[Developing and validating of patient-reported questionnaires - part 1].

Area of Science:

• Health outcomes research
• Psychometrics
• Clinical research methodology

Background:

• Patient-reported outcome measures (PROMs) capture subjective patient experiences like pain and quality of life.
• Developing reliable and valid PROMs is crucial for accurate clinical studies.
• This article focuses on the initial developmental phases of creating a PROM questionnaire.

Purpose of the Study:

• To describe five of the six developmental phases for creating a patient-reported outcome questionnaire.
• To emphasize the importance of methodological rigor in PROM development.
• To highlight the necessity of patient involvement for content and face validation.

Main Methods:

• The study outlines key developmental stages for PROM questionnaires.
• Focus groups involving the target patient population are utilized for validation.
• Methodological adherence is stressed throughout the development process.

Main Results:

• Five developmental phases of a PROM questionnaire are detailed.
• Patient engagement through focus groups is identified as essential for validation.
• The importance of robust methodology for ensuring PROM reliability and validity is underscored.

Conclusions:

• The development of patient-reported outcome questionnaires involves distinct methodological phases.
• Involving patients in the development process, particularly through focus groups, is critical for content and face validity.
• Strict adherence to good methodology is paramount for generating trustworthy results from PROM studies.