Background Intensivists must provide enough analgesia and sedation to ensure dying patients receive good palliative care. However, if it is perceived that too much is given, they risk prosecution for committing euthanasia. The goal of this study is to develop consensus guidelines on analgesia and sedation in dying intensive care unit patients that help distinguish palliative care from euthanasia. Methods Using the Delphi technique, panelists rated levels of agreement with statements describing how analgesics and sedatives should be given to dying (...) ICU patients and how palliative care should be distinguished from euthanasia. Participants were drawn from 3 panels: 1) Canadian Academic Adult Intensive Care Fellowship program directors and Intensive Care division chiefs (N = 9); 2) Deputy chief provincial coroners (N = 5); 3) Validation panel of Intensivists attending the Canadian Critical Care Trials Group meeting (N = 12). Results After three Delphi rounds, consensus was achieved on 16 statements encompassing the role of palliative care in the intensive care unit, the management of pain and suffering, current areas of controversy, and ways of improving palliative care in the ICU. Conclusion Consensus guidelines were developed to guide the administration of analgesics and sedatives to dying ICU patients and to help distinguish palliative care from euthanasia. (shrink)

This article shows how funding research on Alzheimer's disease became a priority for the British Medical Research Council in the late 1970s and 1980s, thanks to work that isolated new pathological and biochemical markers, and showed that the disease affected a significant proportion of the elderly population. In contrast to histories that focus on the emergence of new and competing theories of disease causation in this period, I argue that concerns over the use of different assessment methods ensured the MRC's (...) immediate priority was standardising the ways in which researchers identified and recorded symptoms of Alzheimer's disease in potential research subjects. I detail how the rationale behind the development of standard assessment guidelines was less about arriving at a firm diagnosis and more about facilitating research by generating data that could be easily compared across the disciplines and sites that constitute modern biomedicine. Drawing on criticism of specific tests in the MRC's guidelines, which some psychiatrists argued were "middle class biased", I also show that debates over standardisation did not simply reflect concerns specific to the fields or areas of research that the MRC sought to govern. Questions about the validity of standard assessment guidelines for Alzheimer's disease embodied broader concerns about education and social class, which ensured that distinguishing normal from pathological in old age remained a contested and historically contingent process. (shrink)

Healthcare professionals often face ethical conflicts and challenges related to decision-making that have necessitated consideration of the use of conscientious objection (CO). No current guidelines exist within Spain’s healthcare system regarding acceptable rationales for CO, the appropriate application of CO, or practical means to support healthcare professionals who wish to become conscientious objectors. As such, a procedural framework is needed that not only assures the appropriate use of CO by healthcare professionals but also demonstrates its ethical validity, legislative compliance (...) through protection of moral freedoms and patients’ rights to receive health care. Our proposal consists of prerequisites of eligibility for CO (individual reference, specific clinical context, ethical justification, assurance of non-discrimination, professional consistency, attitude of mutual respect, assurance of patient rights and safety) and a procedural process (notification and preparation, documentation and confidentiality, evaluation of prerequisites, non-abandonment, transparency, allowance for unforeseen objection, compensatory responsibilities, access to guidance and/or consultative advice, and organizational guarantee of professional substitution). We illustrate the real-world utility of the proposed framework through a case discussion in which our guidelines are applied. (shrink)

Background: Moral courage is required at all levels of nursing. However, there is a need for development of instruments to measure nurses’ moral courage. Objectives: The objective of this study is to develop a scale to measure nurses’ self-assessed moral courage, to evaluate the scale’s psychometric properties, and to briefly describe the current level of nurses’ self-assessed moral courage and associated socio-demographic factors. Research design: In this methodological study, non-experimental, cross-sectional exploratory design was applied. The data were collected using Nurses’ (...) Moral Courage Scale and analysed statistically. Participants and research context: The data were collected from a convenience sample of 482 nurses from four different clinical fields in a major university hospital in Finland for the final testing of the scale. The pilot comprised a convenience sample of 129 nurses. Ethical considerations: The study followed good scientific inquiry guidelines. Ethical approval was obtained from the university ethics committee and permission to conduct the study from the participating hospital. Findings: Psychometric evaluation showed that the 4-sub-scale, 21-item Nurses’ Moral Courage Scale demonstrates good reliability and validity at its current state of development showing a good level of internal consistency for a new scale, the internal consistency values ranging from 0.73 to 0.82 for sub-scales and 0.93 for the total scale, thus well exceeding the recommended Cronbach’s alpha value of >0.7. Principal component analysis and confirmatory factor analysis supported the theoretical construct of Nurses’ Moral Courage Scale. Face validity and expert panel assessments markedly contributed to the relevance of items in establishing content validity. Discussion and conclusion: Nurses’ Moral Courage Scale provides a new generic instrument intended for measuring nurses’ self-assessed moral courage. Recognizing the importance of moral courage as a part of nurses’ moral competence and its assessment offers possibilities to develop interventions and educational programs for enhancement of moral courage. Research should focus on further validation measures of Nurses’ Moral Courage Scale in international contexts. (shrink)

