A Study on the Use of Healthcare Resources and Costs of Attention Deficit Hyperactivity Disorder (ADHD) in Adults in England

Healthcare Resources Utilization and Associated Costs of Adult ADHD in England

The main aim of the study is to learn about the demographic and clinical characteristics, healthcare resources utilization (HCRU) and costs associated with before and after ADHD diagnosis in England. No study medicines will be provided to participants in this study. The record available in Clinical Practice Research Datalink (CPRD) database and Hospital Episode Statistics (HES) database for ADHD participants will be assessed.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 2236

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, N19JY
    • IQVIA Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participant diagnosed with ADHD recorded between 01 January 2016 and 30 June 2018.

Description

Inclusion Criteria

1. Age greater than or equal to (>=) 18 years at the beginning of the patient observation period (that is 18-months prior to the adult ADHD diagnosis to ensure they would have been seen in adult health care services).
2. First record of an adult ADHD diagnosis between 01st January 2016 and 30th June 2018.
3. Data availability in the database at least during the 18-months before and after the index date.

Exclusion Criteria

A participant will be excluded from the study if their CPRD linked to HES electronic medical record data includes:

1. Incomplete information for key demographics (that is, missing age or sex).
2. Clinical history of a diagnosis of ADHD during childhood or adolescence.
3. Prescription of a licensed adult ADHD medication (that is, methylphenidate, lisdexamfetamine, dexamfetamine, atomoxetine) during the pre-index period.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participant With ADHD; The record available for ADHD participants in primary care-based electronic medical records in the CPRD database linked to secondary care based episodic claims data available in HES database will be assessed.	Other: No intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of General Practitioner (GP) Appointments	Number of GP appointments will be reported.	Up to approximately 36 months
Number of Referrals to Psychiatrist	Number of referrals to psychiatrist will be reported.	Up to approximately 36 months
Number of Referrals by Specialist	Number of referrals by specialist will be reported.	Up to approximately 36 months
Number of Outpatient Visits by Specialist	Number of outpatient visits by specialist will be reported.	Up to approximately 36 months
Number of Investigations Undergone	Number and type of investigations undergone will be reported.	Up to approximately 36 months
Number of Accident and Emergency Visits	Number of accident and emergency visits will be reported.	Up to approximately 36 months
Number of Reasons for Admission	Number of reasons for admission will be reported.	Up to approximately 36 months
Number of Inpatient Hospitalizations	Number of inpatient hospitalizations will be reported.	Up to approximately 36 months
Length of Stay in Hospital	Length of stay in hospital will be reported.	Up to approximately 36 months
Total Healthcare Costs	Health care cost includes prescription costs, primary health care consultations, investigations, hospital admissions, and outpatient appointments.	Up to approximately 36 months
Number of Participants Prescribed With Pharmacological Treatments	Number of participants prescribed with pharmacological treatment will be reported.	Up to approximately 36 months
Number of Participants Received Non-Pharmacological Treatments	The number of participants who received non-pharmacological treatments will be reported.	Up to approximately 36 months
Number of Participants Received Non-Pharmacological Therapy	The non-pharmacological therapy will be cognitive behavioural therapy. Number of participants who received non-pharmacological therapy will be reported.	Up to approximately 36 months

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: TAK-489-4005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No