A Core Outcome Set for Seamless, Standardized Evaluation of Innovative Surgical Procedures and Devices (COHESIVE): A Patient and Professional Stakeholder Consensus Study.

"Use of a COS does not mean that outcomes in a specific study should be restricted to the COS, and we recommend additional outcomes be collected where relevant. Use of the COS is intended to complement reporting guidelines developed for authors to report studies accurately and comprehensively. For example, stage-specific checklists have recently been published to improve standards of reporting in publications of IDEAL format studies. These checklists recommend that authors declare important contextual information that may be omitted, such as sources of funding and conflicts of interest. A COS specifies what outcomes should be measured. Important next steps to improve the quality and consistency of evaluation of surgical innovation is to reach consensus on how the outcomes should be measured and to evaluate COS uptake in future evaluations. Development of a core measurement set, a set of instruments to measure the COS domains, including identifying a measure of surgeons’ experience, is underway. This involves mapping the COHESIVE COS to COS developed for effectiveness trials to identify outcomes of relevance throughout the innovation lifecycle. In parallel, work with key stakeholders has commenced to co-create a real-time reporting platform to optimize the utility and effective incremental sharing of surgical innovation and outcome data. Future work will consider implementation of the COS in surgical registries and its application to governance processes. Previous research has, for example, explored the benefits of novel methods to improve quality and safety processes for surgical innovation without impeding efficiency and optimal ethical regulation, and the COS is considered complementary to this work. Engagement with the surgical community is essential to ensure uptake of the COS and implementation of real-time outcome sharing, and this work is ongoing. If successful, these measures will promote safe, transparent, and efficient introduction and evaluation of surgical innovation to benefit patients and the wider healthcare community. The authors report no conflicts of interest."

"Use of a COS does not mean that outcomes in a specific study should be restricted to the COS, and we recommend additional outcomes be collected where relevant. Use of the COS is intended to complement reporting guidelines developed for authors to report studies accurately and comprehensively. For example, stage-specific checklists have recently been published to improve standards of reporting in publications of IDEAL format studies. These checklists recommend that authors declare important contextual information that may be omitted, such as sources of funding and conflicts of interest. A COS specifies what outcomes should be measured. Important next steps to improve the quality and consistency of evaluation of surgical innovation is to reach consensus on how the outcomes should be measured and to evaluate COS uptake in future evaluations. Development of a core measurement set, a set of instruments to measure the COS domains, including identifying a measure of surgeons’ experience, is underway. This involves mapping the COHESIVE COS to COS developed for effectiveness trials to identify outcomes of relevance throughout the innovation lifecycle. In parallel, work with key stakeholders has commenced to co-create a real-time reporting platform to optimize the utility and effective incremental sharing of surgical innovation and outcome data. Future work will consider implementation of the COS in surgical registries and its application to governance processes. Previous research has, for example, explored the benefits of novel methods to improve quality and safety processes for surgical innovation without impeding efficiency and optimal ethical regulation, and the COS is considered complementary to this work. Engagement with the surgical community is essential to ensure uptake of the COS and implementation of real-time outcome sharing, and this work is ongoing. If successful, these measures will promote safe, transparent, and efficient introduction and evaluation of surgical innovation to benefit patients and the wider healthcare community. This study was funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at University Hospitals Bristol NHS Foundation Trust and the University of Bristol (BRC-1215-20011). This work was supported by the Royal College of Surgeons of England Bristol Surgical Trials Centre and the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1) (www.bristol.ac.uk/social-community-medicine/centres/conduct2)."