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Minimal Clinically Important Differences of Patient Reported Outcome Information System Physical Function in Tibial Shaft Fracture Patients.
Journal of Orthopaedic Trauma 2023 March 24
OBJECTIVE: Calculate the minimal clinically important differences (MCID) of Patient Reported Outcome Information System Physical Function (PROMIS PF) scores for patients with operatively treated tibial shaft fractures.
DESIGN: Retrospective Cohort Study.
SETTING: A Level 1 trauma center.
PATIENTS: All operatively treated tibial shaft fractures identified by Current Procedural Terminology codes.
INTERVENTION: Enrolled patients treated acutely with operative fixation of their tibia.
MAIN OUTCOME MEASUREMENTS: MCID's were calculated by distribution-based and anchor-based methods, calculated from PROMIS PF scores completed at least at two-time points postoperatively. MCID's were calculated at different time points including overall, 7-12 weeks, 3-6 months, and 6-24 months. MCID's were calculated for different subgroups including open fractures, closed fractures, any complications, and no complications.
RESULTS: MCID for PROMIS PF scores was 5.7 in the distribution-based method and 7.84 (SD 18.65) in the anchor-based method. At 6-24 postoperatively, the months the distribution-based MCID was 5.95 from a postoperative baseline 27.83 (8.74) to 42.85 (9.61),P<0.001. At 6-24 months the anchor-based MCID was 10.62 with a score difference between the improvement group of 16.03 (10.73) and the no improvement group of 5.41 (15.75), P<0.001. Patients with open fractures (distribution-based 6.22 and anchor-based 8.05) and any complications (distribution-based 5.71 and anchor-based 9.29) had similar or higher MCIDs depending on the methodology used than the overall cohort MCIDs.
CONCLUSION: This study identified distribution-based MCID of 5.7 and anchor-based MCID of 7.84 calculated from PROMIS PF scores in operative tibial shaft fractures. Distribution-based methods yielded smaller MCIDs than anchor-based methods. These MCID scores provide a standard to compare clinical and investigational outcomes.
LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.
DESIGN: Retrospective Cohort Study.
SETTING: A Level 1 trauma center.
PATIENTS: All operatively treated tibial shaft fractures identified by Current Procedural Terminology codes.
INTERVENTION: Enrolled patients treated acutely with operative fixation of their tibia.
MAIN OUTCOME MEASUREMENTS: MCID's were calculated by distribution-based and anchor-based methods, calculated from PROMIS PF scores completed at least at two-time points postoperatively. MCID's were calculated at different time points including overall, 7-12 weeks, 3-6 months, and 6-24 months. MCID's were calculated for different subgroups including open fractures, closed fractures, any complications, and no complications.
RESULTS: MCID for PROMIS PF scores was 5.7 in the distribution-based method and 7.84 (SD 18.65) in the anchor-based method. At 6-24 postoperatively, the months the distribution-based MCID was 5.95 from a postoperative baseline 27.83 (8.74) to 42.85 (9.61),P<0.001. At 6-24 months the anchor-based MCID was 10.62 with a score difference between the improvement group of 16.03 (10.73) and the no improvement group of 5.41 (15.75), P<0.001. Patients with open fractures (distribution-based 6.22 and anchor-based 8.05) and any complications (distribution-based 5.71 and anchor-based 9.29) had similar or higher MCIDs depending on the methodology used than the overall cohort MCIDs.
CONCLUSION: This study identified distribution-based MCID of 5.7 and anchor-based MCID of 7.84 calculated from PROMIS PF scores in operative tibial shaft fractures. Distribution-based methods yielded smaller MCIDs than anchor-based methods. These MCID scores provide a standard to compare clinical and investigational outcomes.
LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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