Evidence map›Paper›PMID 31084378›Full record

ArticleClinical trials (London, England)2019

Addressing guideline and policy changes during pragmatic clinical trials.

Lesley H Curtis, Laura M Dember, Miguel A Vazquez, David Murray, Lynn DeBar, Karen L Staman, Edward Septimus, Vincent Mor, Angelo Volandes, Barbara L Wells and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical trials (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Lesley H Curtis1 Duke University School of Medicine, Durham, NC, USA.
Laura M Dember2 Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Miguel A Vazquez3 University of Texas Southwestern Medical Center, Dallas, TX, USA.
David Murray4 National Institutes of Health, Bethesda, MD, USA.
Lynn DeBar5 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Karen L Staman6 Duke Clinical Research Institute, Durham, NC, USA.
Edward Septimus7 Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Vincent Mor8 Department of Health Services, Policy, and Practice, School of Public Health, Brown University and Providence Veterans Administration Medical Center, Providence, RI, USA.
Angelo Volandes9 Massachusetts General Hospital, Boston, MA, USA.
Barbara L Wells10 Division of Cardiovascular Sciences, NHLBI, National Institutes of Health, Bethesda, MD, USA.
Susan S Huang11 Irvine School of Medicine, University of California, Irvine, CA, USA.
Beverly B Green5 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Gloria Coronado12 Kaiser Permanente Center for Health Research, Portland, OR, USA.
Catherine M Meyers13 Office of Clinical and Regulatory Affairs, National Center for Complementary and Integrative Health (NCCIH), Bethesda, MD, USA.
Leah Tuzzio5 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Adrian F Hernandez1 Duke University School of Medicine, Durham, NC, USA.
Jeremy Sugarman14 Johns Hopkins Berman Institute of Bioethics and Department of Medicine, The Johns Hopkins University, Baltimore, MD, USA.

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
Health Care Systems Research Collaboratory SupplementU54AT007748 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2012 to 2017
$15.1M
NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U54 AT007748
6 · The paper itself

Abstract

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

Indexed as

Practice Guidelines as TopicColorectal NeoplasmsHumansInsurance, Health, ReimbursementKidney Failure, ChronicOpioid-Related DisordersPragmatic Clinical Trials as TopicPublic HealthResearch Designguideline changesPragmatic clinical trialspragmatic researchpublic health

Identifiers

PMID31084378
PMCPMC6663617

What OpenQuestion holds

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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.