Search results for: patient´s informed consent

Authors: Rafaella Nogaroli

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It is presented hypothetical cases in the context of AI algorithms to support clinical decisions, in order to discuss the importance of doctors to respect AI ethical principles. Regarding the principle of transparency and explanation, there is an impact on the new model of patient consent and on the understanding of qualified information. Besides, the human control of technology (AI as a tool) should guide the physician's activity; otherwise, he breaks the patient's legitimate expectation in a specific result, with the consequent transformation of the medical obligation nature.

Keywords: medical law, artificial intelligence, ethical principles, patient´s informed consent, medical obligations

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Authors: Anita Puspawati

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A failure in obtaining informed consent from patient occurs because there is not effective communication skill in doctors. Therefore, the language is very important in communication between doctor and patient. This study uses descriptive analysis method, that is a method used mainly in researching the status of a group of people, an object, a condition, a system of thought or a class of events in the present. The result of this study indicates that the communicative language between doctors and patients will increase the trust of patients to their doctors and accordingşy, patients will provide the informed consent voluntarily.

Keywords: communicative, language, doctor, patient

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Authors: Amy Gooden

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Various modes of consent have been utilized in health research, but open consent has not been explored in South Africa’s AI research context. Open consent entails the sharing of data without assurances of privacy and may be seen as an attempt to marry open science with informed consent. Because all potential uses of data are unknown, it has been questioned whether consent can be informed. Instead of trying to adapt existing modes of consent, why not adopt a new perspective? This is what open consent proposes and what this research will explore in AI health research in South Africa.

Keywords: artificial intelligence, consent, health, law, research, South Africa

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Authors: J. Luché-Thayer, C. Perronne, C. Meseko

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We reviewed how certain institutional policies and practices, as well as questionable research, are creating obstacles to care and informed consent for Lyme and relapsing fever Borreliosis patients. The interference is denying access to treatments that meet the internationally accepted standards as set by the Institute of Medicine. This obstruction to care contributes to significant human suffering, disability and negative economic effect across many nations and in many regions of the world. We note how evidence based medicine emphasizes the importance of clinical experience and patient-centered care and how these patients benefit significantly when their rights to choose among treatment options are upheld.  

Keywords: conflicts of interest, obstacles to healthcare accessibility, patient-centered care, the right to informed consent

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Authors: Parsa Keyvani, Alistair Phillips, David Warwick

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Background: The current process for gaining patient consent for hand and wrist surgery at University Hospital Southampton (UHS) is paper-based and makes use of generic forms provided by the NHS and no patient information leaflet is available relating to hand and wrist surgery. Aims: To evaluate the process of obtaining clinical consent and suggest ways in which the service can be improved. Methods: A log-book review of four orthopaedic surgeons at UHS was carried out over a three-month period in order to identify the 10 most common types of elective hand and wrist surgeries performed. A literature review was carried out to identify the complications of these surgeries. The surgeries were then divided into 6 types: nerve, bone, ligament, joint, tendon and dupuytren’s surgery. A digitised consent form was created covering the complications of all 6 surgery types. Finally, the surgeons at the orthopaedic department of UHS were asked whether they prefer the old paper-based or the digitised consent form. Results: All of the surgeons felt that the procedure type-based form was easier to read, use and understand. Conclusion: This research highlights a number of problems related to the use of current NHS consent forms. The proposed solution is to use a set of digitised, procedure type-based consent forms. Digital consent forms can be filled in in advance and sent to the patient electronically along with any relevant information leaflets, thus giving them time to absorb the information and come up with any questions before they have their pre-procedure discussion with their doctor. This would allow the doctor to focus the consultation on the patient rather than writing out the consent form and would ultimately be a step forward in making the NHS a global digital leader and fully embrace the opportunity offered by technology.

Keywords: digitised consent form, elective surgery, hand surgery complications, informed consent, procedure type-based consent form

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Authors: Jia Liu

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This article explores the shifting nature of physician-patient relationship in mainland China. Specifically, it takes the physician-patient relationship during the barefoot doctor program in 1968-1978, the marketization of healthcare services in 1978-2002, and the healthcare reform in 2003-2020 as three typical historical periods, illustrating how the nature of the physician-patient relationship has changed over time in mainland China. Drawing on recent jurisprudential literature that emphasizes the roles and functions done by and through obligation rather than right, it explores how the obligations of physicians and patients along with the implementation of informed consent, marketization of the healthcare system, and the basic healthcare reform have affected their relationship. One key feature of this article is that it analyzes the ways in which commodification and decommodification of healthcare have defined and in many different ways have determined the expectations and practices of physicians and patients, which illustrates how the trust between physicians and patients threatens to collapse and the bond between the citizen and the state fails to be firmly established in the mainland Chinese healthcare context. It also pays special attention to the role played by law and legal institutions—for instance, the implementation of informed consent and the liability law—in being complicit in facilitating the decoupling of the practices of physicians and patients from their ethical senses of obligation and undermining the bond (the trust relationship) between them.

Keywords: healthcare, marketization, physician-patient relationship, sense of obligation

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Authors: Emma Carr, Bilal Aslam-Pervez, David Laraway

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Litigation against surgeons and hospitals continues to increase in Western countries. While verbal consent is all that is required legally, it has for a long time been considered that written consent offers proof of discussion and interaction between the surgeon and the patient. Inadequate consenting of patients continues in the United Kingdom leaving surgeons and Health Trusts open to litigation. We present a standardised consent form which improves patient autonomy and engagement. The General Medical Council recommends that all material risks relevant to the patient are discussed and recorded prior to undergoing surgery, regardless of how likely they are to occur. Current literature was reviewed to evaluate complications associated with surgical management of mandible fractures. Analysis of risks on 52 consent forms were analysed within the Glasgow OMFS department, leading to a procedure-specific form being designed and implemented. This audit showed that the documentation of risks on consent forms was extremely variable- with uncommon risks not being recorded. Interestingly, not a single consent form was found which highlighted all the risks associated with mandible fractures. Our re-audit data confirms 100% of risks being discussed when a procedure specific form is utilised. Our hope, is to introduce further forms for inclusion on the BAOMS website and peripheral distribution. The forms are quick and easy to print and leave more time for consultation with the patient. Whilst we are under no illusion that the forms may not decrease the incidence of intended litigation, we feel confident that they will decrease the chances of it being successful.

Keywords: consent, litigation, mandible fracture, surgery

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Authors: Md. Abdul Karim, Syed Imran Ahmed, Pandora T. Hardtman

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Informed consent is one of the basic human and ethical rights for childbearing women. It plays a central role in promoting informed decision making between patients and service providers during the labor process. It gives mothers rights to accept or reject any examination and/or procedure, increases the respect and dignity of the mother during pregnancy, delivery and postpartum care. To assess the practices of this right during normal vaginal delivery and immediate postpartum care in tertiary level hospital setting in Bangladesh, a quantitative study with cross-sectional design was conducted in Dhaka Medical College & Hospital (DMCH) and Sir Salimullah Medical College & Mitford Hospital (SSMCH) in Dhaka in November 2015. A prevalence-based sample size of 190 was calculated where prevalence, confidence interval and level of significance were at 9.7%, 98% and 5% respectively. The respondents were the mothers who gave normal vaginal childbirth within past 24 hours and received postpartum care there. They were selected through systematic random sampling technique and their face-to-face interview of 190 mothers was done using a structured questionnaire. Data were entered into the spreadsheet (MS Excel 2013 version) and descriptive analysis of findings was done. The result shows the complete absence of informed consent practices and mostly absence of consented care such as right to information, respect for choices of preferences for examination and/or procedure of childbearing women. Although 95% of the mothers were informed that they were being proceeded with normal vaginal delivery, their choice of preference was absent during the process. Only consent (not informed consent) was taken from 50%-72% mothers for examination (except breast examination ‘0%’) and 8%-83% for any procedures during postpartum care. Only one-ninth (11%) of the mothers could ask service providers regarding the services they received. No consent was taken from 3% of the mothers- neither in the labor process nor in postpartum care. This current practice doesn’t comply with the Respectful Maternity Care (RMC) Charter 2011. The issue is not even clarified in the current Standard Clinical Management Protocols of the country. So, improvement of the existing protocol and increased awareness are essential to address this right of child-bearing women and to practice it during normal vaginal delivery and postpartum care.

Keywords: informed consent, normal vaginal delivery, respectful maternity care, tertiary level hospital

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Authors: R. W. Walker, J. M. Lynch, K. Anderson, R. G. Middleton

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Hip and knee arthritis are two of the commonest conditions that result in elective orthopaedic outpatient referral. At clinic appointments advice given regarding lifestyle modifications or treatment options may not be fully understood by patients. The majority of patients now use the internet to research their condition and use this to inform their decision about treatments. This study assessed the quality of patient information regarding hip and knee arthritis. To assess the quality of patient information regarding knee and hip arthritis available on the internet. Two internet searches were carried out one month apart using the search terms “knee arthritis” and “hip arthritis” on Google, a search engine that accounts for over 90% or internet searches in the UK. Sites were evaluated using the DISCERN instrument, a validated tool for measuring the quality of consumer health information. The first 50 results for each search were analysed by two different observers and discrepancies in scores were reviewed by both observers together and a score was agreed upon. In total 200 search result websites were assessed, of which 84 fulfilled the inclusion criteria. 53% (n=44) were funded directly by commercial healthcare businesses and of these, 70% (n=31) were funded by a surgeon/hospital promoting end-user purchase of surgical intervention. Overall 35% (n=29) websites were “for-profit” information websites where funding was from advertising revenues from pharmaceutical and prosthesis companies. 81% (n=67) offered information about surgical treatments however only 43% (n=36) mentioned the risk of complications of surgery. 67% (n=56) did not have any reference to sources for the information they detailed and 57% (n=47) had no apparent date for the production of the information they offered. Overall 17% (n=14) of websites were judged as being of high quality, with 29% (n=24) being of moderate quality and 54% (n=45) being of low quality. The quality of health information regarding hip and knee arthritis on the internet is highly variable and the majority of websites assessed were of poor quality. A preponderance of websites were funded by a commercial surgical service offering athroplasty at consumer cost, with a further third being funded indirectly via advertising revenues from commercial businesses. The vast majority of websites only mentioned surgery as a treatment and nearly half of all websites did not mention the risks or complications of surgical intervention at all. This has implications for the consent process. As such, Clinicians should be aware of the heterogeneous nature of patient information on the internet and be prepared to advise their patients about good quality websites where further reliable information can be sought.

Keywords: hip osteoarthritis, informed consent, knee osteoarthritis, patient information

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Authors: Chia-Ying Lin

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This paper explains how to enhance doctor-patient communication and nurse-patient communication through multiple intelligence signing methods and user-centered. It is hoped that through the implementation of the "electronic consent", the problems faced by the paper consent can be solved: storage methods, resource utilization, convenience, correctness of information, integrated management, statistical analysis and other related issues. Make better use and allocation of resources to provide better medical quality. First, invite the ｍedical records department to assist in the inventory of paper consent in the hospital: organising, classifying, merging, coding, and setting. Second, plan the electronic consent configuration file: set the form number, consent form group, fields and templates, and the corresponding doctor's order code. Next, Summarize four types of rapid methods of electronic consent: according to the doctor's order, according to the medical behavior, according to the schedule, and manually generate the consent form. Finally, system promotion and adjustment: form an "electronic consent promotion team" to improve, follow five major processes: planning, development, testing, release, and feedback, and invite clinical units to raise the difficulties faced in the promotion, and make improvements to the problems. The electronic signature rate of the whole hospital will increase from 4% in January 2022 to 79% in November 2022. Use the saved resources more effectively, including: reduce paper usage (reduce carbon footprint), reduce the cost of ink cartridges, re-plan and use the space for paper medical records, and save human resources to provide better services. Through the introduction of information technology and technology, the main spirit of "lean management" is implemented. Transforming and reengineering the process to eliminate unnecessary waste is also the highest purpose of this project.

