Birnbaum (2011, 2012) questioned the iid (independent and identically distributed) sampling assumptions used by state-of-the-art statistical tests in Regenwetter, Dana and Davis-Stober’s (2010, 2011) analysis of the “linear order model”. Birnbaum (2012) cited, but did not use, a test of iid by Smith and Batchelder (2008) with analytically known properties. Instead, he created two new test statistics with unknown sampling distributions.Our rebuttal has five components: 1) We demonstrate that the Regenwetter et al. data pass Smith and Batchelder’s test of iid with flying colors. 2) We provide evidence from Monte Carlo simulations that Birnbaum’s (2012) proposed tests have unknown Type-I error rates, which depend on the actual choice probabilities and on how data are coded as well as on the null hypothesis of iid sampling. 3) Birnbaum analyzed only a third of Regenwetter et al.’s data. We show that his two new tests fail to replicate on the other two-thirds of the data, within participants. 4) Birnbaum selectively picked data of one respondent to suggest that choice probabilities may have changed partway into the experiment. Such nonstationarity could potentially cause a seemingly good fit to be a Type-II error. We show that the linear order model fits equally well if we allow for warm-up effects. 5) Using hypothetical data, Birnbaum (2012) claimed to show that “true-and-error” models for binary pattern probabilities overcome the alleged short-comings of Regenwetter et al.’s approach. We disprove this claim on the same data.
Background: US guidelines recommend that patients with heart failure with reduced ejection fraction (HFrEF), who tolerate an ACEI (angiotensin-converting enzyme inhibitor) or ARB (angiotensin II receptor blocker), be switched to sacubitril/valsartan to reduce morbidity and mortality. We compared characteristics and healthcare utilization between Veterans with HFrEF who were switched to sacubitril/valsartan versus maintained on an ACEI or ARB. Methods: retrospective cohort study of treated HFrEF (July 2015–June 2017) using Veterans Affairs data. The index date was the first fill for sacubitril/valsartan and if none, for an ACEI or ARB. Treated HFrEF was defined by (1) left ventricular ejection fraction ≤40%, (2) ≥1 in/outpatient HF encounter, and (3) ≥1 ACEI or ARB fill, all within 1-year preindex. Poisson regression models were used to compare baseline characteristics and 1:1 propensity score-matched adjusted 4-month follow-up healthcare utilization between sacubitril/valsartan switchers and ACEI or ARB maintainers. Results: Switchers (1612; 4.2%) were less likely than maintainers (37 065; 95.8%) to have a history of myocardial infarction or hypertension, and more likely to be black, have a lower left ventricular ejection fraction, and higher preindex healthcare utilization. Switchers were less likely to experience follow-up all-cause hospitalizations (11.2% versus 14.0%; risk ratio 0.80 [95% CI, 0.65–0.98], P value 0.035). Conclusions: Few Veterans with treated HFrEF were switched to sacubitril/valsartan within the first 2 years of Food and Drug Administration approval. Sacubitril/valsartan use was associated with a lower risk for all-cause hospitalizations at 4 months follow-up. Reasons for lack of guideline-recommended sacubitril/valsartan initiation warrant investigation and may reveal opportunities for HFrEF care optimization.
BackgroundOpioids and sedatives are commonly prescribed in chronic obstructive pulmonary disease (COPD) patients for symptoms of dyspnoea, pain, insomnia, depression and anxiety. Older adults are advised to avoid these medications due to increased adverse events, including respiratory events. This study examines respiratory event risks associated with concomitant opioid and sedative use compared with opioid use alone in older adults with COPD.MethodsA 5% nationally representative sample of Medicare beneficiaries with COPD and opioid use between 2009 and 2013 was used for this retrospective cohort study. Current and past concomitant use were identified using drug dispensed within 7 days from the censored date: at respiratory event, at death, or at 12 months post index. Concomitant opioid and sedative use were categorised into no overlap (opioid only), 1 to 10, 11 to 30, 31 to 60 and >60 days of total overlap. The primary outcome was hospitalisation or emergency department (ED) visits for respiratory events (COPD exacerbations or respiratory depression). Propensity score matching was implemented and semi-competing risk models were used to address competing risk by death.ResultsAmong 48 120 eligible beneficiaries, 1810 (16.7%) concomitant users were matched with 9050 (83.3%) opioid only users. Current concomitant use of 1 to 10, 11 to 30 and 31 to 60 days was associated with increased respiratory events (HRs (95% CI): 2.8 (1.2 to 7.3), 9.3 (4.9 to 18.2) and 5.7 (2.5 to 12.5), respectively), compared with opioid only use. Current concomitant use of >60 days or past concomitant use of ≤60 days was not significantly associated with respiratory events. Consistent findings were found in sensitivity analyses, including in subgroup analysis of non-benzodiazepine sedatives. Additionally, current concomitant use significantly increased risk of death.ConclusionShort-term and medium-term current concomitant opioid and sedative use significantly increased risk of respiratory events and death in older COPD Medicare beneficiaries. Long-term past concomitant users, however, demonstrated lower risks of these outcomes, possibly reflecting a healthy user effect or developed tolerance to the effects of these agents.
e19513 Background: Treatment options for AML patients ineligible for intensive chemotherapy are limited. This study aims to describe demographic and clinical characteristics, outcomes, and HCRU in this patient population. Methods: This was a retrospective observational study of patients aged > 60 years who received first-line (1L) treatment within 60 days of AML diagnosis between 1/1/2011 – 1/1/2018 and had > 2 visits at US Oncology Network (USON) clinics. Patients were followed until 6/30/2018, last visit, or death, whichever came first. Data were sourced from structured fields of the USON database and chart reviews. Patient characteristics and HRU were assessed using descriptive statistics while overall survival (OS), time-to-treatment failure (TTF), and progression-free survival (PFS) from 1L treatment initiation were assessed using the Kaplan-Meier method. Results: 378 patients were included with median age of 79 years; 62.7% were male, 29.3% had an ECOG score > 2, and 38.4% had poor cytogenetic risk profile. Most patients received 1L hypomethylating agent (HMA) monotherapy: azacitidine (AZA, 57.9%) or decitabine (DEC, 25.9%). Few patients received best supportive care only (7.1%) or other AML treatment (9.1%). Median (range) durations of 1L treatment among patients receiving AZA and DEC were 2.9 (0.0, 46.9) and 2.5 (0.1, 26.4) months, respectively. Median (95% CI) OS, TTF, and PFS in the AZA and DEC cohorts were 7.5 (5.7, 9.6) and 7.3 (4.8, 8.8) months, 3.4 (2.8, 4.4) and 3.7 (2.4, 5.2) months, and 6.7 (5.0, 8.0) and 5.7 (3.4, 7.4) months, respectively. Among patients receiving HMAs, 84.5% received at least one transfusion. Median number of red blood cell and platelet transfusions was 4.0. Hospitalization rates in the AZA and DEC cohorts were 79.9% and 83.7%; proportions with hospitalization > 2 days duration were 64.4% and 66.3%, respectively, with median (range) durations of 6.5 (3.0, 34.0) and 7.0 (3.0, 26.0) days, respectively. Conclusions: The low TTF and OS and high HRU in this real-world community oncology study indicates an unmet need to improve outcomes among AML patients ineligible for intensive chemotherapy. NCCN guidelines were updated since this study and future real-world studies are warranted to evaluate impact of novel therapies on treatment patterns and outcomes.
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