There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient’s rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare professionals, (...) regulators and policy makers. We used a qualitative design to examine Swiss healthcare stakeholders’ experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries’ patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients’ rights and citizens’ involvement on the other. The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare (...) professionals, regulators and policy makers. METHODS: We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. RESULTS: All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other. CONCLUSIONS: The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many patients. (...) Yet, most biomedical researchers working outside of clinics and hospitals are denied access to patient records when, at the same time, clinicians who guard the patient data are not optimally prepared for the data’s analysis. Medical data collection is a time- and cost-intensive process that is most of all tedious, with few elements of intellectual and emotional satisfaction on its own. In this process, clinicians and bioinformaticians, each group with their own interests, have to join forces with the goal to generate medical data sets both from clinical trials and from routinely collected electronic health records that are, as much as possible, free from errors and obvious inconsistencies. The data cleansing effort as we have learned during curation of Singaporean clinical trial data is not a trivial task. The introduction of omics and sophisticated imaging modalities into clinical practice that are only partially interpreted in terms of diagnosis and therapy with today’s level of knowledge warrant the creation of clinical databases with full patient history. This opens up opportunities for re-analyses and cross-trial studies at future time points with more sophisticated analyses of the same data, the collection of which is very expensive. (shrink)

Objective: To systematically analyze the effects of art therapy on the levels of depression, anxiety, blood glucose, and glycated hemoglobin in diabetic patients.Methods: We searched Cochrane Library, PubMed, Embase, and ClinicalTrials.gov databases from inception to January 24, 2021. The language of publication was limited to English. Randomized controlled trials that used art therapy to improve mental disorders in diabetic patients were involved. After selection of eligible studies, data were extracted, including the first author's full-name, year of publication, the first (...) author's country of residence, number of intervention and control groups, the mean age of participants, method of intervention, duration of follow-up, and outcome measures. Assessment of quality of the included studies and data extraction were independently carried out by two researchers. RevMan 5.3 software was used to perform statistical analysis.Results: A total of 396 samples from five studies were included, and the eligible studies were RCTs with a parallel design. Methods of art therapy included music therapy and painting therapy. The results showed that compared with the control group, art therapy could positively affect the levels of depression [standardized mean difference, −1.36; 95% confidence interval, ; P < 0.00001] and blood glucose in diabetic patients [mean difference, −0.90; 95% CI, ; P < 0.0001], while it had no influence on the levels of anxiety [SMD, −0.31; 95% CI, ; P = 0.32] and glycated hemoglobin [MD, 0.22; 95% CI, ; P = 0.07].Conclusion: Art therapy may have significant effects on the levels of depression and blood glucose for diabetic patients. (shrink)

Human consciousness is widely understood to be underpinned by rich and diverse functional networks, whose breakdown results in unconsciousness. Candidate neural correlates of anesthetic-induced unconsciousness include: (1) disrupted frontoparietal functional connectivity; (2) disrupted brain network hubs; and (3) reduced spatiotemporal complexity. However, emerging counterexamples have revealed that these markers may appear outside of the state they are associated with, challenging both their inclusion as markers of conscious level, and the theories of consciousness that rely on their evidence. In this study, (...) we present a case series of three individuals in disorders of consciousness (DOC) who exhibit paradoxical brain responses to exposure to anesthesia. High-density electroencephalographic data were recorded from three patients with unresponsive wakefulness syndrome (UWS) while they underwent a protocol of propofol anesthesia with a targeted effect site concentration of 2 μg/ml. Network hubs and directionality of functional connectivity in the alpha frequency band (8–13 Hz), were estimated using the weighted phase lag index (wPLI) and directed phase lag index (dPLI). The spatiotemporal signal complexity was estimated using three types of Lempel-Ziv complexity (LZC). Our results illustrate that exposure to propofol anesthesia can paradoxically result in: (1) increased frontoparietal feedback-dominant connectivity; (2) posterior network hubs; and (3) increased spatiotemporal complexity. The case examples presented in this paper challenge the role of functional connectivity and spatiotemporal complexity in theories of consciousness and for the clinical evaluation of levels of human consciousness. (shrink)

Objective: The aim of the study was to identify clinical variables associated with changes in specific domains of self-reported depression during treatment by antidepressant and/or repetitive Transcranial Magnetic Stimulation in patients with Major Depressive Disorder.Methods: Data from a trial involving 170 patients with MDD receiving either venlafaxine, rTMS or both were re-analyzed. Depressive symptoms were assessed each week during the 2 to 6 weeks of treatment with the 13-item Beck Depression Inventory. Associations between depression changes on BDI13 domains, treatment (...) arm, time, and clinical variables were tested in a mixed linear model.Results: A significant decrease of self-reported depressive symptoms was observed over time. The main characteristics associated with persistent higher depressive symptomatology on Negative Self-Reference domain of the BDI13 were personality disorders, a past history of suicide attempt, age under 65 years old, and female sex.Conclusions: Early cognitive intervention targeting specifically negative self-referencing process could be considered during pharmacological or rTMS treatment for patients with personality disorders and past history of suicide attempt. (shrink)

When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographic characteristics. However, critics have suggested that even if (...) such a PPP were more accurate, on average, than human surrogates in identifying patient preferences, the proposed algorithm would nevertheless fail to respect the patient’s (former) autonomy since it draws on the ‘wrong’ kind of data: namely, data that are not specific to the individual patient and which therefore may not reflect their actual values, or their reasons for having the preferences they do. Taking such criticisms on board, we here propose a new approach: the Personalized Patient Preference Predictor (P4). The P4 is based on recent advances in machine learning, which allow technologies including large language models to be more cheaply and efficiently ‘fine-tuned’ on person-specific data. The P4, unlike the PPP, would be able to infer an individual patient’s preferences from material (e.g., prior treatment decisions) that is in fact specific to them. Thus, we argue, in addition to being potentially more accurate at the individual level than the previously proposed PPP, the predictions of a P4 would also more directly reflect each patient’s own reasons and values. In this article, we review recent discoveries in artificial intelligence research that suggest a P4 is technically feasible, and argue that, if it is developed and appropriately deployed, it should assuage some of the main autonomy-based concerns of critics of the original PPP. We then consider various objections to our proposal and offer some tentative replies. (shrink)

BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based (...) medical research.MethodsWe therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law. (shrink)

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether (...) their data may be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual’s right to withhold their data from trial analysis while routinely offering the same care to all patients. (shrink)

Respecting privacy and patients’ satisfaction are amongst the main indicators of quality of care and one of the basic goals of health services. This study, carried out in 2007, aimed to investigate the extent to which patient privacy is observed and its correlation with patient satisfaction in three emergency departments of Tehran University of Medical Science, Iran. Questionnaire data were collected from a convenience sample of 360 patients admitted to emergency departments and analysed using SPSS software. The results indicated (...) that, according to 50.6% of the patients, the extent to which their privacy was respected was described as either ‘weak’ or ‘average’. Spearman’s coefficient indicated a significant correlation between respecting privacy and the patients’ satisfaction about the various aspects of privacy studied. Considering the levels of privacy observed together with the patients’ degree of satisfaction, it is imperative that clinical professionals address both aspects from conceptual and practical viewpoints. (shrink)

