Hepatitis A Outbreaks Associated With the Opioid Epidemic in Kentucky Counties, 2017-2018.

Objectives. To describe county-level socioeconomic profiles associated with Kentucky's 2017-2018 hepatitis A outbreak that predominately affected communities affected by the opioid epidemic.Methods. We linked county-level characteristics on socioeconomic and housing variables to counties' hepatitis A rates. Principal component analysis identified county profiles of poverty, education, disability, income inequality, grandparent responsibility, residential instability, and marital status. We used Poisson regression to estimate adjusted relative risks (RRs) and 95% confidence intervals (CIs).Results. Counties with scores reflecting an extremely disadvantaged profile (RR = 1.21; 95% CI = 0.99, 1.48) and greater percentage of nonmarried men, residential instability, and income inequality (RR = 1.15; 95% CI = 0.94, 1.41) had higher hepatitis A rates. Counties with scores reflecting more married adults, residential stability, and lower income inequality despite disability, poverty, and low education (RR = 0.77; 95% CI = 0.59, 1.00) had lower hepatitis A rates. Counties with a higher percentage of workers in the manufacturing industry had slightly lower rates (RR = 0.97; 95% CI = 0.94, 1.00).Conclusions. As expected, impoverished counties had higher hepatitis A rates. Evaluation across the socioeconomic patterns highlighted community-level factors (e.g., residential instability, income inequality, and social structures) that can be collected to augment hepatitis A data surveillance and used to identify higher-risk communities for targeted immunizations.

The Use of High-Risk Criteria to Assess Mortality Risk among Unsheltered Homeless Persons.

We assessed the ability of high-risk criteria developed by Boston Health Care for the Homeless Program to identify increased mortality during a 10-year cohort study (January 2000-December 2009) of 445 unsheltered adults. To qualify as high-risk for mortality, an individual slept unsheltered for six consecutive months or longer plus had one or more of the following characteristics: tri-morbidity, defined as co-occurring medical, psychiatric, and addiction diagnoses; one or more inpatient or respite admissions; three or more emergency department visits; 60 years old or older; HIV/AIDS; cirrhosis; renal failure; frostbite, hypothermia, or immersion foot. A total of 119 (26.7%) individuals met the high-risk criteria. The remaining 326 individuals in the cohort were considered lowerrisk. During the study, 134 deaths occurred; 52 (38.8%) were among high-risk individuals. Compared with sheltered individuals, the age-standardized mortality ratio for the high-risk group was 4.0 (95% confidence interval 3.0, 5.2) times higher and for the lower-risk group was 2.2 (1.8, 2.8) times higher. The hazard ratio, a measure of survival, for the high-risk group was 1.7 (1.2, 2.4) times that of the lower-risk group. High-risk criteria predicted an increased likelihood of mortality among unsheltered individuals. The lower-risk group also had high mortality rates compared with sheltered individuals.

Sociodemographic factors influencing island foods consumption in the Pacific Islander Health Study.

Objectives: Pacific Islander Americans are a small, but quickly growing population that experiences alarming disparities in obesity and obesity-related chronic illnesses influenced by dietary patterns. This population also has a unique culinary heritage including traditional foods and more contemporary imports such as tinned meats and refined carbohydrates. This analysis is a novel attempt to understand the sociodemographic factors influencing island foods consumption.Design: A sample of 240 Samoan and Tongan adults in California from the Pacific Islander Health Study was used. Following univariate and bivariate analyses, a series of four multivariable regression models were created to predict past week frequency of island foods consumption after sequential adjustment for demographic, socioeconomic, and cultural covariates.Results: Participants reported consuming island foods an average of 2.93 times in the previous week, with the largest proportion of participants (20.42%) reporting eating island foods 6 or more times. Age and Samoan ethnicity were initially significant, positive predictors of island foods consumption, but their effect was attenuated after addition of cultural covariates. With the third model that adjusted for birthplace, financial insecurity and Tongan birthplace were positive predictors. Both lost significance in the fourth and final model upon addition of cultural affinity, which was positively associated with island foods.Conclusion: Understanding how sociodemographic factors are associated with island foods consumption is a first step in understanding the broad way in which an ethnically specific dietary pattern may be associated with obesity-related chronic illness risk among Pacific Islander Americans.

Household socio-economic position and individual infectious disease risk in rural Kenya.

