Association of childhood blood lead levels with firearm violence perpetration and victimization in Milwaukee.

Childhood lead exposure impairs future decision-making and may influence criminal behavior, but its role in future firearm violence is unclear. Using public health, education, and criminal justice datasets linked at the individual level, we studied a population-based cohort of all persons born between June 1, 1986 and December 31, 2003 with a valid blood lead test before age 6 years and stable Milwaukee residency (n = 89,129). We estimated associations with firearm violence perpetration (n = 553) and victimization (n = 983) using logistic regression, adjusting for temporal trends, child sex, race, and neighborhood socioeconomic status. Increasing risks for firearm violence perpetration and victimization were found in each higher category of blood lead compared to the lowest, after adjusting for confounding. For perpetration, risk ratios (RR) for increasing comparisons of mean blood lead in categories of ≥5 < 10, ≥10 < 20, and ≥20 µg/dL compared to persons with mean blood lead < 5 µg/dL, were: RR 2.3 (95% CI 1.6, 3.3), RR 2.5 (95% CI 1.7, 3.9), and RR 2.8 (95% CI 1.8, 4.4). For victimization, the same increasing categoric comparisons were: RR 1.8 (95% CI 1.4, 2.3), RR 2.4 (95% CI 1.8, 3.2), RR 3.3 (95% CI 2.4, 4.5). The proportion of firearm violence attributable to blood lead ≥5 µg/dL was 56% for perpetration and 51% for victimization. In Milwaukee, during a period of high lead exposures, childhood levels may have substantially contributed to adult firearm violence. While we cannot definitively conclude causality, the possibility that over half of firearm violence among this sample might be due to lead exposure suggests the potential importance of lead exposure reduction in firearm violence prevention efforts.

Physician Use of Electronic Health Records in Obesity Management.

OBJECTIVE: To assess Wisconsin physician knowledge, attitudes, and practices in obesity management. METHODS: The Wisconsin Medical Society distributed an e-mail survey to 12,372 members with questions on obesity causes, barriers to documentation, and training in obesity management. RESULTS: A total of 590 surveys (4.7%) were completed. Physicians had an accurate fund of knowledge. Reasons given for failure to document obesity were lack of reimbursement, lack of effective treatment, and discomfort in discussing obesity. Only 14% of responding physicians were optimistic about their patients achieving sustained weight loss and only 7% believed they have been successful at treating obesity. Training was infrequent in obesity management. CONCLUSIONS: Survey respondents indicated that additional training and effective tools would help treat obesity. Strategies should be developed that improve physician effectiveness in obesity management.

Aberrant fetal growth and early, late, and postneonatal mortality: an analysis of Milwaukee births, 1996-2007.

OBJECTIVE: The objective of the study was to ascertain the association between fetal growth (small- [SGA], appropriate- [AGA], and large-for-gestational-age [LGA]) and early, late, and postneonatal mortality. STUDY DESIGN: Birth certificate data for nonanomalous singletons, delivered from 1996 to 2007, were obtained for Milwaukee residents. Multivariate logistic regression analyses, adjusted for 19 covariates, determined the association between fetal growth and mortality. RESULTS: Among the 123,383 live births, SGA was 57% higher than LGA (11% vs 7%). The infant mortality rate for SGA was 11.0, AGA, 5.3, and LGA, 2.7/1000 live births. SGA was a significant risk factor for early (adjusted odds ratio, 2.66) and late (2.06) but not postneonatal mortality. The adjusted risk of mortality for LGA was not significantly different from AGA. Over 12 years, 3 types of mortality for aberrant fetal growth did not change significantly. CONCLUSION: In the city of Milwaukee, aberrant fetal growth was variably associated with early, late, and postneonatal mortality.

The effect of alcohol treatment on social costs of alcohol dependence: results from the COMBINE study.

BACKGROUND: The COMBINE (combined pharmacotherapies and behavioral intervention) clinical trial recently evaluated the efficacy of pharmacotherapies, behavioral therapies, and their combinations for the treatment of alcohol dependence. Previously, the cost and cost-effectiveness of COMBINE have been studied. Policy makers, patients, and nonalcohol-dependent individuals may be concerned not only with alcohol treatment costs but also with the effect of alcohol interventions on broader social costs and outcomes. OBJECTIVES: To estimate the sum of treatment costs plus the costs of health care utilization, arrests, and motor vehicle accidents for the 9 treatments in COMBINE 3 years postrandomization. RESEARCH DESIGN: A cost study based on a randomized controlled clinical trial. SUBJECTS: : The study involved 786 participants 3 years postrandomization. RESULTS: Multivariate results show no significant differences in mean costs between any of the treatment arms as compared with medical management (MM) + placebo for the 3-year postrandomization sample. The median costs of MM + acamprosate, MM + naltrexone, MM + acamprosate + naltrexone, and MM + acamprosate + combined behavioral intervention were significantly lower than the median cost for MM + placebo. CONCLUSIONS: The results show that social cost savings are generated relative to MM + placebo by 3 years postrandomization, and the magnitude of these cost savings is greater than the costs of the COMBINE treatment received 3 years prior. Our study suggests that several alcohol treatments may indeed lead to reduced median social costs associated with health care, arrests, and motor vehicle accidents.

Influence of socioeconomic factors and race on birth outcomes in urban Milwaukee.

PURPOSE: A national study found that infants born in low socioeconomic areas had the worst infant mortality rates (IMRs) and the highest racial disparity. Racial disparities in birth outcomes are also evident in the city of Milwaukee, with African American infants at 3 times greater the risk than white infants. This study was conducted to examine the influence of socioeconomic status (SES) and race on birth outcomes in the city of Milwaukee. METHODS: Milwaukee ZIP codes were stratified into lower, middle, and upper SES groups. IMR, low birth weight, and preterm birth rates by race were analyzed by SES group for the years 2003 to 2007. RESULTS: The overall IMR for the lower, middle, and upper SES groups were 12.4, 10.7, and 7.7, respectively. The largest racial disparity in IMR (3.1) was in the middle SES group, versus lower (1.6) and upper (1.8) SES groups. The overall percent of low birth weight infants for the lower, middle, and upper SES groups was 10.9%, 9.5%, and 7.5%, respectively. Racial disparity ratios in low birth weight were 2.0, 1.9, and 1.9 for lower, middle and upper SES groups. The overall percent of preterm birth was 15.4%, 13.2%, and 10.6% of births within the lower, middle, and upper SES groups, respectively, with a disparity ratio of 1.6 across all SES groups. CONCLUSIONS: For all outcomes, African American infants born in the upper SES group fared the same or worse than white infants born in the lower SES group. Although higher SES appeared to have a protective effect for whites in Milwaukee, it did not have the same protective effect for African Americans.

Active consent in urban elementary schools: an examination of demographic differences in consent rates.

The consent process is an integral piece of research and evaluation studies, especially when conducted within a school setting. The challenge of reaching parents of students to obtain consent is an issue with which those conducting school-based studies grapple. The literature suggests that the success of the consent process can affect the representativeness of the sample. This study describes one consent approach and examines the demographic differences between the eligible population, the consenters and the refusers. Demographic differences were found between consenters and refusers and suggestions are offered for further research and for other researchers who conduct school-based projects.

Setting a goal to reduce teen births in Milwaukee by 2015.

INTRODUCTION: Although teen birth rates have declined significantly since 1991, teen pregnancy remains a significant public health problem in Milwaukee, Wis. Using historical teen birth data trends, this study sets a birth rate reduction goal by the year 2015 for Milwaukee teenagers between the ages of 15 and 17. METHODS: Birth counts and birth rates for teenagers between the ages of 15 and 17 were obtained from the Wisconsin Interactive Statistics on Health (WISH). Trend analyses were performed on teen birth rate data gathered between 1991 and 2006 in an effort to forecast and set a birth rate goal for the year 2015. RESULTS/DISCUSSION: Trend analyses yielded a predicted birth rate projection of 35.9 (Adjusted R2 = .95, P < .001) births per 1000 females. Using the exponential function estimate as well as national and state goals, Milwaukee community leaders set a feasible goal of 30 births per 1000 teens aged 15-17 years for the year 2015, which represents a 46% reduction of the 2006 rate of 55/1000.

The Wisconsin Network for Health Research (WiNHR): a statewide, collaborative, multi-disciplinary, research group.

