scholarly journals Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps

2021 ◽  
Vol 8 ◽  
Author(s):  
Jule Bessler ◽  
Gerdienke B. Prange-Lasonder ◽  
Leendert Schaake ◽  
José F. Saenz ◽  
Catherine Bidard ◽  
...  
Keyword(s):  
Best Practices ◽  
Adverse Events ◽  
Safety Assessment ◽  
Rehabilitation Robot ◽  
Safety Skills ◽  
Limit Values ◽  
Testing Procedures ◽  
Robot Safety ◽  
Rehabilitation Robots ◽  
Wide Range

The assessment of rehabilitation robot safety is a vital aspect of the development process, which is often experienced as difficult. There are gaps in best practices and knowledge to ensure safe usage of rehabilitation robots. Currently, safety is commonly assessed by monitoring adverse events occurrence. The aim of this article is to explore how safety of rehabilitation robots can be assessed early in the development phase, before they are used with patients. We are suggesting a uniform approach for safety validation of robots closely interacting with humans, based on safety skills and validation protocols. Safety skills are an abstract representation of the ability of a robot to reduce a specific risk or deal with a specific hazard. They can be implemented in various ways, depending on the application requirements, which enables the use of a single safety skill across a wide range of applications and domains. Safety validation protocols have been developed that correspond to these skills and consider domain-specific conditions. This gives robot users and developers concise testing procedures to prove the mechanical safety of their robotic system, even when the applications are in domains with a lack of standards and best practices such as the healthcare domain. Based on knowledge about adverse events occurring in rehabilitation robot use, we identified multi-directional excessive forces on the soft tissue level and musculoskeletal level as most relevant hazards for rehabilitation robots and related them to four safety skills, providing a concrete starting point for safety assessment of rehabilitation robots. We further identified a number of gaps which need to be addressed in the future to pave the way for more comprehensive guidelines for rehabilitation robot safety assessments. Predominantly, besides new developments of safety by design features, there is a strong need for reliable measurement methods as well as acceptable limit values for human-robot interaction forces both on skin and joint level.

A comparison of rehabilitation robotics languages and software

Robotica ◽  
1997 ◽  
Vol 15 (2) ◽  
pp. 133-151 ◽  
Author(s):  
William S. Harwin ◽  
Ray G. Gosine ◽  
Zunaid Kazi ◽  
David S. Lees ◽  
John L. Dallaway
Keyword(s):  
Rehabilitation Robotics ◽  
Rehabilitation Robot ◽  
Direct Manipulation ◽  
Individuals With Disabilities ◽  
Human Interface ◽  
Rehabilitation Robots ◽  
Wide Range

There is a wide diversity in the functioning and programming of robots designed and programmed to assist individuals with disabilities. The planning and structure of four rehabilitation robot implementations is presented. The first is the CURL language developed for human interface and the most widely used in this field. The second, MUSIIC, explores methods for direct manipulation of objects. RoboGlyph uses symbolic constructs to assist with the direction and programming of rehabilitation robots and finally a multi-tasking operating executive is discussed that controls a bilateral head operated telerobot. These four implementations reflect a wide range of interface concepts for the intended users.

scholarly journals Abdominal pain as an initial symptom of isolated ACTH deficiency induced by nivolumab in a patient with malignant mesothelioma

2021 ◽  
Vol 14 (7) ◽  
pp. e243093
Author(s):  
Koichi Hata ◽  
Chikara Sakaguchi ◽  
Michiko Tsuchiya ◽  
Yukio Nagasaka
Keyword(s):  
Abdominal Pain ◽  
Adverse Events ◽  
Adrenal Insufficiency ◽  
Malignant Mesothelioma ◽  
Adrenocorticotropic Hormone ◽  
Hormone Deficiency ◽  
Initial Symptom ◽  
Isolated Acth Deficiency ◽  
Wide Range ◽  
Isolated Adrenocorticotropic Hormone Deficiency

Used for a wide range of cancers, nivolumab has been reported to cause immune-related adverse events, including isolated adrenocorticotropic hormone deficiency (IAD). We report an 81-year-old woman with malignant mesothelioma who presented with abdominal pain after eight courses of nivolumab therapy, leading to the diagnosis of nivolumab-induced IAD. We should consider adrenal insufficiency (AI) when a patient on nivolumab complains of abdominal pain and has no other explanatory findings. Infusion-resistant hypotension and hyponatraemia can further suggest AI.

scholarly journals The Romano–Wolf multiple-hypothesis correction in Stata

2020 ◽  
Vol 20 (4) ◽  
pp. 812-843
Author(s):  
Damian Clarke ◽  
Joseph P. Romano ◽  
Michael Wolf
Keyword(s):  
Error Rate ◽  
Multiple Testing ◽  
Original Data ◽  
Dependence Structure ◽  
Familywise Error Rate ◽  
Testing Procedures ◽  
Multiple Testing Procedures ◽  
Multiple Hypothesis ◽  
Wide Range ◽  
Performance Gains

When considering multiple-hypothesis tests simultaneously, standard statistical techniques will lead to overrejection of null hypotheses unless the multiplicity of the testing framework is explicitly considered. In this article, we discuss the Romano–Wolf multiple-hypothesis correction and document its implementation in Stata. The Romano–Wolf correction (asymptotically) controls the familywise error rate, that is, the probability of rejecting at least one true null hypothesis among a family of hypotheses under test. This correction is considerably more powerful than earlier multiple-testing procedures, such as the Bonferroni and Holm corrections, given that it takes into account the dependence structure of the test statistics by resampling from the original data. We describe a command, rwolf, that implements this correction and provide several examples based on a wide range of models. We document and discuss the performance gains from using rwolf over other multiple-testing procedures that control the familywise error rate.

scholarly journals SGLT2 inhibitors: a narrative review of efficacy and safety

2021 ◽  
Vol 121 (2) ◽  
pp. 229-239
Author(s):  
Donald S. Nelinson ◽  
Jose M. Sosa ◽  
Robert J. Chilton
Keyword(s):  
Adverse Events ◽  
Sglt2 Inhibitor ◽  
Sglt2 Inhibitors ◽  
Narrative Review ◽  
Atherosclerotic Cardiovascular Disease ◽  
Comorbid Conditions ◽  
Postprandial Plasma Glucose ◽  
Renal Outcomes ◽  
Glucose Levels ◽  
Wide Range

Abstract Type 2 diabetes mellitus (T2DM) is a cardio-renal-metabolic condition that is frequently associated with multiple comorbidities, including atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and chronic kidney disease (CKD). The sodium-glucose co-transporter-2 (SGLT2) inhibitors, which lower glycated hemoglobin, fasting and postprandial plasma glucose levels, body weight, and blood pressure, as well as reduce the risk of a range of cardiovascular and renal outcomes without increasing hypoglycaemic risk, have heralded a paradigm shift in the management of T2DM. These drugs are compatible with most other glucose-lowering agents and can be used in patients with a wide range of comorbid conditions, including ASCVD, HF, and CKD, and in those with estimated glomerular filtration rates as low as 30 mL/min/1.73 m2. However, there are misunderstandings surrounding the clinical implications of SGLT2 inhibitors’ mechanism of action and concerns about the key adverse events with which this class of drugs has been associated. This narrative review summarizes the data that support the efficacy of SGLT2 inhibitors in reducing the risks of cardiovascular and renal outcomes in patients with T2DM and comorbid conditions and clarifies information relating to SGLT2 inhibitor-related adverse events.

Encouraging millennials to collaborate and learn on the job

2015 ◽  
Vol 14 (4) ◽  
pp. 118-123 ◽  
Author(s):  
Lauren Trees
Keyword(s):  
Knowledge Management ◽  
Best Practices ◽  
Social Networking ◽  
Age Groups ◽  
Lessons Learned ◽  
Retention Rates ◽  
Direct Access ◽  
Content Type ◽  
Business Outcomes ◽  
Wide Range

