国际医学研究报告清单和规范.docx

《国际医学研究报告清单和规范.docx》由会员分享，可在线阅读，更多相关《国际医学研究报告清单和规范.docx（29页珍藏版）》请在第一文库网上搜索。

1、目录1-CONSORT Checklist-1缶床干预T生试验21-CONSORT Flow Diagram42Trend“缶乐HE随机干预T生试马佥53-STROBE Checklist 观察性研究才艮告84-STARD Checklist 诊断牛生研究才艮告1OSTARD Checklist for Reporting of Studies of Diagnostic Accuracy1O4-STARD Flow Diagram1 15-CAR.E Checklist 案伶时艮告126- AGREE-Reporting-Checklist临床指南137- CHEERS Checklist

2、干预研究卫生经济学178- ARRIVE 动物试哙国际才艮告才旨南209-PRISN1A Checklist 干预性 meta 分析221 O-MOOSE Checklist X!H,hmeta3*251-CONSORT Checklist临床干预性试验CONSORT 2010 checklist of information to include when reporting a randomised trial*Section/TopicItemNoChecklist ItemReportedon page NoTitle and abstract1a1bIntroductionBackg

3、round and2aobjectives2bMethodsTrial designParticipants3a3b4a4bInterventions 5Outcomes6bo 1 .7aSample size-7bRandomisation:Sequence8ageneration8bAllocationconcealment9mechanismImplementation10Identification as a randomised trial in the titleStructured summary of trial design, methods, results, and co

4、nclusions (for specific guidance see consort forabstracts)Scientific background and explanation of rationaleSpecific objectives or hypothesesDescription of trial design (such as parallel, factorial) including allocation ratioImportant changes to methods after trial commencement (such as eligibility

5、criteria), with reasonsEligibility criteria for participantsSettings and locations where the data were collectedThe interventions for each group with sufficient details to allow replication, including how and whenthey were actually administeredCompletely defined pre-specified primary and secondary o

6、utcome measures, including how and whenthey were assessedAny changes to trial outcomes after the trial commenced, with reasonsHow sample size was determinedWhen applicable, explanation of any interim analyses and stopping guidelinesMethod used to generate the random allocation sequenceType of random

7、isation; details of any restriction (such as blocking and block size)Mechanism used to implement the random allocation sequence (such as sequentially numberedcontainers), describing any steps taken to conceal the sequence until interventions were assignedWho generated the random allocation sequence,

8、 who enrolled participants, and who assignedparticipants to interventionsBlinding11aIf done, who was blinded after assignment to interventions (for example, participants, care providers,those assessing outcomes) and how11bIf relevant, description of the similarity of interventionsStatistical12aStati

9、stical methods used to compare groups for primary and secondary outcomesmethods12bMethods for additional analyses, such as subgroup analyses and adjusted analysesResultsParticipant flow (adiagram is strongly13aFor each group, the numbers of participants who were randomly assigned, received intendedt

10、reatment, and were analysed for the primary outcomerecommended)13bFor each group, losses and exclusions after randomisation, together with reasonsRecruitment14aDates defining the periods of recruitment and follow-up14bWhy the trial ended or was stoppedBaseline data15A table showing baseline demograp

11、hic and clinical characteristics for each groupNumbersanalysed16For each group, number of participants (denominator) included in each analysis and whether theanalysis was by original assigned groupsOutcomes andestimation17aFor each primary and secondary outcome, results for each group, and the estim

12、ated effect size and itsprecision (such as 95% confidence interval)17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommendedAncillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses,distinguishing pre-specified

13、 from exploratoryHarms19All important harms or unintended effects in each group (for specific guidance see consort for harms)DiscussionLimitations20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity ofanalysesGeneralisability21Generalisability (exter

14、nal validity, applicability) of the trial findingsInterpretation22Interpretation consistent with results, balancing benefits and harms, and considering other relevantevidenceOther informationRegistration23Registration number and name of trial registryProtocol24Where the full trial protocol can be ac

15、cessed, if availableFunding25Sources of funding and other support (such as supply of drugs), role of funders*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, wealso recommend reading CONSORT extensions for cluster randomised trials, non-inferi