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Challenges in the conduct of randomised controlled trials in cardiogenic shock complicating acute myocardial infarction

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Journal of Geriatric Cardiology 2022年第2期19卷 125-129页

作者： Anne Freund Steffen Desch Holger Thiele Department of Internal Medicine/Cardiology Heart Center Leipzig at the University of LeipzigLeipzigGermany German Center for Cardiovascular Research(DZHK) BerlinDeutschland

Cardiogenic shock(CS)following acute myocardial infarction(AMI)is a major challenge in cardiovascular care.Mortality remains high with 40%-50%after thirty days.Randomised controlled trials(RCTs)play a key role to generate evidence on optimal care in this field.However,the number of completed or ongoing RCTs is still relatively low compared to the gaps in evidence.Challenges in the conduct of these trials are in particular the selection of patients and ethical issues in the informed consent process.When determining eligibility criteria,special attention should be paid to the severity of CS,to the inclusion of patients with cardiac arrest and to potential age limits.Median age of AMI-CS patients is increasing.Age limits are therefore controversial as it is important to include elderly patients in RCTs in order to make the results generalisable and to address the special needs of this group.As patients with AMI-CS are in most cases unable to provide informed consent themselves,a step-wise approach with acute consent by a legal representative or independent physicians and later informed consent by the patient if possible might be established depending on regularities of the respective ethical review board and country legislation.Multicenter studies should be sought to generate adequate power.

关键词： shock legal consent

Informed consent from an Asian perspective

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Acta Pharmacologica Sinica 1998年第S1期 38-40页

作者：林成义

ＴｈｅｒｅａｒｅｉｓｕｅｓｗｉｔｈｒｅｇａｒｄｓｔｏｉｎｆｏｒｍｅｄｃｏｎｓｅｎｔｔｈａｔａｒｅｐａｒｔｉｃｕｌａｒｔｏＡｓｉａ．ＬｉｔｅｒａｃｙｉｎＡｓｉａｖａｒｉｅｓｆｒｏｍ２７．５％－９３．８％ａｎｄｉｓｕｓｕ... 详细信息

ＴｈｅｒｅａｒｅｉｓｕｅｓｗｉｔｈｒｅｇａｒｄｓｔｏｉｎｆｏｒｍｅｄｃｏｎｓｅｎｔｔｈａｔａｒｅｐａｒｔｉｃｕｌａｒｔｏＡｓｉａ．ＬｉｔｅｒａｃｙｉｎＡｓｉａｖａｒｉｅｓｆｒｏｍ２７．５％－９３．８％ａｎｄｉｓｕｓｕａｌｙｃｏｎｆｉｎｅｄｔｏｔｈｅｎ...

关键词： consent

consent and Quality of Information for Patients in Laparoscopic Surgery at the Academic Hospital Point“G”(Mali)

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Surgical Science 2018年第12期9卷 502-508页

作者： Soumaila Keita Madiassa Konate Mamadi Coulibaly Abdoulaye Kante Traore Amadou Diarra Mamadou Salia Marius Sanou Aboubacar Sidiki Sangare Lamine Soumare Sekou Koumare Oumar Sacko Brahima Dicko D. Kanikomo Zimogo Zie Sanogo Service de Chirurgie A CHU du point GBamakoMali

Objectives: To evaluate the quality of the information provided to patients for their consent to be operated laparoscopically in the “A” surgery service of Point “G” University Hospital in Bamako (Mali). Methodology: The study was transversal, descriptive and prospective from November 1, 2016 to December 31, 2017 (14 months). It was performed at the general and laparoscopic surgery department of the Point “G” University Hospital in Bamako. Laparoscopically operated patients in scheduled or emergency programm whom consented the study and answered the questions before and after the surgical procedure were included. Results: One hundred patients were retained. The sex ratio was 4.2 for women. The surgery was scheduled in 93% (programmed surgery) of cases versus 7% (urgent surgery). Gynecological and obstetric surgery was performed in 54%, digestive surgery in 43% and laparoscopic exploration in 3%. The information was provided by surgeons, anesthetists, fellowship and students in respec-tively 63%, 6%, 11% and 9%. The reflection period before consenting to the act was greater or equal to 3 days in 90%. The media used were found to be suitable in 62%. The information was considered satisfactory preoperatively in 54% and postoperatively in 88%. Patients wanted additional information on post-surgery outcomes in 21%. Conclusion: The establishment of an information system and a free and informed consent form is a prerequisite for the quality of care in laparoscopic surgery.

关键词： Laparoscopy Information consent

Knowledge,Awareness,and Attitude of Doctors and Patients regarding Informed consent to Medical Procedures in Papua New Guinea

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Journal of Health Science 2018年第6期6卷 406-413页

作者： Alfred P.Minei Rachelyn Ann S.Arana Ronald R.Roldan Jr. School of Law University of Papua New GuineaPost Office Box 126WaiganiNational Capital DistrictPapua New Guinea Institute of Statistics College of Arts and SciencesUniversity of the Philippines Los BanosLos BanosLaguna 4031Philippines

This study explores how doctors and patients in Papua New Guinea(PNG)perceive informed consent in medical settings.Doctors and patients from National Capital District and Central Province who responded to the survey were the participants of the study.Researchers asked the participants to fill out questionnaires regarding their knowledge about informed consent for each group,namely,the doctors and participants.From those who responded,six randomly selected participants were chosen to join the focus group discussion which aimed to get experiences from the doctors and patients regarding medical procedures.Results show that both doctors and patients lack knowledge of the legalities of informed consent.Based on the experiences of doctors,they do not use consent forms when seeking permission from patients.Patients,on the other hand,do not see consent forms as important and only served as a formality.Customs,culture surrounding PNG were found to have an impact on how patients perceived informed consent.

关键词： Informed consent surveys focus group discussion PNG.

Audiovisual Multimedia Combined with Standard, Verbal, Informed consent;Enhancing the Satisfaction and Comprehension of Surgical Patients: A Comparative Trial in Patients Undergoing Laparoscopic Cholecystectomies at the HRH Princess Maha Chakri Sirindhorn Medical Center, Thailand

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Surgical Science 2012年第8期3卷 393-398页

作者： Wuttichai Thanapongsathorn Chayapa Imchit Jilapon Phunya HRH Princess MahaChakriSirindhorn Medical Center Department of Surgery Faculty of Medicine Srinakharinwirot University Nakorn-Nayok Thailand

Objective: A comparative study of the audiovisual, multimedia, informed consent procedure enhancing the satisfaction and comprehension in laparoscopic cholecystectomy patients within the contexts of the Thai culture. Methods: A prospective, comparative trial was done in patients undergoing laparoscopic cholecystectomies at the HRH Princess Maha Chakri Sirindhorn Medical Center in Thailand. Before the procedure, all patients who met the selection criteria and agreed to participate in the study by signing the proper consent forms were placed into 2 groups. G1 (group 1) was informed with the standard verbal informed consent and G2 (group 2) was informed with audiovisual multimedia in the form of a DVD in collaboration with the standard, verbal, informed consent procedure. The patients were interviewed by a nurse, using a checklist type of questionnaire, as to their satisfaction and comprehension of the procedure on the day of discharge. Results: In the period of June 2010 through December 2010, 60 patients undergoing laparoscopic cholecystectomies and who had met the conditions of research were included in our study. There were 30 patients in each group. The average satisfaction score in G1 was 3.12 out of a total of 5 and in G2 was 4.51 of 5 (P consent process enhanced the satisfaction and the comp

关键词： Audiovisual Multimedia Informed consent Standard Verbal Informed consent Surgical Patient’s Satisfaction Comprehension

Culture within Informed consent:Papua New Guinea Perspective

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Journal of Health Science 2020年第2期8卷 33-51页

作者： Alfred P.Minei Sam O.Kaipu Jerry M.Minei School of Law University of Papua New GuineaWaiganiP.O.Box 126National Capital District 134Port MoresbyPapua New Guinea PNG Judiciary Center for Judicial ExcellenceWaiganiP.O.Box 126National Capital District 134Port MoresbyPapua New Guinea Townsville Hospital TownsvilleP.O.Box 670TownsvilleQueensland 4810Australia

This paper examines informed consent in medical practice.We have explored the notion of consent and determined its underlying theory and important attributes.We argue that consent is a permissive state of mind that waives the right to bodily integrity.Once communicated to the actor the permission takes effect by justifying the intervention and legitimizing the virtuous exercise of the doctor’s power.The process is usually formally documented by the reading and signing of a“consent form”by both the patient and the doctor who is proposing the treatment that takes place within a clinical setting.Many people grow up in the traditional communities where the idea of informed consent is undeveloped and tend to be passive in their roles in the informed consent process.We have gathered from this study that people tend to stick to their traditional customs and custom has become a source of their rules,brings people together,shares food,and uses for resolving issues in family,land,water rights,and compensation following disputes.In other words,peoples’ways of life revolve around their traditional customs.Family wellbeing decisions and especially health care are usually a family matter but not an individual.Going to receive health care services at the hospital or modern health care center for medical treatment is enough to make a patient say they do not want to follow through the clinical procedure including the process of informed consent.A medical consent form is a common form used in health care facilities to obtain medical consent for a certain treatment or medical procedure or dental.We found in the interview questionnaires that many patients do not understand the use of consent forms.We examined informed consent in the context of the people’s culture and how the healthcare professionals handle the situation with patients that have widespread customs,beliefs and opinions which they strictly adhere to and practice.

关键词： consent consent form medical procedure culture customs

Informed consent in veterinary medicine: legal and medical perspectives in Italy

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Open Journal of Animal Sciences 2011年第3期1卷 128-134页

作者： Annamaria Passantino Valeria Quartarone Maria Russo 不详

During the last four decades the doctrine of in- formed consent (IC) has become a legal stan- dard and an essential component of ethical guidelines in medicine, due to its relevance for basic human rights such as autonomy and re- spect of dignity. Over the last few years, this legal formula has gained importance in veteri- nary medicine, thereby influencing the everyday activities of the veterinary practitioners. This paper briefly describes the ethical and legal background of IC in Italy and examines how it relates to the practice of veterinary medicine, considering the change in social sensibility to- wards animals. It also outlines the discussion that should take place between Veterinarian and client before a planned procedure.

关键词： Informed consent Veterinary Medicine Professional Duty Law Ethics Veterinarian-Client Relationship Animal

合同关系中个人信息处理同意撤回权的限制与展开

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Informed consent under the Ghana Health Service Patients Charter: Practice and Awareness

民商法学 2024年第4期

作者：杨芳

《个人信息保护法》第15条赋予信息主体随时无条件、无负担地撤回信息处理同意的权利。然而，当同意信息处理正是信息主体的合同义务时，撤回权对合同的拘束力和履行构成冲击，因此应当对现有规范进行妥适解释和调整，以限制撤回权制度... 详细信息

《个人信息保护法》第15条赋予信息主体随时无条件、无负担地撤回信息处理同意的权利。然而，当同意信息处理正是信息主体的合同义务时，撤回权对合同的拘束力和履行构成冲击，因此应当对现有规范进行妥适解释和调整，以限制撤回权制度对合同关系的影响。撤回权的适用范围应当限定于个人信息处理行为对人格和财产存在加害高风险且既有人格权保护规则对此存在保护不足的合同场景，即主要限定在消费者合同和劳动合同情形。人格标志商业利用并非需要个人信息保护法事先防范机制介入的风险领域，人格标志许可使用合同中的人格权人也非处于弱势地位，撤回权因此不适用于人格标志许可使用合同。信息主体有权事先放弃撤回权。在撤回权行使后，以同意信息处理为对待给付的双务合同的效力不受影响；撤回属于履行迟延型违约；信息主体因不具可归责事由而不承担违约损害赔偿责任，也无需赔偿信赖利益损失；合同相对人在一定条件下享有解除权。

关键词：个人信息同意撤回权解除权 personal information consent the right of withdrawal the right of termination

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Journal of Biosciences and Medicines 2016年第4期4卷 63-67页

作者： Alexander Acheampong Oti Ernest Owusu-Dapaah Chris Adomako-Kwaakye Daniel Kwesi Sabbah Solomon Obiri-Yeboah Ama Amuasi Adu Tutu Amankwa Ebenezer Adjei-Bediako Eva Adu-Boakye Dental School Kwame Nkrumah University of Science and Technology Kumasi Ghana School of Medical Sciences Kwame Nkrumah University of Science and Technology Kumasi Ghana Faculty of Law Kwame Nkrumah University of Science and Technology Kumasi Ghana Family Medicine Directorate Komfo Anokye Teaching Hospital Kumasi Ghana

Background: Every human being of adult years and sound mind has a right to determine what shall be done with his/her own body. Patient autonomy and the practice of informed patient consent are now pivotal in medical practice. Aim: To assess patient’s knowledge of Patients’ Rights Charter and whether patients receive adequate information to enable them make an informed consent to a particular treatment. Methodology: Patients who were undergoing elective surgery from selected surgical departments of Komfo Anokye teaching hospital in Kumasi were randomly selected and assisted to answer structured questionnaire without the knowledge of their doctors. The study period was in June to December (2014). Descriptive analysis was done using SPSS (II) of the results. Results: 84.7% (144) had no idea about the Patients’ Rights Charter of the Ghana Health Service. 75% (128) did not know or had not heard of informed patient consent. Of those who knew of the charter, 85% (37) had ever stayed in a developed country. 60% (102) did not know of their diagnosis. 79% (134) said the doctor only asked them to either sign or thumb print the consent document without giving them treatment options or possible complications. Conclusion: Most of respondents undergoing various surgical procedures at the Komfo Anokye Teaching Hospital were not aware of the existence of the Patients’ Rights Charter of the Ghana Health Service. Again, practitioners did not provide sufficient information to patients for them to make an informed decision about their health.

关键词： Informed consent Patient Charter Autonomy