Use of patient-reported global assessment measures in clinical trials of chronic pain treatments: ACTTION systematic review and considerations.

ABSTRACT: Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.

Mapas de déficits y mapas de activos en prevención de la obesidad infantil / Deficits and assets’ maps in the prevention of children obesity

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Health-related quality of life in female long-term colorectal cancer survivors.

Although the number of women who survive treatment for colorectal cancer is growing, little is known about the quality of life of long-term survivors. The purpose of analyses presented in this paper is to describe the overall health-related quality of life of female long-term colorectal cancer survivors and the factors that may modify their levels of quality of life. A population-based sample of 726 Wisconsin women diagnosed with colorectal cancer from 1990-1991 was recontacted. Of the 443 women alive in 1999, 307 (69%) completed a follow-up questionnaire including the Medical Outcomes Study Short-Form 36 Health Status Survey, which is comprised of 36 items that generate nine domain scale scores and two summary scores: the Physical Component Summary score and the Mental Component Summary score. The mean follow-up was 9 years (range 7-11), and the mean age at follow-up was 72 years (range 43-85). The mean Physical Component Summary score was lower for participants with greater ages, greater numbers of comorbidities, and greater body masses at the time of follow-up. The mean Mental Component Summary score also was lower for participants with greater numbers of comorbidities. Differences associated with degree of comorbidity were observed for all eight domain scales. Female long-term survivors of colorectal cancer appear to report health-related quality of life comparable with that of similarly aged women in the general population. These data suggest that, over the long term, factors attributable to aging, body weight, and chronic medical conditions play more dominant roles in determining physical and mental health than factors related to the initial colorectal cancer diagnosis.

A method to guide community planning and evaluation efforts in tobacco control using data on smoking during pregnancy.

BACKGROUND: Effective community based tobacco control programmes are critical for state and nationwide impact. However, there is little discussion in the literature of methods for setting local objectives which use locally collected data and account for historical variation in progress. OBJECTIVES: To develop and illustrate a method that uses locally available birth certificate data to model trends in tobacco use during pregnancy among women giving birth, predict future prevalence, and use predictions to set community specific tobacco control objectives. DATA SOURCE: Vital statistics. Wisconsin standard birth certificates, 1990-2000, which record the smoking status of the mother during pregnancy. DATA ANALYSIS: Trends in the prevalence of smoking during pregnancy in Wisconsin statewide and in all counties (n = 72) were modelled using linear regression of log prevalence on year. Model fit was assessed using R(2). Regression slopes, indicating estimated relative annual percentage change in prevalence, were used to predict prevalence in 2005, and objectives were calculated as a 20% reduction from the predicted prevalence in 2005. CONCLUSIONS: Modelling trends in the prevalence of smoking using locally collected data enables communities to set reasonable future tobacco control objectives that account for historical trends in progress.

Trends in malignant melanoma incidence and mortality in Wisconsin, 1979-1997.

OBJECTIVE: To explore trends in malignant melanoma incidence and mortality in Wisconsin from 1979 to 1997, by age, gender and time period. Comparisons are also made to US trends over this period. DATA: Incidence data for Wisconsin were provided by the Wisconsin Cancer Reporting System Bureau of Health Information, within the Wisconsin Department of Health and Family Services, while US data were extracted using SEER*Stat 3.0. Mortality data for both Wisconsin and the US were compiled using CDC WONDER. RESULTS: Wisconsin malignant melanoma incidence rates rose 25% from 1979 to 1998, compared to a US increase of 132%. For mortality rates, however, both Wisconsin (22%) and the US (15%) exhibited only modest increases. Between the mid-1980s and mid-1990s, the largest increases in both incidence and mortality (over 70%) occurred among males over age 65. In contrast, declines of 30% to 40% were found for males age 0-34. Patterns were less consistent among females. CONCLUSIONS: Since the mid-1980s, malignant melanoma incidence in Wisconsin appears to have increased sharply among males and females over age 65, with a corresponding rise in mortality among males in this age group. These trends should be a source of concern for clinicians and policy makers alike. Because current evidence on the effectiveness of early treatment is inconclusive, it is especially important to take preventive measures now--such as educational and community-based interventions--to reduce future incidence.

Increasing incidence of end-stage renal disease in Wisconsin: an unintended consequence of increased survival?

End stage renal disease (ESRD) is an important and costly complication of diabetes, hypertension, and primary kidney disorders. We examined ESRD incidence trends in Wisconsin from 1982 to 1997 and assessed the progress in reaching the ESRD 2000 goal as stated by Healthier People in Wisconsin: A Public Health Agenda for the Year 2000. Since 1982, there has been nearly a three-fold increase in the incidence of ESRD in Wisconsin. The increase was most striking in persons with diabetes and among people age 65 and older. Furthermore, the increase was shared among all racial groups and both genders. Although better disease management reduces the risk of ESRD, it also reduces the risk of other causes of death such as heart disease and cancer. Thus, individuals may be living longer with other chronic diseases, thereby increasing the incidence of ESRD.

