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[The experimental drug prescription program in Andalusia [PEPSA]: procedure for recruiting participants].

In this field note we describe the steps followed in the process of recruiting participants for the experimental drug prescription program in Andalusia (PEPSA). This trial is a comparative, randomized, open study of the difference between intravenous heroin treatment and oral methadone for socially excluded, opiate-dependent patients, in whom other available treatments have been unsuccessful. Because this is a hidden and hard-to-reach population, a specific approach was planned to put as many patients as possible in touch with the program. A previous study of the target population's distribution in the City of Granada was performed and the city was divided into three areas. Potential participants were interviewed in squares, soup kitchens and methadone dispensaries by outreach workers and peers, who suggested they make an appointment with a PEPSA physician. Peer-driven intervention was a crucial instrument in this recruitment procedure, allowing greater access to the target population. Furthermore, this approach allowed contact with drug users who do not attend health and social services. The work of the outreach team involved educating these users in harm reduction and offering them health and social alternatives beyond the clinical trial.

Administration, Oral↗

Practices in the Prevention of Venous Thromboembolism.

Objective: The objective of this study was to determine the proportion of Massachusetts Medicare patients who received prophylaxis for venous thromboembolism following colectomy, hysterectomy, or total hip arthroplasty. Sample frame: All 90 Massachusetts acute care hospitals. Time frame: 1 April through 30 September, 1994. Target population: Patients discharged with an International Classification of Disease (ICD-9-CM) discharge diagnostic code (recorded in the Massachusetts Medicare Claims Database) for colectomy, hysterectomy, or total hip arthroplasty were used to identify the target patient population. Sample population: 1,397 patients randomly selected from the target population, including 467 total hip arthroplasties, 474 colectomies, and 456 hysterectomies. Data extraction: Medical records were reviewed by trained nurse abstractors who collected information on the use of prophylaxis for venous thromboembolism. Results: Prophylaxis for venous thromboembolism was employed by surgeons practicing in Massachusetts hospitals in 93% of total hip arthroplasty cases (regional variation 85-98%), 84% of colectomies (regional variation 57-93%), 66% of hysterectomies (regional variation 35-71%), and in 87% of the subset of 111 hysterectomies with malignancy (regional variation 25-100%). Conclusions: The results of this statewide study demonstrated significant regional and hospital-to-hospital variation in the use of prophylaxis for venous thromboembolism following major surgery. A lower rate of prophylaxis use was observed in hospitals with fewer than 200 beds and in hospitals that did not have teaching programs. Hospitals with below-average rates of prophylaxis were targeted for intensive quality improvement interventions.

Journal Article↗

The National Diabetes, Influenza, and Pneumococcal Campaign: an evaluation of campaign relevancy, partnerships, and media relations.

The Division of Diabetes Translation, Centers for Disease Control and Prevention, collaborated with its 59 Diabetes Prevention and Control Programs (DPCPs) to implement in 1998-1999 the National Diabetes Influenza and Pneumococcal Campaign. Postcampaign evaluation examined DPCPs' perceptions of the relevancy of the campaign in reaching the target population (adults aged 25-64 years with diabetes), establishing successful partnerships, and engaging the media. Most DPCPs stated the campaign reached their target population. DPCPs most commonly partnered with existing networks such as public health organizations or government agencies and direct health care providers. A majority of DPCPs did not find partnerships with direct health care providers to be effective in this campaign, but public health organizations, peer review organizations, and coalitions were described as successful partners. States in which DPCPs conducted follow-up calls to television stations regarding the airing of public service announcements generally had more announcements aired than states in which such calls were not made. Postcampaign evaluation findings also indicate that DPCPs who attempted to engage nontraditional partners (e.g., media outlets) achieved greater campaign success than those who did not. Future campaign efforts will likely benefit from relationships established with nontraditional partners, such as retailers, media outlets, local pharmacies, and faith-based organizations.

Adult↗

Use of a pilot study for designing a large scale probability study of personal exposure to aerosols.

The major objective of the U.S. Environmental Protection Agency's (EPA's) Particle Total Exposure Assessment Methodology (PTEAM) Study is to estimate the frequency distribution of aerosol exposures of a target population of individuals. This objective requires the use of probability sampling techniques for selecting a representative sample of participants from a prescribed target population. To design such a population exposure study in a cost-effective fashion, a number of issues must be addressed. For instance, when and for how long and for whom should personal samples be obtained? What other samples are needed or desirable? Issues like these must be considered from several perspectives--from the point of view of data collection costs, burden on participants, precision and representativeness of resultant estimates, etc. To help address such design issues for the PTEAM population exposure study, we generated descriptive statistics and performed statistical analyses on data from a preliminary nine-home pilot study conducted in March 1989 in the San Gabriel Valley area of Southern California. The analyses showed large temporal variation, with day versus night being a major component (generally higher daytime concentrations); large systematic time-of-week differences were not found. Large house-to-house and person-to-person variabilities were evident, with high exposure levels noted especially in homes with tobacco smoking. Within many homes, there appeared to be little variability in the particulate concentrations among different rooms. The results of the pilot were used to make decisions regarding the spatial and temporal sampling units, the benefits of stratification, and the overall allocation of resources (e.g., multiple monitors within a home versus more homes and participants) for the subsequent population study.

Aerosols↗

Cervical cancer screening in Greece.

The aim of this study was to describe the state of the art in cervical cancer screening in Greece by presenting the two regionally organised screening programmes that currently operate in the country. Both programmes were initiated in 1991 and are partly funded by the European Union. The Ormylia screening programme covers the population of Halkidiki (Northern Greece), a predominantly rural area. The second programme covers the regions of Messinia and Ilia (Southern Greece). Both programmes are targeted at women aged 25-64 years of age and a Papanicolaou (Pap) smear test is recommended every 2-3 years. Electoral and municipal registries are used to identify the target population and personal invitations are sent to the eligible women in the screening programme. The Ormylia programme is based at the Centre 'Our Lady Who Loves Mankind', whereas mobile units are used by the Messinia and Ilia programme. Slide reading for the Ormylia programme is performed in the cytology laboratory of Alexandra Hospital in Athens and epidemiological support is provided by the Department of Hygiene and Epidemiology (Medical School, University of Athens). A specifically designed database is used for data recording. Over 80% of the target population in the region have already been screened. Communication of results is by means of a personal letter upon a negative result and in person upon a suspicious result. Quality assurance in both programmes is based on the European protocol. These two programmes are the sole organised cervical cancer screening activities in Greece in the absence of a national programme. They employ well-trained personnel, they use modern equipment and have strict quality assurance procedures.

Adult↗

Resolving methodological and clinical issues in the design of efficacy trials in assisted reproductive technologies: a mini-review.

The validity, importance and relevance of randomized controlled trials depend on identifying an appropriate target population, ensuring adequate power, careful attention to the details of randomization and blinding, and selection of an endpoint that is important to the target population. With efficacy trials more than effectiveness trials, additional constraints are needed to reduce the variability that is typical of clinical practice: a narrowly defined sample, unvarying pre-randomization procedures and post-randomization treatments and follow-up that are as identical as possible for all patients. Efficacy trials comparing ovarian stimulation protocols should have strict protocol definitions, specific concomitant medications and minimal variability between centres with respect to stimulation goals and dose adjustments. Additionally, there should be narrowly defined criteria for administration of chorionic gonadotrophin, type of luteal support, embryo transfer and freezing policies. The goal of efficacy trials is to minimize the variability that is extrinsic to the comparison. When efficacy has been proven, effectiveness trials are needed to determine whether the effect of the new intervention is robust in the variability of typical clinical settings.

Adult↗

Colonoscopic findings of symptomatic patients aged 50 to 80 years suggest that work-up of tumour suspicious symptoms hardly reduces cancer-induced mortality.

QUESTIONS UNDER STUDY: The risk of colorectal cancer (CRC) starts to increase at the age of 50 years in average persons without special risk factors. The significance of clinical symptoms and frequency of endoscopies done at this age are hitherto unknown. We do not know the stage of colorectal cancers nor the distribution of advanced neoplasms in symptomatic persons above 50 years. These data are of interest to validate the necessity of screening programmes, to define the target population and to interpret results of screening studies in asymptomatic people. METHODS: Endoscopies of the colon performed from 1991 to 2000 in symptomatic patients aged 50 to 80 in the well-defined area of Uri were analysed retrospectively, focusing on symptoms leading to the endoscopy and the occurrence of neoplastic lesions. RESULTS: Sixteen percent of the population at the age of 50-80 years had a colonoscopy for workup of symptoms. A CRC was found in 5.5% of all patients (83 of 1514 patients), in 12.3% of patients with tumour suspicious symptoms, but only in 0.3% of patients with unspecific pain. Stage of tumours was often advanced (82% T3/T4, 38% N1-3, 21% M1). In 2.6% of patients a colorectal cancer was found before the age of 60, mostly in men. Advanced lesions were more frequent in men, increasing with age. CONCLUSIONS: A substantial part of the population above the age of 50 had an endoscopic workup of the colon for symptoms, what has to be considered when defining the target population and the necessary manpower of screening programmes. Tumour-suspicious symptoms were significant predictors for the presence of a CRC, but tumours were often already advanced. This underlines the importance to screen persons before developing symptoms.

Adenoma↗

Occupational and environmental hygiene assessment of fumigations with methyl bromide.

Use of methyl bromide for pest control fumigation may result in adverse exposure to three populations: the actual fumigators; other workers not actually involved in the fumigation; and the general public in the vicinity. The risk of exposure of these three target populations in Switzerland was investigated. The methodology was a combination of occupational hygiene surveys, including a preliminary hazard analysis, with a comprehensive assessment of the safety and health systems in use based on the 'Management Oversight and Risk Tree' (MORT) method [Knox and Eicher, MORT User's Manual, Revision 2. DOE 76-45/4 (1983)]. The target populations most concerned depend on the type of fumigation. Fumigators risk severe accidental exposure although they usually wear personal protection devices. In soil and chamber fumigation, workers not involved in the fumigation may undergo high exposure (75-100 pm for 1 h), far greater than the usual time-weighted average and short-term occupational exposure limits (5-20 ppm range). Occupants of premises adjoining the fumigated buildings may also be exposed to significant concentrations (25-50 ppm for 0.1-2 h). Problems originate mainly from a lack of management controls, failure to apply an appropriate code of practice and the use of personnel who are not properly qualified and trained.

Air Pollutants↗

Using data to plan public health programs: experience from state cancer prevention and control programs.

In 1989 the National Cancer Institute funded the second round of Data-Based Intervention Research (DBIR) cooperative agreements with state health agencies to implement a four-phase cancer prevention and control planning model that would establish ongoing cancer prevention and control programs. Activities included identifying and analyzing relevant data to develop a state cancer control plan. The authors reviewed the data analysis and planning activities of five DBIR projects to understand: how states use different types of available data to make public health planning decisions, in what ways available data were sufficient or insufficient for this planning, and perceived costs and benefits of a data-based planning approach. Many of the sources of and ways in which health statistics and behavioral data were used were consistent across states. Sources and use of data on the availability and utilization of health services and on cancer control policies were less consistent. Data were most useful in making decisions to address specific cancers, to target populations or regions, to identify general barriers, and to influence policy makers and the public. Data were less influential in identifying specific barriers within target populations and determining what proven intervention components should be implemented and how. The process of pulling this information together and involving working groups and coalitions was considered very beneficial in establishing the credibility of the state health agency in addressing the state's cancer problem. This process relied on a national infrastructure that provided financial resources, sources of data, and research results.

