Ulcerative Colitis Patient-Reported Outcomes (UC-PRO)
Expand the efficacy profile of your product with patient-reported outcomes in six critical measures
Gain critical insight into treatment efficacy in adult ulcerative colitis (UC) patients. The UC-PRO is a self-administered patient-reported outcome (PRO) measure developed in accordance with the U.S. Food and Drug Administration (FDA) Guidelines for Content Validity and Instrument Performance. This measure is intended for use in clinical trials evaluating treatment efficacy in adult patients (at least 18 years old) with moderate to severe UC treated in an outpatient setting.
The UC-PRO is conceptually designed as a collection of separate and distinct modules that assess the signs, symptoms and impacts of UC:
Signs and symptoms
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.
Systemic symptoms
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.
Coping Strategies
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.
Daily life impact
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.
Emotional impact
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.
Licensing information
As the contracted agency approved by the UC-PRO copyright holder (Amgen Inc., Genentech Inc., and the University of Michigan) to license and distribute the UC-PRO, we uphold our responsibility to protect the integrity of the UC-PRO as it is distributed for use, including development of translations.
A user agreement is required for all requests to use the UC-PRO in research, and use is granted for a single study only. Fees for licensure vary depending on the type of user making the request and the nature of the research. To inquire about terms and fees for licensure to use the UC-PRO, please choose the appropriate affiliation below to submit your interest, and you will be contacted by a COA expert with information relevant to your needs.
Translations available
Scroll the table below to view all of the available translations.
| Country | Language | Signs & symptoms | Systemic symptoms | Coping strategies | Daily life impact | Emotional impact |
|---|---|---|---|---|---|---|
| Albania | Albanian | X | ||||
| Argentina | Spanish | X | X | X | X | X |
| Australia | English | X | X | X | X | X |
| Austria | German | X | X | X | X | X |
| Belarus | Russian | X | X | |||
| Belgium | Dutch | X | X | X | X | X |
| Belgium | English | X | X | X | X | X |
| Belgium | French | X | X | X | X | X |
| Bosnia & Herzegovina | Bosnian | X | ||||
| Bosnia & Herzegovina | Croatian | X | ||||
| Bosnia & Herzegovina | Serbian-Latin | X | ||||
| Brazil | Portuguese | X | X | X | X | X |
| Bulgaria | Bulgarian | X | X | X | X | X |
| Canada | English | X | X | X | X | X |
| Canada | French | X | X | X | X | X |
| Chile | Spanish | X | ||||
| China | Chinese-Simplified | X | ||||
| Colombia | Spanish | X | ||||
| Croatia | Croatian | X | ||||
| Czech Republic | Czech | X | X | X | X | X |
| Denmark | Danish | X | X | X | X | X |
| Egypt | Arabic | X | ||||
| Estonia | Estonian | X | ||||
| Estonia | Russian | X | ||||
| Finland | Finnish | X | X | X | X | X |
| Finland | Swedish | X | X | X | X | X |
| France | French | X | X | X | X | X |
| Georgia | Georgian | X | X | |||
| Georgia | Russian | X | ||||
| Germany | German | X | X | X | X | X |
| Greece | Greek | X | X | X | X | X |
| Hong Kong | Chinese-Traditional | X | ||||
| Hungary | Hungarian | X | X | X | X | X |
| India | Bengali | X | ||||
| India | English | X | ||||
| India | Gujarati | X | ||||
| India | Hindi | X | ||||
| India | Kannada | X | ||||
| India | Malayalam | X | ||||
| India | Marathi | X | ||||
| India | Odia | X | ||||
| India | Punjabi | X | ||||
| India | Tamil | X | ||||
| India | Telugu | X | ||||
| India | Urdu | X | ||||
| Israel | Arabic | X | X | X | X | X |
| Israel | Hebrew | X | X | X | X | X |
| Israel | Russian | X | X | X | X | X |
| Italy | Italian | X | X | X | X | X |
| Japan | Japanese | X | X | X | X | X |
| Jordan | Arabic | X | ||||
| Latvia | Latvian | X | X | X | X | X |
| Latvia | Russian | X | X | X | X | X |
| Lebanon | Arabic | X | ||||
| Lebanon | French | X | ||||
| Lithuania | Lithuanian | X | ||||
| Lithuania | Russian | X | X | X | X | X |
| Malaysia | Chinese-Simplified | X | ||||
| Malaysia | English | X | ||||
| Malaysia | Malay | X | ||||
| Malaysia | Tamil | X | ||||
| Mexico | Spanish | X | X | X | X | X |
