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PubMed2005

Evaluating national cause-of-death statistics: principles and application to the case of China.

Mortality statistics systems provide basic information on the levels and causes of mortality in populations. Only a third of the world's countries have complete civil registration systems that yield adequate cause-specific mortality data for health policy-making and monitoring. This paper describes the development of a set of criteria for evaluating the quality of national mortality statistics and applies them to China as an example. The criteria cover a range of structural, statistical and technical aspects of national mortality data. Little is known about cause-of-death data in China, which is home to roughly one-fifth of the world's population. These criteria were used to evaluate the utility of data from two mortality statistics systems in use in China, namely the Ministry of Health-Vital Registration (MOH-VR) system and the Disease Surveillance Point (DSP) system. We concluded that mortality registration was incomplete in both. No statistics were available for geographical subdivisions of the country to inform resource allocation or for the monitoring of health programmes. Compilation and publication of statistics is irregular in the case of the DSP, and they are not made publicly available at all by the MOH-VR. More research is required to measure the content validity of cause-of-death attribution in the two systems, especially due to the use of verbal autopsy methods in rural areas. This framework of criteria-based evaluation is recommended for the evaluation of national mortality data in developing countries to determine their utility and to guide efforts to improve their value for guiding policy.

Adolescent↗

PubMedDate not supplied

Industry's perception of presenting pharmacoeconomic models to managed care organizations.

BACKGROUND: Previous research has shown that pharmacoeconomic (PE) data are considered important but may not be optimally utilized by decision makers. No research has compared the effectiveness of different types of PE models. OBJECTIVES: The purpose of this study was to examine the perceived value and understanding of PE models among decision makers in managed care organizations. The perspective of this study was from research scientists working in the pharmaceutical industry who present PE models to managed care clients. The study objectives were to (1) examine what types of models are best received by decision makers, (2) investigate the barriers to using PE models, and (3) recommend methods for improving PE models. METHODS: A telephone survey of 39 items was conducted with 20 PE research scientists from various U.S. pharmaceutical and biotechnology companies. Topics addressed included factors contributing to how well PE models are received, barriers to using PE models, and recommendations for improving PE models. RESULTS: Models have an impact on health policy decision making. Nineteen of 20 respondents had at least one experience where a PE model played a role in optimizing the formulary positioning of a product. No single model format (e.g., decision analytic tools, spreadsheet analyses, Markov models, multivariate regression models) was regarded as the most effective model type. Although 7 of 20 respondents said simple spreadsheet models were most effective, well-designed, scientifically sound regression models were also reported to be very effective. CONCLUSIONS: The respondents commonly used models to share PE information, which was said to play a role in making health policy decisions by decision makers in managed care. There was no consensus regarding the type of model that was most effective. Study participants indicated that a variety of model designs are effective, ranging from simple spreadsheet models to multivariate regression models. Recommendations for improving PE models include (1) producing scientifically sound models, (2) customizing models where possible, (3) making models transparent, (4) making models user friendly, and (5) involving a nonbiased third party for model development.

Decision Making↗

PubMed1984

[Rehabilitation of the handicapped caught between content programming and economic justification].

Notwithstanding the wide socio-cultural scope of theoretical social policy, those, at any rate, who are involved in practical social policy making time and again face the task of providing an economic justification for their respective programmes; the field of rehabilitation of the disabled is no exception to this rule. An economic justification of rehabilitation service provision would however imply their flexibility within economic development: content programming continuity and economic justification will clash as the economic situation changes. Maintaining, or honouring, present rehabilitation service programming will jeopardize economic justification, whereas orientation of rehabilitation practice toward economic justifiability would imply the need to abandon redemption of present content programming. This entails a normative dilemma between rehabilitation content programming, or goal-setting, on the one hand, and its economic-functional, theoretical justification as reflecting given economic circumstances on the other. This normative dilemma gives rise to critically re-consider current practice in, and the rank accorded to, economic justification in rehabilitation service provision.

Cost-Benefit Analysis↗

PubMed2005

Predicting human cloning acceptability: a national Greek survey on the beliefs of the public.

BACKGROUND: In the era of human genome research, there is a large theoretical debate among scientists and authorities on the ethical dimension based on the moral liberty of the individuals and the scientific and economic dimension based on the freedom and the independence of the scientific and technological activities. Meanwhile, the understanding of beliefs on human cloning (HC) and its acceptability are important for the development of evidence-based policy making. However, previous research in the field of public beliefs towards human genetics is limited. Therefore, in the present study, we investigated the role of public beliefs as predictors of the acceptability of the respondents to use HC. METHODS: Personal interviews were conducted with 1020 men and women of urban areas in Greece. Stratified random sampling was performed to select participants. Several scientists, experts in HC, evaluated the content of the instrument initially developed. The final questionnaire was the result of a pilot study. RESULTS: The acceptability of HC for the cure of incurable diseases and transplantation need is very high (70.7 and 58.6%, respectively). Public's intention to have recourse to HC because of "bringing" back to life a loved person or because of reproductive disorders was reported by 35 and 32.5%, respectively. With respect to the role of beliefs: increasing scores of reasons of social benefits, moral/religious reasons and legislative reasons increased the public's intention to have recourse to HC; inversely, decreasing scores of reasons of human commodification/exploitation increased public's intention to have recourse to HC. Additionally, low rates of church attendance appeared to be correlated with high reported acceptability of HC. CONCLUSION: There is great public concern regarding the application of HC, which probably reflects the existing ambivalence over the relationship between technology and society. Scientists and policymakers should take into account these indicators of public disquiet and should manage the public involvement in policy decisions, from which they have so far been excluded.

Adolescent↗

PubMed2002

The high-fat Greek diet: a recipe for all?

OBJECTIVE: To examine critically the published results of dietary surveys on the fat content of the Greek diet, and to assess its evolution and its relationship to the health of the Greeks. To consider the implications of these findings for current views on the nature and health implications of the traditional Mediterranean diet and how best to define it for use in modern policy making. DESIGN: A systematic review of the literature on food consumption in Greece. SETTING: Greece. RESULTS: The first fully published data on the fat content of the Greek diet-the Seven Countries Survey-relates only to a small number of adult males in Crete and Corfu; the legitimacy of extrapolating these results to the rest of Greece is questioned. Earlier studies and chemical validation of intakes point to a lower fat content of the traditional diet than that inferred for Crete. Nearly all later surveys relate only to urban groups in Athens (mostly case-control hospital-based samples) and a variety of non-representative Cretan groups. Only two studies are larger and more representative, but one uses FAO food balance-sheets to reflect the national diet, and the other surveyed school-age children in three out of the 52 Greek counties. Unfortunately recent dietary studies have proved unreliable, given the continuing lack of national food composition tables with survey methods which proved inaccurate for dietary fat content. A progressive upward trend in total and saturated fat intake appears to have occurred with all health indicators in relation to fat indicating remarkable increases in adult and childhood obesity with attendant progressive deterioration in cardiovascular mortality and its risk factors, ie hypertension and diabetes. These data emphasise the need to alter current nutritional advice in Greece, particularly when it focuses on the promotion of olive oil and a high-fat diet. CONCLUSIONS: The findings reaffirm low-moderate fat policies for optimum health, within which olive oil can be an important component of the diet.

Adolescent↗

PubMed1996

Cardiovascular and respiratory responses during a complex decision-making task under prolonged isolation.

Self-administered psychophysiological assessment during a mission is not only feasible, but yields reliable data that can be related to mission demands in a meaningful way. The unique methodology that has been employed during the EXEMSI campaign, may be of great promise for the development of techniques that provide daily monitoring of physiological cost of mission demands. This approach can thus be used for obtaining a better understanding of problems that can arise with regard to the functioning of individual crew members. The response profiles of the individual crew members showed remarkable quantitative and qualitative differences during isolation. Due to the limitations of this study, these differences could by no means all be explained in terms of mission demands, operator workload or other relevant parameters. However, the findings do seem to permit some tentative conclusions. In subjects B and D the cardiovascular response profiles suggested that cumulative stress effects emerged, in particular during the second part of the mission. It is important to note that both subjects carried specific responsibilities for the success of the mission, and that there was evidence for a conflict between them. Concerning the question which physiological measures are most appropriate for in-mission psychophysiological assessment, these results can appear to imply that cardiovascular measures yield more valid information about the effects of mission demands that respiratory measures. However, it should be noted that important aspects of respiratory activity, namely, respiratory volume measures and ventilation, could not be reliably determined in this study. Therefore, definitive conclusions concerning the choice of measures wait until the validity of the measures has been more extensively evaluated. Although the methodology that was developed for this study appears to be promising, it is obvious that its value can only be properly assessed when the physiological findings are correlated with behavioral, performance and subjective data. An extensive analysis of the covariation of the daily variations in physiological response, performance measures, and subjective assessments of workload and mood, is currently in progress in collaboration with Hockey and Sauer. Finally, if the usefulness and validity of this type of in-mission self-administered psychophysiological assessment are confirmed in ongoing and future studies (e.g., the 1994 HUBES mission), protocols will have to be worked out for practical implementation during actual spaceflights. In this regard, it has been advocated that psychophysiological monitoring techniques should include feedback and support policies, make crew members aware of potential risks for breakdown, and enable them to take appropriate measures when necessary. Initially, this can perhaps best be realized by procedures which include a data-link between the spacecraft and ground mission control. On the basis of ground-based analysis and evaluation of the data, psychologists at mission control may decide to provide information to the crew concerning potential individual or intragroup overload or stress problems, and to implement specific supportive measures. The effectiveness of the supportive activities should be closely monitored by mission control. Future work should also be aimed at developing expert-systems, which will enable the crew to maintain an appropriate degree of inflight biobehavioral self-regulation by providing a range of support techniques, like biofeedback, coping techniques against individual and group stressors, work/rest and sleep/wake schedules, and emergency procedures.

Adult↗

PubMed1998

Do specialists do it better? The impact of specialization on the processes and outcomes of care for cancer patients.

OBJECTIVE: To assess the impact of specialization on processes and outcomes of care for cancer patients. DATA SOURCE: Papers published in English between 1980 and 1995 and identified through MEDLINE and Embase (MeSH terms: NEOPLASM (exploded), and PHYSICIAN PRACTICE PATTERNS (or DECISION MAKING, ATTITUDE OF HEALTH PERSONNEL, QUALITY OF HEALTH CARE, DELIVERY OF HEALTH CARE, HEALTH EDUCATION or OUTCOME ASSESSMENT HEALTH CARE), or through the reference lists of review articles. STUDY SELECTION: Studies providing information on the association between quality of care indicators for cancer patients and clinician/centre degree of specialization. A total of 47 papers concerning 46 empirical studies were considered. DATA EXTRACTION: For studies using process of care indicators, the proportion of specific procedures performed by specialists and non-specialists was abstracted. For studies using outcome indicators (e.g., mortality), the effect of specialization was quantified in terms of odds ratio (OR) expressing relative reduction in risk of death. The quality of individual studies using process or outcome indicators was assessed according to study design, avoidance of selection bias in patient identification and data analysis, degree of adjustment of the comparison between clinicians/centres with different levels of specialization. DATA SYNTHESIS: Specialized centres/clinicians fared better both when process and outcome indicators were used. While the former varied widely in different studies and their clinical relevance was often questionable, mortality was consistently lower when care was provided by specialized centres/clinicians, with the effect size being greater in smaller studies. For breast cancer, where all the studies were of sufficiently good quality, a pooled estimate of the effect of specialization was performed which showed that specialized cancer care was associated with an 18% (95% CI: 12%-23%) reduction in mortality. CONCLUSIONS: Despite the fact that care provided by specialized centres/clinicians appeared to be better both when assessed in relation to process indicators and to mortality, this evidence should be considered far from conclusive because of major methodological flaws in these studies. Relative to current efforts to promote evidence-based policy-making, this review underscores the limited capability of scientific information to provide reliable guidelines for structuring better health care systems.

Confidence Intervals↗

PubMed2002

National program for preventing mother-child HIV transmission in Thailand: successful implementation and lessons learned.

OBJECTIVE: To describe the development, components, and initial uptake of Thailand's national program for preventing mother-child HIV transmission. DESIGN: Historical review, interpretation of experience, national program monitoring. SETTING: Public health system, Thailand. PARTICIPANTS: Policymakers, clinicians, HIV-infected pregnant women. INTERVENTION: Voluntary counseling and HIV testing of pregnant women; short-course zidovudine for HIV-infected women and their infants and formula feeding for infants. MAIN OUTCOME MEASURES: Program components implemented and program uptake. RESULTS: Research, monitoring and evaluation of pilot projects, training, and policy-making provided the information, experience, infrastructure, and guidance to develop a program for preventing mother-child HIV transmission that was implemented in all Ministry of Public Health hospitals in Thailand in 2000. A national system was established to monitor program implementation. Monitoring reports were received from 669 hospitals in 65 provinces for the period October 2000 through July 2001. During this period, 93% of 318 721 women who gave birth were tested for HIV; 69% of 3958 HIV-infected women giving birth received zidovudine; and 86% and 80% of the 3865 children born to HIV-infected women received zidovudine and infant formula, respectively, through the program. CONCLUSIONS: A national program for preventing mother-child HIV transmission was successfully implemented in Thailand. Early monitoring indicates good program uptake. Lessons learned from implementing this program include the importance of paying attention to counseling, communication, and training in the program, and using pilot projects and focused monitoring and evaluation data to guide the program development, expansion, and improvement.

AIDS Serodiagnosis↗

PubMed2006

The ADA perspective.

BACKGROUND: The American Dental Association (ADA) has long relied on available scientific evidence in its commitment to use credible scientific data and analyses in policy-making, and its communications with the dental profession and the public. OVERVIEW: The evidence-based dentistry (EBD) process is a systematic approach that reviews and publishes the evidence relevant to specific clinical questions. The goal of this process is to help practitioners provide patients with quality oral health care. The ADA has developed a strategic plan of EBD initiatives and activities in order to increase the knowledge base and improve educational programs; to encourage significant collaboration on EBD-related issues from interested organizations, specialty groups, and various outside agencies; and to increasingly derive the best scientific evidence for use in clinical practice in concert with professional judgment and patient treatment preferences. CONCLUSION: The ADA endeavors to provide relevant information that can assist dentists in translating systematic-review findings and implementing an evidence-based approach in everyday clinical practice. This supports the Association's goal to continue supporting the best available evidence to assist health care teams in the provision of quality patient care and preventive techniques that improve oral health care outcomes.

American Dental Association↗

PubMed1978

Hazards of solid waste management: bioethical problems, principles, and priorities.

The putative hazards of solid waste management cannot be evaluated without placing the problem within a cultural climate of crisis where some persons consider such by-products of "high, hard technology" to have raised unresolved moral and ethical issues. In order to assist scientific and technical efforts to protect public health and safety, a bioethical perspective requires us to examine three controversial aspects of policy-making about public safety. Failure to recognize the qualitative difference between two cognitive activities-risk-measurements (objective, scientific probabilities) and safety-judgments (subjective, shifting value priorities)-has had three unfortunate consequences. Sophisticated methods of risk analysis have been applied in a piecemeal, haphazard, ad hoc fashion within traditional institutions with the false expectation that incremental risk-reducing programs automatically ensure public health and safety. Ethical priorities require, first and foremost, a whole new field of data arranged for comparable risk-analyses. Critics of cost/risk/benefit quantifications attack the absurdity of "putting a price on human life" but have not been confronted with its threefold ethical justification. The widening discrepancy in risk-perceptions and loss of mutual confidence between scientific experts and ordinary citizens has placed a burden of social responsibility on members of the scientific and technical community to engage in more effective public education through the political process, notwithstanding advocates of a nonscientific adversary process. The urgency of effective public education has been demonstrated by the extent to which we have lost our historically balanced judgment about the alleged environmental hazards posed by advanced technology.

Bioethics↗

PubMed1995

Reflections on supply-demand mismatch in dialysis services in Ontario.

The population-based dialysis rate in Ontario more than doubled between 1981 and 1992; yet there is concern about over-loaded facilities, delayed treatment and denial of dialysis through nonreferral and implicit rationing. A working party involving several stakeholders has been established in Ontario to address these issues. However, clinical policy making concerning dialysis services is impeded in all provinces by a lack of information. The causes of the moderately large variations in dialysis rates from province to province remain unclear. The exact extent and risks of delayed therapy have not been well defined. Dialysis protocols vary inexplicably among centres, and cost data on different methods of providing dialysis are limited. Many steps could be taken in Ontario and other provinces to generate a better information base for planning and managing dialysis services. Predialysis clinics with outreach programs could help to ensure equitable access to this life-saving therapy. Criteria for choosing modes and intensities of renal-replacement therapy must be reviewed. In areas of clear disagreement and uncertainty, patients could be randomly assigned to different protocols and outcomes studied. In areas of agreement, the criteria should be standardized. Advance directives may help ascertain patients' wishes concerning the initiation or continuation of dialysis, and more accurate data on prognosis of different patient subgroups would aid in early identification of patients in a hopelessly deteriorating situation. Last, studies comparing the "output" (e.g., hours on hemodialysis) per dollar of different dialysis units and modalities are also needed to ensure that all facilities are opening efficiently without compromising patient outcomes.

Health Policy↗

PubMed1995

Persistent spermatozoa after vasectomy: a survey of British urologists.

OBJECTIVES: To determine the rate of, and main indications for, repeat vasectomy in our department, and to assist in policy-making procedures by determining how urologists in England and Wales manage those men who show small but persistent quantities of motile or non-motile spermatozoa in their ejaculate after vasectomy. SUBJECTS AND METHODS: A retrospective review of all of the vasectomies and repeat vasectomies performed by the Urology Department at Southmead Hospital during a 14-month period was undertaken to determine the rate of and indications for repeat vasectomy. Subsequently, every consultant urologist in England and Wales was canvassed with a questionnaire to determine whether they repeated vasectomy in the presence of persistent motile or non-motile sperms and if so, after what time interval. Any experience of pregnancies arising from these groups was also assessed, and any relevant comments invited. RESULTS: The local review revealed that 5% of all vasectomies were repeated within 6-36 months. Of these, 87% were performed because of persistent sperms in post-vasectomy semen samples, the majority of which showed sperm concentrations of one in 50 to one in 100 high-power fields. A response of 56% was obtained to the questionnaire and of those responding, 23% never repeated a vasectomy where there were presistent non-motile sperms, but almost all urologists would eventually repeat vasectomy where motile sperms were present. The median interval between the first and second vasectomies was 6 months and 12 months for motile and non-motile sperm, respectively. Apart from those cases already published, there was little experience of pregnancy arising from men with persistently few motile or non-motile sperms. CONCLUSIONS: The risk of pregnancy occurring in the presence of non-motile sperms was estimated to be less than the established risk of late recanalization, and this survey provides both logical and medico-legal support for issuing a 'special clearance' to men with few persistent non-motile sperm after vasectomy, providing the risks of pregnancy are properly discussed and documented. For motile sperm, however, there appears to be a stronger precedent for repeating the vasectomy. The technique used for post-vasectomy semen analysis was also an important consideration when determining any policy regarding such cases.

Attitude of Health Personnel↗

PubMed2001

Scale, Efficiency and Organization in Norwegian Psychiatric Outpatient Clinics for Children.

BACKGROUND: It is generally believed that 5 percent of the population under 18 years is in need of specialist psychiatric care. In 1998, however, services were delivered to only 2.1 percent of the Norwegian population. Access to services can be improved by increasing capacity, but also by increasing the utilization of existing capacity. Changing financial incentives has so far not been considered. Based on a relatively low number of registered consultations per therapist (1.1 per therapist day) the ministry has stipulated that productivity should increase by as much as 50 percent. AIMS OF THE STUDY: Measuring productivity in psychiatric care is difficult, but we believe that studies of productivity should be an important input in policy making. The aim of this paper is to provide such an analysis of the productive efficiency of psychiatric outpatient clinics for children and youths, and in particular to focus on three issues: (i) is an increase in productivity of 50 percent a realistic goal, (ii) are there economies of scale in the sector, and (iii) to what extent can differences in productivity be explained by differences in staff-mix and patient-mix? METHODS: We utilize an approach termed Data Envelopment Analysis (DEA) to estimate a best-practice production frontier. The potential for efficiency improvement is measured as the difference between actual and best-practice performance, while allowing for trade-offs between different staff groups and different mixes of service production. The DEA method gives estimates of efficiency and productivity for each clinic without the need for prices, and thus avoids the pitfalls of partial productivity ratios. The Kolmogorov-Smirnov statistic is used to compare efficiency distributions, providing tests of variable specification and scale properties. RESULTS: Based on 135 observations for the years 1997 to 1999, the tests lead to a model with two inputs, two outputs and variable returns to scale. The outputs are number of hours spent on direct and indirect interventions, while neither the number of interventions nor the number of patients was found to be significant. The inputs are the number of university-educated staff and other staff, but disaggregation of the latter group was not significant. The average of estimated clinic efficiencies is 71%. The mean productivity is 64%, but many large clinics have considerably lower performance due mainly to scale inefficiency. DISCUSSION: There seems to be considerable room for improved performance in these clinics. It is interesting that the potential is not that far from the officially stipulated goal of 50% increased productivity. Staff composition does matter for clinic performance, but the different groups do not have significantly different marginal productivities, indicating a lack of ability to utilize specialized skills. It should be noted that these results to some extent depend on the assumptions that medical practice is efficient, and that the available data accurately captures the activities of the clinics. IMPLICATIONS FOR FURTHER RESEARCH AND HEALTH POLICY: More appropriate outcome measures, e.g. global assessment of functioning scores (GAF), will soon be available and will improve the policy value of this type of analysis, as will a more refined data set with information about the number of personnel in training positions. The analyses in this paper indicate that a lack of consensus on the issues of who should be treated, how they should be treated and by whom results in large variations in productive efficiency. These issues are being debated in Norway, and it should be interesting to see whether this in itself leads to higher efficiency or whether a change in the incentive structure will be needed.

Journal Article↗

PubMed2002

Four-year survival of transfusion recipients identified by hepatitis C lookback.

BACKGROUND: Information on the probability of survival of transfused patients is needed for policy making, but there is a paucity of empirical research into this question. A Swedish population-based study reported that the 40-month posttransfusion probability of survival was 51 percent in all patients and 41 percent in recipients of more than 10 units of blood and blood components. These figures were 20 percent lower than the figures reported previously from Olmsted County, Minnesota. STUDY DESIGN AND METHODS: Information was collected on the 4-year survival of 695 patients transfused at the New York University Medical Center between 1988 and 1996. These patients had been identified previously by hepatitis C lookback. RESULTS: Seventy-five percent of patients survived at 1 month after transfusion, 66 percent at 3 months, 60 percent at 6 months, 54 percent at 1 year, 50 percent at 2 years, 45 percent at 3 years, and 41 percent at 4 years. Seventy-eight percent of patients included in the study had received more than 10 units of blood and blood components. The 4-year survival of patients receiving 1 to 3, 4 to 10, or more than 10 units was 62 percent, 48 percent, and 38 percent, respectively (p < 0.0001). CONCLUSIONS: When transfusion dose is taken into account, the probability of survival of patients transfused at the New York University Medical Center in 1988 to 1996 and identified by lookback is similar to that reported for Swedish county residents transfused in 1993. Based on both the Swedish data and the information presented here and in the absence of any recent results from population-based studies, the survival of U.S. patients transfused in the 1990s appears to be 20 percent lower than that of Olmsted County residents transfused in 1981.

Adolescent↗

PubMed2005

Strengthening health information systems to address health equity challenges.

Special studies and isolated initiatives over the past several decades in low-, middle- and high-income countries have consistently shown inequalities in health among socioeconomic groups and by gender, race or ethnicity, geographical area and other measures associated with social advantage. Significant health inequalities linked to social (dis)advantage rather than to inherent biological differences are generally considered unfair or inequitable. Such health inequities are the main object of health development efforts, including global targets such as the Millennium Development Goals, which require monitoring to evaluate progress. However, most national health information systems (HIS) lack key information needed to assess and address health inequities, namely, reliable, longitudinal and representative data linking measures of health with measures of social status or advantage at the individual or small-area level. Without empirical documentation and monitoring of such inequities, as well as country-level capacity to use this information for effective planning and monitoring of progress in response to interventions, movement towards equity is unlikely to occur. This paper reviews core information requirements and potential databases and proposes short-term and longer term strategies for strengthening the capabilities of HIS for the analysis of health equity and discusses HIS-related entry points for supporting a culture of equity-oriented decision-making and policy development.

Developing Countries↗

PubMed1997

Research with cognitively impaired subjects. Unfinished business in the regulation of human research.

In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued an important report that addressed the difficult ethical issues arising in research involving subjects with mental disabilities. However, because of irreconcilable conflicts between the scientific community and rights-oriented advocacy groups, the federal government never issued the special regulations pertaining to these issues that had been envisioned by the National Commission. Because these important ethical issues have not yet been adequately addressed by policy-making bodies, protection of cognitively impaired subjects depends too heavily on the diverse ethical sensitivities of individual investigators and on ad hoc responses of particular institutional review boards. Researchers should support a credible and authoritative process for reexamining and resolving ethical issues relating to research with cognitively impaired subjects. This can be accomplished without leading to the stalemate that doomed the National Commission's proposals. The challenge is to forge a consensus on ethical guidelines and safeguards that will most reasonably accommodate the goals of protecting the dignity and well-being of research subjects while avoiding undue impediments to valuable scientific inquiry.

Advisory Committees↗

PubMed2000

Ethonomics: the ethics of the unaffordable.

The most familiar basis for medical ethics since the 1950s has been principle-based ethics. The 4 basic principles are known as the "Georgetown mantra" of beneficence, nonmaleficence, respect for autonomy, and justice. These principles have served us well since their enunciation in the wake of the activities of the Nazi doctors in the concentration and extermination camps of World War II. In the past 15 years, however, they have begun to serve less well. In the era of resource constraints, however, the clinical relationship has become more complex. It now involves many more stakeholders, who control funds, make policy, and effectively ration services. Lawyers are also involved in important ways. All these people take part with varying directness in the processes of consultation and treatment. The consulting room has become a crowded office. For these reasons, the old ethics will no longer serve us. We need a new ethics that recognizes the involvement of the new stakeholders, and recognizes that resource constraints influence clinical practice.

Cost Control↗

PubMed1999

Meta-analysis of screening data: a survey of the literature.

Meta-analysis has become a popular technique in many areas of biomedical research. While there have been a number of studies and commentaries on the use of meta-analyses and systematic reviews of clinical trials of therapy, little is known about the use of meta-analysis techniques for the evaluation of screening data. This paper presents the first systematic survey of meta-analyses of screening, with an assessment of their methodologic quality and their statistical methods. Our findings show that meta-analysis has not often been used in this area as yet, and that published meta-analyses of screening are often deficient in their reporting of methodology. A brief examination of the evaluative methods of several policy-making groups reveals that they did not routinely use formal quantitative meta-analyses of screening data, at least until 1997. There is considerable potential for meta-analyses of this kind, but improvement in methodological standards will be required to obtain valid conclusions.

Data Interpretation, Statistical↗