书面知情同意书是否全面告知手术患者,这在患者决策中是否有效?

M. Ahsan, Abeer Irshad, Isbah Rashid, S. Waqar, Jawaria Faisal, Abdul Qadir Khuram
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摘要

背景:知情同意(IC)是卫生保健的第一个基本的主要步骤,帮助患者意识到他们的治疗决定的后果。在任何手术前获得有效的知情同意的重要性,这是医患关系的一个重要方面。目的:评价不同治疗策略对原发性产后出血(PPH)的治疗效果。研究设计:观察性、前瞻性。地点:巴基斯坦伊斯兰堡巴基斯坦医学科学院医院普通外科。工期:2019年3月至2019年7月,为期5个月。方法:所有患者被询问一套标准问题,这些问题与他们在手术前提供的信息有关,作为标准知情同意实践的一部分。外科医生在术后患者感到舒适的情况下尽早进行了所有的隐私和保密访谈。使用简单易懂的语言进行提问,使患者易于理解并作出回应。调查问卷旨在了解与外科手术相关的风险/收益,替代治疗方案,是否提供额外详细的口头和/或书面信息,以提高他们的理解。所有信息均通过研究形式记录。结果:183例患者术后接受知情同意访谈,年龄在18 ~ 40岁之间的患者占42.1%。男性占58.5%,女性占41.5%。几乎所有的病例都得到了知情同意,而有些人说他们是在手术前得到的。关于口头信息是否影响进行手术的决定,有一些有争议的答案。几乎所有患者在手术前都被告知他们的病情、手术和麻醉并发症。只有7.7%的患者表示没有给时间回答问题,10.4%的患者对知情同意不满意,而大多数病例是满意的。结论:在研究观察中,大多数患者是满意的,因为大多数手术同意因素是普遍理解的,但仍有一些争议,应考虑其重要性,除了手术的风险,以及对手术团队和患者的可接受性和干预的可行性。书面信息不能为患者提供关于迫在眉睫的健康问题的充分决策工具,因此术前口头信息也需要充分的决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Does Written Informed Consent Comprehensively Inform Surgical Patients and is This Effective in Patient’s Decision-Making?
Background: Informed consent (IC) is first fundamental principal step in health care helps patients to be conscious of consequences of their treatment decisions. The importance of obtaining a valid inform consent before any procedure well established with surgery and it is an important aspect of doctor patient relationship. Objective: To assess outcome of different management strategies in women presenting with primary postpartum hemorrhage (PPH). Study Design: Observational, prospective. Settings: General surgery department of Pakistan Institute of medical Sciences Hospital Islamabad Pakistan. Duration: Five months from March 2019 to July 2019. Methodology: All the patients were asked a set of standard questions, which related to the information they had provided before the operation as a part of standard informed consent practice. The surgeons had taken all the interviews with privacy and confidentiality after postoperatively at the earliest time the patient is comfortable to do so. The questions were asked in the simple languages, which were understandable to patients, so that patients could easily understand and respond to the same. The questionnaire sought information risks/benefits associated with a surgical procedure, alternate treatment options, whether providing additional detailed verbal and/or written information improved their understanding. All the information was recorded via study proforma. Results: Total 183 patients were interviewed post-operatively regarding inform consent and most of them 42.1% were between age 18-40 years. Males were 58.5% and females were 41.5%. Almost all cases had received informed consent, while some said they received just before the surgeries. There were some controversial answers regarding question of oral information influence the decision to proceed to the surgical procedure. Almost all patient had answered that they were informed regarding their conditions, surgical and anesthetic complications prior the surgery. Only 7.7% patient said that the time was not given for the questions and 10.4% patient were unsatisfied regarding informed consent, while the most of the cases were satisfied. Conclusion: In the study observation mostly, patients were satisfied and because mostly surgical consent element is generally understood, but some remained controversial and should consider its importance, beyond risks of the procedures, as well as acceptability and feasibility of intervention to surgical team and patients. Written information has not provided patients with adequate decision-making tools for imminent health matters, so pre-operative oral information also needed to adequate decision-making.
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