Developing a questionnaire for assessing clinician- and patient-reported outcomes in actinic keratosis: Results from an expert panel.

Background: Current assessments on topical treatment attributes in actinic keratosis (AK) do not evaluate safety, effectiveness, and satisfaction from both clinician and patient perspectives, creating an unmet need for more comprehensive AK-specific measures that fully capture the patient experience.
Objective: To develop an actinic keratosis-specific expert panel questionnaire (AK-EPQ) of patient-reported outcomes and clinician-reported outcomes for use in research studies.
Methods: Using interviews of patients with AK and targeted literature reviews, a 9-person consensus panel of dermatologists with expertise in AK treatment was convened to develop the AK-EPQ to assess AK-specific patient-reported outcomes and clinician-reported outcomes.
Results: Nine expert advisers achieved consensus on 11 AK-EPQ items that encompass patient and clinician perspectives of treatment-related local skin reactions, clinical and cosmetic outcomes associated with AK, and satisfaction with treatment; the AK-EPQ will be first implemented in the Patient-Reported Outcomes for Actinic Keratosis study (NCT05260073).
Limitations: The AK-EPQ does not directly measure quality of life, although it can be used with validated quality of life instruments.
Conclusion: The newly developed AK-EPQ elicits insights into the patient and clinician experience with AK treatments. Comparative probing of these perspectives may help optimize precision medicine in AK treatment.
Competing Interests: Dr Berman has served as an investigator, speaker, advisory board member, or consultant for Aclaris, Almirall, AiViva Biopharma, Biofrontera, Evommune, Ferndale Laboratories, Inc, Galderma Laboratories, L.P., GlaxoSmithKline, Lemonex, LEO Pharma, Mediwound, Mino Labs, Miragen, NOVAN, Novartis Pharmaceuticals Corp, Pfizer, Pierre Fabre, PHD Biosciences, Pulse Biosciences, Sensus, and Sirnaomics. Dr Armstrong served as a research investigator and/or scientific adviser to AbbVie, BI, BMS, EPI, Incyte, LEO, UCB, Janssen, Lilly, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, and Pfizer. Dr Lebwohl receives research funding from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc, and is a consultant for Aditum Bio, Almirall, AltruBio Inc, AnaptysBio, Arcutis, Inc, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle BioSciences, Corrona, Dermavant Sciences, Dr. Reddy’s Laboratories, Evelo Biosciences, Evommune, Inc, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica. Dr Grada is the former Head of R&D and Medical Affairs at Almirall, US. Dr Bhatia has been an adviser, consultant, and investigator for AbbVie, Almirall, Arcutis, Arena, Biofrontera, BMS, BI, Brickell, Dermavant, EPI Health, Ferndale, Galderma, Genentech, InCyte, ISDIN, J&J, LaRoche-Posay, Leo, Lilly, Novartis, Ortho, Pfizer, P&G, Regeneron, Sanofi, Stemline, SunPharma, and Verrica. Dr Patel has received honoraria from Regeneron and Almirall, has served as a consultant for PhD Biosciences and Jounce Therapeutics, and has served as a speaker for Regeneron and Sanofi. Dr Rigel has served as a consultant for Almirall, Castle BioSciences, DermTech, and SciBase. Dr Del Rosso has served as a research investigator, consultant/adviser, or speaker for AbbVie, Aclaris, Almirall, Amgen (Celgene), AnaptysBio, Arcutis, Athenex, Bausch (Ortho Dermatologics), Biofrontera, BioPharmX, Biorasi, Blue Creek, Botanix, Brickell, Bristol-Myers Squibb, Cara Therapeutics, Cassiopea, Dermata, Dermavant, Encore, EPI Health, Ferndale, Galderma, Genentech, Incyte, Jem Health, LEO Pharma, La Roche-Posay, Lilly (Dermira), MC2, NOVAN, Pfizer, Ralexar, Regeneron, Sanofi-Genzyme, Sente, Solgel, Sonoma (Intraderm), Sun Pharma, UCB, Verrica, and VYNE (Foamix/Menlo). Dr Schlesinger has received grant/research funding from AbbVie, Aclaris, Allergan, Almirall, Anterios, AOBiome, Arcutis Premier Research, Astellas Pharma US, Inc, Athenex, Biofrontera, Biorasi, Boehringer Ingelheim, Brickell Biotech, Bristol-Myers Squibb, Cara Therapeutics, Castle BioScience, Celgene, Centocor Ortho Biotech (now Janssen Biotech), ChemoCentryx, Coherus Biosciences, Concert Pharmaceutical, Corrona, Cutanea Life Sciences, Dermavant, Dermira (now Lilly), DT Pharmacy & DT Collagen, EPI Health, Galderma (Nestle), Janssen Pharmaceuticals, Inc, Kiniksa, LEO, Lilly, Merz, Nimbus, Novartis, Pfizer, Processa, Pulse Biosciences, Regeneron, Sanofi Genzyme, Sisaf, and Trevi; has received honoraria from AbbVie, Allergen, Almirall, Biofrontera AG, Bristol-Myers Squibb, Castle BioScience, EPI Health, Foundation for Research and Education in Dermatology (FRED), Galderma, Merz, Novartis, Regeneron, and Sun Pharma; has served as a speaker, advisory board member, or consultant for AbbVie, Allergan, Almirall, Amgen, Biofrontera AG, Bristol-Meyers Squibb, Castle BioScience, Celgene, CMS Aesthetics DCME, DUSA/Sun Pharma, EPI Health, Foundation for Research and Education in Dermatology (FRED), Genentech, Greenway Therapeutix, Kintor, Merz, Nextphase, Novartis, Pharmatecture, Prolacta Biosciences, Pulse Biosciences, Regeneron, Remedly, Inc, Sanofi Genzyme, Sun Pharma, UCB, and Verrica; has received consulting fees from Lilly, Ortho Dermatologics, Pierre Fabre, Plasmed, Regeneron, and Skinceuticals/L’Oreal; has been involved in the CME Program for MED Learning Group; has been involved with OncLive SSC Insights Filming/Stacy Jaffe for MJH Associates; has served as Co-Chair of AAD AK Guideline Committee and Co-Chair of AAD Performance Measurement Work Group; is a member of AAD Performance Measurement Committee; and owns stock in Remedly, Inc. Dr Kircik has served as an investigator, speaker, advisory board member, or consultant for Abbott Laboratories, Aclaris, Inc, Allergan, Inc, Almirall, Anacor Pharmaceuticals, Inc, Assos Pharma, Astellas Pharma US, Inc, Asubio Pharma Co, Ltd, Berlex Laboratories (Bayer Healthcare Pharmaceuticals), Biogen-Idec, Inc, Biolife, Biopelle, Boehringer Ingelheim, Breckinridge Pharma, Celgene Corporation, Centocor, Inc, Colbar, CollaGenex, Combinatrix, Connetics Corporation, Coria, Dermik Laboratories, Dermira, Inc, Dow Pharmaceutical Sciences, Inc, Dusa Pharmaceuticals, Inc, Eli Lilly & Co, Embil Pharmaceutical Co, Ltd, EOS, Ferndale Laboratories, Inc, Galderma Laboratories, LP, Genentech, Inc, GlaxoSmithKline, PLC, Health Point Ltd, Idera, Inc, Innocutis Medical, LLC, Innovail, Intendis, Inc, Johnson & Johnson, Laboratory Skin Care, Inc, Leo Pharmaceuticals, Inc, L’Oreal SA, 3M, Maruho Co, Ltd, Medical International Technologies, Medicis Pharmaceutical Corp, Merck & Co, Inc, Merz, Nano Bio Corporation, Novartis Pharmaceutical Corporation, Noven Pharmaceuticals, Inc, Nucryst Pharmaceuticals Corporation, Obagi Medical Products, Inc, Onset, Ortho Dermatologics, OrthoNeutrogena, PediaPharma, Inc, Promius Pharma, LLC, PharmaDerm, Pfizer, Inc, PuraCap, QLT, Inc, Quatrix, Quinnova, Serono (Merck-Serono International SA), SkinMedica, Inc, Stiefel Laboratories, Inc, Sun Pharmaceutical Industries, Ltd, Taro, TolerRx, Inc, Triax, UCB, Inc, Valeant Pharmaceuticals North America LLC, Warner-Chilcott, XenoPort, Inc, and ZAGE. Dr Salem is an employee of Almirall, US. Dr Narayanan is an employee of Avant Health LLC, and has served as a consultant for Almirall, Biogen, Johnson & Johnson, Sarepta Therapeutics, SeaGen, and Takeda. Dr Kasujee is an employee of Almirall, Spain.
(© 2024 Published by Elsevier Inc. on behalf of the American Academy of Dermatology, Inc.)