Knops 2014.
Methods | Randomized to decision aid vs usual care | |
Participants | 91 + 87 patients with asymptomatic abdominal aortic aneurysm considering elective surgery vs watchful waiting | |
Interventions | DA: interactive CD‐ROM on options' outcomes, clinical problem, outcome probabilities, explicit values clarification Comparator: usual care with regular information |
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Outcomes | Primary outcomes: decisional conflict (baseline, 1, 4, and 10 months) Secondary outcomes: patient knowledge (baseline and 1 month), anxiety (baseline, 1, 4, and 10 months), satisfaction with conversation with the surgeon (baseline and 1 month), final treatment choice (10 months), aneurysm rupture (10 months), possible date of surgery (10 months), postoperative morbidity and mortality (10 months), physical quality of life (baseline, 1, 4, and 10 months) |
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Notes | Trial registration: NTR1524 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer‐generated randomisation ALEA v.2.2, NKI‐AVL, the Netherlands) was performed by the investigators" (p 2) |
Allocation concealment (selection bias) | Low risk | "Computer‐generated randomisation ALEA v.2.2, NKI‐AVL, the Netherlands) was performed by the investigators" (p 2) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Patients and investigators could not be blinded after group assignment, a factor which is inherent to the decision aid and the design of the study. Surgeons and nurses involved in the outpatient care of the participants were blinded to the patient's allocation group, although patients were not prohibited from sharing their allocation with them." (p 3) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome measurement is not likely to be influenced by lack of blinding as all outcomes were measured objectively using validated scales and data retrieved from medial records. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to have similar attrition between groups. The proportion of values missing varied from 2% to 9% per outcome measure. Missing values were completed by multiple imputation analysis. If one of the outcome measures had more than 25% missing values, that outcome measure for that patient was excluded from analysis. Therefore, missing data have been handled appropriately (p 3). |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make judgment |
Other bias | High risk | "Considerable number of patients could not be included, were not asked to participation, or declined to participate. Selection bias may have occured in patients that were not included" (p 6) "Both patients and surgeons were aware of the aim and subject of the study and could not be blinded to the allocation. It is possible that surgeons in the contributing centres offered more than average information to their patients" (p 6). Performance bias may have been introduced in terms of altered communication style. |