Ethics. Research. Community.

The new consent form: is it any better?

Annals of the Royal College of Surgeons of England. 
[Record Source: PubMed]
BACKGROUND: 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. AIM: To compare the efficacy of the new consent form with the old on the quality of consent. METHODS: 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. RESULTS: 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%). DISCUSSION AND CONCLUSIONS: 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.
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