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PubMed2003

A feasibility study of the evaluation of the Florida breast cancer early detection program using the statewide cancer registry.

In Florida, a Center for Disease Control and Prevention (CDC)-funded initiative of the Florida Department of Health has targeted socio-economically disadvantaged women for breast and cervical cancer screening. Since 1995, over 12,000 women aged 50-64, within 200% of the federally defined poverty level, with no health insurance, and living in metropolitan catchment areas in Florida, have been screened by the Florida Breast and Cervical Cancer Early Detection Program (BCCEDP). This was a matched cohort cross-sectional analysis of a cohort study of Florida women with breast cancer using the Florida incident cancer registry, the Florida Cancer Data System (FCDS). The study evaluated the hypothesis that there would be no difference in the stage at diagnosis between breast cancer cases in the BCCEDP-screening program and breast cancer cases not diagnosed in the screening program. After linking the BCCEDP records with the FCDS, BCCEDP-screened cases were matched on gender, age, race, ethnicity, and other variables with five groups of FCDS breast cancer cases not screened by BCCEDP to control for demographic and socio-economic factors. Breast cancer cases diagnosed in BCCEDP were significantly more likely to be diagnosed at later stage than non-BCCEDP breast cancer cases in the five matched groups. The BCCEDP is not purely a screening program since it also caters to symptomatic women in the indigent population, therefore these finding were expected. In fact, 71% of the BCCEDP cases were symptomatic at the time of screening/diagnosis and 53% were late-stage diagnosed. These findings show that BCCEDP is indeed servicing its targeted population of medically under-served and symptomatic women in Florida. Furthermore, despite limitations, this study illustrates the potential collaboration between cancer registries and breast cancer screening programs for quality control purposes.

Breast Neoplasms↗
PubMed2005

TB and HIV in St Petersburg, Russia: a looming catastrophe?

BACKGROUND: After decades of improved tuberculosis (TB) control in Russia, notification rates started to rise in 1992. Russia also faces a fast growing human immunodeficiency virus (HIV) epidemic. OBJECTIVE: To document the extent and characteristics of HIV co-infection in TB patients in St Petersburg, Russia. DESIGN: A prospective cross-sectional study of HIV coinfected culture-positive TB cases. Between 15 June 2002 and 31 March 2003, TB cases at the St Petersburg City TB hospitals and dispensaries were screened for HIV infection. At the HIV Prevention and Treatment Center, HIV-infected individuals were offered TB screening. RESULTS: Forty-nine HIV-infected culture-positive TB cases were identified, mainly at TB hospitals and dispensaries. Most were new pulmonary TB cases. The majority were young (69% < or = 30 years of age), male (84%), unemployed (94%) individuals with a history of injection drug use (IDU) (92%), and, in 35% of cases a history of incarceration. Active case finding was high among contacts of cases (9%), but was not successful in HIV-infected IDUs. CONCLUSION: Although the HIV seroprevalence rate is rising among TB patients, HIV does not yet appear to be driving the St Petersburg TB epidemic. Aggressive collaborative TB-HIV control efforts may still avert adverse effects of HIV on the TB epidemic.

Adult↗
PubMed2000

Protection of privacy by third-party encryption in genetic research in Iceland.

As the new human genetics continues its dramatic expansion into many laboratories and medical institutions, the concern for the protection of the personal privacy of individuals who participate increases. It seems that even the smallest of laboratories must confront the issue of how to protect the genetic and phenotypic information of participants in their research. Some have promoted the use of anonymity as a way out of this dilemma. But we are reminded by others that the future cannot be predicted, and that future benefits may be lost when the links to these benevolent volunteers are gone forever. More recently, some ethical bodies have suggested, without specific recommendations, that a reversible third-party encryption system may be a solution to this problem. However, they have not provided a route or even examples of how to proceed. We present here the Icelandic approach to this issue by developing a third-party encryption system in direct collaboration with the Data Protection Commission (DPC) of Iceland. We have incorporated the encryption system within our sample collection and storage software, which minimises inconvenience but enhances security. The strategy assures a barrier between the laboratory and the outside world that can only be crossed by the DPC.

Bioethics↗
PubMed2001

Penicillin-resistant Streptococcus pneumoniae in metropolitan New York hospitals: case control study and molecular typing of resistant isolates.

During the 4-month period from January to April, 1998, 476 patients with Streptococcus pneumoniae infections were detected in 12 metropolitan New York hospitals and 112 penicillin-resistant (PRP) isolates (24%) were identified in 11 institutions. A case control study of 100 patients with penicillin-resistant and susceptible pneumococci from four of the widely dispersed hospitals revealed a high incidence of underlying medical illnesses in adult patients (74%), a preponderance of patients with pneumonia (63%), and a majority of patients who had underlying risk factors for pneumonia or invasive disease (51%). In this limited case control study, no difference was noted between cases and controls regarding known risk factors for penicillin-resistant pneumococcal infections. The percentage of single-patient PRP isolates varied among individual hospitals but the mean percentages of PRP from the four participating University Medical Centers and seven community hospitals were similar: 26% and 22% respectively. By E-test, 60% and 26% were high-level penicillin and ceftriaxone resistant, respectively. Pulsed-field gel electrophoresis identified 26 chromosomal macrorestriction patterns among the 103 PRP isolates available for analysis, but almost half (50 isolates or 48%) of these belong to two drug-resistant internationally spread clones, SP(23)-1 and SP(9/14)-3, that were detected in all hospitals and were recovered from invasive and noninvasive sites in both children and adults.

Adolescent↗
PubMed1995

Fc gamma receptor IIIb enhances Fc gamma receptor IIa function in an oxidant-dependent and allele-sensitive manner.

Two classes of receptors for IgG, Fc gamma RIIa and Fc gamma RIIIb, both of which exist in two allelic forms, are expressed on human neutrophils. Neutrophils from normal donors, homozygous for the different allelic phenotypes of Fc gamma RIIIb, have significantly different levels of Fc gamma receptor-mediated phagocytosis of IgG-opsonized erythrocytes (EA). However, the observation that Fc gamma RIIIb mediates phagocytosis of specific mAb-targeted erythrocytes poorly suggests that this receptor may influence EA internalization by Fc gamma RIIa in an allele-sensitive fashion. Donors homozygous for the NA1 allele of Fc gamma RIIIb showed greater activation of Fc gamma RIIa after Fc gamma RIIIb cross-linking than donors homozygous for the NA2 allele of Fc gamma RIIIb. This increase in receptor-specific internalization reflects both an increase in ligand binding by Fc gamma RIIa and an increase in internalization efficiency of targets bound. Activation of Fc gamma RIIa by Fc gamma RIIIb is transferable by supernatants from activated cells and is blocked by inhibitors of reactive oxygen species and the H2O2-myeloperoxidase-chloride system and by serine protease inhibitors. Thus, cross-linking of Fc gamma RIIIb, which leads to neutrophil degranulation and the generation of reactive oxygen intermediates, in turn alters Fc gamma RIIa avidity and efficiency. These oxidant-mediated changes in Fc gamma RIIa function provide a novel mechanism for receptors to collaborate in both an autocrine and paracrine fashion. The allele sensitivity of these effects suggests that Fc gamma receptor polymorphisms may be inherited disease susceptibility factors in host defense against infection and in the development of autoimmunity.

Adult↗
PubMed1996

[An in vitro alternative to the mouse neutralisation assay for potency testing of betatoxoid containing Clostridium, perfringens type B and type C vaccines for veterinary use]

The quality control of Clostridium (C.) perfringens type B and type C vaccines requires animal experiments according to European Pharmacopoiea monograph 363. For potency estimation, the vaccine is first administered to rabbits. In a second step antibodies from these rabbits against C. perfringens betatoxin are measured quantitatively in a mouse neutralisation assay using lethal doses of betatoxin for the challenge. We report about the development of an in vitro assay enabling specific and reproducible measurement of antibodies against C. perfringens betatoxin in rabbit sera. A Capure-Enzyme Linked Immuno Sorbent Assay (ELISA) using a monoclonal antibody against betatoxin as catching antibody was used. A rabbit serumpool freeze dried in 3500 aliquots was always used as reference. This reference serum can be supplied for further national or international collaborative studies. The estimation of relative potency of unknown sera in a parallel line assay was calculated with a computer programme provided by the World health organisation (WHO). The capture-ELISA did not show unspecific reactivity with pre-vaccination sera of cross-reactivity with sera from rabbits immunised with other clostridial antigens e.g. C. perfringens type D, C. chavoei or C. tetani. Reproducibility studies focused on the linear parts of the dose-response curves resulted in intra-assay coefficient of variations of less then 10%. The inter-assay coefficient varied between 12-25% depending on the serum dilutions used. Correlation studies between the result of the animal experiment (only one test) and the capture-ELISA (10 repetitions) from four rabbit serum pools revealed a coefficient of correlation of 0.81-0.84 depending on the basis for calculation of r (Mean or Median from ELISA repetitions). Therefore this test may be a suitable alternative for the currently required mouse neutralisation assay. For acceptance of this test by the European Pharmacopoiea further validation studies are necessary.

Journal Article↗
PubMed1991

Detecting fabrication of data in a multicenter collaborative animal study.

In 1980-1981 the National Heart, Lung, and Blood Institute (NHLBI) sponsored a multicenter study of animal models for protection of ischemic myocardium (AMPIM). After data collection for the study was complete, problems were identified with data from one of the labs. This article deals with the issue of statistical evidence versus hard evidence as well as the process of crossing the boundary from suspicion to certainty regarding the nature and extent of the problem.

Animals↗
PubMed2005

Older patients' aversion to antidepressants. A qualitative study.

BACKGROUND: Depression is common among older patients yet is often inadequately treated. Patient beliefs about antidepressants are known to affect treatment initiation and adherence, but are often not expressed in clinical settings. OBJECTIVE: To explore attitudes toward antidepressants in a sample of depressed, community-dwelling elders who were offered treatment. DESIGN. Cross-sectional, qualitative study utilizing semi-structured interviews. PARTICIPANTS: Primary care patients age 60 years and over with depression, from academic and community primary care practices of the University of Pennsylvania Health System and the Philadelphia Department of Veterans Affairs. Patients participated in either the Prevention of Suicide in Primary Care Elderly: Collaborative Trial or the Primary Care Research in Substance Abuse and Mental Health for the Elderly Trial. Sixty-eight patients were interviewed and responses from 42 participants with negative attitudes toward medication for depression were analyzed. MEASUREMENTS: Interviews were audiotaped, transcribed, and entered into a qualitative software program for coding and analysis. A multidisciplinary team of investigators coded the transcripts and identified key features of narratives expressing aversion to antidepressants. RESULTS: Four themes characterized resistance to antidepressants: (1) fear of dependence; (2) resistance to viewing depressive symptoms as a medical illness; (3) concern that antidepressants will prevent natural sadness; (4) prior negative experiences with medications for depression. CONCLUSIONS: Many elders resisted the use of antidepressants. Patients expressed concerns that seem to reflect their concept of depression as well as their specific concerns regarding antidepressants. These findings may enhance patient-provider communication about depression treatment in elders.

Aged↗
PubMed1999

Preferences for participation in treatment decision making and information needs of parents of children with cancer: a pilot study.

This study was performed to obtain information on parents of children with cancer: (a) what role parents preferred to assume in treatment decision making (TDM); (b) parents' priority information needs; (c) if a relationship existed between TDM preferences and information needs; and (d) if sociodemographic, disease and treatment variables predicted TDM preferences or information needs. A cross-sectional survey was conducted with a convenience sample of 58 parents who had a child less than 13 years of age diagnosed with cancer in the previous year. Instruments included a Sociodemographic, Disease, and Treatment Questionnaire; the Control Preferences Scale for Pediatrics, and an Information Needs Questionnaire. The results showed that parents had systematic preferences about TDM, preferring collaborative followed by passive and active roles. Nine priorities in information needs (highest to lowest) were found: (a) treatments and tests, (b) cure, (c) caring for my child, (d) emotional impact, (e) side effects, (f) physical impact, (g) disease, (h) coping with painful procedures, and (i) impact on the family. Sociodemographic, disease and treatment variables were not predictive of preferences for TDM or information needs. Concrete informational needs take precedence over issues of emotional or family impact or pain. A low Kendall's coefficient (0.07) indicated that parents as a group do not have uniform information needs. Information giving must be individualized.

Adult↗
PubMed2006

Using standardized methods for research on HIV and injecting drug use in developing/transitional countries: case study from the WHO Drug Injection Study Phase II.

BACKGROUND: Successful cross-national research requires methods that are both standardized across sites and adaptable to local conditions. We report on the development and implementation of the methodology underlying the survey component of the WHO Drug Injection Study Phase II--a multi-site study of risk behavior and HIV seroprevalence among Injecting Drug Users (IDUs). METHODS: Standardized operational guidelines were developed by the Survey Coordinating Center in collaboration with the WHO Project Officer and participating site Investigators. Throughout the duration of the study, survey implementation at the local level was monitored by the Coordinating Center. Surveys were conducted in 12 different cities. Prior rapid assessment conducted in 10 cities provided insight into local context and guided survey implementation. Where possible, subjects were recruited both from drug abuse treatment centers and via street outreach. While emphasis was on IDUs, non-injectors were also recruited in cities with substantial non-injecting use of injectable drugs. A structured interview and HIV counseling/testing were administered. RESULTS: Over 5,000 subjects were recruited. Subjects were recruited from both drug treatment and street outreach in 10 cities. Non-injectors were recruited in nine cities. Prior rapid assessment identified suitable recruitment areas, reduced drug users' distrust of survey staff, and revealed site-specific risk behaviors. Centralized survey coordination facilitated local questionnaire modification within a core structure, standardized data collection protocols, uniform database structure, and cross-site analyses. Major site-specific problems included: questionnaire translation difficulties; locating affordable HIV-testing facilities; recruitment from drug treatment due to limited/selective treatment infrastructure; access to specific sub-groups of drug users in the community, particularly females or higher income groups; security problems for users and interviewers, hostility from local drug dealers; and interference by local service providers. CONCLUSION: Rapid assessment proved invaluable in paving the way for the survey. Central coordination of data collection is crucial. While fully standardized methods may be a research ideal, local circumstances may require substantial adaptation of the methods to achieve meaningful local representation. Allowance for understanding of local context may increase rather than decrease the generalizability of the data.

Adult↗
PubMed2004

[Peripheral arterial disease: what management practices for general practitioners?].

OBJECTIVE: The purpose of this study was to analyze the results of the ATTEST study in order to evaluate general medicine management practices for peripheral arterial disease (PAD). Our analysis was based on the guidelines for good practice which recommend measurement of the systolic pressure index (SPI), search for other localizations of atherothrombosis, treatment of risk factors including smoking, walking exercises, and long-term prescription of anti-platelets. METHODS: ATTEST is a cross-sectional multicentric observational epidemiologic study conducted in metropolitan France. The study has recruited 8.475 analyzable patients with symptomatic PAD alone (3811 patients) or associated with other atherothrombotic localizations (2416 patients) or other cardiovascular diseases (2248 patients). These patients were followed by 3020 physicians. The current analysis thus included 6227 patients (81.2% men, 18.8% women, mean age 67.2 years), including 78.8% who had reached the stage of intermittent claudication. Risk factors included current or past smoking (61%), hypercholesterolemia (66.3%), hypertension (63.1%) and diabetes mellitus (26%). RESULTS: Arterial duplex Doppler exams of the lower limbs were performed in 91.2% of the patients but measurement of the SPI for diagnostic purposes had been performed in only 17%. The majority (85.8%) of the patients with proven coronary artery disease or cervico-encephalic involvement had had an ECG and 69.3% had had a duplex Doppler of the supra-aortic trunks. Smoking continued in 39% of the patients and an aid to cease smoking had been prescribed for only 7% of the patients who were non-smokers for less than one year. Nearly two-thirds of the patients analyzed had received advice concerning physical activities. Finally, anti-platelets had been prescribed for 92.2% of the patients. CONCLUSIONS: The general practitioner plays a crucial role in the diagnosis and treatment of PAD. Although measurement of the SPI is recommended as an early diagnostic tool and for evaluation of severity, it had been performed in less than one-third of the patients. Search for another localization of atherothrombosis had been performed in more than half of the patients. The physicians generally delivered advice on physical exercise and prescribed anti-platelets. The fight against smoking was however largely insufficient. The results of this study warrant further optimization of the collaboration between general practitioners and vascular disease specialists.

