Search

Objective: To summarize the state of research in maternal-fetal surgery regarding the surgical repair of abnormalities in fetuses in the womb.Data Sources: We searched MEDLINE from 1980 to 2010 for studies of maternal-fetal surgery for the following conditions: twin-twin transfusion syndrome, obstructive uropathy, congenital diaphragmatic hernia, myelomeningocele, thoracic lesions, cardiac malformations, and sacrococcygeal teratoma.Methods Of Study Selection: We used pilot-tested data collection forms to screen publications for inclusion and to extract data. We compiled information about how fetal diagnoses were defined, maternal inclusion criteria, type of surgery, study design, country, setting, comparators used, length of follow-up, outcomes measured, and adverse events.Tabulation, Integration, and Results: Two reviewers independently extracted data and discordance was resolved by a third party. Of 1,341 articles located, we retained 258 (comprising 166 unique study populations). Three studies were randomized controlled trials; the majority of the evidence was observational (116 case series [70%], 36 retrospective [22%], and 11 prospective [7%] cohorts). Twin-twin transfusion is the most studied condition, with 84 studies including 2,532 pregnancies. Fewer than 500 pregnancies are represented in the literature for each of the other conditions except congenital diaphragmatic hernia (n=503). Inclusion criteria were poorly specified. Outcomes typically measured were survival to birth, preterm birth, and neonatal death. Longer-term outcomes were sparse but included pulmonary, renal, and neurologic status and developmental milestones. Maternal outcome data were rare.Conclusion: Although developing rapidly, maternal-fetal surgery research has yet to achieve the typical quality of studies and aggregate strength of evidence needed to optimally inform care. [ABSTRACT FROM AUTHOR]

PURPOSE: To examine health and insurance characteristics of adolescents with special health care needs (ASHCN), at state and federal levels. METHODS: We used the National Survey of Children's Health 2003, a nationally representative sample of children in the United States, to study adolescents 14-17 years of age. We present descriptive statistics and regression analyses of adolescents with and without special health care needs, regarding measures of health care use and insurance coverage. RESULTS: Approximately 22% of adolescents 14-17 years old have a special health care need. On average, ASHCN have one more annual office visit per year than their non-SHCN peers (p < .001). ASHCN report three times the rate of unmet medical needs compared to their non-SHCN peers (p < .001), despite higher rates of insurance coverage (94% vs. 88%, p < .001). Overall, 26.9% of ASHCN have public coverage. Nationally, more than half of those ASHCN with public coverage report incomes above 100% of the federal poverty level (FPL), which puts them at risk for losing coverage when they age into adulthood. Across states, proportions of ASHCN on public coverage and with incomes > 100% FPL range from 3.2% to 37.5%. CONCLUSIONS: One in six ASHCN currently has public coverage with household income that would make them ineligible by income criteria for continuing public coverage as adults. It is imperative to examine insurance continuity and corresponding health outcomes for ASHCN as they transition from child to adult health care settings, and to evaluate options for policy interventions that can sustain health care coverage for this vulnerable population. [ABSTRACT FROM AUTHOR]

Examination of screening guideline concordance can help clinics and institutions identify and understand disparities within their own practices. We conducted a study to examine whether screening completion rates within a student-run free clinic (SRFC) reflected, exacerbated, or narrowed population-level disparities in outcomes by race/ethnicity and primary language. We compared completion rates for cervical cancer (n = 114), diabetic retinopathy (n = 91), colorectal cancer (n = 114), and breast cancer (n = 63) by race/ethnicity (Black, n = 37; Hispanic, n = 133; white, n = 54; other, n = 29) and primary language (English, n = 106; Spanish, n = 136; other, n = 11) among patients at Shade tree clinic (STC), an SFRC in Nashville, TN. There were no differences in screening completion rate by race/ethnicity, and Spanish-speaking patients had slightly higher rates of cervical cancer screening [91% (95% confidence interval 84-97%)] than English-speaking patients [72% (57-86%)]. Overall screening rates were comparable to national averages, and in the case of screenings performed within clinic-cervical cancer [82%; (75-89%)] and diabetic retinopathy screening [86% (79-92%)]-exceeded national averages and/or affiliated academic medical center goals. These findings extend the existing literature supporting the ability of SRFCs to provide effective care by also demonstrating one measure of equity in clinic processes, providing a framework for future studies of equity within SRFCs and traditional primary care practices., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To develop and validate algorithms for predicting 30-day fatal and nonfatal opioid-related overdose using statewide data sources including prescription drug monitoring program data, Hospital Discharge Data System data, and Tennessee (TN) vital records. Current overdose prevention efforts in TN rely on descriptive and retrospective analyses without prognostication., Materials and Methods: Study data included 3 041 668 TN patients with 71 479 191 controlled substance prescriptions from 2012 to 2017. Statewide data and socioeconomic indicators were used to train, ensemble, and calibrate 10 nonparametric "weak learner" models. Validation was performed using area under the receiver operating curve (AUROC), area under the precision recall curve, risk concentration, and Spiegelhalter z-test statistic., Results: Within 30 days, 2574 fatal overdoses occurred after 4912 prescriptions (0.0069%) and 8455 nonfatal overdoses occurred after 19 460 prescriptions (0.027%). Discrimination and calibration improved after ensembling (AUROC: 0.79-0.83; Spiegelhalter P value: 0-.12). Risk concentration captured 47-52% of cases in the top quantiles of predicted probabilities., Discussion: Partitioning and ensembling enabled all study data to be used given computational limits and helped mediate case imbalance. Predicting risk at the prescription level can aggregate risk to the patient, provider, pharmacy, county, and regional levels. Implementing these models into Tennessee Department of Health systems might enable more granular risk quantification. Prospective validation with more recent data is needed., Conclusion: Predicting opioid-related overdose risk at statewide scales remains difficult and models like these, which required a partnership between an academic institution and state health agency to develop, may complement traditional epidemiological methods of risk identification and inform public health decisions., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Background: Opioid overdose deaths have continued to rise in Tennessee (TN) with fentanyl emerging as a major contributor. Current data are needed to identify at-risk populations to guide prevention strategies. We conducted a large statewide observational study among TN adult decedents (2013-2016) to evaluate the association of sociodemographic factors and prescribing patterns with opioid overdose deaths., Methods: Among drug overdose decedents identified using death certificate data (n = 5483), we used logistic regression to estimate adjusted odds ratios and 95% confidence intervals for characteristics associated with prescription opioid (PO) (excluding fentanyl), fentanyl, and heroin alone overdoses. Among decedents linked to TN's Prescription Drug Monitoring Database using deterministic algorithms, we obtained prescription history in the year before death (n = 3971), which was evaluated by type of overdose using descriptive statistics., Results: Younger, non-White decedents had lower odds of PO overdose, while females and benzodiazepines as a contributing cause were associated with increased odds of PO overdose. Younger age, Non-Hispanic Black race/ethnicity, greater than high school education, and cocaine/other stimulants as a contributing cause were associated with increased odds of fentanyl or heroin overdoses. Over 55% of PO, 39.2% of fentanyl, and 20.7% of heroin overdoses had an active opioid prescription at death. For PO, fentanyl, and heroin decedents, respectively, 46.0%, 30.5%, and 26.2% had an active prescription for benzodiazepines at death., Conclusions: Prescription opioid overdose deaths were associated with different sociodemographic profiles and prescribing history compared to fentanyl and heroin overdose deaths in TN. Data can guide prevention strategies to reduce opioid overdose mortality., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives Depression and medication nonadherence are important in managing chronic diseases, but little is known about these factors in childhood-onset systemic lupus erythematosus (cSLE). The objectives of this cross-sectional study were to estimate prevalence of depression and medication nonadherence, describe demographic and disease characteristics associated with depression and medication nonadherence, and evaluate the association between depression and medication nonadherence in cSLE patients. Methods Patients with cSLE ( n = 51) completed validated screening questionnaires to identify depression and medication nonadherence, Patient Health Questionnaire-9 and Medication Adherence Self-Report Inventory, respectively. Demographic and disease characteristics were obtained via chart abstraction, and compared between groups of depression or medication nonadherence status. A multivariable linear regression model adjusting for propensity scores was conducted to evaluate the association between depression and medication nonadherence. Results The prevalence of a positive depression screen was 58.8%, and seven patients reported suicidal ideation (13.7%). The prevalence of self-reported medication nonadherence was 19.7%. No statistically significant differences for demographic and disease characteristics were found between patients with a positive vs. negative depression screen. Patients reporting medication nonadherence were more likely to have longer disease duration (4.8 vs. 2.6 years, p = 0.035). As the severity of depression symptoms increased, the degree of medication nonadherence also increased (beta = -1.89; p = 0.011). Conclusions The prevalence of depression and medication nonadherence is high in cSLE, and these factors have a direct relationship. Interventions that better recognize and treat depression and increase rates of medication adherence are needed to improve outcomes in cSLE.

