Development of an Inventory of Patient-Reported Outcome Measures in IBD: RFP
Numerous patient-reported outcome (PRO) instruments are currently used in inflammatory bowel disease (IBD), creating challenges for standardizing outcome measurements across research and clinical care settings. While many instruments assess similar concepts, variation in measures, domains, item content, and methodologies limits the ability to compare findings across studies, aggregate data across cohorts, and evaluate outcomes consistently over time.
Establishing a standardized IBD PRO set would support greater consistency in clinical trials, broader adoption across research and healthcare initiatives, and alignment with regulatory expectations from agencies such as the FDA and EMA. To advance this goal, the Crohn's & Colitis Foundation (Foundation) seeks to develop a comprehensive inventory and characterization of existing IBD PRO instruments, including their frequency of use, domains assessed, source references, and item-level content.
Findings from this work will provide the evidence base for a future consensus-driven effort to define a standardized, actionable IBD PRO set for use across the IBD community.
Scope | Proposal Requirements | Budget | Timeline | How to Apply
Scope
The Foundation seeks a qualified vendor to identify, compile, and characterize patient-reported outcome instruments currently used in IBD research and clinical care. The primary deliverable will be a comprehensive inventory of IBD PRO measures and key instrument characteristics.
At a minimum, the inventory should include:
- Instrument name and acronym (if applicable)
- Source reference(s) and year of publication
- Frequency of use across clinical trials, research studies, cohorts, registries, and other initiatives
- Outcome domains measured (e.g., stool frequency, abdominal pain, fatigue, quality of life, mental health, social functioning)
- Instrument structure, including individual items, response options, scoring methodology, and recall period
- Validation status and available psychometric evidence
- Available translations and cultural adaptations
- Applicability across adult and pediatric populations
- Disease-specific versus generic instrument classification
The vendor should also characterize and organize instruments in a manner that supports:
- Classification and mapping of measured outcome domains
- Identification of overlapping and unique concepts across instruments
- Assessment of similarities and differences in item content
- Evaluation of opportunities for harmonization and standardization across measures
The resulting inventory will serve as the evidence-based resource for a future consensus process to establish a standardized set of IBD PRO measures for use across research and clinical care.
Proposal Requirements and Evaluation Criteria
Proposal should include:
- Proposed methodology
- Project team and roles
- Relevant experience
- Examples of similar work
- Expected Timeline** (see section below)
- Budget
For relevant experience, vendors should describe experience with PRO development and evaluation, expertise in psychometrics and outcomes research, experience conducting systematic reviews or evidence mapping, and knowledge of FDA patient-focused drug development guidance.
Proposals will be evaluated based on:
- Relevant experience (30%)
- Methodology (30%)
- Project team qualifications (20%)
- Budget/value (20%)
Budget
Allocated budget up to $50,000
Note: We encourage your submission even if your rate doesn’t exactly match the amount listed above.
Timeline
Proposals are due by Friday, August 7 to Taylor Weyers. Notifications will be sent around the week of August 24.
**The project start date and the timeline for associated activities will be determined in collaboration with the selected vendor. However, all deliverables noted above must be completed and submitted to the Foundation within 90 calendar days of the agreed start date.
How to Apply
- Click here for program overview and application guidelines.