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PubMed2001

The collaborative practice model for bipolar disorder: design and implementation in a multi-site randomized controlled trial.

Bipolar disorder remains a high morbidity and costly illness in general clinical practice, despite the availability of efficacious medications. This 'efficacy-effectiveness gap' may be addressed by better organizing systems of care. One type of intervention is the 'collaborative practice model' which can be defined as an organization of care that a) emphasizes development in the patient of illness management skills, and b) supports provider capability and availability in order to c) engage patients in timely, joint decision-making regarding their illness. This article describes such a collaborative practice model for bipolar disorder, designed to be widely adoptable and sustainable in general clinical practice. The first part of the article describes the theoretical background from which the collaborative practice approach developed, emphasizing its origins in the lithium clinics of the 1970s, in nursing theory and practice, and more recently in the management of chronic medical diseases. The second part describes the structure of one such intervention, the Bipolar Disorders Program (BDP) developed in the Veterans Affairs health care system. The third part summarizes results from single-site studies of the intervention. The fourth part describes several key issues in its implementation in an ongoing multi-site randomized controlled trial, VA Cooperative Study Program (CSP) # 430. Data to date indicate that such collaborative practice interventions may improve important process and intermediate outcome variables for bipolar disorder. The BDP provides an example of a multi-faceted collaborative practice model that can be manualized and implemented across multiple sites in a randomized controlled trial.

Adult↗
PubMed1988

Attitudes toward sex, arousal, and the retention of contraceptive information.

Previous research has suggested that women with a negative emotional orientation toward sexuality (i.e., erotophobia) have difficulty learning and retaining sexually relevant material such as contraceptive information. It has been hypothesized that these women become aroused by this material and that this arousal interferes with their ability to learn it. The importance of this issue led us to conduct the current study. Erotophobic and erotophilic women viewed presentations about contraception while their physiological responses were being monitored. In addition, they were tested on the information contained in the presentation before, immediately after, and again 4-6 weeks after the presentation. The results indicated that the erotophobic women knew less contraceptive information before the presentation and were more aroused by the presentation. This arousal, however, did not interfere with retention of the material. These results are discussed in terms of individual differences in reactions to sexual material and the ability to learn, retain, and use contraceptive information.

Arousal↗
PubMed2003

Metastatic renal carcinoma comprehensive prognostic system.

The purpose of the study was to identify a comprehensive prognostic system of pretreatment clinical parameters in 425 patients (pts) with metastatic renal-cell carcinoma treated with different subcutaneous (s.c.) recombinant cytokine-based home therapies in consecutive trials. Treatment consisted of (A) s.c. interferon-alpha 2a (INF-alpha), s.c. interleukin-2 (IL-2) (n=102 pts), (B) s.c. IFN-alpha 2a, s.c. IL-2, and i.v. 5-fluorouracil (5-FU) (n=235 pts) or (C) s.c. IFN-alpha 2a, s.c. IL-2, and i.v. 5-FU combined with p.o. 13-cis-retinoic acid (13cRA) (n=88 pts). Kaplan-Meier survival analysis, log-rank statistics, and Cox regression analysis were employed to identify risk factors and to create a multiple risk factor model. The following pretreatment risk factors were identified by univariate analysis: (1) three and more metastatic sites, (2) presence of liver, lymph node or bone metastases, (3) neutrophil count > or = 6500 cells microl(-1), (4) serum lactate dehydrogenase level (LDH) > or = 220 U l(-1), and (5) serum C-reactive protein level (CRP) > or = 11 mg l(-1). Cox regression analysis with forward stepwise variable selection identified neutrophil count as the major prognostic factor (hazard ratio=1.9, P<0.001), while serum levels of LDH and CRP, time between diagnosis of tumour and onset of metastatic disease, number of metastatic sites, and bone metastases were significant but somewhat less important prognostic variables within the multiple risk factor model (hazard ratio < or = 1.5). Patients were assigned to one of the three risk groups according to cumulative risk defined as the sum of simplified risk s.c.ores for six pretreatment variables. Low-, intermediate-, and high-risk patients achieved a median overall survival of 32+ months (95% CI 24, 43; 5-year survival of 27%), 18+ months (95% CI 15, 20; 5-year survival of 11%), and 8+ months (95% CI 6, 10; 5-year survival of 5%), respectively. These prognostic categories are helpful both in individual patient care and in the assessment of patients entering prospective clinical trials.

Carcinoma, Renal Cell↗
PubMed2002

Bacterial vaginosis and vaginal fluid defensins during pregnancy.