The importance of household socio-economic position (SEP) in shaping individual infectious disease risk is increasingly recognised, particularly in low income settings. However, few studies have measured the extent to which this association is consistent for the range of pathogens that are typically endemic among the rural poor in the tropics. This cross-sectional study assessed the relationship between SEP and human infection within a single community in western Kenya using a set of pathogens with diverse transmission routes. The relationships between household SEP and individual infection with Plasmodium falciparum, hookworm (Ancylostoma duodenale and/or Necator americanus), Entamoeba histolytica/dispar, Mycobacterium tuberculosis, and HIV, and co-infections between hookworm, P. falciparum and E. histolytica/dispar, were assessed using multivariable logistic and multinomial regression. Individuals in households with the lowest SEP were at greatest risk of infection with P. falciparum, hookworm and E. histolytica/dispar, as well as co-infection with each pathogen. Infection with M. tuberculosis, by contrast, was most likely in individuals living in households with the highest SEP. There was no evidence of a relationship between individual HIV infection and household SEP. We demonstrate the existence of a household socio-economic gradient within a rural farming community in Kenya which impacts upon individual infectious disease risk. Structural adjustments that seek to reduce poverty, and therefore the socio-economic inequalities that exist in this community, would be expected to substantially reduce overall infectious disease burden. However, policy makers and researchers should be aware that heterogeneous relationships can exist between household SEP and infection risk for different pathogens in low income settings.

Applying a Conceptual Framework to Maximize the Participation of Diverse Populations in Cancer Clinical Trials.

The underrepresentation of ethnically diverse populations in cancer clinical trials results in the inequitable distribution of the risks and benefits of this research. Using a case study approach, we apply a conceptual framework of factors associated with the participation of diverse population groups in cancer clinical trials developed by Dr. Jean Ford and colleagues to increase understanding of the specific strategies, and barriers and promoters addressed by these strategies, that resulted in marked success in accrual of racially and ethnically diverse populations in cancer clinical research. Results indicate that the studies presented were able to successfully engage minority participants due to the creation and implementation of multilevel, multifaceted strategies that included: culturally and linguistically appropriate outreach, education, and research studies that were accessible in local communities; infrastructure to support engagement of key stakeholders, clinicians, and organizations serving minority communities; testimonials by ethnically diverse cancer survivors; availability of medical interpretation services; and providing infrastructure that facilitated the engagement in clinical research of clinicians who care for minority patient populations. These strategic efforts were effective in addressing limited awareness of trials, lack of opportunities to participate, and acceptance of engagement in cancer clinical trials. Careful attention to the context and population characteristics in which cancer clinical trials are conducted will be necessary to address disparities in research participation and cancer outcomes. These studies illustrate that progress on minority accrual into clinical research requires intentional efforts to overcome barriers at all three stages of the accrual process: awareness, opportunity, and acceptance of participation.

A study of urgent and emergency referrals from NHS Direct within England.

OBJECTIVES: The presented study aimed to explore referral patterns of National Health Service (NHS) Direct to determine how patients engage with telephone-based healthcare and how telephone-based healthcare can manage urgent and emergency care. SETTING: NHS Direct, England, UK PARTICIPANTS: NHS Direct anonymised call data (N=1,415,472) were extracted over a representative 1-year period, during the combined month periods of July 2010, October 2010, January 2011 and April 2011. Urgent and emergency calls (N=269,558; 19.0%) were analysed by call factors and patient characteristics alongside symptom classification. Categorical data were analysed using the χ(2) test of independence with cross-tabulations used to test within-group differences. PRIMARY AND SECONDARY OUTCOME MEASURES: Urgent and emergency referrals to 999; accident and emergency or to see a general practitioner urgently, which are expressed as call rate per 100 persons per annum. Outcomes related to symptom variations by patient characteristics (age, gender, ethnicity and deprivation) alongside differences by patient characteristics of call factors (date and time of day). RESULTS: Urgent and emergency referrals varied by a range of factors relating to call, patient and symptom characteristics. For young children (0-4), symptoms related to 'crying' and 'colds and flu' and 'body temperature change' represented the significantly highest referrals to 'urgent and emergency' health services symptoms relating to 'mental health' alongside 'pain' and 'sensation disorders' represented the highest referrals to urgent and emergency health services for adults aged 40+ years. CONCLUSIONS: This study has highlighted characteristics of 'higher likelihood' referrals to urgent and emergency care through the delivery of a national nurse-led telephone healthcare service. This research can help facilitate an understanding of how patients engage with both in and out of hours care and the role of telephone-based healthcare within the care pathway.

A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents.

BACKGROUND: Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Although this is a major problem, relatively few adolescents with, or at risk of developing, depression are identified and referred for treatment. This suggests the need to investigate alternative approaches whereby preventative interventions are made widely available in schools. OBJECTIVE: To investigate the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents. DESIGN: Cluster randomised controlled trial. Year groups ( n = 28) randomly allocated on a 1 : 1 : 1 basis to one of three trial arms once all schools were recruited and balanced for number of classes, number of students, Personal, Social and Health Education (PSHE) lesson frequency, and scheduling of PSHE. SETTING: Year groups 8 to 11 (ages 12-16 years) in mixed-sex secondary schools in the UK. Data were collected between 2009 and 2011. PARTICIPANTS: Young people who attended PSHE at participating schools were eligible ( n = 5503). Of the 5030 who agreed to participate, 1064 (21.2%) were classified as 'high risk': 392 in the classroom-based CBT arm, 374 in the attention control PSHE arm and 298 in the usual PSHE arm. Primary outcome data on the high-risk group at 12 months were available for classroom-based CBT ( n = 296), attention control PSHE ( n = 308) and usual PSHE ( n = 242). INTERVENTIONS: The Resourceful Adolescent Programme (RAP) is a focused CBT-based intervention adapted for the UK (RAP-UK) and delivered by two facilitators external to the school. Control groups were usual PSHE (usual school curriculum delivered by teachers) and attention control (usual school PSHE with additional support from two facilitators). Interventions were delivered universally to whole classes. PRIMARY OUTCOMES: Clinical effectiveness: symptoms of depression [Short Mood and Feelings Questionnaire (SMFQ)] in adolescents at high risk of depression 12 months from baseline. Cost-effectiveness: incremental cost-effectiveness ratios (ICERs) based on SMFQ score and quality-adjusted life-years (from European Quality of Life-5 Dimensions scores) between baseline and 12 months. Process evaluation: reach, attrition and qualitative feedback from service recipients and providers. RESULTS: SMFQ scores had decreased for high-risk adolescents in all trial arms at 12 months, but there was no difference between arms [classroom-based CBT vs. usual PSHE adjusted difference in means 0.97, 95% confidence interval (CI) -0.34 to 2.28; classroom-based CBT vs. attention control PSHE -0.63, 95% CI -1.99 to 0.73]. Costs of interventions per child were estimated at £41.96 for classroom-based CBT and £34.45 for attention control PSHE. Fieller's method was used to obtain a parametric estimate of the 95% CI for the ICERs and construct the cost-effectiveness acceptability curve, confirming that classroom-based CBT was not cost-effective relative to the controls. Reach of classroom-based CBT was good and attrition was low (median 80% attending ≥ 60% of sessions), but feedback indicated some difficulties with acceptability and sustainability. CONCLUSIONS: Classroom-based CBT, attention control PSHE and usual PSHE produced similar outcomes. Classroom-based CBT may result in increased self-awareness and reporting of depressive symptoms. Classroom-based CBT was not shown to be cost-effective. While schools are a convenient way of reaching a wide range of young people, implementing classroom-based CBT within schools is challenging, particularly with regard to fitting programmes into a busy timetable, the lack of value placed on PSHE, and difficulties engaging with teachers and young people. Wider use of classroom-based depression prevention programmes should not be undertaken without further research. If universal preventative approaches are to be pursued, their clinical effectiveness and cost-effectiveness with younger children (aged 10-11 years), before the incidence of depression increases, should be investigated. Alternatively, the clinical effectiveness of indicated school-based programmes targeting those already displaying symptoms of depression should be investigated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19083628. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 47. See the HTA programme website for further project information.

Study of the use of antidepressants for depression in dementia: the HTA-SADD trial--a multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine.

OBJECTIVE: Depression is common in dementia, causing considerable distress and other negative impacts. Treating it is a clinical priority, but the evidence base is sparse and equivocal. This trial aimed to determine clinical effectiveness of sertraline and mirtazapine in reducing depression 13 weeks post randomisation compared with placebo. DESIGN: Multicentre, parallel-group, double-blind placebo-controlled randomised controlled trial of the clinical effectiveness of sertraline and mirtazapine with 13- and 39-week follow-up. SETTING: Nine English old-age psychiatry services. PARTICIPANTS: A pragmatic trial. Eligibility: probable or possible Alzheimer's disease (AD), depression (4+ weeks) and Cornell Scale for Depression in Dementia (CSDD) score of 8+. EXCLUSIONS: clinically too critical (e.g. suicide risk); contraindication to medication; taking antidepressants; in another trial; and having no carer. INTERVENTIONS: (1) Sertraline; (2) mirtazapine; and (3) placebo, all with normal care. Target doses: 150 mg of sertraline or 45 mg of mirtazapine daily. OUTCOME: CSDD score. Randomisation: Allocated 1 : 1 : 1 through Trials Unit, independently of trial team. Stratified block randomisation by centre, with randomly varying block sizes; computer-generated randomisation. Blinding: Double blind: medication and placebo identical for each antidepressant. Referring clinicians, research workers, participants and pharmacies were blind. Statisticians blind until analyses completed. RESULTS: Numbers randomised: 326 participants randomised (111 placebo, 107 sertraline and 108 mirtazapine). OUTCOME: Differences in CSDD at 13 weeks from an adjusted linear-mixed model: mean difference (95% CI) placebo-sertraline 1.17 (-0.23 to 2.78; p = 0.102); placebo-mirtazapine 0.01 (-1.37 to 1.38; p = 0.991); and mirtazapine-sertraline 1.16 (-0.27 to 2.60; p = 0.112). HARMS: Placebo group had fewer adverse reactions (29/111, 26%) than sertraline (46/107, 43%) or mirtazapine (44/108, 41%; p = 0.017); 39-week mortality equal, five deaths in each group. CONCLUSIONS: This is a trial with negative findings but important clinical implications. The data suggest that the antidepressants tested, given with normal care, are not clinically effective (compared with placebo) for clinically significant depression in AD. This implies a need to change current practice of antidepressants being the first-line treatment of depression in AD. From the data generated we formulated the following recommendations for future work. (1) The secondary analyses presented here suggest that there would be value in carrying out a placebo-controlled trial of the clinical effectiveness and cost-effectiveness of mirtazapine in the management of Behavioural and Psychological Symptoms of Dementia. (2) A conclusion from this study is that it remains both ethical and essential for trials of new medication for depression in dementia to have a placebo arm. (3) Further research is required to evaluate the impact that treatments for depression in people with dementia can have on their carers not only in terms of any impacts on their quality of life, but also the time they spend care-giving. (4) There is a need for research into alternative biological and psychological therapies for depression in dementia. These could include evaluations of new classes of antidepressants (such as venlafaxine) or antidementia medication (e.g. cholinesterase inhibitors). (5) Research is needed to investigate the natural history of depression in dementia in the community when patients are not referred to secondary care services. (6) Further work is needed to investigate the cost modelling results in this rich data set, investigating carer burden and possible moderators to the treatment effects. (7) There is scope for reanalysis of the primary outcome in terms of carer and participant CSDD results.

REMCARE: reminiscence groups for people with dementia and their family caregivers - effectiveness and cost-effectiveness pragmatic multicentre randomised trial.

OBJECTIVES: The aim of the REMiniscence groups for people with dementia and their family CAREgivers (REMCARE) study was to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family caregivers as compared with usual care. DESIGN: A multicentre, pragmatic randomised controlled trial with two parallel arms - an intervention group and a usual-care control group - was carried out. A restricted dynamic method of randomisation was used with an overall allocation ratio of 1 : 1, restricted to ensure intervention groups of a viable size. Assessments, blind to treatment allocation, were carried out at baseline, 3 months and 10 months (primary end point). SETTING: Most participants were recruited through NHS Memory Clinics and Community Mental Health Teams for older people. Assessments were usually carried out in the person's home, and treatment groups were held in a variety of community settings. PARTICIPANTS: A total of 488 individuals (mean age 77.5 years) with mild to moderate dementia (meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria), who were initially living in the community, and who had a relative or other caregiver maintaining regular contact, who could act as an informant and was willing and able to participate in the intervention, were recruited to the study. Most carers were spouses (71%). A total of 350 dyads completed the study. INTERVENTIONS: The intervention consisted of joint reminiscence groups held weekly for 12 consecutive weeks, followed by monthly maintenance sessions for a further 7 months. The sessions followed a treatment manual, and were led by two trained facilitators in each centre, supported by a number of volunteers. Up to 12 dyads were invited to attend each group. MAIN OUTCOME MEASURES: The primary outcome measures were self-reported quality of life for the person with dementia and psychological distress for the carer [General Health Questionnaire-28 item version (GHQ-28)]. Secondary outcome measures included autobiographical memory and activities of daily living for the person with dementia, carer stress for the carer and mood, relationship quality and service use and costs for both parties. RESULTS: The intention-to-treat analysis identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes [self-reported quality of life in Alzheimer's disease: mean difference 0.07, standard error (SE) 0.65; F = 0.48; p = 0.53]. Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a subscale of the GHQ-28 at the 10-month end point (mean difference 1.25, SE 0.5; F = 8.28; p = 0.04). Compliance analyses suggested some benefits for people with dementia who attended more reminiscence sessions; however, carers attending more groups showed increased caregiving stress. Use of health- and social-care services was modest, with no significant difference in service use between conditions. Owing to negligible difference in quality-adjusted life-year gains (derived from European Quality of Life-5 Dimensions) between the conditions the planned full economic analysis was curtailed. CONCLUSIONS: This trial does not provide support for the effectiveness or cost-effectiveness of joint reminiscence groups for people with dementia and their carers. Although there may be some beneficial effects for people with dementia who attend sessions as planned, this must be viewed in the context of raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42430123. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 48. See the HTA programme website for further project information.

Comparison of the utility of preoperative versus postoperative B-type natriuretic peptide for predicting hospital length of stay and mortality after primary coronary artery bypass grafting.

BACKGROUND: Preoperative B-type natriuretic peptide (BNP) is known to predict adverse outcomes after cardiac surgery. The value of postoperative BNP for predicting adverse outcomes is less well delineated. The authors hypothesized that peak postoperative plasma BNP (measured postoperative days 1-5) predicts hospital length of stay (HLOS) and mortality in patients undergoing primary coronary artery bypass grafting, even after adjusting for preoperative BNP and perioperative clinical risk factors. METHODS: This study is a prospective longitudinal study of 1,183 patients undergoing primary coronary artery bypass grafting surgery. Mortality was defined as all-cause death within 5 yr after surgery. Cox proportional hazards analyses were conducted to separately evaluate the associations between peak postoperative BNP and HLOS and mortality. Multivariable adjustments were made for patient demographics, preoperative BNP concentration, and clinical risk factors. BNP measurements were log10 transformed before analysis. RESULTS: One hundred fifteen deaths (9.7%) occurred in the cohort (mean follow-up = 4.3 yr, range = 2.38-5.0 yr). After multivariable adjustment for preoperative BNP and clinical covariates, peak postoperative BNP predicted HLOS (hazard ratio [HR] = 1.28, 95% CI = 1.002-1.64, P = 0.049) but not mortality (HR = 1.62, CI = 0.71-3.68, P = 0.25), whereas preoperative BNP independently predicted HLOS (HR = 1.09, CI = 1.01-1.18, P = 0.03) and approached being an independent predictor of mortality (HR = 1.36, CI = 0.96-1.94, P = 0.08). When preoperative and peak postoperative BNP were separately adjusted for within the clinical multivariable models, each independently predicted HLOS (preoperative BNP HR = 1.13, CI = 1.05-1.21, P = 0.0007; peak postoperative BNP HR = 1.44, CI = 1.15-1.81, P = 0.001) and mortality (preoperative BNP HR = 1.50, CI = 1.09-2.07, P = 0.01; peak postoperative BNP HR = 2.29, CI = 1.11-4.73, P = 0.02). CONCLUSIONS: Preoperative BNP may be better than peak postoperative BNP for predicting HLOS and longer term mortality after primary coronary artery bypass grafting surgery.

Joint replacement surgeries among medicare beneficiaries in rural compared with urban areas.

OBJECTIVE: People in rural areas live farther away from hospitals than do people in urban areas. Thus, there is concern that people living in rural areas may be less willing or able to undergo elective surgical procedures. This study was undertaken to determine whether Medicare beneficiaries in rural areas were less likely to have elective total knee or hip replacement surgeries compared with their urban counterparts. METHODS: We performed a cross-sectional study of Medicare beneficiaries, controlling for age, sex, race/ethnicity, and economic status. Beneficiaries were assigned to rural versus urban areas based on their zip code of residence and the 10-point Rural-Urban Commuting Area designation. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated. RESULTS: Compared with urban beneficiaries, rural beneficiaries were 27% more likely to have total knee or hip replacement surgeries (OR 1.27 [95% CI 1.26-1.28]). After adjusting for age, sex, race/ethnicity, median household income, average house value, mean poverty ratio, and state of residence, rural beneficiaries were still 14% more likely to have total joint replacement surgeries (OR 1.14 [95% CI 1.13-1.16]). Differential use of surgery before and after receiving Medicare eligibility did not explain the findings. While significant sex, racial, and ethnic disparities were present in both rural and urban areas, for the most part these disparities were ameliorated rather than accentuated in rural areas. CONCLUSION: Contrary to expectations, our findings indicate that Medicare beneficiaries living in rural areas are more likely to undergo total knee or hip replacement surgeries.

Protecting an endangered species: training physicians to conduct clinical research.