The purpose of this study was to explore the challenges met by nursing staff in a rehabilitation ward. The overall design was qualitative: data were derived from focus interviews with groups of nurses and analyzed from a phenomenological-hermeneutic perspective. The main finding was that challenges emerge on two levels of ethics and rationality: an economic/administrative level and a level of care. An increase in work-load and the changing potential for patient rehabilitation influence the care that nurses can provide in (...) rehabilitating patients, and therefore also affect patients’ feelings of self-worth and dignity. Some patients wish to maintain their independence and autonomy, whereas others seem to ‘lose themselves’. Independence and autonomy are associated with dignity, but their lack is contrary to it. (shrink)

The ability to differentiate between what is just and what is unjust may be considered as the precondition to demand one's own rights. Starting from this point, this research was carried out to describe the level of awareness of patients concerning their rights. The main hypothesis was: the higher the socioeconomic and cultural level of patients, the higher is their awareness of their rights. This research was conducted in one of the state hospitals in Turkey in 1998. It is a (...) descriptive study carried out on 128 inpatients in medical and surgical wards. The data were collected by a questionnaire, which included questions on the rights of patients and gave sample cases. The sample cases were designed by referring to the World Health Organization Declaration on the Promotion of Patients' Rights in Europe. Only 23% of the participants were able to recognize patient rights, while 32% could not; the majority (45%) were undecided in recognizing patient rights. The awareness scores were statistically significantly different for educational level categories (F = 5.84; p<0.001). A continuously declining trend was observed for patient rights awareness scores from the highest educational level to the lowest. This partly proves the hypothesis of the research. However, the awareness scores were not significantly different for the other background variables (p>0.05). Most strikingly, 38% of the patients had no idea about their diagnosis and 63% of those who had undergone surgery did not know why they had had the operation. (shrink)

The UK Government published various circulars to indicate the importance of respecting the privacy and dignity of NHS patients following the implementation of the Human Rights Act, 1998. This research used an ethnographic method to determine the extent to which health professionals had in fact upheld the philosophy of these documents. Fieldwork using nonparticipant observation, and unstructured and semistructured interviews with patients and staff, took place over six months in three acute care wards in a large district NHS trust hospital. (...) Applying the principles of phenomenology and grounded theory, the data were analysed and the contents organized into 11 key categories, leading to the formulation of a privacy model. The level of intrusion into patients’ privacy by health professionals was measured against the benchmarking of the ‘dignity and privacy’ factors contained in the Department of Health’s The essence of care document and Article 8 of the Human Rights Act. The findings established that patients had little privacy in the wards, and that the terms ‘privacy of the person’ and ‘dignity’ are interrelated. (shrink)

Personalized medicine aims to tailor disease prevention, diagnosis, and treatment to individuals on the basis of their genes, lifestyle and environments. Patient and interest organizations may potentially play an important role in the realization of PM. This paper investigates the views and perspectives on PM of a variety of PIOs. Semi-structured telephone interviews were conducted among leading representatives of 13 PIOs located in Europe and North-America. The data collected were analysed using a conventional content analysis approach. The PIO representatives (...) supported the realization of PM but feared that many financial, structural and organizational challenges may delay its realization. They encouraged strategies to modernize drug licencing mechanisms, develop research and data sharing infrastructures, and educate patients and health care professionals in PM. Notably, they emphasized the importance of developing PM in an equitable way and taking into consideration the patients’ needs, values and personal situation. Despite varying levels of awareness regarding PM, the PIO representatives expressed willingness to engage in the PM agenda and recommended that PIOs work closely with policy-makers to design PM in a way that truly addresses the needs and concerns of patients. PIOs have the potential to become central drivers of the PM agenda. Collaborations should be further developed between PIOs, researchers, drug developers and health care authorities. (shrink)

The art of interpretation has traditionally been an integral part of medical practice, but little attention has been devoted to its theory. Hermeneutics or the study of interpretation has grown as a methodological interest primarily within the humanities. Borrowing from the medieval fourfold sense of scripture, which organizes interpretive activity both logically and comprehensively, I propose a hermeneutical model of clinical decision-making. According to the model, a patient is analogous to a literary text which may be interpreted on four levels: (...) (1) the literal facts of the patient's body and the literal story told by the patient, (2) the diagnostic meaning of the literal data, (3) the praxis (prognosis and therapeutic decisions) emanating from the diagnosis, and (4) the change effected by the clinical encounter in both the patient's and clinician's life-worlds. The model is illustrated through application to a medical case. (shrink)

Background Non-invasive prenatal testing (NIPT), which can screen for aneuploidies such as trisomy 21, is being implemented in several public healthcare systems across Europe. Comprehensive communication and information have been highlighted in the literature as important elements in supporting women’s reproductive decision-making and addressing relevant ethical concerns such as routinisation. Countries such as England and France are adopting broadly similar implementation models, offering NIPT for pregnancies with high aneuploidy probability. However, we do not have a deeper understanding of how professionals’ (...) counselling values and practices may differ between these contexts. Methods In this paper, we explore how professionals in England and France support patient decision-making in the provision of NIPT and critically compare professional practices and values. We draw on data from semi-structured interviews with healthcare professionals. Results Both English and French professionals emphasised values relating to patient choice and consent. However, understandings and application of these values into the practice of NIPT provision differed. English interviewees placed a stronger emphasis on interpreting and describing the process of counselling patients and clinical care through a “principle” lens. Their focus was on non-directiveness, standardisation, and the healthcare professional as “decision-facilitator” for patients. French interviewees described their approach through a “procedural” lens. Their focus was on formal consent, information, and the healthcare professional as “information-giver”. Both English and French professionals indicated that insufficient resources were a key barrier in effectively translating their values into practice. Conclusion Our findings illustrate that supporting patient choice in the provision of NIPT may be held as an important value in common on a surface level, but can be understood and translated into practice in different ways. Our findings can guide further research and beneficially inform practice and policy around NIPT provision. (shrink)

BackgroundPatients’ satisfaction arises from their appraisal of experience in hospital services and measuring patients’ satisfaction in hospital has become a global phenomenon. To improve on patients’ satisfaction, radiographers have to imbibe the right ethical attitude in their conduct while discharging duties to patients during radiological examination. The objective of this study is to understand from the patients’ perspective the ethical conduct of radiographers and radiology nurses that constitute factors in patient satisfaction during routine radiological examination. The rationale of the study (...) is to use the findings to improve radiological service delivery and improve on patient satisfaction.MethodsThis is a cross-sectional descriptive study in which 300 respondents in two hospitals were surveyed to ascertain their satisfaction with the ethical conduct of radiographers and services provided by radiology nurses in the department. The data was analyzed using descriptive statistics at 95 % confidence interval for mean scores and Z-values.ResultsThree hundred patients responded to the survey which comprised of 145 patients from the public hospital and 155 patients from the private hospital. Radiographers fell short in some ethical/professional conduct as in informed consent before treatment ; radiographers’ not explaining his/her experience, expectation, knowledge and equipment procedure. However, they did well in some aspects including observation of professional boundaries with patients during treatment and equity in treatment for the patients during the radiological examination. Some services provided by staff members in the department also fell short of patients’ expectation and satisfaction including explanation of what to expect during the exam, whereas they did well in their level of courtesy to patients. There was a significant difference in the satisfaction level experienced by patients at both hospitals in favour of the private hospital.ConclusionsThere is an urgent need for improved ethical/professional conduct of radiographers and general service delivery in the radiology departments of the hospitals where this investigation was carried out to enhance patient satisfaction. Government has to improve the curricular of service providers in radiology service in the university to include ethical/professional conduct and patient/provider relationship. (shrink)

Ontological realism aims at the development of high quality ontologies that faithfully represent what is general in reality and to use these ontologies to render heterogeneous data collections comparable. To achieve this second goal for clinical research datasets presupposes not merely (1) that the requisite ontologies already exist, but also (2) that the datasets in question are faithful to reality in the dual sense that (a) they denote only particulars and relationships between particulars that do in fact exist and (...) (b) they do this in terms of the types and type-level relationships described in these ontologies. While much attention has been devoted to (1), work on (2), which is the topic of this paper, is comparatively rare. Using Referent Tracking as basis, we describe a technical data wrangling strategy which consists in creating for each dataset a template that, when applied to each particular record in the dataset, leads to the generation of a collection of Referent Tracking Tuples (RTT) built out of unique identifiers for the entities described by means of the data items in the record. The proposed strategy is based on (i) the distinction between data and what data are about, and (ii) the explicit descriptions of portions of reality which RTTs provide and which range not only over the particulars described by data items in a dataset, but also over these data items themselves. This last feature allows us to describe particulars that are only implicitly referred to by the dataset; to provide information about correspondences between data items in a dataset; and to assert which data items are unjustifiably or redundantly present in or absent from the dataset. The approach has been tested on a dataset collected from patients seeking treatment for orofacial pain at two German universities and made available for the NIDCR-funded OPMQoL project. (shrink)

The aim of this study was to obtain in-depth knowledge about caring confirmation of patients with cancer, from the patients’ point of view. The research topic was: what is the significance for patients of their being confirmed by nursing personnel? Fifteen men and women between 43 and 80 years of age participated in this study. The method of data collection used was qualitative research interviewing. A hermeneutic approach was used to interpret the data, in which Kvale’s self-perception, the (...) ‘common sense’ level, and theoretical levels were applied. The results are summarized in three areas: an outer confirmation, an inner confirmation, and a lack of the latter. Outer confirmation meant being understood and taken seriously; the maintenance of human dignity and worth indicated inner confirmation. A lack of inner confirmation is primarily manifest in terms of patients’ mental, spiritual and existential concerns. In relation to the theory of Eriksson, these patients were confirmed at the level of having and being, but seldom at the level of becoming. (shrink)

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in the (...) administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

Use of patient clinical photographs requires specific attention to confidentiality and privacy. Although there are policies and procedures for publishing clinical images, there is little systematic evidence about what patients and health professionals actually think about consent for publishing clinical images. We investigated the opinions of three stakeholder groups at 3 academic healthcare institutions and 37 private practices in Croatia. The questionnaire contained patient photographs with different levels of anonymization. All three respondent groups considered that more stringent forms of permission (...) for were needed identifiable photographs than for those with higher levels of anonymization. When the entire face was presented in a photo only 33% of patients considered that written permission was required, compared with 88% of the students and 89% of the doctors. Opinions about publishing patient photographs differed among the three respondent samples: almost half of the patients thought no permission was necessary compared with one-third of students and doctors. These results show poor awareness of Croatian patients regarding the importance of written informed consent as well as unsatisfactory knowledge of health professionals about policies on the publication of patients’ data in general. In conclusion, there is a need for increasing awareness of all stakeholders to achieve better protection of patient privacy rights in research and publication. (shrink)

Background:Promoting patients’ rights is essential for defining the standards of clinical services within a country. Given their responsibilities, nurses can be the primary target for research to investigate the issue of patients’ rights within a healthcare system. As such, assessing the knowledge of nurses about patients’ rights is an essential step toward improving the quality of healthcare in limited resource settings like Sudan.Objectives:We aimed to assess the level of knowledge about patients’ rights among the nursing staff at Friendship Teaching Hospital (...) in Sudan.Methods:This hospital-based cross-sectional study was carried out at the Friendship Teaching Hospital in Sudan. We surveyed the totality of nurses (95) at the hospital using an amended survey. The data were analyzed in SPSS software using descriptive and inferential statistics.Ethical consideration:The study was approved by the Research Unit of Khartoum Ministry of Health and the Hospital administration. All respondents gave verbal consent prior to participating in the study.Results:Only 48.4% of the participants knew about the existence of the Sudanese Charter of patients’ rights. Nonetheless, our analysis found that 65.8% of nurses had acceptable level of knowledge (scored more than 75% of the total knowledge score) of patients’ rights, and none of the participant scored less than 50% of the total knowledge score. Finally, we found no statistical association between the knowledge score and demographic data, educational level, whether the participant knows about the existence of the Charter or not and a number of other factors.Conclusion:Nurses’ lack of knowledge about the existence of the Sudanese Charter of patients’ rights adopted in 2009 rights confirms the need for further efforts by Ministry of Health to promote the document. Furthermore, further research is needed to investigate the disconnect between nurses’ lack of knowledge about the existence of the charter and their awareness of the rights within the charter as well as the actual implementation of rights. (shrink)

There is limited knowledge about cancer patients' experiences of uncertainty while waiting for genome sequencing results, and whether prolonged uncertainty contributes to psychological factors in this context. To investigate uncertainty in patients with a cancer of likely hereditary origin while waiting for genome sequencing results, we collected questionnaire and interview data at baseline, and at three and 12 months follow up. Participants had negative attitudes towards uncertainty at baseline, and low levels of uncertainty at three and 12 months. Uncertainty (...) about genome sequencing did not change significantly over time [t = 0.660, p = 0.510]. Greater perceived susceptibility for cancer [r = 0.14, p < 0.01], fear of cancer recurrence [r = 0.19, p < 0.01], perceived importance of genome sequencing [r = 0.24, p < 0.01], intention to change behavior if a gene variant indicating risk is found [r = 0.29, p < 0.01], perceived ability to cope with results [r = 0.36, p < 0.01], and satisfaction with decision to have genome sequencing [r = 0.52, p < 0.01] were significantly correlated with negative attitudes towards uncertainty at baseline. Multiple primary cancer diagnoses [B = −2.364 [−4.238, −0.491], p = 0.014], lower perceived ability to cope with results [B = −0.1.881 [−3.403, −0.359], p = 0.016] at baseline, greater anxiety about genome sequencing [B = 0.347 [0.148, 0.546], p = 0.0012] at 3 months, and greater perceived uncertainty about genome sequencing [B = 0.494 [0.267, 0.721] p = 0.000] at 3 months significantly predicted greater perceived uncertainty about genome sequencing at 12 months. Greater perceived uncertainty about genome sequencing at 3 months significantly predicted greater anxiety about genome sequencing at 12 months [B = 0.291 [0.072, 0.509], p = 0.009]. Semi-structured interviews revealed that while participants were motivated to pursue genome sequencing as a strategy to reduce their illness and risk uncertainty, genome sequencing generated additional practical, scientific and personal uncertainties. Some uncertainties were consistently discussed over the 12 months, while others emerged over time. Similarly, some uncertainty coping strategies were consistent over time, while others emerged while patients waited for their genome sequencing results. This study demonstrates the complexity of uncertainty generated by genome sequencing for cancer patients and provides further support for the inter-relationship between uncertainty and anxiety. Helping patients manage their uncertainty may ameliorate psychological morbidity. (shrink)

