Meera Viswanathan

A systematic review of outcomes of maternal weight gain according to the Institute of Medicine recommendations: birthweight, fetal growth, and postpartum weight retention.

This systematic review focuses on outcomes of gestational weight gain, specifically birthweight, fetal growth, and postpartum weight retention, for singleton pregnancies with respect to the 1990 Institute of Medicine weight gain recommendations. A total of 35 studies met the inclusion criteria and were reviewed. There was strong evidence to support associations between excessive gestational weight gain and increased birthweight and fetal growth (large for gestational age) as well as inadequate gestational weight gain and decreased birthweight and fetal growth (small for gestational age). There was moderate evidence to support the association between excessive gestational weight gain and postpartum weight retention. Clear clinical recommendations based on this review are challenging because of several limitations in the literature. Improvements in future research include the use of consistent definitions of gestational weight gain and outcomes of interest, assessment of confounders, and better collection of weight and weight gain data.

Interventions to Improve Adherence to Self-administered Medications for Chronic Diseases in the United States: A Systematic Review

BACKGROUNDnSuboptimum medication adherence is common in the United States and leads to serious negative health consequences but may respond to intervention.nnnPURPOSEnTo assess the comparative effectiveness of patient, provider, systems, and policy interventions that aim to improve medication adherence for chronic health conditions in the United States.nnnDATA SOURCESnEligible peer-reviewed publications from MEDLINE and the Cochrane Library indexed through 4 June 2012 and additional studies from reference lists and technical experts.nnnSTUDY SELECTIONnRandomized, controlled trials of patient, provider, or systems interventions to improve adherence to long-term medications and nonrandomized studies of policy interventions to improve medication adherence.nnnDATA EXTRACTIONnTwo investigators independently selected, extracted data from, and rated the risk of bias of relevant studies.nnnDATA SYNTHESISnThe evidence was synthesized separately for each clinical condition; within each condition, the type of intervention was synthesized. Two reviewers graded the strength of evidence by using established criteria. From 4124 eligible abstracts, 62 trials of patient-, provider-, or systems-level interventions evaluated 18 types of interventions; another 4 observational studies and 1 trial of policy interventions evaluated the effect of reduced medication copayments or improved prescription drug coverage. Clinical conditions amenable to multiple approaches to improving adherence include hypertension, heart failure, depression, and asthma. Interventions that improve adherence across multiple clinical conditions include policy interventions to reduce copayments or improve prescription drug coverage, systems interventions to offer case management, and patient-level educational interventions with behavioral support.nnnLIMITATIONSnStudies were limited to adults with chronic conditions (excluding HIV, AIDS, severe mental illness, and substance abuse) in the United States. Clinical and methodological heterogeneity hindered quantitative data pooling.nnnCONCLUSIONnReduced out-of-pocket expenses, case management, and patient education with behavioral support all improved medication adherence for more than 1 condition. Evidence is limited on whether these approaches are broadly applicable or affect longterm medication adherence and health outcomes.nnnPRIMARY FUNDING SOURCEnAgency for Healthcare Research and Quality.

Outcomes and costs of community health worker interventions: A systematic review

Objectives:We conducted a systematic review on outcomes and costs of community health worker (CHW) interventions. CHWs are increasingly expected to improve health outcomes cost-effectively for the underserved. Research Design:We searched Medline, Cochrane Collaboration resources, and the Cumulative Index to Nursing and Allied Health Literature for studies conducted in the United States and published in English from 1980 through November 2008. We dually reviewed abstracts, full-text articles, data abstractions, quality ratings, and strength of evidence grades and resolved disagreements by consensus. Results:We included 53 studies on outcomes of CHW interventions and 6 on cost or cost-effectiveness. For outcomes, limited evidence (5 studies) suggests that CHW interventions can improve participant knowledge compared with alternative approaches or no intervention. We found mixed evidence for participant behavior change (22 studies) and health outcomes (27 studies). Some studies suggested that CHW interventions can result in greater improvements in participant behavior and health outcomes compared with various alternatives, but other studies suggested that CHW interventions provide no statistically different benefits than alternatives. We found low or moderate strength of evidence suggesting that CHWs can increase appropriate health care utilization for some interventions (30 studies). Six studies with economic information yielded insufficient data to evaluate the cost-effectiveness of CHW interventions relative to other interventions. Conclusions:CHWs can improve outcomes for underserved populations for some health conditions. The effectiveness of CHWs in many health care areas requires further research that addresses the methodologic limitations of prior studies and that contributes to translating research into practice.

Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: A Systematic Review and Meta-Analysis

OBJECTIVEnTo evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with major depressive disorder (MDD) and 2 or more prior antidepressant treatment failures (often referred to as treatment-resistant depression [TRD]). These patients are less likely to recover with medications alone and often consider nonpharmacologic treatments such as rTMS.nnnDATA SOURCESnWe searched MEDLINE, EMBASE, the Cochrane Library, PsycINFO, and the International Pharmaceutical Abstracts for studies comparing rTMS with a sham-controlled treatment in TRD patients ages 18 years or older.nnnSTUDY SELECTIONnWe included 18 good- or fair-quality TRD studies published from January 1, 1980, through March 20, 2013.nnnDATA EXTRACTIONnWe abstracted relevant data, assessed each studys internal validity, and graded strength of evidence for change in depressive severity, response rates, and remission rates.nnnRESULTSnrTMS was beneficial compared with sham for all outcomes. rTMS produced a greater decrease in depressive severity (high strength of evidence), averaging a clinically meaningful decrease on the Hamilton Depression Rating Scale (HDRS) of more than 4 points compared with sham (mean decrease = -4.53; 95% CI, -6.11 to -2.96). rTMS resulted in greater response rates (high strength of evidence); those receiving rTMS were more than 3 times as likely to respond as patients receiving sham (relative risk = 3.38; 95% CI, 2.24 to 5.10). Finally, rTMS was more likely to produce remission (moderate strength of evidence); patients receiving rTMS were more than 5 times as likely to achieve remission as those receiving sham (relative risk = 5.07; 95% CI, 2.50 to 10.30). Limited evidence and variable treatment parameters prevented conclusions about which specific treatment options are more effective than others. How long these benefits persist remains unclear.nnnCONCLUSIONSnFor MDD patients with 2 or more antidepressant treatment failures, rTMS is a reasonable, effective consideration.

Cesarean delivery on maternal : Request maternal and neonatal outcomes

OBJECTIVE: To review systematically the evidence about maternal and infant outcomes of cesarean delivery on maternal request and planned vaginal delivery. DATA SOURCES: We searched MEDLINE, Cochrane Collaboration resources, and Embase and identified 1,406 articles through dual review using a priori inclusion criteria. METHODS OF STUDY SELECTION: We included English language studies published from 1990 to June 2005 that compared the key reference group (cesarean delivery on maternal request or proxies) and planned vaginal delivery. TABULATION, INTEGRATION, AND RESULTS: We identified 54 articles for maternal and infant outcomes. Virtually no studies exist on cesarean delivery on maternal request, so the knowledge base rests on indirect evidence from proxies with unique and significant limitations. Most studies compared outcomes by actual routes of delivery, resulting in variable relevance to planned routes of delivery. Primary cesarean delivery on maternal request and planned vaginal delivery likely differ with respect to individual outcomes; for instance, risks of urinary incontinence and maternal hemorrhage were lower with planned cesarean, whereas the risk of neonatal respiratory morbidity was higher and maternal length of stay was longer with planned cesarean delivery. However, our comprehensive assessment, across many outcomes, suggests no major differences between primary cesarean delivery on maternal request and planned vaginal delivery, but the evidence is too weak to conclude definitively that differences are completely absent. If a woman chooses to have a cesarean delivery in her first delivery, she is more likely to have subsequent deliveries by cesarean. With increasing numbers of cesarean delivery, risks occur with increasing frequency. CONCLUSION: The evidence is significantly limited by its minimal relevance to primary cesarean delivery on maternal request. Future research requires developing consensus about terminology, creating a minimum data set for cesarean delivery on maternal request, improving study design and statistical analyses, attending to major outcomes and their special measurement issues, assessing both short- and long-term outcomes with better measurement strategies, dealing better with confounders, and considering the value or utility of different outcomes.

Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle–Ottawa Scale and the RTI item bank

Background The study objective was to compare the Newcastle–Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs. Methods We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic. Results The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86). Conclusion The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB’s developers.

