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Background Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). Methods The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to “lock” the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12–24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations. Discussion SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste. Trial Registration The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35 ) and CONSORT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD ).

Appropriately designed, conducted, and reported randomised controlled trials (RCTs) in children and adolescents inform treatment and healthcare decisions made by young people, families, researchers, clinicians, regulators, funders, policymakers, 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.

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.

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 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 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 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 consists of a checklist with 17 new reporting items for reporting paediatric RCT protocols; four items are youth generated and six youth endorsed. These 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.

Paediatric randomised controlled trials (RCTs) generate critical evidence on the effects of interventions aimed at improving health outcomes in children and adolescents (aged 0-19 years). Evidence from appropriately designed, conducted, and reported RCTs is key to the evaluation and implementation of safe and effective interventions. Clear and comprehensive reporting of paediatric specific trial methods implemented in the trial and of its results facilitates a proper evaluation, including generalisability and applicability considerations and critical appraisal of trial methods and findings. The Consolidated Standards of Reporting Trials (CONSORT) 2025 statement provides general guidance for authors when reporting RCTs but contains no detail specific to paediatric trials. To overcome existing deficiencies in the reporting of paediatric clinical trials, we developed CONSORT-Children and Adolescents (CONSORT-C) 2026 as an extension of CONSORT 2025. A group writing approach was implemented and involved key partners with lived experience relevant to paediatric clinical trials, including family caregivers, trialists, child health researchers, clinicians, journal editors, and methodologists to contribute to this explanation and elaboration paper. This paper was prepared to provide explanations and good reporting examples for the 13 new CONSORT-C 2026 reporting items, paediatric considerations with good reporting examples for eight CONSORT 2025 items, and a glossary. It is recommended to use this explanation and elaboration paper as a resource together with the CONSORT-C 2026 checklist. Widespread implementation of CONSORT-C 2026 should improve reporting quality, enhance critical appraisal of key methodological aspects of paediatric RCTs, facilitate the peer review processes, and foster better understanding and interpretation of study findings by end users. Consequently, effective interventions may be translated to paediatric practice and policy decisions more efficiently, and ultimately improve patient outcomes.

Purpose Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. Methods The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. Results From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. Conclusion PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. Note In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Well reported systematic reviews of health interventions provide valuable information for making therapeutic decisions, informing policies, and identifying research priorities. When reporting a systematic review of interventions used in paediatrics, addressing the heterogeneity of people aged 0-19 years pertaining to the biological, pharmacological, and psychological variabilities during child development (ontogeny) is essential. To enable reporting the essential detail on treatment effects related to age and developmental stages in these systematic reviews, an extension to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guideline was developed: PRISMA-Children and Adolescents (PRISMA-C) 2026. The extension comprises a checklist, explanations, and examples of good reporting for seven main checklist items and four abstract items, and present paediatric examples of good reporting for 10 PRISMA 2020 items to which the ontogeny statement applies. All new items were deemed relevant by evidence end users, including family caregivers. Adherence to the PRISMA-C 2026 extension should improve the reporting of key paediatric specific details that enhance the understandability and interpretability of the evidence on interventions for children and adolescents.

Background In recent years, projects to develop reporting guidelines have attempted to integrate the perspectives of patients and public members. Best practices for patient and public involvement (PPI) in such projects have not yet been established. We recently developed an extension of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), to be used for systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) for OMIs 2024. Patients and public members formed a small but impactful stakeholder group. We critically evaluated the PPI component in this project and developed recommendations for conducting PPI when developing reporting guidelines. Main text A patient partner was an integral research team member at the project development and grant application stage. Once the project started, five patient and public contributors (PPCs) were recruited to participate in the Delphi study; three PPCs contributed to subsequent steps. We collected quantitative feedback through surveys; qualitative feedback was garnered through a focus group discussion after the Delphi study and through debrief meetings after subsequent project activities. Feedback was thematically combined with reflections from the research team, and was predominantly positive. The following themes emerged: importance of PPI partnership, number of PPCs involved, onboarding, design of Delphi surveys, flexibility in the process, complexity of PPI in methodological research, and power imbalances. Impacts of PPI on the content and presentation of the reporting guideline were evident, and reciprocal learning between PPCs and the research team occurred throughout the project. Lessons learned were translated into 17 recommendations for future projects. Conclusion Integrating PPI in the development of PRISMA-COSMIN for OMIs 2024 was feasible and considered valuable by PPCs and the research team. Our approach can be applied by others wishing to integrate PPI in developing reporting guidelines. Plain English summary Reporting guidelines help authors in reporting a specific type of research. They are often presented in the form of a checklist. In recent years, efforts have been made to include the perspectives of patients and members of the public to make sure that what matters to them is also reported. However, best practices for patient and public involvement in such projects do not yet exist. We developed a new reporting guideline for systematic literature reviews of outcome measurement instruments, called “PRISMA-COSMIN for OMIs”. In the development of this guideline, one patient partnered as a member of the research team, and five other patients and public members participated in the project. They all had a positive impact on the content and presentation of the guideline. We invited patients and public members to reflect and give feedback on their involvement in the project. Reflections and feedback were mostly positive. Key strengths of our approach were: Limiting power imbalances by having a patient on the research team. Organizing a preparatory meeting for patients and public members to go over key project details and concepts. Remaining flexible in how patients and public members could contribute. This project shows that our approach is feasible. Here, we share insights we gained throughout the project. We translate “lessons learned” into 17 recommendations. These recommendations can be used by researchers who wish to include patient and public perspectives in developing new reporting guidelines.