Keywords: smart signature, electronic consent, electronic medical records, user-centered, doctor-patient communication, nurse-patient communication

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Authors: Dragana Calic

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The openness, availability and the sheer volume of big data have provided, what some regard as, an invaluable and rich dataset. Researchers, businesses, advertising agencies, medical institutions, to name only a few, collect, share, and analyze this data to enable their processes and decision making. However, there are important ethical considerations associated with the use of big data. The rapidly evolving nature of online technologies has overtaken the many legislative, privacy, and ethical frameworks and principles that exist. For example, should we obtain consent to use people’s online data, and under what circumstances can privacy considerations be overridden? Current guidance on how to appropriately and ethically handle big data is inconsistent. Consequently, this paper focuses on two quite distinct but related ethical considerations that are at the core of the use of big data for research purposes. They include empowering the producers of data and empowering researchers who want to study big data. The first consideration focuses on informed consent which is at the core of empowering producers of data. In this paper, we discuss some of the complexities associated with informed consent and consider studies of producers’ perceptions to inform research ethics guidelines and practice. The second consideration focuses on the researcher. Similarly, we explore studies that focus on researchers’ perceptions and experiences.

Keywords: big data, ethics, producers’ perceptions, researchers’ perceptions

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Authors: Christina Tran, Lu Khoo, Andrea Waylen

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Introduction: The evolution of the dental consultation from paternalism to partnership has been well documented in developed Western countries. Great emphasis is now placed on the importance of empowering patients to make decisions regarding their care, obtaining informed consent, and maintaining patient privacy and confidentiality. With the majority of communication occurring non-verbally, clinicians often adopt behaviours which suggest an approachable and positive attitude. However, evidence indicates that in Asia, a paternalistic model may be favored in medicine. The power imbalance occurring in doctor-patient relationships worldwide may be exacerbated by various factors in Southeast Asia: the strong hierarchical culture, and the large education gap between doctor and patient. Further insight into this matter can be gained by observing patient-dentist communication in Cambodia. The dentist:population ratio in Cambodia is approximately 1:33,000, with rural areas remaining extremely underserviced. We have carried out an observational study of communication in a voluntary dental clinic in Cambodia with the aim of describing whether the patient-dentist relationship follows a paternalistic or patient-centred model. Method: Over a period of two weeks, two clinicians provided dental care as part of a voluntary program in two Cambodian settings: a temporary, rural clinic and a permanent clinic in Phnom Penh. The clinicians independently recorded their experiences in diaries, making observations on the verbal and non-verbal communication between patients and staff. General observations such as the clinic environment were also made. The diaries were then compared and analyzed using a thematic approach. Results: The overall themes that emerged were regarding the clinic environment, verbal communication, and non-verbal communication. Regarding the clinic environment, the rural clinic was arranged in order to easily direct patients from one dentist to another, with little emphasis on continuous patient care. There was also little consideration for patient privacy: patients were often treated in the presence of many observers, including other waiting patients. However, the permanent clinic was structured to allow greater patient privacy, with continuous patient care occurring throughout the appointment. Regarding verbal communication, there was a strongly paternalistic approach to gaining consent and giving instruction. Patients rarely asked questions regarding their treatment, with dentists doing little to encourage patient involvement. Non-verbal communication between patients and dentists was generally paternalistic, with the dentist often addressing the supine patient from above. Patients often avoided making eye-contact, which may have indicated discomfort or lack of engagement. Both adult and paediatric patients rarely raised verbal concerns regarding pain during treatment, despite displaying non-verbal signs of experiencing pain. Anxious paediatric patients were sometimes managed with physical restraint by their mothers to facilitate treatment. Conclusion: Patient-professional communication in the Cambodian dental setting was observed to be generally paternalistic in nature, although more patient-centred aspects were observed in the established, urban setting. However, it should be noted that these observations are subjective in nature, and that the patients’ actual perceptions of their communication experience were unexplored. Further observations in variety of dental settings in Cambodia are needed before any definitive conclusions can be made.

Keywords: patient-dentist communication, paternalism, patient-centered, non-verbal communication

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Authors: Alejandra Cardenas, Ona Flores, Fabiola Gretzinger

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Since the 1990s, legal strategies for the promotion and protection of maternal health rights have achieved significant gains. Successful litigation in courts around the world have shown that these rights can be judicially enforceable. Governments and international organizations have acknowledged the importance of a human rights-based approach to maternal mortality and morbidity, and obstetric violence has been recognized as a human rights issue. Despite the progress made, maternal mortality has worsened in some regions of the world, while progress has stagnated elsewhere, and mistreatment in maternal care is reported almost universally. In this context, issues of maternal autonomy and decision-making during pregnancy, labor, and delivery as a critical barrier to access quality maternal health have been largely overlooked. Indeed, despite the principles of autonomy and informed consent in medical interventions being well-established in international and regional norms, how they are applied particularly during childbirth and pregnancy remains underdeveloped. National and global legal standards and decisions related to maternal health were reviewed and analyzed to determine how maternal autonomy and decision-making during pregnancy, labor, and delivery have been protected (or not) by international and national courts. The results of this legal research and analysis lead to the conclusion that a few standards have been set by courts regarding pregnant people’s rights to make choices during pregnancy and birth; however, most undermine the agency of pregnant people. These decisions recognize obstetric violence and gender-based discrimination, but fail to protect pregnant people’s autonomy, privacy, and their right to informed consent. As current human rights standards stand today, maternal health is the only field in medicine and law in which informed consent can be overridden, and patients can be forced to submit to treatments against their will. Unconsented treatment and loss of agency during pregnancy and childbirth can have long-term physical and mental impacts, reduce satisfaction and trust in health systems, and may deter future health-seeking behaviors. This research proposes a path forward that focuses on the pregnant person as an independent agent, relying on the doctrine of self-determination during pregnancy and childbirth, which includes access to the necessary conditions to enable autonomy and choice throughout pregnancy and childbirth as a critical step towards our approaches to reduce maternal mortality, morbidity, and mistreatment, and realize the promise of access to quality maternal health as a human right.

