No / Check list / Reported on page No
Title and Abstract
Titleand
Abstract / 1 / Informationonhowunitwereallocatedtointerventions
Structured abstractrecommended
Informationontargetpopulationor studysample
Introduction
Background / 2 / Scientificbackgroundandexplanationofrationale
Theoriesused indesigningbehavioralinterventions
Methods
Participants / 3 / Eligibilitycriteria for participants,includingcriteriaat differentlevelsin recruitment/samplingplan(e.g., cities, clinics,subjects)
Methodof recruitment (e.g., referral,self-selection), includingthe sampling methodif asystematicsamplingplanwas implemented
Recruitmentsetting
Settings andlocationswherethe datawere collected
Interventions / 4 / Detailsoftheinterventionsintended for each studyconditionandhow andwhen theywereactuallyadministered,specificallyincluding:
oContent:whatwasgiven?
oDelivery method:howwasthe content given?
oUnit ofdelivery:howwerethe subjectsgrouped duringdelivery?
oDeliverer:whodelivered theintervention?
oSetting:wherewastheinterventiondelivered?
oExposurequantityandduration:howmanysessionsor episodesor eventswereintended tobedelivered?Howlong werethey
intendedtolast?
oTimespan:howlongwasitintended totaketodeliverthe interventiontoeachunit?
oActivitiestoincreasecompliance oradherence(e.g., incentives)
Objectives / 5 / Specificobjectivesandhypotheses
Outcomes / 6 / Clearlydefined primaryandsecondaryoutcomemeasures
Methods usedtocollectdataandany methodsused to enhancethe quality ofmeasurements
Informationonvalidatedinstrumentssuchas psychometricandbiometric properties
Sample Size / 7 / Howsamplesizewasdetermined and,when applicable,explanationof any interimanalysesandstoppingrules
Assignment
Method / 8 / Unit ofassignment(the unitbeingassignedto studycondition,e.g., individual,group, community)
Methodusedtoassignunits tostudyconditions, includingdetails ofany restriction(e.g., blocking, stratification,minimization)
Inclusionofaspectsemployed tohelpminimizepotential bias induced due tonon-randomization(e.g.,matching)
Blinding
(masking) / 9 / Whetheror notparticipants, thoseadministeringthe interventions,and thoseassessingtheoutcomeswereblinded tostudyconditionassignment; if so,statement regardinghowthe blindingwas accomplishedandhowit wasassessed.
Unit ofAnalysis / 10 / Descriptionof thesmallest unit thatis beinganalyzedtoassess interventioneffects(e.g., individual, group,or community)
If the unitof analysis differs from theunitof assignment,the analytical methodusedtoaccountfor this (e.g., adjustingthestandarderror estimatesbythe designeffector usingmultilevelanalysis)
Statistical
Methods / 11 / Statisticalmethodsused tocomparestudygroups forprimary methods outcome(s), includingcomplexmethods of correlateddata
Statisticalmethodsused for additional analyses,suchas asubgroup analysesandadjustedanalysis
Methods for imputingmissingdata, if used
Statisticalsoftwareor programs used
Results
Participantflow / 12 / Flowofparticipantsthrougheachstageof thestudy:enrollment, assignment,allocation, andinterventionexposure,follow-up, analysis (a diagramisstronglyrecommended)
oEnrollment:thenumbersof participantsscreened foreligibility, foundtobeeligible ornoteligible, declinedtobeenrolled, and
enrolled inthe study
oAssignment: thenumbersof participants assignedtoa study condition
oAllocationandinterventionexposure:thenumberof participants assigned to eachstudyconditionandthe numberofparticipants
whoreceivedeach intervention
oFollow-up: thenumberofparticipantswhocompletedthe follow- upor didnotcompletethefollow-up(i.e., lost tofollow-up),by studycondition
oAnalysis:the numberof participantsincludedinorexcluded from themainanalysis, bystudycondition
Descriptionof protocol deviations fromstudyasplanned, alongwith reasons
Recruitment / 13 / Dates definingtheperiodsof recruitment andfollow-up
BaselineData / 14 / Baselinedemographicandclinical characteristicsofparticipantsin each studycondition
Baselinecharacteristicsforeach studyconditionrelevanttospecific diseasepreventionresearch
Baselinecomparisons ofthoselosttofollow-upandthoseretained,overall andbystudycondition
Comparisonbetweenstudypopulationatbaselineandtargetpopulation of interest
Baseline equivalence / 15 / Dataonstudygroupequivalenceatbaselineandstatisticalmethods used tocontrol for baselinedifferences
Numbers
analyzed / 16 / Numberof participants (denominator)included ineachanalysis for each studycondition,particularly whenthedenominators changefor different outcomes;statementoftheresultsin absolutenumberswhen feasible
Indicationofwhetherthe analysis strategy was“intention to treat”or, if
not,descriptionofhownon-compliersweretreatedintheanalyses
Outcomes and
estimation / 17 / For each primaryandsecondary outcome, asummary ofresults for each estimationstudycondition, andtheestimatedeffectsizeandaconfidence intervaltoindicatetheprecision
Inclusionofnull andnegativefindings
Inclusionofresultsfromtestingpre-specifiedcausal pathwaysthrough whichtheinterventionwasintended tooperate,if any
Ancillary
analyses / 18 / Summaryofotheranalysesperformed,includingsubgrouporrestricted analyses,indicatingwhichare pre-specifiedor exploratory
Adverse events / 19 / Summaryof all importantadverse eventsorunintendedeffects in each studycondition(includingsummarymeasures,effectsizeestimates,and confidenceintervals)
DISCUSSION
Interpretation / 20 / Interpretationof theresults, takingintoaccountstudyhypotheses,
sourcesofpotential bias, imprecisionofmeasures, multiplicativeanalyses,
andotherlimitationsorweaknessesofthestudy
Discussionofresults takingintoaccountthemechanismbywhichthe interventionwasintendedto work(causal pathways)or alternative mechanismsorexplanations
Discussionofthe successof andbarriers toimplementingtheintervention, fidelityof implementation
Discussionofresearch, programmatic,or policyimplications
Generalizability / 21 / Generalizability(externalvalidity)of thetrial findings,takingintoaccount the studypopulation, thecharacteristicsof theintervention, length of follow-up, incentives, compliancerates, specificsites/settings involved in the study, and othercontextual issues
Overall
Evidence / 22 / General interpretationof theresultsin the contextofcurrent evidence andcurrenttheory
From:DesJarlais,D.C., Lyles,C., Crepaz, N.,theTrendGroup(2004). Improvingthereportingqualityof nonrandomized evaluations of behavioralandpublichealth interventions: TheTRENDstatement.AmericanJournal of Public Health, 94,361-366.Formoreinformation, visit: