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PubMed2001

Smoking characteristics: differences in attitudes and dependence between healthy smokers and smokers with COPD.

OBJECTIVE: To ascertain the differences in smoking characteristics between a group of smokers with COPD and another group of healthy smokers, both of which were identified in a population-based epidemiologic study. DESIGN AND PARTICIPANTS: This is an epidemiologic, multicenter, population-based study conducted in seven areas of SPAIN: A total of 4,035 individuals, men and women aged 40 to 69 years, who were selected randomly from a target population of 236,412 subjects, participated in the study. INTERVENTIONS: Eligible subjects answered the European Commission for Steel and Coal questionnaire. Spirometry was performed followed by a bronchodilator test when bronchial obstruction was present. The Fagerström questionnaire was used for study of the degree of physical nicotine dependence, and the Prochazka model was followed for analysis of the smoking cessation phase. RESULTS: Of 1,023 active smokers, 153 (15%) met the criteria for COPD. Smokers with COPD were more frequently men (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.21 to 3.95), were > or = 46 years of age (OR, 1.97; 95% CI, 1.18 to 3.31), had a lower educational level (OR, 1.96; 95% CI, 1.23 to 3.14), and had smoked > 30 pack-years (OR, 3.70; 95% CI, 2.42 to 5.65). Smokers with COPD showed a higher dependence on nicotine than healthy smokers (mean [+/- SD] Fagerström test score, 4.77 +/- 2.45 vs 3.15 +/- 2.38, respectively; p < 0.001) and higher concentrations of CO in exhaled air (mean concentration, 19.7 +/- 16.3 vs 15.4 +/- 12.1 ppm, respectively; p < 0.0001). Thirty-four percent of smokers with COPD and 38.5% of smokers without COPD had never tried to stop smoking. CONCLUSIONS: Smokers with COPD have higher tobacco consumption, higher dependence on nicotine, and higher concentrations of CO in exhaled air, suggesting a different pattern of cigarette smoking. Cases of COPD among smokers predominate in men and in individuals with lower educational levels. A significant proportion of smokers have never tried to stop smoking; thus, advice on cessation should be reinforced in both groups of smokers.

Adult↗
PubMedDate not supplied

Pharmacogenetics and pharmacoepidemiology.

This paper seeks to stimulate consideration of the short- and long-term possibilities raised by research into pharmacogenetics and pharmacoepidemiology, to identify potential tissue databanks linked to population data, and to summarize our ethical responsibilities. Short term, we might identify selected disorders or risk factors, such as for drug-associated serious events, and might find selected target populations. Long term, we might incorporate genomics techniques into population data and map genetic risk factors for diseases and drug responses. Tissue specimens that might be linked to clinical data lie in certain data resources: clinical trials, ad hoc cohorts, case registries, and cross-sectional and longitudinal population samples. Specific areas must be addressed in research using human tissue and genetic material, including the ethical threat to privacy. We must avoid misuse of genetic information by breaching confidentiality and putting at risk specific genetically identifiable groups. The National Bioethics Advisory Commission recently addressed the issue of serum and tissue data banks in a published report summarized in this paper. Social, methodologic, and ethical issues relate to any protocol using serum and tissue, and indicate a need for broad educational efforts. We must set guidelines as pharmacogenetics research becomes a dimension of pharmacoepidemiology.

Cohort Studies↗
PubMed1987

Factors affecting place of death in Washington State, 1968-1981.

