Outcomes reported in randomized controlled trials for mixed and non-IgE-mediated food allergy: Systematic review.

BACKGROUND: Mixed and non-IgE-mediated food allergy is a subset of immune-mediated adverse food reactions that can impose a major burden on the quality of life of affected patients and their families. Clinical trials to study these diseases are reliant upon consistent and valid outcome measures that are relevant to both patients and clinicians, but the degree to which such stringent outcome reporting takes place is poorly studied. OBJECTIVE: As part of the Core Outcome Measures for Food Allergy (COMFA) project, we identified outcomes reported in randomized clinical trials (RCT) of treatments for mixed or non-IgE-mediated food allergy. DESIGN: In this systematic review, we searched the Ovid, MEDLINE and Embase databases for RCTs in children or adults investigating treatments for food protein-induced enterocolitis syndrome, food protein-induced allergic proctocolitis, food protein-induced enteropathy and eosinophilic gastrointestinal disorders including eosinophilic esophagitis [EoE], eosinophilic gastritis and eosinophilic colitis published until 14 October 2022. RESULTS: Twenty-six eligible studies were identified, with 23 focused on EoE (88%). Most interventions were corticosteroids or monoclonal antibodies. All EoE studies assessed patient-reported dysphagia, usually using a non-validated questionnaire. Twenty-two of 23 EoE studies used peak tissue eosinophil count as the primary outcome, usually using a non-validated assessment method, and other immunological markers were only exploratory. Thirteen (57%) EoE studies reported endoscopic outcomes of which six used a validated scoring tool recently recommended as a core outcome for EoE trials. Funding source was not obviously associated with likelihood of an RCT reporting mechanistic versus patient-reported outcomes. Only 3 (12%) RCTs concerned forms of food allergy other than EoE, and they reported on fecal immunological markers and patient-reported outcomes. CONCLUSIONS: Outcomes measured in clinical trials of EoE and non-IgE-mediated food allergy are heterogeneous and largely non-validated. Core outcomes for EoE have been developed and need to be used in future trials. For other forms of mixed or non-IgE-mediated food allergies, core outcome development is needed to support the development of effective treatments. SYSTEMATIC REVIEW REGISTRATION: OSF public registry DOI:10.17605/OSF.IO/AZX8S.

Can mixed reality technologies teach surgical skills better than traditional methods? A prospective randomised feasibility study.

BACKGROUND: Basic surgical skills teaching is often delivered with didactic audio-visual content, and new digital technologies may allow more engaging and effective ways of teaching to be developed. The Microsoft HoloLens 2 (HL2) is a multi-functional mixed reality headset. This prospective feasibility study sought to assess the device as a tool for enhancing technical surgical skills training. METHODS: A prospective randomised feasibility study was conducted. 36 novice medical students were trained to perform a basic arteriotomy and closure using a synthetic model. Participants were randomised to receive a structured surgical skills tutorial via a bespoke mixed reality HL2 tutorial (n = 18), or via a standard video-based tutorial (n = 18). Proficiency scores were assessed by blinded examiners using a validated objective scoring system and participant feedback collected. RESULTS: The HL2 group showed significantly greater improvement in overall technical proficiency compared to the video group (10.1 vs. 6.89, p = 0.0076), and a greater consistency in skill progression with a significantly narrower range of scores (SD 2.48 vs. 4.03, p = 0.026). Participant feedback showed the HL2 technology to be more interactive and engaging with minimal device related problems experienced. CONCLUSIONS: This study has demonstrated that mixed reality technology may provide a higher quality educational experience, improved skill progression and greater consistency in learning when compared to traditional teaching methodologies for basic surgical skills. Further work is required to refine, translate, and evaluate the scalability and applicability of the technology across a broad range of skills-based disciplines.

Developing as health professionals through community volunteering: exploring the value of a partnership between medical students and primary schools online compared to in-person.

