Parathyroid Assessment of Symptoms French Version
- Conditions
- Interventions
- Registration Number
- NCT06450431
- Lead Sponsor
- Nantes University Hospital
- 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 ...
- 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...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
-
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).
- 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).
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PHPT 12 months after surgery group SF-36 questionnaire French version and PAS.fr questionnaire Patients operated for PHPT interrogated 12 months after surgery PHPT before surgery group SF-36 questionnaire French version and PAS.fr questionnaire Patients attempting surgical consultation for PHPT. PHPT 36 months after surgery group SF-36 questionnaire French version and PAS.fr questionnaire Patients operated for PHPT interrogated 36 months after surgery Control group SF-36 questionnaire French version and PAS.fr questionnaire Patients attempting surgical consultation for thyroid nodule, with no history of PHPT. PHPT 6 months after surgery group SF-36 questionnaire French version and PAS.fr questionnaire Patients operated for PHPT interrogated 6 months after surgery
- Primary Outcome Measures
Name Time Method Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients 4 weeks The unidimensionality of the 13 items of the PAS.fr questionnaire will be determined based on their suitability for a confirmatory factor analysis (CFA). Suitability will be judged based on the suitability coefficients RMSEA, TLI and CFI. The adequation will be judged acceptable if RMSEA\<0.08, CFI\>0.9 and TLI\>0.9 and will be judged good if RMSEA\<0.05, CF...
- Secondary Outcome Measures
Name Time Method Reliability of the PAS.fr score 4 weeks Reliability measured by Cronbach's alpha coefficient and McDonald's Omega coefficient. Reliability will be considered acceptable if these coefficients are greater than 0.7 and good if they are greater than 0.8.
Content validity to demonstrate the relevance of the French translation compared to the original version of the PAS.fr 4 weeks Content validity: qualitative validation by the author of the original PAS questionnaire after back-translation of the PAS.fr questionnaire.
Discriminant validity to show that the PAS.fr score is significantly correlated with biological values impacted by PHPT and specific to PHPT 4 weeks Discriminant validation: Spearman correlation between the PAS.fr score and measurements of PTH, calcium, and urinary calcium. Moderate to strong correlations (\>0.4) are expected between these values.
Discriminant validity by comparing PAS.fr scores to those of a control population of patients who do not have PHPT 4 weeks Discriminant validation: ANOVA to show differences in PAS.fr scores between HPT1 patients and other patients (control group consisting of patients consulting for thyroidectomy for thyroid nodule (euthyroid)).
Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations 4 weeks Discriminant validation: ANOVA to show differences in the mean PAS.fr scores between a group of HPT1 patients with clinical manifestations (bone involvement defined by the presence of fractures and/or a T-score \< -2.5 on bone densitometry and renal involvement defined by the presence of kidney stones \< 10 years and/or a glomerular filtration rate \< 60 mL/...
Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days 4 weeks Concurrent validation: Spearman correlation coefficients between the PAS.fr score and SF-36 quality of life scores. Weak to moderate positive correlations (\>0.2) are expected. - Reproducibility: Intraclass correlation coefficients between PAS.fr scores obtained from two closely timed administrations of the questionnaire (2-3 weeks apart).
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, Loire-Atlantique, France