Health care organizations are increasingly asked to show accountability about their performance. This paper proposes that accountability can best be achieved through evaluative methods that are based on evidence regarding the relationship between processes of care and expected outcomes. Root cause analysis (RCA) is used as an illustration of how a generic method of inquiring can be transformed into an ongoing monitoring, evaluation, user education and accountability strategy. The role of performance indicators, as well as patient and community expectations, is (...) discussed. (shrink)

Rationale, aims and objectives To compare the pharmacotherapeutic approaches to diabetic hypertension of family physicians (FPs) and general practitioners (GPs). Methods A retrospective prescription-based study was conducted in 15 out of a total of 20 health centres, involving 115 primary care physicians – 77 FPs and 38 GPs, representing 74% of the primary care physicians of Bahrain. Prescriptions were collected during May and June 2000 to comprise a study population of 1266 diabetic-hypertensive patients. Results As monotherapy, angiotensin-converting enzyme (ACE) inhibitors (...) (37.9%) and β-blockers (38.3%) were the most commonly prescribed classes of antihypertensives by FPs and GPs, respectively. Calcium channel blockers (CCBs) were ranked third by both categories of physicians. For two-drug combinations, a β-blocker and an ACE inhibitor was the combination of choice for both physician categories. Patients managed by the FPs were more likely to receive a β-blocker–CCB combination (17.4 vs. 14.9%) or a diuretic–ACE inhibitor combination (16.7 vs. 11.4%) and less likely to receive a β-blocker–diuretic combination (11.8 vs. 16.7%) than those managed by the GPs. The proportion of patients receiving antihypertensive combinations was 40.6 and 38.5% for FPs and GPs, respectively. While the GPs prescribed CCB as a monotherapy to the elderly most often, the FPs choice was a β-blocker. Diuretics were less preferred by both FPs and GPs. β-Blocker–ACE inhibitor was again the most preferred combination of both FPs and GPs. FPs prescribed CCB–β-blocker combinations more often than GPs (P = 0.01), whereas CCB–ACE inhibitor combinations were less preferred (P = 0.09). A trend towards excessive use of short-acting nifedipine as monotherapy for elderly patients, both by FPs and by GPs, was noticed. Glibenclamide, alone or in combination with metformin, was the foremost antidiabetic drug prescribed by FPs and GPs. Middle-aged (45–64 years) patients seen by GPs were more likely to receive glibenclamide than those treated by FPs (P = 0.001) and less likely to receive gliclazide (P = 0.01). Combinations of a β-blocker with either glibenclamide or insulin were prescribed considerably more often by GPs.Conclusions Within the same practice setting, a substantial difference was observed between FPs and GPs in terms of preference for different classes of drugs in the management of diabetic hypertension. The compliance of both FPs and GPs was suboptimal; overall, the compliance of the FPs was closer to the recommended guidelines, however. Educational programmes should specifically address these inadequacies in order to improve the quality of health care. (shrink)

For the successful achievement of evidence-based practice, clinicians, managers and purchasers need evidence on whether a particular intervention works and ways to judge the appropriateness of the outcome criteria and measures used. Guidance is needed on what outcome measure to use, especially within routine clinical care settings. Beginning with a re-clarification of the difference between a health status and an outcome measure, the paper presents an evaluative checklist for use by clinical audit and research staff to review outcome measures for (...) use in routine care settings. Central features include the user-centredness of the measure, its psychometric properties, feasibility of use and utility. The applicability of the checklist is illustrated for outcome measurement in diabetes and stroke care. A modified form of the checklist is proposed for use by the busy clinician as an aid to the critical review of research papers within the context of evidence-based practice and to aid health care practitioners' choice of which outcome measure(s) to use within routine clinical care. (shrink)

Rationale, aims and objectives Given the increasing prevalence of cataract and demand for cataract extraction surgery, patients must often wait to undergo this procedure. We validated a previously developed priority scoring system in terms of clinical variables, pre-intervention health status, appropriateness of surgery and gain in visual acuity (VA) and health-related quality of life (HRQoL).Methods Explicit prioritization criteria for cataract extraction created by a variation of the Research and Development (RAND) and University of California Los Angeles appropriateness methodology were retrospectively (...) applied to a prospective cohort of 5257 patients on waiting lists to undergo cataract by phacoemulsification at 17 hospitals in Spain. Demographic data, clinical data and data related to surgical technique were collected by trained ophthalmologists. Patients were evaluated by their ophthalmologist before the intervention and 6 weeks afterward. They also completed, by mail, the Visual Function Index (VF-14) before the intervention and 3 months afterward.Results High-priority patients experienced greater improvement in VA and HRQoL than those classified as intermediate or low-priority (P < 0.0001), even after adjusting by VA and the VF-14 score at baseline. The time to intervention was the same for high-priority patients as it was for intermediate and low-priority patients.Conclusions The priority score we developed identified patients most likely to experience the greatest improvements from cataract extraction. Use of this tool could provide a fairer and more rational way to prioritize patients for cataract extraction. (shrink)

The question of how we apply knowledge from biomedical science to medical and public health practice has been the subject of heated debates about generalizability and related concepts, such as applicability and inductive inference. In this essay, I interpret the term from the perspective of two causal models: determinism and indeterminism. I suggest that theories of generalizability can be formulated on the basis of both models and take the form of testable but unverifiable hypotheses, an attribute that is common to (...) all scientific theories. Nonetheless, there is one noteworthy difference between the two models: determinism allows one to rationalize a decision to treat a certain kind of patient but only indirectly a decision to treat any particular patient, whereas indeterminism accommodates both types of decisions. (shrink)

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

Objective: To determine whether the marks in the third year Objective Structured Clinical Examination were affected by the collusion reported by the students themselves on an electronic discussion board.Design: A review of the student discussion, examiners’ feedback and a comparison of the marks obtained on the 2 days of the OSCE.Participants: 255 third year medical students.Setting: An OSCE consisting of 15 stations, administered on three sites over 2 days at a UK medical school.Results: 40 students contributed to the discussion on (...) the electronic discussion board. The main points raised were perceived inequity between students who did, or did not, have prior knowledge of the station content, and the lack of honesty and professionalism of their peers. Most contributors claimed to have received, or knew of others receiving, prior knowledge, but none confessed to passing on information. No significant difference was observed in the overall mark for the OSCE on day 1 ) and day 2 ). On day 2, marks were considerably greater for four stations and markedly lower for three stations. It was not obvious why collusion should affect these station marks. A clear indication of the effects of collusion could only be obtained from a single subsection of an individual station where 82 students on day 2 incorrectly gave the diagnosis from day 1.Conclusion: Marks do not provide a sound inference of student collusion in an OSCE and may mask the aspects of professional development of students. (shrink)

Coastal ecosystems are increasingly dominated by humans. Consequently, the human dimensions of sustainability science have become an integral part of emerging coastal governance and management practices. But if we are to avoid the harsh lessons of land management, coastal decision makers must recognize that humans are one of the more coastally dependent species in the biosphere. Management responses must therefore confront both the temporal urgency and the very real compromises and sacrifices that will be necessary to achieve a sustainable coastal (...) ecosystem, one that is economically feasible, socially just, and ecologically sound. (shrink)

The prospect of using cell-based interventions to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause (...) for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment. (shrink)

We assessed how synchronous speech listening and lipreading affects speech recognition in acoustic noise. In simple audiovisual perceptual tasks, inverse effectiveness is often observed, which holds that the weaker the unimodal stimuli, or the poorer their signal-to-noise ratio, the stronger the audiovisual benefit. So far, however, inverse effectiveness has not been demonstrated for complex audiovisual speech stimuli. Here we assess whether this multisensory integration effect can also be observed for the recognizability of spoken words. To that end, we presented audiovisual (...) sentences to 18 native-Dutch normal-hearing participants, who had to identify the spoken words from a finite list. Speech-recognition performance was determined for auditory-only, visual-only (lipreading) and auditory-visual conditions. To modulate acoustic task difficulty, we systematically varied the auditory signal-to-noise ratio. In line with a commonly-observed multisensory enhancement on speech recognition, audiovisual words were more easily recognized than auditory-only words (recognition thresholds of -15 dB and -12 dB, respectively). We here show that the difficulty of recognizing a particular word, either acoustically or visually, determines the occurrence of inverse effectiveness in audiovisual word integration. Thus, words that are better heard or recognized through lipreading, benefit less from bimodal presentation. Audiovisual performance at the lowest acoustic signal-to-noise ratios (45%) fell below the visual recognition rates (60%), reflecting an actual deterioration of lipreading in the presence of excessive acoustic noise. This suggests that the brain may adopt a strategy in which attention has to be divided between listening and lipreading. (shrink)

In this article, we present results from a literature review of intrinsic, instrumental, and relational values of nature conducted for the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services, as part of the Methodological Assessment of the Diverse Values and Valuations of Nature. We identify the most frequently recurring meanings in the heterogeneous use of different value types and their association with worldviews and other key concepts. From frequent uses, we determine a core meaning for each value type, which is (...) sufficiently inclusive to serve as an umbrella over different understandings in the literature and specific enough to help highlight its difference from the other types of values. Finally, we discuss convergences, overlapping areas, and fuzzy boundaries between different value types to facilitate dialogue, reduce misunderstandings, and improve the methods for valuation of nature's contributions to people, including ecosystem services, to inform policy and direct future research. © 2023 The Author(s). Published by Oxford University Press on behalf of the American Institute of Biological Sciences. (shrink)

IntroductionBisphenol A is highly debated and studied in relation to a variety of health outcomes. This large variation in the literature makes BPA a topic that is prone to selective use of literature, in order to underpin one’s own findings and opinion. Over time, selective use of literature, by means of citations, can lead to a skewed knowledge development and a biased scientific consensus. In this study, we assess which factors drive citation and whether this results in the overrepresentation of (...) harmful health effects of BPA.MethodsA citation network analysis was performed to test various determinants of citation. A systematic search identified all relevant publications on the human health effect of BPA. Data were extracted on potential determinants of selective citation, such as study outcome, study design, sample size, journal impact factor, authority of the author, self-citation, and funding source. We applied random effect logistic regression to assess whether these determinants influence the likelihood of citation.ResultsOne hundred sixty-nine publications on BPA were identified, with 12,432 potential citation pathways of which 808 citations occurred. The network consisted of 63 cross-sectional studies, 34 cohort studies, 29 case-control studies, 35 narrative reviews, and 8 systematic reviews. Positive studies have a 1.5 times greater chance of being cited compared to negative studies. Additionally, the authority of the author and self-citation are consistently found to be positively associated with the likelihood of being cited. Overall, the network seems to be highly influenced by two highly cited publications, whereas 60 out of 169 publications received no citations.ConclusionIn the literature on BPA, citation is mostly driven by positive study outcome and author-related factors, such as high authority within the network. Interpreting the impact of these factors and the big influence of a few highly cited publications, it can be questioned to which extent the knowledge development in human literature on BPA is actually evidence-based. (shrink)

The focus of this study was to analyze the content, distribution, and comparative genome relationships of 996 chromosome bin-mapped expressed sequence tags accounting for 2266 restriction fragments on the homoeologous group 3 chromosomes of hexaploid wheat. Of these loci, 634, 884, and 748 were mapped on chromosomes 3A, 3B, and 3D, respectively. The individual chromosome bin maps revealed bins with a high density of mapped ESTs in the distal region and bins of low density in the proximal region of the (...) chromosome arms, with the exception of 3DS and 3DL. These distributions were more localized on the higher-resolution group 3 consensus map with intermediate regions of high-mapped-EST density on both chromosome arms. Gene ontology classification of mapped ESTs was not significantly different for homoeologous group 3 chromosomes compared to the other groups. A combined analysis of the individual bin maps using 537 of the mapped ESTs revealed rearrangements between the group 3 chromosomes. Approximately 232 of the consensus mapped ESTs matched sequences on rice chromosome 1 and revealed large- and small-scale differences in gene order. Of the group 3 mapped EST unigenes ∼21 and 32% matched the Arabidopsis coding regions and proteins, respectively, but no chromosome-level gene order conservation was detected. (shrink)

Background Speech understanding may rely not only on auditory, but also on visual information. Non-invasive functional neuroimaging techniques can expose the neural processes underlying the integration of multisensory processes required for speech understanding in humans. Nevertheless, noise (from fMRI) limits the usefulness in auditory experiments, and electromagnetic artefacts caused by electronic implants worn by subjects can severely distort the scans (EEG, fMRI). Therefore, we assessed audio-visual activation of temporal cortex with a silent, optical neuroimaging technique: functional near-infrared spectroscopy (fNIRS). Methods (...) We studied temporal cortical activation as represented by concentration changes of oxy- and deoxy-hemoglobin in four, easy-to-apply fNIRS optical channels of 33 normal-hearing adult subjects and 5 post-lingually deaf cochlear implant (CI) users in response to supra-threshold unisensory auditory and visual, as well as to congruent auditory-visual speech stimuli. Results Activation effects were not visible from single fNIRS channels. However, by discounting physiological noise through reference channel subtraction, auditory, visual and audiovisual speech stimuli evoked concentration changes for all sensory modalities in both cohorts (p<0.001). Auditory stimulation evoked larger concentration changes than visual stimuli (p<0.001). A saturation effect was observed for the audiovisual condition. Conclusions Physiological, systemic noise can be removed from fNIRS signals by reference channel subtraction. The observed multisensory enhancement of an auditory cortical channel can be plausibly described by a simple addition of the auditory and visual signals with saturation. (shrink)

John Lavery's The First Wounded, London Hospital, August 1914 records a memorable event in the First World War. This painting and the archives of the Royal London Hospital provide a fascinating insight into the nursing and medical care of these early war casualties.

There is a popular hypothesis that performance on implicit and explicit memory tasks reflects 2 distinct memory systems. Explicit memory is said to store those experiences that can be consciously recollected, and implicit memory is said to store experiences and affect subsequent behavior but to be unavailable to conscious awareness. Although this division based on awareness is a useful taxonomy for memory tasks, the authors review the evidence that the unconscious character of implicit memory does not necessitate that it be (...) treated as a separate system of human memory. They also argue that some implicit and explicit memory tasks share the same memory representations and that the important distinction is whether the task (implicit or explicit) requires the formation of a new association. The authors review and critique dissociations from the behavioral, amnesia, and neuroimaging literatures that have been advanced in support of separate explicit and implicit memory systems by highlighting contradictory evidence and by illustrating how the data can be accounted for using a simple computational memory model that assumes the same memory representation for those disparate tasks. (shrink)

In recent years, we have seen a new concern with ethics training for research and development professionals. Although ethics training has become more common, the effectiveness of the training being provided is open to question. In the present effort, a new ethics training course was developed that stresses the importance of the strategies people apply to make sense of ethical problems. The effectiveness of this training was assessed in a sample of 59 doctoral students working in the biological and social (...) sciences using a pre–post design with follow-up and a series of ethical decision-making measures serving as the outcome variable. Results showed not only that this training led to sizable gains in ethical decision making but also that these gains were maintained over time. The implications of these findings for ethics training in the sciences are discussed. (shrink)

This report describes the rationale, approaches, organization, and resource development leading to a large-scale deletion bin map of the hexaploid wheat genome. Accompanying reports in this issue detail results from chromosome bin-mapping of expressed sequence tags representing genes onto the seven homoeologous chromosome groups and a global analysis of the entire mapped wheat EST data set. Among the resources developed were the first extensive public wheat EST collection. Described are protocols for sequencing, sequence processing, EST nomenclature, and the assembly of (...) ESTs into contigs. These contigs plus singletons were used for selection of distinct sequence motif unigenes. Selected ESTs were rearrayed, validated by 5′ and 3′ sequencing, and amplified for probing a series of wheat aneuploid and deletion stocks. Images and data for all Southern hybridizations were deposited in databases and were used by the coordinators for each of the seven homoeologous chromosome groups to validate the mapping results. Results from this project have established the foundation for future developments in wheat genomics. (shrink)

