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Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a
Markus V Heppt1, Theresa Steeb2, Lutz Schmitz3
1Department of Dermatology and Allergy, University Hospital, LMU Munich, Frauenlobstr. 9-11, 80337, Munich, Germany. Markus.Heppt@med.uni-muenchen.de.
Background:
Actinic keratoses (AK) are common skin lesions that can progress 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 randomised controlled trials (RCTs). However, the reported endpoints are highly heterogeneous, making it difficult to assess and compare distinct treatment options and to reach an evidence-based choice of therapy.
Methods:
A systematic literature search will be conducted to analyse which endpoints are reported in RCTs. The focus will be on effectiveness, tolerability, cosmesis, and patient satisfaction. The reported endpoints of these studies, as well as their frequency and data collection times, will be documented in a standardised way to generate a comprehensive list of reported endpoints. In order to complete the identified outcomes in the literature search, focus groups on affected patients and structured interviews with board-certified dermatologists will be conducted to identify both patient- and practice-relevant endpoints. After the identification phase, the evaluation of the endpoints follows. In a two-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardised and transparent manner. A final face-to-face consensus meeting will be conducted after the last Delphi round in which a final list of core outcomes will be consented.
Discussion:
The development of a standardised endpoint set for the treatment of AK will contribute to improving the comparability of therapeutic options. Our catalogue will enhance the synthesis of evidence for the future by reducing heterogeneity in outcomes between RCTs and hence contribute to improving the quality of research, evidence-based and patient-centred treatment.
Trial Registration:
Core Outcome Measures for Effectiveness ( COMET ) database. Registered in December 2018.
Insights
Standardizing outcome measures for actinic keratosis (AK) treatments is crucial. This study aims to develop a core outcome set to improve treatment comparison and evidence-based decision-making for skin cancer prevention.
Area of Science:
- Dermatology
- Clinical Trials
- Evidence-Based Medicine
Background:
- Actinic keratoses (AK) are common pre-malignant skin lesions with potential to develop into squamous cell carcinoma.
- Current randomized controlled trials (RCTs) for AK treatments report highly heterogeneous endpoints.
- This heterogeneity complicates treatment comparison and evidence-based therapeutic choices.
Purpose of the Study:
- To develop a standardized set of core outcome measures for randomized controlled trials (RCTs) evaluating treatments for actinic keratoses (AK).
- To enhance the comparability of different AK treatment options.
- To improve the quality of research and facilitate patient-centered care in dermatology.
Main Methods:
- Systematic literature search of RCTs to identify reported effectiveness, tolerability, cosmesis, and patient satisfaction endpoints.
- Focus groups with patients and interviews with dermatologists to identify practice-relevant endpoints.
- A two-stage Delphi procedure with expert consensus, including patient representatives, to evaluate and select core outcomes.
- A final consensus meeting to agree on a standardized list of core outcomes.
Main Results:
- The study is in the process of developing a standardized endpoint set for AK treatments.
- The identified endpoints will be evaluated and refined through a Delphi procedure and expert consensus.
- A final core outcome set will be established to reduce heterogeneity in AK research.
Conclusions:
- A standardized endpoint set for actinic keratosis (AK) treatment will significantly improve the comparability of therapeutic options.
- This will enhance evidence synthesis for future research by reducing outcome heterogeneity in RCTs.
- Ultimately, this contributes to improved research quality, evidence-based practice, and patient-centered treatment decisions for AK.
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