BACKGROUND CONTEXT: The minimal clinically important difference (MCID) is defined as the smallest change in an outcome that a patient would perceive as meaningful. The Initiative on Methods, Measurement and Assessment in Clinical Trials (IMMPACT) group proposed defining the MCID as a 30% improvement in self-reported pain or function. However, this MCID threshold has not been validated against an objective physical measure. PURPOSE: To test the validity of the IMMPACT-based MCID threshold, using an objective physical measure as an external anchor. STUDY DESIGN/ SETTING: Prospective study of chronic disabling occupational lumbar disorder (CDOLD) patients completing a functional restoration program. PATIENT SAMPLE: A consecutive cohort of 743 CDOLD patients. OUTCOME MEASURES: Self-report measures of pain-related function were compared with an objective lifting measure, the progressive isoinertial lifting evaluation (PILE), obtained after treatment. METHODS: The association between reporting 30% or greater improvement (the IMMPACT's MCID key criterion) and the PILE score after treatment was assessed. RESULTS: A 30% or greater improvement on the self-report measures was significantly associated with improvement in physical function on the PILE task. CONCLUSIONS: Despite extensive use of the MCID to evaluate effects of treatment in spinal disorders, this is the first empirical documentation of the validity of the IMMPACT's 30% change criterion compared with an objective physical anchor.
BACKGROUND CONTEXT: The minimal clinically important difference (MCID) is defined as the smallest change in an outcome that a patient would perceive as meaningful. The Initiative on Methods, Measurement and Assessment in Clinical Trials (IMMPACT) group proposed defining the MCID as a 30% improvement in self-reported pain or function. However, this MCID threshold has not been validated against an objective physical measure. PURPOSE: To test the validity of the IMMPACT-based MCID threshold, using an objective physical measure as an external anchor. STUDY DESIGN/ SETTING: Prospective study of chronic disabling occupational lumbar disorder (CDOLD) patients completing a functional restoration program. PATIENT SAMPLE: A consecutive cohort of 743 CDOLD patients. OUTCOME MEASURES: Self-report measures of pain-related function were compared with an objective lifting measure, the progressive isoinertial lifting evaluation (PILE), obtained after treatment. METHODS: The association between reporting 30% or greater improvement (the IMMPACT's MCID key criterion) and the PILE score after treatment was assessed. RESULTS: A 30% or greater improvement on the self-report measures was significantly associated with improvement in physical function on the PILE task. CONCLUSIONS: Despite extensive use of the MCID to evaluate effects of treatment in spinal disorders, this is the first empirical documentation of the validity of the IMMPACT's 30% change criterion compared with an objective physical anchor.
Authors: X Wu; J Liu; L G Tanadini; D P Lammertse; A R Blight; John L K Kramer; G Scivoletto; L Jones; S Kirshblum; R Abel; J Fawcett; E Field-Fote; J Guest; B Levinson; D Maier; K Tansey; N Weidner; W G Tetzlaff; T Hothorn; A Curt; J D Steeves Journal: Spinal Cord Date: 2014-12-16 Impact factor: 2.772
Authors: Fabíola Costa; Dora Janela; Maria Molinos; Robert G Moulder; Jorge Lains; Virgílio Bento; Justin Scheer; Vijay Yanamadala; Fernando Dias Correia; Steven P Cohen Journal: J Pain Res Date: 2022-07-03 Impact factor: 2.832