A discourse-theoretic perspective on the bioethical-legal framework of genetic counseling

The reflexive nature of reason and the unique relationship reason shares with autonomy in Kant's philosophy is the theoretical basis of this dissertation. The principle of respect for autonomy undergirds the two main legal and ethical tenets of genetic counseling, an emerging profession trying to accommodate the sweeping changes that have occurred in clinical genetics, clinical ethics, and case law applicable to medicine. These two tenets of the counseling profession, informed consent and nondirectiveness, both share a principlist interpretation of autonomy that I argue is flawed due to its connection to: instrumental forms of reasoning, empirical theories of action supporting rational choice, and a liberal paradigm of law. I offer an alternative bioethical-legal framework that is based in the Kantian tradition in law and ethics through the complex theories of Jurgen Habermas. Following Habermas's reconstruction of the mutually constituting notions of private and public autonomy, I will argue for a richer conceptualization of autonomy that can have significant implications for the legal and bioethical concepts supporting the profession of genetic counseling, and which can ultimately change counseling practice. ^

Outcomes assessment of a pediatric practice guideline

Objective. This study examines the structure, processes, and data necessary to assess the outcome variables, length of stay and total cost, for a pediatric practice guideline. The guideline was developed by a group of physicians and ancillary staff members representing the services that most commonly provide treatment for asthma patients at Texas Children's Hospital, as a means of standardizing care. Outcomes have needed to be assessed to determine the practice guideline's effectiveness.^ Data sources and study design. Data for the study were collected retrospectively from multiple hospital data bases and from inpatient chart reviews. All patients in this quasi-experimental study had a diagnosis of Asthma (ICD-9-CM Code 493.91) at the time of admission.^ The study examined data for 100 patients admitted between September 15, 1995 and November 15, 1995, whose physician had elected to apply the asthma practice guideline at the time of the patient's admission. The study examined data for 66 inpatients admitted between September 15, 1995 and November 15, 1995, whose physician elected not to apply the asthma practice guideline. The principal outcome variables were identified as "Length of Stay" and "Cost".^ Principal findings. The mean length of stay for the group in which the practice guideline was applied was 2.3 days, and 3.1 days for the comparison group, who did not receive care directed by the practice guideline. The difference was statistically significant (p value = 0.008). There was not a demonstrable difference in risk factors, health status, or quality of care between the groups. Although not showing statistical significance in the univariate analysis, private insurance showed a significant difference in the logistic regression model presenting an elevated odds ratio (odds ratio = 2.2 for a hospital stay $\le$2 days to an odds ratio = 4.7 for a hospital stay $\le$3 days) showing that patients with private insurance experienced greater risk of a shorter hospital stay than the patients with public insurance in each of the logistic regression models. Public insurance included; Medicaid, Medicare, and charity cases. Private insurance included; private insurance policies whether group, individual, or managed care. The cost of an admission was significantly less for the group in which the practice guideline was applied, with a mean difference between the two groups of $1307 per patient.^ Conclusion. The implementation and utilization of a pediatric practice guideline for asthma inpatients at Texas Children's Hospital has a significant impact in terms of reducing the total cost of the hospital stay and length of the hospital stay for asthma patients admitted to Texas Children's Hospital. ^

