A novel adaptive insertable cardiac monitor algorithm improves the detection of atrial fibrillation and atrial tachycardia in silico.

INTRODUCTION: Insertable cardiac monitors (ICMs) provide a minimally invasive method of continuous monitoring for abnormal heart rhythms. While the benefits of ICMs are clear, current algorithm performance can be improved. The objective of this study is to assess the performance of a novel adaptive atrial fibrillation (AF) detection algorithm and separately programmable atrial tachycardia (AT) algorithm. METHODS: A dual-stage detect-and-verify AF algorithm and separately programmable AT algorithm were developed. Sensitivity and PPV across a range of settings were determined in silico by comparison with an adjudicated Holter data set (n = 1966 with 229 patient days). Finally, the ability to improve performance through simulated remote programming was assessed. RESULTS: The dual-stage algorithm detected AF in all true AF patients (76/76) resulting in a patient-level sensitivity of 100%. Episode-level sensitivity and PPV ranged from 97.6% to 100% and 79.1% to 98.5%, respectively. Thirty-six false-positive episodes were observed and 32 (88.9%) of these were corrected with programming changes. Decoupling of AF and AT durations improved PPV from a range of 10%-22% to a range of 95%-100%. CONCLUSIONS: AF and AT algorithms were designed with novel features including an adaptive morphology assessment for AF detection and separately programmable durations for AT detection. In silico performance yielded improved PPVs while maintaining high sensitivity across a range of settings. Importantly, programming changes that may be made remotely with this system reduced false positives. These algorithms allow clinicians to individualize arrhythmia detection settings thereby improving data management and reducing clinic burden.

Feasibility Study of a New Magnetic Resonance Imaging Mini-capsule Device to Measure Whole Gut Transit Time in Paediatric Constipation.

OBJECTIVE: In England, 27,500 children are referred annually to hospital with constipation. An objective measure of whole gut transit time (WGTT) could aid management. The current standard WGTT assessment, the x-ray radiopaque marker (ROM) test, gives poor definition of colonic anatomy and the radiation dose required is undesirable in children. Our objective was to develop an alternative magnetic resonance imaging (MRI) WGTT measure to the x-ray ROM test and to demonstrate its initial feasibility in paediatric constipation. METHODS: With the Nottingham Young Person's Advisory Group we developed a small (8 × 4 mm), inert polypropylene capsule shell filled with MRI-visible fat emulsion. The capsule can be imaged using MRI fat and water in-phase and out-of-phase imaging. Sixteen patients with constipation and 19 healthy participants aged 7 to 18 years old were recruited. Following a common ROM protocol, the participants swallowed 24 mini-capsules each day for 3 days and were imaged on days 4 and 7 using MRI. The number of successful studies (feasibility) and WGTT were assessed. Participants' EuroQoL Visual Analogue Scale were also collected and compared between the day before the taking the first set of mini-capsules to the day after the last MRI study day. RESULTS: The mini-capsules were imaged successfully in the colon of all participants. The WGTT was 78 ±â€Š35 hours (mean ±â€Šstandard deviation) for patients, and 36 ±â€Š16 hours, P < 0.0001 for healthy controls. Carrying out the procedures did not change the EuroQoL Visual Analogue Scale scores before and after the procedures. CONCLUSIONS: Magnetic Resonance Imaging in Paediatric Constipation was a first-in-child feasibility study of a new medical device to measure WGTT in paediatric constipation using MRI. The study showed that the new method is feasible and is well tolerated.

Management of recurrent benign paroxysmal positional vertigo.

BACKGROUND: Benign paroxysmal positional vertigo is the most common episodic vestibular disorder, although it is often quiescent by the time patients visit a specialist clinic, making the diagnosis difficult to confirm. Patients fear the consequences of a relapse and it is not clear what follow up should be provided. OBJECTIVE: This evaluation reviewed the results of an open access pathway that offered priority appointments to patients with a history of positional vertigo. RESULTS AND CONCLUSION: In total, 664 patients were included in the analysis, 52 per cent of whom had unconfirmed benign paroxysmal positional vertigo. Open follow up improved diagnostic rates by approximately 40 per cent. The rate of benign paroxysmal positional vertigo recurrence was 34 per cent in patients with follow up of at least one year, 41 per cent with follow up of one to two years, and 53 per cent with follow up of two years or more. One in five recurrences occurred in a different semi-circular canal. These results suggest that specialist follow up is required for management of recurrent benign paroxysmal positional vertigo.

