Pignone 2000.
Methods | Randomized to decision aid vs usual care | |
Participants | 125 + 124 adults considering colon cancer screening in the USA | |
Interventions | DA: video of options' outcomes, clinical problem, others' opinion Comparator: video on car safety | |
Outcomes | Primary outcome: uptake of options | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[C]omputerized random number generator" (p 2, Methods, Group assignment) |
Allocation concealment (selection bias) | Low risk | "[R]andomization was performed centrally and was not balanced among centers. Assignments were placed in sealed, opaque, sequentially numbered envelopes and were distributed to the three sites" (p 2, Methods, Group assignment) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "The providers and staff were not blinded to intervention status" "3 to 6 months after, different RA blinded to participant intervention examined clinic records" (p 2) Does not mention whether patients were blinded; unclear if lack of blinding contributed to potential risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | A different research assistant who was blinded to participants' intervention status examined participants' clinic records in a standardized and validated manner to determine whether colon cancer screening tests were actually completed within 3 months of the index visit. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Because of an administrative error, 18 controls did not complete the second and third questionnaires (p 4). |
Selective reporting (reporting bias) | Unclear risk | Protocol was not mentioned |
Other bias | Low risk | Baseline characteristics similar, appear to be no other potential sources of biases. Minimized bias from repeated measurements by administering the same questionnaires to the intervention and control participants |