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PubMed1998

Algorithms for resource allocation of substance abuse prevention funds based on the estimated need: a case study on state of Florida--Part 1.

The purposes of Parts 1-3 of this article is to develop a framework for county-based prevention resource allocation algorithms based on the aggregated need for substance abuse prevention services estimated at the county level. The development of these algorithms is founded upon two databases: statewide student drug survey and a set of social indicators routinely collected and published by various agencies of the state of Florida. The resource allocation models are devised by developing several indices of prevention needs that are conceptualized in terms of: 1) county-based composite drug use index (COMDRUG), 2) the definitions of prevention target populations as envisioned by the Institute of Medicine (IOM), 3) composite risk-factor index score, and 4) a set of social indicators that are empirically related to COMDRUG observed at the county level. The first three models are based on the prevention needs estimated from the statewide student survey on substance abuse. The social indicator model, however, is presented as an alternative resource allocation model which may be used in lieu of or in the absence of statewide survey. The resource allocation algorithms found on these four conceptualizations are thought to be more equitable and appropriate to the prevention needs of various communities than may be contrived otherwise. Due to a significant amount of information leading to the development of these models, Part 1 of this series is devoted to the following three topics: 1) sampling method used, 2) poststratification weighting methods used to estimate county-based COMDRUG, and 3) the development of resource allocation models based on COMDRUG and the IOM definitions of prevention target populations.

Alcoholism↗
PubMed2001

Identification of early predictors for post-traumatic pneumonia.

We demonstrated that the standard clinical criteria of fever, leukocytosis, purulent sputum, and infiltrate on chest radiograph are nonspecific for the diagnosis of post-traumatic pneumonia, and only approximately 50 per cent of patients with these conditions have pneumonia. Quantitative cultures of bronchoalveolar lavage effluent will differentiate pneumonia (requiring antibiotic therapy) from systemic inflammatory response syndrome (not requiring antibiotics). Early identification of patients at risk for pneumonia can target populations for clinical research. Because risk factors for pneumonia when diagnosed by quantitative cultures have not been defined we reviewed our recent experience to identify variables predictive of pneumonia. Patients over a 22-month period who survived > 48 hours were identified from the trauma registry. Pneumonia was defined as growth of > or = 10(5) organisms per milliliter in the bronchoalveolar lavage effluent. Risk factors evaluated included injury severity and severity of shock. There were 7503 patients (75% with blunt and 25% with penetrating injuries). The incidence of pneumonia was 6 per cent (7% of patients with blunt and 2% of patients with penetrating injuries). Logistic regression analysis identified age; Glasgow Coma Scale score; Injury Severity Score; transfusion requirements during resuscitation; spinal cord injury; chest injury severity; and emergent femur fixation, craniotomy, and laparotomy as being independent predictors of pneumonia. We conclude that multiple risk factors, which are all able to be determined early after injury, are predictive of post-traumatic pneumonia. Prompt identification of this high-risk group of patients allows prognostic considerations relative to patient management schemes and targets populations for prophylactic measures or immunomodulation.

Adult↗
PubMedDate not supplied

Mammography screening in Italy: 2003-2004 survey.

GISMa performs a yearly survey to collect process indicators of mammography screening and compare them, using standard values agreed on a national and international basis. This survey is highly representative of the Italian situation, providing summary data stratified by region and by age group. Data come from several different programmes that may have changed over time, and may have different model of organisation and management. Eighty-eight programmes from 15 different regions (out of 21) provided data for 2003. In nine regions individual programmes are part of a comprehensive regional project. During this year about 1,480,000 women aged 50-69 years were invited to have a screening mammogram, and over 843,000 were screened. Theoretical coverage was 56.2%, while 41.4% of the target population received an invitation to screening. An imbalance in coverage can be seen when comparing Northern and Central Italy, where over 3/4 of the population is covered, to Southern Italy, with only a 10.6% coverage by organised screening. National crude attendance rate was 58.3%. A decreasing trend was evident from the North to the Centre to the South of Italy: 61.2%. 56.2%, and 38.1% respectively. Referral rates of 7.8% at first screening and 4.5% at repeat screening were recorded. Direct standardised detection rate was 6.9 x 1000 at first test and 4.8 at repeat test, while benign to malignant ratio for first and repeat screening was 0.33 and 0.23 respectively. Detection rate of "small" cancers (< or =10 mm in size) was 1.5 and 1.4 x 1000 for first and repeat test. Indicators by 5-year age groups confirm greater diagnostic problems at younger ages, with higher referral rates, higher frequency of surgical procedures with benign outcome (B/M ratio), and a substantially lower detection rate as compared to older age groups. The year 2004 was the first in which regions were required to provide data on screening activity to the ONS; data were provided by 120 programmes from 18 regions. Preliminary data showed a coverage rate of 69.4%, while 51.1% of the target population received an invitation to screening. Although a substantial increase in coverage was observed also in Southern Italy. a major imbalance in coverage still exists between Northern-Central and Southern Italy: 82.3%, 98.2% and 30.5% respectively. National crude attendance rate was 55.8%.

