Related Projects

PRECIS-2 – Pragmatic Explanatory Continuum Indicator Summary, developped to help trialist and researches to design and assess trials on the pragmatic-explanatory continuum. The score comprises 9 domains addressing the main features of a RCT that might impact the pragmatic-explanatory continuum.

NIH Collaboratory – Rethinking Clinical Trials, aims to promote effective large-scale research studies with a particular focus on pragmatic trials.

GetReal Initiative offers a tool to guide researchers in the evaluation of the options and implications of introducing real world elements in clinical trial design.

TrialForge aims to make trials more efficient and supports pragmatic trials.

CONSORT extension for pragmatic trials – developed upon the existing CONSORT checklist (Consolidated Standards of Reporting Trials), it gives specific guidance regarding the reporting of pragmatic trials.

Related Publications

Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20(8):637–48

Schwartz D, Lellouch J. doi: 10.1016/0021-9681(67)90041-0

The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.

Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. doi: 10.1136/bmj.h2147

The reporting of studies using routinely collected health data was often insufficient. J Clin Epidemiol. 2016;79:104–11.

Hemkens LG, Benchimol EI, Langan SM, Briel M, Kasenda B, Januel JM, et al. doi: 10.1016/j.jclinepi.2016.06.005

Routinely collected data and comparative effectiveness evidence: promises and limitations. CMAJ. 2016;188(8):E158–64.

Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JP. doi: 10.1503/cmaj.150653

Current use of routinely collected health data to complement randomized controlled trials: a meta-epidemiological survey. CMAJ Open. 2016;4(2):E132-40.

Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JPA. doi: 10.9778/cmajo.20150036

‘Pragmatic’ and ‘Explanatory’ attitudes to randomized trials.The James Lind Library. 2016

Zwarenstein M. doi: Link

Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 2018;16(1):49.

Dal-Re R, Janiaud P, Ioannidis JPA. doi: 10.1186/s12916-018-1038-2

Assessment of Pragmatism in Recently Published Randomized Clinical Trials. JAMA Intern Med. 2018;178(9):1278–80.

Janiaud P, Dal-Re R, Ioannidis JPA. doi: 10.1001/jamainternmed.2018.3321

How Routinely Collected Data for Randomized Trials Provide Long-term Randomized Real-World Evidence. JAMA Netw Open. 2018;1(8):e186014.

Hemkens LG. doi: 10.1001/jamanetworkopen.2018.6014

Commentary on Bertagnolli et al: Clinical trial designs with routinely collected real-world data—issues of data quality and beyond. Clin Trials. 2020 Jun 1;17(3):247–50.

Hemkens LG. doi: 10.1177/1740774520913845

Routinely collected data for randomized trials: promises, barriers, and implications. Trials. 2018;19(1):29.

Mc Cord KA, Al-Shahi Salman R, Treweek S, Gardner H, Strech D, Whiteley W, et al. doi: 10.1186/s13063-017-2394-5

Using electronic health records for clinical trials: Where do we stand and where can we go? CMAJ. 2019;191(5):E128–33.

Mc Cord KA, Hemkens LG. doi: 10.1503/cmaj.180841

Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study. BMJ. 2021;372:n450.

Mc Cord KA et al. doi: 10.1136/bmj.n450