{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,10]],"date-time":"2025-04-10T08:09:59Z","timestamp":1744272599915,"version":"3.37.3"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,10,11]],"date-time":"2019-10-11T00:00:00Z","timestamp":1570752000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,10,11]],"date-time":"2019-10-11T00:00:00Z","timestamp":1570752000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015863","name":"Skin Cancer Council Germany","doi-asserted-by":"crossref","award":["HF02-Z05-P02"],"award-info":[{"award-number":["HF02-Z05-P02"]}],"id":[{"id":"10.13039\/100015863","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n              <jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous\u00a0cell 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.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Core Outcome Measures for Effectiveness (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.comet-initiative.org\/studies\/details\/1242\">COMET<\/jats:ext-link>) database. Registered in\u00a0December 2018.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-019-3696-6","type":"journal-article","created":{"date-parts":[[2019,10,11]],"date-time":"2019-10-11T07:11:42Z","timestamp":1570777902000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4603-1825","authenticated-orcid":false,"given":"Markus V.","family":"Heppt","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theresa","family":"Steeb","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lutz","family":"Schmitz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claus","family":"Garbe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars E.","family":"French","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulrike","family":"Leiter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carola","family":"Berking","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,10,11]]},"reference":[{"issue":"1 Pt 2","key":"3696_CR1","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1067\/mjd.2000.103342","volume":"42","author":"SJ Salasche","year":"2000","unstructured":"Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000;42(1 Pt 2):4\u20137.","journal-title":"J Am Acad Dermatol"},{"issue":"1 Pt 2","key":"3696_CR2","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1067\/mjd.2000.103343","volume":"42","author":"RL Moy","year":"2000","unstructured":"Moy RL. Clinical presentation of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000;42(1 Pt 2):8\u201310.","journal-title":"J Am Acad Dermatol"},{"issue":"11","key":"3696_CR3","doi-asserted-by":"publisher","first-page":"2523","DOI":"10.1002\/cncr.24284","volume":"115","author":"VD Criscione","year":"2009","unstructured":"Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF, et al. Actinic keratoses: natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer. 2009;115(11):2523\u201330.","journal-title":"Cancer."},{"issue":"11","key":"3696_CR4","doi-asserted-by":"publisher","first-page":"2069","DOI":"10.1111\/jdv.13180","volume":"29","author":"RN Werner","year":"2015","unstructured":"Werner RN, Stockfleth E, Connolly SM, Correia O, Erdmann R, Foley P, et al. Evidence- and consensus-based (S3) guidelines for the treatment of actinic keratosis\u2014International League of Dermatological Societies in cooperation with the European Dermatology Forum \u2013 Short version. J Eur Acad Dermatol Venereol. 2015;29(11):2069\u201379.","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"Suppl 3","key":"3696_CR5","doi-asserted-by":"publisher","first-page":"280","DOI":"10.1186\/s13063-017-1978-4","volume":"18","author":"PR Williamson","year":"2017","unstructured":"Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET Handbook: version 1.0. Trials. 2017;18(Suppl 3):280.","journal-title":"Trials."},{"key":"3696_CR6","first-page":"CD004415","volume":"12","author":"AK Gupta","year":"2012","unstructured":"Gupta AK, Paquet M, Villanueva E, Brintnell W. Interventions for actinic keratoses. Cochrane Database Syst Rev. 2012;12:CD004415.","journal-title":"Cochrane Database Syst Rev"},{"issue":"6997","key":"3696_CR7","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1136\/bmj.311.6997.109","volume":"311","author":"N Mays","year":"1995","unstructured":"Mays N, Pope C. Rigour and qualitative research. BMJ. 1995;311(6997):109\u201312.","journal-title":"BMJ."},{"key":"3696_CR8","volume-title":"Qualitative researching. 2nd ed","author":"J Mason","year":"2002","unstructured":"Mason J. Qualitative researching. 