Crohn’s Disease Patient-Reported Outcomes (CD-PRO)

The CD-PRO is a self-administered instrument developed in accordance with FDA Guidelines for Content Validity and Instrument Performance. It is intended for use in clinical trials evaluating treatment efficacy in adult patients (≥18 years of age) with moderate to severe Crohn’s disease (CD) treated in an outpatient setting.

The CD-PRO is conceptually designed as a collection of separate and distinct modules that assess the signs, symptoms, and impacts of CD:

Signs and Symptoms
Systemic Symptoms
Coping Strategies

Daily Life Impact
Emotional Impact

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

The CD-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.

Systemic Symptoms 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 CD.

Coping Strategies 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 CD with work/school, chores activities for enjoyment, sleep, ability to concentrate, leaving home, ability to travel, sex, and planning activities.

Daily Life Impact 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 CD.

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

Licensing Information

Evidera is the contracted agency approved by the CD-PRO copyright holder (Amgen Inc., Genentech Inc., and the University of Michigan) to license and distribute the CD-PRO for use. Our responsibility includes the protection of the integrity of the CD-PRO as it is distributed for use, including development of translations.

License to Use the CD-PRO

A user agreement is required for all requests to use the CD-PRO in research. Use is granted for a single study only. Fees for licensure vary depending on the type of user making the request and nature of the research. To inquire about terms and fees for licensure to use the CD-PRO, please click on your affiliation below for the correct form to submit with your inquiry and an Evidera project manager will get back to you with information relevant to your needs.

Academia or not-for-profit use Pharmaceutical or commercial use

Translations Available

Current lists of the available languages can be found below:

Available translations

If you need a translation that is not on this list:

All translation work must be conducted by Evidera using their preferred vendors who have a history with the work on this clinical outcome assessment (COA)
Standardized methods for COA translation are followed and certification letters are provided
Add your language needs to the information form you submit, and you will be provided with a cost estimate and timeline with our reply to the details of your project

CD-PRO Research Presentations and Publications

The CD-PRO is supported by professional publications and scientific presentations.

CD-PRO Publications and Presentations

CD-PRO 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.

If you have any questions or would like to reach out directly regarding the CD-PRO, please do not hesitate to contact us:

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