OBJECTIVE: The purpose of this study was to examine the association between Gram stain findings of vaginal fluid and the concentration of vaginal fluid neutrophil defensins. STUDY DESIGN: Vaginal fluid specimens obtained from 749 women at 24 to 29 weeks of gestation were tested for bacterial vaginosis and assayed for neutrophil defensins. Bacterial vaginosis was studied as a categoric variable (negative, intermediate, and positive), whereas defensins were examined as a continuous measure and dichotomized on the basis of presence versus absence and at the 90th percentile. Multiple linear and logistic regression models were used to assess the relationship between bacterial vaginosis and defensins. RESULTS: Women with intermediate bacterial vaginosis were more likely to have elevated vaginal fluid neutrophil defensins (>90th percentile) than women with normal vaginal flora (adjusted odds ratio, 2.3; 95% CI, 1.3, 4.2), whereas women with frank bacterial vaginosis were not (adjusted odds ratio, 1.3; 95% CI, 0.7, 2.6). Among women with any detectable defensin (69.5% of the study population), intermediate bacterial vaginosis was associated positively with defensin concentrations in multiple linear regression models (P =.007). Women with intermediate and frank bacterial vaginosis had 5.9 microg/mL and 2.2 microg/mL higher defensin concentrations, respectively, than women who did not have bacterial vaginosis. The presence of leukocytes in vaginal fluids was associated positively with defensin concentrations (P <.0001). CONCLUSION: Changes in vaginal microflora during mid pregnancy are associated with an increased concentration of vaginal fluid neutrophil defensins.

Adolescent↗
PubMed2001

Identification of a conserved erythroid specific domain of histone acetylation across the alpha-globin gene cluster.

We have analyzed the pattern of core histone acetylation across 250 kb of the telomeric region of the short arm of human chromosome 16. This gene-dense region, which includes the alpha-globin genes and their regulatory elements embedded within widely expressed genes, shows marked differences in histone acetylation between erythroid and non-erythroid cells. In non-erythroid cells, there was a uniform 2- to 3-fold enrichment of acetylated histones, compared with heterochromatin, across the entire region. In erythroid cells, an approximately 100-kb segment of chromatin encompassing the alpha genes and their remote major regulatory element was highly enriched in histone H4 acetylated at Lys-5. Other lysines in the N-terminal tail of histone H4 showed intermediate and variable levels of enrichment. Similar broad segments of erythroid-specific histone acetylation were found in the corresponding syntenic regions containing the mouse and chicken alpha-globin gene clusters. The borders of these regions of acetylation are located in similar positions in all three species, and a sharply defined 3' boundary coincides with the previously identified breakpoint in conserved synteny between these species. We have therefore demonstrated that an erythroid-specific domain of acetylation has been conserved across several species, encompassing not only the alpha-globin genes but also a neighboring widely expressed gene. These results contrast with those at other clusters and demonstrate that not all genes are organized into discrete regulatory domains.

Acetylation↗
PubMed1993

Another look at heredity and environment as shapers of the person: a proximal-distal framework for consideration.

"An important psychological question addressed by population researchers pertains to what causes us to be what we are--what might predict reliably to intelligence, interpersonal style, or other aspects of the psycho-social being. The goal of this paper is not to propose or rule out various causal factors, but rather to offer a developmental perspective that may provide a greater understanding of the ways in which distal and proximal factors might influence such processes throughout the life span. We will begin by reviewing some major approaches and will then attempt to meld these into a developmental perspective.... We offer some inferences we have derived from a review of literature pertaining to four stages of development: infancy and early childhood; pre-school and kindergarten; first through sixth grades; and sixth grade through high school."

Behavior↗
PubMedDate not supplied

Proximate determinants of fertility in Nigeria.

Data from the 1981-82 Nigeria Fertility Survey (NFS) are used to identify the key proximate determinants of fertility in Nigeria. The patterns of their individual and collective effects are analyzed in a search for possible sources of fertility change. Exposure to the risk of childbearing through first marriage is found to be the most important proximate determinant of Nigerian fertility. Subsequent to marriage, fertility is determined mainly by breastfeeding and postpartum sexual abstinence. Where fertility shows significant socioeconomic variations, there are equally identifiable patterns of the impact of the proximate determinants which explain these differentials to a large extent. On a national scale, the observed patterns of the impact of the measured proximate determinants do not appear to suggest that Nigerian fertility is soon to experience a large decline.

Adolescent↗
PubMed1987

Anthropometry and subsequent mortality in groups of children aged 6-59 months in Guinea-Bissau.

To assess the importance of nutritional status for subsequent survival, 2228 children aged 6-59 mo were followed for 8-12 mo in four different areas of Guinea-Bissau. The overall death rate was 0.62/100 child-months of follow-up (126 deaths) and 0.63 for the 1756 children who were examined on entering the study (109 deaths). Mortality was twice as high in the periurban as in the rural areas due to an outbreak of measles. In a bivariate analysis the relationship between nutritional status indicators and mortality was confounded by the age dependence of both. Using Cox's regression technique, height-for-age but not weight-for-height was positively correlated with survival. The number of children in the household was a better discriminator for death from measles than was nutritional status. Long-term factors, probably of multiple social origin, are likely causes of both relatively short stature and high mortality.

Body Height↗
PubMed1983

Egg-laying defective mutants of the nematode Caenorhabditis elegans.

