CONSORT Statement 2001 - Checklist
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Transcript of CONSORT Statement 2001 - Checklist
8/12/2019 CONSORT Statement 2001 - Checklist
http://slidepdf.com/reader/full/consort-statement-2001-checklist 1/2
UNIVERSIDAD INDUSTRIAL DE SANTANDERFACULTAD DE SALUDDEPARTAMENTO DE SALUD PÚBLICAESCUELA DE MEDICINAEPIDEMIOLOGÍA ANALÍTICA
Esta es la lista de cheq e! "a#a la #e$isi%& de l!s a#t'c l!s q e #e"!#ta&#es ltad!s de e&sa(!s cl'&ic!s c!&t#!lad!s aleat!#i)ad!s*
CONSORT State+e&t ,--. / Chec0listItems to include when reporting a randomized trial
PAPER SECTION
And topicItem Descriptor Reported on
Page #TITLE & ABSTRACT 1 How participants were allocated to interventions (e.g ., "random
allocation", "randomized", or "randomly assigned").INTRODUCTION
Background2 Scienti ic !ackground and e planation o rationale .
METHODS#articipants
$ %ligi!ility criteria or participants and t&e settings and locationsw&ere t&e data were collected .
'nterventions #recise details o t&e interventions intended or eac& group and&ow and w&en t&ey were actually administered .
!*ectives + Speci ic o!*ectives and &ypot&eses .utcomes -learly de ined primary and secondary outcome measures and,
w&en applica!le, any met&ods used to en&ance t&e uality omeasurements (e.g. , multiple o!servations, training oassessors).
Sample size / How sample size was determined and, w&en applica!le,e planation o any interim analyses and stopping rules .
0andomization Se uence generation
3et&od used to generate t&e random allocation se uence,including details o any restrictions (e.g ., !locking, strati ication)
0andomization 4llocation
concealment
5 3et&od used to implement t&e random allocation se uence (e.g .,num!ered containers or central telep&one), clari ying w&et&er t&ese uence was concealed until interventions were assigned.
0andomization 'mplementation
16 7&o generated t&e allocation se uence, w&o enrolledparticipants, and w&o assigned participants to t&eir groups .
Blinding (masking) 11 7&et&er or not participants, t&ose administering t&einterventions, and t&ose assessing t&e outcomes were !linded togroup assignment . ' done, &ow t&e success o !linding wasevaluated .
Statistical met&ods 12 Statistical met&ods used to compare groups or primaryoutcome(s) 83et&ods or additional analyses , suc& as su!groupanalyses and ad*usted analyses.
RESULTS
#articipant low
1$ 9low o participants t&roug& eac& stage (a diagram is stronglyrecommended). Speci ically, or eac& group report t&e num!erso participants randomly assigned, receiving intended treatment,completing t&e study protocol, and analyzed or t&e primaryoutcome. :escri!e protocol deviations rom study as planned,toget&er wit& reasons .
0ecruitment 1 :ates de ining t&e periods o recruitment and ollow up .Baseline data 1+ Baseline demograp&ic and clinical c&aracteristics o eac& group .
;um!ers analyzed 1 ;um!er o participants (denominator) in eac& group included in
8/12/2019 CONSORT Statement 2001 - Checklist
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eac& analysis and w&et&er t&e analysis was !y "intention totreat" . State t&e results in a!solute num!ers w&en easi!le ( e.g .,16<26, not +6=).
utcomes andestimation
1/ 9or eac& primary and secondary outcome, a summary o resultsor eac& group, and t&e estimated e ect size and its precision
(e.g. , 5+= con idence interval).
4ncillary analyses 1 4ddress multiplicity !y reporting any ot&er analyses per ormed ,including su!group analyses and ad*usted analyses, indicatingt&ose pre speci ied and t&ose e ploratory.
4dverse events 15 4ll important adverse events or side e ects in eac& interventiongroup .
DISCUSSION 'nterpretation
26 'nterpretation o t&e results , taking into account study&ypot&eses, sources o potential !ias or imprecision and t&edangers associated wit& multiplicity o analyses and outcomes.
>eneraliza!ility 21 >eneraliza!ility (e ternal validity) o t&e trial indings .verall evidence 22 >eneral interpretation o t&e results in t&e conte t o current
evidence .
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