Dependence of the minimal clinically important improvement on the baseline value is a consequence of floor and ceiling effects and not different expectations by patients.

Abstract:

OBJECTIVE:Estimates of minimal clinically important improvements (MCIIs) are larger among patients with higher values at baseline, suggesting that these patients require larger changes to appreciate improvements. We examined if baseline dependency of MCIIs was associated with specific patients across three measures, or was owing to floor and ceiling effects. STUDY DESIGN AND SETTING:We prospectively examined 250 outpatients with active rheumatoid arthritis (RA). We used an anchor-based approach to estimate MCIIs for three measures of RA activity (patient global assessment, swollen joint count, and walking time). We examined if the same patients constituted the baseline subgroups with high MCIIs across measures. RESULTS:The MCIIs were greater for those with higher baseline values of all three measures. At the ceiling, there was little opportunity to improve, and judgments were unrelated to measured changes. At midrange, improvements were balanced by worsenings, including some judged as improvements. At the floor, improvements were not similarly balanced. Patients in subgroups with high MCII for patient global assessment were not also predominantly in subgroups with high MCII for the swollen joint count or walking time, and vice versa. CONCLUSION:Variation in MCII by baseline values is because of floor and ceiling effects rather than expectations of particular patients.

journal_name

J Clin Epidemiol

authors

Ward MM,Guthrie LC,Alba M

doi

10.1016/j.jclinepi.2013.10.025

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

689-96

issue

6

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(13)00478-2

journal_volume

67

pub_type

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