A study was carried out to determine factors affecting place of death (home, hospital, nursing home or "other places") among all 426,115 resident deaths in Washington State during 1968-1981, using death certificate information. Sixteen percent of deaths occurred at home, 74% in institutions (51% in hospitals, 23% in nursing homes) and 9% at "other places." Age, marital status and cause of death all strongly affect place of death. Further, the effect of each factor was strongly dependent on the others. Sex had no effect on place of death after controlling for other factors. Elderly people died relatively more frequently in nursing homes, infants and middle aged people in hospitals and young adults in "other places." The frequency of deaths at home was quite constant by age. Hospitals were the most common place of death following both vascular disease (including heart attack) and neoplasms, and nursing homes were the most common place of death following cerebrovascular disease (including "stroke"). Race, socioeconomic status and urban or rural residents affected the place of death only slightly or not at all. The place of death pattern changed little during the time period 1968-1981, except for a slight increase in frequency of home deaths and a corresponding decrease in the frequency of deaths in other places. Among cancer patients, the likelihood of death at home was positively associated with longer periods of survival after diagnosis. Cancer patients of hospitals serving targeted populations, such as veterans, were relatively more likely to die in a hospital and less likely to die in a nursing home compared to other cancer patients, suggesting that the "targeted" hospitals are sometimes serving a nursing home function. There was a marked difference in the terminal cancer caseload by hospital. The number of cancer deaths per cancer diagnosis varied widely across hospitals (0.1 to 1.6) and was unrelated to size of the hospital or level of services offered. Intervention aimed at affecting place of death, such as increasing the number of deaths at home, will need to take account of the joint effect of age, marital status and disease.

Adolescent↗
PubMed1986

Antibody-targeted photolysis: selective photodestruction of human T-cell leukemia cells using monoclonal antibody-chlorin e6 conjugates.

Selective in vitro photodestruction of HPB-ALL human T-cell leukemia cells was accomplished using the photosensitizer chlorin e6 coupled through dextran molecules to an anti-T-cell monoclonal antibody (mAb), anti-Leu-1. Conjugates with mAb/chlorin molar ratios as high as 1:36 retained mAb binding activity, and the absorption spectrum and quantum efficiency for singlet oxygen production of bound chlorin (0.7 +/- 0.2) were unchanged from that of the free photosensitizer. Phototoxicity, as measured by a clonogenic assay and by uptake of ethidium bromide, was dependent on the doses of both mAb-chlorin and 630- to 670-nm light, was enhanced by 2H2O, and was observed only in target populations that bound the mAb. Similarly, free chlorin e6 in solution had no photodynamic effect in amounts 100 times more than that carried by the mAb. For this antibody-targeted system, approximately 10(10) molecules of singlet oxygen were necessary to kill a cell.

Antibodies, Monoclonal↗
PubMed1996

Public health impact of various risk factors for acute otitis media in northern Finland.

The aim of this study was to assess the excess risk attributable to alterable risk factors for acute otitis media in Finnish children, including day care attendance, parental smoking, and a short duration of breastfeeding. Data on a population-based cohort of 2,512 children were gathered from medical records and questionnaires from 1985 to 1988. Excess (attributable) fractions for the risk factors were calculated among 825 children (target population) followed for 2 years, from a dynamic logistic model fitted to the entire cohort (estimation data). In theory, one child out of every five affected in the exposed population would have escaped otitis media completely if he/she had been moved from nursery day care to home care, and two out of every five affected could have escaped recurrent episodes in this way. The corresponding figures for family day care were lower: one and two children out of every six affected, respectively. Cessation of parental smoking and breastfeeding would have smaller effects. The impacts were more modest in the whole population. Nevertheless, approximately 14% of all of the otitis media episodes would have been avoided if all of the children had been cared for at home. These figures are hypothetical, since it is unlikely that use of day care outside the home can be avoided altogether, but they offer further evidence of the notable role of day care attendance as a risk factor for otitis media.

Acute Disease↗
PubMed1998

Age-dependent differences in the prevalence of allergic rhinitis and atopic sensitization between an eastern and a western German city.

