In the midst of a rapidly spreading global pandemic, real-world evidence can offer invaluable insight into the most promising treatments, risk factors, and not only predict but suggest how to improve outcomes. Despite overwhelming news coverage, significant knowledge gaps regarding COVID-19 persist. The current uncertainties regarding incidence and the case fatality rate can only be addressed by widespread testing. But the paucity of testing, and diversity of approaches implemented in different countries, particularly among the general asymptomatic public, perpetuates a lack of understanding about spread and infectivity. The essential indicators that would describe the pandemic more accurately can be obtained using real-world data (RWD). To that purpose, we designed a data collection tool to collect data from hospitals that treat COVID-19 patients. The captured data will enhance our understanding of the COVID-19 pandemic, identify risk factors relevant for triage, relate to other similar seasonal infections and gain insight into the safety and efficacy of experimental and off-label therapies. Knowledge derived from a focused data collection effort will enable clinicians to adjust rapidly clinical protocols and discontinue interventions that turn out to be ineffective or harmful. By deploying our elegantly designed survey to capture routine clinical indicators, we avoid placing an additional burden on practitioners. Systematically generating real-world evidence can decrease the time to insight compared to randomized clinical trials, improving the odds for patients in rapidly changing conditions.
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The usability of STAMP in drug development Arete-Zoe, LLC
Arete-Zoe in cooperation with Stuttgart University
Study authors: Veronika Valdova, Ronald L Sheckler, Asim Abdulkhaleq and Stefan Wagner (Jonathan M Fishbein)
Presentation of synopsis: Veronika Valdova
Presented at STAMP team meeting, PSCI, ACRES on February 26, 2016
All about Clinical Trials_Katalyst HLSKatalyst HLS
Introduction to All about Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Avoidable Patient Harm and Resulting Liability Arete-Zoe, LLC
Avoidable Patient Harm and Resulting Liability
What would it take to improve our insight into the cost of avoidable patient harm?
Medications are the most frequent cause of adverse events in clinical settings.
Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage.
The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The usability of STAMP in drug development Arete-Zoe, LLC
Arete-Zoe in cooperation with Stuttgart University
Study authors: Veronika Valdova, Ronald L Sheckler, Asim Abdulkhaleq and Stefan Wagner (Jonathan M Fishbein)
Presentation of synopsis: Veronika Valdova
Presented at STAMP team meeting, PSCI, ACRES on February 26, 2016
All about Clinical Trials_Katalyst HLSKatalyst HLS
Introduction to All about Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Avoidable Patient Harm and Resulting Liability Arete-Zoe, LLC
Avoidable Patient Harm and Resulting Liability
What would it take to improve our insight into the cost of avoidable patient harm?
Medications are the most frequent cause of adverse events in clinical settings.
Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage.
The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
SYSTEMS-LEVEL QUALITY IMPROVEMENTFrom Cues to Nudge A Knolisandrai1k
SYSTEMS-LEVEL QUALITY IMPROVEMENT
From Cues to Nudge: A Knowledge-Based Framework
for Surveillance of Healthcare-Associated Infections
Arash Shaban-Nejad1,2 & Hiroshi Mamiya2 & Alexandre Riazanov3 & Alan J. Forster4 &
Christopher J. O. Baker2,5 & Robyn Tamblyn2 & David L. Buckeridge2
Received: 3 June 2015 /Accepted: 30 September 2015 /Published online: 4 November 2015
# Springer Science+Business Media New York 2015
Abstract We propose an integrated semantic web framework
consisting of formal ontologies, web services, a reasoner and a
rule engine that together recommend appropriate level of
patient-care based on the defined semantic rules and guide-
lines. The classification of healthcare-associated infections
within the HAIKU (Hospital Acquired Infections – Knowl-
edge in Use) framework enables hospitals to consistently fol-
low the standards along with their routine clinical practice and
diagnosis coding to improve quality of care and patient safety.
The HAI ontology (HAIO) groups over thousands of codes
into a consistent hierarchy of concepts, along with relation-
ships and axioms to capture knowledge on hospital-associated
infections and complications with focus on the big four types,
surgical site infections (SSIs), catheter-associated urinary tract
infection (CAUTI); hospital-acquired pneumonia, and blood
stream infection. By employing statistical inferencing in our
study we use a set of heuristics to define the rule axioms to
improve the SSI case detection. We also demonstrate how the
occurrence of an SSI is identified using semantic e-triggers.
The e-triggers will be used to improve our risk assessment of
post-operative surgical site infections (SSIs) for patients un-
dergoing certain type of surgeries (e.g., coronary artery bypass
graft surgery (CABG)).
Keywords Ontologies . Knowledge modeling .
Healthcare-associated infections . Surveillance . Semantic
framework . Surgical site infections
Introduction
Healthcare-associated Infections (HAIs) affect millions of
patients around the world, killing hundreds of thousands
and imposing, directly or indirectly, a significant socio-
economic burden on healthcare systems [1]. According
to the Centers for Disease Control (CDC) [2], hospital-
acquired infections in the U.S., where the point preva-
lence of HAIs among hospitalized patients is 4 %, result
in an estimated 1.7 million infections, which lead to as
many as 99,000 deaths and cost up to $45 billion annually
[3, 4]. Similar or higher rates of HAI occur in other coun-
tries as well with an estimated 10.5 % of patients in Ca-
nadian hospitals having an HAI [5]. Clinical assessment
and laboratory testing are generally used to detect and
confirm an infection, identify its origin, and determine
appropriate infection control methods to stop the infection
from spreading within a healthcare institution. Failure to
monitor, and detect HAI in timely manner can delay di-
agnosis, leading to complications (e.g., sepsis), and
allowing an epid ...
SYSTEMS-LEVEL QUALITY IMPROVEMENTFrom Cues to Nudge A Kno.docxdeanmtaylor1545
SYSTEMS-LEVEL QUALITY IMPROVEMENT
From Cues to Nudge: A Knowledge-Based Framework
for Surveillance of Healthcare-Associated Infections
Arash Shaban-Nejad1,2 & Hiroshi Mamiya2 & Alexandre Riazanov3 & Alan J. Forster4 &
Christopher J. O. Baker2,5 & Robyn Tamblyn2 & David L. Buckeridge2
Received: 3 June 2015 /Accepted: 30 September 2015 /Published online: 4 November 2015
# Springer Science+Business Media New York 2015
Abstract We propose an integrated semantic web framework
consisting of formal ontologies, web services, a reasoner and a
rule engine that together recommend appropriate level of
patient-care based on the defined semantic rules and guide-
lines. The classification of healthcare-associated infections
within the HAIKU (Hospital Acquired Infections – Knowl-
edge in Use) framework enables hospitals to consistently fol-
low the standards along with their routine clinical practice and
diagnosis coding to improve quality of care and patient safety.
The HAI ontology (HAIO) groups over thousands of codes
into a consistent hierarchy of concepts, along with relation-
ships and axioms to capture knowledge on hospital-associated
infections and complications with focus on the big four types,
surgical site infections (SSIs), catheter-associated urinary tract
infection (CAUTI); hospital-acquired pneumonia, and blood
stream infection. By employing statistical inferencing in our
study we use a set of heuristics to define the rule axioms to
improve the SSI case detection. We also demonstrate how the
occurrence of an SSI is identified using semantic e-triggers.
The e-triggers will be used to improve our risk assessment of
post-operative surgical site infections (SSIs) for patients un-
dergoing certain type of surgeries (e.g., coronary artery bypass
graft surgery (CABG)).
Keywords Ontologies . Knowledge modeling .
Healthcare-associated infections . Surveillance . Semantic
framework . Surgical site infections
Introduction
Healthcare-associated Infections (HAIs) affect millions of
patients around the world, killing hundreds of thousands
and imposing, directly or indirectly, a significant socio-
economic burden on healthcare systems [1]. According
to the Centers for Disease Control (CDC) [2], hospital-
acquired infections in the U.S., where the point preva-
lence of HAIs among hospitalized patients is 4 %, result
in an estimated 1.7 million infections, which lead to as
many as 99,000 deaths and cost up to $45 billion annually
[3, 4]. Similar or higher rates of HAI occur in other coun-
tries as well with an estimated 10.5 % of patients in Ca-
nadian hospitals having an HAI [5]. Clinical assessment
and laboratory testing are generally used to detect and
confirm an infection, identify its origin, and determine
appropriate infection control methods to stop the infection
from spreading within a healthcare institution. Failure to
monitor, and detect HAI in timely manner can delay di-
agnosis, leading to complications (e.g., sepsis), and
allowing an epid.
Should All Patients Having Planned Procedures or Surgeries Be Tested for COVI...JohnJulie1
The current pandemic of Corona Virus Disease-2019 (COVID-19) which is caused by Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) has resulted in lockdown in many countries culminating in a major socio-economic crisis globally. COVID-19 can remain asymptomatic and so is crucial for early diagnosis to prevent further spread of this pandemic.
Should All Patients Having Planned Procedures or Surgeries Be Tested for COVI...suppubs1pubs1
The current pandemic of Corona Virus Disease-2019 (COVID-19) which is caused by Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) has resulted in lockdown in many countries culminating in a major socio-economic crisis globally. COVID-19 can remain asymptomatic and so is crucial for early diagnosis to prevent further spread of this pandemic. Here we highlight the importance of screening asymptomatic patients prior to elective surgery, procedure or scheduled hospital admission. This analysis was done for the month of July 2020 during which 261 asymptomatic people were screened for COVID-19. Out of this, 6 patients (2.29%) were diagnosed to have COVID-19 on nasopharyngeal/ oropharyngeal swabs and subsequently had to delay their elective procedure or surgery. This clearly shows how important it is to screen this cohort of asymptomatic people who could potentially have spread the virus to other patients as well as healthcare professionals.
The Gibraltar COVID-19 Cohort: Determining the True Incidence and Severity Ra...asclepiuspdfs
COVID-19 is a new infectious disease with an unclear incidence and an unknown rate of progression to severe disease. The Gibraltar COVID-19 Cohort utilises two distinct cohorts - a clinical cohort and a random population based cohort -, to provide an accurate assessment of case severity rate. Design: Retrospective analysis of a SARS-CoV2 RT-PCR point prevalence study and a RT-PCR confirmed positive clinical case cohort to calculate case severity rates. Settings and Participants: Over a three day period nasopharyngeal swabs were sampled from a randomly selected 1.2% of the population of Gibraltar and then analysed via RT-PCR to determine the background incidence of COVID-19 infection. The results were then analysed and compared to the clinical case cohort. The rate of progression to severe COVID-19 disease in those with COVID-19 infection was then calculated.
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Sexual assault cases regularly make headlines and can potentially cause serious reputational harm to law enforcement agencies and police departments for mishandling the cases or not pursuing them vigorously enough.
The picture on the left shows the latest developments in a long-term problem of sexual assault on college campuses. In June, Candice Johnson, OCR Acting Assistant Secretary for Civil Rights issued a memo that effectively stalled investigation of civil rights violations including sexual assault on campuses. A month later, Democratic Senators Kirsten Gillibrand from New York State and Claire McCaskill from Missouri urged Secretary of Education Betsy Devos to reverse this decision as unlawful because of failure to protect students under Title IX. Full text of the memo and Title IX, Sec. 1681 Sex are part of your lesson handout.
Similar problem with widespread sexual assault, and especially against minors, is a long-term problem at cruise ships. Because of the nature of cruise ships, there is no immediate response by law enforcement and the ship guards that investigate the matter are the cruise company’s employees therefore often unlikely to be of meaningful help to the victims. Jurisdiction can be federal, state or foreign, depending on the ship’s flag.
Finally, sexual violence in a workplace can be difficult to address because of the unequal relationship between parties and under-reporting. Recently, car company Tesla appeared in the news as a hostile workplace to women.
Mitigating consequences of a drug-facilitated sexual assault .pdfArete-Zoe, LLC
Mitigating consequences of a drug-facilitated sexual assault
First published: 27 Jan 2017
Revised: 19 Jan 2020
Drug-facilitated sexual assault (DFSA) is not just bad sex. It occurs either without the victim’s consent or with consent that cannot be considered valid due to incapacitation of the victim by alcohol or drugs. While opportunistic DFSA is carried out once the victim has been rendered unconscious by own actions, pro-active DFSA describes situations when the perpetrator spikes the victim’s drinks covertly.
The most frequently used drug in DFSA is alcohol. Other drugs often involved include flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are occasionally used also. These drugs rapidly induce drowsiness, sedation and muscle relaxation. Typical symptom is decreased inhibition. Most of the drugs used for DFSA are odorless and tasteless, with the exception of GBL that has a bitter taste. Memoryy loss is common, most victims have little to no recollection of the previous night.
The most common way of obtaining these drugs is through the darknet. Benzodiazepines, GHB (Xyrem), and ketamine (an anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes.
In 2012, in U.S. v. Caronia became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications. Physicians who prescribe Xyrem (GHB) have to pass special certification to ensure safe prescription, handling, and storage of the drug (REMS).
Sedative or tranquilizer Flunitrazepam is still legally manufactured in Europe and some countries in Latin America. The drug has been reformulated, so it imparts an easily identifiable blue color to clear beverages and haziness to colored drinks. Drugs obtained from illegal manufacturing sources naturally do not display this effect.
DFSAs are increasingly popular in bars, clubs, and raves, but also fraternities and at college campuses. Mishandling of cases of sexual assault at college campuses has been subject to much criticism.
It is very difficult to estimate the total number of DFSAs. The main reason for failure to report sexual assault is the reluctance of the victims to go to the police. Indications exist that the numbers are on the increase. Because of memory loss associated with these drugs, victims often feel embarrassed or guilty. Additional reasons for not reporting sexual assault include need to avoid further stigmatization, especially when the evidence does not seem to be sufficient to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion.
