Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data.

Autor: Ibounig T; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland., Juurakko J; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Hand Surgery, Central Finland Central Hospital, Keskussairaalantie 19, 40620, Jyväskylä, Finland., Lähdeoja T; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland., Sumrein BO; Department of Orthopaedics and Traumatology, University of Tampere and Tampere University Hospital, Elämänaukio 2, 33520, Tampere, Finland., Järvinen TLN; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland., Paavola M; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland., Ardern CL; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland.; Department of Family Practice, University of British Columbia, 5950 University Boulevard, Vancouver, V6T 1Z3, Canada., Karjalainen T; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Hand Surgery, Central Finland Central Hospital, Keskussairaalantie 19, 40620, Jyväskylä, Finland., Taimela S; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland., Rämö L; Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, PL266, 00029 HUS, Helsinki, Finland. lasse.ramo@hus.fi.
Jazyk: angličtina
Zdroj: BMC medical research methodology [BMC Med Res Methodol] 2022 Nov 10; Vol. 22 (1), pp. 291. Date of Electronic Publication: 2022 Nov 10.
DOI: 10.1186/s12874-022-01776-6
Abstrakt: Background: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well.
Methods: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale.
Results: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively.
Conclusion: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture.
Trial Registration: ClinicalTrials.gov NCT01719887, first registration 01/11/2012.
(© 2022. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje