| Methods |
Randomised clinical trial. |
| Participants |
Country: USA.
Number randomised: 173.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 173.
Mean age: not stated
Females: not stated
Inclusion criteria
1. Patients undergoing various elective operations (only patients undergoing laparoscopic cholecystectomy were included for this review).
Exclusion criteria
1. Inability to give informed consent as a result of incompetence.
2. Requirement for surrogate consent.
3. Non‐elective surgery.
4. Patients requiring > 1 surgical procedure.
5. Refusal to participate.
6. Inability to communicate in the English language.
7. Severe visual problems that limited ability to read written material.
8. Severe psychiatric illness limiting ability to consent or to meet study requirements including uncontrolled depression, psychosis, schizophrenia, bipolar disorder, mania, schizoaffective disorder, or other serious psychiatric illness.
9. Ongoing substance abuse.
10. Patients previously consented for their procedure using iMedConsent, who had to be re‐consented due to the expiration of the surgical consent after 30 days (per Veterans Health Administration policy). |
| Interventions |
Participants were randomly assigned to 1 of 2 groups.
Group 1: electronic consent procedure with repeat‐back (n = 92).
Group 2: electronic consent without repeat‐back (n = 81). |
| Outcomes |
Patient knowledge. |
| Notes |
Authors contacted in April 2013. No replies were received. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation |
Low risk |
Quote: "Patients who gave consent and met eligibility criteria were randomized using an internet‐based program which used a concealed, computer‐generated simple randomization scheme without stratification." |
| Allocation concealment |
Low risk |
Quote: "The randomization sequence was concealed from each center's study personnel." |
| Blinding of participants and personnel |
High risk |
Comment: It is impossible to blind the patients to the groups. |
| Blinding of outcome assessors |
Unclear risk |
Comment: This information was not available. |
| Incomplete outcome data addressed
All outcomes |
Unclear risk |
Comment: This trial included different types of surgeries. While the post‐randomisation drop‐outs were presented in a flow‐chart, the types of procedures that these patients underwent were not stated and so it was impossible to determine whether there were any post‐randomisation drop‐outs in patients undergoing laparoscopic cholecystectomy. |
| Free of selective reporting |
High risk |
Comment: Important outcomes such as patient mortality and morbidity were not reported. |
| For‐profit bias |
Low risk |
Quote: "Supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (Project no. IAF 05–308–01)." |
