Psychosocial interventions for cancer survivors: A meta-analysis of effects on positive affect.

PURPOSE: Positive affect has demonstrated unique benefits in the context of health-related stress and is emerging as an important target for psychosocial interventions. The primary objective of this meta-analysis was to determine whether psychosocial interventions increase positive affect in cancer survivors. METHODS: We coded 28 randomized controlled trials of psychosocial interventions assessing 2082 cancer survivors from six electronic databases. We calculated 76 effect sizes for positive affect and conducted synthesis using random effects models with robust variance estimation. Tests for moderation included demographic, clinical, and intervention characteristics. RESULTS: Interventions had a modest effect on positive affect (g = 0.35, 95% CI [0.16, 0.54]) with substantial heterogeneity of effects across studies ([Formula: see text]; I2 = 78%). Three significant moderators were identified: in-person interventions outperformed remote interventions (P = .046), effects were larger when evaluated against standard of care or wait list control conditions versus attentional, educational, or component controls (P = .009), and trials with survivors of early-stage cancer diagnoses yielded larger effects than those with advanced-stage diagnoses (P = .046). We did not detect differential benefits of psychosocial interventions across samples varying in sex, age, on-treatment versus off-treatment status, or cancer type. Although no conclusive evidence suggested outcome reporting biases (P = .370), effects were smaller in studies with lower risk of bias. CONCLUSIONS: In-person interventions with survivors of early-stage cancers hold promise for enhancing positive affect, but more methodological rigor is needed. IMPLICATIONS FOR CANCER SURVIVORS: Positive affect strategies can be an explicit target in evidence-based medicine and have a role in patient-centered survivorship care, providing tools to uniquely mobilize human strengths.

Hospital-Based Quality Improvement Interventions for Patients With Acute Coronary Syndrome: A Systematic Review.

BACKGROUND: Quality improvement initiatives have been developed to improve acute coronary syndrome care largely in high-income country settings. We sought to synthesize the effect size and quality of evidence from randomized controlled trials (RCTs) and nonrandomized studies for hospital-based acute coronary syndrome quality improvement interventions on clinical outcomes and process of care measures for their potential implementation in low- and middle-income country settings. METHODS AND RESULTS: We conducted a bibliometric search of databases and trial registers and a hand search in 2016 and performed an updated search in May 2018 and May 2019. We performed data extraction, risk of bias assessment, and quality of evidence assessments in duplicate. We assessed differences in outcomes by study design comparing RCTs to nonrandomized quasi-experimental studies and by country income status. A meta-analysis was not feasible due to substantial, unexplained heterogeneity among the included studies, and thus, we present a qualitative synthesis. We screened 5858 records and included 32 studies (14 RCTs [n=109 763] and 18 nonrandomized quasi-experimental studies [n=54-423]). In-hospital mortality ranged from 2.1% to 4.8% in the intervention groups versus 3.3% to 5.1% in the control groups in 5 RCTs (n=55 942). Five RCTs (n=64 313) reported 3.0% to 31.0% higher rates of reperfusion for patients with ST-segment-elevation myocardial infarction in the intervention groups. The effect sizes for in-hospital and discharge medical therapies in a majority of RCTs were 3.0% to 10.0% higher in the intervention groups. There was no significant difference in 30-day mortality evaluated by 4 RCTs (n=42 384), which reported 2.5% to 15.0% versus 5.9% to 22% 30-day mortality rates in the intervention versus control groups. In contrast, nonrandomized quasi-experimental studies reported larger effect sizes compared to RCTs. There were no significant consistent differences in outcomes between high-income and middle-income countries. Low-income countries were not represented in any of the included studies. CONCLUSIONS: Hospital-based acute coronary syndrome quality improvement interventions have a modest effect on process of care measures but not on clinical outcomes with expected differences by study design. Although quality improvement programs have an ongoing and important role for acute coronary syndrome quality of care in high-income country settings, further research will help to identify key components for contextualizing and implementing such interventions to new settings to achieve their desired effects. Systematic Review Registration: URL: https://www.crd.york.ac.uk/PROSPERO/. Unique identifier: CRD42016047604.

Interventions to enhance self-efficacy in cancer patients: A meta-analysis of randomized controlled trials.

