Brown H, Ramchandani M, Gillow J T, Tsaloumas M D
The Birmingham and Midland Eye Centre, Birmingham, UK.
J Med Ethics. 2004 Apr;30(2):218-20. doi: 10.1136/jme.2003.003723.
To assess, against a checklist of specific areas of required information and using standard published criteria, to what extent leaflets given before cataract surgery provided patients with enough information to give adequately informed consent.
Twelve ophthalmology departments in the West Midlands region were asked to submit the cataract information leaflets given to their patients at the preoperative assessment for analysis. Using criteria published by the General Medical Council, British Medical Association, and Medical Defence Union the leaflets were assessed for their contribution to informed consent for patients considering cataract surgery. Leaflets were scored according to the information they provided on: diagnosis, prognosis, treatment options, costs to the patient, details about the procedure, its purpose, likely benefits, how to prepare for it, what to expect during and after the operation, and the common as well as serious complications that may occur. The readability of the information was also assessed.
All the units' leaflets provided information on diagnosis, the lifestyle changes required postoperatively, and cost involved to the patient. Only five units had leaflets that mentioned the risks involved in cataract surgery. The other areas of information were covered by 50-75% of the leaflets. Fifty per cent of the leaflets included a diagram. The average SMOG readability score was high.
Although present cataract information leaflets make some contribution to the process of informed consent, most do not address important areas outlined by the General Medical Council. Many of the areas of information that are required for informed consent could easily be covered, and should be borne in mind when designing patient information leaflets. Resources are available on the internet including toolkits, guides, and means of assessment for the production of patient information leaflets.
对照一份所需信息特定领域的清单,并使用已发表的标准,评估白内障手术前发放的宣传资料在多大程度上为患者提供了足够信息,使其能够充分知情同意。
西米德兰兹地区的12个眼科科室被要求提交在术前评估时发给患者的白内障信息宣传资料以供分析。根据英国医学总会、英国医学协会和医疗保护联盟公布的标准,对这些宣传资料在考虑白内障手术的患者知情同意过程中的作用进行评估。宣传资料根据其提供的以下信息进行评分:诊断、预后、治疗选择、患者费用、手术详情、目的、可能的益处、如何准备、手术期间及术后预期情况,以及可能发生的常见和严重并发症。还评估了信息的可读性。
所有科室的宣传资料都提供了关于诊断、术后所需生活方式改变以及患者费用的信息。只有5个科室的宣传资料提到了白内障手术的风险。其他信息领域有50%-75%的宣传资料涉及。50%的宣传资料包含一幅图表。平均SMOG可读性分数较高。
尽管目前的白内障信息宣传资料对知情同意过程有一定贡献,但大多数未涉及英国医学总会概述的重要领域。许多知情同意所需的信息领域很容易涵盖,在设计患者信息宣传资料时应予以考虑。互联网上有相关资源,包括工具包、指南以及患者信息宣传资料制作的评估方法。