Background Blood transfusions can serve as a life-saving treatment, but inappropriate blood product transfusions can result in patient harm and excess costs for health systems. Despite published evidence supporting restricted packed red blood cell (pRBC) usage, many providers transfuse outside of guidelines. Here, we report a novel prospective, randomized control trial to increase guideline-concordant pRBC transfusions comparing three variations of clinical decision support (CDS) in the electronic health record (EHR). Methods All inpatient providers at University of Colorado Hospital (UCH) who order blood transfusions were randomized in a 1:1:1 fashion to the three arms of the study: (1) general order set improvements, (2) general order set improvements plus non-interruptive in-line help text alert, and (3) general order set improvements plus interruptive alert. Transfusing providers received the same randomized order set changes for 18 months. The primary outcome of this study is the guideline-concordant rate of pRBC transfusions. The primary objective of this study is to compare the group using the new interface (arm 1) versus the two groups using the new interface with interruptive or non-interruptive alerts (arms 2 and 3, combined). The secondary objectives compare guideline-concordant transfusion rates between arm 2 and arm 3 as well as comparing all of arms of the study in aggregate to historical controls. This trial concluded after 12 months on April 5, 2022. Discussion CDS tools can increase guideline-concordant behavior. This trial will examine three different CDS tools to determine which type is most effective at increasing guideline-concordant blood transfusions. Trial registration Registered on ClinicalTrials.gov 3/20/21, NCT04823273. Approved by University of Colorado Institutional Review Board (19–0918), protocol version 1 4/19/2019, approved 4/30/2019.
BackgroundBlood transfusions can serve as a life-saving treatment for patients, though inappropriate blood product transfusions can result in patient harm and excess costs for health systems. Despite published evidence supporting restricted packed red blood cell (pRBC) usage, many providers transfuse outside of guidelines. Here we report a novel prospective, randomized control trial to increase guideline-concordant pRBC transfusions comparing three variations of clinical decision support (CDS) in the electronic health record (EHR). MethodsAll inpatient providers at University of Colorado Hospital (UCH) who order blood transfusions are randomized in a 1:1:1 fashion to the three arms of the study: (1) general order set improvements; (2) general order set improvements plus non-interruptive in-line help text alert; (3) general order set improvements plus interruptive alert. Transfusing providers receive their same randomized order set changes for 18 months. The primary outcome of this study is a comparison is between the group using the new interface (arm 1) versus the two groups using the new interface with interruptive or non-interruptive alerts (arms 2 and 3, combined). The secondary outcomes compare guideline-concordant transfusion rate between arm 2 and arm 3 as well as comparing all of arms of the study in aggregate to historical controls. This trial is ongoing.DiscussionCDS tools can increase guideline concordant behavior. This trial will examine three different CDS tools to determine which type is most effective at increasing guideline concordant blood transfusions. Trial registration: Registered on ClinicalTrials.gov 3/20/21, NCT04823273, https://clinicaltrials.gov/ct2/show/NCT04823273. Approved by University of Colorado Institutional Review Board (19-0918).
Background: Vincristine- or vinblastine-induced peripheral neuropathy (VIPN) is a common adverse event during lymphoma treatment that can profoundly impact quality of life and survivorship. VIPN often leads to dose-reduction or discontinuation of these agents. However, there is limited data (Annals of Hematology, Utsu 2016; Annals of Hematology, Morth 2018) evaluating the impact of dose reduction or omission of vinca alkaloids on progression-free survival (PFS) or overall survival (OS). We report on a series of lymphoma patients (pts) who had vincristine (Vn) or vinblastine (Vb) dose-reduced or omitted from their initial chemotherapy. Methods: We performed a retrospective chart review of lymphoma pts who were seen in consultation at the University of Colorado from 2015 to 2018. Data included demographics, lymphoma subtypes, Vn- or Vb-containing treatment regimens, PFS, and OS. PFS and OS were examined using Kaplan-Meier method, and stratification techniques were used to compare survival based on full dose versus dose-reduced/omitted treatments. Cox regression methods were used to assess the impact of refractory or progressive disease, disease stage, and prognostic score on PFS. Results: 373 pts who received Vn- or Vb-containing chemotherapy were identified. Of those, 228 pts had complete records available for review for treatment, response and survival data. 133 pts (58.3%) were male. Median age was 56 years (range 19 to 85 years). The most common diagnoses were diffuse large B-cell (59.2%), Hodgkin (26.3%), follicular (8.3%), PTLD (3.1%), Burkitt, (2.6%), and gray zone (0.4%) lymphomas. Chemotherapy regimens administered were REPOCH (35.1%), RCHOP (32.9%), and ABVD/AVD (21.9%). Incidence of neuropathy during treatment was 36.4%. The median follow up is 23.7 months (range 2.5 to 150.7 months). We categorized patients into 2 groups based on chemotherapy dosing: full dose (Group 1: n=155/228; 68%) and dose-reduced or omitted (Group 2: n= 73/228; 32%). There was not a significant difference in stage or prognostic score between Group 1 and Group 2. Group 2 was further sub-categorized into Subgroup 2A (patients with Vn/Vb omitted at any point: n= 46/228; 20.2%) and Subgroup 2B (patients with Vn/Vb dose-reduced: n=27/228; 11.8% ). Of the 73 patients in Group 2, 67 patients had Vn/Vb omitted or reduced due to neuropathy; 6 patients had the drugs omitted (5/73) or reduced (1/73) due to GI side effects. Complete response (CR) rates between Group 1 and Group 2 were similar (81.3% vs 87.7%, respectively). Patients in Group 1 had a higher number of patients with relapsed/refractory disease compared to Group 2 (p<0.01). PFS was better in Group 2 compared to Group 1 (p=0.027). There was no significant difference in OS between the two groups (p=0.83) (Figure 1). There was no significant difference in response rates, PFS, or OS when comparing Subgroup 2A to Group 1 and Subgroup 2B to Group 1 (Figures 2 and 3). There was also no statistically significant difference in response rate, PFS, or OS if Vn/Vb was dose reduced early (first half of total cycles) versus late, when comparing Group 1 versus Group 2, Subgroup 2A, or Subgroup 2B. Conclusions: Our single-center retrospective analysis of patients suggests that reduction or omission of vinca alkaloids from initial chemotherapy does not deleteriously affect outcomes in lymphoma pts. Prospective clinical trials are underway investigating the substitution of vinca alkaloids with novel targeted agents. Our findings further validate the rationale and design of these contemporary trials. Disclosures Kamdar: University of Colorado: Employment; Celgene: Consultancy; Pharmacyclics: Consultancy; AstraZeneca: Consultancy; Seattle Genetics: Speakers Bureau.
Background: Primary central nervous system lymphoma (PCNSL) is a rare type of extranodal non-Hodgkin lymphoma (NHL). Most cases occur in the immunocompetent population. Despite advances in therapy, the prognosis of PCNSL remains poor, with 5-year overall survival (OS) rates at 30-50% (Ferreri 2011). The standard of care treatment regimen includes high-dose methotrexate (HD-MTX), often in combination with other multiagent CNS penetrating chemotherapies. Although the addition of rituximab in systemic aggressive B-cell NHLs has shown improvement in OS, the benefit of this agent in PCNSL has not been confirmed in a prospective dataset (Bromberg 2017). The majority of PCNSLs are classified as diffuse large B-cell lymphomas (DLBCL), and the outcomes based on treatment and cell of origin (germinal center B-cell (GCB) vs. non-GCB subtype) have yet to be fully elucidated. In this review, we report our findings from a series of PCNSL patients based on treatment regimen and cell of origin. Methods: This is a retrospective study of patients with PCNSL diagnosed and treated at the University of Colorado Hospital from 1995 to 2017. Chart abstraction included demographics, DLBCL subtype by Hans algorithm (Hans 2004), treatment details, and outcomes. OS was examined using Kaplan Meier methods, while bootstrap resampling and a z-test was used to compare median survival times across strata. Fisher's exact test was used to determine whether treatment responses were different between those that received treatment withHD-MTX and rituximab versus HD-MTX without rituximab. A significance level of 0.05 was used for all tests. When assessing differences by subtype, treatment type, relapse, and treatment response the data was subset to include only patients without a prior HIV diagnosis. Results: 71 patients with PCNSL were identified. 