Showing papers by "Sebastien Haneuse published in 2018"

Association of the Hospital Readmissions Reduction Program With Mortality Among Medicare Beneficiaries Hospitalized for Heart Failure, Acute Myocardial Infarction, and Pneumonia.

Abstract: Importance The Hospital Readmissions Reduction Program (HRRP) has been associated with a reduction in readmission rates for heart failure (HF), acute myocardial infarction (AMI), and pneumonia. It is unclear whether the HRRP has been associated with change in patient mortality. Objective To determine whether the HRRP was associated with a change in patient mortality. Design, Setting, and Participants Retrospective cohort study of hospitalizations for HF, AMI, and pneumonia among Medicare fee-for-service beneficiaries aged at least 65 years across 4 periods from April 1, 2005, to March 31, 2015. Period 1 and period 2 occurred before the HRRP to establish baseline trends (April 2005-September 2007 and October 2007-March 2010). Period 3 and period 4 were after HRRP announcement (April 2010 to September 2012) and HRRP implementation (October 2012 to March 2015). Exposures Announcement and implementation of the HRRP. Main Outcomes and Measures Inverse probability–weighted mortality within 30 days of discharge following hospitalization for HF, AMI, and pneumonia, and stratified by whether there was an associated readmission. An additional end point was mortality within 45 days of initial hospital admission for target conditions. Results The study cohort included 8.3 million hospitalizations for HF, AMI, and pneumonia, among which 7.9 million (mean age, 79.6 [8.7] years; 53.4% women) were alive at discharge. There were 3.2 million hospitalizations for HF, 1.8 million for AMI, and 3.0 million for pneumonia. There were 270 517 deaths within 30 days of discharge for HF, 128 088 for AMI, and 246 154 for pneumonia. Among patients with HF, 30-day postdischarge mortality increased before the announcement of the HRRP (0.27% increase from period 1 to period 2). Compared with this baseline trend, HRRP announcement (0.49% increase from period 2 to period 3; difference in change, 0.22%,P = .01) and implementation (0.52% increase from period 3 to period 4; difference in change, 0.25%,P = .001) were significantly associated with an increase in postdischarge mortality. Among patients with AMI, HRRP announcement was associated with a decline in postdischarge mortality (0.18% pre-HRRP increase vs 0.08% post-HRRP announcement decrease; difference in change, −0.26%;P = .01) and did not significantly change after HRRP implementation. Among patients with pneumonia, postdischarge mortality was stable before HRRP (0.04% increase from period 1 to period 2), but significantly increased after HRRP announcement (0.26% post-HRRP announcement increase; difference in change, 0.22%,P = .01) and implementation (0.44% post-HPPR implementation increase; difference in change, 0.40%,P Conclusions and Relevance Among Medicare beneficiaries, the HRRP was significantly associated with an increase in 30-day postdischarge mortality after hospitalization for HF and pneumonia, but not for AMI. Given the study design and the lack of significant association of the HRRP with mortality within 45 days of admission, further research is needed to understand whether the increase in 30-day postdischarge mortality is a result of the policy.

Association Between Bariatric Surgery and Macrovascular Disease Outcomes in Patients With Type 2 Diabetes and Severe Obesity.

Abstract: Importance Macrovascular disease is a leading cause of morbidity and mortality for patients with type 2 diabetes, and medical management, including lifestyle changes, may not be successful at lowering risk. Objective To investigate the relationship between bariatric surgery and incident macrovascular (coronary artery disease and cerebrovascular diseases) events in patients with severe obesity and type 2 diabetes. Design, Setting, and Participants In this retrospective, matched cohort study, patients with severe obesity (body mass index ≥35) aged 19 to 79 years with diabetes who underwent bariatric surgery from 2005 to 2011 in 4 integrated health systems in the United States (n = 5301) were matched to 14 934 control patients on site, age, sex, body mass index, hemoglobin A1c, insulin use, observed diabetes duration, and prior health care utilization, with follow-up through September 2015. Exposures Bariatric procedures (76% Roux-en-Y gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) were compared with usual care for diabetes. Main Outcomes and Measures Multivariable-adjusted Cox regression analysis investigated time to incident macrovascular disease (defined as first occurrence of coronary artery disease [acute myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting] or cerebrovascular events [ischemic stroke, hemorrhagic stroke, carotid stenting, or carotid endarterectomy]). Secondary outcomes included coronary artery disease and cerebrovascular outcomes separately. Results Among a combined 20 235 surgical and nonsurgical patients, the mean (SD) age was 50 (10) years; 76% of the surgical and 75% of the nonsurgical patients were female; and the baseline mean (SD) body mass index was 44.7 (6.9) and 43.8 (6.7) in the surgical and nonsurgical groups, respectively. At the end of the study period, there were 106 macrovascular events in surgical patients (including 37 cerebrovascular and 78 coronary artery events over a median of 4.7 years; interquartile range, 3.2-6.2 years) and 596 events in the matched control patients (including 227 cerebrovascular and 398 coronary artery events over a median of 4.6 years; interquartile range, 3.1-6.1 years). Bariatric surgery was associated with a lower composite incidence of macrovascular events at 5 years (2.1% in the surgical group vs 4.3% in the nonsurgical group; hazard ratio, 0.60 [95% CI, 0.42-0.86]), as well as a lower incidence of coronary artery disease (1.6% in the surgical group vs 2.8% in the nonsurgical group; hazard ratio, 0.64 [95% CI, 0.42-0.99]). The incidence of cerebrovascular disease was not significantly different between groups at 5 years (0.7% in the surgical group vs 1.7% in the nonsurgical group; hazard ratio, 0.69 [95% CI, 0.38-1.25]). Conclusions and Relevance In this observational study of patients with type 2 diabetes and severe obesity who underwent surgery, compared with those who did not undergo surgery, bariatric surgery was associated with a lower risk of macrovascular outcomes. The findings require confirmation in randomized clinical trials. Health care professionals should engage patients with severe obesity and type 2 diabetes in a shared decision making conversation about the potential role of bariatric surgery in the prevention of macrovascular events.

Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care: A Matched Cohort Study.

Abstract: Background Bariatric surgery improves glycemic control in patients with type 2 diabetes mellitus (T2DM), but less is known about microvascular outcomes. Objective To investigate the relationship between bariatric surgery and incident microvascular complications of T2DM. Design Retrospective matched cohort study from 2005 to 2011 with follow-up through September 2015. Setting 4 integrated health systems in the United States. Participants Patients aged 19 to 79 years with T2DM who had bariatric surgery (n = 4024) were matched on age, sex, body mass index, hemoglobin A1c level, insulin use, diabetes duration, and intensity of health care use up to 3 nonsurgical participants (n = 11 059). Intervention Bariatric procedures (76% gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) compared with usual care. Measurements Adjusted Cox regression analysis investigated time to incident microvascular disease, defined as first occurrence of diabetic retinopathy, neuropathy, or nephropathy. Results Median follow-up was 4.3 years for both surgical and nonsurgical patients. Bariatric surgery was associated with significantly lower risk for incident microvascular disease at 5 years (16.9% for surgical vs. 34.7% for nonsurgical patients; adjusted hazard ratio [HR], 0.41 [95% CI, 0.34 to 0.48]). Bariatric surgery was associated with lower cumulative incidence at 5 years of diabetic neuropathy (7.2% for surgical vs. 21.4% for nonsurgical patients; HR, 0.37 [CI, 0.30 to 0.47]), nephropathy (4.9% for surgical vs. 10.0% for nonsurgical patients; HR, 0.41 [CI, 0.29 to 0.58]), and retinopathy (7.2% for surgical vs. 11.2% for nonsurgical patients; HR, 0.55 [CI, 0.42 to 0.73]). Limitation Electronic health record databases could misclassify microvascular disease status for some patients. Conclusion In this large, multicenter study of adults with T2DM, bariatric surgery was associated with lower overall incidence of microvascular disease (including lower risk for neuropathy, nephropathy, and retinopathy) than usual care. Primary funding source National Institute of Diabetes and Digestive and Kidney Diseases.

Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care

Abstract: Bariatric surgery results in improved glycemic control in patients with type 2 diabetes mellitus and severe obesity, but whether it affects incidence of microvascular disease is uncertain. This lon...

Predictors of persistent sleep problems among older disaster survivors: A natural experiment from the 2011 Great East Japan earthquake and tsunami

Abstract: Study objectives To examine prospectively the associations of disaster experiences and social support with sleep problems in older adults. Methods Data came from a natural experiment caused by the 2011 Great East Japan earthquake and tsunami. Participants in an ongoing prospective cohort (3547 Japanese individuals aged 65 years or older) were inadvertently exposed to the disaster due to their residential location (Iwanuma city) after the 2010 baseline survey. We conducted a follow-up survey in 2013 to inquire about disaster-related experiences and short sleep duration, sleep insufficiency, poor sleep quality, insomnia symptoms, and sleep medication use. Poisson regression models adjusted for baseline socio-demographic and lifestyle covariates. Results Financial hardship predicted increased risks of short sleep duration (relative risk [RR] = 1.40; 95% confidence interval [CI] [1.03, 1.90]), sleep insufficiency (RR = 1.29; 95% CI [1.01, 1.66]), poor sleep quality (RR = 1.47; 95% CI [1.26, 1.70]), and insomnia symptoms (RR = 1.13; 95% CI [1.01, 1.28]). Home destruction predicted sleep medication use while health care disruption predicted poor sleep quality. Loss of close relatives or friends did not predict any sustained sleep problems. Additionally, having instrumental support reduced risks of all sleep problems while having emotional support reduced risk of poor sleep quality. Conclusions Approximately 2.5 years after the disaster, older survivors' sleep problems were more durably linked to material aspects of disaster damage than to loss of loved ones. Findings could inform targeted recovery efforts for groups with greatest need to promote older survivors' sleep health and overall well-being.

Assessment of Between-Hospital Variation in Readmission and Mortality After Cancer Surgical Procedures

Abstract: Importance Although current federal quality improvement programs do not include cancer surgery, the Centers for Medicare & Medicaid Services and other payers are considering extending readmission reduction initiatives to include these and other common high-cost episodes. Objectives To quantify between-hospital variation in quality-related outcomes and identify hospital characteristics associated with high and low performance. Design, Setting, and Participants This retrospective cohort study obtained data through linkage of the California Cancer Registry to hospital discharge claims databases maintained by the California Office of Statewide Health Planning and Development. All 351 acute care hospitals in California at which 1 or more adults underwent curative intent surgery between January 1, 2007, and December 31, 2011, with analyses finalized July 15, 2018, were included. A total of 138 799 adults undergoing surgery for colorectal, breast, lung, prostate, bladder, thyroid, kidney, endometrial, pancreatic, liver, or esophageal cancer within 6 months of diagnosis, with an American Joint Committee on Cancer stage of I to III at diagnosis, were included. Main Outcomes and Measures Measures included adjusted odds ratios and variance components from hierarchical mixed-effects logistic regression analyses of in-hospital mortality, 90-day readmission, and 90-day mortality, as well as hospital-specific risk-adjusted rates and risk-adjusted standardized rate ratios for hospitals with a mean annual surgical volume of 10 or more. Results Across 138 799 patients at the 351 included hospitals, 8.9% were aged 18 to 44 years and 45.9% were aged 65 years or older, 57.4% were women, and 18.2% were nonwhite. Among these, 1240 patients (0.9%) died during the index admission. Among 137 559 patients discharged alive, 19 670 (14.3%) were readmitted and 1754 (1.3%) died within 90 days. After adjusting for patient case-mix differences, evidence of statistically significant variation in risk across hospitals was identified, as characterized by the variance of the random effects in the mixed model, for all 3 metrics (P Conclusions and Relevance Accounting for patient case-mix differences, there appears to be substantial between-hospital variation in in-hospital mortality, 90-day readmission, and 90-day mortality after cancer surgical procedures. Recognizing the multifaceted nature of hospital performance through consideration of mortality and readmission simultaneously may help to prioritize strategies for improving surgical outcomes.

Prediction of absolute risk of acute graft-versus-host disease following hematopoietic cell transplantation.

Abstract: Allogeneic hematopoietic cell transplantation (HCT) is the treatment of choice for a variety of hematologic malignancies and disorders. Unfortunately, acute graft-versus-host disease (GVHD) is a frequent complication of HCT. While substantial research has identified clinical, genetic and proteomic risk factors for acute GVHD, few studies have sought to develop risk prediction tools that quantify absolute risk. Such tools would be useful for: optimizing donor selection; guiding GVHD prophylaxis, post-transplant treatment and monitoring strategies; and, recruitment of patients into clinical trials. Using data on 9,651 patients who underwent first allogeneic HLA-identical sibling or unrelated donor HCT between 01/1999-12/2011 for treatment of a hematologic malignancy, we developed and evaluated a suite of risk prediction tools for: (i) acute GVHD within 100 days post-transplant and (ii) a composite endpoint of acute GVHD or death within 100 days post-transplant. We considered two sets of inputs: (i) clinical factors that are typically readily-available, included as main effects; and, (ii) main effects combined with a selection of a priori specified two-way interactions. To build the prediction tools we used the super learner, a recently developed ensemble learning statistical framework that combines results from multiple other algorithms/methods to construct a single, optimal prediction tool. Across the final super learner prediction tools, the area-under-the curve (AUC) ranged from 0.613-0.640. Improving the performance of risk prediction tools will likely require extension beyond clinical factors to include biological variables such as genetic and proteomic biomarkers, although the measurement of these factors may currently not be practical in standard clinical settings.

Effects of analgesics on bone mineral density: A longitudinal analysis of the prospective SWAN cohort with three-group matching weights.

Abstract: Purpose To examine the effects of analgesics on bone mineral density (BMD), which have not been examined in a longitudinal study with multiple measurements. Methods We investigated changes in BMD associated with new use of analgesics in a prospective longitudinal cohort of mid-life women. BMD and medication use were measured annually. We compared BMD among new users of acetaminophen, NSAIDs, and opioids. Adjustment for baseline covariates was conducted through propensity score matching weights. On-treatment analysis was conducted with inverse probability of censoring weights. Analysis based on the initial treatment group was also conducted to provide insights into selection bias. Repeated BMD measurements were examined with generalized estimating equations. Results We identified 71 acetaminophen new users, 659 NSAID new users, and 84 opioid new users among 2365 participants. In the on-treatment analysis, the opioid group in comparison to the acetaminophen group had an additional average BMD decline of -0.06% [-1.24, 1.11] per year in the spine and -0.45% [-1.51, 0.61] per year in the femoral neck. BMD mean trajectories over time suggested a fifth-year decline in the opioid persistent users compared with other 2 groups. In the initial treatment group analysis, all 3 groups showed similar trajectories. Conclusion The BMD decline over time was similar among the 3 groups. However, 5 years of continuous opioid use may be associated with a greater BMD decline than 5 years on other analgesics. Further studies examining the relationship between very long-term persistent opioid use and BMD are warranted.

On the Analysis of Case-Control Studies in Cluster-correlated Data Settings.

Abstract: In resource-limited settings, long-term evaluation of national antiretroviral treatment (ART) programs often relies on aggregated data, the analysis of which may be subject to ecological bias. As researchers and policy makers consider evaluating individual-level outcomes such as treatment adherence or mortality, the well-known case-control design is appealing in that it provides efficiency gains over random sampling. In the context that motivates this article, valid estimation and inference requires acknowledging any clustering, although, to our knowledge, no statistical methods have been published for the analysis of case-control data for which the underlying population exhibits clustering. Furthermore, in the specific context of an ongoing collaboration in Malawi, rather than performing case-control sampling across all clinics, case-control sampling within clinics has been suggested as a more practical strategy. To our knowledge, although similar outcome-dependent sampling schemes have been described in the literature, a case-control design specific to correlated data settings is new. In this article, we describe this design, discuss balanced versus unbalanced sampling techniques, and provide a general approach to analyzing case-control studies in cluster-correlated settings based on inverse probability-weighted generalized estimating equations. Inference is based on a robust sandwich estimator with correlation parameters estimated to ensure appropriate accounting of the outcome-dependent sampling scheme. We conduct comprehensive simulations, based in part on real data on a sample of N = 78,155 program registrants in Malawi between 2005 and 2007, to evaluate small-sample operating characteristics and potential trade-offs associated with standard case-control sampling or when case-control sampling is performed within clusters.

SemiCompRisks: An R Package for Independent and Cluster-Correlated Analyses of Semi-Competing Risks Data.

Abstract: Semi-competing risks refer to the setting where primary scientific interest lies in estimation and inference with respect to a non-terminal event, the occurrence of which is subject to a terminal event. In this paper, we present the R package SemiCompRisks that provides functions to perform the analysis of independent/clustered semi-competing risks data under the illness-death multistate model. The package allows the user to choose the specification for model components from a range of options giving users substantial flexibility, including: accelerated failure time or proportional hazards regression models; parametric or non-parametric specifications for baseline survival functions and cluster-specific random effects distribution; a Markov or semi-Markov specification for terminal event following non-terminal event. While estimation is mainly performed within the Bayesian paradigm, the package also provides the maximum likelihood estimation approach for several parametric models. The package also includes functions for univariate survival analysis as complementary analysis tools.

Quantifying and reducing statistical uncertainty in sample-based health program costing studies in low- and middle-income countries.

Abstract: Objectives:In many low- and middle-income countries, the costs of delivering public health programs such as for HIV/AIDS, nutrition, and immunization are not routinely tracked. A number of recent s...

Power and Sample Size for Case-Control Studies

Abstract: This chapter describes some simple ways to estimate power as well as more sophisticated techniques that more accurately estimate power in the presence of complicating factors, such as confounding and measurement error. Protocols for case-control studies usually require a statistical calculation of the required sample size and power of the proposed study. In unmatched case-control studies, a random sample of cases from the source population is compared to a random sample of controls from the population. These approximations do not apply to case-control data, however, because the disease is not rare in the case-control sample and sampling is retrospective. Measurement error in an exposure distorts estimates of odds ratios in case-control studies. Covariate information may be missing by design, as in two-phase case-control studies or for reasons uncontrolled by the investigator. The simulation approach has been used for power calculations, when missingness is by design, as in a two-phase case-control study.