Aged↗
PubMed1998

A phased approach to clinical testing: criteria for progressing from Phase I to Phase II to Phase III studies.

The overall intent of clinical testing is to establish, in a series of phased studies, the clinical tolerance and acceptable "safety" of the candidate vaccine, as well as the type, level and persistence of the immune response after its inoculation, to a representative target population, according to a convenient administration schedule. The final stages involve the direct or indirect demonstration of protective efficacy, if possible in the population(s) for which the vaccine is intended. In addition, consistency of production must be demonstrated. At all these stages, the amount of prior information from preclinical and other studies affects and informs the objectives and design of subsequent studies. Progression from one testing phase to the next is dependent upon attaining the pre-set objectives of each series of studies. The precise objectives to be met will be decided on a case-by-case basis. The earliest assessments in humans (Phase I) involve evaluation of short-term clinical tolerance as measured by local and general reactogenicity, and gross assessments of immunogenicity, in a small number of highly selected individuals in an idealised situation. The selection of "optimal" dose and schedule are the result of further dose-ranging investigations (Phase II), involving more volunteers, with longer, more detailed follow-up assessments. It is at this stage that the accumulated evidence on its immunogenicity profile should be sufficient to assess whether or not the vaccine is worthy of further development. The next level of investigation (Phase III) aims to measure with greater precision the vaccine protective efficacy in the intended target population(s) by comparison of infection and/or disease attack rates in vaccine and placebo recipients. In consistency studies different production lots, manufactured at commercial scale, are tested to demonstrate consistency of manufacture. Additional bridging studies to establish similarity of lots at different production scales, or studies of the duration of the immunity conferred, are conducted in parallel with the progression of the studies in the different phases mentioned above. These latter types of studies are usually carried out concurrently with Phase III studies. This progression continues into the post-marketing period (Phase IV) with surveillance of long term efficacy and observational studies of possible rare adverse events to establish "safety" with more confidence. This paper examines, in general, the aims and designs of studies in each phase as an introduction to the more specific publications that follow.

Clinical Trials as Topic↗
PubMed2006

Predictors of gallstone composition in 1025 symptomatic gallstones from Northern Germany.

BACKGROUND: Gallstones represent a prevalent and costly health problem. The changing epidemiology and the emerging non-surgical interventions for gallstone disease necessitate the definition of target populations for future therapies. This study aimed to define patterns of gallstone composition and identify demographic predictors of gallstone composition in a large sample of symptomatic gallstones from Northern Germany. METHODS: One thousand and seventy-four post-cholecystectomy gallstone specimens were obtained. Demographic and clinical information was provided by questionnaire (N = 1025 independent individuals with complete information). Two samples from each gallstone were analyzed using Fourier transformed infrared spectrometry. RESULTS: The most prevalent substance was cholesterol, which was detected in 95.0% of gallstone specimens. Bilirubin and bilirubinate were present in 30.0% and calcium was detected in 10.0% of the spectra. Ninety-two percent of measurements from the same stone yielded the same "main" substances, indicating a homogenous stone composition in most cases. Female sex and higher body mass index (BMI) were associated with the presence of cholesterol as a main substance in the gallstones (p < 0.001). CONCLUSION: The changing epidemiology of gallstone disease is reflected by a marked shift in stone composition: Only two percent of stones in this study were pigment stones as compared to 91% percent of stones containing cholesterol as a main substance. Obese individuals from Germany with a BMI > 30 kg/m2 have in 95% cholesterol-dominant gallstones and represent a potential target population for non-surgical interventions for the prevention or treatment of cholesterol stones.

Age Factors↗
PubMed2001

Determinants of acceptance of a community-based program for the prevention of falls and fractures among the elderly.