Developing a prototype digital risk mitigation pathway for children and young people admitted to acute paediatric NHS care in mental health crisis: Protocol of the Safety Assessment in Paediatric healthcare Environments (SAPhE) pathway study.

Background: Globally, there are increasing numbers of Children and young people (CYPs) experiencing a mental health crisis requiring admission to acute paediatric inpatient care. These CYPs can often experience fluctuating emotional states accompanied by urges to self-harm or attempt to end their life, leading to reduced safety and poorer experiences. Currently, in the UK National Health Service (NHS) there are no standardised, evidence-based interventions in acute paediatric care to mitigate or minimise immediate risk of self-harm and suicide in CYP admitted with mental health crisis. Objective: To outline the protocol for the SAPhE Pathway study which aims to: 1) identify and prioritise risk mitigation strategies to include in the digital prototype, 2) understand the feasibility of implementing a novel digital risk mitigation pathway in differing NHS contexts, and 3) co-create a prototype digital risk mitigation pathway. Methods: This is a multi-centre study uses a mixed-methods design. A systematic review and exploratory methods (interviews, surveys, and focus groups) will be used to identify the content and feasibility of implementing a digital risk mitigation pathway. Participants will include healthcare professionals, digital experts and CYP with experience of mental health conditions. Data will be collected between January 2022 and March 2023 and analysed using content and thematic analysis, case study, cross-case analysis for qualitative data and descriptive statistics for quantitative data. Findings will inform the experience-based co-design workshops. Ethics and Dissemination: The study received full ethical approval from NHS REC [Ref: 22/SC/0237 and 22/WM/0167]. Findings will be made available to all stakeholders using multiple approaches.

Real-world Characterization and Use of Insertable Cardiac Monitor Remote Programming.

Remote device programming may enable workflow efficiencies and reduce resource strains on clinics as well as patients. Although the remote patient management ecosystem has evolved, several challenges remain, and the role of remote device programming for an insertable cardiac monitor (ICM) has yet to be described in a real-world setting. The purpose of this study was to characterize the initial real-world use of remote programming of an ICM. The cohort included 8,238 patients with the LUX-Dx™ ICM (Boston Scientific, Marlborough, MA, USA) during the first year of commercial use, which is also the first year that remote programming was available for an ICM. A descriptive review of reprogramming events revealed that 24% of devices were reprogrammed and that 82% of all reprogramming events occurred remotely. Over 74% of first reprogramming events occurred within the first 30 days following device insertion, and nearly 80% of devices only had 1 reprogramming event. These early data support the hypothesis that remote programming of an ICM is a clinically useful tool that may improve the clinical experience of device programming optimization, especially within the first month following device insertion.

The INVEST trial: a randomised feasibility trial of psychologically informed vestibular rehabilitation versus current gold standard physiotherapy for people with Persistent Postural Perceptual Dizziness.

BACKGROUND: Persistent postural perceptual dizziness (PPPD) is a common and disabling functional neuro-vestibular disorder. We aimed to determine the feasibility and acceptability of conducting a randomised controlled trial of cognitive-behavioural therapy informed vestibular rehabilitation (INVEST intervention) designed for persistent dizziness. METHODS: A two-armed parallel groups randomised feasibility study of INVEST vs. a time-matched gold standard vestibular rehabilitation (VRT) control. Participants with PPPD were recruited from a specialist vestibular clinic in London, UK. Participants were individually randomised using a minimisation procedure with allocation concealment. Measures of feasibility and clinical outcome were collected and assessed at 4 months. RESULTS: Forty adults with PPPD were randomised to six sessions of INVEST (n = 20) or gold standard VRT (n = 20). Overall, 59% of patients screened met the inclusion criteria, of which 80% enrolled. Acceptability of INVEST, as assessed against the theoretical framework of acceptability (TFA), was excellent and 80% adhered to all 6 sessions. There were small to moderate treatment effects in favour of INVEST across all measures, including dizziness handicap, negative illness perceptions, symptom focussing, fear avoidance, and distress (standardised mean difference [SMD]g = 0.45; SMDg = 0.77; SMDg = 0.56; SMDg = 0.50, respectively). No intervention-related serious adverse events were reported. CONCLUSIONS: The study results give strong support for the feasibility of a full-scale trial. Both arms had high rates of recruitment, retention, and acceptability. There was promising support of the benefits of integrated cognitive-behavioural therapy-based vestibular rehabilitation compared to gold standard vestibular rehabilitation. The study fulfilled all the a-priori criteria to advance to a full-scale efficacy trial. TRIAL REGISTRATION NUMBER: ISRCTN10420559.

