Ezeome E R, Chuke P I, Ezeome I V
Department of Surgery, University of Nigeria Teaching Hospital, Enugu, Nigeria.
Niger J Clin Pract. 2011 Jul-Sep;14(3):311-7. doi: 10.4103/1119-3077.86775.
Surgical informed consent forms should have evidence that their use will enhance a shared decision-making which is the fundamental objective of informed consent in clinical practice. In the absence of any guideline in Nigeria on the content and language of informed consent forms, we sort to examine the surgical and procedure consent forms used by Federal tertiary health institutions in Nigeria, to know whether they fulfill the basic elements of informed consent.
The surgical and procedure informed consent forms of 33 tertiary health institutions in Nigeria were assessed for their readability and contents. Adequacy of their content was evaluated based on provision for 28 content items identified as necessary information to be provided in a good consent form. The potential of the forms to be comprehended were assessed with Flesch readability formula.
The contents of majority of the forms were scant. None of the forms made provision for documentation of the patient's permission for blood transfusion, tissue disposal, awareness of the risks of not undergoing the prescribed treatment, and the risk of anesthesia. Risk disclosures were only mentioned in specific terms in 11.4% of the forms. Less than 10% of the forms made provisions for an interpreter, signature of anesthetists, alternative to the procedure to be mentioned, and answering of the patient's questions. The Flesch reading ease scores of the forms ranged from 34.1 (Difficult) to 67.5 (Standard), with a mean score of 55.2 (Fairly difficult level). Field evaluation of the forms show that they shall be partly understood by 13- to 15-year-old patients with basic education but are best understood by literate adult patients.
The content of majority of the informed consent forms used in Nigerian tertiary health institutions are poor and their readability scores are not better than those used in developed parts of the world. Health Institutions in Nigeria should revise their informed consent forms to improve their contents and do a usability trial on the sample forms before deployment in order to ensure that they are comprehensible for their patient population.
手术知情同意书应有证据表明其使用将促进共同决策，这是临床实践中知情同意的基本目标。由于尼日利亚没有关于知情同意书内容和语言的任何指南，我们着手检查尼日利亚联邦三级医疗机构使用的手术和操作同意书，以了解它们是否符合知情同意的基本要素。
对尼日利亚33家三级医疗机构的手术和操作知情同意书的可读性和内容进行评估。根据一份良好的同意书中应提供的28项内容条款来评估其内容的充分性。使用弗莱什可读性公式评估这些表格被理解的可能性。
大多数表格的内容都很简略。没有一份表格规定记录患者对输血、组织处理、知晓不接受规定治疗的风险以及麻醉风险的许可。只有11.4%的表格以特定术语提及了风险披露。不到10%的表格规定了口译员、麻醉师签名、提及手术替代方案以及回答患者问题。这些表格的弗莱什易读性得分从34.1（困难）到67.5（标准）不等，平均得分为55.2（相当困难级别）。对这些表格的实地评估表明，13至15岁接受过基础教育的患者只能部分理解这些表格，而有文化的成年患者理解得最好。
尼日利亚三级医疗机构使用的大多数知情同意书内容较差，其可读性得分并不优于世界发达地区使用的表格。尼日利亚的医疗机构应修订其知情同意书以改进内容，并在投入使用前对样本表格进行可用性试验，以确保患者能够理解。
