Consortium for the Lifespan Examination of ADHD Registry (CLEAR)
Study: An International, Longitudinal, Observational Study of
Individuals with Attention-Deficit/Hyperactivity Disorder (ADHD)

Naturalistic data regarding the course and burden of ADHD, collected in a
global longitudinal registry is essential
to inform clinicians, health care regulatory agencies, health care payers, and
patients about the disease. The
collection of observational data in a scientifically designed registry allows
for multiple real-world comparison of
clinical, patient-reported process of care and cost outcomes without many of
the constraints of clinical trial
designs. As a result, registry data is more representative of the target
patient population than data collected in
controlled study environments and is often more helpful in understanding the
life course and longitudinal impacts
of a disease.

The overall objectives of CLEAR are to improve our global understanding of the
longitudinal impact of
attention-deficit/hyperactivity disorder (ADHD) and contribute to the body of
scientific evidence regarding the
treatment and evolution of ADHD over the life course by addressing critical
gaps in our current understanding
with prospective data from a scientifically rigorous study. Treatment patterns
and outcomes, burden of illness
(patient rated health outcomes), and costs associated with ADHD and its
treatment will be examined.
Multiple study questions, rather than hypotheses, will be addressed over the
course of the study. Genetic factors
involved in ADHD will also be examined in subsequent years as appropriate
scientific questions are formulated.
The 10 study questions which will be initially addressed are the following:
1. What is the course of ADHD across the lifespan for:
a. Treatment outcomes (patient and physician/clinician reported)?
b. Attitudes about ADHD/treatment?
c. Treatment patterns?
d. ADHD status (severity, symptoms, impairments, co-morbidities)?

2. What is the impact of diagnosis and/or treatment (type of treatment, length
of treatment) in childhood for
adult ADHD parameters?

3. What are the consequences of treatment (type and length of treatment) in
ADHD?
a. Patient-reported treatment outcomes (Quality of Life [QoL], disability, etc.)
b. ADHD status (severity, symptoms, impairments, co-morbidities)?

4. What are the short- and long-term treatment patterns (eg, switching, on/off
pattern, etc.) for ADHD?
a. How can they be classified?
b. What are the factors (both patient and disease) which explain these patterns
(eg, reasons for switching,
non treatment)?

5. What are the differences between ADHD treatments?
a. Compliance (reasons for, rates)
b. Patient-reported treatment outcomes (QoL, disability)
c. Patient characteristics
d. ADHD status (severity, symptoms, impairments, co-morbidities)?

6. What is the relationship between disease severity and:
a. Treatment outcomes (patient and physician/clinician reported)?
b. Treatment patterns?
c. Treatment type?
d. Patient characteristics?

7. Is there increased risk of substance abuse, disruptive behavior, or
intentional self harm that can be attributed
specifically to the disease itself after adjusting for other relevant factors
(co-morbid conditions, treatments) in
ADHD? What are the patient factors that increase or decrease these risks (eg,
pharmacotherapy,
misdiagnosis of ADHD, history of prior substance abuse, etc.)?

8. What are the costs associated with ADHD?
a. From the payer perspective (direct medical, social)?
b. From the patient perspective?
c. Is there a cost offset for treatment?

9. How do physicians/clinicians and countries differ regarding:
a. How patient is identified and diagnosed?
b. Reasons for treatment vs. non-treatment?
c. Time from diagnosis to treatment; reasons for delay of treatment?
d. Types of treatment and reasons for choice?
e. Assessments used to track patient status?
f. Treatment differences for newly diagnosed vs. ongoing treatment?
g. Perspective on abuse potential of treatments?

10. What is the relationship between ADHD status (symptom severity) and costs?
Does a decrease in symptoms
translate into a decrease in costs?

CLEAR is a prospective, observational registry of persons with ADHD. Physicians
and other healthcare clinicians appropriately trained and licensed to conduct
activities related to the management and treatment of ADHD, including
protocol-required assessment measures, will identify/enroll previously and
newly diagnosed ADHD patients. There will be at least 3 types of sites across 5
countries for the registry: primary care practices, psychiatry practices, and
educational institutions* health care centers. Additionally, other appropriate
institutions (as applicable per country) may be considered for inclusion.

To better understand genetic factors involved in ADHD, voluntary saliva samples
may be collected in order to research the association of specific genes and
ADHD. Samples may be collected upon screening/enrollment or at a later regular
clinic visit. After the Screening/Enrollment Visit, patient data will be
collected independently of physician/clinician visits by the Contract Research
Organization (CRO) using either a web-based interface or computer assisted
telephone interview (CATI). Patient data collected by the CRO will only be
shared with their physician/clinician with patient consent, with the exception
of notification of at-risk suicidal behavior/ideation as defined in the
protocol. Physician/clinician-reported data will be collected through medical
record abstraction to a web-based interface. Sites will be monitored for data
quality assurance and adverse drug reactions (ADRs) for Shire marketed products
and prescription ADHD products (ie, labeled for use in ADHD) will be captured.

See also section E9 and E9a of the ABR form.