Literature DB >> 28146330

Using electronic medical record data to report laboratory adverse events.

Tamara P Miller1,2,3, Yimei Li1,4, Kelly D Getz1,2, Jesse Dudley3, Evanette Burrows3, Jeffrey Pennington3, Azada Ibrahimova5, Brian T Fisher2,4,6,7, Rochelle Bagatell1,7, Alix E Seif1,7, Robert Grundmeier3,7, Richard Aplenc1,2,4,7.   

Abstract

Despite the importance of adverse event (AE) reporting, AEs are under-reported on clinical trials. We hypothesized that electronic medical record (EMR) data can ascertain laboratory-based AEs more accurately than those ascertained manually. EMR data on 12 AEs for patients enrolled on two Children's Oncology Group (COG) trials at one institution were extracted, processed and graded. When compared to gold standard chart data, COG AE report sensitivity and positive predictive values (PPV) were 0-21·1% and 20-100%, respectively. EMR sensitivity and PPV were >98·2% for all AEs. These results demonstrate that EMR-based AE ascertainment and grading substantially improves laboratory AE reporting accuracy.
© 2017 John Wiley & Sons Ltd.

Entities:  

Keywords:  accuracy; adverse events; electronic medical record; epidemiology; paediatrics

Mesh：

Year:  2017        PMID： 28146330      PMCID： PMC5384859          DOI： 10.1111/bjh.14538

Source DB:  PubMed          Journal:  Br J Haematol        ISSN： 0007-1048            Impact factor:   6.998


  12 in total

1.  The reliability of medical record review for estimating adverse event rates.

Authors:  Eric J Thomas; Stuart R Lipsitz; David M Studdert; Troyen A Brennan
Journal:  Ann Intern Med       Date:  2002-06-04       Impact factor: 25.391

2.  A national cancer clinical trials system for the 21st century: reinvigorating the NCI Cooperative Group Program.

Authors:  John F Scoggins; Scott D Ramsey
Journal:  J Natl Cancer Inst       Date:  2010-08-03       Impact factor: 13.506

3.  Using natural language processing to improve accuracy of automated notifiable disease reporting.

Authors:  Jeff Friedlin; Shaun Grannis; J Marc Overhage
Journal:  AMIA Annu Symp Proc       Date:  2008-11-06

Review 4.  Comparative Effectiveness Research Through a Collaborative Electronic Reporting Consortium.

Authors:  Alexander G Fiks; Robert W Grundmeier; Jennifer Steffes; William G Adams; David C Kaelber; Wilson D Pace; Richard C Wasserman
Journal:  Pediatrics       Date:  2015-06-22       Impact factor: 7.124

5.  Factors affecting workload of cancer clinical trials: results of a multicenter study of the National Cancer Institute of Canada Clinical Trials Group.

Authors:  Kathyrn Roche; Nancy Paul; Bobbi Smuck; Marlo Whitehead; Benny Zee; Joseph Pater; Mary-Anne Hiatt; Hugh Walker
Journal:  J Clin Oncol       Date:  2002-01-15       Impact factor: 44.544

6.  Low interrater reliability in grading of rectal bleeding using National Cancer Institute Common Toxicity Criteria and Radiation Therapy Oncology Group Toxicity scales: a survey of radiation oncologists.

Authors:  Minh-Phuong Huynh-Le; Zhe Zhang; Phuoc T Tran; Theodore L DeWeese; Daniel Y Song
Journal:  Int J Radiat Oncol Biol Phys       Date:  2014-10-13       Impact factor: 7.038

7.  Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children’s Oncology Group trial AAML0531.

Authors:  Alan S Gamis; Todd A Alonzo; Soheil Meshinchi; Lillian Sung; Robert B Gerbing; Susana C Raimondi; Betsy A Hirsch; Samir B Kahwash; Amy Heerema-McKenney; Laura Winter; Kathleen Glick; Stella M Davies; Patti Byron; Franklin O Smith; Richard Aplenc
Journal:  J Clin Oncol       Date:  2014-09-20       Impact factor: 44.544

8.  Combining free text and structured electronic medical record entries to detect acute respiratory infections.

Authors:  Sylvain DeLisle; Brett South; Jill A Anthony; Ericka Kalp; Adi Gundlapallli; Frank C Curriero; Greg E Glass; Matthew Samore; Trish M Perl
Journal:  PLoS One       Date:  2010-10-14       Impact factor: 3.240

9.  Preliminary Development and Evaluation of an Algorithm to Identify Breast Cancer Chemotherapy Toxicities Using Electronic Medical Records and Administrative Data.

Authors:  Jeanne S Mandelblatt; Karl Huang; Solomon B Makgoeng; Gheorghe Luta; Jun X Song; Michelle Tallarico; Janise M Roh; Julie R Munneke; Cathie A Houlston; Meghan E McGuckin; Ling Cai; Grace Clarke Hillyer; Dawn L Hershman; Alfred I Neugut; Claudine Isaacs; Larry Kushi
Journal:  J Oncol Pract       Date:  2014-08-26       Impact factor: 3.840

10.  An adverse event capture and management system for cancer studies.

Authors:  Alex Lencioni; Laura Hutchins; Sandy Annis; Wanchi Chen; Emre Ermisoglu; Zhidan Feng; Karen Mack; Kacie Simpson; Cheryl Lane; Umit Topaloglu
Journal:  BMC Bioinformatics       Date:  2015-09-25       Impact factor: 3.169
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  13 in total

1.  Unintended consequences of evolution of the Common Terminology Criteria for Adverse Events.

Authors:  Tamara P Miller; Brian T Fisher; Kelly D Getz; Leah Sack; Hanieh Razzaghi; Alix E Seif; Rochelle Bagatell; Peter C Adamson; Richard Aplenc
Journal:  Pediatr Blood Cancer       Date:  2019-04-09       Impact factor: 3.167

Review 2.  Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery.

Authors:  Tamara P Miller; Richard Aplenc
Journal:  Curr Hematol Malig Rep       Date:  2021-03-30       Impact factor: 3.952

3.  Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group.

Authors:  Tamara P Miller; Kelly D Getz; Yimei Li; Biniyam G Demissei; Peter C Adamson; Todd A Alonzo; Evanette Burrows; Lusha Cao; Sharon M Castellino; Marla H Daves; Brian T Fisher; Robert Gerbing; Robert W Grundmeier; Edward M Krause; Judy Lee; Philip J Lupo; Karen R Rabin; Mark Ramos; Michael E Scheurer; Jennifer J Wilkes; Lena E Winestone; Douglas S Hawkins; M Monica Gramatges; Richard Aplenc
Journal:  Lancet Haematol       Date:  2022-07-20       Impact factor: 30.153

4.  Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group.

Authors:  Caitlin W Elgarten; Joel C Thompson; Anne Angiolillo; Zhiguo Chen; Susan Conway; Meenakshi Devidas; Sumit Gupta; John A Kairalla; Jennifer L McNeer; Maureen M O'Brien; Karen R Rabin; Rachel E Rau; Susan R Rheingold; Cindy Wang; Charlotte Wood; Elizabeth A Raetz; Mignon L Loh; Sarah Alexander; Tamara P Miller
Journal:  Pediatr Blood Cancer       Date:  2022-09-09       Impact factor: 3.838

5.  Incidence and risk factors for hypoglycemia during maintenance chemotherapy in pediatric acute lymphoblastic leukemia.

Authors:  Elizabeth Rosenfeld; Kelly D Getz; Tamara P Miller; Alix E Seif; Brian T Fisher; Evanette Burrows; Mark Jason Ramos; Diva D De León; Richard Aplenc; Knashawn H Morales; James P Guevara
Journal:  Pediatr Blood Cancer       Date:  2021-11-22       Impact factor: 3.838

Review 6.  Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Authors:  Gita Thanarajasingam; Lori M Minasian; Frederic Baron; Franco Cavalli; R Angelo De Claro; Amylou C Dueck; Tarec C El-Galaly; Neil Everest; Jan Geissler; Christian Gisselbrecht; John Gribben; Mary Horowitz; S Percy Ivy; Caron A Jacobson; Armand Keating; Paul G Kluetz; Aviva Krauss; Yok Lam Kwong; Richard F Little; Francois-Xavier Mahon; Matthew J Matasar; María-Victoria Mateos; Kristen McCullough; Robert S Miller; Mohamad Mohty; Philippe Moreau; Lindsay M Morton; Sumimasa Nagai; Simon Rule; Jeff Sloan; Pieter Sonneveld; Carrie A Thompson; Kyriaki Tzogani; Flora E van Leeuwen; Galina Velikova; Diego Villa; John R Wingard; Sophie Wintrich; John F Seymour; Thomas M Habermann
Journal:  Lancet Haematol       Date:  2018-06-18       Impact factor: 18.959

7.  Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report.

Authors:  Tamara P Miller; Melissa Z Marx; Christopher Henchen; Nicholas P DeGroote; Sally Jones; Jenny Weiland; Beth Fisher; Adam J Esbenshade; Richard Aplenc; Christopher C Dvorak; Brian T Fisher
Journal:  J Patient Saf       Date:  2022-04-01       Impact factor: 2.844

Review 8.  Artificial intelligence in healthcare: past, present and future.

Authors:  Fei Jiang; Yong Jiang; Hui Zhi; Yi Dong; Hao Li; Sufeng Ma; Yilong Wang; Qiang Dong; Haipeng Shen; Yongjun Wang
Journal:  Stroke Vasc Neurol       Date:  2017-06-21

9.  Bortezomib with standard chemotherapy for children with acute myeloid leukemia does not improve treatment outcomes: a report from the Children's Oncology Group.

Authors:  Richard Aplenc; Soheil Meshinchi; Lillian Sung; Todd Alonzo; John Choi; Brian Fisher; Robert Gerbing; Betsy Hirsch; Terzah Horton; Samir Kahwash; John Levine; Michael Loken; Lisa Brodersen; Jessica Pollard; Susana Raimondi; Edward Anders Kolb; Alan Gamis
Journal:  Haematologica       Date:  2020-02-06       Impact factor: 9.941

10.  Machine learning model combining features from algorithms with different analytical methodologies to detect laboratory-event-related adverse drug reaction signals.

Authors:  Eugene Jeong; Namgi Park; Young Choi; Rae Woong Park; Dukyong Yoon
Journal:  PLoS One       Date:  2018-11-21       Impact factor: 3.240
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