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Legal regulation of the use of race in medical research.

In this article, we discuss current legal restrictions governing the use of race in medical research. In particular, we focus on whether the use of race in various types of research is presently permitted under federal law and the federal constitution. We also discuss whether federal restrictions on the use of race in research ought to be expanded, and whether federal policies that encourage the use of race ought to be abandoned.

Biomedical Research↗

Drug abuse discharges from non-federal short-stay hospitals.

An analysis of inpatient drug abuse cases was done using the National Hospital Discharge Survey (NHDS). An estimated two million discharges with a drug abuse diagnosis occurred in non-federal short-stay hospitals during 1979-85, a figure which is believed to be an underestimate. Compared to other hospital inpatients, drug abuse inpatients are more likely to be male, ages 15-44, and other than White race. Increases in hospital use for drug abuse treatment were found to have occurred between 1979 and 1985, with discharge rates per 10,000 population increasing from 3.1 to 6.0 for drug dependence and from 3.8 to 7.7 for nondependent drug abuse. Concurrent increases in availability of hospital-based inpatient drug and alcohol treatment programs and insurance coverage for drug abuse treatment were found to have occurred during the same period.

Adolescent↗

Morphometric data to FIGO stage and histological type and grade for prognosis of ovarian tumours.

The prognostic value of using histological typing, grading, and morphology, in addition to clinical staging, was assessed in 98 cases of invasive ovarian cancer of the common epithelial types (serous, mucinous, and endometrial). All of these cases had at least five years of follow up. When regression analysis was used, the International Federation of Gynaecology and Obstetrics' (FIGO) staging system was the best indicator for prognosis. Analysis of a combination of morphometric features was the second best indicator, being especially useful for the those patients with stage I disease. Variables that indicated a relatively poor prognostic outcome were mitotic index above 30; volume percentage epithelium above 65%; shortest nuclear axis above a mean of 1 X 1 micrometers. Histological typing of ovarian tumours was of limited value; mucinous tumours have a somewhat better prognosis than serous tumours, but the prognostic value of typing alone was found to be limited. Qualitative histological grading was useful, but the prognostic value of morphometric grading was better. Measurement of morphological features with an interactive computer program is simple and can be done by a pathologist or a technician: in future it is likely that such automated systems of measurement will improve the objectivity of tissue analysis.

Cell Nucleus↗

[Genome analysis of hepatitis C virus strain 274933RU isolated in Russian Federation].

Five overlapping cDNA fragments of hepatitis C virus (HCV) isolate 274933RU, obtained by RT-PCR, were amplified and cloned. Complete nucleotide RNA sequence has been determined. The genomic organization of 274933RU was, from 5' to 3' terminals, 5' UTR (341 nt), polyprotein ORF (9033 nt), 3' UTR (40 nt except for the poly(U-UC) and polypyrimidine stretch), and X-tail (98 nt). Phylogenetic analysis of the core and NS5 genes showed that the isolated strain belonged to HCV 1b subtype.

Acute Disease↗

APA's expert panel in the congressional review of the USS Iowa incident.

In 1989, an explosion aboard the USS Iowa killed 47 sailors. The Navy attributed the explosion to the intentional suicidal acts of Gunners Mate Clayton Hartwig, a conclusion supported primarily by an "equivocal death analysis" conducted by the Federal Bureau of Investigation (FBI). The U.S. House of Representatives Armed Services Committee (HASC) was highly critical of the FBI's report and the Navy's conclusions, in part because of the peer review provided by 12 psychologists organized by the American Psychological Association (APA). This article (a) reviews the nature of equivocal death analysis and related reconstructive psychological evaluations, (b) describes the nature of APA's consultation and involvement with the HASC, (c) discusses the conclusions reached by the HASC and the influence of the APA panelists, and (d) suggests limitations on the use of equivocal death analysis and related procedures in light of scientific concerns and ethical considerations.

Adult↗

Long-term survival following neoadjuvant chemotherapy and radical surgery in locally advanced cervical cancer.

