Validation of a novel patient-reported outcome measure for parathyroid and thyroid disease (PROMPT)

Abstract

Background: Patient-reported outcome measures are being used increasingly to assess disease severity and response to surgery. The purpose of this study was to create and validate a patient-reported outcome measure for symptoms of thyroid enlargement and hyperparathyroidism, 2 conditions where the presence of preoperative symptoms and response to surgery is often questioned.

Methods: A questionnaire reviewing common symptoms was developed from a literature review and expert opinion. Internal validity, reliability, and initial responsiveness to surgery were evaluated.

Results: Patient-Reported Outcome Measure for Parathyroid and Thyroid Disease (PROMPT) consists of 30 items: 10 compressive items and 20 hyperparathyroidism items; we evaluated 302 surveys collected over 10 months. PROMPT showed high internal consistency for compressive and hyperparathyroid constructs (Cronbach's α 0.84 and 0.95). Constructs were scored from 0-100, with greater scores corresponding to increased severity of symptoms. Preoperatively, patients with a goiter demonstrated greater compressive scores compared with other thyroid patients and hyperparathyroid patients (goiter, 47.5; nodule/other, 38.4; hyperparathyroid, 29.8; P < .0001). PROMPT demonstrated high test-retest reliability with acceptable intraclass correlation coefficients for both compressive score and hyperparathyroid score (0.840 and 0.646). Hyperparathyroid scores improved 2 weeks after (48.6 postop, 44.0 preop, P = .0470).

Conclusion: We validated a novel measure for symptoms of hyperparathyroidism and goiter. PROMPT demonstrates high internal consistency, test-retest reliability, and preliminary analysis, which suggests that it is sensitive to change after surgery.