Jennifer Cook Middleton

Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis.

Heart failure (HF) is a leading cause of hospitalization and health care costs in the United States (1). Up to 25% of patients hospitalized with HF are readmitted within 30 days (25). Readmissions after an index hospitalization for HF are related to various conditions. An analysis of Medicare claims data from 2007 to 2009 found that 35% of readmissions within 30 days were for HF; the remainder were for diverse indications (for example, renal disorders, pneumonia, and arrhythmias) (2). To reduce rehospitalization of Medicare patients, in October 2012, the Centers for Medicare & Medicaid Services began decreasing reimbursements to hospitals with excessive risk-standardized readmission (6). This policy incentivizes hospitals to develop programs to reduce readmission rates for persons with HF. Despite advances in the quality of acute and chronic HF disease management, knowledge gaps remain about effective interventions to support the transition of care for persons with HF. Interventions designed to prevent readmissions among populations transitioning from one care setting to another are often called transitional care interventions (7, 8). They aim to avoid poor outcomes caused by uncoordinated care, such as preventable readmissions (9). Although no clear set of components defines transitional care interventions, they focus on patient or caregiver education, medication reconciliation, and coordination among health professionals involved in the transition. We conducted a systematic review of transitional care interventions for persons with HF for the Effective Health Care Program of the Agency for Healthcare Research and Quality (AHRQ) (10). We included a broad range of intervention types (Table 1) applicable to adults transitioning from hospital to home that aimed to prevent readmissions. Although 30-day readmissions are the focus of quality measures, we also included readmissions measured over 3 to 6 months because these are common, costly, and potentially preventable (5). The full technical report addressed 5 questions (Appendix Table 1). For this article, we focused on readmission and mortality outcomes. Table 1. Transitional Care Interventions Appendix Table 1. Scope and Key Questions* Methods We developed and followed a standard protocol. A technical report that details methods and includes complete search strategies and additional evidence tables is available at www.effectivehealthcare.ahrq.gov/reports/final.cfm. Data Sources and Searches We searched MEDLINE, the Cochrane Library, and CINAHL for English-language and human-only studies published from 1 July 2007 to late October 2013, and we used a previous technology assessment on a similar topic to identify randomized, controlled trials (RCTs) published before 1 July 2007 (11). An experienced Evidence-based Practice Center librarian conducted the searches, and a second librarian reviewed them. We manually searched reference lists of pertinent reviews, included trials, and background articles on this topic to look for relevant citations our searches might have missed. We searched for relevant unpublished studies using ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. Study Selection We developed inclusion and exclusion criteria with respect to populations, interventions, comparators, outcomes, timing, settings, and study designs (Appendix Table 2). We included studies of adults recruited during or within 1 week of an index hospitalization for HF that compared a transitional care intervention with another eligible intervention or with usual care (that is, routine or standard care, as defined by the primary studies). We required that interventions include 1 or more of the following components: education of patient or caregiver delivered before or after discharge, planned or scheduled outpatient clinic visits (primary care or multidisciplinary heart failure [MDS-HF] clinic), home visits, telemonitoring, structured telephone support (STS), transition coach or case management, or interventions to increase provider continuity. We required studies to report a readmission rate, mortality rate, or the composite outcome (all-cause readmission or mortality). In the full report, we also assessed emergency department visits, acute care visits, hospital days of subsequent readmissions, quality of life, functional status, and caregiver or self-care burden (10). Appendix Table 2. Inclusion and Exclusion Criteria for Studies of Transitional Care Interventions for Patients Hospitalized for HF Data Extraction and Risk-of-Bias Assessment One team member extracted relevant data from each article, and a second team member reviewed all data extractions for completeness and accuracy. We used predefined criteria based on the AHRQ Methods Guide for Comparative Effectiveness Reviews (12) to rate studies as having low, medium, high, or unclear risk of bias. Two reviewers independently assessed risk of bias