Recent studies have found a higher prevalence of allergic rhinitis and atopic sensitization among adults living in eastern than those living in western Germany. We hypothesize that prevalence rates were similar before Germany was divided and diverged after the division. Because there are no historical data comparing atopic status between the two parts of Germany, we tested this hypothesis by comparing the prevalence of atopy among persons who were born during different decades. As part of the EC Respiratory Health Survey, a respiratory health questionnaire was mailed to a population-based sample of 8363 subjects aged 20-44 years from a city in the former West Germany (Hamburg) and a city in the former East Germany (Erfurt). Of the target population, 6428 (77%) subjects responded. Subsamples of 731 subjects from Erfurt and 1159 subjects from Hamburg participated in medical examinations, including skin prick tests and specific IgE measurements. Prevalence rates of allergic sensitization were similar in Hamburg and Erfurt for those born in the periods 1946-51 and 1952-61, respectively, but differed between Hamburg and Erfurt subjects born in the period 1962-71. After adjustment for several potential predictors, the younger subjects from Hamburg had a higher odds ratio (OR) of sensitization than those Hamburg subjects born before 1952 (skin prick test reactivity: OR 2.06, any specific IgE > 0.35 kU/l: OR 1.61). The younger subjects from Erfurt were not more frequently sensitized than the older subjects (skin prick test reactivity: OR 1.05, any specific IgE > 0.35 kU/l: OR 0.79). No single allergen could be identified as responsible for the observed difference. We conclude that factors related to a "Western lifestyle", which were prevalent in the West German city during the 1960s and 1970s, may be responsible for the higher prevalence of allergic sensitization observed in Hamburg.

Adult↗
PubMed2005

Cost-effectiveness of alendronate therapy for osteopenic postmenopausal women.

BACKGROUND: Treatment guidelines recommend drug treatment to prevent fractures for some postmenopausal women who have low bone mass (osteopenia) but do not have osteoporosis or a history of clinical fractures. OBJECTIVE: To estimate the societal costs and health benefits of alendronate drug treatment to prevent fractures in postmenopausal women with osteopenia. DESIGN: Markov model with 8 health states: no fracture, post-distal forearm fracture, post-clinical vertebral fracture, post-radiographic (but clinically inapparent) vertebral fracture, post-hip fracture, post-hip and vertebral fractures, post-other fracture, and death. DATA SOURCES: Population-based studies of age-specific fracture rates and costs, prospectively measured estimates of disutility after fractures, and the Fracture Intervention Trial of alendronate versus placebo to prevent fracture. TARGET POPULATION: Postmenopausal women 55 to 75 years of age with femoral neck T-scores between -1.5 and -2.4. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: Five years of alendronate therapy or no drug treatment. OUTCOME MEASURES: Costs, quality-adjusted life-years, and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS: For women with no additional fracture risk factors, the cost per quality-adjusted life-year gained ranged from 70,000 dollars to 332,000 dollars, depending on age and femoral neck bone density. RESULTS OF SENSITIVITY ANALYSES: Results were sensitive to changes in fracture risk reduction attributable to alendronate and alendronate cost. LIMITATIONS: Results apply only to postmenopausal white women residing in the United States. CONCLUSION: Alendronate therapy for postmenopausal women with femoral neck T-scores better than -2.5 and no history of clinical fractures or other bone mineral density-independent risk factors for fracture is not cost-effective, assuming U.S. costs of alendronate and currently available estimates of alendronate efficacy in osteopenic women.

Aged↗
PubMed1999

Aging in place: a proposal for rural community-based care for frail elders.

Rural health care is hampered by uneven development of services and multiple definitions of rurality. One of the most vulnerable populations in this setting is older residents. This article explores existing models of long-term care for the older population and proposes a model for rural community-based care. This model emphasizes the contributions of advanced practice nurses as coordinators of a collaborative system of care for the targeted population. Issues of cost and quality, as well as the strengths and limitations of the model, are addressed.

Community Health Nursing↗
PubMed2003

Atrioventricular septal defect--associated anomalies and aneuploidy in prenatal life.

The present study was conducted to estimate the frequency of other-cardiac, extracardiac and chromosomal anomalies in fetuses with A VSD diagnosed in a prenatal diagnosis center, analysed from the database during the 54-month period extending from November 1997 to May 2002. One hundred and three fetuses were diagnosed with A VSD. Among them other-cardiac and extra cardiac anomalies were present in 56 and 75 cases respectively. Of the 22 fetuses that had undergone karyotyping, no metaphase was seen in one case. In the remaining 21, 15 (71.4%) turned out to be normal, three (14.2%) had trisomy 18, two (9.5%) had trisomy 13 and one had trisomy 21 (4.8%). We found that AVSD almost always occurs with other-cardiac or extracardiac anomalies, though the pattern may differ between populations. It seems to be less frequently associated with chromosomal anomalies (especially trisomy 21) in South India. The genetics of AVSD underscores the importance of a thorough understanding of the target population in prenatal decision-making.

Adolescent↗
PubMed1993

[Prevention of sexually transmitted diseases or control of prostitutes and patients with venereal diseases? An exemplary, epicritical study in Bremen].

Data derived from laboratory and activity statistics of the Venereal Disease" department of the Public Health Office in Bremen were analysed between 1961 and 1991. The traditional concept to fight venereal diseases" aimed at controlling persons "at risk" for syphilis, gonorrhoea, chancroid or lymphogranuloma. This "high-risk" approach of STD prevention stressed the compulsory, at least twice monthly screening of female prostitutes and neglected other population groups like clients of prostitutes and young people, who might have an elevated risk in acquiring STD. The spread of STD like chlamydia, HPV, herpes and even HIV in considerable parts of the general population underlines the need for developing a more effective STD prevention, based on scientific diagnosis and treatment. Intervention programmes in STD control must be performed in full partnership with the targeted population; this can require great effort and time. But STD control certainly cannot be achieved under the threat of punishment or proscription.

Adolescent↗
PubMed1998

Population-based mammographic screening in Singapore: what are participants' views?

Mammographic screening for breast cancer has been shown to be an effective tool for reducing mortality from the disease in many studies in the West, if high technical quality and acceptance by the target population are achieved. The objective of the Singapore Breast Screening Project was to determine if the same results could be obtained among local women by inviting a random sample of 69,500 women aged 50 to 64 years for a screening mammogram over two years. To date, the compliance rate among the women invited has been 41.7%. The objective of the present substudy was to determine participants' views on the accessibility and acceptability of organised mammographic screening. Of the three hundred women interviewed, 85% were satisfied with the information given prior to the visit, while 67% needed to change the original appointment given. The majority were satisfied with aspects of the visit such as waiting time, privacy and explanation given during the test. However, 35.1% reported at least moderate discomfort during mammography. A substantial proportion (39.7%) of attenders felt that there was very little hope of cure even if cancer was detected early. When asked the most important reason for attending, most indicated they had taken the opportunity for a free check-up to be assured they were well. Almost all (95.7%) reported a willingness to be screened again, but most would not be willing to pay for a mammogram at the current rates.

Appointments and Schedules↗
PubMed2001

Prevention of obesity--is it possible?

Obesity prevention is necessary to address the steady rise in the prevalence of obesity. Although all experts agree that obesity prevention has high priority there is almost no research in this area. There is also no structured framework for obesity prevention. The effectiveness of different intervention strategies is not well documented. Regarding universal prevention little rigorous evaluation has been carried out in larger populations. Obesity prevention has been integrated into community-wide programmes preventing coronary heart disease. Although effective with respect to reduction in cardiovascular risk factors these programmes did not affect mean body mass index (BMI) of the target populations. Selective prevention directed at high risk individuals (e.g. at children with obese parents) exhibited various degrees of effectiveness. However, at present, definitive statements cannot be made because of the limited number of studies as well as limits in study design. Finally, targeted prevention produced promising results in obese children when compared to no treatment. However, there are only very few longterm follow-up data. There is no clear idea about comprehensive interventions studying combinations of different strategies. It is tempting to speculate that predictors of treatment outcome (e.g. psychological and sociodemographic factors) may also serve as barriers to preventive strategies, but this has not yet been investigated. Taken together, obesity prevention should become a high priority research goal. First results of obesity prevention programmes are promising. As well as health promotion and counselling, better school education and social support appear to be promising strategies for future interventions.

Adult↗
PubMed1997

Characteristics of non-participants and reasons for non-participation in a population survey in Kin-Hu, Kinmen.

