Core Outcome Measures in Effectiveness Trials

Harmonization of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: Development of a core outcome from a German-European perspective

General Information

Summary:
Background: Actinic keratoses (AK) are frequent skin lesions that can lead to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demonstrated in numerous randomized controlled trials (RCTs). However, the reported endpoints are highly heterogeneous in terms of efficacy, tolerability and cosmetic outcome, making it difficult to assess and compare treatment options.

Methods: A systematic literature search will be conducted to analyze which endpoints are reported in RCTs. The focus will be on effectiveness, tolerability, and cosmesis. The reported endpoints of these studies, as well as their frequency and data collection times, will be documented in a standardized way to generate a comprehensive list of reported endpoints. In order to complete the identified outcomes in the literature search, focus groups with patients as well as structured interviews with established dermatologists will be conducted to identify patient-relevant and particularly practice-relevant endpoints. After identification, the evaluation of the endpoints begins. In a three-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardized and transparent manner. A final face-to-face consensus meeting will be the last Delphi round in which a final list of outcomes will be consented.

Contributors:
M.V. Heppt, T, Steeb, C. Berking (Department of Dermatology and Allergy, University Hospital, LMU Munich, Frauenlobstr. 9-11, 80337 Munich, Germany)

L. Schmitz (Department of Dermatology, Venereology and Allergology, Ruhr-University, Bochum, Germany)

U. Leiter, C. Garbe (Department of Dermatology, Center for Dermatooncology, University Hospital Tübingen, Liebermeisterstr. 25, 72076 Tübingen, Germany)

Further Study Information

Current Stage:
Ongoing
Date:
December 2018 - February 2020
Funding source(s):
German Cancer Aid (grant no. 70112351)

Health Area

Disease Category
Cancer
Skin

Disease Name
Actinic keratosis
Field-cancerization
Skin cancer

Target Population

Age Range
18 - 99

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Consensus meeting
Delphi process
Focus group(s)
Survey
Systematic review

-A systematic literature search will be conducted to analyze which endpoints are reported in RCTs.
-Focus groups with patients as well as structured interviews with established dermatologists will be conducted to identify patient-relevant and particularly practice-relevant endpoints.
-In a three-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardized and transparent manner. A final face-to-face consensus meeting will be the last Delphi round in which a final list of outcomes will be consented.


Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives
Policy makers

Study Type

COS for clinical trials or clinical research
COS for practice

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