K A Reynolds1,2, D I Schlessinger1, A F Yanes1, V Godinez-Puig1, B R Chen1, A O Kurta3, J K Cotseones4, S G Chiren1, S Iyengar5, S A Ibrahim1, B Y Kang1, B Worley1, R Behshad3, D M DeHoratius6, P Denes7, A M Drucker8,9, L M Dzubow10, J R Etzkorn6, C A Harwood11,12, J Y S Kim13, N Lawrence14, E H Lee15, G S Lissner16, A A Marghoob17, A Guminiski18, R N Matin19, A R Mattox20, B B Mittal21, J R Thomas22, X A Zhou1, D Zloty23, B G M Hughes24,25,26, M K Nottage26, A C Green27,28, A A E Testori29, G Argenziano30, C Longo31,32, I Zalaudek33, C Lebbe34, J Malvehy35, P Saiag36, S S Cernea37, J Schmitt38, J J Kirkham39, E Poon1, J F Sobanko40,41, T V Cartee42, I A Maher20, M Alam1,22,43. 1. Department of Dermatology, Northwestern University, Chicago, IL, USA. 2. University of Cincinnati College of Medicine, Cincinnati, OH, USA. 3. Department of Dermatology, Saint Louis University, St Louis, MO, USA. 4. Medical & Cosmetic Dermatology Service, Northwestern Medicine Regional Medical Group, Naperville, IL, USA. 5. Department of Dermatology, West Virginia University, Morgantown, WV, USA. 6. Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 7. Division of Cardiology, Northwestern University, Chicago, IL, USA. 8. Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada. 9. Division of Dermatology, Department of Medicine and Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada. 10. Private Practice, Media, PA, USA. 11. Department of Dermatology, Royal London Hospital, Barts Health NHS Trust, London, UK. 12. Centre for Cell Biology and Cutaneous Research, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK. 13. Division of Plastic and Reconstructive Surgery, Northwestern University, Chicago, IL, USA. 14. Division of Dermatologic Surgery, Cooper University Hospital, Camden, NJ, USA. 15. Dermatology Service, Memorial Sloan Kettering Cancer Center, New York City, NY, USA. 16. Department of Ophthalmology, Northwestern University, Chicago, IL, USA. 17. Department of Dermatology, Memorial Sloan Kettering Cancer Center, New York City, NY, USA. 18. Department of Medical Oncology, Royal North Shore and Mater Hospitals, Sydney, Australia. 19. Department of Dermatology, Churchill Hospital, Oxford, UK. 20. Department of Dermatology, University of Minnesota, Minneapolis, MN, USA. 21. Department of Radiation Oncology, Northwestern University, Chicago, IL, USA. 22. Department of Otolaryngology-Head and Neck Surgery, Northwestern University, Chicago, IL, USA. 23. Department of Dermatology & Skin Science, University of British Columbia, Vancouver, BC, Canada. 24. Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia. 25. Department of Medical Oncology, The Prince Charles Hospital, Brisbane, QLD, Australia. 26. Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia. 27. Department of Population Health, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia. 28. CRUK Manchester Institute and University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. 29. Division of Dermatology, Fondazione IRCCS, Policlinico san Matteo, Pavia, Italy. 30. Dermatology Unit, University of Campania, Naples, Italy. 31. Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy. 32. Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Centro Oncologico ad Alta Tecnologia Diagnostica-Dermatologia, Reggio Emilia, Italy. 33. Department of Dermatology, Medical University of Trieste, Trieste, Italy. 34. APHP Department of Dermatology, Saint-Louis Hospital, INSERM U976, Université de Paris, Paris, France. 35. Department of Dermatology, Hospital Clinic of Barcelona, IDIBAPS and CIBER de Enfermedades Raras, Barcelona, Spain. 36. University Department of Dermatology, Université de Versailles-Saint Quentin en Yvelines, APHP, Boulogne, France. 37. Dermatology Department of Hospital do Servidor Público Municipal de São Paulo, São Paulo, SP, Brazil. 38. Center for Evidence-Based Healthcare, Medical Faculty, Carl Gustav Carus, TU Dresden, Dresden, Germany. 39. Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. 40. Department of Dermatology, Perelman Center for Advanced Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. 41. Division of Dermatologic Surgery, Department of Dermatology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. 42. Department of Dermatology, Penn State College of Medicine, Hershey, PA, USA. 43. Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Abstract
BACKGROUND: The lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials. OBJECTIVES: To develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC. METHODS: One hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants. RESULTS: A core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival. CONCLUSIONS: In order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes.
BACKGROUND: The lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials. OBJECTIVES: To develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC. METHODS: One hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants. RESULTS: A core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival. CONCLUSIONS: In order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes.
Authors: Sarah A Ibrahim; Bianca Y Kang; Daniel I Schlessinger; Sarah G Chiren; Jennifer C Tang; Jamie J Kirkham; Jochen Schmitt; Emily Poon; Ian A Maher; Joseph F Sobanko; Todd V Cartee; Murad Alam Journal: BMJ Open Date: 2022-02-04 Impact factor: 2.692
Authors: McKenzie A Dirr; Murad Alam; Christian Apfelbacher; Karl-Philipp Drewitz; Bianca Y Kang; Daniel Munblit; Nikita Nekliudov; Nina Seylanova Journal: Arch Dermatol Res Date: 2022-03-04 Impact factor: 3.017