Copay, Anne G.

Background: The minimum clinically important difference (MCID) attempts to define the patient’s experience of treatment outcomes. Efforts at calculating the MCID have yielded multiple and inconsistent MCID values. The purposes of this review were to describe the usage of the MCID in the most recent orthopaedic literature, to explain the limitations of its current uses, and to clarify the underpinnings of the MCID calculation, so as to help practitioners to understand and utilize the MCID and to guide future efforts to calculate the MCID. In Part I of this review, we sampled the orthopaedic literature in relation to the upper extremity. In this part, Part II, of the review, we will focus on the lower-extremity literature. Methods: A review was conducted of the 2014 to 2016 MCID-related publications in The Journal of Arthroplasty, The Journal of Bone & Joint Surgery, The American Journal of Sports Medicine, Foot & Ankle International, Journal of Orthopaedic Trauma, Journal of Pediatric Orthopaedics, and Journal of Shoulder and Elbow Surgery. Only clinical science articles utilizing patient-reported outcome measures (PROMs) were included in the analysis. A keyword search was then performed to identify articles that used the MCID. Articles were then further categorized into upper-extremity and lower-extremity publications. The MCID utilization in the selected articles was characterized and was recorded. Results: The MCID was referenced in 129 (7.5%) of 1,709 clinical science articles that utilized PROMs: 79 (61.2%) of the 129 articles were related to the lower extremity; of these, 11 (13.9%) independently calculated the MCID values and 68 (86.1%) used previously published MCID values as a gauge of their own results. The MCID values were calculated or were considered for 31 PROMs, of which 24 were specific to the lower extremity. Eleven different methods were used to calculate the MCID. The MCID had a wide range of values for the same questionnaires, for instance, 5.8 to 31.3 points for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Conclusions: There are more than twice as many PROMs for the lower extremity (24) than for the upper extremity (11), confirming that the determination of useful MCID values is, in part, hampered by the proliferation of PROMs in the field of orthopaedics. The difference between significance and clinical importance needs to be further clarified. For instance, the common use of determining sample size with the MCID and comparing group means with the MCID implies that a significant result will also be clinically important. Further, the study of the MCID would benefit from consensus agreement on relevant terminology and the appropriate usage of the MCID determining equations. Clinical Relevance: MCID is increasingly used as a measure of patients’ improvement. However, MCID does not yet adequately capture the clinical importance of patients’ improvement.

Background: The minimum clinically important difference (MCID) attempts to define the patient’s experience of treatment outcomes. Efforts at calculating the MCID have yielded multiple and inconsistent MCID values. The purposes of this review were to describe the usage of the MCID in the most recent orthopaedic literature, to explain the limitations of its current uses, and to clarify the underpinnings of MCID calculation. Subsequently, we hope that the information presented here will help practitioners to better understand the MCID and to serve as a guide for future efforts to calculate the MCID. The first part of this review focuses on the upper-extremity orthopaedic literature. Part II will focus on the lower-extremity orthopaedic literature. Methods: A review was conducted of the 2014 to 2016 publications in The Journal of Arthroplasty, The Journal of Bone & Joint Surgery, The American Journal of Sports Medicine, Foot & Ankle International, Journal of Orthopaedic Trauma, Journal of Pediatric Orthopaedics, and Journal of Shoulder and Elbow Surgery . Only clinical science articles utilizing patient-reported outcome measure (PROM) scores were included in the analysis. A keyword search was then performed to identify articles that calculated or referenced the MCID. Articles were then further categorized into upper-extremity and lower-extremity publications. MCID utilization in the selected articles was subsequently characterized and recorded. Results: The MCID was referenced in 129 (7.5%) of 1,709 clinical science articles that utilized PROMs: 52 (40.3%) of 129 were related to the upper extremity, 5 (9.6%) of 52 independently calculated MCID values, and 47 (90.4%) of 52 used previously published MCID values as a gauge of their own results. MCID values were considered or calculated for 16 PROMs; 12 of these were specific to the upper extremity. Six different methods were used to calculate the MCID. Calculated MCIDs had a wide range of values for the same PROM (e.g., 8 to 36 points for Constant-Murley scores and 6.4 to 17 points for American Shoulder and Elbow Surgeons [ASES] scores). Conclusions: Determining useful MCID values remains elusive and is compounded by the proliferation of PROMs in the field of orthopaedics. The fundamentals of MCID calculation methods should be critically evaluated. If necessary, these methods should be corrected or abandoned. Furthermore, the type of change intended to be measured should be clarified: beneficial, detrimental, or small or large changes. There should also be assurance that the calculation method actually measures the intended change. Finally, the measurement error should consistently be reported. Clinical Relevance: The MCID is increasingly used as a measure of patients’ improvement. However, the MCID does not yet adequately capture the clinical importance of patients’ improvement.