Translation and Validation of the Hypoparathyroidism Patient Experience Scales (HPES) Questionnaire in Patients With Hypoparathyroidism for Use in the Greek Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Translation and validation the HPES-Symptom and the HPES-Impact questionnaires in Greek
研究概览
简要总结
This is a crossectional study that will be conducted at several tertiary centers in Greece.
To participate in the study, patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for >12 months.
Exclusion criteria will include:
-
Patients inadequately controlled with conventional therapy:
-
corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia
-
serum P >5.5 mg/dl
-
Age >80 years
-
Presence of neoplastic disease
-
Pregnancy
-
Diagnosis of psychiatric disease or cognitive impairment
-
Participants experiencing other comorbidities that may affect QoL
-
Lack of informed consent The study will seek approval from the Ethics in Research Committee of its participating center. All participants will be informed about the objectives of the study and will sign an informed consent.
The HPES-Symptom was developed in accordance with the Food and Drug Administration guidance and best research practices for PRO measure development. The methodology used has been previously described.
The first step of the translation process requires two forward translations of the English version of the questionnaire. The translations will be done by two translators who are native speakers of the target (Greek) language and can understand the English version. Then a reconciled translation is made based on the two translations - that is, the chief investigator will review the two translations to achieve the best possible version by choosing one of the two translations or by combining them on the basis of their correctness, wording etc.
The next step requires translating the reconciled version back into English, again done by two translators who will be native speakers of English or at least will have a very good command of English.
详细描述
- Background Hypoparathyroidism (HP) is a chronic disease, characterized by hypocalcemia and hyperphosphatemia, due to low, or inappropriately normal, concentrations of parathyroid hormone (PTH). It is usually the result of remnant parathyroid tissue dysfunction, after thyroidectomy or parathyroidectomy. It is rarely due to autoimmune or genetic disorders. In contrast to other endocrine diseases, patients with HP are typically managed with conventional therapy, which includes oral calcium and active vitamin D. In patients with chronic HP who are refractory or experience intolerance to conventional therapy, replacement therapy with PTH should be considered. Despite the achievement of normal serum calcium and phosphate levels, HP may be associated with increased risk of chronic complications, such as basal ganglia calcification, cataract, nephrolithiasis, chronic kidney disease (CKD), neuropsychiatric disorders and increased mortality.
Another underestimated issue in patients with HP is impairment of quality of life (QoL) in comparison with healthy controls, as well as with patients with a history of thyroidectomy. So far, several scales to assess clinical symptoms and QoL in HP have been used, such as the Short Form-36 (SF-36, although non-specific), as well the disease-specific Hypoparathyroid Patient Questionnaire (HPQ 40/28) and the Hypoparathyroidism Patient Experience Scales (HPES), including the 17-item HPES-Symptom and the 26-item HPES-Impact tools. However, these disease-specific QoL questionnaires have not yet been translated and validated into the Greek language for patients with HP, which is essential for culturally relevant data collection and improved clinical care in this population.
The aim of the present study is to translate and validate the HPES-Symptom and the HPES-Impact questionnaires for patients with HP for use in the Greek population. 2. Study methodology
2.1 Subjects and Settings This is a cross-sectional study that will be conducted at several tertiary centers in Greece.
To participate in the study, patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for >12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for >12 months.
排除标准
- •Patients inadequately controlled with conventional therapy:
- •corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia
- •serum P >5.5 mg/dl
- •Age >80 years
- •Presence of neoplastic disease
- •Diagnosis of psychiatric disease or cognitive impairment
- •Participants experiencing other comorbidities that may affect QoL
- •Lack of informed consent
结局指标
主要结局
Translation and validation the HPES-Symptom and the HPES-Impact questionnaires in Greek
时间窗: 12 months
To translate and validate the HPES-Symptom and the HPES-Impact questionnaires for patients with chronic hypoparathyroidism for use in the Greek population
次要结局
未报告次要终点
研究者
Panagiotis Anagnostis
Assistant Professor
Aristotle University Of Thessaloniki