scholarly journals Remote Monitoring Programs for Cardiac Conditions

2021 ◽  
Vol 1 (11) ◽  
Author(s):  
Health Technology Assessment Team

These recommendations were developed by the CADTH Health Technology Expert Review Panel (HTERP) to address the implementation of remote monitoring or remote management programs for patients with chronic cardiac conditions. The recommendations were developed following HTERP deliberations over multidisciplinary evidence reviewed in a CADTH Health Technology Assessment (HTA) report. The HTA included a realist review conducted to identify key perceived or actual mechanisms of remote monitoring programs, patients’ and caregivers’ expectations and experiences of engaging with remote monitoring programs, and ethical issues raised by the use of remote monitoring for patients with chronic cardiac conditions. HTERP recommends that the design and implementation of remote monitoring programs include a broad range of stakeholder voices with considerations across several key domains. In particular, HTERP recommends that: remote monitoring programs for chronic cardiac conditions be flexible and adaptable to a diverse range of patient circumstances if implemented, remote monitoring should be an integral part of the care pathway for chronic cardiac conditions, with processes and policies to support it jurisdictions understand and be transparent about information flow, and keep patient data use and privacy at the forefront of service contract negotiations remote monitoring programs for cardiac conditions avoid creating or exacerbating inequities in health care remote monitoring programs include an evaluation component to ensure program aims are met.

2021 ◽  
Vol 1 (9) ◽  
Author(s):  
Alexander Clark ◽  
Bailey Sousa ◽  
Andrea Smith ◽  
Duncan Steele ◽  
Tamara Rader ◽  
...  

Remote monitoring is a type of telehealth whereby health care is delivered to patients outside traditional settings by allowing health data to be exchanged between patients and health care providers using telecommunication techniques (e.g., video conferencing) or stand-alone devices (e.g., portable heart rate monitors). The goals of remote monitoring centre around promoting home-based self-management to improve patient outcomes and/or reduce health system usage. CADTH’s Health Technology Assessment included the following analyses: A Realist Review: This sought to identify key perceived or actual mechanisms of remote monitoring programs. Substantial evidence was available regarding the use of remote monitoring programs for heart failure (n = 64) and cardiac rehabilitation (n = 23), limited evidence was available for atrial fibrillation (n = 4), and none was available for hypertension. A Perspectives and Experiences Review: This thematic synthesis of primary qualitative research sought to understand and describe peoples’ experiences with and perspectives on remote monitoring programs for cardiac conditions. CADTH also engaged patients and caregivers directly in a patient engagement section. An Ethics Review: This sought to identify and reflect upon key ethical issues that should be considered when contemplating the implementation of remote monitoring programs. Overall, the vast majority of sampled patients, caregivers, and health professionals consistently found or perceived remote monitoring programs across different cardiac conditions to be easy to use and beneficial to health. Remote monitoring programs may be an attractive adjunct as opposed to an alternative to existing health professionals and services. Although remote monitoring programs may ultimately reduce avoidable hospitalizations, they may increase net costs and workload during set-up and operational phases without careful pathway design and expectations management. More research is needed to identify the costs and cost-effectiveness of remote monitoring programs across chronic cardiac conditions.


Author(s):  
Karola V. Kreitmair ◽  
Mildred K. Cho

Wearable and mobile health technology is becoming increasingly pervasive, both in professional healthcare settings and with individual consumers. This chapter delineates the various functionalities of this technology and identifies its different purposes. It then addresses the ethical challenges that this pervasiveness poses in the areas of accuracy and reliability of the technology, privacy and confidentiality of data, consent, and the democratization of healthcare. It also looks at mobile mental health apps as a case study to elucidate the discussion of ethical issues. Finally, the chapter turns to the question of how this technology and the associated “quantification of the self” affect traditional modes of epistemic access to and phenomenological conceptions of the self.


2017 ◽  
Vol 41 (S1) ◽  
pp. S39-S39
Author(s):  
S. Galderisi ◽  
F. Caputo

IntroductionMobile health (m-health) technology has been growing rapidly in the last decades. The use of this technology represents an advantage, especially for reaching patients who otherwise would have no access to healthcare. However, many ethical issues arise from the use of m-health. Health equity, privacy policies, adequate informed consent and a competent, safe and high quality healthcare need to be guaranteed; professional standards and quality of doctor-patient relationship in the digital setting should not be lower than those set for in-person practice.AimsTo assess advantages and threats that may arise from the wide use of m-health technologies, in order to guarantee the application of the best medical practices, resulting in the highest quality healthcare.MethodsA literature search has been conducted to highlight the most pressing ethical issues emerging from the spreading of m-health technologies.ResultsFew ethical guidelines on the appropriate use of m-health have been developed to help clinicians adopt a professional conduct within digital settings. They focus on the need for professional associations to define ethical guidelines and for physicians to take care of their education and online behavior when using m-health technologies.ConclusionsThe rapid spreading of m-health technologies urges us to evaluate all ethical issues related to its use. It would be advisable to produce an ethical code for the use of these new technologies, to guarantee health equity, privacy protection, high quality doctor-patient relationships and to ensure that m-health is not chosen over traditional care for merely economic purposes.Disclosure of interestSG received honoraria or Advisory board/consulting fees from the following companies: Lundbeck, Janssen Pharmaceuticals, Hoffman-La Roche, Angelini-Acraf, Otsuka, Pierre Fabre and Gedeon-Richter. All other authors have declared.


