The long-term objective of this research is to increase the clinical trial enrollment of US patients via a semi-automated, Natural Language Processing (NLP) based, interactive and patient-centered informaticsapplication. The study design is prospective observational study. Scope is limited to cancer patients. There arethree specific aims for this project.
The first aim i s to identify concepts that overlap between the electronicmedical record's (EMR) clinical notes and the free text of clinical trial announcements. The PI will use theconcepts to develop mapping frames that connect concepts in the text of trial announcements to those found inclinical notes in the medical record. When he has the mapping frames he will build the NLP module for theapplication. In the software development work he will utilize as many publicly available software componentsas possible. He will experiment with UIMA, GATE, MetaMap, Stanford Parser, NegEx algorithm and others.The PI will develop the tool around the National Library of Medicine's Unified Medical Language Systemknowledgebase. He will use Java for programming.
The second aim i s to create an algorithm that automaticallygenerates questions to request information directly from the patient if the information is not available oraccessible in the records.
The third aim i s to evaluate the in-vitro, laboratory performance of the application.For performance evaluation purposes the PI will recruit cancer care specialists to generate the gold standardlists of eligible clinical trials for study patients. He will publicly release the developed code at the end of thegrant period. This K99/R00 project will serve the foundation for future R01 grant applications. The PI is fullycommitted to become faculty in the Clinical Research Informatics domain with a specialization in biomedicalNLP. The support of the K99/R00 grant will enable him to acquire substantial formal training in ComputationalLinguistics while contributing to the body of knowledge of the Clinical Research Informatics field. The five-yeargrant support will ensure success in his endeavor. The proposed work is highly significant because the dismalclinical trial accrual rates (2-4 % nationally) hampers timely development of new drugs. In addition, studiesshow that physicians have statistically significant bias against elderly and minority patients to inviteparticipation in clinical trials. The proposed project is synergistic with physician-centered efforts but the goal isto provide individualized, EMR based clinical trial recommendations directly to the patients. The results of thisresearch will empower the patients and elevate their role in the decision making process.

Public Health Relevance

The long-term objective of this research is to increase the clinical trial enrollment of US patients via a semi- automated, Natural Language Processing (NLP) based, interactive and patient-centered informatics application. The proposed work is highly significant because the dismal clinical trial accrual rates (2-4 % nationally) hampers timely development of new drugs. In addition, studies show that physicians have statistically significant bias against elderly and minority patients to invite participation in clinical trials. The proposed project is synergistic with physician-centered efforts but the goal is to provide individualized, electronic medical record based clinical trial recommendations directly to the patients. The results of this research will empower patients and elevate their role in the decision making process.

Agency
National Institute of Health (NIH)
Institute
National Library of Medicine (NLM)
Type
Research Transition Award (R00)
Project #
5R00LM010227-04
Application #
8215715
Study Section
Special Emphasis Panel (ZLM1-ZH-C (01))
Program Officer
Sim, Hua-Chuan
Project Start
2010-10-02
Project End
2013-09-29
Budget Start
2011-09-30
Budget End
2012-09-29
Support Year
4
Fiscal Year
2011
Total Cost
$239,040
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Dexheimer, Judith W; Tang, Huaxiu; Kachelmeyer, Andrea et al. (2018) A Time-and-Motion Study of Clinical Trial Eligibility Screening in a Pediatric Emergency Department. Pediatr Emerg Care :
Ni, Yizhao; Wright, Jordan; Perentesis, John et al. (2015) Increasing the efficiency of trial-patient matching: automated clinical trial eligibility pre-screening for pediatric oncology patients. BMC Med Inform Decis Mak 15:28
Li, Qi; Spooner, Stephen Andrew; Kaiser, Megan et al. (2015) An end-to-end hybrid algorithm for automated medication discrepancy detection. BMC Med Inform Decis Mak 15:37
Ni, Yizhao; Kennebeck, Stephanie; Dexheimer, Judith W et al. (2015) Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department. J Am Med Inform Assoc 22:166-78
Li, Qi; Kirkendall, Eric S; Hall, Eric S et al. (2015) Automated detection of medication administration errors in neonatal intensive care. J Biomed Inform 57:124-33
Li, Qi; Melton, Kristin; Lingren, Todd et al. (2014) Phenotyping for patient safety: algorithm development for electronic health record based automated adverse event and medical error detection in neonatal intensive care. J Am Med Inform Assoc 21:776-84
Zhai, Haijun; Brady, Patrick; Li, Qi et al. (2014) Developing and evaluating a machine learning based algorithm to predict the need of pediatric intensive care unit transfer for newly hospitalized children. Resuscitation 85:1065-71
Lingren, Todd; Deleger, Louise; Molnar, Katalin et al. (2014) Evaluating the impact of pre-annotation on annotation speed and potential bias: natural language processing gold standard development for clinical named entity recognition in clinical trial announcements. J Am Med Inform Assoc 21:406-13
Deleger, Louise; Lingren, Todd; Ni, Yizhao et al. (2014) Preparing an annotated gold standard corpus to share with extramural investigators for de-identification research. J Biomed Inform 50:173-183
Zhai, Haijun; Lingren, Todd; Deleger, Louise et al. (2013) Web 2.0-based crowdsourcing for high-quality gold standard development in clinical natural language processing. J Med Internet Res 15:e73

Showing the most recent 10 out of 24 publications