Clinical Research Informer

Grand Rounds Biostatistics Series January 5, 2024: Methods for Handling Missing Data in Cluster Randomized Trials (Rui Wang, PhD; Moderator: Fan Li, PhD)

Rethinking Clinical Trials

JANUARY 9, 2024

Significant work has been done on individual level missingness, where there is an observed outcome for each cluster, but an outcome is missing for one individual. Less work focuses on cluster level missingness, where the outcome is missing for an entire cluster of individuals, but researchers have made some progress in analyzing these cases.

Trials

Trials Clinical Trials Clinical Trials Research

Grand Rounds March 10, 2023: Estimands in Cluster-Randomized Trials: Choosing Analyses that Answer the Right Question (Brennan Kahan, PhD)

Rethinking Clinical Trials

MARCH 15, 2023

This concept is especially important in the context of cluster-randomized trials, but it is important to determine if the estimand will reflect participant-average treatment effect versus a cluster-average treatment effect or a marginal versus cluster-specific. The difference relates to how data is weighed.

Trials

Trials Clinical Trials Clinical Trials Research

Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. Hughes, PhD)

Rethinking Clinical Trials

DECEMBER 6, 2023

Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Slides Keywords Design, Analysis, Stepped-Wedge Trial Key Points Stepped-wedge design is typically run by clusters that are randomized. Each of the clusters receive the control and treatment, and each cluster is sequenced to the intervention at different times.

Trials

Trials Clinical Trials Clinical Trials Research

Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)

Rethinking Clinical Trials

DECEMBER 14, 2022

Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. There are two main types of clinical trials: patient randomized trial and cluster randomized trial (CRT). In most cases, a parallel arm or cluster cross would be a better choice. Associate Dean for Research. Key Points. pctGR, @Collaboratory1.

Trials

Trials Clinical Trials Clinical Trials Medicine

Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Rethinking Clinical Trials

APRIL 18, 2023

RECOVER has used cohort data to identify major symptom clusters and develop 5 platform protocols that will investigator priority symptom clusters and their causes; test known and novel interventions across domains; and evaluate treatments to improve Long COVID symptoms.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Rethinking Clinical Trials

OCTOBER 11, 2023

Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. It’s important to note that it’s more difficult to keep the centers, or actual clusters, blinded.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Successful cancer therapy using artificial metalloenzymes to deliver drugs

Scienmag

APRIL 23, 2021

Credit: RIKEN Researchers led by Katsunori Tanaka and Kenward Vong at the RIKEN Cluster for Pioneering Research (CPR) in Japan have demonstrated that tumor growth can be reduced by therapy that tags cancer cells with different therapeutic molecules.

Drugs

Drugs Research Engineer Medicine

Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Rethinking Clinical Trials

SEPTEMBER 28, 2023

The trial was cluster randomized by clinic for usual care or intervention arms; participants were parents with infants 12 months and younger. In areas of quality improvement people often do not consider cluster randomized design or people may be disappointed if they are randomized to usual care.

Trials

Trials Clinical Trials Clinical Trials Research

Grand Rounds April 28, 2023: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial (Matthew W. Semler, MD, MSc)

Rethinking Clinical Trials

MAY 5, 2023

Assistant Professor of Medicine and Biomedical Informatics Medical Director, VICTR Center for Learning Healthcare Vanderbilt University Medical Center Slides Keywords Pragmatic Clinical Trials, Cluster-crossover Trial Key Points More than 3 million adults receive invasive mechanical ventilation each year in the U.S.

Trials

Trials Clinical Trials Clinical Trials Development

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Rethinking Clinical Trials

APRIL 27, 2023

The MyTEMP trial is a pragmatic, cluster randomized controlled trial in Ontario, Canada, to determine if adopting a default center-wide policy of personalized cooler dialysate is superior to a standard temperature dialysate of 36.5 Cluster randomized trials of hemodialysis center-wide policies raise complex ethical issues.

Trials

Trials Clinical Trials Clinical Trials Medicine

Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)

Rethinking Clinical Trials

JULY 19, 2023

This was a cluster-randomized trial of 42 cardiology clinics across the U.S., This can be a limitation of cluster-randomized trials, as the knowledge of which group they are randomized to could impact patient enrollment. Distinguished Professor of Medicine Professor of Nursing Duke University Neha J. Granger, MD; Neha J.

Trials

Trials Cardiology Medicine Nurses

AI-Powered Precision Engagement in Commercial and Medical Functions

Intouch Solutions

APRIL 11, 2024

Clustering and segmentation Once the data is aggregated, AI algorithms are employed to cluster the physicians or the patients into meaningful segments or groups. This iterative process yields several benefits, including: Creating clusters of customers based on actual physician behavior.