Background: Systematic reviews of complex interventions can vary widely in purpose, data availability and heterogeneity, and stakeholder expectations., Rationale: This article addresses the uncertainty that systematic reviewers face in selecting methods for reviews of complex interventions. Specifically, it lays out parameters for systematic reviewers to consider when selecting analytic approaches that best answer the questions at hand and suggests analytic techniques that may be appropriate in different circumstances., Discussion: Systematic reviews of complex interventions comprising multiple questions may use multiple analytic approaches. Parameters to consider when choosing analytic methods for complex interventions include nature and timing of the decision (clinical practice guideline, policy, or other); purpose of the review; extent of existing evidence; logistic factors such as the timeline, process, and resources for deciding the scope of the review; and value of information to be obtained from choosing specific systematic review methods. Reviewers may elect to revise their analytic approach based on new or changing considerations during the course of the review but should guard against bias through transparency of reporting., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: Patient-reported outcome (PRO) measures address the need for patient-centered data and are now used in diverse clinical, research, and policy pursuits. They are important in conditions causing upper airway-related dyspnea in which the patient's reported experience and physiological data can be discrepant., Objectives: To perform a systematic review of the literature on upper airway dyspnea-related PRO measures and to rigorously evaluate each measure's developmental properties, validation, and applicability., Evidence Review: This study strictly adhered to Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. MEDLINE via the PubMed interface, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Health and Psychosocial Instruments (HaPI) database were searched using relevant vocabulary terms and key terms related to PRO measures and upper airway-related dyspnea. Three investigators performed abstract review, and 2 investigators independently performed full-text review by applying an established checklist to evaluate the conceptual model, content validity, reliability, construct validity, scoring and interpretability, and respondent burden and presentation of each identified instrument. The initial literature search was conducted in November 2014 and was updated in April 2016., Findings: Of 1269 studies reviewed, 3 upper airway-related dyspnea PRO measures met criteria for inclusion. One PRO measure was designed de novo to assess upper airway-related dyspnea symptoms and monitor treatment outcomes, while 2 were adapted from established instruments designed for lower airway disease. Measurement properties and psychometric characteristics differed, and none met all checklist criteria. Two met a criterion in each of 7 domains evaluated. Two demonstrated test-retest and internal consistency reliability, and 2 showed that their scores were responsive to change. Thematic deficiencies in current upper airway-related dyspnea PRO measures are lack of patient involvement in item development (content validity), plan for interpretation, and literacy level assessments., Conclusions and Relevance: PRO measures are critical in the assessment of patients with upper airway-related dyspnea. Three instruments with disparate developmental rigor have been designed or adapted to assess this construct. Care must be taken to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives.

Context: Children with autism spectrum disorder (ASD) frequently use special diets or receive nutritional supplements to treat ASD symptoms., Objectives: Our objective was to evaluate the effectiveness and safety of dietary interventions or nutritional supplements in ASD., Data Sources: Databases, including Medline and PsycINFO., Study Selection: Two investigators independently screened studies against predetermined criteria., Data Extraction: One investigator extracted data with review by a second investigator. Investigators independently assessed the risk of bias and strength of evidence (SOE) (ie, confidence in the estimate of effects)., Results: Nineteen randomized controlled trials (RCTs), 4 with a low risk of bias, evaluated supplements or variations of the gluten/casein-free diet and other dietary approaches. Populations, interventions, and outcomes varied. Ω-3 supplementation did not affect challenging behaviors and was associated with minimal harms (low SOE). Two RCTs of different digestive enzymes reported mixed effects on symptom severity (insufficient SOE). Studies of other supplements (methyl B 12 , levocarnitine) reported some improvements in symptom severity (insufficient SOE). Studies evaluating gluten/casein-free diets reported some parent-rated improvements in communication and challenging behaviors; however, data were inadequate to make conclusions about the body of evidence (insufficient SOE). Studies of gluten- or casein-containing challenge foods reported no effects on behavior or gastrointestinal symptoms with challenge foods (insufficient SOE); 1 RCT reported no effects of camel's milk on ASD severity (insufficient SOE). Harms were disparate., Limitations: Studies were small and short-term, and there were few fully categorized populations or concomitant interventions., Conclusions: There is little evidence to support the use of nutritional supplements or dietary therapies for children with ASD., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2017 by the American Academy of Pediatrics.)

Context: Sensory challenges are common among children with autism spectrum disorder (ASD)., Objective: To evaluate the effectiveness and safety of interventions targeting sensory challenges in ASD., Data Sources: Databases, including Medline and PsycINFO., Study Selection: Two investigators independently screened studies against predetermined criteria., Data Extraction: One investigator extracted data with review by a second. Investigators independently assessed risk of bias and strength of evidence (SOE), or confidence in the estimate of effects., Results: Twenty-four studies, including 20 randomized controlled trials (RCTs), were included. Only 3 studies had low risk of bias. Populations, interventions, and outcomes varied. Limited, short-term studies reported potential positive effects of several approaches in discrete skill domains. Specifically, sensory integration-based approaches improved sensory and motor skills-related measures (low SOE). Environmental enrichment improved nonverbal cognitive skills (low SOE). Studies of auditory integration-based approaches did not improve language (low SOE). Massage improved symptom severity and sensory challenges in studies with likely overlapping participants (low SOE). Music therapy studies evaluated different protocols and outcomes, precluding synthesis (insufficient SOE). Some positive effects were reported for other approaches, but findings were inconsistent (insufficient SOE)., Limitations: Studies were small and short-term, and few fully categorized populations., Conclusions: Some interventions may yield modest short-term (<6 months) improvements in sensory- and ASD symptom severity-related outcomes; the evidence base is small, and the durability of the effects is unclear. Although some therapies may hold promise, substantial needs exist for continuing improvements in methodologic rigor., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2017 by the American Academy of Pediatrics.)

