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BACKGROUND Sustainable implementation of telemonitoring in healthcare is challenging. Especially so, if one aims to scale-up telemonitoring initiatives nationwide. OBJECTIVE The purpose of this study protocol is to describe the methodology and evaluation of a collaborative eHealth program, attempting to do precisely so. The National collaborative eHealth program of the Netherlands is supporting implementation of telemonitoring in three clinical domains in all Dutch University Medical Centers (umc’s). The chosen themes are: 1) telemonitoring solutions in the domain of cardiology, 2) telemonitoring solutions providing care-at-a distance in obstetrics and 3) telemonitoring solutions monitoring vital functions in hospital wards. METHODS A before-and-after study will be conducted to assess the degree of successful implementation. Primary outcome of study is the degree of normalization in which health care providers in umc’s consider telemonitoring to be a part of their routine practice. The secondary outcome is the uptake of telemonitoring in the Dutch umc’s. The framework for Non-adoption, Abandonment, Scale-up, Spread and Sustainability (NASSS) will be used to safeguard for structured analysis. Normalization of telemonitoring will be measured using the Normalization MeAsurement Development tool (NoMAD). RESULTS Data will be collected between May 2020 and December 2022. Results will be retrieved in June 2023. CONCLUSIONS This study expects to yield unique evidence and insights about the use of telemonitoring in Dutch umc’s and hence provide better understanding on how to scale-up telemonitoring across the healthcare sector. The study protocol could serve as inspiration for those planning to execute a programmatic intervention supporting a large-scale scale-up of eHealth.

UNSTRUCTURED Despite the increase in use and high expectations of digital health solutions, scientific evidence about the effectiveness of electronic health (eHealth) and other aspects such as usability and accuracy is lagging behind. eHealth solutions are complex interventions, which require a wide array of evaluation approaches that are capable of answering the many different questions that arise during the consecutive study phases of eHealth development and implementation. However, evaluators seem to struggle in choosing suitable evaluation approaches in relation to a specific study phase. The objective of this project was to provide a structured overview of the existing eHealth evaluation approaches, with the aim of assisting eHealth evaluators in selecting a suitable approach for evaluating their eHealth solution at a specific evaluation study phase. Three consecutive steps were followed. Step 1 was a systematic scoping review, summarizing existing eHealth evaluation approaches. Step 2 was a concept mapping study asking eHealth researchers about approaches for evaluating eHealth. In step 3, the results of step 1 and 2 were used to develop an “eHealth evaluation cycle” and subsequently compose the online “eHealth methodology guide.” The scoping review yielded 57 articles describing 50 unique evaluation approaches. The concept mapping study questioned 43 eHealth researchers, resulting in 48 unique approaches. After removing duplicates, 75 unique evaluation approaches remained. Thereafter, an “eHealth evaluation cycle” was developed, consisting of six evaluation study phases: conceptual and planning, design, development and usability, pilot (feasibility), effectiveness (impact), uptake (implementation), and all phases. Finally, the “eHealth methodology guide” was composed by assigning the 75 evaluation approaches to the specific study phases of the “eHealth evaluation cycle.” Seventy-five unique evaluation approaches were found in the literature and suggested by eHealth researchers, which served as content for the online “eHealth methodology guide.” By assisting evaluators in selecting a suitable evaluation approach in relation to a specific study phase of the “eHealth evaluation cycle,” the guide aims to enhance the quality, safety, and successful long-term implementation of novel eHealth solutions.

BACKGROUND Despite the increase in use and high expectations of digital health solutions, scientific evidence about the effectiveness of electronic health (eHealth) and other aspects such as usability and accuracy is lagging behind. eHealth solutions are complex interventions, which require a wide array of evaluation approaches that are capable of answering the many different questions that arise during the consecutive study phases of eHealth development and implementation. However, evaluators seem to struggle in choosing suitable evaluation approaches in relation to a specific study phase. OBJECTIVE The objective of this project was to provide a structured overview of the existing eHealth evaluation approaches, with the aim of assisting eHealth evaluators in selecting a suitable approach for evaluating their eHealth solution at a specific evaluation study phase. METHODS Three consecutive steps were followed. Step 1 was a systematic scoping review, summarizing existing eHealth evaluation approaches. Step 2 was a concept mapping study asking eHealth researchers about approaches for evaluating eHealth. In step 3, the results of step 1 and 2 were used to develop an “eHealth evaluation cycle” and subsequently compose the online “eHealth methodology guide.” RESULTS The scoping review yielded 57 articles describing 50 unique evaluation approaches. The concept mapping study questioned 43 eHealth researchers, resulting in 48 unique approaches. After removing duplicates, 75 unique evaluation approaches remained. Thereafter, an “eHealth evaluation cycle” was developed, consisting of six evaluation study phases: conceptual and planning, design, development and usability, pilot (feasibility), effectiveness (impact), uptake (implementation), and all phases. Finally, the “eHealth methodology guide” was composed by assigning the 75 evaluation approaches to the specific study phases of the “eHealth evaluation cycle.” CONCLUSIONS Seventy-five unique evaluation approaches were found in the literature and suggested by eHealth researchers, which served as content for the online “eHealth methodology guide.” By assisting evaluators in selecting a suitable evaluation approach in relation to a specific study phase of the “eHealth evaluation cycle,” the guide aims to enhance the quality, safety, and successful long-term implementation of novel eHealth solutions.

