Due to improvements in medicine, the figures of patients with disorders of consciousness (DoC) are increasing. Diagnostics of DoC and prognostication of rehabilitation outcome is challenging but necessary to evaluate recovery potential and to decide on treatment options. Such decisions should be made by doctors and patients’ surrogates based on medico-ethical principles. Meeting information needs and communicating effectively with caregivers as the patients´ most common surrogate-decision makers is crucial, and challenging when novel tech-nologies are introduced. This qualitative study (...) aims to explore information needs of informal DoC caregivers, how they manage the obtained information and their perceptions and experiences with caregiver-physician communication in facilities that implemented innovative neurodiagnostics studies. In 2021, we conducted semi-structured interviews with nine caregivers of clinically stable DoC patients in two rehabilitation centers in Italy and Germany. Participants were selected based on consecutive purposeful sampling. Caregivers were recruited at the facilities after written informed consent. All interviews were recorded, transcribed verbatim and translated. For analysis, we used reflexive thematic analysis according to Braun & Clarke (2006). Caregivers experienced the conversations emotionally, generally based on the value of the information provided. They reported to seek positive information, comfort and empathy with-in the communication of results of examinations. They needed detailed information to gain a deep understanding and a clear picture of their loved-one’s condition. The results suggest a mismatch between the perspectives of caregivers and the perspectives of medical profession-als, and stress the need for more elaborate approaches to the communication of results of neu-rodiagnostics studies. (shrink)

BackgroundPeople with upper extremity amputations report receiving insufficient information about treatment options. Furthermore, patients commonly report not knowing what questions to ask providers. A question prompt sheet, or list of questions, can support patient-centered care by empowering patients to ask questions important to them, promoting patient-provider communication, and increasing patient knowledge. This study assessed information needs among people with UE amputations about UE vascularized composite allotransplantation and developed a UE VCA-QPS.MethodsThis multi-site, cross-sectional, mixed-methods study involved in-depth and (...) semi-structured interviews with people with UE amputations to assess information needs and develop a UE VCA-QPS. Qualitative data were analyzed by thematic analysis; quantitative data were analyzed by descriptive statistics. The initial UE VCA-QPS included 130 items across 18 topics.ResultsEighty-nine people with UE amputations participated. Most were male, had a mean age of 46 years, and had a unilateral and below-elbow amputation. Participants desired information about UE VCA eligibility, evaluation process, surgery, risks, rehabilitation, and functional outcomes. After refinement, the final UE VCA-QPS included 35 items, across 9 topics. All items were written at a ≤ 6th grade reading level. Most semi-structured interview participants reported being ‘completely’ or ‘very’ likely to use a UE VCA-QPS.ConclusionPeople with UE amputations have extensive information needs about UE VCA. The UE VCA-QPS aims to address patients’ information needs and foster patient-centered care. Future research should assess whether the UE VCA-QPS facilitates patient-provider discussion and informed decision-making for UE VCA. (shrink)

Informed consent is the practical application of the principle of autonomy, and two of the five core features of informed consent are related to information. Researchers have reported on patients’ expressed needs for information, such as their stated desires for the quantity of and the source of information. A separate body of research has examined patients’ unexpressed needs for information from the perspective of cognitive psychology, such as the emotional tone and order of (...) class='Hi'>information. This article suggests that the autonomy of patients is best served by meeting their expressed and unexpressed information needs in tandem. (shrink)

PurposeIn this paper, patient information is approached from a Heideggerian perspective with the intention to gather an understanding about the personal nature of the information. The purpose of this paper is to analyse the ownership of patient information and then present Datenherrschaft as a suitable model for patient ownership of patient information.Design/methodology/approachThis paper is theoretical in approach. It is based on arguments derived from Heidegger’s work in the Being and Time.FindingsBased on this Heideggerian approcah, a proposal (...) for using the special definition of ownership of patient information – Datenherrschaft – given to a patient is suggested. From a Heideggerian perspective, it can be stated that the patient has the strongest rights towards patient information because this information is crucial for a patient to have an understanding about their Dasein.Research limitations/implicationsDatenherrschaft is used as an example of an ethically justified way of regulating the patient information ownership and should be analysed further. Especially the practical implications of implementing Datenherrschaft need more research.Originality/valuePatient information ownership is an issue that is neither unambiguously solved in many countries, nor has it, in our view, been ethically justified. The potential solution – Datenherrschaft – presented in this paper is clear and has strong philosophical justifications. (shrink)