INTRODUCTION: Imperial College Teddy Bear Hospital (ICSM-TBH) is a student-led volunteering group, which uses interactive, play-based teaching to educate school pupils aged 5-7 years about healthy lifestyles and healthcare. During the COVID-19 pandemic, volunteering sessions shifted online. The aim of this study was to compare the value of online and in-person ICSM-TBH volunteering for volunteers and school pupils. METHODS: Undergraduate university students at Imperial College London (medicine can be taken as a first degree in the UK) who volunteered with ICSM-TBH between 2019 and 22 were invited to complete an anonymous online questionnaire evaluating their experiences of volunteering online and in-person through Likert-scale questions. Those who completed the questionnaire were also invited to an interview. Teachers who hosted online ICSM-TBH sessions were also invited to an in-person interview, exploring their view of their pupils' experiences with these sessions. Questionnaire results were analysed through descriptive statistics. Interviews were analysed through inductive thematic analysis. RESULTS: Thirty-two university students completed the questionnaire. Of these, 9 experienced both in-person and online volunteering, all of whom preferred in-person volunteering. For those who only volunteered in-person, 92% reported that ICSM-TBH sessions were a positive experience, compared to 100% who volunteered online; 92% in person volunteers agreed or strongly agreed that ICSM-TBH volunteering in person improved their mood, compared to 89% online; and 100% agreed or strongly agreed that ICSM-TBH volunteering in person helped them feel part of a community, compared to 84% online. A total of 12 volunteers and 4 teachers were interviewed, from whom five themes emerged: interaction and engagement (interaction and engagement between pupils and volunteers was more readily achieved in-person); personal and professional development (both online and in-person sessions enabled volunteers to gain valuable skills); community and social (greater sense of community was established in-person); emotional wellbeing and enjoyment (both modalities were enjoyed by volunteers and pupils); and workload (online sessions were more convenient for volunteers but with risk of screen fatigue). CONCLUSION: Overall, both in-person and online volunteering were of substantial benefit to volunteers and school pupils. However, most teachers and volunteers preferred in-person volunteering.

The use of mixed reality technology for the objective assessment of clinical skills: a validation study.

BACKGROUND: Mixed Reality technology may provide many advantages over traditional teaching methods. Despite its potential, the technology has yet to be used for the formal assessment of clinical competency. This study sought to collect validity evidence and assess the feasibility of using the HoloLens 2 mixed reality headset for the conduct and augmentation of Objective Structured Clinical Examinations (OSCEs). METHODS: A prospective cohort study was conducted to compare the assessment of undergraduate medical students undertaking OSCEs via HoloLens 2 live (HLL) and recorded (HLR), and gold-standard in-person (IP) methods. An augmented mixed reality scenario was also assessed. RESULTS: Thirteen undergraduate participants completed a total of 65 OSCE stations. Overall inter-modality correlation was 0.81 (p = 0.01), 0.98 (p = 0.01) and 0.82 (p = 0.01) for IP vs. HLL, HLL vs. HLR and IP vs. HLR respectively. Skill based correlations for IP vs. HLR were assessed for history taking (0.82, p = 0.01), clinical examination (0.81, p = 0.01), procedural (0.88, p = 0.01) and clinical skills (0.92, p = 0.01), and assessment of a virtual mixed reality patient (0.74, p = 0.01). The HoloLens device was deemed to be usable and practical (Standard Usability Scale (SUS) score = 51.5), and the technology was thought to deliver greater flexibility and convenience, and have the potential to expand and enhance assessment opportunities. CONCLUSIONS: HoloLens 2 is comparable to traditional in-person examination of undergraduate medical students for both live and recorded assessments, and therefore is a valid and robust method for objectively assessing performance. The technology is in its infancy, and users need to develop confidence in its usability and reliability as an assessment tool. However, the potential to integrate additional functionality including holographic content, automated tracking and data analysis, and to facilitate remote assessment may allow the technology to enhance, expand and standardise examinations across a range of educational contexts.

Effect of Mixed Reality on Delivery of Emergency Medical Care in a Simulated Environment: A Pilot Randomized Crossover Trial.

