Evidence map›Paper›PMID 34766524›Full record

ArticleClinical trials (London, England)2021

Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.

Andrew Garland, Kevin Weinfurt, Jeremy Sugarman

Registry-linked trialAbstract read
In one paragraph

Article in Clinical trials (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06419868 (Acceptability and Feasibility of a Universal Preventive Intervention for Depression and Anxiety in University Students), 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.

NCT06419868 naunknown statusnot on this mapstarted 2024, after this paper: background citation

Acceptability and Feasibility of a Universal Preventive Intervention for Depression and Anxiety in University Students

TypeinterventionalSponsorUniversidad de los Andes, ChileRan2024 to 2025Enrolled272ConditionsDepression/AnxietyArms"Universal preventive intervention for depression and anxiety for university students"
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  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

3 authors.

Andrew GarlandBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0001-8649-0976
Kevin WeinfurtDepartment of Population Health Sciences, School of Medicine, Duke University, Durham, NC, USA.ORCID 0000-0002-0624-7448
Jeremy SugarmanBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0001-7022-8332

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics SupplementU24AT010961 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2019 to 2021
$6.4M
NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24 AT010961
6 · The paper itself

Abstract

Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this article, we examine a set of issues related to incentives and other payments to patients in pragmatic clinical trials. Although many of the ethical concerns related to incentives and payments in explanatory trials pertain to pragmatic clinical trials, the pragmatic features may introduce additional challenges. These include those related to the risk of incentives and payments undermining the scientific validity and social value of pragmatic clinical trials, the sources of data used in pragmatic clinical trials, and when the pragmatic clinical trials are conducted under waivers of consent. Based on our examination of these matters, we offer some preliminary recommendations regarding incentives and payments in pragmatic clinical trials, recognizing that additional data and experiences are needed to refine them.

Indexed as

MotivationPragmatic Clinical Trials as TopicEthics, ResearchHumansPolicyResearch DesignethicsincentivesPragmatic clinical trials

Identifiers

PMID34766524
PMCPMC8597901

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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.