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

NCT03013166 | Completed

• 1 other identifier: SHP617-701
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (3)

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

  4 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 issues

  4 months

Study Arms (4)

Cohort 1

IR hydrocortisone

Other: Corticosteroid medication

Cohort 2

IR prednisolone

Other: Corticosteroid medication

Cohort 3

MR hydrocortisone

Other: Corticosteroid medication

Cohort 4

IR to MR hydrocortisone

Other: Corticosteroid medication

Interventions

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in the THIN database who have a Read code for AI and have been prescribed either IR hydrocortisone or prednisolone or MR hydrocortisone (plenadren) between 2010 and the date of data extraction will be included

You may qualify if:

• 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.

You may not qualify if:

• )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.

Sponsors & Collaborators

• Shire: lead

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: January 6, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 3, 2021

Record last verified: 2021-05