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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03013166
Enrollment
3000
Registered
2017-01-06
Start date
2016-09-01
Completion date
2016-12-01
Last updated
2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency

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.

Interventions

OTHERCorticosteroid medication

Patients will be grouped into Cohort 1 (IR hydrocortisone), cohort 2 (IR prednisolone), cohort 3 (MR hydrocortisone), or cohort 4 (IR to MR hydrocortisone) depending on which oral corticosteroid medications were received during the observation period.

Sponsors

Shire
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Primary care resource use per year in all patients as measured by using number of primary care contacts4 months
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 issues4 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026