Assessment of Clinical Information Quality in Digital Health Technologies: International eDelphi Study.

BACKGROUND: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs. OBJECTIVE: This study explored clinicians' perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework. METHODS: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions. RESULTS: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity. CONCLUSIONS: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-057430.

Developments in the Chemical Synthesis of Heparin and Heparan Sulfate.

Heparin and heparan sulfate represent key members of the glycosaminoglycan family of carbohydrates and underpin considerable repertoires of biological importance. As such, their efficiency of synthesis represents a key requirement, to further understand and exploit the H/HS structure-to-biological function axis. In this review we focus on chemical approaches to and methodology improvements for the synthesis of these essential sugars (from 2015 onwards). We first consider advances in accessing the heparin-derived pentasaccharide anticoagulant fondaparinux. This is followed by heparan sulfate targets, including key building block synthesis, oligosaccharide construction and chemical sulfation techniques. We end with a consideration of technological improvements to traditional, solution-phase synthesis approaches that are increasingly being utilised.

Randomized placebo controlled trial evaluating the safety and efficacy of single low-dose intracoronary insulin-like growth factor following percutaneous coronary intervention in acute myocardial infarction (RESUS-AMI).

BACKGROUND: Residual and significant postinfarction left ventricular (LV) dysfunction, despite technically successful percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), remains an important clinical issue. In preclinical models, low-dose insulin-like growth factor 1 (IGF1) has potent cytoprotective and positive cardiac remodeling effects. We studied the safety and efficacy of immediate post-PCI low-dose intracoronary IGF1 infusion in STEMI patients. METHODS: Using a double-blind, placebo-controlled, multidose study design, we randomized 47 STEMI patients with significantly reduced (≤40%) LV ejection fraction (LVEF) after successful PCI to single intracoronary infusion of placebo (n = 15), 1.5 ng IGF1 (n = 16), or 15 ng IGF1 (n = 16). All received optimal medical therapy. Safety end points were freedom from hypoglycemia, hypotension, or significant arrhythmias within 1 hour of therapy. The primary efficacy end point was LVEF, and secondary end points were LV volumes, mass, stroke volume, and infarct size at 2-month follow-up, all assessed by magnetic resonance imaging. Treatment effects were estimated by analysis of covariance adjusted for baseline (24 hours) outcome. RESULTS: No significant differences in safety end points occurred between treatment groups out to 30 days (χ2 test, P value = .77). There were no statistically significant differences in baseline (24 hours post STEMI) clinical characteristics or LVEF among groups. LVEF at 2 months, compared to baseline, increased in all groups, with no statistically significant differences related to treatment assignment. However, compared with placebo or 1.5 ng IGF1, treatment with 15 ng IGF1 was associated with a significant improvement in indexed LV end-diastolic volume (P = .018), LV mass (P = .004), and stroke volume (P = .016). Late gadolinium enhancement (±SD) at 2 months was lower in 15 ng IGF1 (34.5 ± 29.6 g) compared to placebo (49.1 ± 19.3 g) or 1.5 ng IGF1 (47.4 ± 22.4 g) treated patients, although the result was not statistically significant (P = .095). CONCLUSIONS: In this pilot trial, low-dose IGF1, given after optimal mechanical reperfusion in STEMI, is safe but does not improve LVEF. However, there is a signal for a dose-dependent benefit on post-MI remodeling that may warrant further study.

Use of telemedicine in general practice in Europe since the COVID-19 pandemic: A scoping review of patient and practitioner perspectives.

