Clinical trial NCT06450431: Parathyroid Assessment of Symptoms French Version
Official title: French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life in Primary Hyperparathyroidism
Keywords: Primary hyperparathyroidism
Parathyroidectomy
Quality of life
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was all patients consulting for PHPT in the surgery department at Nantes University Hospital during the study period:

In order to study the discriminant validity and specificity of the PAS.fr for PHPT, a control group consisting of euthyroid patients undergoing thyroidectomy for thyroid nodules will also be included.

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients
timeFrame: 4 weeks
Secondary outcomes:
measure: Reliability of the PAS.fr score
timeFrame: 4 weeks
measure: Content validity to demonstrate the relevance of the French translation compared to the original version of the PAS.fr
timeFrame: 4 weeks
measure: Discriminant validity to show that the PAS.fr score is significantly correlated with biological values impacted by PHPT and specific to PHPT
timeFrame: 4 weeks
measure: Discriminant validity by comparing PAS.fr scores to those of a control population of patients who do not have PHPT
timeFrame: 4 weeks
measure: Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations
timeFrame: 4 weeks
measure: Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: