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Open Access

Potential therapeutic benefit of ursodeoxycholic acid in the management of non hepato-biliary upper gastrointestinal disorders

Yasir M. Khayyat
Saudi Medical Journal May 2023, 44 (5) 431-439; DOI: https://doi.org/10.15537/smj.2023.44.5.20220886

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  • Table 1

    - Consolidated Standards of Reporting Trials 2010 checklist of information to include when reporting a randomized trial.

    TopicItem No.Checklist itemBanerjee 2016Parc 2011Kim 2020Vann 2013Peng 2014Bjorn 2013Aggio 1986Berkhout 2007
    Title and abstract1aIdentification as a randomized trial in the titleMissing111MissingMissingMissingMissing
    1bStructured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)Missing1Missing1Missing1MissingMissing
    Introduction
    Background and objectives2aScientific background and explanation of rationale21,21,222211
    2bSpecific objectives or hypotheses32222211
    Trial design3aDescription of trial design (such as parallel, factorial) including allocation ratio3223Missing2MissingMissing
    3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasonsMissingMissingMissingMissingMissingMissingMissingMissing
    Participants4aEligibility criteria for participants3222,3231,21
    4bSettings and locations where the data were collected3222Missing3MissingMissing
    Interventions5The interventions for each group with sufficient details to allow replication, including how and when they were actually administered422,332,3311
    Methods
    Outcomes6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessed4,523,43,43,4321
    6bAny changes to trial outcomes after the trial commenced, with reasonsMissingMissingMissingMissingMissingMissingMissingMissing
    Sample size7aHow sample size was determinedMissing3MissingMissing4MissingMissingMissing
    7bWhen applicable, explanation of any interim analyses and stopping guidelinesMissingMissingMissingMissingMissingMissingMissingMissing
    Randomization sequence generation8aMethod used to generate the random allocation sequenceMissing3Missing32MissingMissingMissing
    8bType of randomization; details of any restriction (such as blocking and block size)MissingMissing23MissingMissingMissingMissing
    Allocation concealment mechanism9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assignedMissing3Missing3MissingMissingMissingMissing
    Implementation10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventionsMissingMissingMissing3MissingMissingMissingMissing
    Blinding11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and howMissing3Missing3Missing21Missing
    11bIf relevant, description of the similarity of interventionsMissing3Missing3Missing31Missing
    Statistical methods12aStatistical methods used to compare groups for primary and secondary outcomes5344432Missing
    12bMethods for additional analyses, such as subgroup analyses and adjusted analysesMissing3MissingMissingMissingMissingMissingMissing
    Results
    Participant flow (a diagram is strongly recommended)13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome53,434,54,5,1142Missing
    13bFor each group, losses and exclusions after randomization, together with reasons53,434,54,5,1142Missing
    Recruitment14aDates defining the periods of recruitment and follow-up53Missing2MissingMissingMissingMissing
    14bWhy the trial ended or was stoppedMissing354MissingMissingMissingMissing
    Baseline data15A table showing baseline demographic and clinical characteristics for each group11446Missing4MissingMissing
    Numbers analyzed16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups5,63,44,54,5Missing422
    Outcomes and estimation17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)6,73,554,5,6Missing4MissingMissing
    17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommendedMissing35MissingMissingMissingMissingMissing
    Ancillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratoryMissing3MissingMissingMissingMissingMissingMissing
    Harms19All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)Missing3Missing6,8MissingMissingMissingMissing
    Discussion
    Limitations20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses85,68,9986,7Missing2
    Generalizability21Generalizability (external validity, applicability) of the trial findingsMissingMissingMissingMissingMissingMissingMissingMissing
    Interpretation22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence7,858,97,8,97632
    Other information
    Registration23Registration number and name of trial registry11,231,221MissingMissing
    Protocol24Where the full trial protocol can be accessed, if availableMissing1MissingMissingMissing2MissingMissing
    Funding25Sources of funding and other support (such as supply of drugs), role of funders9691086MissingMissing
    Overall CONSORT score (out of 37)183121281421128
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