Rationing, randomizing, and researching in health care provision.
(17/4142)
In this paper the need for valid evidence of the cost-effectiveness of treatments that have not been properly evaluated, yet are already available, albeit in short supply, are examined. Such treatments cannot be withdrawn, pending proper evaluation, nor can they be made more widely available until they have been shown to be cost-effective. As a solution to this impasse the argument put forward recently by Toroyan et al is discussed. They say that randomised controlled trials of such resources could be done but only if resources are randomly allocated independently of a research context. Relevant outcome data could then be collected for research, given this opportunity. (There are already a few investigators who have turned limited resources, mostly health service provision, to their advantage in this way.) We agree. We disagree with Toroyan et al on a number of points. First, they claim that no ethical issue relating to equipoise arises. We disagree and this disagreement depends on our showing that equipoise should be maintained in a relationship that they do not consider. Secondly, they say that consent to data collection is always needed. Again we disagree. Thirdly, they claim that the previous two issues are the only possible ethical issues that could arise. We argue, instead, that there is a further conflict of interests that has ethical import. (+info)
Ethical considerations for services offering one-to-one guidance for primary care practitioners interested in research.
(18/4142)
Initiatives which offer support to primary care practitioners interested in research have become widespread in the UK. There has been little debate, however, about the ethical issues involved in such interactions with practitioners. Established codes of practice and analyses of the institutional and strategic contexts have been used to inform this discussion. The paper concludes with a recommendation that more explicit quasi-contractual relationships should be negotiated between those offering and those seeking help. (+info)
It doesn't cost anything just to ask, does it? The ethics of questionnaire-based research.
(19/4142)
Patient-based outcome measures are increasingly important in health care evaluations, often through the use of paper-based questionnaires. The likely impact of questionnaires upon patients is not often considered and therefore, the balance of benefit and harm not fully explored. Harms that might accrue for research staff are even less frequently considered. This paper describes the use of postal questionnaires within a study of breast disease management in primary care. Questionnaire responses are used to describe the nature of discomfort or harms that may occur in such studies. Ethical issues raised by the harms are discussed in relation to the benefits of the study. Practical suggestions for reducing harm to patients are proposed. A secondary consideration, discomfort to the researcher, is also identified and suggestions made to reduce its effect. Finally, the role of research questionnaires as a study intervention is discussed. (+info)
Outcomes research in the development and evaluation of practice guidelines.
(20/4142)
BACKGROUND: Practice guidelines have been developed in response to the observation that variations exist in clinical medicine that are not related to variations in the clinical presentation and severity of the disease. Despite their widespread use, however, practice guideline evaluation lacks a rigorous scientific methodology to support its development and application. DISCUSSION: Firstly, we review the major epidemiological foundations of practice guideline development. Secondly, we propose a chronic disease epidemiological model in which practice patterns are viewed as the exposure and outcomes of interest such as quality or cost are viewed as the disease. Sources of selection, information, confounding and temporal trend bias are identified and discussed. SUMMARY: The proposed methodological framework for outcomes research to evaluate practice guidelines reflects the selection, information and confounding biases inherent in its observational nature which must be accounted for in both the design and the analysis phases of any outcomes research study. (+info)
Extending life: scientific prospects and political obstacles.
(21/4142)
Aging can be slowed in laboratory rodents by low-calorie diets, and changes in single genes can extend mouse life span by 40 percent or more. Therefore, despite its surface complexity and effects on multiple cells and intercellular systems, aging in mammals might also be retarded by both genetic and nongenetic means. If human aging could be slowed pharmacologically to the extent now possible in rodents, the effect on healthy life expectancy would exceed that of abolishing cancer, cardiovascular disease, and adult-onset diabetes. Why, then, is research on the biological control of aging and longevity poorly funded and shunned by both most scientists and those setting national research priorities? Economic disincentives, disease-specific lobby groups, scientific careerism, and ineffective nostrums, together with gerontologiphobia, must be overcome before such research can improve public health. (+info)
Clinical research in the private office setting--ethical issues.
(22/4142)
A new model for performing clinical investigations has emerged in the United States which utilizes networks of physicians practicing in private office settings. This arrangement has sparked much controversy because of the potential conflicts of interest inherent in the dual roles of physician as clinician and investigator as well as the significant direct financial gains reported by some physicians which might impact on the interests of research subjects. We describe some of the ethical concerns and propose some procedural guidelines to safeguard the interests of research subjects participating in clinical trials in private physician offices. These safeguards include: requiring education of all investigators in research ethics, limiting financial incentives, disclosure to subjects of potential conflicts and financial arrangements, creation of an independent resource available to subjects to discuss concerns and answer questions, and development of educational materials to inform all potential subjects about important issues related to clinical research. (+info)
Academic-industrial collaboration: the good, the bad, and the ugly.
(23/4142)
Academic-industrial collaborations and technology transfer have over the past 50 years played an increasingly prominent role in the biomedical sciences. University partnerships with industry can expedite the availability of innovative drugs and other medical technologies, bringing both important public health benefits and a source of income for universities and their faculty through a variety of financial arrangements. However, these relationships raise ethical concerns, particularly when research involves human subjects in clinical trials. Lapses in oversight of industry-sponsored clinical trials at universities, and especially patient deaths in a number of trials, have brought these issues into the public spotlight and have led the federal government to intensify its oversight of clinical research. The leadership of Harvard Medical School convened a group of leaders in academic medicine to formulate guidelines on individual financial conflicts of interest. They and other groups are working to formulate a national consensus on this issue. (+info)
Randomized trials of high-dose chemotherapy in breast cancer: fraud, the press and the data (or lessons learned in medical policy governing clinical research).
(24/4142)
High dose therapy for breast cancer remains controversial. Of the 15 randomized trials of high dose therapy in breast cancer reported to date, two South African studies have been discredited leaving 13 remaining studies. Mortality was consistently low, in the 0 to 2.5% range, except for the BCNU containing American Intergroup study, which had a 7.4% toxic mortality rate. Seven of the remaining 13 studies randomized fewer than 200 patients. Three of these small studies have significant differences in disease free survival, and a fourth study has a trend in favor of high dose therapy. The other three small studies cannot exclude a survival difference of 20%. Of the 6 remaining moderately large trials of 219 to 885 randomized patients, 5 are adjuvant studies and one included patients with metastatic disease. Of the five adjuvant trials, four have significant differences in relapse rate favoring the high dose arm, and the remaining study has a trend (with a high dose sequential single agent design rather than combination therapy as in the other studies). A planned subset analysis of the first 284 patients in the largest study funded by the Dutch insurance industry showed a significant advantage for high dose therapy. Given the 2-year median time to relapse and an addition 2-year median to death after relapse, the follow up for survival of 3-5 years on these studies is still short. In the only moderately sized metastatic trial from the National Cancer Institute of Canada with a very short median follow-up of 19 months, a significant difference in disease free survival has emerged, with no difference in survival. (+info)