In this paper, we explore the role of reciprocity in the employment of restrictive measures in contexts of contagion. Reciprocity should be understood as a substantive value that governs the use, level and extent of restrictive measures. We also argue that independent of the role reciprocity plays in the legitimisation the use of restrictive measures, reciprocity can also motivate support and compliance with legitimate restrictive measures. The importance of reciprocity has implications for how restrictive measures should be undertaken when preparing (...) and evaluating public health responses to contagion. (shrink)

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg in 2000 were (...) analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

Representatives from eight European countries compared the legal, ethical and professional settings within which decision making for neonates takes place. When it comes to limiting treatment there is general agreement across all countries that overly aggressive treatment is to be discouraged. Nevertheless, strong emphasis has been placed on the need for compassionate care even where cure is not possible. Where a child will die irrespective of medical intervention, there is widespread acceptance of the practice of limiting aggressive treatment or alleviating (...) suffering even if death may be hastened as a result. Where the infant could be saved but the future outlook is bleak there is more debate, but only two countries have tested the courts with such cases. When it comes to the active intentional ending of life, the legal position is standard across Europe; it is prohibited. However, recognising those intractable situations where death may be lingering and unpleasant, Dutch paediatricians have reported that they do sometimes assist babies to die with parental consent. Two cases have been tried through the courts and recent official recommendations have set out standards by which such actions may be assessed. (shrink)

Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for research with Indigenous populations. Lack of informed consent can impact on research findings. The Picture Talk Project was initiated with senior Aboriginal leaders of the Fitzroy Valley community situated in the far north of Western Australia. Aboriginal people (...) were interviewed about their understanding and experiences of research and consent processes. Transcripts were analysed using NVivo10 software with an integrated method of inductive and deductive coding and based in grounded theory. Local Aboriginal interpreters validated coding. Major themes were defined and supporting quotes sourced. Interviews with Aboriginal leaders were facilitated by a local Aboriginal Community Navigator who could interpret if necessary and provide cultural guidance. Participants were from all four major local language groups of the Fitzroy Valley; aged 31 years and above; and half were male. Themes emerging from these discussions included Research—finding knowledge; Being respectful of Aboriginal people, Working on country, and Being flexible with time; Working together with good communication; Reciprocity—two-way learning; and Reaching consent. The project revealed how much more there is to be learned about how research with remote Aboriginal communities should be conducted such that it is both culturally respectful and, importantly, meaningful for participants. We identify important elements in community consultation about research and seeking consent. (shrink)

Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need (1). Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oral antiviral Paxlovid (2) -/- Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and (...) Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend to disadvantage individuals with barriers in access to care (3). There is mounting evidence of racial, ethnic, and socioeconomic disparities in access to medications for COVID-19 (4, 5). -/- One potential method to promote equitable allocation is to use a weighted lottery, which is an allocation strategy that gives all eligible patients a chance to receive the scarce treatment while also allowing the assignment of higher or lower chances according to other ethical considerations (6). We sought to assess the feasibility of implementing a weighted lottery to allocate scarce COVID-19 medications in a large U.S. health system and to determine whether the weighted lottery promotes equitable allocation. (shrink)

Background: Moral case deliberation is increasingly becoming part of various Dutch healthcare organizations. Although some evaluation studies of moral case deliberation have been carried out, research into the results of moral case deliberation within aged care is scarce. Research questions: How did participants evaluate moral case deliberation? What has moral case deliberation brought to them? What has moral case deliberation contributed to care practice? Should moral case deliberation be further implemented and, if so, how? Research design: Quantitative analysis of a (...) questionnaire study among participants of moral case deliberation, both caregivers and team leaders. Qualitative analysis of written answers to open questions, interview study and focus group meetings among caregivers and team leaders. Participants and research context: Caregivers and team leaders in a large organization for aged care in the Netherlands. A total of 61 moral case deliberation sessions, carried out on 16 care locations belonging to the organization, were evaluated and perceived results were assessed. Ethical considerations: Participants gave informed consent and anonymity was guaranteed. In the Netherlands, the law does not prescribe independent ethical review by an Institutional Review Board for this kind of research among healthcare professionals. Findings: Moral case deliberation was evaluated positively by the participants. Content and atmosphere of moral case deliberation received high scores, while organizational issues regarding the moral case deliberation sessions scored lower and merit further attention. Respondents indicated that moral case deliberation has the potential to contribute to care practice as relationships among team members improve, more openness is experienced and more understanding for different perspectives is fostered. If moral case deliberation is to be successfully implemented, top-down approaches should go hand in hand with bottom-up approaches. Conclusion: The relevance of moral case deliberation for care practice received wide acknowledgement from the respondents. It can contribute to the team’s cohesion as mutual understanding for one another’s views is fostered. If implemented well, moral case deliberation has the potential to improve care, according to the respondents. (shrink)

