Browsing by Subject "National Institute on Drug Abuse (U.S.)"

Now showing 1 - 5 of 5
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    Conducting research with racial/ethnic minorities: methodological lessons from the NIDA Clinical Trials Network.
    (The American journal of drug and alcohol abuse, 2011-09) Burlew, A Kathleen; Weekes, Jerren C; Montgomery, La'Trice; Feaster, Daniel J; Robbins, Michael S; Rosa, Carmen L; Ruglass, Lesia M; Venner, Kamilla L; Wu, Li-Tzy
    Multiple studies in the National Institute on Drug Abuse Clinical Trials Network (CTN) demonstrate strategies for conducting effective substance abuse treatment research with racial/ethnic minorities (REMs).The objectives of this article are to describe lessons learned within the CTN to (1) enhance recruitment, retention, and other outcomes; (2) assess measurement equivalence; and (3) use data analytic plans that yield more information.This article includes background information and examples from multiple CTN studies on inclusion, measurement, and data analysis.Seven recommendations are included for conducting more effective research on REMs.
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    Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.
    (Contemporary clinical trials, 2016-09) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Sharma, Gaurav; VanVeldhuisen, Paul; Schwartz, Robert P
    Substance use and its associated use disorders are under-detected and under-treated in primary care. There is a need for a clinically useful brief screening and assessment instrument to identify primary care patients with substance use, sub-threshold substance use disorder (SUD), and SUD to facilitate brief intervention and treatment.We describe the design of the recently completed National Drug Abuse Treatment Clinical Trials Network's tobacco, alcohol, prescription medications, and substance use/misuse screen and brief assessment tool validation study. Study aims included to: develop a 2-stage screening and brief assessment tool (TAPS Tool) to detect substance use, problem use, and SUD among adult primary care patients; examine the validity of both the screen component and the TAPS Tool by comparing them to reference standard screening and assessment measures of no use, problem use, and SUD; and determine the feasibility and acceptability of the self-administration and interviewer-administration of the tool. The design included a pilot testing phase (n=30) and the main study of 2000 adult primary care participants who were randomly assigned in counter-balanced order to have the interviewer-administration or the self-administration of the TAPS Tool followed by the other administration format. Participants' views of feasibility, acceptability and preference for format of self-administration versus interviewer-administration of the TAPS Tool were assessed. Criterion measures of use and DSM-5 SUDs were administered.The TAPS Tool study builds on prior work to develop a 2-stage clinical tool for facilitating the adoption of screening, brief assessment and treatment for SUDs in primary care.
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    Quantifying data quality for clinical trials using electronic data capture.
    (PLoS One, 2008-08-25) Nahm, Meredith L; Pieper, Carl F; Cunningham, Maureen M
    BACKGROUND: Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. METHODS AND PRINCIPAL FINDINGS: The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. CONCLUSIONS: Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks.
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    The national drug abuse treatment clinical trials network data share project: website design, usage, challenges, and future directions.
    (Clinical trials (London, England), 2013-01) Shmueli-Blumberg, Dikla; Hu, Lian; Allen, Colleen; Frasketi, Michael; Wu, Li-Tzy; Vanveldhuisen, Paul
    There are many benefits of data sharing, including the promotion of new research from effective use of existing data, replication of findings through re-analysis of pooled data files, meta-analysis using individual patient data, and reinforcement of open scientific inquiry. A randomized controlled trial is considered as the 'gold standard' for establishing treatment effectiveness, but clinical trial research is very costly, and sharing data is an opportunity to expand the investment of the clinical trial beyond its original goals at minimal costs.We describe the goals, developments, and usage of the Data Share website (http://www.ctndatashare.org) for the National Drug Abuse Treatment Clinical Trials Network (CTN) in the United States, including lessons learned, limitations, and major revisions, and considerations for future directions to improve data sharing.Data management and programming procedures were conducted to produce uniform and Health Insurance Portability and Accountability Act (HIPAA)-compliant de-identified research data files from the completed trials of the CTN for archiving, managing, and sharing on the Data Share website.Since its inception in 2006 and through October 2012, nearly 1700 downloads from 27 clinical trials have been accessed from the Data Share website, with the use increasing over the years. Individuals from 31 countries have downloaded data from the website, and there have been at least 13 publications derived from analyzing data through the public Data Share website.Minimal control over data requests and usage has resulted in little information and lack of control regarding how the data from the website are used. Lack of uniformity in data elements collected across CTN trials has limited cross-study analyses.The Data Share website offers researchers easy access to de-identified data files with the goal to promote additional research and identify new findings from completed CTN studies. To maximize the utility of the website, ongoing collaborative efforts are needed to standardize the core measures used for data collection in the CTN studies with the goal to increase their comparability and to facilitate the ability to pool data files for cross-study analyses.
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    Using a latent variable approach to inform gender and racial/ethnic differences in cocaine dependence: a National Drug Abuse Treatment Clinical Trials Network study.
    (Journal of substance abuse treatment, 2010-06) Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G; Tai, Betty; Stitzer, Maxine L; Woody, George E
    This study applies a latent variable approach to examine gender and racial/ethnic differences in cocaine dependence, to determine the presence of differential item functioning (DIF) or item-response bias to diagnostic questions of cocaine dependence, and to explore the effects of DIF on the predictor analysis of cocaine dependence. The analysis sample included 682 cocaine users enrolled in two national multisite studies of the National Drug Abuse Treatment Clinical Trials Network (CTN). Participants were recruited from 14 community-based substance abuse treatment programs associated with the CTN, including 6 methadone and 8 outpatient nonmethadone programs. Factor and multiple indicators-multiple causes (MIMIC) procedures evaluated the latent continuum of cocaine dependence and its correlates. MIMIC analysis showed that men exhibited lower odds of cocaine dependence than women (regression coefficient, beta = -0.34), controlling for the effects of DIF, years of cocaine use, addiction treatment history, comorbid drug dependence diagnoses, and treatment setting. There were no racial/ethnic differences in cocaine dependence; however, DIF by race/ethnicity was noted. Within the context of multiple community-based addiction treatment settings, women were more likely than men to exhibit cocaine dependence. Addiction treatment research needs to further evaluate gender-related differences in drug dependence in treatment entry and to investigate how these differences may affect study participation, retention, and treatment response to better serve this population.