Keywords: autonomy in childbirth and pregnancy, choice, informed consent, jurisprudential analysis

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Authors: Bei Shan Lin, Chun Mei Lu, Ya Ping Chen, Li Chen Lu

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This study explores the ethical issues concerning the use of physical restraint in geriatric care. Physical restraint use in a medical care setting is seen as a controversial form of treatment that has occurred over decades. There is no doubt that people nowadays are living longer than previous generations. The ageing process is inevitable. Common disease such as impaired comprehension, memory loss, and trouble expressing one’s self contribute to the difficulty that these older patients have in adapting to medical institution. For these reasons, physical restraint is often used in reducing the risk of falling, managing wandering behaviour, preventing agitation, and promoting patient compliance in geriatric care. It can mean that physical restraints are considered as a common practice that is used in the care of older patients. It is most commonly used for three specific purposes, including procedural restraint, restraint to prevent falls, and behavioural restraints. Although there have been well documented instances of morbidity and mortality recognised as being potential risks associated with physical restraint use, it continues to be permitted and used in healthcare, often in the name of safety. However, there is insufficient evidence supporting the effectiveness of physical restraint use reducing injuries from falls and controlling challenging behaviour in geriatric care settings. There is barely any empirical evidence of either a scientific basis or clinical trials have evaluated the improvement in patient safety following physical restraint. In difficult clinical situations, guidelines and practical suggestions for Healthcare professionals to comply requirements can help those making appropriate decisions and to facilitate better judgement regarding physical restraint use. The following recommendations are given for physical restraint use in long-term care settings: an interdisciplinary team approach to assess, evaluate, and treat underlying diseases to determine if treatment can ease issues precipitating physical restraint use; a clearly stated purpose of treatment plan should be made after weighing up the risk of physical restraint use against the risk of without physical restraint use; a care plan for physical restraint has to include individualised treatment planning, informed consent, identification and remedial action to avoid negative consequences, regular assessment and modification, reduction and removal of risks; patients and their families must have the opportunity to consider and give voluntary informed consent prior to physical restraint utilisation; patients, family members, and Healthcare professionals should be educated on use and adverse consequences of physical restraints in order to make raise awareness of potential risks and to take appropriate steps to prevent unnecessary harm; after physical restraint removal, Healthcare professionals should discuss with patients and family members about their experience, feelings, and any anxieties regarding the treatment. Physical restraint should always be considered a last resort as deprive patient’s freedom, control, and individuality. Healthcare professionals should emphasise on providing individualized care, interdisciplinary decision-making process, and creative and collaborative alternatives to promote older patient’s rights, dignity and overall well-being as much as possible.

Keywords: ethics healthcare, geriatric care, healthcare, physical restraint

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Authors: B. Unnikrishnan, Tanuj Kanchan, Ramesh Holla, Nithin Kumar

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Euthanasia has been debated for the ethical, legal, social, and religious implications associated with it. The present research was conducted to study the perceptions of doctors and nurses about ethical and legal aspects of Euthanasia in Indian scenario. The study was carried out at three tertiary care hospitals of Kasturba Medical College (KMC), Mangalore, India. Practicing doctors and nurses working in the hospitals associated with KMC were included in the study after taking written informed consent from the participants. The data was analyzed using SPSS version 11.5. Mann-Whitney U test was used to compare the responses of doctors and nurses. P-value of <0.05 was taken as statistically significant. A total of 144 doctors and nurses participated in the study. Both doctors and nurses agreed that if a terminally ill patient wishes to die, the wish cannot be honored ethically and legally. A significantly larger number of nurses agreed that patient’s wish for euthanasia cannot be honored ethically and legally when compared to the doctors. Though the doctors and nurses were broadly in agreement with the existing legal and ethical views on the issue, their knowledge on the issue with regard to the legal status of euthanasia in India and ethical aspects relating to it needs to be strengthened.

Keywords: euthanasia, ethical aspects, legal aspects, India

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Authors: Nathan Elvidge

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This paper offers a philosophical argument against the possibility of so-called “ethical porn,” that is, pornographic material produced in a way attempting to remain consistent with feminist principles and female empowerment. One key feature of such material is the requirement for the material to be consensual on the part of the actors or those involved in the material. However, in the contemporary pornography industry, this typically amounts to a single historic act of consent given in exchange for a lump-sum payment which grants the producer lifetime property rights over the explicit material. This paper argues that, by the lights of feminist principles, this situation is inherently unjust and that, as a consequence, the pornography industry requires a radical systematic upheaval before any material produced within it can be considered genuinely ethical. These feminist principles require that for the consumption of pornography to be genuinely ethical, the actors must consent not only to the acts recorded in the material but also to the consumption of that material. This paper argues that this consent to consumption should be treated as on par with other matters of sexual consent and, therefore, that actors should have the right to withdraw consent to the consumption of their material. From this, it is argued to follow that the system of third-party ownership of property rights over someone else’s sexually explicit material legally nullifies this right and therefore is inherently unjust.

