Parathyroid Assessment of Symptoms French Version

Phase

N/A

Condition

Hyperparathyroidism

Treatment

SF-36 questionnaire French version and PAS.fr questionnaire

Clinical Study ID

NCT06450431

RC24_0151

2024-A00618-39

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with PHPT

Adult patients
Patients with PHPT, whether operated on or not, defined by a calcium level > 2.60 mmol/L with inappropriate PTH (> 15 pg/mL) or normal calcium with elevatedPTH (> 65 pg/mL) before surgery.
Consulting for PHPT surgery, or at 6, 12, or 36 months post-surgery.
Not opposed to participating in the study (questionnaires will be provided/sentwith the study information sheet. If the patient returns the questionnaires, itwill be considered that they are not opposed to participating in the study).

Control Patients

Adult patients
Patients consulting for thyroid surgery for benign thyroid nodules with normalthyroid function (serum TSH between 0.4 and 4.0 mIU/L) and no hypercalcemia (calcium ≤ 2.6 mmol/L).
Not opposed to participating in the study (questionnaires will be provided/sentwith the study information sheet. If the patient returns the questionnaires, itwill be considered that they are not opposed to participating in the study).

Exclusion

Exclusion Criteria:

Pregnant women at the time of completing the questionnaires (the child's parathyroidglands can influence the mother's parathyroid status).
Minors or protected patients (under guardianship/curatorship).
Patients with secondary/tertiary hyperparathyroidism (defined by hypocalcemia < 2.0mmol/L with elevated PTH, or hypercalcemia with elevated PTH with a history ofkidney transplantation, respectively).

Study Design

SF-36 questionnaire French version and PAS.fr questionnaire

June 15, 2024

January 15, 2026

Study 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.

Connect with a study center

Nantes University Hospital
Nantes, Loire-Atlantique 44093
France
Active - Recruiting

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