Medicine is incorporating genetic services into all avenues of health‐care, ranging from the rarest to the most common diseases. Cognitive theories of decision‐making still dominate professionals’ understanding of patient decision‐making about how to use genetic information and whether to have testing. I discovered a conceptual model of decision‐making while carrying out a phenomenological‐hermeneutic descriptive study of a convenience sample of 12 couples who were interviewed while deciding whether to undergo prenatal genetic testing.Thirty‐two interviews were conducted with 12 men and 12 (...) women separately. Interviews were transcribed verbatim and all data were analyzed using three levels of coding that were sorted into 30 categories and then abstracted into three emergent meta‐themes that described men's and women's attempts to make sense and find meaning in how to best use prenatal genetic technology. Their descriptions of how they thought about, communicated, and coped with their decision were so detailed it was possible to discern nine different types of thinking they engaged in while deciding to accept or decline testing.They believed that decision‐making is a process of working through your own personal style of thinking. This might include only one or any combination of the following types of thinking: analytical, ethical, moral, reflective, practical, hypothetical, judgmental, scary, and second sight, as described in detail by these 12 couples. (shrink)

Medical-legal partnerships connect legal advocates to healthcare providers and settings. Maintaining effectiveness of medical-legal partnerships and consistently identifying opportunities for innovation and adaptation takes intentionality and effort. In this paper, we discuss ways in which our use of data and quality improvement methods have facilitated advocacy at both patient (client) and population levels as we collectively pursue better, more equitable outcomes.

Collecting and deploying poverty-related data is an important starting point for leveraging data regarding social determinants of health in precision medicine. However, we must rethink how we collect and deploy such data. Current modes of collection yield imprecise data that is unsuited for research. Better data can be collected by cross-referencing other sources such as employers and public benefit programs, and by incentivizing and encouraging patients and providers to provide more accurate information. Data thus (...) collected can be used to provide appropriate individual-level clinical and non-clinical care, and to systematically determine what share of social resources healthcare should consume. (shrink)

The General Data Protection Regulation imposes, at European level, a need to seek express or explicit consent for the processing of health data. In the framework of biomedical research, some favor the use of express ‘broad’ consent, whereas other maintain, or wish to maintain the use of presumed or implicit consent, often referred to as ‘non-opposition’ in conditions in which such consent is still authorized. In our view, broad consent and presumed consent are likely to prove to be (...) easy solutions in the short term but much less relevant in the long term, for both hospital and patients, if the bioethical objective remains the improvement of patient quality of life and/or survival, regardless of the disease considered. Dynamic consent could be the best way to achieve this objective because only this type of consent could improve hospital transparency and increase patient confidence by allaying certain fears. (shrink)

Background: Compassion-based practices in midwifery are the most important expression of the depth of care quality. This concept is insufficiently represented in literature, therefore, studies on this subject are of utmost importance. Objectives: This study aims to determine the levels of compassion of midwives working in the delivery room and the factors affecting these levels. The study was carried out in Kocaeli, Turkey. Methods: This descriptive study was carried out from 1 February to 15 April 2019 in delivery rooms of (...) six different hospitals located in the provincial centre of Kocaeli, Turkey, with 78 actively working midwives. Data were collected using a ‘Compassion Scale’ and analysed using the Mann–Whitney U test, the Kruskal–Wallis H test and the Spearman correlation test. Ethical considerations: This study was conducted according to ethical scientific guidelines. Results: The compassion score of the midwives were found to be 4.19 ± 0.39. The total compassion score was affected by professional factors such as number of patients, alternating shift work, number of traumatic births and work satisfaction. While the kindness subscores decreased depending on shift work and number of traumatic births, it was determined that the midwives who were satisfied with their work had higher kindness scores than those who were not. Also, as the age and professional experience of the midwives and the number of traumatic births increased, their indifference score also increased. Midwives who reported that they were not satisfied with their job had higher scores regarding separation and disengagement scores than those who were satisfied with their job. Conclusion: It was determined that the compassion levels of midwives were found to be negatively affected by factors such as age, professional experience, job satisfaction and number of monthly traumatic births in a month. They should be reminded that compassionate midwifery care for women is a basic human right. (shrink)

The level of psychological pain in patients with COVID-19 was investigated in this study by hypothesis testing, one-way ANOVA, multi factor ANOVA, and correlation analysis. The psychological pain thermometer and post-traumatic growth assessment scale were used as research tools. Many factors appear to influence the psychological state of COVID-19 patients including practical problems, communication problems, emotional problems, physical problems, and psychiatric/relative concerns. The severity of the disease, the surrounding environment, family health problems, life perceptions, interpersonal relationships, personal strength, mental changes, (...) new possibilities, and the total post-traumatic growth score are also affected. There is a significant negative correlation between psychological pain and post-traumatic growth. There are significant differences in the degree of psychological pain across the demographic data. Practical problems, communication problems, emotional problems, physical problems, and spiritual/religious concerns show significant effects on the degree of psychological pain. (shrink)

Patient safety has only recently been subjected to wide-spread systematic study. Healthcare differs from other high risk industries in being more diverse and multi-contextual, and less certain and regulated. Also many patient safety problems are low-frequency events associated with many, varied contributing factors. The subject of this paper is the epistemology of patient safety (the science of the method of finding out about patient safety). Patient safety research is considered here on the background of a risk management framework which requires (...) researchers to: • Understand the context - as a subset of healthcare quality, services and systems research, with technical and human behavioural (cultural) components and a range of external and internal organisational influences, a wide range of research disciplines is necessary • Identify the risks - identify the things that go wrong and the frequency and nature of different types of incidents from sources such as medical record review, observational studies, audit, incident and medico-legal reports • Analyse the risks - deconstruct the things that go wrong, identifying contributing factors and trying to detect trends and patterns in contributing factors, detection, mitigation factors, ameliorating factors and actions taken to reduce risk • Evaluate the risks - decide on priorities, identifying preventive and corrective strategies and judging the risk- and cost-benefit of potential corrective strategies such as standardisation or simplification of a process or device • Manage the risk - evaluate and scope preventive and/or corrective strategies and then implement these, or place the problem on a risk register pending solution, or accept that what is needed is unaffordable • Communicate and consult - use interactive sessions, audit, on-going feedback, reminders and patient mediated prompts • Monitor and review the state of the problem - get baseline trends and patterns so that changes can be tracked and properly attributed to an intervention A hierarchy of levels of evidence has been proposed for clinical research and we argue that insufficient weighting has been given to lower ranked levels of research and to qualitative research, although critical interpretive synthesis is now gaining acceptance in mainstream thinking (e.g. by the Cochrane Collaboration). Fundamental challenges remain including how to grasp the elusive concept of patient safety, how to quantify, characterise and cost the problems, how to judge the extent to which harm can be attributed to errors, violations or system failures, how to identify contributing factors and the extent to which they can be implicated, how to judge whether incidents or their precursors are preventable, how to generate strong evidence to make healthcare safer and how to translate research into practice. Future directions include addressing the mundane as well as rare, dramatic events, and developing further research in non-hospital settings and in developing countries. In summary, a mixture of qualitative and quantitative methods, using information from all available data sources and combining retrospective, real time and prospective study designs, is necessary to address some of the more difficult patient safety problems. (shrink)

BackgroundPrecision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review.MethodsWe used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided (...) 665 different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine.ResultsMany patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceive some risks. Commonly perceived risks include: lack of evidence for accuracy of tests and efficacy of treatments; limited knowledge of patients, which makes informed consent more difficult; possible unavailability of access to precision medicine for underprivileged people and ethnic minorities; misuse of data by insurance companies and employers, potential of racial stigmatization due to genetic information; unwanted communication of incidental findings; changes in doctor-patient-relationship through focusing on data; and the problem that patients could feel under pressure to optimize their health.ConclusionsNational legislation and guidelines already minimize many risks associated with precision medicine. However, from our perspective some problems require more attention. Should hopes for precision medicine’s benefits be fulfilled, then the ethical principle of justice would require an unlimited access to precision medicine for all people. The potential for autonomous patients’ decisions must be greatly enhanced by improvements in patient education. Harm from test results must be avoided in any case by the highest possible data security level and communication guidelines. Changes in the doctor-patient relationship and the impact of precision medicine on the quality of life should be further investigated. Additionally, the cost-effectiveness of precision medicine should be further examined, in order to avoid malinvestment. (shrink)

Background:When the contagious COVID-19 spread worldwide, the frontline staff faced unprecedented excessive work pressure and expectations of all of the society.Objective:The aim was to explore healthcare workers’ stress and influencing factors when caring for COVID-19 patients from an altruistic perspective.Methods:A cross-sectional, descriptive study was conducted in a tertiary hospital during the outbreak of COVID-19 between February and March 2020 in Wuhan, the capital city of Hubei province in China. Data were collected from 1208 healthcare workers. Descriptive statistics and multiple (...) linear regression were used to analyze the data.Ethical considerations:Research ethics approval (with the code of TJ-IRB20200379) was obtained from Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology. Written informed consent was also received from participants.Results:Less than 60% of participants chose moderate or severe stress on all stressors, indicating a low stress level among healthcare workers. The main source of stress among frontline healthcare workers caring for COVID-19 patients came from the fear of being infected, the fear of family members being infected, and the discomfort caused by protective equipment. Frontline staff who were nurses, were married, and had worked more than 20 days suffered higher stress, whereas rescue staff showed lower stress.Conclusion:The healthcare workers caring for patients with COVID-19 had low stress level, although they still had the fear of being infected or uncomfortable feeling caused by personal protective equipment. A low stress level among healthcare workers indicated their professional devotion and altruism during COVID-19 epidemic. Medical institutions and the government should continue to strengthen infection prevention measures and provide more comprehensive care involving families of frontline healthcare workers, especially nurses and married staff. It will be a lesson to other countries that awaking healthcare workers’ inside motivation and providing necessary support from government and society were significant. (shrink)

In the Journal of Medical Ethics, Joffe et al recently published an article titled “What do patients value in their hospital care? An empirical perspective on autonomy centred bioethics”.1 This empirical study evaluates whether patients’ willingness to recommend their hospital to others is more strongly associated with their belief that they were treated with respect and dignity than with their belief that they had an adequate say in their treatment.* Joffe et al go on to suggest that confirmation of these (...) empirical hypotheses would constitute a prescription for elevating the principle of respect for persons to the level that the principle of respect for autonomy currently enjoys in our model of the ideal patient–physician relationship .1 In other words, they suggest that by some means empirical findings could influence our ranking of the normative principles. Earlier in the article, they make an even stronger claim about the influence of empirical data on our acceptance of normative principles. They suggest that, if it were demonstrated empirically that some patients prefer to delegate medical decisions to health care professionals, a serious challenge would be levied against the normative assumptions underlying the principle of respect for autonomy, at least under the mandatory autonomy view, which holds that patients not only have a right but also an obligation to act autonomously .1 In the light of many recent empirical studies challenging the centrality of patient autonomy and shared decision making in bioethical theory, I think it is instructive to evaluate the means by which empirical findings, like those offered in Joffe et al, strengthen or weaken our arguments for ethical principles. In particular, I would be interested in how these authors propose that their data led them to the normative conclusions they reached.In the last …. (shrink)

Objective: To examine changes in patients’ desired control of the deep brain stimulator and perception of global life control throughout DBS.Methods: A consecutive cohort of 52 patients with Parkinson’s disease was recruited to participate in a prospective longitudinal study over three assessment points. Semi-structured interviews assessing participants’ desire for stimulation control and perception of global control were conducted at all three points. Qualitative data were coded using content analysis. Visual analog scales were embedded in the interviews to quantify participants’ (...) perceptions of control over time.Results: Participants reported significant increases in their perception of global control over time and significant declines in their desired control of the stimulation. These changes were unrelated to improvements in motor symptoms. Improvements in global control were negatively correlated with a decline in desired stimulation control. Qualitative data indicate that participants have changed, nuanced levels of desired control over their stimulators. Increased global life control following DBS may be attributed to increased control over PD symptoms, increased ability to engage in valued activities, and increased overall self-regulation, while other domains related to global control remained unaffected by DBS.Conclusions: There are few empirical data documenting patients’ desire for stimulation control throughout neuromodulation and how stimulation control is related to other aspects of control despite the growing application of neuromodulation devices to treat a variety of disorders. Our data highlight distinctions in different types of control and have implications for the development of patient-controlled neurostimulation devices. (shrink)

A growing body of research emphasises the role of ‘social determinants of health’ in generating inequalities in health outcomes. How, if at all, should primary care providers respond? In this paper, I want to shed light on this issue by focusing on the role that ‘big data’ might play in allowing primary care providers to respond to the social determinants that affect individual patients’ health. The general idea has been proposed and endorsed by the Institute of Medicine, and the (...) idea has been developed in more detail by Bazemore et al.. In Bazemore et al.’s proposal, patients’ addresses are used to generate information about the patients’ neighbourhood; this information is then included in patients’ health care records and made available to providers. This allows primary care providers to take this information into account when interacting with, and providing care to, patients. I explore three issues arising from this proposal. First, while questions of privacy have been central to discussions about big data, Bazemore et al.’s proposal also allows us to see that there might be costs to not making certain information available. Second, I consider some of the questions arising for primary care from the influence of social factors on health outcomes: given that we know these factors to be significant contributors to social inequalities in health, what precisely should be done about this in the primary care context? Finally, I address problems arising from the use of population level data when dealing with individuals. (shrink)

Slower perceptual alternations, a notable perceptual effect observed in psychiatric disorders, can be alleviated by antidepressant therapies that affect serotonin levels in the brain. While these phenomena have been well documented, the underlying neurocognitive mechanisms remain to be elucidated. Our study bridges this gap by employing a computational cognitive approach within a Bayesian predictive coding framework to explore these mechanisms in depression. We fitted a prediction error (PE) model to behavioral data from a binocular rivalry task, uncovering that significantly (...) higher initial prior precision and lower PE led to a slower switch rate in patients with depression. Furthermore, serotonin‐targeting antidepressant treatments significantly decreased the prior precision and increased PE, both of which were predictive of improvements in the perceptual alternation rate of depression patients. These findings indicated that the substantially slower perception switch rate in patients with depression was caused by the greater reliance on top‐down priors and that serotonin treatment's efficacy was in its recalibration of these priors and enhancement of PE. Our study not only elucidates the cognitive underpinnings of depression, but also suggests computational modeling as a potent tool for integrating cognitive science with clinical psychology, advancing our understanding and treatment of cognitive impairments in depression. (shrink)

Background: Neglect and abuse of elders in care institutions is a recurring issue in the media. Elders in care institutions are vulnerable due to their physical, cognitive, and verbal limitations. Such vulnerabilities may make them more susceptible to mistreatment by caregivers on whom they are heavily dependent. Objectives: The goal was to understand caregivers’ concerns about ensuring correct and proper treatment, as well as their experiences with neglect and abuse of older patients. This article examines resources and challenges of professional (...) ethics within the care setting. Research design: A study was conducted to explore the quality of care provided to older patients in nursing homes, geriatrics institutions, and ambulant care in the northwest region of Switzerland. Participants and research context: A total of 23 semi-structured interviews were conducted with nursing staff of varying experience levels. Ethical considerations: Ethical approval was granted by the competent regional ethics commission, Ethikkomission Nordwest-und Zentralschweiz EKNZ [Ethics Commission Northwest and Central Switzerland]. Findings: Three themes emerged from our data analysis: professional identity, professional context, and professional relationships. Our findings indicate mutual vulnerabilities within these three themes, characterizing the interactions between nursing staff and older patients. Study participants believe that incidences of error, neglect, and abuse are consequences of their own vulnerability since they are not able to meet the demands of an overstraining work situation. Discussion: Different aspects of this mutual vulnerability are described and critically discussed as challenges for professional ethics. Conclusion: Early education, continuous training as well as better management and response from the institution are necessary to maintain professionalism while handling mutual vulnerabilities. (shrink)

It is widely acknowledged that trust plays an important role for the acceptability of data sharing practices in research and healthcare, and for the adoption of new health technologies such as AI. Yet there is reported distrust in this domain. Although in the UK, the NHS is one of the most trusted public institutions, public trust does not appear to accompany its data sharing practices for research and innovation, specifically with the private sector, that have been introduced in (...) recent years. In this paper, we examine the question of, what is it about sharing NHS data for research and innovation with for-profit companies that challenges public trust? To address this question, we draw from political theory to provide an account of public trust that helps better understand the relationship between the public and the NHS within a democratic context, as well as, the kind of obligations and expectations that govern this relationship. Then we examine whether the way in which the NHS is managing patient data and its collaboration with the private sector fit under this trust-based relationship. We argue that the datafication of healthcare and the broader ‘health and wealth’ agenda adopted by consecutive UK governments represent a major shift in the institutional character of the NHS, which brings into question the meaning of public good the NHS is expected to provide, challenging public trust. We conclude by suggesting that to address the problem of public trust, a theoretical and empirical examination of the benefits but also the costs associated with this shift needs to take place, as well as an open conversation at public level to determine what values should be promoted by a public institution like the NHS. (shrink)

Background: Psychological distress is common among patients with cancer, with severe consequences on their quality of life. Anxiety and depression are the most common clinical presentation of psychological distress in cancer patients, but in some cases cancer may represent a traumatic event resulting in posttraumatic stress disorder. Currently, Eye Movement Desensitization and Reprocessing therapy is considered an evidence-based treatment for PTSD, but recent studies also showed its effectiveness for anxiety and depression. The aim of the present systematic review is to (...) summarize the current literature on the effect of EMDR on cancer-related psychological distress.Methods: A literature search was conducted for peer-reviewed articles about “EMDR” and “cancer patients” in the following electronic databases: PubMed, MEDLINE, Science Direct, Google Scholar, and Cochrane library.Results: Our search identified 7 studies in which EMDR was used with a total of 140 cancer patients. The psychiatric diagnosis was PTSD in 3 studies. Otherwise, the diagnosis concerned the anxious and depressive disorder spectrum. Overall, EMDR treatment schedules used were highly heterogeneous, with a different number of sessions and a different duration of therapy. However, across all studies analyzed EMDR therapy was judged to be adequate in reducing symptoms of psychological distress in this population.Conclusions: According to the results of our analysis, the level of evidence regarding EMDR efficacy in cancer patients is limited by the scarcity of studies and their low methodological quality. Although better quality research is needed, available data suggest that EMDR could be a promising treatment for psychological distress in patients with cancer. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Managing the Transition from Patient-Centered Care to ProtocolDavid SlakterI learned that I would need a kidney transplant in the summer of 2015. This was not a complete surprise to me, as I had been subjected to a number of tests and invasive procedures to investigate nephritis since I was a child. I had heard similar stories of clinicians performing repeated tests on my father for similar reasons without any (...) conclusions. Following my recommendation for transplant and consultation with genomics specialists, the cause of my kidney failure was determined to be Alport syndrome. What made Alport syndrome so difficult to diagnose in my case was that the associated mutation is a rare, autosomal-dominant one that has only recently been associated with the condition.After reviewing the data on survival rates for transitioning to dialysis versus a transplant, my family and I then considered the success rates for living versus cadaver donors, and the success rates at various transplant centers. The current data favor the long-term outcomes of transplant over dialysis and living over cadaver donors. Since we had decided to focus on searching for a live donor, my nephrologist recommended contacting Renewal, an organization that specializes in connecting those in need of a kidney transplant with live donors and providing support for donors to make the donation process less burdensome.On Renewal’s recommendation, my family and friends reached out across their social networks to search for potential donors. Many of those tested for compatibility were eliminated on basic matching criteria, others due to previously undiagnosed medical problems. Finally, the wife of a childhood friend came forward as an eligible donor and was also an incredibly close match on the antigens tested for kidney transplants.Having a living donor who was also a friend made the transplant experience somewhat less intimidating than it might have been. It meant the transformation of an existing relationship with someone already close to me, with fewer open questions about what may have motivated them to be so generous than if the donor had been someone I did not know. It also meant our families could be together in the waiting room, and that we shared in each other’s recoveries.Life post-transplant has been a significant improvement from what it was like immediately beforehand. Before my transplant, I regularly weighed food and consulted nutrition charts to gauge how much potassium I was consuming. To prevent too much potassium from building up in my bloodstream, I had to take sodium polystyrene [End Page 111] regularly. As one might guess from the name, it tastes much like burnt Styrofoam, and I could only ingest it with copious amounts of fruit-flavored syrup (strawberry covered up the awful flavor the best). There are other potassium binders on the market now, so fewer people with kidney failure will likely need to engage in such gustatory experimentation.I was also able to engage in more activities than what was possible even years before my transplant. I had long experienced difficulty with aerobic exercises, but assumed the reason was merely being out of shape. Though I have always walked regularly, even the one-mile walk from my office to my apartment had become a chore by the end. Within a few months after my transplant, I was riding a bicycle all over NYC, from Harlem to Brooklyn and back regularly, and hiking trails in nearby state parks. I began sessions with a personal trainer and attained a level of fitness I had not reached since I played soccer as a child.The transition from personalized care to one more driven by protocol has been a surprising and challenging aspect of the transplant process. While my previous experience with medical treatment has been individual meetings with physicians, my post-transplant care is managed by a team of nephrologists and other specialists in transplant care. My initial transplant nephrologist was automatically assigned to me. Because the standard of care for transplant patients is often driven by protocol, my assigned nephrologist recommended a biopsy on my transplanted kidney due to results in my recent lab tests. When pressed on the necessity of a biopsy in my case versus... (shrink)

