Clinical Capital and the Risk of Maternal Labor and Delivery Complications: Hospital Scheduling, Timing, and Cohort Turnover Effects.

The establishment of interventions to maximize maternal health requires the identification of modifiable risk factors. Toward the identification of modifiable hospital-based factors, we analyze over 2 million births from 2005 to 2010 in Texas, employing a series of quasi-experimental tests involving hourly, daily, and monthly circumstances where medical service quality (or clinical capital) is known to vary exogenously. Motivated by a clinician's choice model, we investigate whether maternal delivery complications (1) vary by work shift, (2) increase by the hours worked within shifts, (3) increase on weekends and holidays when hospitals are typically understaffed, and (4) are higher in July when a new cohort of residents enter teaching hospitals. We find consistent evidence of a sizable statistical relationship between deliveries during nonstandard schedules and negative patient outcomes. Delivery complications are higher during night shifts (OR = 1.21, 95% CI: 1.18-1.25), and on weekends (OR = 1.09, 95% CI: 1.04-1.14) and holidays (OR = 1.29, 95% CI: 1.04-1.60), when hospitals are understaffed and less experienced doctors are more likely to work. Within shifts, we show deterioration of occupational performance per additional hour worked (OR = 1.02, 95% CI: 1.01-1.02). We observe substantial additional risk at teaching hospitals in July (OR = 1.28, 95% CI: 1.14-1.43), reflecting a cohort-turnover effect. All results are robust to the exclusion of noninduced births and intuitively falsified with analyses of chromosomal disorders. Results from our multiple-test strategy indicate that hospitals can meaningfully attenuate harm to maternal health through strategic scheduling of staff.

Clinical effectiveness and cost savings in diabetes care, supported by pharmacist counselling.

OBJECTIVE: To determine the effectiveness and cost savings of a real-world, continuous, pharmacist-delivered service with an employed patient population with diabetes over a 5-year period. SETTING: The Patients, Pharmacists Partnerships (P3 Program) was offered as an "opt-in" benefit to employees of 6 public and private self-insured employers in Maryland and Virginia. Care was provided in ZIP code-matched locations and at 2 employers' worksites. PRACTICE DESCRIPTION: Six hundred two enrolled patients with type 1 and 2 diabetes were studied between July 2006 and May 2012 with an average follow-up of 2.5 years per patient. Of these patients, 162 had health plan cost and utilization data. A network of 50 trained pharmacists provided chronic disease management to patients with diabetes using a common process of care. Communications were provided to patients and physicians. PRACTICE INNOVATION: Employers provided incentives for patients who opted in, including waived medication copayments and free diabetes self-monitoring supplies. The service was provided at no cost to the patient. A Web-based, electronic medical record that complied with the Health Insurance Portability and Accountability Act helped to standardize care. Quality assurance was conducted to ensure the standard of care. EVALUATION: Glycosylated hemoglobin (A1c), blood pressure, and total health care costs (before and after enrollment). RESULTS: Statistically significant improvements were shown by mean decreases in A1c (-0.41%, P <0.001), low-density lipoprotein levels (-4.7 mg/dL, P = 0.003), systolic blood pressure (-2.3 mm Hg, P = 0.001), and diastolic blood pressure (-2.4 mm Hg, P <0.001). Total annual health care costs to employers declined by $1031 per beneficiary after the cost of the program was deducted. This 66-month real-world study confirms earlier findings. Employers netted savings through improved clinical outcomes and reduced emergency and hospital utilization when comparing costs 12 months before and after enrollment. CONCLUSION: The P3 program had positive clinical outcomes and economic outcomes. Pharmacist-provided comprehensive medication therapy management services should be included as a required element of insurance offered by employers and health insurance exchanges.

A Pilot study Evaluating a Community-based Intervention Focused on the ISHIB IMPACT Cardiovascular Risk Reduction Toolkit in African American Patients with Uncontrolled Hypertension.

