Digital consults in heart failure care: a randomized controlled trial.

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 .

Implementation and Scale-up of Telemonitoring in the Netherlands.

The healthcare system requires reforms for equitable and sustainable care. Telemonitoring offers a solution, yet its implementation lacks research. In the Netherlands, University Medical Centers (UMCs) lead healthcare transformation through the Citrien-2 network, scaling up three telemonitoring programs from 2020 to 2022. An uncontrolled before-after study design was used to evaluate upscaling. Primary outcomes focused on telemonitoring normalization using the Normalisation Process Theory (NoMAD). Secondary outcomes included patient uptake and qualitative analyses. Results show implementation across projects and UMCs, with overall increased patient uptake. Healthcare professionals perceive telemonitoring positively, but challenges persist in integrating it into workflows. Continuous assessment is crucial for addressing implementation complexities and maximizing telemonitoring's impact on healthcare delivery.

Approaches to Evaluating Digital Health Technologies: Scoping Review.

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.

Experiences of healthcare professionals, patients and families with video calls to stimulate patient- and family-centred care during hospitalization: A scoping review.

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.

Better stoma care using the Stoma App: does it help? A first randomized double-blind clinical trial on the effect of mobile healthcare on quality of life in stoma patients.

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.

Digital consults to optimize guideline-directed therapy: design of a pragmatic multicenter randomized controlled trial.

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.

Watching a movie or listening to music is effective in managing perioperative anxiety and pain: a randomised controlled trial.

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.

Which, how, and what? Using digital tools to train surgical skills; a systematic review and meta-analysis.

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, I2 = 83 %) and completion time (SMD -1.05 [-1.72, -0.38], P = 0.0001, I2 = 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.

Rehabilitation after Distal Radius Fractures: Opportunities for Improvement.

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.

A personalized app to improve quality of life of patients with a stoma: A protocol for a multicentre randomized controlled trial.

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).

The National Coordinated Citrien eHealth Program to Scale Up Telemonitoring: Protocol for a Before-and-After Evaluation Study.

BACKGROUND: Sustainable implementation of telemonitoring in health care is challenging, especially if one aims to scale up telemonitoring initiatives nationwide. The National collaborative eHealth program in the Netherlands is supporting the nationwide upscaling of telemonitoring in 3 clinical domains by implementing telemonitoring in all Dutch university medical centers (UMCs). The chosen telemonitoring concepts are (1) telemonitoring solutions in the domain of cardiology, (2) telemonitoring solutions providing care from a distance in obstetrics, and (3) telemonitoring solutions monitoring vital functions in hospital wards. OBJECTIVE: The aim of this study is to evaluate the upscaling of telemonitoring in Dutch university hospitals in order to gain a better knowledge of the process, methods, and outcomes of nationwide upscaling strategies. Our hypothesis is that by the completion of the Citrien program's scale-up, telemonitoring will be operational in all UMCs but not normalized in routine care. METHODS: A before-and-after study will be conducted to assess upscaling. The theoretical frameworks used are the framework for nonadoption, abandonment, scale-up, spread, and sustainability; the Normalization Process Theory; and a project management tool Project Canvas. The primary outcome of the study is the degree of normalization to which health care providers at UMCs consider telemonitoring a part of their routine practice, measured using the Normalization MeAsurement Development tool (NoMAD). Our secondary outcome is the uptake of telemonitoring at the Dutch UMCs, using management data from UMCs' business intelligence systems query. RESULTS: Data will be collected between May 2020 and December 2022. Results were retrieved in June 2023. UMCs' business intelligence systems are queried for data for the secondary outcome measures. There is a risk that the UMCs will not be able to provide this management information. The laws and regulations governing telemonitoring in the Netherlands are changing, with the Electronic Data Exchange in Health Care Act (Wet elektronische gegevensuitwisseling in de zorg) and the European Health Data Space Act expected to positively influence implementation and upscaling. CONCLUSIONS: The Citrien program is a nationally coordinated change management program that is scaling up telemonitoring across contexts and settings. This study will produce original data on the uptake and upscaling of telemonitoring at Dutch UMCs. Future initiatives to implement eHealth in the health care sector may be guided by the wide range of success factors, obstacles, and experiences collected through this program. The network itself may be of great value impacting future acceleration of eHealth initiatives. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45201.

Patient satisfaction with stoma care and their expectations on mobile apps for supportive care.

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.

Apps in healthcare and medical research; European legislation and practical tips every healthcare provider should know.

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.

Accuracy of a Standalone Atrial Fibrillation Detection Algorithm Added to a Popular Wristband and Smartwatch: Prospective Diagnostic Accuracy Study.

BACKGROUND: Silent paroxysmal atrial fibrillation (AF) may be difficult to diagnose, and AF burden is hard to establish. In contrast to conventional diagnostic devices, photoplethysmography (PPG)-driven smartwatches or wristbands allow for long-term continuous heart rhythm assessment. However, most smartwatches lack an integrated PPG-AF algorithm. Adding a standalone PPG-AF algorithm to these wrist devices might open new possibilities for AF screening and burden assessment. OBJECTIVE: The aim of this study was to assess the accuracy of a well-known standalone PPG-AF detection algorithm added to a popular wristband and smartwatch, with regard to discriminating AF and sinus rhythm, in a group of patients with AF before and after cardioversion (CV). METHODS: Consecutive consenting patients with AF admitted for CV in a large academic hospital in Amsterdam, the Netherlands, were asked to wear a Biostrap wristband or Fitbit Ionic smartwatch with Fibricheck algorithm add-on surrounding the procedure. A set of 1-min PPG measurements and 12-lead reference electrocardiograms was obtained before and after CV. Rhythm assessment by the PPG device-software combination was compared with the 12-lead electrocardiogram. RESULTS: A total of 78 patients were included in the Biostrap-Fibricheck cohort (156 measurement sets) and 73 patients in the Fitbit-Fibricheck cohort (143 measurement sets). Of the measurement sets, 19/156 (12%) and 7/143 (5%), respectively, were not classifiable by the PPG algorithm due to bad quality. The diagnostic performance in terms of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy was 98%, 96%, 96%, 99%, 97%, and 97%, 100%, 100%, 97%, and 99%, respectively, at an AF prevalence of ~50%. CONCLUSIONS: This study demonstrates that the addition of a well-known standalone PPG-AF detection algorithm to a popular PPG smartwatch and wristband without integrated algorithm yields a high accuracy for the detection of AF, with an acceptable unclassifiable rate, in a semicontrolled environment.

The effect of sleep positional therapy on nocturnal gastroesophageal reflux measured by esophageal pH-impedance monitoring.

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.

Mobile applications in gastrointestinal surgery: a systematic review.

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.

The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial.

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.

Digital Training Resources in the Dutch Surgical Residency Curricula and the Perspectives of Residents: A Thematic Analysis of Resident Interviews.

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.