What Are the Minimally Important Changes of Four Commonly Used Patient-reported Outcome Measures for 36 Hand and Wrist Condition-Treatment Combinations?
Authors: Hoogendam Lisa , Koopman Jaimy Emerentiana , van Kooij Yara Eline , Feitz Reinier , Hundepool Caroline Anna , Zhou Chao , Slijper Harm Pieter , Selles Ruud Willem , Wouters Robbert Maarten ,   , and the Hand-Wrist Study Group
Published: December 2021

Abstract

Background
Patient-reported outcome measures (PROMs) are frequently used to assess treatment outcomes for hand and wrist conditions. To adequately interpret these outcomes, it is important to determine whether a statistically significant change is also clinically relevant. For this purpose, the minimally important change (MIC) was developed, representing the minimal within-person change in outcome that patients perceive as a beneficial treatment effect. Prior studies demonstrated substantial differences in MICs between condition-treatment combinations, suggesting that MICs are context-specific and cannot be reliably generalized. Hence, a study providing MICs for a wide diversity of condition-treatment combinations for hand and wrist conditions will contribute to more accurate treatment evaluations.

Questions/purposes
(1) What are the MICs of the most frequently used PROMs for common condition-treatment combinations of hand and wrist conditions? (2) Do MICs vary based on the invasiveness of the treatment (nonsurgical treatment or surgical treatment)?

Methods
This study is based on data from a longitudinally maintained database of patients with hand and wrist conditions treated in one of 26 outpatient clinics in the Netherlands between November 2013 and November 2020. Patients were invited to complete several validated PROMs before treatment and at final follow-up. All patients were invited to complete the VAS for pain and hand function. Depending on the condition, patients were also invited to complete the Michigan Hand outcomes Questionnaire (MHQ) (finger and thumb conditions), the Patient-rated Wrist/Hand Evaluation (PRWHE) (wrist conditions), or the Boston Carpal Tunnel Questionnaire (BCTQ) (nerve conditions). Additionally, patients completed the validated Satisfaction with Treatment Result Questionnaire at final follow-up. Final follow-up timepoints were 3 months for nonsurgical and minor surgical treatment (including trigger finger release) and 12 months for major surgical treatment (such as trapeziectomy). Our database included 55,651 patients, of whom we excluded 1528 who only required diagnostic management, 25,099 patients who did not complete the Satisfaction with Treatment Result Questionnaire, 3509 patients with missing data in the PROM of interest at baseline or follow-up, and 1766 patients who were part of condition-treatment combinations with less than 100 patients. The final sample represented 43% (23,749) of all patients and consisted of 36 condition-treatment combinations. In this final sample, 26% (6179) of patients were managed nonsurgically and 74% (17,570) were managed surgically. Patients had a mean ± SD age of 55 ± 14 years, and 66% (15,593) of patients were women. To estimate the MIC, we used two anchor-based methods (the anchor mean change and the MIC predict method), which were triangulated afterward to obtain a single MIC. Applying this method, we calculated the MIC for 36 condition-treatment combinations, comprising 22 different conditions, and calculated the MIC for combined nonsurgical and surgical treatment groups. To examine whether the MIC differs between nonsurgical and surgical treatments, we performed a Wilcoxon signed rank test to compare the MICs of all PROM scores between nonsurgical and surgical treatment.

Results
We found a large variation in triangulated MICs between the condition-treatment combinations. For example, for nonsurgical treatment of hand OA, the MICs of VAS pain during load clustered around 10 (interquartile range 8 to 11), for wrist osteotomy/carpectomy it was around 25 (IQR 24 to 27), and for nerve decompression it was 21. Additionally, the MICs of the MHQ total score ranged from 4 (nonsurgical treatment of CMC1 OA) to 15 (trapeziectomy with LRTI and bone tunnel), for the PRWHE total score it ranged from 2 (nonsurgical treatment of STT OA) to 29 (release of first extensor compartment), and for the BCTQ Symptom Severity Scale it ranged from 0.44 (nonsurgical treatment of carpal tunnel syndrome) to 0.87 (carpal tunnel release). An overview of all MIC values is available in a freely available online application at: https://analyse.equipezorgbedrijven.nl/shiny/mic-per-treatment/. In the combined treatment groups, the triangulated MIC values were lower for nonsurgical treatment than for surgical treatment (p < 0.001). The MICs for nonsurgical treatment can be approximated to be one-ninth (IQR 0.08 to 0.13) of the scale (approximately 11 on a 100-point instrument), and surgical treatment had MICs that were approximately one-fifth (IQR 0.14 to 0.24) of the scale (approximately 19 on a 100-point instrument).

Conclusion
MICs vary between condition-treatment combinations and differ depending on the invasiveness of the intervention. Patients receiving a more invasive treatment have higher treatment expectations, may experience more discomfort from their treatment, or may feel that the investment of undergoing a more invasive treatment should yield greater improvement, leading to a different perception of what constitutes a beneficial treatment effect.

Clinical Relevance
Our findings indicate that the MIC is context-specific and may be misleading if applied inappropriately. Implementation of these condition-specific and treatment-specific MICs in clinical research allows for a better study design and to achieve more accurate treatment evaluations. Consequently, this could aid clinicians in better informing patients about the expected treatment results and facilitate shared decision-making in clinical practice. Future studies may focus on adaptive techniques to achieve individualized MICs, which may ultimately aid clinicians in selecting the optimal treatment for individual patients.