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Core Outcome Set for Basal Cell Carcinoma

Condition

basal cell carcinoma

Background

Basal cell carcinoma is the most common malignancy among Caucasian populations.  In addition to risk of local destruction, BCC can be associated with pain, functional sensory, loss, disfigurement and psychosocial impact.   Some patients develop many primary BCCs over many years, thereby experiencing BCC as a chronic disease.   There are many effective treatments for BCC, including surgical excision, electrodessication, cryotherapy, topical medications, radiation, chemotherapy, and immunotherapy.   Comparison of treatments for BCC, and different manifestations of BCC, is hindered by the lack of a standardized set of outcomes.  A core outcome set for BCC would be expected to improve researchers’ ability to assess the relative benefits of the diversity of available  therapies.

Scope of the intended COS

  • Study types: e.g. RCTs: RCTs or Controlled Clinical Trials
  • Region, e.g. global scope: Global scope

Methods

We aim to develop a core outcome set by (1) identifying all current outcomes from a systematic review of literature; (2) involving other stakeholder groups such as other clinicians, and regulators to participate in identifying additional outcomes; (3) conducting Delphi consensus exercises on the identified outcomes; (4) presenting all results from the Delphi exercises during a face-to-face (if possible) consensus meeting to vote and agree upon a core set of outcomes important for basal cell carcinoma.

Involvement of stakeholders

Stakeholders, or those invested in the development of a core outcome set, will also be included in the decision process, along with patients. Dermatologists, and industry scientists associated treatments for basal cell carcinomas are potential members that can provide input regarding what outcomes they feel should be represented. Nurses, physician assistants, and other health care practitioners may be included as well to enhance further discussion.

Current status

Completed systematic review of literature, Delphi consensus, and Consensus meeting. Publication submitted.

Funding

Departmental research funds

Involved Countries

USA, UK, Canada

Date of updates

  • 10/08/2020

Lead

  • Murad Alam, MD

Project team members

Steering Committee:

  • Murad Alam, MD
  • Joseph F. Sobanko, MD
  • Ian A. Maher, MD
  • Todd V. Cartee, MD

Responsible member of Methods group (as assigned by CS-COUSIN)

  • Jamie Kirkham, PhD

Contact

Murad Alam, MD (m-alam@northwestern.edu)

Published references

  1. Schlessinger DI, Iyengar S, Yanes AF, Lazaroff JM, Godinez-Puig V, Chen BR, Kurta AO, Henley JK, Chiren SG, Furlan KC, Schmitt J, Deckert S, Poon E, Sobanko JF, Cartee TV, Alam M, Maher IA. Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. Oct 23 2017;18doi:ARTN 490 10.1186/s13063-017-2244-5