Assessing patient reported outcome measures: A practical guide for gastroenterologists.

Area of Science:

• Gastroenterology
• Clinical Research Methodology

Background:

• Gastrointestinal illnesses significantly impact patients' physical, emotional, and social well-being.
• Patient-reported outcome measures (PROMs) are increasingly integral to clinical decision-making, research, and therapy approval.
• The proliferation of PROMs in gastroenterology necessitates careful selection and validation.

Purpose of the Study:

• To review the literature on assessing the validity and reliability of PROMs in gastroenterology.
• To provide a practical guide for gastroenterologists on evaluating PROM instruments.
• To ensure PROMs meet rigorous standards for clinical practice and research.

Main Methods:

• Literature review of current methodologies for assessing PROM validity and reliability.
• Synthesis of key properties required for robust PROMs.
• Development of a practical assessment guide.

Main Results:

• Many PROMs in gastroenterology lack rigorous development and validation.
• Validated PROMs are essential for regulatory approval of new drugs and therapies.
• Key properties for PROM assessment include validity, reliability, and adherence to international guidelines.

Conclusions:

• Gastroenterologists need a clear understanding of PROM properties to select appropriate instruments.
• Rigorous PROM assessment is crucial for advancing patient care and therapeutic innovation.
• This guide aids in the critical evaluation of PROMs for clinical and research applications.