title: Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review.
abstract: BACKGROUND
  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.
authors.forename: Luca G
authors.initials: LG
authors.lastname: Campana
authors.affiliation: Department of Plastic Surgery, Cork University Hospital and Cork Cancer Research Centre, University College Cork, Cork, Ireland.
authors.forename: A James P
authors.initials: AJ
authors.lastname: Clover
authors.forename: Sara
authors.initials: S
authors.lastname: Valpione
authors.affiliation: Department of Medical Sciences, Dermatologic Clinic, University of Torino, Torino, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Quaglino
authors.affiliation: Center for Experimental Drug and Gene Electro transfer, Department of Oncology, Copenhagen University Hospital Herlev, Herlev, Denmark.
authors.forename: Julie
authors.initials: J
authors.lastname: Gehl
authors.affiliation: Department of Dermatology and Allergology, Ludwig-Maximilian University Munich, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Kunte
authors.forename: Marko
authors.initials: M
authors.lastname: Snoj
authors.affiliation: Department of Experimental Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
authors.forename: Maja
authors.initials: M
authors.lastname: Cemazar
authors.forename: Carlo R
authors.initials: CR
authors.lastname: Rossi
authors.affiliation: University of Ljubljana, Faculty of Electrical Engineering, Ljubljana, Slovenia.
authors.forename: Damijan
authors.initials: D
authors.lastname: Miklavcic
authors.affiliation: Department of Experimental Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
authors.forename: Gregor
authors.initials: G
authors.lastname: Sersa
keywords: clinical trials; electrochemotherapy; recommendations