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Use of tumor necrosis factor inhibitors in rheumatoid arthritis: a national survey of practicing United States rheumatologists.

OBJECTIVES: To determine the prescribing practices, laboratory monitoring protocols, and perceived barriers of United States rheumatologists in prescribing tumor necrosis factor (TNF) inhibitors in rheumatoid arthritis (RA). METHODS: A survey questionnaire was mailed to 1970 rheumatologists who were randomly selected from a national sample of 3008 rheumatologists. A one-page non-response questionnaire was mailed to approximately 200 randomly selected non-responding rheumatologists to assess non-response bias. RESULTS: Two mailings yielded a response rate of 22.3% (428 completed, usable surveys out of 1922 deliverable surveys). Rheumatologists reported using all three agents in patients with moderate RA (82-87%), severe RA (94-96%), and in newly diagnosed and mild RA patients (10-18%). In patients with severe RA who inadequately responded to methotrexate, 91% of rheumatologists reported using a TNF inhibitor with one other disease modifying anti-rheumatic drug. Over 94% of rheumatologists reported switching patients from one TNF inhibitor to a different TNF inhibitor due to inadequate response or side effects. Most rheumatologists (96%) ordered the purified protein derivative test for tuberculosis, with almost 82% conducting this test at baseline. Costs to patients and insurance coverage were perceived as major barriers to prescribing these agents although the perception was slightly lower with infliximab than with adalimumab or etanercept. CONCLUSIONS: The use of TNF inhibitors is not restricted to patients with moderate and severe RA. Rheumatologists are fairly similar in their utilization of the three TNF inhibitors although some variation exists in terms of laboratory practices and perceived barriers regarding the use of these agents.

Adalimumab↗

Duration of therapy and health care costs of fluoxetine, paroxetine, and sertraline in 6 health plans.

BACKGROUND: Previous studies comparing fluoxetine, paroxetine, and sertraline, the 3 most common selective serotonin reuptake inhibitors (SSRIs), in naturalistic settings have produced conflicting results. With this study, we provide new evidence as to the similarities and differences among these SSRI therapies with respect to the duration of use and health care costs. METHOD: Data from 6 health maintenance organizations were used to identify patients with new-onset major depression. number of days with filled prescriptions, and total health care and depression-related costs. The sample consisted of 1771 patients given initial prescriptions for sertraline (N = 386), fluoxetine (N = 840), or paroxetine (N = 545) in the period from July 1, 1994, to March 31, 1997. Analyses included Cox proportional hazards models (for duration of initial therapy) and ordinary least squares regression (for cost). RESULTS: Patients who initiated therapy with fluoxetine were more likely to have a later interruption of therapy than patients who initiated therapy with sertraline (p = .03) and paroxetine (p = .001). Total 1-year costs did not differ statistically between the treatment groups, but 1-year depression-related costs were significantly lower for patients who initiated therapy with sertraline or paroxetine than for those who initiated therapy with fluoxetine ($332 less for sertraline, 95% confidence interval [CI] = $125 to $562; $339 less for paroxetine, 95% CI = $144 to $416). LIMITATIONS: A limitation of this observational study, as well as of observational studies in general, is that unobserved characteristics of the patients may lead to biased estimates of the impact of treatment on adherence or cost, even with controls for observed characteristics. CONCLUSION: We found no significant differences in total health care costs among the 3 SSRIs, but noted significant differences in depression-related costs (the costs of fluoxetine are greater than those of sertraline and paroxetine). Importantly, there was no relationship between treatment interruption and increased health care or depression-related costs, in contrast to the findings of some, but not all, prior studies.

Adolescent↗

Are gatekeeper requirements associated with cancer screening utilization?

OBJECTIVE: There is widespread debate over whether health plans should require enrollees to use "gatekeepers," which are primary care providers that coordinate care and control access to specialists. However, little is known about whether health plan gatekeeper requirements improve or reduce quality-of-care. Our objective was to examine whether gatekeeper requirements are associated with the utilization of cancer screening for breast, cervical, and prostate cancer. DATA SOURCES: Three linked sources (N = 13,534): (1) 1996 Medical Expenditure Panel Survey (MEPS) Household Survey, a nationally representative, ongoing survey sponsored by the Agency for Healthcare Research and Quality; (2) 1996 MEPS Health Insurance Plan Abstraction, which codes data from health plan booklets obtained from privately insured respondents, and (3) 1995 National Health Interview Survey. STUDY DESIGN/DATA COLLECTION: Cross-sectional, multivariate logistic regression analysis using secondary data. PRINCIPAL FINDINGS: We found in multivariate analyses that women in gatekeeper plans were significantly more likely to obtain mammography screening (Odds Ratio [OR] = 1.22, 95 percent Confidence Interval [CI] 1.07-1.40), clinical breast examinations (OR = 1.39, 95 percent CI 1.23-1.57), and Pap smears (OR = 1.33, 95 percent CI 1.16-1.52) than women not in gatekeeper plans. In contrast, gatekeeper requirements were not associated with prostate cancer screening (OR = 1.11, 95 percent CI 0.93-1.33). We found no association between screening utilization and aggregate plan types (HMO, POS, PPO, FFS). CONCLUSIONS: Gatekeeper requirements are associated with higher utilization of widely recommended cancer screening procedures, but not with utilization of a less uniformly recommended cancer screening procedure. Researchers should consider the analysis of specific plan characteristics rather than aggregate plan types in conducting future research, and insurers and policymakers should consider the potential benefits of gatekeepers with respect to preventive care when designing health plans and legislation.

Breast Neoplasms↗

[Mortality among steel workers of the Basque Country].

Most of mortality studies among steelworkers pointed out an increased frequency on cancer mortality, above all by lung cancer, and, in a lower proportion, by cancers of digestive and genitourinary systems. In Spain mortality rates are not published by occupation and economic activity to contrast these observations. It was carried out a proportionate mortality study among active or retired workers from an steel mill, Altos Hornos de Vizcaya, died from 1986 to 1993, to make a preliminary death risk assessment associated with job in the steel industry. A sample of 1553 men was drawn from the mortality register of a private Insurance Company. Death causes within the sample and in general population of the Autonomous Community of the Basque Country were compared using a proportionate analysis. Mortality odds ratios (OR) were also computed. The results show an excess of cancer mortality (OR = 1.26, IC: 1.11-1.42), stomach cancer (OR = 1.50, IC: 1.14-1.98) and renal cancer (OR = 1.89; IC: 1.14-3.14) as it has been stated by other authors. It has not been found an increased mortality risk from lung cancer (OR = 1.13, IC: 0.91-1.40), bladder cancer (OR = 1.13, IC: 0.74-1.72) and chronic respiratory disease (OR = 0.94, IC: 0.73-1.20). There is also an excess of liver cancer (OR = 1.56, IC: 1.06-2.28) and cancer of non specified location (OR = 1.85, IC: 1.45-2.36). This can be due to classification bias that affects the study. On the other hand, these and other selection bias, discussed in this paper, could underestimate the lung cancer mortality. We can not conclude that, among the workers of the study, the mortality from several kind of cancer is not associated to occupational exposure. Furthermore, this excess of stomach and kidney cancer mortality may lead us to pose the hypothesis of cause-effect relationship with some not well identified carcinogens present at the steel working place.

Adult↗

The effect of chronic illness on the psychological health of family members.

BACKGROUND: Chronic illness in a family member can cause emotional distress throughout the family, and may impair the family's ability to support the patient. OBJECTIVES: We compare the familial impact of mental illness to other common chronic conditions. We examine the impact of a person's chronic illness on the psychological health of all persons in his or her family and identify both individual and family-level risk factors associated with psychological spillovers. METHODS: Our analysis is based on data from the 1996 Medical Expenditure Panel Survey (MEPS) that, because of its sample design, can be used to model both individual and family health status. Psychological distress is measured using responses to the general mental health question for each family member. The chronic conditions considered include cancer, diabetes, stroke-related disorders, arthritis, asthma, and mental illness (including dementia). We estimate the relationships of interest using a semi-parametric method, the discrete random effects probit model. RESULTS: Brain-related conditions, including mental illness, impose the most significant risk to the psychological well-being of family members. The effects of the other chronic conditions studied, while not as significant, are notable in that their negative impacts on the psychological health of family members are sometimes larger than their direct psychological impacts on the patient. Economic distress not only directly increases the chance that an individual will experience emotional distress, but it appears it also reduces the family's ability as a whole to cope psychologically with chronic illness. DISCUSSION: Our analysis suffers from problems common to all cross-sectional designs, although the impact of selection bias appeared to be small in sensitivity analysis. While health conditions were based on unverified self-reports, condition categories were broadly defined to reduce the required precision of such reports. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Because psychological distress is fairly contagious in families confronted with chronic illness, effective treatment strategies may need to be targeted to all members of the primary patient's family. Providers should be particularly vigilant for intra-family effects when their patients come from families that lack the financial resources that might protect against the stress of caring for a family member with a chronic illness. IMPLICATIONS FOR HEALTH POLICIES: Results suggest that, of the chronic conditions considered, priority for respite care and supportive services should be given to families in which a member has a brain-related disorder, particularly in families with limited financial resources and inadequate insurance coverage. IMPLICATIONS FOR FURTHER RESEARCH: The use of the discrete random effects probit model identified important interpersonal health effects that could not have been detected with standard analytical methods. The potential clinical relevance of the resulting findings underlies the need for additional data collection efforts that, like the MEPS, consider individuals in a family context.