for each study, and disagreements were resolved by consensus. Data Synthesis and Analysis We categorized intervention types primarily on the basis of the method and environment of delivery, as defined in Table 1. One investigator categorized the intervention, and a second team member reviewed the categorization. Disagreements were resolved by consensus. Given heterogeneity of the clinic-based interventions, we subcategorized these by clinic setting: MDS-HF, nurse-led HF, or primary care. We used DerSimonianLaird random-effects models (13) for meta-analyses of outcomes reported by multiple studies that were sufficiently similar to justify combining results. We ran meta-analyses of trials that reported the number of deaths or number of persons readmitted in each group (and not total readmissions per group). When only the total number of readmissions per group was available, we contacted authors for additional data. When we could not obtain the number of persons readmitted, we did not include the results in meta-analyses; instead, we included the results in qualitative syntheses and considered them when grading the strength of evidence (SOE). For readmission and mortality rates, we calculated risk ratios (RRs). We stratified analyses for each intervention category by outcome timing and separated rates reported at 30 days from those after 30 days (that is, rates reported over 3 to 6 months were combined). We did not include studies rated as high or unclear risk of bias in our main analyses but included them in sensitivity analyses, which are available in the technical report (10); we describe them here only when they differed from primary analyses. We assessed statistical heterogeneity using the chi-square and I 2 statistics (14, 15). We calculated the number needed to treat (NNT) for readmission and mortality outcomes when we had statistically significant findings based on our primary analyses of trials rated as low or medium risk of bias, and we found at least low SOE for benefit. The NNT was derived from the RR and median usual care event rate using methods described in the Cochrane Handbook (16). We conducted meta-analyses using Stata, version 11.1 (StataCorp, College Station, Texas). We did meta-analysis stratified by intensity in each intervention category when variation existed. The results of these subgroup analyses are available in the main report (10); we describe them here only when we found a difference in efficacy based on level of intensity. Given the heterogeneity of included interventions, we could not develop a single measure of intensity that could be applied to all intervention categories. For most interventions, we defined intensity as the duration, frequency, or periodicity of patient contact and categorized each intervention as low-, medium-, or high-intensity. We reserved the low-intensity category for interventions that included 1 episode of patient contact or few resources. We graded SOE as high, moderate, low, or insufficient based on guidance established for the Evidence-based Practice Center program (17). The approach incorporates 4 key domains: risk of bias, consistency, directness, and precision. When only 1 study reported an outcome of interest, we usually graded the SOE as insufficient (primarily due to unknown consistency and imprecision); however, when similar interventions had consistent results at other time points, we graded the SOE as low. Two reviewers assessed each domain for each outcome, and differences were resolved by consensus. Role of the Funding Source The AHRQ funded this review, and AHRQ staff participated in the development of the scope of the work and reviewed draft manuscripts. Approval from AHRQ was required before the manuscript could be submitted for publication, but the authors are solely responsible for the content and the decision to submit it for publication. Results Searches of all sources identified 2419 potentially relevant citations. We included 47 RCTs (Appendix Figure 1). Trial characteristics are shown in Appendix Table 3. Most trials compared a transitional care intervention with usual care; 2 directly compared more than 1 intervention (both rated high risk of bias) (18, 19). In general, trials included adults with a mean age of 70 years who were hospitalized with a primary diagnosis of HF. Most reported HF disease severity based on the New York Heart Association classification and included persons with moderate to severe HF. Twenty-nine trials reported mean ejection fraction. Of these, 27 enrolled persons with a mean ejection fraction less than 0.50 and 7 trials specified a reduced ejection fraction as an inclusion criterion. Across most trials, the majority of patients were prescribed an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker. The percentages of patients who were prescribed -blockers at discharge varied widely across trials. Trials were conducted in a range of settings: academic medical centers, Department of Veterans Affairs hospitals,

