Marika Booth

Mental Health Conditions Among Patients Seeking and Undergoing Bariatric Surgery: A Meta-analysis

IMPORTANCE Bariatric surgery is associated with sustained weight loss and improved physical health status for severely obese individuals. Mental health conditions may be common among patients seeking bariatric surgery; however, the prevalence of these conditions and whether they are associated with postoperative outcomes remains unknown. OBJECTIVE To determine the prevalence of mental health conditions among bariatric surgery candidates and recipients, to evaluate the association between preoperative mental health conditions and health outcomes following bariatric surgery, and to evaluate the association between surgery and the clinical course of mental health conditions. DATA SOURCES We searched PubMed, MEDLINE on OVID, and PsycINFO for studies published between January 1988 and November 2015. Study quality was assessed using an adapted tool for risk of bias; quality of evidence was rated based on GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. FINDINGS We identified 68 publications meeting inclusion criteria: 59 reporting the prevalence of preoperative mental health conditions (65,363 patients) and 27 reporting associations between preoperative mental health conditions and postoperative outcomes (50,182 patients). Among patients seeking and undergoing bariatric surgery, the most common mental health conditions, based on random-effects estimates of prevalence, were depression (19% [95% CI, 14%-25%]) and binge eating disorder (17% [95% CI, 13%-21%]). There was conflicting evidence regarding the association between preoperative mental health conditions and postoperative weight loss. Neither depression nor binge eating disorder was consistently associated with differences in weight outcomes. Bariatric surgery was, however, consistently associated with postoperative decreases in the prevalence of depression (7 studies; 8%-74% decrease) and the severity of depressive symptoms (6 studies; 40%-70% decrease). CONCLUSIONS AND RELEVANCE Mental health conditions are common among bariatric surgery patients-in particular, depression and binge eating disorder. There is inconsistent evidence regarding the association between preoperative mental health conditions and postoperative weight loss. Moderate-quality evidence supports an association between bariatric surgery and lower rates of depression postoperatively.

Comparative Effectiveness of Pharmacologic Treatments to Prevent Fractures: An Updated Systematic Review

