Ulcerative Colitis Patient-Reported Outcomes (UC-PRO)

The UC-PRO Signs and Symptoms (UC-PRO/SS) measure is currently under review by the FDA as part of the FDA Qualification Program (DDT COA 000040). In addition, international health authority qualification advice was sought from the EMA and a letter of support was received.

The UC-PRO/SS is a 9-item daily diary designed to quantify the effects of treatment on patient-reported signs and symptoms of ulcerative colitis. The UC-PRO/SS includes two scales—Bowel Signs and Symptoms (6 items) and Functional Symptoms (3 items). Each scale is scored separately; there is no total score for the UC-PRO/SS.

The UC-PRO/SS uses a 24-hour recall and was designed and tested as an eDiary on a handheld device. Electronic administration is strongly recommended. The paper format was used in the cognitive interviewing phase of instrument development only and is available upon request.

The User is responsible for selecting and contracting with the ePRO vendor and ensuring that the proper licenses are in place.

The Systemic Symptoms measure includes 5 items, scored as a single scale, to address the presence and severity of systemic symptoms including pain, feeling tired, lack of appetite, feeling weak, and thirst.

The Systemic Symptoms measure uses a 24-hour recall and was designed and tested as an eDiary on a handheld device. Electronic administration is strongly recommended. The paper format was used in the cognitive interviewing phase of instrument development only and is available upon request.

The User is responsible for selecting and contracting with the ePRO vendor and ensuring that the proper licenses are in place.

The Coping Strategies measure includes 6 items, scored as a single scale, to address coping strategies such as scheduling activities, eating to control bowel movements, avoiding foods, only going out where there are toilets nearby, carrying a change of clothes, and staying home due to UC.

The Coping Strategies measure uses a 24-hour recall and was designed and tested as an eDiary on a handheld device. Electronic administration is strongly recommended. The paper format was used in the cognitive interviewing phase of instrument development only and is available upon request.

The User is responsible for selecting and contracting with the ePRO vendor and ensuring that the proper licenses are in place.

The Daily Life Impact measure includes 9 items, scored as a single scale, to address interference due to UC with work/school, chores activities for enjoyment, sleep, ability to concentrate, leaving home, ability to travel, sex, and planning activities.

The Daily Life Impact measure uses a one week recall and was designed and tested in paper format. The ePRO format (i.e., screenshots) is available upon request.

The Emotional Impact measure includes 8 items, scored as a single scale, to address feeling alone, embarrassed, worried, scared, no control of life, angry, frustrated, and depressed due to UC. The Emotional Impact measure uses a one week recall and was designed and tested in paper format. The ePRO format (i.e., screenshots) is available upon request.