Folic acid supplementation for the prevention of neural tube defects: An updated evidence report and systematic review for the US Preventive Services Task Force

Importance Neural tube defects are among the most common congenital anomalies in the United States. Periconceptional folic acid supplementation is a primary care–relevant preventive intervention. Objective To review the evidence on folic acid supplementation for preventing neural tube defects to inform the US Preventive Services Task Force for an updated Recommendation Statement. Data Sources MEDLINE, Cochrane Library, EMBASE, and trial registries through January 28, 2016, with ongoing surveillance through November 11, 2016; references; experts. Study Selection English-language studies of folic acid supplementation in women. Excluded were poor-quality studies; studies of prepubertal girls, men, women without the potential for childbearing, and neural tube defect recurrence; and studies conducted in developing countries. Data Extraction and Synthesis Two investigators independently reviewed abstracts, full-text articles, and risk of bias of included studies. One investigator extracted data and a second checked accuracy. Because of heterogeneity, data were not pooled. Main Outcomes and Measures Neural tube defects, harms of treatment (twinning, respiratory outcomes). Results A total of 24 studies (N > 58 860) were included. In 1 randomized clinical trial from Hungary initiated in 1984, incidence of neural tube defects for folic acid supplementation compared with trace element supplementation was 0% vs 0.25% (Peto odds ratio [OR], 0.13 [95% CI, 0.03-0.65]; n = 4862). Odds ratios from cohort studies recruiting participants between 1984 and 1996 demonstrated beneficial associations and ranged from 0.11 to 0.27 (n = 19 982). Three of 4 case-control studies with data from 1976 through 1998 reported ORs ranging from 0.6 to 0.7 (n > 7121). Evidence of benefit led to food fortification in the United States beginning in 1998, after which no new prospective studies have been conducted. More recent case-control studies drawing from data collected after 1998 have not demonstrated a protective association consistently with folic acid supplementation, with ORs ranging from 0.93 to 1.4 and confidence intervals spanning the null (n > 13 990). Regarding harms, 1 trial (OR, 1.40 [95% CI, 0.89-2.21]; n = 4767) and 1 cohort study (OR, 1.04 [95% CI, 0.91-1.18]; n = 2620) found no statistically significant increased risk of twinning. Three systematic reviews found no consistent evidence of increased risk of asthma (OR, 1.06 [95% CI, 0.99-1.14]; n = 14 438), wheezing, or allergy. Conclusions and Relevance In studies conducted before the initiation of food fortification in the United States in 1998, folic acid supplementation provided protection against neural tube defects. Newer postfortification studies have not demonstrated a protective association but have the potential for misclassification and recall bias, which can attenuate the measured association of folic acid supplementation with neural tube defects.

Screening for major depressive disorder in children and adolescents: a systematic review for the U.S. Preventive Services Task Force

Major depressive disorder (MDD) is relatively common in childhood and adolescence and is associated with functional impairment and suicide. Nationally representative samples have indicated a past-year prevalence of approximately 8% for adolescents (1, 2) and roughly 3% in younger children (aged 8 to 15 years) (3). The prevalence of depression in primary care settings may be twice that of community samples of children and adolescents (4) and seems to be increasing (5). In addition, nationally representative studies have indicated that fewer than one half of children and adolescents with major depression receive treatment for mental health issues (2, 3, 6). Primary care providers can play a critical role in identifying depression among children and adolescents, particularly because youth with mental health issues frequently use primary care services. Because primary care providers are often the first point of professional contact for children and their families during times of distress, they can facilitate early identification of mental health issues; begin initial management; and refer children, as necessary, for further mental health assessment and treatment. They also serve vital roles in collaborative care and practice networks that include mental health specialists. Schools are also important in identifying and treating depression in children and adolescents. In 2011, 12% of adolescents aged 12 to 17 years reported receiving mental health care at school (2). Early identification and treatment may be particularly important because of the long-term and recurrent nature of MDD (7) and its myriad negative sequelae. Associated functional impairment; decreased academic performance; and troubled relationships with parents, siblings, and peers are common and can affect developmental trajectories (8, 9). In addition, children and adolescents with depression are likely to have other comorbid mental health problems (7, 10); somatic symptoms, such as headache and migraine, stomach aches, and musculoskeletal pain; and chronic medical conditions, such as asthma and diabetes (11). Childhood and adolescent MDD is associated with increased risk for suicidal thoughts, attempts, and completions (12). In 2009, the U.S. Preventive Services Task Force (USPSTF) guidelines recommended routine screening for depression in children and adolescents aged 12 to 18 years in primary care settings when resources are available for additional evaluation and care (13, 14). Although most experts from family medicine, pediatrics, nursing, psychology, and child psychiatry endorse routine surveillance for youth at high risk for depression (15), routine universal screening is still debated. Some pediatricians report discomfort with screening for and diagnosing depression, citing lack of self-efficacy, training, or experience specific to delivering mental health care (16). Some providers are also concerned about access to mental health services for patients with positive screening results. The objective of this report is to update the recommendations released in 2009 for screening adolescents and children for MDD in primary care and similar settings (such as school-based clinics). Methods Scope of the Review We searched for evidence on the benefits and harms of screening; accuracy of feasible screening tests; and potential benefits and risks of treating MDD using collaborative care, psychotherapy, or selective serotonin reuptake inhibitors (SSRIs) among children and adolescents seen in primary care or similar settings, such as school-based clinics. We also wanted to determine whether the benefits and harms differed by age, sex, or race/ethnicity. Appendix Tables 1 and 2 and Appendix Figures 1 and 2 show key questions; search strings; analytic framework; and numbers of identified articles, screened articles, eligible articles for full-text review, and included articles organized as a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) tree (for studies published since May 2007, the end date for the 2009 reviews searches). Appendix Table 1. Search Strings* Appendix Table 2. Key Questions Appendix Figure 1. Analytic framework for screening for childhood depression. MMD = major depressive disorder. Appendix Figure 2. Summary of evidence search and selection. Studies were published since May 2007. HSRProj = Health Services Research Projects in Progress; WHO ICTRP = World Health Organization International Clinical Trials Registry Platform. Data Sources and Searches We searched PubMed (MEDLINE), the Cochrane Library, and PsychInfo for English-language articles published from May 2007 to 4 February 2015. Unpublished literature was identified via searches of ClinicalTrials.gov, Health Services Research Projects in Progress, and the World Health Organizations International Clinical Trials Registry Platform. We also reviewed and included, as appropriate, studies from reference lists of pertinent review articles and all literature suggested by peer reviewers or public comment respondents. Appendix Table 1 and the full evidence report (available at www.uspreventiveservicestaskforce.org) include all of the search strategies used for each key question and the databases searched. Two investigators independently reviewed titles and abstracts. We dually and independently reviewed the full text of studies that at least 1 reviewer indicated as potentially meeting our prespecified criteria for each key question, according to initial abstract review. To reduce heterogeneity and ensure focus on children and adolescents with more serious symptoms because they are more likely to have severe functional impairment and suicidality, we restricted inclusion of efficacy and harms studies to those in which at least 50% of participants had an MDD diagnosis. Screening accuracy studies had to be done in primary care or similar settings, be of feasible length and format to administer in a setting similar to primary care, and include a comparison against a gold-standard assessment tool. We included randomized and nonrandomized trials published between May 2007 and 4 February 2015 and systematic reviews published between January 2011 and 4 February 2015 of MDD treatment efficacy and harms, testretest studies of screening for MDD, and cohort studies with at least 1000 participants for studies of screening and treatment harms. In addition to the new literature searches, we also applied, dually and independently, the inclusion and exclusion criteria described previously to all studies from the 2009 review (17), which included articles published from 1990 to May 2007 that focused on screening for and treatment of depression, but not specifically MDD, in children and adolescents. The exact differences between the inclusion and exclusion criteria applied in the current and former reviews are documented in the full evidence report at www.uspreventive servicestaskforce.org. Data Extraction and Quality Assessment Using predefined criteria developed by the USPSTF and others for additional criteria for diagnostic accuracy studies, 2 investigators independently assessed the quality of each study as good, fair, or poor (18). We resolved disagreements by discussion and consensus. For screening accuracy studies, flaws that resulted in poor-quality ratings included use of an inappropriate reference standard, improper administration of the screening test, biased ascertainment of the reference standard, very small sample size, or very narrowly selected spectrum of patients. For treatment efficacy and harms studies, flaws that resulted in poor-quality ratings included high overall attrition (at least 20%) or differential attrition (at least 15%) between study groups, unreliable or invalid measurement instruments or unequal application across study groups (including not masking outcome assessment), and little or no attention given to key confounders; and, for randomized, controlled trials, the lack of an intention-to-treat analysis. We excluded all studies dually determined to be of poor quality. We rated the overall body of evidence for each key question using the system developed by the USPSTF (18). Data Synthesis and Analysis We organized our findings according to the key questions. We used Comprehensive Meta Analysis, version 3 (Biostat), to calculate effect sizes and 95% CIs. We planned to use meta-analysis to pool the efficacy outcomes by drug (such as escitalopram trials) and drug family (such as all SSRIs), but heterogeneity across studies limited the number of combinable interventions and outcomes, which precluded the calculation of pooled estimates. Role of the Funding Source The Agency for Healthcare Research and Quality funded this study under a contract to support the work of the USPSTF. Members of the USPSTF and the Agency medical officer assisted in the development of the reviews scope, key questions, and analytic framework. The Agency for Healthcare Research and Quality reviewed and approved this manuscript before publication, but the authors are solely responsible for its content and the decision to submit it for publication. Results Only 2 new treatment efficacy studies met our criteria (19, 20). The studies included in the 2009 review, when re-reviewed against our criteria, yielded 5 studies on screening accuracy (2124) and 4 trials in 6 publications on treatment efficacy (3 publications on 1 trial [2527] and 1 publication each on the other 3 trials [2830]). Benefits, Yield, and Harms of Screening We found no trials that directly assessed the benefits or harms of screening children or adolescents for MDD in primary care settings. We also did not find studies that addressed whether screening increases the proportion of children or adolescents identified with MDD or results in harms. No meta-analyses or retrospective cohort studies met our inclusion criteria. We excluded studies if less than half of the sample of children and adolescents had MDD or did not repo

