Castaño 2012.
Methods | Single site, parallel group, RCT Location: Brooklyn, NY, USA Time frame: enrolment from March 2008 to July 2009 Sample size calculation (and outcome of focus): detect 10% change in OC continuation between groups, assuming 40% continuation at 6 months in routine‐care group; N = 480 needed in each group |
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Participants | General with N: 962 women younger than 25 years
Source: family planning health centre Inclusion criteria:
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Interventions | Intervention:
Comparison:
Follow‐up: 6 months by telephone |
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Outcomes | OC continuation (participant had taken pill during the last 7 days), missed pills, interruptions in OC use > 7 days, use of OC at last sexual intercourse. Follow‐up: 6 months by telephone |
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Notes | Intention‐to‐treat analysis used Trial registration: ClinicalTrials.gov NCT 00677703 Funding: Trial was supported by grants from Affinity Health Plan Making a World of Difference Grant Program, William and Flora Hewlett Foundation. Declarations of interest: Two authors were advisory board members of pharmaceutical companies. The remaining authors did not report any potential conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table used with blocks of four |
Allocation concealment (selection bias) | Low risk | Opaque, sequentially‐numbered, sealed envelopes. Investigators masked to allocation while randomizing |
Blinding of participants and personnel (performance bias) All outcomes | High risk | None used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up: 28% for treatment and 30% for control |
Selective reporting (reporting bias) | Low risk | All outcomes prespecified in the protocol registered with ClinicalTrials.gov were reported on (in two publications) |
Other bias | Unclear risk | Did not report objective outcome measures |