Objective: Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability., Design: MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation., Results: Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment., Conclusion: This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We identified several instruments with robust measurement properties in multiple diseases including achalasia, oropharyngeal dysphagia, post-surgical dysphagia, esophageal cancer, and dysphagia related to neurological diseases. Findings herein can assist clinicians and researchers in making more informed decisions in selecting the most fundamentally sound PRO measure for a given clinical, research, or quality initiative., (© The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Context: The effectiveness of tonsillectomy or adenotonsillectomy (hereafter, "tonsillectomy") for obstructive sleep-disordered breathing (OSDB) compared with watchful waiting with supportive care is poorly understood., Objective: To compare sleep, cognitive or behavioral, and health outcomes of tonsillectomy versus watchful waiting with supportive care in children with OSDB., Data Sources: Medline, Embase, and the Cochrane Library., Study Selection: Two investigators independently screened studies against predetermined criteria., Data Extraction: Two investigators independently extracted key data. Investigators independently assessed study risk of bias and the strength of the evidence of the body of literature. Investigators synthesized data qualitatively and meta-analyzed apnea-hypopnea index (AHI) scores., Results: We included 11 studies. Relative to watchful waiting, most studies reported better sleep-related outcomes in children who had a tonsillectomy. In 5 studies including children with polysomnography-confirmed OSDB, AHI scores improved more in children receiving tonsillectomy versus surgery. A meta-analysis of 3 studies showed a 4.8-point improvement in the AHI in children who underwent tonsillectomy compared with no surgery. Sleep-related quality of life and negative behaviors (eg, anxiety and emotional lability) also improved more among children who had a tonsillectomy. Changes in executive function were not significantly different. The length of follow-up in studies was generally <12 months., Limitations: Few studies fully categorized populations in terms of severity of OSDB; outcome measures were heterogeneous; and the durability of outcomes beyond 12 months is not known., Conclusions: Tonsillectomy can produce short-term improvement in sleep outcomes compared with no surgery in children with OSDB. Understanding of longer-term outcomes or effects in subpopulations is lacking., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2017 by the American Academy of Pediatrics.)

Context: The effectiveness of tonsillectomy or adenotonsillectomy ("tonsillectomy") for recurrent throat infection compared with watchful waiting is uncertain., Objective: To compare sleep, cognitive, behavioral, and health outcomes of tonsillectomy versus watchful waiting in children with recurrent throat infections., Data Sources: MEDLINE, Embase, and the Cochrane Library., Study Selection: Two investigators independently screened studies against predetermined criteria., Data Extraction: One investigator extracted data with review by a second. Investigators independently assessed risk of bias and strength of evidence (SOE) and confidence in the estimate of effects., Results: Seven studies including children with ≥3 infections in the previous 1 to 3 years addressed this question. In studies reporting baseline data, number of infections/sore throats decreased from baseline in both groups, with greater decreases in sore throat days, clinician contacts, diagnosed group A streptococcal infections, and school absences in tonsillectomized children in the short term (<12 months). Quality of life was not markedly different between groups at any time point., Limitations: Few studies fully categorized infection/sore throat severity; attrition was high., Conclusions: Throat infections, utilization, and school absences improved in the first postsurgical year in tonsillectomized children versus children not receiving surgery. Benefits did not persist over time; longer-term outcomes are limited. SOE is moderate for reduction in short-term throat infections and insufficient for longer-term reduction. SOE is low for no difference in longer-term streptococcal infection reduction. SOE is low for utilization and missed school reduction in the short term, low for no difference in longer-term missed school, and low for no differences in quality of life., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2017 by the American Academy of Pediatrics.)

Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties., Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables., Results: A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling., Conclusions: PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications.

Objectives: Patient-reported outcome (PRO) measures are often used to diagnose laryngopharyngeal reflux (LPR) and monitor treatment outcomes in clinical and research settings. The present systematic review was designed to identify currently available LPR-related PRO measures and to evaluate each measure's instrument development, validation, and applicability., Data Sources: MEDLINE via PubMed interface, CINAHL, and Health and Psychosocial Instrument databases were searched with relevant vocabulary and key terms related to PRO measures and LPR., Review Methods: Three investigators independently performed abstract review and full text review, applying a previously developed checklist to critically assess measurement properties of each study meeting inclusion criteria., Results: Of 4947 studies reviewed, 7 LPR-related PRO measures (publication years, 1991-2010) met criteria for extraction and analysis. Two focused on globus and throat symptoms. Remaining measures were designed to assess LPR symptoms and monitor treatment outcomes in patients. None met all checklist criteria. Only 2 of 7 used patient input to devise item content, and 2 of 7 assessed responsiveness to change. Thematic deficiencies in current LPR-related measures are inadequately demonstrated: content validity, construct validity, plan for interpretation, and literacy level assessment., Conclusion: Laryngopharyngeal reflux is often diagnosed according to symptoms. Currently available LPR-related PRO measures used to symptomatically identify suspected LPR patients have disparate developmental rigor and important methodological deficiencies. Care should be exercised to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives., (© American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.)

Background: The purpose of this study was to advance a checklist of evaluative criteria designed to assess patient-reported outcome (PRO) measures' developmental measurement properties and applicability, which can be used by systematic reviewers, researchers, and clinicians with a varied range of expertise in psychometric measure development methodology., Methods: A directed literature search was performed to identify original studies, textbooks, consensus guidelines, and published reports that propose criteria for assessing the quality of PRO measures. Recommendations from these sources were iteratively distilled into a checklist of key attributes. Preliminary items underwent evaluation through 24 cognitive interviews with clinicians and quantitative researchers. Six measurement theory methodological novices independently applied the final checklist to assess six PRO measures encompassing a variety of methods, applications, and clinical constructs. Agreement between novice and expert scores was assessed., Results: The distillation process yielded an 18-item checklist with six domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (5) scoring and interpretation, and (6) respondent burden and presentation. With minimal instruction, good agreement in checklist item ratings was achieved between quantitative researchers with expertise in measurement theory and less experienced clinicians (mean kappa 0.70; range 0.66-0.87)., Conclusions: We present a simplified checklist that can help guide systematic reviewers, researchers, and clinicians with varied measurement theory expertise to evaluate the strengths and weakness of candidate PRO measures' developmental properties and the appropriateness for specific applications.

Purpose: In 2011, an Advanced Notice of Proposed Rulemaking proposed that de-identified human data and specimens be included in biobanks only if patients provide consent. The National Institutes of Health Genomic Data Sharing policy went into effect in 2015, requiring broad consent from almost all research participants., Methods: We conducted a systematic literature review of attitudes toward biobanking, broad consent, and data sharing. Bibliographic databases included MEDLINE, Web of Science, EthxWeb, and GenETHX. Study screening was conducted using DistillerSR., Results: The final 48 studies included surveys (n = 23), focus groups (n = 8), mixed methods (n = 14), interviews (n = 1), and consent form analyses (n = 2). Study quality was characterized as good (n = 19), fair (n = 27), and poor (n = 2). Although many participants objected, broad consent was often preferred over tiered or study-specific consent, particularly when broad consent was the only option, samples were de-identified, logistics of biobanks were communicated, and privacy was addressed. Willingness for data to be shared was high, but it was lower among individuals from under-represented minorities, individuals with privacy and confidentiality concerns, and when pharmaceutical companies had access to data., Conclusions: Additional research is needed to understand factors affecting willingness to give broad consent for biobank research and data sharing in order to address concerns to enhance acceptability.Genet Med 18 7, 663-671.

