title: Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.
abstract: METHODS
  .: Prospective observational 1-year study.
  
  
  OBJECTIVE
  .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient.
  
  
  BACKGROUND
  .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined.
  
  
  METHODS
  .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach.
  
  
  RESULTS
  .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively.
  
  
  CONCLUSIONS
  .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients.
  
  
  METHODS
  3.
authors: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
authors: Ki Byung
authors: KB
authors: Park
authors: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
authors: Joon-Shik
authors: JS
authors: Shin
authors: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
authors: Jinho
authors: J
authors: Lee
authors: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
authors: Yoon Jae
authors: YJ
authors: Lee
authors: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
authors: Me-Riong
authors: MR
authors: Kim
authors: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.|Korean Medicine Life Science, University of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors: Jun-Hwan
authors: JH
authors: Lee
authors: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors: Kyung-Min
authors: KM
authors: Shin
authors: Spine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.|Department of Korean Rehabilitation Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
authors: Byung-Cheul
authors: BC
authors: Shin
authors: Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors: Jae-Heung
authors: JH
authors: Cho
authors: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
authors: In-Hyuk
authors: IH
authors: Ha
mesh_terms: D000328:Adult; D000529:Complementary Therapies; D004185:Disability Evaluation; D055111:Failed Back Surgery Syndrome / Q000175:diagnosis* / Q000628:therapy*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007866:Leg; D017116:Low Back Pain / Q000175:diagnosis* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis; D059408:Pain Management; D010147:Pain Measurement / Q000379:methods*; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome