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Jeffrey E Korte1, Carmen L Rosa2, Paul G Wakim2, Harold I Perl21Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, SC, 2Center for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAIntroduction: Historically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants.Purpose: The examination of gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials.Methods: Reports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s).Results: Analysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants.Conclusion: These results are based on a large sample of patients with substance use disorders recruited from a treatment-seeking population. The findings demonstrate that younger participants are less likely than older adults to be retained in clinical trials.Keywords: addiction treatment, age, ethnic minorities, gender difference, substance use disorders, race, recruitment, retention, clinical trials

Background: Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers' Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job.Method: Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-h small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring.Results: JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program). Specifically, one-fifth of participants at 12weeks (20.1-24.3%) and nearly one-third at 24 weeks (31.4-31.9%) had positive outcomes, with "obtaining a new taxed job" accounting for the majority of cases.Conclusion: JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well. [ABSTRACT FROM AUTHOR]

Introduction: Clinical trial recruitment and retention of individuals who use substances are challenging in any setting and can be particularly difficult in emergency department (ED) settings. This article discusses strategies for optimizing recruitment and retention in substance use research conducted in EDs., Methods: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED) was a National Drug Abuse Treatment Clinical Trials Network (CTN) protocol designed to assess the impact of a brief intervention with individuals screening positive for moderate to severe problems related to use of non-alcohol, non-nicotine drugs. We implemented a multisite, randomized clinical trial at six academic EDs in the United States and leveraged a variety of methods to successfully recruit and retain study participants throughout the 12-month study course. Recruitment and retention success is attributed to appropriate site selection, leveraging technology, and gathering adequate contact information from participants at their initial study visit., Results: The SMART-ED recruited 1,285 adult ED patients and attained follow-up rates of 88%, 86%, and 81% at the 3-, 6-, and 12-month follow-up periods, respectively. Participant retention protocols and practices were key tools in this longitudinal study that required continuous monitoring, innovation, and adaptation to ensure strategies remained culturally sensitive and context appropriate through the duration of the study., Conclusion: Tailored strategies that consider the demographic characteristics and region of recruitment and retention are necessary for ED-based longitudinal studies involving patients with substance use disorders.

Objective: Few studies have examined the effectiveness of 12-step peer recovery support programs with drug use disorders, especially stimulant use, and it is difficult to know how outcomes related to 12-step attendance and participation generalize to individuals with non-alcohol substance use disorders (SUDs)., Method: A clinical trial of 12-step facilitation (N=471) focusing on individuals with cocaine or methamphetamine use disorders allowed examination of four questions: Q1) To what extent do treatment-seeking stimulant users use 12-step programs and, which ones? Q2) Do factors previously found to predict 12-step participation among those with alcohol use disorders also predict participation among stimulant users? Q3) What specific baseline "12-step readiness" factors predict subsequent 12-step participation and attendance? And Q4) Does stimulant drug of choice differentially predict 12-step participation and attendance?, Results: The four outcomes variables, attendance, speaking, duties at 12-step meetings, and other peer recovery support activities, were not related to baseline demographic or substance problem history or severity. Drug of choice was associated with differential days of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) attendance among those who reported attending, and cocaine users reported more days of attending AA or NA at 1-, 3- and 6-month follow-ups than did methamphetamine users. Pre-randomization measures of perceived benefit of 12-step groups predicted 12-step attendance at 3- and 6-month follow-ups. Pre-randomization 12-step attendance significantly predicted number of other self-help activities at end-of-treatment, 3- and 6-month follow-ups. Pre-randomization perceived benefit and problem severity both predicted number of self-help activities at end-of-treatment and 3-month follow-up. Pre-randomization perceived barriers to 12-step groups were negatively associated with self-help activities at end-of-treatment and 3-month follow-up. Whether or not one participated in any duties was predicted at all time points by pre-randomization involvement in self-help activities., Conclusions: The primary finding of this study is one of continuity: prior attendance and active involvement with 12-step programs were the main signs pointing to future involvement. Limitations and recommendations are discussed., (Copyright © 2016 Elsevier Inc. All rights reserved.)