Compliance

Compliance Marketing Drugs Pharma Companies

Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)

Rethinking Clinical Trials

AUGUST 30, 2023

The RA PRO dashboard was tested as part of a stepped wedge, cluster randomized trial at the clinician level. There were 4 clusters with 4-6 physicians each (a mix of attendings and fellows). . I am still optimistic that we will see some improvements in the outcomes we specified.

Trials

Trials Clinical Research Coordinator Medicine Clinical Trials

Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Rethinking Clinical Trials

OCTOBER 18, 2023

It is important to look at what is available to people, what interventions are able to be done by the cluster data – by housing authorities, federal groups, and the health system. First steps are getting the data in such a state that would allow us to learn about some of those social determinants of health.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Research

Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)

Rethinking Clinical Trials

FEBRUARY 9, 2023

The effectiveness of the intervention was then evaluated through a cluster randomized trial at four academic tertiary hospitals from December 21, 2020 to January 21, 2022. Researchers considered this an epiphenomenon that likely reflects the imbalance of the COVID-19 patients in the intervention group.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds March 3, 2023: Adoption, Implementation and Sustainment of Family-focused Prevention in Health Care Systems: How Do We Get There? (Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW)

Rethinking Clinical Trials

JULY 14, 2023

GGC4H is a 5-year, longitudinal cluster-randomized trial that took place in pediatric primary care. Tags #pctGR, @Collaboratory1 The post Grand Rounds March 3, 2023: Adoption, Implementation and Sustainment of Family-focused Prevention in Health Care Systems: How Do We Get There?

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds November 18, 2022: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children (Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM)

Rethinking Clinical Trials

NOVEMBER 21, 2022

– Did you find there are clusters of clinicians that consistently found that they were unwilling to randomize someone? The median time to liberation in the HFNC group was 50 hours and the CPAP group was 43 hours. HFNC was not noninferior to CPAP following extubation. Learn more. Read more about the study in JAMA. Discussion Themes.

Trials

Trials Clinical Trials Clinical Trials Packaging

WHO update on Omicron

The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). WHO’s TAG-VE will continue to monitor and evaluate the data as it becomes available and assess how mutations in Omicron alter the behaviour of the virus. Recommended actions for countries.

Vaccination

Vaccination Vaccine Genome Genomics

Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)

Rethinking Clinical Trials

NOVEMBER 6, 2023

In Group- or cluster-randomized trials (GRTs), pre-existing groups are randomized to either control or intervention arms. Both trial types are common, but it’s important to note that observations are correlated before and after randomization.

Trials

Trials Clinical Trials Clinical Trials Contamination

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

MARCH 21, 2023

The PRO-TECT Cancer Symptom Study was a cluster randomized trial at 52 U.S. Tags #pctGR, @Collaboratory1 The post Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc) appeared first on Rethinking Clinical Trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

Rethinking Clinical Trials

AUGUST 28, 2023

The IMPACt-LBP study design is a pragmatic, multi-site, two-arm cluster-randomized trial with randomization at the primary care provider (PCP) clinic level. Their treatment approaches will focus on non-pharmacological approaches recommended by the guideline, including spinal manipulation and exercise.

Trials

Trials Research Medicine Doctors

Women in Science Who Have Paved the Way Forward in Genetics

XTalks

FEBRUARY 11, 2021

They conducted two experiments, one with radioactive phosphorous to label DNA, and one with radioactive sulfur to tag protein (DNA does not contain sulfur and protein does not contain phosphate groups). Through the radioactive labels, they were able to track which of the two, DNA or protein, was injected into the bacteria.

Genetics

Genetics DNA Genome Genomics

Clinical Research Informer

Grand Rounds Biostatistics Series January 5, 2024: Methods for Handling Missing Data in Cluster Randomized Trials (Rui Wang, PhD; Moderator: Fan Li, PhD)

Grand Rounds March 10, 2023: Estimands in Cluster-Randomized Trials: Choosing Analyses that Answer the Right Question (Brennan Kahan, PhD)

Trending Sources

Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. Hughes, PhD)

Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)

Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Successful cancer therapy using artificial metalloenzymes to deliver drugs

Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Grand Rounds April 28, 2023: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial (Matthew W. Semler, MD, MSc)

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)

AI-Powered Precision Engagement in Commercial and Medical Functions

Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)

Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)

Grand Rounds March 3, 2023: Adoption, Implementation and Sustainment of Family-focused Prevention in Health Care Systems: How Do We Get There? (Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW)

Grand Rounds November 18, 2022: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children (Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM)

WHO update on Omicron

Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

Women in Science Who Have Paved the Way Forward in Genetics

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