2019 ◽  
Vol 102 (2) ◽  
pp. 564-569
Author(s):  
Greg Jaudzems ◽  
Fengxia Zhang ◽  
Wu Bolong ◽  
Lei Bao ◽  
Jing Xiao

Abstract Background: In September 2015, both AOAC Official Methods 2015.07and 2015.08 single-laboratory validations (SLVs) were reviewed against Standard Method Performance Requirements® (SMPR) 2014.015by the AOAC Stakeholder Panel for Infant Formula andAdult Nutritional (SPIFAN) Expert Review Panel (ERP). Looking at the similarity and uniqueness of the two methods, the authors agreed, as advised by the ERP, to work together to merge the two methods intoone. This combined method was assigned Method 2016.03. Objective: In order to determine the repeatability and reproducibility of the AOAC First Action 2016.03 method, a collaborative study was organized. The study was divided in two parts: (Part 1) method set up and qualification of participants and (Part 2) collaborative study participation. During Part 1, each laboratory was asked to analyze two practice samples. The laboratories that provided results within a range of expected levels were qualified for Part 2, during which they analyzed 25 samples in blind duplicates. Results: The results were compared with SMPR 2014.015 established for chloride. The precision results (repeatability and reproducibility) were within therequirements stated in the SMPR. In general, the precision results (repeatability and reproducibility)were well within the limits stated in the SMPR. Repeatability ranged from 0.4 to 1.9%, in accordance with data obtained during SLV, with reported RSD of repeatability from 0.03 to 1.6%. Meanwhile, reproducibility ranged from 0.6 to 4.0%. Finally, the Horwitz ratio values were all below 1, from 0.2 to 0.9%. Conclusions: The ERP determined that the data presented met the SMPR and accordingly recommended the method to be granted Final Actionstatus. In January 2018, the Official Methods Boardapproved the method as Final Action.


Radiology ◽  
2020 ◽  
Vol 296 (2) ◽  
pp. E106-E112 ◽  
Author(s):  
Mahmud Mossa-Basha ◽  
Carolyn C. Meltzer ◽  
Danny C. Kim ◽  
Michael J. Tuite ◽  
K. Pallav Kolli ◽  
...  

2017 ◽  
Vol 33 (S1) ◽  
pp. 46-46
Author(s):  
Bjørn Hofmann

INTRODUCTION:Several health technologies used for therapy can also be used for health enhancement. Drugs stimulating cognitive abilities are but one example. Health Technology Assessment (HTA) has not been developed for assessing enhancements. This raises the question of how HTA should address the blurred distinction between therapy and enhancement. Should we (i) carve out a distinction between therapy and enhancement and limit HTA to therapy, (ii) use HTA for both therapy and enhancement (with some modifications), or (iii) should we develop a separate health enhancement assessment (HEA)?METHODS:A literature search of the medical, philosophical, and bioethical literature was conducted for debates, arguments, and suggested solutions to the issue of therapy versus enhancement.RESULTS:The same improvement in health may be therapeutic in one patient, but an enhancement in another. Moreover, both therapy and enhancement share the same goal: increased health and wellbeing. A wide range of arguments try to establish a difference between therapy and enhancement. They refer to naturalness, rehabilitation, normality, species-typical functioning/potential, disease, sustainability, and responsibility. On closer scrutiny few of these arguments do the job in bolstering the therapy-enhancement distinction. We already use a wide range of means to extend human abilities. Moreover, the therapy-enhancement distinction raises a wide range of ethical issues that are relevant for the assessment of a number of emerging health technologies.CONCLUSIONS:Existing HTA methodology can address a wide range of non-therapeutic health enhancements. However, a series of broader issues related to the goal of health care and responsibility for altering human evolution may not be addressed within traditional HTA frameworks. Specific HEAs may therefore be helpful.


2018 ◽  
Vol 34 (S1) ◽  
pp. 30-30
Author(s):  
Meredith Vanstone ◽  
Julia Bidonde ◽  
Ken Bond ◽  
Julia Abelson ◽  
Lisa Schwartz ◽  
...  

