Impact of a wearable-based physical activity and sleep intervention in multimorbidity patients: protocol for a randomized controlled trial.

BACKGROUND: The benefits of physical activity (PA) and adequate sleep are well documented, and their importance strengthens with the increasing prevalence of chronic diseases and multimorbidity (MM). Interventions to promote physical activity and sleep that use commercial activity trackers may be useful non-pharmacological approaches to managing individual health; however, limited evidence exists on their use to improve physical activity in older adult patients with MM. METHODS: This study aims to measure the effects of behavioral change techniques (BCTs) delivered by a wearable device on physical activity and quality of sleep (QS) in older adult patients with MM. We designed an open-label randomized controlled trial with participants recruited through primary care and a specialist outpatient clinic. Participants must be more than 65 years old, have MM, and have access to smartphones. All eligible participants will receive PA promotion content and will be randomly assigned to wear a smartwatch. The primary outcome will be the participants' PA measurement at baseline and at six months using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Secondary outcomes will include changes in the participants' frailty status, biometric measurements, quality of life, and biopsychosocial assessments. A sample size of 40 participants per arm was calculated to detect group differences, with 50 participants planned to recruit and randomize into each arm. DISCUSSION: This study aims to contribute to a better understanding of PA patterns and the impact of wearable-based PA interventions in patients with MM. In addition, we aim to contribute to more knowledge about the relationship between PA patterns, Patient Reported Outcomes Measures (PROMs), and healthcare resource utilization in patients with MM. To achieve this, the study will leverage a locally developed PROMs registry and assess data from participants' medical records, in order to understand the added impact of wearable data and medical information data on predicting PROMs and unplanned hospital admissions. TRIAL REGISTRATION: NCT05777291.

Preclinical Assessment of Mesenchymal-Stem-Cell-Based Therapies in Spinocerebellar Ataxia Type 3.

The low regeneration potential of the central nervous system (CNS) represents a challenge for the development of new therapeutic strategies for neurodegenerative diseases, including spinocerebellar ataxias. Spinocerebellar ataxia type 3 (SCA3)-or Machado-Joseph disease (MJD)-is the most common dominant ataxia, being mainly characterized by motor deficits; however, SCA3/MJD has a complex and heterogeneous pathophysiology, involving many CNS brain regions, contributing to the lack of effective therapies. Mesenchymal stem cells (MSCs) have been proposed as a potential therapeutic tool for CNS disorders. Beyond their differentiation potential, MSCs secrete a broad range of neuroregulatory factors that can promote relevant neuroprotective and immunomodulatory actions in different pathophysiological contexts. The objective of this work was to study the effects of (1) human MSC transplantation and (2) human MSC secretome (CM) administration on disease progression in vivo, using the CMVMJD135 mouse model of SCA3/MJD. Our results showed that a single CM administration was more beneficial than MSC transplantation-particularly in the cerebellum and basal ganglia-while no motor improvement was observed when these cell-based therapeutic approaches were applied in the spinal cord. However, the effects observed were mild and transient, suggesting that continuous or repeated administration would be needed, which should be further tested.

Perfusion weighted imaging using combined gradient/spin echo EPIK: Brain tumour applications in hybrid MR-PET.

Advanced perfusion-weighted imaging (PWI) methods that combine gradient echo (GE) and spin echo (SE) data are important tools for the study of brain tumours. In PWI, single-shot, EPI-based methods have been widely used due to their relatively high imaging speed. However, when used with increasing spatial resolution, single-shot EPI methods often show limitations in whole-brain coverage for multi-contrast applications. To overcome this limitation, this work employs a new version of EPI with keyhole (EPIK) to provide five echoes: two with GEs, two with mixed GESE and one with SE; the sequence is termed "GESE-EPIK." The performance of GESE-EPIK is evaluated against its nearest relative, EPI, in terms of the temporal signal-to-noise ratio (tSNR). Here, data from brain tumour patients were acquired using a hybrid 3T MR-BrainPET scanner. GESE-EPIK resulted in reduced susceptibility artefacts, shorter TEs for the five echoes and increased brain coverage when compared to EPI. Moreover, compared to EPI, EPIK achieved a comparable tSNR for the first and second echoes and significantly higher tSNR for other echoes. A new method to obtain multi-echo GE and SE data with shorter TEs and increased brain coverage is demonstrated. As proposed here, the workflow can be shortened and the integration of multimodal clinical MR-PET studies can be facilitated.

