Yin Ting Cheung1, Yu Lee Foo2, Maung Shwe2, Yee Pin Tan3, Gilbert Fan3, Wei Sean Yong4, Preetha Madhukumar4, Wei Seong Ooi5, Wen Yee Chay5, Rebecca A Dent6, Soo Fan Ang5, Soo Kien Lo5, Yoon Sim Yap5, Raymond Ng6, Alexandre Chan7. 1. 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. 2. Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543. 3. Department of Psychosocial Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. 4. Department of Surgical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. 5. Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. 6. Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610; Department of Clinical Sciences, Duke-NUS Graduate Medical School Singapore, 8 College Road Singapore 169857. 7. 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. Electronic address: phaac@nus.edu.sg.
Abstract
OBJECTIVES: This 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 SETTING: Breast 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). RESULTS: There 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). CONCLUSION: The 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.
OBJECTIVES: This 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 cancerpatients' perceived cognitive deterioration. STUDY DESIGN AND SETTING:Breast cancerpatients (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). RESULTS: There 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). CONCLUSION: The 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.
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