This paper focuses on the relationships among the U.S. Preventive Services Task Force (USPSTF); Agency for Healthcare Research and Quality (AHRQ); and NIH. After a brief description of the Task Force, AHRQ, NIH, and an example of how they interact, we describe the steps that have been taken recently by NIH to enhance their coordination. We also discuss several challenges that remain and consider potential remedies that NIH, AHRQ, and investigators can take to provide the USPSTF with the data it needs to make recommendations, particularly those pertaining to behavioral interventions., (Published by Elsevier Inc.)

Importance: Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization., Objective: To contrast the effects of a brief intervention with telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO) among drug-using ED patients., Design, Setting, and Participants: Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs, were randomized to MSO (n = 431), SAR (n = 427), or BI-B (n = 427). Follow-up assessments were conducted at 3, 6, and 12 months by blinded interviewers., Interventions: Following screening, MSO participants received only an informational pamphlet. The SAR participants received assessment plus referral to addiction treatment if indicated, and the BI-B participants received assessment and referral as in SAR, plus a manual-guided counseling session based on motivational interviewing principles and up to 2 "booster" sessions by telephone during the month following the ED visit., Main Outcomes and Measures: Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples. The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up., Results: Follow-up rates were 89%, 86%, and 81% at 3, 6, and 12 months, respectively. For the primary outcome, estimated differences in number of days of use (95% CI) were as follows: MSO vs BI-B, 0.72 (-0.80 to 2.24), P (adjusted) = .57; SAR vs BI-B, 0.70 (-0.83 to 2.23), P (adjusted) = .57; SAR vs MSO, -0.02 (-1.53 to 1.50), P (adjusted) = .98. There were no significant differences between groups in self-reported days using the primary drug, days using any drug, or heavy drinking days at 3, 6, or 12 months. At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280 [95%]) than did participants in the MSO group (253 of 287 [88%]) or the BI-B group (244 of 275 [89%]). Hair analysis differences between groups at other time points were not significant., Conclusions and Relevance: In this sample of drug users seeking emergency medical treatment, a relatively robust brief intervention did not improve substance use outcomes. More work is needed to determine how drug use disorders may be addressed effectively in the ED., Trial Registration: clinicaltrials.gov Identifier:NCT01207791.

This study examined whether level of exposure to Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), a 12-Step facilitative therapy, is related to treatment outcome. Data were from a large National Drug Abuse Treatment Clinical Trials Network (CTN) study comparing STAGE-12 combined with treatment-as-usual (TAU) to TAU alone. These analyses include only those randomized to STAGE-12 (n=234). Assessments occurred at baseline and 30, 60, 90, and 180 days following randomization. High-exposure patients (n=158; attended at least 2 of 3 individual, and 3 of 5 group, sessions), compared to those with less exposure (n=76), demonstrated: (1) higher odds of self-reported abstinence from, and lower rates of, stimulant and non-stimulant drug use; (2) lower probabilities of stimulant-positive urines; (3) more days of attending and lower odds of not attending 12-Step meetings; (4) greater likelihood of reporting no drug problems; (5) more days of duties at meetings; and (6) more types of 12-Step activities. Many of these differences declined over time, but several were still significant by the last follow-up. Treatment and research implications are discussed., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Aims: The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service., Design: Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs)., Setting: Intensive outpatient substance treatment programs., Participants: Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated., Measurements: Urinalysis and self-reports of substance use and 12-step attendance and activities., Intervention: Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers., Findings: Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU., Conclusions: The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings., Objectives: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners., Methods: This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each., Results: The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability., Conclusion: The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN., Scientific Significance: Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.

Background: Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although screening, brief intervention, and referral to treatment models have been extensively studied and are considered effective for individuals with alcohol problems presenting in EDs and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs., Objectives: This article describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an screening, brief intervention, and referral to treatment model in medical EDs, highlighting considerations that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings., Methods: The protocol is described, and critical design decisions are discussed., Results: Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis., Conclusion: Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings., Scientific Significance: Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.