Approach to preparing for a biological attack (2017)Arete-Zoe, LLC
Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
Improving the resilience of vulnerable populationsArete-Zoe, LLC
Vulnerable populations in terms of health care disparities include the economically disadvantaged and uninsured, the elderly, and people with chronic health conditions. Low-education status compounds the problem and leads to poorer outcomes than in people with the same disease but higher educational status. Significant disparities include namely risk factors relating to morbidity and mortality and access to healthcare. In the domain of physical health, the worst affected are people with chronic health conditions such as respiratory diseases and metabolic syndrome, including hyperlipidemia and diabetes, and resulting in heart diseases and hypertension. Vulnerable populations often experience accumulation of problems that are multiplied by poor health, yet the medical and non-medical needs of these populations are still underestimated. A significant number of vulnerable people with at least one chronic condition skip purchasing prescription drugs because of the costs involved. The most relevant risk factors that result in poor access to health care include low income and uninsured status, in combination with a lack of regular care. Chronic conditions such as dyslipidemia may not be particularly apparent now, yet represent a high risk of future disability (“Vulnerable Populations: Who Are They?”, 2006).
Medical innovation, increasing the complexity of care, and the relationships between stakeholders gradually lead to the increase in prices of healthcare for consumers. Lack of transparency affects the cost of premiums as well as out-of-pocket expenses. Policymakers in their considerations need to include more indicators than just insurance coverage that, without other measures, will not curb soaring healthcare expenses. Delayed care is a public health concern because of the risk of disability and under-treatment of otherwise treatable conditions. The presentation of data to non-technical audiences, including decision-makers, has to be understandable to convey the information reliably. Systems modeling techniques should be considered to estimate stakeholder behavior in a dynamic system accurately. Currently, many instances of abuse exist within the system. As an example, chargemaster fees apply to uninsured or out-of-network patients. Hospital fees are, however, tackled by state laws rather than at the federal level. Consumers in health care tend to behave differently than in other industries and often think less about the costs involved. Physicians’ education should include the delivery of cost-conscious care to prevent financial harm to their patients. Transparency of cost is one of the most effective mechanisms that enable patients and providers to make informed choices.
Handling a high-risk HIPAA Breach Published April 2017 Part of scenarios for patient privacy crisis management Every hospital encounters patients, who for the reason of their social circumstances, dependent status, personal characteristics, or the nature of their condition, are more vulnerable than the general population. While compliance with HIPAA is indeed important, because of the potential to inflict significant liability on the hospital resulting from compliance failure, it should not be the only consideration when caring for vulnerable patients. Mere compliance with the minimum requirements of HIPAA does not guarantee the safety of vulnerable patients. In the case study scenario, the hospital emergency department in a small town admitted a 15-year-old female with emergency labor. After delivery in the emergency room, the mother and the baby were moved to Obstetrics and Neonate. Despite appropriate care, the infant presented with multiple medical problems, which may or may not be resolved in the future. A nurse, who took care of the young mother, accidentally disclosed the patient’s identity and condition to her young daughter, who spread the news in all high schools in the area by the following day. The 15-year-old managed to hide her pregnancy from her family. To complicate matters, the young mother’s mother and aunt work in the same hospital.
Addressing pediatric medication errors in ED setting utilizing Computerized P...Arete-Zoe, LLC
Pediatric patients who are treated in general acute care hospitals are at increased risk of medication errors. The main reasons are the lack of experience with the special needs of pediatric patients, their lower ability to tolerate medication errors, medication-related problems such as forms and packaging designed primarily for adults and labeling with insufficient information on the dosing of pediatric patients. Medication errors can be reduced significantly by appropriate medication management systems. Computerized Provider Order Entry (CPOE) systems reduce the frequency of medication errors in all stages of the process. IT technology introduces an additional vulnerability in the form of IT-related medication errors. Nurses are the last individuals in the medication management process who can detect and intercept a medication error and prevent incorrect medication orders from reaching and harming their patients. To be able to do so, nurses have to be familiar with the medication management system in their hospital and escalate incorrect orders as appropriate and relevant.
Let's talk causality attribution: Current practices and path forward Arete-Zoe, LLC
Consistent and reliable causality attribution at the case level is the cornerstone of confident signal detection.
The current practice relies on study investigators to establish causal relationships based on their observations. The Sponsor (Company) can add their assessment based on additional information about the drug. The current industry standard, E2B (R3), accounts for multiple assessment methods and presents the data elements for each drug-event pair evaluated by multiple sources in a matrix.
There are many causality assessment methods used within the industry, some universal, others more specialized. Most commonly used methods include WHO-UMC, Naranjo, Roussel-Uclaf (RUCAM) - to detect drug-associated liver injury, Karch and Lasagna, the French PV Algorithm, Bayesian Adverse Reactions Diagnostic Instrument (BARDI), MacBARDI, and Updated Logistic method. Expert judgment remains the most common method used.
Serious challenges prevent the practical implementation of existing algorithms by the industry. Many of the algorithms cannot be applied rigorously because of missing data. Additionally, an accurate definition of clinical harm is often lacking (e.g., peripheral neuropathy, vasculitis). Brighton Collaboration Case Definitions partly address this component.