Status epilepticus and multiple organ system dysfunction

Recent reports have suggested the possible association of status epilepticus and multiple organ system failure. The purpose of this case control study was to investigate this association and to identify factors that predispose individuals with status epilepticus (SE) or aborted status epilepticus (ASE) to develop multiple organ system failure (MOSF) or multiple organ system dysfunction (MODS).^ For the purpose of the study, definitions of SE, ASE, MOSF, and MODS were operationalized as follows: SE was defined as any seizure lasting for a duration of $\ge$30 minutes or intermittent seizures lasting for $\ge$30 minutes from which the patient does not regain consciousness. ASE was defined as any seizure lasting for a duration of $\ge$10 minutes but $<$30 minutes and which was aborted as a result of a medical intervention. MOSF was defined as the failure of $\ge$2 organ systems in the same patient; organ system failure was said to be present whenever standard MOSF criteria were met. MODS was defined as the dysfunction of $\ge$2 organ systems in the same patient; organ system dysfunction was said to be present, whenever the monitor(s) of that organ's function exceeded the normal range for the physiological or laboratory parameters.^ Medical records of 686 individuals between the age of 5 and 44 years, with history of seizures needing hospitalization at the Texas Children's Hospital or Methodist Hospital, Houston, Texas, between 1991-95 were reviewed and 100 individuals with SE/ASE were identified. Of these 100 individuals with SE/ASE, 45 developed MOSF/MODS during their hospitalization and 9 of these individuals died. Using multivariate analyses, it was found that adult individuals who had an "acute" etiology of their seizure disorder (OR = 5.23; 95%CI: 0.41, 66.24) and children who had a "remote" etiology of their seizure disorder (OR = 3.92; 95%CI: 0.53, 29.22), were more likely to develop MOSF/MODS compared with those who had other etiologies of the seizure disorder. Individuals with SE lasting more than one hour were more likely to develop MOSF/MODS compared with individuals with SE lasting less than 1 hour (OR = 6.51; 95%CI: 1.63, 25.92). Individuals who presented with the SE/ASE episode as their first seizure episode were more likely to develop MOSF/MODS compared to those with a previous history of seizure episodes (OR = 1.78; 95%CI: 0.36, 8.82).^ The major limitations of this study includes the relatively small sample size and the study being performed in only two institutions. However, this is the first study of this kind and should therefore be viewed as largely exploratory in nature. Future studies should investigate the relationship of the risk factors identified in this study using a larger number of institutions and patients. ^

Tumors in the contralateral breast following radiation therapy for breast cancer

The proportional distribution of independent malignant tumors in the contralateral breast following treatment for breast cancer was investigated to assess the influence of scattered radiation as a cause of these tumors. In a population of 172 patients the proportion of contralateral tumors in each quadrant and the center (the nipple-areolar complex) was compared with the expected, or natural, distribution found in the general population, in the absence of radiation. The observed/expected ratio for contralateral tumors was 1.43 for the upper-inner quadrant; 0.97, lower-inner quadrant; 1.51, center; 0.76, upper-outer quadrant; and 0.64, lower-outer quadrant. In each quadrant, except the lower-inner, the observed/expected ratio differed from 1.00 with statistical significance at the 5% level (one-tail). The same analysis, stratified by age and menopausal status, showed a similar shift of tumors, with more than expected in the inner quadrants and center and less than expected in the outer quadrants, although the results did not show statistical significance at the 5% level for all strata. For each patient the mean absorbed radiation dose for each quadrant and center of the breast was estimated, based on measurements in a tissue-equivalent phantom. Among patients the doses ranged from 0.5 to 8 Gy; within individuals, doses to the inner quadrants typically were a factor of three times higher than doses to the outer quadrants. The results suggest that radiation may be a risk factor for contralateral breast tumors and warrants further investigation. ^

AIDS talk

The observations of Michel Foucault, noted Twentieth Century French philosopher, regarding modern power relations and orders of discourse, form the framework utilized to analyze and interpret the power struggles of AIDS activists and their opponents--the religious and radical right, and the administrative agencies of the 'Liberal' welfare State. Supported by the tools of sociolinguistic inquiry, the analysis highlights the success of a safer sex campaign in Houston, Texas to illustrate the dynamics of cultural and political change by means of discursive transformations initiated by the gay micro-culture. The KS/AIDS Foundation, allied with both the biomedical community and gay entertainment spheres, was successful in conveying biomedical cautions that resulted in altered personal behavior and modified public attitudes by using linguistic conventions consonant with the discourse of the Houston gay micro-culture. The transformation of discursive practices transgressed not only the Houston gay micro-culture's boundaries, but the city boundaries of Houston as well. In addition to cultural and political change, moderate and confrontational gay activists also sought to change the cognitive boundaries surrounding 'the gold standard' for clinical research trials.^ From a Foucauldian perspective, the same-sex community evolved from the subordinated Other to a position of power in a period of five years. Transformations in discursive practices and power relations are exemplified by the changing definitions employed by AIDS policy-makers, the public validation of community-based research and the establishment of parallel track drug studies. Finally, transformations in discursive practices surrounding the issues of HIV antibody testing are interpreted using Foucault's six points of power relations. The Montrose Clinic provides the case study for this investigation. The clinic turned the technical rationalities of the State against itself to achieve its own ends and those of the gay micro-culture--anonymous testing with pre and post test counseling. AIDS Talk portrays a dramatic transformation in discursive practices and power relations that transcends the historical moment to provide a model for future activists. Volume 2 contains copies of fugitive primary source materials largely unavailable elsewhere. Original documents are archived in the Harris County Medical Archives in the Houston Academy of Medicine located in the Texas Medical Center Library, Houston, Texas. ^

Contribution of the genes of the renin-angiotensin system to interindividual differences in blood pressure levels in Caucasians from Rochester, Minnesota

The Renin-Angiotensin system (RAS) regulates blood pressure through its effects on vascular tone, renal hemodynamics, and renal sodium and fluid balance. The genes encoding the four major components of the RAS, angiotensinogen, renin, angiotensin I-converting enzyme (ACE), and angiotensin II receptor type 1 (AT1), have been investigated as candidate genes in the pathogenesis of essential hypertension. However, studies have primarily focused on small samples of diseased individuals, and, therefore, have provided little information about the determinants of interindividual variation in blood pressure (BP) in the general population.^ Using data from a large population-based sample from Rochester, MN, I have evaluated the contribution of variation in the region of the RAS genes to interindividual variation in systolic, diastolic, and mean arterial pressure in the population-at-large. Marker genotype data from four polymorphisms located within or very near these genes were first collected on 3,974 individuals from 583 randomly ascertained three-generation pedigrees. Haseman-Elston regression and variance component methods of linkage analysis were then carried out to estimate the proportion of interindividual variance in BP attributable to the effects of variation at these four measured loci.^ A significant effect of the ACE locus on interindividual variation in mean arterial pressure (MAP) was detected in a sample of siblings belonging to the youngest generation. After allowing for measured covariates, this effect accounted for 15-25% of the interindividual variance in MAP, and was even greater in a subset with a positive family history of hypertension. When gender-specific analyses were carried out, this effect was significant in males but not in females. Extended pedigree analyses also provided evidence for an effect of the ACE locus on interindividual variation in MAP, but no difference between males and females was observed. Circumstantial evidence suggests that the ACE gene itself may be responsible for the observed effects on BP, although the possibility that other genes in the region may be at play cannot be excluded.^ No definitive evidence for an effect of the renin, angiotensinogen, or AT1 loci on interindividual variation in BP was obtained in this study, suggesting that the impact of these genes on BP may not be great in the Caucasian population-at-large. However, this does not preclude a larger effect of these genes in some subsets of individuals, especially among those with clinically manifest hypertension or coronary heart disease, or in other populations. ^

Genetic predisposition to prostate cancer

Prostate cancer (PC) is a significant economic and health burden in the U.S. and Europe but its causes are largely unknown. The most significant risk factors (after gender) are age and family history of the disease. A gene with high penetrance but low frequency on chromosome 1q, HPC 1, has been suggested to cause a proportion of the familial aggregation of PC but other more common genes, conferring less risk, are also thought to contribute to disease predisposition. We have pursued a strategy to study both types of genetic risk in PC. To identify high penetrance genes, affected men from thirteen families have been genotyped for genetic linkage analysis at six microsatellite markers spanning 45 cM of 1q24-25. Both LOD score and non-parametric statistics provide no significant support for HPC1 in this genomic region, although 3 of the families did combine to produce a LOD score of 0.9. These families will be included in a genome wide search for other PC predisposition genes as part of a multinational collaboration.^ For study of common genetic factors in PC development, leukocyte DNA samples from an unselected series of 55 patients and 67 controls have been examined for genetic differences in two other candidate genes, the androgen receptor gene, hAR, at Xq11-12, and the vitamin D receptor gene, hVDR, at 12q12-14. hAR was typed for two trinucleotide repeat length polymorphisms, (CAG)$\rm\sb{n}$ and (GGC)$\rm\sb{n},$ encoding polyglutamine and polyglycine tracts, respectively, which have been implicated in PC susceptibility. These data, combined with similarly processed patients and controls from the U.K. show no consistent association of allele length with PC risk. A novel finding, however, has been a significant association between the number of GGC repeats and the length of time between diagnosis and relapse in stage T1-T4 Caucasian patients irrespective of therapy and age of the patient. Of 49 patients who relapsed out of 108 entering the study, those with 16 or fewer GGC repeats had an average relapse-free-period of 101 (+/$-$7.7) months while for those with more than 16 repeats the period averaged 48 (+/$-$2.9) months, a difference of 2.1 fold or 4.4 years.^ The second gene, hVDR, was genotyped at two polymorphisms, a synonymous C/T substitution in exon 9 identified by differential TaqI enzymatic digestion and a variable length polyA tract in the 3$\sp\prime$ UTR. Although these polymorphisms are in strong linkage disequilibrium only the polyA region showed a possible association with PC risk. Men homozygous for alleles with fewer than 18 A's had an increased risk (OR = 3.0, p = 0.0578) compared to controls. This result is opposite to the findings of others and may either indicate off-setting random errors which together balance out to no significant overall effect or reflect more complex genetic and/or environmental associations.^ Overall, this research suggests that single gene familial predisposition may be less prominent in PC than in other cancers and that the characteristics of PC pathology may be useful in identifying the effects of common genetic factors. ^

A process evaluation of the childhood lead poisoning prevention program in Houston, Texas, 1992--1995

A process evaluation of the Houston Childhood Lead Poisoning Prevention Program, 1992-1995, was conducted. The Program's goal is to reduce lead poisoning prevalence. The study proposed to determine to what extent the Program was implemented as planned by measuring how well Program services were actually: (1) received by the intended target population; (2) delivered to children with elevated blood lead levels; (3) delivered in compliance with the Centers for Disease Control and Prevention and Program guidelines and timetables; and (4) able to reduce lead poisoning prevalence among those rescreened. Utilizing a program monitoring design, the Program's pre-collected computer records were reviewed. The study sample consisted of 820 children whose blood lead levels were above 15 micrograms per deciLiter, representing approximately 2.9% of the 28,406 screened over this period. Three blood lead levels from each participant were examined: the initial elevated result; the confirmatory result; and the next rescreen result, after the elevated confirmatory level. Results showed that the Program screened approximately 18% (28,406 of 161,569) of Houston's children under age 6 years for lead poisoning. Based on Chi-square tests of significance, results also showed that lead-poisoned participants were more likely to be younger than 3 years, male and Hispanic, compared to those not lead poisoned. The age, gender and ethnic differences observed were statistically significant (p =.01, p =.00, p =.00). Four of the six Program services: medical evaluations, rescreening, environmental inspections and confirmation, had satisfactory delivery completion rates of 71%-98%. Delivery timetable compliance rates for three of the six services examined: outreach contacts, home visits and environmental inspections were below 32%. However, dangerously elevated blood lead levels fell and lead poisoning prevalence dropped from 3.3% at initial screening to 1.2% among those rescreened, after intervention. From a public health perspective, reductions in lead poisoning prevalence are very meaningful. Based on these findings, the following are recommendations for future research: (1) integrate Program database files by utilizing a computer database management program; (2) target services at Hispanic male children under age 3 years living in the highest risk neighborhoods; (3) increase resources to: improve tracking and documentation of service delivery and provide more non-medical case management and environmental services; and (4) share the evaluation methodology/findings with the Centers for Disease Control and Prevention administrators; the implications may be relevant to other program managers conducting such assessments. ^

The evolution and assessment of pharmaceutical care: Structure, processes, and outcomes