The aim was to characterize non-participants and to investigate reasons for non-participation in a health survey in Kin-Hu township, Kinmen, Republic of China. The non-participants represented 25.6% of the target population of 4,451 registered residents aged 30 and older. Baseline demographic characteristics and two-year mortality for the participants and non-participants were compared. A house-to-house visit was attempted to all of the non-participants for reasons of refusal. The mean age of the non-participants was significantly older than that of the participants (54.3 versus 48.5 years, p < 0.001). The response rate for women was significantly higher than that for men (77.2% versus 71.6%, p < 0.001). The probability of death was significantly different between the two groups (1.2% versus 8.8% for participants and non-participants, respectively, p < 0.001). Major reason for not having participated in the health survey was 'not notified or informed of the examination' (32.7%). These data suggest that non-participants were less healthy.

Adult↗
PubMed2000

An individual bioequivalence criterion: regulatory considerations.

Over the years, concerns have been raised regarding the appropriateness of using the average bioequivalence approach for evaluation of comparability between formulations. In lieu of average bioequivalence, scientists from academia, industry and regulatory agencies have spent considerable effort and time in exploring the concepts of population and individual bioequivalence, and developing the statistical methods to assess the bioavailability metrics using these approaches. Recently, the Food and Drug Administration (FDA) has published a preliminary draft guidance entitled 'In vivo bioequivalence studies based on population and individual bioequivalence approaches'. The concept of prescribability and switchability underscores the difference between the population and individual bioequivalence approaches. The most important consideration for individual bioequivalence, the focus of this paper, rests on the assurance that products deemed bioequivalent can be used interchangeably in the target population (switchability). In addition to the comparison of averages, the individual bioequivalence approach compares within-subject variabilities and assesses subject-by-formulation interaction. The proposed criterion represents substantial departure from the current practice and thus has resulted in extensive public discussion. In contrast to the current average bioequivalence procedure, the proposed individual bioequivalence approach offers flexible equivalence criteria based on the individual therapeutic window and variability of the reference drug product. The proposed criterion rewards manufacture of less variable drug products, allows scaling criteria for highly variable/narrow therapeutic range drugs, and promotes the use of subjects from the general population in bioequivalence studies. The FDA is currently considering various approaches for resolution of issues raised from the public debate on the subject-by-formulation interaction term, statistical methods and resource implications.

Area Under Curve↗
PubMed2004

Contaminants as viral cofactors: assessing indirect population effects.

Current toxicological methods often miss contaminant effects, particularly when immune suppression is involved. The failure to recognize and evaluate indirect and sublethal effects severely limits the applicability of those methods at the population level. In this study, the Vitality model is used to evaluate the population level effects of a contaminant exerting only indirect, sublethal effects at the individual level. Juvenile rainbow trout (Oncorhynchus mykiss) were injected with 2.5 or 10.0 mg/kg doses of the model CYP1A inducer, beta-naphthoflavone (BNF) as a pre-stressor, then exposed to a challenge dose of 10(2) or 10(4) pfu/fish of infectious hematopoietic necrosis virus (IHNV), an important viral pathogen of salmonids in North America. At the end of the 28-d challenge, the mortality data were processed according to the Vitality model which indicated that the correlation between the average rate of vitality loss and the pre-stressor dose was strong: R2=0.9944. Average time to death and cumulative mortality were dependent on the BNF dose, while no significant difference between the two viral dosages was shown, implying that the history of the organism at the time of stressor exposure is an important factor in determining the virulence or toxicity of the stressor. The conceptual framework of this model permits a smoother transfer of results to a more complex stratum, namely the population level, which allows the immunosuppressive results generated by doses of a CYP1A inducer that more accurately represent the effects elicited by environmentally-relevant contaminant concentrations to be extrapolated to target populations. The indirect effects of other environmental contaminants with similar biotransformation pathways, such as polycyclic aromatic hydrocarbons (PAH), could be assessed and quantified with this model and the results applied to a more complex biological hierarchy.