Background: The exploration of the ethical climate in the care settings for older people is highlighted in the literature, and it has been associated with various aspects of clinical practice and nurses’ jobs. However, ethical climate is seldom studied in the older people care context. Valid, reliable, feasible measures are needed for the measurement of ethical climate. Objectives: This study aimed to test the reliability, validity, and sensitivity of the Hospital Ethical Climate Survey in healthcare settings for older people. (...) Design: A non-experimental cross-sectional study design was employed, and a survey using questionnaires, including the Hospital Ethical Climate Survey was used for data collection. Data were analyzed using descriptive statistics, inferential statistics, and multivariable methods. Participants and research context: Survey data were collected from a sample of nurses working in the care settings for older people in Finland (N = 1513, n = 874, response rate = 58%) in 2011. Ethical considerations: This study was conducted according to good scientific inquiry guidelines, and ethical approval was obtained from the university ethics committee. Results: The mean score for the Hospital Ethical Climate Survey total was 3.85 (standard deviation = 0.56). Cronbach’s alpha was 0.92. Principal component analysis provided evidence for factorial validity. LISREL provided evidence for construct validity based on goodness-of-fit statistics. Pearson’s correlations of 0.68–0.90 were found between the sub-scales and the Hospital Ethical Climate Survey. Discussion: The Hospital Ethical Climate Survey was found able to reveal discrimination across care settings and proved to be a valid and reliable tool for measuring ethical climate in care settings for older people and sensitive enough to reveal variations across various clinical settings. Conclusion: The Finnish version of the Hospital Ethical Climate Survey, used mainly in the hospital settings previously, proved to be a valid instrument to be used in the care settings for older people. Further studies are due to analyze the factor structure and some items of the Hospital Ethical Climate Survey. (shrink)

Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...) with ontology terms to make inferences that promote knowledge discovery. Therefore, it is important not only to include in ontologies multiple types of definitions in both formal and in natural languages, but also to ensure that these definitions meet good quality standards so they are useful. While tools such as Protégé can assist in creating well-formed logical definitions, producing good definitions in a natural language is still to a large extent a matter of human ingenuity supported at best by just a small number of general principles. For lack of more precise guidelines, definition authors are often left to their own personal devices. This paper aims to fill this gap by providing the ontology community with a set of principles and conventions to assist in definition writing, editing, and validation, by drawing on existing definition writing principles and guidelines in lexicography, terminology, and logic. (shrink)

Publishing has become, in several respects, more challenging in recent years. Academics are faced with evolving ethics that appear to be more stringent in a bid to reduce scientific fraud, the emergence of science watchdogs that are now scrutinizing the published literature with critical eyes to hold academics, editors and publishers more accountable, and a barrage of checks and balances that are required between when a paper is submitted and eventually accepted, to ensure quality control. Scientists are often under increasing (...) pressure to produce papers in an increasingly stringent publishing environment. In such a climate, timing is everything, as is the efficiency of the process. Academics appreciate that rejections are part of the fabric of attempting to get a paper published, but they expect the reason to be clear, based on careful evaluation of their work, and not on superficial or unsubstantiated excuses. A desk rejection occurs when a paper gets rejected even before it has entered the peer review process. This paper examines the features of some desk rejections and offers some guidelines that would make desk rejections valid, fair and ethical. Academics who publish are under constant pressure to do so quickly, but effectively. They are dependent on the editors’ good judgment and the publisher’s procedures. Unfair, unsubstantiated, or tardy desk rejections disadvantage academics, and editors and publishers must be held accountable for wasting their time, resources, and patience. (shrink)

Background: Nurses’ collegiality is topical because patient care is complicated, requiring shared knowledge and working methods. Nurses’ collaboration has been supported by a number of different working models, but there has been less focus on ethics. Aim: This study aimed to develop nurses’ collegiality guidelines using the Delphi method. Method: Two online panels of Finnish experts, with 35 and 40 members, used the four-step Delphi method in December 2013 and January 2014. They reformulated the items of nurses’ collegiality identified by (...) the literature and rated based on validity and importance. Content analysis and descriptive statistical methods were used to analyze the data, and the nurses’ collegiality guidelines were formulated. Ethical considerations: Organizational approval was received, and an informed consent was obtained from all participants. Information about the voluntary nature of participation was provided. Results: During the first Delphi panel round, a number of items were reformulated and added, resulting in 32 reformulated items. As a result of the second round, 8 of the 32 items scored an agreement rate of more than 75%, with the most rated item being collegiality means that professionals respect each other. The item with second highest rating was collegiality has a common objective: what is best for patients, followed by the third highest which was professional ethics is the basis of collegiality. Conclusion: Nurses’ collegiality and its content are well recognized in clinical practice but seldom studied. Collegiality can be supported by guidelines, and nurses working in clinical practice, together with teachers and managers, have shared responsibilities to support and develop it. More research in different nursing environments is needed to improve understanding of the content and practice of nursing collegiality. (shrink)