Introduction:It is widely recognized that the incorporation of patient and public perspectives can enrich health policy decision-making. Methodological and practical advice on engaging patients and the public has proliferated in recent years, with many health technology assessment (HTA) agencies working to formalize their processes in this area. However, despite growing enthusiasm for patient and public engagement, many ethical issues remain unaddressed including: balancing risks and benefits to participants; recruitment methods; reimbursement for time spent participating; representation; and, information disclosure.Methods:In this critical analysis, we draw on our collective experiences engaging with patients and public in the context of HTA. We use principles from two theories, i) research ethics, and ii) participatory governance, to analyze these challenges. The purpose of this analysis is to explore the ways in which risks and benefits to patient and public participants might be balanced in HTA activities.Results:We begin by describing some ethically challenging experiences we have faced when soliciting views and values from patients and members of the public, some anticipated and some unexpected. These challenges include unexpected disclosures of information, navigating power differentials when working with vulnerable populations, eliciting information about potentially traumatizing experiences, and fairly representing controversial and conflicting opinions. We offer examples about what types of patient engagement activities may subject participants to unreasonable risk, and suggest some guiding principles to help plan ethical patient and public engagement activities.Conclusions:Patient and public engagement requires more than just procedural methodological expertise- it also requires the ability to identify and analyze relevant ethical issues. We posit that health technology assessors have a moral obligation to ensure that the risks of patient and public engagement activities do not outweigh the benefits. We call upon the HTA community to engage in thoughtful deliberation about what can be learned from experiences within HTA and in other contexts.


2016 ◽  
Vol 99 (1) ◽  
pp. 53-54
Author(s):  
Sharon L Brunelle

Abstract A previously validated method for determination of chondroitin sulfate in raw materials and dietary supplements was submitted to the AOAC Expert Review Panel (ERP) for Stakeholder Panel on Dietary Supplements Set 1 Ingredients (Anthocyanins, Chondroitin, and PDE5 Inhibitors) for consideration of First Action Official MethodsSM status. The ERP evaluated the single-laboratory validation results against AOAC Standard Method Performance Requirements 2014.009. With recoveries of 100.8–101.6% in raw materials and 105.4–105.8% in finished products and precision of 0.25–1.8% RSDr within-day and 1.6–4.72% RSDr overall, the ERP adopted the method for First Action Official Methods status and provided recommendations for achieving Final Action status.


2013 ◽  
Vol 96 (4) ◽  
pp. 798-801 ◽  
Author(s):  
Lawrence H Pacquette ◽  
Alan M Levenson ◽  
Joseph J Thompson ◽  
Dawn Dowell

Abstract After an assessment of data generated from a single-laboratory validation study published in the Journal of AOAC INTERNATIONAL 95, 169–176 (2012), a method for determining the total level of iodine in infant formula and nutritional products was presented for consideration for adoption by AOAC during the AOAC Annual Meeting held September 30–October 3, 2012 in Las Vegas, NV. An Expert Review Panel on Infant Formula and Adult Nutritionals concluded that the method met the established standard method performance requirements, and approved the method as AOAC Official First Action. The method involves digestion of the sample with nitric acid in a closed vessel microwave oven, followed by determination by inductively coupled plasma/MS using tellurium as the internal standard. The method LOQ for total iodine was 1.5 μg/100 g, but a practical LOQ was used at 5 μg/100 g total iodine. The analytical range of the method was 5–100 μg/100 g total iodine. The recoveries from 15 spiked nutritional products ranged from 90 to 105%.


2010 ◽  
Vol 26 (4) ◽  
pp. 441-449 ◽  
Author(s):  
Sigrid Droste ◽  
Charalabos-Markos Dintsios ◽  
Andreas Gerber

Background: Comprehensive health technology assessments (HTAs) include thorough reflections on ethical issues associated with health technologies, their use, and value-based decisions in the assessment process. As methods of information retrieval for effectiveness assessments are not applicable to information retrieval on ethical issues, a specific methodological approach is necessary.Objectives: In the absence of existing adapted methods, our objective was to develop a methodological approach for the systematic retrieval of information on ethical issues related to health technologies.Method and Results: A literature search was conducted to verify the non-existence of published comprehensive methodological approaches for the information retrieval on ethical issues for HTAs, and resulted in no hits. We, therefore, developed a step-by-step workflow following the workflow of information retrieval for effectiveness assessments: Step 1: Translation of the search question using the PICO scheme and additional components. Step 2: Concept building by modeling and linking search components. Step 3: Identification of synonyms in all relevant languages. Step 4: Selection of relevant information sources. Step 5: Design of search strategies for bibliographic databases. Step 6: Execution of search strategies and information seeking, including hand-searching. Step 7: Saving of retrieval results and standardized reporting of the process and results. Step 8: Final quality check and calculation of precision and recall.Conclusions: Systematic searching for information on ethical issues related to health technologies can be performed following the common retrieval workflow for effectiveness assessments, but should be performed separately applying adapted procedures and search terms on ethical issues relevant to the research question.


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