Adult↗
PubMedDate not supplied

Does patient-provider gender concordance affect mental health care received by primary care patients with major depression?

PURPOSE: We sought to determine whether patient-provider gender concordance influences the detection and care of depression and comorbid anxiety and substance use in patients with major depression METHODS: Cross-sectional analyses of baseline patient survey data linked with provider data were performed. Data based on routine primary care visits in clinics from a variety of health systems serving diverse patient populations across the United States. Participants all had major depression. Depression care was examined in the Quality Improvement for Depression (QID) Collaboration sample (n patients = 1,428, n providers = 389). In a subanalysis of data solely from 714 patients and 157 providers from Partners-In-Care, one of the projects participating in QID, we also examined detection of anxiety disorder and alcohol or drug problems. MAIN FINDINGS: Rates of detection and care of mental health problems in primary care were low even among patients with major depression. Except for anxiety counseling in female patients, patient-provider gender concordance did not improve care as hypothesized. However, female providers were more likely to counsel on anxiety and less likely to counsel on alcohol or drug use than male providers. Female patients were less likely to be counseled on alcohol or drug use compared with male patients. CONCLUSION: Detection and care of mental health and substance use problems for patients with major depression is not influenced by patient-provider gender concordance. However, depressed female patients may have greater unmet needs for alcohol and drug use counseling than their male counterparts.

Adult↗
PubMed2000

A collaborative approach to developing nursing skills to meet service needs.

Academics, educators and health service managers came together to explore, within their local area, the nature of the perceptions of beginning registered nurses (BRNs) and Nursing Unit Managers (NUMs) to the skills utilised by BRNs within the first six months of practice. A group of 71 BRNs and nine NUMs participated in a cross-sectional survey. BRNs were also asked to rate their preparedness in each particular skill, dependent on the method of teaching--theory/lectures, nursing laboratories and clinical experience. Some 21 skills, relating to medication/fluid administration and skin and wound care, were perceived by 95 per cent or more of the graduates as being used within the first six months. Similar perceptions existed for NUMs and BRNs for 52.4 per cent of the listed skills. Differences in perceptions have led to academics altering the scope of skills being taught and focusing assessment on critical skills for BRNs, and managers increasing awareness among NUMs as to the source of the differences and developing programs to improve clinical interpretation skills. Improvements in the experience of the BRN are likely to occur when all parties work together to bring about positive change. By Barbara Somerville,

Adult↗
PubMed1979

Distribution of high density and other lipoproteins in selected LRC prevalence study populations: a brief survey.

Selected lipid and lipoprotein data from the Lipid Research Clinics (LRC) Prevalence Study are presented, with particular emphasis given to high-density lipoprotein (HDL) values. Cross-sectional age- and sex-specific mean values are shown for 7007 white participants in the ten North American LRCs. Comparisons are drawn for males and females (including the pediatric group) and for females using or not using sex hormones. The US-USSR Collaborative Program is summarized, and selected comparisons are noted for the Soviet and United States samples.

Adolescent↗
PubMed2004

Nursing in Russia: A "travelogue".

The following article provides highlights from a Russian and United States-sponsored nursing conference entitled, "Building Bridges Between US and Russian Nurses." This "travelogue" was written by two pediatrics nurses who participated in the 2003 conference. One of these nurses, Rachel, has been a co-organizer of these biannual conferences. Rachel and Diane have had significant, ongoing interests in Russia and Russian nursing. In their travelogue, they use first person to accentuate what was most meaningful to them. The background information about Russian nursing is an example of collaborative work among Rachel, Diane, and their Russian colleague, Marina, a pediatrics nurse from St. Petersburg, Russia.

