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Pre-validation methods for developing a patient reported outcome instrument.

Maria E Prior¹, Jemaima Che Hamzah, Jillian J Francis

¹Health Services Research Unit, University of Aberdeen, Aberdeen AB252ZD, UK. m.e.prior@abdn.ac.uk

BMC Medical Research Methodology

|August 11, 2011

Summary

This summary is machine-generated.

This study introduces a 5-step methodology for developing patient-reported outcome (PRO) instruments. This systematic approach ensures transparent and replicable development, enhancing the quality of health outcome measures in clinical trials.

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Area of Science:

Health outcomes research
Patient-reported outcome measures (PROMs)
Clinical trial methodology

Background:

Patient-assessed health measures are crucial for randomized controlled trials.
Developing new PRO instruments requires robust and transparent pre-validation methods.
Existing PRO instruments offer a valuable resource for new instrument development.

Purpose of the Study:

To present a systematic and generalizable 5-step pre-validation methodology for developing PRO instruments.
To illustrate the methodology using the Aberdeen Glaucoma Questionnaire (AGQ) as an example.
To ensure transparency and replicability in the development of PRO instruments.

Main Methods:

A 5-step process: item pool generation, multi-phase item de-duplication, multi-phase item reduction, content coverage assessment against a theoretical framework (e.g., ICF), and qualitative exploration with the target population.
The method was applied to develop the Aberdeen Glaucoma Questionnaire (AGQ).
Qualitative exploration involved a 'think aloud' study.

Main Results:

The initial item pool for the AGQ contained 725 items.
De-duplication and item reduction phases significantly reduced the item count.
The final draft AGQ contained 68 items after qualitative refinement, demonstrating good content coverage.

Conclusions:

The presented methodology offers a novel, transparent, and replicable approach to PRO instrument development.
The method integrates literature review, theoretical frameworks, and patient input for comprehensive instrument design.
This systematic approach enhances the appropriateness, acceptability, and validity of new PRO instruments in research.