Osteoporosis is a skeletal disorder characterized by compromised bone strength, increasing the risk for fracture (1). Risk factors include, but are not limited to, increasing age, female sex, postmenopause for women, low body weight, parental history of a hip fracture, cigarette smoking, race, hypogonadism, certain medical conditions (particularly rheumatoid arthritis), and certain medications for chronic diseases (such as glucocorticoids). During ones expected remaining life, 1 in 2 postmenopausal women and 1 in 5 older men are at risk for an osteoporosis-related fracture (2). The increasing prevalence and cost of osteoporosis have heightened interest in the effectiveness and safety of the many interventions currently available to prevent osteoporotic fracture. In 2007, we conducted a systematic review of the comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis (3, 4). Since that time, new drugs have been approved for treatment, and new studies have been published about existing drugs. Additional issues about pharmacologic treatments for osteoporosis that have become particularly salient include the optimal duration of therapy; the safety of long-term therapy; and the role of bone mineral density (BMD) measurement, both for screening and for monitoring treatment. Therefore, we updated our original systematic review. Methods This article is a condensed and further updated version of an evidence review conducted for the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers program (5). This article focuses on the comparative benefits and risks of short- and long-term pharmacologic treatments for low bone density. In addition, we address issues regarding monitoring and duration of therapy. For this updated review, we followed the same methods as our 2007 review, with a few exceptions. A protocol for this review was developed and posted on the Effective Health Care Program Web site (6). Data Sources and Searches We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the ACP Journal Club database, the National Institute for Clinical Excellence, the Food and Drug Administrations (FDA) MedWatch database, and relevant pharmacologic databases from 2 January 2005 to 3 June 2011. The search strategy followed that of the original report, with the addition of terms for new FDA-approved drugs (such as denosumab) and newly reported adverse events. The full search strategies are in our evidence report (5). We later updated this search to 21 January 2013 and used a machine learning method that a previous study showed had high sensitivity for detecting relevant evidence for updating a search of the literature on osteoporosis treatments (7) and then updated the searches to 4 March 2014 using the full search strategy. Study Selection Eligible studies were systematic reviews and randomized, controlled trials (RCTs) that studied FDA-approved pharmacotherapy (excluding calcitonin and etidronate) for women or men with osteoporosis that was not due to a secondary cause (such as glucocorticoid therapy and androgen-deprivation therapy) and also measured fractures as an outcome at a minimum follow-up of 6 months. In addition, we included observational studies with more than 1000 participants for adverse events and case reports for rare events. As in our original review, only English-language studies were included. Data Extraction and Quality Assessment Reviews were done in duplicate by pairs of reviewers. Study characteristics were extracted in duplicate, and outcomes data (both benefits and harms) were extracted by the study statistician. Study quality was assessed as it was in the 2007 report using the Jadad scale for clinical trials (with several questions added to assess allocation concealment and other factors) and the NewcastleOttawa Scale for observational studies (8, 9). Systematic reviews were assessed using a modified version of the 11 AMSTAR (A Measurement Tool to Assess Systematic Reviews) criteria (the modifications included eliminating the requirements to list all of the excluded studies and assess the conflicts of interest for all of the included studies) (10). The assessments of efficacy and effectiveness used reduction in fracture (all, vertebral, nonvertebral, spine, hip, wrist, or other) as the outcome (studies reporting changes in BMD but not fracture were excluded). Data Synthesis and Analysis Evidence on efficacy and effectiveness was synthesized narratively. For adverse events, we pooled data as in the 2007 report: We compared agent versus placebo and agent versus agent for agents within the same class and across classes. For groups of events that occurred in 3 or more trials, we estimated the pooled odds ratio (OR) and its associated 95% CI. Because many events were rare, we used exact conditional inference to perform the pooling rather than applying the usual asymptotic methods that assume normality. StatXact PROCs software was used for the analysis (11, 12). Large cohort and casecontrol studies were included to assess adverse events. Strength of evidence was assessed using the criteria of the Agency for Healthcare Research and Quality Evidence-based Practice Centers program, which are similar to those proposed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group (13). Role of the Funding Source The update that included studies identified in the 3 June 2011 search was funded by AHRQ. Subsequent updating received no external funding. Although AHRQ formulated the initial study questions for the original report, it did not participate in the literature search, determination of study eligibility criteria, data analysis, or interpretation of the data. Staff from AHRQ reviewed and provided comments on the report. Results The first search yielded 26366 titles, 2440 of which were considered potentially relevant (Figure). Of these, 661 full-text articles were reviewed, resulting in 255 articles that were included in the update report. Of these, 174 articles were relevant to this article. The second update search plus hand searching initially yielded 16589 titles, and machine learning and full-text review identified 107 as relevant. The third update yielded 12131 titles. After title, abstract, and full-text screening, 34 were relevant. Thus, 55086 titles were screened and 315 articles met eligibility criteria for inclusion. Not every eligible study is cited in this article. A complete list of studies that met eligibility criteria is available at www.rand.org/health/centers/epc. Figure. Summary of evidence search and selection. FRAX = Fracture Risk Assessment Tool; HRT = hormone replacement therapy; LBD = low bone density. *Original LBD report (4). Fracture Prevention Our previous review (3) identified 76 randomized trials and 24 meta-analyses and concluded that there was good-quality evidence that alendronate, etidronate, ibandronate, risedronate, zoledronic acid, estrogen, parathyroid hormone, and raloxifene prevented osteoporotic fractures, although not all of these agents prevented hip fractures. The principal new efficacy findings since that time are additional data about zoledronic acid and data about a new agent, denosumab (Tables 1 and 2). The data for zoledronic acid came from 6 placebo-controlled studies of various doses in postmenopausal women (1419), the 2 largest of which enrolled 7230 women (15) and 2127 women (14). Both studies showed statistically significant reductions in nearly all types of fractures assessed, with relative risk reductions ranging from 0.23 to 0.73 at time points from 24 to 36 months after initiation of treatment. The data for denosumab came from 2 placebo-controlled trials in postmenopausal women, one small (332 enrolled women) (20) and one much larger that followed 7521 women for 36 months (21). This latter study found statistically significant reductions in each anatomical fracture type measured (hip, nonvertebral, vertebral, and new clinical vertebral), with hazard ratios of 0.31 to 0.80. Many secondary analyses and open-label extension results of this trial report the effectiveness of denosumab in various subpopulations and other circumstances (2228). Table 1. Principal Conclusions About Drug Efficacy/Effectiveness and Adverse Events Table 2. Principal Conclusions About Monitoring and Treatment Duration Despite some difficulties in comparing results across trials because of differences in the outcomes reported, high-strength evidence shows that bisphosphonates (alendronate, ibandronate, risedronate, and zoledronic acid), denosumab, and teriparatide (the 1,34 amino acid fragment of the parathyroid hormone) reduce fractures compared with placebo in postmenopausal women with osteoporosis, with relative risks for fractures generally in the range of 0.40 to 0.60 for vertebral fractures and 0.60 to 0.80 for nonvertebral fractures. This range translates into a number needed to treat of 60 to 89 to prevent 1 vertebral fracture and 50 to 67 to prevent 1 hip fracture over 1 to 3 years of treatment, using a pooled average of the incidence of these fractures in the placebo groups from included studies. The effect of ibandronate on hip fracture risk reduction is unclear because hip fracture was not a separately reported outcome in placebo-controlled trials of this agent. The selective estrogen receptor modulator raloxifene has been shown in placebo-controlled trials to reduce only vertebral fractures; reduction in the risk for hip or nonvertebral fractures was not statistically significant. There is only one randomized, controlled trial of men with osteoporosis that was designed with a primary fracture reduction outcome. Nearly 1200 men with osteoporosis were randomly assigned to placebo or zoledronic acid intravenously once per year for 2 years. At follow-up, 1.6% of treated men had new radio