The rapid dynamics of COVID-19 calls for quick and effective tracking of virus transmission chains and early detection of outbreaks, especially in the “phase 2” of the pandemic, when lockdown and other restriction measures are progressively withdrawn, in order to avoid or minimize contagion resurgence. For this purpose, contact-tracing apps are being proposed for large scale adoption by many countries. A centralized approach, where data sensed by the app are all sent to a nation-wide server, raises concerns about citizens’ (...) privacy and needlessly strong digital surveillance, thus alerting us to the need to minimize personal data collection and avoiding location tracking. We advocate the conceptual advantage of a decentralized approach, where both contact and location data are collected exclusively in individual citizens’ “personal data stores”, to be shared separately and selectively, voluntarily, only when the citizen has tested positive for COVID-19, and with a privacy preserving level of granularity. This approach better protects the personal sphere of citizens and affords multiple benefits: it allows for detailed information gathering for infected people in a privacy-preserving fashion; and, in turn this enables both contact tracing, and, the early detection of outbreak hotspots on more finely-granulated geographic scale. The decentralized approach is also scalable to large populations, in that only the data of positive patients need be handled at a central level. Our recommendation is two-fold. First to extend existing decentralized architectures with a light touch, in order to manage the collection of location data locally on the device, and allow the user to share spatio-temporal aggregates—if and when they want and for specific aims—with health authorities, for instance. Second, we favour a longer-term pursuit of realizing a Personal Data Store vision, giving users the opportunity to contribute to collective good in the measure they want, enhancing self-awareness, and cultivating collective efforts for rebuilding society. (shrink)

Objectives: To investigate the quality of consent gained for the use in research of tissue that is surplus after surgery. To compare the use of two consent forms: a simple locally introduced form and a more complex centrally instigated form. To discuss the attitudes of patients towards the use of their surplus tissue in research.Design: Data were collected through interviews and analysed with a combination of quantitative and qualitative analytical techniques.Participants and setting: Patients of the breast care unit at (...) a teaching hospital were interviewed at home or in a quiet room at the hospital.Results: 57 people were interviewed out of 81 approached, between October 2003 and March 2004. Most participants had a poor level of knowledge about the consent they had given, but reported being happy about having given it. The patients who had signed the locally introduced form had considerably more knowledge than those who had signed the centrally instigated form . Participants considered being well informed to be less important than believing that their opinions were valued and respected.Conclusions: The findings suggest that traditional models of informed consent are not universally applicable and, in this case, seem to overstate what people wish to know. The simple consent form achieved a better quality of informed consent and provided a better model of practice than the complex form, and it seemed that a focused approach to consent seeking is more effective and acceptable than more complex approaches. (shrink)

Introduction Respecting the Patients’ Rights Charter leads to the demands of patients for their rights and the response of rehabilitation therapists by increasing their compliance. The present study aimed to compare the views of patients and rehabilitation therapists about the importance and extent of compliance with the Patients’ Rights Charter. Methods This cross-sectional study was conducted for 3 months on 114 patients and 55 therapists who were selected using the convenience sampling method. The data collection tools included a demographic (...) information form and the Justification and Practice of Patient Rights Questionnaire. The collected data were analyzed using descriptive statistics, independent t-test, paired t-test, and Pearson correlation coefficient. Results Mean scores of the importance of compliance with the Patients’ Rights Charter were 2.21 ± 0.40 and 2.31 ± 0.43 in the group of patients and therapists, respectively. Moreover, the mean scores of compliance with the Patients’ Rights Charter were 1.45 ± 0.48 and 1.53 ± 0.61 from the perspective of patients and therapists, respectively. There was no statistically significant difference between the views of patients and therapists on the importance and extent of compliance with the Patients’ Rights Charter. Discussion and Conclusion The importance of respecting the Patients’ Rights Charter from the perspective of patients and therapists was at a desirable level while the level of compliance with it from the perspective of both groups was moderate. It seems that more research is needed to explain the causes of this discrepancy and increase compliance with the Patients’ Rights Charter in rehabilitation clinics. (shrink)

Visual Associative agnosia is a rare perceptual impairment generally resulting from lesions in the infero temporal cortex. Patients suffering from associative agnosia are able to make accurate copies of line drawings, but they are unable to visually recognize objects - including those represented in line drawings - as belonging to familiar high-level kinds. The Rich Content View claims that visual experience can represent high-level kind properties. The phenomenon of associative agnosia appears to present us with a strong case for the (...) Rich Content View. There are reasons for thinking that the experiences of an agnosic patient differ from those of a healthy subject. Given that there is a phenomenal contrast between the experiences of an associative agnosic and those of a healthy perceiver, one may argue that this contrast is due to differences in abilities to represent high-level kinds. I claim that there is indeed a phenomenal contrast between the visual experiences of an agnosic and those of a healthy perceiver. However, the explanation of this contrast that best fits the empirical data is compatible with the view that visual experience does not represent high-level kinds. (shrink)

The authors interpret the data to mean that patients think that their physicians should make relevant decisions in Learning Health System based trials, and label that as being of 'utmost importance'. However, the patients themselves (in the excerpts provided) emphasize that trust in physicians is instrumental for obtaining protection of patient's bests interests (which seems to be of utmost importance for patients). Furthermore, the perceived bias regarding outcome certainty deserves more discussion. Namely, the decision to defer to physician's opinion (...) is linked to perceived certainty of best clinical outcomes and instrumental for protection of best interest, while it lacks appreciation of the level of uncertainty that exists in clinical decision-making. Finally, a discussion on what are the implications of patient perspectives for individual, vs. relational autonomy is something the authors don't pursue, but instead use "physician-patient autonomy" throughout the paper. (shrink)

