PMID- 31845032 OWN - NLM STAT- MEDLINE DCOM- 20210615 LR - 20210615 IS - 1432-0932 (Electronic) IS - 0940-6719 (Linking) VI - 29 IP - 6 DP - 2020 Jun TI - Validity of the Japanese Core Outcome Measures Index (COMI)-Back for thoracic and lumbar spine surgery: a prospective cohort study. PG - 1435-1444 LID - 10.1007/s00586-019-06249-x [doi] AB - PURPOSE: To investigate the psychometric properties of the Japanese version of the Core Outcome Measures Index-Back (COMI-Back), only recently published according to the established linguistic and cultural conversion guidelines, in patients undergoing spine surgery. METHODS: We recruited 145 patients who underwent thoracic or lumbar spine surgery in one of the five specific tertiary care institutions. They were asked to complete a booklet questionnaire (the COMI-Back, the Numerical Rating Scale for pain, the Short Form-12, Euro-QOL-5 dimensions, and Oswestry Disability Index) at baseline and 12 months postoperatively to investigate floor/ceiling effect, construct validity, and postoperative responsiveness. The patients were also asked to answer an anchor question (Global Treatment Outcome) to analyze the minimum clinically important difference (MCID) by receiver operating characteristics curves. Of the 145 patients, 112 completed the study. Another group of 59 volunteers with chronic symptoms completed the questionnaire twice within a 7-14-day interval for the test-retest reproducibility. RESULTS: The COMI summary score displayed no notable floor or ceiling effects. Except for symptom-specific well-being, the individual COMI domains and the COMI summary score correlated as expected with the scores of the chosen reference measures (rho = 0.4-0.8). A similar trend was observed between the pre-/postoperative changes in the COMI score and those in the reference measures. The MCID for the COMI summary score was 2.5. The intraclass correlation coefficient and minimum detectable change (MDC95%) were 0.93 and 1.26, respectively. CONCLUSION: The Japanese COMI-Back was a reliable and responsive questionnaire in our Japanese patients undergoing thoracic/lumbar spine surgery. These slides can be retrieved under Electronic Supplementary Material. FAU - Nagata, Kosei AU - Nagata K AD - Department of Orthopaedic Surgery and Spinal Surgery, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Oshima, Yasushi AU - Oshima Y AD - Department of Orthopaedic Surgery and Spinal Surgery, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Nakamoto, Hideki AU - Nakamoto H AD - Department of Orthopaedic Surgery and Spinal Surgery, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Sakamoto, Ryuji AU - Sakamoto R AD - Department of Orthopedic Surgery, Yokohama Rosai Hospital, 3211 Kozukue-Cho, Kohoku-Ku, Yokohama, Kanagawa, 222-0036, Japan. FAU - Ohtomo, Nozomu AU - Ohtomo N AD - Department of Spine and Orthopedic Surgery, Japanese Red Cross Medical Center, 4-1-22 Hiroo, Shibuya-ku, Tokyo, 150-8935, Japan. FAU - Izuka, Masaaki AU - Izuka M AD - Department of Spine Surgery, Japan Community Health-care Organization Tokyo Shinjuku Medical Center, 5-1, Tsukudo-cho, Shinjuku-ku, Tokyo, 162-8453, Japan. FAU - Nakajima, Koji AU - Nakajima K AD - Department of Orthopedic Surgery, Kanto Rosai Hospital, 1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Kanagawa, 211-8510, Japan. FAU - Yoshimoto, Takahiko AU - Yoshimoto T AD - Department of Hygiene, Public Health and Preventive Medicine, Showa University School of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Fujii, Tomoko AU - Fujii T AD - Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Matsudaira, Ko AU - Matsudaira K AD - Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Tanaka, Sakae AU - Tanaka S AD - Department of Orthopaedic Surgery and Spinal Surgery, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. FAU - Oka, Hiroyuki AU - Oka H AD - Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. okah-tky@umin.ac.jp. LA - eng PT - Journal Article DEP - 20191216 PL - Germany TA - Eur Spine J JT - European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society JID - 9301980 SB - IM MH - *Disability Evaluation MH - Humans MH - Japan MH - Outcome Assessment, Health Care MH - Pain Measurement MH - Prospective Studies MH - *Quality of Life MH - Reproducibility of Results MH - Surveys and Questionnaires OTO - NOTNLM OT - COMI OT - Japanese OT - Minimum clinically important difference OT - Psychometric property OT - Thoracic/lumbar spine surgery EDAT- 2019/12/18 06:00 MHDA- 2021/06/16 06:00 CRDT- 2019/12/18 06:00 PHST- 2019/03/17 00:00 [received] PHST- 2019/12/08 00:00 [accepted] PHST- 2019/10/30 00:00 [revised] PHST- 2019/12/18 06:00 [pubmed] PHST- 2021/06/16 06:00 [medline] PHST- 2019/12/18 06:00 [entrez] AID - 10.1007/s00586-019-06249-x [pii] AID - 10.1007/s00586-019-06249-x [doi] PST - ppublish SO - Eur Spine J. 2020 Jun;29(6):1435-1444. doi: 10.1007/s00586-019-06249-x. Epub 2019 Dec 16.