Association between early-childhood antibiotic exposure and subsequent asthma in the US Medicaid population.

BACKGROUND: Although socioeconomically disadvantaged children have an increased risk of asthma, the association between early-childhood antibiotics and the incidence of asthma among such children has had limited study. OBJECTIVE: To examine the association between antibiotic fills in the first 2 years of life and risk of developing asthma among children enrolled in Medicaid plans. METHODS: This retrospective cohort study of children with continuous medical and pharmacy coverage from birth to 2.5 years of age was performed from July 1, 2012, to November 31, 2018. We excluded children with a diagnosis of asthma before 2.5 years of age. Hazard ratios (HRs) and 95% CIs were estimated from Cox proportional hazards regression models. Covariates included sex, preterm birth, cesarean delivery, and mother's asthma status. RESULTS: There were 79,582 children in the study cohort of whom 29,931 (37.6%) had 0 antibiotic prescriptions filled, 27,403 (34.4%) had 1 or 2 prescriptions filled, and 22,248 (28.0%) had 3 or more prescriptions filled. A total of 2381 new cases of asthma were observed in 89,545 person-years of follow-up. After adjustment, receipt of 1 or 2 antibiotics was associated with an increased risk of developing asthma, relative to 0 antibiotics (HR, 1.34; 95% CI, 1.21-1.49), and receipt of 3 or more antibiotics was associated with greater increased risk relative to 0 antibiotics (HR, 1.71; 95% CI, 1.54-1.90). After adjustment, the absolute risk of developing asthma by age 4.0 years increased from 2.7% (0 antibiotics) to 3.6% (1-2 antibiotics) and 4.5% (≥3 antibiotics). CONCLUSION: Antibiotic prescriptions filled in the first 2 years of life were associated with an increased risk of asthma diagnosis from 2.5 to 5 years of age in a Medicaid population.

Risk of Developing Dementia at Older Ages in the United States.

Dementia is increasingly recognized as a major source of disease burden in the United States, yet little research has evaluated the lifecycle implications of dementia. To address this research gap, this article uses the Aging, Demographics, and Memory Study (ADAMS) to provide the first nationally representative, longitudinal estimates of the probability that a dementia-free person will develop dementia later in life. For the 1920 birth cohort, the average dementia-free 70-year-old male had an estimated 26.9 % (SE = 3.2 %) probability of developing dementia, and the average dementia-free 70-year-old female had an estimated 34.7 % (SE = 3.7 %) probability. These estimates of risk of dementia are higher for younger, lower-mortality cohorts and are substantially higher than those found in local epidemiological studies in the United States, suggesting a widespread need to prepare for a life stage with dementia.

Developing a quality measure to assess use of antibiotic medications for respiratory conditions.

Objective: Antibiotics are essential medications for treating life-threatening infections. However, incorrect prescribing can lead to adverse events and contribute to antibiotic resistance. We sought to develop a utilization quality measure that could be used by health insurance plans to track overall prescribing for respiratory conditions. Design: A consensus-based process that included evidence review, testing, and stakeholder input was used to develop a measure and assess its usefulness for the Healthcare Effectiveness Data and Information Set (HEDIS), a national quality measurement tool. Methods: Guidelines and literature were reviewed to establish the rationale for the measure. The measure was tested in claims data for commercial, Medicaid and Medicare Advantage enrollees to assess feasibility of collecting and reporting needed information. The measure was vetted with multistakeholder advisory panels and posted for public comment to solicit wide input on relevance and usability. Results: Respiratory conditions are frequent reasons for outpatient care in the data assessed. On average, across all lines of business, the measure revealed that approximately one-third of outpatient visits for respiratory conditions are followed by antibiotics. Stakeholders supported the measure as a tool for monitoring antibiotic prescribing across health plans alongside existing measures that assess inappropriate prescribing for specific conditions. The final measure assesses the number of antibiotic prescriptions dispensed across all outpatient respiratory-related encounters at a health-plan level. Conclusions: The measure on antibiotic prescribing for respiratory conditions was relevant, feasible, and useful. Stakeholders strongly supported the newly developed measure and recommended its integration into HEDIS.

Costs Associated With Progression of Mildly Reduced Kidney Function Among Medicare Advantage Enrollees.

