Citations

Abstract Activated B cell (ABC) type diffuse large B cell lymphoma (DLBCL), double hit lymphoma (DHL) and double expressor lymphoma (DEL) have poor outcomes to frontline R‐CHOP but impact of these molecular features on outcomes of relapsed/refractory (R/R) disease is not well‐characterized. We evaluated the association of diagnostic cell of origin (COO), double hit and double expressor status with overall survival after first relapse in DLBCL patients who were enrolled into the Molecular Epidemiology Resource (MER) cohort. COO was available from immunohistochemistry (IHC) using Hans criteria or gene expression profiling (GEP) (Nanostring) on the diagnostic FFPE biopsy. Of 373 pts with R/R DLBCL, 278 had COO by IHC: 152 were GCB, 107 were non‐GCB. One hundred and fourty had COO by GEP: 44 were ABC, 65 were GCB and 13 were unclassifiable. Nineteen out of 163 (12%) were DHL; 30 out of 135 (22%) had DEL. COO, either by IHC (2 years OS GCB: 45% [CI 95 : 38–54] vs. non‐GCB: 44% [CI 95 :36–55], p > 0.05) or GEP (2 years OS ABC: 42% [CI 95 : 29–59] vs. GCB: 40% [CI 95 : 30–54], p > 0.05), was not associated with difference in OS. DHL (2 years OS 16 [CI 95 :6–45] vs. 45% [CI 95 : 34–59], p < 0.01) and DEL (2 years OS 33% [CI 95 : 20–56], vs. 50% [CI 95 : 41–60], p < 0.05) had lower OS than non‐DHL and non‐DEL/non‐DHL counterparts, respectively. COO by IHC or GEP was not associated with OS in R/R DLBCL while DHL and DEL were adverse prognostic markers in DLBCL at first relapse.

Individual or pooled commercial claims data sources such as the IBM MarketScan and PearlDiver provide information from health-care encounters by individuals enrolled in participating health insurance plans. These data sources contain deidentified data on demographic characteristics, enrollment start and end dates, inpatient and outpatient procedures and medical diagnoses with associated service dates and settings, and dispensed medications. Although there are concerns that long-term follow-up is limited because of interruptions in the continuity of coverage and reliance on billing data may overrecord or underrecord diagnoses and confounders, these data sources are nevertheless valuable for orthopaedic studies focusing on short-term complications, costs, and utilization.

Abstract: Direct data abstraction from a patient’s chart by experienced medical professional data abstractors has been the historical gold standard for quality and accuracy in clinical medical research. The limiting challenge to population-wide studies for quality and public health purposes is the high personnel costs associated with very large-scale efforts of this type. Two historically related programs that are at least partially able to successfully circumvent this problem and provide high-quality data relating to surgical procedures and the early postoperative period are reviewed in this article. Both utilize similar data abstraction efforts by specially trained and qualified medical abstractors of a sample subset of the total procedures performed at participating hospitals. The Veterans Affairs Surgical Quality Improvement Program (VASQIP), detailed by Nicholas J. Giori, MD, PhD, in the first section of this article, makes use of trained abstractors and has undergone recent additions and updates, including the development of an associated total hip registry for the VA system. The data elements and data integrity provided by both of these programs establish important benchmarks for other “big data” efforts, which often attempt to use alternative less-expensive methods of data collection in order to achieve more widespread or even nationwide data collection. In the second section, Elizabeth B. Habermann, PhD, MPH, provides a detailed review of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), the data elements collected, and examples of the range of quality improvement and outcomes studies in orthopaedic surgery that it has made possible, along with information on data that have not been collected and the resulting limitations. The ACS NSQIP was actually modeled after the very similar earlier effort started by the United States Department of Veterans Affairs (VA).

PURPOSE:High-dose methotrexate (HDMTX; > 500 mg/m2) is an important component of lymphoma therapy. Serum MTX monitoring at 48 hours is the standard approach to identify those at increased risk of developing MTX toxicity. Our aim was to characterize the incidence of complications and their association with MTX levels.METHODS:A retrospective review of our institutional electronic medical record was conducted to identify patients with lymphoma who received HDMTX between January 1, 2002, and December 31, 2018. We characterized the incidence of acute kidney injury (AKI), intensive care unit (ICU) admission, length of hospital stay (LOS), and 30-day mortality across 48-hour MTX levels. To establish an association between 48-hour MTX levels and the complications listed, we performed chi-square analysis for dichotomous variables and Kruskal-Wallis for nonparametric data. Receiver operator characteristic curve analysis was performed to identify the MTX level where AKI grade ≥ 2 was more likely. Multivariate logistic regression analysis was performed to identify risk factors for this MTX level.RESULTS:We identified 642 patients with 2,804 cycles of HDMTX. The incidence of AKI was 19.1% with AKI grade ≥ 2 making up 21% of cases. Rates of AKI, ICU admission, and 30-day mortality are associated with elevated 48-hour MTX levels. There was a significant increase in median LOS with elevated MTX levels ( P < .001). Receiver operator characteristic curve analysis for AKI grade ≥ 2 demonstrated a 48-hour MTX level threshold of 1.28 μmol/L. Multivariate logistic regression analysis revealed age, male sex, elevated body surface area, higher MTX dose, monotherapy, and first cycle as independent factors.CONCLUSION:Elevated MTX levels are associated with a significant increased rate of AKI, ICU admission, prolonged LOS, and 30-day mortality. Elevated 48-hour MTX levels, particularly > 1.28 μmol/L, should alert clinicians for complications and to initiate measures to reduce MTX levels.