Currently, the Agency for Healthcare Research and Quality (AHRQ) Common Format for nursing homes (NHs) accommodates voluntary reporting for 4 adverse events: falls with injury, pressure ulcers, medication errors, and infections. In 2015, AHRQ funded a technical brief to describe the state of the science related to safety in the NH setting to inform a research agenda. Thirty-six recent systematic reviews evaluated NH safety-related interventions to address these 4 adverse events and reported mostly mixed evidence about effective approaches to ameliorate them. Furthermore, these 4 events are likely inadequate to capture safety issues that are unique to the NH setting and encompass other domains related to residents' quality of care and quality of life. Future research needs include expanding our definition of safety in the NH setting, which differs considerably from that of hospitals, to include contributing factors to adverse events as well as more resident-centered care measures. Second, future research should reflect more rigorous implementation science to include objective measures of care processes related to adverse events, intervention fidelity, and staffing resources for intervention implementation to inform broader uptake of efficacious interventions. Weaknesses in implementation contribute to the current inconclusive and mixed evidence base as well as remaining questions about what outcomes are even achievable in the NH setting, given the complexity of most resident populations. Also related to implementation, future research should determine the effects of specific staffing models on care processes related to safety outcomes. Last, future efforts should explore the potential for safety issues in other care settings for older adults, most notably dementia care within assisted living., (Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.)

Context: Infantile hemangiomas (IH) may be associated with significant functional impact., Objective: The objective of this study was to meta-analyze studies of pharmacologic interventions for children with IH., Data Sources: Data sources were Medline and other databases from 1982 to June 2015., Study Selection: Two reviewers assessed studies using predetermined inclusion criteria., Data Extraction: One reviewer extracted data with review by a second., Results: We included 18 studies in a network meta-analysis assessing relative expected rates of IH clearance associated with β-blockers and steroids. Oral propranolol had the largest mean estimate of expected clearance (95%; 95% Bayesian credible interval [BCI]: 88%-99%) relative to oral corticosteroids (43%, 95% BCI: 21%-66%) and control (6%, 95% BCI: 1%-11%). Strength of evidence (SOE) was high for propranolol's effects on reducing lesion size compared with observation/placebo. Corticosteroids demonstrated moderate effectiveness at reducing size/volume (moderate SOE for improvement in IH). SOE was low for effects of topical timolol versus placebo., Limitations: Methodologic limitations of available evidence may compromise SOE. Validity of meta-analytic estimates relies on the assumption of exchangeability among studies, conditional on effects of the intervention. Results rely on assumed lack of reporting bias., Conclusions: Propranolol is effective at reducing IH size compared with placebo, observation, and other treatments including steroids in most studies. Corticosteroids demonstrate moderate effectiveness at reducing IH size/volume. The meta-analysis estimates provide a relative ranking of anticipated rates of lesion clearance among treatments. Families and clinicians making treatment decisions should also factor in elements such as lesion size, location, number, and type, and patient and family preferences., (Copyright © 2016 by the American Academy of Pediatrics.)

Pharmacologic agents to promote mucus clearance may reduce the sequelae of obstructive secretions. We systematically reviewed comparative studies of pharmacologic agents for mucus clearance in hospitalized or postoperative subjects without cystic fibrosis and over 12 months of age. We searched MEDLINE and other databases from January 1970 to July 2014 to identify relevant literature. Two reviewers independently assessed each study against predetermined inclusion/exclusion criteria. Two reviewers also independently extracted data regarding subject and intervention characteristics and outcomes and assigned overall quality ratings. The 9 studies meeting review criteria included 5 randomized controlled trials, 3 crossover randomized controlled trials, and one retrospective cohort study. Studies were small and together included a total of 379 subjects (mean of 42 subjects per study). N-acetylcysteine, heparin plus N-acetylcysteine, albuterol, ipratropium bromide, and saline were assessed. Studies reported no benefit of studied agents on expectoration, pulmonary function, and atelectasis and little effect on changes in sputum volume, weight, or viscosity. Adverse effects of agents were not consistently reported. Nausea was reported in 2 studies of N-acetylcysteine (one paper reported 2 experiments and did not clearly identify in which experiment adverse effects occurred), 3 studies reported that there were no adverse events, and 3 studies did not address adverse effects at all. Further research with clearly characterized populations and interventions is needed to understand the potential benefits and adverse effects of mucoactive agents., (Copyright © 2015 by Daedalus Enterprises.)

Background: Approximately 750,000 children in the United States with special health care needs will transition from pediatric to adult care annually. Fewer than half receive adequate transition care., Methods: We had conversations with key informants representing clinicians who provide transition care, pediatric and adult providers of services for individuals with special health care needs, policy experts, and researchers; searched online sources for information about currently available programs and resources; and conducted a literature search to identify research on the effectiveness of transition programs., Results: We identified 25 studies evaluating transition care programs. Most (n = 8) were conducted in populations with diabetes, with a smaller literature (n = 5) on transplant patients. We identified an additional 12 studies on a range of conditions, with no more than 2 studies on the same condition. Common components of care included use of a transition coordinator, a special clinic for young adults in transition, and provision of educational materials., Conclusions: The issue of how to provide transition care for children with special health care needs warrants further attention. Research needs are wide ranging, including both substantive and methodologic concerns. Although there is widespread agreement on the need for adequate transition programs, there is no accepted way to measure transition success. It will be essential to establish consistent goals to build an adequate body of literature to affect practice., (Copyright © 2014 by the American Academy of Pediatrics.)

Importance: Positron emission tomography (PET) combined with fludeoxyglucose F 18 (FDG) is recommended for the noninvasive diagnosis of pulmonary nodules suspicious for lung cancer. In populations with endemic infectious lung disease, FDG-PET may not accurately identify malignant lesions., Objectives: To estimate the diagnostic accuracy of FDG-PET for pulmonary nodules suspicious for lung cancer in regions where infectious lung disease is endemic and compare the test accuracy in regions where infectious lung disease is rare., Data Sources and Study Selection: Databases of MEDLINE, EMBASE, and the Web of Science were searched from October 1, 2000, through April 28, 2014. Articles reporting information sufficient to calculate sensitivity and specificity of FDG-PET to diagnose lung cancer were included. Only studies that enrolled more than 10 participants with benign and malignant lesions were included. Database searches yielded 1923 articles, of which 257 were assessed for eligibility. Seventy studies were included in the analysis. Studies reported on a total of 8511 nodules; 5105 (60%) were malignant., Data Extraction and Synthesis: Abstracts meeting eligibility criteria were collected by a research librarian and reviewed by 2 independent reviewers. Hierarchical summary receiver operating characteristic curves were constructed. A random-effects logistic regression model was used to summarize and assess the effect of endemic infectious lung disease on test performance., Main Outcome and Measures: The sensitivity and specificity for FDG-PET test performance., Results: Heterogeneity for sensitivity (I2 = 87%) and specificity (I2 = 82%) was observed across studies. The pooled (unadjusted) sensitivity was 89% (95% CI, 86%-91%) and specificity was 75% (95% CI, 71%-79%). There was a 16% lower average adjusted specificity in regions with endemic infectious lung disease (61% [95% CI, 49%-72%]) compared with nonendemic regions (77% [95% CI, 73%-80%]). Lower specificity was observed when the analysis was limited to rigorously conducted and well-controlled studies. In general, sensitivity did not change appreciably by endemic infection status, even after adjusting for relevant factors., Conclusions and Relevance: The accuracy of FDG-PET for diagnosing lung nodules was extremely heterogeneous. Use of FDG-PET combined with computed tomography was less specific in diagnosing malignancy in populations with endemic infectious lung disease compared with nonendemic regions. These data do not support the use of FDG-PET to diagnose lung cancer in endemic regions unless an institution achieves test performance accuracy similar to that found in nonendemic regions.

