Harron, K

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Using reporting guidelines to publishpaediatric researchKatie HarronMany medicines and devices used for thehealthcare of children are unlicensed anduntested for use in paediatrics, and clini-cians often have to rely on evidence inadults that may not be generalisable tochildren.1 2 There are a number ofreasons why evidence in adults cannotalways be safely extrapolated to children,including different pharmacokinetic andpharmacodynamic processes, and drugsafety and efﬁcacy being dependent onstage of development. Growing recogni-tion of these issues has led to initiatives toincrease the number of paediatric trials.3In addition, recognition of the importantdifferences in design and interpretation oftrials conducted in adults and children—including ethical issues, validity of out-comes, age-speciﬁc and developmentalstage-speciﬁc harms and confounders—has highlighted deﬁciencies in the qualityof paediatric trial conduct and reportingand prompted repeated calls for child-speciﬁc reporting guidelines.4Reporting guidelines such asConsolidated Standards Of ReportingTrials (CONSORT) and STrengthening theReporting of OBservational studies inEpidemiology (STROBE) aim to improvetransparency, allowing identiﬁcation ofpotential biases, critical assessments ofrobustness and replication in different set-tings.5 6 Many leading journals activelyendorse reporting guidelines and referauthors to the Enhancing the QUAlityand Transparency Of health Research(EQUATOR) Network website (http://www.equator-network.org). The EQUATORNetwork was established to improve thereliability and usability of health researchliterature by facilitating accurate and com-plete reporting of research studies.7Despite the comprehensive collection ofexisting resources and reporting guidelinesavailable on the EQUATOR website, therehas been a lack of guidance for the report-ing of paediatric studies until now.8Aiming to ﬁll this gap, and in response tothe need to improve quality in reportingof paediatric research, several child-speciﬁc extensions to established guide-lines are under development, includingfor CONSORT, Standard Protocol Itemsfor Randomised Trials (SPIRIT) andPreferred Reporting Items for Systematicreviews and Meta-analysis (PRISMA).5 8–10These initiatives will complementprevious guidelines by recommendingconsideration of paediatric-speciﬁc issues,including choice of appropriate outcomes,stratiﬁcation by age or development,dosing or formulation, safety and ethicalconsiderations. For example, detailedreporting of the age distribution of studyparticipants is vital for understanding out-comes, treatment effects and potentialeffects of growth and maturation; report-ing the validity of outcome measures inpaediatric populations is also important,as valid outcomes for adult populationsmay not be relevant across childhood.11Reporting long-term safety outcomes isalso required in situations where harmsmay appear later on in development.The most informative reporting guide-lines are underpinned by robust methodo-logical development, typically throughestablishing consensus from experts andstakeholders in an iterative process offeedback and review. However, providingrobust evidence about the impact ofguidelines on quality of reporting is chal-lenging.12 13 The list of 320 reportingguidelines currently published on theEQUATOR website is continuing to grow(as of July 2016), and while some arguethat these checklists represent anotherhurdle to publication, others recognise thatany tool to improve the quality and trans-parency of research reports can onlyincrease the likelihood of manuscriptacceptance.14 In addition to supportingauthors in producing accurate and transpar-ent representations of their research, report-ing checklists are also a valuable aid for peerreviewers assessing the quality of studiessubmitted for publication.15 Despite thewell-recognised shortcomings of peerreview, including inevitable inconsistencies,limited capacity to identify all errors orweaknesses and potential reviewer biases,the current system is a crucial component ofscientiﬁc research publication. Encouragingthe use of reporting checklists can help toimprove the process and support reviewersin providing quality reviews.16Journals implement