Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set.
Consensus
Consensus Development Conferences as Topic
Delphi Technique
Endpoint Determination
Evidence-Based Medicine
Humans
Keratosis, Actinic
/ diagnosis
Patient Participation
Patient Satisfaction
Randomized Controlled Trials as Topic
/ methods
Remission Induction
Research Design
Research Personnel
Stakeholder Participation
Treatment Outcome
Actinic keratosis
Core outcome sets
Delphi
Focus groups
Randomised controlled trials
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Oct 2019
11 Oct 2019
Historique:
received:
18
04
2019
accepted:
03
09
2019
entrez:
13
10
2019
pubmed:
13
10
2019
medline:
24
3
2020
Statut:
epublish
Résumé
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. 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. 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. Core Outcome Measures for Effectiveness ( COMET ) database. Registered in December 2018.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
Core Outcome Measures for Effectiveness ( COMET ) database. Registered in December 2018.
Identifiants
pubmed: 31604473
doi: 10.1186/s13063-019-3696-6
pii: 10.1186/s13063-019-3696-6
pmc: PMC6787971
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
589Subventions
Organisme : Skin Cancer Council Germany (NVKH)
ID : HF02-Z05-P02
Références
Cochrane Database Syst Rev. 2012 Dec 12;12:CD004415
pubmed: 23235610
J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):8-10
pubmed: 10607350
Trials. 2012 Aug 06;13:132
pubmed: 22867278
J Clin Epidemiol. 2011 Apr;64(4):395-400
pubmed: 21194891
PLoS Med. 2017 Nov 16;14(11):e1002447
pubmed: 29145404
Trials. 2018 Aug 22;19(1):451
pubmed: 30134949
Cancer. 2009 Jun 1;115(11):2523-30
pubmed: 19382202
Value Health. 2014 Nov;17(7):A435
pubmed: 27201147
Trials. 2018 Oct 5;19(1):541
pubmed: 30290840
Int J Qual Health Care. 2007 Dec;19(6):349-57
pubmed: 17872937
J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):4-7
pubmed: 10607349
Trials. 2017 Jun 20;18(Suppl 3):280
pubmed: 28681707
BMJ. 1995 Jul 8;311(6997):109-12
pubmed: 7613363
J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2069-79
pubmed: 26370093