Evidence map›Paper›PMID 28847457›Full record

Trial reportJournal of substance abuse treatment2017

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.

Ashleigh A Allen, Donna T Chen, Richard J Bonnie, Tomohiro M Ko, Colleen E Suratt, Joshua D Lee, Peter D Friedmann, Michael Gordon, Ryan McDonald, Sean M Murphy and 3 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of substance abuse treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Interventions for female drug-using offenders.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Review
  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

13 authors at 8 institutions in 2 countries.

Ashleigh A AllenUniversity of Virginia Institute of Law, Psychiatry, and Public Policy, Charlottesville, VA, USA. Electronic address: aaa5q@virginia.edu.
Donna T ChenCenter for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, VA, USA. Electronic address: dtc6k@virginia.edu.
Richard J BonnieUniversity of Virginia School of Law, Charlottesville, VA, USA. Electronic address: rbonnie@virginia.edu.
Tomohiro M KoUniversity of Virginia Institute of Law, Psychiatry, and Public Policy, Charlottesville, VA, USA. Electronic address: tmk5fw@virginia.edu.
Colleen E SurattDepartment of Public Health Sciences, University of Virginia, Charlottesville, VA, USA. Electronic address: ces7kt@virginia.edu.
Joshua D LeeDepartment of Population Health, New York University, New York, NY, USA; Department of Medicine, Division of General Internal Medicine, New York University, New York, NY, USA. Electronic address: Joshua.Lee@nyumc.org.
Peter D FriedmannOffice of Research, University of Massachusetts Medical School-Baystate, Baystate Health, Springfield, MA, USA. Electronic address: Peter.FriedmannMD@baystatehealth.org.
Michael GordonFriends Research Institute, Baltimore, MD, USA. Electronic address: mgordon@friendsresearch.org.
Ryan McDonaldDepartment of Population Health, New York University, New York, NY, USA. Electronic address: Ryan.Mcdonald@nyumc.org.
Sean M MurphyDepartment of Healthcare Policy and Research, Cornell University, New York, NY, USA. Electronic address: smm2010@med.cornell.edu.
Tamara Y BoneyUniversity of Pennsylvania, Philadelphia, PA, USA. Electronic address: Tamara.Boney@va.gov.
Edward V NunesNew York State Psychiatric Institute, Columbia University, College of Physicians and Surgeons, New York, NY, USA. Electronic address: Nunesed@nyspi.columbia.edu.
Charles P O'BrienUniversity of Pennsylvania, Philadelphia, PA, USA. Electronic address: obrien@mail.med.upenn.edu.
University of Virginia · USNew York University · USColumbia University · USCornell University · USFriends Research Institute · USPitney Bowes (France) · FRUniversity of Massachusetts Chan Medical School · USUniversity of Pennsylvania · US

Funding

Utilization of health services after engagement with opioid use disorder (OUD) treatment provider by individuals with and without post-traumatic stress disorderP30DA040500 · NIDA · WEILL MEDICAL COLL OF CORNELL UNIV · PI ZACHARY Franklin MEISEL · 2015 to 2026
$20.7M
Treatment Study Using Depot Naltrexone(1/6)Philadelphia Coord/Data Mgmt SiteR01DA024553 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI O'BRIEN, CHARLES P · 2008 to 2013
$3.0M
Treatment Study Using Depot Naltrexone (3/6) NY/Bellevue Protocol Treatment SiteR01DA024555 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI LEE, JOSHUA D · 2008 to 2014
$2.0M
Treatment Study Using Depot Naltrexone(2/6)Rhode Island Protocol Treatment SiteR01DA024549 · NIDA · RHODE ISLAND HOSPITAL · PI FRIEDMANN, PETER D · 2008 to 2014
$1.9M
Treatment Studies Using Depot Naltrexone (4/6) Columbia Protocol Treatment SiteR01DA024554 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI NUNES, EDWARD V. · 2008 to 2014
$1.8M
Drug Abuse Treatment Development and Research MentoringK24DA022412 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI NUNES, EDWARD V. · 2007 to 2016
$1.7M
Treatment Study Using Depot Naltrexone(5/6)Baltimore Protocol Treatment SiteR01DA024550 · NIDA · FRIENDS RESEARCH INSTITUTE, INC. · PI KINLOCK, TIMOTHY W · 2008 to 2014
$1.5M
NIDA NIH HHS K24 DA022412NIDA NIH HHS P30 DA040500NIDA NIH HHS R01 DA024549NIDA NIH HHS R01 DA024550NIDA NIH HHS R01 DA024553NIDA NIH HHS R01 DA024554NIDA NIH HHS R01 DA024555
6 · The paper itself

Abstract

Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit.

Indexed as

Clinical Trials as TopicPatient SelectionAdultCriminalsHumansInformed ConsentNaltrexoneNarcotic AntagonistsOpioid-Related DisordersSecondary PreventionNaltrexoneNarcotic AntagonistsCriminal justice supervisionInformed consentResearch ethicsSubstance use disorder

Identifiers

PMID28847457
PMCPMC5849444
OpenAlexW2740935381

What OpenQuestion holds

Textmetadata
LicenceTDM
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.