Evidence map›Paper›PMID 11706908›Full record

ArticleCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2001

How well is the clinical importance of study results reported? An assessment of randomized controlled trials.

K B Chan, M Man-Son-Hing, F J Molnar, A Laupacis

Registry-linked trialAbstract read
PubMed Full text at PMC
In one paragraph

Article in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00143715 (A Multicentre, Multinational Study of Oral Vitamin K for the Treatment of Warfarin Associated Coagulopathy), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 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.

NCT00143715 phase3completednot on this mapstarted 2004, after this paper: background citation

A Multicentre, Multinational Study of Oral Vitamin K for the Treatment of Warfarin Associated Coagulopathy

TypeinterventionalSponsorSt. Joseph's Healthcare HamiltonRan2004 to 2007Enrolled690ConditionsCoagulation, Bleeding, ThrombosisArmsPhytonadione (Vitamin K1)
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
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  9. DELTATrials · 2018
    Article
  10. DELTABMJ (Clinical research ed.) · 2018
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. The minimal important difference in the 6-minute walk test for patients with pulmonary arterial hypertension.American journal of respiratory and critical care medicine · 2012 · on this map
    Article
  16. Article
  17. Article
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  19. Effectiveness of a parent "buddy" program for mothers of very preterm infants in a neonatal intensive care unit.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2003
    Article
  20. Determination of the clinical importance of study results.Journal of general internal medicine · 2002
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

K B ChanClinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Ont.
M Man-Son-Hing
F J Molnar
A Laupacis

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe interpretation of the results of randomized controlled trials (RCTs) has traditionally emphasized statistical significance rather than clinical importance. Our aim was to assess the quality of reporting of factors related to clinical importance in a sample of published RCTs.

methodsA random sample of 27 (of a total of 266) RCTs published in 5 major medical journals over a 1-year period were reviewed by 4 independent reviewers for factors considered important in the interpretation of the clinical importance of study results: identification of a clearly defined primary outcome, reporting of the expected difference between groups used in the calculation of sample size (the delta value) and whether it was based on the minimal clinically important difference of the intervention, the statistical significance of the results, presentation of pertinent confidence intervals, and the authors' interpretation of the clinical importance of the results.

resultsTwenty-two of 27 (81%) articles explicitly reported a single primary outcome. Of the 20 articles that included a sample size calculation, 18 (90%) reported a delta value. Two of the 18 (11%) articles explicitly stated that the delta value was chosen to reflect the minimal clinically important difference of the intervention. For the primary outcomes, confidence intervals surrounding the point estimates of the efficacy of the interventions were reported in 11 of 27 (41%) studies. The study results were interpreted from the perspective of clinical importance in 20 of 27 (74%) of the articles. Of these 20 reports, 5 (25%) provided justification for their clinical interpretation of the results.

interpretationAuthors of RCTs published in major general medical and internal medicine journals do not consistently provide their own interpretation of the clinical importance of their results, and they often do not provide sufficient information to allow readers to make their own interpretation.

Indexed as

Periodicals as TopicPublishingRandomized Controlled Trials as Topic

Identifiers

PMID11706908
PMCPMC81581

What OpenQuestion holds

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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.