OBJECTIVE: Self-efficacy expectations are associated with improvements in problematic outcomes widely considered clinically significant (ie, emotional distress, fatigue, and pain), related to positive health behaviors, and as a type of personal agency, inherently valuable. Self-efficacy expectancies, estimates of confidence to execute behaviors, are important in that changes in self-efficacy expectations are positively related to future behaviors that promote health and well-being. The current meta-analysis investigated the impact of psychological interventions on self-efficacy expectations for a variety of health behaviors among cancer patients. METHODS: Ovid Medline, PsycINFO, CINAHL, EMBASE, Cochrane Library, and Web of Science were searched with specific search terms for identifying randomized controlled trials (RCTs) that focused on psychologically based interventions. Included studies had (a) an adult cancer sample, (b) a self-efficacy expectation measure of specific behaviors, and (c) an RCT design. Standard screening and reliability procedures were used for selecting and coding studies. Coding included theoretically informed moderator variables. RESULTS: Across 79 RCTs, 223 effect sizes, and 8678 participants, the weighted average effect of self-efficacy expectations was estimated as g = 0.274 (P < .001). Consistent with the self-efficacy theory, the average effect for in-person intervention delivery (g = 0.329) was significantly greater than for all other formats (g = 0.154, P = .023; eg, audiovisual, print, telephone, and Web/internet). CONCLUSIONS: The results establish the impact of psychological interventions on self-efficacy expectations as comparable in effect size with commonly reported outcomes (distress, fatigue, pain). Additionally, the result that in-person interventions achieved the largest effect is supported by the social learning theory and could inform research related to the development and evaluation of interventions.

Systematic review of orthoses for stroke-induced upper extremity deficits.

Background: Orthoses for individuals with stroke is considered an integral part of the neurorehabilitation process. However, there are no universal guidelines to determine the initiation period, duration, or type of orthosis for stroke patients. Objectives: For this study, we systematically reviewed the evidence surrounding the use of orthoses for stroke-related upper extremity deficits. Methods: Medical librarians searched MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, Health Technology Assessment Database, Physiotherapy Evidence Database, and OTSeeker using subject headings and keywords related to upper extremities, orthoses, and stroke. The resulting articles were evaluated for inclusion by the systematic review team. Articles that met the inclusion criteria were appraised for content and quality using the "Evaluation Guidelines for Rating the Quality of an Intervention Study" (EQIS). Results: 14 studies were included, with the mean score of 31.29 (out of 48) for the EQIS using an ordinal scale with a range of 23-43.6 studies produced significant outcomes with effect sizes ranging from d = .52 (wrist flexion PROM) to d = 9.02 (patient satisfaction with orthosis). Conclusion: Future studies should aim to utilize homogenous outcome measures while exploring variability in dosage and level of upper extremity impairment upon initiation. Additionally, universal guidelines for initiation period, duration, and type of orthosis for patients post-stroke need to be established.

Effects of psychosocial interventions on meaning and purpose in adults with cancer: A systematic review and meta-analysis.

Meaning and purpose in life are associated with the mental and physical health of patients with cancer and survivors and also constitute highly valued outcomes in themselves. Because meaning and purpose are often threatened by a cancer diagnosis and treatment, interventions have been developed to promote meaning and purpose. The present meta-analysis of randomized controlled trials (RCTs) evaluated effects of psychosocial interventions on meaning/purpose in adults with cancer and tested potential moderators of intervention effects. Six literature databases were systematically searched to identify RCTs of psychosocial interventions in which meaning or purpose was an outcome. Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, rater pairs extracted and evaluated data for quality. Findings were synthesized across studies with standard meta-analytic methods, including meta-regression with robust variance estimation and risk-of-bias sensitivity analysis. Twenty-nine RCTs were identified, and they encompassed 82 treatment effects among 2305 patients/survivors. Psychosocial interventions were associated with significant improvements in meaning/purpose (g = 0.37; 95% CI, 0.22-0.52; P < .0001). Interventions designed to enhance meaning/purpose (g = 0.42; 95% CI, 0.24-0.60) demonstrated significantly higher effect sizes than those targeting other primary outcomes (g = 0.18; 95% CI, 0.09-0.27; P = .009). Few other intervention, clinical, or demographic characteristics tested were significant moderators. In conclusion, the results suggest that psychosocial interventions are associated with small to medium effects in enhancing meaning/purpose among patients with cancer, and the benefits are comparable to those of interventions designed to reduce depression, pain, and fatigue in patients with cancer. Methodological concerns include small samples and ambiguity regarding allocation concealment. Future research should focus on explicitly meaning-centered interventions and identify optimal treatment or survivorship phases for implementation.

Hospital-based quality improvement interventions for patients with heart failure: a systematic review.