_ Source: _Volume 40, Issue 1, pp 104 - 115 It is intended in this study to present initial reliability and validity data for the Russian adaptation of the Multidimensional Inventory of Religious/Spiritual Well-being, as being related to personality factors and psychopathology. Therefore, the first version of the MI-RSWB-R was applied to a sample of 192 non-clinical subjects, together with the NEO Five Factor Inventory and the Symptom-Check-List. The original six-factor structure of the scale could be replicated for the MI-RSWB-R, (...) which also provides satisfying psychometric properties. In accordance with previous research the RSWB total score was linked to more favorable personality traits such as Extraversion, Openness to Experience, and Agreeableness, which was paralleled by substantial negative correlations with increased psychopathology. Our findings support the reliability and structural validity of the MI-RSWB-R as a standardized instrument for addressing the spiritual dimension in Russian populations. Further research in clinical surroundings is now recommended. (shrink)

Background: Dementia care at home often involves decisions in which the caregiver must weigh safety concerns with respect for autonomy. These dilemmas can lead to situations where caregivers provide care against the will of persons living with dementia, referred to as involuntary treatment. To prevent this, insight is needed into how family caregivers of persons living with dementia deal with care situations that can lead to involuntary treatment. Objective: To identify and describe family caregivers’ experiences regarding care decisions for situations (...) that can lead to involuntary treatment use in persons living with dementia at home. Research design: A qualitative descriptive interview design. Data were analysed using the Qualitative Analysis Guide of Leuven. Participants and research context: A total of 10 family caregivers providing care for 13 persons living with dementia participated in in-depth semi-structured interviews. Participants were recruited by registered nurses via purposive sampling. Ethical consideration: The study protocol was approved by the Ethics Committee of the University Hospitals Leuven and the Medical Ethical Test Committee Zuyderland. Findings: Family caregivers experience the decision-making process concerning care dilemmas that can lead to involuntary treatment as complicated, stressful and exhausting. Although they consider safety and autonomy as important values, they struggle with finding the right balance between them. Due to the progressive and unpredictable nature of dementia, they are constantly seeking solutions while they adapt to new situations. Family caregivers feel responsible and experience social pressure for the safety of persons living with dementia. They may be blamed if something adverse happens to the persons living with dementia, which increases an already stressful situation. Their experience is influenced by characteristics of the care triad such as practical and emotional support, knowledge, and previous experiences. Discussion and conclusion: To prevent involuntary treatment, professionals need to proactively inform family caregivers, and they need to support each other in dealing with complex care situations. (shrink)

The US neutrino community gathered at the Workshop on the Intermediate Neutrino Program at Brookhaven National Laboratory February 4-6, 2015 to explore opportunities in neutrino physics over the next five to ten years. Scientists from particle, astroparticle and nuclear physics participated in the workshop. The workshop examined promising opportunities for neutrino physics in the intermediate term, including possible new small to mid-scale experiments, US contributions to large experiments, upgrades to existing experiments, R&D plans and theory. The workshop was organized into (...) two sets of parallel working group sessions, divided by physics topics and technology. Physics working groups covered topics on Sterile Neutrinos, Neutrino Mixing, Neutrino Interactions, Neutrino Properties and Astrophysical Neutrinos. Technology sessions were organized into Theory, Short-Baseline Accelerator Neutrinos, Reactor Neutrinos, Detector R&D and Source, Cyclotron and Meson Decay at Rest sessions.This report summarizes discussion and conclusions from the workshop. (shrink)

We conducted a cross-sectional survey of a random sample of 1943 spouses of home-dwellers with Alzheimer’s disease (AD) to examine the prevalence of court-appointed guardians or financial powers of attorney for persons with AD, related factors and the need for information about these issues among caregiving families. The questionnaire consisted questions on variables of demographic characteristics, disability, symptoms and care needs of the person with dementia, the strain of caregiving, the use of court-appointed legal guardians or powers of attorney, as (...) well as discussions about these issues—and the need for them—with a doctor. The response rate was 77% and the mean ages of those with AD and caregivers were 80.2 and 78.2 years, respectively. The use of legal guardians was rare (4.3%), while the use of financial powers of attorney was more common (37.8%). Only 9.9% of the couples had discussed these issues with their doctor, whereas 47.9% expressed a need for it. The factors associated with the use of these legal arrangements were related to the severity of dementia, including experiencing dementia symptoms for more than 3 years, poor functioning, incontinence and behavioural symptoms. There is a clear need for information on medico-legal issues related to dementia among caregivers of AD patients. If held soon after the diagnosis, such discussions could support the autonomy of these persons in spite of AD and enable them to plan for the future as they wish. (shrink)

