Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research - Report - 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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Clinical Report: CONSORT-C 2026 Extension Enhances Pediatric RCT Reporting

Overview

The CONSORT-C 2026 extension provides tailored reporting guidelines for randomized controlled trials (RCTs) involving newborns, infants, children, and adolescents aged 0-19 years. This initiative addresses the unique challenges and reporting deficiencies in pediatric RCTs to improve transparency, quality, and applicability of pediatric clinical research.

Background

Randomized controlled trials are essential for evidence-based healthcare decisions, yet pediatric RCTs remain underrepresented and often suffer from suboptimal reporting. Critical aspects such as consent processes, age-appropriate outcomes, and intervention details are frequently inadequately described, complicating appraisal and interpretation. The pediatric population is heterogeneous, with distinct biological and developmental considerations that necessitate specialized reporting standards. Existing CONSORT guidelines lacked pediatric-specific extensions, prompting the development of CONSORT-C 2026 to fill this gap.

Data Highlights

Key data points include the identification of common reporting deficiencies in pediatric RCTs such as incomplete consent and assent details, insufficient description of comparator interventions, and inadequate reporting of trial-associated pain and harms prevention. The development process involved multidisciplinary experts and incorporated input from young people and family caregivers to ensure relevance and comprehensiveness.

Key Findings

  • Pediatric RCTs are underrepresented and often incompletely reported compared to adult trials.
  • Critical reporting elements frequently missing include consent/assent processes, intervention details, randomization, blinding, and age-appropriate outcome measures.
  • The pediatric population’s heterogeneity requires specialized reporting considerations distinct from adult trials.
  • CONSORT-C 2026 provides a harmonized checklist tailored for pediatric RCTs aged 0-19 years, developed through international consensus and stakeholder involvement.
  • Young people and family caregivers were actively involved in the guideline development to enhance relevance and applicability.
  • The extension complements the SPIRIT-C 2026 protocol guideline, together aiming to improve pediatric trial design and reporting quality.

Clinical Implications

Clinicians and researchers should adopt the CONSORT-C 2026 extension to ensure comprehensive and transparent reporting of pediatric RCTs, facilitating critical appraisal and evidence synthesis. Improved reporting will support better-informed clinical decisions and policy-making tailored to the unique needs of children and adolescents. Engagement of patients and families in research reporting enhances relevance and trustworthiness of pediatric trial outcomes.

Conclusion

The CONSORT-C 2026 extension addresses a critical gap in pediatric clinical research by providing specific guidance to improve the quality and transparency of RCT reporting in children and adolescents. Its adoption promises to enhance the evidence base and ultimately improve pediatric healthcare outcomes.

References

  1. CONSORT-C 2026 Development Group -- Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research

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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