| Methods |
Randomised clinical trial. |
| Participants |
Country: Germany.
Number randomised: 80.
Post‐randomisation drop‐outs: 4 (5%).
Revised sample size: 76.
Mean age: 55 years.
Females: 47 (61.8%).
Inclusion criteria
1. Patients admitted for elective laparoscopic cholecystectomy.
2. Capable of understanding the printed literature in German.
3. Age > 18 years.
Exclusion criteria
1. Patients undergoing emergency surgery or open cholecystectomy.
2. Cholecystectomy performed during another operation. |
| Interventions |
Participants were randomly assigned to 1 of 2 groups.
Group 1: patient education (n = 35).
Further details: computer‐based multimedia programme.
Group 2: standard care (n = 41). |
| Outcomes |
Patient anxiety and patient knowledge. |
| Notes |
Authors contacted in April 2013. They replied in April 2013.
Reasons for post‐randomisation drop‐outs: refusal to participate (2 in intervention group and 1 in control group); unreadable questionnaire (1 in intervention group). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation |
Low risk |
Quote: "Once the patient name was registered at Study headquarters, a random list was used to assign patients to the standard or Multimedia‐Based Information Program (MM‐IP) groups." |
| Allocation concealment |
Unclear risk |
Quote: "The patients were selected for participating in this study by the physician of the hospital. He informed the study‐nurse. The study nurse asked for the next envelope from central point" (author replies). |
| Blinding of participants and personnel |
High risk |
Comment: It is impossible to blind the patients to the groups. |
| Blinding of outcome assessors |
Unclear risk |
Quote: "Patients answered to the questions, but there was no blinding" (author replies). |
| Incomplete outcome data addressed
All outcomes |
High risk |
Comment: There were post‐randomisation drop‐outs. |
| Free of selective reporting |
High risk |
Comment: Important outcomes such as patient mortality and morbidity were not reported. |
| For‐profit bias |
Unclear risk |
Comment: This information was not available. |