Despite the billions of dollars spent on health-focused research and the hundreds of billions spent on delivering health services each year, relatively little money and effort are directed toward investigating how best to connect the two. This results in missed opportunities to assure that research findings inform and improve quality across healthcare in general and for addiction prevention and treatment in particular. There is an asymmetrical focus that favors the identification of new interventions and neglects the implementation of science-based knowledge in actual practice. The consequences of that neglect are severe: significantly diminished progress in research on how to implement treatments that could improve the lives of persons with addiction problems, their families, and the rest of society. While the advancement of knowledge regarding effective implementation is lagging, it is clear that existing systemic incentives in the conduct of science inhibit rather than facilitate widespread adoption of evidence-based practices. This commentary proposes three interrelated strategies for improving the implementation process. First, develop scientific tools to understand implementation better, by expanding investigations on the science of implementation and broadening approaches to the design and execution of research. Second, nurture and support a collaborative implementation workforce comprised of scientists and on-the-ground practitioners, with an explicit focus on enhancing appropriate incentives for both. Third, pay closer attention to crafting research that seeks answers that are most relevant to clinicians' actual needs, primarily by ensuring that the anticipated users of the evidence-based practice are full partners in developing the questions right from the start., (Published by Elsevier Ltd.)

While some aspects of addiction can be studied in laboratory or controlled settings, the study of long-term recovery management and the health services that support it requires going out into the community and dealing with populations and systems that are much more diverse and less under our control. This in turn raises many methodological challenges for the health service researchers studying alcohol and other drug abuse treatment. This paper identifies some of these challenges related to the design, measurement, implementation and effectiveness of health services research. It then recommends 25 strategies (and key primers) for addressing them: (1) identifying in advance all stakeholders and issues; (2) developing conceptual models of intervention and context; (3) identifying the population to whom the conclusions will be generalized; (4) matching the research design to the question; (5) conducting randomized experiments only when appropriate and necessary; (6) balancing methodological and treatment concerns; (7) prioritizing analysis plans and increasing design sensitivity, (8) combining qualitative and quantitative methods; (9) identifying the four basic types of measures needed; (10) identifying and using standardized measures; (11) carefully balancing measurement selection and modification; (12) developing and evaluating modified and new measures when necessary; (13) identifying and tracking major clinical subgroups; (14) measuring and analyzing the actual pattern of services received; (15) incorporating implementation checks into the design; (16) incorporating baseline measures into the intervention; (17) monitoring implementation and dosage as a form of quality assurance; (18) developing procedures early to facilitate tracking and follow-up of study participants; (19) using more appropriate representations of the actual experiment; (20) using appropriate and sensitive standard deviation terms; (21) partialing out variance due to design or known sources prior to estimating experimental effect sizes; (22) using dimensional, interval and ratio measures to increase sensitivity to change; (23) using path or structural equation models; (24) integrating qualitative and quantitative analysis into reporting; and (25) using quasi-experiments, economic or organizational studies to answer other likely policy questions. Most of these strategies have been tried and tested in this and other areas, but are not widely used. Improving the state of the art of health services research and bridging the gap between research and practice do not depend upon using the most advanced methods, but rather upon using the most appropriate methods.

Many of the failures to replicate clinical findings of treatment efficacy in more realistic field and community settings can be attributed to inappropriate research designs and other methodological shortcomings. In order to increase research designers' awareness of existing methodologies that may be better suited to answer the critical questions inherent in health services research on alcohol-related issues, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) convened an expert conference with three specific goals; (1) to identify the critical issues involved in alcohol services research; (2) to develop a primer that explicated each key area; and (3) to compile the resulting primers into an accessible resource for researchers, policy makers and consumers. The 9 papers in this special supplement are the product of that conference and are organized broadly around three phases of the research process: study design and implementation, data collection and use, and the analysis and interpretation of data. A final summary paper discusses the issues and offers a synthesis of key themes as well as some direction for the future.

Like measures of outcome, measures of implementation are most useful and analytically powerful when measured at client-level and are quantitative. However, high-quality, individual-level, quantitative service utilization data can be expensive, intrusive, or otherwise impractical to obtain. Cruder data--for example, presence versus absence of a given service--are often more feasible to collect, as well as more likely to be available. Consequently, evaluators can benefit by finding ways to better exploit such data at the analysis phase to compensate for shortcomings at the collection phase. This article documents one such instance in which this was done. Specifically, it describes how quantitative, client-level implementation scales were derived from qualitative (categorical) data and used to support a cross-site synthesis of implementation and outcome analyses in a multisite evaluation. It also suggests additional scenarios in which quantitative implementation scales might be derived form qualitative services data.