About one third of patients with epilepsy have seizures refractory to the medical treatment. Electrical stimulation mapping is the gold standard for the identification of “eloquent” areas prior to resection of epileptogenic tissue. However, it is time-consuming and may cause undesired side effects. Broadband gamma activity recorded with extraoperative electrocorticography during cognitive tasks may be an alternative to ESM but until now has not proven of definitive clinical value. Considering their role in cognition, the alpha and beta bands could further (...) improve the identification of eloquent cortex. We compared gamma, alpha and beta activity, and their combinations for the identification of eloquent cortical areas defined by ESM. Ten patients with intractable focal epilepsy participated in a delayed-match-to-sample task, where syllable sounds were compared to visually presented letters. We used a generalized linear model approach to find the optimal weighting of each band for predicting ESM-defined categories and estimated the diagnostic ability by calculating the area under the receiver operating characteristic curve. Gamma activity increased more in eloquent than in non-eloquent areas, whereas alpha and beta power decreased more in eloquent areas. Diagnostic ability of each band was close to 0.7 for all bands but depended on multiple factors including the time period of the cognitive task, the location of the electrodes and the patient’s degree of attention to the stimulus. We show that diagnostic ability can be increased by 3–5% by combining gamma and alpha and by 7.5–11% when gamma and beta were combined. We then show how ECoG power modulation from cognitive testing can be used to map the probability of eloquence in individual patients and how this probability map can be used in clinical settings to optimize ESM planning. We conclude that the combination of gamma and beta power modulation during cognitive testing can contribute to the identification of eloquent areas prior to ESM in patients with refractory focal epilepsy. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

Maria Triassi,1 Elena Giancotti,2 Antonio Nardone,1 Giulia Mancini,3 Fabiana Rubba1 1Public, Preventive and Social Medicine School, University Federico II of Naples, Naples, Italy; 2Procurement and Transplantation Coordination, Naples, Italy; 3Sociology Unit, G D'annunzio University, Chieti-Pescara, Italy Introduction: The growing disparity between organ availability for transplantation and the number of patients in need has challenged the donation and transplantation community to develop innovative processes, ideas, and techniques to bridge this gap. Advances in the sharing of best practices in the donation community (...) have contributed greatly to this aim over the past 5 years. Studies published during the past five years were analyzed to gain insight on the evolving organizational areas and tools that the procurement and transplantation pathways have been focused on. The hypothesis assessed is that networking and efficacious handling of this complex path may be ameliorated by an adaptive organizational toolbox. Methods: A thorough search has been conducted using various databases, ie, Cochrane library, PubMed, EMBASE, Federico II University Open Archive. The evidence was considered following the Effective Practice and Organization of Care Group checklist. Prevalent organizational attitudes and areas were assessed, and various scenarios were analyzed. Initially, all titles and abstracts were screened. In the next phase, the full text of all abstracts considered potentially relevant by at least one of the reviewers was evaluated. Inconsistencies in decision-making within this second phase were solved based on consensus between both reviewers. In this phase, for every study we defined whether the organization was considered relevant and what the scenario was. The information was extracted from each study based on bibliographic details. As many as 1,071 studies were analyzed, and 81 were selected as potentially relevant. Results: We found three prevalent areas of interest focused on organizational elements: global organizational strategies scenario, clinical hospital organization, and citizenship and social scenario. Conclusion: We reached the conclusion that organization has a central role in different scenarios of procurement and transplantation in a continuum from government to hospital and finally among citizens. A standardized hospital pathway definitely remains the essential step in order to ameliorate either procurement or transplantation. Keywords: transplant procurement, management, organizational tool, network. (shrink)

The editors welcome letters from readers, although we cannot guarantee that all will be published. To ensure timeliness, correspondents must respond to an article within seven weeks and not exceed two double‐spaced pages. Letters become the property of the editors and may be edited and shortened at our discretion.

The editors welcome letters from readers, although we cannot guarantee that all will be published. To ensure timeliness, correspondents must respond to an article within seven weeks and not exceed two double‐spaced pages. Letters become the property of the editors and may be edited and shortened at our discretion.

Background: Legislation on physician-assisted suicide is being considered in a number of states since the passage of the Oregon Death With Dignity Act in 1994. Opinion assessment surveys have historically assessed particular subsets of physicians.Objective: To determine variables predictive of physicians’ opinions on PAS in a rural state, Vermont, USA.Design: Cross-sectional mailing survey.Participants: 1052 physicians licensed by the state of Vermont.Results: Of the respondents, 38.2% believed PAS should be legalised, 16.0% believed it should be prohibited and 26.0% believed it should (...) not be legislated. 15.7% were undecided. Males were more likely than females to favour legalisation . Physicians who did not care for patients through the end of life were significantly more likely to favour legalisation of PAS than physicians who do care for patients with terminal illness . 30% of the respondents had experienced a request for assistance with suicide.Conclusions: Vermont physicians’ opinions on the legalisation of PAS is sharply polarised. Patient autonomy was a factor strongly associated with opinions in favour of legalisation, whereas the sanctity of the doctor–patient relationship was strongly associated with opinions in favour of not legislating PAS. Those in favour of making PAS illegal overwhelmingly cited moral and ethical beliefs as factors in their opinion. Although opinions on legalisation appear to be based on firmly held beliefs, approximately half of Vermont physicians who responded to the survey agree that there is a need for more education in palliative care and pain management. (shrink)

This study examines the specificvalues held by consumers towards organic andconventionally produced meat, with particularreference to moral issues surrounding foodanimal production. A quota sample of 30 femalesfrom both a rural and an urban area of Scotland, were interviewed. Overall, there was lowcommitment towards the purchase of organicmeats and little concern for ethical issues.Price and product appearance were the primarymeat selection criteria, the latter being usedas a predictor of eating quality. Manyattitude-behavior anomalies were identified,mainly as a result of respondents' cognitivedissonance and (...) lack of understanding regardingmeat production criteria underpinning meatquality marks, e.g., Soil Association label.Responsibilities for ethical issues appeared tobe delegated by the consumer to the meatretailer or government. This raises issuesabout educating consumers and bringingconsumers closer to understanding meatproduction systems. A conceptual framework isproposed that illustrates the significance ofconsumer involvement in how meat-purchasingdecisions are approached in terms of theevaluation of tangible and or intangiblequality attributes. The results also point tothe need for further research into thoseaspects of quality that individuals tend toaddress at the level of the citizen,rather than at the point of purchase. (shrink)

To localize wheat ESTs on chromosomes, 882 homoeologous group 6-specific ESTs were identified by physically mapping 7965 singletons from 37 cDNA libraries on 146 chromosome, arm, and sub-arm aneuploid and deletion stocks. The 882 ESTs were physically mapped to 25 regions flanked by 23 deletion breakpoints. Of the 5154 restriction fragments detected by 882 ESTs, 2043 were localized to group 6 chromosomes and 806 were mapped on other chromosome groups. The number of loci mapped was greatest on chromosome 6B and (...) least on 6D. The 264 ESTs that detected orthologous loci on all three homoeologs using one restriction enzyme were used to construct a consensus physical map. The physical distribution of ESTs was uneven on chromosomes with a tendency toward higher densities in the distal halves of chromosome arms. About 43% of the wheat group 6 ESTs identified rice homologs upon comparisons of genome sequences. Fifty-eight percent of these ESTs were present on rice chromosome 2 and the remaining were on other rice chromosomes. Even within the group 6 bins, rice chromosomal blocks identified by 1-6 wheat ESTs were homologous to up to 11 rice chromosomes. These rice-block contigs were used to resolve the order of wheat ESTs within each bin. (shrink)

Pain, suffering and positive emotions in patients in vegetative state/unresponsive wakefulness syndrome (VS/UWS) and minimally conscious states (MCS) pose clinical and ethical challenges. Clinically, we evaluate behavioural responses after painful stimulation and also emotionally-contingent behaviours (e.g., smiling). Using stimuli with emotional valence, neuroimaging and electrophysiology technologies can detect subclinical remnants of preserved capacities for pain which might influence decisions about treatment limitation. To date, no data exist as to how healthcare providers think about end-of-life options (e.g., withdrawal of artificial nutrition (...) and hydration) in the presence or absence of pain in non-communicative patients. Here, we aimed to better clarify this issue by re-analyzing previously published data on pain perception (Prog Brain Res 2009 177, 329–38) and end-of-life decisions (J Neurol 2010 258, 1058–65) in patients with disorders of consciousness. In a sample of 2259 European healthcare professionals we found that, for VS/UWS more respondents agreed with treatment withdrawal when they considered that VS/UWS patients did not feel pain (77%) as compared to those who thought VS/UWS did feel pain (59%). This interaction was influenced by religiosity and professional background. For MCS, end-of-life attitudes were not influenced by opinions on pain perception. Within a contemporary ethical context we discuss (1) the evolving scientific understandings of pain perception and their relationship to existing clinical and ethical guidelines; (2) the discrepancies of attitudes within (and between) healthcare providers and their consequences for treatment approaches, and (3) the implicit but complex relationship between pain perception and attitudes toward life-sustaining treatments. (shrink)