Bollschweiler Elfriede, Apitzsch Jonas, Obliers Rainer, Koerfer Armin, Mönig Stefan P, Metzger Ralf, Hölscher Arnulf H
Department of Visceral and Vascular Surgery, University of Cologne, Cologne, Germany.
Ann Surg. 2008 Aug;248(2):205-11. doi: 10.1097/SLA.0b013e318180a3a7.
The term "informed consent" explains the process by which a patient, before treatment, is provided comprehensive and impartial information regarding a planned operative procedure so that he/she understands the implications of the procedure before consenting. The goal of the current study was to investigate whether standard methods of consenting can be improved using a multimedia-based information program (MM-IP).
In a prospective multicenter study, 80 patients undergoing laparoscopic cholecystectomy went through the standard informed consent process. One group of patients was also given access to a MM-IP. Questionnaires were completed before surgery. These evaluated how patients perceived their own understanding of important aspects of their illness (ie, disease, therapeutic alternatives, operation, risks) and satisfaction with the consenting process. Patients' anxiety levels were also assessed. These questionnaires were used to evaluate the effectiveness of the MM-IP for improving the consent process.
Seventy-six patients (47 women, 29 men, median age 54 years) were included. There was no significant age or gender variation between the groups (standard n = 41 and MM-IP n = 35). Eighty-two percent of all respondents were satisfied with the standard informed consent process. However, perceived understanding of the material was significantly improved in the MM-IP group (P < 0.001). Patients with less formal education profited particularly from the MM-IP. Preoperative anxiety did not vary between the groups.
Use of the multimedia-based program was positively evaluated by patients, and significantly improved patients' perceived understanding of their disease and its treatment. It is, therefore, valuable in the informed consent process.
“知情同意”一词解释了患者在治疗前被提供有关计划手术程序的全面且公正信息的过程，以便其在同意前理解该程序的影响。本研究的目的是调查基于多媒体的信息程序（MM - IP）是否能改进标准的同意程序。
在一项前瞻性多中心研究中，80例行腹腔镜胆囊切除术的患者经历了标准的知情同意过程。一组患者还可使用MM - IP。术前完成问卷调查。这些问卷评估患者如何看待自己对疾病重要方面（即疾病、治疗选择、手术、风险）的理解以及对同意过程的满意度。还评估了患者的焦虑水平。这些问卷用于评估MM - IP对改进同意程序的有效性。
纳入76例患者（47例女性，29例男性，中位年龄54岁）。两组之间在年龄或性别上无显著差异（标准组n = 41，MM - IP组n = 35）。所有受访者中有82%对标准知情同意过程满意。然而，MM - IP组对相关内容的理解有显著改善（P < 0.001）。受教育程度较低的患者尤其从MM - IP中受益。两组术前焦虑水平无差异。
患者对基于多媒体的程序评价积极，且显著提高了患者对自身疾病及其治疗的理解。因此，它在知情同意过程中具有价值。