The evolution of pharmaceutical care is identified through a complete review of the literature published in the American Journal of Health-System Pharmacy, the sole comprehensive publication of institutional pharmacy practice. The evolution is categorized according to characteristics of structure (organizational structure, the role of the pharmacist), process (drug delivery systems, formulary management, acquiring drug products, methods to impact drug therapy decisions), and outcomes (cost of drug delivery, cost of drug acquisition and use, improved safety, improved health outcomes) recorded from the 1950s through the 1990s. While significant progress has been made in implementing basic drug distribution systems, levels of pharmacy involvement with direct patient care is still limited.^ A new practice framework suggests enhanced direct patient care involvement through increase in the efficiency and effectiveness of traditional pharmacy services. Recommendations advance internal and external organizational structure relationships that position pharmacists to fully use their unique skills and knowledge to impact drug therapy decisions and outcomes. Specific strategies facilitate expansion of the breadth and scope of each process component in order to expand the depth of integration of pharmacy and pharmaceutical care within the broad healthcare environment. Economic evaluation methods formally evaluate the impact of both operational and clinical interventions.^ Outcome measurements include specific recommendations and methods to increase efficiency of drug acquisition, emphasizing pharmacists' roles that impact physician prescribing decisions. Effectiveness measures include those that improve safety of drug distribution systems, decrease the potential of adverse drug therapy events, and demonstrate that pharmaceutical care can significantly contribute to improvement in overall health status.^ The implementation of the new framework is modeled on a case study at the M.D. Anderson Cancer Center. The implementation of several new drug distribution methods facilitated the redeployment of personnel from distributive functions to direct patient care activities with significant personnel and drug cost reduction. A cost-benefit analysis illustrates that framework process enhancements produced a benefit-to-cost ratio of 7.9. In addition, measures of effectiveness demonstrated significant levels of safety and enhanced drug therapy outcomes. ^

Patterns of care and outcomes for pregnant inmates and their infants in Texas state prisons: Epidemiologic and ethnographic analyses

Female inmates make up the fastest growing segment in our criminal justice system today. The rapidly increasing trend for female prisoners calls for enhanced efforts to strategically plan the correctional facilities that address the needs of this growing population, and to work with communities to prevent crime in women. The incarcerated women in the U.S. have an estimated 145,000 minor children who are predisposed to unique psychosocial problems as a result of parental incarceration.^ This study examined the patterns of care and outcomes for pregnant inmates and their infants in Texas state prisons between 1994 and 1996. The study population consists of 202 pregnant inmates who delivered in a 2-year period, and a randomly sampled comparison cohort of 804 women from general Texas population, matched on race and educational levels. Both quantitative and qualitative data were used to elucidate the inmates' risk-factor profile, delivery/birth outcomes, and the patterns of care during pregnancy. The continuity-of-care issues for this population were also explored.^ Epidemiologic data were derived from multiple record systems to establish the comparison between two cohorts. A significantly great proportion of the inmates have prior lifestyle risk-factors (smoking, alcohol, and illicit drug abuse), poorer health status, and worse medical history. However, most of these existing risk-factors seem to show little manifestation in their current pregnancy. On the basis of maternal labor/delivery outcome and a number of neonatal indicators, this study found some evidence of a better pregnancy outcome for the inmate cohort when compared to the comparison group. Some possible explanations of this paradox were discussed. Seventeen percent of inmates gave birth to infants with suspected congenital syphilis. The placement patterns for the infants' care immediately after birth were elucidated.^ In addition to the quantitative data, an ethnographic approach was used to collect qualitative data from a subset of the inmate cohort (n = 20) and 12 care providers. The qualitative data were analyzed for their contents and themes, giving rise to a detailed description of the inmates' pregnancy experience. Eleven themes emerged from the study's thematic analysis, which provides the context for interpreting the epidemiologic data.^ Meaningful findings in this study were presented in a three-dimensional matrix to shed light on the apparent relationship between outcome indicators and their potential determinants. The suspected "linkages" between the outcome and their determinants can be used to generate hypotheses for future studies. ^

