Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).
Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered "developing" countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS (UNAIDS) embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process. (+info)
Clinical ethics committees and the formulation of health care policy.
For some time, clinical ethics committees (CECs) have been a prominent feature of hospitals in North America. Such committees are less common in the United Kingdom and Europe. Focusing on the UK, this paper evaluates why CECs have taken so long to evolve and assesses the roles that they should play in health care policy and clinical decision making. Substantive and procedural moral issues in medicine are differentiated, the former concerning ethicolegal principles and their paradigmatic application to clinical practice and the latter dealing with how such application should be negotiated in the face of disagreement and/or uncertainty. It will be argued that the role of CECs is both substantive and procedural. Provided that they do not overstep their appropriate moral and professional boundaries, CECs will be shown to have an important and positive function in improving hospital care within the UK and elsewhere. (+info)
Quality and methods of developing practice guidelines.
BACKGROUND: It is not known whether there are differences in the quality and recommendations between evidence-based (EB) and consensus-based (CB) guidelines. We used breast cancer guidelines as a case study to assess for these differences. METHODS: Five different instruments to evaluate the quality of guidelines were identified by a literature search. We also searched MEDLINE and the Internet to locate 8 breast cancer guidelines. These guidelines were classified in three categories: evidence based, consensus based and consensus based with no explicit consideration of evidence (CB-EB). Each guideline was evaluated by three of the authors using each of the instruments. For each guideline we assessed the agreement among 14 decision points which were selected from the NCCN (National Cancer Comprehensive Network) guidelines algorithm. For each decision point we recorded the level of the quality of the information used to support it. A regression analysis was performed to assess if the percentage of high quality evidence used in the guidelines development was related to the overall quality of the guidelines. RESULTS: Three guidelines were classified as EB, three as CB-EB and two as CB. The EB guidelines scored better than CB, with the CB-EB scoring in the middle among all instruments for guidelines quality assessment. No major disagreement in recommendations was detected among the guidelines regardless of the method used for development, but the EB guidelines had a better agreement with the benchmark guideline for any decision point. When the source of evidence used to support decision were of high quality, we found a higher level of full agreement among the guidelines' recommendations. Up to 94% of variation in the quality score among guidelines could be explained by the quality of evidence used for guidelines development. CONCLUSION: EB guidelines have a better quality than CB guidelines and CB-EB guidelines. Explicit use of high quality evidence can lead to a better agreement among recommendations. However, no major disagreement among guidelines was noted regardless of the method for their development. (+info)
Inter-rater agreement in the scoring of abstracts submitted to a primary care research conference.
BACKGROUND: Checklists for peer review aim to guide referees when assessing the quality of papers, but little evidence exists on the extent to which referees agree when evaluating the same paper. The aim of this study was to investigate agreement on dimensions of a checklist between two referees when evaluating abstracts submitted for a primary care conference. METHODS: Anonymised abstracts were scored using a structured assessment comprising seven categories. Between one (poor) and four (excellent) marks were awarded for each category, giving a maximum possible score of 28 marks. Every abstract was assessed independently by two referees and agreement measured using intraclass correlation coefficients. Mean total scores of abstracts accepted and rejected for the meeting were compared using an unpaired t test. RESULTS: Of 52 abstracts, agreement between reviewers was greater for three components relating to study design (adjusted intraclass correlation coefficients 0.40 to 0.45) compared to four components relating to more subjective elements such as the importance of the study and likelihood of provoking discussion (0.01 to 0.25). Mean score for accepted abstracts was significantly greater than those that were rejected (17.4 versus 14.6, 95% CI for difference 1.3 to 4.1, p = 0.0003). CONCLUSIONS: The findings suggest that inclusion of subjective components in a review checklist may result in greater disagreement between reviewers. However in terms of overall quality scores, abstracts accepted for the meeting were rated significantly higher than those that were rejected. (+info)
Priority setting for new technologies in medicine: a transdisciplinary study.
