Paediatric randomised controlled trials (RCTs) are key to evaluating new and existing interventions that can improve health outcomes in newborns, infants, children, and adolescents (aged 0-19 years). Well reported RCT protocols facilitate the planning and implementation of trials that generate high quality, reproducible evidence, and strengthen the foundations of paediatric healthcare decisions and ultimately improve patient outcomes. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 statement contains a checklist of essential reporting items and an explanation and elaboration paper. However, SPIRIT 2025 does not consider important elements that are unique to paediatric RCT protocols. As a paediatric extension to SPIRIT, we developed the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 checklist, which this explanation and elaboration paper accompanies. We adopted a group writing approach to prepare this explanation and elaboration paper, and involved key partners with lived experience relevant to paediatric clinical trials, including family caregivers, trialists, child health researchers, clinicians, journal editors, and methodologists. This explanation and elaboration paper presents examples, explanations, and key elements for the 17 new SPIRIT-C 2026 reporting items; paediatric considerations with good reporting examples for six SPIRIT 2025 items; and a glossary. This paper also promotes the reporting of methodological rigor, patient safety, promotes a patient oriented approach, and facilitates the generation of high quality, reproducible trial evidence that will strengthen paediatric practice and policy decisions and ultimately improve patient outcomes.
Key information is often omitted from pediatric randomized controlled trial (RCT) protocols, including details on dose adjustments of interventions based on age, body surface area, or weight; developmental appropriateness of trial outcome measures and processes; or strategies to minimize participants’ anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonized, comprehensive reporting of pediatric RCT protocols involving participants aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, the Standard Protocol Items: Recommendations for Interventional Trials–Children and Adolescents (SPIRIT-C) 2026 consists of 17 new items recommended to be reported in addition to the SPIRIT 2025 items in pediatric RCT protocols. To develop a pediatric reporting guideline extension to the SPIRIT 2025 guideline, SPIRIT-C 2026, that supports comprehensive and transparent reporting of pediatric RCT protocols. The methodological framework for developing reporting guidelines published by the EQUATOR Network was implemented to develop a pediatric extension to the SPIRIT 2025 guidelines called SPIRIT-C 2026. A list of candidate reporting items was generated from the literature, and a Youth Advisory Group and a Family Caregiver Advisory Group contributed vital input throughout the project. An international Delphi study with a priori consensus thresholds, a consensus meeting, group writing of the explanation and elaboration paper, and pilot testing of the draft guideline were conducted. SPIRIT-C 2026 details key reporting items applicable to pediatric RCT protocols involving children and adolescents aged 0 to 19 years. All relevant items are aligned with those in Consolidated Standards of Reporting Trials–Children and Adolescents 2026, a new reporting guideline for completed pediatric RCTs. SPIRIT-C 2026 consists of a checklist with 17 new reporting items for reporting pediatric RCT protocols; 4 items are youth generated and 6 youth endorsed. These can be considered a minimum set of reporting items pertinent to pediatric RCT protocols that are relevant to various interest holders, including young people, family caregivers, researchers, pediatric trialists, ethics committees, regulators, funders, and journal editors. Widespread implementation and uptake of SPIRIT-C 2026 should enhance the quality and usefulness of protocols for RCTs that involve participants from birth through adolescence and ultimately foster high-quality pediatric trials. Inclusion of these SPIRIT-C 2026 items supports comprehensive, meaningful, relevant, and transparent reporting, which can improve both the quality and usefulness of pediatric RCT protocols. RCT protocols contain essential details needed to understand and evaluate the trial’s planned aims, design, data collection methods, monitoring, data analysis, and participants’ safety.
Appropriately designed, conducted, and reported randomised controlled trials (RCTs) in children and adolescents inform treatment and health-care decisions made by young people, families, researchers, clinicians, regulators, funders, policy makers, and other interest holders. To critically evaluate, interpret, and apply trial results, readers require access to a complete and transparent report of what was planned, done, and found, taking unique considerations specific to children and adolescents into account. Harmonised guidance based on evidence and consensus is needed to optimise standardised reporting and reduce research waste in paediatric RCTs. As an extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 statement, the CONSORT-Children and Adolescents (CONSORT-C) 2026 reporting guideline aims to improve the quality and completeness of reporting of paediatric RCTs that involve participants aged 0-19 years. The Enhancing the Quality of Transparency of Health Research (EQUATOR) Network's published framework primarily informed the development of CONSORT-C 2026. A literature review was conducted to generate a list of candidate reporting items. To obtain direct input from young people and family caregivers throughout the project, a Youth Advisory Group and a Family Caregiver Advisory Group were formed. An international Delphi study with a priori consensus thresholds, consensus meeting, group writing of the explanation and elaboration paper, and pilot testing were conducted. CONSORT-C 2026 consists of a checklist with 13 new reporting items, including one youth-generated and six youth-endorsed items; the accompanying explanation and elaboration paper explains all items and offers examples of good reporting. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to paediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders. Widespread implementation and uptake of CONSORT-C 2026 should optimise the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.
Randomised controlled trial (RCT) protocols contain essential details needed to understand and evaluate the trial's planned aims, design, data collection methods, monitoring, data analysis, and participants' safety. However, key information is often omitted from paediatric RCT protocols, including details on dose adjustments of interventions based on age, body surface area, or weight; developmental appropriateness of trial outcome measures and processes; or strategies to minimise participants' anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonised, comprehensive reporting of paediatric RCT protocols involving participants aged 0-19 years. The methodological framework for developing reporting guidelines published by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network was implemented to develop a paediatric extension to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 guidelines, called SPIRIT-Children and Adolescents (SPIRIT-C) 2026. A list of candidate reporting items was generated from the literature, and a Youth Advisory Group and a Family Caregiver Advisory Group contributed essential input throughout the project. An international Delphi study with a priori consensus thresholds, a consensus meeting, group writing of the explanation and elaboration paper, and pilot testing of the draft guideline were conducted. SPIRIT-C 2026 consists of a checklist with 17 new reporting items for reporting paediatric RCT protocols; four items are youth generated and six youth endorsed. SPIRIT-C 2026 can be considered a minimum set of reporting items pertinent to paediatric RCT protocols that are relevant to various interest holders, including young people, family caregivers, researchers, paediatric trialists, ethics committees, regulators, funders, and journal editors. The accompanying explanation and elaboration paper explains all items and offers examples of good reporting. Widespread implementation and uptake of SPIRIT-C 2026 should enhance the quality and usefulness of protocols for RCTs that involve participants from birth through adolescence, and ultimately foster high-quality paediatric trials.
