TY - JOUR
T1 - A first step to assess harm and benefit in clinical trials in one scale
AU - Boers, Maarten
AU - Brooks, Peter
AU - Fries, James F.
AU - Simon, Lee S.
AU - Strand, Vibeke
AU - Tugwell, Peter
PY - 2010/6
Y1 - 2010/6
N2 - Objective: 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. Results: 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. Conclusion: 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.
AB - Objective: 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. Results: 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. Conclusion: 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.
KW - Benefit
KW - Benefiterisk assessment
KW - Clinical epidemiology
KW - Clinical pharmacology
KW - Clinical trial
KW - Drug treatment
KW - Harm
KW - Outcome assessment
KW - Risk
UR - http://www.scopus.com/inward/record.url?scp=77956633372&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2009.07.002
DO - 10.1016/j.jclinepi.2009.07.002
M3 - Article
C2 - 19800197
AN - SCOPUS:77956633372
SN - 0895-4356
VL - 63
SP - 627
EP - 632
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 6
ER -