Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study.

BACKGROUND: 300 million operations and procedures are performed annually across the world, all of which require a patient's informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. METHODS: The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration- https://www.comet-initiative.org/Studies/Details/1024 ). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. RESULTS: 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the 'consensus in' criteria. 6 met 'consensus in' all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting 'consensus in' were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. CONCLUSION: This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.

Surgical trainee experience and opinion of robotic surgery in surgical training and vision for the future: a snapshot study of pan-specialty surgical trainees.

BACKGROUND:  Robotic surgery is well established across multiple surgical specialities in the United Kingdom (UK) and Republic of Ireland (ROI). We aimed to elucidate current surgical trainee experience of and attitudes to robotic surgery in a surgical training programme across the UK and ROI to determine the future role of robotic surgery in international surgical training programmes. Methods: A pan-specialty trainee cross-sectional study was performed on behalf of the Association of Surgeons in Training (ASiT) using mixed-methodology. Round 1: a digital questionnaire was disseminated to all ASiT members. Round 2: 'live-polling' was performed prior to and following the Robotic Surgery plenary session convened at the ASiT 2020 International Conference (Birmingham). Data analysis was performed using a combination of quantitative and qualitative methods. RESULTS:  Three hundred and four responses were analysed (n = 244 digital questionnaire, n = 60 live-polling). Overall, 73.8% (n = 180) of trainees would value greater access to robotic surgery training. 73.4% (n = 179) believed that robotic surgery was important for the future of their desired specialty and 77.2% (n = 156) believed it should be incorporated into formal surgical training. Qualitative analysis identified that trainees believe that robotic training should have a formal role in surgical training. Perceived disadvantages of robotic surgery experience in surgical training included expense and the current impact of consultant robotic learning curves on training. CONCLUSION:  Current surgical trainees desire greater access to robotic surgery in surgical training. Robotic surgery is developing an increasing role in current surgical practice and it is important that it is introduced in a timely, evidence-based fashion to surgical trainees at an appropriate stage of training.