[HTML][HTML] The need for increased pragmatism in cardiovascular clinical trials

MS Usman, HGC Van Spall, SJ Greene… - Nature Reviews …, 2022 - nature.com
The majority of cardiovascular randomized controlled trials (RCTs) test interventions in
selected patient populations under explicitly protocol-defined settings. Although these …

Trends in the explanatory or pragmatic nature of cardiovascular clinical trials over 2 decades

N Sepehrvand, W Alemayehu, D Das, AK Gupta… - JAMA …, 2019 - jamanetwork.com
Importance Pragmatic trials test interventions using designs that produce results that may be
more applicable to the population in which the intervention will be eventually applied …

Good clinical practice guidance and pragmatic clinical trials: balancing the best of both worlds

RJ Mentz, AF Hernandez, LG Berdan, T Rorick… - Circulation, 2016 - Am Heart Assoc
Randomized, clinical trials are commonly regarded as the highest level of evidence to
support clinical decisions. Good Clinical Practice guidelines have been constructed to …

[HTML][HTML] Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?

R Dal-Ré, P Janiaud, JPA Ioannidis - BMC medicine, 2018 - Springer
Introduction Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and
they are critical to inform decision-making by patients, clinicians and policy-makers in real …

[HTML][HTML] Series: Pragmatic trials and real world evidence: Paper 1. Introduction

MGP Zuidgeest, I Goetz, RHH Groenwold… - Journal of clinical …, 2017 - Elsevier
This is the introductory paper in a series of eight papers. In this series, we integrate the
theoretical design options with the practice of conducting pragmatic trials. For most new …

[HTML][HTML] Pragmatic randomized clinical trials: best practices and statistical guidance

V Gamerman, T Cai, A Elsäßer - Health Services and Outcomes Research …, 2019 - Springer
Randomized clinical trials often serve the purpose of assessing the efficacy and safety of a
compound. By combining real-world evidence and randomization, pragmatic randomized …

Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week

AC Fanaroff, RM Califf, RA Harrington… - Journal of the American …, 2020 - jacc.org
Concerns about the external validity of traditional randomized clinical trials (RCTs), together
with the widespread availability of real-world data and advanced data analytic tools, have …

[HTML][HTML] Against pragmatism: on efficacy, effectiveness and the real world

DM Kent, G Kitsios - Trials, 2009 - Springer
Explanatory and pragmatic trials represent ends of a continuum of attitudes about clinical
trial design. Recent literature argues that pragmatic trials are more informative about clinical …

Pros and cons of pragmatic clinical trials

JD Lurie, TS Morgan - Journal of comparative effectiveness …, 2013 - becarispublishing.com
Traditional randomized controlled trials are the 'gold standard'for evaluating health
interventions and are typically designed to maximize internal validity, often at the cost of …

A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing

SG Nicholls, K Carroll, SP Hey, M Zwarenstein… - Journal of clinical …, 2021 - Elsevier
Objective We established a large database of trials to serve as a resource for future
methodological and ethical analyses. Here, we use meta-data to describe the broad …