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Please cite this paper as: Schreuder H, Wolswijk R, Zweemer R, Schijven M, Verheijen R. Training and learning robotic surgery, time for a more structured approach: a systematic review. BJOG 2012;119:137-149. Background Robotic assisted laparoscopic surgery is growing rapidly and there is an increasing need for a structured approach to train future robotic surgeons. Objectives To review the literature on training and learning strategies for robotic assisted laparoscopic surgery. Search strategy A systematic search of MEDLINE, EMBASE, the Cochrane Library and the Journal of Robotic Surgery was performed. Selection criteria We included articles concerning training, learning, education and teaching of robotic assisted laparoscopic surgery in any specialism. Data collection and analysis Two authors independently selected articles to be included. We categorised the included articles into: training modalities, learning curve, training future surgeons, curriculum design and implementation. Main results We included 114 full text articles. Training modalities such as didactic training, skills training (dry lab, virtual reality, animal or cadaver models), case observation, bedside assisting, proctoring and the mentoring console can be used for training in robotic assisted laparoscopic surgery. Several training programmes in general and specific programmes designed for residents, fellows and surgeons are described in the literature. We provide guidelines for development of a structured training programme. Authors' conclusions Robotic surgical training consists of system training and procedural training. System training should be formally organised and should be competence based, instead of time based. Virtual reality training will play an import role in the near future. Procedural training should be organised in a stepwise approach with objective assessment of each step. This review aims to facilitate and improve the implementation of structured robotic surgical training programmes. [ABSTRACT FROM AUTHOR]

Background: The Enhanced Recovery After Surgery (ERAS) protocol improved perioperative colorectal care. Although the protocol is firmly implemented across hospital settings, there are benefits to gain by actively involving patients in their recovery. The main objective of this study was to investigate whether compliance with selected items in the ERAS protocol could further improve by using a patient-centred mobile application., Method: This multicentre, randomised controlled trial was conducted between October 2019 and September 2022. Patients aged 18 years or older who underwent elective colorectal surgery, and in possession of a smartphone were included. The intervention group used a mobile application combined with an activity tracker to be guided and supported through the ERAS pathway. The control group received standard care and wore an activity tracker to monitor their daily activities. The primary outcome was overall compliance with selected active elements of the ERAS protocol., Results: In total, 140 participants were randomised to either the intervention (n = 72) or control group (n = 68). The use of the ERAS App demonstrated a significant improvement in overall compliance by 10%, particularly in early solid food intake by 42% and early mobilization by 27%. Postoperative or patient reported outcomes did not differ between groups., Conclusion: The smartphone application 'ERAS App' is able to improve adherence to the active elements of the ERAS protocol for colorectal surgery. This is an important step towards optimizing perioperative care for colorectal surgery patients and enabling patients to optimize being in control of their own recovery. Trial registration: ERAS APPtimize, NTR7314 (https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON29410)., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Sebastiaan van der Storm, Malou Mulder, Hendrik Marsman, Frank den Boer, have no conflicts of interest to disclose. Marilou Jansen is the content developer of the app and Marlies Schijven is the owner of the app. Esther Consten is Proctor for Intuitive Surgical. Willem Bemelman declares that he has received scientific grants from VIFOR and has received speaker fees from Janssen, Medtronic and Galapagos. Christianne Buskens declares that she has received scientific grants from Boehringer Ingelheim and Roche and has received speaker fees from Janssen, Medtronic and Galapagos Hans de Boer is Chairman ERAS Society and Chairman Dutch ERAS Society.

Introduction: Surgical gastric fundoplication is an effective treatment option for gastroesophageal reflux disease. In contrast to acid suppression, fundoplication nearly abolishes all types of reflux, acid and nonacid. However, in some cases lasting side effects of the procedure may overshadow its positive effects. It has remained difficult to determine which patients are the most suitable candidates for fundoplication., Areas Covered: This review aims to evaluate the available data on preoperative factors that are associated with the outcome of fundoplication and to determine which combination of patient characteristics and preoperative test results provides optimal selection. In addition, we assess the need for tailoring the procedure on the basis of the preoperative quality of esophageal peristalsis., Expert Opinion: Surgical treatment of gastroesophageal reflux disease is underutilized as it may provide an excellent option for a subset of GERD patients. It is not sensible to restrict surgical treatment to patients who do not respond to acid suppression. However, meticulous patient selection is key. Most importantly, surgical treatment should not be considered in patients in whom there is no convincing evidence that the symptoms are caused by reflux. Impaired esophageal peristalsis should not be regarded as a contraindication against fundoplication.

Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Online video consultation (OVC) is increasingly used in patient-surgeon pre-surgical and follow-up consultation but a comprehensive review assessing its benefits and downsides as compared to face-to-face (F2F) consultation is currently lacking. This systematic review evaluated the effectiveness of OVC as compared to F2F consultation., Methods: A literature search (Ovid/Medline, Embase, and Clarivate Analytics/Web of Science Core Collection) was conducted including studies comparing efficacy, patient and surgeon satisfaction, and information recall between OVC and F2F patient-surgeon consultation (inception-December 4, 2023)., Results: Out of 1021 studies, 14 studies with 13,564 patients met the eligibility criteria, consisting of seven RCTs, three prospective, and four retrospective studies. Various types of surgical consultations were evaluated, including new referrals, routine follow-ups, postoperative follow-ups, and mixed consultations (both pre- and postoperative). None of the randomized trials exclusively compared OVC with F2F consultations in the high-demand preoperative setting, or assessed patient information recall. Efficacy outcomes were reported by seven studies. Among these, three RCTs showed that OVC improved efficacy in terms of waiting time (8.2 vs. 20.7 min, P = 0.01) and total appointment time (24 vs 71 min, P = 0.001, and 21.9 vs. 154.8 min, P = 0.001). Patient satisfaction was reported by 10 studies. Regarding patient satisfaction, one "mixed design" study favoured OVC (92% vs. 63%, P = 0.04), while eight studies reported similar outcomes., Conclusions: This systematic review identified some benefits of OVC such as shorter waiting and total appointment times as compared to F2F patient-surgeon consultation, although the true value of OVC remains unknown due to the limited available evidence. Future pragmatic RCTs are needed, which should include the pre-surgical consultation and assess patient information recall., Competing Interests: Declarations. Disclosures: ten Haaft, Montorsi, Barsom, Kazemier, Schijven, and Besselink declare no competing interests., (© 2024. The Author(s).)

Recent publications on digital health technologies highlight the importance of 'responsible' use. References to the concept of responsibility are, however, frequently made without providing clear definitions of responsibility, thus leaving room for ambiguities. Addressing these uncertainties is critical since they might lead to misunderstandings, impacting the quality and safety of healthcare delivery. Therefore, this study investigates how responsibility is interpreted in the context of using digital health technologies, including artificial intelligence (AI), telemonitoring, wearables and mobile apps. We conducted a scoping review with a systematic search in PubMed, Web of Science, Embase, CINAHL and Philosopher's Index. A total of 34 articles were included and categorized using a theoretical framework of responsibility aspects, and revealed two main findings. First, we found that digital health technologies can expand and shift existing 'role responsibilities' among caregivers, patients and technology. Second, moral responsibility is often equated with liability or accountability, without clear justification. Articles describe new ways in which physicians can be held accountable, particularly in the context of AI, and discuss the emergence of a 'responsibility gap' where no-one can be fully responsible for AI-generated outcomes. The literature also shows that m-Health technologies can increase patients' accountability for their own health. However, there was limited discussion in the reviewed literature on whether these attributions of accountability are appropriate. We conclude with implications for practice and suggestions for expanding the theoretical framework of moral responsibility, recommending further study on responsibility of collectives and artificial entities, and on the role of virtue in digital health., Competing Interests: Declarations. Competing interests: The authors have no competing interests to declare that are relevant to the content of this article., (© 2024. The Author(s).)

Guideline-directed medical therapy (GDMT) has clear benefits on morbidity and mortality in patients with heart failure; however, GDMT use remains low. In the multicenter, open-label, investigator-initiated ADMINISTER trial, patients (n = 150) diagnosed with heart failure and reduced ejection fraction (HFrEF) were randomized (1:1) to receive usual care or a strategy using digital consults (DCs). DCs contained (1) digital data sharing from patient to clinician (pharmacotherapy use, home-measured vital signs and Kansas City Cardiomyopathy Questionnaires); (2) patient education via a text-based e-learning; and (3) guideline recommendations to all treating clinicians. All remotely gathered information was processed into a digital summary that was available to clinicians in the electronic health record before every consult. All patient interactions were standardly conducted remotely. The primary endpoint was change in GDMT score over 12 weeks (ΔGDMT); this GDMT score directly incorporated all non-conditional class 1 indications for HFrEF therapy with equal weights. The ADMINISTER trial met its primary outcome of achieving a higher GDMT in the DC group after a follow-up of 12 weeks (ΔGDMT score in the DC group: median 1.19, interquartile range (0.25, 2.3) arbitrary units versus 0.08 (0.00, 1.00) in usual care; P < 0.001). To our knowledge, this is the first multicenter randomized controlled trial that proves a DC strategy is effective to achieve GDMT optimization. ClinicalTrials.gov registration: NCT05413447 ., (© 2024. The Author(s).)

Purpose: The purpose of this research was to develop the Satisfaction Concerning Stoma Care Questionnaire (SSCQ) and evaluate its structural and convergent validity and internal reliability., Design: Instrument development and evaluation of validity and reliability., Subjects and Setting: A preliminary 22-item SSCQ was administered in a larger web-based survey to members of 2 ostomy-related patient associations with members throughout the Netherlands. The data of patients who underwent surgery within 2 years were selected for analysis., Methods: The development of the SSCQ was informed by a preexisting survey that focused on the experiences of stoma patients with general health care. Structural validity and homogeneity of the SSCQ were assessed using explanatory factor analysis and Cronbach's α coefficients. Convergent validity was also evaluated., Results: The final SSCQ comprised 20 items covering 3 domains: "preoperative care and information," "postoperative care and guidance," and "contact with and ostomy nurse." The SSCQ demonstrated structural and convergent validity and internal reliability. The Cronbach's α value of the SSCQ was 0.95, whereas the independent domains retrieved a high α coefficient ranging from 0.90 to 0.93. The SSCQ and independent domains were able to distinguish between high and low patients' ratings for satisfaction concerning the received stoma care., Conclusions: The SSCQ demonstrated structural and convergent reliability, along with internal consistency. It may be used to measure the satisfaction of patients with ostomies concerning stoma care. Future prospective studies using the SSCQ are needed to generate additional insights into providing optimal care for ostomy patients., Competing Interests: The authors have no disclosures or conflicts of interest., (Copyright © 2024 by the Wound, Ostomy, and Continence Nurses Society.)

Background: Profound scientific evaluation of novel digital health technologies (DHTs) is key to enhance successful development and implementation. As such, we previously developed the eHealth evaluation cycle. The eHealth evaluation cycle contains 5 consecutive study phases: conceptual, development, feasibility, effectiveness, and implementation., Objective: The aim of this study is to develop a better understanding of the daily practice of the eHealth evaluation cycle. Therefore, the objectives are to conduct a structured analysis of literature data to analyze the practice of the evaluation study phases and to determine which evaluation approaches are used in which study phase of the eHealth evaluation cycle., Methods: We conducted a systematic literature search in PubMed including the MeSH term "telemedicine" in combination with a wide variety of evaluation approaches. Original peer-reviewed studies published in the year 2019 (pre-COVID-19 cohort) were included. Nonpatient-focused studies were excluded. Data on the following variables were extracted and systematically analyzed: journal, country, publication date, medical specialty, primary user, functionality, evaluation study phases, and evaluation approach. RStudio software was used to summarize the descriptive data and to perform statistical analyses., Results: We included 824 studies after 1583 titles and abstracts were screened. The majority of the evaluation studies focused on the effectiveness (impact; 304/824, 36.9%) study phase, whereas uptake (implementation; 70/824, 8.5%) received the least focus. Randomized controlled trials (RCTs; 170/899, 18.9%) were the most commonly used DHT evaluation method. Within the effectiveness (impact) study phase, RCTs were used in one-half of the studies. In the conceptual and planning phases, survey research (27/78, 35%) and interview studies (27/78, 35%) were most frequently used. The United States published the largest amount of DHT evaluation studies (304/824, 36.9%). Psychiatry and mental health (89/840, 10.6%) and cardiology (75/840, 8.9%) had the majority of studies published within the field., Conclusions: We composed the first comprehensive overview of the actual practice of implementing consecutive DHT evaluation study phases. We found that the study phases of the eHealth evaluation cycle are unequally studied and most attention is paid to the effectiveness study phase. In addition, the majority of the studies used an RCT design. However, in order to successfully develop and implement novel DHTs, stimulating equal evaluation of the sequential study phases of DHTs and selecting the right evaluation approach that fits the iterative nature of technology might be of the utmost importance., (©Anneloek Rauwerdink, Pier Spinazze, Harm Gijsbers, Juul Molendijk, Sandra Zwolsman, Marlies P Schijven, Niels H Chavannes, Marise J Kasteleyn. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 28.08.2024.)

Aim: To synthesize the literature on the experiences of patients, families and healthcare professionals with video calls during hospital admission. Second, to investigate facilitators and barriers of implementation of video calls in hospital wards., Design: Scoping review., Methods: PubMed, CINAHL and Google Scholar were searched for relevant publications in the period between 2011 and 2023. Publications were selected if they focused on experiences of patients, families or healthcare professionals with video calls between patients and their families; or between families of hospitalized patients and healthcare professionals. Quantitative and qualitative data were summarized in data charting forms., Results: Forty-three studies were included. Patients and families were satisfied with video calls as it facilitated daily communication. Family members felt more engaged and felt they could provide support to their loved ones during admission. Healthcare professionals experienced video calls as an effective way to communicate when in-person visits were not allowed. However, they felt that video calls were emotionally difficult as it was hard to provide support at distance and to use communication skills effectively. Assigning local champions and training of healthcare professionals were identified as facilitators for implementation. Technical issues and increased workload were mentioned as main barriers., Conclusion: Patients, families and healthcare professionals consider video calls as a good alternative when in-person visits are not allowed. Healthcare professionals experience more hesitation towards video calls during admission, as it increases perceived workload. In addition, they are uncertain whether video calls are as effective as in-person conservations., Implications for the Clinical Practice: When implementing video calls in hospital wards, policymakers and healthcare professionals should select strategies that address the positive aspects of family involvement at distance and the use of digital communication skills., Patient Contribution: No patient or public contribution., (© 2024 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.)

Background: Receiving a stoma significantly impacts patients' quality of life. Coping with this new situation can be difficult, which may result in a variety of physical and psychosocial problems. It is essential to provide adequate guidance to help patients cope with their stoma, as this positively influences self-efficacy in return. Higher self-efficacy reduces psychosocial problems increasing patient's quality of life. This study investigates whether a new mobile application, the Stoma App, improves quality of life. And if personalized guidance, timed support, and peer contact offered as an in-app surplus makes a difference., Methods: A double-blind, randomized controlled trial was conducted between March 2021 and April 2023. Patients aged > 18 years undergoing ileostomy or colostomy surgery, in possession of a compatible smartphone were included. The intervention group received the full version of the app containing personalized and time guidance, peer support, and generic (non-personalized) stoma-related information. The control group received a restricted version with only generic information. Primary outcome was stoma quality of life. Secondary outcomes included psychological adaption, complications, re-admittance, reoperations, and length of hospital stay., Results: The intervention version of the app was used by 96 patients and the control version by 112 patients. After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month postoperatively (p = 0.038). On secondary outcomes, no significant improvements could be retrieved of the intervention group., Conclusion: The Stoma App improves the quality of life of stoma patients. Peer support and personalized guidance are of significant importance in building self-efficacy. It is to be recommended to implement Stoma app-freely available software qualifying as a medical device-in standard stoma care pathways for the benefits of both patients and healthcare providers., (© 2024. The Author(s).)

Aims: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consults (DCs) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. The investigator-initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled open-label trial to evaluate efficacy and safety of DC in patients on HF treatment., Methods and Results: Patients (n = 150) diagnosed with HF with a reduced ejection fraction will be randomized to DC or standard care (1:1). The intervention group receives multifaceted DCs including (i) digital data sharing (e.g. exchange of pharmacotherapy use and home-measured vital signs), (ii) patient education via an e-learning, and (iii) digital guideline recommendations to treating clinicians. The consults are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, and secondary outcomes include time till full GDMT optimization, patient and clinician satisfaction, time spent on healthcare, and Kansas City Cardiomyopathy Questionnaire. Results will be reported in accordance to the CONSORT statement., Conclusions: The ADMINISTER trial will offer the first randomized controlled data on GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient- and clinician-targeted DC for GDMT optimization., (© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Purpose: Despite the use of perioperative anxiolytics and pain medication, surgery can be a stressful and painful experience. Providing patients with distractions using video and/or audio tools in addition to medication may be helpful. To date, no studies have compared different distraction modalities in a same-day surgical setting in adults. This study aims to determine whether audio-visual distraction with video glasses (AVD) is more effective in reducing anxiety and pain compared to audio distraction (AD) in conscious patients undergoing orthopaedic surgery. It was hypothesised that AVD, being the more immersive modality, would be more effective than AD on the outcome parameters., Methods: Fifty patients undergoing orthopaedic surgery with local and/or regional anaesthesia in a clinical day-care setting were randomly assigned to receive either fixed-scenery AVD or patient-choice AD with music. Primary outcome was anxiety, as measured by the Dutch version of the Spielberger State-Trait Anxiety Inventory-6 (STAI-6) prior to and 15 min after the intervention. Secondary outcomes were pain (Numeric Rating Scale Pain [NRS-P]), systolic and diastolic blood pressure, heart rate and patient satisfaction., Results: Within each group, there was a significant reduction in anxiety (p = 0.028 for AVD, p < 0.001 for AD). In contrast to our hypothesis, listening to music without watching a video (AD group) reduced anxiety significantly more than experiencing full AVD (p = 0.018). The mean pain score did not change significantly within either user group, nor did pain scores differ between user groups., Conclusion: In conscious patients undergoing surgery, watching a movie (using video glasses and a headphone set) and listening to music (using only a headphone set) are able to significantly reduce anxiety. AVD, although believed to provide higher levels of distraction, did not prove to be superior to AD. The clinical relevance of this study highlights the potential benefits of AVD or AD modalities in improving the surgical experience for conscious patients. Further research is required to examine the influence of freedom of choice in content on the aforementioned outcomes. To estimate the true value of higher immersion levels, different distraction modalities (e.g. AVD versus virtual reality) featuring the exact same scenery or content need to be compared., Level of Evidence: Level I., (© 2023. The Author(s).)

Background: Digital tools like digital box trainers and VR seem promising in delivering safe and tailored practice opportunities outside of the surgical clinic, yet understanding their efficacy and limitations is essential. This study investigated Which digital tools are available to train surgical skills, How these tools are used, How effective they are, and What skills they are intended to teach., Methods: Medline, Embase, and Cochrane libraries were systematically reviewed for randomized trials, evaluating digital skill-training tools based on objective outcomes (skills scores and completion time) in surgical residents. Digital tools effectiveness were compared against controls, wet/dry lab training, and other digital tools. Tool and training factors subgroups were analysed, and studies were assessed on their primary outcomes: technical and/or non-technical., Results: The 33 included studies involved 927 residents and six digital tools; digital box trainers, (immersive) virtual reality (VR) trainers, robot surgery trainers, coaching and feedback, and serious games. Digital tools outperformed controls in skill scores (SMD 1.66 [1.06, 2.25], P  < 0.00001, I 2  = 83 %) and completion time (SMD -1.05 [-1.72, -0.38], P  = 0.0001, I 2  = 71 %). There were no significant differences between digital tools and lab training, between tools, or in other subgroups. Only two studies focussed on non-technical skills., Conclusion: While the efficacy of digital tools in enhancing technical surgical skills is evident - especially for VR-trainers -, there is a lack of evidence regarding non-technical skills, and need to improve methodological robustness of research on new (digital) tools before they are implemented in curricula., Key Message: This study provides critical insight into the increasing presence of digital tools in surgical training, demonstrating their usefulness while identifying current challenges, especially regarding methodological robustness and inattention to non-technical skills., Competing Interests: The authors declare no conflict of interest., (© 2023 The Authors.)

Aim: Proper education, guidance and support is crucial before and following creation of a stoma. Patients with a stoma and their close relatives need to adapt to and cope with this new - and sometimes unforeseen - situation, which may result in insecurities and a variety of psychosocial problems. Self-efficacy is associated both with a reduction in psychosocial problems and with improved quality of life. The main objective of this study was to investigate whether self-reported quality of life of patients with a stoma can be enhanced by offering personalized and timed guidance, as well as peer contact, in a patient-centred mobile application., Method: A multicentre, double-blind, randomized controlled trial will be conducted. Consented adults >18 years of age who will receive an ileostomy or colostomy and possess an eligible smartphone will be included. The intervention group will be given the full version of the application (containing personalized and timed guidance, such as operation-specific information and information on the associated care pathway) to install on their smartphone. In addition, the intervention group has access to a protected peer-support platform within the app. The control group will receive a restricted version of the application that contains only generic (non-personalized) stoma-related information. The primary outcome is quality of life, 3 months postoperatively. Secondary outcomes are Patient Reported Outcome Measures (PROMs), such as psychological adaption, as well as number of complications, re-admission and re-operation rates and the length of hospital stay., Results: Patient enrolment began in March 2021. Data collection was not complete when this protocol was submitted., Conclusion: We hypothesize that patients with a stoma who are supported by the intervention version of the app will report a significantly higher quality of life than patients with a stoma who are supported by the control version of the app (ie, are not offered personalized and timed guidance and information and do not have access to peer support in the app)., (© 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

Aim: Self-efficacy in stoma care is essential, as it reduces morbidity and psychosocial problems. Mobile applications (apps) may optimise patients' self-efficacy. This article investigates patients' satisfaction with stoma care, their attitudes towards a supporting app aiming to promote self-efficacy and evaluate which functionalities are desired., Method: A survey was sent to members of the two stoma-related patient associations in the Netherlands. Associations between patient characteristics, satisfaction concerning received stoma care, and willingness to use an app were evaluated., Results: The survey was completed by 1868 patients. Overall satisfaction was scored as 6.6, with shortfalls reported in the preoperative information provision, stoma site selection, and postoperative care. Patients of older age, who were unaware of getting a stoma, had an ileostomy, a low quality of life or psychosocial problems, were less satisfied. An app was expected to be of added value by 59.4% of the patients having a stoma for less than three years, compared to the significantly lower 43.8% expectation rate of the remaining study population (p < 0.001). Moreover, patients with a high frequency of physical or psychosocial problems expressed higher levels of interest., Conclusion: Patients were only moderately satisfied with their received stoma care. A supportive app is most likely beneficial for patients who had a stoma for less than three years, were in an acute situation, and/or have stoma-related problems. Most patients prefer information via internet or on paper, although apps may offer additional benefits. It is important to acknowledge digital literacy and to council patients appropriately about the benefits and help them to use apps., (© 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

Background: The use of apps in healthcare and medical research is increasing. Apps in healthcare may be beneficial to patients and healthcare professionals, but their use comes with potential risks. How to use apps in clinical care is not standard part of medical training, resulting in a lack of knowledge. As healthcare professionals and their employers can be held accountable for the wrongful use of medical apps, this situation is undesirable. This article addresses the most important European legislation regarding medical apps from the perspective of healthcare providers., Methods: This review provides an overview of current and changing regulations, focusing on apps used in healthcare and medical research. Three topics are discussed: 1) the relevant European legislation and its enforcement, 2) the responsibilities and liability of the medical professional when using these apps, and 3) an overview of the most practical considerations medical professionals should know when using or building a medical app., Results: When using and developing medical apps, data privacy must be guaranteed according to the GDPR guidelines. Several international standards make it easier to comply with the GDPR, such as ISO/IEC 27001 and 27002. Medical Devices Regulation was implemented on May 26, 2021, and as a result, medical apps will more often qualify as medical devices. The important guidelines for manufacturers to comply with Medical Devices Regulation are ISO 13485, ISO 17021, ISO 14971 and ISO/TS 82304-2., Conclusion: The use of medical apps in healthcare and medical research can be beneficial to patients, medical professionals, and society as a whole. This article provides background information on legislation and a comprehensive checklist for anyone wanting to start using or building medical apps., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background & Aims: The aim of the study was to evaluate the effect of an electronic positional therapy wearable device on nocturnal gastroesophageal reflux measured by pH-impedance reflux monitoring., Methods: We performed a single-center, prospective, interventional study in 30 patients with nocturnal reflux symptoms and a nocturnal esophageal acid exposure time (AET) ≥1.5% measured off acid-suppressive medication by ambulatory pH-impedance reflux monitoring. Patients were treated with an electronic positional therapy wearable device for 2 weeks. The device vibrates in the right lateral decubitus position so it conditions patients to avoid that sleep position. After 2 weeks treatment, the pH-impedance study was repeated. Primary outcome was the change in nocturnal AET. Secondary outcomes include change in number of reflux episodes and reflux symptoms., Results: Complete data were available for 27 patients (13 females, mean age 49.8 years). The median nocturnal AET decreased from 6.0% (IQR, 2.3-15.3) to 3.1% (0.1-10.8) after 2 weeks of treatment (p = 0.079). The number of reflux episodes was significantly reduced after 2 weeks of treatment (baseline: 8.0 (3.0-12.3) vs. end: 3.0 (1.0-8.0); p = 0.041). Treatment led to a statistically significant decrease in time spent in right lateral decubitus position (baseline: mean 36.9% ± 15.2% vs. end: 2.7% ± 8.2%; p = <0.001) and an increase in the left lateral decubitus position (baseline 29.2% ± 14.8% vs. end: 63.3% ± 21.9%; p = <0.001). Symptom improvement was reported by 70.4% of the patients., Conclusions: Sleep positional therapy using an electronic wearable device promotes sleeping in the left lateral decubitus position and improves reflux parameters measured by pH-impedance reflux monitoring., (© 2023 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.)

Background  Exercises are frequently prescribed to regain function; yet there is no consensus on a standardized protocol, and adherence is low. Smart technology innovations, such as mobile applications, may be useful to provide home-based patient support in rehabilitation after distal radius fractures. Purposes  Our purpose was to establish the potential of digital innovations for support and monitoring of patients and treatment adherence in rehabilitation programs, and additionally, to compare the current practice among physiotherapists to the various wrist exercise regimens and their effectiveness as described in the literature. Methods  Standard practice, including the use of support tools for treatment adherence, was evaluated using a nationwide survey. Then, scientific databases were searched using "distal radius fracture" and "physiotherapy" or "exercise therapy," and related search terms, up until 23 March 2023. Results of the survey and literature review were compared. Results  The survey was completed by 92 therapists. Nonstandardized support tools were used by 81.6% of respondents; 53.2% used some form of technology, including taking photos on the patients' smartphone for home reference. In the literature review, 23 studies were included, of which five described an exercise protocol. Treatment adherence was not reported in any of the included studies. Two studies described the use of smart technology or support tools. Conclusions  There is no consensus on a standardized exercise protocol for rehabilitation after distal radius fractures, neither from a systematic literature search nor from a nationwide survey. Smart technology may facilitate monitoring of patients and exercise adherence, hereby supporting self-efficacy and improving adherence and outcomes., (Thieme. All rights reserved.)