reporting guide-lines in various ways, but commonly referto relevant reporting guidelines in theirInstructions to Authors. Some journalshave explicit philosophies of transparency,accuracy and completeness in reporting.For example, the BMJ journal group’s‘Transparency Policy’ requests that authorsfollow complete reporting checklists priorto submission (http://www.bmj.com/about-bmj/resources-authors/forms-policies-and-checklists/transparency-policy). For Archivesof Disease in Childhood, as for other BMJjournals, authors are referred to theEQUATOR Network website and encour-aged to use appropriate guidelines to“ensure that you provide enough informa-tion for editors, peer reviewers andreaders to understand how the researchwas performed and to judge whether theﬁndings are likely to be reliable”. Otherjournals, such as PLoS Medicine, requireauthors to submit appropriate checklistsalongside their manuscript or to providean explanation if no relevant guidelineexists.Given the challenges in conducting ran-domised trials in children, observationalstudies based on population-based admin-istrative data sources are increasinglybeing used to provide evidence andsupport quality improvement for paediat-rics. Administrative or electronic healthdata sources contain individual-levelrecords primarily collected for reasonsother than research (eg, ﬁnancial orclinical management) and can providerich, detailed information on patient path-ways.17 However, there are unique chal-lenges for the analysis of such data.18Administrative data do not always containthe complete, accurate information thatresearchers require. For example, a studyof children with and without diabetesrequires accurate classiﬁcation of thedisease, which is reliant on (i) the clinicianrecognising the diagnosis, (ii) the diagno-sis being recorded in clinical notes, (iii)medical coders correctly coding the diag-nosis and (iv) researchers including thecorrect codes in their analysis. Omissionsin any of these steps could lead to missinginformation, which could in turn lead tobias. Transparency of reporting is there-fore key to producing valid and reliableresearch based on administrative data. TheREporting of studies Conducted usingObservational Routinely-collected healthData (RECORD) initiative aims to comple-ment the STROBE guidelines by providingguidance on issues relating speciﬁcally toadministrative data, including the use ofdata linkage, access and availability of dataand code list validation.19 For example,RECORD recommends that algorithms orcodes used to identify the study population,Correspondence to Dr Katie Harron, London Schoolof Hygiene and Tropical Medicine, 15-17 Tavistock Place,London WC1H 9SH, UK; katie.harron@lshtm.ac.uk401Harron K. Arch Dis Child May 2017 Vol 102 No 5Leading article on 21 September 2018 by guest. Protected by copyright.http://adc.bmj.com/Arch Dis Child: first published as 10.1136/archdischild-2016-311248 on 8 October 2016. Downloaded from exposures, outcomes and other variables arelisted in detail; that any ﬁltering based ondata quality, data availability or linkageshould be described and that the implica-tions of using data not collected speciﬁcallyfor research should be discussed.19Positive public perception of paediatricresearch is crucial, both in facilitatingrecruitment of children into trials and inexploiting existing data sources for childhealth research. Both authors and journalshave an important role to play in support-ing the public in making informed deci-sions about the use of their data, throughmaintaining a high level of transparencyand quality in reporting of paediatrichealth research. The use of reportingguidelines by authors and reviewers canaid careful interpretation of ﬁndings andenable those working in health policy tomake evidence-based decisions on paediat-ric care and health systems.Acknowledgements Thanks go to Tim Cole forproviding helpful comments on a draft of this article.Funding KH is funded as a Sir Henry WellcomePostdoctoral Research Fellow by the Wellcome Trust(103975/Z/14/Z).Competing interests KH is a statistical reviewer forADC and a member of the RECORD initiative workingcommittee.Provenance and peer review Commissioned;externally peer reviewed.Open Access This is an Open Access articledistributed in accordance