A COMPREHENSIVE PARADIGM TO ESTIMATE MINIMAL CLINICALLY IMPORTANT DIFFERENCES (MCID)

Author(s)

Michael Treglia, PhD, Associate Director, Outcomes Research, Jessica Mancuso, PhD, Associate Director, Joseph Cappelleri, PhD, MPH, Director, Biostatistics, Andrew G. Bushmakin, MS, Manager, Verne Pitman, PharmD, Associate Director Pfizer Inc, Groton, CT, USA

Objective: Due to the existence of many methods for estimating MCID and a lack of consensus on choosing among the potential estimates, an integrated approach for generating a MCID change score on Patient Reported Outcomes (PRO) measures is proposed. When incorporating PRO in clinical trials, clinicians and researchers face the challenge of determining whether a mean difference on a measure is clinically important. Currently available methods for interpreting the scores on PRO measures are often classified as being either anchor-based or distribution-based. These methods may yield a variety of candidates as potential MCID estimates. However, there is no agreed method of choosing among these candidates. Methods: A strategy is proposed that integrates these two methods of MCID estimation and extends to selection among the candidate values by incorporating their natural variability and distinctions as well as the critical role of clinical judgment. The strategy consists of three steps: 1) generating multiple estimates of a MCID and corresponding confidence intervals (CIs) and range of variability; 2) integrating across the estimates from Step 1 by applying adopted normative descriptive criteria for MCID; 3) incorporating clinical judgment. An illustration of the proposed strategy is provided. Results: Across the candidate MCID values, the maximum, minimum, mean of the estimates, minimum and mean of the 80% CI lower bounds, as well as the range of variability, were selected with consideration given to clinical insight. The comprehensive paradigm resulted in a MCID estimate that integrates normative, descriptive criteria. Conclusion: The proposed paradigm serves as a unifying approach that integrates available methods for estimating a MCID for a PRO.

Conference/Value in Health Info

2008-05, ISPOR 2008, Toronto, Ontario, Canada

Value in Health, Vol. 11, No. 3 (May/June 2008)

Code

PMC39

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Multiple Diseases

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