Berry 2013.
Methods | Randomized to decision aid vs usual care | |
Participants | 266 + 228 men considering prostate cancer treatment in the USA | |
Interventions | DA: interactive web based video on options' outcomes, clinical problem, outcome probabilities, others' opinion, guidance (list of questions to ask doctor and automated summary) Comparator: usual care |
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Outcomes | Primary outcome: decisional conflict Secondary outcome: preferred/actual treatment choice (pre‐ and post‐DA), proportion undecided Other outcomes (Bosco 2012): choice concordance (6 months post‐DA). (Data from 239 + 209 men) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Methods section‐ second paragraph, p 3: "Participants were randomized automatically by the P3P application to study groups (1:1 using a simple randomization scheme with no blocking)" |
Allocation concealment (selection bias) | Low risk | Methods section, p 3: "Participants were randomized automatically by the P3P application to study groups" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were not blinded and study does not address the effect on the results |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear whether outcome assessors are blinded, but outcomes are not subject to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Used intention‐to‐treat analysis and low dropout (p 4) |
Selective reporting (reporting bias) | Low risk | Protocol made available |
Other bias | Unclear risk | Was a multicentre trial which could have lead to contamination, protocol violation and biased questionnaire completion |