Introduction and Objective: The Dutch university medical centres (UMC's) are on the forefront when it comes to validation, implementation and research of telemonitoring. To aid the UMC's in their effort, the Dutch Government has supported the UMC's by fostering the 'Citrien eHealth program'. This program aims at nationwide implementation and upscaling of telemonitoring via a collaborative network. To quantify the success of this program, this study aims to provide insights into the current adoption of telemonitoring by health care professionals (HCP) within Dutch UMC's., Methods: Based on the evaluation framework as adapted from the Normalization Process Theory (NPT) a cross-sectional study was conducted in all Dutch UMC's. Thirty healthcare professionals (HCPs) per UMC were invited to complete the 23-item Normalization MeAsure Development (NoMAD) questionnaire, a tool to assess the degree of normalisation of telemonitoring., Results: The over-all response rate was 52.4% (124/240). Over 80% of respondents agreed or strongly agreed that they understand how telemonitoring affects the nature of their work, with a mean score of 1.49 (N = 117, SD 0.74). HCPs reported to believe telemonitoring will become a normal part of their work in the near future (N = 124, mean = 8.67, SD = 1.38). Using the Wilcoxon signed-rank test, the difference between current practise and future use of telemonitoring predicts to be statistically significant (Z =  - 7.505, p ≤ 0.001). Mean scores for appropriate training and sufficient resources are relatively low (2.39 and 2.70 respectively), indicating a barrier for collective action., Conclusion: This is the first study to assess the implementation of telemonitoring as standard practise across Dutch UMCs. The HCPs in this study are the frontrunners, believing that telemonitoring will become standard practise in the future despite the fact that it is currently not. Based on the results of this study, both educational and implementation strategies including practical skills training are highly recommended in order to scale up telemonitoring widely., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Mobile applications can facilitate or improve gastrointestinal surgical care by benefiting patients, healthcare providers, or both. The extent to which applications are currently in use in gastrointestinal surgical care is largely unknown, as reported in literature. This systematic review was conducted to provide an overview of the available gastrointestinal surgical applications and evaluate their prospects for surgical care provision., Methods: The PubMed, EMBASE and Cochrane databases were searched for articles up to October 6th 2022. Articles were considered eligible if they assessed or described mobile applications used in a gastrointestinal surgery setting for healthcare purposes. Two authors independently evaluated selected studies and extracted data for analysis. Descriptive data analysis was conducted. The revised Cochrane risk of bias (RoB-2) tool and ROBINS-I assessment tool were used to determine the methodological quality of studies., Results: Thirty-eight articles describing twenty-nine applications were included. The applications were classified into seven categories: monitoring, weight loss, postoperative recovery, education, communication, prognosis, and clinical decision-making. Most applications were reported for colorectal surgery, half of which focused on monitoring. Overall, a low-quality evidence was found. Most applications have only been evaluated on their usability or feasibility but not on the proposed clinical benefits. Studies with high quality evidence were identified in the areas of colorectal (2), hepatopancreatobiliary (1) and bariatric surgery (1), reporting significantly positive outcomes in terms of postoperative recovery, complications and weight loss., Conclusions: The interest for applications and their use in gastrointestinal surgery is increasing. From our study, it appears that most studies using applications fail to report adequate clinical evaluation, and do not provide evidence on the effectiveness or safety of applications. Clinical evaluation of objective outcomes is much needed to evaluate the efficacy, quality and safety of applications being used as a medical device across user groups and settings., (© 2023. The Author(s).)

Background & Aims: For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM., Methods: This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment., Results: Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015)., Conclusions: Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis., Netherlands Trial Registry: NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Backgrounds: To date, it is unclear what the educational response to the restrictions on minimally invasive surgery imposed by the COVID-19 pandemic have been, and how MIS-surgeons see the post-pandemic future of surgical education. Using a modified Delphi-methodology, this study aims to assess the effects of COVID on MIS-training and to develop a consensus on the educational response to the pandemic., Methods: A three-part Delphi study was performed among the membership of the European Association of Endoscopic Surgery (EAES). The first survey aimed to survey participants on the educational response in four educational components: training in the operating room (OR), wet lab and dry lab training, assessment and accreditation, and use of digital resources. The second and third survey aimed to formulate and achieve consensus on statements on, and resources in, response to the pandemic and in post-pandemic MIS surgery., Results: Over 247 EAES members participated in the three rounds of this Delphi survey. MIS-training decreased by 35.6-55.6%, alternatives were introduced in 14.7-32.2% of respondents, and these alternatives compensated for 32.2-43.2% of missed training. OR-training and assessments were most often affected due to the cancellation of elective cases (80.7%, and 73.8% affected, respectively). Consensus was achieved on 13 statements. Although digital resources were deemed valuable alternatives for OR-training and skills assessments, face-to-face resources were preferred. Videos and hands-on training-wet labs, dry labs, and virtual reality (VR) simulation-were the best appreciated resources., Conclusions: COVID-19 has severely affected surgical training opportunities for minimally invasive surgery. Face-to-face training remains the preferred training method, although digital and remote training resources are believed to be valuable additions to the training palette. Organizations such as the EAES are encouraged to support surgical educators in implementing these resources. Insights from this Delphi can guide (inter)national governing training bodies and hospitals in shaping surgical resident curricula in post pandemic times., (© 2022. The Author(s).)

