NCT06450431

Parathyroid Assessment of Symptoms French Version

French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary hyperparathyroidism has been associated with an impaired quality of life. Surgery has been suggested to improve this outcome in patients with baseline quality of life impairment; however, few studies have used specific tool for quality of life assessment this pathology, none being validated in French version. The aim of this study is to validate the parathyroid assessment of symptoms (PAS) questionnaire in French language to evaluate quality of life impairment and the impact of surgery in patients with primary hyperparathyroidism.

Detailed description

Besides classic target organs of primary hyperparathyroidism (PHPT) that are the bone and kidneys, patients also present with non-specific and neurocognitive symptoms that impair quality of life (QoL). Several studies have assessed QoL in these patients and the impact of surgery, but using varied tools for QoL evaluation. While observational studies strongly suggest symptoms and QoL improvement after surgery, randomized studies with fewer included patients showed milder results. Therefore, international guidelines have not accepted QoL impairment as an indication for surgery. The reasons of these discrepancies between studies include the use of varied tools to evaluate QoL, either specific or not for this pathology. Using a specific tool for PHPT-related QoL could be more appropriate to understand the impact of surgery; however, no such questionnaire has been validated in French version up today. A specific questionnaire named the parathyroid assessment of symptoms (PAS) has been proposed by the team of J.Pasieka several years ago and has been demonstrated to specifically describe QoL impairment in PHPT based on 13 frequent non-specific symptoms. For the present study, a French version of the PAS (PAS.fr) have been created by double translation followed by a backtranslation that has been validated by the author of the original questionnaire. The aim of this study is to validate the use of PAS.fr in a French population of patients with PHPT to evaluate their QoL impairment and the impact of surgery.

Conditions

• Quality of Life in Primary Hyperparathyroidism

Interventions

Type	Name	Description
OTHER	SF-36 questionnaire French version and PAS.fr questionnaire	Patients will receive both the SF-36 questionnaire (control generic questionnaire for QoL evaluation validated in French language) and the PAS.fr questionnaire at the designated time (before surgery, 6, 12 or 36 months after surgery) during the consultation, or by mail. For concurrent validation of the PAS.fr questionnaire, a second questionnaire will be sent to the patients 2-4 weeks thereafter.

Timeline

• Start date: 2024-06-15
• Primary completion: 2025-12-15
• Completion: 2026-01-15
• First posted: 2024-06-10
• Last updated: 2024-06-18

Locations

1 site across 1 country: France