• Yin Ting Cheung, Yu Lee Foo, Maung Shwe, Yee Pin Tan, Gilbert Fan, Wei Sean Yong, Preetha Madhukumar, Wei Seong Ooi, Wen Yee Chay, Rebecca A Dent, Soo Fan Ang, Soo Kien Lo, Yoon Sim Yap, Raymond Ng, and Alexandre Chan.
• Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543; Department of Pharmacy, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610.
• J Clin Epidemiol. 2014 Jul 1;67(7):811-20.

ObjectivesThis is the first reported study to determine the minimal clinically important difference (MCID) of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), a validated subjective neuropsychological instrument designed to evaluate cancer patients' perceived cognitive deterioration.Study Design And SettingBreast cancer patients (n = 220) completed FACT-Cog and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) at baseline and at least 3 months later. Anchor-based approach used the validated EORTC-QLQ-C30-Cognitive Functioning scale (EORTC-CF) as the anchor for patients who showed minimal deterioration and a receiver operating characteristic (ROC) curve to identify the optimal MCID cutoff for deterioration. Distribution-based approach used one-third standard deviation (SD), half SD, and one standard error of measurement (SEM) of the total FACT-Cog score (148 points).ResultsThere was a moderate correlation between changes in FACT-Cog and EORTC-CF scores (r = 0.43; P < 0.001). The EORTC-CF-anchored MCID was 9.6 points (95% confidence interval: 4.4, 14.8). The MCID from the ROC method was 7.5 points (area under the curve: 0.75; sensitivity: 75.6%; specificity: 68.8%). For the distribution-based approach, the MCIDs corresponding to one-third SD, half SD, and one SEM were 6.9, 10.3, and 10.6 points, respectively. Combining the approaches, the MCID identified for FACT-Cog ranged from 6.9 to 10.6 points (4.7-7.2% of the total score).ConclusionThe estimates of 6.9-10.6 points as MCID can facilitate the interpretation of patient-reported cognitive deterioration and sample size estimates in future studies.Copyright © 2014 Elsevier Inc. All rights reserved.

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