Chronic Disease↗

Immunization coverage and its relationship to preventive health care visits among inner-city children in Baltimore.

OBJECTIVE: To provide empirical data on immunization coverage and the receipt of preventive health care to inform policy makers' efforts to improve childhood immunization. DESIGN AND METHODS: We surveyed a random sample drawn from a birth cohort of 557 2-year-old children living in the inner-city of Baltimore. Complete information on all their preventive health care visits and immunization status was obtained from medical record audits of their health care providers. MAIN OUTCOME MEASURES: Age-appropriate immunizations and preventive health care visits. RESULTS: By 3 months of age, nearly 80% made an age-appropriate preventive health visit, but by 7 months of age, less than 40% had a preventive visit that was age-appropriate. In the second year of life, 75% made a preventive health visit between their 12- and 17-month birthdays. The corresponding age-appropriate immunization levels were 71% for DTP1, 39% for DTP3, and 53% for measles-mumps-rubella vaccine. Infants who received their DTP1 on-time were twice as likely to be up-to-date by 24 months of age. CONCLUSIONS: Our analyses focus attention on the performance of the primary health care system, especially during the first 6 months of life. Many young infants are underimmunized despite having age-appropriate preventive visits, health insurance coverage through Medicaid, and providers who receive free vaccine from public agencies. Measles vaccination coverage could be improved by initiating measles-mumps-rubella vaccine vaccination, routinely, at 12 months among high risk populations.

Baltimore↗

Willingness-to-pay for community-based insurance in Burkina Faso.

PURPOSE: To study the willingness-to-pay (WTP) for a proposed community-based health insurance (CBI) scheme in order to provide information about the relationship between the premium that is required to cover the costs of the scheme and expected insurance enrollment levels. In addition, factors that influence WTP were to be identified. METHODS: Data were collected from a household survey using a two-stage cluster sampling approach, with each household having the same probability of being selected. Interviews were conducted with 2414 individuals and 705 household heads. The take-it-or-leave-it (TIOLI) and the bidding game were used to elicit WTP. RESULTS: The average individual was willing to pay 2384 (elicited by the TIOLI) or 3191 (elicited by the bidding game) CFA (3.17 US dollars or 4.25 US dollars) to join CBI for him/herself. The head of household agreed to pay from 6448 (elicited by the TIOLI) or 9769 (elicited by the bidding game) CFA (8.6 US dollars or 13.03 US dollars) to join the health insurance scheme for his/her household. These results were influenced by household and individual ability-to-pay, household and individual characteristics, such as age, sex and education. The two methods yielded similar patterns of estimated WTP, in that higher WTP was obtained for higher income level, higher previous medical expenditure, higher education, younger people and males. A starting point bias was found in the case of the bidding game. CONCLUSIONS: Both TIOLI and bidding game methods can elicit a value of WTP for CBI. The value elicited by the bidding game is higher than by the TIOLI, but the two approaches yielded similar patterns of estimated WTP. WTP information can be used for setting insurance premium. When setting the premiums, it is important to consider differences between the real market and the theoretical one, and between the WTP and the cost of benefits package. The beneficiaries of CBI should be enrolled at the level of households or villages in order to protect vulnerable groups such as women, elders and the poor.

Adult↗

Ethical, social and legal implications of genetic testing in liver disease.

