Análisis del Sector

Bias domain Signaling questions Response Description/Support for judgement

Bias arising from the randomization process

1a.1 Was the allocation sequence random? Probably Yes Randomization was stratified by clinic size by a

computer-generated schedule by an independent statistician.

1a.2 Is it likely that the allocation sequence was subverted? No

1a.3Were there baseline imbalances that suggest a problem with the randomization process?

Probably No

Risk of bias judgement Low

Bias arising from the timing of identification and recruitment of individual participants in relation to timing of randomization

1b.1 Were all the individual participants identified before randomization of clusters (and if the trial specifically recruited patients were they all recruited before randomization of clusters)?

No Women were identified after randomization /

intervention. Unlikely that individuals were recruited based on the knowledge of the intervention.

1b.2 If N/PN/NI to 1b.1: Is it likely that selection of individual participants was

affected by knowledge of the intervention? Probably No

1b.3 Were there baseline imbalances that suggest differential identification or

recruitment of individual participants between arms? No Baseline characteristics balanced at study enrolment

Risk of bias judgement Low Low

Bias due to deviations from intended interventions

2.1a Were participants aware that they were in a trial? Yes Participants received a study flyer prior to being

invited to participate and screening. Intervention was provided to clinic, not the participants. 2.1b If Y/PY/NI to 2.1a: Were participants aware of their assigned intervention

during the trial? Probably No

2.2. Were carers and trial personnel aware of participants' assigned intervention during the trial?

Yes Yes, intervention directed at the clinicians 2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended

intervention beyond what would be expected in usual practice? Probably No Unlikely as it was just an education and technical program on LARC specific issues. 2.4. If Y/PY to 2.3: Were these deviations from intended intervention unbalanced

between groups and likely to have affected the outcome? NA

2.5a Were any clusters analysed in a group different from the one to which they

were assigned? No ITT analysis

2.5b Were any participants analysed in a group different from the one to which their original cluster was randomized?

No ITT analysis

2.6 If Y/PY/NI to 2.5: Was there potential for a substantial impact (on the

estimated effect of intervention) of analysing participants in the wrong group? NA

Bias due to missing outcome data

3.1a Were outcome data available for all, or nearly all, clusters randomized? Yes Data available for all clusters

Control: 698 patients enrolled (78 excluded) > 620 (89%) included in STI analysis (45 excluded) > 575 (82%) dual method use

Intervention: 802 patients enrolled (66 excluded) > 736 (92%) included in STI analysis (64 excluded) > (84%) 672 dual method use 3.1b Were outcome data available for all, or nearly all, participants within

clusters?

3.2 If N/PN/NI to 3.1a or 3.1b: Are the proportions of missing outcome data and reasons for missing outcome data similar across intervention groups?

NA 3.3 If N/PN/NI to 3.1a or 3.1b: Is there evidence that results were robust to the

presence of missing outcome data? NA

Risk of bias judgement Low

Bias in

measurement of the outcome

4.1a Were outcome assessors aware that a trial was taking place? Yes Outcome assessors were patients (self-report). No

information on whether assessors of medical record data for STI knew status.

4.1b If Y/PY/NI to 4.1: Were outcome assessors aware of the intervention

received by study participants? NI No information.

4.2 If Y/PY/NI to 4.1: Was the assessment of the outcome likely to be influenced

by knowledge of intervention received? Probably No

Risk of bias judgement Low Low for Dual Method / Some Concern for STI

Bias in selection of the reported result

Are the reported outcome data likely to have been selected, on the basis of the results, from...

5.1. ... multiple outcome measurements (e.g. scales, definitions, time points)

within the outcome domain? Probably No

5.2 ... multiple analyses of the data? Probably No

Risk of bias judgement Low

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