The angiotensin-converting enzyme insertion/deletion polymorphism and its associations with carotid artery wall thickness and coronary heart disease: The atherosclerosis risk in communities study

Coronary heart disease (CHD) is the leading cause of death in the United States. Recently, renin-angiotensin system (RAS) was found associated with atherosclerosis formation, with angiotensin II inducing vascular smooth muscle cell growth and migration, platelet activation and aggregation, and stimulation of plasminogen activator inhibitor-1. Angiotensin II is converted from angiotensin I by angiotensin I-converting enzyme (ACE) and this enzyme is mainly genetically determined. The ACE gene has been assigned to chromosome 17q23 and an insertion/deletion (I/D)polymorphism has been characterized by the presence/absence of a 287 bp fragment in intron 16 of the gene. The two alleles form three genotypes, namely, DD, ID and II and the DD genotype has been linked to higher plasma ACE levels and cell ACE activity.^ In this study, the association between the ACE I/D polymorphism and carotid artery wall thickness measured by B-mode ultrasound was investigated in a biracial sample, and the association between the gene and incident CHD was investigated in whites and if the gene-CHD association in whites, if any, was due to the gene effect on atherosclerosis. The study participants are from the prospective Atherosclerosis Risk in Communities (ARIC) Study, including adults aged 45 to 65 years. The present dissertation used a matched case-control design for studying the associations of the ACE gene with carotid artery atherosclerosis and an unmatched case-control design for the association of the gene with CHD. A significant recessive effect of the D allele on carotid artery thickness was found in blacks (OR = 3.06, 95% C.I: 1.11-8.47, DD vs. ID and II) adjusting for age, gender, cigarette smoking, LDL-cholesterol and diabetes. No similar associations were found in whites. The ACE I/D polymorphism is significantly associated with coronary heart disease in whites, and while stratifying data by carotid artery wall thickness, the significant associations were only observed in thin-walled subgroups. Assuming a recessive effect of the D allele, odds ratio was 2.84 (95% C.I:1.17-6.90, DD vs. ID and II) and it was 2.30 (95% C.I:1.22-4.35, DD vs. ID vs. II) assuming a codominant effect of the D allele. No significant associations were observed while comparing thick-walled CHD cases with thin-walled controls. Following conclusions could be drawn: (1) The ACE I/D polymorphism is unlikely to confer appreciable increase in the risk of carotid atherosclerosis in US whites, but may increases the risk of carotid atherosclerosis in blacks. (2) ACE I/D polymorphism is a genetic risk factor for incident CHD in US whites and this effect is separate from the chronic process of atherosclerosis development. Finally, the associations observed here are not causal, since the I/D polymorphism is in an intron, where no ACE proteins are encoded. ^

HIV-related malignancies: A community-based study using a linkage of cancer registry and HIV registry data

Background. Increased incidence of cancer is documented in immunosuppressed transplant patients. Likewise, as survival increases for persons infected with the Human Immunodeficiency Virus (HIV), we expect their incidence of cancer to increase. The objective of this study was to examine the current gender specific spectrum of cancer in an HIV infected cohort (especially malignancies not currently associated with Acquired Immunodeficiency Syndrome (AIDS)) in relation to the general population.^ Methods. Cancer incidence data was collected for residents of Harris County, Texas who were diagnosed with a malignancy between 1975 and 1994. This data was linked to HIV/AIDS registry data to identify malignancies in an HIV infected cohort of 14,986 persons. A standardized incidence ratio (SIR) analysis was used to compare incidence of cancer in this cohort to that in the general population. Risk factors such as mode of HIV infection, age, race and gender, were evaluated for contribution to the development of cancer within the HIV cohort, using Cox regression techniques.^ Findings. Of those in the HIV infected cohort, 2289 persons (15%) were identified as having one or more malignancies. The linkage identified 29.5% of these malignancies (males 28.7% females 60.9%). HIV infected men and women had incidences of cancer that were 16.7 (16.1, 17.3) and 2.9 (2.3, 3.7) times that expected for the general population of Harris County, Texas, adjusting for age. Significant SIR's were observed for the AIDS-defining malignancies of Kaposi's sarcoma, non-Hodgkin's lymphoma, primary lymphoma of the brain and cancer of the cervix. Additionally, significant SIR's for non-melanotic skin cancer in males, 6.9 (4.8, 9.5) and colon cancer in females, 4.0 (1.1, 10.2) were detected. Among the HIV infected cohort, race/ethnicity of White (relative risk 2.4 with 95% confidence intervals 2.0, 2.8) or Spanish Surname, 2.2 (1.9, 2.7) and an infection route of male to male sex, with, 3.0 (1.9, 4.9) or without, 3.4 (2.1, 5.5) intravenous drug use, increased the risk of having a diagnosis of an incident cancer.^ Interpretation. There appears to be an increased risk of developing cancer if infected with the HIV. In addition to the malignancies routinely associated with HIV infection, there appears to be an increased risk of being diagnosed with non-melanotic skin cancer in males and colon cancer in females. ^

