left ventricular assist device (LVAD) compared with intra-aortic balloon pump (IABP) has been associated with increased risk of mortality and bleeding among patients with acute myocardial infarction (AMI) and cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). However, evidence on the association of device therapy with a broader array of clinical outcomes, including data on long-term outcomes and cost, is limited. OBJECTIVE To examine the association between intravascular LVAD or IABP use and clinical outcomes and cost in patients with AMI complicated by CS. DESIGN, SETTING, AND PARTICIPANTSThis retrospective propensity-matched cohort study used administrative claims data for commercially insured patients from 14 states across the US. Patients included in the analysis underwent PCI for AMI complicated by CS from January 1, 2015, to April 30, 2020. Data analysis was performed from April to November 2021.EXPOSURES Use of either an intravascular LVAD or IABP. MAIN OUTCOMES AND MEASURESThe primary outcomes were mortality, stroke, severe bleeding, repeat revascularization, kidney replacement therapy (KRT), and total health care costs during the index admission. Clinical outcomes and cost were also assessed at 30 days and 1 year. RESULTS Among 3077 patients undergoing PCI for AMI complicated by CS, the mean (SD) age was 65.2 (12.5) years, and 986 (32.0%) had cardiac arrest. Among 817 propensity-matched pairs, intravascular LVAD use was associated with significantly higher in-hospital (36.2% vs 25.8%; odds ratio [OR], 1.63; 95% CI, 1.32-2.02), 30-day (40.1% vs 28.3%; OR, 1.71; 95% CI, 1.37-2.13), and 1-year mortality (58.9% vs 45.0%; hazard ratio [HR], 1.44; 95% CI, 1.21-1.71) compared with IABP. At 30 days, intravascular LVAD use was associated with significantly higher bleeding (19.1% vs 14.5%; OR, 1.35; 95% CI, 1.04-1.76), KRT (12.

Purpose To describe outcomes after granulocyte colony-stimulating factor (G-CSF) prophylaxis in patients with breast cancer who received chemotherapy regimens with low-to-intermediate risk of induction of neutropenia-related hospitalization. Patients and Methods We identified 8,745 patients age ≥ 18 years from a medical and pharmacy claims database for 14 commercial US health plans. This retrospective analysis included patients with breast cancer who began first-cycle chemotherapy from 2008 to 2013 using docetaxel and cyclophosphamide (TC); docetaxel, carboplatin, and trastuzumab (TCH); or doxorubicin and cyclophosphamide (conventional-dose AC) regimens. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of beginning chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days of initiating chemotherapy. Multivariable regressions and number-needed-to-treat analyses were used. Results A total of 4,815 patients received TC (2,849 PP; 1,966 no PP); 2,292 patients received TCH (1,444 PP; 848 no PP); and 1,638 patients received AC (857 PP; 781 no PP) regimen. PP was associated with reduced risk of neutropenia-related hospitalization for TC (2.0% PP; 7.1% no PP; adjusted odds ratio [AOR], 0.29; 95% CI, 0.22 to 0.39) and TCH (1.3% PP; 7.1% no PP; AOR, 0.19; 95% CI, 0.12 to 0.30), but not AC (4.7% PP; 3.8% no PP; AOR, 1.21; 95% CI, 0.75 to 1.93) regimens. For the TC regimen, 20 patients (95% CI, 16 to 26) would have to be treated for 21 days to avoid one neutropenia-related hospitalization; with the TCH regimen, 18 patients (95% CI, 13 to 25) would have to be treated. Conclusion Primary G-CSF prophylaxis was associated with low-to-modest benefit in lowering neutropenia-related hospitalization in patients with breast cancer who received TC and TCH regimens. Further evaluation is needed to better understand which patients benefit most from G-CSF prophylaxis in this setting.

BackgroundAn estimated 30.3 million Americans have diabetes mellitus. The US Department of Health and Human Services created national objectives via its Healthy People 2020 initiative to improve the quality of life for people who either have or are at risk for diabetes mellitus, and hence, lower the personal and national economic burden of this debilitating chronic disease. Diabetes self-management education interventions are a primary focus of this initiative.ObjectiveThe aim of this study was to evaluate the impact of the Better Choices Better Health Diabetes (BCBH-D) self-management program on comorbid illness related to diabetes mellitus, health care utilization, and cost.MethodsA propensity score matched two-group, pre-post design was used for this study. Retrospective administrative medical and pharmacy claims data from the HealthCore Integrated Research Environment were used for outcome variables. The intervention cohort included diabetes mellitus patients who were recruited to a diabetes self-management program. Control cohort subjects were identified from the HealthCore Integrated Research Environment by at least two diabetes-associated claims (International Classification of Diseases-Ninth Revision, ICD-9 250.xx) within 2 years before the program launch date (October 1, 2011-September 30, 2013) but did not participate in BCBH-D. Controls were matched to cases in a 3:1 propensity score match. Outcome measures included pre- and postintervention all-cause and diabetes-related utilization and costs. Cost outcomes are reported as least squares means. Repeated measures analyses (generalized estimating equation approach) were conducted for utilization, comorbid conditions, and costs.ResultsThe program participants who were identified in HealthCore Integrated Research Environment claims (N=558) were matched to a control cohort of 1669 patients. Following the intervention, the self-management cohort experienced significant reductions for diabetes mellitus–associated comorbid conditions, with the postintervention disease burden being significantly lower (mean 1.6 [SD 1.6]) compared with the control cohort (mean 2.1 [SD 1.7]; P=.001). Postintervention all-cause utilization was decreased in the intervention cohort compared with controls with −40/1000 emergency department visits vs +70/1000; P=.004 and −5780 outpatient visits per 1000 vs −290/1000; P=.001. Unadjusted total all-cause medical cost was decreased by US $2207 in the intervention cohort compared with a US $338 decrease in the controls; P=.001. After adjustment for other variables through structural equation analysis, the direct effect of the BCBH-D was –US $815 (P=.049).ConclusionsPatients in the BCBH-D program experienced reduced all-cause health care utilization and costs. Direct cost savings were US $815. Although encouraging, given the complexity of the patient population, further study is needed to cross-validate the results.