Keywords: consent, feminism, pornography, sex work

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Authors: Anne N. Heirman, Song Duimel, Rob van Son, Lisette van der Molen, Richard Dirven, Gyorgi B. Halmos, Julia van Weert, Michiel W.M. van den Brekel

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Objectives: Treatments for head-neck cancer are drastic and often significantly impact the quality of life and appearance of patients. Shared decision-making (SDM) beholds a collaboration between patient and doctor in which the most suitable treatment can be chosen by integrating patient preferences, values, and medical information. SDM has a lot of advantages that would be useful in making difficult treatment choices. The objective of this study was to determine the current level of SDM among patients and head-and-neck surgeons. Methods: Consultations of patients with a non-cutaneous head-and-neck malignancy facing a treatment decision were selected and included. If given informed consent, the consultation was recorded with an audio recorder, and the patient and surgeon filled in a questionnaire immediately after the consultation. The SDM level of the consultation was scored objectively by independent observers who judged audio recordings of the consultation using the OPTION5-scale, ranging from 0% (no SDM) to 100% (optimum SDM), as well as subjectively by patients (using the SDM-Q-9 and Control preference scale) and clinicians (SDM-Q-Doc, modified control preference scale) percentages. Preliminary results: Five head-neck surgeons have each at least seven recorded conversations with different patients. One of them was trained in SDM. The other four had no experience with SDM. Most patients were male (74%), and oropharyngeal carcinoma was the most common diagnosis (41%), followed by oral cancer (33%). Five patients received palliative treatment of which two patients were not treated recording guidelines. At this moment, all recordings are scored by the two independent observers. Analysis of the results will follow soon. Conclusion: The current study will determine to what extent there is a discrepancy between the objective and subjective level of shared decision-making (SDM) during a doctor-patient consultation in Head-and-Neck surgery. The results of the analysis will follow shortly.

Keywords: head-and-neck oncology, patient involvement, physician-patient relations, shared decision making

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Authors: Yirui Wang

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In the past few decades, patient safety has been the focus of much attention in the global medical and health field. As medical standards continue to improve and develop, the demand for patient safety is also growing. As one of the important dimensions in assessing patient safety, the Patient Perception Patient Safety Assessment Tool provides unique and valuable information from the patient's own perspective and plays an important role in promoting patient safety. This article aims to summarize and analyze the assessment content, assessment methods and applications of currently commonly used patient-perceived patient safety assessment tools at home and abroad, with a view to providing a reference for medical staff to select appropriate patient-perceived patient safety assessment tools.

Keywords: patients, patient safety, perception, assessment tools, review

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Authors: Sandhyarani Guggilla

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For several reasons no two individuals can be considered identical and hence individualization of therapy is the current trend in treating the patients. Influence of menstrual cycle on the pharmacokinetics of Doxycycline. Twelve healthy female volunteers have been included in the study after obtaining written informed consent. The age ranged from 16 to 25 years. Experimental design: The volunteer selection and recruitment will be carried out after obtaining informed consent from each volunteer. The drug administration will be done to each volunteer at 7 a.m along with a glass of water after an overnight fasting on 3rd, 13th and 23rd day of menstrual cycle. These saliva samples will be stored under frozen conditions until HPLC analysis. Results: In the present study the changes in estrogen levels during ovulatory phase have not shown any influence onAUCo-t of Doxycycline. Only AUCo-t of doxycycline showed an increasing trend with increasing levels of estrogen in ovulatory phase, but not in other phases. Even though the FSH levels differed significantly among volunteers during different phases FSH does not seem to influence the overall pharmacokinetic behavior of Doxycycline during different phases. The present study indicated only the trend that the hormone levels may influence the pharmacokinetic behavior of the Doxycycline. Conclusion: In the present study the changes in hormones have shown an increasing C-max, increasing AUCo-t of Doxycycline pharmacokinetics significantly in follicular phase than ovulatory and luteal phases among volunteers during different phases. In other pharmacokinetic properties like clearance, biological half-life, volume of distribution, mean residence time the change was not significant.

Keywords: menstrual cycle, doxycycline, estrogen, FSH, ovulatory phase

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Authors: Roya Yumul, Ofelia Loani Elvir-Lazo, Sevan Komshian, Ruby Wang, Jun Tang

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BACKGROUND: An objective means for monitoring the anti-nociceptive effects of perioperative medications has long been desired as a way to provide anesthesiologists information regarding a patient’s level of antinociception and preclude any untoward autonomic responses and reflexive muscular movements from painful stimuli intraoperatively. To this end, electroencephalogram (EEG) based tools including BIS and qCON were designed to provide information about the depth of sedation while qNOX was produced to inform on the degree of antinociception. The goal of this study was to compare the reliability of qCON/qNOX to BIS as specific indicators of response to nociceptive stimulation. METHODS: Sixty-two patients undergoing general anesthesia with LMA were included in this study. Institutional Review Board (IRB) approval was obtained, and informed consent was acquired prior to patient enrollment. Inclusion criteria included American Society of Anesthesiologists (ASA) class I-III, 18 to 80 years of age, and either gender. Exclusion criteria included the inability to consent. Withdrawal criteria included conversion to the endotracheal tube and EEG malfunction. BIS and qCON/qNOX electrodes were simultaneously placed on all patients prior to induction of anesthesia and were monitored throughout the case, along with other perioperative data, including patient response to noxious stimuli. All intraoperative decisions were made by the primary anesthesiologist without influence from qCON/qNOX. Student’s t-distribution, prediction probability (PK), and ANOVA were used to statistically compare the relative ability to detect nociceptive stimuli for each index. Twenty patients were included for the preliminary analysis. RESULTS: A comparison of overall intraoperative BIS, qCON and qNOX indices demonstrated no significant difference between the three measures (N=62, p> 0.05). Meanwhile, index values for qNOX (62±18) were significantly higher than those for BIS (46±14) and qCON (54±19) immediately preceding patient responses to nociceptive stimulation in a preliminary analysis (N=20, * p= 0.0408). Notably, certain hemodynamic measurements demonstrated a significant increase in response to painful stimuli (MAP increased from 74 ±13 mm Hg at baseline to 84 ± 18 mm Hg during noxious stimuli [p= 0.032] and HR from 76 ± 12 BPM at baseline to 80 ± 13 BPM during noxious stimuli [p=0.078] respectively). CONCLUSION: In this observational study, BIS and qCON/qNOX provided comparable information on patients’ level of sedation throughout the course of an anesthetic. Meanwhile, increases in qNOX values demonstrated a superior correlation to an imminent response to stimulation relative to all other indices

Keywords: antinociception, BIS, general anesthesia, LMA, qCON/qNOX

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Authors: Kamran Yazdanbakhsh, Somayeh Mahmoudi

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Three reasons make good use of the decision theory in medicine: 1. Increased medical knowledge and their complexity makes it difficult treatment information effectively without resorting to sophisticated analytical methods, especially when it comes to detecting errors and identify opportunities for treatment from databases of large size. 2. There is a wide geographic variability of medical practice. In a context where medical costs are, at least in part, by the patient, these changes raise doubts about the relevance of the choices made by physicians. These differences are generally attributed to differences in estimates of probabilities of success of treatment involved, and differing assessments of the results on success or failure. Without explicit criteria for decision, it is difficult to identify precisely the sources of these variations in treatment. 3. Beyond the principle of informed consent, patients need to be involved in decision-making. For this, the decision process should be explained and broken down. A decision problem is to select the best option among a set of choices. The problem is what is meant by "best option ", or know what criteria guide the choice. The purpose of decision theory is to answer this question. The systematic use of decision models allows us to better understand the differences in medical practices, and facilitates the search for consensus. About this, there are three types of situations: situations certain, risky situations, and uncertain situations: 1. In certain situations, the consequence of each decision are certain. 2. In risky situations, every decision can have several consequences, the probability of each of these consequences is known. 3. In uncertain situations, each decision can have several consequences, the probability is not known. Our aim in this article is to show how decision theory can usefully be mobilized to meet the needs of physicians. The decision theory can make decisions more transparent: first, by clarifying the data systematically considered the problem and secondly by asking a few basic principles should guide the choice. Once the problem and clarified the decision theory provides operational tools to represent the available information and determine patient preferences, and thus assist the patient and doctor in their choices.

Keywords: decision making, medicine, treatment strategies, patient

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Authors: Baluku Nathan

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Transferring critically ill patients from one health facility to another poses a major risk to the patient because of increased oxygen demands. transferring patients with critical COVID-19 from a rural health canter in a rural district to a national referral hospital over 350 km in 7 hours would require three size H oxygen cylinders for successful transfer. It was always difficult to arrange the three size cylinders in the ambulance as workspace was greatly compromised for the ambulance assistant. Purpose: The purpose of this study was to investigate the impact and effectiveness of transport ventilators on the transportation of the critically ill patients from rural health canters to national referral hospitals in Uganda. Methodology: This was a descriptive cross-sectional study conducted in sept 2022 among critical care nurses and ambulance assistants who had used both methods of transportation (ventilators and cylinders). A semi structured questionnaire was used to collect quantitative data after informed consent. Results: From the findings, distribution of transport ventilators to the regional referral hospitals by the Ministry of Health has gradually improved patient transfer as the team requires less than one size oxygen cylinder to successfully transfer a patient. We use two ambulance assistants (a critical care nurse and another nurse who has been trained on use of the ventilator) when transferring patients with critical COVID-19 as the teams have to interchange over the long distance. Conclusions: Transport ventilators are effective and efficient in transferring critically ill patients, therefore should be rolled out to lower levels coupled with user training to improve outcomes of patients transferred in ambulances in lower income countries.

Keywords: emergency medical technician, critically ill, COVID-19, transport ventilator

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Authors: Herlin Vallejo, Jhon Osorio

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Quality is a concept that has gained importance in different scenarios over time, especially in the area of health. The nursing staff is one of the actors that contributes most to the care process and the satisfaction of the users in the evaluation of quality. However, until now, there are few tools to measure the quality of care in specialized performance scenarios. Patients receiving ambulatory cancer treatments can face various problems, which can increase their level of distress, so improving the quality of outpatient care for cancer patients should be a priority for oncology nursing. The experience of the patient in relation to the care in these services has been little investigated. The purpose of this study was to understand the perception that patients have about quality care in outpatient chemotherapy services. A qualitative, exploratory, descriptive study was carried out in 9 patients older than 18 years, diagnosed with cancer, who were treated at the Institute of Cancerology, in outpatient chemotherapy rooms, with a minimum of three months of treatment with curative intention and which had given your informed consent. The total of participants was determined by the theoretical saturation, and the selection of these was for convenience. Unstructured interviews were conducted, recorded and transcribed. The analysis of the information was done under the technique of content analysis. Three categories emerged that reflect the perception that patients have regarding quality care: patient-centered care, care with love and effects of care. Patients highlighted situations that show that care is centered on them, incorporating elements of patient-centered care from the institutional, infrastructure, qualities of care and what for them, in contrast, means inappropriate care. Care with love as a perception of quality care means for patients that the nursing staff must have certain qualities, perceive caring with love as a family affair, limits on care with love and the nurse-patient relationship. Quality care has effects on both the patient and the nursing staff. One of the most relevant effects was the confidence that the patient develops towards the nurse, besides to transform the unreal images about cancer treatment with chemotherapy. On the other hand, care with quality generates a commitment to self-care and is a facilitator in the transit of oncological disease and chemotherapeutic treatment, but from the perception of a healing transit. It is concluded that care with quality from the perception of patients, is a construction that goes beyond the structural issues and is related to an institutional culture of quality that is reflected in the attitude of the nursing staff and in the acts of Care that have positive effects on the experience of chemotherapy and disease. With the results, it contributes to better understand how quality care is built from the perception of patients and to open a range of possibilities for the future development of an individualized instrument that allows evaluating the quality of care from the perception of patients with cancer.

