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Cancer Control : Journal of the Moffitt... 2018Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and... (Review)
Review
OBJECTIVE
Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic.
METHODS
A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis.
RESULTS
At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor-parent relationship.
CONCLUSION
Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary consent. Researchers are encouraged to adopt a stepwise approach during the informed consent process.
Topics: Adolescent; Child; Female; Humans; Informed Consent; Male; Medical Oncology; Research Design
PubMed: 29716399
DOI: 10.1177/1073274818773720 -
International Journal of Environmental... Apr 2022The aim of this study was to map and summarize the published research findings on hospital ethical climate and its relationship with nursing staff job satisfaction as... (Review)
Review
The aim of this study was to map and summarize the published research findings on hospital ethical climate and its relationship with nursing staff job satisfaction as well as strategies proposed in the literature for the improvement of hospital ethical climate and job satisfaction through the actions of nursing staff in leadership positions. A scoping review has been performed in accordance with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension scoping reviews statement (PRISMA-ScR). Three electronic bibliographic databases were searched: the SCOPUS, Medline, and CINHAL Complete using a combination of keywords with the range of years 1994-2021. A total of 15 papers out of 235 records identified were eligible for the analysis. The literature review confirmed a significant relationship between ethical climate and job satisfaction of nurses. Furthermore, the interdependence of ethical climate and job satisfaction of nursing staff affects many different aspects including patients, co-workers, an organization and research. Identifying factors that influence ethical climate and job satisfaction as well as the relationship between these variables may help to reduce the dropout concerning a change of profession among nursing staff.
Topics: Ethics, Nursing; Hospitals; Humans; Job Satisfaction; Leadership; Nurses; Nursing Staff, Hospital; Organizational Culture; Surveys and Questionnaires
PubMed: 35457422
DOI: 10.3390/ijerph19084554 -
Expert Review of Pharmacoeconomics &... 2016This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through... (Review)
Review
This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.
Topics: Budgets; Conflict of Interest; Humans; Insurance, Pharmaceutical Services; Pharmaceutical Preparations; Reimbursement Mechanisms; Technology Assessment, Biomedical
PubMed: 26923561
DOI: 10.1586/14737167.2016.1159958 -
Adolescent Health, Medicine and... 2020Disruptive behavior could represent an (un)moral behavioral component of multi-dimensional construct of morality that includes affective and cognitive aspects. Thus, it... (Review)
Review
Disruptive behavior could represent an (un)moral behavioral component of multi-dimensional construct of morality that includes affective and cognitive aspects. Thus, it is pivotal to investigate their interplay between affective and cognitive processes the better to understand how to intervene to contrast disruptive behavior and its antisocial outcomes. The present review has examined the relationship between affective and cognitive processes implied in moral functioning by focusing on callous-unemotional traits (CU) and moral disengagement. Starting from 1005 records identified by PsycINFO, Pubmed, and Pubpsych, only 13 studies have been selected. These studies show different theoretical approaches and methodologies and put in evidence the nuances of possible interactions of CU and moral disengagement during adolescence based on different research field. Overall, most of the scholars seem to conclude that different interplay can be plausible, suggesting that it is likely that during the adolescence the influence of moral disengagement and CU is reciprocal and longitudinal. Specifically, in adolescents with Disruptive Behavior Disorders CU and moral disengagement can move together in organizing and becoming chronic of antisocial affective-cognitive system, and in particular moral disengagement may give a free way to engage in disruptive behavior.
PubMed: 32099503
DOI: 10.2147/AHMT.S151699 -
Maternal & Child Nutrition Jul 2021Negative maternal affect (e.g., depression and anxiety) has been associated with shorter breastfeeding duration and poorer breastfeeding intention, initiation, and... (Review)
Review
Negative maternal affect (e.g., depression and anxiety) has been associated with shorter breastfeeding duration and poorer breastfeeding intention, initiation, and exclusivity. Other affective states, including guilt and shame, have been linked with formula feeding practice, though existing literature has yet to be synthesised. A narrative synthesis of quantitative data and a framework synthesis of qualitative and quantitative data were conducted to explore guilt and/or shame in relation to infant feeding outcomes. Searches were conducted on the DISCOVER database between December 2017 and March 2018. The search strategy was rerun in February 2020, together yielding 467 studies. The study selection process identified 20 articles, published between 1997 and 2017. Quantitative results demonstrated formula feeders experienced guilt more commonly than breastfeeding mothers. Formula feeders experienced external guilt most commonly associated with healthcare professionals, whereas breastfeeding mothers experienced guilt most commonly associated with peers and family. No quantitative literature examined shame in relation to infant feeding outcomes, warranting future research. The framework synthesis generated four distinct themes which explored guilt and/or shame in relation to infant feeding outcomes: 'underprepared and ineffectively supported', 'morality and perceived judgement' (breastfeeding), 'frustration with infant feeding care' and 'failures, fears and forbidden practice' (formula feeding). Both guilt and shame were associated with self-perception as a bad mother and poorer maternal mental health. Guilt and shame experiences were qualitatively different in terms of sources and outcomes, dependent on infant feeding method. Suggestions for tailored care to minimise guilt and shame, while supporting breastfeeding, are provided.
