8/12/2019 CONSORT Statement 2001 - Checklist

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UNIVERSIDAD INDUSTRIAL DE SANTANDERFACULTAD DE SALUDDEPARTAMENTO DE SALUD PÚBLICAESCUELA DE MEDICINAEPIDEMIOLOGÍA ANALÍTICA

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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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