_The purpose _of the article is to introduce into scientific circulation works by Ukrainian scholar Taras Zakydalsky on the philosophy of Hryhorii Skovoroda. Taras Zakydalsky is a representative of the Ukrainian diaspora, philosopher, and member of Canadian NTSh (Shevchenko Scientific Society of Canada). _Theoretical basis._ We consider the uniqueness of H. Skovoroda’s philosophy, which stimulates not only intellectually but also spiritually enlightens the reader. The reasons for the complex perception and interpretation of Hryhorii Skovoroda’s philosophy are highlighted. We have verified (...) the main methods of its interpretation given in the works by Dmytro Chyzhevskyi. The influence of philosophical thought of thinkers of Antiquity and the Middle Ages: Aristotle, Epicurus, the Church Fathers, and Tertullian has been studied. We have comprehended H. Skovoroda’s interpretation of the Bible as a two-layer existence, the symbolic world that makes the foundation of his philosophy. The peculiarity of the thinker’s division of the heart into "internal" and "external" is analyzed. Hryhorii Skovoroda’s position on the Good and the evil is stated. The Good is identified with God, and the evil – with the real world, the man can choose between the two. Much attention is paid to the understanding of man as a microcosm – rational thinking, and thought is the fundamental cause of human activity, which generates all existence. Hryhorii Skovoroda’s philosophy of metaphysics as the existence of three worlds is highlighted: the first is the macrocosm (the whole surrounding world), the second is the microcosm (the man), and the third is the symbolic world (the Bible). "Monodualism" as a characteristic feature of H. Skovoroda’s work is analyzed. We have highlighted H. Skovoroda’s attitude to the transcendence of God, which is not separated from the world but is present in it directly. The understanding of faith as a forced act of self-love is analyzed because by loving ourselves we love God. The criteria for true and false faith have been clarified. The significance of H. Skovoroda’s aphorism that _what is necessary is useful, and not useful is unnecessary_ is considered. Examples of ethical principles in H. Skovoroda’s philosophy are considered. Peculiarities of the concept HAPPINESS are revealed. This concept is a universal means of existence of the Good, its source is gratitude to God. _Originality_ of the article is in the systematic presentation of the philosophy of the heart by Hryhorii Skovoroda and the analysis of the integrity of the "inner man", the true meaning of life as interpreted by Taras Zakydalsky. _Conclusions_ summarize the "anthropological pragmatism" of the philosopher, whose main idea is to apply practical skills for the benefit of society. (shrink)

Background Informed consent is a requirement for all research. It is not, however, clear how much information is sufficient to make an informed decision about participation in research. Information on an online questionnaire about childhood development was provided through an unfolding electronic participant sheet in three levels of information. Methods 552 participants, who completed the web-based survey, accessed and spent time reading the participant information sheet (PIS) between July 2008 and November 2009. The information behaviour of the participants was investigated. (...) The first level contained less information than might be found on a standard PIS, the second level corresponded to a standard PIS, and the third contained more information than on a standard PIS. The actual time spent on reading the information provided in three incremental levels and the participants' evaluation of the information were calculated. Results 77% of the participants chose to access the first level of information, whereas 12% accessed the first two levels, 6% accessed all three levels of information and 23% participated without accessing information. The most accessed levels of information were those that corresponded to the average reading times. Conclusion The brief information provided in the first level was sufficient for participants to make informed decisions, while a sizeable minority of the participants chose not to access any information at all. This study adds to the debate about how much information is required to make a decision about participation in research and the results may help inform the future development of information sheets by providing data on participants' actual needs when deciding about questionnaire surveys. (shrink)

The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral (...) anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research. (shrink)