Purpose – The purpose of this paper is to present enterprise social networking and gamification as two potential tools to help organizations engage Millennial employees in collaboration and learning. Design/methodology/approach – The research provides general descriptions of enterprise social networking and gamification approaches, shares data on adoption of these approaches from APQC’s “2015 Knowledge Management Priorities Data Report” (based on a January 2015 survey of 524 knowledge management professionals) and includes four company examples adapted from APQC’s Connecting People to Content and Transferring and Applying Critical Knowledge best practices studies. The methodology for APQC’s best practices studies involves screening 50 or more organizations with potential best practices in a given research scope area and identifying five or six with proven best practices. APQC then conducts detailed site visits with the selected organizations and publishes case studies based on those site visits. Findings – Enterprise social networking platforms are in place at 50 per cent of organizations, with another 25 per cent planning to implement them by the end of 2015. By providing near-immediate access to information and answers, enterprise social networking helps Millennials learn the ropes at their new workplaces, gives them direct access to more knowledgeable colleagues who can assist and mentor them, and helps them improve their business outcomes by reusing knowledge and lessons learned across projects. Younger workers can also harness the power of social networking to create a sense of belonging and build their reputations in large, dispersed firms, where it is particularly difficult for them to gain visibility. A recent APQC survey indicates that 54 per cent of organizations either currently employ gamification to encourage collaboration or expect to implement it within the next three years. The rush to gamify the enterprise is, at least in part, a reflection of employers’ desire to satisfy Millennials and make them feel connected to a community of co-workers. Although games appeal to a wide range of age groups, Millennials grew up with digital interaction and tend to prefer environments that emphasize teamwork, social learning and frequent feedback – all of which can be delivered through gamification. Originality/value – The value of this paper is to introduce the value of and relationship between enterprise social networking and gamification platforms to human resource (HR) professionals looking to increase engagement and retention rates for Millennial employees.

Identification and Elucidation of the Biology of Adverse Events: The Challenges of Safety Assessment and Translational Medicine

2011 ◽  
Vol 17 (21) ◽  
pp. 6641-6645 ◽  
Author(s):  
Kenneth W. Turteltaub ◽  
Myrtle A. Davis ◽  
Leigh Ann Burns-Naas ◽  
Michael P. Lawton ◽  
Adam M. Clark ◽  
...  
Keyword(s):  
Adverse Events ◽  
Translational Medicine ◽  
Safety Assessment

Nivolumab and ipilimumab for second-line therapy in elderly patients with advanced esophageal squamous cell cancer: Safety interim analysis of the RAMONA trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4029-4029
Author(s):  
Nicolai Hartel ◽  
Nadja M Meindl-Beinker ◽  
Martin Maenz ◽  
Wolfgang Hiegl ◽  
Johannes Betge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Interim Analysis ◽  
Treatment Duration ◽  
Safety Assessment ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

4029 Background: Advanced esophageal squamous cell cancer (ESCC) is frequently diagnosed in elderly patients (pts) with additional comorbidities. Limited treatment options are available. We report the safety interim analysis of a phase II clinical trial evaluating nivolumab and ipilimumab as second-line therapy for advanced ESCC in elderly pts. Methods: RAMONA is a multicenter open-label phase II trial assessing nivolumab/ipilimumab combination therapy in elderly pts (≥65 years). The geriatric status of the pts was assessed using the G8 screening tool and the Deficit Accumulation Frailty Index (DAFI). After a run-in phase of 3 cycles nivolumab (240mg Q2W), cohort assignment was based on a safety assessment. Pts with toxicities grade ≤2 were considered eligible for escalation to nivolumab (240mg Q2W)/ipilimumab (1mg/kg Q6W) combination therapy (cohort B). Other pts remained on nivolumab monotherapy (cohort A). Primary endpoint is overall survival (OS). Key secondary endpoint is time to Quality of Life deterioration defined as a loss of ≥ 10 points in the EORTC QLQ-C30 compared to baseline. Adverse events were assessed according to NCI-CTCAE version 4.03. Results: From February 2018 until February 2020, 69 pts entered the study. 61 pts were eligible for safety interim analysis. Median age of the pts was 71.9 yrs (± 5.4), median KPS score was 80% (50-100%). In 73.8% of the pts, metastases were detected at the time of study inclusion. Most pts received the IO therapy in ≥ 2nd line (91.8%). The mean G8-score at screening was 11.9 points (46 pts ≤ 14 points, 75.4%) (mean DAFI: 0.19). Based on safety assessment, 42 pts were escalated to nivolumab/ipilimumab, while 9 pts remained on nivolumab monotherapy. 10 pts were not allocated at the time of analysis. Median numbers of cumulative doses were 3.0 [1.0 - 3.0] for the run-in phase (nivolumab), 6.0 [1.0 – 48.0] for nivolumab therapy (cohort A/B) and 2.5 [1.0 – 16.0] for ipilimumab (cohort B). Median treatment duration was 144.5 days (56-781 days) in cohort A and 231 days (85-484 days) in cohort B. Frailty indices remained stable after 3 cycles of nivolumab with limited toxicity at the time of the safety assessment. Drug-related treatment emergent adverse events (AEs) were observed in 42 pts (68.9%); 29/42 in cohort A, 8/9 in cohort B, and 5/10 pts not allocated at the time of analysis. Grade ≥3 AEs were detected in 9 pts of 42 in cohort A and 4 of 9 pts in cohort B. Drug-related treatment emergent serious adverse events (SAEs) were detected in 12 pts (19.7%); 8/42 in cohort A, 2/9 pts in cohort B, and 2/10 pts not yet allocated. Conclusions: Combined nivolumab/ipilimumab is a safe and feasible second-line therapy for elderly pts with advanced ESCC. Most pts could be escalated to nivolumab/ipilimumab. Treatment duration was exceptional long for a subset of pts. Clinical trial information: NCT03416244.

