CONSORT-C and SPIRIT-C 2026: The New Pediatric Trial Reporting Guidelines Every Clinical Author Needs to Know

Most clinical researchers who run trials in children and adolescents are familiar with CONSORT and SPIRIT. They are the reporting checklists journals require at submission for completed randomized trials and trial protocols respectively, and they have been part of the manuscript preparation workflow in academic medicine for years. What those researchers may not have appreciated until February 2026 is just how much those checklists left unasked about pediatric-specific trial conduct: how doses were adjusted for a six-year-old versus a sixteen-year-old, whether the outcome measures chosen were validated for children, how assent was obtained from participants too old to be treated as objects of parental consent but too young to sign their own, and what the trial meant for a child's school attendance or family routine.

On February 24, 2026, the EnRICH team at The Hospital for Sick Children in Toronto published CONSORT-Children and Adolescents 2026 (CONSORT-C) and SPIRIT-Children and Adolescents 2026 (SPIRIT-C) simultaneously across The Lancet Child & Adolescent Health, The BMJ, and JAMA Pediatrics. These are not standalone documents. They are extensions of the existing 2025 CONSORT and SPIRIT statements, meaning that any pediatric trial published after their release needs to satisfy the core CONSORT 2025 or SPIRIT 2025 checklist plus the new pediatric items on top. For authors currently finalizing manuscripts of pediatric trials, the window to prepare for these requirements is now.

Why the Original Checklists Were Not Enough

The case for pediatric-specific reporting guidelines rested on a straightforward observation: children are not small adults, but the reporting standards governing clinical trial manuscripts treated them as if they were. CONSORT 2010 and the earlier versions of SPIRIT contained no items asking how intervention doses were adapted across the age range of enrolled participants, no prompts for reporting the developmental validity of outcome measures, and no structured place to describe assent processes for participants who were old enough to express a view but below the legal age for independent consent. Authors filling in these checklists simply did what they could with items designed for different populations.

The practical consequences showed up in the literature. Studies examining adherence in pediatric oncology trials, for example, found highly variable reporting quality. A review of neuro-oncology trial reports found mean adherence to SPIRIT averaging around 76 percent for protocols and closer to 70 percent for final trial reports against CONSORT, with the gaps concentrated precisely in the areas that most distinguish pediatric from adult research: dosing rationale, developmental appropriateness of outcomes, and participant safety procedures specific to children. These were not items authors were forgetting to report. They were items the checklist never asked about.

Growing evidence about the specific elements missing from pediatric trial protocols led the EnRICH research group to undertake a formal guideline development process beginning around 2022. Their 2024 protocol paper, published in BMC Trials, documented three categories of information that were consistently absent from pediatric manuscripts: details on how doses were adjusted based on age, weight, or body surface area; information on whether outcome measures were validated for different developmental stages; and descriptions of how consent and assent processes were handled across a participant age range that might span infants through late adolescents.

What CONSORT-C 2026 Adds: 13 New Items for Final Trial Reports

CONSORT-C 2026 addresses completed randomized controlled trials. It adds 13 new reporting items to the existing 2025 CONSORT checklist, covering the title and abstract through the participant flow, outcomes, and post-trial considerations. The items are numbered as extensions of the CONSORT structure (for example, item 1a.1, item 6.2, item 6.3, item 13.1, item 13.2, item 15.1, item 29.1), which allows journals to cross-reference the new requirements against the core checklist without rebuilding their submission systems from scratch.

Six of the 13 new CONSORT-C items are youth-endorsed, meaning they were generated in consultation with young people aged 10 to 24 who participated in the guideline development process as active contributors rather than subjects. One item, item 13.2, is explicitly youth-generated: it asks authors to describe how trial participants received recognition for their contribution to the research. This is not a thank-you note requirement. It is a reporting item addressing the reality that participation in pediatric clinical trials is a meaningful burden on children and families, and that how that burden is acknowledged is relevant information for future trial design and recruitment.

The intervention-related items are where CONSORT-C will require the most new writing from many authors. Item 6.2 requires authors to report how the intervention and any comparator were adapted for different developmental stages across the enrolled age range. A trial enrolling participants aged two through seventeen, for instance, cannot be adequately described by a single dose or a single description of intervention delivery. How the drug was formulated for toddlers versus teenagers, or how a behavioral intervention was adapted for primary school children versus adolescents, are now explicit reporting requirements. Item 6.3 requires reporting on whether outcome measures were validated for the developmental stages of enrolled participants, a question that most CONSORT submissions currently leave unanswered.

What SPIRIT-C 2026 Adds: 17 New Items for Trial Protocols

SPIRIT-C 2026 covers trial protocols, the documents that describe the planned trial before it begins, and it adds 17 new reporting items to the SPIRIT 2025 structure. The scope is broader than CONSORT-C because protocols are forward-looking documents that need to anticipate and describe pediatric-specific procedures before the trial runs, not report them afterward.

Four of the 17 new SPIRIT-C items are youth-generated and six are youth-endorsed, reflecting the same participatory development process used for CONSORT-C. The youth-generated items in SPIRIT-C focus on the information that child participants and their families reported wanting to see in trial protocols but rarely found: anticipated impact of trial participation on daily life, strategies for recognizing contribution, and explicit descriptions of what happens in the ancillary and post-trial period for enrolled children.

The dosing and eligibility items in SPIRIT-C are likely to be the most immediately demanding for authors of pharmacological trials. Protocols now need to specify explicitly how doses were calculated across the enrolled age range, whether dose capping was applied, and what the rationale was for the dosing algorithm. A protocol that states a dose in mg/kg without describing how that calculation was handled for different age subgroups, or whether age-specific pharmacokinetic data existed to support it, will not satisfy the new SPIRIT-C standard at journals that have adopted it.

Consent and assent reporting received particular attention in SPIRIT-C. The existing SPIRIT statement has a consent item, but it was not designed for the layered consent situation common in pediatric trials, where parents or guardians provide formal legal consent while children provide assent that varies in formality, documentation, and weight depending on the child's age and the trial's risk level. SPIRIT-C now requires protocols to describe the assent process separately from the parental consent process, to specify at what ages assent will be sought, in what form it will be documented, and what will happen if a child refuses to assent despite parental consent.

The Youth Involvement Story: Why It Matters for Authors

The participation of young people in developing CONSORT-C and SPIRIT-C is not incidental. It is the methodological story that distinguishes these guidelines from most previous reporting extensions, and it has direct implications for what authors now need to report.

Young people aged 10 to 24 were involved throughout the guideline development process, not only as survey respondents but as members of working groups that generated and ranked items. The EnRICH team at SickKids developed a structured process for including young people's priorities alongside those of clinical experts, and the result is visible in the final checklists. The item asking authors to describe how participants will receive recognition for their contribution to the trial (item 13.2 in CONSORT-C) came directly from young people who had participated in trials and found the absence of recognition or follow-up feedback one of the most frustrating aspects of being a trial participant.

For authors, this matters in a practical sense because several of the youth-endorsed items ask about things that most clinical researchers have not thought to document. Reporting whether participants were told the results of the trial they helped to run, whether they were given feedback about their individual data where appropriate, and whether there was any mechanism for them to stay connected with the research team after trial completion are not standard elements of most pediatric trial manuscripts. They will become standard as journals adopt the new checklists.

Authors who currently design pediatric trials without formal patient and public involvement should note that SPIRIT-C does not require that young people were involved in designing the specific trial described in the protocol. But it does require that the protocol describes how participants' perspectives and preferences shaped the trial design, and that reporting frameworks now exist to surface whether those perspectives were genuinely integrated or pro forma.

The Consent and Assent Reporting Item: Where Authors Are Likely to Struggle

Among all the new items in CONSORT-C and SPIRIT-C, the ones covering consent and assent are likely to generate the most revision requests and the most uncertainty among authors. The practical and ethical complexity of obtaining assent from a spectrum of developmental stages in a single trial has never previously been a reporting requirement, and most manuscript templates do not contain a section for it.

