Ulcerative Colitis Patient-Reported Outcomes (UC-PRO)

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

This measure uses a 24-hour recall and was designed and tested as an e-diary 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 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 by the European Medicines Agency (EMA) and a letter of support was received. 

It is the user’s responsibility to select and contract with the ePRO vendor and ensure that the proper licenses are in place. 

The Systemic Symptoms measure includes five items, scored as a single scale, to address the presence and severity of systemic symptoms, including pain, fatigue, lack of appetite, weakness and thirst. 

This measure uses a 24-hour recall and was designed and tested as an e-diary 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. 

It is the user’s responsibility to select and contract with the ePRO vendor and ensure that the proper licenses are in place. 

The Coping Strategies measure includes six items, scored as a single score, to address coping strategies such as scheduling activities, eating to control bowel movements, avoiding foods, not going out unless toilets are nearby, carrying a change of clothes and staying home due to UC.  

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

It is the user’s responsibility to select and contract with the ePRO vendor and ensure that the proper licenses are in place. 

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

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

The Emotional Impact measure includes eight items, scored as a single scale, to address feeling alone, embarrassed, worried, scared, having no control in life, angry, frustrated and depressed due to UC. 

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