Algorithms do not consider medication errors and are not easy to use with interactions, contributory causation, or secondary harms. Information obtained from the reporter is usually insufficient to establish a causal relationship, and follow-up requests for information must be sent, often repeatedly. The result is a very high share of unassessable reports and poor internal consistency of existing assessments.
I suggest modifying the ADE reporting to incorporate components enabling structured causality assessment directly by the reporting physician (postmarket) or investigator (clinical trials). Guiding questions would assist the reporting physician in determining causal relationships and facilitate algorithmic attribution upon submission:
Temporal relationship is a key component of causality assessment. Safety databases routinely calculate latency and last dose latency that feed the algorithm.
Dechallenge and Rechallenge represent key concepts in pharmacovigilance. This information is typically missing from reports. A series of questions regarding Outcome and Response (Action taken with drug) guide the reporting physician through a checklist for all suspect and interacting drugs, reliably and consistently calculating dechallenge/rechallenge for each drug-event pair.
Biological plausibility is a complex component requiring knowledge of the drug and the patient's medical condition.
Finally, it is important to ask the reporting physician about any underlying diseases that could have contributed to the event. A clear answer to this question is an essential component of the causality assessment algorithms.
Clinical documentation for medical devices Arete-Zoe, LLC
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
Zpracování klinické dokumentace dle EU MDR 2017/745 Arete-Zoe, LLC
Zpracování klinické dokumentace dle EU MDR 2017/745
- Strategie generování klinického důkazu
- Zpracování klinické dokumentace
- Design PMCF studií a zkoušek
- Návrhy aktualizací existující dokumentace
Služby
Poradenství
Strategie generování klinického důkazu
Design PMCF studií a zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
Klinické hodnocení (plán/zpráva)
PMCF, PMS (plán/zpráva), PSUR
Biologické hodnocení
Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
Klinický expert relevantní pro daný lékařský obor
Specialista na management rizika
Laboratoř na testování software, včetně AI/ML
Zpracování ostatních částí technické dokumentace
Klinické hodnocení (Plán, Zpráva)
Protokol literární rešerše
Biologické hodnocení
Post-Market Clinical Follow-Up (PMCF) (Plán, Zpráva)
Post-Market Surveillance (PMS) (Plán, Zpráva)
Periodic Safety Update Report (PSUR)
Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP).
Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics.
VAERS Explorer https://www.aretezoe.com/vaers-explorer
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Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
Pharmacovigilance Workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
Case studies:
Mylotarg (Gemtuzumab ozogamicin): no benefit, risk of death
Roaccutane (isotretinoin): teratogenic effect
Lariam (mefloquine): neuropsychiatric side effects
Zyprexa (olanzapine): stroke in patients with dementia
Avandia (rosiglitazone): myocardial infarction, death due to cardiovascular causes
Seroxat (paroxetine): suicidality
Xyrem (sodium oxybate): diversion, abuse
Coumadin (warfarin): bleeding
https://www.aretezoe.com/pharmacovigilance-workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
https://www.aretezoe.com/pharmacovigilance-workshop
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)Arete-Zoe, LLC
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention
First published April 2017
Part of test scenarios for implementation of new sepsis guidelines
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
2. Gazette of Pharmacology and Clinical Research Valdova V, et al. Page 1 of 2
Citation: Valdova V, Penna S, Tobin M, Fishbein J. The value of real-world evidence for clinicians and clinical researchers in the coronavirus crisis.
G Pharmacol Clin Res 2020; 1:001.
cases and deaths rather than standard epidemiological indicators
such as incidence and prevalence, the number of infected per
100,000, number of hospitalizations per 100,000 or case fatality
risk [2][3][4]. These indicators are not yet available because
they are dependent on the standardization of testing. Moreover,
thresholds for hospitalization vary significantly among countries
and regions, so significant uncertainty remains with regards to the
percentage of hospitalized patients who require critical care.
Even when standard epidemiological indicators have been
attempted, they are piecemeal, incomplete and unconnected.
E.g., in Germany physicians report COVID-19 cases into a
national database maintained by the Robert Koch Institute [5].
According to this source, the highest incidence was reported
in the German states of Hamburg and Bavaria, approximately
126 cases per 100,000. About 86% of the 732 reported deaths to
date (April 1, 2020) occurred in persons aged 70 years or older.
Germany performs about 50,000 tests a day [6].
A sampling of other tracking:
● Iceland shows an incidence of about 1%, based on
220 confirmed cases out of 2,278 samples taken at
Landspítali hospital [7].
● In the UK, a widely publicized and debated Oxford
study suggests most cases are asymptomatic and that
nearly half of the UK population has already been
infected. [8][9].
