials including adolescents/children (age 5-18 years), only regularly supported self-management showed statistically significant benefits (healthcare use: SMD –0.21, −0.40 to −0.03; quality of life: 0.23, 0.03 to 0.48). Multidisciplinary case management (SMD –0.32, −0.50 to −0.16) and regularly supported self-management (–0.32, −0.53 to −0.11) were most effective at reducing healthcare use in patients with symptoms of severe asthma at baseline. Conclusions This network meta-analysis indicates that regularly supported self-management reduces the use of healthcare resources and improves quality of life across all levels of asthma severity. Future healthcare investments should provide support that offer reviews totalling at least two hours to establish self-management skills, reserving multidisciplinary case management for patients with complex disease. Systematic review registration PROSPERO number CRD42019121350.

Financial satisfaction is considered to be one of the determinants of Subjective well-being (SWB), yet the assumption that financial satisfaction is closely associated with SWB has not been tested across nations. This first systematic review and meta-analysis examines the association between financial satisfaction and SWB and tests whether any association is affected by key operational and methodological factors. Following Cochrane and PRISMA guidelines, a systematic (Web of Science, Medline, Embase, PsycINFO and Google scholar) search was conducted (January 1980 to August 2019). Meta-analyses, meta-regressions and subgroup analysis using random-effects models were performed. 24 studies were included in the meta-analysis and the overall association between financial satisfaction and SWB was medium, significant and positive (pooled r= 0.41, 95% CI= 0.38 to 0.44; Q= 7108, I2= 99.7 %, p

Importance: Physician burnout has taken the form of an epidemic that may affect core domains of health care delivery, including patient safety, quality of care, and patient satisfaction. However, this evidence has not been systematically quantified. Objective: To examine whether physician burnout is associated with an increased risk of patient safety incidents, suboptimal care outcomes due to low professionalism, and lower patient satisfaction. Data Sources: MEDLINE, EMBASE, PsycInfo, and CINAHL databases were searched until October 22, 2017, using combinations of the key terms physicians, burnout, and patient care. Detailed standardized searches with no language restriction were undertaken. The reference lists of eligible studies and other relevant systematic reviews were hand-searched. Study Selection: Quantitative observational studies. Data Extraction and Synthesis: Two independent reviewers were involved. The main meta-analysis was followed by subgroup and sensitivity analyses. All analyses were performed using random-effects models. Formal tests for heterogeneity (I2) and publication bias were performed. Main Outcomes and Measures: The core outcomes were the quantitative associations between burnout and patient safety, professionalism, and patient satisfaction reported as odds ratios (ORs) with their 95% CIs. Results: Of the 5234 records identified, 47 studies on 42 473 physicians (25 059 [59.0%] men; median age, 38 years [range, 27-53 years]) were included in the meta-analysis. Physician burnout was associated with an increased risk of patient safety incidents (OR, 1.96; 95% CI, 1.59-2.40), poorer quality of care due to low professionalism (OR, 2.31; 95% CI, 1.87-2.85), and reduced patient satisfaction (OR, 2.28; 95% CI, 1.42-3.68). The heterogeneity was high and the study quality was low to moderate. The links between burnout and low professionalism were larger in residents and early-career (≤5 years post residency) physicians compared with middle- and late-career physicians (Cohen Q = 7.27; P = .003). The reporting method of patient safety incidents and professionalism (physician-reported vs system-recorded) significantly influenced the main results (Cohen Q = 8.14; P = .007). Conclusions and Relevance: This meta-analysis provides evidence that physician burnout may jeopardize patient care; reversal of this risk has to be viewed as a fundamental health care policy goal across the globe. Health care organizations are encouraged to invest in efforts to improve physician wellness, particularly for early-career physicians. The methods of recording patient care quality and safety outcomes require improvements to concisely capture the outcome of burnout on the performance of health care organizations.

Reporting bias is a major threat to the validity and credibility of systematic reviews. This article outlines the rationale for accessing clinical study reports and other regulatory documents (regulatory data) as a means of addressing reporting bias and identifies factors that may help decide whether (or not) to include regulatory data in systematic reviews. The article also describes the origins and current state of regulatory data access and summarises a survey of current systematic reviewers’ practices in considering regulatory data for inclusion in systematic reviews. How to access and extract regulatory data is not addressed. Organisations and other stakeholders such as Cochrane should encourage the use of data from clinical study reports as an important source of data in reviews of pharmaceutical interventions particularly when the intervention in question is of high importance and the risk of reporting bias is great.

Background Clinical study reports (CSRs) are produced for marketing authorisation applications. They often contain considerably more information about, and data from, clinical trials than corresponding journal publications. Use of data from CSRs might help circumvent reporting bias, but many researchers appear to be unaware of their existence or potential value. Our survey aimed to gain insight into the level of familiarity, understanding and use of CSRs, and to raise awareness of their potential within the systematic review community. We also aimed to explore the potential barriers faced when obtaining and using CSRs in systematic reviews. Methods Online survey of systematic reviewers who (i) had requested or used CSRs, (ii) had considered but not used CSRs and (iii) had not considered using CSRs was conducted. Cochrane reviewers were contacted twice via the Cochrane monthly digest. Non-Cochrane reviewers were reached via journal and other website postings. Results One hundred sixty respondents answered an open invitation and completed the questionnaire; 20/160 (13%) had previously requested or used CSRs and other regulatory documents, 7/160 (4%) had considered but not used CSRs and 133/160 (83%) had never considered this data source. Survey respondents mainly sought data from the European Medicines Agency (EMA) and/or the Food and Drug Administration (FDA). Motivation for using CSRs stemmed mainly from concerns about reporting bias 11/20 (55%), specifically outcome reporting bias 11/20 (55%) and publication bias 5/20 (25%). The barriers to using CSRs noted by all types of respondents included current limited access to these documents (43 respondents), the time and resources needed to obtain and include these data in evidence syntheses (n = 25) and lack of guidance about how to use these sources in systematic reviews (n = 26). Conclusions Most respondents (irrespective of whether they had previously used them) agreed that access to CSRs is important, and suggest that further guidance on how to use and include these data would help to promote their use in future systematic reviews. Most respondents who received CSRs considered them to be valuable in their systematic review and/or meta-analysis. Electronic supplementary material The online version of this article (10.1186/s13643-018-0766-x) contains supplementary material, which is available to authorized users.

Objective To determine the standard of reporting of harms-related data, in randomised controlled trials (RCTs) according to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for harms. Design Systematic review. Data sources The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature. Eligibility criteria for selecting studies We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs. Results We identified 7 studies which included between 10 and 205 RCTs. The clinical areas of the 7 studies were: hypertension (1), urology (1), epilepsy (1), complimentary medicine (2) and two not restricted to a clinical topic. Quality of the 7 studies was assessed by a risk of bias tool and was found to be variable. Adherence to the CONSORT harms criteria reported in the 7 studies was inadequate and variable across the items in the checklist. Adverse events are poorly defined, with 6 studies failing to exceed 50% adherence to the items in the checklist. Conclusions Readers of RCT publications need to be able to balance the trade-offs between benefits and harms of interventions. This systematic review suggests that this is compromised due to poor reporting of harms which is evident across a range of clinical areas. Improvements in quality could be achieved by wider adoption of the CONSORT harms criteria by journals reporting RCTs.