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Evaluation of visual patient predictive for enhancing level 3 situation awareness: protocol for a multicentre randomised computer-based simulation and diagnostic accuracy study (true positive rate, precision, average lead time)

Por: Hunn · C. A. · Bruns · H. · Sahli · S. · Wachtendorf · L. · Schäfer · J. · Schwerin · S. · Delis · A. · Kalisch · M. · Dugac · G. · Rahrisch · A. · Ebensperger · M. · Karimitar · A. · Massoth · G. · Neuhaus · C. · Dubatovka · A. · Nöthiger · C. B. · Gasciauskaite · G. · Roche · T. R.
Introduction

Visual Patient Predictive (VPP) is an AI-based extension of the Visual Patient Avatar (VPA) that integrates deep learning models to predict upcoming vital sign deviations and display them as dashed visual elements. By explicitly showing anticipated changes, the system aims to support level 3 situation awareness—the projection of future patient states. This multicentre simulation study will evaluate whether predictive algorithms and visualisations integrated into the VPA (resulting in VPP) improve clinicians’ ability to anticipate critical vital sign changes compared with conventional number-based and waveform-based monitoring and examine its effects on decision-making, confidence, workload and user acceptance.

Methods and analysis

This investigator-initiated, randomised, within-subjects crossover, computer-based simulation trial will be conducted at five academic centres in Switzerland, Germany and the United States. Medical professionals from anaesthesiology departments will complete scenario-based prediction tasks using both VPP (as the index test) and conventional monitoring (as the reference standard) in randomised order, with the same participant evaluating both modalities and the identical underlying clinical scenario used in each condition, following video-based training and a learnability test. The primary outcome is recall (true positive rate) of vital sign deviation predictions. Secondary outcomes include average lead time, precision, prediction confidence, number and correctness of proposed interventions, perceived workload (NASA-TLX) and qualitative usability feedback. Quantitative data will be analysed using a logistic generalised linear mixed model with random intercepts for centre and participant, and a random slope for the intervention effect. Qualitative interviews will undergo thematic analysis.

Ethics and dissemination

The leading ethics committee (Zurich, Switzerland; BASEC-Req-2023–00465) reviewed and approved the study protocol. Ethics committees at the other participating centres have obtained their respective approvals or waivers. Bonn: 2025–144-BO, Boston: 2025P000501, Heidelberg: S-376/2025, Munich: 2025–357 W-CB. As this simulation study involves only healthcare professionals performing prediction tasks based on simulated vital sign scenarios—without collection of patient data or any medically relevant personal data—it does not constitute human subjects research under applicable regulations. Study results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Palliative care in the education of occupational therapists in Germany: an anonymised cross-sectional survey among trainees and students

Por: Pape · A. E. · Militzer · T. · Schmitt · A. · Vradelis · P. · Volberg · C.
Objectives

The objective of this study is to assess the extent to which palliative care content is integrated into occupational therapy education in Germany. In addition, the study will examine trainees’ and students’ knowledge, experiences and attitudes towards palliative care.

Design

A cross-sectional quantitative survey study using a structured online questionnaire.

Setting

Institutions and universities across Germany that offer training in occupational therapy.

Participants

A total of 451 subjects completed the survey (89.4% female). Of these, 91.4% were trainees at vocational schools, while 8.6% were university students. The inclusion criteria stipulated that subjects must be enrolled in an occupational therapy programme in Germany at the time of data collection.

Interventions

Not applicable.

Primary and secondary outcome measures

The primary outcomes of the study were knowledge, educational experience and attitudes towards palliative care among occupational therapy trainees and students. Secondary outcomes encompassed practical experience with palliative care patients and expressed interest in further training.

Results

A total of 451 occupational therapy trainees and students participated in the survey. The majority of participants (89.4%) were female and in training (91.4%). Although 90.8% had no previous medical training, 69.2% could define palliative care and 92.6% were familiar with the concept of a hospice. However, 68.1% of respondents reported that they had not received any teaching on palliative care as part of their occupational therapy training. A strong interest in further education in this area was expressed by 95.1%. Only 23.9% had practical experience with palliative clients, mainly in nursing homes.

Conclusions

A substantial discrepancy exists between the recognised importance of palliative care and its representation in occupational therapy education. The findings underline the necessity for a more robust and methodical incorporation of palliative care into occupational therapy curricula. This integration is crucial to ensure that trainees and students are adequately equipped with the theoretical knowledge and practical skills necessary to provide support to seriously ill and dying patients.

Trial registration

DRKS00033464.

Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol

Por: Fiore · J. F. · Shirzadi · S. · Roversi · K. · Prakash · I. · Wong · S. · Meterissian · S. · Meguerditchian · A. N. · Desbiens · C. · Rivard · J. · Delisle · M. · Findlay-Shirras · L. · Abou Khalil · J. · Maciver · A. · Quan · M. L. · Verreault · K. · Johnston · S. · Feldman · L. · McDon
Introduction

Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?

Methods and analysis

This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.

Ethics and dissemination

This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.

Trial registration number

NCT06507345.

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