When physicians search the web for personal information about their patients, others have argued that this undermines patients’ trust, and the physician-patient relationship in general. We add that this practice also places other relationships at risk, and could jeopardize a physician’s career. Yet there are also reports of web searches that have unambiguously helped in the care of patients, suggesting circumstances in which a routine search of the web could be beneficial. We advance the notion that, just as nonverbal (...) cues and unsolicited information can be useful in clinical decision making, so too can online information from patients. As electronic records grow more voluminous and span more types of data, searching these resources will become a clinical skill, to be used judiciously and with care—just as evaluating the literature is, today. But to proscribe web searches of patients’ information altogether is as nonsensical as disregarding findings from physical exams—instead, what’s needed are guidelines for when to look and how to evaluate what’s uncovered, online. (shrink)

Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a (...) prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means. (shrink)

Background In recent years, patient advocacy has emerged as a prominent concept within healthcare. How nursing students decide what is best for their patients is not well understood. Objective The objective is to examine nursing students' views on doing what is best for patients during their clinical experiences and how they seek to establish patient interests when providing care. Research questions guiding the interview were as follows: (1) What are nursing students' perceptions of patient interests? (2) What factors influence nursing (...) students' perceptions of advocating for patient’s interests? Research design Qualitative descriptive research using thematic analysis. Participants and research context Data was collected through individual online interviews with nine nursing students with clinical experience. Ethical considerations The study was approved by the University Research Ethics Committee. Participants provided digital informed consent. Results The students asserted that they are able to understand the patients' interests by placing emphasis on the patients' needs. They believe that it is crucial to adopt a collaborative strategy for the provision of care to meet these requirements. In addition, some of them expressed concern over the most effective methods of advocating for the interests of patients. Three themes were identified. (1) Focussing on patient needs first, (2) taking a collective approach, and (3) learning how to advocate. Conclusions Students understand and value the ethical commitments associated with advocating for the patient's best interest by considering factors such as prioritising the patient's needs, adopting a strategy that involves everyone, and acquiring the ability to undertake the advocacy role. Additionally, nursing education strategies in clinical contexts require additional study to inspire students to do what is in their patient’s best interests. (shrink)

High-quality doctor-patient communication in end-of-life care results in better quality of life for patients. In linguistically and culturally diverse societies, language discordant consultations become daily practice, leading to difficulties in eliciting patient preferences toward end-of-life care. Although family members invariably act as informal interpreters, this may cause some ethical dilemmas. We present a case of a palliative patient whose son acted as an interpreter. This case generated a triple- layered ethical dilemma: how to safeguard patient autonomy against paternalistic interventions by (...) family members, how to respect the relational context in which patient autonomy can be realized, and how to respect the ethno-cultural values of the patient and his family. These issues are being discussed and reflected upon within the framework shared decision making involving informal- and professional interpreters. The complementary use of professional interpreters next to family members acting as informal interpreters is recommended. (shrink)

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to (...) gauge the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice. (shrink)

Owing to its grappling with a motley of intricate socioeconomic, as well as medico-legal, crises, Haiti has found itself bereft of some of its people, many of whom have had to leave the Caribbean country in search of improved lives elsewhere. Receiving some of the Haitian refugees fleeing abject poverty, unemployment, and other harms and barriers has been the United States, one of Haiti's northern neighbors and a country that has played an outcome-determinative, if not outsized, role in steering the (...) country toward its presently hobbled state. Drawing on the U.S.’s recent treatment of Haitian refugees, this paper argues that U.S. reception of Haitian immigrants rubs salt in the wound of a long history of dehumanizing and oppressive abuses endured by Haitians. Furthermore, and more importantly, this paper posits that U.S. failure to wholly embrace its legal obligation to accept Haitian refugees under international law needs to be understood in the light of the specific horrors inflicted by science, in pre-independence Haiti, on non-consenting, Afro-Haitian experimental subjects. And by extension, such a contextually-nuanced understanding is crucial in shaping the delivery of healthcare services to Haitian refugees fortunate enough to remain in the U.S. —as an awareness and appreciation of the socio-historical context of patients' lived experiences, i.e., their complete social history, can furnish important clues vis-à-vis the presence and etiologies of disease, influence the foci of physical exams, and generally pave the way for the provision of cost-efficient and evidence-based care. (shrink)

