1. 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)
- Author
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Jesmond Zahra, Rhiannon C Macefield, Robert J. Hinchliffe, Kerry N L Avery, Shelley Potter, Natalie S Blencowe, Daisy Elliott, Sian Cousins, Jane M Blazeby, Nicholas Wilson, and Barry Main
- Subjects
operative ,Consensus ,Delphi Technique ,Outcome Assessment ,Device Approval ,Endpoint Determination ,education ,Delphi method ,Guidelines as Topic ,Surgical Equipment ,03 medical and health sciences ,0302 clinical medicine ,Documentation ,Stakeholder Participation ,Surveys and Questionnaires ,Protocol ,Humans ,Medicine ,030212 general & internal medicine ,outcome assessment ,computer.programming_language ,Protocol (science) ,Research ethics ,Medical education ,device approval ,Surgical Procedures ,business.industry ,Stakeholder ,General Medicine ,Operative ,surgical procedures ,3. Good health ,Research Design ,Centre for Surgical Research ,030220 oncology & carcinogenesis ,Plain English ,Practice Guidelines as Topic ,Surgery ,business ,computer ,guidelines as topic ,Delphi - Abstract
IntroductionRigorous 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 analysisA COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific 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 identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified 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 final content of the reporting guidance and COS(s).Ethics and disseminationEthical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific 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.
- Published
- 2019
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