PIÑATA: Pinpoint insertion of intravenous needles via augmented reality training assistance.

Conventional needle insertion training relies on medical dummies that simulate surface anatomy and internal structures such as veins or arteries. These dummies offer an interesting space to augment with useful information to assist training practices, namely, internal anatomical structures (subclavian artery and vein, internal jugular vein and carotid artery) along with target point, desired inclination, position and orientation of the needle. However, limited research has been conducted on Optical See-Through Augmented Reality (OST-AR) interfaces for training needle insertion, especially for central venous catheterization (CVC). In this work we introduce PIÑATA, an interactive tool to explore the benefits of OST-AR in CVC training using a dummy of the upper torso and neck; andexplore if PIÑATA complements conventional training practices.. Our design contribution also describes the observation and co-design sessions used to collect user requirements, usability aspects and user preferences. This was followed by a comparative study with 18 participants - attending specialists and medical residents - that performed needle insertion tasks for CVC with PIÑATAand the conventional training system. The performance was objectively measured by task completion time and number of needle insertion errors. A correlation was found between the task completion time in the two training methods, suggesting the concurrent validity of our OST-AR tool. An inherent difference in the task completion time (p =0.040) and in the number of errors (p = 0.036) between novices and experts proved the construct validity of the new tool. The qualitative answers of the participants also suggest its face and content validity, a high acceptability rate and a medium perceived workload. Finally, the result of semi-structured interviews with these 18 participants revealed that 14 of them considered that PIÑATA can complement the conventional training system, especially due to the visibility of the vessels inside the simulator. 13 agreed that OST-AR adoption in these scenarios is likely, particularly during early stages of training. Integration with ultrasound information was highlighted as necessary future work. In sum, the overall results show that the OST-AR tool proposed can complement the conventional training of CVC.

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies.

OBJECTIVE: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. METHODS: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. RESULTS: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. CONCLUSION: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

B1+ inhomogeneity mitigation in CEST using parallel transmission.

PURPOSE: In order to benefit from the increased spectral bandwidth at ultrahigh field (UHF), the use of parallel transmission (pTx) to mitigate flip-angle inhomogeneity in chemical exchange saturation transfer (CEST) imaging is investigated. THEORY AND METHODS: A pTx basis pulse is homogenised by magnitude least-squares (MLS) optimization and expanded to form a frequency-selective saturation pulse for CEST. The pTx saturation pulse was simulated with a three-pool Bloch-McConnell equation to evaluate the impact of pTx on CEST contrast. In vivo CEST imaging performance (7 T) of the pTx saturation pulse and the standard Gaussian saturation in circularly polarized mode were compared. Two-spokes pTx homogeneous excitation was used in all in vivo experiments to ensure fair comparison of the two saturation pulses. Magnetization transfer ratio and inverse Z-spectrum analyses were used as metrics in evaluating the data from 3 healthy volunteers. RESULTS: Bloch-McConnell simulations showed that side bands of the pTx saturation pulse at ±20 ppm did not affect any CEST contrast. Improved homogeneity in contrasts and relaxation-compensated CEST metrics were observed in our in vivo data when the pTx saturation pulse was used. CONCLUSION: A pTx-based pulsed CEST presaturation scheme is proposed and validated by simulations and 7T in vivo imaging. Magn Reson Med 78:2216-2225, 2017. © 2017 International Society for Magnetic Resonance in Medicine.