Advances in molecular genetics challenge the hepatology community to understand and implement genetic knowledge. Despite excitement about the potential benefits of new genetic information, concerns have been raised about the inappropriate use of genetic testing, clinicians' incorrect ordering and misinterpretation of test results, and discrimination in employment and insurability based on tests results. Among the public there is fear and mistrust, in part based on horrifying historical events that were gross violations of medical ethical standards. Clinicians, scientists, patient advocacy groups, and government agencies worldwide are debating the optimal legal protections to prevent abuse. In addition, these groups are developing clinical guidelines for optimal use. Traditional ethical and legal standards of confidentiality between physicians and their patients are under scrutiny. A new principle, "the duty to warn," is emerging that has applications specific to genetic testing and may conflict with the duty to maintain patient confidentiality. Emerging ethical, legal, and social issues involve the appropriate use and protection of confidential data in tissue and serum banks. Education of the profession and the public at many levels will increase the likelihood that the unraveling of the human genome will maximally benefit society. If fear of genetic testing can be alleviated, selection bias in research could be reduced. Professional and lay organizations concerned with liver disease should consider a more active role in the public and professional debate, and foster education at all levels.

Attitude of Health Personnel↗

Attrition in the new beneficiary survey and followup, and its correlates.

Panel surveys interview the same individuals more than once over a period of time. Attrition from the survey occurs when those individuals die, refuse to be interviewed again, or, for some other reason, cannot be contacted. If the original sample was representative of a specific population, then survey analysis may provide misleading conclusions about changes in population characteristics over time if these individuals leave the sample in a nonrandom way. Therefore, it is important to identify the characteristics of individuals who leave the survey for various reasons. This article explores the extent of and reasons for attrition in the New Beneficiary Survey (NBS) between the first interview in 1982 and the followup interview in 1991. Presented is a comparison of the characteristics of survivors (the reinterviewed sample) with attriters (those in the sample not reinterviewed) from the retired-worker and disabled-worker samples. The article explores a variety of potential determinants of attrition to the probability of attrition. These determinants are examined alone and in a multivariate framework. The NBS sample population is drawn from and linked to Social Security Administrative records, which have exact matched data on mortality as a cause of attrition. These data do not depend on survey-reported reasons for attrition; hence, it allows the examination of the differences in the patterns and predictors of attrition due to death and due to other reasons, primarily, the refusal to be interviewed. Attrition due to death must be identified precisely because misidentification of death as refusal to be interviewed may lead researchers to infer more selective attrition than might be the case. Different patterns of attrition are evident in the comparison of attrition levels and the determinants of attrition for the retired and disabled samples, both composed of persons with relatively high mortality risk. In particular, individuals' health, health insurance coverage, and level of education have different impacts on their likelihood of attrition. In general, it appears that refusal to be interviewed is more evenly spread across populations and characteristics than is death. The analysis shows that attrition due to death and attrition due to refusal are quite different processes, even though health conditions play a role in both processes. The results suggest that because attrition patterns (including death) may be quite different across population samples, sample-specific attrition patterns must be analyzed over the lifetime of any panel study. Long-term studies of panel attrition are necessary to provide researchers analyzing the data with information on potential biases due to nonrandom attrition.

Aged↗

Comparison of 1997 Medicare relative value units for gender-specific procedures: is Adam still worth more than Eve?

BACKGROUND: On January 1, 1992, Congress implemented a Medicare payment system based on relative value units (RVUs). The total RVU (which is made up of work, practice, and malpractice RVUs) is multiplied by a dollar conversion factor to set the reimbursement for all procedures covered by Medicare. In a previous study, we found that significant gender bias exists in Medicare reimbursement for female-specific services. Recently, HCFA approved increases (beginning January 1997) in the work RVU for many gynecologic procedures. This study was undertaken to compare work and total RVUs for gender-specific procedures effective January 1, 1997. METHODS: Using the May 1996 Federal Register, we compared work and total RVUs for 24 pairs of gender-specific procedures. The groups were matched so that the amount of work and level of difficulty would be similar, if not identical. We validated our selection of procedures for comparison by also evaluating the average time required to perform these procedures. RESULTS: Comparison of work RVUs for the 24 paired procedures revealed that in 19 cases (80%), male-specific procedures had a higher RVU; in 3 cases (12%), female-specific procedures were higher; and in 2 cases, there was no difference. On average, work RVUs were 49% higher for urologic procedures than for gynecologic procedures. Comparison of total RVUs revealed that in 20 cases (83%), urologic procedures had a higher total RVU and in 3 cases (12%), gynecologic procedures were higher. On average, male-specific surgeries are reimbursed at an amount which is 37% higher than that for female-specific surgeries. CONCLUSION: Recent increases in work RVUs for many gynecologic procedures have resulted in improved reimbursement. However, even with these improvements, significant gender bias still exists in the Medicare reimbursement of female-specific procedures. This gender bias is further magnified as more private insurance carriers use the system to set reimbursement.

Female↗

Randomized database studies: a new method to assess drugs' effectiveness?

The need to evaluate drugs' effects in real clinical practice is increasingly important. Randomized clinical trials (RCTs) and database analyses (DBA) are the two main methods to assess treatments effectiveness. RCTs remain the "gold standard" for comparing alternative treatments. However, they are conducted under strict, protocol-driven conditions that may limit their generalizability. Advantages of new high quality clinical databases, on the other hand, include the simple and economic access to large number and range of cases, and the ability to capture all aspects of actual medical practice. The main potential limitation of DBA is the potential for comparison bias due to the lack of randomization. Despite the efforts to design naturalistic trials and to use sophisticated statistical techniques to minimize selection bias, the inherent limitations of both methods (problems of external and internal validity, respectively) have not been completely solved. Thus, the actual challenge is the development of some new strategy capable of generating results with an acceptable balance between internal and external validity. As randomization is essential to minimize comparison bias, we point out the possibility to include randomization modules in computer-based patient records. The theoretical foundation of these "randomized database studies" is the simultaneous use of both experimental and observational methods in the assessment of drugs' effectiveness. The progressive standardization of clinical practice and the development and adoption of improved computer-based patient records could facilitate the use of this new research strategy.

Databases, Factual↗

Who gets chemotherapy for metastatic lung cancer?

STUDY OBJECTIVES: To determine the prevalence and factors associated with chemotherapy use in elderly patients presenting with advanced lung cancer. DESIGN: A retrospective cohort study using administrative data. SETTING AND PATIENTS: We analyzed the medical bills for the 6,308 Medicare patients > 65 years old with diagnosed stage IV non-small cell lung cancer (NSCLC) in the 11 SEER (survival, epidemiology, and end results) regions between 1991 and 1993. The main outcome measure, chemotherapy administration, was identified by the relevant medical billing codes. Patient sociodemographic and disease characteristics were obtained from the SEER database and census data. RESULTS: Almost 22% of patients received chemotherapy at some time for their metastatic NSCLC. As expected, younger patients and those with fewer comorbid conditions were more likely to receive chemotherapy. However, several nonmedical factors, such as nonblack race, higher socioeconomic status, treatment in a teaching hospital, and living in the Seattle/Puget Sound or Los Angeles SEER regions, also significantly increased a patient's likelihood of receiving chemotherapy. CONCLUSION: Compared to previous reports, the prevalence of chemotherapy use for advanced NSCLC appears to be increasing. However, despite uniform health insurance coverage, there is wide variation in the utilization of palliative chemotherapy among Medicare patients, and nonmedical factors are strong predictors of whether a patient receives chemotherapy. While it is impossible to know the appropriate rate of usage, nonmedical factors should only influence a patient's likelihood of receiving treatment if they reflect patient treatment preference. Research to further clarify the costs, benefits, and patient preferences for chemotherapy in this patient population is warranted in order to minimize the effect of nonmedical biases on management decisions.

Aged↗

Clinical evaluation vs. economic evaluation: the case of a new drug.

To economically evaluate a new drug or other medical innovation one must assess both the changes in costs and in benefits. Safety and efficacy matter, but so do resources costs and social benefits. This paper evaluates the effects on expenditures of the recent introduction of cimetidine, a drug used in the prevention and treatment of duodenal ulcers. This evaluation is of interest in its own right and also as a "guide" for studying similar effects of other innovations. State Medicaid records are used to test the effects on hospitalization and aggregate medical care expenditures of this new medical innovation. After controlling to the extent possible for potential selection bias, we find that: 1) usage of cimetidine is associated with a lower level of medical care expenditures and fewer days of hospitalization per patient for those duodenal ulcer patients who had zero health care expenditures and zero days of hospitalization during the presample period; an annual cost saving of some $320.00 (20 per cent) per patient is indicated. Further analysis disclosed, however, that this saving was lower for patients with somewhat higher levels of health care expenditures and hospitalization in the presample period, and to some extent was reversed for the patients whose prior year's medical care expenditures and hospitalization were highest.