A quality of life subscale for terminally ill cancer patients

A subscale was developed to assess the quality of life of cancer patients with a life expectancy of six months or less. Phase I of this study identified the major concerns of 74 terminally ill cancer patients (19 with breast cancer, 19 with lung cancer, 18 with colorectal cancer, 9 with renal cell cancer, 9 with prostate cancer), 39 family caregivers, and 20 health care professionals. Patients interviewed were being treated at the University of Texas M. D. Anderson Cancer Center or at the Hospice at the Texas Medical Center in Houston. In Phase II, 120 patients (30 with breast cancer, 30 with lung cancer, 30 with colorectal cancer, 15 with prostate cancer, and 15 with renal cell cancer) rated the importance of these concerns for quality of life. Items retained for the subscale were rated as "extremely important" or "very important" by at least 60% of the sample and were reported as being applicable by at least two-thirds of the sample. The 61 concerns that were identified were formatted as a questionnaire for Phase III. In Phase III, 356 patients (89 with breast cancer, 88 with lung cancer, 88 with colorectal cancer, 44 with prostate cancer, and 47 with renal cell cancer) were interviewed to determine the subscale's reliability and sensitivity to change in clinical status. Both factor analysis and item response theory supported the inclusion of the same 35 items for the subscale. Internal consistency reliability was moderate to high for the subscale's domains: spiritual (0.87), existential (0.76), medical care (0.68), symptoms (0.67), social/family (0.66), and emotional (0.61). Test-retest correlation coefficients also were high for the domains: social/family (0.86), emotional (0.83), medical care (0.83), spiritual (0.75), existential (0.75), and symptoms (0.81).^ In addition, concurrent validity was supported by the high correlation between the subscale's symptom domain and symptom items from the European Organization for Research and Treatment of Cancer (EORTC) scale (r = 0.74). Patients' functional status was assessed with the Eastern Cooperative Oncology Group (ECOG) Performance status rating. When ECOG categories were compared to subscale domains, patients who scored lower in functional status had lower scores in the spiritual, existential, social/family, and emotional domains. Patients who scored lower in physical well-being had higher scores in the symptom domain. Patient scores in the medical care domain were similar for each ECOG category. The results of this study support the subscale's use in assessing quality of life and the outcomes of palliative treatment for cancer patients in their last six months of life. ^

An evaluation of a community-based program for homeless adults with mental disorders and comorbid alcohol drug and mental disorders