● Based upon published reports thus far, epidemiologist
John Ioannidis from Stanford University School of
Medicine places the COVID-19 death rate anywhere
between 50 and 1000 per 100,000 [10].
While these reports attempt to define the magnitude of the
epidemic, they produce no actionable information, only
overwhelming news coverage that frightens the public rather
than conveys hope.
Regarding effect of testing on epidemiological indicators:
Only widespread testing can answer the question of incidence
and death rate. Until that occurs, there is reliance on tests
performed upon hospitalizations, resulting in a highly biased
sample of severe cases.
● The small Italian town of Vò is an example of a timely,
well-managed initiative to test the entire population and
stop the spread of the disease. The University of Padua,
in collaboration with the Veneto Region and the Red
Cross, tested all 3,300 inhabitants in response to their
first COVID-19 fatality. They found ninety positive
cases, of which six were asymptomatic. Therefore,
the researchers were able to contain the infection by
isolating all people who tested positive [11].
● The Financial Times, citing the Oxford study, argue that
the reason for this uncertainty about the COVID-19
death rate is the biased sample of people tested: Only
the most severe cases are identified as positives, while
the majority of cases are mild or asymptomatic [9].
This paucity of testing, particularly among the general
asymptomatic public, perpetuates lack of understanding
about spread and infectivity. Testing an entire population to
detect mild and asymptomatic cases and silent spreaders is
not feasible, partly due to the limited availability of tests, their
often-problematic sensitivity and reliability and also inevitable
prioritization of clinically relevant cases.
The Centre of Mathematical Modeling of Infectious Diseases
(CMMID) estimated under-reporting by using a delay-
adjusted case fatality ratio estimate as available from the
European Centre for Disease Prevention and Control (ECDC).
They argue that the delay between case creation (positive test)
and fatal outcome leads to a bias in the estimate of the case
fatality ratio.
The authors used an adjustment of 13 days (SD 12.7 days) for
this delay. They calculated the delay from the time lag between
the date of hospitalization and date of death. The second cause
of bias is the underreporting of positives [12].
In short, the data collected about COVID-19 so far worldwide
has generated limited knowledge. The important indicators
that would describe the pandemic in a more accurate manner
are still largely absent. Real-world evidence addresses this
shortcoming. This approach has been utilized to combat
other similar seasonal infections. To assess seasonal influenza,
standard indicators have included an estimate of the number
of symptomatic illnesses, medical visits, hospitalizations, and
deaths per 100,000 and per annum. These indicators are still
unknown for SARS-CoV-2. The percentage of hospitalizations
and deaths of all infected individuals is significantly harder to
estimate due to the availability and reliability of population-
wide tests. This knowledge gap forces overreliance on statistical
models that are highly unreliable without accurate input data.
What information do we need to collect at the hospital
level to answer epidemiological questions?
● Population
The manifestation of SARS-CoV-2 depends, among other
factors, on the individual’s age, comorbidities and immune status.
While in most people the course of infection is mild or entirely
asymptomatic,othersdevelopseverediseasethatrequiresextensive
supportive treatment. We have directed our attention to collecting
data on patients whose primary diagnosis at hospitalization is
COVID-19 and whose condition requires inpatient treatment.
● Chronology
To provide measurable output for epidemiologists, there is
a need to collect data points describing the development of
the disease accurately over time. Specifically, epidemiologists
need to know the time lag between the onset of symptoms
and hospitalization and time to death. When presented
chronologically, this information enables the detection of shifts
in pathogenicity and virulence of the virus.
The time lag between the onset of symptoms and the time of
testing and availability of results indicates how much a timely
diagnosis and aggressive treatment improves outcomes.
3. Gazette of Pharmacology and Clinical Research Valdova V, et al. Page 1 of 3
Citation: Valdova V, Penna S, Tobin M, Fishbein J. The value of real-world evidence for clinicians and clinical researchers in the coronavirus crisis.
G Pharmacol Clin Res 2020; 1:001.
The time spent in regular hospital care, in intensive care units
and on mechanical ventilation and other types of oxygen
support enable classification of severity of the disease and
efficacy of any therapeutic interventions.
● Type of testing
It is safe to assume that most mild cases remain undiagnosed.
How does time from onset of symptoms to diagnosis affect
outcomes? The type of test used, COVID-19 RT-PCR, Human
SARS-CoV-2 IgG/IgM (2019-nCoV/Coronavirus) ELISA
Kit, or assumed diagnosis based on clinical presentation and
medical imaging needs to be captured to understand how the
type of test and time lag between onset of symptoms, diagnosis
and hospitalization affect course of the disease, probability of
serious complications and the risk of death.
Treating COVID-19
Hospital care for COVID-19 patients currently consists of
infection control and supportive care, such as high flow oxygen
and positive pressure ventilation.