Background: Informed consent for genetic tests is a well-established practice. It should be based on good quality information and in keeping with the patient’s values. Existing informed consent assessment tools assess knowledge and values. Nevertheless, there is no consensus on what specific elements need to be discussed or considered in the consent process for genetic tests.Methods: We performed a systematic review to identify all factors involved in the decision-making and consent process about genetic testing, from the perspective of patients. (...) Through public databases, we identified studies reporting factors that influence the decision to accept or decline genetic testing. Studies were included if they reported the perspective of patients or at-risk individuals. All articles were thematically coded.Results: 1989 articles were reviewed: 70 met inclusion criteria and 12 additional articles were identified through the references of included studies. Coding of the 82 articles led to the identification of 45 factors involved in decision-making and consent, which were initially divided into three domains: in favor of, against or with an undetermined influence on genetic testing. Each factor was also divided into three subdomains relating to the informed choice concept: knowledge, values or other. The factors in the “other” subdomain were all related to the context of testing (e.g. timing, cost, influence of family members, etc), and were present in all three domains.Conclusions: We describe the network of factors contributing to decision-making and consent process and identify the context of genetic testing as a third component to influence this process. Future studies should consider the evaluation of contextual factors as an important and relevant component of the consent and decision-making process about genetic tests. Based on these results, we plan to develop and test a more comprehensive tool to assess informed consent for genetic testing. (shrink)

Background There is broad international agreement from clinicians and academics that healthcare rationing should be undertaken as explicitly as possible, and the BMA have publicly supported the call for more accountable priority setting for some time. However, studies in the UK and elsewhere suggest that clinicians experience a number of barriers to rationing openly, and the information needs of patients at the point of provision are largely unknown. Methodology In-depth interviews were undertaken with NHS professionals working at the (...) community level of provision, and with patients and professionals receiving or providing treatment for morbid obesity and breast cancer (n=52). Results Nearly all patients wanted to know about healthcare rationing and had high expectations of their clinical professionals to provide all relevant information about treatment options. However, professionals did not always understand these information requirements, and cases of implicit rationing were common. The existence of relevant national guidance was not always known about, meaning that patients were often reliant on other sources of information about treatment options, which included the popular media, the internet, patient advocacy groups and informal networks of support. Discussion Clinical professionals need to understand patients' need for detailed information when it comes to rationing, and to understand that they are the main gateway for this to be provided. However, disclosure could be distressing for both patients and professionals, and thus the most sensitive and acceptable ways to make this information available requires further investigation. (shrink)

The use of Next Generation Sequencing such as Whole Genome Sequencing is a promising step towards a better understanding and treatment of neurological diseases. WGS can result into unexpected information, and information with uncertain clinical significance. In the context of a Genome Canada project on ‘Personalized Medicine in the Treatment of Epilepsy’, we intended to address these challenges surveying neurologists’ opinions about the type of results that should be returned, and their professional responsibility toward recontacting patients regarding new (...) discovered mutations. Potential participants were contacted through professional organizations or direct invitations. A total of 204 neurologists were recruited. Fifty nine percent indicated that to be conveyed, WGS results should have a demonstrated clinical utility for diagnosis, prognosis or treatment. Yet, 41% deemed appropriate to return results without clinical utility, when they could impact patients’ reproductive decisions, or on patients’ request. Current use of targeted genetic testing and age of patients influenced respondents’ answers. Respondents stated that analysis of genomics data resulting from WGS should be limited to the genes likely to be relevant for the patient’s specific medical condition, so as to limit IFs. Respondents felt responsible to recontact patients and inform them about newly discovered mutations related to the medical condition that triggered the test for as long as they are following up on the patient. Finally, 53.5% of the respondents felt responsible to recontact and inform patients of clinically significant, newly discovered IFs. Our results show the importance of formulating professional guidelines sensitive to the various – and sometimes opposite – viewpoints that may prevail within a same community of practice, as well as flexible so as to be attuned to the characteristics of the neurological conditions that triggered a WGS. (shrink)

BackgroundThe principles of informed consent, confidentiality and privacy are often neglected during patient care in developing countries. We assessed the degree to which doctors in Lahore adhere to these principles during outpatient consultations.Material & MethodThe study was conducted at medical out-patient departments (OPDs) of two tertiary care hospitals (one public and one private hospital) of Lahore, selected using multi-stage sampling. 93 patients were selected from each hospital. Doctors' adherence to the principles of informed consent, privacy and confidentiality was observed through (...) client flow analysis performed by trained personnel. Overall patient perception was also assessed regarding these practices and was compared with the assessment made by our data collectors.ResultsSome degree of informed consent was obtained from only 9.7% patients in the public hospital and 47.8% in the private hospital. 81.4% of patients in the public hospital and 88.4% in the private hospital were accorded at least some degree of privacy. Complete informational confidentiality was maintained only in 10.8% and 35.5% of cases in public & private hospitals respectively. Informed consent and confidentiality were better practiced in the private compared to the public hospital (two-sample t-test > 2, p value < 0.05). There was marked disparity between the patients' perspective of these ethical practices and the assessment of our trained data collectors.ConclusionObservance of medical ethics is inadequate in hospitals of Lahore. Doctors should be imparted formal training in medical ethics and national legislation on medical ethics is needed. Patients should be made aware of their rights to medical ethics. (shrink)

Introduction Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients’ baseline levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. Design A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of (...) receiving placebos. Setting Participants recruited from community settings completed the study online. Results 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly. However, few participants correctly answered questions about the nocebo effect and the impact of the colour of a placebo pill. Conclusions The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects. (shrink)

Background Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020. Methods A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face interviews were conducted using structured questionnaires. A systematic (...) sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant. Results Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction. Conclusion Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients' needs and obey a standard informed consent to improve patient satisfaction. (shrink)

ObjectiveThis study aims to investigate the lived experience in patients with obstructive sleep apnea syndrome and comorbid obesity following after continuous positive airway pressure therapy made with the disease the device, and to identify barriers and facilitators to the use of CPAP to improve rehabilitation provision and aid in disease self-management.MethodsQualitative research was conducted using three focus groups with a representative sample of 32 inpatients undergoing a 1-month pulmonary rehabilitation program at the IRCSS Istituto Auxologico Italiano San Giuseppe Hospital, Verbania, (...) Italy. The focus groups were recorded on tape, and contemporaneous notes were made. The tapes were transcribed verbatim, and Interpretative Phenomenological Analysis was used to develop themes.ResultsSix main themes were extracted: Living the diagnosis as a shock; You should not sleep on it: the importance of prevention; The adjustment to CPAP; Barriers and facilitators to the use of CPAP; Three in a bed; and The relationship with the healthcare system.ConclusionResults of this study suggest potential avenues for interventions to increase adherence to CPAP, including the provision of information and continued support. Individual counseling providing strategies aimed at helping the person to cope with the emotional problem and relational difficulties associated with the use of CPAP, and at strengthening self-efficacy and self-management skills are also encouraged for optimal care during the rehabilitation program. (shrink)

It is commonly held that, given multiple medically permissible ways of proceeding, each with a different impact on the patient’s future, it is extremely important, and part of respecting patient autonomy, that patients not be under substantial pressure to defer to their physicians’ presumed authority. Some, however, worry that the focus on patient autonomy can be detrimental and that, at least in cases where it is hard to grasp what it is really like to live with certain outcomes without any (...) first‐hand or second‐hand experience, it is best if patient choice is firmly directed, or at least effectively nudged, by the recommendation of an experienced medical professional. The idea seems to be that, since physicians cannot get their patients to promptly assimilate a large amount of information and experience, physicians must, if they are to really help their patients make good decisions in hard cases, exert non‐argumentative influence on them. But this neglects an interesting possibility, namely the possibility of influencing patients by providing them with evidence regarding what decisions have proved most satisfactory for patients with their profile. Approximations of patient profile tests are already employed in medical practice. But the potential of the profile‐test approach in medical practice (and research) has been obscured by ongoing debate that neglects the significance of the approach with respect to the apparent dilemma faced by patients who need to make informed, autonomous decisions but cannot be expected to fully assimilate, in short order, the knowledge and experience of their physicians. (shrink)

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the (...) rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully. (shrink)

Informed consent is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions. Adult postsurgical patients in nine general hospitals of Italy’s Campania Region were interviewed via (...) a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire. The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients and patients with higher levels of education were more likely to read the written IC form. The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients’ needs. To improve the quality of communication we suggest enhancing physicians’ communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in (...) a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, this (...) paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (shrink)

Patients and their physicians frequently make important health care decisions with incomplete information. Memory fails; records are incomplete; the onset of significant events is confused with other life stories; and even the most basic information about medications, laboratory tests, allergies, and problems is often the result of guesswork. As providers and as patients, we suffer because information vital to health care is not available when and where it is needed. Data required for care are dispersed across various (...) settings and represented in a range of formats; incentives to bring these data together do not exist.In recent years, four specific approaches have emerged to address patient-centered information access. The first model attempts to consolidate all care into a single care delivery and financing system. This model — prevalent in many European countries — is to some degree extant at Kaiser-Permanente and other integrated care and financing systems. This model is ideal if and when one organization is responsible for all care delivery and financing. Such models present “one-stop shopping” for managing health information, coordinating care, communicating with providers and support groups, and ensuring both payment and accountability. (shrink)

Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. -/- Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points (...) to Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. -/- Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. -/- Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion. (shrink)

