Transparent Reporting of Evaluations with Nonrandomized Designs (TREND)

TREND Statement Checklist: Non-randomised evaluations of behavioural and public health interventions

Sectin/Topic Item Check list Reported No on page No Title and Abstract Title and 1 Information on how unit were allocated to interventions Abstract Structured abstract recommended Information on target population or study sample Introduction Background 2 Scientific background and explanation of rationale Theories used in designing behavioral interventions Methods Participants 3 Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (e.g., cities, clinics, subjects) Method of recruitment (e.g., referral, self-selection), including the sampling method if a systematic sampling plan was implemented Recruitment setting Settings and locations where the data were collected Interventions 4 Details of the interventions intended for each study condition and how and when they were actually administered, specifically including: o Content: what was given? o Delivery method: how was the content given? o Unit of delivery: how were the subjects grouped during o Deliverer: who delivered the intervention? o Setting: where was the intervention delivered? o Exposure quantity and duration: how many sessions or episodes or events were intended to be delivered? How long were they intended to last? o Time span: how long was it intended to take to deliver the intervention to each unit? o Activities to increase compliance or adherence (e.g., Objectives 5 Specific objectives and hypotheses Outcomes 6 Clearly defined primary and secondary outcome measures Methods used to collect data and any methods used to enhance the quality of measurements Information on validated instruments such as psychometric and biometric properties Sample Size 7 How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules Assignment 8 Unit of assignment (the unit being assigned to study condition, e.g., Method individual, group, community) Method used to assign units to study conditions, including details of any restriction (e.g., blocking, stratification, minimization) Inclusion of aspects employed to help minimize potential bias induced due to non-randomization (e.g., matching) TREND Statement Checklist: Non-randomised evaluations of behavioural and public health interventions TREND Statement Checklist: Non-randomised evaluations of behavioural and public health interventions

Numbers 16 Number of participants (denominator) included in each analysis for each analyzed study condition, particularly when the denominators change for different outcomes; statement of the results in absolute numbers when feasible Blinding 9 WhetherIndicatio onr onfo wt partichetherip theant s,an talysishose asdtrmatiengisteriy wasng “ theint eninttieornv entito toreans,t” and or, if (masking) thnot,se d assescriessiptniogn t hoef ohuotwco nomnes-c womerpe lbierslind wedere to t restuadteyd cionnd thitie aonal yses Outcomes 17 assiForgnm eachent; prima if sory, staandte mseentcond regaaryrd oiuntgco hmoew, athe su blmindmairnyg o wf rasesu lts for each and aescctoimmatplishedion stud andy c hoondwit iito wasn, a nasd stesshe edst.imated effect size and a estimation confidence interval to indicate the precision Inclusion of null and negative findings Unit of 10 Description of the smallest unit that is being analyzed to assess Inclusion of results from testing pre-specified causal pathways through Analysis intervention effects (e.g., individual, group, or community) Ifwhich the u nthite o ifn taneravlentysisio dni ffewasrs inten fromd tedhe tuno oitp eraof ate,ssi ifgn amnyent, the analytical Ancillary 18 mSeutmmhoda urysed of toother acc oanaunlty fsoesr t hperfis (oer.gm.,ed, ad jincustiludngi nthge su stbgandroardup oerrr roers tricted analyses esantialysmates,s byind theicati dnesig gwnh eichffect are o prr use-spinge cifiedmultil eovr elexp anlalysis)oratory StatisticalAdverse 1119 StatisticalSummary mofe tallho dims pusedorta ntot acdovmersepare e svtentsudy ogr ouupnins tfeondr perimaryd effec tms einth eoadchs Meveentsthods ostuutcdoym ce(sond),iti inconlud (ininclgud comping sulexmm meatrhyo mdse asofu cres,orrel effateectd datasize estimates, and Statisticalconfidence m inteethordvsals) used for additional analyses, such as a subgroup DISCUSSION analyses and adjusted analysis Interpretation 20 MInettehropdretas fotiro inm opuf ttihneg resu misltss,in tgaki data,ng inif tusedo account study hypotheses, Statisticalsources o fs opfottwentialare o bir pars,o gimrapmreciss usedion of measures, multiplicative Results analyses, Discussion of results taking into account the mechanism by which the Participant 12 Flow of participants through each stage of the study: enrollment, intervention was intended to work (causal pathways) or alternative assignment, allocation, and intervention exposure, follow-up, analysis (a flow mechanisms or explanations diagram is strongly recommended) Discussion of the success of and barriers to implementing the o Enrollment: the numbers of participants screened for intervention, fidelity of implementation eligibility, found to be eligible or not eligible, declined to be enrolled, Discussion of research, programmatic, or policy implications and Generalizabil 21 oGeneralizabAssilityign (emxtenernt:al th veal nidumityb)e orsf othf epa trialrtici fipndanitngs assigs, takinedng to in ato s tudy ity cacondcoitiunotn the study population, the characteristics of the intervention, olength of foAllollwocat-upi,o incen andnt iinteves,r vceonmptiolian enxpceo ratsuree:s, tsphee cificnum bsierte os/fse ttings piarticinvolvpedan tsin assithe gnstueddy to, and each other stud cyo cnotenxdtitiualo niss andues the number of Overall 22 particGeneralipa nintsterpretation of the results in the context of current evidence Evidence oand current Folltheoorwy -up: the number of participants who completed the follow- up or did not complete the follow-up (i.e., lost to follow-up), by study condition o Analysis: the number of participants included in or excluded from the main analysis, by study condition Description of protocol deviations from study as planned, along with reasons Recruitment 13 Dates defining the periods of recruitment and follow-up Baseline 14 Baseline demographic and clinical characteristics of participants in each Data study condition Baseline characteristics for each study condition relevant to specific disease prevention research Baseline comparisons of those lost to follow-up and those retained, overall and by study condition Comparison between study population at baseline and target population of interest Baseline 15 Data on study group equivalence at baseline and statistical methods used equivalence to control for baseline differences