Curbside Consults Podcast

Published June 26, 2020

In this episode of Curbside Consults: Statistical Review, we explore the interpretation of secondary outcomes in clinical trials using the following two articles recently published in NEJM:

To help explain the approach to outbreak study analysis, we are joined once again by Dr. David Harrington, statistical consultant at NEJM and Professor Emeritus of Biostatistics at Harvard T.H. Chan School of Public Health.

0:00 – Introduction
1:54 – Defining primary and secondary outcomes
3:53 – Value of secondary outcomes in trials
4:50 – Principles of interpreting secondary outcomes
6:00 – Interpreting secondary outcomes that are variations of the primary outcome
8:30 – Hierarchical testing and prespecified testing
12:00 – Mortality as a secondary outcome
14:16 – Interpreting safety outcomes
17:12 – p values in secondary outcomes
20:21 – Outro

Resources and articles discussed in this episode:

1. Bonaca MP et al. Rivaroxaban in Peripheral Artery Disease after Revascularization 
2. Curbside Consults: Rivaroxaban for Reducing Vascular Event Risks after Limb Revascularization for Peripheral Artery Disease – The VOYAGER PAD Trial with Dr. Marc Bonaca
3. Cao B et al. A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19
4. Curbside Consults: Statistical Review on Power
5. Curbside Consults: Statistical Review on Composite Outcomes

The Curbside Consults series complements the foundational information in Rotation Prep by taking a deep dive into key clinical topics with expert clinicians and educators. These podcasts explore and critique the evidence behind clinical practice and break down statistical concepts for the busy clinical trainee.

David Harrington is Emeritus Professor of Biostatistics and Statistics at Harvard T.H. Chan School of Public Health
Ken Wu is a 2019-2020 NEJM Editorial Fellow and a paediatrician working in the National Health Service of the United Kingdom. He graduated from Imperial College School of Medicine and is training in general paediatrics in London.