Rationale & Objective: The prevalence of early chronic kidney disease (CKD) in older adults has increased in the past 2 decades, yet CKD disease progression, overall, is variable. It is unclear whether health care costs differ by progression trajectory. The purpose of this study was to estimate the trajectories of CKD progression and examine Medicare Advantage (MA) health care costs of each trajectory over a 3-year period in a large cohort of MA enrollees with mildly reduced kidney function. Study Design: Cohort study. Setting & Population: 421,187 MA enrollees with stage G2 CKD in 2014-2017. Outcomes: We identified 5 trajectories of kidney function over time. Model Perspective & Timeframe: Mean total health care costs for each of the trajectories were described in each of the following 3 years from a payer perspective: 1 year before and 2 years after the index date establishing stage G2 CKD (study entry). Results: The mean estimated glomerular filtration rate (eGFR) at study entry was 75.9 mL/min/1.73 m2 and the median (interquartile range) follow-up period was 2.6 (1.6, 3.7) years. The cohort had a mean age of 72.6 years and had predominantly female participants (57.2%), and White (71.2%). We identified the following 5 distinct trajectories of kidney function: a stable eGFR (22.3%); slow eGFR decline with a mean eGFR at study entry of 78.6 (30.2%); slow eGFR decline with an eGFR at study entry of 70.9 (28.4%); steep eGFR decline (16.3%); and accelerated eGFR decline (2.8%). Mean costs of enrollees with accelerated eGFR decline were double the MA enrollees' mean costs in each of the other 4 trajectories in every year ($27,738 vs $13,498 for a stable eGFR 1 year after study entry). Limitations: Results may not generalized beyond MA and a lack of albumin values. Conclusions: The small fraction of MA enrollees with accelerated eGFR decline has disproportionately higher costs than other enrollees with mildly reduced kidney function.

Use of Optimal Evidence-Based Anticancer Drug Regimens in Physician Offices Versus Hospital Outpatient Facilities.

PURPOSE: Cancer care has increasingly shifted from physician offices (MDOs) to hospital-based outpatient departments (HOPDs). This study compared the proportion of patients receiving optimal, evidence-based anticancer drug regimens and the cost of care when administered in these sites. METHODS: Patients with breast, lung, or colorectal cancer were identified from a large health insurance database. Anticancer drug regimens were considered on pathway when they were on the payer's program list of optimal regimens when administered. Anticancer drug-related costs included all patient- and plan-paid costs on claims for anticancer drugs over the 6-month postindex period; total per-patient costs were summed over all claims in that period. RESULTS: A total of 38,140 patients (MDO, n = 18,998; HOPD, n = 19,142) were included. On-pathway status was similar in HOPDs (59.5%; 95% CI, 58.6% to 60.4%) versus MDOs (60.8%; 95% CI, 59.8% to 61.8%; P = .069). HOPDs had substantially higher costs. Adjusted cancer drug-related costs were $63,763 (95% CI, $62,301 to $65,224) for HOPDs versus $36,500 (95% CI, $35,729 to $37,271) for MDOs (P < .001); adjusted total costs were $115,843 (95% CI, $113,642 to $118,044) for HOPDs versus $77,346 (95% CI, $76,072 to $78,620) for MDOs (P < .001). For Medicare Advantage, adjusted total costs were $61,812 for HOPDs compared with $62,769 for MDOs; adjusted drug-related costs were $31,610 for HOPDs compared with $33,168 for MDOs. For commercial insurance, total costs were $119,288 for HOPDs compared with $77,613 for MDOs; drug-related costs were $65,930 for HOPDs compared with $36,366 for MDOs. CONCLUSION: Total and cancer drug-related per-patient costs were higher in HOPDs versus MDOs, but on-pathway status was similar. The cost differential between HOPDs and MDOs was driven by commercially insured members rather than Medicare Advantage members.

Association Between a National Insurer's Pay-for-Performance Program for Oncology and Changes in Prescribing of Evidence-Based Cancer Drugs and Spending.

