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This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions.
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| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate that the following PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome) | The primary measures to demonstrate equivalency of electronic to paper PRO instruments are Usability and Cognitive Debriefing. Usability data is gathered using systematic observation under controlled conditions to determine how well the device may be used by subjects. Qualitative, Content Analysis of Cognitive Debriefing Data The cognitive debriefing data will be content analyzed for subject understanding of the instructions on the device used to deliver the PRO instrument. | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
• Unwilling to complete the 3 electronic PRO questionnaires or participate in an interview during completion of questionnaires
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COPD Subjects
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Vig, MS | nSpire Health | Study Director |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |