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Call for papers: Big data for randomized trials

Edited by: Dr Lars Hemkens

Trials invites you to submit to our new thematic series, ‘Big data for randomized trials’.

The Editors will consider articles that report on what is currently known about using big data or routinely collected data (such as electronic health records, registries or administrative databases) for randomized trials, the promises and limitations of using such data sources for trials and how we could make best use of them to improve clinical trial research for better patient care. 

We encourage articles on any topic relevant to big data for conducting randomized trials on any level of health care. This includes articles describing the current knowledge about how using this data may make trials more feasible or would allow exploring research questions otherwise not possible to be explored , or which novel designs would be possible. Topics related to ethical implications, costs, or methodological aspects are very welcome. We are highly interested in empirical research on research studies. Commentaries and opinion pieces are welcome, especially those looking explicitly to practical challenges and offering solutions. All articles should make clear the relevance of using big data for randomized trials and current research gaps, and they should describe how the results or opinions in the article can be used to improve trial design and conduct in the future.

Manuscripts should be formatted according to our submission guidelines and submitted via the online submission system. In the submission system please make sure the correct collection title is chosen from the additional information tab. Please also indicate clearly in the covering letter that the manuscript is to be considered in the ‘Big data for randomized trials’ series.

For further information, please use the contact us email on the journal website.

  1. The advantages of laparoscopic left-sided hepatectomy (LLH) for treating hepatolithiasis in terms of the time to postoperative length of hospital stay (LOS), morbidity, long-term abdominal wall hernias, hospit...

    Authors: Shu-bo Pan, Chun-li Wu, Da-chen Zhou, Qi-ru Xiong, Xiao-ping Geng and Hui Hou
    Citation: Trials 2024 25:137
  2. As part of the German Medical Informatics Initiative, the MIRACUM project establishes data integration centers across ten German university hospitals. The embedded MIRACUM Use Case “Alerting in Care - IT Suppo...

    Authors: Martin Boeker, Daniela Zöller, Romina Blasini, Philipp Macho, Sven Helfer, Max Behrens, Hans-Ulrich Prokosch and Christian Gulden
    Citation: Trials 2024 25:125
  3. Our previous randomized controlled trial (RCT) have demonstrated that intermittent Pringle’s maneuver (IPM) with a 25-min ischemic interval can be applied safely and efficiently in open or laparoscopic hepatec...

    Authors: Yang Huang, Liangliang Xu, Ning Wang, Xingyu Pu, Wentao Wang, Tianfu Wen, Mingqing Xu and Li Jiang
    Citation: Trials 2023 24:774
  4. Recent studies have demonstrated a correlation between intestinal flora and the severity of myocardial infarction as well as post-myocardial infarction repair. However, few studies have investigated whether pr...

    Authors: Yequn Chen, Rongbing Chen, Xin Wang, Yan Zhou, Liekai Hong, Nianling Xiong, Jinxiu Zhu, Shu Ye and Xuerui Tan
    Citation: Trials 2023 24:429
  5. Treatment of pediatric cataract remains challenging because of the extremely high incidence of postoperative adverse events (AEs), especially the AEs related to the locations of secondary implanted intraocular...

    Authors: Yingshi Zou, Ling Jin, Bo Qu, Hui Chen, Mingbing Zeng, Xia Li, Xinhua Liu, Lixia Luo, Zhenzhen Liu and Yizhi Liu
    Citation: Trials 2023 24:388
  6. The incidence of colorectal cancer among the middle-aged and elderly is gradually increasing in China. Colonoscopy is an effective method for the early diagnosis of colorectal cancer, and bowel preparation is ...

    Authors: Xing Wang Zhu, Jun Yan, Long Miao, Ying Li He, Hai Ping Wang and Xun Li
    Citation: Trials 2023 24:168
  7. Acquired immune deficiency syndrome is caused by humans and is high worldwide. Active antiretroviral therapy emerged in the late 1990s and is effective against AIDS. However, despite the extensive research on ...

    Authors: Xue Ding, Pengfei Meng, Xiuxia Ma, Weifeng Cui, Liangping Li, Xiyuan Song, Jiangrong Wang, Chengjie Ma, Xin Chen and Liran Xu
    Citation: Trials 2022 23:665
  8. The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript ...

    Authors: Sophie Relph, Maria Elstad, Bolaji Coker, Matias C. Vieira, Natalie Moitt, Walter Muruet Gutierrez, Asma Khalil, Jane Sandall, Andrew Copas, Deborah A. Lawlor and Dharmintra Pasupathy
    Citation: Trials 2021 22:195
  9. It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The r...

    Authors: Susanna Dodd, Nicola Harman, Nichole Taske, Mark Minchin, Toni Tan and Paula R. Williamson
    Citation: Trials 2020 21:570
  10. Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) acces...

    Authors: Sarah Lensen, Archie Macnair, Sharon B. Love, Victoria Yorke-Edwards, Nurulamin M. Noor, Meredith Martyn, Alexandra Blenkinsop, Carlos Diaz-Montana, Graham Powell, Elizabeth Williamson, James Carpenter and Matthew R. Sydes
    Citation: Trials 2020 21:398
  11. We aimed to test whether a common set of key data items reported across high-impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonata...

    Authors: Sena Jawad, Neena Modi, A. Toby Prevost and Chris Gale
    Citation: Trials 2019 20:731
  12. The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be us...

    Authors: Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami and Toshi A. Furukawa
    Citation: Trials 2019 20:706