Serologic Screening for Genital Herpes: An Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance Genital herpes simplex virus (HSV) infection is a prevalent sexually transmitted infection. Vertical transmission of HSV can lead to fetal morbidity and mortality. Objective To assess the evidence on serologic screening and preventive interventions for genital HSV infection in asymptomatic adults and adolescents to support the US Preventive Services Task Force for an updated recommendation statement. Data Sources MEDLINE, Cochrane Library, EMBASE, and trial registries through March 31, 2016. Surveillance for new evidence in targeted publications was conducted through October 31, 2016. Study Selection English-language randomized clinical trials (RCTs) comparing screening with no screening in persons without past or current symptoms of genital herpes; studies evaluating accuracy and harms of serologic screening tests for HSV-2; RCTs assessing preventive interventions in asymptomatic persons seropositive for HSV-2. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality; pooled sensitivities and specificities of screening tests using a hierarchical summary receiver operating characteristic curve analysis when at least 3 similar studies were available. Main Outcomes and Measures Accuracy of screening tests, benefits of screening, harms of screening, reduction in genital herpes outbreaks. Results A total of 17 studies (n = 9736 participants; range, 24-3290) in 19 publications were included. No RCTs compared screening with no screening. Most studies of the accuracy of screening tests were from populations with high HSV-2 prevalence (greater than 40% based on Western blot). Pooled estimates of sensitivity and specificity of the most commonly used test at the manufacturers cutpoint were 99% (95% CI, 97%-100%) and 81% (95% CI, 68%-90%), respectively (10 studies; n = 6537). At higher cutpoints, pooled estimates were 95% (95% CI, 91%-97%) and 89% (95% CI, 82%-93%), respectively (7 studies; n = 5516). Use of this test at the manufacturers cutpoint in a population of 100 000 with a prevalence of HSV-2 of 16% (the seroprevalence in US adults with unknown symptom status) would result in 15 840 true-positive results and 15 960 false-positive results (positive predictive value, 50%). Serologic screening for genital herpes was associated with psychosocial harms, including distress and anxiety related to positive test results. Four RCTs compared preventive medications with placebo, 2 in nonpregnant asymptomatic adults who were HSV-2 seropositive and 2 in HSV-2-serodiscordant couples. Results in both populations were heterogeneous and inconsistent. Conclusions and Relevance Serologic screening for genital herpes is associated with a high rate of false-positive test results and potential psychosocial harms. Evidence from RCTs does not establish whether preventive antiviral medication for asymptomatic HSV-2 infection has benefit.

