The need for child-centric reporting guides for pediatric clinical trial and systematic review protocols and reports

Systematic reviews (SRs) and meta-analyses (MAs) of clinical trial results are regarded as the highest level of medical evidence to establish the effectiveness and safety of interventions in a comprehensive, transparent, and reproducible nature. Unfortunately, evidence shows that not all SRs and trials are guaranteed to have been performed with the necessary methodological rigor. A study published today in Systematic Reviews reports on evidence of incomplete child-centric reporting details. Here the authors tell us more.

Avenues for improvement: research reporting first

Despite the availability of Preferred Reporting Items for Systematic reviews and Meta-Analysis – PRISMA-2009 and PRISMA-P 2015 – statements that were developed to improve the transparency and quality of reporting of SR reports and protocols, respectively, uncertainty on how to deal with child-centric methodological challenges of SRs impairs decision-making in child health. More importantly, given the large degree of physiological, pharmacological and psychological differences among different age groups (i.e., neonates, children, adolescents, adults and elderly people), child-centric SRs require additional methodological considerations.

Published today in Systematic Reviews, our group reports on the evidence on incomplete reporting of child-centric reporting details across SRs and MAs on intervention studies in children published between 2010 and 2014.

It turns out that reports and protocols with a mixed children/adult population are more prone to incomplete reporting than child-only populations while Cochrane reviews are of a better reporting standard than non-Cochrane reviews. Overall, our results provide reasons for swift adoption of the PRISMA and PRISMA-P reporting guidelines, and a basis for child-centric extensions and modifications to these reporting standards. This could enhance the ability of decision-makers to inform policy and program decisions for specific age groups.

Child health clinical trials

The identified pitfalls in the reporting of child centric SRs and MAs find their origin in the primary research that these SRs aim to synthesize. In a recent study, we found that child-centric randomized controlled trials (RCTS) protocols and reports also suffer from incomplete reporting.

Responding to demands from the research filed, we are extending the current reporting statements and in collaboration with members of the original reporting guideline groups. The end-products will be evidence and consensus based checklists of essential items that authors should include when reporting the protocol and results of child-centric RCTs and SRs: SPIRIT-C, CONSORT-C, PRISMA-PC and PRISMA-C. The detailed methodology on the development of PRISMA-PC and PRISMA-C guidelines is reported here.

Outcomes in child health research

Clinical research in children encounters specific challenges including the need to obtain ethical approval from multiple independent research ethics boards, choosing and justifying a valid comparator treatment, and obtaining the child’s and/or parents informed consent under, at many times, difficult circumstances. Within all updated checklists, special attention is given to the selection, validation, and measurement of trial outcomes in children. In addition to the issues specific to reporting of child-centric research, recent evidence demonstrates that, despite its widely acknowledged importance, outcome quality remains poor in up to 80% of RCTs done in population expanding from neonatology to geriatrics.

Without the appropriate selection and complete reporting of the outcomes that have been studied, decision makers cannot reliably choose interventions that are the most safe and effective. This will also prevent researchers from replicating or building on existing research findings.

To improve the completeness of reporting of outcomes, making them fit for clinical decision-making, for informing health policy and for regulatory purposes, the Canadian Institutes of Health Research, funded a 2016 Project Grant that enables an international group of experts and stakeholders to develop, validate and implement a new outcome-reporting standard: Instrument for reporting of Planned Endpoints in CTs (InsPECT).

New tools on the block: suffocating scientists?

Following the methodological framework for developing reporting guidelines, our group has completed the evidence synthesis, Delphi survey and international consensus. The checklists have been finalized (available on request). Statements and Explanation and Elaboration documents of these reporting guidelines will be published in Q2-3-Q4 2017.

But there is one huge caveat when it comes to uptake: there are too many reporting guidelines out there. Authors may get lost, and we certainly don’t need duplication!

Indeed, any new reporting guideline would merely add one more to the list of existing guidelines. The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network provides a great platform to improve the reliability and usability of published health research literature by promoting transparent reporting and wider use of robust reporting guidelines. EQUATOR works tirelessly to help authors, not hinder them, and is seeking solutions for the challenges navigation the growing catalogue of research reporting standards.

As a potential solution, we propose the development of a child-centric plug-in to existing widely endorsed reporting guidelines like CONSORT, SPIRIT, PRISMA, STARD, etc.  How would this work? If a SR or RCT identifies its target population as either child only or mixed, the system would recommend reporting on the child-centric reporting items in addition to the existing reporting items from PRISMA, PRISMA-P, CONSORT or SPIRIT. We have therefore collaborated with international experts and world leaders in research reporting standards, outcomes research methodology, RCTs, SRs.

Finally

Child health research is coming of age. But, how do we get researchers to use reporting guidelines? While there is some evidence to suggest that journal endorsement of the CONSORT Statement improves adherence to reporting guidelines, reporting is still below acceptable levels. Research on the barriers and enablers to appropriate reporting would be valuable, as would evaluations of interventions to improve design, conduct and reporting of randomized trials.

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