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The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to:
An instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concept elicitation interviews (Step I) | Approximately 20 participants will be included. | ||
| Cognitive interviews (Step II) | Approximately 30 participants will be included. |
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| Measure | Description | Time Frame |
|---|---|---|
| List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire | Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from approximately 5 clinical sites based in the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Rob Myers, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital, Denver Health Medical Center | Aurora | Colorado | 80045 | United States | ||
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| University of Miami Miller School of Medicine - Schiff Center for Liver Diseases |
| Miami |
| Florida |
| 33136 |
| United States |
| Evidera | Bethesda | Maryland | 20814 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Organ Care Research Swedish Medical Center | Seattle | Washington | 98104 | United States |