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

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.

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Key information

Conditions

Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

Treatment and study plan

Corticosteroid medication

Other

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.

Primary outcomes

Primary care resource use per year in all patients as measured by using number of primary care contacts

Time frame: 4 months
Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)

Time frame: 4 months
Primary care resource use per year in all patients as measured by number of sick notes issues

Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jan 6, 2017
Registry last updated: Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed