Nila A Sathe

A Systematic Review of Early Intensive Intervention for Autism Spectrum Disorders

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.

A Systematic Review of Medical Treatments for Children With Autism Spectrum Disorders

CONTEXT: As many as 1 in every 110 children in the United States has an autism spectrum disorder (ASD). Many medical treatments for ASDs have been proposed and studied, but there is currently no consensus regarding which interventions are most effective. OBJECTIVE: To systematically review evidence regarding medical treatments for children aged 12 years and younger with ASDs. METHODS: We searched the Medline, PsycInfo, and ERIC (Education Resources Information Center) databases from 2000 to May 2010, regulatory data for approved medications, and reference lists of included articles. Two reviewers independently assessed each study against predetermined inclusion/exclusion criteria. Studies of secretin were not included in this review. Two reviewers 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: Evidence supports the benefit of risperidone and aripiprazole for challenging and repetitive behaviors in children with ASDs. Evidence also supports significant adverse effects of these medications. Insufficient strength of evidence is present to evaluate the benefits or adverse effects for any other medical treatments for ASDs, including serotonin-reuptake inhibitors and stimulant medications. CONCLUSIONS: Although many children with ASDs are currently treated with medical interventions, strikingly little evidence exists to support benefit for most treatments. Risperidone and aripiprazole have shown benefit for challenging and repetitive behaviors, but associated adverse effects limit their use to patients with severe impairment or risk of injury.

A Systematic Review of Vocational Interventions for Young Adults With Autism Spectrum Disorders

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.

Medications for Adolescents and Young Adults With Autism Spectrum Disorders: A Systematic Review

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.

Evolution of a Mature Clinical Informationist Model

Achieving evidence-based practice will require new approaches to providing information during health care delivery and to integrating evidence and informatics at the point of care. To support evidence-based practice, Vanderbilt University Medical Centers Eskind Biomedical Library (EBL) introduced the role of clinical informationist, an information specialist with sufficient knowledge and insight to function as a true partner in the health care team. To further disseminate evidence-based knowledge, the Vanderbilt University Medical Centers (VUMC) electronic medical record system and pathway development processes integrate advanced information synthesis capabilities provided by clinical informationists. Combining clinical informationist expertise with informatics tools is an effective strategy for delivering the evidence needed to support patient care decisions.

A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States

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.

Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis.

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.

Nonpharmacologic Airway Clearance Techniques in Hospitalized Patients: A Systematic Review

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.

A systematic review of validated methods for identifying systemic lupus erythematosus (SLE) using administrative or claims data

PURPOSE To examine the validity of billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify patients with systemic lupus erythematosus (SLE) in administrative and claims databases. METHODS We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to SLE. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. The two reviewers independently extracted data regarding participant and algorithm characteristics and assessed a studys methodologic rigor using a pre-defined approach. RESULTS Twelve studies included validation statistics for the identification of SLE in administrative and claims databases. Seven of these studies used the ICD-9 code of 710.0 in selected populations of patients seen by a rheumatologist or patients who had experienced the complication of SLE-associated nephritis, other kidney disease, or pregnancy. The other studies looked at limited data in general populations. The algorithm in the selected populations had a positive predictive value (PPV) in the range of 70-90% and of the limited data in general populations it was in the range of 50-60%. CONCLUSIONS Few studies use rigorous methods to validate an algorithm for the identification of SLE in general populations. Algorithms including ICD-9 code of 710.0 in physician billing and hospitalization records have a PPV of approximately 60%. A requirement that the code is obtained from a record based on treatment by a rheumatologist increases the PPV of the algorithm but limits the generalizability in the general population.

Systematic review of therapies for noncyclic chronic pelvic pain in women.

Abstract We synthesized the literature (articles published between 1990 and May 2011) on the treatment of noncyclic and mixed cyclic/noncyclic chronic pelvic pain (CPP) in adult women. Two reviewers assessed studies against predetermined inclusion/exclusion criteria, extracted data regarding participant and intervention characteristics and outcomes, and assigned overall quality and strength of evidence ratings. Of 2081 studies, 21 addressed surgical or nonsurgical interventions. Definitions of CPP and participant characteristics varied across studies, and most studies were of poor quality, which precluded data synthesis. Although surgical and nonsurgical approaches both improved pain, neither was more effective when directly compared in 3 studies. Laparoscopic adhesiolysis or laparoscopic uterosacral nerve ablation did not further improve pain scores over diagnostic laparoscopy. The evidence to conclude that surgical intervention is either effective or ineffective or that one technique is superior to another is insufficient. Most studies on nonsurgical approaches evaluated hormonal therapies in endometriosis-associated CPP and were not placebo controlled. Few studies addressed nonhormonal or nonpharmacologic approaches. Harms reporting was limited. Overall, no nonsurgical treatment was more or less effective than another, except for the clear negative effect of raloxifene. In general, the literature addressing therapies for CPP in women is of poor quality and inconclusive. Improved characterizations of the targeted condition and interventions in CPP research, including a uniform definition and standardized evaluation, are necessary to inform treatment choices. Target Audience: Obstetricians & Gynecologists, Family Physicians Learning Objectives: After completion of this article, the reader should be able to assess the effects of surgical and nonsurgical interventions on the outcomes of pain status, functional status, satisfaction with care, and quality of life; to evaluate the effectiveness of interventions for noncyclic chronic pelvic pain; and to categorize areas of future research need.