In response to the goals of the Wisconsin Partnership Program and the National Institutes of Health (NIH) Initiatives to Improve Healthcare, the Wisconsin Network for Health Research (WiNHR) was formed. As a collaborative, multi-disciplinary statewide research network, WiNHR encourages and fosters the discovery and application of scientific knowledge for researchers and practitioners throughout Wisconsin. The 4 founding institutions--Aurora Health Care/Center for Urban Population Health (CUPH), Gundersen Lutheran Medical Foundation, Marshfield Clinic Research Foundation, and the University of Wisconsin-Madison--representing geographically diverse areas of the state, are optimistic and committed to WiNHR's success. This optimism is based on the relevance of its goals to public health, the quality of statewide health care research, and, most importantly, the residents of Wisconsin who recognize the value of health research.

Facilitating Factors and Barriers to Weight Management in Women: Physician Perspectives.

PURPOSE: The complexity of addressing overweight and obesity in women has been an ongoing public health and health care challenge. While the mechanism for addressing overweight and obesity in women remains unclear, it has been speculated that disparities in overweight and obesity by race and gender contribute to the complexity. The purpose of the present study was to examine perceptions of primary care physicians when discussing weight management with their patients. METHODS: We conducted focus group discussions exploring facilitators and barriers to discussing weight management and weight loss among women patients. Participants included 18 family medicine and internal medicine physicians who were recruited using a snowball sampling technique from two large urban institutions. Focus group discussions were transcribed verbatim. Responses were then codified and analyzed in frequency of occurrence using specialized computer software. RESULTS: Nine themes emerged from group discussions. These recurring themes reflected three overarching critical points: 1) potential utility of the primary care setting to address weight management; 2) the importance of positive patient-provider communication in supporting weight loss efforts; and 3) acknowledgement of motivation as intrinsic or extrinsic, and its role in obesity treatment. CONCLUSIONS: Physician perceptions of their own lack of education or training and their inability to influence patient behaviors play crucial roles in discussing weight management with patients.

Patient Barriers for Weight Management Among African American Women.

PURPOSE: The primary aim of this study was to assess the perceptions of local African American women who are overweight or obese using semi-structured focus groups to identify barriers to weight management and factors that support strategy success. The secondary aim of this study was to determine recommendations for patient-centered weight management interventions established specifically for African American women in the Milwaukee-area community. METHODS: Three semi-structured focus groups to explore barriers to weight management were performed among women patients. Participants (N=41) were recruited via email, postal mail, and phone as available from an academic medical center in Milwaukee, Wisconsin. Focus group discussions were transcribed verbatim, reviewed by the study team, and coded based on recurring themes within and across interviews. Responses were analyzed by frequency of occurrence using qualitative computer software. RESULTS: Five primary barriers to weight management were identified from focus groups: food choices, lifestyle changes, social support, locus of control, and health education. Based on participant reports, improvements to present practice and health literacy for patients may be merited. There was expressed interest by patients for being involved in future research and development of patient-centered interventions. CONCLUSIONS: This study provides support for the use of a community-based participatory research approach in determining appropriate considerations for weight management interventions suitable for this patient population. Future research should include stakeholders not included in this study, such as community organization leaders, and primary care physicians to develop a refined intervention targeting the primary barriers to weight management.

The Milwaukee Homicide Review Commission: an interagency collaborative process to reduce homicide.

The Milwaukee Hoimicide Review Commission (MHRC) is a multi-level, multi-disciplinary, and multiagency homicide review process aimed at reducing the occurrence of homicides in Milwaukee. Based on the public health approach to violence reduction, the MHRC has 3 goals: (1) to gain a better understanding of homicide through strategic problem analysis, (2) to develop innovative, effective responses, and (3) to focus limited enforcement and intervention activities on identifiable risks. The MHIRC creates an environment for many disciplines and agencies to share information and work collectively on violence prevention strategies. Since its inception, the MHRC has reviewed over 150 homicides and developed over 100 recommendations aimed at reducing homicide. These recommendations are based on themes that emerge from case reviews and focus on initiating change at system, agency/organization, and individual levels. The MHRC has many accomplishments to date, including improved communication between local, state, and federal criminal justice agencies; assistance in immediate investigations new strategic criminal justice activities; changes in ineffective agency practices; and new cooperative efforts between community service providers. Future plans include the continuation and expansion of initiatives including greater community impact and developinga Center of Excellence in community and public safety serving Milwaukee and the state of Wisconsin.

Health disparities in Milwaukee by socioeconomic status.

BACKGROUND: In 2006, the city of Milwaukee ranked worse than any Wisconsin county for health outcomes and worse than all but 1 county for health determinants. METHODS: To further examine disparities in health, Milwaukee city ZIP codes were stratified into 3 groups (lower, middle, and upper) by socioeconomic status (SES). Health determinants (15 measures) and health outcomes (2 measures) were compared across these ZIP code groups, and to the rest of Wisconsin. RESULTS: The risk ratio for the lower SES group in comparison to the upper SES group was at least 2.0 for 5 of the 17 measures examined, and was at least 1.5 for 13 of the 17 measures. The upper SES group in Milwaukee, while the healthiest in the city, was worse than the state average in 6 measures. CONCLUSIONS: Large health disparities within the city of Milwaukee are associated with geographic regions of differing socioeconomic status. As the state's largest urban center, Milwaukee's relatively poor health and significant health disparities have a considerable impact on the overall health of the state. To improve population health in Wisconsin, substantial efforts and resources are needed to address these disparities, and their related upstream factors.

Trends and Progress in Reducing Teen Birth Rates and the Persisting Challenge of Eliminating Racial/Ethnic Disparities.

PURPOSE: We examined progress made by the Milwaukee community toward achieving the Milwaukee Teen Pregnancy Prevention Initiative's aggressive 2008 goal of reducing the teen birth rate to 30 live births/1000 females aged 15-17 years by 2015. We further examined differential teen birth rates in disparate racial and ethnic groups. METHOD: We analyzed teen birth count data from the Wisconsin Interactive Statistics on Health system and demographic data from the US Census Bureau. We computed annual 2003-2014 teen birth rates for the city and four racial/ethnic groups within the city (white non-Hispanic, black non-Hispanic, Hispanic/Latina, Asian non-Hispanic). To compare birth rates from before (2003-2008) and after (2009-2014) goal setting, we used a single-system design to employ two time series analysis approaches, celeration line, and three standard deviation (3SD) bands. RESULTS: Milwaukee's teen birth rate dropped 54 % from 54.3 in 2003 to 23.7 births/1000 females in 2014, surpassing the goal of 30 births/1000 females 3 years ahead of schedule. Rate reduction following goal setting was statistically significant, as five of the six post-goal data points were located below the celeration line and points for six consecutive years (2010-2014) fell below the 3SD band. All racial/ethnic groups demonstrated significant reductions through at least one of the two time series approaches. The gap between white and both black and Hispanic/Latina teens widened. CONCLUSION: Significant reduction has occurred in the overall teen birth rate of Milwaukee. Achieving an aggressive reduction in teen births highlights the importance of collaborative community partnerships in setting and tracking public health goals.

Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial.

CONTEXT: Alcohol dependence treatment may include medications, behavioral therapies, or both. It is unknown how combining these treatments may impact their effectiveness, especially in the context of primary care and other nonspecialty settings. OBJECTIVES: To evaluate the efficacy of medication, behavioral therapies, and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted January 2001-January 2004 among 1383 recently alcohol-abstinent volunteers (median age, 44 years) from 11 US academic sites with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnoses of primary alcohol dependence. INTERVENTIONS: Eight groups of patients received medical management with 16 weeks of naltrexone (100 mg/d) or acamprosate (3 g/d), both, and/or both placebos, with or without a combined behavioral intervention (CBI). A ninth group received CBI only (no pills). Patients were also evaluated for up to 1 year after treatment. MAIN OUTCOME MEASURES: Percent days abstinent from alcohol and time to first heavy drinking day. RESULTS: All groups showed substantial reduction in drinking. During treatment, patients receiving naltrexone plus medical management (n = 302), CBI plus medical management and placebos (n = 305), or both naltrexone and CBI plus medical management (n = 309) had higher percent days abstinent (80.6, 79.2, and 77.1, respectively) than the 75.1 in those receiving placebos and medical management only (n = 305), a significant naltrexone x behavioral intervention interaction (P = .009). Naltrexone also reduced risk of a heavy drinking day (hazard ratio, 0.72; 97.5% CI, 0.53-0.98; P = .02) over time, most evident in those receiving medical management but not CBI. Acamprosate showed no significant effect on drinking vs placebo, either by itself or with any combination of naltrexone, CBI, or both. During treatment, those receiving CBI without pills or medical management (n = 157) had lower percent days abstinent (66.6) than those receiving placebo plus medical management alone (n = 153) or placebo plus medical management and CBI (n = 156) (73.8 and 79.8, respectively; P<.001). One year after treatment, these between-group effects were similar but no longer significant. CONCLUSIONS: Patients receiving medical management with naltrexone, CBI, or both fared better on drinking outcomes, whereas acamprosate showed no evidence of efficacy, with or without CBI. No combination produced better efficacy than naltrexone or CBI alone in the presence of medical management. Placebo pills and meeting with a health care professional had a positive effect above that of CBI during treatment. Naltrexone with medical management could be delivered in health care settings, thus serving alcohol-dependent patients who might otherwise not receive treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00006206.

Prevalence of children with special health care needs in Milwaukee, Wisconsin: data from the Milwaukee metropolitan statistical area.

BACKGROUND: The Milwaukee Health Department and the Wisconsin Southeast Regional Center for Children with Special Health Care Needs (CSHCN) were interested in understanding the level of need and prevalence of CSHCN in the city of Milwaukee. It was determined that a survey of the Milwaukee area was needed to obtain a prevalence estimate. METHODS: A survey to identify children with special health care needs in the Milwaukee metropolitan statistical area (MSA) was conducted using the CSHCN Screener. The survey was administered as part of the Greater Milwaukee Survey in October and November of 2004. Results from this survey were compared to state and national data from the National Survey of Children with Special Health Care Needs, 2001. RESULTS: The prevalence of CSHCN in Milwaukee (23.5%) was found to be almost double that of the surrounding Milwaukee MSA counties (12.1%), the state (13.4%), and the nation (12.8%). The number and type of positive screener questions were not significantly different among the geographic areas. CONCLUSIONS: The prevalence of CSHCN has been consistently associated with poverty in numerous other studies. The survey conducted in Milwaukee MSA indicated increased prevalence in Milwaukee among poor and African American children. Improvement and augmentation of services available to urban poor is necessary to alleviate this excessive burden.

Discovering Outliers of Potential Drug Toxicities Using a Large-scale Data-driven Approach.

We systematically compared the adverse effects of cancer drugs to detect event outliers across different clinical trials using a data-driven approach. Because many cancer drugs are toxic to patients, better understanding of adverse events of cancer drugs is critical for developing therapies that could minimize the toxic effects. However, due to the large variabilities of adverse events across different cancer drugs, methods to efficiently compare adverse effects across different cancer drugs are lacking. To address this challenge, we present an exploration study that integrates multiple adverse event reports from clinical trials in order to systematically compare adverse events across different cancer drugs. To demonstrate our methods, we first collected data on 186,339 clinical trials from ClinicalTrials.gov and selected 30 common cancer drugs. We identified 1602 cancer trials that studied the selected cancer drugs. Our methods effectively extracted 12,922 distinct adverse events from the clinical trial reports. Using the extracted data, we ranked all 12,922 adverse events based on their prevalence in the clinical trials, such as nausea 82%, fatigue 77%, and vomiting 75.97%. To detect the significant drug outliers that could have a statistically high possibility of causing an event, we used the boxplot method to visualize adverse event outliers across different drugs and applied Grubbs' test to evaluate the significance. Analyses showed that by systematically integrating cross-trial data from multiple clinical trial reports, adverse event outliers associated with cancer drugs can be detected. The method was demonstrated by detecting the following four statistically significant adverse event cases: the association of the drug axitinib with hypertension (Grubbs' test, P < 0.001), the association of the drug imatinib with muscle spasm (P < 0.001), the association of the drug vorinostat with deep vein thrombosis (P < 0.001), and the association of the drug afatinib with paronychia (P < 0.01).

Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data.

BACKGROUND: Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. OBJECTIVES: The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. METHODS: Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. RESULTS: In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (P<.001) when compared with the lowest incidence in the 20-29 years-old group. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (P<.001). Adverse event diversity increased at an average rate of 77% for each age group (older than 30 years) until reaching the 60-69 years-old group, which had a diversity level of 54.7 different types of adverse events per trial arm. The 70-100 years-old group showed the highest diversity level of 55.5 events per trial arm, which is approximately 3.44 times more than the 20-29 years-old group (P<.001). We also observe that adverse events display strong age-related patterns among different categories. CONCLUSION: The results show that there is a significant adverse event variance at the population level between different age groups in clinical trials. The data suggest that age-associated adverse events should be considered in planning, monitoring, and regulating clinical trials.

Obese Employee Participation Patterns in a Wellness Program.

The purpose of this research was to retrospectively examine whether demographic differences exist between those who participated in an employee wellness program and those who did not, and to identify the selection of employees' choice in weight management activities. A nonequivalent, 2-group retrospective design was used. This study involved employees at a large, not-for-profit integrated health system. Of the total organization employee pool (29,194), 19,771 (68%) employees volunteered to be weighed (mean body mass index [BMI]=28.9) as part of an employee wellness program. Weight management activities available included: (1) Self-directed 5% total body weight loss; (2) Healthy Solutions at home; (3) Weight Watchers group meetings; (4) Weight Watchers online; and (5) Employee Assistance Program (EAP)-directed healthy weight coaching. Measures were participation rate and available weight management activity participation rate among obese employees across demographic variables, including sex, age, race, job type, and job location. The analysis included chi-square tests for all categorical variables; odds ratios were calculated to examine factors predictive of participation. Of the total 19,771 employees weighed, 6375 (32%) employees were obese (defined as BMI ≥30); of those, 3094 (49%) participated in available weight management activities. Participation was higher among females, whites, those ages >50 years, and non-nursing staff. In conclusion, participation rate varied significantly based on demographic variables. Self-directed 5% weight loss was the most popular weight management activity selected. (Population Health Management 2016;19:132-135).

Weight Loss Associated With Employee Income in an Incentivized Employee Wellness Program.

OBJECTIVE: We examined the relationship between the type of incentivized wellness program and employee weight loss and the effects of participant income. METHODS: We retrospectively examined employees who participated in one of six weight loss wellness programs, which were categorized for the present analysis: reweigh/body mass index, Coaching, and Weight Watchers/Meal Replacement. Those who participated were eligible for a $350/year insurance premium discount. RESULTS: Employees in the low-income category of $45K or less participated at a higher rate, however, did not lose as much weight as those participants in the higher income categories of $70K or more. We found a positive association with weight loss in two of the categories, reweigh/body mass index, and Weight Watchers/Meal Replacement programs. CONCLUSION: Wellness programs have a significant impact on employee weight loss, but this relationship may vary across the income level of participants.

Assessing nondrinking outcomes in combined pharmacotherapy and psychotherapy clinical trials for the treatment of alcohol dependence.

OBJECTIVE: This article argues that nondrinking outcomes are essential to include in complex trials such as COMBINE to assess the hypothesized mechanisms of action and behavioral change associated with both medications and psychotherapy. Toward this end, COMBINE is used as a case study for (1) discussing hypothesized mechanisms of action for behavior change, (2) discussing distinctive design features of combined studies, (3) highlighting issues in the selection of outcome measures, (4) providing a framework for organizing outcome domains and measures and (5) providing a dose-response model for assessing alcoholism treatment outcomes. METHOD: A review of the literature and discussion of methodological issues in assessing nondrinking outcomes is provided as well as a case study in developing a conceptual framework for selecting outcome measures. RESULTS: The results of the review and case study include the development of a framework for categorizing outcome dimensions and measures into condition-specific clinical status, condition-specific symptoms and personal and interpersonal functioning outcomes. In addition, a model is provided for assessing the dose-response of combined alcoholism treatment with multiple dimensions of outcome during and after treatment. CONCLUSIONS: Consistent with previous observations that recovery from alcohol dependence is a multidimensional developmental process, the COMBINE Study will examine the effects of different combinations of pharmacotherapy and behavioral interventions on the magnitude and pattern of changes in various outcome dimensions (both drinking and nondrinking) over time.