There are also a range of approaches tried so far:
● The use of glucocorticoids is limited to the management
of COPD based on previous experience with influenza,
MERS and SARS.
● The value of NSAIDs is uncertain, although some
clinicians believe they may in fact be harmful.
● DrugsandbiologicsadministeredtoCOVID-19patients
include remdesivir, chloroquine, hydroxychloroquine
and IL-6 inhibitors, although their efficacy is not yet
substantiated.
● Antiretrovirals have been tried as well, with some
success reported for favipiravir [13].
● On March 24, 2020, the FDA permitted the emergency
useofconvalescentplasmainsevereandlife-threatening
COVID-19 cases [14].
The number of new treatments tried is likely to increase.
The important indicators required to understand the epidemic
better include the number of hospitalized patients who require
intensive care, what type of interventions are required, and
for how long. It is imperative to gain insight into treatment
effectiveness to rapidly adjust clinical protocols as more data
becomes available. At the same time, for the sake of patient
safety it is essential to understand the harmful effects of drugs
in specific clinical scenarios as early as possible. The systematic
collection of real-world evidence can make this happen.
Reducing Burden on Practitioners and Researchers
Reducing burden on practitioners and researchers involves two
aspects: use of better data to reduce treatment demands and
simple, quick collection of data points. With both achieved,
data such as that found below could be applied quickly.
A series of studies published in Lancet evaluated the risk of
death in patients with various co-morbidities. Patients with
high Sequential Organ Failure Assessment (SOFA) score
on admission are more likely to die [15]. Zaim et al. (2020)
stressed the risk of progression to multi-organ failure,
especially in the presence of comorbidities and organ injury.
Patients with significant co-morbidities were more likely to
develop complications and die [16].
According to a study performed on 191 patients in Jinyintan
Hospital and Wuhan Pulmonary Hospital, older age, high
SOFA score on admission, and elevated d-dimer were
associated with a higher risk of death [17].
The Center for Disease Control and Prevention (CDC) warns
that the severe form of COVID-19 most threatens people
who have underlying medical conditions, namely chronic
lung disease or asthma, serious heart conditions, severe
obesity, diabetes, liver disease, and patients on dialysis or with
conditions that compromise the immune system [18].
Optimizing Time of Hospitalization to Improve
Outcomes
Would SOFA score on admission be lower had these patients
beenhospitalizedearlier?Wouldariskscorechartthataccounts
for symptoms as well as significant comorbidities enable more
effective triage and management of patients? Would earlier
hospitalization and symptom management prevent escalation
of symptoms and progression of COVID-19 and treatment in
intensive care units? How much would the outcomes improve
had patients at risk been hospitalized earlier? Does earlier
hospitalization, as measured by SOFA score on admission,
decrease the need for intensive care?
● The most appropriate indicators need to be identified to
enable detection of candidates for hospitalization before
they deteriorate and their SOFA score progressively
worsens.
● Relevant comorbidities need to be known at time of
testing to allow triage personnel to prioritize and plan
hospital admissions.
● The impact of relevant comorbidities needs to be
quantified in terms of prolongation of hospitalization,
the need for critical care, and the risk of death.
Charlson Comorbidity Index [19] is an important predictor of
risk of death in COVID-19 patients as well as length of time
in critical care. Significant comorbidities contribute to all-
cause mortality under normal circumstances, and during the
coronavirus crisis as well.
Charlson Comorbidity Index (CCI) is a widely used tool that
predicts the ten-year survival depending on age and comorbid
conditions. Comorbidities used to calculate the score include
diabetes mellitus (uncomplicated and with end-organ damage),
peripheral vascular disease, COPD, liver disease (mild, moderate
andsevere,asdefined),moderateorseverechronickidneydisease,
solid tumors localized and metastatic, congestive heart failure,
cerebrovascular accidents or AIDS. In COVID-19 patients, CCI
is useful to standardize reporting of significant comorbidities.
Past studies observed that additional risk factors for COVID-19
patients include hypertension, obesity and smoking.
4. Gazette of Pharmacology and Clinical Research Valdova V, et al. Page 1 of 4
Citation: Valdova V, Penna S, Tobin M, Fishbein J. The value of real-world evidence for clinicians and clinical researchers in the coronavirus crisis.
G Pharmacol Clin Res 2020; 1:001.
SOFA score on admission and Charlson Comorbidity Index
seem to be the most appropriate indicators to measure the
impact of COVID-19 in the context of a patient’s overall
health. Most patients with COVID-19 have mild symptoms
and stay at home, waiting for the disease to run its course and
pass. In some patients however, the symptoms progress and
require hospitalization. Earlier detection of symptoms that are
likely to progress into severe disease, in combination with the
patient’s individual risk score would be instrumental for triage
personnel. Armed with continuously updated risk score charts,
first responders would be in a better position to advise patients
to either continue symptomatic treatment at home and monitor
specific indicators, or to proceed with hospitalization before it
is too late. RWD collection methods will enable quantification
of impact of comorbidities on length of hospitalization and the
need for intensive care.
