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Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections.生物样本库研究中知情同意书模板的参与式改进——研究结果与方法学思考
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2
Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique.使用改良德尔菲技术为肢体创伤患者在清创手术前制作知情同意视频并进行试点测试。
BMC Med Ethics. 2017 Nov 29;18(1):67. doi: 10.1186/s12910-017-0228-3.
3
Patient satisfaction and informed consent for surgery.患者对手术的满意度和知情同意。
Am J Obstet Gynecol. 2017 Aug;217(2):181.e1-181.e7. doi: 10.1016/j.ajog.2017.03.020. Epub 2017 Mar 28.
4
Defining reasonable patient standard and preference for shared decision making among patients undergoing anaesthesia in Singapore.界定新加坡接受麻醉患者共同决策的合理患者标准及偏好。
BMC Med Ethics. 2017 Feb 2;18(1):6. doi: 10.1186/s12910-017-0172-2.
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Innovative approaches for improving maternal and newborn health--A landscape analysis.改善孕产妇和新生儿健康的创新方法——一项现状分析。
BMC Pregnancy Childbirth. 2015 Dec 17;15:337. doi: 10.1186/s12884-015-0784-9.
6
Informed consent in clinical practice: patients' experiences and perspectives following surgery.临床实践中的知情同意:患者术后的经历与观点
BMC Res Notes. 2015 Dec 9;8:765. doi: 10.1186/s13104-015-1754-z.
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The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review.全球医疗机构中分娩期间对妇女的虐待:一项混合方法的系统评价。
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8
Analysis of medical malpractice clams and measures proposed by the Health Professionals Ethics Federal Committee of Ethiopia: review of the three years proceedings.埃塞俄比亚卫生专业人员伦理联邦委员会对医疗事故索赔的分析及提出的措施:三年诉讼程序回顾
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Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting.大学教学医院外科护理的知情同意实践:资源匮乏地区的一个案例
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Effective in-service training design and delivery: evidence from an integrative literature review.有效在职培训的设计与实施:来自综合文献回顾的证据。
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提高埃塞俄比亚一家教学医院妇产科手术中的手术知情同意书质量:一项前后对照研究。

Improving surgical informed consent in obstetric and gynaecologic surgeries in a teaching hospital in Ethiopia: A before and after study.

机构信息

Department of Obstetrics and Gynecology, School of Medicine, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.

School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.

出版信息

BMJ Open. 2019 Jan 24;9(1):e023408. doi: 10.1136/bmjopen-2018-023408.

DOI:10.1136/bmjopen-2018-023408
PMID:30679291
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6347859/
Abstract

OBJECTIVES

Even though surgical informed consent (SIC) has marked benefits, in many settings the information is not provided appropriately. In Ethiopia, minimal attention is given to SIC. This study assesses whether an intervention designed to improve SIC in obstetric and gynaecologic surgeries is associated with receipt of SIC components.

DESIGN

Pre-intervention and post-intervention surveys were conducted at Hawassa University Comprehensive Specialized Hospital among women who underwent obstetric or gynaecologic surgeries. The intervention consisted of a 3-day training on standard counselling for surgical procedures offered to health professionals. A total of 457 women were surveyed (230 pre-intervention, 227 post-intervention). An adjusted Poisson regression analysis was used to identify the association between the intervention and the number of SIC components received.

RESULTS

The majority of participants were 25-34 years of age in both the pre-intervention and post-intervention groups (p=0.66). 45.7% of the pre-intervention and 51.5% of the post-intervention survey participants underwent elective surgery (p=0.21). Additionally, 70.4% of pre-intervention survey participants received counselling immediately before surgery, compared with 62.4% of post-intervention participants (p<0.001). 5.7% of pre-intervention and 6.6% of post-intervention participants reported the belief that SIC consists entirely of signing on a piece of paper (p=0.66). After controlling for effects of potential confounders, the number of SIC components reported by post-intervention survey participants was 16% higher than what is received by pre-intervention ones (adjusted coefficient=1.16 (1.06-1.28)). Having elective versus emergency surgery was not associated with the number of components received by participants in either group (adjusted coefficient=0.98 (0.88-1.09)).

CONCLUSION

Training on the delivery of standard SIC is associated with receipt of a higher number of standard counselling components. However, there is a need to evaluate whether a one-time intervention leads to sustained improvement. A system-wide study of factors that promote SIC is required.

摘要

目的

尽管手术知情同意(SIC)有明显的益处,但在许多情况下,信息提供并不恰当。在埃塞俄比亚,SIC 几乎没有得到关注。本研究评估了一项旨在改善妇产科手术中 SIC 的干预措施是否与接受 SIC 内容有关。

设计

在 Hawassa 大学综合专科医院,对接受妇产科手术的女性进行了干预前和干预后调查。干预措施包括对卫生专业人员进行为期 3 天的关于手术标准咨询的培训。共有 457 名女性接受了调查(干预前 230 名,干预后 227 名)。采用校正泊松回归分析来确定干预与接受 SIC 内容之间的关联。

结果

干预前和干预后组的大多数参与者年龄在 25-34 岁(p=0.66)。45.7%的干预前和 51.5%的干预后调查参与者接受的是择期手术(p=0.21)。此外,70.4%的干预前调查参与者在手术前立即接受了咨询,而干预后组的这一比例为 62.4%(p<0.001)。5.7%的干预前和 6.6%的干预后参与者认为 SIC 完全由在一张纸上签字组成(p=0.66)。在控制了潜在混杂因素的影响后,干预后调查参与者报告的 SIC 内容比干预前参与者多 16%(调整系数=1.16(1.06-1.28))。择期手术与两组参与者接受的组件数量无关(调整系数=0.98(0.88-1.09))。

结论

关于标准 SIC 交付的培训与接受更多标准咨询内容有关。然而,需要评估一次性干预是否会导致持续改善。需要对促进 SIC 的系统因素进行全面研究。