| Moldova | Romanian | X | ||||
| Moldova | Russian | X | ||||
| Netherlands | Dutch | X | X | X | X | X |
| New Zealand | English | X | ||||
| Norway | Norwegian | X | ||||
| Philippines | Cebuano | X | ||||
| Philippines | English | X | ||||
| Philippines | Hiligaynon | X | ||||
| Philippines | Tagalog | X | ||||
| Poland | Polish | X | X | X | X | X |
| Portugal | Portuguese | X | X | |||
| Puerto Rico | Spanish | X | ||||
| Romania | Romanian | X | X | X | X | X |
| Russia | Russian | X | X | X | X | X |
| Saudi Arabia | Arabic | X | ||||
| Serbia | Serbian-Cyrillic | X | ||||
| Serbia | Serbian-Latin | X | X | X | X | X |
| Singapore | Chinese-Simplified | X | ||||
| Singapore | Malay | X | ||||
| Slovakia | Slovak | X | X | X | X | X |
| Slovenia | Slovene | X | X | X | X | X |
| South Africa | Afrikaans | X | X | |||
| South Africa | English | X | X | |||
| South Africa | Sesotho | X | ||||
| South Africa | Xhosa | X | ||||
| South Africa | Zulu | X | ||||
| South Korea | Korean | X | X | X | X | X |
| Spain | Catalan | X | X | X | X | X |
| Spain | Galician | X | X | X | X | X |
| Spain | Spanish | X | X | X | X | X |
| Sweden | Swedish | X | X | X | X | X |
| Switzerland | French | X | X | X | X | X |
| Switzerland | German | X | X | X | X | X |
| Switzerland | Italian | X | X | X | X | X |
| Taiwan | Chinese-Traditional | X | X | X | X | X |
| Thailand | Thai | X | ||||
| Turkey | Turkish | X | X | X | X | X |
| UK | English | X | X | X | X | X |
| Ukraine | Russian | X | X | X | X | X |
| Ukraine | Ukrainian | X | X | X | X | X |
| USA | Spanish | X | X | X | X | X |
While the list of available translations is extensive, the process for any additional translations needed is outlined below:
- We must conduct all translation work using our preferred vendors who have a history with this COA
- Standardized methods for COA translation are followed and certification letters are provided
- Please provide your language needs on your submission form, and you will be provided with a cost estimate and timeline with our reply to the details of your project
Available resources
Publications
Higgins PDR, Harding G, Revicki DA, Globe G, Patrick DL, et al. Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-PRO/SS) diary. JPRO. May 2018;2:26.
Posters and presentations
Pulley J, Galloway D, Devine J, Oh YS, Petrek H, Kadva A, Mastui A. Minimal Clinically Important Difference (MCID) for the Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) Tool. Poster presented at: 16th Congress of the European Crohn’s and Colitis Organisation (ECCO) Congress; July 2-3 & 8-10, 2021; Virtual.
Higgins PDR, DeBusk K, Pulley J, Scalori A, Oh YS, Matsui A. Responder Definitions for the Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) Tool Using Patients With Ulcerative Colitis Treated With Etrolizumab. Poster presented at: Digestive Disease Week; May 18-21, 2019; San Diego, CA.
Higgins PDR, DeBusk K, Pulley J, Scalori A, Oh YS, Matsui A. Responder Definitions for the Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) Tool Using Patients With Ulcerative Colitis Treated With Etrolizumab. Poster presented at: 14th Congress of European Crohn’s and Colitis Organisation; March 6–9, 2019; Copenhagen, Denmark.
Higgins PD, Harding G, Patrick DL, Revicki D, Chen WH, Globe G, Viswanathan HN, Fitzgerald K, Trease S, Borie D, Ortmeier BG, Leidy NK. Psychometric Evaluation of the Coping, Daily Life Impact, and Emotional Impact Modules of the Ulcerative Colitis Patient-Reported Outcomes (UC-PRO) Measure. Poster presented at: UEG Week 2014; October 18–22, 2014; Vienna, Austria.
Higgins PD, Harding G, Patrick DL, Revicki D, Chen WH, Globe G, Viswanathan HN, Fitzgerald K, Trease S, Borie D, Ortmeier BG, Leidy NK. Psychometric Evaluation of the Signs and Symptoms Modules of the Ulcerative Colitis Patient-Reported Outcomes Measure (UC-PRO/SS). Poster presented at: UEG Week 2014; October 18–22, 2014; Vienna, Austria.
Higgins PDR, Harding G, Patrick DL, Revicki D, Globe G, Viswanathan HN, Trease S, Fitzgerald K, Borie D, Ortmeier BG, Leidy N. Development of the Ulcerative Colitis Patient-Reported Outcomes (UC-PRO) Questionnaire. Poster presented at: Digestive Disease Week 2013; May 18–21, 2013; Orlando, FL.
User Manual
The CD-PRO User Manual provides an overview of the development and validation studies for the five modules and describes the scoring method.