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Can claims-based data be used to recruit black and Hispanic subjects into clinical trials?

ABSTRACT: Evaluate the accuracy of an algorithm at identifying ethnic minorities from administrative claims for enrollment into a clinical trial.Claims data from a health benefits company.We compared results of a three-step algorithm to self-reported race/ethnicity.Using the algorithm, we identified subjects with high probability of being minority and ascertained self-reported race/ethnicity.We identified 164 subjects as likely minority based on our algorithm. Of these, 94 completed the survey and 87 identified themselves as black or Hispanic. The positive predictive value of the algorithm was 93 percent (CI: 85-97).Claims data can be used to efficiently identify minorities for participation in clinical trials.

SUBMITTER: Palacio AM

PROVIDER: S-EPMC3419888 | biostudies-other | 2012 Apr

REPOSITORIES: biostudies-other

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Can claims-based data be used to recruit black and Hispanic subjects into clinical trials?

Palacio Ana M AM Tamariz Leonardo J LJ Uribe Claudia C Li Hua H Salkeld Ellen J EJ Hazel-Fernandez Leslie L Carrasquillo Olveen O

Health services research 20110830 2

<h4>Objective</h4>Evaluate the accuracy of an algorithm at identifying ethnic minorities from administrative claims for enrollment into a clinical trial.<h4>Data sources/study setting</h4>Claims data from a health benefits company.<h4>Study design</h4>We compared results of a three-step algorithm to self-reported race/ethnicity.<h4>Data collection/extraction methods</h4>Using the algorithm, we identified subjects with high probability of being minority and ascertained self-reported race/ethnicit ...[more]

PMID: 22091834

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Project description:INTRODUCTION:The safety profile of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) is well established. TCZ was approved to treat giant cell arteritis (GCA) in 2017 in the USA and Europe, and its safety profile in patients with GCA continues to be defined. The objective of this analysis was to examine incidence rates (IRs) of adverse events of special interest (AESI) occurring during the TCZ clinical development program and in healthcare claims data in patients with GCA or RA. METHODS:TCZ-naïve patients with GCA or RA were identified in the MarketScan administrative healthcare claims database. TCZ-treated patients with GCA from the GiACTA trial and TCZ-treated patients with RA from pooled clinical trial data were analyzed. The IRs of AESI (AESI IRs) were calculated for all cohorts. In the claims cohorts, risks of AESI were estimated using Poisson regression. RESULTS:TCZ-naïve claims cohorts comprised 4804 patients with GCA [mean (standard deviation) age 73.4 (9.8) years; follow-up 3.9 (3.1) years] and 15,164 patients with RA [age 60.3 (8.2) years; follow-up, 4.5 (2.8) years]. TCZ-treated clinical trial cohorts comprised 149 patients with GCA [age 69.5 (8.4) years; exposure approx. 138 patient-years (PY)] and 7647 with RA [age 52 (12.6) years; exposure approx. 22,394 PY]. The IRs of infections, stroke, malignancies, myocardial infarction, and gastrointestinal perforations in the GCA claims cohort exceeded those in the RA claims cohort; the risk of AESI (adjusted for age and glucocorticoid use) was higher in patients with GCA than in those with RA. Similar patterns to the claims cohorts in terms of the AESI IRs were observed in clinical trial cohorts, although the number of events was limited in the GCA trial cohort. CONCLUSION:Higher IRs of AESI were observed in patients with GCA versus those with RA in both TCZ-naïve and -treated cohorts. Differences in underlying disease, age, and glucocorticoid use may influence AESI incidence, irrespective of intervention. FUNDING:This study was funded by F. Hoffmann-La Roche Ltd and Genentech, Inc. Article processing charges were funded by F. Hoffmann-La Roche Ltd. Plain language summary is available for this article.

Project description:ObjectivesTo compare 3 different treatment regimens for vitamin D deficiency in minority adolescents and to explore factors that impact treatment efficacy.Study designWe conducted an 8-week, prospective, open-label, randomized clinical trial in an urban, academic, children's hospital. A total of 183 vitamin D-deficient adolescents, mean 25-hydroxyvitamin D or 25(OH)D 13.7 ± 3.9 ng/mL; mean age 16.6 ± 2.2 years, were randomized into 3 vitamin D3 (cholecalciferol) treatment arms: 50,000 IU/wk; 5000 IU/d; and 1000 IU/d. Serum 25(OH)D and vitamin D binding protein (VDBP) levels were measured pre-and posttreatment; 122 (67%) participants completed posttreatment measures. Complete-case and multiple-imputation, intention-to-treat analyses were performed.ResultsMean change in 25(OH)D level posttreatment was significantly different among the 3 arms, 24.9 ± 15.1 vs 21.0 ± 15.2 vs 6.2 ± 6.5 ng/mL, for 50,000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Both high-dose treatments were effective in increasing the 25(OH)D level out of deficiency range (≥ 20 ng/mL) in more than 80% of participants, and 60% remained deficient after low-dose treatment. Only 72%, 56%, and 2% achieved vitamin D sufficiency (>30 ng/mL) with 50,000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Obese participants had substantially less mean change in 25(OH)D level after treatment than normal-weight participants, 13.7 ± 10.7 vs 21.9 ± 16.9 ng/mL, P < .001. Mean baseline VDBP level was almost twice as high in Hispanic compared with black participants (P < .001) and did not alter treatment response or change with treatment.ConclusionsAdult-sized adolescents require 8 weeks of high-dose cholecalciferol, at least 5000 IU/d, to correct deficiency. Obese adolescents have poorer response to treatment and may need higher doses than nonobese youth. Hispanic and black adolescents have different VDBP levels but similar treatment responses.Trial registrationClinicalTrials.gov: NCT01784029.

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Can claims-based data be used to recruit black and Hispanic subjects into clinical trials?

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Can claims-based data be used to recruit black and Hispanic subjects into clinical trials?

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