OBJECTIVE: To estimate the direction and magnitude of effect and quality of evidence for hospital-based heart failure (HF) quality improvement interventions on process of care measures and clinical outcomes among patients with acute HF. REVIEW METHODS: We performed a structured search to identify relevant randomised trials evaluating the effect of in-hospital quality improvement interventions for patients hospitalised with HF through February 2017. Studies were independently reviewed in duplicate for key characteristics, outcomes were summarised and a qualitative synthesis was performed due to substantial heterogeneity. RESULTS: From 3615 records, 14 randomised controlled trials were identified for inclusion with multifaceted interventions. There was a trend towards higher in-hospital use of ACE inhibitors (ACE-I; 57.9%vs40.0%) and beta-blockers (BBs; 46.7%vs10.2%) in the intervention than the comparator in one trial (n=429 participants). Five trials (n=78 727 participants) demonstrated no effect of the intervention on use of ACE-I or angiotensin receptor blocker at discharge. Three trials (n=89 660 participants) reported no effect on use of BB at discharge. Two trials (n=419 participants) demonstrated a trend towards lower hospital readmission up to 90 days after discharge. There was no consistent effect of the quality improvement intervention on 30-day all-cause mortality, hospital length of stay and patient-level health-related quality of life. CONCLUSIONS: Randomised trials of hospital-based HF quality improvement interventions do not show a consistent effect on most process of care measures and clinical outcomes. The overall quality of evidence for the prespecified primary and key secondary outcomes was very low to moderate, suggesting that future research will likely influence these estimates. TRIAL REGISTRATION NUMBER: CRD42016049545.

Presentation, Evaluation, Management, and Outcomes of Acute Stroke in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis.

AIMS: We performed a systematic review to evaluate stroke presentation, evaluation, management, and outcomes among studies conducted in low- and middle-income countries (LMIC). METHODS: We searched MEDLINE (Ovid), Embase (Elsevier), and the Global Health (EBSCOhost) databases between January 2005 and June 2017 for studies conducted in LMICs defined by the World Bank. We pooled prevalence estimates using an inverse-variance weighting method and stratified by the country income group. RESULTS: The search identified 36 hospital-based studies (64,256 participants) in LMICs. Mean (SD) age ranged from 51 (14) to 72 (12) years, and 29-56% of patients were women. Hypertension was the most commonly reported risk factor (64% [95% CI 59-69]). In settings where MRI was not used, head CT scans were reported among 90% patients (95% CI 79-97). Overall, 3% (95% CI 2-4) of patients were treated with tissue plasminogen activator, and 78% (95% CI 66-88) were treated with antiplatelet therapy. Overall, the rate of in-hospital mortality was 14% (95% CI 10-19), and the rate of in-hospital pneumonia was 17% (95% CI 14-20). CONCLUSIONS: Our review revealed the low use of evidence-based practices for acute stroke care in LMIC. The true use in hospitals that do not conduct this research is probably even lower. Strategies to evaluate and improve health system performance for acute stroke care, including implantation of stroke units and making thrombolysis more available and affordable are needed in LMIC. Registration in Prospero: CRD42017069325.

Feeling validated yet? A scoping review of the use of consumer-targeted wearable and mobile technology to measure and improve sleep.

The objectives of this review were to evaluate the use of consumer-targeted wearable and mobile sleep monitoring technology, identify gaps in the literature and determine the potential for use in behavioral interventions. We undertook a scoping review of studies conducted in adult populations using consumer-targeted wearable technology or mobile devices designed to measure and/or improve sleep. After screening for inclusion/exclusion criteria, data were extracted from the articles by two co-authors. Articles included in the search were using wearable or mobile technology to estimate or evaluate sleep, published in English and conducted in adult populations. Our search returned 3897 articles and 43 met our inclusion criteria. Results indicated that the majority of studies focused on validating technology to measure sleep (n = 23) or were observational studies (n = 10). Few studies were used to identify sleep disorders (n = 2), evaluate response to interventions (n = 3) or deliver interventions (n = 5). In conclusion, the use of consumer-targeted wearable and mobile sleep monitoring technology has largely focused on validation of devices and applications compared with polysomnography (PSG) but opportunities exist for observational research and for delivery of behavioral interventions. Multidisciplinary research is needed to determine the uses of these technologies in interventions as well as the use in more diverse populations including sleep disorders and other patient populations.

Natural Language Processing for EHR-Based Pharmacovigilance: A Structured Review.

The goal of pharmacovigilance is to detect, monitor, characterize and prevent adverse drug events (ADEs) with pharmaceutical products. This article is a comprehensive structured review of recent advances in applying natural language processing (NLP) to electronic health record (EHR) narratives for pharmacovigilance. We review methods of varying complexity and problem focus, summarize the current state-of-the-art in methodology advancement, discuss limitations and point out several promising future directions. The ability to accurately capture both semantic and syntactic structures in clinical narratives becomes increasingly critical to enable efficient and accurate ADE detection. Significant progress has been made in algorithm development and resource construction since 2000. Since 2012, statistical analysis and machine learning methods have gained traction in automation of ADE mining from EHR narratives. Current state-of-the-art methods for NLP-based ADE detection from EHRs show promise regarding their integration into production pharmacovigilance systems. In addition, integrating multifaceted, heterogeneous data sources has shown promise in improving ADE detection and has become increasingly adopted. On the other hand, challenges and opportunities remain across the frontier of NLP application to EHR-based pharmacovigilance, including proper characterization of ADE context, differentiation between off- and on-label drug-use ADEs, recognition of the importance of polypharmacy-induced ADEs, better integration of heterogeneous data sources, creation of shared corpora, and organization of shared-task challenges to advance the state-of-the-art.

Radiotherapy for cranial and brain metastases from prostate cancer: a systematic review.

Intracranial metastasis from prostate cancer is rare. As treatment of castration-resistant prostate cancer improves, the incidence of men with intracranial metastasis from prostate cancer is increasing. Radiation therapy for treatment of intracranial metastasis from prostate cancer is systematically reviewed. A comprehensive review examining peer-reviewed, English language articles from 1990 to 2015 was performed on multiple databases, yielding 1274 articles. These articles were reviewed and selected for studies that met the following inclusion criteria: (1) patients with intracranial metastases from prostate cancer; (2) patients underwent radiation therapy as primary or adjuvant therapy; (3) the sample size of patients was larger than 2. All studies that met inclusion criteria utilized whole-brain radiation therapy (WBRT) in at least one patient. Other treatment regimens included stereotactic radiosurgery (SRS), surgical resection followed by WBRT, as well as concurrent cabazitaxel and WBRT. The range of average time from initial diagnosis of prostate cancer to diagnosis of brain metastasis was 29-45 months. The range of reported median survival time after WBRT was 4-9 months, whereas median survivals after SRS ranged from 9 to 13 months. Intracranial metastases from prostate cancer occur late in the disease process, and are increasing as novel therapies for metastatic disease prolong survival. The reviewed literature suggests that outcomes of patients with prostate cancer intracranial metastases appear similar to those of intracranial metastases from other histologies. Prospective examinations of systemic therapies that cross the blood-brain barrier in conjunction with targeted radiotherapy appear warranted for this increasingly common clinical problem.

Pre-hospital policies for the care of patients with acute coronary syndromes in India: A policy document analysis.

BACKGROUND AND OBJECTIVE: Ischemic heart disease is the leading cause of death in India. In high-income countries, pre-hospital systems of care have been developed to manage acute manifestations of ischemic heart disease, such as acute coronary syndrome (ACS). However, it is unknown whether guidelines, policies, regulations, or laws exist to guide pre-hospital ACS care in India. We undertook a nation-wide document analysis to address this gap in knowledge. METHODS AND RESULTS: From November 2014 to May 2016, we searched for publicly available emergency care guidelines and legislation addressing pre-hospital ACS care in all 29 Indian states and 7 Union Territories via Internet search and direct correspondence. We found two documents addressing pre-hospital ACS care. CONCLUSION: Though India has legislation mandating acute care for emergencies such as trauma, regulations or laws to guide pre-hospital ACS care are largely absent. Policy makers urgently need to develop comprehensive, multi-stakeholder policies for pre-hospital emergency cardiovascular care in India.

Risk scoring for the primary prevention of cardiovascular disease.

