Developing a COPD Case Finding Methodology for Primary Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Current smokers<br>Current smokers (>10 pk yrs.) | |
| Ex-smokers<br>Ex-smokers with a history of >10 pk yrs | |
| Never-smokers<br>Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Case Finding Tool |  | 24 months |