Adaptation and implementation of a mobile phone–based remote symptom monitoring system for people with cancer in Europe

Background: There has been an international shift in health care, which has seen an increasing focus and development of technological and personalized at-home interventions that aim to improve health outcomes and patient-clinician communication. However, there is a notable lack of empirical evidence describing the preparatory steps of adapting and implementing technology of this kind across multiple countries and clinical settings. Objective: This study aimed to describe the steps undertaken in the preparation of a multinational, multicenter randomized controlled trial (RCT) to test a mobile phone–based remote symptom monitoring system, that is, Advanced Symptom Management System (ASyMS), designed to enhance management of chemotherapy toxicities among people with cancer receiving adjuvant chemotherapy versus standard cancer center care. Methods: There were 13 cancer centers across 5 European countries (Austria, Greece, Ireland, Norway, and the United Kingdom). Multiple steps were undertaken, including a scoping review of empirical literature and clinical guidelines, translation and linguistic validation of study materials, development of standardized international care procedures, and the integration and evaluation of the technology within each cancer center. Results: The ASyMS was successfully implemented and deployed in clinical practices across 5 European countries. The rigorous and simultaneous steps undertaken by the research team highlighted the strengths of the system in clinical practice, as well as the clinical and technical changes required to meet the diverse needs of its intended users within each country, before the commencement of the RCT. Conclusions: Adapting and implementing this multinational, multicenter system required close attention to diverse considerations and unique challenges primarily related to communication and clinical and technical issues. Success was dependent on collaborative and transparent communication among academics, the technology industry, translation partners, patients, and clinicians as well as a simultaneous and rigorous methodological approach within the 5 relevant countries

The eSMART study protocol : a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081

Adaptation and implementation of a multinational eHealth intervention for people with cancer : reflections from the field

Background: There has been an international shift in healthcare which has seen an increasing focus and development of technological and personalized at-home interventions which aim to improve health outcomes and patient-clinician communication. However, there is a notable lack of empirical evidence describing the preparatory steps of adapting and implementing technology of this kind across multiple countries and clinical settings. Objective: To describe the steps undertaken in the preparation of a multinational, multicentre randomized controlled trial to test a mobile phone-based remote symptom monitoring system, i.e. Advanced Symptom Management System Remote Technology (ASyMS), designed to enhance management of chemotherapy toxicities amongst people with cancer receiving adjuvant chemotherapy versus standard cancer centre care. Methods: Multiple steps were undertaken, including; a scoping review of empirical literature and clinical guidelines, translation and linguistic validation of study materials, development of standardised international care procedures and the integration and evaluation of the technology within each cancer centre. Results: ASyMS was successfully implemented and deployed in clinical practice across five European countries. The rigorous and simultaneous steps undertaken by the research team highlighted the strengths of the system in clinical practice, as well as the clinical and technical changes required to meet the diverse needs of its intended users within each country, prior to the commencement of the randomized controlled trial. Conclusions: Adapting and implementing this multinational, multicentre system required close attention to diverse considerations and unique challenges, primarily related to communication, clinical and technical issues. Success was dependent on collaborative and transparent communication amongst academics, technology industry, translation partners, patients, and clinicians as well as a simultaneous and rigorous methodological approach within the five relevant countries

Neuromuscular electrical stimulation-promoted plasticity of the human brain

The application of neuromuscular electrical stimulation (NMES) to paretic limbs has demonstrated utility for motor rehabilitation following brain injury. When NMES is delivered to a mixed peripheral nerve, typically both efferent and afferent fibres are recruited. Muscle contractions brought about by the excitation of motor neurons are often used to compensate for disability by assisting actions such as the formation of hand aperture, or by preventing others including foot drop. In this context, exogenous stimulation provides a direct substitute for endogenous neural drive. The goal of the present narrative review is to describe the means through which NMES may also promote sustained adaptations within central motor pathways, leading ultimately to increases in (intrinsic) functional capacity. There is an obvious practical motivation, in that detailed knowledge concerning the mechanisms of adaptation has the potential to inform neurorehabilitation practice. In addition, responses to NMES provide a means of studying CNS plasticity at a systems level in humans. We summarize the fundamental aspects of NMES, focusing on the forms that are employed most commonly in clinical and experimental practice. Specific attention is devoted to adjuvant techniques that further promote adaptive responses to NMES thereby offering the prospect of increased therapeutic potential. The emergent theme is that an association with centrally initiated neural activity, whether this is generated in the context of NMES triggered by efferent drive or via indirect methods such as mental imagery, may in some circumstances promote the physiological changes that can be induced through peripheral electrical stimulation. (Figure presented.)

