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  • 1
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 3042-3042
    Abstract: Abstract 3042 Central line-associated blood stream infection (CLABSI) surveillance is increasingly utilized as an objective measure of quality of care provided by individual hospitals. CLABSI is defined by the National Healthcare Safety Network (NHSN) as a primary bloodstream infection (BSI) in a patient with a central line within the 48-hour period before the development of the BSI (NHSN CLABSI). This traditional definition of CLABSI includes pathogens better described as hospital-acquired blood stream infections (HABSI), such as enteric gram-negative bacilli (GNB) and streptococcus viridans - pathogens inherently more common in patients undergoing hematopoietic cell transplantation (HCT) due to the resultant neutropenia and disruption of mucosal barriers, and unlikely to be line-related. To avoid this misclassification, we have developed a modified CLABSI definition (MCLABSI) which excludes HABSI (DiGiorgio, Infect Control Hosp Epidemiol. 33: 865–8, 2012). MCLABSI includes all of the pathogens under the NHSN definition of CLABSI except Viridans group streptococci species in patients with mucositis, and Enterococcus, Enterobacteriaceae, or Candida species in patients with neutropenia or graft-vs-host disease of the gut. We compared the incidence of CLABSI and its impact on survival using both definitions in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients undergoing SCT. AML and MDS patients undergoing HCT between August 2009 and December 2011 were identified from the Cleveland Clinic Unified Transplant Database, and NHSN CLABSI and MCLABSI rates were obtained from the infection control database. CLABSI incidence was estimated using Kaplan-Meier method, and risk factors for mortality were identified using stepwise Cox proportional hazards analyses. Of the 73 patients identified (median age 52, range 16–70), 48 were male, 44 had AML, and 29 MDS. Patients received a median of 2 prior chemotherapy regimens (range 0–6), 3 had prior radiation, and 6 had prior transplant. 54 underwent myeloablative and 19 reduced-intensity preparative regimens; stem cell source included bone marrow (BM, n=34), peripheral stem cells (PSC, n=24), and cord blood cells (CBC, n=15). The median CD34+ count was 2.42 × 106/kg and median time to neutrophil recovery (absolute neutrophil count 〉 500/μL) was 14 days (range 6–24) with BM/PSC and 28 days (range 19–77) with CBC. Most (88%) had mucositis, including 17 (28%) with grade 3 or 4. Twenty-three (31.5%) developed NHSN CLABSI, compared to 8 (11.0%) who developed MCLABSI following HCT, of whom 16 (69.6%) and 7 (87.5%) died, respectively. The majority (16/23) of NHSN CLABSI occurred within 14 days (median 9 days, range 2–211 days) of HCT (Figure), varying from a median of 5 days (range 2–12 days) for CBC and 78 days for BM/PSC (range 7–211 days, p 〈 .001). Pathogens in NHSN CLABSI included 11 enteric Gram-negative bacilli, 7 Streptococcus viridans group, 6 enterococcus (3 vancomycin resistant), 5 Staphylococcus (3 methicillin resistant), 2 fungal species, 2 Gram-positive bacilli, 1 Pseudomonas, 1 other Streptococcus species, and 1 Stenotrophomonas. MCLABSI occurred a median of 12 days (range 5–176 days) from HCT (Figure), 7 days for CBC (range 5–12 days) compared to 77 days (range 13–176 days) for BM/PSC (p 〈 .001). Pathogens isolated in MCLABSI included 5 Staphylococcal species (3 MRSE), 2 Streptococcus viridans group, 2 GPB, 1 VRE, and 1 Pseudomonas. 4 NHSN CLABSI and 2 MCLABSI were polymicrobial, and 4 patients had recurrent CLABSI (all of whom died, including 3 MCLABSI). When NHSN CLABSI was analyzed as a time-varying covariate in univariable analysis, it was associated with an increased risk of mortality (HR 3.72, 95% CI 1.88 – 7.36, p 〈 .001), as was MCLABSI (HR 2.96, CI 1.27–6.89, p=.012). CLABSI remained a significant risk factor for mortality in multivariable analysis, by both the NHSN (HR 7.14, CI 3.31 – 15.31, p 〈 .001) and MCLABSI (HR 6.44, CI 2.28–18.18, p 〈 .001) definitions. CLABSI is a common complication in AML and MDS patients undergoing SCT, and is associated with decreased survival. CLABSI is identified less commonly with the exclusion of HABSI in the modified definition, which more precisely identifies patients with BSI related to their central lines. The distinction between these definitions is important to guide preventative infectious control measures, particularly given CLABSI's role as a quality measure influencing reimbursement. Disclosures: Hill: Teva Pharmaceuticals: Honoraria, Speakers Bureau.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 2
    In: Journal of Pharmacy Practice, SAGE Publications, Vol. 34, No. 4 ( 2021-08), p. 573-576
    Abstract: Intravenous (IV) iron sucrose can be used for iron deficiency anemia (IDA), but little information exists on total dose infusion (TDI) of this drug. At a tertiary hospital, an iron sucrose TDI protocol was implemented with staff pharmacists aiding physicians in appropriate dosing. Objectives: We sought to define the safety and efficacy of this protocol in adults ≥18 years old with IDA. Methods: We conducted a retrospective chart review of patients who received iron sucrose TDI. Inclusion criteria included patients ≥18 years old who were hospitalized and received iron sucrose in doses ≥300 mg. We reviewed the medical record for adverse reactions to any TDI of iron sucrose as well as pre-TDI and post-TDI hemoglobin (Hgb) levels to assess efficacy. Results: A total of 238 patients received iron sucrose TDI for IDA during the study period. One hundred ninety-three (81%) patients were female, and the mean age in our cohort was 60.6 years. Mean pre-TDI Hgb was 8.76 g/dL. The mean total dose of iron sucrose in the total cohort was 680 mg (range: 300-2500 mg). Adverse effects attributable to iron sucrose were reported in 15 patients, with nausea being the most common effect (7/238, 2.9%). When matching patients’ preadmission and postadmission records, a Hgb increase of 2.1 g/L was found ( P 〈 .001). No increase in liver function tests was found in any patient. Conclusions: A pharmacist-assisted iron sucrose TDI protocol for patients with IDA successfully increased serum Hgb and was well tolerated. Anaphylaxis was not reported.
    Type of Medium: Online Resource
    ISSN: 0897-1900 , 1531-1937
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2131091-9
    SSG: 15,3
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  • 3
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 19, No. 5 ( 2013-05), p. 720-724
    Type of Medium: Online Resource
    ISSN: 1083-8791
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2013
    detail.hit.zdb_id: 3056525-X
    detail.hit.zdb_id: 2057605-5
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  • 4
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e24200-e24200
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e24200-e24200
    Abstract: e24200 Background: The Distress Thermometer (DT) is a tool used to evaluate distress among cancer patients. The DT can provide information for intervention recommendations such as social work, psychological, and other ancillary services. The National Comprehensive Cancer Network (NCCN) recommends recurrent use of the tool. The DT is widely used as a standard of care for an initial screening of cancer patients, but data on subsequent use is lacking. The aim of this research was to evaluate repeat DT scores in a heterogeneous cancer patient population. Methods: Clinical investigators conducted a longitudinal study of DT ratings for cancer patients receiving outpatient care at a community-based oncology subspecialty practice in a mid-sized city from 2018 to 2019. Study objectives included reviewing referrals and evaluating the relationship between the initial screening and the screening at the 6-month checkup. The Distress Thermometer was used (i.e., 0-10; zero is “no distress” and ten “extreme distress”) with scores of four or greater regarded as a signal of greater risk for patient distress. Results: The study sample included 79 patients with an average score of 4.3 and 4.0 at baseline and the 6-month screening, respectively. Patient referrals included physical and emotional therapy (n=1) or social/psychosocial worker assessment (n=26). Patients with a documented referral had a crude 1.7 (95% CI: 0.6, 3.3) greater point decrease in scores compared to patients not offered a service referral. When adjusting for baseline scores and the time between scores, referral accounted for 1% (95% CI: 0%, 14%) of variability in score changes, while baseline scores accounted for 40% (95% CI: 22%, 52%) and time accounted for 3% (95% CI: 0%, 14%). Conclusions: Study results reveal a possible decrease in higher scores from the initial screening to the 6-month check-up. Patients with a referral did not have their service utilization confirmed and this study failed to show an additional decrease in scores based on referrals when controlling for baseline score and time. Most previous research has focused on one specific cancer type. This study revealed the possible importance in understanding DT scores in a heterogenous cancer patient population. Furthermore, large scale research is needed to confirm preliminary data and further expound on distress at initial and subsequent screenings after interventions. A better understanding of this content area may function to improve future care and patient well-being.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 12004-12004
    Abstract: 12004 Background: The majority of head/neck (HN) patients who undergo radiotherapy develop RIX. Unfortunately, existing treatments are of limited benefit and have side effects. Initial small studies suggest acupuncture may treat chronic RIX. A multicenter, phase III, randomized, sham-controlled trial (NCT02589938) was conducted to compare true acupuncture (TA) with sham acupuncture (SA) and wait list control (WLC) group in treating chronic RIX. Methods: HN patients with chronic RIX at least 12 months post-RT were recruited through the WF NCORP RB network (2UG1CA189824). Patients must have received bilateral radiation therapy with subsequent grade 2 or 3 xerostomia per modified RTOG scale, with no history of xerostomia or other illness known to affect salivation prior to HN XRT. All patients received standard oral hygiene and were randomized to TA, SA, or WLC. Patients in TA and SA were treated 2 times per week for 4 weeks. Those experiencing a marginal response (10-19 point decrease on the Xerostomia questionnaire (XQ)) received another 4 weeks of the respective treatment. Patients who had no response (increase in XQ score or decrease of 〈 10 points from baseline), partial response (20 or more point decrease in XQ score from baseline), or complete response (XQ score = 0) did not receive further treatment. Patient outcomes including XQ and FACT-HN were collected at baseline, 4, 8, and 12 weeks; the primary endpoint was XQ at 4 weeks. A sample size of 80 per group (240 total), had 80% power to detect a difference of 10 points between groups, assuming two-sided alpha = 0.013 and 20% attrition. Analysis of covariance adjusted for baseline XQ and Bonferroni corrections for pairwise comparisons. Results: 258 from 33 different practices participated. Average age was 65 years, 78% male, and 67% had AJCC stage IV a,b disease. At week 4, there was a group main effect on the XQ (P = 0.02) revealing significant between group differences between TA and WLC (51.1 vs 56.8, P = 0.008), with marginal between group difference between TA and SA (51.1 vs 54.5, P = 0.066) and no difference between SA and WLC (P = 0.36). A similar pattern was seen at week 8 (TA = 48.3, SA = 50.8, WLC = 54.8; only TA vs WLC significant, P = 0.012) and 12 (TA = 48.6, SA = 49.3.8, WLC = 54.6; TA vs WLC, P = 0.02; SA vs WLC, P = 0.04; TA vs SA, P = 0.79). Incidence of clinically significant RIX (XQ scores 〉 30) followed a similar pattern. The FACT-HN at week 12 revealed statistically and clinically significant group differences for the total score and several subscales between TA vs SA and WLC with no differences between SA and WLC. Completer and mediation analyses will be presented. Conclusions: True acupuncture was more effective in treating chronic RIX and improving QOL one or more years after the end of XRT than sham acupuncture or standard oral hygiene. Clinical trial information: NCT02589938.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 6
    In: Blood, American Society of Hematology, Vol. 132, No. Supplement 1 ( 2018-11-29), p. 5824-5824
    Abstract: Introduction Iron deficiency anemia (IDA) is the leading cause of anemia in the United States. Although oral iron formulations can correct IDA, they are generally poorly tolerated due to gastrointestinal side effects and may require long term use to maintain normal hemoglobin. Intravenous iron is an alternative to oral iron especially in adults who cannot tolerate or absorb oral iron. Intravenous iron preparations avoid problems of malabsorption and can quickly correct IDA but little data exists on the safety or efficacy in patients without chronic kidney disease (CKD) with or without dialysis, heart failure, uterine bleeding, and inflammatory bowel disease. Long term safety of IV therapy is not well established. At a tertiary midwestern medical center between 2008-2018, a dosing protocol was implemented with staff pharmacists aiding physicians in identifying candidates for total dose infusions (TDI) and calculating iron deficits for patients with IDA. We sought to define the safety and efficacy of IV iron in adult ≥ 18 years old with IDA. Methods We conducted a retrospective chart review of patients at a tertiary midwestern medical center from 8/1/14 to 8/1/17. Inclusion criteria includes adult patients ≥ 18 years old who were seen in either the inpatient or outpatient setting who received iron sucrose in doses ≥ 300mg. We excluded patients who were receiving the drug for anemia associated with chronic kidney disease or receiving renal replacement therapy. Data was collected and secured using a standardized data extraction sheet administered via online survey. We extracted demographic information, amount of iron sucrose given, and laboratory values such as discharge hemoglobin, serum iron studies, and liver function tests (prior to and after administration). We assessed physician and nurses' notes from the electronic medical record for the development of adverse effects due to TDI. In patients with a 14 to 28 day follow-up labs in our health-system, we assessed hemoglobin and liver function tests. We compared pre-TDI hemoglobin to follow-up hemoglobin in matched patients using the paired student t -test. Results A total of 238 patients received iron sucrose TDI for IDA during the study period. 193 patients (81%) were female, and the mean age in our cohort was 60.6 years. Mean weight of our patients was 80.92 Kg. Mean Pre-TDI hemoglobin was 8.76 g/dL. Out of the 238 patients, initial iron studies were completed on 201 patients (88%) with a mean ferritin of 80 ng/mL (range 1.0-607.0 ng/mL) and iron saturation 6.8% (range 1.0-25.0%), respectively. The mean dose of iron sucrose in the total cohort was 680 mg (range 300-2500 mg). Adverse effects attributable to iron sucrose were reported in 15 patients with nausea being the most common effect (7/238, 2.9%). No anaphylaxis episodes were reported unlike prior formulations. Eighty-one patients had accessible labs available between 14 to 28 days. When matching the patients' preadmission and postadmission records, a hemoglobin increase of 2.1 g/L was found (p 〈 0.001). No increase in liver function tests were found in any patient Conclusions A pharmacist assisted iron sucrose TDI protocol for patients with IDA successfully increased serum hemoglobin and was well tolerated with nausea being the most common side effect. Unlike, prior formulations where anaphylaxis was the most common side effect this was never reported in our patient population, which further proves that newer formulations of IV Venofer have fewer side effects. Pharmacy assisted protocols will increase the number of patients who are identified as candidates and correctly treated for iron deficit with intravenous iron therapy. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2018
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 7
    Online Resource
    Online Resource
    Elsevier BV ; 2013
    In:  Leukemia Research Vol. 37, No. 9 ( 2013-9), p. 986-994
    In: Leukemia Research, Elsevier BV, Vol. 37, No. 9 ( 2013-9), p. 986-994
    Type of Medium: Online Resource
    ISSN: 0145-2126
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2013
    detail.hit.zdb_id: 2008028-1
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  • 8
    Online Resource
    Online Resource
    OMICS Publishing Group ; 2014
    In:  Clinical Microbiology: Open Access Vol. 03, No. 06 ( 2014)
    In: Clinical Microbiology: Open Access, OMICS Publishing Group, Vol. 03, No. 06 ( 2014)
    Type of Medium: Online Resource
    ISSN: 2327-5073
    Language: Unknown
    Publisher: OMICS Publishing Group
    Publication Date: 2014
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  • 9
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2013
    In:  Current Hematologic Malignancy Reports Vol. 8, No. 2 ( 2013-6), p. 91-97
    In: Current Hematologic Malignancy Reports, Springer Science and Business Media LLC, Vol. 8, No. 2 ( 2013-6), p. 91-97
    Type of Medium: Online Resource
    ISSN: 1558-8211 , 1558-822X
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2013
    detail.hit.zdb_id: 2374151-X
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  • 10
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 4481-4481