"A little (PPI) MAGIC can take you a long way" : involving children and young people in research from inception of a novel medical device to multi-centre clinical trial Roald Dahl, James and the Giant Peach (1961).

BACKGROUND: There is often a great urgency to be inclusive when conducting research and to focus efforts with groups and communities that can be referred to as marginalised. This is especially the case in research concerning medical devices aimed at children and young people (CYP). Although involvement methodology has developed over the last two decades, it can be challenging to involve and engage CYP with confidence and clarity of purpose. MAIN BODY: Our aim was to provide a reflective narrative account of the involvement of CYP, over a period of 5 years, in a research project from conception of a new paediatric medical device through to practical application. We explored a model of patient and public involvement (PPI) through the Nottingham Young Persons Advisory Group (YPAG), part of the National Institute for Health Research (NIHR) GenerationR Alliance, in a NIHR funded research project. The YPAG designed and created a model of the human gut, co-designed the Transicap™ mini-capsules and their packaging, co-produced patient information sheets, came up with the idea to disseminate through a project website and co-wrote and created animation videos. The YPAG involvement continued through the writing and award of the follow-on research grant (MAGIC2). During this process the YPAG modified the clinical study protocol insisting that all participants in the control arm were given the imaging test results as well, save for a delayed reading compared to the intervention arm. CONCLUSION: Involvement of the YPAG over the last 5 years, led to the development of a mutually beneficial partnership, enabling genuine knowledge exchange between researchers and CYP. This influenced the design, plans and actions of the MAGIC study and well into the subsequent MAGIC2 follow-on project. Moreover, these involvement models applied within a feasibility study setting, have enhanced the realism and pragmatism of the study, contributing to the project's overall success.

Importance and Difficulties of Pursuing rTMS Research in Acute Stroke.

Although much research has been done on repetitive transcranial magnetic stimulation (rTMS) in chronic stroke, only sparse research has been done in acute stroke despite the particularly rich potential for neuroplasticity in this stage. We attempted a preliminary clinical trial in one active, high-quality inpatient rehabilitation facility (IRF) in the -United States. But after enrolling only 4 patients in the grant period, the study was stopped because of low enrollment. The purpose of this paper is to offer a perspective describing the important physiologic rationale for including rTMS in the early phase of stroke, the reasons for our poor patient enrollment in our attempted study, and recommendations to help future studies succeed. We conclude that, if scientists and clinicians hope to enhance stroke outcomes, more attention must be directed to leveraging conventional rehabilitation with neuromodulation in the acute phase of stroke when the capacity for neuroplasticity is optimal. Difficulties with patient enrollment must be addressed by reassessing traditional inclusion and exclusion criteria. Factors that shorten patients' length of stay in the IRF must also be reassessed at all policy-making levels to make ethical decisions that promote higher functional outcomes while retaining cost consciousness.

N-of-1 Trial in Person with Pontine Stroke Receiving Repetitive Transcranial Magnetic Stimulation to Improve Hand Function.

Stroke characteristics vary widely between individuals making it difficult to assess the value of stroke rehabilitation interventions. To eliminate inter-subject variability, this study used an N-of-1 randomized, controlled design to explore the efficacy of repetitive transcranial magnetic stimulation (rTMS) in one unique individual with pontine stroke. We hypothesized that five days of active 6-Hz primed, low-frequency rTMS to the contralesional primary motor area (M1), combined with finger movement tracking training, would accomplish greater gains in hand function than sham rTMS combined with tracking training. We assessed hand function (Box and Block test and finger tracking test), cortical activation (laterality index during functional magnetic resonance imaging), and cortical excitability (interhemispheric inhibition testing (IHI) with transcranial magnetic stimulation (TMS)). Diffusion tensor imaging (DTI) assessed the integrity of his corticospinal tracts at baseline. Results showed no improvement in the Box and Block or finger tracking tests, unreliable IHI findings, and no change in laterality index following active rTMS. DTI suggested truncation of the left corticospinal tract (CST) at the pons. His non-dexterous hand movements combined with no elicitable motor evoked potentials with TMS to ipsilesional M1 and his DTI findings lead us to speculate a reticulospinal mechanism for preserving his rudimentary paretic hand control. We conclude that rTMS combined with tracking training was not effective in the absence of CST pathways and that research is needed to confirm markers of reticulospinal function in humans as an alternative to defective CST function.