Developing a COPD Case Finding Methodology for Primary Care



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:5/12/2016
Start Date:February 2013
End Date:January 2015

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A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases

The purpose of this qualitative work is to inform the content and structure of a new
screening measure for identifying undiagnosed at-risk COPD cases in primary care and support
content validity of the measure. This work will build on the results of a comprehensive
literature review and data mining analyses by identifying the symptomatic and health event
experiences of at-risk and newly diagnosed patients, as described by the patients
themselves. Specific objectives are as follows:

Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent
diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The
qualitative information obtained in these focus groups will be used to develop a new
questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.

Objective 2: To review the new questionnaire with a new set of participants with a recent
COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b)
the content of each question is appropriate and understandable to participants, (c) the
intended connotation of each questions is consistent with participants' interpretation or
assigned meaning, and (d) to assure that content is not seen as redundant across items. This
will be done through one-on-one cognitive interviews.

Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without
or with a new diagnosis of COPD and the consistency of readings between electronic and
mechanical readings in these patients. This information will be used to inform the
development of peak-flow meter instructions for use as part of the screening methodology.


Inclusion Criteria:

- 1. Age ≥40 years

- 2. Current smokers (>10 pk yrs.) or Ex-smokers with a history of >10 pk yrs. or
Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life

- 3. Stable state PFT values from within the last 12 months available or obtainable

- 4. Willing and able to attend the focus group session or cognitive interview

- 5. Able to read and speak in English

- 6. Willing and able to provide written Informed Consent

Exclusion Criteria:

- 1. Cognitive impairment, hearing or sight difficulty, or severe psychopathology that
could interfere with ability to participate in the study

- 2. Patient was hospitalized for respiratory infection within the past 30 days
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