The minimal clinically important difference of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and upper extremity computer adaptive tests and QuickDASH in the setting of elbow trauma

Dustin J Randall; Yue Zhang; Andrew P Harris; Yuqing Qiu; Haojia Li; Andrew R Stephens; Nikolas H Kazmers

doi:10.1016/j.jseint.2021.06.005

The minimal clinically important difference of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and upper extremity computer adaptive tests and QuickDASH in the setting of elbow trauma

JSES Int. 2021 Aug 8;5(6):1132-1138. doi: 10.1016/j.jseint.2021.06.005. eCollection 2021 Nov.

Authors

Dustin J Randall^{1

2}, Yue Zhang³, Andrew P Harris⁴, Yuqing Qiu⁵, Haojia Li³, Andrew R Stephens¹, Nikolas H Kazmers¹

Affiliations

¹ Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA.
² Oakland University William Beaumont School of Medicine, Rochester, MI, USA.
³ Division of Public Health, University of Utah, Salt Lake City, UT, USA.
⁴ University Orthopedic Surgeons, Knoxville, TN, USA.
⁵ Weill Cornell Medicine, Department of Population Health Sciences, New York, NY, USA.

Abstract

Background: Minimal clinically important difference (MCID) estimates are useful for gauging clinical relevance when interpreting changes or differences in patient-reported outcomes scores. These values are lacking in the setting of elbow trauma. Our primary purpose was to estimate the MCID of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) computer adaptive test (CAT), the PROMIS upper extremity (UE) CAT, and the QuickDASH using an anchor-based approach for patients recovering from elbow trauma and related surgeries. Secondarily, we aimed to estimate the MCID using the 1/2 standard deviation method.

Materials & methods: Adult patients undergoing treatment for isolated elbow injuries between July 2014 and April 2020 were identified at a single tertiary academic medical center. Outcomes, including the PROMIS PF CAT v1.2/2.0, PROMIS UE CAT v1.2, and QuickDASH, were collected via a tablet computer. For inclusion, baseline (6 months before injury up to 11 days postoperatively or after injury) and follow-up (11 to 150 days postoperative or after injury) PF or UE CAT scores were required, as well as a response to an anchor question querying improvement in physical function. The MCID was calculated using (1) an anchor-based approach using the difference in mean score change between anchor groups reporting "No change" and "Slightly Improved/Improved" and (2) the 1/2 standard deviation method.

Results: Of the 146 included patients, the mean age was 46 ± 18 years and 67 (46%) were women. Most patients (129 of 146 or 88%) were recovering from surgery, and the remaining 12% were recovering from nonoperatively managed fractures and/or dislocations. The mean follow-up was 157 ± 192 days. Scores for each instrument improved significantly between baseline and follow-up. Anchor-based MCID values were calculated as follows: 5.7, 4.6, and 5.3 for the PROMIS PF CAT, PROMIS UE CAT, and QuickDASH, respectively. MCID values estimated using the 1/2 standard deviation method were 4.3, 4.8, and 11.7 for the PROMIS PF CAT, PROMIS UE CAT, and QuickDASH, respectively.

Conclusions: In the setting of elbow trauma, we propose MCID ranges of 4.3 to 5.7 for the PROMIS PF CAT, 4.6 to 4.8 for the PROMIS UE CAT, and 5.3 to 11.7 for the QuickDASH. These values will provide a framework for clinical relevance when interpreting clinical outcomes studies, or powering clinical trials, for populations recovering from trauma.

Keywords: Elbow; Minimal clinically important difference (MCID); Orthopaedic/orthopedic trauma; PROMIS physical function (PF) computer adaptive test (CAT); PROMIS upper extremity (UE) computer adaptive test; QuickDash.