U.S. Food and Drug Administration - PRO Instruments for Use in Medical Device Evaluation - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.
U.S. Food and Drug Administration - Clinical Outcome Assessments (COAs) in Medical Device Decision Making - FDA encourages inclusion of clinical outcomes assessments (COA), including patient-reported outcomes (PRO), in the evaluation of medical devices.
U.S. Food and Drug Administration - Medical Device Development Tools (MDDT) - Using this program, the FDA qualifies tools that medical device sponsors can use in developing and evaluating medical devices.
The International Dermatology Outcome Measures Group: Formation of patient-centered outcome measures in dermatology.
B Gottlieb, Alice & A Levin, Adriane & Armstrong, April & Abernethy, April & Duffin, Kristina & Bhushan, Reva & Garg, Amit & Merola, Joseph & Maccarone, Mara & Christensen, Robin. (2014).
Achieving Consensus on Patient-Reported Outcome Measures in Clinical Practice for Inflammatory Skin Disorders On Behalf of International Dermatology Outcome Measures and the American Academy of Dermatology.
Lourdes Perez-Chada, Vanina L Taliercio, Alice Gottlieb, Marta Van Beek, Kristina Callis Duffin, Margo Reeder, Joseph F Merola, Robert A Swerlick.