Sustainability Issues in Finance

2012 ◽  
pp. 15-38
Author(s):  
Margherita Mori
Keyword(s):  
Best Practices ◽  
Inclusive Growth ◽  
Private Partnership ◽  
Europe 2020 ◽  
Wide Range ◽  
Challenging Tasks ◽  
Equator Principles ◽  
Sustainable Finance ◽  
Environmental Development ◽  
Partnership Models

Sustainable finance calls for unprecedented attention, in sight of promoting sustainability beyond the original focus on economic, social and environmental development. Much room remains for progress, as shown by the wide range of topics that fit into the sustainability agenda of the "Rio+20" Earth Summit. A key role can be played by the process of financial innovation, far from exhausted. Challenging tasks include a more massive recourse to public-private partnership models (such as JESSICA, JEREMIE and JASMINE) and to the best practices in sustainable finance. The adoption of the Equator Principles and sustainability indexes on a larger scale in lending and investing may significantly contribute to the sustainable - as well as smart and inclusive - growth that "Europe 2020" is aimed at.

scholarly journals Adverse events with ayurvedic medicines- possible adulteration and some inherent toxicities

2019 ◽  
Vol 4 ◽  
pp. 23 ◽  
Author(s):  
Buddhi Paudyal ◽  
Astha Thapa ◽  
Keshav Raj Sigdel ◽  
Sudeep Adhikari ◽  
Buddha Basnyat
Keyword(s):  
Rheumatoid Arthritis ◽  
Nephrotic Syndrome ◽  
Side Effects ◽  
Liver Injury ◽  
Adverse Events ◽  
Indian Subcontinent ◽  
Ayurvedic Medicine ◽  
Gold Salt ◽  
Traditional System ◽  
Wide Range

Ayurvedic medicine, a traditional system of medicine practiced in the Indian subcontinent is considered to be devoid of adverse events. We report three cases which highlight the possibility of adverse events related with the use of ayurvedic products. A 35 year old woman with hepatitis took ayurvedic powder medicine and swarnabhasma (gold salt) and had her liver injury worsened, possibly due to alkaloids, and developed nephrotic syndrome, possibly due to gold salt. A 57 year old hypertensive man was taking ayurvedic medicine containing reserpine which had long been withdrawn from the allopathic system of medicine due to wide range of side effects. A 47 year old woman with rheumatoid arthritis was taking an unknown tablet containing steroid as an adulterant for 2 years and developed side effects typical of steroid excess. We would like to highlight the fact that ayurvedic medicines do have propensity to cause adverse events due to adulteration or inherent constituents like alkaloids, and hence may not always be completely safe.

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