Minimal clinically important difference in patients who underwent decompression alone for lumbar degenerative disease |
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| Institution: | 1. Department of Orthopaedic Surgery, Faculty of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan;2. University of Tokyo Spine Group (UTSG), 7-3-1, Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan;3. Department of Spine and Orthopedic Surgery, Japanese Red Cross Medical Center, 4-2, Hiroo, Shibuya-Ku, Tokyo 150-8935, Japan;4. Department of Orthopedic Surgery, Kanto Rosai Hospital, 1-1, Kizukisumiyoshi-Cho, Nakahaha-Ku, Kawasaki City, Kanagawa 211-8510, Japan;5. Department of Orthopedic Surgery, Yokohama Rosai Hospital, 3211, Kozukue-Cho, Kohoku-Ku, Yokohama City, Kanagawa 222-0036, Japan;6. Spine center, Toranomon Hospital, 2-2-2, Toranomon, Minato-Ku, Tokyo 105-8470, Japan;7. Department of Spinal Surgery, Japan Community Health-care Organization Tokyo Shinjuku Medical Center, 5-1, Tsukudo-Cho, Shinjuku-Ku, Tokyo 162-8543, Japan;8. Department of Orthopedic Surgery, Japanese Red Cross Musashino Hospital, 1-26-1, Kyonancho, Musashino City, Tokyo 180-0023, Japan;9. Department of Orthopedic Surgery, Saitama Red Cross Hospital, 1-5, Shintoshin, Chuo-Ku, Saitama City, Saitama 330-8553, Japan;1. Department of Orthopaedic Surgery, National University Hospital, 1E Kent Ridge Road, NUHS Tower Block Level 11, Singapore 119228;2. National University of Singapore Engineering Programme (NUSTEP), Department of Orthopedic Surgery, Yong Loo Lin School of Medicine, National University of Singapore (NUS), 10 Medical Dr, Singapore 117597;3. Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore (NUS), 10 Medical Dr, Singapore 117597;4. Institute of Medical Biology (IMB), Agency for Science, Technology and Research (A*STAR), 8a Biomedical Grove, Singapore 138648;5. Bruker Singapore Pte Ltd, Singapore, 30 Biopolis St, Singapore 138671;1. Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA 22908, USA;2. Department of Anesthesiology, Shengjing hospital, China Medical University, Shenyang, China;3. Department of Orthopaedic Surgery, Chaoyang Hospital, Capital Medical School, Beijing, China;4. Department of Biochemistry and Molecular Genetics, University of Virginia, Charlottesville, VA 22908, USA;5. Department of Medicine and Center for Immunity, Inflammation, and Regenerative Medicine, University of Virginia, Charlottesville, VA 22908, USA;6. Department of Biomedical Engineering, University of Virginia, Charlottesville, VA 22904, USA;1. Department of Orthopedic Surgery, Osaka Medical and Pharmaceutical University, 2-7, Daigakumachi, Takatsuki, Osaka 569-8686, Japan;2. Department of Anatomy and Cell Biology, Osaka Medical and Pharmaceutical University, 2-7, Daigakumachi, Takatsuki, Osaka 569-8686, Japan;1. School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan;2. Department of Orthopedics and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan;3. Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan;4. Institute of Statistics, National Yang Ming Chiao Tung University, Hsinchu, Taiwan;5. Institute of Data Science and Engineering, National Yang Ming Chiao Tung University, Hsinchu, Taiwan;6. Program of Artificial Intelligence and Information Security, Fu Jen Catholic University, New Taipei City, Taiwan;1. Department of Orthopaedic Surgery – Orthopaedic Oncology Service, Massachusetts General Hospital – Harvard Medical School, Yawkey 3A, 55 Fruit St, Boston, MA 02114, USA;2. Division of Musculoskeletal Imaging and Intervention, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Yawkey 6E, 55 Fruit St, Boston, MA 02114, USA;1. Aerospace Medicine and Rehabilitation Laboratory, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, United Kingdom;2. School of Health Sciences and Social Work, Griffith University, Nathan Campus, Brisbane, Australia;3. Northwestern University, Feinberg School of Medicine Department of Physical Therapy and Human Movement Sciences, Chicago, IL, USA;4. Northern Sydney Local Health District and The University of Sydney, Faculty of Medicine and Health, The Kolling Institute Sydney, Australia;5. Northwestern University, McCormick School of Engineering, Department of Biomedical Engineering, Evanston, IL, USA;6. Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany;7. NIHR Oxford Biomedical Research Center, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom;8. Center for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom;9. The University of Queensland, NHMRC Center for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Sciences, Brisbane, Australia;10. Space Medicine Team (HRE-OM), European Astronaut Center, Cologne, Germany;11. KBR GmbH, Cologne, Germany |
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| Abstract: | Background ContextThe minimal clinically important difference (MCID) represents the smallest change in an outcome measure recognized as clinically meaningful to a patient after receiving a clinical intervention. Most studies that discussed the MCIDs for lumbar spinal stenosis (LSS) included mixed pathologies or procedures despite that the MCID value should be different depending on the intervention. Moreover, despite the efficacy of adopting percentage-change improvement for the MCID threshold, there are limited reports and discussions in the field of lumbar surgery.PurposeThe aim of the present study was to elucidate the MCIDs for the Oswestry Disability Index (ODI), EuroQOL 5-dimension 3-level (EQ-5D-3L), physical component summary (PCS) of the Short Form of the Medical Outcomes Study, and Numeric Rating Scale (NRS) in patients with degenerative LSS treated with decompression surgery without fusion.Study Design/SettingA multicenter retrospective cohort study was performed.Patient SampleA total of 422 patients who underwent decompression surgery for LSS and answered a complete set of questionnaires were included in the study. Patients who underwent endoscopic or revision surgery were excluded.Outcome MeasuresPreoperative and 1-year postoperative scores of each health-related quality of life questionnaires (HRQOLs) and patient satisfaction questionnaire responseMethodsThe patient satisfaction question was used as an anchor, and the cutoff values were estimated based on absolute point improvement from baseline using a receiver-operating characteristic (ROC) curve analysis and the “mean change” method for MCIDs. The MCID values for percentage-change in HRQOLs were also calculated using ROC curve analysis. The three cutoff values for each HRQOL were validated using the Youden index for determining the most robust MCIDs.ResultsOf the patients, 356 (84.4%) were at least “somewhat satisfied” with the treatment results. The two cutoff values of absolute point-change in each HRQOL, which were estimated by two different anchor-based methods, were similar. The area under the curve of the ROC curve for percentage-change tended to be higher than that for absolute point-change. Moreover, the Youden index of the percentage-change in each HRQOL was higher than that of the absolute point-change calculated by either the “mean change” method or the ROC curve analysis. Based on these results, it was proposed that MCID was 42.4% for percentage-change in ODI, 22.0% for EQ-5D-3L, 13.7% for PCS, 25.0% for NRS (low back pain), 55.6% for NRS (leg pain), 22.2% for NRS (leg numbness).ConclusionsThe MCIDs of HRQOLs were calculated in patients with LSS treated with decompression surgery without concomitant fusion procedure. The MCID cutoffs based on percentage-change from baseline were more effective than those of absolute point-change. |
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