Aim: The aim of the study was to systematically review surgical intervention for feeding difficulties in cerebral palsy., Method: We searched databases including MEDLINE from 1980 to July 2012. Two reviewers independently assessed studies and rated the overall quality and strength of the evidence., Results: Thirteen publications (11 unique studies) met the inclusion criteria and addressed gastrostomy outcomes or treatment of reflux via fundoplication. In nine studies, gastrostomy-fed children gained weight. Relative to typically developing populations, baseline weight z-scores ranged from -3.56 to -0.39 and follow-up z-scores ranged from -2.63 to -0.33. Other growth measures were mixed. Two studies assessed fundoplication: in one, both Nissen fundoplication and vertical gastric plication reduced reflux (by 57% and 43% respectively), while in one case series, reflux recurred within 12 months in 30% of children. The highest rates of adverse events across studies were site infection (59%), granulation tissue (42%), and recurrent reflux (30%). Death rates ranged from 7 to 29%; however, the underlying cause was probably not surgery., Interpretation: Evidence for the effectiveness of surgical interventions is insufficient to low. Studies of gastrostomy typically demonstrated significant weight gain. Results for other measures were mixed. Many children remained underweight, although, given a lack of appropriate reference standards, these results should be interpreted cautiously., (© 2013 Mac Keith Press.)

Background: We systematically reviewed evidence addressing the effectiveness of nitrous oxide for the management of labor pain, the influence of nitrous oxide on women's satisfaction with their birth experience and labor pain management, and adverse effects associated with nitrous oxide for labor pain management., Methods: We searched the MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases for articles published in English. The study population included pregnant women in labor intending a vaginal birth, birth attendees or health care providers who may be exposed to nitrous oxide during labor, and the fetus/neonate., Results: We identified a total of 58 publications, representing 59 distinct study populations: 2 studies were of good quality, 11 fair, and 46 poor. Inhalation of nitrous oxide provided less effective pain relief than epidural analgesia, but the quality of studies was predominately poor. The heterogeneous outcomes used to assess women's satisfaction with their birth experience and labor pain management made synthesis of studies difficult. Most maternal adverse effects reported in the literature were unpleasant side effects that affect tolerability, such as nausea, vomiting, dizziness, and drowsiness. Apgar scores in newborns whose mothers used nitrous oxide were not significantly different from those of newborns whose mothers used other labor pain management methods or no analgesia. Evidence about occupational harms and exposure was limited., Conclusions: The literature addressing nitrous oxide for the management of labor pain includes few studies of good or fair quality. Further research is needed across all of the areas examined: effectiveness, satisfaction, and adverse effects.

Purpose: To identify and assess billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify the following health outcomes in administrative and claims databases: acute disseminated encephalomyelitis (ADEM), optic neuritis, tics, and Henoch Schönlein purpura (HSP)., Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to the conditions. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria and extracted case validation data from those studies meeting inclusion criteria., Results: Two eligible studies addressed ADEM, two addressed optic neuritis, and four studies addressed tics. Only one study addressed HSP. Among these, one study of ADEM reported a positive predictive value of 66%, however the identification algorithm contained a combination of International Classification of Diseases (ICD) codes and other identification methods and the performance of the ICD-9 codes alone was not reported. No other studies reported validation data., Conclusions: The lack of data on the validity of algorithms to identify these conditions may hamper our ability to determine incidence patterns with respect to infection and vaccination exposures. Further epidemiologic research to define validated methods of identifying cases could improve surveillance using large linked healthcare databases., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To identify and assess diagnosis, procedure and pharmacy dispensing codes used to identify stillbirths and spontaneous abortion in administrative and claims databases from the United States or Canada., Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to stillbirth or spontaneous abortion. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics and assessed each study's methodological rigor using a pre-defined approach., Results: Ten publications addressing stillbirth and four addressing spontaneous abortion met our inclusion criteria. The International Classification of Diseases, Ninth Revision (ICD-9) codes most commonly used in algorithms for stillbirth were those for intrauterine death (656.4) and stillborn outcomes of delivery (V27.1, V27.3-V27.4, and V27.6-V27.7). Papers identifying spontaneous abortion used codes for missed abortion and spontaneous abortion: 632, 634.x, as well as V27.0-V27.7. Only two studies identifying stillbirth reported validation of algorithms. The overall positive predictive value of the algorithms was high (99%-100%), and one study reported an algorithm with 86% sensitivity. However, the predictive value of individual codes was not assessed and study populations were limited to specific geographic areas., Conclusions: Additional validation studies with a nationally representative sample are needed to confirm the optimal algorithm to identify stillbirths or spontaneous abortion in administrative and claims databases.', (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To identify and assess billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify acute bronchospasm in administrative and claims databases., Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to bronchospasm, wheeze and acute asthma. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics., Results: Our searches identified 677 citations of which 38 met our inclusion criteria. In these 38 studies, the most commonly used ICD-9 code was 493.x. Only 3 studies reported any validation methods for the identification of bronchospasm, wheeze or acute asthma in administrative and claims databases; all were among pediatric populations and only 2 offered any validation statistics. Some of the outcome definitions utilized were heterogeneous and included other disease based diagnoses, such as bronchiolitis and pneumonia, which are typically of an infectious etiology. One study offered the validation of algorithms utilizing Emergency Department triage chief complaint codes to diagnose acute asthma exacerbations with ICD-9 786.07 (wheezing) revealing the highest sensitivity (56%), specificity (97%), PPV (93.5%) and NPV (76%)., Conclusions: There is a paucity of studies reporting rigorous methods to validate algorithms for the identification of bronchospasm in administrative data. The scant validated data available are limited in their generalizability to broad-based populations., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To identify algorithms that can capture incident cases of myocarditis and pericarditis in administrative and claims databases; these algorithms can eventually be used to identify cardiac inflammatory adverse events following vaccine administration., Methods: We searched MEDLINE from 1991 to September 2012 using controlled vocabulary and key terms related to myocarditis. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics as well as study conduct., Results: Nine publications (including one study reported in two publications) met criteria for inclusion. Two studies performed medical record review in order to confirm that these coding algorithms actually captured patients with the disease of interest. One of these studies identified five potential cases, none of which were confirmed as acute myocarditis upon review. The other study, which employed a search algorithm based on diagnostic surveillance (using ICD-9 codes 420.90, 420.99, 422.90, 422.91 and 429.0) and sentinel reporting, identified 59 clinically confirmed cases of myopericarditis among 492,671 United States military service personnel who received smallpox vaccine between 2002 and 2003. Neither study provided algorithm validation statistics (positive predictive value, sensitivity, or specificity)., Conclusions: A validated search algorithm is currently unavailable for identifying incident cases of pericarditis or myocarditis. Several authors have published unvalidated ICD-9-based search algorithms that appear to capture myocarditis events occurring in the context of other underlying cardiac or autoimmune conditions., (Copyright © 2013. Published by Elsevier Ltd.)

