Van Peperstraten 2010.
| Methods | Randomized to decision aid vs usual care | |
| Participants | 152 + 156 infertile women on wait list for in vitro fertilization in the Netherlands | |
| Interventions | DA: self‐administered booklet on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, guidance (step‐by‐step process for making decision, worksheet with questions relevant to decision‐making process; 1 or more questions that asked patients to clarify their preferences; summary to be shared with practitioner), coaching (by trained in vitro fertilization nurse) + standard in vitro fertilization care Comparator: standard in vitro fertilization care, including a session in which the number of embryos transferred was discussed |
|
| Outcomes | Primary outcomes: actual choice (postintervention and consult) Secondary outcomes: knowledge (pre, post‐DA and consult), empowerment (pre, post‐DA and consult), participation in decision making, decisional conflict (post‐DA and consult), levels of anxiety (pre, post‐DA and consult), depression (pre, post‐DA and consult), cost evaluation of empowerment strategy (post‐DA and consult), condition‐specific health outcomes (pregnancies) (post‐DA and consult) |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated list (p 2, Methods section) |
| Allocation concealment (selection bias) | Low risk | Central allocation (p 2, Methods section) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Because of the nature of the intervention it was not possible to blind the participants or in vitro fertilisation doctors to the allocation. Participation in our trial did not change the normal in vitro routine." (p 2, Methods section) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes assessed were not subjective to interpretation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There are categories in each column of table 1 (p 3) where the denominators do not match the number of people in the group and no reason was given to explain why this would be or if this affects the study |
| Selective reporting (reporting bias) | Low risk | Outcomes same as those registered with ClinicalTrials.gov |
| Other bias | Low risk | The study appear to be free of other sources of bias |