The Academic Medical Center, Amsterdam, has started a trial to evaluate the usefulness to team debriefings of performance reports generated by a medical data recorder (MDR) in the operating room (OR). Outcome performance reports in structured debriefings in a secure, non-punitive environment are likely to heighten the level of situational awareness of OR teams. This may prevent future error. In addition, the use of video and - even more likely - use of an MDR may contribute to establishing a 'just culture' in the OR. MDRs offer a wealth of data, but only if these data are processed well do the resulting outcome reports reveal insights useful for structured debriefings. The implementation of video recordings or MDRs must be preceded by carefully addressing privacy and litigation issues relating to both OR staff and patients. In this article, we address viewpoints and discuss implementation strategy and the legal considerations involved in enabling the use of video and data registration in the OR.

The aim of the study was to determine if the concept of face and construct validity may apply to the SurgicalSim Educational Platform (SEP) "robot" simulator. The SEP robot simulator is a virtual reality (VR) simulator aiming to train users on the Da Vinci Surgical System. To determine the SEP's face validity, two questionnaires were constructed. First, a questionnaire was sent to users of the Da Vinci system (reference group) to determine a focused user-group opinion and their recommendations concerning VR-based training applications for robotic surgery. Next, clinical specialists were requested to complete a pre-tested face validity questionnaire after performing a suturing task on the SEP robot simulator. To determine the SEP's construct validity, outcome parameters of the suturing task were compared, for example, relative to participants' endoscopic experience. Correlations between endoscopic experience and outcome parameters of the performed suturing task were tested for significance. On an ordinal five-point, scale the average score for the quality of the simulator software was 3.4; for its hardware, 3.0. Over 80% agreed that it is important to train surgeons and surgical trainees to use the Da Vinci. There was a significant but marginal difference in tool tip trajectory (p = 0.050) and a nonsignificant difference in total procedure time (p = 0.138) in favor of the experienced group. In conclusion, the results of this study reflect a uniform positive opinion using VR training in robotic surgery. Concepts of face and construct validity of the SEP robotic simulator are present; however, these are not strong and need to be improved before implementation of the SEP robotic simulator in its present state for a validated training curriculum to be successful .

To prevent unnecessary mistakes and avoidable complications in laparoscopic surgery, there has to be proper training. A safe way to train surgeons for laparoscopy is simulation. This study addresses the face validity of ProMIS, an Augmented Reality laparoscopic simulator, as a tool for training suturing skills in laparoscopic surgery. A two-paged, 12-item structured questionnaire, using a five-point-Likert scale, was presented to 50 surgeons/surgical interns. The participants were allotted to two groups: an "expert" (50 procedures; N=23) and a referent group (50 procedures; N=27). Non-parametric statistics were used to determine statistical differences. General consensus existed in both expert and referent groups, delineating ProMIS as a useful tool in teaching suturing skills surgeons/surgical interns (mean + or - st dev, resp, score 4.91 + or - 0.42 and 4.93 + or - 0.38) with regard to realism, tactile feedback, and suturing techniques. Significant differences in opinion regarding the ergonomics and design of ProMIS between the expert and referent groups existed. The ProMIS Augmented Reality laparoscopic simulator is regarded as a useful tool in laparoscopic training in both expert and referent groups. Although significant differences in opinion existed with regards to ergonomics and design of ProMIS, they were present between experts and novices.

The aim of the study was to determine if the concept of face and construct validity may apply to the SurgicalSim Educational Platform (SEP) "robot" simulator. The SEP robot simulator is a virtual reality (VR) simulator aiming to train users on the Da Vinci Surgical System. To determine the SEP's face validity, two questionnaires were constructed. First, a questionnaire was sent to users of the Da Vinci system (reference group) to determine a focused user-group opinion and their recommendations concerning VR-based training applications for robotic surgery. Next, clinical specialists were requested to complete a pre-tested face validity questionnaire after performing a suturing task on the SEP robot simulator. To determine the SEP's construct validity, outcome parameters of the suturing task were compared, for example, relative to participants' endoscopic experience. Correlations between endoscopic experience and outcome parameters of the performed suturing task were tested for significance. On an ordinal five-point, scale the average score for the quality of the simulator software was 3.4; for its hardware, 3.0. Over 80% agreed that it is important to train surgeons and surgical trainees to use the Da Vinci. There was a significant but marginal difference in tool tip trajectory (p = 0.050) and a nonsignificant difference in total procedure time (p = 0.138) in favor of the experienced group. In conclusion, the results of this study reflect a uniform positive opinion using VR training in robotic surgery. Concepts of face and construct validity of the SEP robotic simulator are present; however, these are not strong and need to be improved before implementation of the SEP robotic simulator in its present state for a validated training curriculum to be successful

This study determines the expert and referent face validity of LAP Mentor, the first procedural virtual-reality (VR) trainer. After a hands-on introduction to the simulator a questionnaire was administered to 49 participants (21 expert laparoscopists and 28 novices). There was a consensus on LAP Mentor being a valid training model for basic skills training and the procedural training of laparoscopic cholecystectomies. As 88% of respondents saw training on this simulator as effective and 96% experienced this training as fun it will likely be accepted in the surgical curriculum by both experts and trainees. Further validation of the system is required to determine whether its performance concurs with these favourable expectations

This study determines the expert and referent face validity of LAP Mentor, the first procedural virtual-reality (VR) trainer. After a hands-on introduction to the simulator a questionnaire was administered to 49 participants (21 expert laparoscopists and 28 novices). There was a consensus on LAP Mentor being a valid training model for basic skills training and the procedural training of laparoscopic cholecystectomies. As 88% of respondents saw training on this simulator as effective and 96% experienced this training as fun it will likely be accepted in the surgical curriculum by both experts and trainees. Further validation of the system is required to determine whether its performance concurs with these favourable expectations.