BACKGROUND: The current paradigm for cardiovascular disease (CVD) emphasises absolute risk assessment to guide treatment decisions in primary prevention. Although the derivation and validation of multivariable risk assessment tools, or CVD risk scores, have attracted considerable attention, their effect on clinical outcomes is uncertain. OBJECTIVES: To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes, risk factor levels, preventive medication prescribing, and health behaviours. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (2016, Issue 2), MEDLINE Ovid (1946 to March week 1 2016), Embase (embase.com) (1974 to 15 March 2016), and Conference Proceedings Citation Index-Science (CPCI-S) (1990 to 15 March 2016). We imposed no language restrictions. We searched clinical trial registers in March 2016 and handsearched reference lists of primary studies to identify additional reports. SELECTION CRITERIA: We included randomised and quasi-randomised trials comparing the systematic provision of CVD risk scores by a clinician, healthcare professional, or healthcare system compared with usual care (i.e. no systematic provision of CVD risk scores) in adults without CVD. DATA COLLECTION AND ANALYSIS: Three review authors independently selected studies, extracted data, and evaluated study quality. We used the Cochrane 'Risk of bias' tool to assess study limitations. The primary outcomes were: CVD events, change in CVD risk factor levels (total cholesterol, systolic blood pressure, and multivariable CVD risk), and adverse events. Secondary outcomes included: lipid-lowering and antihypertensive medication prescribing in higher-risk people. We calculated risk ratios (RR) for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data using 95% confidence intervals. We used a fixed-effects model when heterogeneity (I²) was at least 50% and a random-effects model for substantial heterogeneity (I² > 50%). We evaluated the quality of evidence using the GRADE framework. MAIN RESULTS: We identified 41 randomised controlled trials (RCTs) involving 194,035 participants from 6422 reports. We assessed studies as having high or unclear risk of bias across multiple domains. Low-quality evidence evidence suggests that providing CVD risk scores may have little or no effect on CVD events compared with usual care (5.4% versus 5.3%; RR 1.01, 95% confidence interval (CI) 0.95 to 1.08; I² = 25%; 3 trials, N = 99,070). Providing CVD risk scores may reduce CVD risk factor levels by a small amount compared with usual care. Providing CVD risk scores reduced total cholesterol (MD -0.10 mmol/L, 95% CI -0.20 to 0.00; I² = 94%; 12 trials, N = 20,437, low-quality evidence), systolic blood pressure (MD -2.77 mmHg, 95% CI -4.16 to -1.38; I² = 93%; 16 trials, N = 32,954, low-quality evidence), and multivariable CVD risk (SMD -0.21, 95% CI -0.39 to -0.02; I² = 94%; 9 trials, N = 9549, low-quality evidence). Providing CVD risk scores may reduce adverse events compared with usual care, but results were imprecise (1.9% versus 2.7%; RR 0.72, 95% CI 0.49 to 1.04; I² = 0%; 4 trials, N = 4630, low-quality evidence). Compared with usual care, providing CVD risk scores may increase new or intensified lipid-lowering medications (15.7% versus 10.7%; RR 1.47, 95% CI 1.15 to 1.87; I² = 40%; 11 trials, N = 14,175, low-quality evidence) and increase new or increased antihypertensive medications (17.2% versus 11.4%; RR 1.51, 95% CI 1.08 to 2.11; I² = 53%; 8 trials, N = 13,255, low-quality evidence). AUTHORS' CONCLUSIONS: There is uncertainty whether current strategies for providing CVD risk scores affect CVD events. Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm. There were multiple study limitations in the identified studies and substantial heterogeneity in the interventions, outcomes, and analyses, so readers should interpret results with caution. New models for implementing and evaluating CVD risk scores in adequately powered studies are needed to define the role of applying CVD risk scores in primary CVD prevention.

Concomitant atrial fibrillation surgery for people undergoing cardiac surgery.

BACKGROUND: People with atrial fibrillation (AF) often undergo cardiac surgery for other underlying reasons and are frequently offered concomitant AF surgery to reduce the frequency of short- and long-term AF and improve short- and long-term outcomes. OBJECTIVES: To assess the effects of concomitant AF surgery among people with AF who are undergoing cardiac surgery on short-term and long-term (12 months or greater) health-related outcomes, health-related quality of life, and costs. SEARCH METHODS: Starting from the year when the first "maze" AF surgery was reported (1987), we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (March 2016), MEDLINE Ovid (March 2016), Embase Ovid (March 2016), Web of Science (March 2016), the Database of Abstracts of Reviews of Effects (DARE, April 2015), and Health Technology Assessment Database (HTA, March 2016). We searched trial registers in April 2016. We used no language restrictions. SELECTION CRITERIA: We included randomised controlled trials evaluating the effect of any concomitant AF surgery compared with no AF surgery among adults with preoperative AF, regardless of symptoms, who were undergoing cardiac surgery for another indication. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We evaluated the risk of bias using the Cochrane 'Risk of bias' tool. We included outcome data on all-cause and cardiovascular-specific mortality, freedom from atrial fibrillation, flutter, or tachycardia off antiarrhythmic medications, as measured by patient electrocardiographic monitoring greater than three months after the procedure, procedural safety, 30-day rehospitalisation, need for post-discharge direct current cardioversion, health-related quality of life, and direct costs. We calculated risk ratios (RR) for dichotomous data with 95% confidence intervals (CI) using a fixed-effect model when heterogeneity was low (I² ≤ 50%) and random-effects model when heterogeneity was high (I² > 50%). We evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to create a 'Summary of findings' table. MAIN RESULTS: We found 34 reports of 22 trials (1899 participants) with five additional ongoing studies and three studies awaiting classification. All included studies were assessed as having high risk of bias across at least one domain. The effect of concomitant AF surgery on all-cause mortality was uncertain when compared with no concomitant AF surgery (7.0% versus 6.6%, RR 1.14, 95% CI 0.81 to 1.59, I² = 0%, 20 trials, 1829 participants, low-quality evidence), but the intervention increased freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off antiarrhythmic medications > three months (51.0% versus 24.1%, RR 2.04, 95% CI 1.63 to 2.55, I² = 0%, eight trials, 649 participants, moderate-quality evidence). The effect of concomitant AF surgery on 30-day mortality was uncertain (2.3% versus 3.1%, RR 1.25 95% CI 0.71 to 2.20, I² = 0%, 18 trials, 1566 participants, low-quality evidence), but the intervention increased the risk of permanent pacemaker implantation (6.0% versus 4.1%, RR 1.69, 95% CI 1.12 to 2.54, I² = 0%, 18 trials, 1726 participants, moderate-quality evidence). Investigator-defined adverse events, including but limited to, need for surgical re-exploration or mediastinitis, were not routinely reported but were not different between the two groups (other adverse events: 24.8% versus 23.6%, RR 1.07, 95% CI 0.85 to 1.34, I² = 45%, nine trials, 858 participants), but the quality of this evidence was very low. AUTHORS' CONCLUSIONS: For patients with AF undergoing cardiac surgery, there is moderate-quality evidence that concomitant AF surgery approximately doubles the risk of freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off anti-arrhythmic drugs while increasing the risk of permanent pacemaker implantation. The effects on mortality are uncertain. Future, high-quality and adequately powered trials will likely affect the confidence on the effect estimates of AF surgery on clinical outcomes.

Drugs for Primary Prevention of Atherosclerotic Cardiovascular Disease: An Overview of Systematic Reviews.

IMPORTANCE: The Million Hearts initiative emphasizes ABCS (aspirin for high-risk patients, blood pressure [BP] control, cholesterol level management, and smoking cessation). Evidence of the effects of drugs used to achieve ABCS has not been synthesized comprehensively in the prevention of primary atherosclerotic cardiovascular disease (ASCVD). OBJECTIVE: To compare the efficacy and safety of aspirin, BP-lowering therapy, statins, and tobacco cessation drugs for fatal and nonfatal ASCVD outcomes in primary ASCVD prevention. EVIDENCE REVIEW: Structured search of the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database (HTA), MEDLINE, EMBASE, and PROSPERO International Prospective Systematic Review Trial Register to identify systematic reviews published from January 1, 2005, to June 17, 2015, that reported the effect of aspirin, BP-lowering therapy, statin, or tobacco cessation drugs on ASCVD events in individuals without prevalent ASCVD. Additional studies were identified by searching the reference lists of included systematic reviews, meta-analyses, and health technology assessment reports. Reviews were selected according to predefined criteria and appraised for methodologic quality using the Assessment of Multiple Systematic Reviews (AMSTAR) tool (range, 0-11). Studies were independently reviewed for key participant and intervention characteristics. Outcomes that were meta-analyzed in each included review were extracted. Qualitative synthesis was performed, and data were analyzed from July 2 to August 13, 2015. FINDINGS: From a total of 1967 reports, 35 systematic reviews of randomized clinical trials were identified, including 15 reviews of aspirin, 4 reviews of BP-lowering therapy, 12 reviews of statins, and 4 reviews of tobacco cessation drugs. Methodologic quality varied, but 30 reviews had AMSTAR ratings of 5 or higher. Compared with placebo, aspirin (relative risk [RR], 0.90; 95% CI, 0.85-0.96) and statins (RR, 0.75; 95% CI, 0.70-0.81) reduced the risk for ASCVD. Compared with placebo, BP-lowering therapy reduced the risk for coronary heart disease (RR, 0.84; 95% CI, 0.79-0.90) and stroke (RR, 0.64; 95% CI, 0.56-0.73). Tobacco cessation drugs increased the odds of continued abstinence at 6 months (odds ratio range, 1.82 [95% CI, 1.60-2.06] to 2.88 [95% CI, 2.40-3.47]), but the direct effects on ASCVD were poorly reported. Aspirin increased the risk for major bleeding (RR, 1.54; 95% CI, 1.30-1.82), and statins did not increase overall risk for adverse effects (RR, 1.00; 95% CI, 0.97-1.03). Adverse effects of BP-lowering therapy and tobacco cessation drugs were poorly reported. CONCLUSIONS AND RELEVANCE: This overview demonstrates high-quality evidence to support aspirin, BP-lowering therapy, and statins for primary ASCVD prevention and tobacco cessation drugs for smoking cessation. Treatment effects of each drug can be used to enrich discussions between health care professionals and patients in primary ASCVD prevention.

Implantable defibrillators versus medical therapy for cardiac channelopathies.

