Protocol for the systematic review of the reporting of transoral robotic surgery

Abstract

IntroductionTransoral robotic surgery (TORS) has been adopted in some parts of the world as an innovative approach to the resection of oropharyngeal tumours. The development, details and outcomes of early-to-later phase evaluation of this technique and the quality of evidence to support its adoption into practice have hitherto not been summarised. The aim of this review is to identify and summarise the early and later phase studies of, and evidence for, TORS and to understand how early phase studies report intervention development, governance procedures and selection and reporting of outcomes to optimise methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice. The protocol has been written in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist.Methods and analysisElectronic searches in OVID SP versions of Medline and EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews from the start of indexing to 30 April 2017 will identify studies reporting TORS. At least two independent researchers will identify studies for inclusion. Two researchers will extract data from each paper. Studies will be categorised into IDEAL stages of study design from ‘pre-IDEAL’ to randomised controlled trials (stage 3). Data will be collected about the (1) novel intervention and criteria for modification, (2) governance arrangements and patient information provision, (3) outcome domains selected and reported and (4) quality of study design, conduct and reporting. Descriptive statistics and a narrative synthesis will be presented.Ethics and disseminationThe results of this systematic review will be presented at relevant conferences. The methods will be used to inform future reviews exploring other novel surgical innovations. The findings will be published in a peer-reviewed journal. This study does not require ethical approval.

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

“…The review was conducted in line with the PRISMA statement. Methods were based on those described previously.…”

“…Data collection was based on IDEAL recommendations, and included information about general study characteristics, patient selection, regulatory and governance arrangements, operator and centre expertise, technique description and outcome reporting. Outcome data were extracted from papers reporting follow‐up of initial studies included in the review to acquire information about long‐term outcomes; however, other data were not included to avoid double‐counting of results.…”

“…The IDEAL (Idea, Development, Exploration, Assessment, Long‐term follow‐up) framework aims to overcome this problem using a stepwise means of introducing and evaluating innovative surgical procedures and devices (IDEAL‐D), with the objective of improving transparency, evaluation and reporting of innovation in surgery, and informing evidence‐based practice. Key IDEAL recommendations relate to incremental changes in study design, clinical indications, technique standardization, governance arrangements and outcomes, as the innovation progresses from first‐in‐human to long‐term follow‐up.…”

“…Key IDEAL recommendations relate to incremental changes in study design, clinical indications, technique standardization, governance arrangements and outcomes, as the innovation progresses from first‐in‐human to long‐term follow‐up. To date, reviews of the evidence for MSA have not studied its introduction into clinical practice, so compliance with these IDEAL guidelines for evaluating innovative surgical procedures and devices is unknown. This study therefore aimed to summarize and appraise the reporting of studies of MSA, to understand how this innovative procedure has been introduced and evaluated in relation to the IDEAL recommendations.…”

Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty

“…This systematic review identified published studies of pPIPJa and was conducted in line with the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) [ 21 ]. Methods were based on a previously published protocol and are summarised below [ 22 ].…”