PURPOSE: The Program in Clinical Effectiveness (PCE) at Harvard School of Public Health is a postgraduate program emphasizing clinical research. The authors sought to evaluate the research careers of physician graduates and to determine correlates of National Institutes of Health (NIH) grant funding. METHOD: In 2006, all 1,489 graduates from 1986-2005 were sent a 48-item survey that collected information on demographics, program experience, chosen career path, grant awards, and research pursued postprogram. Reported NIH grants were verified on the NIH Computer Retrieval of Information on Scientific Projects Web site. Cox proportional hazard regression was used to determine participant and program features associated with NIH grant funding. RESULTS: Overall, 994 of the 1,365 located graduates (73%) responded to the survey. Graduates pursued research in the following areas: 437 respondents (44%) pursued clinical trials, 537 (54%) pursued epidemiology, and 408 (41%) pursued health services research. A total of 156 respondents (24%) were principal investigators on an NIH grant. Correlates of receiving NIH grant funding included age less than 40 years at time of program enrollment (hazard ratio [HR] 1.87, CI 1.03, 3.41), generalist status (HR 1.57, CI 1.14, 2.16), and publishing research begun as course projects (HR 1.65, CI 1.19, 2.31). Gender, academic status at enrollment, ethnicity, tuition sponsorship, and earning an advanced degree were not associated with receipt of NIH grant funding. CONCLUSIONS: Physicians who enrolled in the PCE at an early age and generalist physicians were particularly successful in establishing careers as clinician-investigators. Programs such as the PCE can help to sustain the workforce of physician-investigators.

Effectiveness of a barcode medication administration system in reducing preventable adverse drug events in a neonatal intensive care unit: a prospective cohort study.

OBJECTIVE: Patients are at risk of harm from medication errors. Barcode medication administration (BCMA) systems are recommended to mitigate preventable adverse drug events (ADEs). Our hypothesis was that a BCMA system would reduce preventable ADEs by 45% in a neonatal intensive care unit. STUDY DESIGN: We conducted a prospective, observational, cohort study of a BCMA system intervention in a neonatal intensive care unit. Participants were admitted neonates during 50 weeks. Medication errors and potential or preventable ADEs were detected by a daily structured audit of each subject's medical record, with assignment of an event as a preventable ADE made by blinded assessors. The generalized estimating equation method was used in modeling the targeted, preventable ADE rate with covariates. RESULTS: A total of 92,398 medication doses were administered to 958 subjects. The generalized estimating equation method yielded a relative risk of preventable ADE when the system was implemented of 0.53 (95% confidence limits 0.29 to 0.91, P = .04), adjusted for log(10)doses of medication/subject/day, a significant predictive covariate (P < .001), as well as for birth weight, sex, Caucasian race, birth cohort number, and nursing hours/subject/day. CONCLUSION: The BCMA system reduced the risk of targeted, preventable ADEs by 47%, controlling for the number of medication doses/subject/day, an important risk exposure.

Health literacy not race predicts end-of-life care preferences.

BACKGROUND: Several studies have reported that African Americans are more likely than whites to prefer aggressive treatments at the end of life. OBJECTIVE: Since the medical information presented to subjects is frequently complex, we hypothesized that apparent differences in end-of-life preferences and decision making may be due to disparities in health literacy. A video of a patient with advanced dementia may overcome communication barriers associated with low health literacy. DESIGN: Before and after oral survey. PARTICIPANTS: Subjects presenting to their primary care doctors. METHODS: Subjects were asked their preferences for end-of-life care after they heard a verbal description of advanced dementia. Subjects then viewed a 2-minute video of a patient with advanced dementia and were asked again about their preferences. For the analysis, preferences were dichotomized into comfort care and aggressive care. Health literacy was measured using the Rapid Estimate of Adult Literacy in Medicine (REALM) and subjects were divided into three literacy categories: low (0-45, sixth grade and below), marginal (46-60, seventh to eighth grade) and adequate (61-66, ninth grade and above). Unadjusted and adjusted logistic regression models were fit using stepwise algorithms to examine factors related to initial preferences before the video. RESULTS: A total of 80 African Americans and 64 whites completed the interview. In unadjusted analyses, African Americans were more likely than whites to have preferences for aggressive care after the verbal description, odds ratio (OR) 4.8 (95% confidence interval [CI] 2.1-10.9). Subjects with low or marginal health literacy were also more likely than subjects with adequate health literacy to have preferences for aggressive care after the verbal description, OR 17.3 (95% CI 6.0-49.9) and OR 11.3 (95% CI 4.2-30.8) respectively. In adjusted analyses, health literacy (low health literacy: OR 7.1, 95% CI 2.1-24.2; marginal health literacy OR 5.1, 95% CI 1.6-16.3) but not race (OR 1.1, 95% CI 0.3-3.2) was an independent predictor of preferences after the verbal description. After watching a video of advanced dementia, there were no significant differences in the distribution of preferences by race or health literacy. CONCLUSIONS: Health literacy and not race was an independent predictor of end-of-life preferences after hearing a verbal description of advanced dementia. In addition, after viewing a video of a patient with advanced dementia there were no longer any differences in the distribution of preferences according to race and health literacy. These findings suggest that clinical practice and research relating to end-of-life preferences may need to focus on a patient education model incorporating the use of decision aids such as video to ensure informed decision-making.

