Aplicativo móvel educativo e de follow up para pacientes com doença arterial periférica

Objective: to describe the development of a prototype mobile educational application for nursing follow-up aimed at patients diagnosed with peripheral arterial disease. Method: a prototypebased technological production study. The construction followed the contextualized instructional design model using two steps: analysis and design and development. Results: the pedagogical content of the application was based on a survey of needs of patients with Peripheral Arterial Disease and treatments recommended in the literature. The prototype developed contained concepts, risk factors, signs and symptoms, treatment, importance of medications and their side effects, frequent doubts, necessary health care, and follow-up of patients by monitoring the evolution of the cicatricial process of lesions and possible complications, clarification of doubts and stimulus for continuation of treatment. Conclusion: the use of health applications is a technological tool with the potential to improve the follow-up of patients regarding the progress of the disease and self-care, monitoring of risk factors, co-participation of the patient in the treatment, family participation, as well as planning of individualized care, and cost reduction for the health system.Objetivo: describir el desarrollo de un prototipo de aplicativo móvil educativo y de follow up de enfermería para pacientes con diagnóstico de enfermedad arterial periférica. Método: estudio de producción tecnológica del tipo prototipación, la construcción siguió el modelo del design instruccional contextualizado, utilizando dos etapas: análisis y design y desarrollo. Resultados: el contenido pedagógico del aplicativo se basó en el levantamiento de las necesidades de los pacientes con Enfermedad Arterial Periférica y en los tratamientos recomendados por la literatura. El prototipo desarrollado fue compuesto por conceptos, factores de riesgo, señales y síntomas, tratamiento, importancia de los medicamentos y sus efectos colaterales, dudas frecuentes, cuidados necesarios con la salud y el follow up de los pacientes por medio del monitoreo de la evolución del proceso cicatricial de las lesiones y posibles complicaciones, aclarar dudas y estimular la continuidad del tratamiento. Conclusión: el uso de aplicativos en salud es una herramienta tecnológica con potencial para mejorar el acompañamiento de pacientes como a la evolución de la enfermedad y autocuidado, en el acompañamiento de los factores de riesgo, coparticipación en su tratamiento, la participación familiar, así como planificar un cuidado individualizado y reducción de costos para el sistema de salud.Objetivo: descrever o desenvolvimento de um protótipo de aplicativo móvel educativo e de follow up de enfermagem para pacientes com diagnóstico de doença arterial periférica. Método: estudo de produção tecnológica do tipo prototipagem, a construção seguiu o modelo do design instrucional contextualizado, utilizando duas etapas: análise e design e desenvolvimento. Resultados: o conteúdo pedagógico do aplicativo baseou-se no levantamento das necessidades dos pacientes com Doença Arterial Periférica e nos tratamentos recomendados pela literatura. O protótipo desenvolvido foi composto por conceitos, fatores de risco, sinais e sintomas, tratamento, importância dos medicamentos e seus efeitos colaterais, dúvidas frequentes, cuidados necessários com a saúde e o follow up dos pacientes por meio da monitorização da evolução do processo cicatricial das lesões e possíveis complicações, esclarecer dúvidas e estimular a continuidade do tratamento. Conclusão: o uso do aplicativos em saúde é uma ferramenta tecnológica com potencial para melhorar o acompanhamento de pacientes quanto à evolução da doença e autocuidado, no acompanhamento dos fatores de risco, coparticipação no seu tratamento, a participação familiar, bem como planejar um cuidado individualizado e redução de custos para o sistema de saúde

Tailored risk assessment and forecasting in intermittent claudication

BackgroundGuidelines recommend cardiovascular risk reduction and supervised exercise therapy as the first line of treatment in intermittent claudication, but implementation challenges and poor patient compliance lead to significant variation in management and therefore outcomes. The development of a precise risk stratification tool is proposed through a machine-learning algorithm that aims to provide personalized outcome predictions for different management strategies.MethodsFeature selection was performed using the least absolute shrinkage and selection operator method. The model was developed using a bootstrapped sample based on patients with intermittent claudication from a vascular centre to predict chronic limb-threatening ischaemia, two or more revascularization procedures, major adverse cardiovascular events, and major adverse limb events. Algorithm performance was evaluated using the area under the receiver operating characteristic curve. Calibration curves were generated to assess the consistency between predicted and actual outcomes. Decision curve analysis was employed to evaluate the clinical utility. Validation was performed using a similar dataset.ResultsThe bootstrapped sample of 10 000 patients was based on 255 patients. The model was validated using a similar sample of 254 patients. The area under the receiver operating characteristic curves for risk of progression to chronic limb-threatening ischaemia at 2 years (0.892), risk of progression to chronic limb-threatening ischaemia at 5 years (0.866), likelihood of major adverse cardiovascular events within 5 years (0.836), likelihood of major adverse limb events within 5 years (0.891), and likelihood of two or more revascularization procedures within 5 years (0.896) demonstrated excellent discrimination. Calibration curves demonstrated good consistency between predicted and actual outcomes and decision curve analysis confirmed clinical utility. Logistic regression yielded slightly lower area under the receiver operating characteristic curves for these outcomes compared with the least absolute shrinkage and selection operator algorithm (0.728, 0.717, 0.746, 0.756, and 0.733 respectively). External calibration curve and decision curve analysis confirmed the reliability and clinical utility of the model, surpassing traditional logistic regression.ConclusionThe machine-learning algorithm successfully predicts outcomes for patients with intermittent claudication across various initial treatment strategies, offering potential for improved risk stratification and patient outcomes

