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April 2025

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Comprehensive reporting of clinical trial design, conduct and analyses is crucial for the accurate interpretation of trial results. In this issue, the CONSORT 2025 statement and SPIRIT 2025 statement provide updated guidance on reporting randomised clinical trials and protocols to improve reporting quality and facilitate more transparent communication of clinical trial data and design. This accompanying Editorial, written on behalf of the PLOS Medicine editors, delves into the power that improving clinical trial reporting can ultimately confer to trial design and reproducibility.

Image Credit: Laura James

Editorials

Predatory journals: What can we do to protect their prey?

Christine Laine, Dianne Babski, Vivienne C. Bachelet, Till W. Bärnighausen, Christopher Baethge, Kirsten Bibbins-Domingo, Frank Frizelle, Laragh Gollogly, Sabine Kleinert, Elizabeth Loder, João Monteiro, Eric J. Rubin, Peush Sahni, Christina C. Wee, Jin-Hong Yoo, Lilia Zakhama

Guidelines and Guidance

CONSORT 2025 statement: Updated guideline for reporting randomised trials

Sally Hopewell, An-Wen Chan, Gary S. Collins, Asbjørn Hróbjartsson, David Moher, Kenneth F. Schulz, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A. Berlin, Nita Bhandari, Nancy J. Butcher, Marion K. Campbell, Runcie C. W. Chidebe, Diana Elbourne, Andrew Farmer, Dean A. Fergusson, Robert M. Golub, Steven N. Goodman, Tammy C. Hoffmann, John P. A. Ioannidis, Brennan C. Kahan, Rachel L. Knowles, Sarah E. Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P. Richards, Frank W. Rockhold, David L. Schriger, Nandi L. Siegried, Sophie Staniszewska, Rod S. Taylor, Lehana Thabane, David Torgerson, Sunita Vohra, Ian R. White, Isabelle Boutron

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SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

An-Wen Chan, Isabelle Boutron, Sally Hopewell, David Moher, Kenneth F. Schulz, Gary S. Collins, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A. Berlin, Nita Bhandari, Nancy J. Butcher, Marion K. Campbell, Runcie C. W. Chidebe, Diana R. Elbourne, Andrew J. Farmer, Dean A. Fergusson, Robert M. Golub, Steven N. Goodman, Tammy C. Hoffmann, John P. A. Ioannidis, Brennan C. Kahan, Rachel L. Knowles, Sarah E. Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P. Richards, Frank W. Rockhold, David L. Schriger, Nandi L. Siegfried, Sophie Staniszewska, Rod S. Taylor, Lehana Thabane, David J. Torgerson, Sunita Vohra, Ian R. White, Asbjørn Hróbjartsson

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Research Articles

Frailty in randomized controlled trials of glucose-lowering therapies for type 2 diabetes: An individual participant data meta-analysis of frailty prevalence, treatment efficacy, and adverse events

Heather Wightman, Elaine Butterly, Lili Wei, Ryan McChrystal, Naveed Sattar, Amanda Adler, David Phillippo, Sofia Dias, Nicky Welton, Andrew Clegg, Miles Witham, Kenneth Rockwood, David A. McAllister, Peter Hanlon

Food additive mixtures and type 2 diabetes incidence: Results from the NutriNet-Santé prospective cohort

Marie Payen de la Garanderie, Anaïs Hasenbohler, Nicolas Dechamp, Guillaume Javaux, Fabien Szabo de Edelenyi, Cédric Agaësse, Alexandre De Sa, Laurent Bourhis, Raphaël Porcher, Fabrice Pierre, Xavier Coumoul, Emmanuelle Kesse-Guyot, Benjamin Allès, Léopold K. Fezeu, Emmanuel Cosson, Sopio Tatulashvili, Inge Huybrechts, Serge Hercberg, Mélanie Deschasaux-Tanguy, Benoit Chassaing, Héloïse Rytter, Bernard Srour, Mathilde Touvier

Maternal dietary patterns, breastfeeding duration, and their association with child cognitive function and head circumference growth: A prospective mother–child cohort study

David Horner, Jens Richardt Møllegaard Jepsen, Bo Chawes, Rebecca Vinding, Julie B. Rosenberg, Parisa Mohammadzadeh, Yang Luo, Birgitte Fagerlund, Trine Flensborg-Madsen, Thomas Ragnar Wood, Janine F. Felix, Louise Monnerup, Birte Y. Glenthøj, Klaus Bønnelykke, Bjørn H. Ebdrup, Jakob Stokholm, Morten Arendt Rasmussen

Genome-wide nucleosome footprints of plasma cfDNA predict preterm birth: A case-control study

Zhiwei Guo, Ke Wang, Xiang Huang, Kun Li, Guojun Ouyang, Xu Yang, Jiayu Tan, Haihong Shi, Liangping Luo, Min Zhang, Bowei Han, Xiangming Zhai, Jinhai Deng, Richard Beatson, Yingsong Wu, Fang Yang, Xuexi Yang, Jia Tang

Recurrence prediction using circulating tumor DNA in patients with early-stage non-small cell lung cancer after treatment with curative intent: A retrospective validation study

Milou M. F. Schuurbiers, Christopher G. Smith, Koen J. Hartemink, Robert C. Rintoul, Davina Gale, Kim Monkhorst, Bas L. R. Mandos, Anna L. Paterson, Daan van den Broek, Nitzan Rosenfeld, Michel M. van den Heuvel, On Behalf of the LEMA Study Group and the LUCID Study Group

First-trimester exposure to macrolides and risk of major congenital malformations compared with amoxicillin: A French nationwide cohort study

Anh Tran, Mahmoud Zureik, Jeanne Sibiude, Sara Miranda, Jérôme Drouin, Lise Marty, Alain Weill, Rosemary Dray-Spira, Xavier Duval, Sarah Tubiana

Endovascular thrombectomy in acute stroke with a large ischemic core: A systematic review and meta-analysis of randomized controlled trials

Chun-Hsien Lin, Meng Lee, Bruce Ovbiagele, David S. Liebeskind, Borja Sanz-Cuesta, Jeffrey L. Saver

Progressing towards the 2030 health-related SDGs in ASEAN: A systematic analysis

Yafei Si, Lei Guo, Shu Chen, Xinyu Zhang, Xiaochen Dai, Daniel Wang, Yunguo Liu, Bach Xuan Tran, Paul Michael Pronyk, Shenglan Tang

A deep-learning algorithm using real-time collected intraoperative vital sign signals for predicting acute kidney injury after major non-cardiac surgeries: A modelling study

Sehoon Park, Soomin Chung, Yisak Kim, Sun-Ah Yang, Soie Kwon, Jeong Min Cho, Min Jae Lee, Eunbyeol Cho, Jiwon Ryu, Sejoong Kim, Jeonghwan Lee, Hyung Jin Yoon, Edward Choi, Kwangsoo Kim, Hajeong Lee

Corrections

Correction: Comparing cervical cerclage, pessary and vaginal progesterone for prevention of preterm birth in women with a short cervix (SuPPoRT): A multicentre randomised controlled trial

Natasha L. Hezelgrave, Natalie Suff, Paul Seed, Vicky Robinson, Jenny Carter, Helena Watson, Alexandra Ridout, Anna L. David, Susana Pereira, Fatemeh Hoveyda, Joanna Girling, Latha Vinayakarao, Rachel M. Tribe, Andrew H. Shennan, The SuPPoRT Collaborating Team

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