Hospital fall prevention: a systematic review of implementation, components, adherence, and effectiveness

To systematically document the implementation, components, comparators, adherence, and effectiveness of published fall prevention approaches in U.S. acute care hospitals.

Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires : A Systematic Review of Surgical Never Events

IMPORTANCE Serious, preventable surgical events, termed never events, continue to occur despite considerable patient safety efforts. OBJECTIVE To examine the incidence and root causes of and interventions to prevent wrong-site surgery, retained surgical items, and surgical fires in the era after the implementation of the Universal Protocol in 2004. DATA SOURCES We searched 9 electronic databases for entries from 2004 through June 30, 2014, screened references, and consulted experts. STUDY SELECTION Two independent reviewers identified relevant publications in June 2014. DATA EXTRACTION AND SYNTHESIS One reviewer used a standardized form to extract data and a second reviewer checked the data. Strength of evidence was established by the review team. Data extraction was completed in January 2015. MAIN OUTCOMES AND MEASURES Incidence of wrong-site surgery, retained surgical items, and surgical fires. RESULTS We found 138 empirical studies that met our inclusion criteria. Incidence estimates for wrong-site surgery in US settings varied by data source and procedure (median estimate, 0.09 events per 10,000 surgical procedures). The median estimate for retained surgical items was 1.32 events per 10,000 procedures, but estimates varied by item and procedure. The per-procedure surgical fire incidence is unknown. A frequently reported root cause was inadequate communication. Methodologic challenges associated with investigating changes in rare events limit the conclusions of 78 intervention evaluations. Limited evidence supported the Universal Protocol (5 studies), education (4 studies), and team training (4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent retained surgical items by using data-matrix-coded sponge-counting systems (5 pertinent studies). Evidence for preventing surgical fires was insufficient, and intervention effects were not estimable. CONCLUSIONS AND RELEVANCE Current estimates for wrong-site surgery and retained surgical items are 1 event per 100,000 and 1 event per 10,000 procedures, respectively, but the precision is uncertain, and the per-procedure prevalence of surgical fires is not known. Root-cause analyses suggest the need for improved communication. Despite promising approaches and global Universal Protocol evaluations, empirical evidence for interventions is limited.

Risk of bias: a simulation study of power to detect study-level moderator effects in meta-analysis.

BackgroundThere are both theoretical and empirical reasons to believe that design and execution factors are associated with bias in controlled trials. Statistically significant moderator effects, such as the effect of trial quality on treatment effect sizes, are rarely detected in individual meta-analyses, and evidence from meta-epidemiological datasets is inconsistent. The reasons for the disconnect between theory and empirical observation are unclear. The study objective was to explore the power to detect study level moderator effects in meta-analyses.MethodsWe generated meta-analyses using Monte-Carlo simulations and investigated the effect of number of trials, trial sample size, moderator effect size, heterogeneity, and moderator distribution on power to detect moderator effects. The simulations provide a reference guide for investigators to estimate power when planning meta-regressions.ResultsThe power to detect moderator effects in meta-analyses, for example, effects of study quality on effect sizes, is largely determined by the degree of residual heterogeneity present in the dataset (noise not explained by the moderator). Larger trial sample sizes increase power only when residual heterogeneity is low. A large number of trials or low residual heterogeneity are necessary to detect effects. When the proportion of the moderator is not equal (for example, 25% ‘high quality’, 75% ‘low quality’ trials), power of 80% was rarely achieved in investigated scenarios. Application to an empirical meta-epidemiological dataset with substantial heterogeneity (I2 = 92%, τ2 = 0.285) estimated >200 trials are needed for a power of 80% to show a statistically significant result, even for a substantial moderator effect (0.2), and the number of trials with the less common feature (for example, few ‘high quality’ studies) affects power extensively.ConclusionsAlthough study characteristics, such as trial quality, may explain some proportion of heterogeneity across study results in meta-analyses, residual heterogeneity is a crucial factor in determining when associations between moderator variables and effect sizes can be statistically detected. Detecting moderator effects requires more powerful analyses than are employed in most published investigations; hence negative findings should not be considered evidence of a lack of effect, and investigations are not hypothesis-proving unless power calculations show sufficient ability to detect effects.

Meditation for Posttraumatic Stress: Systematic Review and Meta-analysis.

Objective: We conducted a systematic review and meta-analysis that synthesized evidence from randomized controlled trials of meditation interventions to provide estimates of their efficacy and safety in treating adults diagnosed with posttraumatic stress disorder (PTSD). This review was based on an established protocol (PROSPERO: CRD42015025782) and is reported according to PRISMA guidelines. Outcomes of interest included PTSD symptoms, depression, anxiety, health-related quality of life, functional status, and adverse events. Method: Meta-analyses were conducted using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: In total, 10 trials on meditation interventions for PTSD with 643 participants met inclusion criteria. Across interventions, adjunctive meditation interventions of mindfulness-based stress reduction, yoga, and the mantram repetition program improve PTSD and depression symptoms compared with control groups, but the findings are based on low and moderate quality of evidence. Effects were positive but not statistically significant for quality of life and anxiety, and no studies addressed functional status. The variety of meditation intervention types, the short follow-up times, and the quality of studies limited analyses. No adverse events were reported in the included studies; only half of the studies reported on safety. Conclusions: Meditation appears to be effective for PTSD and depression symptoms, but in order to increase confidence in findings, more high-quality studies are needed on meditation as adjunctive treatment with PTSD-diagnosed participant samples large enough to detect statistical differences in outcomes.

Economic Evaluation of Quality Improvement Interventions Designed to Prevent Hospital Readmission: A Systematic Review and Meta-analysis

Importance Quality improvement (QI) interventions can reduce hospital readmission, but little is known about their economic value. Objective To systematically review economic evaluations of QI interventions designed to reduce readmissions. Data Sources Databases searched included PubMed, Econlit, the Centre for Reviews & Dissemination Economic Evaluations, New York Academy of Medicines Grey Literature Report, and Worldcat (January 2004 to July 2016). Study Selection Dual reviewers selected English-language studies from high-income countries that evaluated organizational or structural changes to reduce hospital readmission, and that reported program and readmission-related costs. Data Extraction and Synthesis Dual reviewers extracted intervention characteristics, study design, clinical effectiveness, study quality, economic perspective, and costs. We calculated the risk difference and net costs to the health system in 2015 US dollars. Weighted least-squares regression analyses tested predictors of the risk difference and net costs. Main Outcomes and Measures Main outcomes measures included the risk difference in readmission rates and incremental net cost. This systematic review and data analysis is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Results Of 5205 articles, 50 unique studies were eligible, including 25 studies in populations limited to heart failure (HF) that included 5768 patients, 21 in general populations that included 10 445 patients, and 4 in unique populations. Fifteen studies lasted up to 30 days while most others lasted 6 to 24 months. Based on regression analyses, readmissions declined by an average of 12.1% among patients with HF (95% CI, 8.3%-15.9%; P < .001; based on 22 studies with complete data) and by 6.3% among general populations (95% CI, 4.0%-8.7%; P < .001; 18 studies). The mean net savings to the health system per patient was

Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis

972 among patients with HF (95% CI, −

Patient engagement in the process of planning and designing outpatient care improvements at the Veterans Administration Health‐care System: findings from an online expert panel

642 to

Acupuncture for substance use disorders: A systematic review and meta-analysis

2586; P = .23; 24 studies), and the mean net loss was