June 7, 2023: This Week’s PCT Grand Rounds Will Feature the DUPLICATE Initiative

Headshot of Dr. Shirley Wang
Dr. Shirley Wang

In this Friday’s PCT Grand Rounds, Shirley Wang of Harvard Medical School will present “Emulating Randomized Clinical Trials With Non-randomized Real-World Evidence Studies: Results From the RCT DUPLICATE Initiative.” The Grand Rounds session will be held on Friday, June 9, 2023, at 1:00 pm eastern.

The DUPLICATE initiative is building an empirical evidence base for using longitudinal insurance claims prospectively to achieve large-scale replication of randomized controlled trials. Dr. Wang, a codirector of the initiative,  is an associate professor of medicine at Harvard Medical School and associate epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.

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May 31, 2023: PROACT Xa Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds

Headshot of Dr. John Alexander
Dr. John Alexander

In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern.

PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients with an On-X mechanical aortic valve. The trial’s pragmatic design features enabled the investigators to conduct the the trial successfully during the COVID-19 public health emergency.

Dr. Alexander is a cardiologist and professor of medicine in the Duke University School of Medicine and a faculty member in the Duke Clinical Research Institute.

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March 29, 2023: This Friday’s PCT Grand Rounds Features Novel Approach to Lowering Blood Pressure in QUARTET USA Trial

Headshot of Dr. Jody CiolinoIn this Friday’s PCT Grand Rounds, Jody Cioliono will present “Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension (QUARTET USA): Results From a Randomized Controlled Trial.” The Grand Rounds session will be held on Friday, March 31, 2023, at 1:00 pm eastern.

The QUARTET USA trial tested a novel approach to lowering blood pressure compared with standard-dose monotherapy. The trial was embedded within a network of federally qualified healthcare centers in the Chicago metropolitan area. Ciolino is an associate professor of preventive medicine (biostatistics) and director of the master of science in biostatistics program in the Northwestern University Feinberg School of Medicine.

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October 5, 2022: PCT Grand Rounds to Feature Randomized Trial of Intraoperative Anesthesia Handovers

Headshot of Dr. Melanie Meersch-DiniIn this Friday’s PCT Grand Rounds, Dr. Melanie Meersch-Dini of University Hospital Münster (Germany) will present “Impact of Handovers of Anesthesia Care on Morbidity and Mortality.” The Grand Rounds session will be held on Friday, October 7, 2022, at 1:00 pm eastern.

Dr. Meersch-Dini will discuss the results of the HandiCAP trial (Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes), a parallel-group, randomized clinical trial of intraoperative handover of anesthesia care in 12 centers in Germany.

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April 15, 2022: SODIUM-HF: Should Our Patients Consume Less Dietary Sodium? (Justin A. Ezekowitz, MBBCh, MSc)

Speaker

Justin A. Ezekowitz, MBBCh, MSc
Professor of Medicine and Alberta Health Services Chair in Cardiac Sciences
Director, Cardiovascular Research
Co-Director, Canadian VIGOUR Centre
University of Alberta

Cardiologist, Mazankowski Alberta Heart Institute

 

 

Keywords

PCORnet; COVID-19; Electronic health record (EHR); Surveillance data

 

Key Points

  • Prior randomized controlled studies on dietary intake of sodium have shown no consistent or conclusive results.
  • SODIUM-HF is a pragmatic randomized trial of 806 patients in 6 countries with heart failure randomized to usual care or a low-sodium diet (≤1500 mg/day NA) and followed for 12 months. The primary outcome measures were mortality, hospitalizations, and emergency department (ED) visits.
  • Patients started out around 2200 mg of dietary sodium per day. The usual care group showed little reduction while the SODIUM intervention group saw a 28% reduction to around 1658 mg per day.
  • The intervention group did not have a statistically significant positive outcome for the primary endpoints of mortality, hospitalizations, or ED visits.
  • Patients reported a modestly higher quality of life after 6 and 12 months on the lower sodium diet as reported on the KCCQ quality of life questionnaire.
  • As part of an overall health strategy, clinicians may want to encourage a low sodium diet for patients with HF as a therapy to improve a patient’s quality of life.

Discussion Themes

– The top 3 challenges to the SODIUM-HF study were finding patients willing to change their diet, maintaining fidelity to the study intervention across multiple sites, and the impact of COVID on recruitment.

– No study sites were in the US due to cost restrictions.

– Efficacy trials are still very important and we need to get better at funding them and running them for longer periods.

Read more about the SODIUM-HF trial and results from the study.