BACKGROUND: Sudden cardiac death is a significant cause of mortality in both the US and globally. However, 5% to 15% of people with sudden cardiac death have no structural abnormalities, and most of these events are attributed to underlying cardiac ion channelopathies. Rates of cardiac ion channelopathy diagnosis are increasing. However, the optimal treatment for such people is poorly understood and current guidelines rely primarily on expert opinion. OBJECTIVES: To compare the effect of implantable cardioverter defibrillators (ICD) with antiarrhythmic drugs or usual care in reducing the risk of all-cause mortality, fatal and non-fatal cardiovascular events, and adverse events in people with cardiac ion channelopathies. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 6), EMBASE, MEDLINE, Conference Proceedings Citation Index - Science (CPCI-S), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) in July 2015. We applied no language restrictions. SELECTION CRITERIA: We included all randomized controlled trials of people aged 18 years and older with ion channelopathies, including congenital long QT syndrome, congenital short QT syndrome, Brugada syndrome, or catecholaminergic polymorphic ventricular tachycardia. Participants must have been randomized to ICD implantation and compared to antiarrhythmic drug therapy or usual care. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion and extracted the data. We included all-cause mortality, fatal and non-fatal cardiovascular events, and adverse events for our primary outcome analyses and non-fatal cardiovascular events, rates of inappropriate ICD firing, quality of life, and cost for our secondary outcome analyses. We calculated risk ratios (RR) and associated 95% confidence intervals (CIs) for dichotomous outcomes, both for independent and pooled study analyses. MAIN RESULTS: From the 468 references identified after removing duplicates, we found two trials comprising 86 participants that met our inclusion criteria. Both trials included participants with Brugada syndrome who were randomized to ICD versus ß-blocker therapy for secondary prevention for sudden cardiac death. Both studies were small, were performed by the same investigators, and exhibited a high risk of bias across multiple domains. In the group randomized to ICD therapy, there was a nine-fold lower risk of mortality compared with people randomized to medical therapy (0% with ICD versus 18% with medical therapy; RR 0.11, 95% CI 0.01 to 0.83; 2 trials, 86 participants). There was low quality evidence of a difference in the rates of combined fatal and non-fatal cardiovascular events, and the results were imprecise (26% with ICD versus 18% with medical therapy; RR 1.49, 95% CI 0.66 to 3.34; 2 trials, 86 participants). The rates of adverse events were higher in the ICD group, but these results were imprecise (28% with ICD versus 10% with medical therapy; RR 2.44, 95% CI 0.92 to 6.44; 2 trials, 86 participants). For secondary outcomes, the risk of non-fatal cardiovascular events was higher in the ICD group, but these results were imprecise and were driven entirely by appropriate ICD-termination of cardiac arrhythmias (26% with ICD versus 0% with medical therapy; RR 11.4, 95% CI 1.57 to 83.3; 2 trials, 86 participants). Approximately 25% of the ICD group experienced inappropriate ICD firing, all of which was corrected by device reprogramming. No data were available for quality of life or cost. We considered the quality of evidence low using the GRADE methodology, due to study limitations and imprecision of effects. AUTHORS' CONCLUSIONS: Among people with Brugada syndrome who have survived a prior episode of sudden cardiac death, ICD therapy appeared to reduce mortality when compared to ß-blocker therapy, but the true magnitude may be substantially different from the estimate of the effect because of study limitations and imprecision. Due to the large magnitude of effect, it is unlikely that there will be additional studies evaluating the role of ICDs for secondary prevention in this population. Further studies are necessary to determine the optimal treatment, if any, to prevent an initial episode of sudden cardiac death in people with cardiac ion channelopathies.

Control condition design and implementation features in controlled trials: a meta-analysis of trials evaluating psychotherapy for depression.

ABSTRACT: Control conditions are the primary methodology used to reduce threats to internal validity in randomized controlled trials (RCTs). This meta-analysis examined the effects of control arm design and implementation on outcomes in RCTs examining psychological treatments for depression. A search of MEDLINE, PsycINFO, and EMBASE identified all RCTs evaluating psychological treatments for depression published through June 2009. Data were analyzed using mixed-effects models. One hundred twenty-five trials were identified yielding 188 comparisons. Outcomes varied significantly depending control condition design (p < 0.0001). Significantly smaller effect sizes were seen when control arms used manualization (p = 0.006), therapist training (p = 0.002), therapist supervision (p = 0.009), and treatment fidelity monitoring (p = 0.003). There were no significant effects for differences in therapist experience, level of expertise in the treatment delivered, or nesting vs. crossing therapists in treatment arms. These findings demonstrate the substantial effect that decisions regarding control arm definition and implementation can have on RCT outcomes.

Meta-analysis of efficacy of interventions for elevated depressive symptoms in adults diagnosed with cancer.