This dissertation is focused on the validity of “the data” that are collected in psychotherapy research for the purpose of evidencing treatment efficacy. In the ‘Evidence Based Treatment’ paradigm, researchers rely on the so-called ‘gold standard methodology’ to gather sound and trustworthy evidence, which increasingly influences the organization of mental health care worldwide. In the gold standard, data are collected by quantified self-report measures, to assess the presence and severity of symptoms before and after treatment. When the pre-post (...) difference is larger for a group of people that received the treatment of interest and a group of people who received no or an alternative treatment, the treatment of interest is called effective. In this methodological procedure, researchers tend to assume that when this gold standard methodology is conducted properly, “the data” will speak for themselves. However, when evidence is based on data, that evidence is principally limited by that data. In other words: output depends on input. That implies that when input is flawed, output will be flawed, even when the very best methods of analysis would be used. So what if “the data” yield validity issues despite being collected by validated measures? When “the data” do not straightforwardly evidence treatment effects, will the subsequent steps in the analysis of these data be enough to secure that the evidence in the end does evidence treatment efficacy? In this dissertation, the focus is turned to validity of “the data” that are concretely provided by patient-participants by scoring their own experienced symptoms in self-report questionnaires, in function of evidencing treatment efficacy. A series of empirical case studies were conducted to scrutinize how patient-participants in a randomized controlled psychotherapy study experienced the process of data collection, and how these experiences affected the data that they provided. Each of the studied patient-participants experienced a substantial effect of the questionnaire administration on their complaints. This impacted the level of complaints, but also changed the way in which the complaints were understood at all, and how patient-participants perceived themselves. Thus, rather than neutrally measuring symptoms, questionnaire administration changed the experienced complaints ‘performatively’, which turned measurement into a clinical intervention of its own. Consequently, what is measured cannot straightforwardly be called ‘treatment efficacy’, as it may be entangled with, enabled by or even obstructed by effects of measurement and research. Therefore, the act of measurement itself can pose a vital threat to the validity of “the data”. This way, the empirical case studies exhibited that data can yield validity problems despite the use of validated measures. Consequently, the validity of a measure as such is no guarantee for the validity of data. Nonetheless, in gold standard research, the data are straightforwardly taken as input for analyses of general treatment efficacy. The question is what happens with those validity issues on the level of individual data, when they pursue their journey towards becoming evidence. In this dissertation, it was argued that the validity issues are not sufficiently solved in the methodological steps after data collection, so when data are invalid in the beginning, these validity issues will simply become part of the data set that forms the input for analysis of the final evidence. This urges that validity issues should be solved on the level of individually provided data, as the validity issues will otherwise become inherent to “the data”. Put formally: valid data is a precondition for evidence in EBT. In conclusion, it is crucial for a sound evidence-base to scrutinize the validity of data in function of the overall goal and utility of the research. For this, it is important not to take “the data” as speaking for themselves, but to regard them as clinical narratives, which are framed in a specific format to be communicated between researcher and respondent in a research context. This emphasizes that the choice for a certain format determines what can be evidenced, so it is vital that these choices indeed allow for obtaining evidence that is useful and valid to serve the clinical goal of EBT. (shrink)

One of the goals of The Patient Protection and Affordable Care Act is the reduction and elimination of health inequities, generally defined as population-level health differences that adversely affect disadvantaged groups. The ACA provides powerful new tools to collect, analyze, and share standardized data on these inequities. Prior to the ACA, disability was marginalized in data collection efforts, limiting our ability to understand and address significant health inequities experienced by millions of Americans. Now, for the first time, we (...) can use these tools to collect valuable new data on the nature and extent of health inequities experienced by people with disabilities across the country. Standardized health data collection is critical to health equity. (shrink)

In China's healthcare sector, a popular and socio-culturally distinctive phenomenon known as guanxi jiuyi, whereby patients draw on their guanxi with physicians when seeking healthcare, is thriving. Integrating anthropological investigation with normative inquiry, this paper examines medical guanxi through the lens of patient–physician trust and mistrust. The first-hand empirical data acquired – on the lived experiences and perspectives of both patients and physicians – is based on six months' fieldwork carried out in a county hospital in Guangdong, southern China, (...) which included in-depth interviews with 20 patients and 20 medical professionals. Patients who emphasized the positive effects of guanxi on patient–physician trust believed that it facilitates access to experienced medical specialists, enhances clinical communication, and reduces the financial and medical risks of over diagnosis and overtreatment by physicians. At the same time, these findings reveal patients' strong sense of mistrust, not only towards individual health professionals but also to the medical profession and China's commercialized healthcare industry. While some health professionals in the study responded favourably to medical guanxi, most were opposed to it on the grounds that it undermines professional standards and equitable healthcare. We found that the practice of medical guanxi is not morally justifiable, chiefly because it reinforces the present high levels of patient–physician mistrust and erodes trust between patients and the medical profession as a whole. In China, both the medical profession and the state need to promote patient–physician trust based on medical professionalism and institutional norms, rather than on guanxi or individual relationships. (shrink)

AimsThis study evaluates a protocol for early, routine ethics consultation for patients on extracorporeal membrane oxygenation to support decision-making in the context of clinical uncertainty with the aim of mitigating ethical conflict and moral distress.MethodsWe conducted a single-site qualitative analysis of EC documentation for all patients receiving ECMO support from 15 August 2018 to 15 May 2019. Detailed analysis of 20 ethically complex cases with protracted ethics involvement identifies four key ethical domains: limits of prognostication, bridge to nowhere, burden of (...) treatment and system-level concerns. There are three subthemes: relevant contextual factors, the role of EC and observed outcomes. Content analysis of transcripts from interviews with 20 members of the multidisciplinary ECMO team yields supplemental data on providers’ perceptions of the impact of the early intervention protocol.ResultsLimited outcome data for ECMO, unclear indications for withdrawal, adverse effects of treatment and an obligation to attend to programme metrics present significant ethical challenges in the care of this patient population. Upstream EC mitigates ethical conflict by setting clear expectations about ECMO as a time limited trial, promoting consistent messaging among multiple services and supporting surrogate decision-makers. When ECMO becomes a ‘bridge to nowhere’, EC facilitates decision-making that respects patient values yet successfully sets limits on non-beneficial use of this novel therapy.ConclusionData from this study support the conclusion that ECMO poses unique ethical challenges that necessitate a standardised protocol for early, routine EC—at least while this medical technology is in its nascent stages. (shrink)

Background Immense volumes of personal health information are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences. Methods Patients were invited to complete a 27-item survey focusing on: broad versus specific consent; opt-in versus opt-out approaches; comfort level sharing with different recipients; attitudes towards commercialization; and options to track PHI use and study results. Results 222 participants were included in the analysis; (...) 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients were more uncomfortable than older patients. While 56% of patients preferred broad consent, 38% preferred specific consent; 6% preferred not sharing at all. The majority of patients preferred to be asked for permission before entry into a contact pool. Again, this trend was more pronounced for younger patients. Approximately half of patients were uncomfortable sharing PHI with commercial enterprises. Most patients preferred to track PHI usage, with the highest proportion once again reported by the youngest patients. A majority of patients also wished to be notified regarding study results. Conclusions While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research. (shrink)