health outcomes

February 19, 2021: Beyond Politics: Promoting COVID Vaccination in the United States (Kevin A. Schulman, MD)

Posted on by Gina Uhlenbrauck

Speaker

Kevin A. Schulman, MD
Professor of Medicine and Economics
Stanford University

Topic

Beyond Politics: Promoting COVID Vaccination in the United States

Keywords

COVID-19; Vaccine hesitancy; Marketing strategies; Herd immunity; Vaccine adoption

Key Points

  • One key strategy is to promote the COVID-19 vaccine as a tool that will get us back to school and work again.
  • We need targeted COVID-19 marketing campaigns at each health system to achieve 100% vaccination of healthcare workers.
  • It is crucial that we tamp down vaccine misinformation. We must be vocal in telling the accurate stories of people’s experience with the vaccine, as these resonate with the public and can have an impact.

Discussion Themes

Many of these strategies could apply to clinical trials, for example, a scarcity, an honor for participation, a frontier. Could these tactics could be used to increase participation in clinical trials, especially COVID-19 trials?

Another strategy is to just open the floodgates for everyone to get the vaccine, and this will avoid having stock waste on the shelves. If high-risk groups are resistant to vaccination, perhaps highly motivated people can fill the gap.

How can private payers support COVID-19 vaccine marketing efforts?

Read more about Beyond Politics—Promoting Covid-19 Vaccination in the United States in the New England Journal of Medicine.

Tags

#pctGR, @Collaboratory1

February 5, 2021: Generating High-Quality Evidence During a Pandemic: The Brazilian COALITION Experience (Renato Lopes, MD, MHS, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Renato D. Lopes, MD, MHS, PhD
Professor of Medicine
Division of Cardiology
Duke University Medical Center
Duke Clinical Research Institute
Brazilian Clinical Research Institute

Topic

Generating High-Quality Evidence During a Pandemic: The Brazilian COALITION Experience

Keywords

COVID-19; Patient outcomes; Cardiology; Randomized clinical trials; COALITION; Levels of evidence

Key Points

  • The SARS-CoV-2 infection affects the cardiovascular system and is associated with complications such as myocardial ischemia, myocarditis, arrhythmias, and thromboembolic events. These manifestations result mainly from the intense systemic inflammatory response and disorders of the coagulation system. 
  • The COALITION collaborative includes several major Brazilian hospitals and research networks with the aim of accelerating multicenter randomized controlled trials that generate high-quality evidence to guide the treatment of patients with COVID-19.
  • To move toward a world in which most clinical decisions are supported by high-quality evidence requires structural changes in the clinical trials ecosystem.

Discussion Themes

How did you overcome contractual and regulatory concerns to execute your trials?

Instead of “publish or perish,” it should be “collaborate or perish.” Collaboration is the key to surviving in modern academic medicine.

Read more about the need for high-quality evidence to treat COVID-19 patients in Anticoagulation in COVID-19: It Is Time for High-Quality Evidence (J Am Coll Cardiol, 2020)

Tags

#pctGR, @Collaboratory1

January 29, 2021: The COVID-19 Citizen Science Study (Gregory M. Marcus, MD, MAS)

Posted on by Gina Uhlenbrauck

Speaker

Gregory M. Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic

The COVID-19 Citizen Science Study

Keywords

Eureka digital research platform; COVID-19 infections; Mobile health; Risk factors; Citizen science; Geolocation; Participant engagement

Key Points

  • Eureka is an NIH-supported digital research platform built to use mobile health technology to combat the novel coronavirus, focusing on identifying risk factors for infection, transmission, and severity of disease that may inform best practices.
  • Eureka is also intended to serve as a platform for collaborating investigators to answer their own research questions.
  • As a citizen science project, any adult with a smartphone can participate and contribute information. Nearly 50,000 participants have enrolled to date.

Discussion Themes

The COVID-19 Citizen Science website provides data visualizations that show how people answered the survey questions. A study blog through the app is used to translate key information to participants.

Will this project be collaborating with other entities that are potentially overlapping in terms of their COVID-19 applications?

Best practices in mHealth include keeping it simple, avoiding over-explaining, listening to participants, and providing a feedback pathway.

Learn more about the Eureka platform. The smartphone app is available under the name “UCSF Eureka Research.”

Tags

#pctGR, @Collaboratory1  

January 15, 2021: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic (Pamela Tenaerts, MD, MBA; Sara Calvert, PharmD; Leanne Madre, JD, MHA)

Posted on by Gina Uhlenbrauck

Speakers

Pamela Tenaerts, MD, MBA
Executive Director
Clinical Trials Transformation Initiative

Sara Calvert, PharmD
Senior Project Manager
Clinical Trials Transformation Initiative

Leanne Madre, JD, MHA
Directory of Strategy
Clinical Trials Transformation Initiative

Topic

How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic

Keywords

Clinical Trials Transformation Initiative (CTTI); Best practices; COVID-19 treatment trials; RECOVERY Trial; Digital health technology; Decentralized clinical trials

Key Points

  • During 2020, CTTI conducted a series of intensive surveys, discussions, and collaborations across the clinical trials ecosystem, which shaped the creation of public webinars, a Best Practices for Conducting Trials During the COVID-19 Pandemic playbook, and a searchable, real-time AACT COVID-19 Trials Spreadsheet, among other efforts.

  • CTTI’s efforts helped the research community successfully navigate the challenges associated with adjusting trials that were underway when the pandemic hit, as well as launching new trials for COVID-19 treatments.

  • Among the best practices for conducting clinical trials during the pandemic: keep participants informed, perform ongoing risk-benefit assessment, adjust study startup and enrollment based on current risks, pivot to remote study visits, and switch to remote monitoring.

Discussion Themes

Because of the COVID-19 pandemic, there is more momentum toward digital health technology and decentralized clinical trials.

With the pandemic, we are seeing trial results go straight to practice, bypassing input from the clinical community at large—will this continue after the pandemic?

To what extent do you think the IRB/research oversight sphere might be permanently reshaped by the pandemic’s impact on the conduct of clinical trials? 

Read more about CTTI’s efforts around clinical trials during the COVID-19 pandemic.

Tags

#pctGR, @Collaboratory1

January 8, 2021: HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data (Emily O’Brien, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Emily O’Brien, PhD
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Topic

HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data

Keywords

Vaccine development; COVID-19; Pandemic: Vaccine hesitancy; HERO-TOGETHER; Healthcare workers; Clinical outcomes: Observational study

Key Points

  • According to the World Health Organization, vaccine hesitancy refers to the delay in acceptance of, or refusal of, vaccines despite availability of vaccination services.

  • Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence. Hesitancy occurs on a continuum, from acceptance of all vaccines, to acceptance but doubt, to vaccine delayers, refusers, and deniers.

  • HERO-TOGETHER is a prospective, observational, multicenter cohort study of 20,000 adult U.S. healthcare workers who received a COVID-19 vaccine within the past 60 days. The study will collect data from participants that includes their experience with receiving the vaccine, medical history, unexpected medical care, safety events, and quality of life.

Discussion Themes

There is no universal best practice to address vaccine hesitancy in all its contexts. Locally tailored and multicomponent approaches will be needed.

How has the political environment influenced the hesitancy around receiving the COVID-19 vaccine?

What are your approaches to evaluating vaccine safety? What about safety for women during child-bearing years?

Read more about the HERO-TOGETHER study.

Tags

#pctGR, @Collaboratory1

December 11, 2020: PREVENTABLE: Starting a Pragmatic Trial in a Pandemic (Karen Alexander, MD; Schuyler Jones, MD)

Posted on by Gina Uhlenbrauck

Speakers

Karen P. Alexander, MD
Professor of Medicine/Cardiology
Duke University School of Medicine

W. Schuyler Jones, MD
Associate Professor of Medicine/Cardiology
Duke University School of Medicine

Topic

PREVENTABLE: Starting a Pragmatic Trial in a Pandemic

Keywords

Heart disease; Dementia; Cholesterol; Statins; Pragmatic trial; National Heart, Lung, and Blood Institute; National Institute on Aging; Mild cognitive impairment

Key Points

  • More than half of older adults (age 75+) in the United States have cognitive impairment or frailty or both.
  • PREVENTABLE is one of the largest research studies in older adults. The purpose is to learn if taking a statin could help older adults live well for longer by preventing dementia, functional decline, or heart disease.
  • The study medication (statin) is mailed directly to participants’ homes. Study sites are part of the research infrastructure within PCORnet and Veterans Affairs (VA).
  • Pragmatic aspects of the trial include the study question: Do statins work in practice for outcomes that matter most to older adults? Also, enrollment is telehealth-enabled, and consent is electronic (e-Consent).

Discussion Themes

How did the study team work with IT to make the EHR system changes (eg, tools and workflow) needed to conduct the research?

Are older participants able to interact well with the technology used in the trial?

Are there special considerations embedded within the study to encourage the retention of study participants?

Read more about the PREVENTABLE study.

Tags

#pctGR, @Collaboratory1

December 4, 2020: The Yale New Haven Health System as an Evidence Generation Ecosystem for Heart Failure (Tariq Ahmad, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Tariq Ahmad, MD, MPH
Director, Advanced Heart Failure Program
Yale School of Medicine and Yale New Haven Health

Topic

The Yale New Haven Health System as an Evidence Generation Ecosystem for Heart Failure

Keywords

Heart failure; Best practice alerts; Electronic health records; Risk prediction; Guideline-directed medical therapy; REVEAL-HF

Key Points

  • The REVEAL-HF study is a pragmatic randomized controlled trial testing an electronic alert system that informs clinicians about the 1-year predicted mortality for their patients with heart failure using validated data from the EHR.
  • It is important to use guideline-directed medical therapy for patients with heart failure. The hypothesis of the trial is that providing prognostic information for a patient with heart failure will lead to improved use of therapies and appropriate referral to subspecialties.

Discussion Themes

How did you get health system leadership and all of the clinicians, IT folks, and others to buy in to implementing your trial?

How can we make risk information valuable and actionable to healthcare providers?

Clinicians bring something to the table that an algorithm does not. It will be interesting to see how clinician behavior is affected by using the prediction models and interacting with the data.

Read more about the REVEAL-HF trial.

Tags

#pctGR, @Collaboratory1

November 20, 2020: Drug Development in Kidney Disease: Proceedings from a Multi-Stakeholder Panel (Daniel Edmonston, MD)

Posted on by Gina Uhlenbrauck

Speaker

Daniel Edmonston, MD
Medical Instructor
Duke University School of Medicine

Topic

Drug Development in Kidney Disease: Proceedings from a Multi-Stakeholder Panel

Keywords

Chronic kidney disease (CKD); Dialysis; Evidence-based medicine; Electronic health records; Think Tank

Key Points

  • Only 5 percent of treatment recommendations for kidney disease reach a Grade A level of evidence.
  • In 2019, the DCRI convened a panel to address the urgent need for evidence-based treatments for kidney disease. “Accelerating Drug Development for Chronic Kidney Disease and End-Stage Renal Disease” included stakeholders from regulatory agencies, kidney societies, patient advocacy organizations, academia, and industry.
  • Key discussions explored the uses of interconnected data and site research networks, pragmatic and adaptive trial designs, robust surrogate endpoints, real-world data, and methods to improve the generalizability of trial results and uptake of approved drugs for kidney-related diseases.

Discussion Themes

Since there is more than one therapeutic agent showing promise for CKD, how should evidence be generated to understand the right combination of agents?

Could the principles laid out in the FDA Patient Focused Drug Development guidance be applied in these trials to ensure the patient perspective is included?

What are your thoughts on whether to focus on enrolling early CKD patients—some of whom will not progress—or patients later in the course of disease, when disease modification may be more challenging?

Read more about the Think Tank in a special report in the American Journal of Kidney Disease.

Tags

#pctGR, @Collaboratory1

November 6, 2020: Appendectomy Versus Antibiotics for Appendicitis–Early Results from the CODA Trial (David R. Flum, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

David R. Flum
Professor, Surgery, Health Services, and Pharmacy
Associate Chair for Research, Department of Surgery
University of Washington

Topic

Appendectomy Versus Antibiotics for Appendicitis–Early Results from the CODA Trial

Keywords

Appendectomy; Antibiotic therapy; CODA Collaborative; Comparative effectiveness research; Patient-centered outcomes research; Pragmatic clinical trial; Noninferiority; PCORI

Key Points

  • The CODA (Comparing Outcomes of Drugs and Appendectomy) Collaborative involved 25 sites across 14 states. The Co-PIs included surgeons and emergency medicine physicians.
  • The CODA pragmatic trial aimed to inform the health decision for appendicitis treatment by asking two research questions:
    • Are antibiotics as effective as appendectomy for appendicitis?
    • Which patients are most likely to have a successful outcome with antibiotics?
  • Instead of appendectomy, the intervention group received antibiotics intravenously for 24 hours followed by pills for a  total of 10 days. The primary outcome in the trial was 30-day health status, as assessed with the European Quality of Life-5 Dimensions questionnaire.
  • The patients who received antibiotics cared about outcomes such as “Am I going to feel better,” followed by “Is it safe,” and “Will I return to work sooner?”

Discussion Themes

Antibiotics for appendicitis can be a good choice for some but not all. Decision-makers must weigh patient characteristics, preferences, and circumstances.

Can you comment on the relative “disappearance” of appendicitis during the COVID-19 pandemic? 

Based on your results, how would you counsel a patient (or parent) in the emergency department with a diagnosis of appendicitis?

Will there eventually be a biomarker that’s predictive for appendectomy?

Read more about CODA results in the New England Journal of Medicine.

Tags

#pctGR, @Collaboratory1

October 30, 2020: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience (David Boulware, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

David R. Boulware MD, MPH
Professor of Medicine
Infectious Disease & International Medicine
Department of Medicine
University of Minnesota

Topic

Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience

Keywords

COVID-19; Patient-reported outcomes (PROs); Hydroxychloroquine; Epidemiology; Virtual trials

Key Points

  • These virtual randomized controlled trials evaluated hydroxychloroquine as a post-exposure prophylaxis, pre-emptive early treatment, and pre-exposure prophylaxis for COVID-19.
  • The trial of post-exposure prophylaxis employed patient-reported outcomes around COVID-19 symptoms and severity as well as side effects of hydroxychloroquine.
  • Enrollment and screening of eligible participants was automated through a REDCap survey.

Discussion Themes

Being a virtual trial, were there concerns about practicing medicine “across state lines?”

There has been a mix of science and politics over the course of the COVID-19 pandemic. Because your trial had substantial media coverage, how did the publicity affect enrollment?

Many big strategy questions can be studied virtually. What changes do you see for trials during future pandemics?

Read reports of these virtual trials in New England Journal of Medicine, Annals of Internal Medicine, and the medRxiv preprint server.

Tags

#pctGR, @Collaboratory1