PURPOSE: Cancer drug prescribing by medical oncologists accounts for the greatest variation in practice and the largest portion of spending on cancer care. We evaluated the association between a national commercial insurer's ongoing pay-for-performance (P4P) program for oncology and changes in the prescribing of evidence-based cancer drugs and spending. METHODS: We conducted an observational difference-in-differences study using administrative claims data covering 6.7% of US adults. We leveraged the geographically staggered, time-varying rollout of the P4P program to simulate a stepped-wedge study design. We included patients age 18 years or older with breast, colon, or lung cancer who were prescribed cancer drug regimens by 1,867 participating oncologists between 2013 and 2017. The exposure was a time-varying dichotomous variable equal to 1 for patients who were prescribed a cancer drug regimen after the P4P program was offered. The primary outcome was whether a patient's drug regimen was a program-endorsed, evidence-based regimen. We also evaluated spending over a 6-month episode period. RESULTS: The P4P program was associated with an increase in evidence-based regimen prescribing from 57.1% of patients in the preintervention period to 62.2% in the intervention period, for a difference of +5.1 percentage point (95% CI, 3.0 percentage points to 7.2 percentage points; P < .001). The P4P program was also associated with a differential $3,339 (95% CI, $1,121 to $5,557; P = .003) increase in cancer drug spending and a differential $253 (95% CI, $100 to $406; P = .001) increase in patient out-of-pocket spending, but no significant changes in total health care spending ($2,772; 95% CI, -$181 to $5,725; P = .07) over the 6-month episode period. CONCLUSION: P4P programs may be effective in increasing evidence-based cancer drug prescribing, but may not yield cost savings.

Association of Utilization Management Policy With Uptake of Hypofractionated Radiotherapy Among Patients With Early-Stage Breast Cancer.

Importance: Breast cancer accounts for the largest portion of cancer-related spending in the United States. Although hypofractionated radiotherapy after breast-conserving surgery is a cost-effective and convenient treatment strategy for patients with early-stage breast cancer, less than 40% of eligible women received hypofractionated radiotherapy in 2013. Objective: To assess the association of a large commercial payer's utilization management policy with the use of hypofractionated radiotherapy among women with early-stage breast cancer and its associated cost. Design, Setting, and Participants: A retrospective, adjusted difference-in-differences economic analysis was conducted using administrative claims data from January 1, 2012, to June 1, 2018, of women 18 years or older with early-stage breast cancer who were eligible for hypofractionated radiotherapy according to 2011 guidelines from the American Society for Radiation Oncology and were continuously enrolled in 14 geographically diverse commercial health plans covering 6.9% of US adult women. Women who received mastectomy, brachytherapy, or less than 11 or more than 40 external beam fractions of radiotherapy were excluded. A utilization management policy was used to encourage the use of hypofractionated radiotherapy among women in fully insured and Medicare Advantage (fully insured) plans. Under the new policy, claims for extended-course radiotherapy were not reimbursed for fully insured women who were eligible for hypofractionated radiotherapy. This policy did not apply to women in self-insured or Medicare supplemental insurance (self-insured) plans, allowing these groups to serve as a comparison group. Main Outcomes and Measures: The primary outcome was use of hypofractionated radiotherapy, and the secondary outcome was the cost of this type of radiotherapy. Results: Of 10 540 eligible women, 3619 (34.3%) were in fully insured plans and thus subject to the policy. There were no meaningful differences between the fully insured and self-insured groups in mean (SD) age at the start of radiotherapy (63.8 [8.6] vs 65.0 [8.9] years), mean (SD) Charlson Comorbidity Index score (3.0 [1.5] vs 3.2 [1.6]), or practice setting (outpatient hospital setting, 2982 of 3619 [82.4%] vs 5600 of 6921 [80.9%]). The policy was associated with an increase in use of hypofractionated radiotherapy among fully insured patients subject to the policy (adjusted percentage point difference-in-difference, 4.2%; 95% CI, 0.0%-8.4%; P = .05) and a nonsignificant decrease in radiotherapy-associated expenditures (-$2275 relative to self-insured patients; P = .09). Spillover analyses revealed a significantly higher uptake of hypofractionated radiotherapy among self-insured patients who were indirectly exposed to the policy (adjusted percentage point difference-in-difference, 8.5%; 95% CI, 3.6%-13.5%; P < .001) compared with those who were not exposed. Conclusions and Relevance: This study suggests that a payer's utilization management policy was associated with direct and spillover increases in the use of hypofractionated radiotherapy, even after accounting for a long-term secular trend in the uptake of hypofractionated radiotherapy in the control groups. Utilization management may promote evidence-based cancer care.

Using claims data to attribute patients with breast, lung, or colorectal cancer to prescribing oncologists.

