How informed is consent in a modern ENT department

The Department of Health issued a model consent form for use throughout the NHS from the 1st April 2002. Details of benefits and serious or frequent risks should be included on the form. We undertook a study to identify what proportion of complications from otolaryngology procedures were being recorded. Local morbidity and mortality records and case notes were examined from March to November 2004. Complications were identified and recorded. The consent forms for these operations were examined to identify if these complications had been recorded on the form prior to surgery. Complications were classified as "serious", causing significant morbidity or increasing length of hospital stay or "frequent", occurring in 1% or more of cases. A total of 2,978 operations were performed between March and November 2004. Seventy complications were identified in 60 patients (2% of operated patients). Twenty-three complications were not recorded on the consent forms in 20 (33%) patients. A total of 67% of all the complications were documented on the form as potential problems resulting from planned operations. Seven (74%) of complications that occurred but were not recorded on the consent forms were judged as "serious" or "frequent". A significant proportion of serious or frequent complications are not being documented on the national consent forms before otolaryngological procedures and may not have been discussed. This may reflect a lack of openness during the consent process. In the current medical climate, this has serious ethical and medico-legal ramifications. It may also reflect a problem with the form and a need for a re-think of its design.