OBJECTIVE: To evaluate blood pressure (BP) control utilizing the International Society on Hypertension in Blacks (ISHIB) cardiovascular risk reduction toolkit in an African American community with uncontrolled hypertension. METHODS: This is a randomized controlled pilot study conducted in two Baltimore community-based physicians' offices assigned adults (18-64 years) with uncontrolled hypertension (systolic blood pressure [SBP] ≤ 169 mm Hg; diastolic blood pressure [DBP] ≤ 109 mm Hg). The study compares usual care to a community-based intervention. In the usual care group, the patients' BP was managed by the treating physician based on their normal office patient care protocol. In the intervention group, usual care was provided but, a community health worker also gave comprehensive education and assessment to the patients based on the ISHIB IMPACT cardiovascular toolkit during study initiation and follow-up visits. The main outcome of study was change in BP from baseline to six months. A secondary outcome was the proportion of patients achieving BP < 135/< 85 mm Hg at six months. RESULTS: Fifty-four African American patients were enrolled; 37 completed six months of follow-up (usual care, n = 25; intervention, n = 12). At six months the mean (95% CI) change from baseline in SBP was significantly greater in the intervention group vs the usual care group: -34.75 (-46.55 to -22.95) mm Hg vs -5.65 (-12.84 to 1.54) mm Hg (P < .001). Mean (95% CI) change in DBP from baseline to six months was significantly greater for the intervention group vs the usual care group: -16.19 (-24.00 to -8.39) mm Hg vs -4.36 (-8.26 to -0.46) mm Hg (P = .009). Median change in BP was significantly greater for SBP in the intervention group compared with the usual care group (P = .007), but not for DBP (P = .197). The proportion of patients achieving BP < 135/ <85 at six months was 83% (10/12) in the intervention group vs 60% (15/25) in the usual care group (P = .263). CONCLUSIONS: This pilot study on the ISHIB IMPACT toolkit in managing uncontrolled hypertension in the African American community suggests better control of systolic BP and a tendency to better hypertension control with the community-based intervention. The findings support further studies in clinical settings serving African American hypertensive patients to assess effectiveness of approaches for improving BP control and related outcomes.

Disease-modifying therapy and hospitalization risk in heart failure patients.

OBJECTIVES: To examine comorbidity and therapy use rates in a Medicaid population with heart failure (HF), evaluate hospitalization risk as a function of comorbidity and therapy use, and assess the impact of modification on costs to the Medicaid program. STUDY DESIGN: Historical prospective cohort study. Claims were from adult enrollees in Maryland Medicaid (managed care organization or fee-for-service) diagnosed with HF between 2005 and 2009. METHODS: The end point was first hospitalization after index HF. Average hazard ratios (HRs) were estimated by multivariate weighted Cox regression. Budget impact of modifications was assessed using annual number-needed-to-treat calculations and external estimate of average cost of HF hospitalization. RESULTS: Most patients were >45 years (71%), women (56%), and black (60%). Medication use: beta-blockers (26%), angiotensin-converting enzyme inhibitors and/or angiotensin II receptor antagonists (ACEi/ARBs) (29%), aldosterone antagonists (5%), and others including nitrates-hydralazine (37%). Nearly all (98%) were diagnosed with 1 or more comorbidities. Relative risk of hospitalization was higher with most, but not all, comorbidities investigated. ACEi/ARBs (HR, 0.77; CI, 0.73-0.81), beta-blockers (HR, 0.83; CI, 0.79-0.87), and other cardiovascular drugs (HR, 0.76; CI, 0.72-0.80) had beneficial effects. A 20% increase in the use prevalence of ACEi/ARBs and beta-blockers translated to annual Medicaid savings of at least $85 and $57 per HF patient, respectively. CONCLUSIONS: Findings call attention to comorbidities and optimization of disease-modifying therapy in Medicaid patients with HF. Certain disease-modifying medications mitigated risk, but were used infrequently. Substantive outcome improvement and savings to Medicaid may be achieved with small changes in prescribing rates or comorbidity prevalence.

Incident depression increases medical utilization in Medicaid patients with hypertension.

UNLABELLED: Hypertension is an important risk factor for cardiovascular disease and occurs disproportionately among patients with depression. Few studies have rigorously examined outcomes specifically among hypertensive patients with newly diagnosed comorbid depression. AIM: We hypothesized that incident depression would exacerbate hypertensive disease and that this would be evident through greater utilization of medical services than would otherwise occur in the absence of depression. METHODS: Claims data for hypertensive patients enrolled in Maryland Medicaid (2005-2010) were used to estimate the change in annualized utilization following incident depression, compared to a matched cohort of hypertensive patients never diagnosed with depression. Multivariate regression was used to adjust for changes in antihypertensive medications, adherence and comorbidity that followed depression onset. RESULTS: While medical utilization increased after incident depression, additional encounters tended to be for nonacute medical care and there was no significant increase in encounters specifically for cardiovascular or hypertension-related conditions. DISCUSSION: The results contribute to the discussion on the relationship between depression and cardiovascular disease and will inform future studies that aim to look at longer term outcomes in patients with hypertension.

Multispecialist Care and Mortality in Hepatocellular Carcinoma.

PURPOSE: Multidisciplinary physician care has increased for many cancers yet little evidence exists for hepatocellular carcinoma (HCC). The purpose of this study was to explore the association between multispecialist care and mortality in HCC. METHODS: Treated patients with an HCC primary diagnosis from 2000 to 2007 were studied using Surveillance, Epidemiology, and End Results-Medicare data. A surrogate variable for multidisciplinary care was defined-multispecialist care-as the number of disciplines among surgeons, radiology oncologist, intervention radiologist, hematologist/medical oncologist, gastroenterologist, and generalist in the pretreatment period. Multivariate survival analysis was conducted and adjusted for selection and survival bias. RESULTS: Of 3588 treated HCC patients, 1434 (40%) saw 1, 1343 (37%) saw 2, and 811 (23%) saw 3 or more specialists. Patients with multispecialist care received treatment that differed from patients who saw a single specialist. In propensity score-adjusted survival analysis, patients who saw 3 or more specialist types were associated with 10% (P=0.04) reduced mortality, compared with those who saw 1 specialist. When stratified by treatment received, patients on chemotherapy who saw 3 or more specialist types were associated with 28% (P=0.002) reduced mortality, compared with those who saw 1 specialist. CONCLUSIONS: Multispecialist care for treated HCC patients was associated with reduced mortality, particularly among chemotherapy recipients. While adjusting for selection and survival bias, our study is limited in capturing a causal relationship between coordinated multidisciplinary care and mortality. Our findings may provide support for the development of coordinated care delivery models but should be confirmed through more rigorous examination in future studies.

Development of heart failure in Medicaid patients with type 2 diabetes treated with pioglitazone, rosiglitazone, or metformin.

BACKGROUND: Medicaid covers a high-risk population typically underrepresented in clinical trial data and largely absent in observational studies of real-world cardiovascular risks associated with thiazolidinediones (TZDs), such as pioglitazone and rosiglitazone, which are used to manage type 2 diabetes. In November 2013, the FDA removed prescribing restrictions for rosiglitazone in light of new evidence that rosiglitazone did not increase the risk of heart attack compared with standard type 2 diabetes medications. Further investigation is needed to elucidate whether the risk of heart failure (HF) associated with TZDs may be exacerbated in the Medicaid population. OBJECTIVE: To determine the relative risk of incident HF in patients initiating rosiglitazone, pioglitazone, and metformin therapy in a Medicaid population. METHODS: We retrospectively examined claims data for patients with type 2 diabetes enrolled in Maryland State Medicaid and managed care or fee-for-service programs between July 2005 and June 2010. Patients initiated on metformin, pioglitazone, or rosiglitazone treatments were extracted for analysis. Relative risks of incident HF after initiating treatment were compared using survival analysis, adjusting for switching or adding antidiabetic therapies during follow-up and other baseline risk factors for HF. RESULTS: Of 6,271 patients meeting inclusion criteria, 88% were started on metformin; 7% were started on pioglitazone; and 5% were started on rosiglitazone. Patients who initiated rosiglitazone had higher risk of HF than patients who initiated metformin using either univariate (HR = 1.81, 95% CI = 1.37-2.39), multivariate (HR = 1.57, 95% CI = 1.15-2.15), or propensity score-matched (HR = 1.79, 95% CI = 1.16-2.76) analysis. There was no significant difference in risk between patients who initiated pioglitazone and metformin therapy. CONCLUSIONS: Compared with metformin, there may be higher risk of developing HF in Medicaid patients started on rosiglitazone but not pioglitazone. While pioglitazone was associated with a lower risk of developing HF compared with rosiglitazone, health care professionals should continue to work closely with their patients to determine the treatment options most appropriate.

Maternal exposure to neighborhood soil Pb and eclampsia risk in New Orleans, Louisiana (USA): evidence from a natural experiment in flooding.

BACKGROUND: Previous studies link maternal blood lead (Pb) levels and pregnancy-related hypertensive disorders. OBJECTIVE: Assess the relationship between neighborhood soil Pb and maternal eclampsia risk. METHODS: Zip code summarized high density soil survey data of New Orleans collected before and after Hurricanes Katrina and Rita (HKR) were merged with pregnancy outcome data on 75,501 mothers from the Louisiana office of public health. Cross-sectional logistic regression analyses are performed testing the association between pre-HKR accumulation of Pb in soils in thirty-two neighborhoods and eclampsia risk. Then we examine whether measured declines in soil Pb following the flooding of the city resulted in corresponding reductions of eclampsia risk. RESULTS: Cross-sectional analyses show that a one standard deviation increase in soil Pb increases the odds of eclampsia by a factor of 1.48 (95% CI: 1.31, 1.66). Mothers in zip code areas with soil Pb>333 mg/kg were 4.00 (95% CI: 3.00, 5.35) times more likely to experience eclampsia than mothers residing in neighborhoods with soil Pb<50mg/kg. Difference-in-differences analyses capturing the exogenous reduction in soil Pb following the 2005 flooding of New Orleans indicate that mothers residing in zip codes experiencing decrease in soil Pb (-387.9 to -33.6 mg/kg) experienced a significant decline in eclampsia risk (OR=0.619; 95% CI: 0.397, 0.963). CONCLUSIONS: Mothers residing in neighborhoods with high accumulation of Pb in soils are at heightened risk of experiencing eclampsia.

Maternal exposure to hurricane destruction and fetal mortality.

BACKGROUND: The majority of research documenting the public health impacts of natural disasters focuses on the well-being of adults and their living children. Negative effects may also occur in the unborn, exposed to disaster stressors when critical organ systems are developing and when the consequences of exposure are large. METHODS: We exploit spatial and temporal variation in hurricane behaviour as a quasi-experimental design to assess whether fetal death is dose-responsive in the extent of hurricane damage. Data on births and fetal deaths are merged with Parish-level housing wreckage data. Fetal outcomes are regressed on housing wreckage adjusting for the maternal, fetal, placental and other risk factors. The average causal effect of maternal exposure to hurricane destruction is captured by difference-in-differences analyses. RESULTS: The adjusted odds of fetal death are 1.40 (1.07-1.83) and 2.37 (1.684-3.327) times higher in parishes suffering 10-50% and >50% wreckage to housing stock, respectively. For every 1% increase in the destruction of housing stock, we observe a 1.7% (1.1-2.4%) increase in fetal death. Of the 410 officially recorded fetal deaths in these parishes, between 117 and 205 may be attributable to hurricane destruction and postdisaster disorder. The estimated fetal death toll is 17.4-30.6% of the human death toll. CONCLUSIONS: The destruction caused by Hurricanes Katrina and Rita imposed significant measurable losses in terms of fetal death. Postdisaster migratory dynamics suggest that the reported effects of maternal exposure to hurricane destruction on fetal death may be conservative.

Clinical value of tapentadol extended-release in painful diabetic peripheral neuropathy.

Painful diabetic peripheral neuropathy is difficult to treat, partially because the underlying mechanism of pain is not fully understood. Various treatment guidelines recommend first-line agents, such as α2-δ ligands, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants but combination therapy of alternative agents including opiates is often warranted. Tapentadol extended-release has a novel dual mechanism of action; it is both a mu-opioid receptor agonist and a norephinephrine reuptake inhibitor. It has been in the spotlight since it was FDA-approved specifically for the treatment of painful diabetic peripheral neuropathy in 2012. Previous reviews of tapentadol have focused on chronic pain. The purpose of this review article is to assess the efficacy and safety of tapentadol extended-release in adult populations with painful diabetic peripheral neuropathy and provide guidance for formulary decisions.

A quasi-experimental analysis of maternal altitude exposure and infant birth weight.

OBJECTIVES: We analyzed singleton births to determine the relationship between birth weight and altitude exposure. METHODS: We analyzed 715,213 singleton births across 74 counties from the western states of Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, and Washington from January 1, 2000, to December 31, 2000. Birth data were obtained from the Division of Vital Statistics, National Center for Health Statistics, for registered births. RESULTS: Regression analyses supported previous research by showing that a 1000-meter increase in maternal altitude exposure in pregnancy was associated with a 75.9-gram reduction in birth weight (95% confidence interval = -84.1, -67.6). Quantile regression models indicated significant and near-uniform depressant effects from altitude exposure across the conditional distribution of birth weight. Bivariate sample-selection models showed that a 1000-meter increase in altitude exposure, over and above baseline residential altitude, decreased birth weight by an additional 58.8 grams (95% confidence interval = -98.4, -19.2). CONCLUSIONS: Because of calculable health care-related costs associated with lower birth weight, our reported results might be of interest to clinicians practicing at higher altitudes.

Comparative and cost effectiveness of treatment modalities for hepatocellular carcinoma in SEER-Medicare.

BACKGROUND: The incidence of hepatocellular carcinoma (HCC) is increasing in the USA and worldwide. Several treatments are available for patients diagnosed at any disease stage. It remains unclear how medical expenditures vary across patients who remain untreated or undergo different modes of therapy. We evaluate the comparative and cost effectiveness of treatment modalities for HCC from a Medicare perspective. METHODS: The Surveillance, Epidemiology, and End Results (SEER) registries and linked Medicare database with claims from Parts A/B were used to identify Medicare enrollees with initial diagnosis of HCC between 2000 and 2007 and followed through 2009. Patients were assigned to treatment modalities based on HCC staging systems: transplant, resection, liver directed, radiation, chemotherapy or no treatment. Survival benefits and cumulative Medicare expenditures were estimated in multivariate models, stratified by initial disease stage, to control for confounding. Cost-effectiveness ratios compared costs and benefits of the modalities across initial stages. RESULTS: Cancer stages I, II, III, IV and unstaged represented 24, 9, 14, 17 and 37 % of 11,047 patients, respectively. Fewer than 40 % received any treatment. Relative to no treatment, transplant was most effective in reducing mortality, followed by resection, liver directed, and radiation or chemotherapy. Resection tended to be most cost effective in early staged and unstaged patients; transplant was least cost effective. In stage IV patients, liver directed therapy was more cost effective than chemotherapy or radiation. CONCLUSIONS: Survival benefit was attributable to all treatment modalities. More effective treatments incurred greater Medicare expenditures, but resection patients incurred the least expenditures per year of life gained.

Transarterial chemoembolization treatment: association between multiple treatments, cumulative expenditures, and survival.

OBJECTIVES: To examine cumulative survival and Medicaid-paid expenses associated with multiple courses of transarterial chemoembolization (TACE) as primary treatment for hepatocellular carcinoma (HCC). METHODS: Medicare enrollees diagnosed with primary HCC from 2000 to 2007, ever treated with TACE, but not transplant/resection, followed through 2009 by using the Surveillance, Epidemiology and End-Results Program and linked Medicare databases. Cumulative all-cause/HCC-related survival was estimated by using multivariate Cox proportional hazards models stratified by the total number of TACE treatments. Multivariate weighted Cox regressions estimated the average risk of mortality faced with nonproportional hazards. Lin's inverse probability-weighted least squares regression method estimated cumulative Medicare expenditures adjusted for censoring and covariates. RESULTS: Of 1228 patients, 34% were stage 1, 16% stage 2, 19% stage 3, 6% stage 4, and 26% unstaged. About 44% were aged 65 to 75 years, 69% were men, and 72% were Caucasian. Over half (57%) of the patients received one course, 24% two, 11% three, and 8% four courses of TACE. One-course patients incurred an average $74,788 (95% confidence interval [CI] $71,890-$77,686), two-course patients $101,126 (95% CI $94,395-$107,856), three-course patients $111,776 (95% CI $101,931-$121,621), and four-plus-course patients $148,878 (95% CI $136,346-$161,409). One-course patients lived (all-cause) an average 1.86 (95% CI 1.82-1.90), two-course patients 2.09 (95% CI 2.05-2.13), three-course patients 2.81 (95% CI 2.66-2.97), and four-plus-course patients 3.06 (95% CI 2.95-3.18) years after diagnosis. Average risk of all-cause mortality was not significantly different between one/two courses or three/four-plus courses. CONCLUSIONS: Cumulative Medicare expenditures nearly doubled from one-course to four-plus-course patients. On average, four-plus-course patients lived over one more year than did one-course patients. Physician/patient decisions should be balanced with consideration of efficient use of limited resources, but payer's intervention in physician discretion may not be important in this setting.

Delivering cost-effective care for COPD in the USA: recent progress and current challenges.

Chronic obstructive pulmonary disease (COPD) imposes a significant and growing economic burden on the US health care system. A brief exploration of reviews on the therapeutic management of COPD reveals a range of pharmacologic and nonpharmacologic options for reducing deleterious and costly exacerbations. Consensus is that both forms of therapy provide the greatest benefit to all patients. However, prescribing physicians must account for availability of resources and patients' ability to pay, as well as patient response and their likely persistence or adherence to recommended therapies. The ongoing challenge is to overcome barriers to comprehensive, real-world economic evaluations in order to establish the most cost-effective mix of therapies for every patient in the heterogeneous COPD population. Only then can evidence-based guidelines be translated into the most cost-effective delivery of care.

The use of age-period-cohort analysis to determine the impact of economic development on COPD mortality in Hong Kong.

Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. The rising trend in COPD-related mortality can be linked to aging populations and trends in risk factors possibly correlated with macroeconomic development. An age-period-cohort analysis of data on a recently developed economy, Hong Kong, is able to decompose sex-specific COPD mortality rates into age, period and birth-cohort effects to examine the possible impacts of defined macro-level events. The findings of this study corroborate the relationship between COPD incidence and an aging population, shows strong evidence for declining COPD mortality among generations raised in a more economically developed environment, but, possibly due to modeling limitations, only mixed results regarding the impact of changes in air quality.