The cost of a patient activation intervention for achieving successful outcomes: results from the PAADRN randomized controlled trial.

In a large, pragmatic clinical trial, we calculated the costs of achieving four successful patient-centered outcomes using a tailored patient activation DXA result letter accompanied by a bone health brochure. The cost to achieve one successful outcome (e.g., a 0.5 standard deviation improvement in care satisfaction) ranged from $127.41 to $222.75. INTRODUCTION: Pragmatic randomized controlled trials (RCTs) should focus on patient-centered outcomes and report the costs for achieving those outcomes. We calculated per person incremental intervention costs, the number-needed-to-treat (NNT), and incremental per patient costs (cost per NNT) for four patient-centered outcomes in a direct-to-patient bone healthcare intervention. METHODS: The Patient Activation after DXA Result Notification (PAADRN) pragmatic RCT enrolled 7749 patients presenting for DXA at three health centers between February 2012 and August 2014. Interviews occurred at baseline and 52 weeks post-DXA. Intervention subjects received an individually tailored DXA result letter accompanied by an educational bone health brochure 4 weeks post-DXA, while the usual care subjects did not. Outcomes focused on patients (a) correctly identifying their results, (b) contacting their providers, (c) discussing their results with their providers, and (d) satisfaction with their bone healthcare. NNTs were determined using intention-to-treat linear probability models, per person incremental intervention costs were calculated, and costs per NNT were computed. RESULTS: Mean age was 66.6 years old, 83.8% were women, and 75.3% were non-Hispanic whites. The incremental per patient cost (costs per NNT) to increase the ability of a patient to (a) correctly identify their DXA result was $171.07; (b) contact their provider about their DXA result was $222.75; (c) discuss their DXA result with their provider was $193.55; and (d) achieve a 0.5 SD improvement in satisfaction with their bone healthcare was $127.41. CONCLUSION: An individually tailored DXA result letter accompanied by an educational brochure can improve four patient-centered outcomes at a modest cost. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01507662.

Predictors of bone mineral density testing among older women on Medicare.

Although dual-energy X-ray absorptiometry (DXA) is recommended for all women ≥65 and is covered by Medicare, 40 % of women on Medicare report never having had a DXA. In a longitudinal cohort of 3492 women followed for two decades, we identified several risk factors that should be targeted to improve DXA testing rates. INTRODUCTION: DXA is used to measure bone mineral density, screen for osteoporosis, and assess fracture risk. DXA is recommended for all women ≥65 years old. Although Medicare covers DXA every 24 months for women, about 40 % report never having had a DXA test, and little is known from prospective cohort studies about which subgroups of women have low use rates and should be targeted for interventions. Our objective was to identify predictors of DXA use in a nationally representative cohort of women on Medicare. METHODS: We used baseline and biennial follow-up survey data (1993-2012) for 3492 women ≥70 years old from the nationally representative closed cohort known as the Survey on Assets and Health Dynamics among the Oldest Old (AHEAD). The survey data for these women were then linked to their Medicare claims (1991-2012), yielding 17,345 person years of observation. DXA tests were identified from the Medicare claims, and Cox proportional hazard regression models were used with both fixed and time-dependent predictors from the survey interviews including demographic characteristics, socioeconomic factors, health status, health habits, and the living environment. RESULTS: DXA use was positively associated with being Hispanic American, better cognition, higher income, having arthritis, using other preventative services, and living in Florida or other southern states. DXA use was negatively associated with age, being African-American, being overweight or obese, having mobility limitations, and smoking. CONCLUSIONS: Interventions to increase DXA use should target the characteristics that were observed here to be negatively associated with such screening.

Liver-related mortality in countries of the developed world: an ecological study approach to explain the variability.

