Understanding the enablers and barriers to implementing a patient-led escalation system: a qualitative study.

BACKGROUND: The management of acute deterioration following surgery remains highly variable. Patients and families can play an important role in identifying early signs of deterioration but effective contribution to escalation of care can be practically difficult to achieve. This paper reports the enablers and barriers to the implementation of patient-led escalation systems found during a process evaluation of a quality improvement programme Rescue for Emergency Surgery Patients Observed to uNdergo acute Deterioration (RESPOND). METHODS: The research used ethnographic methods, including over 100 hours of observations on surgical units in three English hospitals in order to understand the everyday context of care. Observations focused on the coordination of activities such as handovers and how rescue featured as part of this. We also conducted 27 interviews with a range of clinical and managerial staff and patients. We employed a thematic analysis approach, combined with a theoretically focused implementation coding framework, based on Normalisation Process Theory. RESULTS: We found that organisational infrastructural support in the form of a leadership support and clinical care outreach teams with capacity were enablers in implementing the patient-led escalation system. Barriers to implementation included making changes to professional practice without discussing the value and legitimacy of operationalising patient concerns, and ensuring equity of use. We found that organisational work is needed to overcome patient fears about disrupting social and cultural norms. CONCLUSIONS: This paper reveals the need for infrastructural support to facilitate the implementation of a patient-led escalation system, and leadership support to normalise the everyday process of involving patients and families in escalation. This type of system may not achieve its goals without properly understanding and addressing the concerns of both nurses and patients.

No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.

Objective: The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments. Design: A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method. Participants: Surgeons and surgical researchers from any country. Main outcome measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings. Results: The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway. Conclusions: The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally.

Prospective development study of the Versius Surgical System for use in transoral robotic surgery: an IDEAL stage 1/2a first in human and initial case series experience.

PURPOSE: Transoral robotic surgery is well established in the treatment paradigm of oropharyngeal pathology. The Versius Surgical System (CMR Surgical) is a robotic platform in clinical use in multiple specialities but is currently untested in the head and neck. This study utilises the IDEAL framework of surgical innovation to prospectively evaluate and report a first in human clinical experience and single centre case series of transoral robotic surgery (TORS) with Versius. METHODS: Following IDEAL framework stages 1 and 2a, the study evaluated Versius to perform first in human TORS before transitioning from benign to malignant cases. Iterative adjustments were made to system setup, instrumentation, and technique, recorded in accordance with IDEAL recommendations. Evaluation criteria included successful procedure completion, setup time, operative time, complications, and subjective impressions. Further evaluation of the system to perform four-arm surgery was conducted. RESULTS: 30 TORS procedures were successfully completed (15 benign, 15 malignant) without intraoperative complication or conversion to open surgery. Setup time significantly decreased over the study period. Instrumentation challenges were identified, urging the need for TORS-specific instruments. The study introduced four-arm surgery, showcasing Versius' unique capabilities, although limitations in distal access were observed. CONCLUSIONS: TORS is feasible with the Versius Surgical System. The development of TORS-specific instruments would benefit performance and wider adoption of the system. 4-arm surgery is possible however further evaluation is required. Multicentre evaluation (IDEAL stage 2b) is recommended.

Length of hysterotomy for fetal spina bifida repair is associated with prematurity risk.