BACKGROUND: Gout is a chronic inflammatory condition associated with poor urate metabolism. Xanthine oxidase inhibitors such as allopurinol and febuxostat are recommended to reduce uric acid levels and to prevent gout attacks in adult patients. Under budget-driven constraints, health care payers are faced with the broader challenge of assessing the economic value of these agents for formulary placement. However, the economic value of allopurinol versus febuxostat has not be assessed in patients with gout over a 5-year time period in the United States.

Background The supplementation of electronic health records data with administrative claims data may be used to capture outcome events more comprehensively in longitudinal observational studies. This study investigated the utility of administrative claims data to identify outcomes across health systems using a comparative effectiveness study of different types of bariatric surgery as a model. Methods This observational cohort study identified patients who had bariatric surgery between 2007 and 2015 within the HealthCore Anthem Research Network (HCARN) database in the National Patient-Centered Clinical Research Network (PCORnet) common data model. Patients whose procedures were performed in a member facility affiliated with PCORnet Clinical Research Networks (CRNs) were selected. The outcomes included a 30-day composite adverse event (including venous thromboembolism, percutaneous/operative intervention, failure to discharge and death), and all-cause hospitalization, abdominal operation or intervention, and in-hospital death up to 5 years after the procedure. Outcomes were classified as occurring within or outside PCORnet CRN health systems using facility identifiers. Results We identified 4899 patients who had bariatric surgery in one of the PCORnet CRN health systems. For 30-day composite adverse event, the inclusion of HCARN multi-site claims data marginally increased the incidence rate based only on HCARN single-site claims data for PCORnet CRNs from 3.9 to 4.2%. During the 5-year follow-up period, 56.8% of all-cause hospitalizations, 31.2% abdominal operations or interventions, and 32.3% of in-hospital deaths occurred outside PCORnet CRNs. Incidence rates (events per 100 patient-years) were significantly lower when based on claims from a single PCORnet CRN only compared to using claims from all health systems in the HCARN: all-cause hospitalization, 11.0 (95% Confidence Internal [CI]: 10.4, 11.6) to 25.3 (95% CI: 24.4, 26.3); abdominal operations or interventions, 4.2 (95% CI: 3.9, 4.6) to 6.1 (95% CI: 5.7, 6.6); in-hospital death, 0.2 (95% CI: 0.11, 0.27) to 0.3 (95% CI: 0.19, 0.38). Conclusions Short-term inclusion of multi-site claims data only marginally increased the incidence rate computed from single-site claims data alone. Longer-term follow up captured a notable number of events outside of PCORnet CRNs. The findings suggest that supplementing claims data improves the outcome ascertainment in longitudinal observational comparative effectiveness studies.

