scholarly journals Practice of informed consent in Guangdong, China: a qualitative study from the perspective of in-hospital patients

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e020658 ◽  
Author(s):  
Ni Gong ◽  
Yinhua Zhou ◽  
Yu Cheng ◽  
Xiaoqiong Chen ◽  
Xuting Li ◽  
...  

ObjectiveThis study aimed to investigate the practice of informed consent in China from the perspective of patients.DesignA qualitative study using in-depth interviews with in-hospital patients focusing on personal experience with informed consent.SettingGuangdong Province, China.Participants71 in-hospital patients in rehabilitation after surgical operations were included.ResultsMedical information is not actively conveyed by doctors nor effectively received by patients. Without complete and understandable information, patients are unable to make an autonomous clinical decision but must sign an informed consent form following the doctor’s medical arrangement. Three barriers to accessing medical information by patients were identified: (1) medical information received by patients was insufficient to support their decision-making, (2) patients lacked medical knowledge to understand the perceptions of doctors and (3) patient–doctor interactions were insufficient in clinical settings.ConclusionsInformed consent is implemented as an administrative procedure at the hospital level in China. However, it has not been embedded in doctors’ clinical practices because, from the perspective of patients, doctors do not fulfil the obligation of medical information provision. As a result, the informed part of informed consent was neglected by individual doctors in China. Reforming medical education, monitoring the process of informed consent in clinical settings and redesigning medical institutional arrangements are pathways to restoring the practice of informed consent and patient-centred models in China.

Author(s):  
Deyan WANG

LANGUAGE NOTE | Document text in Chinese; abstract also in English.理解是實現知情同意的基礎,而理解與知情同意的語境學問題有密切關係。醫生常常抱怨病人聽不懂,病人也認為醫生的解釋過科術語化。問題就在於醫患雙方語境的差異。20世紀80年代對知情同意的研究已經開始從告訴病人什麼資訊轉向了怎樣告訴病人的研究。因此醫生除了關心病人敘述的意義之外,還需要關注以各㮔語言為中介與事實之間所建立的聯繫,注意語句的規範性以及正確地把握雙方的語言意圖和目的。本文試圖對知情同意進行語義學、語形學和語用學的分析,以便從這三者統一上來透視和闡述知情同意的各種語境的規定性,以提高知情同意的可理解性。Understanding, being closely associated with the context, is the basis of realization of informed consent. Physician often complains that patients cannot well comprehend medical information, while patients are often unsatisfied with the explanatory statements and technical terms given by physicians. Since 1980s the emphasis in the studies of informed consent has shifted from what should be presented to patient to how to present the related information to patients. Besides being concerned with the meaning of the narratives of patients, physician should pay close attention to the connection of the medical facts or information and the everyday language, to maintain the norms of the syntax, and to understand the real goal and intention of the patients. This paper aims to approach the context of informed consent by semantic analysis, syntax and pragmatics.Informed consent involves much more than merely reading and signing a paper. It normally has two essential parts: a document and a process. The document of informed consent should be understandable to any ordinary patient in the local population. It should be written in such a way that anyone with an education level of the ninth grade or lower can read it. To make the document of informed consent easy-to-read, the following requirements should be met. First, the language is everyday language and familiar to the readers. Any scientific, medical, or legal terms should be defined clearly. Second, terms and key concepts should be consistent throughout the document. Third, sentences should be short, direct, and easy to comprehend. Fourth, the paragraph should be short too. Each paragraph coveys one major idea only. Fifth, every idea should be clear and logically sequenced. Last but not least important, readability analysis should be to determine the reading level of the document.The process of informed con sent process requires physicians to provide the patient with ongoing explanations so that patients can make his or her informed decisions. This is to say, before the patient makes his or her decisions, the physician should fully discuss related issues with the patient. Of course, the physician's communications kills are usually difficult to change. However, physicians can improve their communication skills through learning and practicing.Of course, in China, not only researchers and physicians, but patients and research participants, including the public who can be regarded as the potential subjects, lack the full understanding of the principle of informed consent. It is thus important to improve the nationwide level of education, for it is only by doing that the principle of informed consent can be carried out in reality. The current level of education of the nation is not high yet, and many people even cannot fully understand some basic terms in medical and life sciences. There is s till a still considerable amount of illiterates in China. In medical education, especially in the educating of medical ethics, we have not paid enough attention to on the principle of informed consent so that some medical students even never heard the term" informed consent." As a result, there is still a long way for us to go.Informed consent, serving as an effective measure to protect the subjects and patients, has enjoyed the wide recognition in the fields of medical and related laws. It has become the paradigm of consent in medical research and clinical practice internationally. Many international relative organization s have regarded informed consent a basic ethical requirement. Legally speaking, physicians and patients are equal. But in reality they are not equal. There is an imbalance of medical knowledge between doctors and patients. Although the patient has the right to make his or her own decision, he or she is often not capable of deciding and choosing. It is necessary to establish the law in order to guarantee the realization of the patient's rights such as informed consent.DOWNLOAD HISTORY | This article has been downloaded 13 times in Digital Commons before migrating into this platform.


Author(s):  
Andrea Amorim ◽  
Luis Santos ◽  
Omero Poli-Neto ◽  
Luiz Brito

Objective To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries. Methods A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim. We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period. Results The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were the most frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document. Conclusion Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process.


2016 ◽  
Vol 19 (2) ◽  
pp. 168-173
Author(s):  
Raden Roro Anja Eutheriana

Informed consent is a communication process between doctors and patients pertaining an agreement about medical treatments performed by doctors to their patients then continued by signing informed consent form. It originates from the legal and ethical right the patient has to direct what happens to her body and from the ethical duty of the physician to involve the patient in her health care. The most important goal of informed consent is that the patient has an opportunity to be an informed participant in his health care decisions. Informed consent usually also protects doctor from liability (with exceptions) provided that the procedure is properly execute according to the prevailing standard of care without negligence. Approval for informed consent must be based on medical information regarding the disease from the relevant medical doctors. This matter is regulated in Article 45 of Law 29 of 2004 about medical practices. It can be concluded that an informed consent is one of legal efforts in protecting patients from medical neglect that medical doctors commited.


GeroPsych ◽  
2017 ◽  
Vol 30 (3) ◽  
pp. 97-108 ◽  
Author(s):  
Tanja Schatz ◽  
Julia Haberstroh ◽  
Kerstin Bindel ◽  
Frank Oswald ◽  
Johannes Pantel ◽  
...  

Abstract. Older adults are frequently required to undergo medical informed consent procedures. This study investigates the influence of four types of written language and visual support (Elaborated Plain Language, Easy-to-Read Language, Standard Version with additional picture, Easy-to-Read-Language with additional picture) on comprehension and affect, compared with the Standard Version alone. In an online survey, n = 87 younger participants aged 26–59 and n = 72 older participants aged 60–81 read a simulation of an informed consent form. Directly after reading it, we used the Understanding dimension of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) to ask them about the information presented in the form. The results showed that, by reducing complexity and elaborating the provided information, comprehension of medical information could be improved in the older participant group. In the so-called Elaborated Plain Language groups, the results were the same for younger and older participants. This was not true for the groups that received the Standard Version, on which younger participants performed better. Variations in the language used had no influence on affect. Our conclusion is that Elaborated Plain Language can be recommended for use in medical informed consent procedures with older patients and should be taught to medical professionals.


2014 ◽  
Vol 5 (2) ◽  
pp. 73-79 ◽  
Author(s):  
Fayemi Ademola Kazeem

The Nijmegen method of ethical case deliberation is one of the ways of reflecting, clarifying, evaluating and making decisions about moral problems, conflicts and dilemmas in the clinical settings. It is a hybrid concentration of relevant ideas from different normative ethical traditions applied to the clinical practices. As a team multidisciplinary based deliberation, the method involves a professional ethicist serving as both a critical tutor and a facilitator in the process of deliberating and arriving at most ethical decision in clinical dilemmas. In such process, the Nijmegen method is not a democratic replacement of the decision and responsibility of the healthcare team. Rather it helps to motivate rational decision and reasoned responsibility in healthcare through consensus building which does not attenuate moral uprightness. The Nijmegen method is part of the healthcare process and aims at improving communication among patient, family and the healthcare team as well as enriching the decision making process. It is a promising method in resolving moral dilemmas in healthcare especially in multicultural societies. Besides enhancing the quality and transparency of the decision making process, ethical case deliberation on the ward using the Nijmegen method has prospect of serving as a baseline in guiding through similar dilemmas in the future. DOI: http://dx.doi.org/10.3329/bioethics.v5i2.19618 Bangladesh Journal of Bioethics 2014 Vol.5(2):73-79


2021 ◽  
Vol 12 ◽  
Author(s):  
Ilaria Falvo ◽  
Maddalena Fiordelli ◽  
Rebecca Amati ◽  
Aliaa Ibnidris ◽  
Emiliano Albanese ◽  
...  

Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair participant selection in dementia research is not known. In preparation of a future epidemiological study on the prevalence and impact of dementia in Switzerland, we aimed to conduct a qualitative study to explore participants' comprehension of the purpose of informed consent form and process shortly after participation in the pilot and validation study that preceded the large scale survey.Methods: We conducted a qualitative study with 22 participants of the validation phase of an epidemiological study on the prevalence and impact of dementia in Switzerland to capture their understanding of both the nature and the content of the informed consent form and process. Participants were older adults (65 years or more) eligible for a dementia epidemiological study and their informant (a person who could provide information on their health and cognition). None of the participants reported to be suffering from dementia at the time of the interview.Results: We found that participants held inaccurate and potentially trust-threatening beliefs regarding the scope of the informed consent. Participants identified contradictory contextual, formal and content needs that are difficult to be fulfilled, and misperceived the clinical and research settings in terms of informed consent procedures.Conclusions: Participants and their proxies should be informed about both the scope of the informed consent process, and the content of the informed consent document in a focused, age-appropriate manner, while dispelling confusion about the purpose of research.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Steven A. Hicks ◽  
Jonas L. Isaksen ◽  
Vajira Thambawita ◽  
Jonas Ghouse ◽  
Gustav Ahlberg ◽  
...  

AbstractDeep learning-based tools may annotate and interpret medical data more quickly, consistently, and accurately than medical doctors. However, as medical doctors are ultimately responsible for clinical decision-making, any deep learning-based prediction should be accompanied by an explanation that a human can understand. We present an approach called electrocardiogram gradient class activation map (ECGradCAM), which is used to generate attention maps and explain the reasoning behind deep learning-based decision-making in ECG analysis. Attention maps may be used in the clinic to aid diagnosis, discover new medical knowledge, and identify novel features and characteristics of medical tests. In this paper, we showcase how ECGradCAM attention maps can unmask how a novel deep learning model measures both amplitudes and intervals in 12-lead electrocardiograms, and we show an example of how attention maps may be used to develop novel ECG features.


2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Briana S. Last ◽  
Simone H. Schriger ◽  
Carter E. Timon ◽  
Hannah E. Frank ◽  
Alison M. Buttenheim ◽  
...  

An amendment to this paper has been published and can be accessed via the original article.


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