Certification↗
PubMed2004

Training and field methods in the WorldSAFE collaboration to study family violence.

INTRODUCTION: This paper describes the collaborative efforts of research teams from medical schools in India, Chile, Egypt, the Philippines, Brazil, and the United States to develop and implement a core protocol for household surveys on family violence and to conduct standardized training for field workers. Our objectives are to share successes and difficulties encountered in training and field work and to offer recommendations for similar undertakings. METHODS: Study methods, developed by a multidisciplinary group of international investigators, were documented in a procedures manual. On-site standardized training was conducted and field workers were monitored for adherence to protocol. Special attention was given to safety and ethical issues. RESULTS: Overall, the training protocol and field methods were successful with relatively few problems encountered. Study participants were receptive to the interview and cooperated in safety procedures. The most common problem in the field was interruptions of the interview, mostly by children. Community advisory boards were actively involved in some of the sites, providing guidance on the safety and logistical aspects of the study, facilitating access to study communities, and providing community service information that could be shared with all study participants. CONCLUSIONS: WorldSAFE successes were attributed to rigorous standardized training and monitoring of field work; meticulous protocol implementation; unflagging attention to the ethical issues and to safeguarding study participants, field workers, and data; and openness and trust developed among the collaborators during the extended developmental phase.

Brazil↗
PubMed1979

Cellular and genetic control of antibody responses. V. Helper T-cell recognition of H-2 determinants on accessory cells but not B cells.

Requirements for helper T-cell recognition of H-2 determinants expressed on adherent accessory cells and on B cells was individually assessed in the anti-hapten PFC responses to TNP-KLH. Complicating allogeneic effects were minimized or avoided by the use of helper T cells from normal F1 hybrids, parent leads to F1 chimeras, and F1 leads to parent chimeras. The results of both in vitro and in vivo experiments demonstrated that: (a) helper T cells are not required to recognize the identical H-2 determinants on both accessory cells and B cells; (b) helper T cells are required to recognize K or I-A region-encoded determinants expressed on accessory cells; (c) no requirement was observed in vitro or in vivo for helper T-cell recognition of B-cell-expressed H-2 determinants; and (d) no requirement was observed for H-2 homology between accessory cells and B cells. The absence of required helper T-cell recognition of the identical H-2 determinants on both accessory cells and B cells was demonstrated in two ways: (a) naive of KLH-primed (A x B)F1 hybrid helper T cells collaborated equally well with B cells from either parentA or parentB in the presence of accessory cells from either parent; (b) A leads to (A x B)F1 chimeric spleen cells depleted of accessory cells collaborated equally well with accessory cells from either parentA or parentB, even though the B cells only expressed the H-2 determinants of parentA. A requirement for helper T-cell recognition of K or I-A region-encoded H-2 determinants on accessory cells was also demonstrated in two ways: (a) (A x B)F1 leads to parentA chimeric spleen cells depleted of accessory cells collaborated with accessory cells from parentA but not parentB; and (b) (A x B)F1 leads to parentA chimeric helper T cells collaborated with normal F1 B cells only in the presence of parental or recombinant accessory cells that expressed the K or I-A region-encoded determinants of parentA. Although restricted in their ability to recognize H-2 determinants on accessory cells, it was demonstrated both in vitro and in vivo that (A x B)F1 leads to parentA chimeric helper T cells were able to collaborate with B cells from either parentA or parentB. In vitro in the presence of accessory cells from parentA, (A x B)F1 leads to parentA chimeric helper T cells collaborated equally well with B cells from either parent. In addition, the inability of (A x B)F1 leads to parentA chimeric helper T cells to collaborate with (B + accessory) cells from parentB was successfully reversed by the addition of parentA SAC as added accessory cells. In vivo, upon the addition of parentA accessory cells, (A x B)F1 leads to parentA chimeric helper T cells collaborated with parentB B cells in short-term adoptive transfer experiments.

Animals↗