Electric blanket or mattress cover use and breast cancer incidence in women 50-79 years of age.

Previous research has demonstrated inconsistent associations between electromagnetic radiation, especially from electric blanket use, and breast cancer. Breast cancer risk according to electric blanket or mattress cover use was examined as part of a multicenter population-based case-control study. Breast cancer patients 50-79 years of age (N = 1949) were identified from statewide tumor registries in Massachusetts, New Hampshire, and Wisconsin from the period June 1994 to July 1995. Women of similar age were randomly selected from population lists as controls. Information regarding electric blanket and mattress cover use and breast cancer risk factors was obtained through telephone interviews. After adjustment for age, body mass index, and other breast cancer risk factors, the risk of breast cancer was similar among ever-users (relative risk = 0.93; 95% confidence interval = 0.82-1.06) and lower among current users than among never-users (relative risk = 0.79; 95% confidence interval = 0.66-0.95). There was no evidence of a dose-response relation with increasing number of months that electric blankets had been used. This study provides evidence against a positive association between electric blanket or mattress cover use and breast cancer.

Women's Health Alliance Intervention Study: increasing community breast and cervical cancer screening.

The Women's Health Alliance Intervention Study is a quasi-experimental intervention designed to test if county-based coalitions can increase breast and cervical cancer screening compliance among women aged 40 years and older living in rural communities. A number of interventions were designed and implemented by coalitions in four counties in north-central Wisconsin during a 2-year period. Four control counties in southwestern Wisconsin were identified for comparison. Judging from the results of this study, community-based intervention efforts can increase breast and cervical cancer screening compliance significantly among women living in rural communities.

Women's Health Alliance Intervention Study: description of a breast and cervical cancer screening program.

The Women's Health Alliance Intervention Study is a community-based intervention study designed to determine if county-based coalitions can increase breast and cervical cancer screening rates among women aged 40 and older in four rural Wisconsin counties. This article describes the intervention process and demonstrates the feasibility of rural volunteer coalitions to promote breast and cervical cancer screening in communities. An accompanying article in this issue describes the effectiveness of these interventions.

Trends in self-reported cigarette smoking, Wisconsin, 1984-1999.

The purpose of this study is to assess trends in self-reported cigarette smoking among adults in Wisconsin. Behavioral Risk Factor Survey data from 1984-1999 were analyzed to determine changes in smoking prevalence. Results of this analysis show almost no change in overall adult smoking prevalence over the past 15 years. Smoking prevalence rates did, however, decrease slightly for men from 29% in 1984 to 22% in 1999. Moreover, smoking prevalence for adults 18 to 24 years of age increased from 25% in 1994 to 36% in 1999. These results show that despite state and national efforts over the past 15 years to reduce cigarette smoking among adults, minimal progress has been made. Furthermore, the increase in smoking rates among 18 to 24 year olds highlights the need for additional prevention and cessation efforts targeted toward this group. Understanding past trends in cigarette smoking is critical for the Wisconsin Tobacco Control Board and other public health advocates to monitor progress toward the goal of reducing tobacco use.

Cigarette smoking in Wisconsin: the influence of race, ethnicity, and socioeconomics.

A disparate burden of cigarette use has been demonstrated among demographic subgroups both in the United States and Wisconsin. We examined patterns of adult current smoking prevalence in Wisconsin by race, Hispanic ethnicity, household income, and education to assess whether differences exist among these subgroups. This analysis revealed a strong graded relationship between household income, education, and smoking prevalence, consistent among non-Hispanic whites and blacks, though not Hispanics. Respondents with less than a high school education had significantly higher smoking prevalence rates (41%) than those with a college degree or more (13%). Smoking prevalence rates did not significantly differ between the race and ethnicity subgroups overall, or by gender and education, although they differed in some age and income subgroups. Possible explanations for the socioeconomic gradient include differences in tobacco product marketing practices, indoor workplace smoking policies, and access to health information, resources, and consistent, high-quality health care.

Smoking during pregnancy in Wisconsin compared to the United States, 1997.

PURPOSE: The purpose of this study is to identify disparities in maternal smoking between Wisconsin and United States women and to determine differences that explain the higher percentage of pregnant women who smoke in Wisconsin compared to the United States. METHODS: 1997 Wisconsin and US birth certificate data were compared and stratified by age, education, and race/ethnicity. The relative risks (the risk of Wisconsin women smoking during pregnancy compared to US women smoking during pregnancy) were calculated by direct standardization to the 1997 US distribution for these characteristics. RESULTS: In 1997, 17.9% of Wisconsin women smoked during pregnancy, compared with 13.2% nationally (relative risk [RR] = 1.4; Wisconsin women were 40% more likely to smoke than US women). Age and education adjusted RRs among Wisconsin women aged 20 and older were 2.3 (American Indian), 2.8 (Hispanic), and 2.2 (non-Hispanic black), while the RR was 1.2 for non-Hispanic white mothers. Among women 20 and older, the crude RR for Wisconsin was 1.5; adjusting for age, education, and race/ethnicity only slightly decreased the RR to 1.4. CONCLUSIONS: The percentage of women who smoke during pregnancy in Wisconsin continues to be above the national rate and the Healthy People 2000 goal of 10% or less. Disparities with the US average are particularly great for minority women in Wisconsin. Adjusting for age, education and ethnicity does not explain Wisconsin's higher prenatal smoking rate.

Progress in reducing per capita cigarette sales in Wisconsin, 1985-1999.

Over the past several decades, initiatives have been undertaken both on a national and state level to reduce cigarette smoking and its resultant health consequences. We compared trends in per capita cigarette sales in Wisconsin versus other states from 1985-1999. During this time period, per capita cigarette sales declined 21% in Wisconsin, versus 26% in the United States. Although the average per capita sales in Wisconsin were less than sales in the United States in both 1985 (107 versus 122 packs per capita) and 1999 (84 versus 90 packs per capita), Wisconsin's sales have declined at a slower rate, narrowing the gap between Wisconsin and US sales. Other states, such as California and Massachusetts, with large statewide tobacco control programs had rates of decline in cigarette sales over twice the Wisconsin decline from 1985-1999. In 1985, only 10 states had lower per capita sales than Wisconsin. By 1999, 24 states had lower rates, indicating greater relative progress in reducing sales in other states. Possible explanations for the greater decline in per capita cigarette sales in other states include differences in tobacco control programs, tobacco excise tax increases, and other tobacco policy initiatives.

Smoking policies in manufacturing and assembly workplaces, Wisconsin, 1999.

Although Wisconsin's clean indoor air law prohibits or restricts smoking in certain areas, it specifically exempts manufacturing and assembly workplaces from its provisions. We conducted a mail survey of 1500 randomly selected employers to determine the nature and extent of smoking policies in Wisconsin's blue-collar workforce. Of the 1042 (70%) respondents, 49% prohibit all smoking; 26% allow smoking only in designated areas; 18% allow smoking in all areas except designated non-smoking areas; and 7% allow smoking anywhere. Larger employers were more likely to have smoking policies. Of the 61% of respondents who indicated having a formal smoking policy, the reasons for having the policy were safety (40%), health (38%), or employee request (12%). For those employers without a smoking policy, the main reasons were that few employees smoke (37%), the decision is left to the employee's discretion (32%), or employees may object to having a policy (10%). About half of the employees in manufacturing and assembly workplaces continue to be exposed to environmental tobacco smoke.

Lung cancer mortality report card: measuring progress in Wisconsin's counties, 1979-1998.

PURPOSE: To compare and contrast trends in lung cancer mortality in Wisconsin's 72 counties, as a measure of long-term progress in tobacco control. METHODS: Lung cancer mortality data were abstracted from the Centers for Disease Control and Prevention's WONDER database from 1979 to 1998. Percent change in lung cancer mortality rates were analyzed at the county and national levels from 1979-1983 to 1994-1998. RESULTS: In Wisconsin, lung cancer mortality rates increased 23%, compared to a 19% increase in the United States. There was more variation in lung cancer mortality trends between Wisconsin counties than between states, with increases in 67 of Wisconsin's 72 counties. Lung cancer mortality rates increased for men in 44 counties and for women in 68 counties. Only 4 counties in Wisconsin had fewer lung cancer deaths in 1994-1998 compared with 1979-1983. CONCLUSIONS: Progress in reducing lung cancer mortality in Wisconsin--a long-term measure of progress in tobacco control--has lagged behind the rest of the United States. Nevertheless, some Wisconsin counties have experienced more progress in reducing the health burden from lung cancer, suggesting that differences exist between communities in the effectiveness of their tobacco control efforts.

Predictors, prodromes and incidence of postpartum depression.