General practice is generally the first point of contact for patients presenting with COVID-19. Since the start of the COVID-19 pandemic general practitioners (GPs) across Europe have had to adopt to using telemedicine consultations in order to minimise the number of social contacts made. GPs had to balance two needs: preventing the spread of COVID-19, while providing their patients with regular care for other health issues. The aim of this study was to conduct a scoping review of the literature examining the use of telemedicine for delivering routine general practice care since the start of the pandemic from the perspectives of patients and practitioners. The six-stage framework developed by Arksey and O'Malley, with recommendations by Levac et al was used to review the existing literature. The study selection process was conducted according to the PRISMA Extension for Scoping Reviews guidelines. Braun and Clarke's' Thematic Analysis' approach was used to interpret data. A total of eighteen studies across nine countries were included in the review. Thirteen studies explored the practitioner perspective of the use of telemedicine in general practice since the COVID-19 pandemic, while five studies looked at the patient perspective. The types of studies included were: qualitative studies, literature reviews, a systematic review, observational studies, quantitative studies, Critical incident technique study, and surveys employing both closed and open styled questions. Key themes identified related to the patient/ practitioner experience and knowledge of using telemedicine, patient/ practitioner levels of satisfaction, GP collaboration, nature of workload, and suitability of consultations for telemedicine. The nature of general practice was radically changed during the COVID-19 pandemic. Certain patient groups and areas of clinical and administrative work were identified as having performed well, if not better, by using telemedicine. Our findings suggest a level of acceptability and satisfaction of telemedicine by GPs and patients during the pandemic; however, further research is warranted in this area.

Using NMR to Dissect the Chemical Space and O-Sulfation Effects within the O- and S-Glycoside Analogues of Heparan Sulfate.

Heparan sulfate (HS), a sulfated linear carbohydrate that decorates the cell surface and extracellular matrix, is ubiquitously distributed throughout the animal kingdom and represents a key regulator of biological processes and a largely untapped reservoir of potential therapeutic targets. The temporal and spatial variations in the HS structure underpin the concept of "heparanome" and a complex network of HS binding proteins. However, despite its widespread biological roles, the determination of direct structure-to-function correlations is impaired by HS chemical heterogeneity. Attempts to correlate substitution patterns (mostly at the level of sulfation) with a given biological activity have been made. Nonetheless, these do not generally consider higher-level conformational effects at the carbohydrate level. Here, the use of NMR chemical shift analysis, NOEs, and spin-spin coupling constants sheds new light on how different sulfation patterns affect the polysaccharide backbone geometry. Furthermore, the substitution of native O-glycosidic linkages to hydrolytically more stable S-glycosidic forms leads to observable conformational changes in model saccharides, suggesting that alternative chemical spaces can be accessed and explored using such mimetics. Employing a series of systematically modified heparin oligosaccharides (as a proxy for HS) and chemically synthesized O- and S-glycoside analogues, the chemical space occupied by such compounds is explored and described.

Successfully implementing a national electronic health record: a rapid umbrella review.

AIM: To summarize the findings from literature reviews with a view to identifying and exploring the key factors which impact on the success of an EHR implementation across different healthcare contexts. INTRODUCTION: Despite the widely recognised benefits of electronic health records (EHRs), their full potential has not always been achieved, often as a consequence of the implementation process. As more countries launch national EHR programmes, it is critical that the most up-to-date and relevant international learnings are shared with key stakeholders. METHODS: A rapid umbrella review was undertaken in collaboration with a multidisciplinary panel of knowledge-users and experts from Ireland. A comprehensive literature review was completed (2019) across several search engines (PubMed, CINAHL, Scopus, Embase, Web of Science, IEEE Xplore, ACM Digital Library, ProQuest, Cochrane) and Gray literature. Identified studies (n = 5,040) were subject to eligibility criterion and identified barriers and facilitators were analysed, reviewed, discussed and interpreted by the expert panel. RESULTS: Twenty-seven literature reviews were identified which captured the key organizational, human and technological factors for a successful EHR implementation according to various stakeholders across different settings. Although the size, type and culture of the healthcare setting impacted on the organizational factors, each was deemed important for EHR success; Governance, leadership and culture, End-user involvement, Training, Support, Resourcing, and Workflows. As well as organizational differences, individual end-users have varying Skills and characteristics, Perceived benefits and incentives, and Perceived changes to the health ecosystem which were also critical to success. Finally, the success of the EHR technology depended on Usability, Interoperability, Adaptability, Infrastructure, Regulation, standards and policies, and Testing. CONCLUSION: Fifteen inter-linked organizational, human and technological factors emerged as important for successful EHR implementations across primary, secondary and long-term care settings. In determining how to employ these factors, the local context, individual end-users and advancing technology must also be considered.