Background: Moral courage as a part of nurses’ moral competence has gained increasing interest as a means to strengthen nurses acting on their moral decisions and offering alleviation to their moral distress. To measure and assess nurses’ moral courage, the development of culturally and internationally validated instruments is needed. Objective: The objective of this study was to validate the Dutch-language version of the four-component Nurses’ Moral Courage Scale originally developed and validated in Finnish data. Research design: This methodological study used (...) non-experimental, cross-sectional exploratory design. Participants and research context: A total of 559 nurses from two hospitals in Flanders, Belgium, completed the Dutch-language version of the Nurses’ Moral Courage Scale. Ethical considerations: Good scientific inquiry guidelines were followed throughout the study. Permission to translate the Nurses’ Moral Courage Scale was obtained from the copyright holder, and the ethical approval and permissions to conduct the study were obtained from the participating university and hospitals, respectively. Findings: The four-component 21-item, Dutch-language version of the Nurses’ Moral Courage Scale proved to be valid and reliable as the original Finnish Nurses’ Moral Courage Scale. The scale’s internal consistency reliability was high (0.91) corresponding with the original Nurses’ Moral Courage Scale validation study (0.93). The principal component analysis confirmed the four-component structure of the original Nurses’ Moral Courage Scale to be valid also in the Belgian data explaining 58.1% of the variance. Confirmatory factor analysis based on goodness-of-fit indices provided evidence of the scale’s construct validity. The use of a comparable sample of Belgian nurses working in speciality care settings as in the Finnish study supported the stability of the structure. Discussion and conclusion: The Dutch-language version of the Nurses’ Moral Courage Scale is a reliable and valid instrument to measure nurses’ self-assessed moral courage in speciality care nursing environments. Further validation studies in other countries, languages and nurse samples representing different healthcare environments would provide additional evidence of the scale’s validity and initiatives for its further development. (shrink)

For years there was no focus within the U.S. federal government for alternatives to animal toxicity testing. Questions coming to regulatory agencies fell upon individuals to address in the best way they could. Given this void, the ad hoc Interagency Regulatory Alternatives Group was founded by staff in a number of federal agencies in the late 1980s to coalesce efforts in the field. The group sponsored two international workshops on eye irritation, the first making proposals for change in the current (...) test method in rabbits, the second reviewing available data on in vitro alternatives. The result has been that the Organization for Economic Cooperation and Development (OECD) is considering revision of the in vivo eye irritation test guideline to incorporate a number of the workshop deliberations. However, movement of the in vitro eye irritation alternatives has been disappointing; attempts to determine their practical testing significance have thus far been unrewarding. (shrink)

BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, (...) ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/ucla method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process. (shrink)

Research Ethics, Volume 18, Issue 1, Page 51-63, January 2022. Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines that govern research with these (...) populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships. (shrink)

Rationale At the request of a Dutch governmental organization, a multidisciplinary group of osteoporosis experts in the Netherlands published in 2002 a guideline on case finding, diagnosis, prevention and treatment of osteoporosis. These guidelines were evaluated for their validity and applicability. Methods Analysis by 5 external osteoporosis experts using the 'Appraisal of Guidelines for Research & Evaluation' ('AGREE') instrument. Results The score for the 6 domains of AGREE was 88% for the scope and purpose domain, 76% for stakeholder (...) involvement, 81% for rigour of development, 84% for clarity and presentation, 77% for applicability and 73% for editorial independence. For single components of the domains of AGREE, highest scores were found for systematic methods used to search for evidence (100%), inclusion of individuals from all the relevant professional groups (95%) and ease of identifying key recommendations (95%). Lowest scores to single components of the several domains were given for piloting among target users (44%). All experts recommended the guidelines for use in practice. Conclusions The AGREE instrument scored high for development, clarity and presentation but low for piloting among target users and implementation. Based on the guideline, algorithms from case finding to treatment were constructed that could be tested for piloting among target users and for implementation of the guideline. (shrink)

