Jay 1984.
Methods | Single site, parallel group RCT Location: Children and Youth Project site in Augusta, GA, USA Time frame: no mention Sample size estimation and outcome of focus: no mention |
|
Participants | General with N: 57 adolescents randomized (participants were 14 to 19 years old) Inclusion criteria:
Exclusion criteria:
|
|
Interventions | Study focus: increasing OC adherence Intervention:
Comparison:
Both groups had 3 appointments. |
|
Outcomes | Primary:
Secondary:
Follow‐up: 4 months |
|
Notes | 31 (54%) subjects were assigned to the nurse‐counselor group, and 26 (46%) were assigned to the peer‐counselor group. 50% (28 or 29) of the participants were expected to be assigned to each group. A sampling error of this degree was not significant with a sample size of 57. Trial registration: no details Funding: funded in part by a grant from the Georgia Department of Human Services Declarations of interest: no details provided |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details provided of blinding of participants or providers; not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Urine samples for fluorescence: 3 independent observers evaluated in double‐blind fashion No details provided of blinding of self‐reported pregnancy and pill count for non‐adherence scale |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up: 33% overall; nurse‐counseled, 42%; peer‐counseled, 23% |
Selective reporting (reporting bias) | Unclear risk | No protocol was available, however the outcomes of compliance/non‐compliance prespecified in the manuscript were reported. |
Other bias | Low risk | Appeared free of other sources of bias |