Evidence map›Paper›PMID 35987403›Full record

ReviewJournal of clinical epidemiology2022

An analysis of published trials found that current use of pragmatic trial labels is uninformative.

Monica Taljaard, Stuart G Nicholls, Alison H Howie, Hayden P Nix, Kelly Carroll, Paxton M Moon, Natalie M Nightingale, Bruno Giraudeau, Spencer P Hey, Sandra M Eldridge and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of clinical epidemiology, 2022. 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. Review
  2. Article
  3. Review
  4. Article
  5. Article
  6. 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

12 authors.

Monica TaljaardOttawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: mtaljaard@ohri.ca.
Stuart G NichollsOttawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada.
Alison H HowieWestern Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada.
Hayden P NixSchulich School of Medicine & Dentistry, Western University, London, Ontario N6G 2M1, Canada.
Kelly CarrollOttawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada.
Paxton M MoonDepartment of Family Medicine, Western Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada.
Natalie M NightingaleWestern Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada.
Bruno GiraudeauUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France; INSERM CIC1415, CHRU de Tours, Tours, France.
Spencer P HeyCenter for Bioethics, Harvard Medical School, Boston, MA, USA.
Sandra M EldridgeWolfson Institute of Population Health, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.
Charles WeijerDepartments of Medicine, Epidemiology & Biostatistics, and Philosophy, Western University, London, Ontario N6A 5W9, Canada.
Merrick ZwarensteinDepartment of Family Medicine, Western Centre for Public Health and Family Medicine, 1465 Richmond St., London, Ontario N6G 2M1, Canada.

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI JASON H KARLAWISH · 2019 to 2026
$125.9M
CIHR PJT-153045NIA NIH HHS U54 AG063546
6 · The paper itself

Abstract

objectivesRandomized trials labelled as "pragmatic" are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains). STUDY DESIGN AND

settingWe reviewed primary trial reports published 2014-2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.

resultsAmong 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.

conclusionCurrent use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent.

Indexed as

Research DesignHumansPatient-reported outcomesRandomized controlled trialReal-world trialsResearch ethicsRoutinely collected dataTrial designs

Identifiers

PMID35987403
PMCPMC11307297

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.