Table 1.

FDA-recommended qualities of patient preference studies (6)

Recommended Quality (definition)	Consideration in Survey Development
Patient centeredness (Ensure that the patient, not the health care professional is focus of the study)	• Patient input • Concept elicitation interviews • Pretesting
Representativeness of the sample and generalizability of results (Measure the preferences of a representative sample of adequate size)	• Pilot testing • Fielding planning • Purposive sampling on specific respondent characteristics
Capturing heterogeneity of patients’ preferences (Reflect preferences of patients from full spectrum of disease for which the device is intended to be used)	• Concept elicitation interviews • Pretesting • Purposive sampling on specific respondent characteristics
Established good research practices (Follow guidelines established by a recognized professional organization)	• All development steps aligned with ISPOR and Medical Device Innovation Consortium best practices (31,32) • Involvement of PPI experts in study design
Effective communication of benefit, harm, risk, and uncertainty (Communicate the quantitative aspects of the health information in ways that the patient can understand and cognitively process this information)	• Patient input • Survey construction using best practices • Pretesting • Pilot testing
Minimal cognitive bias (Minimize potential cognitive biases such as framing, anchoring, simplifying heuristics, or ordering effect)	• Survey construction • Pretesting • Pilot testing
Logical soundness (Test logic and consistency of presented data)	• Patient input • Pretesting • Pilot testing
Relevance (Include critical aspects of harm, risk, benefit, and uncertainty, ensuring some consistency with end points from clinical studies of the device)	• Concept elicitation interviews • Patient, regulator, and expert input
Robustness of analysis of results (Ensure appropriate interpretation of the collected evidence with attention to understanding the potential sources for uncertainty)	• Involvement of PPI experts in study design
Study conduct (Administer by trained research staff or, when self-administered, use a tutorial and quiz before answering questions to ensure adequate comprehension)	• Survey construction • Pilot testing • Fielding planning
Comprehension by study participants (Ensure that participants fully understand the harm, risk, benefit, and uncertainty and other medical information being communicated to them)	• Patient input • Pretesting • Pilot testing

FDA, Food and Drug Administration; PPI, patient preference information.