Measurement properties of Patient-Reported Outcome Measures in patients with a tibial shaft fracture; validation study alongside the multicenter TRAVEL study

Abstract

The aim of this study was to evaluate the measurement properties of the Short Musculoskeletal Function Assessment (SMFA) and Lower Extremity Functional Scale (LEFS) in patients who sustained a tibial shaft fracture, by comparing them with the scores of a general health-related quality of life instrument scale (i.e., EuroQoL-5D).Data of 136 patients participating in a multicenter randomized controlled trial comparing incisions for intramedullary nail entry in adults with a tibial shaft fracture were used. Patients completed the SMFA, LEFS, EQ-5D and an anchor question at 2 and 6 weeks, and at 3, 6 and 12 months. Reliability (internal consistency), construct validity, responsiveness (longitudinal validity), floor and ceiling effects, minimal important change (MIC), and smallest detectable change (SDC) were determined.The SMFA and LEFS (sub)scales showed adequate internal consistency (0.84 <α< 0.94). Construct and longitudinal validity were also adequate (correctly predicted hypotheses between 83%-100%). Floor effects were not present. Ceiling effects were present at 12 months for the SMFA lower extremity dysfunction and bother subscales (22% and 19%, respectively) and the LEFS (19%). MICs could not be determined with the available data. The SDC was 13.84 points for the SMFA and 38.74 points for the LEFS.This study confirms that the SMFA and LEFS are reliable, valid, and responsive instruments for monitoring functional limitation in patients after sustaining a tibia shaft fracture during at least the first six months post-injury. An anchor-based MIC for the SMFA remains to be determined.

Enhancing the Evaluation of Physical Function Following Orthopaedic Trauma Care: Comparison of PROMIS Computerized Adaptive Testing and Short Musculoskeletal Function Assessment

“…13,15 Ceiling effects were reported to be especially pronounced (up to 35%) in populations with certain injuries and in cohorts with prolonged durations of follow-up, limiting the ability of the SMFA to detect improvement over time. [10][11][12] In terms of factors associated PROMIS CAT scores, the results showed an independent relationship between elevated levels of depression (among other factors) and worse physical function and pain interference scores. This is in accordance with growing evidence to support the critical importance of mental illness to poor outcomes in orthopaedic trauma patients.…”

“…13,15 Ceiling effects were reported to be especially pronounced (up to 35%) in populations with certain injuries and in cohorts with prolonged durations of follow-up, limiting the ability of the SMFA to detect improvement over time. 10–12…”

“…8,9 Its common use notwithstanding, the SMFA has been found to have suboptimal performance in certain patient groups and takes considerable time to complete. [10][11][12][13][14][15] This is important as "questionnaire fatigue" among patients is a common concern, particularly when PROMs use is considered in daily clinical practice.…”

Minimal Clinically Important Differences of Patient-Reported Outcomes Measurement Information System Physical Function in Patients With Tibial Shaft Fracture

“…29 To the best of authors knowledge, this is the first MCID validated for the tibial shaft population and using the PROMIS PF. Leliveld et al 30 reported various PROMs in patients with tibial shaft fracture; however, MCIDs could not be reliably reported based on their results. To overcome the lack of an MCID, past tibial shaft fracture PROM literature has used an MCID of 5 as a cutoff to evaluate the impact of clinical exposures.…”

Effect of Transverse Versus Longitudinal Incisions on Anterior Knee Pain After Tibial Nailing (TRAVEL)

“…The primary outcome measure was pain during kneeling as assessed on a numeric rating scale (NRS, 0 to 10) at 12 months. Secondary outcome measures included knee pain during 8 other daily activities (NRS 0 to 10), the Short Musculoskeletal Functional Assessment (SMFA) 16 , the Lower Extremity Functional Scale (LEFS) 16 , the EuroQol-5 Dimensions (EQ-5D), range of motion of the knee and ankle, nail prominence, scar cosmesis (5-point Likert scale), return to work and daily activities, and the occurrence of complications with associated secondary interventions. Knee pain scores during daily activities were based on patient responses and not physical performance during the outpatient clinic visit.…”