Keywords: nursing care, oncology service hospital, quality management, qualitative studies

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Authors: Mohammad ASadian, Samira RajiAsadabadi

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Osteoporosis is very common, particularly in post-menopausal women and is characterized by a decrease in bone mass and strength. Osteoporosis also affects the jawbone and it is considered a potential contraindication to the placement of dental implants. The present paper reviews the literature regarding the effect of osteoporosis on the osseointegration of implants. Experimental models have shown that osteoporosis affects the process of osseointegration, which can be reversed by treatment. However, studies in subjects with osteoporosis have shown no differences in the survival of the implants compared to healthy individuals. Therefore, osteoporosis cannot be considered a contraindication for implant placement. Oral bisphosphonates are the most commonly used pharmacological agents in the treatment of osteoporosis. Although there have been cases of osteonecrosis of the jaw in patients treated with bisphosphonates, they are very rare and it is more usually associated with intravenous bisphosphonates in patients with neoplasms or other serious diseases. Nevertheless, patients treated with bisphosphonates must be informed in writing about the possibility of this complication and must give informed consent. Ceasing to use of bisphosphonates before implant placement does not seem to be necessary.

Keywords: Osteoporosis, dental implant, bisphosphonates, survival

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Authors: Ofelia Loani Elvir Lazo, Roya Yumul, Sevan Komshian, Ruby Wang, Jun Tang

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Background: Monitoring the anti-nociceptive drug effect is useful because a sudden and strong nociceptive stimulus may result in untoward autonomic responses and muscular reflex movements. Monitoring the anti-nociceptive effects of perioperative medications has long been desiredas a way to provide anesthesiologists information regarding a patient’s level of antinociception and preclude any untoward autonomic responses and reflexive muscular movements from painful stimuli intraoperatively.To this end, electroencephalogram (EEG) based tools includingBIS and qCON were designed to provide information about the depth of sedation whileqNOXwas produced to informon the degree of antinociception.The goal of this study was to compare the reliability of qCON/qNOX to BIS asspecific indicators of response to nociceptive stimulation. Methods: Sixty-two patients undergoing general anesthesia with LMA were included in this study. Institutional Review Board(IRB) approval was obtained, and informed consent was acquired prior to patient enrollment. Inclusion criteria included American Society of Anesthesiologists (ASA) class I-III, 18 to 80 years of age, and either gender. Exclusion criteria included the inability to consent. Withdrawal criteria included conversion to endotracheal tube and EEG malfunction. BIS and qCON/qNOX electrodes were simultaneously placed o62n all patientsprior to induction of anesthesia and were monitored throughout the case, along with other perioperative data, including patient response to noxious stimuli. All intraoperative decisions were made by the primary anesthesiologist without influence from qCON/qNOX. Student’s t-distribution, prediction probability (PK), and ANOVA were used to statistically compare the relative ability to detect nociceptive stimuli for each index. Twenty patients were included for the preliminary analysis. Results: A comparison of overall intraoperative BIS, qCON and qNOX indices demonstrated no significant difference between the three measures (N=62, p> 0.05). Meanwhile, index values for qNOX (62±18) were significantly higher than those for BIS (46±14) and qCON (54±19) immediately preceding patient responses to nociceptive stimulation in a preliminary analysis (N=20, * p= 0.0408). Notably, certain hemodynamic measurements demonstrated a significant increase in response to painful stimuli (MAP increased from74±13 mm Hg at baseline to 84± 18 mm Hg during noxious stimuli [p= 0.032] and HR from 76±12 BPM at baseline to 80±13BPM during noxious stimuli[p=0.078] respectively). Conclusion: In this observational study, BIS and qCON/qNOX provided comparable information on patients’ level of sedation throughout the course of an anesthetic. Meanwhile, increases in qNOX values demonstrated a superior correlation to an imminent response to stimulation relative to all other indices.

Keywords: antinociception, bispectral index (BIS), general anesthesia, laryngeal mask airway, qCON/qNOX

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Authors: Gamze Dogan Birer

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Women’s shelters provide service to women who had been subjected to physical, psychological, economical, and sexual violence. It is proposed that adopting a trauma-informed approach in these shelters would contribute to the ‘woman-defined’ success of the service. This includes reshaping the physical qualities of the shelter, contacts, and interventions that women face during their stay in a way that accepts and addresses their traumatic experiences. It is stated in this paper that the trauma-informed approach has commonalities with the basic psychological needs that are proposed by self-determination theory. Therefore, it is proposed that self-determination theory can be used as a theoretical background for trauma-informed approach

Keywords: self determination theory, trauma informed approach, violence against women, women's shelters

