Zhu 2009.
Methods | Design: cluster RCT Location: Beijing, Shanghai, and Zhengzhou (China); 8 abortion clinics (hospitals) per city Time frame: May to November 2006 Sample size estimation and outcome of focus: based on simulations for varying rates of contraceptive use (0%, 5%, or 10%), needed ≥ 60 women; 80% power when effect size > 10% in contraceptive use. For 25% loss to follow‐up, needed 1800 participants; 900 each arm Cluster randomized trial: 24 hospitals (8 per city) matched in pairs (characteristics of clinics, mainly abortion in 2005; "no substantial difference" in characteristics of women); randomly assigned to 1 of 2 intervention packages 8 pairs of hospitals in analysis: 2 Beijing; 4 Shanghai; 2 Zhengzhou 5 hospitals did not follow randomization protocol; 4 pairs of hospitals ineligible for analysis |
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Participants | General with N: 16 hospitals; 2336 women who requested abortion in 2‐month period Inclusion criteria: < 25 years old; first trimester of pregnancy; seeking abortion Exclusion criteria: no information |
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Interventions | Study focus: improve contraceptive use and reduce repeat abortion rate Theory or model: none apparent; interventions adapted for cultural and socioeconomic appropriateness Provider training for both groups; service guidelines and training module
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Outcomes | Primary (questionnaire): contraceptive use; use of more effective contraceptive methods (condoms, OCs, IUDs and implants); regular intake of OCs among OC users; consistent and correct use of condoms among condom users; pregnancy; repeat induced abortion during follow‐up plus unwanted pregnancies (counted once) Secondary: knowledge of contraception (13 items); postabortion family planning services received; patient satisfaction with clinic services Follow‐up: 6 months (mostly by phone) |
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Notes | Data collected before randomization of hospitals and after intervention implementation. Analysis: Investigators used conditional logistic regression to account for hospital matching and robust variance estimates to account for baseline differences. Final models adjusted for potential confounding factors showed significant effects. Investigators estimated relative effects using an interaction term to account for baseline differences. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization via coin tossing by "neutral person" not involved in study at 1 research center 5 hospitals did not follow randomization protocol, therefore 4 pairs of hospitals ineligible for analysis 8 pairs of hospitals in analysis: Beijing 2; Shanghai 4; Zhengzhou 2 |
Allocation concealment (selection bias) | Unclear risk | Cluster randomization with matching of hospitals as above; no further information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Presume no blinding of participant or provider; not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Interviewers not blinded to intervention group |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: special intervention 44% (473/1065); comparison 40% (372/927) |
DMPA: depot medroxyprogesterone acetate IUD: intrauterine device LARC: long‐acting reversible contraception OC: oral contraceptive OR: odds ratio RCT: randomized controlled trial STI: sexually transmitted infection