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PRO development: rigorous qualitative research as the crucial foundation
Kathryn Eilene Lasch1, Patrick Marquis, Marc Vigneux
1Mapi Values, Boston, MA, USA. kathy.lasch@mapivalues.com
Summary
This study outlines qualitative methods for developing Patient-Reported Outcomes (PROs) with content validity. It emphasizes subject input through interviews and focus groups for meaningful health outcome measures.
Area of Science:
- Health Research Methodology
- Qualitative Research in Health
- Patient-Reported Outcomes (PROs) Development
Background:
- Limited guidance exists on qualitative methods for Patient-Reported Outcomes (PROs) development.
- Existing literature often prioritizes quantitative psychometric properties over qualitative content validity.
- There is a growing need for assurance regarding the meaning and relevance of PRO items and scales to subjects.
Purpose of the Study:
- To present rigorous qualitative research methods for developing PROs with content validity.
- To address the gap in the literature concerning the qualitative development of PROs.
- To ensure PROs are meaningful and relevant to the target population.
Main Methods:
- Utilized an international, interdisciplinary expert group (psychologists, psychometricians, regulatory experts, physician, sociologist).
- Employed a phenomenological theoretical framework.
- Integrated grounded theory for data collection and analysis.
Main Results:
- Developed and described specific qualitative research methods for PRO development.
- Demonstrated an approach combining phenomenology and grounded theory.
- Aimed to yield PRO items and scales with robust content validity.
Conclusions:
- The described methods provide a rigorous approach to developing content-valid PROs.
- Subject input through qualitative methods is crucial for PRO relevance.
- This framework enhances the credibility and trustworthiness of PRO development.
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