BACKGROUND: Alternative payment models frequently require attribution of patients to individual physicians to assign cost and quality outcomes. Our objective was to examine the performance of three methods for attributing a patient with cancer to the likeliest physician prescriber of anticancer drugs for that patient using administrative claims data. METHODS: We used the HealthCore Integrated Research Environment to identify patients who had claims for anticancer medication along with diagnosis codes for breast, lung, or colorectal lung cancer between July 2013 and September 2017. The index date was the first date with a record for anticancer medication and cancer diagnosis code. Included patients had continuous medical coverage from 6 months before index to at least 7 days after index. Patients who received anticancer drugs during the 6 months prior to index were excluded. The three methods attributed each patient to the physician with whom the patient had the most evaluation and management (E&M) visits within a 90-day window around the index date (Method 1); the most E&M visits with no time window (Method 2); or the E&M visit nearest in time to the index date (Method 3). We assessed the performance of the methods using the percentage of the study cohort successfully attributed to a physician, and the positive predictive value (PPV) relative to available physician-reported data on patient(s) they treat. RESULTS: In total, 70,641 patients were available for attribution to physicians. Percentages of the study cohort attributed to a physician were: Method 1, 92.6%; Method 2, 96.9%; and Method 3, 96.9%. PPVs for each method were 84.4%, 80.6%, and 75.8%, respectively. CONCLUSION: We found that a claims-based algorithm - specifically, a plurality method with a 90-day time window - correctly attributed nearly 85% of patients to a prescribing physician. Claims data can reliably identify prescribing physicians in oncology.

Validation of a claims-based algorithm identifying eligible study subjects in the ADAPTABLE pragmatic clinical trial.

OBJECTIVE: Validate an algorithm that uses administrative claims data to identify eligible study subjects for the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) pragmatic clinical trial (PCT). MATERIALS AND METHODS: This study used medical records from a random sample of patients identified as eligible for the ADAPTABLE trial. The inclusion criteria for ADAPTABLE were a history of acute myocardial infarction (AMI) or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), or other coronary artery disease (CAD), plus at least one of several risk-enrichment factors. Exclusion criteria included a history of bleeding disorders or aspirin allergy. Using a claims-based algorithm, based on International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) and 10th Edition (ICD-10) codes and Current Procedural Terminology (CPT) codes, we identified patients eligible for the PCT. The primary outcome was the positive predictive value (PPV) of the identification algorithm: the proportion of sampled patients whose medical records confirmed their ADAPTABLE study eligibility. Exact 95% confidence limits for binomial random variables were calculated for the PPV estimates. RESULTS: Of the 185 patients whose medical records were reviewed, 168 (90.8%; 95% Confidence Interval: 85.7%, 94.6%) were confirmed study eligible. This proportion did not differ between patients identified with codes for AMI and patients identified with codes for PCI or CABG. CONCLUSION: The estimated PPV was similar to those in claims-based identification of drug safety surveillance events, indicating that administrative claims data can accurately identify study-eligible subjects for pragmatic clinical trials.

Association between Objectively Measured Physical Activity and Mortality in NHANES.

PURPOSE: We examined total activity, light activity, and moderate-to-vigorous physical activity (MVPA) as predictors of mortality in a nationally representative sample of older adults. Then we explored the theoretical consequences of replacing sedentary time with the same duration of light activity or MVPA. METHODS: Using accelerometer-measured activity, the associations between total activity, light activity (100-2019 counts per minute), and MVPA (>2019 counts per minute) counts and mortality were examined in adults age 50 to 79 yr in the National Health and Nutrition Examination Survey, 2003-2006 (n = 3029), with mortality follow-up through December 2011. Cox proportional hazard models were fitted to estimate mortality risks. An isotemporal substitution model was used to examine the theoretical consequences of replacing sedentary time with light activity or MVPA on mortality. RESULTS: After adjusting for potential confounders, including age, sex, race/ethnicity, education, BMI, and the presence of comorbid conditions, those in the highest tertile of total activity counts had one fifth the risk of death of those in the lowest tertile (hazard ratio [HR] = 0.21, 95% confidence interval [CI] = 0.12-0.38), and those in the middle tertile had one third the risk of death (HR = 0.36, 95% CI = 0.30-0.44). In addition, replacing 30 min of sedentary time with light activity was associated with significant reduction in mortality risk (after 5 yr of follow-up: HR = 0.80, 95% CI = 0.75-0.85). Replacing 30 min of sedentary time with MVPA was also associated with reduction in mortality risk (HR = 0.49, 95% CI = 0.25-0.97). CONCLUSIONS: Greater total activity is associated with lower all-cause mortality risk. Replacing sedentary time with light activity or MVPA may reduce mortality risk for older adults.