The relevance of the study is related to the need to increase the validity of formative assessment in classrooms, which is a factor in improving the quality of education and the development of students. The purpose of the study is to determine the criteria for the validity of formative assessment, which will allow gaps in its implementation in national schools and provide professional support to teachers to improve practice. The research methods used were lesson observation (the analysis of (...) teachers’ approaches to formative assessment of students’ achievements) and a questionnaire, which revealed similarities and differences in the views of teachers and students on the practice of formative assessment. The results showed that the experience of formative assessment of teachers is associated with their knowledge and skills of implementing formative assessment. However, it also became known that the knowledge and views of teachers about formative assessment does not always correspond to their practice. The results of the study will allow us to develop guidelines for the implementation of formative assessment and ensuring its validity, which will contribute to improving the quality of education in schools in Kazakhstan. (shrink)

The author of this paper discusses why the issue of financial conflicts of interest in psychiatry has important public health implications for women and why FCOI complicate the informed consent process. For example, when psychiatric diagnostic and treatment guidelines are unduly influenced by industry, informed consent becomes a critical issue, because women may be assigned diagnostic labels that are not valid and may also be receiving imbalanced or even inaccurate information about their mental health treatment options. However, mere disclosure of (...) industry relationships is an insufficient solution. Following Ells, the author offers a more robust account of autonomy, inspired by Foucault, to strengthen informed consent practices. In addition to addressing power relations, this Foucauldian account of autonomy emphasizes the relational and dialogical aspect of the physician–patient relationship. (shrink)

Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; clinically (...) important research question; the risk to patients is minimised and reasonable; there is uncertainty about treatment allocation rather than deception; there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool. Placebo-controlled trials in surgery will most often be justified when surgery is performed to improve function or relieve symptoms and when objective outcomes are not available, while the risk of mortality or significant morbidity is low. In line with medical placebo-controlled trials, the surgical trial should be sufficiently powered and standardised so that its results are valid, consent should be valid, the standard treatment or rescue medication should be provided if possible, and after the trial, the patients should be told which treatment they received and there should be provision for post-trial care if the study may result in long-term negative effects. We comment and contrast our guidelines with those of the American Medical Association. (shrink)

Background and rationale Clinicians often encounter a variety of ethical challenges in their routine clinical practice, and it varies across healthcare and cultural settings of their practice. Despite of this, there are no clear-cut available guidelines concerning the right course of action in a given ethically challenging situation. A validated instrument that could capture the health care providers’ (HCP’s) viewpoints in this regard is lacking from Indian settings. Thus, the current study aimed at developing an instrument to assess the HCP’s (...) perspective regarding different ethically challenging situations encountered in the Indian settings. Methods The questionnaire was developed by involving 15 medical experts. A mixed-method approach, Delphi-technique, and online survey were used for item generation and validation. Results The questionnaire comprised of 11 items (accounts 57% variance; having an α = 0.68) representing four factors: health-resource constraints, medical responsibility of the HCP, obtaining patients/family members’ consent for the treatment, and treatment beyond the standard protocol. The gender and clinical disciplines of the participants were related to their level of endorsement for various domains of the ECCS-Q. Conclusions Ethical challenges in the clinical practice fall in different clusters. The clinicians’ course of action in such situations have many socio-demographic and professional determinants. Future studies are warranted to investigate these phenomena. (shrink)

Through featuring a historical review of the L2 speaking assessment scales applied in related studies, this paper targets at providing responses for the following three questions (a) How are the scales assessing L2 speaking anxiety developed and adapted in related research? (b) What are the frequently adopted methods for validating speaking anxiety scales? (c) How is L2 speaking anxiety represented and interpreted with a dynamic approach? Based on analyzing the development process of frequently-used scales for assessing test anxiety, foreign language (...) classroom anxiety, and speaking anxiety, the author classified the scales into three categories: test-based scales measuring speaking anxiety, classroom-based scales measuring speaking anxiety, and activity-based scales measuring L2 speaking anxiety. As for the scale validation methods, Classical Testing Theory (CTT) and Rasch measurement were introduced as two major statistical paradigms for guaranteeing the reliability of the scales. This paper also summarizes the emerging themes generalized from research focusing speaking anxiety assessment, where the dynamic approach is discussed as a guideline to interpret the relationship among anxiety, language performance, and other factors involved in language learning. This paper ends with highlighting possible directions for anxiety-related research in the future, where technology intervention and the “positivity ratio” might become new attempts for pedagogical design. (shrink)

Ecologically valid procedures for eliciting and measuring children's anger are needed to enhance researchers' theories of children's emotional competence and to guide intervention efforts aimed at reactive aggression. The purpose of this article is to describe a laboratory-based game-playing procedure that has been used successfully to elicit and measure children's anger across observational, physiological, and self-report channels. Steps taken to ensure that participants are treated ethically and fairly are discussed. The article highlights recently published data that emphasize the importance of (...) provoking and assessing children's anger across multiple channels using laboratory-based procedures. Finally, it presents preliminary data that suggest that the safeguards taken to protect children were successful in making both children and their parents feel well treated and comfortable. (shrink)

Automated neuropsychiatric batteries have been used in research and clinical practice, including for chronic diseases, such as Systemic Lupus Erythematosus. The Pediatric Automated Neuropsychological Assessment Metrics battery, originally developed for use in American-English speaking individuals, allows tracking of cognitive functions. It can be applied to people over 9 years old. The aim of this study was to translate and present initial validation data from the Ped-ANAM into Brazilian-Portuguese. We translated the battery according to Beaton’s guidelines. Psychometric properties were tested, internal (...) consistency was analyzed by Cronbach’s alpha coefficient, test-retest reliability by the intraclass correlation coefficient. Further, we measured the test execution speed at both times as a temporal stability. Principal component analysis was used for structural validity. Evidence of construct validity was assessed through assessment of the relationships with the Wechsler Intelligence Scales. All participants prior to the start of study related activities signed an informed consent form approved by the local ethics committee. A sample of 230 individuals [mean of age: 23 years; 65% females] was included; a subset of 51 individuals [mean of age: 18 years, 59% female] completed the Ped-ANAM twice to assess test-retest reliability, and another subset of 54 individuals [mean of age: 20.4 years; 67% female] completed the Wechsler Intelligence Scales for Children and Adult for assessment of the Ped-ANAM’s construct validity. Our results suggest that the internal consistency of the Ped-ANAM and its subtest test-retest reliability were excellent. There was no clustering in the Principal Components Analysis, suggestive of non-grouping of the evaluated variables. Construct validity assessment to the Wechsler Scales showed expected ranges of low to strong correlations. We concluded that, based on the results of this study, a cross-culturally validated Brazilian-Portuguese version of the Ped-ANAM has been developed and it is a reliable tool for the screening cognitive function. (shrink)

Background: A short version of the Posttraumatic Diagnostic Scale comprising only re-experiencing symptom items has been recently validated on Japanese adults. This short-version-PDS had good psychometric properties among Japanese adults with and without posttraumatic stress disorder. The aim of this study was to translate and culturally validate the short-version-PDS for the Brazilian sociolinguistic context.Methods: A translation of the short-version-PDS was performed based on established guidelines. We enrolled 53 patients with PTSD as a potential comorbidity. The translation and cross-cultural adaptation of (...) the short-version-PDS included forward and back-translation by a Japanese Brazilian researcher and a certified translator; synthesis was achieved by consensus, backward translation, pilot test, and finalization. Content validity coefficient was used to assess quality of adaptation. Internal consistency was calculated using Cronbach's alpha coefficient. Spearman correlations were between the new short-version-PDS and the Brazilian version of the posttraumatic Stress Disorder Checklist for DSM-5, and a receiver operating characteristic curve was used to determine the best cut-off values for the short-version-PDS.Results: The short-version-PDS was well accepted by all subjects, none of the questions were experienced as inappropriate, and all questions of the 3 items were judged important. Item 1 presented CVCt = 0.92; item 2 had a CVCt = 0.87 and item 3 had a CVCt = 0.95. The internal consistency of the final version as measured by Cronbach's alpha was 0.78. The short-version-PDS scale correlated positively with the DSM-5 scale with a Spearman rho of 0.64 (95%CI [0.4-0.8], p 31.0 with sensitivity and specificity are 86.4 and 93.5%, respectively.Conclusions: This Brazilian Portuguese version of the short-version-PDS had good psychometric properties among Brazilian adults with and without PTSD. Transferability and generalizability of the cut-off scores should be further analyzed. (shrink)

SummaryThe dichotomy between ‘scientific’ and ‘practical’ approaches to guideline development is false and divisive. Instead we should concentrate on developing mechanisms to develop and implement valid guidelines to improve patient care. The development of valid guidelines requires considerable expertise and is time consuming and expensive. It is most efficiently done at a regional or national level. The implementation of valid guidelines requires local action including the identification and modification of valid guidelines and a coordinated evidence-based implementation strategy (Grimshaw & (...) Eccles 1998). (shrink)

It is widely assumed that the use of deception in research is always inconsistent with obtaining valid consent. In addition, guidelines and regulations permit research without valid consent only when it poses no greater than minimal risk. Current practice thus prohibits studies that use deception and pose greater than minimal risk, including studies that rely on deceptive methods to evaluate experimental treatments. To assess whether these prohibitions are justified, the present paper evaluates five arguments that might be thought to support (...) the assumption that deception is always inconsistent with valid consent. Analysis of these arguments reveals that deception is frequently, but not always, inconsistent with obtaining valid consent for research. This conclusion suggests that, in order to avoid unnecessarily blocking valuable research, current policies and practice should be revised to recognize the conditions under which the use of deception can be consistent with obtaining research participants’ valid consent. (shrink)

Trop peu connu des théologiens et des communautés chrétiennes, l'accord oecuménique Guidelines for Admission to the Eucharist Between the Chaldean Church and the Assyrian Church of the East n'en est pas moins significatif au plan ecclésiologique, liturgique et dogmatique. Il invite à accueillir les différences légitimes et suggère aux catholiques occidentaux de revisiter la théologie médiévale de l'eucharistie.

Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it’. This (...) paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of ‘how to obtain and ascertain valid consent to participation in health-related research’ cannot always be fully answered by exclusive reference to pre-determined criteria/guidance provided by the guidelines and prior research’. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased. Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be – general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines’ nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts. (shrink)

This article discusses the benefits and limitations of collecting electronic data for large-scale thematic content analysis. We will discuss a number of methodological and technical issues. The first one is the construction of a list of relevant keywords that serves as the primary data collecting device. This is not only a technical necessity, but also secures a theoretically and empirically valid collection of data. The second concern is the quality of electronic archive information. Finally, source-specific data characteristics and coding difficulties (...) are dealt with. In conclusion, seven guidelines for electronic data collecting are proposed. (shrink)

Infertility constitutes an essential source of stress in the individual and couple’s life. The Infertility-Related Stress Scale is of clinical interest for exploring infertility-related stress affecting the intrapersonal and interpersonal domains of infertile individuals’ lives. In the present study, the IRSS was translated into Brazilian–Portuguese, and its factor structure, reliability, and relations to sociodemographic and infertility-related characteristics and depression were examined. A sample of 553 Brazilian infertile individuals completed the Brazilian–Portuguese IRSS, and a subsample of 222 participants also completed the (...) BDI-II. A sample of 526 Italian infertile individuals was used to test for the IRSS measurement invariance across Brazil and Italy. Results of exploratory structural equation modeling indicated that a bifactor solution best represented the structure underlying the IRSS-BP. Both the general and the two specific intrapersonal and interpersonal IRSS-BP factors showed satisfactory levels of composite reliability. The bifactor ESEM solution replicated well across countries. As evidence of relations to other variables, female gender, a longer duration of infertility, and higher depression were associated with higher scores in global and domain-specific infertility-related stress. The findings offer initial evidence of validity and reliability of the IRSS-BP, which could be used by fertility clinic staff to rapidly identify patients who need support to deal with the stressful impact of infertility in the intrapersonal and interpersonal life domains, as recommended by international guidelines for routine psychosocial care in infertility settings. (shrink)

Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about the (...) potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy. (shrink)

The Hospital Ethical Climate Survey was developed in the USA and later shortened. HECS has previously been translated into Swedish and the aim of this study was to describe a process of translating and culturally adapting HECS-S and to develop a Swedish multi-professional version, relevant for paediatrics. Another aim was to describe decisions about retaining versus modifying the questionnaire in order to keep the Swedish version as close as possible to the original while achieving a good functional level and trustworthiness. (...) In HECS-S, the respondents are asked to indicate the veracity of statements. In HECS and HECS-S the labels of the scale range from ‘almost never true’ to ‘almost always true’; while the Swedish HECS labels range from ‘never’ to ‘always’. The procedure of translating and culturally adapting the Swedish version followed the scientific structure of guidelines. Three focus group interviews and three cognitive interviews were conducted with healthcare professionals. Furthermore, descriptive data were used from a previous study with healthcare professionals, employing a modified Swedish HECS. Decisions on retaining or modifying items were made in a review group. The Swedish HECS-S consists of 21 items including all 14 items from HECS-S and items added to develop a multi-professional version, relevant for paediatrics. The descriptive data showed that few respondents selected ‘never’ and ‘always’. To obtain a more even distribution of responses and keep Swedish HECS-S close to HECS-S, the original labels were retained. Linguistic adjustments were made to retain the intended meaning of the original items. The word ‘respect’ was used in HECS-S with two different meanings and was replaced in one of these because participants were concerned that respecting patients’ wishes implied always complying with them. The process of developing a Swedish HECS-S included decisions on whether to retain or modify. Only minor adjustments were needed to achieve a good functional level and trustworthiness although some items needed to be added. Adjustments made could be used to also improve the English HECS-S. The results shed further light on the need to continuously evaluate even validated instruments and adapt them before use. (shrink)

Accurately assessing youth mental health involves obtaining reports from multiple informants who typically display low levels of correspondence. This low correspondence may reflect situational specificity. That is, youth vary as to where they display mental health concerns and informants vary as to where and from what perspective they observe youth. Despite the frequent need to understand and interpret these informant discrepancies, no consensus guidelines exist for integrating informants’ reports. The path to building these guidelines starts with identifying factors that reliably (...) predict the level and form of these informant discrepancies, and do so for theoretically and empirically relevant reasons. Yet, despite the knowledge of situational specificity, few approaches to integrating multi-informant data are well-equipped to account for these factors in measurement, and those that claim to be well-positioned to do so have undergone little empirical scrutiny. One promising approach was developed roughly 20 years ago by Kraemer and colleagues. Their Satellite Model leverages principal components analysis and strategic selection of informants to instantiate situational specificity in measurement, namely components reflecting variance attributable to the context in which informants observe behavior, the perspective from which they observe behavior, and behavior that manifests across contexts and perspectives. The current study represents the first construct validation test of the Satellite Model. A mixed-clinical/community sample of 134 adolescents and their parents completed six parallel surveys of adolescent mental health. Adolescents also participated in a series of simulated social interactions with research personnel trained to act as same-age, unfamiliar peers. A third informant viewed these interactions and completed the same surveys as parents and adolescents. We applied the Satellite Model to each set of surveys and observed high internal consistency estimates for each of the six-item trait, context, and perspective components. Scores reflecting the trait, context, and perspective components displayed distinct patterns of relations to a battery of criterion variables that varied in the context, perspective, and source of measurement. The Satellite Model instantiates situational specificity in measurement and facilitates unifying conceptual and measurement models of youth mental health. (shrink)

BackgroundCommonly applied measures of symptoms of anxiety are not sensitive to disease-specific anxiety in patients with chronic obstructive pulmonary disease. There is a need for validated instruments measuring COPD-specific anxiety. Therefore, we translated the COPD-Anxiety Questionnaire into Danish and performed an initial validation of the psychometric properties in a sample of patients with COPD.Materials and MethodsTranslation procedures followed the World Health Organization guidelines. Participants with COPD completed questionnaires measuring COPD-specific anxiety, general psychological distress as well as variables related to COPD, (...) quality of life, and socio-demography.ResultsA total of 260 patients with COPD completed questionnaires. The Danish version of CAF-R-DK demonstrated acceptable Cronbach’s α values that were comparable with those of the original CAF. As expected, the CAF-R-DK showed positive correlations with convergent constructs and negative correlations with discriminant constructs. However, the results for specific subdomains of the CAF-R-DK indicated inconsistency in the underlying concept of disease-specific anxiety, which was also suggested based on the subsequent confirmatory and exploratory factor analyzes.ConclusionThe CAF could serve as an important supplement to generic psychological distress screening of patients with COPD in somatic health care settings, and the questionnaire is now available in Danish. Translation into other languages is needed with the purpose of obtaining data for further testing the psychometric properties of the questionnaire. (shrink)

Estimating the effects of introducing a range of smart mobility solutions within an urban area is a crucial concern in urban planning. The lack of a simulator for the assessment of mobility initiatives forces local public authorities and mobility service providers to base their decisions on guidelines derived from common heuristics and best practices. These approaches can help planners in shaping mobility solutions; however, given the high number of variables to consider, the effects are not guaranteed. Therefore, a solution conceived (...) respecting the available guidelines can result in a failure in a different context. In particular, difficult aspects to consider are the interactions between different mobility services available in a given urban area and the acceptance of a given mobility initiative by the inhabitants of the area. In order to fill this gap, we introduce Tangramob, an agent-based simulation framework capable of assessing the impacts of a smart mobility initiative within an urban area of interest. Tangramob simulates how urban traffic is expected to evolve as citizens start experiencing newly offered traveling solutions. This allows decision makers to evaluate the efficacy of their initiatives, taking into account the current urban system. In this paper, we provide an overview of the simulation framework along with its design. To show the potential of Tangramob, three mobility initiatives are simulated and compared in the same scenario. This demonstrates how it is possible to perform comparative experiments so as to align mobility initiatives to the user goals. (shrink)

Audiovisual communication is greatly contributing to the emerging research field of affective computing. The use of audiovisual stimuli within immersive virtual reality environments is providing very intense emotional reactions, which provoke spontaneous physical and physiological changes that can be assimilated into real responses. In order to ensure high-quality recognition, the artificial intelligence system must be trained with adequate data sets, including not only those gathered by smart sensors but also the tags related to the elicited emotion. Currently, there are very (...) few techniques available for the labeling of emotions. Among them, the Self-Assessment Manikin devised by Lang is one of the most popular. This study shows experimentally that the graphic proposal for the original SAM labelling system, as devised by Lang, is not neutral to gender and contains gender biases in its design and representation. Therefore, a new graphic design has been proposed and tested according to the guidelines of expert judges. The results of the experiment show an overall improvement in the labeling of emotions in the pleasure–arousal–dominance affective space, particularly, for women. This research proves the relevance of applying the gender perspective in the validation of tools used throughout the years. (shrink)