Background: According to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what “adequately informed” might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part in (...) such trials feel they have been given adequate information, or whether they feel able to understand that information.Objectives: To explore trial participants' views on the amount of information provided, and of their own understanding of that information.Design: Structured interviews of patients participating in clinical trials for the treatment of chronic medical condition.Findings: Patients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given outwith the research setting, patients generally felt they received more information when participating in a clinical trial.Conclusions: Researchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate. (shrink)

Patients have the right to refuse their treatment; however, this refusal should be informed. We evaluated the quality of the informed refusal process in Iranian hospitals from patients' viewpoints. To this end, we developed a questionnaire that covered four key aspects of the informed refusal process including; information disclosure, voluntariness, comprehension, and provider-patient relationship. A total of 284 patients who refused their treatment from 12 teaching hospitals in the Isfahan Province, Iran, were recruited and surveyed to produce a convenience (...) sample. Patients' perceptions about the informed refusal process were scored and the mean scores of the four components were calculated. The findings showed that the practice of information disclosure was perceived to be moderate, however, comprehension, voluntariness and provider–patient relationship were perceived to be relatively good. We found that patients, who refused their care before any treatment had commenced, reported a lower quality of information disclosure and voluntariness. Patients informed by nurses and those who had not had a previous related admission, reported lower scores for comprehension and relationship. In conclusion, the process of obtaining informed refusal was relatively satisfactory except for levels of information disclosure. To improve current practices, Iranian patients need to be better informed about; different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow-ups after refusal. Developing more informative refusal forms is needed. (shrink)

Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible with her rights and interests. First, we defend the need for (...) traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation. (shrink)

Using patients as teaching tools raise many ethical issues like informed consent, privacy, confidentiality and beneficence. The current study highlights issues on respecting patient’s choice and acquiring informed consent with its spirit rather than as mere formality. The study was conducted in out-patient department of The Kidney Center Postgraduate Training Institute Karachi Pakistan in May 2008 to July 2008. All patients who had come for the first time to see the author were included in the study. The said study explored (...) the willingness of patients to allow medical students to be present during history taking and physical examination by the consultant. There were 18 male and 03 female patients. Age ranging from 22 to 73 years with mean age of 53.5 ± 13.7 years. There were total of 21 patient–students encounters out of which two encounters were with male students only and two with female students only. So in 17 Patient–students encounters, students of both genders were present. All patients permitted history taking in the presence of medical students except one who had a history of extramarital sexual contact and signs and symptoms suggestive of sexually transmitted disease. Of the male patients 50% (9/18) did not allow intimate examination before medical students. Out of these nine patients who refused, four consented earlier but when enquired again about their true willingness, they expressed their preference not to have medical students in the room while undergoing digital rectal and external genital examinations. Physicians need to develop sensitivity to acquire informed consent in its true essence rather than just as a formality by exploring actual willingness of the patient. One should refrain from being judgmental on the basis of gender, looks, religion or norms. (shrink)

Cancer care has transitioned from clinical-based to home-based care to support longterm care in a more familiar and comfortable environment. This care transition has put family caregivers (FCGs) in a strategic position as care providers. Cancer care at home involves psychological and emotional treatment at some point, making FCGs deal with the stress of cancer patients frequently. Due to their limited care competencies, they need supportive care from healthcare professionals in cancer stress management. This study aims to examine how types (...) of demanded healthcare information affect the FCG’s role in reducing the stress of female cancer patients. The mindsponge theory was used in conceptual development and interpretation. Bayesian Mindsponge Framework (BMF) analytics were used for statistical analysis on a dataset of 48 spouses (husbands) and 12 other family members in five congested communities of Surabaya, Indonesia. Results showed that among the six types of healthcare information, FCGs with higher demand for cancer-specific information were more likely to need support in reducing the stress of female cancer patients. Meanwhile, FCGs with a higher demand for information about support services were less likely to need support to reduce cancer patients’ stress. Other types of healthcare information have ambiguous effects on the need for support in reducing cancer-induced stress. This study reveals that the demanded cancer-specific information, e.g., cancer prognosis or likely outcome, must be prioritized to assist FCG’s role in managing cancer stress. (shrink)

The ideal moral standard for surgical informed‐consent calls upon surgeons to carry out a disclosure dialogue with patients so they have as full as possible an understanding of the procedure before they sign the informed‐consent form. This study is the first to empirically explore patient preferences regarding disclosure dialogue. Twelve Israelis who underwent life‐saving surgeries participated in a narrative study. Three themes emerged from the analysis: objectification of patients, anxiety provoking processes and information, and lack of information that (...) was essential for patients. Findings contribute to existing debates among surgeons regarding the scope and importance of some disclosure components. Analysis led to our formulation of an augmented subjective model of information disclosure that participants prefer, which extends beyond the immediate present of the surgery to the period after discharge, and until return to routine. Surgeons should be aware of patient preferences in disclosure, and gaps between perceptions of surgeons, and preferences and needs of patients. (shrink)

