CONSORT 2010 checklist of information to include when reporting a randomised trial*

Section/Topic
Title and abstract 1a 1b Introduction ac!ground and ob"ecti#es Methods Trial design Identification as a randomised trial in the title Structured summary of trial design, methods, results, and conclusions
guidance see CONSORT for abstracts) (for specific

Item No Checklist item

Reported on page No

$a $b &a &b *a *b , -a -b 1a 1b 6a 6b 9

Scientific bac!ground and e%planation of rationale Specific ob"ecti#es or hypotheses 'escription of trial design (such as parallel, factorial) including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria), (ith reasons +ligibility criteria for participants Settings and locations (here the data (ere collected The inter#entions for each group (ith sufficient details to allo( replication, including ho( and (hen they (ere actually administered Completely defined pre.specified primary and secondary outcome measures, including ho( and (hen they (ere assessed /ny changes to trial outcomes after the trial commenced, (ith reasons 2o( sample si0e (as determined 3hen applicable, e%planation of any interim analyses and stopping guidelines 7ethod used to generate the random allocation se5uence Type of randomisation8 details of any restriction (such as bloc!ing and bloc! si0e) 7echanism used to implement the random allocation se5uence (such as se5uentially numbered containers), describing any steps ta!en to conceal the se5uence until inter#entions (ere assigned 3ho generated the random allocation se5uence, (ho enrolled participants, and
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)articipants Inter#entions Outcomes

Sample si0e Randomisation4 Se5uence generation /llocation concealment mechanism Implementation

CONSORT 2010 checklist

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linding

11a 11b 1$a 1$b 1&a 1&b 1*a 1*b 1, 111a 11b

Statistical methods Results )articipant flo( (a diagram is strongly recommended) Recruitment aseline data Numbers analysed Outcomes and estimation

(ho assigned participants to inter#entions If done, (ho (as blinded after assignment to inter#entions (for e%ample, participants, care pro#iders, those assessing outcomes) and ho( If rele#ant, description of the similarity of inter#entions Statistical methods used to compare groups for primary and secondary outcomes 7ethods for additional analyses, such as subgroup analyses and ad"usted analyses ;or each group, the numbers of participants (ho (ere randomly assigned, recei#ed intended treatment, and (ere analysed for the primary outcome ;or each group, losses and e%clusions after randomisation, together (ith reasons 'ates defining the periods of recruitment and follo(.up 3hy the trial ended or (as stopped / table sho(ing baseline demographic and clinical characteristics for each group ;or each group, number of participants (denominator) included in each analysis and (hether the analysis (as by original assigned groups ;or each primary and secondary outcome, results for each group, and the estimated effect si0e and its precision (such as 9,< confidence inter#al) ;or binary outcomes, presentation of both absolute and relati#e effect si0es is recommended Results of any other analyses performed, including subgroup analyses and ad"usted analyses, distinguishing pre.specified from e%ploratory /ll important harms or unintended effects in each group (for specific guidance see CONSORT
for harms)

/ncillary analyses 2arms Discussion =imitations >eneralisability Interpretation Other information Registration )rotocol
CONSORT 2010 checklist

16 19

$: $1 $$

Trial limitations, addressing sources of potential bias, imprecision, and, if rele#ant, multiplicity of analyses >eneralisability (e%ternal #alidity, applicability) of the trial findings Interpretation consistent (ith results, balancing benefits and harms, and considering other rele#ant e#idence Registration number and name of trial registry 3here the full trial protocol can be accessed, if a#ailable
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$& $*

;unding

$,

Sources 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 E !lanation and Ela"oration #or im!ortant clari#ications on all the items$ %# rele&ant' we also recommend reading CONSORT e tensions #or cluster randomised trials' non(in#eriority and e)ui&alence trials' non(!harmacological treatments' her"al inter&entions' and !ragmatic trials$ *dditional e tensions are #orthcoming+ #or those and #or u! to date re#erences rele&ant to this chec,list' see www$consort(statement$org$

CONSORT 2010 checklist

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