We have isolated 145 fertile mutants of C. elegans that are defective in egg laying and have characterized 59 of them genetically, behaviorally and pharmacologically. These 59 mutants define 40 new genes called egl. for egg-laying abnormal. Most of the other mutants are defective in previously identified genes. The egl mutants differ with respect to the severity of their egg-laying defects and the presence of behavioral or morphological pleiotropies. We have defined four distinct categories of mutants based on their responses to the pharmacological agents serotonin and imipramine, which stimulate egg laying by wild-type hermaphrodites. These drugs test the functioning of the vulva, the vulval and uterine muscles and the hermaphrodite-specific neurons (HSNs), which innervate the vulval muscles. Mutants representing 14 egl genes fail to respond to serotonin and to imipramine and are likely to be defective in the functioning of the vulva or the vulval and uterine muscles. Four mutants (representing four different genes) lay eggs in response to serotonin but not to imipramine and appear to be egg-laying defective because of defects in the HSNs; three of these four were selected specifically for these drug responses. Mutants representing seven egl genes lay eggs in response to serotonin and to imipramine. One egl mutant responds to imipramine but not to serotonin. The remaining egl mutants show variable or intermediate responses to the drugs. Two of the HSN-defective mutants, egl-1 and her-1(n695), lack HSN cell bodies and are likely to be expressing the normally male-specific program of HSN cell death. Whereas egl-1 animals appear to be defective specifically in HSN development, her-1(n695) animals exhibit multiple morphological pleiotropies, displaying partial transformation of the sexual phenotype of many cells and tissues. At least two of the egl mutants appear to be defective in the processing of environmental signals that modulate egg laying and may define new components of the neural circuitry that control egg laying.

Animals↗
PubMed1988

Case-control studies of the effect of environmental sanitation on diarrhoea morbidity: methodological implications of field studies in Africa and Asia.

The problems and prospects in the use of case-control studies to assess the effects of improvements in environmental sanitation on diarrhoea morbidity are discussed on the basis of two field studies. It is concluded that an adequate design is available for assessing the effects of a single improvement on diarrhoeal disease. The estimates of effect appear to be valid and sufficiently precise. For addressing more complex questions of interactions, sample sizes would have to be increased substantially. The experience with two field studies suggests that there is hope that a simpler protocol may be feasible, in which only limited information is collected, in which few home visits are made, and in which analytical techniques are simple. Until more field studies have been conducted definitive conclusions cannot be reached on the applicability of such a simple, rapid and inexpensive approach.

Child, Preschool↗
PubMed1992

Menstrual function after tubal sterilization.

More than 10 million women in the United States have undergone tubal sterilization. There has been concern that this procedure may increase the risk of later menstrual dysfunction. The Collaborative Review of Sterilization (CREST) is a large, multicenter, prospective study of tubal sterilization in the United States. This report describes CREST participants who were interviewed immediately before sterilization and again in annual poststerilization interviews for up to 5 years between 1978 and 1988. The authors analyzed reported changes in six menstrual cycle characteristics for 5,070 women undergoing interval sterilizations. Longitudinal, multivariate regression was used to adjust for baseline menstrual function and other potential confounders. Five years after sterilization, 35% of the CREST participants reported high levels of menstrual pain, 49% reported heavy or very heavy menstrual flow, and 10% reported spotting between periods. In contrast to the fifth year, the first year of follow-up was similar to presterilization menstrual function; in the first year, 27% of participants reported high menstrual pain, 41% reported heavy menstrual flow, and 7% reported spotting. These findings may be affected by aging of the cohort and other study limitations, but they suggest that if tubal sterilization leads to changes in menstrual function, such changes may take some time to develop.

Adolescent↗
PubMed1999

Responsiveness of outcome measures in juvenile chronic arthritis. Italian Pediatric Rheumatology Study Group.

OBJECTIVE: To examine the responsiveness of the disease activity measures more commonly used in juvenile chronic arthritis (JCA) clinical trials. METHODS: Data were obtained from an open-label, non-controlled, multicentre trial designed to investigate the efficacy of methotrexate (MTX) in children with JCA. Outcome measures, including physician and parent global assessments, functional ability measures, articular variables, and laboratory indicators of systemic inflammation, were assessed at baseline and after 6 months of MTX treatment in 132 patients. Responsiveness of endpoint variables was evaluated by assessing the effect size (ES) and the standardized response median (SRM). RESULTS: Physician and parent global assessments were the more responsive instruments, showing ES and SRM above 1.0. Erythrocyte sedimentation rate, C-reactive protein, functional status measures and articular variables showed intermediate responsiveness. Morning stiffness, haemoglobin and platelet count were the least responsive instruments. CONCLUSION: The results of our analysis indicate that subjective estimations of the disease activity, either by the physician or parents, are the most responsive instruments in the assessment of the therapeutic response in children with JCA. The responsiveness of outcome measures in JCA should be further investigated in prospective controlled studies.

Adolescent↗