Edwards A G, Weale A R, Morgan J D
Department of Surgery, Southmead Hospital, Bristol BS10 5NB, UK.
Postgrad Med J. 2005 Mar;81(953):188-90. doi: 10.1136/pgmj.2004.024760.
This study was performed to assess how well completed the new consent forms are for patients undergoing renal transplantation.
100 patients were randomly selected from the 160 who had a renal transplantation, at a single centre in the UK, over an 18 month period. The notes were located and the consent forms scrutinised.
Seven sets of notes could not be traced and 10 did not contain a relevant consent form. Forty eight per cent of completed forms mentioned the source of organ while 8% mentioned on which side the operation was to be performed. Twelve risks and complications were identified as being relevant to this procedure but no single form mentioned all 12. In most cases a senior member of the surgical team obtained consent.
The demonstrated variability in the amount of detail on consent forms lends weight to the call for the use of procedure specific forms. While such variability does not necessarily equate with not gaining valid, informed consent, this form, at present, serves as the only record of what has been discussed with the patient. These findings should encourage all surgeons to complete the forms themselves, be as detailed as possible, and ensure that the form is filed in the patients' notes.
本研究旨在评估肾移植患者新的知情同意书填写的完善程度。
在英国的一个单一中心,从18个月内接受肾移植的160名患者中随机选取100名。找到病历并仔细检查知情同意书。
7套病历无法找到,10套病历没有相关的知情同意书。48%的已填写表格提及了器官来源,8%提及了手术将在身体哪一侧进行。确定了12项与该手术相关的风险和并发症,但没有一份表格提及所有12项。在大多数情况下,由手术团队的一名高级成员获取同意。
知情同意书细节量的差异表明,有理由呼吁使用特定手术的表格。虽然这种差异不一定等同于未获得有效、知情的同意,但目前这份表格是与患者讨论内容的唯一记录。这些发现应促使所有外科医生自己填写表格,尽可能详细,并确保将表格归档到患者病历中。