    Abstract: Abstract 4481 Patients undergoing hematopoietic cell transplantation (HCT) require central venous access during treatment, predisposing this inherently susceptible population to infection. Central line-associated blood stream infection (CLABSI) is defined by the National Healthcare Safety Network as a primary bloodstream infection (BSI) in a patient with a central line within the 48-hour period before the development of the BSI. CLABSI surveillance is being increasingly used as an objective measure of quality of care delivered at individual hospitals. The Centers for Disease Control and Prevention have developed guidelines for the insertion, surveillance, and timely removal of these lines to prevent CLABSI, of which approximately 10% are fatal, and the Centers for Medicare & Medicaid will adjust reimbursement for CLABSI. The incidence, risk factors, and impact on survival of CLABSI in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients undergoing HCT has not been reported. AML or MDS patients undergoing HCT between August 2009 and December 2011 were identified from the Cleveland Clinic Unified Transplant Database, and occurrence of CLABSI was determined from the infection control database. Variables analyzed included occurrence of CLABSI, as well as patient demographics, disease type, prior treatment, HCT comorbidity index, transplant type/HLA-match, CD34+ count, and time to neutrophil recovery (absolute neutrophil count 〉 500). CLABSI incidence was estimated using Kaplan-Meier method, and univariable and multivariable risk factors were identified by Cox proportional hazards analyses. Of the 73 patients identified, 48 were male; 68 were Caucasian; 44 had AML, and 29 MDS. The median age at transplant was 52 (range 16–70), and 39 had a low to intermediate HCT comorbidity index (0–2), while 34 had a high index (≥3). Patients received a median of 2 prior chemotherapy regimens (range 0–6), 3 had prior radiation, and 6 had prior transplant. Preparative regimen was myeloablative (n=54) or reduced-intensity (n=19); 34 received bone marrow (BM), 24 peripheral stem cells (PSC), and 15 cord blood cells (CBC). The median CD34+ count was 2.42 × 106/kg and median time to neutrophil recovery was 14 days (range 6–24) with BM/PSC compared to 28 days with CBC (range 19–77). Among these 73 patients, 23 (31.5%) developed CLABSI, of whom 16 (69.6%) died. The majority (16/23) of CLABSI occurred within 14 days (median 9 days, range 2–211 days) from HCT (Figure 1), but timing of CLABSI was highly associated with cell source: median of 5 days (range 2–12 days) for CBC and 78 days (range 7–211 days) for BM/PSC (p 〈 .001). Etiologies of CLABSI included 11 enteric Gram-negative bacilli, 7 Streptococcus viridans group, 6 enterococcus (3 vancomycin resistant), 5 Staphylococcus (3 methicillin resistant), 2 fungal species, 2 Gram-positive bacilli, 1 Pseudomonas, 1 other Streptococcus species, and 1 Stenotrophomonas. 4 patients had polymicrobial infections, and 5 (all of whom died) had more than one separately documented CLABSI. Univariable risk factors for CLABSI included cord blood transplant (p 〈 .001), HLA-mismatch (p=.005), low CD34+ count (p=.007), and non-Caucasian race (p=.017). Risk factors for CLABSI in multivariable analysis were CBC (p 〈 .001) and high comorbidity index (p=.002); 4 distinct populations of patients were created based on this data, ranging from a high comorbidity index/cord blood cohort to a low to intermediate co-morbidity index/marrow cohort (Figure 2). When CLABSI was analyzed as a time-varying covariate in univariable analyses, it was associated with an increased risk of mortality (HR 3.17, 95% CI 1.61–6.22, p 〈 .001). Multivariable risk factors for mortality included CLABSI (HR 7.14, CI 3.31 – 15.37, p 〈 .001), MDS diagnosis (HR 5.21, CI 2.40–11.33, p 〈 .001), and age (HR 1.81, CI 1.21–2.71, p=.004). CLABSI is a common complication in AML and MDS patients undergoing HCT, and is associated with remarkably decreased survival. Cord blood, perhaps related to the extent and duration of severe immune deficiency, and high HCT comorbidity index place patients at higher risk of CLABSI. Efforts to identify patients at high risk of CLABSI, careful adherence to preventative infectious control measures, and design of methods to enhance immune reconstitution post-transplant in the high risk population could improve outcome in a substantial portion of patients. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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