2nd ed; 2002."},{"key":"3696_CR9","volume-title":"A practical guide for applied research","author":"R Krueger","year":"2015","unstructured":"Krueger R, Casey M. A practical guide for applied research. Thousand Oaks: SAGE; 2015."},{"key":"3696_CR10","unstructured":"Mayring P. Qualitative Inhaltsanalyse. Handbuch qualitativer Forschung: Grundlagen, Konzepte, Methoden und Anwendungen; Beltz Verlag, Weinheim und Basel,\u00a01991."},{"issue":"6","key":"3696_CR11","doi-asserted-by":"publisher","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","volume":"19","author":"A Tong","year":"2007","unstructured":"Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349\u201357.","journal-title":"Int J Qual Health Care"},{"key":"3696_CR12","unstructured":"Bundes\u00e4rztekammer. \u00c4rztestatistik zum 31. Dezember 2017; (11.10.2018). Available from: \n                    https:\/\/www.bundesaerztekammer.de\/fileadmin\/user_upload\/downloads\/pdf-Ordner\/Statistik2017\/Stat17AbbTab.pdf\n                    \n                  . Accessed 11 Oct 2018."},{"issue":"7","key":"3696_CR13","doi-asserted-by":"publisher","first-page":"A435","DOI":"10.1016\/j.jval.2014.08.1118","volume":"17","author":"E Gargon","year":"2014","unstructured":"Gargon E, Gurung B, Medley N, Altman D, Blazeby J, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. Value Health. 2014;17(7):A435.","journal-title":"Value Health"},{"issue":"1","key":"3696_CR14","doi-asserted-by":"publisher","first-page":"451","DOI":"10.1186\/s13063-018-2819-9","volume":"19","author":"P Healy","year":"2018","unstructured":"Healy P, Gordijn S, Ganzevoort W, Beune I, Baschat A, Khalil A, et al. Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE). Trials. 2018;19(1):451.","journal-title":"Trials."},{"issue":"11","key":"3696_CR15","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002447","volume":"14","author":"JJ Kirkham","year":"2017","unstructured":"Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med. 2017;14(11):e1002447.","journal-title":"PLoS Med"},{"issue":"1","key":"3696_CR16","doi-asserted-by":"publisher","first-page":"541","DOI":"10.1186\/s13063-018-2904-0","volume":"19","author":"R Qiu","year":"2018","unstructured":"Qiu R, Li M, Zhang X, Chen S, Li C, Shang H. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials. 2018;19(1):541.","journal-title":"Trials."},{"issue":"4","key":"3696_CR17","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1016\/j.jclinepi.2010.09.012","volume":"64","author":"GH Guyatt","year":"2011","unstructured":"Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395\u2013400.","journal-title":"J Clin Epidemiol"},{"key":"3696_CR18","doi-asserted-by":"publisher","first-page":"132","DOI":"10.1186\/1745-6215-13-132","volume":"13","author":"PR Williamson","year":"2012","unstructured":"Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.","journal-title":"Trials."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3696-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-019-3696-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3696-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,10,9]],"date-time":"2020-10-09T23:18:32Z","timestamp":1602285512000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3696-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,11]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["3696"],"URL":"https:\/\/doi.org\/10.1186\/s13063-019-3696-6","relation":{},"ISSN":["1745-6215"],"issn-type":[{"type":"electronic","value":"1745-6215"}],"subject":[],"published":{"date-parts":[[2019,10,11]]},"assertion":[{"value":"18 April 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 September 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 October 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study received an Institutional Review Board exemption from the Ethics Committee of the Medical Faculty of the LMU Munich on 2 April 2019 (approval number 19\u2013098).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"CB has been a member of advisory boards for Almirall Hermal, Biofrontera, Galderma, ISDIN, and Leo Pharma. CB has received speaker\u2019s honoraria from Almirall Hermal, Galderma, and Leo Pharma. CB has received funding for clinical research from Leo Pharma. LS has received speaker\u2019s honoraria from Almirall Hermal, Galderma, Biofrontera, Mylan, and Beiersdorf. LS has been a member of advisory boards for Almirall Hermal. The remaining authors declare no conflicts of interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"589"}}