OP143 Assessment Of mHealth Apps: Is Current Regulation Policy Adequate?

2019 ◽  
Vol 35 (S1) ◽  
pp. 33-33
Author(s):  
Magdalena Moshi ◽  
Jacqueline Parsons ◽  
Rebecca Tooher ◽  
Tracy Merlin
Keyword(s):  
Medical Device ◽  
Clinical Evaluation ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
International Standards ◽  
Regulatory Agencies ◽  
Guidance Document ◽  
Regulatory Bodies ◽  
Mhealth Apps

IntroductionAustralians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.MethodsA policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.ResultsAll included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.ConclusionsNone of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.

Evaluation of Mobile Health Applications: Is Regulatory Policy Up to the Challenge?

2019 ◽  
Vol 35 (4) ◽  
pp. 351-360 ◽  
Author(s):  
Magdalena Ruth Moshi ◽  
Jacqueline Parsons ◽  
Rebecca Tooher ◽  
Tracy Merlin
Keyword(s):  
Case Studies ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
The United States ◽  
Risk Classification ◽  
International Standards ◽  
Guidance Document ◽  
Regulatory Bodies

AbstractObjectivesThe aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies.MethodsThe policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized.ResultsAll included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences.ConclusionsThe risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated.

scholarly journals Variation in LOD Across SARS-CoV-2 Assay Systems: Need for Standardization

2020 ◽  
Author(s):  
Youvraj Sohni
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Limit Of Detection ◽  
Clinical Decision ◽  
International Standards ◽  
Performance Characteristics ◽  
Clinical Testing ◽  
Factors Affecting ◽  
Diagnostic Assays ◽  
Technology Platforms

Abstract Multiple SARS-CoV-2 emergency use authorization (EUA) tests are being used for clinical testing across various clinical testing laboratories for meeting the diagnostic challenges of the ongoing pandemic. However, cross-assay variations in performance characteristics need to be recognized. A better understanding is needed of the clinical implications of cross-assay variation in performance characteristics, particularly in the limit of detection (LOD) of the SARS-CoV-2 assays used for clinical testing. Herein, a snapshot of the diversity of SARS-CoV-2 EUA analytical assay systems including methodologies, assay designs, and technology platforms is presented. Factors affecting the variations in LOD are discussed. Potential measures that may standardize across the various assay systems are suggested. Development of international standards and reference materials for the establishment of performance characteristics may substantially alleviate potential clinical decision-making challenges. Finally, cross-assay variation in LODs among the diverse SARS-CoV-2 diagnostic assays impacts clinical decision-making with multiple assay systems in use and lack of standardization across platforms. International standards in parallel with continued cross-platform studies and collaborative efforts across pertinent healthcare entities will help mitigate some of the clinical decision-making challenges.

scholarly journals Integrating Patient-Generated Health Data Into Clinical Care Settings or Clinical Decision-Making: Lessons Learned From Project HealthDesign

2016 ◽  
Vol 3 (2) ◽  
pp. e26 ◽  
Author(s):  
Deborah J Cohen ◽  
Sara R Keller ◽  
Gillian R Hayes ◽  
David A Dorr ◽  
Joan S Ash ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
Health Data ◽  
Lessons Learned

scholarly journals ACADEMIA’S ROLE TO DRIVE CHANGE IN THE ORTHOTICS AND PROSTHETICS PROFESSION

2021 ◽  
Vol 4 (2) ◽  
Author(s):  
Géza Kogler ◽  
Christopher Hovorka
Keyword(s):  
Technology Use ◽  
Clinical Training ◽  
Clinical Decision Making ◽  
New Technologies ◽  
Clinical Care ◽  
Clinical Decision ◽  
The United States ◽  
Academic Program ◽  
Number Of Patients ◽  
Curricular Emphasis

This position paper outlines the important role of academia in shaping the orthotics and prosthetics (O&P) profession and preparing for its future. In the United States, most healthcare professions including O&P are under intense pressure to provide cost effective treatments and quantifiable health outcomes. Pivotal changes are needed in the way O&P services are provided to remain competitive. This will require the integration of new technologies and data driven processes that have the potential to streamline workflows, reduce errors and inform new methods of clinical care and device manufacturing. Academia can lead this change, starting with a restructuring in academic program curricula that will enable the next generation of professionals to cope with multiple demands such as the provision of services for an increasing number of patients by a relatively small workforce of certified practitioners delivering these services at a reduced cost, with the expectation of significant, meaningful, and measurable value. Key curricular changes will require replacing traditional labor-intensive and inefficient fabrication methods with the integration of newer technologies (i.e., digital shape capture, digital modeling/rectification and additive manufacturing). Improving manufacturing efficiencies will allow greater curricular emphasis on clinical training and education – an area that has traditionally been underemphasized. Providing more curricular emphasis on holistic patient care approaches that utilize systematic and evidence-based methods in patient assessment, treatment planning, dosage of O&P technology use, and measurement of patient outcomes is imminent. Strengthening O&P professionals’ clinical decision-making skills and decreasing labor-intensive technical fabrication aspects of the curriculum will be critical in moving toward a digital and technology-centric practice model that will enable future practitioners to adapt and survive. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/36673/28349 How To Cite: Kogler GF, Hovorka CF. Academia’s role to drive change in the orthotics and prosthetics profession. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 2, No.21. https://doi.org/10.33137/cpoj.v4i2.36673 Corresponding Author: Géza F. KoglerOrthotics and Prosthetics Unit, Kennesaw State University.E-Mail: [email protected] ID: https://orcid.org/0000-0003-0212-5520

scholarly journals Multiparametric MR mapping in clinical decision-making for diffuse liver disease

2020 ◽  
Vol 45 (11) ◽  
pp. 3507-3522 ◽  
Author(s):  
Helena B. Thomaides-Brears ◽  
Rita Lepe ◽  
Rajarshi Banerjee ◽  
Carlos Duncker
Keyword(s):  
Liver Disease ◽  
Liver Diseases ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
Chronic Liver ◽  
Diffuse Liver Disease ◽  
Treatment Pathway ◽  
Recent Developments ◽  
Potential Applications

Abstract Accurate diagnosis, monitoring and treatment decisions in patients with chronic liver disease currently rely on biopsy as the diagnostic gold standard, and this has constrained early detection and management of diseases that are both varied and can be concurrent. Recent developments in multiparametric magnetic resonance imaging (mpMRI) suggest real potential to bridge the diagnostic gap between non-specific blood-based biomarkers and invasive and variable histological diagnosis. This has implications for the clinical care and treatment pathway in a number of chronic liver diseases, such as haemochromatosis, steatohepatitis and autoimmune or viral hepatitis. Here we review the relevant MRI techniques in clinical use and their limitations and describe recent potential applications in various liver diseases. We exemplify case studies that highlight how these techniques can improve clinical practice. These techniques could allow clinicians to increase their arsenals available to utilise on patients and direct appropriate treatments.

scholarly journals Clinical value of measurable residual disease testing for assessing depth, duration, and direction of response in multiple myeloma

2020 ◽  
Vol 4 (14) ◽  
pp. 3295-3301
Author(s):  
Joaquin Martinez-Lopez ◽  
Sandy W. Wong ◽  
Nina Shah ◽  
Natasha Bahri ◽  
Kaili Zhou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Decision Making ◽  
Residual Disease ◽  
Clinical Care ◽  
Progression Free Survival ◽  
Clinical Decision ◽  
Routine Practice ◽  
Clinical Value ◽  
The Impact ◽  
Measurable Residual Disease

Abstract Few clinical studies have reported results of measurable residual disease (MRD) assessments performed as part of routine practice. Herein we present our single-institution experience assessing MRD in 234 multiple myeloma (MM) patients (newly diagnosed [NDMM = 159] and relapsed [RRMM = 75]). We describe the impact of depth, duration, and direction of response on prognosis. MRD assessments were performed by next-generation sequencing of immunoglobulin genes with a sensitivity of 10−6. Those achieving MRD negativity at 10−6, as well as 10−5, had superior median progression-free survival (PFS). In the NDMM cohort, 40% of the patients achieved MRD negativity at 10−6 and 59% at 10−5. Median PFS in the NDMM cohort was superior in those achieving MRD at 10−5 vs <10−5 (PFS: 87 months vs 32 months; P < .001). In the RRMM cohort, 36% achieved MRD negativity at 10−6 and 47% at 10−5. Median PFS was superior for the RRMM achieving MRD at 10−5 vs <10−5 (PFS: 42 months vs 17 months; P < .01). Serial MRD monitoring identified 3 categories of NDMM patients: (A) patients with ≥3 MRD 10−6 negative samples, (B) patients with detectable but continuously declining clonal numbers, and (C) patients with stable or increasing clonal number (≥1 log). PFS was superior in groups A and B vs C (median PFS not reached [NR], NR, 55 respectively; P < .001). This retrospective evaluation of MRD used as part of clinical care validates MRD as an important prognostic marker in NDMM and RRMM and supports its use as an endpoint in future clinical trials as well as for clinical decision making.