OBJECTIVE: To investigate whether prenatal repair of spina bifida aperta through mini-hysterotomy results in less prematurity, as compared to standard hysterotomy, when adjusting for known prematurity risks. METHODS: We performed a bi-centric, propensity score matched, controlled study, that is, adjusting for factors earlier reported to result in premature delivery or membrane rupture, in consecutive women having prenatal repair either through stapled hysterotomy or sutured mini-hysterotomy (≤3.5 cm). Matches were pairwise compared and cox-regression analysis was performed to define the hazard ratio of delivery <37 weeks. RESULTS: Of 346 meeting the MOMS-criteria, 78 comparable pairs were available for matched-controlled analysis. Mini-hysterotomy patients were younger and had a higher BMI. Mini-hysterotomy was associated with a 1.67-lower risk of delivery <37 weeks (hazard ratio: 0.60; 95% CI: 0.42-0.85; p = 0.004) and 1.72 for delivery <34 + 6 weeks (hazard ratio: 0.58; 95% CI: 0.34-0.97; p = 0.037). The rate of intact uterine scar at birth (mini-hysterotomy: 98.7% vs. hysterotomy: 90.4%; p = 0.070), the rate of reversal of hindbrain herniation within 1 week after surgery (88.9% vs. 97.4%; p = 0.180) and the rate of cerebrospinal fluid leakage (0% vs. 2.7%; p = 0.50) were comparable. CONCLUSION: Prenatal spina bidifa repair through mini-hysterotomy was associated with a later gestational age at delivery and a comparable intact uterus rate without apparent compromise in neuroprotection.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.

Holistic Human-Serving Digitization of Health Care Needs Integrated Automated System-Level Assessment Tools.

Digital health tools, platforms, and artificial intelligence- or machine learning-based clinical decision support systems are increasingly part of health delivery approaches, with an ever-greater degree of system interaction. Critical to the successful deployment of these tools is their functional integration into existing clinical routines and workflows. This depends on system interoperability and on intuitive and safe user interface design. The importance of minimizing emergent workflow stress through human factors research and purposeful design for integration cannot be overstated. Usability of tools in practice is as important as algorithm quality. Regulatory and health technology assessment frameworks recognize the importance of these factors to a certain extent, but their focus remains mainly on the individual product rather than on emergent system and workflow effects. The measurement of performance and user experience has so far been performed in ad hoc, nonstandardized ways by individual actors using their own evaluation approaches. We propose that a standard framework for system-level and holistic evaluation could be built into interacting digital systems to enable systematic and standardized system-wide, multiproduct, postmarket surveillance and technology assessment. Such a system could be made available to developers through regulatory or assessment bodies as an application programming interface and could be a requirement for digital tool certification, just as interoperability is. This would enable health systems and tool developers to collect system-level data directly from real device use cases, enabling the controlled and safe delivery of systematic quality assessment or improvement studies suitable for the complexity and interconnectedness of clinical workflows using developing digital health technologies.

Reduction in transfer of micro-organisms between patients and staff using short-sleeved gowns and hand/arm hygiene in intensive care during the COVID-19 pandemic: A simulation-based randomised trial.

Background: Current personal protective equipment (PPE) practices in UK intensive care units involve "sessional" use of long-sleeved gowns, risking nosocomial infection transmitted via gown sleeves. Data from the first wave of the COVID19 pandemic demonstrated that these changes in infection prevention and control protocols were associated with an increase in healthcare associated bloodstream infections. We therefore explored the use of a protocol using short-sleeved gowns with hand and arm hygiene to reduce this risk. Methods: ICU staff were trained in wearing short-sleeved gowns and using a specific hand and arm washing technique between patients (experimental protocol). They then underwent simulation training, performing COVID-19 intubation and proning tasks using either experimental protocol or the standard (long-sleeved) control protocol. Fluorescent powder was used to simulate microbial contamination, detected using photographs under ultraviolet light. Teams were randomised to use control or experimental PPE first. During the simulation, staff were questioned on their feelings about personal safety, comfort and patient safety. Results: Sixty-eight staff and 17 proning volunteers were studied. Experimental PPE completely prevented staff contamination during COVID-19 intubation, whereas this occurred in 30/67 staff wearing control PPE (p = .003, McNemar). Proning volunteers were contaminated by staff in 15/17 control sessions and in 1/17 with experimental PPE (p = .023 McNemar). Staff comfort was superior with experimental PPE (p< .001, Wilcoxon). Their personal safety perception was initially higher with control PPE, but changed towards neutrality during sessions (p < .001 start, 0.068 end). Their impressions of patient safety were initially similar (p = .87), but finished strongly in favour of experimental PPE (p < .001). Conclusions: Short-sleeved gowns with hand and forearm cleansing appear superior to sessional long-sleeved gowns in preventing cross-contamination between staff and patients.