Data Collection↗

Screening in liver disease.

A disease is suitable for screening if it is common, if the target population can be identified and reached and if both a good screening test and an effective therapy are available. Of the most common liver diseases only viral hepatitis and genetic hemochromatosis partially satisfy these conditions. Hepatitis C is common, the screening test is good and the therapy eliminates the virus in half of the cases, but problems arise in the definition of the target population. In fact generalized population screening is not endorsed by international guidelines, although some recommend screening immigrants from high prevalence countries. Opportunistic screening (case finding) of individuals with classic risk factors, such as transfusion before 1992 and drug addiction, is the most frequently used strategy, but there is disagreement whether prison inmates, individuals with a history of promiscuous or traumatic sex and health care workers should be screened. In a real practice setting the performance of opportunistic screening by general practitioners is low but can be ameliorated by training programs. Screening targeted to segments of the population or mass campaigns are expensive and therefore interventions should be aimed to improve opportunistic screening and the detection skills of general practitioners. Regarding genetic hemochromatosis there is insufficient evidence for population screening, but individual physicians can decide to screen racial groups with a high prevalence of the disease, such as people in early middle age and of northern European origin. In the other cases opportunistic screening of high risk individuals should be performed, with a high level of suspicion in case of unexplained liver disease, diabetes, juvenile artropathy, sexual dysfunction and skin pigmentation.

Hemochromatosis↗

Innovations: evidence-based practices: establishing the evidence base for psychiatric services: estimating the impact on the population.

The impact of evidence-based interventions for individual patients is clear, but a broader approach is needed. The authors describe a six-step method for calculating the population impact of introducing a new evidence-based intervention. The steps involve identifying the prevalence of a condition, the proportion of persons in the larger population eligible for the intervention, and the baseline risk that the intervention is meant to address. Obtaining useful results from this mathematical calculation depends on having accurate and robust data about the prevalence of a condition, the size of the targeted population, and the effectiveness of the intervention. Results for different interventions for the same condition and target population can then be compared.

Evidence-Based Medicine↗

Electrocardiographic findings in 888 patients > or =90 years of age.

The oldest old are the fastest growing component of many national populations. No large-scale analysis of electrocardiographic findings in this group exists to date. This study cataloged the frequencies of specific electrocardiographic (ECG) findings in the target population and compared the frequencies of these findings by gender and race. The electrocardiograms of 888 subjects aged > or =90 years presenting for any reason were retrospectively analyzed using standard criteria for 128 separate ECG findings. Left ventricular enlargement (28%), first-degree atrioventricular block (16%), and atrial fibrillation (15%) were the most common abnormalities found in the population as a whole. In contrast to previous studies, which demonstrated a predominance of left-axis deviation, 91% of the electrocardiograms analyzed in our study demonstrated a mean frontal QRS axis ranging from -30 degrees to +90 degrees . Sinus rhythm was observed in 79% of the population. More Caucasians than African-Americans had atrial fibrillation (19% vs 12%, p = 0.004). Women had more normal ECG results than men (6% vs 2%, p = 0.02), and more women demonstrated complete right bundle branch block (13% vs 7%, p = 0.002). In conclusion, few patients aged > or =90 years who have their electrocardiograms recorded at hospitals have completely normal ECG results. The frequencies of some ECG findings in the target population vary by gender and race.

Aged, 80 and over↗

Growth factors and growth control of heterogeneous cell populations.