A Novel Simulated Training Platform and Study of Performance Among Different Levels of Learners in Flexible Cystoscopy.

INTRODUCTION: The aims of this study were to test a novel simulation platform suitable for flexible cystoscopy using a standard scope, to assess the platform's proposed use as a training tool for flexible cystoscopy, and to assess the user experience through surveyed response. METHODS: Thirty-one urologists (11 novices, 20 experts) were evaluated using a novel light-based bladder model and standard flexible cystoscope. Time to complete full inspection of the simulated bladder was measured, and the scope trajectory was recorded. Participants also completed a survey of the training platform. RESULTS: Thirty participants completed a simulated inspection of a portable bladder model with a mean ± SD time for 153.1 ± 76.1 seconds. One participant failed to complete. Novice urologists (defined as those having completed less than 50 flexible cystoscopies in clinic) had a mean ± SD time of 176.9 ± 95.8 seconds, whereas with experts, this decreased to 139.3 ± 60.7 seconds. Dynamic trajectory maps identified "blind spots" within each user's cystoscopy performance. In a poststudy follow-up, 27 participants considered the tool valuable or extremely valuable for training, whereas 19 participants considered that the tool either very well or excellently replicated the clinical setting. All participants ranked the tool as very good or excellent for overall quality of training. DISCUSSION: Advances in electronic technology make portable low-cost models a potential low-cost alternative to endourology training platforms. In providing a quantifiable measure of user performance, the tool may shorten the learning curve in flexible cystoscopy and, potentially, reduce clinical errors and provide quantifiable measures for further clinical training.

The role of primary care in management of rare diseases in Ireland.

BACKGROUND: 'Slaintecare' aims to address complex patient care needs in an integrated fashion with an emphasis on patient-centred, patient-empowered community care.Currently there is a lack of knowledge of the impact of rare disease management in primary care and of the information tools required by general practitioners to deliver integrated care for rare disease patients. AIMS: To complete a pilot survey to estimate the general practice clinical workload attributable to selected rare diseases and assess the use of relevant information sources. METHODS: A retrospective cross-sectional survey was carried out of general practice consultations (2013-2017) for patients with 22 commonly recognised rare diseases. RESULTS: Around 31 general practitioners from 10 Irish practices completed information on 171 patients with rare diseases over 3707 consultations. General practice-specific coding systems were inadequate for rare disease patient identification. Over 139 (81.3%) patients were adult, and 32 (18.7%) were children. Management of care was hospital and not primary care based in 63%. Those eligible for state-reimbursed care had a significantly higher median number of consultations (23 consultations, IQR = 13-37, or 5.8 consultations/year) than those who paid privately (10 consultations, IQR = 4-19, or 2.5 consultations/year) (p < 0.005).General practitioners had access to public information resources on rare diseases but few had knowledge of (35.5%), or had ever used (12.9%) Orphanet, the international rare disease information portal. CONCLUSIONS: Both specific rare disease-specific coding and use of the relevant rare disease information sources are lacking in general practice in Ireland.

Pre-clinical validation of virtual bronchoscopy using 3D Slicer.

PURPOSE: Lung cancer still represents the leading cause of cancer-related death, and the long-term survival rate remains low. Computed tomography (CT) is currently the most common imaging modality for lung diseases recognition. The purpose of this work was to develop a simple and easily accessible virtual bronchoscopy system to be coupled with a customized electromagnetic (EM) tracking system for navigation in the lung and which requires as little user interaction as possible, while maintaining high usability. METHODS: The proposed method has been implemented as an extension to the open-source platform, 3D Slicer. It creates a virtual reconstruction of the airways starting from CT images for virtual navigation. It provides tools for pre-procedural planning and virtual navigation, and it has been optimized for use in combination with a [Formula: see text] of freedom EM tracking sensor. Performance of the algorithm has been evaluated in ex vivo and in vivo testing. RESULTS: During ex vivo testing, nine volunteer physicians tested the implemented algorithm to navigate three separate targets placed inside a breathing pig lung model. In general, the system proved easy to use and accurate in replicating the clinical setting and seemed to help choose the correct path without any previous experience or image analysis. Two separate animal studies confirmed technical feasibility and usability of the system. CONCLUSIONS: This work describes an easily accessible virtual bronchoscopy system for navigation in the lung. The system provides the user with a complete set of tools that facilitate navigation towards user-selected regions of interest. Results from ex vivo and in vivo studies showed that the system opens the way for potential future work with virtual navigation for safe and reliable airway disease diagnosis.