13 patients were HIV positive (the HIV status of 1 patient was unknown). Of the remaining 57 immunocompetent patients, 39 patients were treated with HD-MTX, of which 29 patients received rituximab in combination therapy. The most commonly received regimen was rituximab with methotrexate, procarbazine, and vincristine (R-MPV) (43.6%, 17 of 39). Median age in the HD-MTX subgroup was 65 years, with 83% of patients with KPS>70 at diagnosis. EBV positivity was noted in only 4 of 39 samples (10.2%), while 25 of 39 (64.1%) tested negative; the remaining patients' data was not available. Median OS was 29.9 months for all 71 patients (Figure 1). There was no significant difference in median OS between those with and without HIV (p=0.127). 22 of 29 (75.9%) patients in the HD-MTX with rituximab group achieved a complete response (CR) while no patients (0%; 0 of 10) in the HD-MTX without rituximab group achieved a CR. The number of patients with a CR was significantly higher for those that received HD-MTX with rituximab compared to those that received HD-MTX without rituximab (p<0.001). Median OS for HIV negative patients treated with HD-MTX without rituximab (N = 10) was 32.6 months whereas median OS for HIV negative patients treated with HD-MTX with rituximab (N = 29) has not been reached at a median follow up of 33.4 months (range 1.5 - 116.9 months) (Figure 2) Subtyping was available for 23 patients without HIV treated with HD-MTX with or without additional agents. 6 patients had GCB subtype and 16 had non-GCB subtype. Median OS for GCB subtype has not yet been reached, while median OS for non-GCB subtype was 33.4 months (Figure 3). When analyzing data for patients who received HD-MTX and rituximab, median OS for GCB has not been reached, while median OS for non-GCB was 43.8 months (Figure 4). Conclusions: Our review of patients with PCNSL suggests that the addition of rituximab to a high dose MTX-based regimen improves survival although numbers are too small to determine any overarching statistical conclusion. CR rates were significantly higher in patients receiving rituximab in addition to HD-MTX compared to HD-MTX without rituximab. Patients with non-GCB subtype treated with HD-MTX and rituximab had increased median OS compared to median OS of non-GCB patients treated with HD-MTX without rituximab. However, in line with previous data we demonstrated worse outcomes associated with non-GCB subtype compared to GCB subtype. Future research is needed to focus on the characteristics of this subtype of PCNSL to improve outcomes with novel therapeutics. Disclosures Kamdar: Genentech: Consultancy; Seattle Genetics: Speakers Bureau. Haverkos:Viracta Therapeutics: Membership on an entity's Board of Directors or advisory committees.
Background To improve blood transfusion practices, we applied user-centered design (UCD) to evaluate potential changes to blood transfusion orders. Objectives The aim of the study is to build effective transfusion orders with different designs to improve guideline adherence. Methods We developed three different versions of transfusion orders that varied how information was presented to clinicians ordering blood transfusions. We engaged 14 clinicians (residents, advanced practice providers [APPs], and attending physicians) from different specialties. We used the think aloud technique and rapid qualitative analysis to generate themes to incorporate into our modified orders. Results Most end-users who participated in the semi-structured interviews preferred the interruptive alert design plus behavioral nudges (n = 8/14, 57%). The predominant rationale was that the in-line alert was not visually effective in capturing the end-user's attention, while the interruptive alert forced a brief stop in the workflow to consider the guidelines. All users supported the general improvements, though for different reasons, and as a result, the general improvements remained in the designs for the forthcoming trial. Conclusion The user experience uncovered through the think aloud approach produced a clear and rich understanding of potentially confounding factors in the initial design of different intervention versions. Input from end-users guided the creation of all three designs so each was addressing human factors with parity, which ensured that the results of our study reflected differences in interruptive properties of the alerts and not differences in design.
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