Parathyroid Assessment of Symptoms French Version

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
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).
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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).
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PHPT 12 months after surgery groupSF-36 questionnaire French version and PAS.fr questionnairePatients operated for PHPT interrogated 12 months after surgery
PHPT before surgery groupSF-36 questionnaire French version and PAS.fr questionnairePatients attempting surgical consultation for PHPT.
PHPT 36 months after surgery groupSF-36 questionnaire French version and PAS.fr questionnairePatients operated for PHPT interrogated 36 months after surgery
Control groupSF-36 questionnaire French version and PAS.fr questionnairePatients attempting surgical consultation for thyroid nodule, with no history of PHPT.
PHPT 6 months after surgery groupSF-36 questionnaire French version and PAS.fr questionnairePatients operated for PHPT interrogated 6 months after surgery
Primary Outcome Measures
NameTimeMethod
Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients4 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
NameTimeMethod
Reliability of the PAS.fr score4 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.fr4 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 PHPT4 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 PHPT4 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 manifestations4 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 days4 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

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Nantes, Loire-Atlantique, France

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