Background: Digital training resources show great promise in augmenting traditional surgical education - especially in times of social distancing and limited surgical caseload. Embedding digital resources in surgical curricula is however not current, nor common practice in Dutch hospitals. While the digital world has become part of a resident's everyday life, surprisingly little is known about surgical residents' experiences and expectations towards use of digital resources for their own surgical education. This study aims to identify digital resources currently used in Dutch surgical curricula and to describe surgical residents' perspectives towards digital education., Methods: A series of semi-structured interviews with Dutch surgical residents were conducted until data sufficiency occurred. The interviews consisted of two parts: 1) current surgical training and implemented digital resources, and 2) future surgical training and the role of digital resources therein. All interviews were digitally recorded, transcribed verbatim, and thematically analyzed., Results: Sixteen surgical residents were interviewed - two out of each of the eight educational regions for surgery in the Netherlands. Five digital resource categories were identified and four general educational themes (requirements, advantages, disadvantages, and general education themes), overarching 13 sub-themes. In general, residents were enthusiastic with regard to using digital resources, especially when the perceived advantages supported their autonomy., Conclusions: Dutch surgical residents indicate that digital resources may support their educational experiences, but state that ideally they must be combined with much appreciated on-the-job training, and be offered to them tailored to their individual needs. No resources are considered to be a "magic bullet" in itself. The specific needs of residents and educators need to be addressed clearly in order to successfully adopt and implement digital resources on a larger scale., Competing Interests: Conflict of Interests Nothing to declare., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: In recent years, the use of Indocyanine Green (ICG) fluorescence-guided surgery during open and laparoscopic procedures has exponentially expanded across various clinical settings. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference on this topic with the aim of creating evidence-based statements and recommendations for the surgical community., Methods: An expert panel of surgeons has been selected and invited to participate to this project. Systematic reviews of the PubMed, Embase and Cochrane libraries were performed to identify evidence on potential benefits of ICG fluorescence-guided surgery on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by the panel; they were then submitted to all EAES members through a two-rounds online survey and results presented at the EAES annual congress, Barcelona, November 2021., Results: A total of 18,273 abstracts were screened with 117 articles included. 22 statements and 16 recommendations were generated and approved. In some areas, such as the use of ICG fluorescence-guided surgery during laparoscopic cholecystectomy, the perfusion assessment in colorectal surgery and the search for the sentinel lymph nodes in gynaecological malignancies, the large number of evidences in literature has allowed us to strongly recommend the use of ICG for a better anatomical definition and a reduction in post-operative complications., Conclusions: Overall, from the systematic literature review performed by the experts panel and the survey extended to all EAES members, ICG fluorescence-guided surgery could be considered a safe and effective technology. Future robust clinical research is required to specifically validate multiple organ-specific applications and the potential benefits of this technique on clinical outcomes., (© 2023. The Author(s).)

Background & Aims: Experimental studies have suggested that sleep position plays a role in the occurrence of nocturnal gastroesophageal reflux and the left lateral decubitus position is most favorable. The aim of this study was to evaluate the effect of a novel electronic sleep positional therapy wearable device on sleep position and nocturnal reflux symptoms., Methods: We performed a double-blind, randomized, sham-controlled trial in patients with nocturnal symptoms of gastroesophageal reflux. Patients were advised to sleep in the left lateral decubitus position and were assigned randomly (1:1) to an electronic sleep positional therapy wearable device, programmed to either produce a vibration when in the right lateral position (intervention) or only during the first 20 minutes (sham). The primary outcome was treatment success, defined as a 50% or more reduction in the nocturnal reflux score. Secondary outcomes included change in sleep position and reflux symptoms., Results: One hundred patients were randomized. In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group (22 of 50) vs 24% in the sham group (12 of 50) (risk difference, 20%; 95% CI, 1.8%-38.2%; P = .03). Treatment led to a significant avoidance of sleeping in the right lateral decubitus position (intervention 2.2% vs sham 23.5%; P = .000) and increased time sleeping in the left lateral decubitus position (intervention 60.9% vs sham 38.5%; P = .000). More reflux-free nights were observed in the intervention group (intervention 9 nights [interquartile range, 6-11 nights] vs sham 6 nights [interquartile range, 3-9 nights]; P = .01)., Conclusions: Sleep positional therapy using an electronic wearable device promotes sleeping in the left lateral decubitus position and effectively alleviates nocturnal reflux symptoms compared with sham treatment (https://www.trialregister.nl, NL8655)., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Surgical errors often occur because of human factor-related issues. A medical data recorder (MDR) may be used to analyze human factors in the operating room. The aims of this study were to assess intraoperative safety threats and resilience support events by using an MDR and to identify frequently discussed safety and quality improvement issues during structured postoperative multidisciplinary debriefings using the MDR outcome report., Methods: In a cross-sectional study, 35 standard laparoscopic procedures were performed and recorded using the MDR. Outcome data were analyzed using the automated Systems Engineering Initiative for Patient Safety model. The video-assisted MDR outcome report reflects on safety threat and resilience support events (categories: person, tasks, tools and technology, psychical and external environment, and organization). Surgeries were debriefed by the entire team using this report. Qualitative data analysis was used to evaluate the debriefings., Results: A mean (SD) of 52.5 (15.0) relevant events were identified per surgery. Both resilience support and safety threat events were most often related to the interaction between persons (272 of 360 versus 279 of 400). During the debriefings, communication failures (also category person) were the main topic of discussion., Conclusions: Patient safety threats identified by the MDR and discussed by the operating room team were most frequently related to communication, teamwork, and situational awareness. To create an even safer operating culture, educational and quality improvement initiatives should aim at training the entire operating team, as it contributes to a shared mental model of relevant safety issues., Competing Interests: Dr Grantcharov holds intellectual property ownership of Surgical Safety Technologies Inc, is the founder of the OR Black Box, and is supported by research grants from Medtronic Canada, Ethicon Canada, Baxter Canada, Olympus Canada, Takeda Canada, and Intuitive Canada. Dr Jung receives consulting fee from Surgical Safety Technologies Inc. Dr Schijven has no conflicts of interest but has been appointed as affiliate scientist to the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto. Drs van Dalen, Dr. Buskens, Dr. Nieveen van Dijkum, and Dr. Bemelman have no conflicts of interest or financial ties considered relevant to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Backgrounds: COVID-19 related reduction of surgical procedures jeopardizes learning on the job of surgical residents. Many educators resorted to digital resources in the search for alternatives. However, these resources are often limited to the extent they offer resident-surgeon interaction like a joint surgical performance does. Here we present a roadmap of livestreaming surgical procedures, and evaluate how surgical livestreams on human cadavers address the unmet educational needs of surgical residents in our Dutch nationwide initiative., Methods: Technical and organizational feasibility, and definition of outcome deliverables for the livestream series and per livestream were essential in livestream development. Faculty selected interventions, lecture contents, and participant preparations. Appropriate location, technical setup, and support were imperative for a stable, high-quality stream with integrated interaction, while maintaining digital privacy. A survey was sent to livestream participants to evaluate each livestream, and allow for constant improvement during the broadcasting of the series. Only surveys which were completed by surgical residents were included in the analysis of this study., Results: Each livestream attracted 139-347 unique viewers and a total of 307 surveys were completed by participants (response rate of 23-38% per livestream). Sixty percent of surveys (n = 185) were completed by surgical residents. Livestreams were highly valued (appreciation 7.7 ± 1.1 and recommendation 8.6 ± 1.1), especially the live procedures combined with interaction and theoretical backgrounds. Criticized were technical difficulties and timing of the livestreams between 5 and 7 pm, which interfered with clinical duties., Conclusion: Livestreaming surgical procedures on human cadavers is a valid and valued solution to augment resident education. Digital privacy and a stable, high-quality interactive stream are essential, as are appropriate moderation and relevant lectures. While livestreaming cannot replace hands-on training in the operating room, it enables surgeon-resident interaction which is key in education-and missed in pre-recorded surgical procedures which are currently available online., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction and Objective: Telemonitoring is a method to monitor a person's vital functions via their physiological data at distance, using technology. While pilot studies on the proposed benefits of telemonitoring show promising results, it appears challenging to implement telemonitoring on a larger scale. The aim of this scoping review is to identify the enablers and barriers for upscaling of telemonitoring across different settings and geographical boundaries in healthcare., Methods: PubMed, Embase, Cinahl, Web of Science, ProQuest and IEEE databases were searched. Resulting outcomes were assessed by two independent reviewers. Studies were considered eligible if they focused on remote monitoring of patients' vital functions and data was transmitted digitally. Using scoping review methodology, selected studies were systematically assessed on their factors of influence on upscaling of telemonitoring., Results: A total of 2298 titles and abstracts were screened, and 19 articles were included for final analysis. This analysis revealed 89 relevant factors of influence: 26 were reported as enabler, 18 were reported as barrier and 45 factors were reported being both. The actual utilisation of telemonitoring varied widely across studies. The most frequently mentioned factors of influence are: resources such as costs or reimbursement, access or interface with electronic medical record and knowledge of frontline staff., Conclusion: Successful upscaling of telemonitoring requires insight into its critical success factors, especially at an overarching national level. To future-proof and facilitate upscaling of telemonitoring, it is recommended to use this type of technology in usual care and to find means for reimbursement early on. A wide programme on change management, nationally or regionally coordinated, is key. Clear regulatory conditions and professional guidelines may further facilitate widespread adoption and use of telemonitoring. Future research should focus on converting the 'enablers and barriers' as identified by this review into a guideline supporting further nationwide upscaling of telemonitoring., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To determine the validity of wrist range of motion (ROM) measurements by the wearable-controlled ReValidate! wrist-rehabilitation game, which simultaneously acts as a digital goniometer. Furthermore, to establish the reliability of the game by contrasting ROM measurements to those found by medical experts using a universal goniometer., Methods: As the universal goniometer is considered the reference standard, inter-rater reliability between surgeons was first determined. Internal validity of the game ROM measurements was determined in a test-retest setting with healthy volunteers. The reliability of the game was tested in 34 patients with a restricted range of motion, in whom the ROM was measured by experts as well as digitally. Intraclass-correlation coefficients (ICCs) were determined and outcomes were analyzed using Bland-Altman plots., Results: Inter-rater reliability between experts using a universal goniometer was poor, with ICCs of 0.002, 0.160 and 0.520. Internal validity testing of the game found ICCs of - 0.693, 0.376 and 0.863, thus ranging from poor to good. Reliability testing of the game compared to medical expert measurements, found that mean differences were small for the flexion-extension arc and the radial deviation-ulnar deviation arc., Conclusion: The ReValidate! game is a reliable home-monitoring device digitally measuring ROM in the wrist. Interestingly, the test-retest reliability of the serious game was found to be considerably higher than the inter-rater reliability of the reference standard, being healthcare professionals using a universal goniometer., Trial Registration Number: (internal hospital registration only) MEC-AMC W17&#95;003 #17.015., (© 2021. The Author(s).)

