Negash Wogene, Assefa Nega, Baraki Negga, Wilfong Tara
Nursing Department, School of Health Science, Madda Walabu University Goba Referral Hospital, Goba, Ethiopia.
School of Nursing and Midwifery, College of Health and Medical Sciences, Haramaya University, Haramaya, Ethiopia.
Int J Gen Med. 2021 Nov 8;14:7807-7817. doi: 10.2147/IJGM.S338243. eCollection 2021.
Medical malpractice, poor patient outcome and medical suits among health-care workers result from improper consenting practices. Therefore, this study aimed to assess practice and factors associated with the informed consenting process for major surgical procedures among health-care workers in public hospitals of Bale Zone, South Eastern Ethiopia.
An institutional-based cross-sectional study was conducted from March 9 to 24, 2020, among all nurses, midwives, doctors (general physicians, surgeons, gynecologists), emergency surgery officers, anesthetists) who were working at Bale Zone public hospitals during the study period. A self-administered pretested questionnaire was employed. Variables with a p-value of less than 0.25 (age group, sex, educational profession, working unit, work experience, adequate content of consent form, training on informed consent, policy/regulation in institution, administrative support, average number of patient cared per shift, time spent for consent process, knowledge, attitude) at 95% confidence interval in the binary logistic regression analysis were considered for multivariable regression model to control for possible confounding effect.
Of the total sample size (639 health-care workers), 621 (97.2%) were included in this study, of which 311 (50.1%, 95% CI: 46.1-53.8) practiced proper informed consent during major surgical procedures. Being age above 35 (AOR: 3.032, 95% CI: 1.148-8.010), male (AOR: 1.607, 95% CI: 1.047-2.465), above 10 years of working experience (AOR: 2.339, 95% CI: 1.104-4.955), adequate content of consent form (AOR: 2.785, 95% CI: 1.772-4.377), having training on informed consent (AOR: 2.305, 95% CI: 1.204-4.414), spending more time (>30minutes) for consent process (AOR: 3.014, 95% CI: 1.095-8.298), having good knowledge (AOR: 1.808, 95% CI: 1.195-2.737) and favorable attitude (AOR: 2.188, 95% CI: 1.456-3.287) were significantly associated with good informed consent practice.
Only half of health-care workers practiced good informed consent. Further emphasis needs to be given to improve consent practice.
医疗过失、患者不良预后以及医护人员面临的医疗诉讼均源于不当的知情同意程序。因此，本研究旨在评估埃塞俄比亚东南部巴勒州公立医院医护人员在重大外科手术知情同意过程中的实践情况及相关因素。
于2020年3月9日至24日开展了一项基于机构的横断面研究，研究对象为研究期间在巴勒州公立医院工作的所有护士、助产士、医生（普通内科医生、外科医生、妇科医生）、急诊外科医生、麻醉师。采用了一份经过预测试的自填式问卷。在二元逻辑回归分析中，p值小于0.25的变量（年龄组、性别、教育职业、工作单位、工作经验、同意书内容是否充分、知情同意培训、机构政策/规定、行政支持、每班护理患者的平均数量、同意过程所花费的时间、知识、态度）在95%置信区间被纳入多变量回归模型，以控制可能的混杂效应。
在总样本量（639名医护人员）中，621人（97.2%）纳入本研究，其中311人（50.1%，95%CI：46.1 - 53.8）在重大外科手术期间进行了恰当的知情同意。年龄在35岁以上（调整后比值比：3.032，95%CI：1.148 - 8.010）、男性（调整后比值比：1.607，95%CI：1.047 - 2.465）、工作经验超过10年（调整后比值比：2.339，95%CI：1.104 - 4.955）、同意书内容充分（调整后比值比：2.785，95%CI：1.772 - 4.377）、接受过知情同意培训（调整后比值比：2.305，95%CI：1.204 - 4.414）、同意过程花费更多时间（>30分钟）（调整后比值比：3.014，95%CI：1.095 - 8.298）、具备良好知识（调整后比值比：1.808，95%CI：1.195 - 2.737）和积极态度（调整后比值比：2.188，95%CI：1.456 - 3.287）与良好的知情同意实践显著相关。
只有一半的医护人员进行了良好的知情同意。需要进一步加强以改善知情同意实践。
