The new consent form: is it any better?

The UK Department of Health (DoH) introduced a new consent form into the National Health Service (NHS) in April 2002 following the Bristol Royal Infirmary Inquiry.

To compare the efficacy of the new consent form with the old on the quality of consent.

A questionnaire consisting of 11 questions was distributed to two groups of 100 patients before and after the introduction of the new consent form in the pre-assessment clinic at Glenfield Hospital, Leicester.

Of the 11 questions, there were four significant differences that favoured the new consent form. These were: (i) success and benefits of the operation (old, 81%; new, 97%, P < 0.001; 95% CI, 7.3-24.4%); (ii) information that patients received about the operation from the doctor (old, 34%; new, 93%; P < 0.001; 95% CI, 46.7%-68.9%) and nurse (old, 21%; new, 67%; P < 0.001; 95% CI, 33.3-58.3%) in the pre-assessment clinic; (iii) postoperative recovery (old, 56%; new, 96%; P < 0.001; 95% CI, 30.0%-51.2%); and (iv) ability to list potential complications that could arise from the operation (old, 61%; new, 97%; P < 0.001; 95% CI, 26.4-52.6%). Despite the above differences, an overall assessment involving all questions failed to show a significant improvement with the new consent form (old, 57%; new, 67%; P = 0.264;, 95% CI, -35.6% to 12.6%).

The new consent form resulted in improvement in some, but not all, aspects of consent and no question reached the ideal standard of 100%. We suggest a formatted consent form for procedures in conjunction with additional information.