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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:

  3. In recent years, the prevalence of infertility has significantly increased and has become a global reproductive health problem. The female ovarian reserves have been shown to decrease progressively with an inc...

    Authors: Yingjie Ma, Xianling Cao, Jingyan Song, Dandan Gao, Xinlei Wang, Li Li and Zhengao Sun
    Citation: Trials 2021 22:917
    Content type: Study protocol Published on:

  4. Coronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interv...

    Authors: Xiaofen Ruan, Yiping Li, Yuanlong Sun, Meijun Jia, Xiaowen Xu, Li Huo, Wei Song, Yili Yao and Xiaolong Wang
    Citation: Trials 2021 22:466
    Content type: Study protocol Published on:

  5. Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access...

    Authors: Karin Gallandat, Aurélie Jeandron, Ian Ross, Jaime Mufitini Saidi, Baron Bashige Rumedeka, Vercus Lumami Kapepula, Simon Cousens, Elizabeth Allen, Amy MacDougall and Oliver Cumming
    Citation: Trials 2021 22:408
    Content type: Study protocol Published on:

  6. Borderline personality disorder (BPD) is a high prevalence and serious mental health disorder that has historically challenged the finite resources of health services. Despite empirical evidence supporting str...

    Authors: Judy A. Pickard, Adam Finch, Elizabeth Huxley, Michelle L. Townsend, Stephanie Deuchar, Kate L. Lewis, Jason Pratt and Brin F. S. Grenyer
    Citation: Trials 2021 22:383
    Content type: Study protocol Published on:

  7. Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to...

    Authors: Xin Xue, Xue-Ming Jin, Kai-Liang Luo, Xin-Hao Liu, Li Zhang and Jun Hu
    Citation: Trials 2021 22:265
    Content type: Study protocol Published on:

  8. Sjogren’s syndrome (SS) is a chronic autoimmune rheumatic disease with an incidence of 0.03 to 0.3%. In recent years, there are an increasing number of randomized controlled trials of traditional Chinese medic...

    Authors: Ming Liu, Ya Gao, Yuan Yuan, Shuzhen Shi, Kelu Yang, Jiyuan Shi, Jiarui Wu, Junhua Zhang and Jinhui Tian
    Citation: Trials 2021 22:233
    Content type: Study protocol Published on:

  11. 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:

  12. 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:

  13. Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could...

    Authors: Fangyuan Li, Hua Lu, Xinxin Wang, Qi Zhang, Qianchen Liu and Tong Wang
    Citation: Trials 2021 22:73
    Content type: Study protocol Published on:

  14. 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:

  15. 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:

  16. 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:

  17. Exercise has been shown to significantly improve pain and function in individuals with fibromyalgia. Research into the effectiveness of exercise is often based on standardised exercise programmes that are chos...

    Authors: T. Rulleau, L. Planche, F. Etcheverrigaray, A. Dorion, N. Kacki, M. Miot, A. Liaigre, Y. Ganem, A. Schmidt, F. Taddéi, S. Acapo, J. Nizard and Y. M. Pluchon
    Citation: Trials 2020 21:800
    Content type: Study protocol Published on:

  18. 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:

  19. Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease characterized by excessive fat accumulation in the liver. One of the underlying pathophysiological mechanisms is insulin resistance (...

    Authors: Jingjuan Xu, Ruirui Wang, Shengfu You, Lei Zhang, Peiyong Zheng, Guang Ji and Baocheng Liu
    Citation: Trials 2020 21:512
    Content type: Study protocol Published on:

  20. 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:

  21. We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents...

    Authors: Anneli Olsson, Camilla Ring, Johan Josefsson, Annika Eriksson, Rebecca Rylance, Ole Fröbert, Stefan James, David Sparv and David Erlinge
    Citation: Trials 2020 21:246
    Content type: Research Published on:

  22. Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known ...

    Authors: Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr., Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel and Jeanette A. Waxmonsky
    Citation: Trials 2020 21:65
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2020 21:195

  23. 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:

  24. 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:

  25. 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:

  26. 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: