Evidence map›Paper›PMID 31443894›Full record

Trial reportJournal of substance abuse treatment2019

Understanding site variability in a multisite clinical trial of a technology-delivered psychosocial intervention for substance use disorders.

Leila M Vaezazizi, Aimee N C Campbell, Martina Pavlicova, Mei-Chen Hu, Edward V Nunes

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of substance abuse treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Leila M VaezaziziDivision on Substance Use Disorders, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA.
Aimee N C CampbellDivision on Substance Use Disorders, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA. Electronic address: anc2002@cumc.columbia.edu.
Martina PavlicovaDepartment of Biostatistics, Columbia University Mailman School of Public Health, 722 West 168th St, New York, NY 10032, USA. Electronic address: mp2370@columbia.edu.
Mei-Chen HuDepartment of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA. Electronic address: mh2236@cumc.columbia.edu.
Edward V NunesDivision on Substance Use Disorders, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA. Electronic address: Edward.nunes@nyspi.columbia.edu.

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
NIDA CLINICAL TRIALS NETWORK - NYC EAST SIDE NODEU10DA013046 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ROTROSEN, JOHN P · 2000 to 2009
$20.2M
Translational Clinical Research Fellowship on Substance Use DisordersT32DA007294 · NIDA · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI Frances Rudnick Levin, Diana M Martinez · 1993 to 2026
$9.3M
Advancing Clinical Research Training within Addiction Residency ProgramsR25DA033211 · NIDA · BOSTON MEDICAL CENTER · PI Patrick O'Connor, JEFFREY H. SAMET · 2012 to 2026
$4.2M
NIDA NIH HHS R25 DA033211NIDA NIH HHS T32 DA007294NIDA NIH HHS U10 DA013046NIDA NIH HHS UG1 DA013035
6 · The paper itself

Abstract

backgroundSignificant fixed effects of site (main effects of site and/or site by treatment interactions) on primary outcome have been identified in the majority of studies performed by NIDA's National Drug Abuse Treatment Clinical Trials Network. While rarely explored, identifying patient- and site-level variables that are associated with site effects can provide information about the context in which outcome is optimized.

methodsIn a 10-site clinical trial that evaluated the effectiveness of a web-based psychosocial intervention compared to usual treatment of patients (N = 507) with substance use disorders, the primary outcome analysis revealed significant main effect of site, modeled as a fixed effect, on the outcome of abstinence (Campbell et al., 2014). In the current analysis, we use a two-level, hierarchical generalized linear model (HGLM) to identify patient- and site-level variables associated with abstinence outcome, while modeling site as a random factor.

resultsThe site-specific percentage of patients abstinent in the last 4 weeks of the study varied from 6.1% to 40%. However, only 6.7% (p = 0.08) of variability in end-of-study abstinence was accounted for by site, indicating a small-moderate effect. Among patient-level predictors, older age (OR = 1.40; 95% CI = 1.15, 1.71; p = 0.0009), abstinence at baseline (OR = 2.77; 95% CI = 1.73, 4.45; p < 0.0001), and among site-level predictors, higher annual clinic admissions (OR = 1.28; 95% CI = 1.03, 1.59; p = 0.0251) were significantly associated with increased likelihood of abstinence. When controlling for these three variables in a HGLM, only patient age and abstinence at baseline remained significant, and random factor site explained only 1.4% of variability in end-of-study abstinence, a 79% reduction in magnitude.

conclusionsThe findings suggest that only some amount of variability in abstinence outcomes among sites can be explained by a combination of patient- and site-level variables. Our findings support the case that variability between sites is a natural phenomenon, and our methodological recommendation is that site be modeled as a random factor when analyzing multi-site clinical trials.

Indexed as

Community Mental Health ServicesResearch DesignSubstance-Related DisordersAdultAgedAge FactorsFemaleHumansInternetMaleMiddle AgedNational Institute on Drug Abuse (U.S.)United StatesCommunity mental health servicesMulticenter studiesResearch designSubstance-related disordersTreatment outcome

Identifiers

PMID31443894
PMCPMC8459398

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.