BACKGROUND: Cancer patients are at increased risk for depression compared with individuals with no cancer diagnosis, yet few interventions target depressed cancer patients. METHODS: Efficacy of psychotherapeutic and pharmacologic interventions for depression in cancer patients who met an entry threshold for depressive symptoms was examined by meta-analysis. Five electronic databases were systematically reviewed to identify randomized controlled trials meeting the selection criteria. Effect sizes were calculated using Hedges' g and were pooled to compare pre- and postrandomization depressive symptoms with a random effects model. Subgroup analyses tested moderators of effect sizes, such as comparison of different intervention modalities, with a mixed effects model. All statistical tests were two-sided. RESULTS: Ten randomized controlled trials (six psychotherapeutic and four pharmacologic studies) met the selection criteria; 1362 participants with mixed cancer types and stages had been randomly assigned to treatment groups. One outlier trial was removed from analyses. The random effects model showed interventions to be superior to control conditions on reducing depressive symptoms postintervention (Hedges' g = 0.43, 95% confidence interval = 0.30 to 0.56, P < .001). In the four psychotherapeutic trials with follow-up assessment, interventions were more effective than control conditions up to 12-18 months after patients were randomly assigned to treatment groups (P < .001). Although each approach was more effective than the control conditions in improving depressive symptoms (P < .001), subgroup analyses showed that cognitive behavioral therapy appeared more effective than problem-solving therapy (P = .01), but not more effective than pharmacologic intervention (P = .07). CONCLUSIONS: Our findings suggest that psychological and pharmacologic approaches can be targeted productively toward cancer patients with elevated depressive symptoms. Research is needed to maximize effectiveness, accessibility, and integration into clinical care of interventions for depressed cancer patients.

Meta-analysis of psychosocial interventions to reduce pain in patients with cancer.

PURPOSE: Pain is one of the most common, burdensome, and feared symptoms experienced by patients with cancer. American Pain Society standards for pain management in cancer recommend both pharmacologic and psychosocial approaches. To obtain a current, stable, and comprehensive estimate of the effect of psychosocial interventions on pain-an important clinical topic-we conducted a meta-analysis of randomized controlled studies among adult patients with cancer published between 1966 and 2010. METHODS: Three pairs of raters independently reviewed 1,681 abstracts, with a systematic process for reconciling disagreement, yielding 42 papers, of which 37 had sufficient data for meta-analysis. Studies were assessed for quality using a modified seven-item Physiotherapy Evidence Database (PEDro) coding scheme. Pain severity and interference were primary outcome measures. RESULTS: Study participants (N = 4,199) were primarily women (66%) and white (72%). The weighted averaged effect size across studies for pain severity (38 comparisons) was 0.34 (95% CI, 0.23 to 0.46; P < .001), and the effect size for pain interference (four comparisons) was 0.40 (95% CI, 0.21 to 0.60; P < .001). Studies that monitored whether treatment was delivered as intended had larger effects than those that did not (P = .04). CONCLUSION: Psychosocial interventions had medium-size effects on both pain severity and interference. These robust findings support the systematic implementation of quality-controlled psychosocial interventions as part of a multimodal approach to the management of pain in patients with cancer.

Behavioral intervention to promote smoking cessation and prevent weight gain: a systematic review and meta-analysis.

AIMS: The prospect of weight gain discourages many cigarette smokers from quitting. Practice guidelines offer varied advice about managing weight gain after quitting smoking, but no systematic review and meta-analysis have been available. We reviewed evidence to determine whether behavioral weight control intervention compromises smoking cessation attempts, and if it offers an effective way to reduce post-cessation weight gain. METHODS: We identified randomized controlled trials (RCTs) that compared combined smoking treatment and behavioral weight control to smoking treatment alone for adult smokers. English-language studies were identified through searches of PubMed, Ovid MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials. Of 779 articles identified and 35 potentially relevant RCTs screened, 10 met the criteria and were included in the meta-analysis. RESULTS: Patients who received both smoking treatment and weight treatment showed increased abstinence [odds ratio (OR) = 1.29, 95% confidence interval (CI) = 1.01, 1.64] and reduced weight gain (g = -0.30, 95% CI = -0.57, -0.02) in the short term (<3 months) compared with patients who received smoking treatment alone. Differences in abstinence (OR = 1.23, 95% CI = 0.85, 1.79) and weight control (g = -0.17, 95% CI = -0.42, 0.07) were no longer significant in the long term (>6 months). CONCLUSIONS: Findings provide no evidence that combining smoking treatment and behavioral weight control produces any harm and significant evidence of short-term benefit for both abstinence and weight control. However, the absence of long-term enhancement of either smoking cessation or weight control by the time-limited interventions studied to date provides insufficient basis to recommend societal expenditures on weight gain prevention treatment for patients who are quitting smoking.