In an earlier work a model of the autocrine and paracrine pathways of tumor growth control was developed (Michelson and Leith. 1991. Autocrine and paracrine growth factors in tumor growth. Bull. math. Biol. 53, 639-656). The target population, a generic tumor, was modeled as a single, homogeneous population using the standard Verhulst equation of logistic growth. Mitogenic signals were represented by modifications to the Malthusian growth parameter and adaptational signals were represented by modifications to the carrying capacity. Three growth scenarios were described: (1) normal tissue wound healing, (2) unperturbed tumor growth, and (3) tumor growth in a radiation damaged environment, a phenomenon termed the Tumor Bed Effect (TBE). In this paper, we extend those results to include a "triad" of growth factor controls (autocrine, paracrine and endocrine) and heterogeneity of the target population. The heterogeneous factors in the model represent either intrinsic, epigenetic or environmental differences in both normally differentiating tissues and tumors. Three types of growth are modeled: (1) normal tissue differentiation or wound healing, assuming no communication between differentiated and undifferentiated cell compartments; (2) normal wound healing with feedback inhibition, due to signalling from the differentiated compartment; and (3) the development of hypoxia in a spherical tumor. The signal processing within the triad is discussed for each model and biologically reasonable constraints are defined for limits on growth control.

Animals↗

Trastuzumab plus docetaxel in HER2/neu-positive non-small-cell lung cancer: a California Cancer Consortium screening and phase II trial.

HER2 is reported to be overexpressed in 20% of cases of non-small-cell lung cancer (NSCLC), principally adenocarcinoma. Trastuzumab is a monoclonal antibody against HER2 that, when combined with a taxane, improves survival compared with chemotherapy alone in advanced breast cancer. In view of these observations, we conducted a phase II HER2 screening and efficacy trial of trastuzumab plus weekly docetaxel in cases of advanced NSCLC in which primary platinum-based therapy had failed. Patients with advanced or metastatic NSCLC were screened for HER2 overexpression by immunohistochemistry. Patients with HER2-positive tumors (2+ or 3+) were initially randomized to either single-agent trastuzumab or docetaxel. After completing 2 treatment cycles, all patients went on to receive the trastuzumab/docetaxel combination regardless of response to the single agents. Treatment consisted of docetaxel 30 mg/m2 weekly for 6 weeks followed by a 2-week break and trastuzumab 4 mg/kg intravenously on week 1 followed by 2 mg/kg per week thereafter. Cycle length was 8 weeks. Sixty-nine patients with NSCLC (33 men, 36 women) were screened between August 1999 and March 2001. Only 13 patients (19%) had HER2-positive disease; all 13 enrolled in the efficacy trial. Of 9 patients receiving docetaxel alone, 1 partial response (PR) was seen. None responded to trastuzumab alone. The overall outcomes to the sequence of single-agent therapy followed by combination therapy included a PR rate in 8% of cases, stable disease in 23%, progression in 46%, and nonassessable disease in 23%. Estimated event-free and overall survival times were 4.3 and 5.7 months, respectively. Treatment was well tolerated. The screening component of this trial demonstrated that the target population for trastuzumab therapy in NSCLC is relatively small. Because of the limited clinical activity of trastuzumab-based therapy in this cohort and the similar disappointing reports from other studies of trastuzumab in NSCLC, this trial was closed to further accrual. In view of the limited target population for HER2 inhibition, future efforts and resources should be directed toward molecular targets other than HER2 in NSCLC.

Adenocarcinoma↗

Needs assessment report for a young people's sexual health project in West Bengal.

In collaboration with AIMS Research in Calcutta and with funding support from the West Bengal Sexual Health Project/Department for International Development, UK, the Thoughtshop Foundation conducted a study of the sexual health problems and information needs of young people in urban and rural West Bengal. The study was conducted during March-April 1997, targeting both male and female adolescents in the 12-19 age group, both in and out of school. The study involved a content analysis of letters received by the AIDS, Sex, Knowledge column; focus group discussions; interviews with key personalities who exert major influence on young people; and an institutional analysis of sexual health services available to the target population. The study's findings point to an almost lack of sexual awareness of sexual health issues and knowledge of the human anatomy among the target population and the people who influence them most (e.g., parents and teachers). Very often the very same people discourage young people's access to information about sexual health. While the institutional analysis indicates some progress in the provision of sexual health services to young people (e.g., awareness programs, counseling and condom promotion), access to reliable sources of information, including the mass media, is not available to many of them.