Purpose: To review the evidence supporting the validity of billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify patients with rheumatoid arthritis (RA) in administrative and claim databases., Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to RA and reference lists of included studies were searched. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria and extracted the data. Data collected included participant and algorithm characteristics., Results: Nine studies reported validation of computer algorithms based on International Classification of Diseases (ICD) codes with or without free-text, medication use, laboratory data and the need for a diagnosis by a rheumatologist. These studies yielded positive predictive values (PPV) ranging from 34 to 97% to identify patients with RA. Higher PPVs were obtained with the use of at least two ICD and/or procedure codes (ICD-9 code 714 and others), the requirement of a prescription of a medication used to treat RA, or requirement of participation of a rheumatologist in patient care. For example, the PPV increased from 66 to 97% when the use of disease-modifying antirheumatic drugs and the presence of a positive rheumatoid factor were required., Conclusions: There have been substantial efforts to propose and validate algorithms to identify patients with RA in automated databases. Algorithms that include more than one code and incorporate medications or laboratory data and/or required a diagnosis by a rheumatologist may increase the PPV., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To review algorithms used to identify uveitis in administrative and claims databases., Methods: We searched the MEDLINE database via PubMed from 1991 to September 2012 using vocabulary and key terms related to uveitis. We also searched the reference lists of included studies. Two investigators independently assessed studies against pre-determined inclusion criteria. The same two investigators independently extracted data regarding participant and algorithm characteristics and assessed a study's methodological rigor using a pre-defined approach., Results: Seven studies met inclusion criteria. Variability exists among algorithms employed in these studies for finding cases of uveitis and related conditions as well as in use and implementation of validation methods. Of the seven included studies, three involved case validation. One used a narrow algorithm in addition to text mining of electronic medical records to identify incident cases and found a positive predictive value of 52.1%. The other two, which used broader uveitis definitions and included both incident and prevalent cases, found positive predictive values of 24.8% and 52.6%., Conclusions: Further research, with case as well as individual code validation, is needed to determine appropriate uveitis algorithms for purposes of active surveillance in administrative data. Decisions about which algorithm to use will depend on the desired balance of sensitivity and specificity., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

This report provides an overview of methods used to conduct systematic reviews for the US Food and Drug Administration (FDA) Mini-Sentinel project, which is designed to inform the development of safety monitoring tools for FDA-regulated products including vaccines. The objective of these reviews was to summarize the literature describing algorithms (e.g., diagnosis or procedure codes) to identify health outcomes in administrative and claims data. A particular focus was the validity of the algorithms when compared to reference standards such as diagnoses in medical records. The overarching goal was to identify algorithms that can accurately identify the health outcomes for safety surveillance. We searched the MEDLINE database via PubMed and required dual review of full text articles and of data extracted from studies. We also extracted data on each study's methods for case validation. We reviewed over 5600 abstracts/full text studies across 15 health outcomes of interest. Nearly 260 studies met our initial criteria (conducted in the US or Canada, used an administrative database, reported case-finding algorithm). Few studies (N=45), however, reported validation of case-finding algorithms (sensitivity, specificity, positive or negative predictive value). Among these, the most common approach to validation was to calculate positive predictive values, based on a review of medical records as the reference standard. Of the studies reporting validation, the ease with which a given clinical condition could be identified in administrative records varied substantially, both by the clinical condition and by other factors such as the clinical setting, which relates to the disease prevalence., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To identify and assess billing, procedural, or diagnosis code, or pharmacy claims-based algorithms used to identify Bell's palsy in administrative and claims databases., Methods: We searched the MEDLINE database via PubMed from 1991 to September 2012 using controlled vocabulary and key terms related to Bell's palsy. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics and assessed a study's methodologic rigor., Results: One study identified Bell's palsy using an algorithm that included ICD-9 code 351.x and H-ICDA code 350.x, and two other studies analyzed a dataset for ICD-9 code 351.0. The positive predictive values of these studies were 0.81 and 0.88, based on case adjudication of ICD-9 matches. Two further studies calculated incidence rates without validation of their methods, also including ICD-9 code 351.0. No study reported the sensitivity of algorithms to identify Bell's palsy., Conclusions: Few publications used rigorous methods to identify a validated algorithm that could identify cases of Bell's palsy from an administrative database. The best evidence from two different datasets in the literature addressed in this review used ICD-9 code 351.0 or a collection of ICD-9 codes 351.x for facial nerve disorders including Bell's palsy, along with other ICD-9 and H-ICDA codes for facial weakness. Each study had acceptable PPV, suggesting that ICD-9 based-algorithms have some utility in detecting Bell's palsy cases., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To identify and assess algorithms used to identify Kawasaki syndrome/Kawasaki disease in administrative and claims databases., Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to Kawasaki disease. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics., Results: Our searches identified 177 citations of which 22 met our inclusion criteria. All studies used algorithms including International Classification of Diseases, Ninth Revision (ICD-9) code 446.1 either alone, or with evidence of intravenous immunoglobulin (IVIG) administration, or with ICD-10 code M30.3. Six studies confirmed diagnoses by medical chart review. Three of these six studies reported validation statistics, with positive predictive values of 74%, 84%, and 86%, respectively., Conclusions: All studies that reported algorithms used either the ICD-9 code 446.1 either alone, with evidence of IVIG administration or with ICD-10 code M30.3. The ICD-9 code 446.1 alone produced positive predictive values of 74%, 84%, and 86% in separate studies in Georgia and California. The sensitivity of these codes to detect Kawasaki disease is unknown, as no sampling of medical records for missed true cases of Kawasaki disease was done. Further research would be helpful to determine whether the relatively high positive predictive values found in southern California are seen elsewhere and also to evaluate the performance of other codes to identify cases of Kawasaki disease and the sensitivity of the narrow algorithms that have been used to date., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: To identify and assess billing, procedural, or diagnostic code algorithms used to identify transverse myelitis in administrative databases., Methods: We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to transverse myelitis. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics., Results: Three studies met criteria for inclusion in this review. The only algorithm based solely on administrative claims data with a reported positive predictive value included five ICD-9 codes (codes 341.20, 341.21, 341.22, 323.8, 323.9). The positive predictive value for physician-diagnosed acute transverse myelitis was 62%., Conclusions: More research is needed to establish an accurate algorithm to identify transverse myelitis in large administrative databases using diagnosis and/or procedure codes. Use of standardized consensus definitions, clear description for algorithm selection, and reporting of validation procedure and results would be most beneficial., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Nonpharmacologic airway clearance techniques are used to reduce the sequelae of obstructive secretions. We systematically reviewed comparative studies of nonpharmacologic interventions that health professionals can employ to achieve mucus clearance in hospitalized or postoperative patients without cystic fibrosis, over the age of 12 months. We searched MEDLINE and other databases from 1990 to 2012 to identify relevant literature. Two reviewers independently assessed each study against predetermined inclusion/exclusion criteria. Two reviewers also independently extracted data regarding subject and intervention characteristics and outcomes, and assigned overall quality ratings. The 32 studies meeting the review criteria included 24 randomized controlled trials, 7 crossover randomized controlled trials, and one prospective cohort study. Studies were typically small and together included a total of 2,453 subjects (mean 76/study). Studies generally examined chest physical therapy/physiotherapy modalities in postoperative or critically ill subjects or those with COPD. Interventions, comparators, and populations varied considerably across studies, hampering our ability to draw firm conclusions. Interventions, including conventional chest physical therapy/physiotherapy, intrapulmonary percussive ventilation, and positive expiratory pressure, typically provided small benefits in pulmonary function, gas exchange, oxygenation, and need for/duration of ventilation, among other outcomes, but differences between groups were generally small and not significant. Harms of the techniques were not consistently reported, though airway clearance techniques were generally considered safe in studies that did comment on adverse effects. Further research with clearly characterized populations and interventions is needed to understand the potential benefits and harms of these techniques.