BACKGROUND: Liver-related mortality varies across developed nations. AIM: To assess the relative role of various risk factors in relation to liver-related mortality in an ecological study approach. METHODS: Data for liver-related mortality, prevalence data for hepatitis B and C, human immunodeficiency virus (HIV), alcohol consumption per capita, Type 2 Diabetes mellitus (T2DM), overweight and obesity were extracted from peer-reviewed publications or WHO databases for different developed countries. As potential other risk-modifying factors, purchase power parity (PPP)-adjusted gross domestic product (GDP) per capita and health expenditure per capita were assessed. As an environmental 'hygiene factor', we also assessed the effect of the prevalence of Helicobacter pylori. Only countries with a PPP-adjusted GDP greater than $20 000 and valid information for at least 8 risk modifiers were included. Univariate and multivariate analyses were utilised to quantify the contribution to the variability in liver-related mortality. RESULTS: The proportion of chronic liver diseases (CLD)-related mortality ranged from 0.73-2.40% [mean 1.56%, 95% CI (1.43-1.69)] of all deaths. Univariately, CLD-related mortality was significantly associated with Hepatitis B prevalence, alcohol consumption, PPP-adjusted GDP (all P < 0.05) and potentially H. pylori prevalence (P = 0.055). Other investigated factors, including hepatitis C, did not yield significance. Backward elimination suggested hepatitis B, alcohol consumption and PPP-adjusted GDP as risk factors (explaining 66.3% of the variability). CONCLUSION: Hepatitis B infection, alcohol consumption and GDP, but not hepatitis C or other factors, explain most of the variance of liver-related mortality.

Increased prevalence of autoimmune diseases in functional gastrointestinal disorders: case-control study of 23471 primary care patients.

BACKGROUND: There is increasing evidence that impaired mucosal defence mechanisms are implicated in the pathogenesis of the functional gastrointestinal disorders (FGIDs), allowing inappropriate immune activation. AIM: To test the hypothesis that an excess of autoimmune disorders among sufferers, using a large primary care database to examine this. METHODS: Cases were diagnosed with FGIDs - irritable bowel syndrome (IBS), functional dyspepsia (FD), chronic idiopathic constipation (CIC), and multiple FGIDs. Controls were those without FGIDs. Prevalence of autoimmune disorders was compared between cases and controls using odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We included 23,471 patients (mean age 51.4 years, 66.1% female). Prevalence of autoimmune disorders was greater among all FGIDs, compared with controls without. In those with FD (OR 1.35; 95% CI 1.12-1.63), CIC (OR 1.75; 95% CI 1.11-2.75), or multiple FGIDs (OR 1.49; 95% CI 1.25-1.77) this was statistically significant after controlling for age and gender. Rheumatological autoimmune disorders were significantly more frequent in those with FD (OR 1.44; 95% CI 1.15-1.80), CIC (OR 1.84; 95% CI 1.08-3.13), or multiple FGIDs (OR 1.53; 95% CI 1.24-1.88), after controlling for age and gender. However, endocrine autoimmune disorders were no more frequent in those with FGIDs, after controlling for age and gender. CONCLUSIONS: In a large sample of primary care patients, there was a significantly higher prevalence of autoimmune disorders among those with FD, CIC, or multiple FGIDs not explained by differences in age or gender. We were unable to control for concomitant drug use, which may partly explain this association.

Current practice and resource utilisation in men diagnosed with premature ejaculation.

OBJECTIVES: To compare the healthcare resource utilisation of men diagnosed with premature ejaculation (PE) with that of age-matched men without a PE diagnosis, through a retrospective analysis of US medical claims data. METHODS: Data were from the PHARMetrics Database. Records of patients > or = 18 years of age diagnosed with PE (n = 1245) and age-matched controls (n = 3915) were compared with regard to number of physician encounters, concomitant medical diagnoses, drug therapies and treatment costs. RESULTS: Men diagnosed with PE visited their physicians twice as frequently in the year before their diagnosis as men in the control group. Men diagnosed with PE were more likely to receive a prescription for a selective serotonin reuptake inhibitor or a phosphodiesterase-5 inhibitor after their diagnosis than before and used more of these compared with controls. Prior to their PE diagnosis, patients received more (and more frequent) comorbid diagnoses than controls, and their mean yearly diagnosis and prescription costs were $1320 (vs. $447 for controls). In the year after the PE diagnosis, diagnosis and prescription costs fell by 24% (to $998), primarily because of a reduction in physician visits. CONCLUSIONS: Compared with controls, men with PE who sought help from a healthcare professional consumed more medical resources, primarily because of a higher number of physician visits and greater use of prescription drugs. Further research is warranted to determine if the observed associations between PE and other diagnoses indicate genuine aetiological factors or reporting bias.

Acid suppression in gastro-oesophageal reflux disease: Why? How? How much and when?

For patients with suboptimal relief from lifestyle modifications, acid suppressive therapy remains a cornerstone of treatment for gastro-oesophageal reflux disease (GORD). While a great deal of attention is focused on complications of GORD, adequate symptom relief remains an important and practical therapeutic goal. Adequate symptom relief is an achievable and easily measurable endpoint that both restores quality of life and prevents many potential complications.

Cost-effectiveness of automated external defibrillators on airlines.

CONTEXT: Installation of automated external defibrillators (AEDs) on passenger aircraft has been shown to improve survival of cardiac arrest in that setting, but the cost-effectiveness of such measures has not been proven. OBJECTIVE: To examine the costs and effectiveness of several different options for AED deployment in the US commercial air transportation system. DESIGN, SETTING, AND SUBJECTS: Decision and cost-effectiveness analysis of a strategy of full deployment on all aircraft as well as several strategies of partial deployment only on larger aircraft, compared with a baseline strategy of no AEDs on aircraft (but training flight attendants in basic life support) for a hypothetical cohort of persons experiencing cardiac arrest aboard US commercial aircraft. Estimates for costs and outcomes were obtained from the medical literature, the Federal Aviation Administration, the Air Transport Association of America, a population-based cohort of Medicare patients, AED manufacturers, and the Bureau of Labor Statistics. MAIN OUTCOME MEASURES: Quality-adjusted survival after cardiac arrest; costs of AED deployment on aircraft and of medical care for cardiac arrest survivors. RESULTS: Adding AEDs on passenger aircraft with more than 200 passengers would cost $35 300 per quality-adjusted life-year (QALY) gained. Additional AEDs on aircraft with capacities between 100 and 200 persons would cost an additional $40 800 per added QALY compared with deployment on large-capacity aircraft only, and full deployment on all passenger aircraft would cost an additional $94 700 per QALY gained compared with limited deployment on aircraft with capacity greater than 100. Sensitivity analyses indicated that the quality of life, annual mortality rate, and the effectiveness of AEDs in improving survival were the most influential factors in the model. In 85% of Monte Carlo simulations, AED placement on large-capacity aircraft produced cost-effectiveness ratios of less than $50 000 per QALY. CONCLUSION: The cost-effectiveness of placing AEDs on commercial aircraft compares favorably with the cost-effectiveness of widely accepted medical interventions and health policy regulations, but is critically dependent on the passenger capacity of the aircraft. Placing AEDs on most US commercial aircraft would meet conventional standards of cost-effectiveness.

Low socioeconomic class is a risk factor for upper and lower gastrointestinal symptoms: a population based study in 15 000 Australian adults.

BACKGROUND: The association of social class with health has been extensively studied, yet relationships between social class and gastrointestinal symptoms remain almost unexplored. AIMS: To examine relationships between social class and gastrointestinal symptoms in a population sample. METHODS: The prevalence of 16 troublesome gastrointestinal symptoms was determined by a postal questionnaire sent to 15 000 subjects (response rate 60%) and compared with a validated composite measure of socioeconomic status (index of relative socioeconomic disadvantage). Comparisons across social class were explored for five symptom categories (oesophageal symptoms; upper dysmotility symptoms; bowel symptoms; diarrhoea; and constipation). Results are reported as age standardised rate ratios with the most advantaged social class as the reference category. RESULTS: There were clear trends for the prevalence rates of all gastrointestinal symptoms to increase with decreasing social class. These trends were particularly strong for the five symptom categories. Lower social class was associated with a significantly (p<0.0001) higher number of symptoms reported overall and with a higher proportion of individuals reporting 1-2 symptoms and more than five symptoms. In both sexes, the most pronounced effects for subjects in the lowest social class were found for constipation (males: rate ratio 1.83 (95% confidence intervals (CI) 1.16-2.51); females: rate ratio 1.68 (95% CI 1.31-2.04)) and upper dysmotility symptoms (males: rate ratio 1.45 (95% CI 1.02-1.88); females: rate ratio 1.35 (95% CI 1.07-1.63)). Oesophageal symptoms and diarrhoea were not associated with social class. CONCLUSIONS: Troublesome gastrointestinal symptoms are linked to socioeconomic status with more symptoms reported by subjects in low socioeconomic classes. Low socioeconomic class should be considered a risk factor for both upper and lower gastrointestinal symptoms.

Regression diagnostics for the class A regressive model with quantitative phenotypes.

Regression diagnostic methods are developed and investigated under the Class A regressive model proposed by Bonney [(1984) Am J Med Genet 18:731-749]. We call a family whose phenotypic distribution does not conform to the same genetic model as the majority of the families an etiotic family. The exact case-deletion approach for identifying etiotic families, based on examining the changes in each model parameter estimate by excluding one family at a time, is very time-consuming. We proposed three alternative diagnostic methods: the empirical influence function (EIF), the one-step approximation, and the approximated one-step approach. These methods can be computed efficiently and were incorporated into the existing software package S.A.G.E. A thorough Monte-Carlo investigation of the performance of the diagnostic methods was conducted and generally supports the EIF approach as the recommended alternative. The phenotypic variance is the parameter whose associated regression diagnostic most frequently and correctly identified etiotic families in the models that were examined. An analysis of body mass index data from 402 individuals in 122 Muscatine, Iowa families is used to illustrate the methods. A Class A regressive model with a recessive major locus and equal mother-offspring and father-offspring correlations provided the best-fitting model. The proposed regression diagnostics identified up to 7.4% of the 122 families as etiotic. As a result of this investigation, case-deletion diagnostic assessment is now a practical component in the analysis of quantitative family data.

Statistical analysis of K 2 x 2 tables: a comparative study of estimators/test statistics for association and homogeneity.

In order to control for confounding variables, epidemiologists often obtain data in the form of a 2 x 2 table. One variable is usually the disease status, while the other variable represents a dichotomous exposure variable that is suspected of being a risk factor. If a confounding variable is present, the data are often stratified into several 2 x 2 tables. The objectives of the analysis are to test for the association between the suspected risk factor and the disease and to estimate the strength of this relationship. Before estimating a common odds ratio, it is important to check whether the odds ratios are homogeneous. This paper presents the results of a Monte Carlo study that was performed to determine the size and power of a number of tests of association and homogeneity when the data are sparse. We also evaluated the performance of three estimators of the common odds ratio. For the Monte Carlo studies, equal numbers of cases and controls were used in a wide variety of sparse data situations. On the basis of these studies, we recommend the Breslow-Day test for nonsparse data, and the T4 and T5 statistics for sparse data to test for homogeneity. The Mantel-Haenszel test of association is recommended for sparse and nonsparse data sets. With sparse data, none of the odds ratio estimators are entirely satisfactory.

A Monte Carlo investigation of homogeneity tests of the odds ratio under various sample size configurations.

Epidemiologic data for case-control studies are often summarized into K 2 x 2 tables. Given a fixed number of cases and controls, the degree of sparseness in the data depends on the number of strata, K. The effect of increasing stratification on size and power of seven tests of homogeneity of the odds ratio is studied using Monte Carlo methods. In all the designs considered here, the numbers of cases and controls per stratum are the same. Considering both size and power in non-sparse-data settings, we recommend the Breslow-Day statistic (1980, Statistical Methods in Cancer Research, 1. The Analysis of Case-Control Studies, p. 142; Lyon: International Agency for Research on Cancer) for general use. In sparse-data settings the T4 statistic of Liang and Self (1985, Biometrika 72, 353-358) performs the best when all tables, regardless of sample size, have odds ratios generated from the same distribution. In sparse-data settings characterized by a large table with an odds ratio of 1 and many small tables with odds ratios greater than 1, the T5 statistic of Liang and Self (1985) performs the best. One of the most important results of this study is the generally low power for all homogeneity tests especially when the data are sparse.