BACKGROUND: Low-energy fractures among the elderly may be prevented by measures aimed at reducing the risk of falling or increasing the strength of the skeleton. Acceptance of these interventions in the target population is necessary for their success. METHODS: The total elderly population in a Danish municipality 7,543 community-dwelling persons aged 66+ years, were offered participation in one of three intervention programs: 2,550 persons were offered a home safety inspection, evaluation of prescribed medicine, and identification of possible health and food problems (Program I); 2,445 persons were offered 1000 mg of elemental calcium and 400 IU (10 microg) of vitamin D(3) per day in combination with evaluation of prescribed medicine (Program II); and 2,548 persons were offered a combination of the two programs (Program III). Acceptance was defined as willingness to receive an introductory visit by a nurse. RESULTS: Acceptance of Program I was 50%; of Program II, 56% (P < 0.00005 as contrasted with Program I); and of Program III, 46% (P < 0.005). Acceptance was associated with gender (females, 53%; males, 47%) and did not change from ages 66 to 84 but decreased significantly after the age of 85. Widows aged 66-84 had the highest acceptance (57%) and never married males aged 66-84 the lowest (30%). An important determinant, however, was the individual social service center that communicated the specific program. Acceptance varied from 39 to 66% between the social centers. CONCLUSIONS: Acceptance of a fall and fracture prevention program varies with intervention type; with gender, age, and social status of the target population; and with the motivation and attitude of the health workers involved in the implementation of the program.

Accidental Falls↗
PubMed2002

Epidemiologic risk factors for preterm delivery.

BACKGROUND: Prematurity remains the most significant cause of neonatal morbidity and mortality. Knowing which group of women is at risk for developing preterm labor will define a target population for better prenatal care and prevention modalities. OBJECTIVE: To examine whether preterm delivery rates are associated with ethnicity, age, parity, and style of living. METHODS: We conducted a longitudinal case series examining obstetric and demographic data of 17,493 deliveries that occurred between June 1994 and May 1999. All deliveries were performed in the obstetric department of HaEmek Medical Center (Afula, Israel), which serves as a referral center. The main outcome measures were preterm delivery, as related to the women's ethnicity, age parity, and style of living--namely, town, village, or kibbutz. RESULTS: The overall preterm delivery rate was 8.5%. The preterm delivery rate in non-Jewish women (10.5%) was higher than in Jewish women (7.1%) (P < 0.00001). The preterm delivery rate in women younger than 20 or older than 40 (12.5%) was much higher than in women between the ages of 21 and 40 (8.0%) (P < 0.00001). Grand-multipara women (> 8) had a higher preterm delivery rate (13.8%) than less parous women (8.5%) (P < 0.012). Style of living was also associated with the preterm delivery rate (P < 0.00001): kibbutz 5.5%, Jewish towns 7.8%, non-Jewish towns 8.7%, Jewish villages 6.7%, and non-Jewish villages 11.0%. CONCLUSIONS: Style of living, ethnicity, age and parity are statistically significant risk factors for preterm delivery in our area. These factors provide a more definable target population for better prenatal care.

Adult↗
PubMed1984

Knowledge of diabetes and glaucoma in a rural North Carolina community.

Effective use of time, money, and personnel in the delivery of health care services to rural areas requires baseline information on the target population with respect to the problem being addressed. Prior to the initiation of an educational program on diabetes and glaucoma, the Public Health Department of Davie County, North Carolina, conducted a survey of county residents to determine knowledge, attitudes, and practices concerning these illnesses. The goals of the survey were to determine (1) basic knowledge with respect to the nature of each illness, symptoms, and high-risk groups, (2) the stigma attached to each illness, and (3) health practices in terms of previous tests for diabetes and glaucoma and whether or not the respondents know where to go for such tests. Information was obtained through a telephone survey of randomly sampled households in Davie County. Results of the survey indicated that the level of knowledge for both diabetes and glaucoma is particularly low with respect to identification of high-risk groups and symptoms, and approximately one-quarter of all respondents felt there was some stigma attached to diabetes and glaucoma. The lowest levels of knowledge were observed in the youngest and oldest respondents, males, the unmarried, and those with low levels of educational attainment. The differences in knowledge by age, marital status, and sex were found to be partially a function of differing levels of educational attainment. These data have provided information useful in the selection of content areas for the programs and in the identification of target populations for special emphasis.

Adolescent↗
PubMed1991

Development of a strategy to encourage attendance for screening mammography.

