Evidence map›Paper›PMID 24172115›Full record

ArticleJournal of studies on alcohol and drugs2013

Representativeness of patients enrolled in influential clinical trials: a comparison of substance dependence with other medical disorders.

Keith Humphreys, Natalya C Maisel, Janet C Blodgett, John W Finney

Open access · bronzeAbstract read
In one paragraph

Article in Journal of studies on alcohol and drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.7field-weighted citation impact, top 14% of its field
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

7 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
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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

4 authors at 2 institutions in 1 country.

Keith HumphreysCenter for Health Care Evaluation, Veterans Affairs (VA) Palo Alto Health Care System, Menlo Park, California, Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, California.
Natalya C Maisel
Janet C Blodgett
John W Finney
VA Palo Alto Health Care System · USStanford University · US

Funding

META-ANALYSIS OF ALCOHOLISM TREATMENT OUTCOME RESEARCHR01AA008689 · NIAAA · PALO ALTO VETERANS INSTIT FOR RESEARCH · PI FINNEY, JOHN W. · 1990 to 2011
$766k
NIAAA NIH HHS AA008689NIAAA NIH HHS R01 AA008689
6 · The paper itself

Abstract

objectiveThe purpose of this study was to determine whether randomized trials of treatments for substance dependence differ from those for other medical disorders on quality of enrollment information reporting and sample representativeness.

methodTwenty highly cited clinical trials (publication date 2002-2010) of treatments for each of 14 prevalent disorders were identified by structured literature search. The disorders were alcohol dependence, drug dependence, nicotine dependence, Alzheimer's disease, breast cancer, colorectal cancer, chronic obstructive pulmonary disease, depression, diabetes, HIV/AIDS, hypertension, ischemic heart disease, lung cancer, and schizophrenia. The 280 clinical trials were coded for number of individuals screened for eligibility, number of screened individuals meeting eligibility criteria, and number of eligible individuals refusing to participate.

resultsSubstance-dependence treatment trials were significantly more likely to track and report enrollment information (75% vs. 45% of clinical trials for other disorders, p < .001). Substance-dependence trials did not differ from trials focused on other disorders on mean rate of non-enrollment. Across disorders, the primary driver of non-enrollment appeared to be clinical trial exclusion criteria rather than eligible patients refusing to enroll.

conclusionsRelative to other disorders, trials in the substance-dependence field do a better (although imperfect) job of tracking and reporting enrollment information. Low enrollment rates and unrepresentative samples are not challenges unique to treatment outcome studies in the substance-dependence field. Across a range of disorders, clinical trials that use eligibility criteria judiciously are more likely to produce findings that generalize to front-line clinical practice than are trials that restrict enrollment to a small and unrepresentative subset of patients.

Indexed as

Patient SelectionHumansRandomized Controlled Trials as TopicRefusal to ParticipateResearch DesignSubstance-Related DisordersTreatment Outcome

Identifiers

PMID24172115
PMCPMC3817050
OpenAlexW2057408350

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.