Development of a core outcome set for cutaneous squamous cell carcinoma trials: identification of core domains and outcomes

被引：9

作者：

Reynolds, K. A. ^{[1
,8
]}

Schlessinger, D., I ^{[1
]}

Yanes, A. F. ^{[1
]}

Godinez-Puig, V ^{[1
]}

Chen, B. R. ^{[1
]}

Kurta, A. O. ^{[9
]}

Cotseones, J. K. ^{[10
]}

Chiren, S. G. ^{[1
]}

Iyengar, S. ^{[11
]}

Ibrahim, S. A. ^{[1
]}

Kang, B. Y. ^{[1
]}

Worley, B. ^{[1
]}

Behshad, R. ^{[9
]}

DeHoratius, D. M. ^{[12
]}

Denes, P. ^{[2
]}

Drucker, A. M. ^{[13
,14
,15
]}

Dzubow, L. M.

Etzkorn, J. R. ^{[12
]}

Harwood, C. A. ^{[16
,17
]}

Kim, J. Y. S. ^{[3
]}

Lawrence, N. ^{[18
]}

Lee, E. H. ^{[19
]}

Lissner, G. S. ^{[4
]}

Marghoob, A. A. ^{[20
]}

Guminiski, A. ^{[21
]}

Matin, R. N. ^{[22
]}

Mattox, A. R. ^{[23
]}

Mittal, B. B. ^{[5
]}

Thomas, J. R. ^{[6
]}

Zhou, X. A. ^{[1
]}

Zloty, D. ^{[24
]}

Hughes, B. G. M. ^{[25
,26
,27
]}

Nottage, M. K. ^{[27
]}

Green, A. C. ^{[28
,29
,30
]}

Testori, A. A. E. ^{[31
]}

Argenziano, G. ^{[32
]}

Longo, C. ^{[33
,34
]}

Zalaudek, I ^{[35
]}

Lebbe, C. ^{[36
]}

Malvehy, J. ^{[37
,38
]}

Saiag, P. ^{[39
]}

Cernea, S. S. ^{[40
]}

Schmitt, J. ^{[41
]}

Kirkham, J. J. ^{[42
]}

Poon, E. ^{[1
]}

Sobanko, J. F. ^{[43
,44
]}

Cartee, T., V ^{[45
]}

Maher, I. A. ^{[23
]}

Alam, M. ^{[1
,6
,7
]}

机构：

[1] Northwestern Univ, Dept Dermatol, Feinberg Sch Med, Chicago, IL 60611 USA

[2] Northwestern Univ, Div Cardiol, Feinberg Sch Med, Chicago, IL 60611 USA

[3] Northwestern Univ, Div Plast & Reconstruct Surg, Feinberg Sch Med, Chicago, IL 60611 USA

[4] Northwestern Univ, Dept Ophthalmol, Feinberg Sch Med, Chicago, IL 60611 USA

[5] Northwestern Univ, Dept Radiat Oncol, Feinberg Sch Med, Chicago, IL 60611 USA

[6] Northwestern Univ, Dept Otolaryngol Head & Neck Surg, Feinberg Sch Med, Chicago, IL 60611 USA

[7] Northwestern Univ, Dept Surg, Feinberg Sch Med, Chicago, IL 60611 USA

[8] Univ Cincinnati, Coll Med, Cincinnati, OH USA

[9] St Louis Univ, Dept Dermatol, St Louis, MO 63103 USA

[10] Northwestern Med Reg Med Grp, Med & Cosmet Dermatol Serv, Naperville, IL USA

[11] West Virginia Univ, Dept Dermatol, Morgantown, WV 26506 USA

[12] Univ Penn, Dept Dermatol, Perelman Sch Med, Philadelphia, PA 19104 USA

[13] Univ Toronto, Dept Med, Div Dermatol, Toronto, ON, Canada

[14] Womens Coll Hosp, Dept Med, Div Dermatol, Toronto, ON, Canada

[15] Womens Coll Hosp, Womens Coll Res Inst, Toronto, ON, Canada

[16] Barts Hlth NHS Trust, Dept Dermatol, Royal London Hosp, London, England

[17] Queen Mary Univ London, Ctr Cell Biol & Cutaneous Res, Barts & London Sch Med & Dent, Blizard Inst, London, England

[18] Cooper Univ Hosp, Div Dermatol Surg, Camden, NJ USA

[19] Mem Sloan Kettering Canc Ctr, Dermatol Serv, 1275 York Ave, New York, NY 10021 USA

[20] Mem Sloan Kettering Canc Ctr, Dept Dermatol, 1275 York Ave, New York, NY 10021 USA

[21] Royal North Shore & Mater Hosp, Dept Med Oncol, Sydney, NSW, Australia

[22] Churchill Hosp, Dept Dermatol, Oxford, England

[23] Univ Minnesota, Dept Dermatol, Minneapolis, MN 55455 USA

[24] Univ British Columbia, Dept Dermatol & Skin Sci, Vancouver, BC, Canada

[25] Univ Queensland, Fac Med, Brisbane, Qld, Australia

[26] Prince Charles Hosp, Dept Med Oncol, Brisbane, Qld, Australia

[27] Royal Brisbane & Womens Hosp, Canc Care Serv, Herston, Qld, Australia

[28] QIMR Berghofer Med Res Inst, Dept Populat Hlth, Brisbane, Qld, Australia

[29] CRUK Manchester Inst, Manchester, Lancs, England

[30] Univ Manchester, Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England

[31] Fdn IRCCS, Div Dermatol, Policlin San Matteo, Pavia, Italy

[32] Univ Campania, Dermatol Unit, Naples, Italy

[33] Univ Modena & Reggio Emilia, Dept Dermatol, Modena, Italy

[34] Ctr Oncol Ad Alta Tecnol Diagnost Dermatol, Azienda Unita Sanit Locale IRCCS Reggio Emilia, Reggio Emilia, Italy

[35] Med Univ Trieste, Dept Dermatol, Trieste, Italy

[36] Univ Paris, St Louis Hosp, AP HP, INSERM U976, Paris, France

[37] Hosp Clin Barcelona, Dept Dermatol, IDIBAPS, Barcelona, Spain

[38] CIBER Enfermedades Raras, Barcelona, Spain

[39] Univ Versailles St Quentin Yvelines, AP HP, Univ Dept Dermatol, Boulogne, France

[40] Hosp Servidor Publ Municipal Sao Paulo, Dermatol Dept, Sao Paulo, SP, Brazil

[41] Tech Univ Dresden, Ctr Evidence Based Healthcare, Med Fac, Carl Gustav Carus, Dresden, Germany

[42] Univ Manchester, Manchester Acad Hlth Sci Ctr, Ctr Biostat, Manchester, Lancs, England

[43] Hosp Univ Penn, Dept Dermatol, Perelman Ctr Adv Med, Philadelphia, PA 19104 USA

[44] Hosp Univ Penn, Dept Dermatol, Div Dermatol Surg, Philadelphia, PA 19104 USA

[45] Penn State Coll Med, Dept Dermatol, Hershey, PA USA

来源：

BRITISH JOURNAL OF DERMATOLOGY | 2021年 / 184卷 / 06期

关键词：

BASAL-CELL; METASTASIS; DISEASE;

D O I：

10.1111/bjd.19693

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

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.

引用

页码：1113 / 1122

页数：10

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