NCT03013166已完成不适用
Resource Use and Clinical Outcomes in Patients With Adrenal Insufficiency Prescribed Either an Immediate Release or Modified Release Hydrocortisone Formulation or Prednisolone: A THIN (The Health Improvement Network) Database Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 3,000
- 主要终点
- Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)
研究概览
简要总结
To describe clinical outcomes and both primary and secondary care health care resource use in patients who have been prescribed either immediate-release (IR) hydrocortisone or modified-release (MR) hydrocortisone or prednisolone in the UK.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1 (IR hydrocortisone): All patients with a Read code for AI and a prescription of IR hydrocortisone between 2010 and data extraction but no prescription for MR hydrocortisone at any time during this period, and no earlier prescription for IR prednisolone during this period
- •Cohort 2 (IR prednisolone): All patients with a Read code for AI and a prescription of IR prednisolone between 2010 and data extraction but no prescription for MR prednisolone at any time during this period, and no earlier prescription for IR prednisolone during this period
- •Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription of MR hydrocortisone between 2010 and data extraction
- •Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have switched from IR to MR hydrocortisone.
- •A list of pre-defined READ codes will be used to identify all patients with primary or secondary AI or CAH in the THIN database.
排除标准
- •Patients who have not received a prescription of hydrocortisone or prednisolone in the past five years will be excluded as the aim of the study is to describe recent experience.
结局指标
主要结局
Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)
时间窗: 4 months
Primary care resource use per year in all patients as measured by number of sick notes issues
时间窗: 4 months
Primary care resource use per year in all patients as measured by using number of primary care contacts
时间窗: 4 months
次要结局
未报告次要终点
研究者
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