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The future of pragmatic trials

Edited by: Prof Marion Campbell and Prof Sandra Eldridge

A thematic series published in Trials.

This series includes articles reporting on current understandings of the role and definition of the pragmatic design (including comparative effectiveness research and real world trials), its use and applicability to modern-day healthcare challenges, its relevance to and use with novel trial designs (e.g. cohort multiple, stepped wedge, cluster randomized, registry trials), and considerations of ethical issues (e.g. streamlined research ethics review, patient engagement, different types of consent).

The deadline for submissions to this thematic series was 31 December 2020. Further articles will be added in due course following peer review.

  1. Prehabilitation has been shown to have a positive effect on the postoperative recovery of functional capacity in patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy. The optimal way to im...

    Authors: Yuchao Liu, Zijia Liu, Yuelun Zhang, Yushang Cui, Lijian Pei and Yuguang Huang
    Citation: Trials 2023 24:194
    Content type: Study protocol Published on:

  2. The purpose of this study is to verify the improvement of remote qigong intervention on the quality of life and physical fitness of breast cancer patients after surgery by means of a randomized controlled tria...

    Authors: Chengxiang Li, Xiaosheng Dong, Lina Yu, Kai Yuan, Xiangren Yi, Yuanlong Shen and Hu Niu
    Citation: Trials 2023 24:186
    Content type: Study protocol Published on:

  5. This manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching interv...

    Authors: Allyson L. Dir, Dennis P. Watson, Matthew Zhiss, Lisa Taylor, Bethany C. Bray and Alan McGuire
    Citation: Trials 2021 22:114
    Content type: Update Published on:

  6. New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional r...

    Authors: Guillaume Marquis-Gravel, Holly Robertson, W. Schuyler Jones, Danielle Riley, Daniel E. Ford, David Crenshaw, Yvonne A. Joosten, Lindsey Rudov, Adrian F. Hernandez and Rachel Hess
    Citation: Trials 2021 22:90
    Content type: Commentary Published on:

  7. In a five-arm randomized clinical trial (RCT) with stratified randomization across 54 sites, we encountered low primary outcome event proportions, resulting in multiple sites with zero events either overall or...

    Authors: Jiyu Kim, Andrea B. Troxel, Scott D. Halpern, Kevin G. Volpp, Brennan C. Kahan, Tim P. Morris and Michael O. Harhay
    Citation: Trials 2020 21:917
    Content type: Methodology Published on:

  8. Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. Howe...

    Authors: Caroline French, Hilary Pinnock, Gordon Forbes, Imogen Skene and Stephanie J. C. Taylor
    Citation: Trials 2020 21:916
    Content type: Review Published on:

  9. Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experie...

    Authors: Susan N. Hastings, Karen M. Stechuchak, Ashley Choate, Elizabeth P. Mahanna, Courtney Van Houtven, Kelli D. Allen, Virginia Wang, Nina Sperber, Leah Zullig, Hayden B. Bosworth and Cynthia J. Coffman
    Citation: Trials 2020 21:863
    Content type: Methodology Published on:

  10. Traditional randomised controlled trials remain the gold standard for improving clinical care but they do have their limitations, including their associated high costs, high failure rate and limited external v...

    Authors: Bill Karanatsios, Khic-Houy Prang, Ebony Verbunt, Justin M. Yeung, Margaret Kelaher and Peter Gibbs
    Citation: Trials 2020 21:552
    Content type: Review Published on:

  11. Pragmatic trials provide the opportunity to study the effectiveness of health interventions to improve care in real-world settings. However, use of open-cohort designs with patients becoming eligible after ran...

    Authors: Jennifer F. Bobb, Hongxiang Qiu, Abigail G. Matthews, Jennifer McCormack and Katharine A. Bradley
    Citation: Trials 2020 21:289
    Content type: Research Published on:

  12. Building capacity in research funding organizations to support the conduct of pragmatic clinical trials is an essential component of advancing biomedical and public health research. To date, efforts to increas...

    Authors: Wynne E. Norton, Merrick Zwarenstein, Susan Czajkowski, Elisabeth Kato, Ann O’Mara, Nonniekaye Shelburne, David A. Chambers and Kirsty Loudon
    Citation: Trials 2019 20:779
    Content type: Commentary Published on:

  13. There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled ...

    Authors: Stuart G. Nicholls, Kelly Carroll, Merrick Zwarenstein, Jamie C. Brehaut, Charles Weijer, Spencer P. Hey, Cory E. Goldstein, Ian D. Graham, Jeremy M. Grimshaw, Joanne E. McKenzie, Dean A. Fergusson and Monica Taljaard
    Citation: Trials 2019 20:765
    Content type: Research Published on:

  14. Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a trial design tool which conside...

    Authors: Gordon Forbes, Kirsty Loudon, Megan Clinch, Stephanie J. C. Taylor, Shaun Treweek and Sandra Eldridge
    Citation: Trials 2019 20:711
    Content type: Research Published on:

  15. The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 cont...

    Authors: Jennifer A. Palmer, Victoria A. Parker, Lacey R. Barre, Vincent Mor, Angelo E. Volandes, Emmanuelle Belanger, Lacey Loomer, Ellen McCreedy and Susan L. Mitchell
    Citation: Trials 2019 20:656
    Content type: Research Published on: