Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee

Rationale, aims and objectives Within‐study selective reporting is widely believed to exist, although to date there have been no empirical studies to assess the extent of the problem in clinical research. The present study aimed to examine this process. Methods We undertook a pilot study, involving a single local research ethics committee (LREC), in which we compared the outcomes, analysis and sample size proposed in the original approved study protocol with the results presented in the subsequent study report. Results We received 41 (73%) replies from lead researchers of 56 projects, which were a complete cohort of clinical research applications approved in a particular time period by the LREC. Fifteen of these projects, which were completed and published at the time of our study, were further investigated. Only six (40%) stated which outcome variables were of primary interest and four (67%) of these showed consistency in the reports. Eight (53%) of the 15 studies mentioned an analysis plan. However, seven (88%) of these eight studies did not follow their prescribed analysis plan: the analysis of outcome variables or associations between certain variables were found to be missing from the report. Conclusions Our pilot study has shown that within‐study selective reporting may be examined qualitatively by comparing the study report with the study protocol. Our results suggest that it might well be substantial; however, the bias can only be broadly identified as protocols are not sufficiently precise.     

Do Not Resuscitate orders and older patients: findings from an ethnographic study of hospital wards for older people

BACKGROUND AND AIM: This paper reports on the findings from an ethnographic study involving three wards in two hospitals in the Northwest of England and focuses on the controversial issue of Do Not Resuscitate (DNR) orders. The study aimed to explore the way in which terminal care was provided to older patients and examined the way in which DNR orders were a socially constructed part of the practices of both nurses and doctors. METHOD: An ethnographic approach was adopted that used participant observation and semi-structured interviews with nurses and doctors. A purposive sample of 28 qualified nurses and five medical staff were interviewed. The decision-making process of DNR orders became the focus of the interview questions. FINDINGS: The findings reveal that DNR decision-making was largely socially constructed from the interactions of hospital staff. Patients were not asked their preference and were excluded from any decision-making about Cardiopulmonary Resuscitation (CPR) or DNR orders. Two major findings emerge. First, DNR orders and the non-use of CPR could be seen as a form of medical beneficence, resulting from the often described paternalistic attitudes of hospital doctors. Second, there was a clear indication that DNR orders and the non-use of CPR for certain patients was based on improving the quality of patients' lives. CONCLUSION: The study raises issues about the quality of care received by frail older patients whom the nurses felt would not survive a futile medical procedure. The conclusion considers the need for hospitals to formulate and implement CPR policies, particularly in the prevailing climate in which patients are encouraged to become active participants in their own health care.     

Shifting sands: the complexities and uncertainties of the evolving US regulatory,policy, and scientific landscape for biospecimen research

Human tissue biorepositories and the biospecimens they provide play a critical role in advancing research and medical care, especially in supporting research to develop precision medicine. However, advancements in genomics, informatics, and other sophisticated technologies and extensive biospecimen and data sharing have raised questions about how best to protect research participants. Complex ethical issues remain unresolved, such as the identifiability of biospecimens and associated data, the best consent models for future research, ownership and commercial use of biospecimens, and return of individual research results.This review summarizes the relevant US regulations and recent changes to them, as well as current and future ethical and policy issues related to biospecimen research. Because many issues remain unresolved, additional policy development will be needed. We discuss approaches for how researchers and other stakeholders can provide input to ensure that these policies will protect research participants while facilitating research important for scientific and medical advancements.     

A proposal for a code of ethics for nurse practitioners

PURPOSE: To review established codes for health care professionals and standards of practice for the nurse practitioner (NP) and to utilize these codes and standards, general ethical themes, and a new ethical triangle to propose an ethical code for NPs. DATA SOURCES: Reviews of three generally accepted ethical themes (deontological, teleological, and areteological), the ethical triangle by Potter, the American Academy of Nurse Practitioners (AANP) standards of practice for NPs, and codes of ethics from the American Nurses Association (ANA) and the American Medical Association (AMA). CONCLUSIONS: A proposal for a code of ethics for NPs is presented. This code was determined by basic ethical themes and established codes for nursing, formulated by the ANA, and for physicians, formulated by the AMA. The proposal was also developed in consideration of the AANP standards of practice for NPs. IMPLICATIONS FOR PRACTICE: The role of the NP is unique in its ethical demands. The authors believe that the expanded practice of NPs presents ethical concerns that are not addressed by the ANA code and yet are relevant to nursing and therefore different than the ethical concerns of physicians. This proposal attempts to broaden NPs' perspective of the role that ethics should hold in their professional lives.     

Development of the ethical dimension in nursing theory

Nurses encounter ethical dilemmas in their practice and need guidance in making relevant patient-care decisions. Nursing theory is believed to be the best source of such guidance. The aim of this paper is to describe the ethical dimension in nursing theory. A literature review shows the intricate relationship between ethics and nursing, yet there is lack of elaboration of ethical features in nursing theories. The identified elements of the ethical dimension include ethical theories and principles, values, ethical practice issues, moral reasoning and contextual factors. Criteria for the development and evaluation of the ethical dimension are presented, with an example using a middle range theory. The ethical components pertinent to a nursing theory need to be made explicit if theory is to guide practice. Nursing scholars are invited to elucidate the ethical dimension in their theories in order to enhance moral reasoning and provide a framework for ethical practice.     

Effectiveness and acceptability of non-pharmacological interventions to reduce wandering in dementia: a systematic review

BACKGROUND: Wandering occurs in 15-60% of people with dementia. Psychosocial interventions rather than pharmacological methods are recommended, but evidence for their effectiveness is limited and there are ethical concerns associated with some non-pharmacological approaches, such as electronic tracking devices. OBJECTIVE: To determine the clinical and cost effectiveness and acceptability of non-pharmacological interventions to reduce wandering in dementia. DESIGN: A systematic review to evaluate effectiveness of the interventions and to assess acceptability and ethical issues associated with their use. The search and review strategy, data extraction and analysis followed recommended guidance. Papers of relevance to effectiveness, acceptability and ethical issues were sought. RESULTS: (i) Clinical effectiveness. Eleven studies, including eight randomised controlled trials, of a variety of interventions, met the inclusion criteria. There was no robust evidence to recommend any intervention, although there was some weak evidence for exercise. No relevant studies to determine cost effectiveness met the inclusion criteria. (ii) Acceptability/ethical issues. None of the acceptability papers reported directly the views of people with dementia. Exercise and music therapy were the most acceptable interventions and raised no ethical concerns. Tracking and tagging devices were acceptable to carers but generated considerable ethical debate. Physical restraints were considered unacceptable. CONCLUSIONS: In order to reduce unsafe wandering high quality research is needed to determine the effectiveness of non-pharmacological interventions that are practically and ethically acceptable to users. It is important to establish the views of people with dementia on the acceptability of such interventions prior to evaluating their effectiveness through complex randomised controlled trials.     

老子思想与图书馆建设

老子作为有史以来最早的“图书馆馆长”,其思想籍著《道德经》对华夏民族产生了巨大的影响,也在无影无形之中影响着图书馆的生存方式,所创造的道德文化对图书馆建设有着深刻的启迪。     

传染病防治的伦理对策

人为因素是传染病发生和传播的重要原因,所以传染病的防治离不开对人的社会行为的伦理矫正。我们要通过落实系统的传染病防治的伦理对策,促使人们接受可持续发展的伦理观,追求健康的生活方式,实现公正的卫生保健,达到有效遏制传染病,保障人民健康的目的。