French Validation of a Specific Tool for Quality of Life Evaluation in Primary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 548
- 试验地点
- 2
- 主要终点
- Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Control group
Patients attempting surgical consultation for thyroid nodule, with no history of PHPT.
干预措施: SF-36 questionnaire French version and PAS.fr questionnaire (Other)
PHPT before surgery group
Patients attempting surgical consultation for PHPT.
干预措施: SF-36 questionnaire French version and PAS.fr questionnaire (Other)
PHPT 6 months after surgery group
Patients operated for PHPT interrogated 6 months after surgery
干预措施: SF-36 questionnaire French version and PAS.fr questionnaire (Other)
PHPT 12 months after surgery group
Patients operated for PHPT interrogated 12 months after surgery
干预措施: SF-36 questionnaire French version and PAS.fr questionnaire (Other)
PHPT 36 months after surgery group
Patients operated for PHPT interrogated 36 months after surgery
干预措施: SF-36 questionnaire French version and PAS.fr questionnaire (Other)
结局指标
主要结局
Validate the unidimensionality of the PAS.fr for assessing quality of life in PHPT patients
时间窗: 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.
次要结局
- Reliability of the PAS.fr score(4 weeks)
- Content validity to demonstrate the relevance of the French translation compared to the original version of the PAS.fr(4 weeks)
- 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 validity by comparing PAS.fr scores to those of a control population of patients who do not have PHPT(4 weeks)
- Discriminant validity to show that the PAS.fr score can distinguish HPT1 patients with different clinical manifestations(4 weeks)
- Concurrent validation with the SF-36 questionnaire - Reproducibility in stable patients over a period of 15 days(4 weeks)