Screening for Cardiovascular Disease Risk With Resting or Exercise Electrocardiography: Evidence Report and Systematic Review for the US Preventive Services Task Force

Importance Cardiovascular disease (CVD) is the leading cause of death in the United States. Objective To review the evidence on screening asymptomatic adults for CVD risk using electrocardiography (ECG) to inform the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, and trial registries through May 2017; references; experts; literature surveillance through April 4, 2018. Study Selection English-language randomized clinical trials (RCTs); prospective cohort studies reporting reclassification, calibration, or discrimination that compared risk assessment using ECG plus traditional risk factors vs traditional risk factors alone. For harms, additional study designs were eligible. Studies of persons with symptoms or a CVD diagnosis were excluded. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings. Main Outcomes and Measures Mortality, cardiovascular events, reclassification, calibration, discrimination, and harms. Results Sixteen studies were included (N = 77 140). Two RCTs (n = 1151) found no significant improvement for screening with exercise ECG (vs no screening) in adults aged 50 to 75 years with diabetes for the primary cardiovascular composite outcomes (hazard ratios, 1.00 [95% CI, 0.59-1.71] and 0.85 [95% CI, 0.39-1.84] for each study). No RCTs evaluated screening with resting ECG. Evidence from 5 cohort studies (n = 9582) showed that adding exercise ECG to traditional risk factors such as age, sex, current smoking, diabetes, total cholesterol level, and high-density lipoprotein cholesterol level produced small improvements in discrimination (absolute improvements in area under the curve [AUC] or C statistics, 0.02-0.03, reported by 3 studies); whether calibration or appropriate risk classification improves is uncertain. Evidence from 9 cohort studies (n = 66 407) showed that adding resting ECG to traditional risk factors produced small improvements in discrimination (absolute improvement in AUC or C statistics, 0.001-0.05) and appropriate risk classification for prediction of multiple cardiovascular outcomes, although evidence was limited by imprecision, quality, considerable heterogeneity, and inconsistent use of risk thresholds used for clinical decision making. Total net reclassification improvements ranged from 3.6% (2.7% event; 0.6% nonevent) to 30% (17% event; 19% nonevent) for studies using the Framingham Risk Score or Pooled Cohort Equations base models. Evidence on potential harms (eg, from subsequent angiography or revascularization) in asymptomatic persons was limited. Conclusions and Relevance RCTs of screening with exercise ECG found no improvement in health outcomes, despite focusing on higher-risk populations with diabetes. The addition of resting ECG to traditional risk factors accurately reclassified persons, but evidence for this finding had many limitations. The frequency of harms from screening is uncertain.

Screening for Atrial Fibrillation With Electrocardiography: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance Atrial fibrillation is the most common arrhythmia and increases the risk of stroke. Objective To review the evidence on screening for nonvalvular atrial fibrillation with electrocardiography (ECG) and stroke prevention treatment in asymptomatic adults 65 years or older to inform the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, and trial registries through May 2017; references; experts; literature surveillance through June 6, 2018. Study Selection English-language randomized clinical trials (RCTs), prospective cohort studies evaluating detection rates of atrial fibrillation or harms of screening, and systematic reviews evaluating stroke prevention treatment. Eligible treatment studies compared warfarin, aspirin, or novel oral anticoagulants (NOACs) with placebo or no treatment. Studies were excluded that focused on persons with a history of cardiovascular disease. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality. When at least 3 similar studies were available, random-effects meta-analyses were conducted. Main Outcomes and Measures Detection of previously undiagnosed atrial fibrillation, mortality, stroke, stroke-related morbidity, and harms. Results Seventeen studies were included (n = 135 300). No studies evaluated screening compared with no screening and focused on health outcomes. Systematic screening with ECG identified more new cases of atrial fibrillation than no screening (absolute increase, from 0.6% [95% CI, 0.1%-0.9%] to 2.8% [95% CI, 0.9%-4.7%] over 12 months; 2 RCTs, n = 15 803), but a systematic approach using ECG did not detect more cases than an approach using pulse palpation (2 RCTs, n = 17 803). For potential harms, no eligible studies compared screening with no screening. Warfarin (mean, 1.5 years) was associated with a reduced risk of ischemic stroke (relative risk [RR], 0.32 [95% CI, 0.20-0.51]) and all-cause mortality (RR, 0.68 [95% CI, 0.50-0.93]) and with increased risk of bleeding (5 trials, n = 2415). Participants in treatment trials were not screen detected, and most had long-standing persistent atrial fibrillation. A network meta-analysis reported that NOACs were associated with a significantly lower risk of a composite outcome of stroke and systemic embolism (adjusted odds ratios compared with placebo or control ranged from 0.32-0.44); the risk of bleeding was increased (adjusted odds ratios, 1.4-2.2), but confidence intervals were wide and differences between groups were not statistically significant. Conclusions and Relevance Although screening with ECG can detect previously unknown cases of atrial fibrillation, it has not been shown to detect more cases than screening focused on pulse palpation. Treatments for atrial fibrillation reduce the risk of stroke and all-cause mortality and increase the risk of bleeding, but trials have not assessed whether treatment of screen-detected asymptomatic older adults results in better health outcomes than treatment after detection by usual care or after symptoms develop.

