Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research - Summary - MDSpire

Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research

  • By

  • Ami Baba

  • Maureen Smith

  • Beth K. Potter

  • An-Wen Chan

  • David Moher

  • Alene Toulany

  • Amanda Doherty-Kirby

  • Begonya Nafria Escalera

  • Catherine Stratton

  • Chris Gale

  • Colin Macarthur

  • Diane Purper-Ouakil

  • Edmund Juszczak

  • Eyal Cohen

  • Giorgio Reggiardo

  • Jennifer Preston

  • Jérémie F. Cohen

  • Julia Upton

  • Karel Allegaert

  • Katelynn Boerner

  • Kayur Mehta

  • Kim An Nguyen

  • Kimberly Courtney

  • Lisa Hartling

  • Menelaos Konstantinidis

  • Michal Odermarsky

  • Nancy J. Butcher

  • Niina Kolehmainen

  • Patricia E. Longmuir

  • Peter J. Gill

  • Piet Leroy

  • Reinhard Feneberg

  • Ramesh Poluru

  • Shaun K. Morris

  • Stefan J. Friedrichsdorf

  • Tanya Chute Nagy

  • Terry P. Klassen

  • Thierry Lacaze-Masmonteil

  • Wes Onland

  • Martin Offringa

  • April 1, 2026

  • 0 min

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Objective:

To develop a CONSORT extension specific to pediatric RCTs to improve reporting standards and address the critical underrepresentation of children in clinical trials, which affects the quality of evidence for pediatric care.

Key Findings:
  • Children are often underrepresented in RCTs, leading to a lack of quality evidence for pediatric care, exemplified by inadequate reporting on consent processes and treatment effects.
  • Many pediatric RCTs are not completed or published, and those that are often have suboptimal reporting, particularly in critical areas such as randomization and blinding.
  • The CONSORT-C extension provides a checklist of essential reporting items tailored for pediatric populations, addressing common reporting deficiencies.
Interpretation:

The development of CONSORT-C 2026 aims to enhance the quality of reporting in pediatric RCTs, ultimately improving the evidence base for interventions in children and adolescents.

Limitations:
  • The heterogeneity in defining pediatric populations may affect the applicability of the guidelines, necessitating further research to standardize definitions.
  • Challenges in ensuring adherence to reporting standards across diverse research settings may be mitigated through targeted training and resources for researchers.
Conclusion:

The CONSORT-C 2026 extension is a crucial step towards improving the quality of pediatric RCT reporting, which is essential for informed healthcare decisions affecting children and adolescents.

Original Source(s)

Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research

  • by Ami Baba, Maureen Smith, Beth K. Potter, An-Wen Chan, David Moher, Alene Toulany, Amanda Doherty-Kirby, Begonya Nafria Escalera, Catherine Stratton, Chris Gale, Colin Macarthur, Diane Purper-Ouakil, Edmund Juszczak, Eyal Cohen, Giorgio Reggiardo, Jennifer Preston, Jérémie F. Cohen, Julia Upton, Karel Allegaert, Katelynn Boerner, Kayur Mehta, Kim An Nguyen, Kimberly Courtney, Lisa Hartling, Menelaos Konstantinidis, Michal Odermarsky, Nancy J. Butcher, Niina Kolehmainen, Patricia E. Longmuir, Peter J. Gill, Piet Leroy, Reinhard Feneberg, Ramesh Poluru, Shaun K. Morris, Stefan J. Friedrichsdorf, Tanya Chute Nagy, Terry P. Klassen, Thierry Lacaze-Masmonteil, Wes Onland, Martin Offringa

  • April 1, 2026

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