Though the control of blood phenylalanine (Phe) levels is essential for minimizing impairment in individuals with phenylketonuria (PKU), the empirical basis for the selection of specific blood Phe levels as targets has not been evaluated. We evaluated the current evidence that particular Phe levels are optimal for minimizing or avoiding cognitive impairment in individuals with PKU. This work uses meta-estimates of blood Phe-IQ correlation to predict the probability of low IQ for a range of Phe levels. We believe this metric is easily interpretable by clinicians, and hence useful in making recommendations for Phe intake. The median baseline association of Phe with IQ was estimated to be negative, both in the context of historical (median = -0.026, 95 % BCI = [-0.040, -0.013]) and concurrent (-0.007, [-0.014, 0.000]) measurement of Phe relative to IQ. The estimated additive fixed effect of critical period Phe measurement was also nominally negative for historical measurement (-0.010, [-0.022, 0.003]) and positive for concurrent measurement (0.007, [-0.018, 0.035]). Probabilities corresponding to historical measures of blood Phe demonstrated an increasing chance of low IQ with increasing Phe, with a stronger association seen between blood Phe measured during the critical period than later. In contrast, concurrently-measured Phe was more weakly correlated with the probability of low IQ, though the correlation is still positive, irrespective of whether Phe was measured during the critical or non-critical period. This meta-analysis illustrates the utility of a Bayesian hierarchical approach for not only combining information from a set of candidate studies, but also for combining different types of data to estimate parameters of interest.

Background and Objective: Controversy remains concerning the optimal treatment approach for cryptorchidism. The objective of this study was to assess effectiveness of hormone therapy or surgery for cryptorchidism., Methods: We searched Medline and other databases from 1980 to February 2012. Two reviewers independently assessed studies against predetermined criteria. Two reviewers independently extracted data and assigned overall quality and strength of evidence ratings using predetermined criteria., Results: Fourteen studies addressed effectiveness of hormonal treatments, and 26 studies addressed surgical intervention outcomes. Hormonal treatment is associated with testicular descent in some children, but rates generally do not exceed those seen with placebo by >10%. Surgical treatment is associated with success rates of testicular descent ranging from 33% to 100%, depending on surgery. Weighted success averages were 78.7% for 1-stage Fowler-Stephens (FS), 86% for 2-stage FS, and 96.4% for primary orchiopexy. Descent rates were similar among studies comparing laparoscopic and open surgeries. Reported harms of hormonal treatments were mild and transient. Adverse effects specifically associated with surgical repair were rare., Conclusions: The body of the reviewed literature comprises primarily fair- and poor-quality studies, limiting our ability to draw definitive conclusions. Hormonal treatment is marginally effective relative to placebo but is successful in some children and with minimal harms, suggesting that it may be an appropriate trial of care for some patients. Surgical options are effective, with high rates of testicular descent (moderate strength of evidence for FS procedures, high for primary orchiopexy). Comparable outcomes occur with laparoscopic and open approaches.

Background and Objective: Preoperative imaging techniques may guide management of nonpalpable, cryptorchid testicles. We evaluated conventional MRI for identifying and locating nonpalpable testicles in prepubescent boys via meta-analysis., Methods: Databases including Medline were searched from 1980 to February 2012. Eligible studies included ≥10 boys with cryptorchidism/suspected cryptorchidism and reported data on testicular presence/absence and position (abdominal, inguinal, or scrotal) as determined by imaging and surgery. Two investigators independently reviewed studies against inclusion criteria. We captured the number of testicles that were correctly and incorrectly identified and located, relative to surgically verified status, and estimated sensitivity and specificity by using a random-effects model., Results: Eight unique prospective case series included 171 boys with 193 nonpalpable testicles (22 with bilateral testicles). Surgery identified 158 testicles (81.9%) present and 35 absent. MRI correctly identified testicles with an estimated median sensitivity of 0.62 (95% Bayesian credible interval [BCI]: 0.47-0.77) and a specificity of 1.0 (95% BCI: 0.99-1.0). MRI located intraabdominal testicles with a sensitivity of 0.55 (95% BCI: 0.09-1.0) and inguino-scrotal testicles with a sensitivity of 0.86 (95% BCI: 0.67-1.0). We were not able to obtain estimates for MRI sensitivity or specificity for locating atrophied testicles. The estimated specificity for location-specific testicles reached almost 100%., Conclusions: Conventional MRI has low sensitivity for estimating the population sensitivity for identifying the presence of nonpalpable cryptorchid testicles. When testicles are identified, MRI is poor at locating both atrophied and intraabdominal testicles but performs modestly well in locating those in the inguino-scrotal regions.

Context: Dietary management is the mainstay of effective treatment in PKU, but dietary restriction is difficult and additional treatment options are needed., Objective: To systematically review evidence regarding sapropterin (BH4) use as an adjunct to dietary restriction in individuals with PKU., Data Sources: Five databases including MEDLINE up to August 2011., Study Selection: Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria., Data Extraction: Two reviewers independently extracted data regarding participant and intervention characteristics and outcomes and assigned overall quality and strength of evidence ratings based on predetermined criteria., Results: BH4 research includes two randomized controlled trials (RCTs) and three uncontrolled open-label trials. Phenylalanine (Phe) levels were reduced by at least 30 % in up to half of treated participants (32-50 %). In one RCT comparing placebo on likelihood of a 30 % reduction in Phe, 9 % of those on placebo achieved this effect, compared with 44 % of the treated group after 6 weeks. Phe tolerance and variability were improved in treated participants in studies assessing those outcomes. No comparative studies assessed long-term outcomes including cognitive effects, nutritional status, or quality of life., Conclusions: Adjuvant pharmacologic therapy has the potential to support individuals in achieving optimal Phe levels. BH4 has been shown to reduce Phe levels in some individuals, with significantly greater reductions seen in treated versus placebo groups. The strength of the evidence is moderate for short-term effects on reducing Phe in a subset of initially BH4-responsive individuals, moderate for a lack of significant harms, low for longer-term effects on cognition, and insufficient for all other outcomes.

Objective: Systematic reviewers often use a "best evidence" approach to address the key questions, but what is meant by "best" is often unclear. The goal of this project was to create a decision framework for "best evidence" approaches to increase transparency in systematic reviews., Study Design and Setting: The project was separated into three areas: 1) inclusion criteria, 2) evidence prioritization strategies, and 3) evaluative approaches. This commentary focuses only on the second task. The full report is available on the Effective Healthcare Web site of the Agency for Healthcare Research and Quality., Results: The four identified strategies were as follows: 1) Use only the single best study; 2) Use the best set of studies; 3) Same as 2, but also consider whether the evidence permits a conclusion; and 4) Same as 3, but also consider the overall strength of the evidence. Simpler strategies (such as #1) are less likely to produce false conclusions, but are also more likely to yield insufficient evidence (possibly because of imprecise data)., Conclusion: Systematic reviewers routinely prioritize evidence in numerous ways. This document provides a conceptual construct to enhance the transparency of systematic reviewers' decisions., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background and Objective: Although many treatments have been studied in children with autism spectrum disorders (ASDs), less attention has focused on interventions that may be helpful in adolescents and young adults with ASD. The goal of this study was to systematically review evidence regarding medication treatments for individuals between the ages of 13 and 30 years with ASD., Methods: The Medline, PsycINFO, and ERIC databases were searched (1980-December 2011), as were reference lists of included articles. Two investigators independently assessed studies against predetermined inclusion/exclusion criteria. Two investigators independently extracted data regarding participant and intervention characteristics, assessment techniques, and outcomes and assigned overall quality and strength of evidence ratings on the basis of predetermined criteria., Results: Eight studies of medications were identified that focused on 13- to 30-year-olds with ASD; 4 of the studies were of fair quality. The strength of evidence was insufficient for all outcomes associated with medications tested in this population; however, the 2 available studies of the atypical antipsychotic medication risperidone in this age range were consistent with the moderate evidence in children with ASD for treating problem behavior, including aggression, and high strength of evidence for adverse events, including sedation and weight gain., Conclusions: There is a marked lack of data on use of medication treatments for adolescents and young adults with ASD. The evidence on the use of risperidone in this age range is insufficient when considered alone but is consistent with the data in the population of children with ASD.

