Application of the STROBE statement to the hypospadias literature: Report of the international pediatric urology task force on hypospadias

SummaryIntroductionObservational studies, particularly case series, represent the majority of the current hypospadias research. As a result, this literature lacks standardization of surgical techniques, uniform definitions of hypospadias complications, and consistency of outcome reporting, which may make it difficult to compare results across studies. A modified version of the STROBE statement, containing 20 items, was presented at the International Pediatric Urology Task Force on Hypospadias meeting to assist with clear and transparent reporting of hypospadias studies. The adoption and implementation of this modified tool will allow investigators and health care providers to critically evaluate quality and identify bias within the literature. In addition this instrument will ensure consistency of reporting, improving objective comparisons between studies, unification of results, and development of evidence-based clinical guidelines.MethodsIn this article, we have applied the modified STROBE statement to the hypospadias literature, aiming to create a guide on study reporting for pediatric urologists, and ultimately improve the quality of research in our field. We present itemized recommendations for adequate reporting of hypospadias studies and case series, ranging from drafting the abstract to addressing biases and potential sources of confounding. Included with each item is a brief explanation of its importance and potential effect on the study, as well as pertinent examples of hypospadias articles.ResultsA modified STROBE summary table containing 20 items is presented in (Supplementary Table 1).ConclusionsIf properly conducted and reported, hypospadias studies have the potential to provide useful information to clinicians and surgeons. However, authors should recognize the inherent limitations of these observational studies, especially in the form of bias, which may introduce invalid data or limit generalizability. Thus, we expect that the use of this guiding tool will not only improve transparency of hypospadias reporting, but also improve its methodological quality, allowing proper comparison and interpretation of data across different institutions.Supplementary Table 1. Strobe Summary table.ItemDescriptionTitle and Abstract1TitleUse the PICOT format (Population, Intervention, Comparative intervention, Outcome, Time horizon).AbstractProvide a brief but detailed summary of the study. Include methodology, results and interpretation.Introduction2Background/RationaleExplain the purpose of conducting the research.3ObjectivesSpecify the objectives of the study and state the predetermined hypotheses.Methods4Study designPresent the general study design and indicate the primary and secondary outcomes.5SettingDescription of the location of the study and relevant dates.6Eligibility criteriaInclude both the inclusion and exclusion criteria and describe patient selection process.7VariablesInclude all outcome measures, interventions, risk factors, predictors, potential confounders, and other applicable variables.8Data sources/managementDescribe how each variable was recorded, the source and methods of data and how the data was collected.9BiasAcknowledge and explain how potential sources of bias were addressed.10Study sizeDescribe and explain how sample size was reached.11Statistical methodsClear explanation of all statistical methods.Control for confoundingOutline the methods used to control for confounding.Subgroup/Interaction analysisIdentify if these were a priori or post hoc analyses.Handling of missing dataEvaluate and explain if missing data is random or systematic.Sensitivity analysesDescribe any sensitivity analyses.Results12No. of participants at each stageState the number of subjects included in each stage of the study.Reason for non-participationState why participants were excluded at each phase of the study.Flow diagramUse a flow diagram to display information efficiently.13Study participantsInclude baseline patient characteristics table.Missing dataProvide the number of subjects with missing data for each outcome.14Outcome dataReport the number of outcome events or summary measures.15Unadjusted and adjusted estimatesReport both adjusted and unadjusted estimates of your main results. Clarify which confounders were included or excluded, and why.Discussion16Key resultsDescribe the main results highlighting the original goals and objectives.17LimitationsAcknowledge possible sources of bias, and other study limitations.18GeneralizabilityIndicate the extent to which study results are generalizable.Other information19FundingState the funding sources and the role of the funders.20Summary of findings tableUse a standardized Summary of findings table to effectively communicate key study findings.