Are there regional differences in gynecologic cancer outcomes in the context of a single-payer, publicly-funded health care system? A population-based study.

BACKGROUND: Canada has a single-payer, publicly-funded health care system that provides comprehensive health care, and therefore significant disparities in health outcomes are not expected in our population. The objective of this study was to determine if differences exist in endometrial cancer outcomes across regions in Ontario. METHODS: This was a population-based study of all endometrial (uterine) cancer cases diagnosed from 1996 to 2000 in Ontario and linked to various administrative databases. Univariate analyses examined trends in demographics (age, income, co-morbidities), treatment (surgical staging and adjuvant pelvic radiotherapy), and pathology (grade, histology, stage) across 14 geographic regions defined by local health integration networks (LHINs) in Ontario. Primary outcome was 5-year overall survival among LHINs, which were compared in a multilevel Cox regression model to account for clustering of patient data at the hospital level. RESULTS: There were 3,875 evaluable cases with complete information on demographics, treatment, pathology, and outcomes. There was significant variation in patient demographics, treatment, and pathology across the 14 LHINs. Low income level and surgery at a low-volume, community hospital without gynecologic oncologists were not associated with a higher risk of death. There was a trend towards clustering of patients within hospitals. After adjustment for covariates, there was no significant difference in survival across LHINs. CONCLUSIONS: In the context of a single-payer, publicly-funded health care system, we did not find significant regional differences in endometrial cancer outcomes.

Application of a decision support tool for anticoagulation in patients with non-valvular atrial fibrillation.

BACKGROUND: Atrial fibrillation affects more than two million Americans and results in a fivefold increased rate of embolic strokes. The efficacy of adjusted dose warfarin is well documented, yet many patients are not receiving treatment consistent with guidelines. The use of a patient-specific computerized decision support tool may aid in closing the knowledge gap regarding the best treatment for a patient. METHODS: This retrospective, observational cohort analysis of 6,123 Ohio Medicaid patients used a patient-specific computerized decision support tool that automated the complex risk-benefit analysis for anticoagulation. Adverse outcomes included acute stroke, major gastrointestinal bleeding, and intracranial hemorrhage. Cox proportional hazards models were developed to compare the group of patients who received warfarin treatment with those who did not receive warfarin treatment, stratified by the decision support tool's recommendation. RESULTS: Our decision support tool recommended warfarin for 3,008 patients (49%); however, only 9.9% received warfarin. In patients for whom anticoagulation was recommended by the decision support tool, there was a trend towards a decreased hazard for stroke with actual warfarin treatment (hazard ratio 0.90) without significant increase in gastrointestinal hemorrhage (0.87). In contrast, in patients for whom the tool recommended no anticoagulation, receipt of warfarin was associated with statistically significant increased hazard of gastrointestinal bleeding (1.54, p = 0.03). CONCLUSIONS: We have shown that our atrial fibrillation decision support tool is a useful predictor of those at risk of major bleeding for whom anticoagulation may not necessarily be beneficial. It may aid in weighing the benefits versus risks of anticoagulation treatment.

Evaluating uses of data mining techniques in propensity score estimation: a simulation study.

BACKGROUND: In propensity score modeling, it is a standard practice to optimize the prediction of exposure status based on the covariate information. In a simulation study, we examined in what situations analyses based on various types of exposure propensity score (EPS) models using data mining techniques such as recursive partitioning (RP) and neural networks (NN) produce unbiased and/or efficient results. METHOD: We simulated data for a hypothetical cohort study (n = 2000) with a binary exposure/outcome and 10 binary/continuous covariates with seven scenarios differing by non-linear and/or non-additive associations between exposure and covariates. EPS models used logistic regression (LR) (all possible main effects), RP1 (without pruning), RP2 (with pruning), and NN. We calculated c-statistics (C), standard errors (SE), and bias of exposure-effect estimates from outcome models for the PS-matched dataset. RESULTS: Data mining techniques yielded higher C than LR (mean: NN, 0.86; RPI, 0.79; RP2, 0.72; and LR, 0.76). SE tended to be greater in models with higher C. Overall bias was small for each strategy, although NN estimates tended to be the least biased. C was not correlated with the magnitude of bias (correlation coefficient [COR] = -0.3, p = 0.1) but increased SE (COR = 0.7, p < 0.001). CONCLUSIONS: Effect estimates from EPS models by simple LR were generally robust. NN models generally provided the least numerically biased estimates. C was not associated with the magnitude of bias but was with the increased SE.

Health-Related Quality of Life for Eating Disorders questionnaire version-2 was responsive 1-year after initial assessment.

OBJECTIVES: To assess the responsiveness of the Health-Related Quality of Life for Eating Disorders questionnaire version-2 (HeRQoLEDv2) and present the psychometric characteristics of a new binge domain. STUDY DESIGN AND SETTING: Patients with an eating disorder completed the HeRQoLEDv2, the Eating Attitudes Test-26, Short Form Health Survey-12, and two items from the Eating Disorder Inventory-2, at baseline and after 1 year. At the second assessment, patients completed the HeRQoLEDv2, as part of the battery of tests, along with health transitional questions. Validity and reliability analyses of the new binge domain were performed. Responsiveness was evaluated using distributional and anchor-based approaches, comparison of mean changes, mean change correlations, the minimal detectable change (MDC) at the individual and group level, and the minimal important difference (MID). RESULTS: Items in the binge domain loaded above 0.40. Cronbach alpha was 0.82. Regarding responsiveness, the mean changes detected by the HeRQoLEDv2 correlated above 0.30 with the criterion measures. Patients who reported improvement showed significant changes, and effect sizes above 0.30. The MDC(90%ind) was larger than the MID. CONCLUSION: The HeRQoLEDv2 includes the new binge domain. It responded to change at the group level. Further research regarding the MID is needed.

Agreement of diagnosis and its date for hematologic malignancies and solid tumors between medicare claims and cancer registry data.

PURPOSE: Claims data may be a suitable source studying associations between drugs and cancer. However, linkage between cancer registry and claims data including pharmacy-dispensing information is not always available. We examined the accuracy of claims-based definitions of incident cancers and their date of diagnosis. METHODS: Four claims-based definitions were developed to identify incident leukemia, lymphoma, lung, colorectal, stomach, and breast cancer. We identified a cohort of subjects aged >or=65 (1997-2000) from Pennsylvania Medicare and drug benefit program data linked with the state cancer registry. We calculated sensitivity, specificity, and positive predictive values of the claims-based definitions using registry as the gold standard. We further assessed the agreement between diagnosis dates from two data sources. RESULTS: All definitions had very high specificity (>or=98%), while sensitivity varied between 40% and 90%. Test characteristics did not vary systematically by age groups. The date of first diagnosis according to Medicare data tended to be later than the date recorded in the registry data except for breast cancer. The differences in dates of first diagnosis were within 14 days for 75% to 88% of the cases. Bias due to outcome misclassification of our claims-based definition of cancer was minimal in our example of a cohort study. CONCLUSIONS: Claims data can identify incident hematologic malignancies and solid tumors with very high specificity with sufficient agreement in the date of first diagnosis. The impact of bias due to outcome misclassification and thus the usefulness of claims-based cancer definitions as cancer outcome markers in etiologic studies need to be assessed for each study setting.

Hospital workload and adverse events.

CONTEXT: Hospitals are under pressure to increase revenue and lower costs, and at the same time, they face dramatic variation in clinical demand. OBJECTIVE: : We sought to determine the relationship between peak hospital workload and rates of adverse events (AEs). METHODS: A random sample of 24,676 adult patients discharged from the medical/surgical services at 4 US hospitals (2 urban and 2 suburban teaching hospitals) from October 2000 to September 2001 were screened using administrative data, leaving 6841 cases to be reviewed for the presence of AEs. Daily workload for each hospital was characterized by volume, throughput (admissions and discharges), intensity (aggregate DRG weight), and staffing (patient-to-nurse ratios). For volume, we calculated an "enhanced" occupancy rate that accounted for same-day bed occupancy by more than 1 patient. We used Poisson regressions to predict the likelihood of an AE, with control for workload and individual patient complexity, and the effects of clustering. RESULTS: One urban teaching hospital had enhanced occupancy rates more than 100% for much of the year. At that hospital, admissions and patients per nurse were significantly related to the likelihood of an AE (P < 0.05); occupancy rate, discharges, and DRG-weighted census were significant at P < 0.10. For example, a 0.1% increase in the patient-to-nurse ratio led to a 28% increase in the AE rate. Results at the other 3 hospitals varied and were mainly non significant. CONCLUSIONS: Hospitals that operate at or over capacity may experience heightened rates of patient safety events and might consider re-engineering the structures of care to respond better during periods of high stress.