Factors influencing the quality of clinical trials on traditional Chinese medicine—Qualitative interviews with trial auditors, clinicians and academic researchers

Abstract

Multi-institutional data describing remedial parathyroidectomy compared with index parathyroidectomy are scarce.Using data in the Collaborative Endocrine Surgery Quality Improvement Program (2014–2017), baseline characteristics and outcomes of patients undergoing remedial parathyroidectomy versus index parathyroidectomy were examined using bivariate and multivariate methods. Rates of hypercalcemia and hypocalcemia at ≥ 180 days were assessed.Among 6,795 patients, 367 (5.4%) underwent remedial parathyroidectomy. A single localization study was done in 24.8% versus 26.9% of remedial parathyroidectomy versus index parathyroidectomy (P = .37). Patients undergoing remedial parathyroidectomy had higher rates of preoperative laryngoscopy (45.5% versus 6.2%, P < .001), intraoperative nerve monitoring (57.5% versus 34.5%, P < .001), and < 50% drop in hyperparathyroidism than those undergoing index parathyroidectomy (9.6% versus 3.3%, P < .001). Among patients with ≥ 180 days follow-up, none of the remedial parathyroidectomy versus three index parathyroidectomy patients (0.3%) had vocal cord dysfunction. Hypercalcemia rates for remedial parathyroidectomy and index parathyroidectomy were 10.5% versus 5.0 (P = .07), and hypocalcemia rates were 10.5% versus 2.4% (P < .001). After multivariate adjustment, failure to cure was 4.0 times more likely in remedial parathyroidectomy than index parathyroidectomy (P < .001).This is the first multi-institutional examination of remedial parathyroidectomy outcomes in the Collaborative Endocrine Surgery Quality Improvement Program. Nerve injury rates are low; high rates of hypercalcemia and hypocalcemia suggest potential opportunities to refine the preoperative and intraoperative management of patients undergoing remedial parathyroidectomy.