Background: Patients undergoing invasive cardiothoracic procedures are prone for pre-procedural anxiety and depression. Patient education is known to reduce anxiety. This study was performed to assess the effect of Virtual Reality (VR) as a means to educate patients to reduce pre-procedural anxiety in adult patients undergoing percutaneous closure of a patent foramen ovale (PFO) or atrial septal defect (ASD)., Methods and Results: We randomly assigned 60 patients (48% male; age 44 ​± ​11 years) with an indication for percutaneous PFO or ASD closure to receive pre-procedural education by their cardiologist (control) or to receive additional education through a VR information film depicting the day of the procedure (intervention). The primary outcome was change in the pre-procedural anxiety as assessed using the State Trait Anxiety Inventory (STAI) and the Amsterdam Pre-operative Anxiety and Information Scale (APAIS) questionnaires, filled-in during the outpatient clinic visit (baseline) and one week prior to the procedure (follow-up). At baseline patients in both groups experienced equal levels of anxiety (STAI state anxiety: control 40 ​± ​10 vs. intervention 39 ​± ​9; p ​= ​0.70). During follow-up, anxiety increased in the control group, but remained unchanged in the intervention group (45 ​± ​11 vs. 38 ​± ​7, p ​= ​0.02). No differences were found for the APAIS anxiety scale., Conclusion: Patient education using Virtual Reality is effective in reducing pre-procedural anxiety in patients undergoing percutaneous PFO or ASD closure. General introduction of VR for a large population of patients undergoing invasive cardiac procedures should be considered to reduce anxiety in this already fragile population., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)

Objective: There is no evidence-based treatment for persistent dysphagia after laparoscopic fundoplication. The aim of this study was to evaluate the effect of pneumatic dilation on persistent dysphagia after laparoscopic fundoplication., Design: We performed a multicentre, single-blind, randomised sham-controlled trial of patients with persistent dysphagia (>3 months) after laparoscopic fundoplication. Patients with an Eckardt symptom score ≥4 were randomly assigned to pneumatic dilation (PD) using a 35 mm balloon or sham dilation. Primary outcome was treatment success, defined as an Eckardt score <4 and a minimal reduction of 2 points in the Eckardt score after 30 days. Secondary outcomes included change in stasis on timed barium oesophagogram, change in high-resolution manometry parameters and questionnaires on quality of life, reflux and dysphagia symptoms., Results: Forty-two patients were randomised. In the intention-to-treat analysis, the success rates of PD (7/21 patients (33%)) and sham dilation (8/21 patients (38%)) were similar after 30 days (risk difference -4.7% (95% CI (-33.7% to 24.2%) p=0.747). There was no significant difference in change of stasis on the timed barium oesophagogram after 2 min (PD vs sham: median 0.0 cm, p25-p75 range 0.0-4.3 cm vs median 0.0 cm, p25-p75 range 0.0-0.0; p=0.122) or change in lower oesophageal sphincter relaxation pressure (PD vs sham: 10.54±6.25 vs 14.60±6.17 mm Hg; p=0.052). Quality of life, reflux and dysphagia symptoms were not significantly different between the two groups., Conclusion: Pneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication., Competing Interests: Competing interests: JT received grant support from Sofar, received consulting fees from Ironwood and received speaker fees from Truvion. AJB received grant support from Bayer, Norgine, Nutricia, SST, and received speaker and/or consulting fees from Reckitt Benckiser, Laborie, Medtronic, Regeneron, Celgene, Arena, Esocap, Calypso, AstraZeneca and DrFalk., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: One of the steps of the Surgical Safety Checklist is for the team members to introduce themselves. The objective of this study was to implement a tool to help remember and use each other's names and roles in the operating theatre., Methods: This study was part of a pilot study in which a video and medical data recorder was implemented in one operating theatre and used as a tool for postoperative multidisciplinary debriefings. During these debriefings, name recall was evaluated. Following the implementation of the medical data recorder, this study was started by introducing the theatre cap challenge, meaning the use of name (including role) stickers on the surgical cap in the operating theatre., Findings: In total, 41% (n = 40 out of 98) of the operating theatre members were able to recall all the names of their team at the team briefings. On average 44.8% (n = 103) was wearing the name sticker., Conclusions: The time-out stage of the Surgical Safety Checklist might be inadequate for correctly remembering and using your operating theatre team members' names. For this, the theatre cap challenge may help.

