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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. [ABSTRACT FROM AUTHOR]

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. ^-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 B12, 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. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voicerelated 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Individuals with phenylketonuria (PKU) have defective enzyme activity, leading to toxic accumulation of phenylalanine (Phe) in blood and tissues. Adherence to a Phe-restricted diet can mitigate poor outcomes; however, dietary restriction is difficult. Large neutral amino acids (LNAAs), which putatively decrease brain Phe concentration, have been suggested as a potential supplementary treatment in addition to a Phe-restricted diet. To systematically review evidence regarding LNAA usage in individuals with PKU, we searched 5 databases including Medline up to August 2011 and the reference lists of included articles. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two reviewers independently extracted data regarding participant and intervention characteristics and outcomes; using their extracted data, they assigned overall quality and strength of evidence ratings based on predetermined criteria. Three small studies (two randomized controlled trials and one uncontrolled open label trial) of fair to poor quality investigated LNAAs. The studies included a total of 47 participants with severe PKU between 11 and 45 years of age receiving LNAAs for 1 to 8 weeks. In all three studies, blood Phe decreased after one week of treatment, but remained above clinically acceptable levels. The one trial measuring correlation between blood and brain Phe found no association. Research on adjuvant therapy in PKU to complement dietary restriction is early in its development and substantially more work is needed. The three very small studies of LNAAs to date cannot be considered as more than proof of concept. [ABSTRACT FROM AUTHOR]

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 shortterm (<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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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.‘ [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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, PsyclNFO, 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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, PsyclNFO, 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. [ABSTRACT FROM AUTHOR]