Limited research has been conducted evaluating programs that are designed to improve the outcomes of homeless adults with mental disorders and comorbid alcohol, drug and mental disorders. This study conducted such an evaluation in a community-based day treatment setting with clients of the Harris County Mental Health and Mental Retardation Authority's Bristow Clinic. The study population included all clients who received treatment at the clinic for a minimum of six months between January 1, 1995 and August 31, 1996. An electronic database was used to identify clients and to track their program involvement. A profile was developed of the study participants and their level of program involvement included an examination of the amount of time spent in clinical, social and other interventions, the type of interventions encountered and the number of interventions encountered. Results were analyzed to determine whether social, demographic and mental history affected levels of program involvement and the effects of the levels of program involvement on housing status and psychiatric functioning status.^ A total of 101 clients met the inclusion criteria. Of the 101 clients, 96 had a mental disorder, and five had comorbidity. Due to the limited numbers of participants with comorbidity, only those with mental disorders were included in the analysis. The study found the Bristow Clinic population to be primarily single, Black, male, between the ages of 31 and 40 years, and with a gross family income of less than $4,000. There were more persons residing on the streets at entry and at six months following treatment than in any other residential setting. The most prevalent psychiatric diagnoses were depressive disorders and schizophrenia. The Global Assessment of Functioning (GAF) scale which was used to determine the degree of psychiatric functioning revealed a modal GAF score of 31--40 at entry and following six months in treatment. The study found that the majority of clients spent less than 17 hours in treatment, had less than 51 encounters and had clinical, social, and other encounters. In regard to social and demographic factors and levels of program involvement, there were statistically significant associations between gender and ethnicity and the types of interventions encountered as well as the number of interventions encountered. There was also a statistically significant difference between the amount of time spent in clinical interventions and gender. Relative to outcomes measured, the study found female gender to be the only background variable that was significantly associated with improved housing status and the female gender and previous MHMRA involvement to be statistically associated with improvement in GAF score. The total time in other (not clinical or social) interventions and the total number of encounters with other interventions were also significantly associated with improvement in housing outcome. The analysis of previous services and levels of program involvement revealed significant associations between time spent in social and clinical interventions and previous hospitalizations and previous MHMRA involvement.^ Major limitations of this study include the small sample size which may have resulted in very little power to detect differences and the lack of generalizability of findings due to site locations used in the study. Despite these limitations, the study makes an important contribution to the literature by documenting the levels of program involvement and the social and demographic factors necessary to produce outcomes of improved housing status and psychiatric functioning status. ^

Incidence, etiology and risk factors of neonatal seizures Harris County, Texas, 1992--1994

This study was conducted to determine the incidence and etiology of neonatal seizures, and evaluate risk factors for this condition in Harris County, Texas, between 1992 and 1994. Potential cases were ascertained from four sources: discharge diagnoses at local hospitals, birth certificates, death certificates, and a clinical study of neonatal seizures conducted concurrent with this study at a large tertiary care center in Houston, Texas. The neonatal period was defined as the first 28 days of life for term infants, and up to 44 weeks gestation for preterm infants.^ There were 207 cases of neonatal seizures ascertained among 116,048 live births, yielding and incidence of 1.8 per 1000. Half of the seizures occurred by the third day of life, 70% within the first week, and 93% within the first 28 days of life. Among 48 preterm infants with seizures 15 had their initial seizure after the 28th day of life. About 25% of all seizures occurred after discharge from the hospital of birth.^ Idiopathic seizures occurred most frequently (0.5/1000 births), followed by seizures attributed to perinatal hypoxia/ischemia (0.4/1000 births), intracranial hemorrhage (0.2/1000 births), infection of the central nervous system (0.2/1000 births), and metabolic abnormalities (0.1/1000 births).^ Risk factors were evaluated based on birth certificate information, using univariate and multivariate analysis (logistic regression). Factors considered included birth weight, gender, ethnicity, place of birth, mother's age, method of delivery, parity, multiple birth and, among term infants, small birth weight for gestational age (SGA). Among preterm infants, very low birth weight (VLBW, $<$1500 grams) was the strongest risk factor, followed by birth in private/university hospitals with a Level III nursery compared with hospitals with a Level II nursery (RR = 2.9), and male sex (RR = 1.8). The effect of very low birth weight varied according to ethnicity. Compared to preterm infants weighing 2000-2999 grams, non-white VLBW infants were 12.0 times as likely to have seizures; whereas white VLBW infants were 2.5 times as likely. Among term infants, significant risk factors included SGA (RR = 1.8), birth in Level III nursery private/university hospitals versus hospitals with Level II nursery (RR = 2.0), and birth by cesarean section (RR = 2.2). ^