Clinical Practice Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Mar 18, 2018; 9(3): 41-49
Published online Mar 18, 2018. doi: 10.5312/wjo.v9.i3.41
Establishing minimum clinically important difference values for the Patient-Reported Outcomes Measurement Information System Physical Function, hip disability and osteoarthritis outcome score for joint reconstruction, and knee injury and osteoarthritis outcome score for joint reconstruction in orthopaedics
Man Hung, Jerry Bounsanga, Maren W Voss, Charles L Saltzman
Man Hung, Jerry Bounsanga, Maren W Voss, Charles L Saltzman, Department of Orthopaedic Surgery Operations, University of Utah, Salt Lake City, UT 84108, United States
Man Hung, Division of Public Health, University of Utah, Salt Lake City, UT 84108, United States
Man Hung, Population Health Research Foundation, University of Utah, Salt Lake City, UT 84112, United States
Author contributions: Hung M was instrumental in study design, data collection, data processing, data analysis, interpretation, study oversight, literature review, manuscript writing and editing; Bounsanga J was instrumental in data processing, data analysis, manuscript writing and editing; Voss MW was instrumental in literature review, data analysis, manuscript writing and editing; Saltzman CL was instrumental in study design, data collection, interpretation and manuscript editing.
Supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, No. U01AR067138. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Institutional review board statement: Institutional review board approval/waiver was obtained through the University of Utah, IRB #00053404.
Informed consent statement: Study participants completed PRO measures as part of the standard of care in treatment.
Conflict-of-interest statement: The authors have no conflicts of interest to disclose.
Data sharing statement: The dataset analyzed during the current study is not publicly available due to HIPAA regulations but may be available from the University of Utah if the requestor has obtained proper IRB approval from the University of Utah and its Enterprise Data Warehouse.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Man Hung, PhD, Associate Professor, Department of Orthopaedic Surgery Operations, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108, United States. man.hung@hsc.utah.edu
Telephone: +1-801-5875372 Fax: +1-801-5875411
Received: January 4, 2018
Peer-review started: January 4, 2018
First decision: January 23, 2018
Revised: January 30, 2018
Accepted: February 6, 2018
Article in press: February 6, 2018
Published online: March 18, 2018
Processing time: 70 Days and 15.4 Hours
ARTICLE HIGHLIGHTS
Research background

Newly developed patient-reported outcomes have many advantages, but require further studies, including establishing minimum clinically important difference (MCID) values. Determining the MCID for the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS® PF) will be useful for orthopaedic clinical practice and it is helpful to understand the MCID in the context of previously used measures like the hip disability and osteoarthritis outcome score for joint reconstruction (HOOS JR), and the knee injury and osteoarthritis outcome score for joint reconstruction (KOOS JR), Anchor-based and distribution-based methods can both be used to determine MCID.

Research motivation

New instruments require studies to inform their score interpretation. Because of the lack of consensus on MCID methods, a comprehensive approach was taken, using both anchor- and distribution-based methods at multiple levels of precision and multiple follow-up time points. Cross verification of MCID values using powerful triangulation methods allow researchers and clinicians to understand the complexity of MCID evaluation and conscientiously select the most appropriate one for themselves.

Research objectives

To determine MCIDs for the PROMIS PF, HOOS JR and KOOS JR in a general joint orthopaedic patient population applying comprehensive methods.

Research methods

Consecutively enrolled patients aged 18 and older from a large academic orthopaedic joint clinic completed PROs at their first clinic visit and at follow-up points from 3-mo to 6-mo and beyond. These patients also completed an anchor question that queried how much their physical function had improved since their first clinic visit. They were grouped into change and no-change categories. Anchor-based analyses looked at mean change scores and the receiver operating curve to maximize the best cut-off based on sensitivity and specificity. Distribution-based analyses looked at the standard deviation, and minimum detectable change.

Research results

There were 2226 patients who participated with a mean age of 61.16 (SD = 12.84) years, 41.6% male, and 89.7% Caucasian. Mean change ranged from 7.29 to 8.41 for the PROMIS® PF CAT; from 14.81 to 19.68 for the HOOS JR; and from 14.51 to 18.85 for the KOOS JR. ROC cut-offs ranged from 1.97-8.18 for the PF CAT, 6.33-43.36 for the HOOS JR, and 2.21-8.16 for the KOOS JR. Distribution-based methods estimated MCID values ranging from 2.45 to 21.55 for the PROMIS® PF CAT; from 3.90 to 43.61 for the HOOS JR; and from 3.98 to 40.67 for the KOOS JR. The median MCID value in the range was similar to the mean change score for each measure and was 7.9 for the PF CAT, 18.0 for the HOOS JR, and 15.1 for the KOOS JR.

Research conclusions

Overall this study identified a large range of MCIDs for the PROMIS® PF, HOOS JR, and KOOS JR in an orthopaedic sample of patients with joint ailments. This range reflects the comprehensive strategies applied to determine MCIDs at varying levels of precision and cut off standards. The range of MCIDs presented in this study can be incorporated into decision making to guide treatment recommendations, compute sample size for research studies and clinical trials, and conduct respondent analyses.

Research perspectives

Decisions on which MCID value to select or which MCID value is useful should be based on an individual’s personal value and belief. Future research direction should focus on investigation of MCIDs with a more diverse demographic sample and to link MCIDs with baseline scores using Rasch-based methods.