Substantial Inconsistency and Variability Exists Among Minimum Clinically Important Differences for Shoulder Arthroplasty Outcomes: A Systematic Review

Abstract

Background As the value of patient-reported outcomes becomes increasingly recognized, minimum clinically important difference (MCID) thresholds have seen greater use in shoulder arthroplasty. However, MCIDs are unique to certain populations, and variation in the modes of calculation in this field may be of concern. With the growing utilization of MCIDs within the field and value-based care models, a detailed appraisal of the appropriateness of MCID use in the literature is necessary and has not been systematically reviewed. Questions/purposes We performed a systematic review of MCID quantification in existing studies on shoulder arthroplasty to answer the following questions: (1) What is the range of values reported for the MCID in commonly used shoulder arthroplasty patient-reported outcome measures (PROMs)? (2) What percentage of studies use previously existing MCIDs versus calculating a new MCID? (3) What techniques for calculating the MCID were used in studies where a new MCID was calculated? Methods The Embase, PubMed, and Ovid/MEDLINE databases were queried from December 2008 through December 2020 for total shoulder arthroplasty and reverse total shoulder arthroplasty articles reporting an MCID value for various PROMs. Two reviewers (DAK, MAM) independently screened articles for eligibility, specifically identifying articles that reported MCID values for PROMs after shoulder arthroplasty, and extracted data for analysis. Each study was classified into two categories: those referencing a previously defined MCID and those using a newly calculated MCID. Methods for determining the MCID for each study and the variability of reported MCIDs for each PROM were recorded. The number of patients, age, gender, BMI, length of follow-up, surgical indications, and surgical type were extracted for each article. Forty-three articles (16,408 patients) with a mean (range) follow-up of 20 months (0.75 to 68) met the inclusion criteria. The median (range) BMI of patients was 29.3 kg/m 2 (28.0 to 32.2 kg/m 2 ), and the median (range) age was 68 years (53 to 84). There were 17 unique PROMs with MCID values. Of the 112 MCIDs reported, the most common PROMs with MCIDs were the American One of the authors (AJ) certifies receipt of personal payments or benefits, during the study period, in an amount of less than USD 10,000 from DJO Global; in an amount of less than USD 10,000 from Ignite Orthopedics; in an amount of less than USD 10,000 from DePuy Synthes. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request. Ethical approval for this study was not sought.

Substantial clinical benefit values demonstrate a high degree of variability when stratified by time and geographic region

“…The MCID values have been shown to be highly variable between previous publications. 12 It is likely that Patient Acceptable Symptomatic State values are variable as well; however, further study is warranted to make this conclusion. This study included those who “met” surgical expectations for pain relief in the substantially improved group with the assumption that patients’ surgical expectations are likely a significant improvement in their preoperative pain.…”

“…Interestingly, a systematic review by Kolin et al found similar heterogeneity previously reported MCID values for shoulder arthroplasty outcome measurements. 12 …”

Responsiveness and minimal clinically important difference of EQ-5D-5L in patients with coronary heart disease after percutaneous coronary intervention: A longitudinal study

“…The MCID values may vary according to disease, interventions, and baseline characteristics, including socio-demographic and clinical characteristics; therefore, MCID may vary by gender, education level, type of CHD, and different comorbidities in this study ( 47 , 70 ). In particular, studies found that the prognosis of male patients with CHD after PCI was better than that of female patients; the mortality, incidence of major adverse cardiovascular events, and bleeding events after PCI in female patients were higher than those in male patients; and the health status (such as HRQoL, mental health) of female patients after PCI was worse than that of male patients ( 71–73 ).…”

CORR Insights®: Substantial Inconsistency and Variability Exists Among Minimum Clinically Important Differences for Shoulder Arthroplasty Outcomes: A Systematic Review

“…In this month’s Clinical Orthopaedics and Related Research ® , Kolin et al [4] systematically reviewed 43 studies on the use of the MCID to assess the outcomes of total shoulder arthroplasty. They aimed to closely evaluate how MCIDs were used and reported, and to determine whether there was any meaningful consistency.…”