Nantes University Hospital
Nantes, Loire-Atlantique, 44093, France
Location status: Recruiting
Location contact
Eric MIRALLIE, PHD
CONTACT
Eric MIRALLIE, PHD
PRINCIPAL_INVESTIGATOR
Samuel Frey, PHD
SUB_INVESTIGATOR
NCT Number: NCT06450431
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nantes, Loire-Atlantique, 44093, France
Location status: Recruiting
Eric MIRALLIE, PHD
CONTACT
Eric MIRALLIE, PHD
PRINCIPAL_INVESTIGATOR
Samuel Frey, PHD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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, CFI>0.95 and TLI>0.95.
Time frame: 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.
Time frame: 4 weeks
Content validity: qualitative validation by the author of the original PAS questionnaire after back-translation of the PAS.fr questionnaire.
Time frame: 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.
Time frame: 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)).
Time frame: 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/min) and other patients.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Eric MIRALLIE
CONTACT
Samuel FREY
CONTACT
Nantes University Hospital
Other
French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
Acronym: PAS_fr
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