Clinical Decision Making in the ICU: Dysphagia Screening, Assessment, and Treatment

2019 ◽  
Vol 40 (03) ◽  
pp. 170-187 ◽  
Author(s):  
Martin B. Brodsky ◽  
Emily B. Mayfield ◽  
Roxann Diez Gross
Keyword(s):  
Intensive Care Unit ◽  
Decision Making ◽  
Intensive Care ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
Level Of Care ◽  
Assessment And Treatment ◽  
Proper Training ◽  
Screening Assessment

AbstractClinicians often perceive the intensive care unit as among the most intimidating environments in patient care. With the proper training, acquisition of skill, and approach to clinical care, feelings of intimidation may be overcome with the great rewards this level of care has to offer. This review—spanning the ages of birth to senescence and covering oral/nasal endotracheal intubation and tracheostomy—presents a clinically relevant, directly applicable review of screening, assessment, and treatment of dysphagia in the patients who are critically ill for clinical speech–language pathologists and identifies gaps in the clinical peer-reviewed literature for researchers.

scholarly journals Predictive Glucose Trends From Continuous Glucose Monitoring: Friend or Foe in Clinical Decision Making?

2019 ◽  
Vol 13 (5) ◽  
pp. 963-966 ◽  
Author(s):  
Kathryn Fantasia ◽  
Katherine Modzelewski ◽  
Devin Steenkamp
Keyword(s):  
Clinical Decision Making ◽  
Clinical Care ◽  
Glucose Monitoring ◽  
Clinical Decision ◽  
The United States ◽  
Rate Of Change ◽  
Inherent Difficulty ◽  
Continuous Glucose Monitor ◽  
Freestyle Libre ◽  
Practical Recommendations

In this commentary, we briefly review the currently recommended approaches to interpretation and management of continuous glucose monitor (CGM) rate of change (ROC) trend arrows and discuss the inherent difficulty in incorporating practical recommendations for their application into routine clinical care. We have limited our review and discussion to the currently available Dexcom G5 and G6 CGM systems and Abbott’s Freestyle Libre flash glucose monitor (FGM) system, as they are the most widely used and currently approved for nonadjunctive use in the United States.

scholarly journals A importância do treinamento, reprodutibilidade e calibragem para a qualidade dos estudos

2021 ◽  
Vol 41 (1) ◽  
pp. 3-7
Author(s):  
Cristiano Susin ◽  
Cassiano Kuchenbecker Rösing
Keyword(s):  
Decision Making ◽  
Scientific Knowledge ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
International Standards ◽  
Scientific Methodology ◽  
Biological Processes ◽  
The Way

Dentistry is undergoing a deep transformation in its way of producing, using and interpreting the scientific knowledge. The need for utilizing the best possible evidence for the understanding of the physical and biological processes, as well as to clinical decision making, has risen the interest in the study of subjects that were not regarded as important before. In this scene, the capacity of evaluating the quality of different studies and of producing them under international standards has enhanced the seeking for knowledge in scientific methodology. The way by which the data are obtained and the procedures are performed in research might definitively influence its capacity to generate evidence. Thus, training, reproducibility and calibration are principles that have to be part of everything concerning the process of creating and using the knowledge.

scholarly journals Transcranial Doppler Use in Non-traumatic Critically Ill Children: A Multicentre Descriptive Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Virginie Rollet-Cohen ◽  
Philippe Sachs ◽  
Pierre-Louis Léger ◽  
Zied Merchaoui ◽  
Jérôme Rambaud ◽  
...  
Keyword(s):  
Transcranial Doppler ◽  
Neurological Disorders ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Central Nervous System Infection ◽  
Clinical Decision ◽  
Primary Diagnosis ◽  
Critically Ill Children ◽  
Normative Values ◽  
The Impact

Background: The use and perceived value of transcranial Doppler (TCD) scope in paediatric critical care medicine has not been extensively documented.Objective: To describe the use of TCD to assess non-traumatic brain injury in patients admitted to four paediatric intensive care units (PICUs) in France.Methods: We prospectively included all children (aged under 18) assessed with inpatient TCD between November 2014 and October 2015 at one of the four PICUs. The physicians completed a questionnaire within 4 h of performing TCD.Results: 152 children were included. The primary diagnosis was neurological disease in 106 patients (70%), including post ischemic-anoxic brain insult (n = 42, 28%), status epilepticus (n = 19, 13%), and central nervous system infection/inflammation (n = 15, 10%). TCD was the first-line neuromonitoring assessment in 110 patients (72%) and was performed within 24 h of admission in 112 patients (74%). The most common indications for TCD were the routine monitoring of neurological disorders (n = 85, 56%) and the detection of asymptomatic neurological disorders (n = 37, 24). Concordance between the operator's interpretation of TCD and the published normative values was observed for 21 of the 75 (28%) TCD abnormal findings according to the published normative values. The physicians considered that TCD was of value for the ongoing clinical management of 131 (86%) of the 152 patients.Conclusion: TCD is commonly used in French PICUs and tends to be performed early after admission on patients with a broad range of diseases. The physicians reported that the TCD findings often helped their clinical decision making. In view of the subjectivity of bedside interpretation, true TCD contribution to clinical care remains to be determined. Objective studies of the impact of TCD on patient management and clinical outcomes are therefore warranted.

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