THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone

Completed

• Conditions: Adrenal Insufficiency
• Interventions: Other: Corticosteroid medication

• Registration Number: NCT03013166
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-10-20
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-30
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. 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
2. 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
3. Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription of MR hydrocortisone between 2010 and data extraction
4. Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have switched from IR to MR hydrocortisone.
5. 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.

Exclusion Criteria

1)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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 4	Corticosteroid medication	IR to MR hydrocortisone
Cohort 1	Corticosteroid medication	IR hydrocortisone
Cohort 2	Corticosteroid medication	IR prednisolone
Cohort 3	Corticosteroid medication	MR hydrocortisone

Primary Outcome Measures

Name	Time	Method
Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)	4 months
Primary care resource use per year in all patients as measured by number of sick notes issues	4 months
Primary care resource use per year in all patients as measured by using number of primary care contacts	4 months