Topics: Breast Feeding; Female; Guilt; Humans; Infant; Mothers; Postpartum Period; Shame
PubMed: 33491303
DOI: 10.1111/mcn.13141 -
Systematic Reviews Mar 2021The nature and existence of free will have been debated for centuries. Since some psychiatric disorders are known to interfere with one's ability to control their... (Review)
Review
BACKGROUND
The nature and existence of free will have been debated for centuries. Since some psychiatric disorders are known to interfere with one's ability to control their actions and thoughts (e.g., schizophrenia), the investigation of the psychiatric facet of free will beliefs seems to be relevant. In this systematic review, we were interested in clarifying if and how having a mental disorder affects individuals' beliefs in free will by comparing psychiatric vs. non-psychiatric samples.
METHODS
A systematic search of MEDLINE, Web of Science, EMBASE, and PsycINFO databases was performed between 04 and 09 November 2020. The search strategy included "free will" and related constructs and terms related to DSM-5 mental disorders characterized by psychotic, compulsive, avoidant, or impulsive symptoms. Eligible designs of studies included case-control and cohort studies. Study selection took place in committee meetings consisting of six researchers. Quality assessment of the selected studies was performed through the Joanna Briggs Institute Appraisal Checklist for Case Control Studies.
RESULTS
After removing duplicates, a total of 12,218 titles/abstracts were screened. Inclusion and exclusion criteria were followed, and three articles were eventually selected.
CONCLUSIONS
It is not possible to provide unequivocal confirmation that having a mental disorder can or cannot affect someone's belief in free will. Studies with different mental disorders should be conducted in this field.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42018109468.
Topics: Case-Control Studies; Humans; Mental Disorders; Personal Autonomy
PubMed: 33726858
DOI: 10.1186/s13643-021-01621-9 -
Orphanet Journal of Rare Diseases Jun 2021The number of market approvals of orphan medicinal products (OMPs) has been increasing steadily in the last 3 decades. While OMPs can offer a unique chance for patients... (Review)
Review
BACKGROUND
The number of market approvals of orphan medicinal products (OMPs) has been increasing steadily in the last 3 decades. While OMPs can offer a unique chance for patients suffering from rare diseases, they are usually very expensive. The growing number of approved OMPs increases their budget impact despite their low prevalence, making it pressing to find solutions to ethical challenges on how to fairly allocate scarce healthcare resources under this context. One potential solution could be to grant OMPs special status when considering them for reimbursement, meaning that they are subject to different, and less stringent criteria than other drugs. This study aims to provide a systematic analysis of moral reasons for and against such a special status for the reimbursement of OMPs in publicly funded healthcare systems from a multidisciplinary perspective.
RESULTS
With a systematic review of reasons, we identified 39 reasons represented in 243 articles (scientific and grey literature) for and against special status for the reimbursement of OMPs, then categorized them into nine topics. Taking a multidisciplinary perspective, we found that most articles came from health policy (n = 103) and health economics (n = 49). More articles took the position for a special status of OMPs (n = 97) than those against it (n = 31) and there was a larger number of reasons identified in favour (29 reasons) than against (10 reasons) this special status.
CONCLUSION
Results suggest that OMP reimbursement issues should be assessed and analysed from a multidisciplinary perspective. Despite the higher occurrence of reasons and articles in favour of a special status, there is no clear-cut solution for this ethical challenge. The binary perspective of whether or not OMPs should be granted special status oversimplifies the issue: both OMPs and rare diseases are too heterogeneous in their characteristics for such a binary perspective. Thus, the scientific debate should focus less on the question of disease prevalence but rather on how the important variability of different OMPs concerning e.g. target population, cost-effectiveness, level of evidence or mechanism of action could be meaningfully addressed and implemented in Health Technology Assessments.
