PMID- 24656406 OWN - NLM STAT- MEDLINE DCOM- 20140829 LR - 20181202 IS - 1878-5921 (Electronic) IS - 0895-4356 (Linking) VI - 67 IP - 7 DP - 2014 Jul TI - Minimal clinically important difference (MCID) for the functional assessment of cancer therapy: cognitive function (FACT-Cog) in breast cancer patients. PG - 811-20 LID - S0895-4356(14)00005-5 [pii] LID - 10.1016/j.jclinepi.2013.12.011 [doi] AB - 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. CI - Copyright (c) 2014 Elsevier Inc. All rights reserved. FAU - Cheung, Yin Ting AU - Cheung YT AD - 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. FAU - Foo, Yu Lee AU - Foo YL AD - Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543. FAU - Shwe, Maung AU - Shwe M AD - Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543. FAU - Tan, Yee Pin AU - Tan YP AD - Department of Psychosocial Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Fan, Gilbert AU - Fan G AD - Department of Psychosocial Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Yong, Wei Sean AU - Yong WS AD - Department of Surgical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Madhukumar, Preetha AU - Madhukumar P AD - Department of Surgical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Ooi, Wei Seong AU - Ooi WS AD - Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Chay, Wen Yee AU - Chay WY AD - Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Dent, Rebecca A AU - Dent RA AD - 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. FAU - Ang, Soo Fan AU - Ang SF AD - Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Lo, Soo Kien AU - Lo SK AD - Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Yap, Yoon Sim AU - Yap YS AD - Department of Medical Oncology, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 169610. FAU - Ng, Raymond AU - Ng R AD - 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. FAU - Chan, Alexandre AU - Chan A AD - 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. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20140318 PL - United States TA - J Clin Epidemiol JT - Journal of clinical epidemiology JID - 8801383 SB - IM MH - Adult MH - Breast Neoplasms/*psychology/*therapy MH - Cognition/*physiology MH - Cognition Disorders/*diagnosis MH - Female MH - Humans MH - Longitudinal Studies MH - Middle Aged MH - Prospective Studies MH - Quality of Life MH - ROC Curve MH - Self Report/standards MH - Surveys and Questionnaires OTO - NOTNLM OT - Breast cancer OT - Chemotherapy OT - Cognitive function OT - FACT-Cog OT - Minimal clinically important difference OT - Quality of life EDAT- 2014/03/25 06:00 MHDA- 2014/08/30 06:00 CRDT- 2014/03/25 06:00 PHST- 2013/08/12 00:00 [received] PHST- 2013/12/03 00:00 [revised] PHST- 2013/12/18 00:00 [accepted] PHST- 2014/03/25 06:00 [entrez] PHST- 2014/03/25 06:00 [pubmed] PHST- 2014/08/30 06:00 [medline] AID - S0895-4356(14)00005-5 [pii] AID - 10.1016/j.jclinepi.2013.12.011 [doi] PST - ppublish SO - J Clin Epidemiol. 2014 Jul;67(7):811-20. doi: 10.1016/j.jclinepi.2013.12.011. Epub 2014 Mar 18.