How to improve drug dosing for patients with renal impairment in primary care - a cluster-randomized controlled trial

Background: Patients with chronic kidney disease (CKD) are at increased risk for inappropriate or potentially harmful prescribing. The aim of this study was to examine whether a multifaceted intervention including the use of a software programme for the estimation of creatinine clearance and recommendation of individual dosage requirements may improve correct dosage adjustment of relevant medications for patients with CKD in primary care. Methods: A cluster-randomized controlled trial was conducted between January and December 2007 in small primary care practices in Germany. Practices were randomly allocated to intervention or control groups. In each practice, we included patients with known CKD and elderly patients (>=70 years) suffering from hypertension. The practices in the intervention group received interactive training and were provided a software programme to assist with individual dose adjustment. The control group performed usual care. Data were collected at baseline and at 6 months. The outcome measures, analyzed across individual patients, included prescriptions exceeding recommended maximum daily doses, with the primary outcome being prescriptions exceeding recommended standard daily doses by 30% or more. Results: Data from 44 general practitioners and 404 patients are included. The intervention was effective in reducing prescriptions exceeding the maximum daily dose per patients, with a trend in reducing prescriptions exceeding the standard daily dose by more than 30%. Conclusions: A multifaceted intervention including the use of a software program effectively reduced inappropriately high doses of renally excreted medications in patients with CKD in the setting of small primary care practices

The role of guidelines and the patient's life-style in GPs' management of hypercholesterolaemia

BACKGROUND: Recent Swedish and joint European guidelines on hyperlipidaemia stress the high coronary risk for patients with already established arterio-sclerotic disease (secondary prevention) or diabetes. For the remaining group, calculation of the ten-year risk for coronary events using the Framingham equation is suggested. There is evidence that use of and adherence to guidelines is incomplete and that tools for risk estimations are seldom used. Intuitive risk estimates are difficult and systematically biased. The purpose of the study was to examine how GPs use knowledge of guidelines in their decisions to recommend or not recommend a cholesterol-lowering drug and the reasons for their decisions. METHODS: Twenty GPs were exposed to six case vignettes presented on a computer. In the course of six screens, successively more information was added to the case. The doctors were instructed to think aloud while processing the cases (Think-Aloud Protocols) and finally to decide for or against drug treatment. After the six cases they were asked to describe how they usually reason when they meet patients with high cholesterol values (Free-Report Protocols). The two sets of protocols were coded for cause-effect relations that were supposed to reflect the doctors' knowledge of guidelines. The Think-Aloud Protocols were also searched for reasons for the decisions to prescribe or not to prescribe. RESULTS: According to the protocols, the GPs were well aware of the importance of previous coronary heart disease and diabetes in their decisions. On the other hand, only a few doctors mentioned other arterio-sclerotic diseases like stroke and peripheral artery disease as variables affecting their decisions. There were several instances when the doctors' decisions apparently deviated from their knowledge of the guidelines. The arguments for the decisions in these cases often concerned aspects of the patient's life-style like smoking or overweight- either as risk-increasing factors or as alternative strategies for intervention. CONCLUSIONS: Coding verbal protocols for knowledge and for decision arguments seems to be a valuable tool for increasing our understanding of how guidelines are used in the on treatment of hypercholesterolaemia. By analysing arguments for treatment decisions it was often possible to understand why departures from the guidelines were made. While the need for decision support is obvious, the current guidelines may be too simple in some respects

Technology-Enabled Remote Monitoring and Self-Management - Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol.

BACKGROUND: Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT-VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. OBJECTIVE: Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). METHODS: CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise-death, myocardial infarction, and nonfatal stroke- all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups. RESULTS: Study start-up is underway and usability testing is scheduled to begin in the fall of 2016. CONCLUSIONS: Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS

Physical Activity and Exercise with Blood Flow Restriction as Medicine During the COVID-19 Pandemic and Beyond

During the COVID-19 pandemic, physical activity levels have decreased and sitting time has increased. This is a major concern as physical inactivity increases the risk for severe COVID-19 outcomes. Evidence also indicates that COVID-19 survivors can experience reduced physical function (i.e., ability to complete daily living activities) long after acute illness. Currently, there are no evidence-based guidelines for recovering physical function following COVID-19 infection. Exercise with blood flow restriction (BFR) presents a promising rehabilitation strategy as the benefits of traditional exercise can be achieved using lower intensities. However, several barriers such as cost, access to equipment, and lack of standardized methods limit its use. The goal of this research was to promote and facilitate the use of physical activity as a critical form of medicine during the COVID-19 pandemic and beyond. With study 1, I implemented a community-based program to provide free physical activity resources to the rural Upper Peninsula during the pandemic. Physical activity was promoted through a widespread media campaign and over 260 virtual home-based workouts were delivered to community members using several platforms (i.e., Zoom, Facebook Live, YouTube, TV, DVD). With study 2, I developed a working hypothesis and theoretical framework for using BFR to help restore physical function in those individuals infected with COVID-19. Specifically, I hypothesized that passive BFR modalities can mitigate losses of muscle mass and muscle strength that occur during acute infection and 2) exercise with BFR can serve as an effective alternative to traditional higher intensity exercise for regaining muscle mass, muscle strength, and aerobic capacity during convalescence. With study 3, I collected laboratory-based measures using Doppler ultrasound and anthropometric techniques in healthy adults (n=143) and applied linear regression methods to develop and validate a prediction equation for performing BFR without the need for specialized equipment. Finally, with study 4, I developed and usability tested a web-based application designed to serve as user support tool that aids physical therapists in implementing BFR. Collectively, my research addressed two major public health problems (COVID-19 and physical inactivity) and sought to enhance accessibility of physical activity and exercise with BFR during the pandemic and beyond

Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program.

BackgroundPatient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process.MethodsConcept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items.ResultsDuring concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders.ConclusionDevelopment of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program

Telemedicine in patients with peripheral arterial disease:is it worth the effort?

Introduction: For patients with peripheral arterial disease (PAD), the various components of telemedicine, such as telemonitoring, telecoaching, and teleconsultation, could be valuable in daily management. The objective of this review was to give an overview of the current use of telemedicine interventions in PAD. Areas covered: A literature search was performed for studies that evaluated patients with PAD of the aorto-pedal trajectory, who were monitored by telemedicine and acted upon accordingly. The primary outcome was health-related outcomes. The studies that were found focused mainly on wearable activity monitoring and telecoaching in PAD (n = 4) or wound monitoring after vascular surgery (n = 2). Main results indicate that telemedicine interventions are able to detect (post-operative) complications early, improve functional capacity and claudication onset time, and improve PAD patients’ quality of life. Expert opinion: The use of telemedicine in PAD patients is still an under-explored area. Studies investigating the use of telemedicine in PAD are very limited and show varying results. Owing to its high potential in improving physical ability, lifestyle coaching, and timely detection of deterioration, future research should focus on proper implementation of telemedicine in PAD patients, including clinical and feasibility outcomes, effect on workload of nurses, and cost-efficiency.</p

Recent Advances and the Potential for Clinical Use of Autofluorescence Detection of Extra-Ophthalmic Tissues

The autofluorescence (AF) characteristics of endogenous fluorophores allow the label-free assessment and visualization of cells and tissues of the human body. While AF imaging (AFI) is well-established in ophthalmology, its clinical applications are steadily expanding to other disciplines. This review summarizes clinical advances of AF techniques published during the past decade. A systematic search of the MEDLINE database and Cochrane Library databases was performed to identify clinical AF studies in extra-ophthalmic tissues. In total, 1097 articles were identified, of which 113 from internal medicine, surgery, oral medicine, and dermatology were reviewed. While comparable technological standards exist in diabetology and cardiology, in all other disciplines, comparability between studies is limited due to the number of differing AF techniques and non-standardized imaging and data analysis. Clear evidence was found for skin AF as a surrogate for blood glucose homeostasis or cardiovascular risk grading. In thyroid surgery, foremost, less experienced surgeons may benefit from the AF-guided intraoperative separation of parathyroid from thyroid tissue. There is a growing interest in AF techniques in clinical disciplines, and promising advances have been made during the past decade. However, further research and development are mandatory to overcome the existing limitations and to maximize the clinical benefits