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.

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.

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).

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.

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.