Yoshioka H
Department of Orthopedic Surgery, Yodogawa Christian Hospital, Osaka, Japan.
Nihon Seikeigeka Gakkai Zasshi. 1993 Jan;67(1):40-8.
Twenty-eight patients who had total joint replacement (TJR) and twenty-eight patients who sustained open reduction for fracture within or close to the joint were studied to determine their recall of the informed consent procedure. The questionnaire covered a postoperative time range of more than 5 months and less than 6 years (average: 2 years and 4 months). The patient's recall and the doctor's document of informed consent were scored 4 points for diagnosis and treatment, 1 point for prognosis, 3 points for benefits, 4 points for complications and 1 point for alternatives with a total of 13 points. In TJR, the average recall and document score were 8.6 points and 6.5 points respectively; and in fracture, 6.6 points and 4.9 points. Fifty-seven per cent of the patients with TJR recalled the risk of infection; and 54 per cent recalled the problem of loosening. Twenty-nine per cent of the patients with fracture recalled the risk of infection, and 29 per cent the risk of nonunion. In TJR, the recall score was related to the patient's age and the document score. There was significant difference in document scores among doctors. As a result of this study, standard documents for informed consent in each operation have been compiled with the aid of a word-processor to improve the quality of informed consent.
对28例行全关节置换术（TJR）的患者和28例在关节内或关节附近骨折后接受切开复位术的患者进行了研究，以确定他们对知情同意程序的记忆情况。调查问卷涵盖的术后时间范围超过5个月且少于6年（平均：2年4个月）。患者的记忆情况以及医生的知情同意记录在诊断和治疗方面得4分，预后得1分，益处得3分，并发症得4分，替代方案得1分，总分13分。在全关节置换术组中，记忆情况和记录的平均得分分别为8.6分和6.5分；骨折组则分别为6.6分和4.9分。全关节置换术组中57%的患者记得感染风险；54%的患者记得松动问题。骨折组中29%的患者记得感染风险，29%的患者记得骨不连风险。在全关节置换术组中，记忆得分与患者年龄及记录得分相关。医生之间的记录得分存在显著差异。作为这项研究的成果，借助文字处理器编制了每种手术的知情同意标准文件，以提高知情同意的质量。
