Klevens 2012a.
Methods | Study design: randomised controlled trial Randomisation method: the audio computer‐assisted self interview computer program applied simple randomisation (simple randomisation was written into the code of the software program), which facilitated individual randomisation of women to 1 of 3 trial arms Power calculation: none provided Study dates: from 22 April 2008 to 26 September 2008 |
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Participants | Setting: women's health clinics (obstetrical, gynaecological, and family planning clinics) at a public hospital Country: USA Inclusion criteria: females, at least 18 years of age Exclusion criteria: women who did not speak English; were accompanied by their partner or a child over 3 years of age; who were visually, hearing, or mentally impaired; women who had no access to a telephone or were over 36 weeks pregnant Number (%) of eligible recruited: 126/228 (55%) Numbers recruited 126: intervention group 46, control group 80 Number of dropouts: 24; intervention group 10, control group 14 Numbers analysed (% recruited): 102; intervention group 36 (78%), control group 66 (83%) Age: mean 35.8 years (SD 14.4 years) Ethnicity: 6.3% White, 78.6% Black, 11.9% Latino, 3.2% Asian Education background: ≤ high school 42.4%, ≤ college/vocational training 41.9% Insurance status: Medicaid/care 37.3%, private insurance 5.6%, uninsured 57.1% |
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Interventions | Intervention group
Control group The study authors combined the 2 A‐CASI arms
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Outcomes | Primary outcomes 3 screening outcomes:
Referral outcomes:
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Notes | Funding: Centers for Disease Control and Prevention | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomisation was written into the code of the computer program used to screen women and individually assigned participants to 1 of the 3 trial arms |
Allocation concealment (selection bias) | Low risk | Research assistants obtained informed consent from participants prior to any knowledge of the allocation. The allocation was revealed to the participant directly via the computer program used to conduct the health interview |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded. While any impact of non‐blinding on performance was likely to have been low in the pure A‐CASI condition, the potential for involvement of HCPs in the other 2 arms may have influenced the performance of participants especially in the face‐to‐face arm |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Except for data on women's contact with local advocacy services, which was provided by blinded advocacy staff, assessment of outcomes was not blinded. The research assistant collecting the data was aware of the assignment of individuals and therefore there was potential for introducing a bias into the assessment of outcomes. Also "HCPs were asked to respond to a checklist for compliance with the screening and referral protocol, HCPs were not actually observed to establish the validity of this checklist and the accuracy of their reporting" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Participants lost to follow‐up were similar in level of education and insurance status, but were significantly younger. However, there were no differences between assigned study groups for demographic characteristics among the 24 women lost to follow‐up" |
Selective reporting (reporting bias) | Unclear risk | None noted but study protocol not available. Study was not registered |
Other bias | High risk | Protection against contamination: there was a high risk of potential for contamination across conditions given that all 3 conditions were delivered in the same clinics. Also, a decision was made to combine data from the 2 A‐CASI (A‐CASI with HCP endorsement and A‐CASI alone) arms in the analysis; it is unclear if this was a decision made a priori. It is possible that such a measure could have led to contamination given the similarities between A‐CASI with HCP endorsement and the HCP alone conditions |