Loss of flexion during bronchoscopy: a physical experiment and case study of commercially available systems.

During routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures, especially with biopsy of lymph nodes in or around the left upper lobe, frequent reports have noted the loss of ultrasound image and needle angulation leading to an inability to biopsy nodes visualised by EBUS. The aim of this research was to investigate and compare this loss of angulation with commercially available scopes. Bench-top experiments and a clinical case study demonstrated the varying loss of scope angulation, flexibility and manoeuvrability with different scopes and biopsy instruments leading to procedural implications. Improvements in both the EBUS scope and needle characteristics are required to overcome this limitation which has implications in bronchoscope navigation and the diagnostic yield of EBUS-TBNA.

Automated Catheter Navigation With Electromagnetic Image Guidance.

This paper describes a novel method of controlling an endoscopic catheter by using an automated catheter tensioning system with the objective of providing clinicians with improved manipulation capabilities within the patient. Catheters are used in many clinical procedures to provide access to the cardiopulmonary system. Control of such catheters is performed manually by the clinicians using a handle, typically actuating a single or opposing set of pull wires. Such catheters are generally actuated in a single plane, requiring the clinician to rotate the catheter handle to navigate the system. The automation system described here allows closed-loop control of a custom bronchial catheter in tandem with an electromagnetic tracking of the catheter tip and image guidance by using a 3D Slicer. An electromechanical drive train applies tension to four pull wires to steer the catheter tip, with the applied force constantly monitored through force sensing load cells. The applied tension is controlled through a PC connected joystick. An electromagnetic sensor embedded in the catheter tip enables constant real-time position tracking, whereas a working channel provides a route for endoscopic instruments. The system is demonstrated and tested in both a breathing lung model and a preclinical animal study. Navigation to predefined targets in the subject's airways by using the joystick while using virtual image guidance and electromagnetic tracking was demonstrated. Average targeting times were 29 and 10 s, respectively, for the breathing lung and live animal studies. This paper presents the first reported remote controlled bronchial working channel catheter utilizing electromagnetic tracking and has many implications for future development in endoscopic and catheter-based procedures.

Evaluation of Endoscopically Deployed Radiopaque Tumor Models in Bronchoscopy.

BACKGROUND: Radiopaque markers and soft tissue models have been used extensively in clinical applications to target cancerous lesions and to calibrate and characterize imaging systems. However, the development of radiopaque, soft tissue models for pulmonary lesions is yet to be optimized. Such a material may improve endoscopic training techniques and also be useful to evaluate bronchoscopy navigation systems by the targeting and sampling of tumor models with computed tomography. METHODS: This study investigates a modified agarose-based model and a novel contrast-infused tripe model to create clinically relevant pulmonary tumor models. An iodine-enhanced agarose model presents an injectable solution with high image contrast under computed tomography capable of reaching distal bronchial airways. The tripe solution presents a cheap and easily deployed method to quickly establish a fiducial marker that may be used during bronchial imaging system training and evaluation. RESULTS: The iodine-enriched agarose model demonstrates desirable mechanical characteristics ex vivo, but has a number of limitations when administered in a live setting. The tripe solution presents a far more effective in vivo pulmonary tumor model and offers an effective radiopaque marker. However, the size of the tripe tumor samples required for effective insertion limits its ability to reach more distal airways. An iterative testing process was used to optimize the model composition, culminating in live animal investigations (n=3). CONCLUSION: Both contrast-infused agarose and tripe models present a promising analog to a pulmonary lesion and may act as a radiopaque marker for bronchoscopic training and biopsy evaluation.

Navigational Bronchoscopy for Early Lung Cancer: A Road to Therapy.