Background and Objective: Many individuals with autism spectrum disorders (ASDs) are approaching adolescence and young adulthood; interventions to assist these individuals with vocational skills are not well understood. This study systematically reviewed evidence regarding vocational interventions for individuals with ASD between the ages of 13 and 30 years., Methods: The Medline, PsycINFO, and ERIC databases (1980-December 2011) and reference lists of included articles were searched. Two reviewers independently assessed each study against predetermined inclusion/exclusion criteria. Two reviewers independently extracted data regarding participant and intervention characteristics, assessment techniques, and outcomes, and assigned overall quality and strength of evidence ratings based on predetermined criteria., Results: Five studies were identified; all were of poor quality and all focused on on-the-job supports as the employment/vocational intervention. Short-term studies reported that supported employment was associated with improvements in quality of life (1 study), ASD symptoms (1 study), and cognitive functioning (1 study). Three studies reported that interventions increased rates of employment for young adults with ASD., Conclusions: Few studies have been conducted to assess vocational interventions for adolescents and young adults with ASD. As such, there is very little evidence available for specific vocational treatment approaches as individuals transition to adulthood. All studies of vocational approaches were of poor quality, which may reflect the recent emergence of this area of research. Individual studies suggest that vocational programs may increase employment success for some; however, our ability to understand the overall benefit of supported employment programs is limited given the existing research.

Objective: This review evaluates the effectiveness of quality improvement (QI) strategies in reducing disparities in health and health care., Data Sources: We identified papers published in English between 1983 and 2011 from the MEDLINE® database, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Web of Science Social Science Index, and PsycINFO., Review Methods: All abstracts and full-text articles were dually reviewed. Studies were eligible if they reported data on effectiveness of QI interventions on processes or health outcomes in the United States such that the impact on a health disparity could be measured. The review focused on the following clinical conditions: breast cancer, colorectal cancer, diabetes, heart failure, hypertension, coronary artery disease, asthma, major depressive disorder, cystic fibrosis, pneumonia, pregnancy, and end-stage renal disease. It assessed health disparities associated with race or ethnicity, socioeconomic status, insurance status, sexual orientation, health literacy/numeracy, and language barrier. We evaluated the risk of bias of individual studies and the overall strength of the body of evidence based on risk of bias, consistency, directness, and precision., Results: Nineteen papers, representing 14 primary research studies, met criteria for inclusion. All but one of the studies incorporated multiple components into their QI approach. Patient education was part of most interventions (12 of 14), although the specific approach differed substantially across the studies. Ten of the studies incorporated self-management; this would include, for example, teaching individuals with diabetes to check their blood sugar regularly. Most (8 of 14) included some sort of provider education, which may have focused on the clinical issue or on raising awareness about disparities affecting the target population. Studies evaluated the effect of these strategies on disparities in the prevention or treatment of breast or colorectal cancer, cardiovascular disease, depression, or diabetes. Overall, QI interventions were not shown to reduce disparities. Most studies have focused on racial or ethnic disparities, with some targeted interventions demonstrating greater effect in racial minorities--specifically, supporting individuals in tracking their blood pressure at home to reduce blood pressure and collaborative care to improve depression care. In one study, the effect of a language-concordant breast cancer screening intervention was helpful in promoting mammography in Spanish-speaking women. For some depression care outcomes, the collaborative care model was more effective in less-educated individuals than in those with more education and in women than in men., Conclusions: The literature on QI interventions generally and their ability to improve health and health care is large. Whether those interventions are effective at reducing disparities remains unclear. This report should not be construed to assess the general effectiveness of QI in the health care setting; rather, QI has not been shown specifically to reduce known disparities in health care or health outcomes. In a few instances, some increased effect is seen in disadvantaged populations; these studies should be replicated and the interventions studied further as having potential to address disparities.

Objective: To describe poisoning hospitalisations among reproductive-aged women from 1998 to 2006., Methods: 1998-2006 data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilisation Project were used to identify hospitalisations for poisonings among US women aged 15-44 years. Differences in hospitalisation characteristics were compared by intent using χ(2) statistics. Trends in poisoning hospitalisation rates were calculated overall and by subgroup., Results: There were approximately 636,000 poisoning hospitalisations in women aged 15-44 years during 1998-2006. Hospitalisations for intentionally self-inflicted poisonings had a higher proportion of women aged 15-24 years and privately insured women than did unintentional poisonings (p<0.001). Poisoning hospitalisations in rural areas and those that resulted in death were more likely to be of undetermined intent than those for which intent was specified (p<0.001). Co-diagnoses of substance abuse (34.5%) or mental disorders (66.5%) were high. The rate of poisoning hospitalisations overall and unintentional poisoning hospitalisations increased 6% and 22%, respectively, during this period (p<0.001). The most frequently diagnosed poisoning agent was acetaminophen. Poisonings attributable to acetaminophen, opioids, central nervous system stimulants and benzodiazepines increased, while poisonings attributable to antidepressants decreased (p<0.05)., Conclusions: The increase in unintentional poisoning hospitalisations among women aged 15-44 years and the changing profile of poisoning agents should inform the healthcare community's poisoning prevention strategies. Poisoning prevention strategies should include a component to address substance abuse and mental health disorders among reproductive-age women.

Context: Early intensive behavioral and developmental interventions for young children with autism spectrum disorders (ASDs) may enhance developmental outcomes., Objective: To systematically review evidence regarding such interventions for children aged 12 and younger with ASDs., Methods: We searched Medline, PsycINFO, and ERIC (Education Resources Information Center) from 2000 to May 2010. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two reviewers independently extracted data regarding participant and intervention characteristics, assessment techniques, and outcomes and assigned overall quality and strength-of-evidence ratings using predetermined criteria., Results: Thirty-four unique studies met inclusion criteria. Seventeen studies were case series; 2 were randomized controlled trials. We rated 1 study as good quality, 10 as fair quality, and 23 as poor quality. The strength of the evidence overall ranged from insufficient to low. Studies of University of California Los Angeles/Lovaas-based interventions and variants reported clinically significant gains in language and cognitive skills in some children, as did 1 randomized controlled trial of an early intensive developmental intervention approach (the Early Start Denver Model). Specific parent-training approaches yielded gains in short-term language function and some challenging behaviors. Data suggest that subgroups of children displayed more prominent gains across studies, but participant characteristics associated with greater gains are not well understood., Conclusions: Studies of Lovaas-based approaches and early intensive behavioral intervention variants and the Early Start Denver Model resulted in some improvements in cognitive performance, language skills, and adaptive behavior skills in some young children with ASDs, although the literature is limited by methodologic concerns.