Models of Cancer Survivorship Care: Overview and Summary of Current Evidence

INTRODUCTIONnThis article, derived from a Technical Brief prepared for the Agency for Healthcare Research and Quality, presents an overview on current models of care for survivors of adult-onset cancer who have completed active treatment.nnnMETHODSnThis article integrates reviewed literature on background, context, research gaps, and future research directions for survivorship care models. We also conducted a systematic literature review of current evidence from studies of survivorship care models.nnnRESULTSnOur systematic review identified nine empirical studies of survivorship care models, covering multiple models types and illustrating the heterogeneity in this field. The literature review indicated considerable heterogeneity in models of survivorship care, components of models, survivor populations, and target outcomes. Models of survivorship care are highly individualized to the institution or setting where they are provided. Usual care is often uncoordinated and highly varied across cancer survivors and within cancer programs. Anticipated shortages in the oncology workforce may require the expanded use of nurse practitioners and physician assistants and shared care with primary care providers to deliver survivorship care to the growing number of survivors. Concerns associated with survivorship care models include payment considerations, adequacy of training, and the potential for lack of coordination and fragmented care.nnnCONCLUSIONnThere is substantial variation in survivorship care models. The optimal nature, timing, intensity, format, and outcomes of survivorship care models are uncertain and require further research. Specific research questions need to be addressed by the survivorship community to better understand the advantages and limitations of survivorship models.

Grading the strength of a body of evidence when assessing health care interventions: an EPC update

OBJECTIVESnTo revise 2010 guidance on grading the strength of evidence (SOE) of the effectiveness of drugs, devices, and other preventive and therapeutic interventions in systematic reviews produced by the Evidence-based Practice Center (EPC) program, established by the US Agency for Healthcare Research and Quality (AHRQ).nnnSTUDY DESIGN AND SETTINGnA cross-EPC working group reviewed authoritative systems for grading SOE [primarily the approach from the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group] and conducted extensive discussions with GRADE and other experts.nnnRESULTSnUpdated guidance continues to be conceptually similar to GRADE. Reviewers are to evaluate SOE separately for each major treatment comparison for each major outcome. We added reporting bias as a required domain and retained study limitations (risk of bias), consistency, directness, and precision (and three optional domains). Additional guidance covers scoring consistency, precision, and reporting bias, grading bodies of evidence with randomized controlled trials and observational studies, evaluating single study bodies of evidence, using studies with high risk of bias, and presenting findings with greater clarity and transparency. SOE is graded high, moderate, low, or insufficient, reflecting reviewers confidence in the findings for a specific treatment comparison and outcome.nnnCONCLUSIONnNo single approach for grading SOE suits all reviews, but a more consistent and transparent approach to reporting summary information will make reviews more useful to the broad range of audiences that AHRQs work aims to reach. EPC working groups will consider ongoing challenges and modify guidance as needed, on issues such as combining trials and observational studies in bodies of evidence, weighting domains, and combining qualitative and quantitative syntheses.

Balancing “Fidelity” and Community Context in the Adaptation of Asthma Evidence-Based Interventions in the “Real World”

The Merck Childhood Asthma Network (MCAN) initiative selected five sites (New York City, Puerto Rico, Chicago, Los Angeles, and Philadelphia) to engage in translational research to adapt evidence-based interventions (EBIs) to improve childhood asthma outcomes. The authors summarize the sites’ experience by describing criteria defining the fidelity of translation, community contextual factors serving as barriers or enablers to fidelity, types of adaptation conducted, and strategies used to balance contextual factors and fidelity in developing a “best fit” for EBIs in the community. A conceptual model captures important structural and process-related factors and helps frame lessons learned. Site implementers and intervention developers reached consensus on qualitative rankings of the levels of fidelity of implementation for each of the EBI core components: low fidelity, adaptation (major vs. minor), or high fidelity. MCAN sites were successful in adapting core EBI components based on their understanding of structural and other contextual barriers and enhancers in their communities. Although the sites varied regarding both the EBI components they implemented and their respective levels of fidelity, all sites observed improvement in asthma outcomes. Our collective experiences of adapting and implementing asthma EBIs highlight many of the factors affecting translation of evidenced-based approaches to chronic disease management in real community settings.

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 (Nu2009>u200958u2009860) 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]; nu2009=u20094862). Odds ratios from cohort studies recruiting participants between 1984 and 1996 demonstrated beneficial associations and ranged from 0.11 to 0.27 (nu2009=u200919u2009982). Three of 4 case-control studies with data from 1976 through 1998 reported ORs ranging from 0.6 to 0.7 (nu2009>u20097121). 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 (nu2009>u200913u2009990). Regarding harms, 1 trial (OR, 1.40 [95% CI, 0.89-2.21]; nu2009=u20094767) and 1 cohort study (OR, 1.04 [95% CI, 0.91-1.18]; nu2009=u20092620) 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]; nu2009=u200914u2009438), 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.