Background Patient-reported outcome measures (PROMs) are frequently used to assess the impact of total knee arthroplasty (TKA) on patients. However, mere statistical comparison of PROMs is not sufficient to assess the value of TKA to the patient, especially given the risk profile of arthroplasty. Evaluation of treatment effect sizes is important to support the use of an intervention; this is often quantified with the minimum clinically important difference (MCID). MCIDs are unique to specific PROMs, as they vary by calculation methodology and study population. Therefore, a systematic review of calculated MCID values, their respective ranges, and assessment of their applications is important to guide and encourage their use as a critical measure of effect size in TKA outcomes research. Questions/purposes In this systematic review of MCID calculations and reporting in primary TKA, we asked: (1) What are the most frequently reported PROM MCIDs and their reported ranges in TKA? (2) What proportion of studies report distribution-versus anchor-based MCID values? (3) What are the most common methods by which these MCID values are derived for anchor-based values? (4) What are the most common derivation methods for distribution-based values? (5) How do the reported medians and corresponding interquartile ranges (IQR) compare between calculation methods for each PROM? Methods Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review was conducted using the PubMed, EMBASE, and MEDLINE databases from inception through March 2022 for TKA articles reporting an MCID value for any PROMs. Two independent reviewers screened articles for eligibility, including any article that calculated new MCID values for PROMs after primary TKA, and extracted these data for analysis. Overall, 576 articles were identified, 38 of which were included in the final analysis. These studies had a total of 710,128 patients with a median age of 67.7 years and median BMI of 30.9 kg/m 2 . Women made up more than 50% of patients in most studies, and the median follow-up period was 17 months (range 0.25 to 72 months). The overall risk of bias was assessed as moderate using the Jadad criteria for one randomized controlled trial (3 of 5 ideal global score) and the modified Methodological Index for Nonrandomized Studies criteria for comparative studies (mean 17.2 6 1.8) and noncomparative studies (mean 9.6 6 1.3). There were 49 unique PROMs for which 233 Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. 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.
BackgroundThe minimum clinically important difference (MCID) is intended to detect a change in a patient-reported outcome measure (PROM) large enough for a patient to appreciate. Their growing use in orthopaedic research stems from the necessity to identify a metric, other than the p value, to better assess the effect size of an outcome. Yet, given that MCIDs are population-specific and that there are multiple calculation methods, there is concern about inconsistencies. Given the increasing use of MCIDs in total hip arthroplasty (THA) research, a systematic review of calculated MCID values and their respective ranges, as well as an assessment of their applications, is important to guide and encourage their use as a critical measure of effect size in THA outcomes research.Questions/purposesWe systematically reviewed MCID calculations and reporting in current THA research to answer the following: (1) What are the most-reported PROM MCIDs in THA, and what is their range of values? (2) What proportion of studies report anchor-based versus distribution-based MCID values? (3) What are the most common methods by which anchor-based MCID values are derived? (4) What are the most common derivation methods for distribution-based MCID values? (5) How do the reported medians and corresponding ranges compare between calculation methods for each PROM?MethodsThe EMBASE, MEDLINE, and PubMed databases were systematically reviewed from inception through March 2022 for THA studies reporting an MCID value for any PROMs. Two independent authors reviewed articles for inclusion. All articles calculating new PROM MCID scores after primary THA were included for data extraction and analysis. MCID values for each PROM, MCID calculation method, number of patients, and study demographics were extracted from each article. In total, 30 articles were included. There were 45 unique PROMs for which 242 MCIDs were reported. These studies had a total of 1,000,874 patients with a median age of 64 years and median BMI of 28.7 kg/m2. Women made up 55% of patients in the total study population, and the median follow-up period was 12 months (range 0 to 77 months). The overall risk of bias was assessed as moderate using the modified Methodological Index for Nonrandomized Studies criteria for comparative studies (the mean score for comparative papers in this review was 18 of 24, with higher scores representing better study quality) and noncomparative studies (for these, the mean score was 10 of a possible 16 points, with higher scores representing higher study quality). Calculated values were classified as anchor-based, distribution-based, or not reported. MCID values for each PROM, MCID calculation method, number of patients, and study demographics were extracted from each study. Anchor-based and distribution-based MCIDs were compared for each unique PROM using a Wilcoxon rank sum test, given the non-normal distribution of values.ResultsThe Oxford Hip Score (OHS) and the Hip Injury and Osteoarthritis Score (HOOS) Pain and Quality of Life subscore M...
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