The purpose of this study was to determine the incidence of clinically significant depression occurring between 1 and 4 months postpartum and to investigate whether somatic complaints, subsyndromal depressive symptoms, or birth-related concerns among non-depressed women at 1 month were predictive of postpartum depression. This is a prospective cohort study of 465 women from the Wisconsin Maternity Leave and Health Project (WMLHP). Women who were not depressed at 1 month postpartum were reassessed 3 months later for depression occurring at any time in the interval between 1 and 4 months postpartum. Depression was defined as either meeting the criteria for major depression on the National Institute of Mental Health (NIMH) Diagnostic interview Schedule (DIS) or scoring above 15 on the Center for Epidemiologic Studies Depression Scale (CES-D). Physical symptoms were assessed by an adapted Health Responses Scale. Other measures were developed specifically for the WMLHP. Of 465 women, 27 (5.8%) became clinically depressed between 1 and 4 months postpartum. In a logistic regression analysis, four variables (maternal age, depression during pregnancy, thoughts of death and dying at 1 month postpartum, and difficulty falling asleep at 1 month postpartum) were predictive of depression at 4 months postpartum. Breast-feeding, mode of delivery, family income, parity and mother's education did not predict depression. The existence of subsyndromal depressive symptoms, particularly thoughts of death and dying, may represent a prodromal phase of depression and should alert clinicians to the possibility of future postpartum depression. Women with a history of depression during pregnancy should be monitored for signs of postpartum depression for a minimum of 4 months. Obstetricians are in a unique position during the postpartum check-up to screen women for these predictors of future postpartum depression and possibly to avert the development of a clinically significant depressive episode.

Progress in cancer control in Wisconsin.

INTRODUCTION: The burden of cancer in Wisconsin is significant, with cancer accounting for nearly 25% of all deaths in 1997. State and national trends indicate a decline in overall cancer mortality since the early 1990s. This report reviews the progress in cancer control in Wisconsin in the past decade and assesses progress toward reaching the 2000 cancer objectives outlined in the Wisconsin Public Health Agenda. METHODS: Mortality data were abstracted from CDC WONDER from 1984-1997 in a manner consistent with the data presented in the Wisconsin Public Health Agenda. Overall cancer mortality, as well as site-specific cancer mortality rates, was analyzed by calculating the percent change in the baseline period (1984-1986) versus the most recent available data (1995-1997). RESULTS: Overall cancer mortality rates in Wisconsin decreased 1% from 1984-1986 to 1995-1997, decreasing among those under age 65 but increasing among those 65 years of age and older. Rates declined in the white population, but increased among blacks and other races. Site-specific data indicate a 6% decrease in cervical cancer, an 18% decrease in breast cancer, and a 20% decrease in colorectal cancer occurred during this time period. Increases were seen in lung and prostate cancers, and in malignant melanoma. DISCUSSION: This analysis indicates progress in the reduction of overall cancer mortality among persons under age 65. Objectives for 2000 will be met in both breast and colorectal cancer, with some progress noted in reversing the steady increase in lung cancer mortality in the state.

A cost analysis of community screening for diabetes in the central Wisconsin Medicare population (results from the MetaStar pilot project in Wausau).

CONTEXT: Type 2 diabetes mellitus is often undiagnosed and untreated. OBJECTIVE: To estimate the costs and possible savings of screening for Type 2 diabetes mellitus in the Wisconsin Medicare population from a population health perspective. DESIGN: The costs and benefits of community screening were analyzed using various primary and secondary data sources. Data on the community screening were obtained by MetaStar, collaborators at the screening site, and published material. Results from a Monte Carlo simulation model, developed by the CDC Diabetes Cost-Effectiveness Study Group, and recent developments in diabetes research were used to estimate the incidence levels of major complications for Type 2 diabetes. SETTING AND PARTICIPANTS: Medicare beneficiaries in central Wisconsin residing in the Wausau Hospital Service Area, which is composed of 14 zip codes. RESULTS: Of 826 Medicare patients screened, 32 were diagnosed as having diabetes. If we use the same assumptions offered by the CDC Study Group, we find that the excess lifetime costs from screening and early treatment ($4850) exceed costs saved from preventing complications ($378), costing an average of $4471 per diabetic. However, if we alter assumptions on cardiovascular disease reduction risk and routine care costs, we find that screening could save an average of $619 per diabetic detected. CONCLUSIONS: The costs of community screening, using the CDC Study Group's assumptions, are greater than the costs of diabetes without screening in this population. However, recent evidence on cardiovascular disease risk and routine care costs could alter the results, leading to lower costs and greater benefits in the future. More research is necessary, particularly in the area of quality of life measures, to more accurately reflect the benefits of screening.

Diabetes mortality trends in Wisconsin, 1979-1997: the increasing gap between whites and blacks.

Diabetes is a leading cause of morbidity and mortality in Wisconsin and the United States. We examined mortality trends for diabetes as an underlying cause of death for the years 1979-1997 for Wisconsin and the United States. Diabetes mortality rates in Wisconsin have increased over the past 18 years, from 13.5/100,000 in 1979 to 16.7/100,000 in 1997. Much of this increase is attributable to a change in the death certificate in 1989. Blacks in Wisconsin have a higher rate of diabetes mortality when compared with whites, especially among women and persons less than 65 years of age. This disparity has increased markedly over the decade. Public health efforts in Wisconsin need to focus on reducing diabetes mortality overall and on minimizing disparities in diabetes mortality between whites and blacks.