Adolescent↗

The impact of public insurance expansions on children's access and use of care.

OBJECTIVE: Our goal was to examine the impact of the State Children's Health Insurance Program nationally on children's access and use of health care. OBJECTIVE: Our data source was the National Health Interview Survey, using 1997 as a baseline, which predates the implementation of the State Children's Health Insurance Program, and 2003 as the end point of the analysis. We analyzed 25,734 children aged 0 to 18 years (1997 and 2003 combined) to examine changes in health insurance coverage rates, health care access, and utilization for children in the State Children's Health Insurance Program target population, defined here as those living in families with incomes between 100% and 199% of the federal poverty level. RESULTS: Children in the State Children's Health Insurance Program target income group showed the largest reduction in rates of uninsurance among 3 income groups (< 100%, 100%-199%, and > or = 200% of the federal poverty level) between 1997 and 2003 (15.1%-8.7%). Significant reductions occurred in the proportion of children without a usual source of care in the target income group (9.4%-7.3%) and in the proportion of children without a provider visit in the past year (10.8%-9.8%). Other measures (unmet needs, delayed care, volume of provider visits, receipt of well-child care, and dental care) showed no significant changes over this time period. A separate multivariate analysis restricted to the State Children's Health Insurance Program target population in 2003 showed that children with continuous public coverage had significantly better access and utilization on all measures studied when compared with uninsured children and performed as well or better than children with continuous private coverage. CONCLUSIONS: Implementation of the State Children's Health Insurance Program is associated with substantial gains in public coverage for children in the target income group. Although some of these gains were offset by losses in private coverage, our findings demonstrate that public health insurance provides significant benefits in terms of access and utilization for children living in the target income group.

Adolescent↗

The prevalence of antiretroviral drug resistance in the United States.

BACKGROUND: Antiretroviral therapy has dramatically reduced the morbidity and mortality of infection due to HIV. The emergence of drug-resistant virus has limited the usefulness of many drugs. OBJECTIVE: To determine the prevalence of HIV drug resistance in the population of adults receiving care in the United States. DESIGN AND METHODS: HIV drug susceptibility assays were performed on plasma virus from a random sample representative of the 132500 HIV-infected American adults who had received medical care in early 1996 yet were viremic with > 500 copies/ml of HIV RNA in late 1998. A blood sample was obtained from 1797 patients who comprised a representative sample of the 208900 adults receiving urban care for HIV infection in early 1996 who survived to late 1998. The sampling procedure permitted weighting each evaluated patient to reflect demographic and other characteristics of the target population. RESULTS: We estimated that 132500 (63%) of the target population had HIV viremia of > 500 copies/ml. Among viremic patients, an estimated 76% had resistance to one or more antiretroviral drugs. The odds of resistance were significantly higher in patients with a history of antiretroviral drug use, advanced HIV disease, higher plasma HIV viral load and lowest CD4 cell count by self-report. CONCLUSIONS: The frequent selection for drug-resistant virus among viremic patients during the first 3 years of widespread use of potent antiretroviral combination therapy has significant implications for HIV treatment and transmission.

Adolescent↗

Pneumococcal vaccination. Controversies and opportunities.

The morbidity and mortality associated with pneumococcal infections are preventable in many high-risk individuals by immunization with 23-valent pneumococcal vaccine. While the clinical effectiveness of the current vaccine is less than ideal, use of the vaccine is cost effective. In spite of recommendations for pneumococcal vaccination of elderly and other high-risk persons, and federal reimbursement for vaccination Medicare enrollees, it was estimated in 1985 that only 10% to 15% of this target population was immunized. Strategies for immunizing high-risk individuals with pneumococcal vaccine need to involve physicians, public health professionals, health advocacy groups, and persons in the targeted populations.

Antibodies, Bacterial↗