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Precision Implementation of Minimal Erythema Dose (MED) Testing to Assess Individual Variation in Human Inflammatory Response

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The minimal detectable change cannot reliably replace the minimal important difference.

Dan Turner¹, Holger J Schünemann, Lauren E Griffith

¹Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, Jerusalem 91031, Israel. turnerjd2001@walla.com

Journal of Clinical Epidemiology

|October 6, 2009

Summary

This summary is machine-generated.

This study compared the minimal important difference (MID) with the minimal detectable change (MDC) for quality-of-life instruments and disease-activity indices. Distribution-based methods for MDC showed variability, suggesting they should temporarily substitute for anchor-based MID values.

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Area of Science:

Health Outcomes Research
Psychometrics
Clinical Trial Methodology

Background:

Determining the minimal important difference (MID) and minimal detectable change (MDC) is crucial for interpreting changes in patient-reported outcomes and disease activity indices.
Distribution-based methods are commonly used to estimate MDC, but their relationship with anchor-based MID is not fully understood.

Purpose of the Study:

To compare the minimal important difference (MID) with the minimal detectable change (MDC) estimated using distribution-based methods.
To evaluate the performance of various distribution-based strategies in estimating MID and MDC for different types of instruments.

Main Methods:

Longitudinal data from two quality-of-life instruments (Chronic Respiratory Questionnaire [CRQ] and Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ]) and two physician-rated disease-activity indices (Pediatric Ulcerative Colitis Activity Index [PUCAI] and Pediatric Crohn's Disease Activity Index [PCDAI]) were analyzed.
MID values were derived from global ratings of change using receiver-operating characteristic (ROC) curves and mean change.
Five distribution-based methods were employed to calculate MDC and compared against the MID estimates.

Main Results:

The 95% limits of agreement and reliable change index produced the largest MDC estimates.
For patient-rated instruments, 0.5 standard deviation (SD) and 1 standard error of measurement (SEM) generally fell between mean change and ROC estimates.
The reliable change index most closely approximated the MID for moderate changes in physician-rated indices.

Conclusions:

For patient-rated instruments, 0.5 SD and 1 SEM are closest to anchor-based MID for small changes.
The reliable change index is closest to anchor-based MID for moderate changes in physician-rated indices.
The inconsistency across measures highlights that distribution-based methods should be temporary substitutes for empirically established anchor-based MID values.