Evidence map›Paper›PMID 30414865›Full record

ArticleContemporary clinical trials2019

Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.

Dustin C Krutsinger, Jacqueline McMahon, Alisa J Stephens-Shields, Brian Bayes, Steven Brooks, Brian L Hitsman, Su Fen Lubitz, Celine Reyes, Robert A Schnoll, S Ryan Greysen and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02697799 (A Randomized Trial of Recruitment Strategies for Research Participation), which is not on this 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.

NCT02697799 nacompletednot on this map

A Randomized Trial of Recruitment Strategies for Research Participation

TypeinterventionalSponsorUniversity of PennsylvaniaRan2016 to 2019Enrolled1,296ConditionsIncentives, Research EthicsArmsHigh-level recruitment strategy consent form, Mid-level recruitment strategy consent form
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

18 authors.

Dustin C KrutsingerDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: Dustin.Krutsinger@uphs.upenn.edu.
Jacqueline McMahonPalliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Alisa J Stephens-ShieldsPalliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Brian BayesPalliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Steven BrooksPalliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Brian L HitsmanDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Su Fen LubitzDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Celine ReyesDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Robert A SchnollDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
S Ryan GreysenDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Ashley MercedeDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Mitesh S PatelDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.
Catherine RealeDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Fran BargDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA; Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; Department of Anthropology, University of Pennsylvania School of Arts and Sciences, Philadelphia, PA, United States.
Jason KarlawishDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Penn Memory Center at the Penn Neuroscience Center, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Daniel PolskyDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA.
Kevin G VolppDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, PA, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Scott D HalpernDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Funding

UPenn ADCC Biomarker CoreP30AG010124 · NIA · UNIVERSITY OF PENNSYLVANIA · PI VAN DEERLIN, VIVIANNA M · 1991 to 2020
$35.1M
Training in Critical Care Health Policy ResearchT32HL098054 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Scott D Halpern · 2010 to 2026
$8.2M
Behavioral Activation and Varenicline for Smoking Cessation in Depressed SmokersR01CA184211 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI HITSMAN, BRIAN L · 2014 to 2018
$3.2M
A Randomized Trial of Incentives for Research ParticipationR01CA197332 · NCI · UNIVERSITY OF PENNSYLVANIA · PI HALPERN, SCOTT D · 2015 to 2019
$2.9M
NCI NIH HHS R01 CA184211NCI NIH HHS R01 CA197332NHLBI NIH HHS T32 HL098054NIA NIH HHS P30 AG010124
6 · The paper itself

Abstract

introductionThe most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs. METHODS AND ANALYSES: We are conducting randomized trials of real incentives embedded within two parent RCTs. In each of two trials conducted in parallel, we are randomizing 576 participants to one of three incentive groups. Following preliminary determination of patients' eligibility in the parent RCT, we assess patients' research attitudes, demographic characteristics, perceived research risks, time spent reviewing consent documents, ability to distinguish research from patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews for a selected group of participants that more deeply explore patients' motivations for trial participation. The trials are each designed to have adequate power to rule out undue and unjust inducement. We are also exploring potential benefits of incentives, including possible increased attention to research risks and cost-effectiveness.

Indexed as

Decision MakingInformed ConsentPatient ParticipationAttitude to HealthCoercionComprehensionHumansMotivationPatient SelectionPerceptionRandomized Controlled Trials as TopicResearch SubjectsRiskTherapeutic MisconceptionBehavioral economicsEthicsIncentivesNudgeRandomized controlled trials

Identifiers

PMID30414865
PMCPMC6354250

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Registered trials

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.