Screening to Prevent Osteoporotic Fractures: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force

Importance Osteoporotic fractures cause significant morbidity and mortality. Objective To update the evidence on screening and treatment to prevent osteoporotic fractures for the US Preventive Services Task Force. Data Sources PubMed, the Cochrane Library, EMBASE, and trial registries (November 1, 2009, through October 1, 2016) and surveillance of the literature (through March 23, 2018); bibliographies from articles. Study Selection Adults 40 years and older; screening cohorts without prevalent low-trauma fractures or treatment cohorts with increased fracture risk; studies assessing screening, bone measurement tests or clinical risk assessments, pharmacologic treatment. Data Extraction and Synthesis Dual, independent review of titles/abstracts and full-text articles; study quality rating; random-effects meta-analysis. Main Outcomes and Measures Incident fractures and related morbidity and mortality, diagnostic and predictive accuracy, harms of screening or treatment. Results One hundred sixty-eight fair- or good-quality articles were included. One randomized clinical trial (RCT) (n = 12 483) comparing screening with no screening reported fewer hip fractures (2.6% vs 3.5%; hazard ratio [HR], 0.72 [95% CI, 0.59-0.89]) but no other statistically significant benefits or harms. The accuracy of bone measurement tests to identify osteoporosis varied (area under the curve [AUC], 0.32-0.89). The pooled accuracy of clinical risk assessments for identifying osteoporosis ranged from AUC of 0.65 to 0.76 in women and from 0.76 to 0.80 in men; the accuracy for predicting fractures was similar. For women, bisphosphonates, parathyroid hormone, raloxifene, and denosumab were associated with a lower risk of vertebral fractures (9 trials [n = 23 690]; relative risks [RRs] from 0.32-0.64). Bisphosphonates (8 RCTs [n = 16 438]; pooled RR, 0.84 [95% CI, 0.76-0.92]) and denosumab (1 RCT [n = 7868]; RR, 0.80 [95% CI, 0.67-0.95]) were associated with a lower risk of nonvertebral fractures. Denosumab reduced the risk of hip fracture (1 RCT [n = 7868]; RR, 0.60 [95% CI, 0.37-0.97]), but bisphosphonates did not have a statistically significant association (3 RCTs [n = 8988]; pooled RR, 0.70 [95% CI, 0.44-1.11]). Evidence was limited for men: zoledronic acid reduced the risk of radiographic vertebral fractures (1 RCT [n = 1199]; RR, 0.33 [95% CI, 0.16-0.70]); no studies demonstrated reductions in clinical or hip fractures. Bisphosphonates were not consistently associated with reported harms other than deep vein thrombosis (raloxifene vs placebo; 3 RCTs [n = 5839]; RR, 2.14 [95% CI, 0.99-4.66]). Conclusions and Relevance In women, screening to prevent osteoporotic fractures may reduce hip fractures, and treatment reduced the risk of vertebral and nonvertebral fractures; there was not consistent evidence of treatment harms. The accuracy of bone measurement tests or clinical risk assessments for identifying osteoporosis or predicting fractures varied from very poor to good.

