Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Feb 18, 2021; 12(2): 69-81
Published online Feb 18, 2021. doi: 10.5312/wjo.v12.i2.69
Evaluation of joint awareness after acetabular fracture: Validation of the Forgotten Joint Score according to the COSMIN checklist protocol
Viola Freigang, Johannes Weber, Karolina Mueller, Christian Pfeifer, Michael Worlicek, Volker Alt, Florian Michael Baumann
Viola Freigang, Johannes Weber, Christian Pfeifer, Michael Worlicek, Volker Alt, Florian Michael Baumann, Department of Trauma Surgery, Regensburg University Medical Center, Regensburg 93042, Germany
Karolina Mueller, Center for Clinical Studies, Regensburg University Medical Center, Regensburg 93042, Germany
Author contributions: Freigang V carried out data interpretation, performed literature research and drafted the manuscript; Weber J, Mueller K, Alt V, Pfeifer C and Worlicek M were involved in conduction of the study and significantly participated in preparation of the manuscript; Baumann FM was involved in the design, coordination, and draft of the manuscript; all authors read and approved the final version of the manuscript.
Institutional review board statement: This study was carried out in accordance with the Declaration of Helsinki and approved by the ethics committee at the University of Regensburg in December 2015 (Institutional Review Board Number 15-101-0241). We obtained written informed consent from all study participants.
Clinical trial registration statement: Center for Clinical Studies Registry at University of Regensburg. Registered 01 October 2014, Trial registration number: Z-2014-0389-10.
Informed consent statement: We obtained consent for publication from all study participants.
Conflict-of-interest statement: The authors declare that there is no conflict of interest.
Data sharing statement: The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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/
Corresponding author: Florian Michael Baumann, MD, Associate Professor, Surgeon, Department of Trauma Surgery, Regensburg University Medical Center, Franz-Josef-Strauß-Allee 11, Regensburg 93042, Germany. florian.baumann@ukr.de
Received: September 16, 2020
Peer-review started: September 16, 2020
First decision: December 1, 2020
Revised: December 14, 2020
Accepted: January 21, 2021
Article in press: January 21, 2021
Published online: February 18, 2021
ARTICLE HIGHLIGHTS
Research background

Patient-reported outcome (PRO) measurement is gaining more and more importance in clinical decision-making. Evaluation of psychometric properties of PRO tools is essential to assure validity.

Research motivation

A fracture of the acetabulum is an uncommon but serious injury. Outcome evaluation tools in patients after acetabular fractures are outdated. However, research based on large registries are dependent on valid outcome tools to allow the comparability.

Research objectives

Aim of the study was to validate the Forgotten Joint Score (FJS) according the COSMIN checklist. The FJS is a novel PRO tool to disease-specific quality of life in musculo-skeletal disorders.

Research methods

The COSMIN checklist is a standard protocol to assure methodical quality of validation studies. The COSMIN checklist consists of ten items giving recommendations for design, conduction and interpretation of medical validation studies. Relevant characteristics are study design, content validity, structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness.

Research results

We found the FJS to be a valid and reliable tool for evaluation of PRO in posttraumatic condition after an acetabular fracture. With a Cronbach’s alpha of 0.95, internal consistency of the questionnaire was good. Test-retest reliability was excellent with an ICC of 0.99. Based on the anchor variable, the smallest detectable change indicating a real clinical improvement was 8.8 points in the FJS. We could confirm responsiveness of the FJS and found no relevant floor- or ceiling effects.

Research conclusions

Clinicians are suggested to use the FJS for evaluation of PRO after fractures of the acetabulum.

Research perspectives

Further studies are needed to confirm the study results, especially concerning longitudinal data. Based on the study results, the FJS can now be used for further clinical studies on post-traumatic conditions after fractures of the acetabulum.