Davidson 2015.
Methods | Design: individually randomized Location: Chicago, IL (USA) Time frame: June to September 2013 Sample size calculation (and outcome of focus): assumed LARC initiation immediately after abortion at 6% control and 21% intervention. To detect 15% increase in LARC initiation (from 6% to 21%) using 2‐sided alpha P = 0.05 and 80% power, 188 subjects needed (94 each arm). Due to protocol violations by interim analysis, recruited 5 additional participants |
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Participants | General with N: 191 participants (96 intervention; 95 control)
Inclusion criteria: English‐speaking women 18 to 29 years old; presenting for surgical abortion; not desiring pregnancy in next 12 months Exclusion criteria: nonviable or anomalous pregnancy; pregnancy as result of sexual assault; not English‐speaking |
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Interventions | Study focus: pregnancy prevention; initiate LARC after abortion Theory or model: Transtheoretical model (assumed most women seeking abortion in precontemplation or contemplation for LARC)
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Outcomes | Primary: initiation of LARC Secondary: NA Follow‐up: NA; immediately after abortion |
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Notes | Not included in this review: satisfaction (and perceived autonomy) survey regarding usual care counseling for both groups (5 items); groups did not differ significantly | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization (random.org); 1:1 allocation and blocks of 10 |
Allocation concealment (selection bias) | Low risk | Sequence entered into software (RedCap), which automatically randomized following baseline survey |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Counselors and clinicians blinded to study arm allocation Presume no blinding of participants; not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) | Low risk | No mention; initiation of LARC from medical records |
Outcome measures | Low risk | Contraceptive method selection from chart review |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: NA; method initiation assessed on same day as procedure Excluded after randomization: 1 did not have abortion and 1 ineligible due to age |
Other bias | Unclear risk | Analysis for cluster randomized trial: NA |