The aim of this study was to analyse the long-term survival and the relationships between prognostic factors at presentation, chemoresponsiveness and disease outcome in patients with locally advanced cervical cancer treated by neoadjuvant chemotherapy and radical surgery (RS). Two consecutive studies of neoadjuvant chemotherapy containing cisplatin, bleomycin plus/minus methotrexate followed by radical hysterectomy and systematic aortic and pelvic lymphadenectomy were carried out between January 1986 and September 1990 on 130 patients with > or = 4 cm stage IB2-III cervical cancer. Survival analysis was performed using the Kaplan and Meier test and Cox's multivariate regression analysis. 128 (98%) of the patients enrolled were evaluable for clinical response and survival, 83% (106) of the patients responded to chemotherapy, with a 15% complete response rate. Logistic regression analysis demonstrated that International Federation of Gynecology and Obstetrics (FIGO) stage, cervical tumour size, parametrial involvement and histotype are highly predictive of response. Responding patients underwent laparotomy, but 8% were not amenable for radical surgery. The 10-year survival estimates were 91%, 80% and 34.5% for stage IB2-IIA bulky, IIB and III, respectively (P < 0.001). After Cox's regression analysis, the parameters significantly associated with survival were the same factors predicting response to neoadjuvant chemotherapy. No stage IB2-IIA bulky patient has so far relapsed, while 12% stage IIB and 56% stage III patients recurred. The 10-year disease-free survival estimates are 91% and 44% for stage IB2-IIB and III, respectively (P < 0.001). Metastatic nodes and persistent tumour in the parametria were the only two independent factors for disease-free survival after multiple regression analysis. After a long-term follow-up (median follow-up 98 months (20-129+)), our results give new evidence of the prognostic value of response to neoadjuvant chemotherapy and of a possible therapeutic benefit of the sequential treatment adopted which, however, must be verified in a randomised setting.

Adult↗

Winston's "No Additives" campaign: "straight up"? "no bull"?

OBJECTIVE: The author used data from a larger study to examine adolescents' and adults' responses to Winston cigarettes' "No Additives" advertising campaign. METHODS: The author analyzed responses from 400 adolescents ages 12-17 and 203 adults ages 30-50 who were asked what they believed the meaning of the "No Additives" slogan to be. The author also analyzed adolescents' responses to questions about four specific Winston "No Additives" ads. RESULTS: Two-thirds of adolescents and 27% of adults believed that "No Additives" meant one or more of the following: that Winston cigarettes are healthier than other cigarettes, that they are less likely to harm health, or that they are less likely to be addictive. Adolescents perceived the models in three ads to be younger than 25 years old. Among adolescent respondents, smokers were more likely than nonsmokers to like the ads and to believe the ads made smoking more appealing. CONCLUSIONS: The "No Additives" slogan was perceived by a majority of adolescents and about a quarter of adults as implying one or more health claims. The results of this analysis suggest that the Federal Trade Commission's action in requiring a disclaimer on the "No Additives" ads is well founded but the disclaimer should be strengthened.

Adolescent↗

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 1993 rates--HCFA. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement necessary changes arising from our continuing experience with the systems. In addition, in the addendum to this final rule, we are describing changes in the amounts and factors necessary to determine prospective payment rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes will be applicable to discharges occurring on or after October 1, 1992. We are also setting forth rate-of-increase limits for hospitals and hospital units excluded from the prospective payment systems. Finally, we are changing and clarifying the criteria and procedures concerning the reclassification of hospitals by the Medicare Geographic Classification Review Board (MGCRB). These changes result from public comment and our analysis of hospital reclassifications for Federal fiscal year (FY) 1992.

Capital Expenditures↗

Symposium: animal food safety and dairy regulations, now and in the future. Animal food safety and dairy regulations, now and in the future: from farm to fork, a state perspective.

The enforcement of dairy and food safety regulations has fallen most heavily on the states in the past, and this responsibility will no doubt continue, and even expand, in the future. States must be concerned not only about their own state laws but also about the impact of increasing federal regulations. The protection of sample integrity and chain of custody is an important function of a state regulatory program for food safety. Because of increasing demands imposed by new technology and food safety requirements, and because of very limited resources, states have difficulty maintaining adequate regulatory programs. The future challenge will be the ability of states to coordinate regulation, sample analysis, and enforcement between federal and state agencies. States must continue their roles of ensuring consumers that food is safe and wholesome while maintaining viable state food industries.

Dairying↗

Incorporating efficiency in hospital-capacity planning in Germany.

Hospital occupancy is a key metric in hospital-capacity planning in Germany, even though this metric neglects important drivers of economic efficiency, for example treatment costs and case mix. We suggest an alternative metric, which incorporates economic efficiency explicitly, and illustrate how this metric can be used in the hospital-capacity planning cycle. The practical setting of this study is the hospital capacity planning process in the German federal state of Rheinland-Pfalz. The planning process involves all 92 acute-care hospitals of this federal state. The study is based on standard hospital data, including annual costs, number of cases--disaggregated by medical departments and ICD codes, respectively--length-of-stay, certified beds, and occupancy rates. Using the developed metric, we identified 18 of the 92 hospitals as inefficient and targets for over-proportional capacity cuts. On the upside, we identified 15 efficient hospitals. The developed model and analysis has affected the federal state's most recent medium term planning cycle.

Bed Occupancy↗

Forensic DNA analysis and the United States Government.

All three branches of the United States Government are, directly or indirectly, promoting the use and judicial acceptance of forensic DNA analysis. In addition, the establishment of a US national DNA databank has been authorized. The US Congress has passed the 'DNA Identification Act of 1994', which provides, inter alia, funding to the states for developing and/or improving forensic laboratories capable of conducting DNA analysis, and also creates a framework for federal supervision of forensic DNA technology. Specifically, the Executive Branch, through the Department of Justice and particularly its Federal Bureau of Investigation, has been directed to develop standards and practices in order to speed the admissibility of forensic DNA analysis as scientifically acceptable evidence in US courts. Finally, the federal judiciary has been ordered by the US Supreme Court to abandon or modify the 70-year-old Frye standard, which the Federal courts previously used to determine whether scientific evidence is deemed admissible, a move that will directly impact the judicial acceptance of forensic DNA analysis in all federal courts and undoubtedly will affect the admissibility of DNA evidence in many American state courts.

Criminal Law↗

The effect of cigarette taxes on cigarette consumption.

OBJECTIVES: This paper reexamines the work of Meier and Licari in a previous issue of the Journal. METHODS: The impact of excise taxes on cigarette consumption and sales was measured via standard regression analysis. RESULTS: The 1983 federal tax increase is shown to have an anomalous effect on the regression results. When those data are excluded, there is no significant difference between state and federal tax increases. Further investigation suggests that firms raised cigarette prices substantially in the years surrounding the 1983 federal tax increase, which accounts for the relatively large decrease in consumption during this period. CONCLUSIONS: Federal excise taxes per se do not appear to be more effective than state excise taxes in terms of reducing cigarette consumption. The reaction of cigarette firms to government policies appears to be an important determinant of the success of antismoking initiatives.

Commerce↗

Research by pathologists in the United States: analysis of publications.

Academic pathology is a unique profession in which the ability to pursue almost any type of academic or scholarly endeavor can be supported. Although it is difficult to define methods of comparing individual achievements in medicine, for investigative activity, common measures of academic productivity are numbers of peer-reviewed publications and National Institute of Health support. Articles from pathology departments were randomly selected from MEDLINE. One hundred and five articles were examined for the following features: financial support, human subjects, the presence of a photomicrograph, molecular biology techniques, and the number of times each article was cited as determined using the Science Citation Index. The articles were assigned to one of the following categories: anatomical pathology, clinical pathology, or research. The following percentages of articles were federally funded: total, 43.8; anatomical pathology, 33.3; clinical pathology, 9.5 and research, 74.4. The citations per article for federally funded and not federally funded articles, respectively, for each as these categories was as follows: total, 18.7 and 5.3; anatomical pathology, 15.7 and 5.5; clinical pathology, 2.0 and 4.9; and research, 21.4 and 5.7. It can be concluded from the data presented that federally funded articles from departments of pathology are cited more often than articles that are not federally funded. The most impressive finding in reviewing the articles is the wide diversity of research conducted in pathology departments. The use of federal funding or citation analysis to evaluate the performance of an individual pathologist would be a mistake.

Efficiency↗

U.S. federally funded television public service announcements (PSAs) to prevent HIV/AIDS: a content analysis.

This article reports a content analysis of 56 English-language public service announcements (PSAs) for HIV/AIDS prevention produced since 1987 by the U.S. federal government for television broadcast. These PSAs do not lead target audiences through a logical sequence from awareness to motivation, skill building, and maintenance. The PSAs underutilize a strategy of "strategic ambiguity" to craft individual PSAs that can address the needs of and appeal to multiple target audiences, thereby directing information not only to heterosexuals, the primary target of these PSAs, but also to homosexuals and bisexuals. The PSAs largely ignore issues related to injection drug use and needle sharing. What drug-related portrayals there are focus on African American street junkies, which perpetuates racial stereotypes and fails to address occasional injection drug use. The PSAs exploit fear of HIV/AIDS to discourage drug use but do not offer drug treatment or counseling information. PSAs produced by the Clinton administration to promote condom use do not fully address key reasons why people fail to use condoms: concern about sexual pleasure, embarrassment about obtaining condoms, and lack of skills to negotiate condom use with sexual partners. Implications of these conclusions for the future of U.S. HIV/AIDS prevention are discussed.

Acquired Immunodeficiency Syndrome↗

[Import risk analysis in animal disease control].

At the Swiss Federal Veterinary Office risk analyses are conducted according to international standards. A risk analysis contains the elements risk management, risk assessment and risk communication. A risk assessment is based on risk profile, hazard identification and a pathway model. All available information is gathered, documented and assessed and the risk estimated. The question. "What is the probability that unprocessed wild boar meat imported to Switzerland from the federal state Mecklenburg Western Pommerania is contaminated with classical swine fever virus?" was answered by a release assessment. The hazard identification recognized classical swine fever virus and attenuated live virus vaccine used for oral immunization as hazards. The probability of contamination was estimated to be small. The question: "What is the likelihood to introduce Aujeszky's disease to Switzerland and infect the indigenous pig population with the disease, by means of importing pork and meat products?" was answered by assessing the release, exposure and resulting consequences. The risk of an infection of the indigenous pig population was estimated to be very small, as 80% of the imported products derive from countries or zones free from Aujeszky's disease. Furthermore the majority of the imported products are processed. The strict implementation of the regulations governing feeding of food wastes to pigs reduces the probability of exposure. In all assessments the risk management decides on a strategy to deal with the risk, taking into consideration the results and recommendations derived from the risk assessment as well as other relevant factors.

Animal Diseases↗

[Current structural and procedural quality markers of psychiatric day hospitals in Germany].

BACKGROUND: Particularly in the last 10 years the conceptual models of partial hospitalization are subjected to major changes, reflecting to the integration of day hospitals in regional mental health service systems and especially to the provision of an alternative to acute inpatient treatment. Systematic nation-wide surveys assessing these changes are missing. METHOD: After developing a structured questionnaire integrating differences in European mental health care systems, a German national survey of current structural and procedural quality markers of psychiatric day hospitals was carried out in 2001. 51.4 % of the addressed psychiatric hospitals (N = 191) returned the questionnaire. Analysis is based on descriptive and correlational methods, compares the situation in the Eastern and Western German Federal States, and uses cluster analysis to differentiate the day hospitals according to their main program function. RESULTS: In general, establishment of day hospitals in Germany has not yet reached the evidence-based capacity level. This statement especially applies to the situation in rural areas. 56 % of the day hospitals currently assess themselves as an alternative to inpatient treatment simultaneously providing differentiated psychotherapeutic treatment. Comparing clinical institutions in the Eastern and Western parts of Germany demonstrates the clearer orientation towards acute psychiatric treatment in the recently (mostly after 1995) established East-German hospitals. This is reflected in the spectrum of main clinical diagnoses, in the average length of treatment episodes, in the definitions of contraindications, and in the provided diagnostic measures. While administrative circumstances are homogeneous for day hospitals, there is a considerable variation in staff numbers related to the core professions. CONCLUSIONS: Guidelines for professional training and continuous qualification as well as staffing have to be modified according to requirements resulting from the change of clinical functions. Each day hospital has to clarify and define its main program function(s), and has to better communicate the consequences for the regional mental health service system.

Combined Modality Therapy↗