Anne van Dalen

86 I Chapter 3 METHODS Participants, privacy and surgical case selection To ensure the privacy of all participants, the research protocol was checked to be compliant with applicable privacy, legal and regulatory requirements by conducting an official Privacy Impact Assessment (PIA). 19 Legal guidelines were explored before set-up of study. 19 This study was approved by the Hospital Directorate and Works Council (staff representation). An institutional review board (IRB) approval did hence not have to be obtained. 19 The research coordinators (AvD and MS) gave several oral presentations at the different clinical departments involved in the OR to inform all participants about the Transparency in the Operating Room (TOPPER) trial. The objectives and methods were explained, questions were answered and they were asked to give their written informed consent prior to participation. From February 2017 until January 2018, consecutive elective gastro-intestinal laparoscopy cases were recorded using theORBlack Box® (Surgical Safety Technologies Inc., Toronto, Canada). The standardized questionnaire was tested for its adequacy and measured the operating team’s satisfaction, using factor analysis for optimal assessment of underlying constructs. Patients were pre-operatively informed about the study and asked whether they would have any objections to be operated in an OR where an MDR was being used (“opt-out” option). 19 Operating room set-up The OR Black Box® is an MDR that was installed in the ‘ENDOALPHA’ operating suite (Olympus Europa SE & Co. KG, Hamburg) in the Amsterdam University Medical Centres, location AMC. 18, 20 This recorder is able to capture a multitude of data streams in perfect synchronization. Figure 1 depicts the OR theatre set-up, including the position of the cameras, microphones and OR Black Box® touchscreen. Cases were recorded between the time-out and sign-out time stamp of the surgical procedure, according to most recent SURPASS (Surgical Safety Checklist) guidelines, with the consented patient fully draped to optimally ensure the consented