Quality and safety interventions in surgery.

Medical errors resulting in treatment-related harm have been a challenge for many years, with particularly severe consequences in surgery. Efforts to improve safety should focus on system-based changes to response and rescue pathways, and will require further research and adequate engagement by clinical staff.

Evaluating Patient Identification Practices During Intrahospital Transfers: A Human Factors Approach.

INTRODUCTION: Reliable patient identification is essential for safe care, and failures may cause patient harm. Identification can be interfered with by system factors, including working conditions, technology, organizational barriers, and inadequate communications protocols. The study aims to explore systems factors contributing to patient identification errors during intrahospital transfers. METHODS: We conducted a qualitative study through direct observation and interviews with porters during intrahospital patient transfers. Data were analyzed using the Systems Engineering Initiative for Patient Safety human factors model. The patient transfer process was mapped and compared with the institutional Positive Patient Identification policy. Potential system failures were identified using a Failure Modes and Effects Analysis. RESULTS: A total of 60 patient transfer handovers were observed. In none of the evaluable cases observed, patient identification was conducted correctly according to the hospital policy at every step of the process. The principal system factor responsible was organizational failure, followed by technology and team culture issues. The Failure Modes and Effects Analysis methodology revealed that miscommunication between staff and lack of key patient information put patient safety at risk. CONCLUSIONS: Patient identification during intrahospital patient transfer is a high-risk event because several factors and many people interact. In this study, the disconnect between the policy and the reality of the workplace left staff and patients vulnerable to the consequences of misidentification. Where a policy is known to be substantially different from work as done, urgent revision is required to eliminate the serious risks associated with the unguided evolution of working practice.

Intraoperative Applications of Artificial Intelligence in Robotic Surgery: A Scoping Review of Current Development Stages and Levels of Autonomy.

OBJECTIVE: A scoping review of the literature was conducted to identify intraoperative artificial intelligence (AI) applications for robotic surgery under development and categorize them by (1) purpose of the applications, (2) level of autonomy, (3) stage of development, and (4) type of measured outcome. BACKGROUND: In robotic surgery, AI-based applications have the potential to disrupt a field so far based on a master-slave paradigm. However, there is no available overview about this technology's current stage of development and level of autonomy. METHODS: MEDLINE and EMBASE were searched between January 1, 2010 and May 21, 2022. Abstract screening, full-text review, and data extraction were performed independently by 2 reviewers. The level of autonomy was defined according to the Yang and colleagues' classification and stage of development according to the Idea, Development, Evaluation, Assessment, and Long-term follow-up framework. RESULTS: One hundred twenty-nine studies were included in the review. Ninety-seven studies (75%) described applications providing Robot Assistance (autonomy level 1), 30 studies (23%) application enabling Task Autonomy (autonomy level 2), and 2 studies (2%) application achieving Conditional autonomy (autonomy level 3). All studies were at Idea, Development, Evaluation, Assessment, and Long-term follow-up stage 0 and no clinical investigations on humans were found. One hundred sixteen (90%) conducted in silico or ex vivo experiments on inorganic material, 9 (7%) ex vivo experiments on organic material, and 4 (3%) performed in vivo experiments in porcine models. CONCLUSIONS: Clinical evaluation of intraoperative AI applications for robotic surgery is still in its infancy and most applications have a low level of autonomy. With increasing levels of autonomy, the evaluation focus seems to shift from AI-specific metrics to process outcomes, although common standards are needed to allow comparison between systems.

Examining the empirical evidence for IDEAL 2b studies: the effects of preceding prospective collaborative cohort studies on the quality and impact of subsequent randomized controlled trials of surgical innovations - protocol for a systematic review and case-control analysis.

Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective collaborative cohort studies with specific properties (IDEAL 2b studies) to increase the quality and feasibility of surgical RCTs. Little empirical evidence exists for this proposition, and specifically designed 2b studies are currently uncommon. Prospective collaborative cohort studies are, however, relatively common, and might provide similar benefits. We will, therefore, assess the association between prior 'IDEAL 2b-like' cohort studies and the quality and impact of surgical RCTs. We propose a systematic review using two parallel case-control analyses, with surgical RCTs as subjects and study quality and journal impact factor (IF) as the outcomes of interest. We will search for surgical RCTs published between 2015 and 2019 and and prior prospective collaborative cohort studies authored by any of the RCT investigators. RCTs will be categorized into cases or controls by (1) journal (IF ≥or <5) and (2) study quality (PEDro score ≥or < 7). The case/control OR of exposure to a prior '2b like' study will be calculated independently for quality and impact. Cases will be matched 1: 1 with controls by year of publication, and confounding by peer-reviewed funding, author academic affiliation and trial protocol registration will be examined using multiple logistic regression analysis. This study will examine whether preparatory IDEAL 2b-like studies are associated with higher quality and impact of subsequent RCTs.

Assessing the development status of intraoperative fluorescence imaging for anatomy visualisation, using the IDEAL framework.

Objectives: Intraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: visualising anatomy, assessing tissue perfusion, identifying/localising cancer and mapping lymphatic systems. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging used to visualise anatomical structures using the IDEAL framework, a framework designed to describe the stages of innovation in surgery and other interventional procedures. Design: IDEAL staging based on a thorough literature review. Setting: All publications on intraoperative fluorescence imaging for visualising anatomical structures reported in PubMed through 2020 were identified for five surgical procedures: cholangiography, hepatic segmentation, lung segmentation, ureterography and parathyroid identification. Main outcome measures: The IDEAL stage of research evidence was determined for each of the five procedures using a previously described approach. Results: 225 articles (8427 cases) were selected for analysis. Current status of research evidence on fluorescence imaging was rated IDEAL stage 2a for ureterography and lung segmentation, IDEAL 2b for hepatic segmentation and IDEAL stage 3 for cholangiography and parathyroid identification. Enhanced tissue identification rates using fluorescence imaging relative to conventional white-light imaging have been documented for all five procedures by comparative studies including randomised controlled trials for cholangiography and parathyroid identification. Advantages of anatomy visualisation with fluorescence imaging for improving short-term and long-term postoperative outcomes also were demonstrated, especially for hepatobiliary surgery and (para)thyroidectomy. No adverse reactions associated with fluorescent agents were reported. Conclusions: Intraoperative fluorescence imaging can be used safely to enhance the identification of anatomical structures, which may lead to improved postoperative outcomes. Overviewing current research knowledge using the IDEAL framework aids in designing further studies to develop fluorescence imaging techniques into an essential intraoperative navigation tool in each surgical field.

Am I safe? An Interpretative Phenomenological Analysis of Vulnerability as Experienced by Patients With Complications Following Surgery.

Abdominal surgery carries with it risks of complications. Little is known about patients' experiences of post-surgical deterioration. There is a real need to understand the psychosocial as well as the biological aspects of deterioration in order to improve care and outcomes for patients. Drawing on in-depth interviews with seven abdominal surgery survivors, we present an idiographic account of participants' experiences, situating their contribution to safety within their personal lived experiences and meaning-making of these episodes of deterioration. Our analysis reveals an overarching group experiential theme of vulnerability in relation to participants' experiences of complications after abdominal surgery. This encapsulates the uncertainty of the situation all the participants found themselves in, and the nature and seriousness of their health conditions. The extent of participants' vulnerability is revealed by detailing how they made sense of their experience, how they negotiated feelings of (un)safety drawing on their relationships with family and staff and the legacy of feelings they were left with when their expectations of care (care as imagined) did not meet the reality of their experiences (care as received). The participants' experiences highlight the power imbalance between patients and professionals in terms of whose knowledge counts within the hospital context. The study reveals the potential for epistemic injustice to arise when patients' concerns are ignored or dismissed. Our data has implications for designing strategies to enable escalation of care, both in terms of supporting staff to deliver compassionate care, and in strengthening patient and family involvement in rescue processes.