The new items do not prescribe a single correct approach to assent. They require that authors describe the approach they took. Did the trial obtain written assent from participants over a specified age? What was that age threshold and how was it determined? Was assent verbal or written, and how was it documented in the trial records? What happened when a child who initially assented later expressed reluctance or refusal? Did the trial have a policy distinguishing between momentary procedural reluctance (a child who did not want the blood draw today) and genuine withdrawal from the trial?

These are not hypothetical scenarios. They are common situations in pediatric trial conduct, and the fact that they have not been consistently reported means that the published literature on pediatric trial methods is substantially incomplete. Readers, systematic reviewers, and future trialists trying to design consent procedures based on existing evidence are working from an underreported record. SPIRIT-C's assent item is not asking authors to have had a perfect process. It is asking them to describe the process they had.

Which Journals Are Requiring CONSORT-C and SPIRIT-C Now

The three co-publishing journals (The Lancet Child & Adolescent Health, The BMJ, and JAMA Pediatrics) are implementing the new checklists as part of their standard submission requirements for pediatric trials submitted after February 2026. Explanation and Elaboration papers accompanying both guidelines were published in The BMJ, giving editors and reviewers a reference document to use when assessing compliance.

Beyond the three co-publishing journals, adoption among pediatric and general medical journals is at an early stage. The EQUATOR Network has added CONSORT-C and SPIRIT-C to its guideline database, which is the reference point journals use when updating their instructions for authors. Journals within the BMJ Publishing Group and several Lancet-family titles are expected to incorporate the new checklists into their submission systems through the second half of 2026. Journals in the Springer Nature and Elsevier portfolios that cover pediatric medicine, neonatal care, and child health more broadly have not yet published updated guidance at the time of writing, but Explanation and Elaboration papers are publicly available and the EQUATOR database listings are already current.

General medical journals that publish pediatric trials as part of a broader portfolio (NEJM, JAMA, the main Lancet) have not yet explicitly updated their author guidelines to require the pediatric extensions, though the existing requirement to comply with CONSORT and SPIRIT provides the framework into which the extensions fit. Authors submitting pediatric trials to general journals should prepare documentation covering the new items regardless, because peer reviewers in pediatric medicine will increasingly expect to see them.

Neonatal medicine journals and journals focused specifically on pediatric oncology, pediatric cardiology, and pediatric surgery are, practically speaking, the highest-volume venues affected. Authors submitting to Archives of Disease in Childhood, Pediatric Blood & Cancer, the Journal of Pediatrics, Pediatrics, and similar specialist titles should check the current instructions for authors directly before submission. The adoption pace in specialist pediatric journals is likely to be faster than in general medicine, because their readership and editorial boards are more likely to have been involved in or aware of the guideline development.

The Dosing and Pharmacology Items: A Separate Problem for Drug Trials

Authors of pharmacological pediatric trials face a specific challenge with the SPIRIT-C dosing items that goes beyond paperwork. The new items require protocols to explain how doses were calculated for different ages and weights, what the source of that dosing rationale was (for example, pediatric pharmacokinetic data, allometric scaling from adult data, or an empirical dose-finding approach used in the trial itself), and whether any age-specific dose capping was applied and why.

For many pediatric drug trials, the honest answer to these questions is that the dosing rationale was extrapolated from adult data with limited pediatric pharmacokinetic support. That is not a disqualifying admission in a protocol, but it is exactly the kind of information that SPIRIT-C is designed to surface. A protocol that says "dose of X mg/kg adjusted for body weight" without explaining whether body-weight scaling was appropriate for a drug with nonlinear kinetics in young children, whether the formula was validated in the enrolled age range, or whether adolescents received the same dose as young children, is now incomplete.

The CONSORT-C dosing items ask for corresponding information in the final report: what doses participants actually received disaggregated by age group, whether dose modifications were made during the trial and why, and whether adherence was reported separately across developmental stages where different formulations were used. A trial where toddlers received a liquid formulation and teenagers received tablets, for instance, needs to report adherence separately because the formulations are different interventions for practical purposes.

