Racial Health Equity and Social Needs Interventions: A Review of a Scoping Review.

Importance: Social needs interventions aim to improve health outcomes and mitigate inequities by addressing health-related social needs, such as lack of transportation or food insecurity. However, it is not clear whether these studies are reducing racial or ethnic inequities. Objective: To understand how studies of interventions addressing social needs among multiracial or multiethnic populations conceptualize and analyze differential intervention outcomes by race or ethnicity. Evidence Review: Sources included a scoping review of systematic searches of PubMed and the Cochrane Library from January 1, 1995, through November 29, 2021, expert suggestions, and hand searches of key citations. Eligible studies evaluated interventions addressing social needs; reported behavioral, health, or utilization outcomes or harms; and were conducted in multiracial or multiethnic populations. Two reviewers independently assessed titles, abstracts, and full text for inclusion. The team developed a framework to assess whether the study was "conceptually thoughtful" for understanding root causes of racial health inequities (ie, noted that race or ethnicity are markers of exposure to racism) and whether analyses were "analytically informative" for advancing racial health equity research (ie, examined differential intervention impacts by race or ethnicity). Findings: Of 152 studies conducted in multiracial or multiethnic populations, 44 studies included race or ethnicity in their analyses; of these, only 4 (9%) were conceptually thoughtful. Twenty-one studies (14%) were analytically informative. Seven of 21 analytically informative studies reported differences in outcomes by race or ethnicity, whereas 14 found no differences. Among the 7 that found differential outcomes, 4 found the interventions were associated with improved outcomes for minoritized racial or ethnic populations or reduced inequities between minoritized and White populations. No studies were powered to detect differences. Conclusions and Relevance: In this review of a scoping review, studies of social needs interventions in multiracial or multiethnic populations were rarely conceptually thoughtful for understanding root causes of racial health inequities and infrequently conducted informative analyses on intervention effectiveness by race or ethnicity. Future work should use a theoretically sound conceptualization of how race (as a proxy for racism) affects social drivers of health and use this understanding to ensure social needs interventions benefit minoritized racial and ethnic groups facing social and structural barriers to health.

Evaluation of the functional goal-setting and self-management tool for osteoarthritis, a patient-centred tool to improve osteoarthritis care.

OBJECTIVE: Recent American College of Rheumatology guidelines emphasise functional improvement as part of osteoarthritis (OA) management. We developed and evaluated a tool to promote provider and patient engagement in functional goal setting in OA care. METHODS: We developed the Functional Goal-setting And Self-management Tool (FAST-OA) with clinician input and pilot tested it in two US outpatient clinics. Baseline and end-of-project surveys addressed attitudes toward incorporating function into care and tool evaluation. We analysed survey data descriptively. RESULTS: Nineteen providers and 49 patients completed surveys. At baseline, both groups endorsed the importance of functional assessment and goal setting. Providers perceived challenges to patients' ability to communicate about function. Both patients and providers highly valued the FAST-OA to promote collaborative discussion and prioritising function. More than half of both groups agreed that they would recommend it to others. End-of-project results suggested changes in provider attitudes toward patients' ability to communicate functional progress. While participants valued the FAST-OA, streamlining content may foster ongoing use. CONCLUSION: This pilot study illustrates the potential of a function-focused, patient-facing tool to introduce self-management goal-setting strategies into busy clinical workflow, foster the provider-patient relationship, and encourage alignment with guidelines. These results can inform tailoring of tools for use in practice and to address needs of patients and providers optimally.

Uncovering Outcome Disparities of ß2 Adrenergic Agonists in Blacks: A Systematic Review.

PURPOSE: Outcome differences driven by variation in Blacks' biologic response to treatment may contribute to persistent racial disparities in asthma morbidity and mortality. This review assessed systematic variation in ß2 agonist treatment outcomes among Blacks compared to other groups. METHODS: We conducted a systematic review of studies reporting differential response to ß2 agonists among Blacks, including studies identifying pharmacogenetic variants. RESULTS: Of 3158 papers, 20 compared safety or efficacy of ß2 agonists among Blacks as compared with other subgroups. Six papers evaluating efficacy of short-acting ß2 agonists (SABA) found similar or improved results among Blacks compared with other groups, while one small study found reduced response to SABA therapy among Blacks. Reports of safety and efficacy of long-acting ß2 agonists (LABA) indicated similar results among Blacks in four papers, while four reports found reduced safety among Blacks, as compared with other groups. Four papers assessed genomic variation and relative treatment response in Blacks, with two finding significant effects of the p.Arg16Gly variant in ADRB2 on ß2 agonist response and one finding significant gene-gene IL6/IL6R interaction effects on albuterol response. CONCLUSIONS: Evidence suggests the potential for differences in ß2 agonist outcomes among Blacks compared with other groups. This literature, however, remains small and significantly underpowered for substantive conclusions. There are notable opportunities for adequately-powered investigations exploring safety and efficacy of ß2 agonists among Blacks, including pharmacogenomic modifiers of response.

