Validation of PROMIS Banks With COPD Exacerbations

This is a prospective longitudinal study of adult patients with chronic obstructive
pulmonary disease (COPD) who will be enrolled when their COPD is considered clinically
stable or during an acute exacerbation. This design will allow both within-person and
between-person comparisons by exacerbation experience. Comprehensive clinical and
patient-reported assessments will be performed at baseline and at 3 months (end of study).
Subsets of items will be administered by interactive voice response (IVR) over the course of
the study to measure changes in key symptoms over the course of recovery from an
exacerbation. A subset of patients will be interviewed at the end of the study to assess
content validity of PROMIS items in this patient population.

With such a study design, we will be able to evaluate the validity of the PROMIS items in
this patient population under acute and stable conditions and evaluate responsiveness of
several PROMIS item banks under conditions of known change in an underlying chronic disease.
We will also evaluate stability of sub-domains that are not hypothesized to change with
COPD exacerbations.

Inclusion Criteria:

- An established clinical history of COPD in accordance with the Global Initiative for
Chronic Obstructive Lung Disease (GOLD) definition: COPD is a preventable and
treatable disease with some significant extrapulmonary effects that may contribute to
the severity in individual patients. Its pulmonary component is characterized by
airflow limitation that is not fully reversible. The airflow limitation is usually
progressive and associated with an abnormal inflammatory response of the lung to
noxious particles or gases.

- A history of smoking (at least 10 pack/year history)

- Access to and able to communicate on a touch tone telephone

- Read and speak English

- Able to see and interact with a computer screen, mouse, and keyboard

- A signed and dated written informed consent prior to study participation

- For those enrolled into the exacerbation group: Treatment for an exacerbation may
have been started no more than 3 days prior to the day of enrollment for patients
recruited in the outpatient setting and no more than 6 days prior to the day of
enrollment for patients recruited in the in-patients setting.

- For those enrolled in the stable state group, the patient will be considered stable
if he or she has been exacerbation-free for a minimum of 2 months prior to
enrollment.

Exclusion Criteria:

- Any concurrent medical or psychiatric condition that may preclude participation in
this study or completion of self-administered questionnaires (e.g., moderate to
severe dementia and/or severe, uncontrolled schizophrenia, or other condition that
would render the participant unable to complete a questionnaire)

- History of asthma without co-existent COPD as the primary diagnosis

- Experiencing a current heart failure exacerbation. (A diagnosis of heart failure is
not in itself an exclusion criterion.)