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Implementing a Novel Quality Improvement-Based Approach to Data Quality Monitoring and Enhancement in a Multipurpose Clinical Registry

Pratt, Jesse; Jeffers, Daniel; King, Eileen C; Kappelman, Michael D; Collins, Jennifer; Margolis, Peter; Baron, Howard; Bass, Julie A; Bassett, Mikelle D; Beasley, Genie L; Benkov, Keith J; Bornstein, Jeffrey A; Cabrera, José M; Crandall, Wallace; Dancel, Liz D; Garin-Laflam, Monica P; Grunow, John E; Hirsch, Barry Z; Hoffenberg, Edward; Israel, Esther; Jester, Traci W; Kiparissi, Fevronia; Lakhole, Arathi; Lapsia, Sameer P; Minar, Phillip; Navarro, Fernando A; Neef, Haley; Park, K T; Pashankar, Dinesh S; Patel, Ashish S; Pineiro, Victor M; Samson, Charles M; Sandberg, Kelly C; Steiner, Steven J; Strople, Jennifer A; Sudel, Boris; Sullivan, Jillian S; Suskind, David L; Uppal, Vikas; Wali, Prateek D
Objective/UNASSIGNED:To implement a quality improvement based system to measure and improve data quality in an observational clinical registry to support a Learning Healthcare System. Data Source/UNASSIGNED:ImproveCareNow Network registry, which as of September 2019 contained data from 314,250 visits of 43,305 pediatric Inflammatory Bowel Disease (IBD) patients at 109 participating care centers. Study Design/UNASSIGNED:The impact of data quality improvement support to care centers was evaluated using statistical process control methodology. Data quality measures were defined, performance feedback of those measures using statistical process control charts was implemented, and reports that identified data items not following data quality checks were developed to enable centers to monitor and improve the quality of their data. Principal Findings/UNASSIGNED:There was a pattern of improvement across measures of data quality. The proportion of visits with complete critical data increased from 72 percent to 82 percent. The percent of registered patients improved from 59 percent to 83 percent. Of three additional measures of data consistency and timeliness, one improved performance from 42 percent to 63 percent. Performance declined on one measure due to changes in network documentation practices and maturation. There was variation among care centers in data quality. Conclusions/UNASSIGNED:A quality improvement based approach to data quality monitoring and improvement is feasible and effective.
PMCID:6777196
PMID: 31646151
ISSN: 2327-9214
CID: 4147512

Log reduction of multidrug-resistant Gram-negative bacteria by the neutrophil-derived recombinant bactericidal/permeability-increasing protein

Weitz, Andrea; Spotnitz, Russell; Collins, Jennifer; Ovadia, Steven; Iovine, Nicole M
Multidrug-resistant (MDR) Gram-negative bacterial infections are a serious and ever-increasing threat for which limited therapeutic options exist. The bactericidal/permeability-increasing protein (BPI) is a cationic, neutrophil-derived, lipopolysaccharide (LPS)-binding protein that binds to Gram-negative bacteria (GNB) and LPS via its lipid A region. A recombinant fragment, rBPI-21, was studied extensively in clinical trials for meningococcal disease in the 1990s and exhibited no significant safety issues. In this report, a dose-dependent 1-2 log reduction of MDR Pseudomonas and Acinetobacter after 1h incubation with rBPI-21 using clinically achievable doses is described. Given the dearth of novel antimicrobials expected to emerge from the pharmaceutical pipeline in the near future, exploration of rBPI-21 to combat MDR GNB is now warranted.
PMID: 24189329
ISSN: 0924-8579
CID: 666162

The Incidence of Systemic Allergic Reaction During Subcutaneous and Cluster Immunotherapy: A Retrospective Chart Review [Meeting Abstract]

Seiden, Danielle S; Lee, Jayeon; De Vos, Gabriele; Collins, Jennifer S
ISI:000316550800811
ISSN: 0091-6749
CID: 1753812

Lower serum hepcidin and greater parenchymal iron in nonalcoholic fatty liver disease patients with C282Y HFE mutations

Nelson, James E; Brunt, Elizabeth M; Kowdley, Kris V; Abrams, Stephanie H; Angeli, Leanel; McCullough, Arthur J; Brandt, Patricia; Bringman, Diane; Dasarathy, Srinivasan; Dasarathy, Jaividhya; Hawkins, Carol; Liu, Yao-Chang; Rogers, Nicholette; Stager, Margaret; Whitwell, Judy; McCullough, Arthur J; Dasarathy, Srinivasan; Pagadala, Mangesh; Sargent, Ruth; Yerian, Lisa; Zein, Claudia; Merriman, Raphael; Nguyen, Anthony; Mohan, Parvathi; Nair, Kavita; DeVore, Stephanie; Kohli, Rohit; Lake, Kathleen; Xanthakos, Stavra; Cosme, Yohaime; Lavine, Joel E; Mencin, Ali; Ovchinsky, Nadia; Abdelmalek, Manal F; Buie, Stephanie; Diehl, Anna Mae; Gottfried, Marcia; Guy, Cynthia; Hanna, Meryt; Kigongo, Christopher; Killenberg, Paul; Kwan, Samantha; Pan, Yi-Ping; Piercy, Dawn; Smith, Melissa; Srivastava, Savita; Byam, Elizabeth; Chalasani, Naga; Cummings, Oscar W; Ghabril, Marwan; Klipsch, Ann; Molleston, Jean P; Ragozzino, Linda; Subbarao, Girish; Tandra, Sweta; Vuppalanchi, Raj; Devadason, Caroline; Pfeifer, Kimberly; Scheimann, Ann; Torbenson, Michael; Kerkar, Nanda; Narayanappa, Sreevidya; Suchy, Frederick; Dunne, Katherine; Fishbein, Mark H; Jacques, Katie; Quinn, Ann; Riazi, Cindy; Whitington, Peter F; Barlow, Sarah; Derdoy, Jose; King, Debra; Morris, Andrea; Siegner, Joan; Stewart, Susan; Neuschwander-Tetri, Brent A; Thompson, Judy; Behling, Cynthia; Collins, Jennifer; Durelle, Janis; Hassanein, Tarek; Lavine, Joel E; Loomba, Rohit; Morgan, Anya; Rose, Steven; Patton, Heather; Schwimmer, Jeffrey B; Sirlin, Claude; Stein, Tanya; Aouizerat, Bradley; Bambha, Kiran; Bass, Marissa; Bass, Nathan M; Ferrell, Linda D; Filipowski, Danuta; Fleck, Shannon; Gu, Bo; Hameed, Bilal; Langlois, Camille; Pabst, Mark; Rosenthal, Monique; Rosenthal, Philip; Steel, Tessa; Coffey, Melissa; Galdzicka, Sarah; Murray, Karen; Yeh, Matthew; Boyett, Sherry; Contos, Melissa J; Fuchs, Michael; Jones, Amy; Luketic, Velimir A C; Puri, Puneet; Sandhu, Bimalijit; Sanyal, Arun J; Sargeant, Carol; Noble, Kimberly; White, Melanie; Ackermann, Sarah; Kowdley, Kris V; Park, Jane; Pierce, Tracey; Mooney, Jody; Nelson, James; Shaw, Cheryl; Stead, Alice; Wang, Chia; Brunt, Elizabeth M; Kleiner, David E; Grave, Gilman D; Doo, Edward C; Hoofnagle, Jay H; Robuck, Patricia R; Sherker, Averell; Belt, Patricia; Brancati, Frederick L; Clark, Jeanne M; Colvin, Ryan; Donithan, Michele; Green, Mika; Hollick, Rosemary; Isaacson, Milana; Jin, Wana K; Lydecker, Alison; Mann, Pamela; May, Kevin P; Miriel, Laura; Sternberg, Alice; Tonascia, James; Unalp-Arida, Aynur; Van Natta, Mark; Vaughn, Ivana; Wilson, Laura; Yates, Katherine
UNLABELLED:Hepcidin regulation is linked to both iron and inflammatory signals and may influence iron loading in nonalcoholic steatohepatitis (NASH). The aim of this study was to examine the relationships among HFE genotype, serum hepcidin level, hepatic iron deposition, and histology in nonalcoholic fatty liver disease (NAFLD). Single-nucleotide polymorphism genotyping for C282Y (rs1800562) and H63D (rs1799945) HFE mutations was performed in 786 adult subjects in the NASH Clinical Research Network (CRN). Clinical, histologic, and laboratory data were compared using nonparametric statistics and multivariate logistic regression. NAFLD patients with C282Y, but not H63D mutations, had lower median serum hepcidin levels (57 versus 65 ng/mL; P = 0.01) and higher mean hepatocellular (HC) iron grades (0.59 versus 0.28; P < 0.001), compared to wild-type (WT) subjects. Subjects with hepatic iron deposition had higher serum hepcidin levels than subjects without iron for all HFE genotypes (P < 0.0001). Hepcidin levels were highest among patients with mixed HC/reticuloendothelial system cell (RES) iron deposition. H63D mutations were associated with higher steatosis grades and NAFLD activity scores (odds ratio [OR], ≥1.4; 95% confidence interval [CI]: >1.0, ≤2.5; P ≤ 0.041), compared to WT, but not with either HC or RES iron. NAFLD patients with C282Y mutations had less ballooning or NASH (OR, ≤0.62; 95% CI: >0.39, <0.94; P ≤ 0.024), compared to WT subjects. CONCLUSIONS/CONCLUSIONS:The presence of C282Y mutations in patients with NAFLD is associated with greater HC iron deposition and decreased serum hepcidin levels, and there is a positive relationship between hepatic iron stores and serum hepcidin level across all HFE genotypes. These data suggest that body iron stores are the major determinant of hepcidin regulation in NAFLD, regardless of HFE genotype. A potential role for H63D mutations in NAFLD pathogenesis is possible through iron-independent mechanisms.
PMCID:3462887
PMID: 22611049
ISSN: 0270-9139
CID: 2807682

Increased allergic sensitization to mugwort in chronic urticaria

de Vos, Gabriele; Kravvariti, Evrydiki; Collins, Jennifer; Tavdy, Anna; Nazari, Ramin; Hudes, Golda; Rosenstreich, David
BACKGROUND: Mugwort pollen is known to cross-react with a variety of spices and vegetables that are typically part of elimination diets used in the treatment of chronic urticaria (CU). OBJECTIVE: We sought to investigate the association between CU and allergic sensitization to mugwort pollen. METHODS: We conducted 2 case-control studies comparing aeroallergen skin prick test results between patients with and without CU and with or without allergic rhinitis (total n = 202). RESULTS: CU patients with coexisting allergic rhinitis were more than twice as likely to be sensitized to mugwort as subjects not suffering from CU (67 vs. 30%; p = 0.004). Ragweed, cat, rat and mite sensitization were also significantly associated with CU. Overall, patients with CU had more positive aeroallergen skin tests than patients without CU (p < 0.005). CONCLUSION: Mugwort sensitization was associated with CU, possibly contributing to beneficial effect of elimination diets.
PMID: 23018776
ISSN: 1421-9832
CID: 1753702

Allergic bronchopulmonary aspergillosis treated successfully for one year with omalizumab

Collins, Jennifer; Devos, Gabriele; Hudes, Golda; Rosenstreich, David
BACKGROUND: Current therapy for allergic bronchopulmonary aspergillosis (ABPA) uses oral corticosteroids, exposing patients to the adverse effects of these agents. There are reports of the steroid-sparing effect of anti-IgE therapy with omalizumab for ABPA in patients with cystic fibrosis (CF), but there is little information on its efficacy against ABPA in patients with bronchial asthma without CF. OBJECTIVE: To examine the effects of omalizumab, measured by asthma control, blood eosinophilia, total serum immunoglobulin E (IgE), oral corticosteroid requirements, and forced expiratory volume spirometry in patients with ABPA and bronchial asthma. METHODS: A retrospective review of charts from 2004-2006 of patients treated with omalizumab at an academic allergy and immunology practice in the Bronx, New York were examined for systemic steroid and rescue inhaler usage, serum immunoglobulin E levels, blood eosinophil counts, and asthma symptoms, as measured by the Asthma Control Test (ACT). RESULTS: A total of 21 charts were screened for the diagnosis of ABPA and bronchial asthma. Four patients with ABPA were identified; two of these patients were male. The median monthly systemic corticosteroid use at 6 months and 12 months decreased from baseline usage. Total serum IgE decreased in all patients at 12 months of therapy. Pre-bronchodilator forced expiratory vital capacity at one second (FEV(1)) was variable at 1 year of treatment. There was an improvement in Asthma Control Test (ACT) symptom scores for both daytime and nighttime symptoms. CONCLUSIONS: Treatment with omalizumab creates a steroid-sparing effect, reduces systemic inflammatory markers, and results in improvement in ACT scores in patients with ABPA.
PMCID:3508546
PMID: 23204847
ISSN: 1178-6965
CID: 1753692

THE FIRST CASE REPORT OF CHRONIC OTITIS MEDIA TREATMENT WITH OMALIZUMAB [Meeting Abstract]

Wong, K; Codrin, I; Kim, H; Collins, J
ISI:000296825700183
ISSN: 1081-1206
CID: 1753832

Campylobacter capsule and lipooligosaccharide confer resistance to serum and cationic antimicrobials

Keo, Thormika; Collins, Jennifer; Kunwar, Pratima; Blaser, Martin J; Iovine, Nicole M
The innate immune system plays a critical role in host defense against mucosal bacteria. Campylobacter jejuni is a major cause of human gastroenteritis that usually resolves spontaneously within several days, suggesting that innate mechanisms are important to control the infection. However, the specific means by which this occurs is not well understood. While diarrheal isolates of C. jejuni usually are susceptible to human serum, we found that a systemic strain of C. jejuni, isolated from the cerebrospinal fluid of an infant with meningitis, is relatively more resistant to human serum, the Bactericidal/Permeability-Increasing Protein (BPI), an endogenous cationic antimicrobial protein, and the cationic peptide antibiotic polymyxin B. To test the hypothesis that the surface properties of this strain contributed to its ability to withstand these innate host defenses, we constructed isogenic mutants in capsule (kpsM) and lipooligosaccharide (waaF) and complemented these mutants by insertion of the complementation construct in trans into hipO, a chromosomal locus. We found that capsule expression was essential for serum resistance, whereas lipooligosaccharide played no substantial role. In contrast, the lipooligosaccharide mutant showed increased sensitivity to polymyxin B, alpha-defensins, cathelicidins, and BPI. These findings suggest that the polysaccharides of C. jejuni strains contribute differently to resistance against host innate immunity; whereby capsule is more important for resisting human complement and lipooligosaccharide is more important for protection against killing mediated by cationic antimicrobial peptides and proteins
PMCID:3073237
PMID: 21266840
ISSN: 2150-5608
CID: 123208

Mastocytic enterocolitis: an uncommon cause of [Meeting Abstract]

Chang, E; Jariwala, SP; Collins, Jennifer S; Hudes, G; Rosenstriech, D
ORIGINAL:0009837
ISSN: 1081-1206
CID: 1753872

Increased Pollen Sensitization In Patients With Chronic Urticaria [Meeting Abstract]

Collins, JS
ISI:000263596300412
ISSN: 0091-6749
CID: 1753852