Exploring Biologic Predictors Response Disparities to Atypical Antipsychotics among Blacks: A Quasi-Systematic Review.

Purpose: Management of schizophrenia among Blacks in the United States is affected by persistent disparities. This review explored response to atypical antipsychotics among Blacks compared with other groups to assess systematic variation that may contribute to disparities. Methods: We conducted a quasi-systematic review of studies reporting response to atypical antipsychotics among Blacks compared with other groups, including effects of genetic variation. Results: Of 48 identified research articles, 29 assessed differences in outcomes without inclusion of genetic variation and 20 explored effects of genetic variation; of note: one article included both types of data. Analysis of the 29 papers with clinical outcomes only suggests that while data on efficacy and risk of movement disorders were heterogeneous, findings indicate increased risk of metabolic effects and neutropenia among Blacks. Of the 20 articles exploring effects of genetic variation, allelic or genotypic variations involving several genes were associated with altered efficacy or safety among Blacks but not Whites, including risk of decreased response involving variation in DRD4 and DRD1, and improved efficacy associated with variants in DRD2, COMT, and RGS4. Others showed significant improvement in treatment response only among Whites, including variation in DTNBP1, DRD4, and GNB3. Conclusions: The current analysis can help tailor management among Blacks using an atypical antipsychotic. Heterogeneity in genetic variation effects and response allele frequency suggests that pharmacogenetics approaches for atypical antipsychotics will need to explicitly incorporate race and ethnicity.

Healthcare professionals' perceptions of challenges to chronic pain management.

OBJECTIVES: To explore healthcare professionals' perceptions of challenges to chronic pain management. STUDY DESIGN: Qualitative interview study. METHODS: Semistructured telephone interviews with healthcare professionals involved in chronic pain management and thematic analysis of transcriptions. RESULTS: Respondents (N = 16) described multiple challenges to chronic pain management: Management occurs in a complex care context complicated by the multidimensional, subjective nature of pain. A lack of systematic approaches fosters variation in care, and clinicians lack time and resources to manage pain holistically. Efforts to date have focused primarily on opioid reduction versus strategic approaches to manage chronic pain across the system. CONCLUSIONS: Comprehensive approaches to identify and manage chronic pain are nascent and, typically, narrowly focused on reducing opioid use. Respondents, however, recognized the importance of effective systematic management across inpatient and outpatient settings. These findings underscore the need to consider chronic pain as a chronic condition that warrants coordinated approaches to care such as standardized assessments; consistent, patient-centered outcome measures; and multimodal treatments that target both physical relief and underlying psychosocial factors.

A systematic literature review of individuals' perspectives on privacy and genetic information in the United States.

Concerns about genetic privacy affect individuals' willingness to accept genetic testing in clinical care and to participate in genomics research. To learn what is already known about these views, we conducted a systematic review, which ultimately analyzed 53 studies involving the perspectives of 47,974 participants on real or hypothetical privacy issues related to human genetic data. Bibliographic databases included MEDLINE, Web of Knowledge, and Sociological Abstracts. Three investigators independently screened studies against predetermined criteria and assessed risk of bias. The picture of genetic privacy that emerges from this systematic literature review is complex and riddled with gaps. When asked specifically "are you worried about genetic privacy," the general public, patients, and professionals frequently said yes. In many cases, however, that question was posed poorly or only in the most general terms. While many participants expressed concern that genomic and medical information would be revealed to others, respondents frequently seemed to conflate privacy, confidentiality, control, and security. People varied widely in how much control they wanted over the use of data. They were more concerned about use by employers, insurers, and the government than they were about researchers and commercial entities. In addition, people are often willing to give up some privacy to obtain other goods. Importantly, little attention was paid to understanding the factors-sociocultural, relational, and media-that influence people's opinions and decisions. Future investigations should explore in greater depth which concerns about genetic privacy are most salient to people and the social forces and contexts that influence those perceptions. It is also critical to identify the social practices that will make the collection and use of these data more trustworthy for participants as well as to identify the circumstances that lead people to set aside worries and decide to participate in research.

Patient-Reported Outcome Measures in Upper Airway-Related Dyspnea: A Systematic Review.

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.

Tonsillectomy for Obstructive Sleep-Disordered Breathing: A Meta-analysis.

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.

Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review.

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.

Defining Safety in the Nursing Home Setting: Implications for Future Research.

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.

Procedures and Uterine-Sparing Surgeries for Managing Postpartum Hemorrhage: A Systematic Review.

IMPORTANCE: Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity worldwide. OBJECTIVE: The aim of this study was to systematically review literature on procedures (eg, uterine artery embolization) and uterine-sparing surgeries for PPH. EVIDENCE ACQUISITION: We searched MEDLINE and other databases from 1990 to November 2014. Two reviewers independently evaluated studies against predetermined criteria, extracted data, and assessed study quality and strength of the evidence (confidence in the effect). RESULTS: Twenty-eight small studies addressed 1 or more procedures (19 studies of embolization, 5 of uterine tamponade) or surgeries (5 studies of arterial ligation, 5 of uterine compression sutures). Studies primarily evaluated bleeding control and adverse effects. Rates of hemostasis were typically greater than 60% in studies reporting such data after failure of conservative management. Postprocedure infertility occurred in 0% to 43% of women in a small number of studies that reported these data. Uterine tamponade successfully controlled bleeding in more than 50% of women, with few harms reported. Success rates for ligation and sutures ranged from 36% to 96%; harms included surgical injury, infection, and fertility-associated effects. CONCLUSIONS AND RELEVANCE: A limited body of evidence addresses these interventions for PPH. Median rates of hemostasis ranged from 36% to 98%; however, these data come from few studies with less than 2100 total participants. Harms were not well characterized. Some studies with longer-term follow-up reported infertility in women undergoing embolization. Few adverse events with tamponade, ligation, or sutures were reported. Given the insufficient evidence, clinicians must continue to make individual care decisions based on each woman's clinical situation and available management options.

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 ß-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.

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.

Laser treatment of infantile hemangioma: A systematic review.

BACKGROUND AND OBJECTIVE: To systematically review studies of laser treatment of infantile hemangioma (IH). STUDY DESIGN/METHODS AND MATERIALS: We searched multiple databases including MEDLINE® and EMBASE from 1982 to June 2015. Two investigators independently screened studies against predetermined criteria and extracted key data. Investigators independently assessed study risk of bias and the strength of the evidence of the body of literature. RESULTS: We identified 29 studies addressing lasers: 4 randomized controlled trials, 8 retrospective cohort studies, and 17 case series. Lasers varied across studies in type, pulse width, or cooling materials. Most comparative studies (n = 9) assessed variations of pulsed dye laser (PDL) and examined heterogeneous endpoints. Most studies reported on treatment of cutaneous lesions. Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for cutaneous lesions; Nd:YAG was the most commonly used intralesionally. Most studies reported a higher success rate with longer pulse PDL compared with observation in managing the size of IH, although the magnitude of effect differed substantially. CO2 laser was used for subglottic IH in a single study, and was noted to have a higher success rate and lower complication rate than both Nd:YAG and observation. Studies comparing laser with ß-blockers or in combination with ß-blockers reported greater improvements in lesion size in combination arms versus ß-blockers alone and greater effects of lasers on mixed superficial and deep IH. Strength of the evidence for outcomes after laser treatments ranged from insufficient to low for effectiveness outcomes. Strength of the evidence was insufficient for the effects of laser compared with ß-blockers or in combination with ß-blockers as studies evaluated different agents and laser types. Studies assessing outcomes after CO2 and Nd:YAG lasers typically reported some resolution of lesion size, but heterogeneity among studies limits our abilities to draw conclusions. CONCLUSION: Studies of laser treatment of IH primarily addressed different laser modalities compared with observation or other laser modalities. PDL was the most commonly studied laser type, but multiple variations in treatment protocols did not allow for demonstration of superiority of a single method. Most studies reported a higher success rate with longer pulse PDL compared to observation in managing the size of IH, although the magnitude of effect differed substantially. Studies generally found PDL more effective than other types of lasers for cutaneous lesions. When first introduced as a primary treatment for IH, various laser modalities generally offered superior outcomes compared with steroid therapy and observation. In the era of ß-blocker therapy, laser treatment may retain an important role in the treatment of residual and refractory lesions.

Pharmacologic Agents That Promote Airway Clearance in Hospitalized Subjects: A Systematic Review.

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.

Surgical intervention for feeding and nutrition difficulties in cerebral palsy: a systematic review.

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.

Methods for systematic reviews of administrative database studies capturing health outcomes of interest.

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.

A systematic review of validated methods to capture several rare conditions using administrative or claims data.

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.

A systematic review of validated methods for identifying Kawasaki disease using administrative or claims data.

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.

A systematic review of validated methods to capture myopericarditis using administrative or claims data.

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.