Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods...

Area of Science:

• Clinical Trials
• Patient-Reported Outcomes
• Mixed Methods Research

Background:

• Patient-Reported Outcomes or Experience Measures (PROMS/PREMS) are vital in clinical studies.
• Quantitative methods alone lack depth in capturing real-world participant experiences.
• Qualitative assessments are time-consuming and often limited to small samples.

Purpose of the Study:

• To pilot the feasibility and acceptability of the Participant-Generated Experience and Satisfaction (PaGES) Index.
• To assess a new mixed qualitative/quantitative Patient-Reported Experience Measure (PREM) tool.
• To evaluate the PaGES Index within a randomized controlled trial of labor induction.

Main Methods:

• The PaGES Index was administered to hypertensive pregnant women before and after labor induction in India.
• Participants ranked and rated aspects of their birth experience.
• A qualitative evaluation (qMOLI) involved interviews and focus groups with participants, researchers, and clinicians.

Main Results:

• Participants and researchers found the PaGES Index easy to use and administer.
• Mothers appreciated the opportunity to discuss their experiences.
• Qualitative analysis revealed commonalities and differences in participant priorities and satisfaction, with stable scores pre- and post-birth.

Conclusions:

• The PaGES Index is a feasible and acceptable tool integrating qualitative and quantitative research strengths.
• It allows for a comprehensive before-and-after evaluation of all trial participants' expectations and experiences.
• The PaGES Index can be effectively used across different languages and literacy levels with research assistant support.