Lewis 2010.
Methods | Cluster‐randomized to decision aid vs usual care | |
Participants | 211 + 232 patients considering colorectal cancer screening in the USA | |
Interventions | DA: web‐based, DVD and VHS videotape formats + stage targeted brochures (and booster kit if patients had not been screened) on options' outcomes, clinical problem, outcome probabilities, others' opinion, guidance (encouraged patients to communicate with their practitioners by asking questions and sharing preferences; summary) Comparator: usual care using Aetna annual reminders to obtain CRC screening |
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Outcomes | Knowledge of the age at which screening should begin (post‐DA), completion of colorectal cancer screening (pre, post‐DA), intrusive thoughts (pre, post‐DA), interest in CRC screening (pre, post‐DA), intent to ask provider about screening (pre, post‐DA), readiness to be screened (pre, post‐DA), perceived risk of colon cancer (pre, post‐DA), general beliefs about colon cancer (pre, post‐DA), fears about colorectal cancer screening (pre, post‐DA), perceptions about whether participants had enough information (post‐DA), whether participants had enough information about specific screening tests (post‐DA), willingness to pay for screening tests (post), desire to participate in medical decision (post) Practice level measures: assess CRC screening practices (pre, post‐DA), referrals (pre, post‐DA), quality improvement initiatives |
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Notes | Primary outcome was not specified | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was done using matched pairs and a blocking procedure." (p 2, Practice recruitment and randomization section) |
Allocation concealment (selection bias) | Unclear risk | "Thus, purposive assignment to treatment group was used, resulting in a hybrid randomisation" (p 3, Practice recruitment and randomization section). There is no mention of the effect of this purposive assignment on the study |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | As mentioned above, staff used purposive assignment and were therefore not blinded, but there is no mention of the effect on the study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study did not address this outcome, but outcomes were objectively measured. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There appear to be no missing outcome data |
Selective reporting (reporting bias) | Unclear risk | No mention of study protocol |
Other bias | High risk | Unadjusted cluster analysis |