Cimetidine↗

Use of antipsychotic medications in treating schizophrenia among different financing and delivery systems.

BACKGROUND: In 1995 in an effort to control costs, the State of Colorado implemented a pilot capitated payment system for individuals eligible for public financing of their mental health services. Contracts were with both Not-For-Profit (NFP) firms and For-Profit (FP) firms; the remainder were in the fee-for-service system (FFS). Pharmaceuticals were not included in the capitation rate. However, antipsychotic medications were included in the formularies for consumers who received their medical care through a Health Maintenance Organization (HMO). AIMS: This paper examines the use of antipsychotic medication compared to the use of atypical antipsychotics among consumers who are (i) enrolled in a medical HMO or not enrolled in a medical HMO and (ii) whose mental health services are reimbursed on a fee-for-service basis (FFS) or through a capitated system. METHODS: Data for this study were collected between 1995 and 1997 as part of the Colorado's Medicaid Mental Health Capitation Pilot Program. Atypical antipsychotics included in the study are: clozapine, risperidone, and olanzapine. The sample of this study consisted of 282 individuals diagnosed with schizophrenia. RESULTS: The utilization of antipsychotics was lower among consumers in HMOs. Compared to consumers in FFS areas of the state, the utilization of atypical antipsychotics was higher in capitated areas of the state. DISCUSSION: There was a strong incentive for the utilization of atypical antipsychotics to increase in capitated systems, unless consumers received their medication prescriptions through an HMO. Limitations include differences in observable and unobservable characteristics among the FFS, DC and MBHO areas, unavoidable selection bias and the small number of HMO enrollees. CONCLUSIONS: Capitation of mental health services provides incentives for more cost-effective treatments. HMO enrollment was not a crucial factor to determine access to atypical antipsychotic prescriptions. IMPLICATIONS FOR POLICY: These data suggest that capitation can affect the use of substitute services not in the capitation rate. Before recommending policy changes, we need to better understand whether the increased utilization leads to better outcomes. IMPLICATION FOR FURTHER RESEARCH: The next step is to determine whether the increased use of atypical antipsychotics leads to better outcomes for consumers.

Adolescent↗

District health systems in a neoliberal world: a review of five key policy areas.

District health systems, comprising primary health care and first referral hospitals, are key to the delivery of basic health services in developing countries. They should be prioritized in resource allocation and in the building of management and service capacity. The relegation in the World Health Report 2000 of primary health care to a 'second generation' reform--to be superseded by third generation reforms with a market orientation--flows from an analysis that is historically flawed and ideologically biased. Primary health care has struggled against economic crisis and adjustment and a neoliberal ideology often averse to its principles. To ascribe failures of primary health care to a weakness in policy design, when the political economy has starved it of resources, is to blame the victim. Improvement in the working and living conditions of health workers is a precondition for the effective delivery of public health services. A multidimensional programme of health worker rehabilitation should be developed as the foundation for health service recovery. District health systems can and should be financed (at least mainly) from public funds. Although in certain situations user fees have improved the quality and increased the utilization of primary care services, direct charges deter health care use by the poor and can result in further impoverishment. Direct user fees should be replaced progressively by increased public finance and, where possible, by prepayment schemes based on principles of social health insurance with public subsidization. Priority setting should be driven mainly by the objective to achieve equity in health and wellbeing outcomes. Cost effectiveness should enter into the selection of treatments for people (productive efficiency), but not into the selection of people for treatment (allocative efficiency). Decentralization is likely to be advantageous in most health systems, although the exact form(s) should be selected with care and implementation should be phased in after adequate preparation. The public health service should usually play the lead provider role in district health systems, but non-government providers can be contracted if needed. There is little or no evidence to support proactive privatization, marketization or provider competition. Democratization of political and popular involvement in health enhances the benefits of decentralization and community participation. Integrated district health systems are the means by which specific health programmes can best be delivered in the context of overall health care needs. International assistance should address communicable disease control priorities in ways that strengthen local health systems and do not undermine them. The Global Fund to Fight AIDS, Tuberculosis and Malaria should not repeat the mistakes of the mass campaigns of past decades. In particular, it should not set programme targets that are driven by an international agenda and which are achievable only at the cost of an adverse impact on sustainable health systems. Above all the targets must not retard the development of the district health systems so badly needed by the rural poor.