Animals↗
PubMed2003

Annual screening for oral cancer detection.

Most oral cancer and oral mucosal screening programs initiated in the past 20 years have been limited to a single examination of the population under study. Age specific, annual oral mucosal screening examination as a part of general health screening has been in operation in Tokonama city, Japan, from 1986. From 1996 the same target population aged 40 years and older has been invited for screening. The program coverage extended to 26% of the city population. During 1995-1998, out of 9536 attendees who participated in a general health and oral mucosal screening program in Tokoname city 6340 subjects (66.5%) re-attended at least for one further screening examination. There was no difference in the attendance for two annual mucosal examinations between male (67.0%) and female (66.2%) subjects. Three thousand nine hundred thirty-five subjects attended oral screening all 3 years (1996-1999) and the overall show-up rate for three consecutive examinations was 61%. During September-October 1996, 42 volunteer dentists carried out 6705 mouth examinations among those aged 40 years and older at the Municipal Center. One oral cancer was detected in 1996, in a subject free of any mucosal disease in the previous year. Among the screen-negative cases in 1996, 78% re-attended for screening in 1997 and 79% re-attended in the subsequent year. In the cohort that re-attended screening (1996-1998), oral mucosal pathology detected in three consecutive screenings included 18 leukoplakias, 24 with oral lichen planus and 343 other benign mucosal lesions. The number of subjects who complied to return and who remained disease-free over the 3-year period amounted to 3860, 59% of the disease-free subjects seen in 1996. A regular smoker was less likely to attend oral cancer screening in the three consecutive years of follow-up (odds ratio: 0.832, 95% CI 0.701-0.988). Satisfactory participation can be obtained for annual oral mucosal screening in Japan: this allows detection of new lesions, including oral cancer and leukoplakia (a surrogate marker of cancer risk). The number of new oral cancers detected in the program was too low to determine the optimal frequency for oral cancer screening but new oral leukoplakias were found on annual re-screening: the data indicate that the interval between two screens for this population should not be greater than 12 months.

Adult↗
PubMed2005

Economic evaluation of interventions for problem drinking and alcohol dependence: cost per QALY estimates.

AIMS: To compare the performance of competing and complementary interventions for prevention or treatment of problem drinking and alcohol dependence. To provide an example of how health maximising decision-makers might use performance measures such as cost per quality adjusted life year (QALY) league tables to formulate an optimal package of interventions for problem drinking and alcohol dependence. METHODS: A time-dependent state-transition model was used to estimate QALYs gained per person for each intervention as compared to usual care in the relevant target population. RESULTS: Cost per QALY estimates for each of the interventions fall below any putative funding threshold for developed economies. Interventions for problem drinkers appear to offer better value than interventions targeted at those with a history of severe physical dependence. CONCLUSIONS: Formularies such as Australia's Medicare should include a comprehensive package of interventions for problem drinking and alcohol dependence.

Adolescent↗
PubMedDate not supplied

Group A meningococcal disease in the U.S. Pacific Northwest: epidemiology, clinical features, and effect of a vaccination control program.

In 1975 an outbreak of group A meningococcal disease began in Seattle, Washington, and cases subsequently were recognized throughout the Pacific Northwest. Nearly one-half of the affected persons were Native Americans; two-thirds were alcohol abusers and/or habitués of skid road communities. In Seattle, group A meningococci colonized asymptomatic persons only if these individuals had contact with skid road (P = .006). The epidemic strain may have spread from American Indians in Manitoba, Canada. Traditional migration routes connect the two populations; asymptomatic American Indians on reservations in Washington carried group A meningococci. Vaccination programs were undertaken in four cities but only after cases occurred. In Seattle, vaccination reached 80% of the target population and was associated with a significant decrease in incidence of the disease, but cases recurred after the program ended. The social habits of skid road communities, combined with the "case-triggering" approach to, and premature termination of, vaccination programs, may have resulted in 56% of regional cases occurring after the start of the vaccination program in Seattle.

Adult↗