Background: Medical confidentiality underpins the doctor–patient relationship and ensures privacy so that intimate information can be exchanged to improve, preserve, and protect the health of the patient. The right to information applies to the patient alone, and, only if expressly desired, can it be extended to family members. However, it must be remembered that one of the primary tenets of family medicine is precisely that patient care occurs ideally within the context of the family. There may be, then, (...) certain occasions when difficulties will arise as to the extent of the information provided to family members.Objectives: This study aimed to describe family doctors’ attitudes to confidentiality and providing patient information to relatives as well as their justifications for sharing information.Method: A descriptive postal questionnaire was self-administered by family doctors.Results: Of 227 doctors, 95.1% provided information to a patient’s family and over a third disclosed information to others without prior patient consent.Conclusions: The findings reveal that family doctors should pay more attention to their patients’ rights to information, privacy, and confidentiality, and reflect very carefully on the fine balance between this and the occasional need for the support and collaboration of family members in delivery of care. Emphasis should be placed on ethics and legal problems during undergraduate education and in-service training of doctors. (shrink)

Background Obtaining informed consent in the clinical setting is an important yet challenging aspect of providing safe and collaborative care to patients. While the medical profession has defined best practices for obtaining informed consent, it is unclear whether these standards meet the expressed needs of patients, their families as well as healthcare providers. The authors sought to address this gap by comparing the responses of these three groups with a standardised informed consent paradigm. Methods Piloting a web-based ‘reverse’ simulation (...) paradigm, participants viewed a video showing a standardised doctor engaging in an informed consent discussion. The scenario depicted a simulated patient with psychotic symptoms who is prescribed an atypical antipsychotic medication. 107 participants accessed the simulation online and completed a web-based debriefing survey. Results Survey responses from patients, family members and healthcare providers indicated disparities in information retention, perception of the doctor's performance and priorities for required elements of the consent process. Conclusions To enhance existing informed consent best practices, steps should be taken to improve patient retention of critical information. Adverse events should be described in the short-term and long-term along with preventative measures, and alternative psychosocial and pharmacological treatment options should be reviewed. Information about treatment should include when the medication takes therapeutic effect and how to safely maintain the treatment. The reverse simulation design is a model that can discern gaps in clinical practice, which can be used to improve patient care. (shrink)

The concerns regarding patient autonomy presented in August A. Culbert et al.’s “Navigating Informed Consent and Patient Safety in Surgery: Lessons for Medical Students and Junior Trainees” fall just short of addressing the main issue. Patient autonomy is not something that just one member of a team should consider, and it should not be something that any protocol should have the power to subvert, particularly in an environment as tenuous as the operating room. This article will take the concerns regarding (...) the ethics of removing a patient’s hearing aid prior to entering the operating room presented in the aforementioned article and show the necessity for a new standard operating procedure. (shrink)

The aim of this paper is to evaluate the extent of the practice of using informal payments for accessing the services of public clinics or hospitals across Europe and to explain the prevalence of this corrupt practice using the framework of institutional theory. To achieve this, a multi-level mixed-effect logistic regression on 25,744 interviews undertaken in 2020 with patients across 27 European Union countries is conducted. The finding is that the practice of making informal payments remains a prevalent practice, although (...) there are large disparities in the usage of this practice in different European countries. However, informal payments by patients are more likely when there is a lower institutional trust and a higher degree of asymmetry between formal and informal institutions. The resultant proposal is that policy makers need to address the institutional environment to tackle such informal payments. How this can be achieved is outlined. (shrink)

Nurses need to adapt to various interactional situations and design their talk for different recipients. One essential communicative task for nurses is to transmit information on test and measurement results both to the patient and to the physician. This article examines how nurses design their talk on numerical values according to the recipient and the activity. The nurse can deliver the information either plainly through numbers or by formulating some type of qualitative description of the value. The data (...) consist of 7.5 hours of video-recorded interaction in a Finnish hospital. Using conversation analysis, we demonstrate how the institutional roles and the ongoing activity sequence affect how nurses formulate their talk. When nurses discuss results with their patients, they typically use qualitative descriptions, whereas when they talk with doctors, the typical turn involves numeric information. It will be demonstrated that nurses construct their professional identity involving both care and medical expertise through their linguistic-interactional choices. (shrink)