Background Patient and public involvement (PPI) is increasingly recognized as important, yet no guidance exists on integrating young people and family caregiver perspectives in the development of research reporting guidelines. We developed two paediatric-specific extensions with young people (ages 10–24 years) and family caregivers (YPFC) for the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines: SPIRIT-Children and Adolescents 2025 (SPIRIT-C) and CONSORT-Children and Adolescents 2025 (CONSORT-C). This case study describes how we involved YPFC in the development of SPIRIT-C and CONSORT-C and identified enablers of impactful PPI. Main text We formed a Youth Advisory Group (ages 13–19 years) and a Family Caregiver Advisory Group. A miniseries of two Young Person Reporting Guideline workshops aimed at generating randomised controlled trials (RCT) reporting items were conducted virtually in Canada, England, France, Scotland, and Spain, engaging 42 young people (ages 10–21 years). Young people (ages 19–24 years) and family caregivers participated as panellists in an international Delphi study. Family caregiver advisors actively contributed to the Consensus Meeting and to the writing process of the guidelines’ Explanation and Elaboration (E&E) documents. After each project stage, YPFC feedback was collected. PPI impact was defined as tangible changes, learnings, and outcomes, both positive and negative, to the guideline development process and the final guidelines resulting from YPFC co-development. YPFC found their involvement in the project a valuable experience. Their contributions to key project stages, such as the Delphi study, Consensus Meeting, and the development of the E&E documents impacted the final guidelines and E&E documents, with the inclusion of four new youth generated reporting items. Feedback throughout the project informed six “enablers” for productive partnerships in reporting guideline development: (1) designated point person, (2) tailored training, (3) access to project materials, (4) clear expectations on time commitment and compensation, (5) structured check-in sessions, and (6) demonstrated openness to feedback. Conclusion With careful preparation, investing in impactful PPI enablers, YPFC can meaningfully contribute to the development of research reporting guidelines, improve final deliverables, and ultimately shape research that reflects their perspectives. Plain English summary Young people and family caregivers (YPFC) are end-users of paediatric research reports. To ensure that items of importance to them are reported, they should have a say in what key items of a study should be reported. While there is increased interest in involving YPFC in health research, guidance on how best to involve young people ages 10–24 years and family caregivers in the development of research reporting guidelines does not exist. Recently, recommendations on how patient and public partners can be meaningfully involved in research reporting guideline development were published, though these recommendations were informed by the experiences of adult partners. This study is the first to involve YPFC in the development of reporting guidelines for paediatric randomised controlled trials (RCTs). It describes the experience of this involvement from multiple perspectives and evaluates YPFC’s impact on the final guidelines. YPFCs contributed to the generation of candidate reporting items, a three-round Delphi study, Consensus Meeting, and writing/review of the Explanation and Elaboration documents. Using formal evaluations after each project stage, we identified six enablers for their effective involvement in future projects that aim to add value to child health research by integrating YPFCs perspectives. Investing in enablers for effective YPFC involvement may improve research practice and yield increased relevance and utility of child health research deliverables and outcomes for end-users and add value to research reflecting YPFC perspectives.

Background Pediatric trials are possible through voluntary participation of children, youth (age ≤ 18 years), and their families. Despite important arguments for trialists to provide trial progress or results, and evidence that participants desire it, this information remains rarely shared with youth and their families. Little guidance exists on how trialists can best communicate trial results back to participants and their families. Guided by Liabo et al.’s framework, we describe how we developed a pediatric-specific, “plain language summary” clinical trial results template called CommuniKIDS with an adult patient partner, family partner (parent), youth advisors, and parent advisors, taking into account their unique knowledge needs and preferences. Main text Patient and Public Involvement (PPI) was integrated in the development of the CommuniKIDS template. In collaboration with Clinical Trials Ontario, we used a generic trial results template as a starting point. The core project leadership team included a patient partner and a family partner from project inception to completion. Five youth (ages 13–18 years) and eight parent advisors were consulted at each point of the development process through three virtual workshops conducted separately; youth workshops were led by a youth facilitator. During these workshops, advisors agreed on the importance and value of sharing trial results, and expressed their preferences on content, format, and timing of sharing trial results. PPI-led improvements included the addition of three new sections to the CommuniKIDS template: “at a glance,” “side effects,” and “next steps.” We reflect on our PPI strategy in the context of five “values” and six “practicalities” identified as good PPI principles, and summarize lessons learned when collaborating with youth and families from this project. Conclusion Involvement of a patient partner, a family partner, youth advisors, and parent advisors in the development of CommuniKIDS was critical to create a clinical trial results template that is useful and relevant to its end-users. To our knowledge, CommuniKIDS is the first to meaningfully engage youth and parents as advisors and partners in developing a plain language summary results template for pediatric trial participants and their families. Our experience of co-developing CommuniKIDS demonstrates that meaningful PPI can be achieved in trial results communication and knowledge translation practices. This report provides resources for those seeking to involve youth and families in their initiatives and in meaningfully sharing trial results. Plain English summary The voluntary participation of youth aged 18 and under in clinical trials makes it possible for researchers and healthcare providers to study medications and other treatments. However, most youth and their families who take part in clinical trials do not get any information on the trial’s progress or results, leaving many to wonder if anything useful came from their participation. There is an ethical obligation to give this information back to youth and their families, who might take risks by participating in trials. The aim of the CommuniKIDS project was to develop a “plain language summary” results template to share trial results back to youth and their families. Working with a patient partner, a family partner, five youth advisors (ages 13–18), and eight parent advisors, we set out to understand what youth and parents would like to see in a plain language summary of clinical trial results. The needs and preferences discussed with the advisors were included to create a child/youth health-specific template. The CommuniKIDS project is the first to involve youth and parents as advisors in developing a plain language summary results template for child/youth health trials. Here, we describe how we involved youth and parents in the development of CommuniKIDS, how the template was customized to be youth and family-friendly and reflect on lessons learned.