Parathyroid Assessment of Symptoms French Version (PAS_fr)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Quality of Life in Primary Hyperparathyroidism

Treatments: Other: SF-36 questionnaire French version and PAS.fr questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06450431

RC24_0151

2024-A00618-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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 elevated PTH (> 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/sent with the study information sheet. If the patient returns the questionnaires, it will be considered that they are not opposed to participating in the study).

2. Control Patients

   • Adult patients
   • Patients consulting for thyroid surgery for benign thyroid nodules with normal thyroid 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/sent with the study information sheet. If the patient returns the questionnaires, it will be considered that they are not opposed to participating in the study).

Exclusion criteria

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

Trial design

750 participants in 5 patient groups

Control group

Description:

Patients attempting surgical consultation for thyroid nodule, with no history of PHPT.

Treatment:

Other: SF-36 questionnaire French version and PAS.fr questionnaire

PHPT before surgery group

Description:

Patients attempting surgical consultation for PHPT.

Treatment:

Other: SF-36 questionnaire French version and PAS.fr questionnaire

PHPT 6 months after surgery group

Description:

Patients operated for PHPT interrogated 6 months after surgery

Treatment:

Other: SF-36 questionnaire French version and PAS.fr questionnaire

PHPT 12 months after surgery group

Description:

Patients operated for PHPT interrogated 12 months after surgery

Treatment:

Other: SF-36 questionnaire French version and PAS.fr questionnaire

PHPT 36 months after surgery group

Description:

Patients operated for PHPT interrogated 36 months after surgery

Treatment:

Other: SF-36 questionnaire French version and PAS.fr questionnaire