Parathyroid Assessment of Symptoms French Version

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients [Срок оценки: 4 weeks]

Вторичные конечные точки (6)

• Reliability of the PAS.fr score [Срок оценки: 4 weeks]
• Content validity to demonstrate the relevance of the French translation compared to the original version of the PAS.fr [Срок оценки: 4 weeks]
• Discriminant validity to show that the PAS.fr score is significantly correlated with biological values impacted by PHPT and specific to PHPT [Срок оценки: 4 weeks]
• Discriminant validity by comparing PAS.fr scores to those of a control population of patients who do not have PHPT [Срок оценки: 4 weeks]
• Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations [Срок оценки: 4 weeks]
• Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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).
• 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), or seen in post-operative consultation following a cholecystectomy or appendectomy for simple appendicitis, who have not experienced post-operative complications
• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Nantes University Hospital — Nantes

Идентификаторы

NCT: NCT06450431 · RC24_0151 · 2024-A00618-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