How CONSORT-C and SPIRIT-C Fit With CONSORT 2025 and SPIRIT 2025

Because CONSORT-C and SPIRIT-C are extensions of the 2025 core standards, authors of pediatric trials need to work through three layers of reporting requirements. First, the core CONSORT 2025 or SPIRIT 2025 checklist applies in full. Second, any other relevant extensions apply. A pediatric trial of a surgical intervention would need CONSORT 2025 plus the TIDieR reporting framework for intervention description plus CONSORT-C. A trial using an AI-based diagnostic tool as the intervention would need SPIRIT 2025 plus SPIRIT-AI plus SPIRIT-C. Third, any journal-specific requirements apply on top.

This layering is intentional and the EQUATOR Network guidance supports it. The practical implication for authors is that completing any single checklist is not a guarantee of compliance. A completed CONSORT 2025 checklist submitted with a pediatric trial is now technically incomplete at journals requiring CONSORT-C, in the same way that a CONSORT 2020 checklist for a surgical trial was technically incomplete without the relevant surgical extensions.

Authors who routinely submit to journals with structured checklist requirements in their submission systems should verify whether those systems have been updated to include CONSORT-C and SPIRIT-C fields. Submission systems at some journals remain based on older CONSORT versions even when the author instructions reference the 2025 update. If the system does not prompt for the pediatric extension items, completing them in a supplementary table or in the relevant sections of the manuscript body is still the author's responsibility.

A Practical Pre-Submission Checklist for Pediatric Trial Authors

If you are preparing a manuscript reporting a completed pediatric randomized trial, or finalizing a protocol for a pediatric trial to be submitted to a journal as a registered report or protocol publication, the following questions reflect the minimum that CONSORT-C and SPIRIT-C now require. Work through them before you submit rather than at revision, when co-authors may be less available and editorial goodwill may be thinner.

What This Means for Authors With Trials Currently in Progress

Authors who initiated their pediatric trials before February 2026 face the same situation that faces researchers whenever a new reporting guideline is published mid-trial: the protocol was written against a standard that has since been updated, and the trial was not designed to collect some of the data the new items request. This is not an insurmountable problem. The EQUATOR Network and most journal editors take the position that authors should report what was done, not retroactively pretend that the study was designed against a checklist it predated.

The practical approach for mid-trial teams is to assess which of the new CONSORT-C and SPIRIT-C items can be answered from existing study records and which cannot. Items on assent, for example, can usually be addressed retrospectively if the trial collected any documentation of the assent process, even if the documentation was less formal than the new items envision. Items on dosing rationale can be answered in the methods section even if they were not in the original protocol, as long as the description matches what was actually done. Items asking for recognition of participant contribution can be addressed prospectively for participants still in the trial or by reporting what feedback was provided to completed participants.

Items that genuinely cannot be addressed because the data were not collected (age-disaggregated harm reports in a trial that did not collect data separately by age group, for instance) should be acknowledged as limitations. A sentence in the limitations noting that the trial predated CONSORT-C 2026 and that age-disaggregated harm data were not systematically collected is an honest and appropriate response. Editors will accept this. What they are less likely to accept after CONSORT-C is widely adopted is a complete absence of any engagement with the pediatric-specific reporting items, as though the trial enrolled a single adult age cohort.

For teams planning new pediatric trials, the clearest practical step is to incorporate SPIRIT-C item requirements into your protocol before registration, not after. Trial registration at ClinicalTrials.gov, ISRCTN, or WHO ICTRP does not yet prompt for most SPIRIT-C specific items, but your protocol document can and should address them before ethics approval and first enrollment. Reviewers who see a 2026 pediatric trial protocol that already incorporates SPIRIT-C language will read it as methodologically current. Reviewers who see one that omits developmental appropriateness, assent process, and dosing rationale will flag those gaps at peer review.

Further Reading