A first step to assess harm and benefit in clinical trials in one scale

Boers, Maarten, Brooks, Peter, Fries, James F., Simon, Lee S., Strand, Vibeke and Tugwell, Peter (2010) A first step to assess harm and benefit in clinical trials in one scale. Journal of Clinical Epidemiology, 63 6: 627-632. doi:10.1016/j.jclinepi.2009.07.002

Author Boers, Maarten
Brooks, Peter
Fries, James F.
Simon, Lee S.
Strand, Vibeke
Tugwell, Peter
Title A first step to assess harm and benefit in clinical trials in one scale
Journal name Journal of Clinical Epidemiology   Check publisher's open access policy
ISSN 1878-5921
Publication date 2010-06
Year available 2009
Sub-type Article (original research)
DOI 10.1016/j.jclinepi.2009.07.002
Volume 63
Issue 6
Start page 627
End page 632
Total pages 6
Place of publication Philadelphia, PA, United States
Publisher Elsevier
Collection year 2011
Language eng
Formatted abstract
To develop a simple system to assess benefit and harm of treatment on a single scale. Harm and benefit signals from trials need to be placed in the proper perspective to decide on the value of a treatment. Several systems have been developed for assessment, but few attempt to incorporate both benefit and risk in the same metric while retaining enough simplicity to aid patients and clinicians in their decision making.

Study Design and Setting

We designed a very simple 3 × 3 table (Outcome Measures in Rheumatology [OMERACT] 3 × 3) that comprises three ranks for both beneficial and harm outcomes: for benefit, these are “none,” “substantial,” and “(near) remission”; for harm, these are “none,” “severe,” and “(near) death.” Patients are ranked both for benefit and harm and subsequently counted in a 3 × 3 table.


The system was feasible when applied to one trial dataset (patient-level information) and a meta-analysis. To become applicable as a tool, several issues need to be resolved in further development, especially the definitions and cutoffs for the ranks.


A simple 3 × 3 table to rank both benefit and harm outcomes is feasible. For rheumatology this will be further developed in the context of the OMERACT initiative.
Keyword Benefit
Outcome assessment
Benefit risk assessment
Drug treatment
Clinical trial
Clinical pharmacology
Clinical epidemiology
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online 1 October 2009.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Faculty of Health and Behavioural Sciences -- Publications
Official 2011 Collection
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 10 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 10 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Sun, 30 May 2010, 00:03:27 EST