BackgroundPersonal health information and biospecimens are valuable research resources essential for the advancement of medicine and protected by national standards and provincial statutes. Research ethics and privacy standards attempt to balance individual interests with societal interests. However these standards may not reflect public opinion or preferences. The purpose of this study was to assess the opinions and preferences of patients with kidney disease about the use of their health information and biospecimens for medical research.MethodsA 45-item survey was distributed (...) to a convenience sample of patients at an outpatient clinic in a large urban centre. The survey briefly addressed sociodemographic and illness characteristics. Opinions were sought on the research use of health information and biospecimens including consent preferences.ResultsTwo hundred eleven of 400 distributed surveys were completed. Respondents were generally supportive of medical research and trusting of researchers. Many respondents supported the use of their information and biospecimens for health research and also preferred consent be sought for use of health information and biospecimens. Some supported the use of their information and biospecimens for research without consent. There were significant differences in the opinions people offered regarding the research use of biospecimens compared to health information. Some respondent perspectives about consent were at odds with current regulatory and legal standards.ConclusionsClinical health data and biospecimens are valuable research resources, critical to the advancement of medicine. Use of these data for research requires balancing respect for individual autonomy, privacy and the societal interest in the greater good. Incongruence between some respondent perspectives and the regulatory standards suggest both a need for public education and review of legislation to increase understanding and ensure the public’s trust is maintained. (shrink)

Background Patients with unmet medical needs sometimes resort to non-standard treatment options, including the use of unapproved, investigational drugs in the context of clinical trials, compassionate use or named-patient programs. The views and experiences of patients with unmet medical needs regarding unapproved, investigational drugs have not yet been examined empirically. Methods In this qualitative study, exploratory interviews and focus groups were held with patients with chronic or life-threatening diseases, about topics related to non-standard treatment options, such as the (...) search for non-standard treatment options, patients’ views of the moral obligations of doctors, and the conditions under which they would or would not wish to use non-standard treatment options, including expanded access to unapproved, investigational drugs. Results Respondents had very little knowledge about and/or experience with existing opportunities for expanded access to investigational drugs, although some respondents were actively looking for non-standard treatment options. They had high expectations of their treating physicians, assuming them to be aware of non-standard treatment options, including clinical trials elsewhere and expanded access programs, and assuming that they would inform their patients about such options. Respondents carefully weighed the risks and potential benefits of pursuing expanded access, citing concerns related to the scientific evidence of the safety and efficacy of the drug, side effects, drug-drug interactions, and the maintaining of good quality of life. Respondents stressed the importance of education and assertiveness to obtain access to good-quality health care, and were willing to pay out of pocket for investigational drugs. Patients expressed concerns about equal access to new and/or non-standard treatment options. Conclusion When the end of a standard treatment trajectory comes into view, patients may prefer that treating physicians discuss non-standard treatment options with them, including opportunities for expanded access to unapproved, investigational drugs. Although our respondents had varying levels of understanding of expanded access programs, they seemed capable of making well-considered choices with regard to non-standard treatment options and had realistic expectations with regard to the safety and efficacy of such options. Dutch patients might be less likely to fall prey to false hope than often presumed. (shrink)

Fear of cancer is mostly related to cancer recurrence, metastasis, additional cancer, and diagnostic tests. Its legacy as a lethal disease has raised fear of approaching death. Currently, cancer’s total suffering and the worsening phenomena have raised fear, especially among female patients. Family caregivers (FCGs) who are responsible for the day-to-day cancer care at home need to help the patients deal with this fear frequently. Due to the limited care competencies, they need supportive care from healthcare professionals in cancer fear (...) management. This study aims to assess how types of demanded healthcare information affect the FCG’s role in reducing the fear of female cancer patients. The mindsponge theory was used in conceptual development and interpretation. Bayesian Mindsponge Framework (BMF) analytics were used for statistical analysis on a dataset of 48 spouses (husbands) and 12 other family members in five congested communities of Surabaya, Indonesia. Results showed that among the six types of healthcare information, FCGs with higher demand on cancer-specific information and information on cancer physical needs were more likely to need support in reducing the fear of female cancer patients. Meanwhile, FCGs with a higher demand for information on support services were less likely to need support to reduce cancer patients’ fear. Other types of healthcare information have ambiguous effects on the need for support in reducing cancer-induced fear. This study reveals that the demanded cancer-specific information, e.g., cancer’s prognosis or likely outcome and information on cancer physical needs, need to be met in priority to assist FCG’s role in cancer fear management. (shrink)

Background: There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opiate use. Aims: This paper discusses the issues related to informed consent for this population. Ethical considerations: Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants. Method: This was a qualitative interpretive descriptive study. 22 participants (...) were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations. Results: The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent. Conclusions: It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story. (shrink)