Importance: Mixed-reality (MR) technology has the potential to enhance care delivery, but there remains a paucity of evidence for its efficacy and feasibility. Objective: To assess the efficacy and feasibility of MR technology to enhance emergency care delivery in a simulated environment. Design, Setting, and Participants: This pilot randomized crossover trial was conducted from September to November 2021 at a single center in a high-fidelity simulated environment with participants block randomized to standard care (SC) or MR-supported care (MR-SC) groups. Participants were 22 resident-grade physicians working in acute medical and surgical specialties prospectively recruited from a single UK Academic Health Sciences Centre. Data were analyzed from September to December 2022. Intervention: Participants resuscitated a simulated patient who was acutely unwell, including undertaking invasive procedures. Participants completed 2 scenarios and were randomly assigned to SC or MR-SC for the first scenario prior to crossover. The HoloLens 2 MR device provided interactive holographic content and bidirectional audiovisual communication with senior physicians in the MR-SC group. Main Outcomes and Measures: The primary outcome was error rate assessed via the Imperial College Error Capture (ICECAP) multidimensional error-capture tool. Secondary outcomes included teamwork (Observational Teamwork Assessment for Surgery [OTAS]; range, 0-6 and Teamwork Skills Assessment for Ward Care [T-SAW-C]; range, 1-5), scenario completion, stress and cognitive load (NASA Task Load Index [NASA-TLX; range 0-100]), and MR device user acceptability. Results: A total of 22 physicians (15 males [68.2%]; median [range] age, 28 [25-34] years) were recruited. MR technology significantly reduced the mean (SD) number of errors per scenario compared with SC (5.16 [3.34] vs 8.30 [3.09] errors; P = .003), with substantial reductions in procedural (0.79 [0.75] vs 1.52 [1.20] errors; P = .02), technical (1.95 [1.40] vs 3.65 [2.03] errors; P = .01), and safety (0.37 [0.96] vs 0.96 [0.85] errors; P = .04) domains. MR resulted in significantly greater scenario completion rates vs SC (22 scenarios [100%] vs 14 scenarios [63.6%]; P = .003). It also led to significant improvements in the overall quality of teamwork and interactions vs SC as measured by mean (SD) OTAS (25.41 [6.30] vs 16.33 [5.49]; P < .001) and T-SAW-C (27.35 [6.89] vs 18.37 [6.09]; P < .001) scores. As reported via mean (range) NASA-TLX score, there were significant reductions for MR-SC vs SC in participant temporal demands (38 [20-50] vs 46 [30-70]; P = .03) and significant improvements in self-reported task performance (50 [30-60] vs 39 [10-70]; P = .01). Overall, 19 participants (86.4%) reported that they were more confident in making clinical decisions and undertaking clinical procedures with MR support. Conclusions and Relevance: This study found that the use of MR technology reduced error, improved teamwork, and enhanced practitioner confidence when used to support the delivery of simulated emergency medical care. Trial Registration: ClinicalTrials.gov Identifier: NCT05870137.

Evaluating risk stratification scoring systems to predict mortality in patients with COVID-19.

BACKGROUND: The COVID-19 pandemic has necessitated efficient and accurate triaging of patients for more effective allocation of resources and treatment. OBJECTIVES: The objectives are to investigate parameters and risk stratification tools that can be applied to predict mortality within 90 days of hospital admission in patients with COVID-19. METHODS: A literature search of original studies assessing systems and parameters predicting mortality of patients with COVID-19 was conducted using MEDLINE and EMBASE. RESULTS: 589 titles were screened, and 76 studies were found investigating the prognostic ability of 16 existing scoring systems (area under the receiving operator curve (AUROC) range: 0.550-0.966), 38 newly developed COVID-19-specific prognostic systems (AUROC range: 0.6400-0.9940), 15 artificial intelligence (AI) models (AUROC range: 0.840-0.955) and 16 studies on novel blood parameters and imaging. DISCUSSION: Current scoring systems generally underestimate mortality, with the highest AUROC values found for APACHE II and the lowest for SMART-COP. Systems featuring heavier weighting on respiratory parameters were more predictive than those assessing other systems. Cardiac biomarkers and CT chest scans were the most commonly studied novel parameters and were independently associated with mortality, suggesting potential for implementation into model development. All types of AI modelling systems showed high abilities to predict mortality, although none had notably higher AUROC values than COVID-19-specific prediction models. All models were found to have bias, including lack of prospective studies, small sample sizes, single-centre data collection and lack of external validation. CONCLUSION: The single parameters established within this review would be useful to look at in future prognostic models in terms of the predictive capacity their combined effect may harness.