with the terms of the CreativeCommons Attribution (CC BY 4.0) license, whichpermits others to distribute, remix, adapt and buildupon this work, for commercial use, provided theoriginal work is properly cited. See: http://creativecommons.org/licenses/by/4.0/REFERENCES1 Magalhães J, Rodrigues AT, Roque F, et al. Use ofoff-label and unlicenced drugs in hospitalisedpaediatric patients: a systematic review. Eur J ClinPharmacol 2015;71:1–13.2 Klassen TP, Hartling L, Craig JC, et al. Children arenot just small adults: the urgent need forhigh-quality trial evidence in children. PLoS Med2008;5:e172.3 Frakking F, van der Lee J, Klassen T, et al. The StaRChild Health Project: Standard for Research withChildren. Survey of current guidance for child healthclinical trials. 2011. http://www.who.int/childmedicines/publications/GUIDANCECHILDHEALTH.pdf (accessed 26 Jul 2016).4 Clyburne-Sherin AV, Thurairajah P, Kapadia MZ,et al. Recommendations and evidence for reportingitems in pediatric clinical trial protocols and reports:two systematic reviews. Trials 2015;16:417.5 Schulz KF, Altman DG, Moher D. CONSORT 2010statement: updated guidelines for reporting parallelgroup randomised trials. BMJ 2010;340:c332.6 von Elm E, Altman DG, Egger M, et al.Strengthening the reporting of observational studiesin epidemiology (STROBE) statement: guidelines forreporting observational studies. BMJ2007;335:806–8.7 Simera I. Chapter 5.6: Reporting guidelines: a tool toincrease completeness, transparency, and value ofhealth research published in your journal. In: SmartP, Maisonneuve H, Polderman A, eds. ScienceEditors’ Handbook European Association of ScienceEditors. 2013. http://www.ease.org.uk8 Hartling L, Wittmeier KDM, Caldwell P, et al., StaRChild Health Group. StaR Child Health: developingevidence-based guidance for the design, conduct,and reporting of pediatric trials. Pediatrics 2012;129(Suppl 3):S112–17.9 Liberati A, Altman DG, Tetzlaff J, et al. The PRISMAstatement for reporting systematic reviews andmeta-analyses of studies that evaluate healthcareinterventions: explanation and elaboration. BMJ2009;339:b2700.10 Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT2013 explanation and elaboration: guidancefor protocols of clinical trials. BMJ 2013;346:e7586.11 Sinha I, Jones L, Smyth RL, et al. A systematic reviewof studies that aim to determine which outcomes tomeasure in clinical trials in children. PLoS Med2008;5:e96.12 Turner L, Shamseer L, Altman DG, et al. Does theCONSORT Statement inﬂuence the quality ofreporting of RCTs published in medical journals?A Cochrane review. Syst Rev 2012;1:60.doi: 10.1186/2046-4053-1-60, MR000030.13 Moher D, Jones A, Lepage L. Use of the CONSORTstatement and quality of reports of randomized trials:a comparative before-and-after evaluation. JAMA2001;285:1992–5.14 The PLOS Medicine Editors. From checklists to tools:lowering the barrier to better research reporting.PLoS Med 2015;12:e1001910.15 Hirst A, Altman DG. Are peer reviewersencouraged to use reporting guidelines? A surveyof 116 health research journals. PLoS ONE2012;7:e35621.16 Cobo E, Cortés J, Ribera JM, et al. Effect of usingreporting guidelines during peer review on quality ofﬁnal manuscripts submitted to a biomedical journal:masked randomised trial. BMJ 2011;343:d6783.17 Jutte DP, Roos LL, Brownell MD. Administrativerecord linkage as a tool for public health research.Annu Rev Public Health 2011;32:91–108.18 Hashimoto RE, Brodt ED, Skelly AC, et al.Administrative database studies: goldmine orgoose chase? Evid Based Spine Care J2014;5:74–6.19 Benchimol EI, Smeeth L, Guttmann A, et al. TheREporting of studies Conducted using ObservationalRoutinely-collected health Data (RECORD) Statement.PLoS Med 2015;12:e1001885.402 Harron K. Arch Dis Child May 2017 Vol 102 No 5Leading articleTo cite Harron K. Arch Dis Child 2017;102:401–402.Arch Dis Child 2017;102:401–402.doi:10.1136/archdischild-2016-311248Received 8 August 2016Accepted 30 August 2016Published Online First 8 October 2016 on 21 September 2018 by guest. Protected by copyright.http://adc.bmj.com/Arch Dis Child: first published as 10.1136/archdischild-2016-311248 on 8 October 2016. Downloaded from 

Using reporting guidelines to publish paediatric research

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