Community Health Planning↗

Methodologic issues in the study of second malignant neoplasms and pregnancy outcomes.

For future studies of late effects, it will be necessary for investigators to consider methodologic issues carefully as a means of insuring the quality of research in this increasingly important area. Recognizing the advantages and limitations in univariate and multivariate analyses will help in selecting the best analytic approach. There are many methods for denoting risk. Selection of the method will often be dependent on study design, but should also be the one believed most effective for communicating the study results. There is little question there is a need for well-designed studies for second malignancies, especially those designed to evaluate late-occurring second cancer (i.e., in the second, third, and fourth decade following treatment). With the aging of the childhood cancer survivor population, questions regarding pregnancy issues are increasing. These questions range from those relating to fertility to others associated with mutagenesis. When considering studies of these late effects, it is important to recognize the need for selecting the most appropriate study design and statistical methods.

Adolescent↗

Patient assessments of hospital maternity care: a useful tool for consumers?

OBJECTIVE: To examine three issues related to using patient assessments of care as a means to select hospitals and foster consumer choice-specifically, whether patient assessments (1) vary across hospitals, (2) are reproducible over time, and (3) are biased by case-mix differences. DATA SOURCES/STUDY SETTING: Surveys that were mailed to 27,674 randomly selected patients admitted to 18 hospitals in a large metropolitan region (Northeast Ohio) for labor and delivery in 1992-1994. We received completed surveys from 16,051 patients (58 percent response rate). STUDY DESIGN: Design was a repeated cross-sectional study. DATA COLLECTION: Surveys were mailed approximately 8 to 12 weeks after discharge. We used three previously validated scales evaluating patients' global assessments of care (three items)as well as assessments of physician (six items) and nursing (five items) care. Each scale had a possible range of 0 (poor care) to 100 (excellent care). PRINCIPAL FINDINGS: Patient assessments varied (p<.001) across hospitals for each scale. Mean hospital scores were higher or lower (p<.01) than the sample mean for seven or more hospitals during each year of data collection. However, within individual hospitals, mean scores were reproducible over the three years. In addition, relative hospital rankings were stable; Spearman correlation coefficients ranged from 0.85 to 0.96 when rankings during individual years were compared. Patient characteristics (age, race, education, insurance status, health status, type of delivery) explained only 2-3 percent of the variance in patient assessments, and adjusting scores for these factors had little effect on hospitals' scores. CONCLUSIONS: The findings indicate that patient assessments of care may be a sensitive measure for discriminating among hospitals. In addition, hospital scores are reproducible and not substantially affected by case-mix differences. If our findings regarding patient assessments are generalizable to other patient populations and delivery settings, these measures may be a useful tool for consumers in selecting hospitals or other healthcare providers.

Adult↗

International harmonization of bioequivalence studies and issues shared in common.

In the course of a review of the current health insurance system in Japan, promotion of the use of generic products of lower price is expected in direction for minifying the drug costs which occupy about 20% thereof. However, the use of generic products has not increased so much as expected. One of the reasons to explain the fact might be that concerns exist about switchability from an innovator product to a generic product or among generic products because of bias in bioequivalence. Namely, hesitation about the difference in quality between generic products and innovator products, particularly in bioequivalence due to differences in the manufacturing process and pharmaceutical technology, exists among professionals in medical practice. The bioequivalence study to guarantee that a generic product is bioequivalent to an innovator product in terms of effectiveness and safety is most important in assuring the quality of generic products. There are various specifications and study methods to prove bioequivalence which differ slightly from one to another in different countries. We have investigated bioequivalence studies which are conducted in the major countries. Consequently, we clarified that bioequivalence studies are in international harmonization in terms of the major portions thereof. However, different conditions, e.g., selection of subjects, food effect, application of multiple dose study, and in vitro dissolution study, are still employed for the studies. Therefore, we consider that these differences constitute the topics to be reviewed in future.

Biological Availability↗