Tags

#pctGR, @Collaboratory1

April 13, 2022: SODIUM-HF Trial Will Be Featured in This Week’s PCT Grand Rounds

Head shot of Dr. Justin EzekowitzIn this Friday’s PCT Grand Rounds, Dr. Justin Ezekowitz of University of Alberta will present “SODIUM-HF: Should Our Patients Consume Less Dietary Sodium?” The Grand Rounds session will be held on Friday, April 15, at 1:00 pm eastern.

The SODIUM-HF trial is open-label, randomized controlled trial conducted at 26 sites in Australia, Canada, Chile, Colombia, Mexico, and New Zealand to test whether reduction in dietary sodium reduces the incidence of future clinical events.

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February 4, 2022: SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-Based Randomized Clinical Trial(Adam DeVore, MD, MHS; Lars Lund, MD, PhD)

Speakers

Adam DeVore, MD, MHS
Associate Professor of Medicine
Duke University Medical Center
Duke Clinical Research Institute

Lars Lund, MD, PhD
Professor of Cardiology
Karolinska Institutet
Karolinska University Hospital

Topic

SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-based Randomized Clinical Trial

Keywords

Heart Failure; SPIRRIT-HFpEF; Randomized clinical trial; Spironolactone; Eplerenone; Swedish Heart Failure Registry (SwedeHF)

Key Points

  • The SPIRRIT-HFpEF trial, conducted Sweden and the US, was a randomized pragmatic clinical trial of spironolactone or eplerenone in heart failure.
  • Death from heart disease is decreasing while death from Heart Failure is increasing.
  • The SPIRRIT-HFpEF trial focused on improving the trajectory for the growing heart failure population.
  • Patients treated with Spironolactone had a modest but not statistically significant improvement over placebo, but total hospitalizations were less.
  • Patients with a lower ejection fraction were more likely to benefit than patients with a higher ejection fraction.
  • The Swedish Heart Failure Registry (SwedeHF) has been collecting data from HF patients since 2000.’

Discussion Themes

The hardest aspect of a clinical trial is recruitment and enrollment. Patients are spread out over the health care system. The challenge is getting staff and personnel to do the work of screening and prescreening.

In the SPIRRIT-HFpEF, the drawbacks of not blinding were small and the costs of blinding would have been huge.

 

Learn more about the SPIRRIT-HFpEF trial and the Swedish Heart Failure Registry.  Read about the SPIRRIT-HFpEF trial results.

 

Tags

#pctGR, @Collaboratory1

February 2, 2022: This Friday in PCT Grand Rounds, the SPIRRIT-HFpEF Registry-Based Randomized Clinical Trial

Headshots of Dr. Adam DeVore and Dr. Lars Lund
Dr. Adam DeVore and Dr. Lars Lund

In this Friday’s PCT Grand Rounds, Dr. Adam DeVore of Duke University and Dr. Lars Lund of the Karolinska Institutet will present “SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-Based Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, February 4, at 1:00 pm eastern.

SPIRRIT-HFpEF is using a registry-based randomized clinical trial design to determine whether initiation of spironolactone plus usual care improves outcomes of patients with heart failure with preserved ejection fraction compared with usual care alone.

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August 30, 2021: New Living Textbook Materials on Designing a Trial to Match Its Intention

The Living Textbook has recently published materials that explore how randomized trials can be designed to promote both internal and external validity. The new contributions, from Drs. Merrick Zwarenstein, Ahmed Al-Jaishi, and Amit Garg, explain that consideration of the trial’s intention, whether pragmatic or explanatory, is the key to designing a trial that successfully answers its primary research question. While there is a contrast between pragmatic and explanatory intentions, there is not a dichotomy. Instead, trials will vary across the spectrum of design decisions leaning toward choices that match the trial’s purpose. The PRECIS-2 tool can help investigators design their trial to align with its intention. The authors illustrate these points in a new Living Textbook section, PRECIS-2 Case Study, which contrasts the design decisions made for two trials in a renal dialysis setting.

“The purpose should be decided before embarking on designing a trial, and each element of the trial design should be aligned to the chosen purpose.”­– Zwarenstein et al. 2021

Read more at:

August 25, 2021: Good Clinical Trials Collaborative Seeks Input on Draft Guidance for Randomized Controlled Trials

Logo for Good Clinical Trials CollaborativeThe Good Clinical Trials Collaborative has opened a 6-week public consultation period on its draft guidance for randomized controlled trials. The consultation period will last until September 15.

Launched in June 2020 with the support of Wellcome, the Bill & Melinda Gates Foundation, and the African Academy of Sciences, the Collaborative is developing guidance “to enable and promote informative, ethical, and efficient randomized controlled clinical trials.” The purpose of the guidance is to identify the fundamental principles of randomized controlled trials and enable their application to a wide range of healthcare settings and interventions.

Through a web-based survey, the Collaborative is seeking feedback to help shape the guidance and ensure that it is applicable in all settings. Read more about the draft guidance and provide your feedback.