The present study describes a method for the data-driven structuring of interventions to increase participation in screening mammography. We interviewed 668 randomly selected women from the target population of an Australian pilot screening mammography program before this Program commenced. The aims of the study were to use cross-sectional data to determine factors which predicted women's intentions regarding attendance at the Program, and on the basis of these results to develop optimal strategies to encourage attendances. Of the sample, 64% said they intended to go to the Program, while 11% were unsure. A number of variables were significantly associated with intention and regression analysis was used to determine the best model for predicting intention. Ten variables entered the final regression model: the intensity of thought about getting breast cancer; a belief that early detection is extremely desirable and that screening mammograms are accurate; having had a Pap test within the last 2 years; a belief that health is controlled by chance; perceived ease of getting to the hospital; subjective familiarity with the hospital location of the Program; age; having heard about screening mammography; and a feeling of personal susceptibility to breast cancer. This model explained 20% of the variance in intention to have a mammogram (R 2 = 0.20, F(10,492) = 12.08; P less than 0.0001). The practical applications of these findings are discussed in this report. It is recommended that if a campaign were to concentrate on changing women's perceptions on the dimensions found to be significantly associated with intention, then it would have maximum chance of encouraging attendance amongst women in the target population. The strategies we have developed based on these findings are discussed in this paper.

Aged↗
PubMed1995

Diabetes as a risk factor for stroke. A population perspective.

Stroke incidence, case fatality and mortality in diabetic patients were compared to non-diabetic subjects in a 35-74-year-old population in northern Sweden (target population 241,000). During an 8-year period, 1,544 stroke events in diabetic patients and 4,826 events in non-diabetic subjects were recorded. The crude incidence of stroke was 1,000 per 100,000 in the diabetic men vs 247 in the non-diabetic men (relative risk 4.1; 95% confidence interval 3.2-5.2). Among diabetic women, the crude incidence was 757 per 100,000 and 152 in non-diabetic women (relative risk 5.8; 95% confidence interval 3.7-6.9). The 28-day case fatality among men was similar in the diabetic and non-diabetic stroke patients (18.6 vs 17.1%; p = 0.311), but significantly higher in diabetic women compared with non-diabetic women (22.2 vs 17.9%; p = 0.02). When compared with the non-diabetic population, the overall mortality from stroke in the diabetic population (first and recurrent) was 4.4-times higher in male and 5.1-times higher in the female patients. Hypertension, atrial fibrillation, heart failure or myocardial infarction were all significantly more common in diabetic than in non-diabetic stroke patients. The population attributable risk, a crude estimate of all strokes ascribed to diabetes mellitus, was 18% in men and 22% in women. In Sweden, about 50 strokes are annually directly attributed to diabetes in a population of 100,000 in this age group.

Adult↗
PubMed1994

Effects of radiation on rat respiratory epithelial cells: critical target cell populations and the importance of cell-cell interactions.

The oncongenic effects of radiation on rat respiratory tissues are modulated in vivo within the intact tissue. The degree of modulation as well as the mechanism whereby modulation occurs appears to be different for different types of ionizing radiations. A combined cell culture -in vivo model is described. This model has been developed to evaluate the influence of the host and tissue environment on development and expression of the neoplastic phenotype in irradiated rat trachea. Our data indicates that the potentially oncogenic effects of neutrons, X Rays, and alpha-particles are different depending on the exposure conditions employed and the conditions under which exposed cells are maintained following exposure.

Alpha Particles↗
PubMed1992

DNA damaging activity of cadmium in Leydig cells, a target cell population for cadmium carcinogenesis in the rat testis.

To clarify the mechanism by which Cd initiates rat testicular cancer, the ability of Cd or H2O2 to induce DNA single strand breakage was evaluated in testicular Leydig cells using a simple and rapid DNA precipitation method. Effects of Cd, Fe, Zn and Ca on the oxidant-induced DNA damage and effects of reduced glutathione (GSH) on the genotoxicity caused by the peroxide and/or Fe were also assessed. H2O2 induced strong DNA single strand breakage. Cd alone did not exhibit such a genotoxicity nor did it enhance the peroxide-induced DNA damage. Ca and Fe(II) potentiated the oxidant-induced DNA single strand breakage, while Zn partially protected cells from the oxidative damage of DNA caused by the peroxide. GSH attenuated single strand breaks of DNA brought about by H2O2 and/or Fe. These results suggest that the initiation of carcinogenesis in the rat testis by Cd is triggered by active oxygen species such as H2O2, which is generated by the metal exposure, rather than by a direct genotoxicity of Cd. The oxidant-mediated initiation is clearly a complicated event accomplished by multiple factors.

Animals↗
PubMed1989

The clinical trial as a paradigm for epidemiologic research.