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision-making tools are needed to (...) help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Background: Guidelines for breaking bad news are largely directed at and validated in oncology patients, based on expert opinion, and neglect those with other diagnoses. We sought to determine whether existing guidelines for breaking bad news, particularly SPIKES, are consistent with patient preferences across patient populations. Methods: Patients from an online community responded to 5 open-ended and 11 Likert-scale questions identifying their preferences in having bad news delivered. Patient participants received a diagnosis of cancer, lupus, amyotrophic lateral sclerosis, multiple sclerosis, (...) HIV/AIDS, or Parkinson’s disease. Additionally, we surveyed all 14 English-curriculum Canadian medical schools regarding resources used to teach breaking bad news. Results: Ten of 12 responding schools used the SPIKES model. Preferences of 1337 patients were consistent with the recommendations of SPIKES. There was one exception: Most patients disagree that empathetic physical touch is important and some described apprehension. Responses were consistent across disease states. Content analysis of 220 open-ended patient responses revealed 16 patient-important themes. Themes were largely addressed by the SPIKES guidelines, but five were not: ensuring timely follow-up is planned; offering informational sheets about the diagnosis; offering contact information of support organizations, with some patients preferring patient support groups while others preferring counselors; and conveying a sense of determination to aid the patient through the diagnosis. The four most patient-important components of SPIKES were physicians conveying empathy, taking their time, explaining the diagnosis and its implications, and asking the patient if they understand. Conclusion: SPIKES is the most commonly taught framework for breaking bad news in Canadian medical schools. This is the first work to demonstrate that the existing guidelines in breaking bad news such as SPIKES largely reflect the perspectives of many patient groups, as assessed by quantitative and qualitative measures. We highlight the most important components of SPIKES to patients and identify five additional suggestions to aid clinicians in breaking bad news. (shrink)

BackgroundInternational guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.MethodsIt was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee (...) for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.ResultsIn total, 106 clinical trial protocols were identified from 2173 protocols seen in the archive and 104 included for review. Seventy six trials did not include the surveillance of adverse events as part of their objective. A total of 91 protocols did not budget for adverse event surveillance, 76 did not have a data safety management board, 11 included insurance for participants, 47 did not include a case definition for serious adverse events, 33 described procedures to detect adverse events, 33 described procedure for reporting and 22 described procedure for investigating adverse events.DiscussionsMost clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.ConclusionClinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee. (shrink)

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made. Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research (...) or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and, consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as it pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented. (shrink)

Introduction: Clinical policies control several aspects of clinical practice, including individual treatment and care, resource management and healthcare professionals’ etiquette. This article presents Clinical Policy Ethics Assessment Tool, an ethical assessment tool for clinical policies that could be used not only by clinical ethics committees but also by policy committees or other relevant groups. Aim: The aim of this study was to find or create a tool to identify ethical issues and/or confirm ethical validity in nursing practice policies, protocols (...) and guidelines. Methodology: The development of Clinical Policy Ethics Assessment Tool involved first a literature review, followed by modification of the Research Protocol Ethics Assessment Tool, which was created to identify research protocols’ ethical issues, and finally, a trial of Clinical Policy Ethics Assessment Tool to ensure its reliability and validity. Ethical consideration: The policies analysed trialling Clinical Policy Ethics Assessment Tool were in the public domain and did not contain any confidential information. Despite that, Clinical Policy Ethics Assessment Tool also had the approval of a research ethics committee. Results: Research Protocol Ethics Assessment Tool was chosen as the template for a Clinical Policy Ethics Assessment Tool, to which several modifications were added to adapt it to work within a nursing practice context. Clinical Policy Ethics Assessment Tool was tested twice, which resulted in a general test–retest reliability coefficient = 0.86, r = 0.84, α1 = 0.817, α2 = 0.824 and interclass correlation coefficient = 0.874. Discussion: Contemporary nursing practice in a developed country is often ruled by clinical policies. The use of Clinical Policy Ethics Assessment Tool could confirm the ethical validity of those clinical practice policies, impacting on nurses’ education, values and quality of care. Conclusion: Clinical Policy Ethics Assessment Tool has the potential to detect ethical issues and facilitate the correction and improvement of clinical policies and guidelines in a structured way. This is especially so as it has shown reliability in detecting issues in clinical policies involving human participants and in encouraging policymakers to consider common ethical dilemmas in nursing practice. (shrink)