scholarly journals Evaluation of Intravenous Diphenhydramine Use in Patients with Sickle Cell Vaso-Occlusive Crisis

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3575-3575
Author(s):  
Ifeyinwa Osunkwo ◽  
Shelby Merchant ◽  
Rachel Crawford ◽  
Katherine Rector ◽  
Justin Arnall ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Safety Monitoring ◽  
Data Safety Monitoring Board ◽  
Opioid Therapy ◽  
High Dose ◽  
Data Safety ◽  
Safety Monitoring Board ◽  
Data Safety Monitoring ◽  
Daily Dose ◽  
Oral Group

Abstract Inpatient management of sickle cell disease (SCD) vaso-occlusive crisis (VOC) often involves use of high-dose opioids, which may result in opioid-induced pruritus (OIP). This OIP is typically treated with antihistamines like diphenhydramine either orally or intravenously. The oversedation adverse effects of diphenhydramine may be magnified when given in combination with high-dose opioid therapy. Current recommendations made by the National Heart, Lung, and Blood Institute endorse using oral rather than intravenous (IV) antihistamines to avoid the cumulative effect on sedation. Despite this guideline, IV diphenhydramine use is still prevalent in many hospitals that treat persons with SCD. We performed a retrospective, single-center, cohort study comparing rates of oversedation among patients who received IV and oral diphenhydramine for management of opioid-induced pruritus in a large SCD inpatient population. Patients with SCD VOC admitted to an urban hospital between June 1, 2016 to July 30, 2017 were included if they were ≥ 18 years old and received either IV or oral diphenhydramine for OIP. Exclusion criteria: Pregnancy, received <24 hours of diphenhydramine, or <50% of their "as needed" doses of diphenhydramine. Primary endpoint: comparative incidence of oversedation in SCD VOC receiving IV versus oral diphenhydramine. Oversedation was defined as meeting two or more of the following criteria: documentation of oversedation in clinician notes, medication doses held by a nurse due to sedation, a PASERO opioid-sedation score ≤3, or documented hypoxemia with O2 percent saturation ≥ 2 points below baseline. Secondary endpoints included: evaluation of hospital length of stay, amount of diphenhydramine administered per day, indication for IV therapy, and number of days receiving diphenhydramine. Individual admissions were portioned by route of diphenhydramine administration cohorts (IV versus oral). Within each cohort, study endpoints were derived at the patient level. Oversedation was determined at the patient level i.e. experiencing at least one occurrence over the course of their admissions. The number of admissions, length of stay, and days of diphenhydramine treatment were totaled across admissions for each patient. The daily dose of diphenhydramine administration (mg/day) was averaged across the admissions per patient. The proportion of subjects experiencing oversedation was summarized by cohort and compared using Fisher's exact test. Length of stay, number of days on treatment, and average daily dose of diphenhydramine were analyzed with analysis of variance (ANOVA) techniques. Length of stay and number of days on treatment were log-transformed prior to statistical analyses. The number of admissions was analyzed with Poisson regression. Fifty unique patients were included in the analysis representing 121 admissions. Seven patients received both formulations on separate admissions and were included in both groups, 15 received oral diphenhydramine, and 42 received the IV formulation. The percent of patients experiencing oversedation was higher in the IV group, however the difference was not statistically significant (p = 0.312). The average number of admissions was significantly higher in the IV versus oral group (2.45 vs. 1.20; p = 0.005) with average and median length of stay also significantly higher in the IV versus oral group (30.57, 16.0 vs. 10.67, 10.0; p = 0.003). Similarly, the average and median number of days on diphenhydramine treatment in the IV group was significantly higher than in the oral group (28.79, 14.5 vs. 9.73, 7.0; p = 0.001). The average daily dose of diphenhydramine was similar in the two cohorts with no compelling indications documented for use of IV over oral formulation. In summary, while we did not find a statistically significant difference in the rates of oversedation with use of IV versus oral diphenhydramine formulations, patients with SCD VOC who received IV diphenhydramine were more likely to have more frequent admissions, and a longer length of stay. These findings have clear impact on clinical outcomes and cost of care and clinicians may consider oral diphenhydramine preferentially in appropriate patients over IV administration. Larger, prospective studies are needed to evaluate the absolute risk to benefit ratio between the two formulations particularly among person receiving concomitant parenteral opioid therapy. Disclosures Osunkwo: Terumo BCT: Speakers Bureau; Prolog Pharmaceuticals LLC: Consultancy; Novartis Pharmaceuticals LLC: Consultancy, Speakers Bureau. Symanowski:Immatics: Other: Data Safety Monitoring Board; Eli Lily & Co: Other: Data Safety Monitoring Board; Boston Biomedical: Other: Data Safety Monitoring Board ; Five Prime Therapeutics: Other: Data Safety Monitoring Board .

scholarly journals Patient Reported Financial Toxicity in Acute Leukemia

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4796-4796 ◽  
Author(s):  
Thomas G. Knight ◽  
Myra Robinson ◽  
Michael R. Grunwald ◽  
Lauren M. Bohannon ◽  
Erin Blackwell ◽  
...  
Keyword(s):  
Acute Leukemia ◽  
Board Of Directors ◽  
Research Funding ◽  
Safety Monitoring ◽  
Data Safety Monitoring Board ◽  
Financial Toxicity ◽  
Advisory Committees ◽  
Data Safety ◽  
Safety Monitoring Board ◽  
Data Safety Monitoring

Abstract Background: Financial Toxicity (FT) is increasingly recognized as a major contributor to morbidity and mortality in a variety of cancers. Treatment of acute leukemia is associated with heavy healthcare utilization and high costs. The purpose of this study was to define rates, risk factors, and mortality implications for FT in patients with acute leukemia using patient reported data. Methods: All patients seen at the Levine Cancer Institute, a tertiary hospital-based leukemia practice, were surveyed prior to each visit over a six-month period. All patients were aged ≥18 years and were diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The survey consisted of the PROMIS Global-10 measure and two questions from the COST measure. FT was defined as scoring 4 or less (maximum: 10) in agreement with the COST questions: "I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment" and "I am satisfied with my current financial situation." Demographic data and disease characteristics were abstracted from the medical record. Model selection was carried out using logistic regression to identify factors impacting the incidence of financial toxicity. Correlation of numerical financial toxicity scores with PROMIS scores and with mortality data was assessed using linear regression. Results: Of the 106 patients, 58 (54%) met the definition of exhibiting FT. The factors associated with incidence of FT included: age, race, and insurance type. The odds of FT in those patients <65 years of age were 2.7 times the odds of FT in those ≥65, adjusting for race, insurance, and time since first treatment (95% CI: 0.884 - 8.438, p = .081). The odds of FT in African American patients were 4.3 times the odds of FT in Caucasian patients, adjusting for age, insurance, and time since first treatment (CI: 0.408 - 44.824, p = .150). The odds of FT in patients with Medicaid insurance were 14.2 times the odds of FT in patients with commercial insurance, adjusting for age, race, and time since first treatment (CI: 1.658 - 121.862, p = .106). Gender, distance from the hospital, type of acute leukemia, history of blood/marrow transplant, and history of relapsed disease were not found to be significant. There was a significant correlation for both the PROMIS global physical (p < .001) and mental (p < .001) scores with the FT score. Lower FT score (higher degree of FT) was associated with lower mental and physical scores. There was no statistically significant difference in survival between patients with FT scores >4 compared to patients with FT scores <=4; however, there was a trend toward decreased survival in those with lower FT scores (Figures 1 and 2). Conclusions: Patients with acute leukemia represent an extremely vulnerable population for financial toxicity with rates of distress even higher than other reported malignancies. Urgent interventions are indicated in this population. Disclosures Grunwald: Medtronic: Equity Ownership; Cardinal Health: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; Merck: Consultancy, Membership on an entity's Board of Directors or advisory committees; Forma Therapeutics: Research Funding; Janssen: Research Funding; Incyte Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Alexion: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Ariad: Consultancy, Membership on an entity's Board of Directors or advisory committees; Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees. Avalos:Juno: Membership on an entity's Board of Directors or advisory committees. Symanowski:Five Prime Therapeutics: Other: Data Safety Monitoring Board ; Boston Biomedical: Other: Data Safety Monitoring Board ; Eli Lily & Co: Other: Data Safety Monitoring Board; Immatics: Other: Data Safety Monitoring Board.

Hemophilia Prophylaxis No Longer Just for Children without Inhibitors - Increasing Use of Prophylaxis in Other Groups (children with inhibitors and adults with and without inhibitors)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3535-3535 ◽  
Author(s):  
Manuel Carcao ◽  
Maria L. Avila ◽  
Victor S. Blanchette ◽  
Elena Santagostino ◽  
Carmen Escuriola-Ettingshausen ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Safety Monitoring ◽  
Data Safety Monitoring Board ◽  
Advisory Committees ◽  
Data Safety ◽  
Safety Monitoring Board ◽  
Data Safety Monitoring ◽  
Adults And Children

Abstract Background: Long-term prophylaxis is standard of care in children with severe hemophilia A (SHA) and B (SHB) without inhibitors. Studies have shown benefit from long-term prophylaxis in adults with SH and in both adults and children with SH and inhibitors. Yet there is little data on the prevalence of prophylaxis in these groups. Aim/Methods: To understand the current use of long-term prophylaxis in these groups of patients in countries capable of underwriting the high cost of prophylaxis we surveyed (2013) hemophilia treatment centers (HTCs) in countries where long-term prophylaxis in children is routinely used. Results: 134 HTC from 14 countries in North America, Australasia, and Western Europe reported on 4,763 adults with SH (4,011 SHA; 752 SHB) and on 751 children and adults with inhibitors. Prophylaxis use in these groups is shown in table 1: Table 1. Prophylaxis use in adults with SH (without inhibitors). Adults without inhibitors Children and adults with inhibitors HA HB In ITI setting In non-ITI setting % on Prophylaxis 59 49 29 28 Most common regimen EOD 2 d/wk FEIBA EOD or 3 d/wk FEIBA EOD or 3 d/wk EOD, every other day Adults without inhibitors: A higher proportion of SHA (59%) vs SHB adults (49%) were on prophylaxis (Χ2 p<.001). This was particularly true in the age group of 18-30 y [74% (SHA) vs 60% (SHB)]. For SHA the use of prophylaxis was progressively less in older age groups: 31-40 y (55%), 41-50 y (47%), 51-70 y (39%) and >70 y (29%). There was little drop in the proportion of SHB adults on prophylaxis with increasing age. 67% of SHA adults on prophylaxis were receiving ≥3 infusions/wk while 80% of SHB adults on prophylaxis were receiving ≥2 infusions/wk. Once/wk prophylaxis was reported in 3% of SHA and by 19% of SHB patients on prophylaxis. Daily prophylaxis was rarely reported in both groups. Children and adults with inhibitors: Data was available on 407 children and 344 adults with SH and inhibitors. Table 2 shows the proportion of children and adults on/not on Immune tolerance induction (ITI) and on/not on bypassing agent prophylaxis (BA-P). Most children (78%) were on either ITI (with or without BA-P) or on BA-P alone and as such were having some bleed protection. In contrast only 28% of adults were on either ITI (with or without BA-P) or on BA-P and as such most adults with inhibitors are not on any bleed protection. Table 2. Use of ITI and of BA-P in children and adults with SH (+ inhibitors). 403 children 344 adults On ITI. Not on BA-P 43% 8% On ITI. On BA-P 17% 4% Not on ITI. Not on BA-P 23% 71% Not on ITI. On BA-P 18% 16% In total, 185 patients had received FEIBA prophylaxis while 70 had received rFVIIa prophylaxis. FEIBA prophylaxis was particularly more common (vs. rFVIIa prophylaxis) in the non-ITI setting [FEIBA (n=107 pts) vs rFVIIa (n=33 pts)]. The most common prophylactic FEIBA regimen was EOD or 3/wk while the most common rFVIIa prophylaxis regimen was daily. Conclusions: This survey captured data on 4,763 adults with SHA/SHB and on 751 adults and children with SH and inhibitors. This is the largest survey of prophylaxis in these 2 groups of patients. Given the benefits of prophylaxis in children it is reassuring to observe that prophylaxis in adults (without inhibitors) is more prevalent than previously reported. Use of BA-P in patients with inhibitors still however lags far behind the use of prophylaxis in non-inhibitor patients - particularly in adults. FEIBA is more commonly used for prophylaxis than rFVIIa. Our survey did not capture longterm patient outcome data; this needs evaluation. Note: This abstract includes data presented as separate abstracts at the ISTH 2015 meeting. The data has been combined and analyzed in this abstract to show the increasing use of prophylaxis outside of children without inhibitors. Disclosures Blanchette: Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Octapharma: Other: Data Safety Monitoring Board; Novo Nordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer Healthcare: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Baxter Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Data Safety Monitoring Board, Research Funding. Santagostino:CSL Behring: Speakers Bureau; Pfizer: Research Funding, Speakers Bureau; Biogen/Sobi: Speakers Bureau; Bayer: Speakers Bureau; Novo Nordisk: Speakers Bureau; Baxter/Baxalta: Speakers Bureau; Kedrion: Speakers Bureau; Biotest: Speakers Bureau; Octapharma: Speakers Bureau; Roche: Speakers Bureau. Leissinger:Bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novo Nordisk: Membership on an entity's Board of Directors or advisory committees, Research Funding; Baxter: Membership on an entity's Board of Directors or advisory committees, Research Funding; Kedrion: Membership on an entity's Board of Directors or advisory committees; Biogen: Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees. Aledort:Baxter Healthcare: Membership on an entity's Board of Directors or advisory committees, Other: DSMB Participation; Kedrion BioPharma: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Increasing Quality Improvement Capability in a Hemophilia Treatment Center

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5908-5908 ◽  
Author(s):  
Courtney Thornburg ◽  
Heidi Lane ◽  
Katharine Farrow ◽  
Rosalie Brooks ◽  
Mina Jahan ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Social Worker ◽  
Research Funding ◽  
Safety Monitoring ◽  
Data Safety Monitoring Board ◽  
Basic Knowledge ◽  
Improvement Program ◽  
Data Safety ◽  
Safety Monitoring Board ◽  
Data Safety Monitoring

Abstract Introduction Persons with hemophilia require complex medical care by a multi-disciplinary team throughout life. There are opportunities for Hemophilia Treatment Centers (HTC) to enhance the care of persons with hemophilia through participation in quality improvement (QI) initiatives. Maintaining comprehensive care and excellent health outcomes are national priorities for Health Resources and Services Administration (HRSA) and the American Thrombosis and Hemostasis Network (ATHN), the National Hemophilia Program Coordinating Center (NHPCC). Rady Children's Hospital San Diego (RCHSD) HTC participated in the NHPCC Dartmouth Improvement Program pilot program with the aim to develop QI capabilities within the HTCs to enhance the care of persons with hemophilia. Methods RCHSD participated in the NHPCC Dartmouth Improvement Program starting in December 2015. A QI team was established including the HTC medical director, nurse case managers, pediatric social worker and the social worker of the collaborating adult HTC. The QI team was coached by an expert TDIMA coach and a "coach in training" from another HTC. The team learned QI methods through in person training, web-based training and weekly team meetings with the coaches. The team assessed HTC data (The 5Ps-purpose, patients, professionals, processes, and patterns) to gain system knowledge and insights to determine a QI theme, global aim, specific aims and associated PDSA cycles. Results The RCHSD HTC QI team established a QI theme to focus on the transfer from pediatric to adult care. The Global Aim of the team is to improve autonomous communication in RCHSD HTC. The process begins with the 12 year old comprehensive clinic visit and ends with a new patient visit at an adult HTC. By working on the process, we expect patients to have the communication skills to be able to arrange medical insurance, call the home care company to order factor and to communicate their health and personal care needs to adult health care providers. We developed four specific aims which are in various stages of testing in PDSA cycles (Table 1). For Aim 1, we found that patients have only basic knowledge of insurance information. For Aim 2, we found that we needed to adjust our clinic process to make sure that patients receive their "after visit summary" that includes the insurance information prior to leaving clinic. Conclusions We developed a QI program within RCHSD HTC focused on improving transfer of care. Once we have completed the specific aim PDSA cycles we will standardize the new and improved procedures. We will continue to develop the program based on internal needs assessment and family input. This training model may be adapted by other HTCs to enhance patient care. Disclosures Thornburg: Mast Pharmaceuticals: Research Funding; Bayer Pharmaceuticals: Research Funding; Shire: Consultancy; Biogen Idec: Other: Data Safety Monitoring Board; Bluebird inc: Other: Data Safety Monitoring Board.

Adaptive designs from a Data Safety Monitoring Board perspective: Some controversies and some case studies

2017 ◽  
Vol 14 (5) ◽  
pp. 462-469 ◽  
Author(s):  
Bruce W Turnbull
Keyword(s):  
Clinical Trials ◽  
Case Studies ◽  
Adaptive Design ◽  
Safety Monitoring ◽  
Data Safety Monitoring Board ◽  
Adaptive Designs ◽  
Data Safety ◽  
Safety Monitoring Board ◽  
Data Safety Monitoring ◽  
Personal Experiences

This article describes vignettes concerning interactions with Data Safety Monitoring Boards during the design and monitoring of some clinical trials with an adaptive design. Most reflect personal experiences by the author.

scholarly journals 730. Hospital Readmissions Following Laboratory-Confirmed Influenza

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S262-S263
Author(s):  
David Dobrzynski ◽  
Danielle Ndi ◽  
Tiffanie Markus ◽  
Yuwei Zhu ◽  
William Schaffner ◽  
...  
Keyword(s):  
Hospital Readmissions ◽  
Safety Monitoring ◽  
Data Safety Monitoring Board ◽  
Categorical Variables ◽  
Discharge Data ◽  
Data Safety ◽  
Safety Monitoring Board ◽  
Data Safety Monitoring ◽  
Increased Risk ◽  
Research Grant

Abstract Background Further understanding of hospital readmissions after influenza illness could reduce readmissions. The aim of our study was to characterize the morbidity associated with laboratory confirmed influenza hospitalizations. Methods This was a retrospective study using data from 2006 to 2016 from the Tennessee (TN) Emerging Infections Program Influenza Surveillance Network, which prospectively identifies laboratory-confirmed influenza hospitalizations in Nashville, TN and surrounding counties. Using the TN Hospital Discharge Data System, which collects information on all hospitalizations and discharges in TN, cases were linked to subsequent hospitalizations up to 1 year. The International Classification of Diseases was used to define the primary diagnosis associated with each hospitalization. Demographic characteristics and outcomes were compared by using χ2 tests for categorical variables. Multivariable logistic regression was used to compare study outcomes. Results Of the 2,897 patients with a laboratory-confirmed influenza hospitalization, 1,364 (47%) had a hospital readmission during the subsequent year (figure). Multiple readmissions occurred in 740 patients (54%). The readmission group was older, female predominant, and had more comorbidities than patients not re-hospitalized. Acute COPD/asthma exacerbation, pneumonia, septicemia, and acute renal failure were the most common causes for readmission. Underlying cardiovascular disease (OR 1.6), lung disease (OR 1.6), kidney disease (OR 1.7), diabetes (OR 1.3), immunosuppression (OR 1.6), and liver disease (OR 2.1) were associated with increased risk of readmission (table). Conclusion An influenza hospitalization is associated with increased hospital readmissions. Approximately 47% of patients hospitalized with influenza are readmitted within 1 year. Patient comorbidities could be an important link to influenza readmissions. Disclosures W. Schaffner, Merck: Member, Data Safety Monitoring Board, Consulting fee. Pfizer: Member, Data Safety Monitoring Board, Consulting fee. Dynavax: Consultant, Consulting fee. Seqirus: Consultant, Consulting fee. SutroVax: Consultant, Consulting fee. Shionogi: Consultant, Consulting fee. H. K. Talbot, sanofi pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.

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