Kasper 2008.
Methods | Randomized to decision aid vs usual care | |
Participants | 150 + 147 multiple sclerosis patients considering immunotherapy in Germany | |
Interventions | DA: booklet and worksheet on options' outcomes, clinical problem, outcome probabilities, explicit values clarification (based on IPDAS) Comparator: information material on immunotherapy (80 pages) |
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Outcomes | Primary outcomes: role in decision making Secondary outcomes: choice, feeling undecided, helpfulness with making a decision, attitudes toward immunotherapy, expectations of side effects realized at 6 months |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[A]llocation using computer generated random numbers" (p 5) |
Allocation concealment (selection bias) | Unclear risk | Randomization was carried out by concealed allocation, but method of concealment was not described (p 2, Assignment) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were not told whether the information they received was standard information or the newly developed DA (p 3, Masking) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors were not told whether the information they received was standard information or the newly developed DA (p 3, Masking) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow of participants (p 2, Fig 1); baseline data/characteristics included |
Selective reporting (reporting bias) | Low risk | "The protocol of this study has been published with the trial registration at http://controlled‐trials.com/ ISRCTN25267500" (p 2) |
Other bias | Unclear risk | Difference in preferred interaction style between groups at baseline (P value 0.04) (p 5) |