Disease-related challenges are often associated with perceived uncertainties in individuals, triggering attempts to cope with the situation. Our study aims to understand patients’ coping strategies regarding health information-seeking behaviors (HISBs). It is guided by the Uncertainty Management Theory, and seeks to grant insights into multi-channel HISB by describing how uses of interpersonal and media channels interact to cope with uncertainties, and how trust influences the process of multi-channel HISB. Patients diagnosed with osteoarthrosis (N = 34) participated in qualitative semi-structured (...) interviews, from which five patterns of multi-channel HISB, ranging from a focus on the physician to a focus on the internet, were identified. These patterns are distinguished by underlying functions of trust – including trust serving as an additional coping strategy, and as an important influencing factor for perceiving information as meaningful – and by whether information needs remain and patients turn to multiple sources. These findings form the basis for further theory development considering the iterative nature of HISB and the role of trust. (shrink)

Background: Medical decision making is based on patient autonomy and informed consent, which is an integral part of medical ethics, risk management and clinical governance. Consent to treatment has been extensively discussed, but the viewpoint of patients is not well represented. A new consent form was introduced by the Department of Health in 2001.Aims: To determine the information most important to patients, to facilitate evidence-based guidelines and to provide a valid and reliable consent-procedure-satisfaction questionnaire.Methods: An anonymous quantitative survey was (...) carried out, asking 100 patients 15 questions regarding procedures they may need to undergo, using a Visual Analogue Scale to test the importance of each question.Results and discussion: In total there were 77 respondents and the mean age was 48.8 years. There were 52% women and 48% men. Major complications, such as not undergoing the procedure, future management and long-term effect on work, all scored a median of 95%. Least concerns were related to technical details of the procedure and minor complications . All other questions were still considered important . No significant differences were observed between sex, age and professional groups, but a significant difference was observed between the education groups. Qualifications of the doctor did not correlate to any other question.Conclusions: This questionnaire is proposed as a basis for informed consent guidelines to health workers and for measures of satisfaction with the consent procedure. (shrink)

OBJECTIVES: To analyse the attitudes of medical personnel towards terminally ill patients and their right to be fully informed. DESIGN: Self-administered questionnaire composed of 56 closed questions. SETTING: Three general hospitals and eleven health centres in Granada (Spain). The sample comprised 168 doctors and 207 nurses. RESULTS: A high percentage of medical personnel (24.1%) do not think that informing the terminally ill would help them face their illness with greater serenity. Eighty-four per cent think the patient's own home is the (...) best place to die: 8.9% of the subjects questioned state that the would not like to be informed of an incurable illness. CONCLUSION: In our opinion any information given should depend on the patient's personality, the stage of the illness and family circumstances. Our study confirms that a hospital is not the ideal environment for attending to the needs of the terminally ill and their families. (shrink)

The U.S. health care system is ostensibly market based and therefore at least partially reliant on competition and consumer demand to regulate costs. Yet information about an essential feature of market transactions—costs—is typically obscure to patients until long after treatment. When discussing what must be disclosed for informed consent, the same list of required information is often mentioned regardless of the health care system in question, and information about costs rarely merits a place within this list. However, (...) our assumptions about what a moral principle requires need to be responsive to the realities of the health care system in which the principle is applied.This paper explores the moral foundations of disclosure and informed consent to argue that, in a market‐based system of the sort found in the United States, these same considerations support a requirement to disclose out‐of‐pocket costs before patients receive care. Next, I consider two objections to this view: first, that health care practitioners should focus solely on medical considerations in their encounters with patients and, second, that disclosing out‐of‐pocket costs would be too difficult to be mandated. I argue that medical and financial interests are inseparable within the U.S. health care system. If the difficulties in disclosing costs are deemed insurmountable, then the current system may prove unsustainable, both morally and financially, since we face the same practical impediments to implementing any meaningful consumer‐driven, market‐based health care reform. Finally, I explore some of the consequences of failing to disclose costs. The requirements of disclosing costs can be supported by the principle of respect for autonomy, regardless of the consequences, but in light of the consequences of the decision of whether to disclose, a concern about justice provides further support. (shrink)

The process of obtaining informed consent to participate in a clinical study presents many challenges for research conducted in a population of patients with schizophrenia. Morally valid, informed consent must include information sharing, decisional capacity, and capacity for voluntarism. This paper examines the unique features of schizophrenia that may threaten each of these elements of informed consent, and it proposes additional safeguards in the process of gaining informed consent from individuals with schizophrenia in order to maximise the decision-making potential (...) of this patient population. (shrink)