Incident Diabetes and Mobility Limitations: Reducing Bias Through Risk-set Matching.

BACKGROUND: Increased prevalence of diabetes in the U.S. population could contribute substantially to increases in disability at older ages. Previous studies have examined the association between prevalent diabetes and various impairments and disabilities. Methods considering incident, rather than prevalent, diabetes as the exposure of interest can reduce bias in estimates of these associations. METHODS: Risk-set matching, a type of propensity score matching meant to handle time-varying exposures, was used to estimate the relationship between incident diabetes and mobility limitations among adults in the Health and Retirement Study. This approach ensures that covariates precede diabetes onset rather than follow it. RESULTS: Individuals who were diagnosed with diabetes during the study period accumulated more subsequent mobility limitations than were accumulated by matched controls. Among observationally similar pairs of individuals, those who developed diabetes reported an average of 24.9% more mobility limitations at study exit than those who did not. CONCLUSIONS: The magnitude of the relationship between diabetes and limitations estimated in this article is smaller than that presented in previous studies, but the method presented here is likely to provide a less-biased estimate of the association between diabetes and accumulation of mobility limitations.

Effects of categorization and self-report bias on estimates of the association between obesity and mortality.

PURPOSE: The health consequences of obesity are often assessed using categorical, self-reported data on body mass index (BMI). This article investigates the combined effects of categorization and self-report bias on the estimated association between obesity and mortality. METHODS: We used the National Health and Nutrition Examination Survey (1988-2008) linked to death records through 2011. Cox models and age-standardized death rates were used to evaluate the effects of categorization and self-report bias on the mortality risks and percent of deaths attributable to obesity. RESULTS: Despite a correlation between measured and self-reported BMI of 0.96, self-reports miscategorized 20% of adults. Hazard ratios using self-reports were overstated for the obese 1 (BMI, 30-35 kg/m(2)) and obese 2 (BMI ≥ 35 kg/m(2)) categories. The bias was much smaller using a continuous measure of BMI. In contrast, the percent of deaths attributable to excess weight was lower using self-reported versus measured data because self-reports led to systematic downward bias in the BMI distribution. CONCLUSIONS: Categorization of BMI and self-report bias combine to produce substantial error in the estimated hazard ratios and percent of deaths attributable to obesity. Future studies should use caution when estimating the association between obesity and mortality using categorical self-reported data.

The dynamics of diabetes among birth cohorts in the U.S.

OBJECTIVE Using a nationally representative sample of the civilian noninstitutionalized U.S. population, we estimated trends in diabetes prevalence across cohorts born 1910-1989 and provide the first estimates of age-specific diabetes incidence using nationally representative, measured data. RESEARCH DESIGN AND METHODS Data were from 40,130 nonpregnant individuals aged 20-79 years who participated in the third National Health and Nutrition Examination Survey (NHANES III), 1988-1994, and the continuous 1999-2010 NHANES. We defined diabetes as HbA1c ≥6.5% (48 mmol/mol) or taking diabetes medication. We estimated age-specific diabetes prevalence for the 5-year age-groups 20-24 through 75-79 for cohorts born 1910-1919 through 1980-1989 and calendar periods 1988-1994, 1999-2002, 2003-2006, and 2007-2010. We modeled diabetes prevalence as a function of age, calendar year, and birth cohort, and used our cohort model to estimate age-specific diabetes incidence. RESULTS Age-adjusted diabetes prevalence rose by a factor of 4.9 between the birth cohorts of 1910-1919 and 1980-1989. Diabetes prevalence rose with age within each birth cohort. Models based on birth cohorts show a steeper age pattern of diabetes prevalence than those based on calendar years. Diabetes incidence peaks at 55-64 years of age. CONCLUSIONS Diabetes prevalence has risen across cohorts born through the 20th century. Changes across birth cohorts explain the majority of observed increases in prevalence over time. Incidence peaks between 55 and 64 years of age and then declines at older ages.

A novel endoscopic delivery system for placement of a duodenal-jejunal implant for the treatment of obesity and type 2 diabetes.

The EndoBarrier Delivery System is a unique product capable of reliably delivering an implant into the small intestine. Further improvements to the product can likely be made to facilitate tracking and improved navigation through the small bowel. This unique system and its related technology may have additional applications where access to the small bowel is desired such as drug delivery, diagnostic and therapeutic endoscopy and small bowel stent delivery.