Background/aims Health plan administrative claims data present a cost-effective complement to traditional trial-specific ascertainment of clinical events typically conducted through patient report or a single health system electronic health record. We aim to demonstrate the value of health plan claims data in improving the capture of endpoints in longitudinal pragmatic clinical trials. Methods This retrospective cohort study paralleled the design of the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial designed to compare the effectiveness of two doses of aspirin. We applied the ADAPTABLE identification query in claims data from Anthem, an American health insurance company, and identified health plan members who met the ADAPTABLE trial criteria. Among the ADAPTABLE eligible members, we selected overlapping members with PCORnet Clinical Data Research Networks in the 2 years prior to the index date (1 April 2014). PCORnet Clinical Data Research Networks consist of network partners (or healthcare systems) that store their electronic health record data in the same format to support multi-institutional research. ADAPTABLE outcome events—cardiovascular hospitalizations including admissions for myocardial infarction, stroke, or cardiac procedures; hospitalizations for major bleeding; and in-hospital deaths—were evaluated for a 2-year follow-up period. Events were classified as within or outside PCORnet Clinical Data Research Networks using facility identifiers affiliated with each hospital stay. Patient characteristics were examined with descriptive statistics, and incidence rates were reported for available Clinical Data Research Networks and claims data. Results Among 884,311 ADAPTABLE eligible health plan members, 11,101 patients overlapped with PCORnet Clinical Data Research Networks. Average age was 70 years, 71% were male, and average follow-up was 20.7 months. Patients had 1521 cardiovascular hospitalizations (571 (37.5%) occurred outside PCORnet Clinical Data Research Networks), 710 for major bleeding (296 (41.7%) outside PCORnet Clinical Data Research Networks), and 196 in-hospital deaths (67 (34.2%) outside PCORnet Clinical Data Research Networks). Incidence rates (events per1000 patient-months) differed between available network partners and claims data: cardiovascular hospitalizations, 4.1 (95% confidence interval: 3.9, 4.4) versus 6.6 (95% confidence interval: 6.3, 7.0), major bleeding, 1.8 (95% confidence interval: 1.6, 2.0) versus 3.1 (95% confidence interval: 2.9, 3.3), and in-hospital death, 0.56 (95% confidence interval: 0.47, 0.67) versus 0.85 (95% confidence interval: 0.74, 0.98), respectively. Conclusion This study demonstrated the value of supplementing longitudinal site-based clinical studies with administrative claims data. Our results suggest that claims data together with network partner electronic health record data constitute an effective vehicle to capture patient outcomes since >30% of patients have non-fatal and fatal events outside of enrolling sites.

Purpose Obesity is a highly prevalent condition with severe clinical burden. Bariatric procedures are an important and expanding treatment option. This study compared short-(30-day composite adverse events) and long-term (intervention/operation, endoscopy, hospitalization, and mortality up to 5 years) safety outcomes associated with three bariatric surgical procedures. Materials and Methods This observational cohort study replicated an electronic health record study comparing short- and long-term problems associated with three bariatric surgical procedures between January 1, 2006, and September 30, 2015, within a Health Plan Research Network. Results Of 95,251 adults, 34,240 (36%) underwent adjustable gastric banding (AGB), 36,206 (38%) Roux-en-Y gastric bypass (RYGB), and 24,805 (26%) sleeve gastrectomy (SG). Median (interquartile range) years of follow-up was 3.3 (1.4–5.0) (AGB), 2.5 (1.0–4.6) (RYGB), and 1.1 (0.5–2.1) (SG). Overall mean (SD) age was 44.2 (11.4) years. The cohort was predominantly female (76%). Thirty-day composite adverse events occurred more frequently following RYGB (3.8%) than AGB (3.1%) and SG (2.8%). Operation/intervention was less likely in SG than in RYGB (adjusted hazard ratio (AHR), 0.87; 95%CI, 0.80–0.96; P=0.003), and more likely in AGB than in RYGB (AHR, 2.10; 95%CI, 2.00–2.21; P<0.001). Hospitalization was less likely after ABG and SG than after RYGB: AGB vs. RYGB, AHR=0.73; 95%CI, 0.71–0.76; P<0.001; SG vs. RYGB, AHR=0.79; 95%CI, 0.76–0.83; P<0.001. Mortality was most likely for RYGB (SG vs. RYGB: AHR, 0.76; 95%CI, 0.64–0.92; P=0.004; AGB vs. RYGB: AHR, 0.49; 95%CI, 0.43–0.56; P=0.001). Conclusions Interventions, operations, and hospitalizations were more often associated with AGB and RYGB than SG while RYGB had the lowest risk for revision. Graphical abstract

Objective To compare prescribed opioid use and invasive surgical interventions between patients using acupuncture and those using non-steroidal anti-inflammatory drugs (NSAIDs)/Physical Therapy (PT). Design Retrospective observational study of administrative claims Setting Large commercial insurance plan Subjects 52,346 each treated with either acupuncture or NSAIDs/PT Methods Users of acupuncture and NSAIDs/PT were identified from January 1, 2014 to December 31, 2017. The first date of each service was defined as the index date. Acupuncture patients were 1:1 propensity score matched to the NSAIDs/PT group on baseline characteristics. Outcomes included opioid use, subsequent invasive surgical procedures, healthcare utilization such as hospitalizations or emergency department (ED) visits, and costs. These were assessed in the 12-month period before index date (baseline) and 12-month period following index date (follow-up) using difference-in-difference (DID) analysis. Results for opioid use were stratified by those with and without baseline opioid use. Results The acupuncture group had fewer patients initiating opioids post-index both among those with (49.2% vs. 56.5%, p &lt; 0.001) and without (15.9% vs. 22.6%, p &lt; 0.001) baseline opioid use. There was a small increase in invasive surgical procedures with acupuncture (3.1% vs. 2.8% p = 0.006). A reduction in ED visits was observed with acupuncture (DID -4.3% for all-cause; -3.3% for pain-related, all p &lt; 0.001). Acupuncture was associated with higher total medical and pharmacy costs (DID +$1,331 per patient, p = 0.006). Conclusions Acupuncture showed a modest effect in reducing opioid use and ED visits. More research on acupuncture’s place in emergency care, pain relief, and comparison to other types of non-opioid treatment is needed.