Peripheral lung nodules remain challenging for accurate localization and diagnosis. Once identified, there are many strategies for diagnosis with heterogeneous risk benefit analysis. Traditional strategies such as conventional bronchoscopy have poor performance in locating and acquiring the required tissue. Similarly, while computerized-assisted transthoracic needle biopsy is currently the favored diagnostic procedure, it is associated with complications such as pneumothorax and hemorrhage. Video-assisted thoracoscopic and open surgical biopsies are invasive, require general anesthesia and are therefore not a first-line approach. New techniques such as ultrathin bronchoscopy and image-based guidance technologies are evolving to improve the diagnosis of peripheral lung lesions. Virtual bronchoscopy and electromagnetic navigation systems are novel technologies based on assisted-computerized tomography images that guide the bronchoscopist toward the target peripheral lesion. This article provides a comprehensive review of these emerging technologies.

Electropermanent magnetic anchoring for surgery and endoscopy.

The use of magnets for anchoring of instrumentation in minimally invasive surgery and endoscopy has become of increased interest in recent years. Permanent magnets have significant advantages over electromagnets for these applications; larger anchoring and retraction force for comparable size and volume without the need for any external power supply. However, permanent magnets represent a potential hazard in the operating field where inadvertent attraction to surgical instrumentation is often undesirable. The current work proposes an interesting hybrid approach which marries the high forces of permanent magnets with the control of electromagnetic technology including the ability to turn the magnet OFF when necessary. This is achieved through the use of an electropermanent magnet, which is designed for surgical retraction across the abdominal and gastric walls. Our electropermanent magnet, which is hand-held and does not require continuous power, is designed with a center lumen which may be used for trocar or needle insertion. The device in this application has been demonstrated successfully in the porcine model where coupling between an intraluminal ring magnet and our electropermanent magnet facilitated guided insertion of an 18 Fr Tuohy needle for guidewire placement. Subsequent investigations have demonstrated the ability to control the coupling distance of the system alleviating shortcomings with current methods of magnetic coupling due to variation in transabdominal wall thicknesses. With further refinement, the magnet may find application in the anchoring of endoscopic and surgical instrumentation for minimally invasive interventions in the gastrointestinal tract.

Evaluation of a novel tracking system in a breathing lung model.

We present the evaluation of an electromagnetic position tracking system for use with virtual bronchoscopy systems. Our system utilises a planar magnetic coil array and commercially available search coil sensors. Experimental results show the EM tracking accuracy to be in the range of 11.5mm, which is comparable to both commercial and research systems. The use of a bench-top breathing lung model is used to verify system operation in the in vitro setting. A novel fiducial-free registration method is implemented to reduce errors resulting from inaccurate landmark identification commonly associated with point-based registration. After registration, there is good agreement between the measured position of the sensor probe during endoscopic navigation and the lung airways as visualised in a 3D model of the phantom.

Design, development and evaluation of an inflatable retractor for atraumatic retraction in laparoscopic colectomy.

Laparoscopic colectomy is the gold standard in the treatment of malignant tumours arising in the mucosa of the colon wall. The procedure is performed under general endotracheal anaesthesia and involves establishing a pneumoperitoneum with the patient in the Trendelenburg position. However this position can cause anaesthetic difficulties due to excess blood flow to the head and neck, increased pressure on the diaphragm and increased venous pressure. In the absence of steep head-down positioning, the bowels fall or "spill" into the operating field, obstructing the surgical space. The primary goal of this work is to design an atraumatic laparoscopic retractor to minimise the Trendelenburg position whilst effectively retracting the bowels from the operating field. This work details the design, evaluation and optimisation of a novel, hand held, inflatable, laparoscopic retractor, through physical experimentation, computer simulation, and pre-clinical animal investigation. The optimised design for the inflatable retractor performs in line with simulated expectations, and was successfully tested for safety and technical feasibility in vivo in a porcine model, where the bowels were effectively removed from the operating space whilst the model remained in the supine position. These initial results represent a promising approach for the mitigation of the Trendelenburg position, whilst effectively retracting the bowels during laparoscopic colectomy, using this atraumatic, inflatable retractor.