Evidence map›Paper›PMID 34896234›Full record

ReviewJournal of clinical epidemiology2022

Review of pragmatic trials found that multiple primary outcomes are common but so too are discrepancies between protocols and final reports.

Pascale Nevins, Shelley Vanderhout, Kelly Carroll, Stuart G Nicholls, Seana N Semchishen, Jamie C Brehaut, Dean A Fergusson, Bruno Giraudeau, Monica Taljaard

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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  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

9 authors.

Pascale NevinsDepartment of Chemistry and Biomolecular Sciences, University of Ottawa, STEM Complex 150 Louis-Pasteur Pvt, Room 342, Ottawa, Ontario, K1N 6N5, Canada.
Shelley VanderhoutOttawa 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, 600 Peter Morand Crescent, Room 101, Ottawa, Ontario, K1G 5Z3, Canada.
Kelly CarrollOttawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada.
Stuart G NichollsOttawa Hospital Research Institute, Clinical Epidemiology Program, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada.
Seana N SemchishenSchool of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Room 101, Ottawa, Ontario, K1G 5Z3, Canada.
Jamie C BrehautOttawa 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, 600 Peter Morand Crescent, Room 101, Ottawa, Ontario, K1G 5Z3, Canada.
Dean A FergussonOttawa 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, 600 Peter Morand Crescent, Room 101, Ottawa, Ontario, K1G 5Z3, Canada; University of Ottawa, Roger Guindon Hall 451 Smyth Rd, Ottawa, Ontario, K1H 8M5, Canada.
Bruno GiraudeauUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France; INSERM CIC1415, CHRU de Tours, Tours, France.
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, 600 Peter Morand Crescent, Room 101, Ottawa, Ontario, K1G 5Z3, Canada. Electronic address: mtaljaard@ohri.ca.

Funding

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

Abstract

objectivesTo describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials. STUDY DESIGN AND

settingIndividually randomized trials labeled as pragmatic, published 2014-2019 in MEDLINE and registered with ClinicalTrials.gov.

resultsWe identified 262 final reports and located protocols for 159 (61%); primary outcomes were clearly reported in 145 (91%) protocols and 256 (98%) final reports. Thirty (19%) protocols and 38 (15%) final reports had multiple primary outcomes. Primary outcomes were present and identical in 128 (81%) matched protocol-final reports. Among 140 pairs with target sample sizes reported, 28 (20.0%) reduced their target sample size (mean 543 fewer participants per trial) and 16 (11.4%) increased it (mean 192 more participants per trial). Thirteen (29.5%) provided an explanation. Only 2 of 30 (7%) protocols and 4 of 38 (11%) final reports with co-primary outcomes explained how results would be interpreted in light of multiplicity; 21 of 30 (70%) protocols and 20 of 38 (53%) final reports accounted for co-primary outcomes in power calculations.

conclusionCo-primary outcomes are common in pragmatic trials; improved transparency around design and analysis decisions involving co-primary outcomes is required.

Indexed as

Neoplasms, Multiple PrimaryHumansSample SizeMultiplicityOutcome selectionPragmatic trialsPrimary outcomeSample size calculation

Identifiers

PMID34896234
PMCPMC9058220

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.