NLM Scrubber: NLM s Software Application to De-identify Clinical Text Documents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Personally Identifiable Information. Basic parameters: from 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NLM Scrubber: NLM's Software Application to De-identify Clinical Text Documents
Overview
Background: Electronic health records contain a vast amount of data about diseases and treatments. Researchers could use this data to test their ideas, but they would need to use records from more than just their own group of patients. But access to those records is restricted to ensure patient privacy. U.S. National Library of Medicine (NLM) has created a computer tool called NLM Scrubber. This program recognizes and deletes personal information from health records. The researchers who developed this program now need access to the original records. This will allow them to see how well the program removes personal information from patient records and how they can make it more accurate. Objectives: To find ways to improve clinical text de-identification. Eligibility: No new participants. Researchers will review data that have already been collected. Design: Researchers will collect a random sample of reports. These will be from different doctors in different fields. Researchers will manually remove personal information from the records. Researchers will also automatically remove personal information from original records using NLM-Scrubber. Researchers will compare the results of the computer program versus the manual changes. They will note when the program has not been removing personal information correctly. They will also note when the program has been deleting nonpersonal health information incorrectly. Researchers will use the results to revise the program. They will keep testing it until the de-identification process is complete.
Detailed description
This study is about the quality assessment, improvement, and monitoring of an automatic clinical text de-identification software application called NLM Scrubber, which has been developed at the National Library of Medicine (NLM). The application has been developed so that clinical reports can be used in secondary scientific studies (i.e., for secondary use) without breaching patient privacy. Research on methods for protecting patient privacy and on the development of NLM Scrubber have been conducted by following the guidelines of and in compliance with HIPAA and the Privacy Act.
In order to further develop and improve NLM Scrubber and assess its de-identification performance effectively, the investigators require the original / unredacted samples from all potential clinical report types and sources. To this end, NLM investigators have been
collaborating with entities within NIH, namely, NIH Clinical Center, BTRIS, and NCI as well as outside entities, Kentucky State Registry administered by University of Kentucky and researchers from the University of Pittsburgh, who stated their interest in integrating NLM
Scrubber to their application called Text Information Extraction System. These entities collect samples of various types of clinical reports for assessing and improving NLM Scrubber performance. However we also need access to the original data in order to assess
potential problems and improve the accuracy of NLM Scrubber.
Primary outcome measures
- The rate of de-identification of PII [Time frame: 01/01/2017-01/31/2027]
Secondary outcome measures (1)
- The rate of erroneously redacted clinical information [Time frame: 01/01/2017-01/31/2027]
Eligibility criteria
- No new participant enrollment. Researchers will review data that have already been collected.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- National Library of Medicine — Bethesda
Publications
- Kayaalp M. Patient Privacy in the Era of Big Data. Balkan Med J. 2018 Jan 20;35(1):8-17. doi: 10.4274/balkanmedj.2017.0966. Epub 2017 Sep 13. PMID 28903886
- Kayaalp M, Browne AC, Dodd ZA, Sagan P, McDonald CJ. De-identification of Address, Date, and Alphanumeric Identifiers in Narrative Clinical Reports. AMIA Annu Symp Proc. 2014 Nov 14;2014:767-76. eCollection 2014. PMID 25954383
- Kayaalp M, Browne AC, Callaghan FM, Dodd ZA, Divita G, Ozturk S, McDonald CJ. The pattern of name tokens in narrative clinical text and a comparison of five systems for redacting them. J Am Med Inform Assoc. 2014 May-Jun;21(3):423-31. doi: 10.1136/amiajnl-2013-001689. Epub 2013 Sep 11. PMID 24026308
Identifiers
NCT: NCT02795806 · 999916122 · 16-LM-N122