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 …

Characteristics of randomized clinical trials in surgery from 2008 to 2020: a systematic review

NB Robinson, S Fremes, I Hameed… - JAMA network …, 2021 - jamanetwork.com
Importance Randomized clinical trials (RCTs) provide the highest level of evidence to
evaluate 2 or more surgical interventions. Surgical RCTs, however, face unique challenges …

Optimizing clinical nutrition research: the role of adaptive and pragmatic trials

CE Orsso, KL Ford, N Kiss, EB Trujillo… - European journal of …, 2023 - nature.com
Evidence-based nutritional recommendations address the health impact of suboptimal
nutritional status. Efficacy randomized controlled trials (RCTs) have traditionally been the …

Pragmatic trials of pain therapies: a systematic review of methods

D Hohenschurz-Schmidt, BA Kleykamp, J Draper-Rodi… - Pain, 2022 - journals.lww.com
Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision
making. Here, we systematically review methods and design of pragmatic trials of pain …

Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

DJ Hohenschurz-Schmidt, D Cherkin, ASC Rice… - Pain, 2023 - journals.lww.com
Many questions regarding the clinical management of people experiencing pain and related
health policy decision-making may best be answered by pragmatic controlled trials. To …

Participation in a heart failure clinical trial: perspectives and opportunities from the VICTORIA trial and VICTORIA simultaneous registry

J Ezekowitz, RJ Mentz, CM Westerhout… - Circulation: Heart …, 2021 - Am Heart Assoc
Background: Randomized controlled trials (RCTs) often target enrollment of patients with
demographics and outcomes less representative of the broader population of interest. To …

Pragmatic comparative effectiveness trials and learning health systems in pain medicine: Opportunities and challenges

V Salmasi, AS Terkawi… - Anesthesiology …, 2023 - anesthesiology.theclinics.com
Despite increased available pain therapies, more than 50 to 100 million people in the United
States still live with pain and 20 million live with high-impact chronic pain that frequently …

Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool

WE Norton, K Loudon, DA Chambers… - Implementation …, 2021 - Springer
Abstract Background First articulated by Schwartz and Lellouch (1967), randomized
controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to …

Analysis of the characteristics and the degree of pragmatism exhibited by pragmatic-labelled trials of antineoplastic treatments

R Saesen, K Depreytere, K Krupianskaya… - BMC Medical Research …, 2023 - Springer
Abstract Background Pragmatic clinical trials (PCTs) are designed to reflect how an
investigational treatment would be applied in clinical practice. As such, unlike their …

Improving cardiovascular drug and device development and evidence through patient-centered research and clinical trials: a call to action from the value in healthcare …

JJ Warner, HL Crook, KM Whelan… - … Quality and Outcomes, 2020 - Am Heart Assoc
The pipeline of new cardiovascular drugs is relatively limited compared with many other
clinical areas. Challenges causing lagging drug innovation include the duration and …