Characteristics of corticospinal projections to the intrinsic hand muscles in skilled harpists

The process of learning to play a musical instrument necessarily alters the functional organisation of the cortical motor areas that are involved in generating the required movements. In the case of the harp, the demands placed on the motor system are quite specific. During performance, all digits with the sole exception of the little finger are used to pluck the strings. With a view to elucidating the impact of having acquired this highly specialized musical skill on the characteristics of corticospinal projections to the intrinsic hand muscles, focal transcranial magnetic stimulation (TMS) was used to elicit motor evoked potentials (MEPs) in three muscles (of the left hand): abductor pollicis brevis (APB); first dorsal interosseous (FDI); and abductor digiti minimi (ADM) in seven harpists. Seven non-musicians served as controls. With respect to the FDI muscle – which moves the index finger, the harpists exhibited reliably larger MEP amplitudes than those in the control group. In contrast, MEPs evoked in the ADM muscle – which activates the little finger, were smaller in the harpists than in the non-musicians. The locations on the scalp over which magnetic stimulation elicited discriminable responses in ADM also differed between the harpists and the non-musicians. This specific pattern of variation in the excitability of corticospinal projections to these intrinsic hand muscles exhibited by harpists is in accordance with the idiosyncratic functional demands that are imposed in playing this instrument

The eSMART Project: real time symptom management in the oncology setting

In 2013 European Union funding was awarded for the eSMART (Electronic Symptom Management Using the ASyMS Remote Technology) study, to evaluate the use of mobile phone technology for management of chemotherapy symptoms in a two-part, pragmatic, RCT across fourteen European clinical sites, including four in the Republic of Ireland (ROI).European Commission - Seventh Framework Programme (FP7

Feasibility of Repeated Assessment of Cognitive Function in Older Adults Using a Wireless, Mobile, Dry-EEG Headset and Tablet-Based Games

Access to affordable, objective and scalable biomarkers of brain function is needed to transform the healthcare burden of neuropsychiatric and neurodegenerative disease. Electroencephalography (EEG) recordings, both resting and in combination with targeted cognitive tasks, have demonstrated utility in tracking disease state and therapy response in a range of conditions from schizophrenia to Alzheimer's disease. But conventional methods of recording this data involve burdensome clinic visits, and behavioural tasks that are not effective in frequent repeated use. This paper aims to evaluate the technical and human-factors feasibility of gathering large-scale EEG using novel technology in the home environment with healthy adult users. In a large field study, 89 healthy adults aged 40–79 years volunteered to use the system at home for 12 weeks, 5 times/week, for 30 min/session. A 16-channel, dry-sensor, portable wireless headset recorded EEG while users played gamified cognitive and passive tasks through a tablet application, including tests of decision making, executive function and memory. Data was uploaded to cloud servers and remotely monitored via web-based dashboards. Seventy-eight participants completed the study, and high levels of adherence were maintained throughout across all age groups, with mean compliance over the 12-week period of 82% (4.1 sessions per week). Reported ease of use was also high with mean System Usability Scale scores of 78.7. Behavioural response measures (reaction time and accuracy) and EEG components elicited by gamified stimuli (P300, ERN, Pe and changes in power spectral density) were extracted from the data collected in home, across a wide range of ages, including older adult participants. Findings replicated well-known patterns of age-related change and demonstrated the feasibility of using low-burden, large-scale, longitudinal EEG measurement in community-based cohorts. This technology enables clinically relevant data to be recorded outside the lab/clinic, from which metrics underlying cognitive ageing could be extracted, opening the door to potential new ways of developing digital cognitive biomarkers for disorders affecting the brain