Research reporting guidelines, such as SPIRIT (Standard Protocol Items for Randomized Trials) and CONSORT (Consolidated Standards of Reporting Trials) guidelines offers a standard way for authors to prepare protocols and reports for randomized controlled trials. These guidelines facilitate complete and transparent reporting, which in turn aids their critical appraisal and interpretation. Over the years, SPIRIT and CONSORT have led to improved reporting and better implementation of trials; however, specific elements for trials with children (from newborns, infants, children, to adolescents, detailing the intervention, drug dose and delivery, validity of the outcomes studied, etc.) are not included. Growing evidence suggests the need for additional and modified items specific to child health that factor in these unique considerations to improve reporting in child health randomized controlled trials and reduce research waste.

In collaboration with members of the SPIRIT and CONSORT Group, we extended the current SPIRIT and CONSORT statements and developed a checklist of essential reporting items that authors should include when writing paediatric (aged 0-19 years) randomized controlled trial protocols and reports. These new guidelines are called SPIRIT-Children and Adolescents (SPIRIT-C) 2026 and CONSORT-Children and Adolescents (CONSORT-C) 2026. SPIRIT | CONSORT-C 2026 comprise reporting items that cover various key elements associated with paediatric trials that differ from adult trials. 

Developed with an international group of experts, young people (aged 10-24 years), and family caregivers, the SPIRIT-C 2026 guideline comprises 17 reporting items, and CONSORT-C 2026 includes 13 reporting items. The SPIRIT-C 2026 and CONSORT-C 2026 guidelines have been published in The BMJ, The Lancet Child and Adolescent Health, and JAMA Pediatrics. Explanation and Elaboration (E&E) papers for both guidelines have been published in The BMJ. Links to all publications are available below.

The Statement papers have been co-published in The BMJ, JAMA Pediatrics, and The Lancet Child and Adolescent Health:

The Explanation and Elaboration (E&E) papers are published in The BMJ:

Downloadable, fillable checklists:

  • SPIRIT-C 2026 (PDF)
  • CONSORT-C 2026 (PDF)

Involvement of young people and family caregivers: Baba A, Smith M, Preston J, Escalera BN, Gaillard S, Dicks P, Prebeg M, Doherty-Kirby A, Courtney K, Mendonza L, Nagy TC, Hooft L, Offringa M. Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study. Res Involv Engagem. 2025 Jul 1;11(1):71. doi: 10.1186/s40900-025-00751-x. PMID: 40598557; PMCID: PMC12211127.

Feature: Paediatric clinical trial guidelines co-designed by those who take part

Systematic review: Clyburne-Sherin AV, Thurairajah P, Kapadia MZ, Sampson M, Chan WW, Offringa M. Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. Trials. 2015 Sep 18;16:417. doi: 10.1186/s13063-015-0954-0. PMID: 26385379; PMCID: PMC4574457.

Viewpoint: Baba A, Offringa M. Transparent Reporting-SPIRIT-C/CONSORT-C Pediatric Updates. JAMA Pediatr. 2023 Dec 26. doi: 10.1001/jamapediatrics.2023.5740. Epub ahead of print. PMID: 38147343.

Protocol: Baba A, Smith M, Potter BK, Chan AW, Moher D, Offringa M. Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children. Trials. 2024 Jan 30;25(1):96. doi: 10.1186/s13063-024-07948-7. PMID: 38287439.

Editorials and commentary about SPIRIT-C and CONSORT-C:

Sethi NJ, Nygaard U, Schmiegelow K, Gluud C. Making trials in children and adolescents count: why CONSORT-C matters. BMJ. 2026 Feb 24;392:s311. doi: 10.1136/bmj.s311. PMID: 41734973.

Rollins N, Becquet R. The importance of SPIRIT-C and CONSORT-C for child health and equity. 2026 Feb 24. doi: 10.1016/ S2352-4642(26)00044-1. 

The Lancet Child and Adolescent Health. CONSORT-C: a shared responsibility for truth and quality. 2026 Feb 24. doi: 10.1016/ S2352-4642(26)00041-6.

Christakis DA. Editor’s Note on CONSORT-C and SPIRIT-C Guidelines. JAMA Pediatr. 2026 Feb 24. doi: 10.1001/jamapediatrics.2026.0150. Epub ahead of print. PMID: 41734889.

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Podcast episode on the Lancet Voice

JAMA Pediatrics Patient Page: What Young People and Parents Need to Know When Reading Clinical Trial Reports 

Informational video coming soon!

SPIRIT-Children and Adolescents (SPIRIT-C) 2026:

  1. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials. BMJ. 2026;392:e085061. https://doi.org/10.1136/bmj-2025-085061.
  2. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials. The Lancet Child and Adolescent Health. 2026. https://doi.org/10.1016/S2352-4642(26)00004-0. 
  3. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials. JAMA Pediatrics. 2026. https://doi.org/10.1001/jamapediatrics.2026.0104. 
CONSORT-Children and Adolescents (CONSORT-C) 2026: 
  1. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols. BMJ. 2026;392:e085062. https://doi.org/10.1136/bmj-2025-085062.
  2. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols. The Lancet Child and Adolescent Health. 2026. https://doi.org/10.1016/S2352-4642(26)00005-2. 
  3. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols. JAMA Pediatrics. 2026. https://doi.org/10.1001/jamapediatrics.2026.0113. 
E&E papers:
  1. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. CONSORT-C 2026 Explanation and Elaboration: Recommendations for enhancing the reporting and impact of paediatric randomised trials. BMJ. 2026;392:e085063. https://doi.org/10.1136/bmj-2025-085063.
  2. Baba A, Smith M, Potter BK, Chan A-W, Moher D, Toulany A, Doherty-Kirby A, Escalera BN, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy PL, Feneberg R, Poluru R, Morris S, Friedrichsdorf S, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. SPIRIT-C 2026 Explanation and Elaboration: Recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols. BMJ. 2026;392:e085064. https://doi.org/10.1136/bmj-2025-085064. 

This project was supported by the Canadian Institutes of Health Research (CIHR), the CIHR Strategy for Patient-Oriented Research (SPOR), and the Ontario Child Health Support Unit.

Logo designed by Matthew Prebeg

Updated February 2026