Our psychometricians complement the survey research and data collection team by providing expert guidance on developing and/or choosing scientifically valid and reliable instruments for measuring patient-reported outcomes (PRO) within or independent of clinical trials. Our team, trained in both quantitative and qualitative methodologies, also offers a variety of consulting services for your psychometric needs.
Review Existing Instruments
When tasked with identifying an optimal PRO measurement strategy, our project teams perform a comprehensive review of existing measurement instruments for your study. The process typically includes:
Identifying existing instruments
Conducting literature reviews
Consulting with subject matter experts (clinicians and colleagues)
Exploring online resources
Comparing instruments
Reviewing previous use of the instrument within the given therapeutic area
Determining potential for acceptance by regulators
Conducting formal scientific evaluations of the instrument
Identifying administration mode(s)
Determining availability of validated translations
Develop New Instruments
If no suitable instrument exists for your research needs, our team of psychometricians can develop and evaluate the psychometric properties of a new instrument, consistent with the Draft PRO Guidance released by the FDA. Specific tasks may include:
Establish a project advisory board
Consult with key opinion leaders
Identify relevant constructs
Conduct literature and instrument reviews
Perform in-depth interviews and focus groups with patients and/or caregivers
Create draft questionnaire
Determine initial items and response scales using principles grounded in the survey methods literature
Pretest and revise the questionnaire
Conduct iterative sets of cognitive interviews with patients
Revise the questionnaire based on pretest results
Document evidence and rationale for all modifications
Evaluate the psychometric properties of the new instrument
