Evidence map›Paper›PMID 12133163›Full record

ReviewJournal of general internal medicine2002

Determination of the clinical importance of study results.

Malcolm Man-Son-Hing, Andreas Laupacis, Keith O'Rourke, Frank J Molnar, Jeffery Mahon, Karen B Y Chan, George Wells

Registry-linked trialAbstract readReview
In one paragraph

Review in Journal of general internal medicine, 2002. 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 65 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 10 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

65 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  3. The effects of transcranial magnetic stimulation in motor symptoms of Parkinson's disease: an overview of systematic reviews with meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Pooled it
  4. Heterogeneity in measurement of NIHSS: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Pooled it
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  18. Reporting of second-generationContemporary clinical trials communications · 2026
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5 more citing papers are in PubMed but not listed here.

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

7 authors.

Malcolm Man-Son-HingReceived from the Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, Ottawa, Canada. mhing@ottawahospital.on.ca
Andreas Laupacis
Keith O'Rourke
Frank J Molnar
Jeffery Mahon
Karen B Y Chan
George Wells

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Formal statistical methods for analyzing clinical trial data are widely accepted by the medical community. Unfortunately, the interpretation and reporting of trial results from the perspective of clinical importance has not received similar emphasis. This imbalance promotes the historical tendency to consider clinical trial results that are statistically significant as also clinically important, and conversely, those with statistically insignificant results as being clinically unimportant. In this paper, we review the present state of knowledge in the determination of the clinical importance of study results. This work also provides a simple, systematic method for determining the clinical importance of study results. It uses the relationship between the point estimate of the treatment effect (with its associated confidence interval) and the estimate of the smallest treatment effect that would lead to a change in a patient's management. The possible benefits of this approach include enabling clinicians to more easily interpret the results of clinical trials from a clinical perspective, and promoting a more rational approach to the design of prospective clinical trials.

Indexed as

Data Interpretation, StatisticalHumansPatient CareResearch

Identifiers

PMID12133163
PMCPMC1495062

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.