Screening for Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force

Importance Intimate partner violence (IPV), elder abuse, and abuse of vulnerable adults are common and result in adverse health outcomes. Objective To review the evidence on screening and interventions for IPV, elder abuse, and abuse of vulnerable adults to inform the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, EMBASE, and trial registries through October 4, 2017; references; experts; literature surveillance through August 1, 2018. Study Selection English-language randomized clinical trials (RCTs), studies evaluating test accuracy, and cohort studies with a concurrent control group assessing harms. Data Extraction and Synthesis Dual review of titles and abstracts, full-text articles, and study quality; qualitative synthesis of findings. Data were not pooled, primarily because of heterogeneity of populations, interventions, and outcomes. Main Outcomes and Measures Abuse or neglect, morbidity caused by abuse, test accuracy, and harms. Results Thirty studies were included (N = 14 959). Three RCTs (n = 3759) compared IPV screening with no screening; none found significant improvements in outcomes (eg, IPV or quality of life) over 3 to 18 months and 2 (n = 935) reported no harms of screening. Nine studies assessed tools to detect any past-year or current IPV in women; for past-year IPV (5 studies [n = 6331]), sensitivity of 5 tools ranged from 65% to 87% and specificity ranged from 80% to 95%. The accuracy of 5 tools (4 studies [n = 1795]) for detecting current abuse varied widely; sensitivity ranged from 46% to 94% and specificity ranged from 38% to 95%. Eleven RCTs (n = 6740) evaluated interventions for women with screen-detected IPV. Two enrolling pregnant women (n = 575) found significantly less IPV among women in the intervention group: 1 home visiting intervention (standardized mean difference [SMD], −0.34 [95% CI, −0.59 to −0.08]) and 1 behavioral counseling intervention for multiple risks (IPV, smoking, depression, tobacco exposure) (SMD, −0.40 [95% CI, −0.68 to −0.12]). No studies evaluated screening or interventions for elder abuse or abuse of vulnerable adults. One study assessing a screening tool for elder abuse had poor accuracy (sensitivity, 46% and specificity, 73% for detecting physical or verbal abuse). Conclusions and Relevance Although available screening tools may reasonably identify women experiencing IPV, trials of IPV screening in adult women did not show a reduction in IPV or improvement in quality of life over 3 to 18 months. Limited evidence suggested that home visiting and behavioral counseling interventions that address multiple risk factors may lead to reduced IPV among pregnant or postpartum women. No studies assessed screening or treatment for elder abuse and abuse of vulnerable adults.

Quality improvement, implementation, and dissemination strategies to improve mental health care for children and adolescents: A systematic review

BackgroundSome outcomes for children with mental health problems remain suboptimal because of poor access to care and the failure of systems and providers to adopt established quality improvement strategies and interventions with proven effectiveness. This review had three goals: (1) assess the effectiveness of quality improvement, implementation, and dissemination strategies intended to improve the mental health care of children and adolescents; (2) examine harms associated with these strategies; and (3) determine whether effectiveness or harms differ for subgroups based on system, organizational, practitioner, or patient characteristics.MethodsSources included MEDLINE®, the Cochrane Library, PsycINFO, and CINAHL, from database inception through February 17, 2017. Additional sources included gray literature, additional studies from reference lists, and technical experts. Two reviewers selected relevant randomized controlled trials (RCTs) and observational studies, extracted data, and assessed risk of bias. Dual analysis, synthesis, and grading of the strength of evidence for each outcome followed for studies meeting inclusion criteria. We also used qualitative comparative analysis to examine relationships between combinations of strategy components and improvements in outcomes.ResultsWe identified 18 strategies described in 19 studies. Eleven strategies significantly improved at least one measure of intermediate outcomes, final health outcomes, or resource use. Moderate strength of evidence (from one RCT) supported using provider financial incentives such as pay for performance to improve the competence with which practitioners can implement evidence-based practices (EBPs). We found inconsistent evidence involving strategies with educational meetings, materials, and outreach; programs appeared to be successful in combination with reminders or providing practitioners with newly collected clinical information. We also found low strength of evidence for no benefit for initiatives that included only educational materials or meetings (or both), or only educational materials and outreach components. Evidence was insufficient to draw conclusions on harms and moderators of interventions.ConclusionsSeveral strategies can improve both intermediate and final health outcomes and resource use. This complex and heterogeneous body of evidence does not permit us to have a high degree of confidence about the efficacy of any one strategy because we generally found only a single study testing each strategy.Trial registrationPROSPERO, CRD42015024759.

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series

BackgroundWe investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews.MethodWe considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review’s last literature search, screened the records using the review’s eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review.ResultsAcross the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov’s inception date of 2000.ConclusionImproved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.