Background: A total of 8 Dutch university hospitals are at the forefront of contributing meaningfully to a future-proof health care system. To stimulate nationwide collaboration and knowledge-sharing on the topic of evidence-based eHealth, the Dutch university hospitals joined forces from 2016 to 2019 with the first Citrien Fund (CF) program eHealth; 29 eHealth projects with various subjects and themes were selected, supported, and evaluated. To determine the accomplishment of the 10 deliverables for the CF program eHealth and to contribute to the theory and practice of formative evaluation of eHealth in general, a comprehensive evaluation was deemed essential., Objective: The first aim of this study is to evaluate whether the 10 deliverables of the CF program eHealth were accomplished. The second aim is to evaluate the progress of the 29 eHealth projects to determine the barriers to and facilitators of the development of the CF program eHealth projects., Methods: To achieve the first aim of this study, an evaluation study was carried out using an adapted version of the Commonwealth Scientific and Industrial Research Organization framework. A mixed methods study, consisting of a 2-part questionnaire and semistructured interviews, was conducted to analyze the second aim of the study., Results: The 10 deliverables of the CF program eHealth were successfully achieved. The program yielded 22 tangible eHealth solutions, and significant knowledge on the development and use of eHealth solutions. We have learned that the patient is enthusiastic about accessing and downloading their own medical data but the physicians are more cautious. It was not always possible to implement the Dutch set of standards for interoperability, owing to a lack of information technology (IT) capacities. In addition, more attention needed to be paid to patients with low eHealth skills, and education in such cases is important. The eHealth projects' progress aspects such as planning, IT services, and legal played an important role in the success of the 29 projects. The in-depth interviews illustrated that a novel eHealth solution should fulfill a need, that partners already having the knowledge and means to accelerate development should be involved, that clear communication with IT developers and other stakeholders is crucial, and that having a dedicated project leader with sufficient time is of utmost importance for the success of a project., Conclusions: The 8 Dutch university hospitals were able to collaborate successfully and stimulate through a bottom-up approach, nationwide eHealth development and knowledge-sharing. In total, 22 tangible eHealth solutions were developed, and significant eHealth knowledge about their development and use was shared. The eHealth projects' progress aspects such as planning, IT services, and legal played an important role in the successful progress of the projects and should therefore be closely monitored when developing novel eHealth solutions., International Registered Report Identifier (irrid): RR2-10.1016/j.ceh.2020.12.002., (©Anneloek Rauwerdink, Marise J Kasteleyn, Niels H Chavannes, Marlies P Schijven. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 25.11.2021.)

Background . Artificial intelligence (AI) is an era upcoming in medicine and, more recently, in the operating room (OR). Existing literature elaborates mainly on the future possibilities and expectations for AI in surgery. The aim of this study is to systematically provide an overview of the current actual AI applications used to support processes inside the OR. Methods . PubMed, Embase, Cochrane Library, and IEEE Xplore were searched using inclusion criteria for relevant articles up to August 25th, 2020. No study types were excluded beforehand. Articles describing current AI applications for surgical purposes inside the OR were reviewed. Results . Nine studies were included. An overview of the researched and described applications of AI in the OR is provided, including procedure duration prediction, gesture recognition, intraoperative cancer detection, intraoperative video analysis, workflow recognition, an endoscopic guidance system, knot-tying, and automatic registration and tracking of the bone in orthopedic surgery. These technologies are compared to their, often non-AI, baseline alternatives. Conclusions . Currently described applications of AI in the OR are limited to date. They may, however, have a promising future in improving surgical precision, reduce manpower, support intraoperative decision-making, and increase surgical safety. Nonetheless, the application and implementation of AI inside the OR still has several challenges to overcome. Clear regulatory, organizational, and clinical conditions are imperative for AI to redeem its promise. Future research on use of AI in the OR should therefore focus on clinical validation of AI applications, the legal and ethical considerations, and on evaluation of implementation trajectory.

Objective: The objective of this study is to determine the characteristics and frequency of intraoperative safety threats and resilience supports using a human factors measurement tool., Background: Human factors analysis can provide insight into how system elements contribute to intraoperative adverse events. Empiric evidence on safety threats and resilience in surgical practice is lacking., Methods: A cross-sectional study of 24 patients undergoing elective laparoscopic general surgery at a single center in the Netherlands from May to November, 2017 was conducted. Video, audio, and patient physiologic data from all included procedures were obtained through a multichannel synchronized recording device. Trained analysts reviewed the recordings and coded safety threats and resilience supports. The codes were categorized into 1 of 6 categories (person, task, tools and technology, physical environment, organization, and external environment)., Results: A median of 14 safety threats [interquartile range (IQR) 11-16] and 12 resilience supports (IQR 11-16) were identified per case. Most safety threat codes (median 9, IQR 7-12) and resilience support codes (median 10, IQR 7-12) were classified in the person category. The organization category contained a median of 2 (IQR 1-2) safety threat codes and 2 (IQR 2-3) resilience support codes per case. The tools and technology category contributed a small number of safety threats (median 1 per case, IQR 0-1), but rarely provided resilience support., Conclusions: Through a detailed human factors analysis of elective laparoscopic general surgery cases, this study provided a quantitative analysis of the existing safety threats and resilience supports in a modern endoscopic operating room., (Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Video consultation (VC) has been scaled up at our academic centre attempting to facilitate and accommodate patient-provider interaction in times of social distancing during the recent and ongoing COVID-19 pandemic., Objectives: This study evaluates qualitative outcomes with data insights from the electronic health record, to contrast satisfaction outcomes with the actual use of VC., Methods: Healthcare providers and patients using VC during the COVID-19 pandemic at a large academic centre in the Netherlands were surveyed for user satisfaction and experiences with VC. In addition, quantitative technical assessment was performed using data related to VC from the EHR record., Results: In total, 1,027/4,443 patients and 87/166 healthcare providers completed their online questionnaire. Users rated the use of VC during a pandemic with an average score of 8.3/10 and 7.6/10 respectively. Both groups believed the use of VC was a good solution to continue the provision of healthcare during this pandemic. The use of VC increased from 92 in March 2020 to 837 in April 2020., Conclusion: This study strongly signals that VC is an important modality in futureproofing outpatient care during and beyond pandemic times. Further development in end-user technology is needed for EHR integrated VC solutions. Guidelines needs to be developed advising both patients and healthcare providers. Such guidelines should not solely focus on technical implementation and troubleshooting, but must also consider important aspects such as digital health literacy, patient and provider authentication, privacy and ethics., (Copyright © 2021. Published by Elsevier B.V.)