Prospective study for establishing minimal clinically important differences in patients with surgery for lower extremity metastases.

ABSTRACT

BACKGROUND: The clinical relevance of patient-reported outcomes score changes is often unclear. Especially in patients undergoing surgery due to lower extremity metastases - where surgery is performed in the palliative setting and the goal is to optimize functional mobility, relieve pain and improve overall quality of life. This study assessed the minimal clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, Cancer-specific Physical Function, and Global (Physical and Mental Health) in patients treated surgically for impending or completed pathologic fractures. METHODS: Patients undergoing surgery for osseous metastasis of the lower extremity because of an impending or completed pathologic fracture were consecutively enrolled in this tertiary center study. Patients completed the three PROMIS questionnaires preoperatively (n = 56) and at postoperative follow-up (n = 33) assessment one to three months later. Of the 23 patients that did not complete the postoperative survey, 5 patients died within 1-3 months and 18 patients were alive at 3-months but did not respond or show up at their postoperative consult. Thirty-one patients (94%) of the 33 included patients reported at least minimal improvement and two patients (6.1%) no change 1-3 months after the surgery based on an anchor-based approach. RESULTS: The PROMIS MCIDs (95% confidence interval) for Pain Interference was 7.5 (3.4-12), Physical Function 4.1 (0.6-7.6), Global Physical Health 4.2 (2.0-6.6), and Global Mental Health 0.8 (-4.5-2.9). CONCLUSION: This prospective study successfully defined a MCID for PROMIS Pain Interference of 7.5 (3.4-12), PROMIS Physical Function of 4.1 (0.6-7.6), and Global Physical Health of 4.2 (2.0-6.6) in patients with (impending) pathological fractures due to osseous metastases in the lower extremity; no MCID could be established for PROMIS Global Mental Health. Defining a narrower MCID value for each subpopulation requires a large, prospective, multicenter study. Nevertheless, the provided MCID values allow guidance to clinicians to evaluate the impact of surgical treatment on a patient's QoL. LEVEL OF EVIDENCE Level II Diagnostic study.