Topics: Budgets; Humans; Morals; Orphan Drug Production; Rare Diseases; Technology Assessment, Biomedical
PubMed: 34193232
DOI: 10.1186/s13023-021-01925-y -
BMC Medicine Oct 2016Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical... (Review)
Review
BACKGROUND
Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed.
METHODS
A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature.
RESULTS
We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information.
CONCLUSIONS
While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.
Topics: Clinical Competence; Decision Making; Ethics, Clinical; Evidence-Based Medicine; Humans; Morals; Public Health; Public Policy; Technology Assessment, Biomedical
PubMed: 27716264
DOI: 10.1186/s12916-016-0688-1 -
Nursing Ethics May 2019The aim of this narrative synthesis was to explore the necessary and sufficient conditions required to define moral distress.
AIMS
The aim of this narrative synthesis was to explore the necessary and sufficient conditions required to define moral distress.
BACKGROUND
Moral distress is said to occur when one has made a moral judgement but is unable to act upon it. However, problems with this narrow conception have led to multiple redefinitions in the empirical and conceptual literature. As a consequence, much of the research exploring moral distress has lacked conceptual clarity, complicating attempts to study the phenomenon.
DESIGN
Systematic literature review and narrative synthesis (November 2015-March 2016).
DATA SOURCES
Ovid MEDLINE In-Process & Other Non-Indexed Citations 1946-Present, PsycINFO 1967-Present, CINAHL Plus 1937-Present, EMBASE 1974-24 February 2016, British Nursing Index 1994-Present, Social Care Online, Social Policy and Practice Database (1890-Present), ERIC (EBSCO) 1966-Present and Education Abstracts.
REVIEW METHODS
Literature relating to moral distress was systematically retrieved and subjected to relevance assessment. Narrative synthesis was the overarching framework that guided quality assessment, data analysis and synthesis.
RESULTS
In all, 152 papers underwent initial data extraction and 34 were chosen for inclusion in the narrative synthesis based on both quality and relevance. Analysis revealed different proposed conditions for the occurrence of moral distress: moral judgement, psychological and physical effects, moral dilemmas, moral uncertainty, external and internal constraints and threats to moral integrity.
CONCLUSION
We suggest the combination of (1) the experience of a moral event, (2) the experience of 'psychological distress' and (3) a direct causal relation between (1) and (2) together are necessary and sufficient conditions for moral distress.
Topics: Bioethics; Burnout, Professional; Concept Formation; Humans; Stress Disorders, Post-Traumatic; Stress, Psychological
PubMed: 28990446
DOI: 10.1177/0969733017724354 -
PloS One 2017Over the last three decades, various instruments were developed and employed to assess medical professionalism, but their measurement properties have yet to be fully... (Review)
Review
BACKGROUND
Over the last three decades, various instruments were developed and employed to assess medical professionalism, but their measurement properties have yet to be fully evaluated. This study aimed to systematically evaluate these instruments' measurement properties and the methodological quality of their related studies within a universally acceptable standardized framework and then provide corresponding recommendations.
METHODS
A systematic search of the electronic databases PubMed, Web of Science, and PsycINFO was conducted to collect studies published from 1990-2015. After screening titles, abstracts, and full texts for eligibility, the articles included in this study were classified according to their respective instrument's usage. A two-phase assessment was conducted: 1) methodological quality was assessed by following the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist; and 2) the quality of measurement properties was assessed according to Terwee's criteria. Results were integrated using best-evidence synthesis to look for recommendable instruments.
RESULTS
After screening 2,959 records, 74 instruments from 80 existing studies were included. The overall methodological quality of these studies was unsatisfactory, with reasons including but not limited to unknown missing data, inadequate sample sizes, and vague hypotheses. Content validity, cross-cultural validity, and criterion validity were either unreported or negative ratings in most studies. Based on best-evidence synthesis, three instruments were recommended: Hisar's instrument for nursing students, Nurse Practitioners' Roles and Competencies Scale, and Perceived Faculty Competency Inventory.
CONCLUSION
Although instruments measuring medical professionalism are diverse, only a limited number of studies were methodologically sound. Future studies should give priority to systematically improving the performance of existing instruments and to longitudinal studies.
Topics: Attitude of Health Personnel; Health Status; Humans; Professionalism
PubMed: 28498838
DOI: 10.1371/journal.pone.0177321