The extent to which the clinical trial serves, and fails, as a paradigm for epidemiologic research in general is examined. It is argued, first, that the traditional paradigms--investigating epidemic and endemic occurrence of illness in the context of public-health activities, inclusive of the deployment of census, vital and morbidity statistics and sample surveys--are misleading for scientific research. Major examples of the consequences of these paradigms are the preoccupations with time and place, and with "the general population" or some other "target population"--both alien from the vantage of clinical trials and, indeed, of science in general. Then it is shown, by the use of the clinical trial paradigm, that traditional epidemiologic thought and practice in cause-effect research are misguided in the context of such common contexts as the use of empirical contrasts between exposure and unspecified nonexposure, the employment of "representative" distributions of determinants, and, even, as to the belief that cohort and "case-control" studies constitute alternatives to each other. On the other hand, it is argued that for etiologic research the ordinary (parallel) clinical trial is misleading as a paradigm, especially as for learning about the essential temporal aspects of the cause-effect relation.

Clinical Trials as Topic↗
PubMed2005

Pregnant women as a sentinel population to target and implement hepatitis B virus (HBV) vaccine coverage: a three-year survey in Palermo, Sicily.

Hepatitis B virus (HBV) vaccine coverage was assessed using serologic patterns of infection (HBsAg, anti HBc) and vaccine-induced immunity (isolated anti HBs) among 3318 pregnant women attending the Obstetrical Unit of the University Hospital in Palermo who were screened over 3 years (2001-2003). Three thousand and eight of them (90.6%) were born in Sicily, whereas 310 (9.4%) were immigrants from non-EU countries. The overall prevalence of HBsAg was 1.1%, and it was significantly higher among immigrant than indigenous women (4.2% versus 0.8%; OR 5.26; p < 0.0001). Serologic evidence of past HBV infection (anti HBc) also was significantly higher in immigrants than in Sicilian women (24.5% versus 5.2%, respectively). Women aged 17-21 in our study were in cohorts that had been targeted since 1991 for mandatory HBV vaccination at age 12. In this targeted age group, 74.2% of the Sicilian women had isolated anti HBs, compared to only 15.0% among immigrants. The results suggest the need to improve HBV immunization of Sicilian adolescents and especially to implement active surveillance and to launch an HBV immunization programme that targets immigrants to Sicily.

Adolescent↗
PubMed1999

Safety of low-density lipoprotein cholestrol reduction with atorvastatin versus simvastatin in a coronary heart disease population (the TARGET TANGIBLE trial).

Reduction in plasma lipids has been recognized as one of the primary cardiovascular risk reduction strategies in the secondary prevention of coronary heart disease (CHD). The primary end points of TARGET TANGIBLE were the safety (adverse events and laboratory measurements) and efficacy (responder rates) of therapy with atorvastatin versus simvastatin with the aim of achieving low-density lipoprotein (LDL) cholesterol lowering to < or =100 mg/dl (2.6 mmol/L). A total of 3,748 CHD patients with LDL cholesterol levels > or =130 mg/dl (3.4 mmol/L) entered a run-in diet phase of 6 weeks without any lipid-lowering drug therapy. At the end of the diet phase, 2,856 patients met the lipid criteria and were randomized to active treatment for 14 weeks. Patients received 10 to 40 mg of either drug in an optional titration design at 2:1 randomization for atorvastatin versus simvastatin. Adverse event rates were statistically equivalent (p<0.01) for simvastatin (35.7%) and for atorvastatin patients (36.3%). Both drugs were well tolerated; <5% of patients in both groups were withdrawn due to adverse events. In all, 37 atorvastatin patients (2%) and 27 simvastatin patients (3%) had serious adverse events. Drug-related side effects (elevations in creatine kinase, liver enzymes) occurred in both groups at similar rates with 10 atorvastatin patients (0.5%) and 5 simvastatin patients (0.5%) presenting confirmed transaminase elevations >3 x the upper limit of the normal range. Significantly fewer patients in the atorvastatin group (n = 724) required titration to 40 mg compared with the simvastatin group (n = 514) (38% vs. 54%, respectively; p<0.001). Atorvastatin resulted in a significantly greater number of patients reaching the LDL cholesterol goal than those treated with simvastatin, with 67% of atorvastatin patients and 53% of simvastatin patients reaching the target LDL cholesterol level of < or =100 mg/dl (2.6 mmol/L) (p<0.001). Both atorvastatin and simvastatin are safe for use by patients in the secondary prevention of CHD, with patients in both drug groups having similar adverse event rates. Despite the use of concomitant medications there was no drug-induced rhabdomyolysis with either atorvastatin or simvastatin.

Anticholesteremic Agents↗