Real-World Data Collection Techniques
Real-world evidence enhances understanding and RWD
collection techniques can rely on routinely collected indicators
without placing additional burden on practitioners. Surveys
and questionnaires may be used to collect information from
hospitals without the need to perform any additional tests
or procedures. The design of a questionnaire should address
all the critically important gaps in knowledge while keeping
the effort required to fill in such survey to the minimum.
An additional requirement is the need to serve multiple
monitoring systems and initiatives at the same time. To avoid
the need for duplicated collection of overlapping datasets,
these critical knowledge gaps can be pooled and combined in
a single survey. The final dataset should provide information
on epidemiological indicators, efficacy and safety of various
management approaches including experimental and off-label
treatments and adverse drug events associated with the use
of novel treatment protocols and prolonged use of supportive
care interventions.
There is currently no dedicated disease registry for
COVID-19 patients, so our survey addresses a critical need.
The data gathered as part of routine care can be very helpful
in determining the most effective therapy protocols and
management strategies. Retrospectively capturing U.S. case
reports since the beginning of the pandemic would provide
insight faster than limiting the survey to patients who are
leaving hospitals right now. Limiting the survey geographically
to U.S. hospitals will only eliminate some of the methodological
differences that make treatment approaches and outcomes so
difficult to compare.
Value of Real-World Data, Real-World Evidence in
Clinical Care and Research
The FDA is increasingly embracing real-world evidence to
monitor post-market safety of drugs, to support regulatory
submissions, and to generate data to support clinical decisions.
A series of guidelines exist on the nuances of utilizing real-
world data to generate evidence [20]. The agency appreciates
that real-world data is ideally suited to support large simple
trials and pragmatic clinical trials as well as observational
studies. Furthermore, real-world data approaches can provide
results quickly and in sufficient quantity and quality of
evidence.
During the COVID-19 pandemic, it is essential to collect
information that fills the current knowledge gaps to reduce
uncertainty relating to this novel disease. This data collection
effort shall serve more than one purpose and provide insight
into the effectiveness of novel therapies, quickly detect harmful
interventions, and facilitate triage and timely hospitalization of
patients who are most at risk of rapid deterioration.
Differing methodologies produce vastly different results due
to the wide range of symptoms and their severity, differences
in criteria for diagnosis of COVID-19 on admission and on
discharge, differences in recording COVID-19 on death
certificates, and the unprecedented response of the media that
influence decision-making at both institutional and individual
level.
Significant knowledge gaps exist concerning the infectivity and
spreadofthevirusandtheriskfactorslinkedtothedevelopment
of a critical disease. Uncertainties exist regarding time-lapse
from the onset of symptoms and the need for hospitalization,
duration of symptoms that require hospital care and intensive
care management, interventions, and treatments that can
reduce the length of hospitalization and need for invasive
procedures. These knowledge gaps need to be addressed with
greater accuracy and confidence to optimize patient outcomes,
reduce the need for intensive care, reduce avoidable patient
casualty, and facilitate appropriate distribution of resources
within anticipated hotspots.
Our survey was designed to collect information about
hospitalized Covid-19 patients at the point of care in a
structured and standardized manner and make this cumulative
experience available to the public. Data collected this way
enables real-time and future exploratory analysis. The data
can be further utilized to generate hypotheses on the possible
relationships between timelines, risk factors, laboratory
markers, interventions and outcomes, and direct future
research to specific focus areas. The aggregated dataset will be
made available to other researchers and physicians in the form
of interactive dashboards.
More focused data collection efforts within formal clinical
trials will always be necessary to prove or disprove efficacy and
safety of a specific intervention. However, a broad, general,
non-discriminatory approach to collecting data directly at
point of care that standardizes the input utilizing widely
used, clinically relevant thresholds, is a good way to quickly
gain insight into multiple problem areas at once. Systematic
data collection effort that enables instant visibility of results
through interactive analytical dashboards will reduce time to
insight and help guide future research.
To Summarize
In the throes of a global pandemic, uniform collection
and analysis of such data is imperative. Collecting relevant
information such as treatment outcomes and adverse drug
5. Gazette of Pharmacology and Clinical Research Valdova V, et al. Page 1 of 5
Citation: Valdova V, Penna S, Tobin M, Fishbein J. The value of real-world evidence for clinicians and clinical researchers in the coronavirus crisis.
G Pharmacol Clin Res 2020; 1:001.
events at the point of care will help the medical and scientific
communities evaluate the data in near-real-time and respond
accordingly by adjusting treatment protocols and triage
practices. Every new patient should have better odds of survival
and full recovery as the system learns from past experiences.
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