International Dermatology Outcome Measures

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.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-selecting-developing-modifying-and-adapting-patient-reported-outcome-instruments-use
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.

https://www.fda.gov/medical-devices/medical-device-development-tools-mddt#mddts
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.

https://www.fda.gov/medical-devices/medical-device-development-tools-mddt#mddts
The International Dermatology Outcome Measures Group: Formation of patient-centered outcome measures in dermatology.

https://www.dermoutcomes.org/pdfs/6-ideom-feb2015.pdf

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.

https://pubmed.ncbi.nlm.nih.gov/31525439/

Lourdes Perez-Chada, Vanina L Taliercio, Alice Gottlieb, Marta Van Beek, Kristina Callis Duffin, Margo Reeder, Joseph F Merola, Robert A Swerlick.

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Resources

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.

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.

Patient Research Partner Glossary