Methods |
Randomised clinical trial. |
Participants |
Country: Germany.
Number randomised: 259.
Post‐randomisation drop‐outs: 47 (18.1%).
Revised sample size: 212.
Mean age: 53 years.
Females: 148 (69.8%).
Inclusion criteria
1. Patients undergoing laparoscopic cholecystectomy for cholecystolithiasis. |
Interventions |
Participants were randomly assigned to 1 of 2 groups.
Group 1: patient education (n = 114).
Further details: multimedia DVD programme.
Group 2: standard care (n = 98). |
Outcomes |
Patient satisfaction and patient knowledge. |
Notes |
Authors contacted in April 2013. They replied in April 2013.
Reasons for post‐randomisation drop‐outs: did not return questionnaire (groups not stated). |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation |
Low risk |
Quote: "All patients were assigned randomly to either the DVD or the control group using a specifically built randomisation list and after having given informed consent concerning participating the study"; "We used a computer generated randomization list" (author replies).
Comment: The information about the random list was generated was not stated. |
Allocation concealment |
Unclear risk |
Comment: This information was not available. |
Blinding of participants and personnel |
High risk |
Comment: It is impossible to blind the patients to the groups. |
Blinding of outcome assessors |
Low risk |
Quote: "Those who assessed the patients' education level did not have any information concerning the allocation to the respective study arms" (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 |
Low risk |
Quote: "There was no funding of the study, the study was conducted as an internal project and in cooperation with the department of media sciences of the LMU Munich" (author replies). |