Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review

dc.contributor.authorCampana, Luca G.
dc.contributor.authorClover, Anthony J. P.
dc.contributor.authorValpione, Sara
dc.contributor.authorQuaglino, Pietro
dc.contributor.authorGehl, Julie
dc.contributor.authorKunte, Christian
dc.contributor.authorSnoj, Marko
dc.contributor.authorCemazar, Maja
dc.contributor.authorRossi, Carlo R.
dc.contributor.authorMiklavcic, Damijan
dc.contributor.authorSersa, Gregor
dc.date.accessioned2019-11-27T12:27:40Z
dc.date.available2019-11-27T12:27:40Z
dc.date.issued2016-02-16
dc.description.abstractBackground: Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting results, which should strengthen evidence-based practice recommendations. This consensus should be derived from high quality clinical data collection, clinical expertise and summarizing patient feedback. The first step, which is addressed in this paper, aims to critically analyze the quality of published studies and to provide the recommendations for reporting clinical trials on electrochemotherapy. Methods: The quality of reporting in published studies on electrochemotherapy was analyzed in order to produce procedure specific reporting recommendations. A comprehensive literature search of studies published from 2006 to 2015 was performed followed by qualitative analysis of manuscripts assessing for 47 quality criteria grouped into four major clusters: (1) trial design, (2) description of patient population, (3) description of treatment delivery and patient outcome, (4) analysis of results and their interpretation. The summary measure during literature assessment was the proportion of studies fulfilling each manuscript quality criteria. Results: A total of 56 studies were screened, from the period 2006 to 2015, of which 33 were included in the qualitative analysis, with a total of 1215 patients. Overall, the quality of reporting was highly variable. Twenty-four reports (73%) were single-center, non-comparative studies, and only 15 (45%) were prospective in nature (only 2 of them were entered into a clinical trials registry). Electrochemotherapy technique was consistently reported, with most studies (31/33) adhering closely to published standard operating procedures. The quality of reporting the patient population was variable among the analyzed studies, with only between 45% and 100% achieving dedicated quality criteria. Reporting of treatment delivery and patient outcome was also highly variable with studies only fulfilling between 3% and 100%. Finally, reporting study results critically varied, fulfilling from 27% to 100% of the quality criteria. Based on the critical issues emerging from this analysis, recommendations and minimal requirements for reporting clinical data on electrochemotherapy were prepared and summarized into a checklist. Conclusions: There is an increasing body of published clinical data on electrochemotherapy, but more high quality clinical data are needed. Published papers often lack accurate description of study population, treatment delivery as well as patient outcome. Our recommendations, provided in the form of a summary checklist, are intended to ameliorate data reporting in future studies on electrochemotherapy and help researchers to provide a solid evidence basis for clinical practice.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationCampana, L. G., Clover, A. J. P., Valpione, S., Quaglino, P., Gehl, J., Kunte, C., Snoj, M., Cemazar, M., Rossi, C. R., Miklavcic, D. and Sersa, G. (2016) 'Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review', 50(1), pp. 1-13. doi: 10.1515/raon-2016-0006en
dc.identifier.doi10.1515/raon-2016-0006en
dc.identifier.eissn1581-3207
dc.identifier.endpage13en
dc.identifier.issn1318-2099
dc.identifier.issued1en
dc.identifier.journaltitleRadiology and Oncologyen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/9268
dc.identifier.volume50en
dc.language.isoenen
dc.publisherSciendoen
dc.rights© 2016, the Authors. This is an open access article under the Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported (CC BY-NC-ND 3.0) licence.en
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0en
dc.subjectElectrochemotherapyen
dc.subjectClinical trialsen
dc.subjectRecommendationsen
dc.titleRecommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic reviewen
dc.typeArticle (peer-reviewed)en
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