1 Avery K, et al. BMJ Open 2019;9:e029574. doi:10.1136/bmjopen-2019-029574 Open access Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study) Kerry Avery,  1 Jane Blazeby, 1,2 Nicholas Wilson, 1 Rhiannon Macefeld, 1 Sian Cousins, 1 Barry Main,  1,2 Natalie S Blencowe,  1,2 Jesmond Zahra, 1 Daisy Elliott, 1 Robert Hinchliffe, 1,3 Shelley Potter  1,4 To cite: Avery K, Blazeby J, Wilson N, et al. Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study). BMJ Open 2019;9:e029574. doi:10.1136/ bmjopen-2019-029574 ► Prepublication history for this paper is available online. To view these fles please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2019- 029574). KA and SP contributed equally. Received 31 January 2019 Revised 20 June 2019 Accepted 09 July 2019 For numbered affliations see end of article. Correspondence to Dr Kerry Avery; kerry.avery@bristol.ac.uk Protocol © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. Strengths and limitations of this study ► Consensus methods will be used to develop guid- ance and core outcome sets (COS) for seamless, standardised evaluation and reporting of outcomes of innovative invasive procedures and medical devices. ► Guidance and COS(s) will be developed with multi- national, multi-stakeholder input, including patients, surgeons, device manufacturers, regulators, meth- odologists and journal editors. ► Multiple novel data sources beyond traditional sys- tematic reviews will generate a list of guidance items and outcomes of relevance to evaluating in- novative procedures and devices. ► An integrated randomised methodological study will investigate methods for optimally achieving consen- sus during Delphi surveys. ► Further work is needed to explore how to optimal- ly implement and monitor use of the guidance and COS(s). ABSTRACT Introduction Rigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation. Methods and analysis A COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modifcation and, if necessary, supplementary domains relevant to specifc phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS- STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases: 1. Generation of a list of relevant outcome domains and reporting items identifed from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identifed items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items. 2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome. 3. A consensus meeting with key stakeholders will discuss and agree the fnal content of the reporting guidance and COS(s). Ethics and dissemination Ethical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientifc meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events. INTRODUCTION Methods for introducing innovative invasive (surgical) procedures and medical devices (any devices used inside the body including