The Status of Diagnosis and Treatment of Chronic Hypoparathyroidism in Chinese Adults: a Multicenter Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 524
- 试验地点
- 7
- 主要终点
- The proportion of patients with different symptoms of HP
研究概览
简要总结
This multicenter registry study aims to understand the status of diagnosis and treatment, quality of life, medical costs and unmet medical needs of adult patients with chronic hypoparathyroidism in China.
详细描述
Hypoparathyroidism (HP) is a rare (orphan) endocrine disease with low calcium and inappropriately low circulating parathyroid hormone levels, most often in adults secondary to thyroid surgery. The present study contains four parts.
The first part is a multicenter registry study. According to our predefined search criteria determined through pilot study, all patients admitted between June 1, 2020 and May 31, 2021 will be searched from the hospital information system and patients diagnosed with HP and those with suspected HP will be retrieved. The diagnosis of all or a random sample of these patients will be reviewed by endocrinologists through medical records. Patients with a confirmed diagnosis of chronic HP will served as the study population of the first part of the study.
The second part is a multicenter hospital-based survey, to investigate the missed diagnosis, quality of life, medical costs, medical experience and unmet medical needs in adult patients with chronic HP. All local patients with definite chronic HP and those with suspected HP will be invited to participate in the hospital on-site investigation. Among them, suspected HP patients need to first undergo necessary examinations to confirm the diagnosis of HP.
The third part is the verification of the reliability and validity of two quality of life scales, the Short-Form Six-Dimension version 2 (SF-6Dv2) scale and Hypoparathyroidism Patient Experience Scale (HPES). The first 100 patients with chronic HP who participate in the on-site investigation in the Peking Union Medical College Hospital will be invited.
The fourth part is a survey on physicians about the unmet need of chronic HP. All endocrinologists from each site will be invited to take part in the survey.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Existing diagnosis of HP
排除标准
- •Age<18 at the time of screening
- •Search criteria of suspected HP:
- •Inclusion Criteria:
- •Hypocalcemia plus neck surgery
- •Hypocalcemia plus convulsions/tetany/epilepsy
- •Hypocalcemia plus PTH<upper limit, and no hypoalbuminemia
- •Hypocalcemia without any of the following conditions: neck surgery, convulsions/tetany/epilepsy, PTH testing, hypoalbuminemia, critical illness and vitamin D deficiency-related diseases.
- •Exclusion Criteria:
- •Age<18 at the time of screening
- •Diagnosis of chronic HP:
- •Inclusion Criteria:
- •Hypocalcemia (albumin adjusted total calcium < lower limit) with inappropriate reduction of serum PTH level (PTH < upper limit).
- •The course of hypoparathyroidism should be more than 6 months.
- •Inclusion Criteria:
- •Patients with chronic HP confirmed through medical records review
- •Patients with suspected HP confirmed through medical records review
- •Obtain written informed consent
- •Exclusion Criteria:
- •Non-local residents
- •Inclusion Criteria:
- •Patients with chronic HP
- •Participating in the on-site survey in the Peking Union Medical College Hospital
- •Inclusion criteria:
- •Endocrinologists involved in HP care from 7 sites
- •Obtain written informed consent
结局指标
主要结局
The proportion of patients with different symptoms of HP
时间窗: 0 day （cross-sectional）
The most common symptoms of HP include tetany, seizures, laryngospasm, numbness, blood in the urine, renal colic and vision loss.
The proportion of patients with positive Chvostek sign
时间窗: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with positive Trousseau's sign
时间窗: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with different classification of hypoparathyroidism (HP)
时间窗: 0 day （cross-sectional）
HP is classified into postsurgical and non-postsurgical HP.
The proportion of patients with abnormal corrected calcium
时间窗: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with different first-visit reasons
时间窗: 0 day （cross-sectional）
First-visit reason was excerpted from previous medical records
The proportion of patients with abnormal parathyroid hormone (PTH)
时间窗: 0 day （cross-sectional）
The situation at the time of diagnosis
The proportion of patients with abnormal 24-hour urine calcium
时间窗: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with different first-visit departments
时间窗: 0 day （cross-sectional）
First-visit department was excerpted from previous medical records
次要结局
- The proportion of patients with previous experience of misdiagnosis of HP(0 day （cross-sectional）)
- Median medical costs(0 day （cross-sectional）)
- The prevalence of chronic HP in adults visiting top hospitals in China(0 day （cross-sectional）)
- The proportion of patients with chronic HP receiving treatment(0 day （cross-sectional）)
- The mean score of Hypoparathyroidism Patient Experience Scale (HPES)(0 day （cross-sectional）)
- The mean score of Short-Form Six-Dimension version 2 (SF-6Dv2)(0 day （cross-sectional）)
- The proportion of patients with chronic HP meeting treatment targets(0 day （cross-sectional）)
- The proportion of patients with missed diagnosis of chronic HP(0 day （cross-sectional）)
- The proportion of patients with HP complications(0 day （cross-sectional）)
- The proportion of patients with different unmet medical needs(0 day （cross-sectional）)