BACKGROUND: Decision makers in health care organizations struggle with how to set priorities for new technologies in medicine. Traditional approaches to priority setting for new technologies in medicine are insufficient and there is no widely accepted model that can guide decision makers. DISCUSSION: Daniels and Sabin have developed an ethically based account about how priority setting decisions should be made. We have developed an empirically based account of how priority setting decisions are made. In this paper, we integrate these two accounts into a transdisciplinary model of priority setting for new technologies in medicine that is both ethically and empirically based. SUMMARY: We have developed a transdisciplinary model of priority setting that provides guidance to decision makers that they can operationalize to help address priority setting problems in their institution. (+info)
Consensus guidelines on analgesia and sedation in dying intensive care unit patients.
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. (+info)
Development of the Knee Standardized Clinical Interview: a research tool for studying the primary care clinical epidemiology of knee problems in older adults.
OBJECTIVE: To develop a standardized clinical interview, incorporating the perspectives of general practitioners (GPs) and rheumatologists, for primary care clinical epidemiological studies of adults aged 50 yr and over with knee problems. METHODS: Two parallel, consensus development studies using a modified nominal group technique involving GPs (n=5) and consultant rheumatologists (n=4) from North Staffordshire with reference panels of GPs (n=28) and rheumatologists (n=11) from selected centres in Great Britain, respectively. A single standardized clinical interview was formed using the clinical history questions identified in the consensus development studies and its feasibility was tested in a small sample of patients. RESULTS: In the GP consensus development study, 115 clinical history questions were identified, of which 71 were of agreed importance following postal rating, face-to-face discussion and re-rating. In the rheumatologist study, 158 questions were identified, of which 47 were of agreed importance. There was considerable overlap in the clinical history questions independently developed by the two studies. A single standardized clinical interview containing 74 questions was formed. It contained questions on the history, onset and recent course of the complaint; nature, location and severity of current knee symptoms; impact of knee problem; past history of knee problems; family history; comorbidity; previous/current investigations and treatment; ideas, concerns and expectations. In preliminary testing it took 20-45 min to conduct and was comprehensible to patients. CONCLUSIONS: A research tool-the Knee Standardized Clinical Interview (KNE-SCI)-has been formed from consensus development studies involving GPs and rheumatologists. In preliminary testing, it is comprehensible to patients, and forms a coherent clinical interview for research data collection. However, further evaluation is required to determine its accuracy and reliability and its usefulness for clinical epidemiological research. (+info)
Building consensus on nomenclature and disease classification for ankylosing spondylitis: results and discussion of a questionnaire prepared for the International Workshop on New Treatment Strategies in Ankylosing Spondylitis, Berlin, Germany, 18-19 January 2002.
BACKGROUND: There is currently no universal consensus on nomenclature for spondyloarthropathy (SpA), or on activity and severity criteria for ankylosing spondylitis (AS). METHOD: Points of agreement and majority opinions among 28 international experts in the field were identified by questionnaire. Agreement was defined as >80% concurrence, clear majority as >60% concurrence, and a majority or trend as >50% concurrence. RESULTS: Respondents agreed on the need for one term that reflects the inflammatory nature of the disease, but no agreement was reached on a specific term. Agreement included subdivision of patients with SpA into AS, psoriatic arthritis, inflammatory bowel disease associated arthritis, and undifferentiated spondyloarthritis/spondyloarthropathy. A majority of experts defined active disease as fulfilling classification criteria for AS and/or a SpA, and disease activity measured by a Bath AS Disease Activity Index (BASDAI) score >4 determined by two patient visits during a two month period, but no maximum radiographic score. The majority of participants considered failure of treatment response to non-steroidal anti-inflammatory drugs (NSAIDs) alone to be a prerequisite for active/severe AS, and 15/28 (54%) thought that NSAID treatment failure should be defined as lack of response to two or more NSAIDs. CONCLUSIONS: Respondents agreed that a two to five year study is the ethical method to demonstrate effects of anti-tumour necrosis factor alpha (TNFalpha) therapy on radiographic progression of AS, and that inclusion criteria should include a certain level of disease activity (measured by BASDAI) and failure of certain treatments. After the efficacy of anti-TNFalpha therapy in AS and psoriatic arthritis is proved, respondents agreed that more studies will be needed to show efficacy for other SpA subsets. (+info)