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Authors: Geir Kirkebøen

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Most patients with serious diagnoses want to know their prognosis, in particular their expected survival time. As part of the informed consent process, physicians are legally obligated to communicate such information to patients. However, there is no established (evidence based) ‘best practice’ for how to do this. The two questions explored in this study are: How do physicians communicate expected survival time to patients, and how should it be done? We explored the first, descriptive question in a study with Norwegian oncologists as participants. The study had a scenario and a survey part. In the scenario part, the doctors should imagine that a patient, recently diagnosed with a serious cancer diagnosis, has asked them: ‘How long can I expect to live with such a diagnosis? I want an honest answer from you!’ The doctors should assume that the diagnosis is certain, and that from an extensive recent study they had optimal statistical knowledge, described in detail as a right-skewed survival curve, about how long such patients with this kind of diagnosis could be expected to live. The main finding was that very few of the oncologists would explain to the patient the variation in survival time as described by the survival curve. The majority would not give the patient an answer at all. Of those who gave an answer, the typical answer was that survival time varies a lot, that it is hard to say in a specific case, that we will come back to it later etc. The survey part of the study clearly indicates that the main reason why the oncologists would not deliver the mortality prognosis was discomfort with its uncertainty. The scenario part of the study confirmed this finding. The majority of the oncologists explicitly used the uncertainty, the variation in survival time, as a reason to not give the patient an answer. Many studies show that patients want realistic information about their mortality prognosis, and that they should be given hope. The question then is how to communicate the uncertainty of the prognosis in a realistic and optimistic – hopeful – way. Based on psychological research, our hypothesis is that the best way to do this is by explicitly describing the variation in survival time, the (usually) right skewed survival curve of the prognosis, and emphasize to the patient the (small) possibility of being a ‘lucky outlier’. We tested this hypothesis in two scenario studies with lay people as participants. The data clearly show that people prefer to receive expected survival time as a median value together with explicit information about the survival curve’s right skewedness (e.g., concrete examples of ‘positive outliers’), and that communicating expected survival time this way not only provides people with hope, but also gives them a more realistic understanding compared with the typical way expected survival time is communicated. Our data indicate that it is not the existence of the uncertainty regarding the mortality prognosis that is the problem for patients, but how this uncertainty is, or is not, communicated and explained.

Keywords: cancer patients, decision psychology, doctor-patient communication, mortality prognosis

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Authors: Sangbok Lee

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There has been much effort on process improvement for outpatient clinics to provide quality and acute care to patients. One of the efforts is no-show analysis or prediction. This work analyzes patient no-shows along with patient health conditions. The health conditions refer to clinical symptoms that each patient has, out of the followings; hyperlipidemia, diabetes, metastatic solid tumor, dementia, chronic obstructive pulmonary disease, hypertension, coronary artery disease, myocardial infraction, congestive heart failure, atrial fibrillation, stroke, drug dependence abuse, schizophrenia, major depression, and pain. A dataset from a regional hospital is used to find the relationship between the number of the symptoms and no-show probabilities. Additional analysis reveals how each symptom or combination of symptoms affects no-shows. In the above analyses, cross-classification of patients by age and gender is carried out. The findings from the analysis will be used to take extra care to patients with particular health conditions. They will be forced to visit clinics by being informed about their health conditions and possible consequences more clearly. Moreover, this work will be used in the preparation of making institutional guidelines for patient reminder systems.

Keywords: healthcare system, no show analysis, process improvment, statistical data analysis

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Authors: Ayami Umemura

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The purpose of this paper is to examine the meaning of verbalization in clinical practice using the keywords silence and singularity. A patient's experience of illness and treatment is singular, irreplaceable, and irreproducible and ultimately cannot be compared with that of others. In his book Difference and Repetition, Gilles Deleuze positioned irreplaceable singularity as the opposite concept of particularity as a generalizable and substitutable property and matched the former with universality. He also said that singularity could not be represented because of its irreplaceable nature. Representation or verbalization is a procedure that converts an irreplaceable, idiosyncratic reality into something that can be substituted. Considering the act of verbalizing medical diagnosis based on this, it can be said that diagnosis is the practice of decontextualizing and generalizing the suffering embedded in the patient's irreplaceable life history as a disease. This paper examines the above with the key concept of the practice of "non-verbalization" in traditional medical practices in Sri Lanka. In the practice of Sri Lankan traditional medicine and the inheritance of medical knowledge and care techniques, there is a tendency to avoid verbalizing specific matters or stating them aloud. Specifically, the following should be avoided. The healer informs the patient of the name of the disease, mentions the name of the herb used in front of the patient, explains the patient's condition to the healer, and referring the names of poisonous animals, such as poisonous snakes that have been damaged. And so on. Furthermore, when passing on medical knowledge and skills, it is also possible to avoid verbalizing knowledge of medicinal herbs and medical treatment methods and explaining them verbally. In addition to the local belief that the soul of language in Sri Lanka is deeply involved in this background, Sri Lankan traditional medicine has a unique view of the human body and personality that is rooted in the singularity that appears in the relationship with the movement of celestial bodies and the supernatural realm. It can be pointed out that it is premised on the view. In other words, the “silence” in Sri Lankan indigenous medicine is the reason for emphasizing specificity. Furthermore, we can say that "non-verbalization" is a practice aimed at healing. Based on these discussions, this paper will focus on the unique relationships between practitioners and patients that become invisible due to verbalization, which is overlooked by clinical medicine, where informed consent, ensuring transparency, and audit culture is dominant. We will examine the experience of treatment and aim to relativize clinical medicine, which is based on audit cultures.

Keywords: audit cultures, indigenous medicine, singularity, verbalization

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Authors: Dongqi Sun, Juan Tao, Yingying Wu

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This paper reexamines the appropriateness of contrarian trades as a proxy of informed trades, using high frequency Chinese stock data. Employing this measure for 5 minute intervals, a U-shaped intraday pattern of probability of informed trades (PIN) is found for the CSI300 stocks, which is consistent with previous findings for other markets. However, while dividing the trades into different sizes, a reversed U-shaped PIN from large-sized trades, opposed to the U-shaped pattern for small- and medium-sized trades, is observed. Drawing from the mixed evidence with different trade sizes, the price impact of trades is further investigated. By examining the relationship between trade imbalances and unexpected returns, larges-sized trades are found to have significant price impact. This implies that in those intervals with large trades, it is non-contrarian trades that are more likely to be informed trades. Taking account of the price impact of large-sized trades, non-contrarian trades are used to proxy for informed trading in those intervals with large trades, and contrarian trades are still used to measure informed trading in other intervals. A stronger U-shaped PIN is demonstrated from this modification. Auto-correlation and information advantage tests for robustness also support the modified informed trading measure.

Keywords: contrarian trades, informed trading, price impact, trade imbalance

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