Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-20 @ 6:00 PM
Study NCT ID:
NCT04432961
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Language Processing (NLP) Analysis of Free Text Notes to Investigate Coronavirus (COVID-19)
Sponsor:
Organization:
Raw JSON
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Patient with severe disease requiring ITU admission and non severe disease managed on an inpatient ward will be included. The variables of interest will include patient characteristics and specific encounter related information including length of stay and baseline investigations (e.g., blood tests) and interventions received'}], 'secondaryOutcomes': [{'measure': 'A set of annotation guidelines to produce human-expert (gold) labelled data for a subset of the EHR', 'timeFrame': '6 months'}, {'measure': 'A comparison of the NLP output to terms in the structured problem list to identify missing terms in the structured problem list', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Natural Language Processing'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'A retrospective cohort study investigating clinical notes using Natural Language Processing in combination with structured data from the Electronic Health Record (EHR) to create a database for analytics to identify features associated with outcomes.', 'detailedDescription': "Patients admitted to Cambridge University Hospitals (CUH)with COVID-19 have undergone routine clinical documentation and specific investigation and testing for COVID-19. The pathway for these patients ranges from supportive measures on the ward to deterioration requiring Intensive therapy Unit (ITU) admission and ventilatory support. Patients are also at risk of developing complications such as Acute Kidney Injury and thromboembolism. Identification of the risk factors for these and other outcomes such as the requirement for ventilation remain a challenge and reviewing the clinical data for these patients is critical in the understanding of the relationship between patient characteristics and outcomes.\n\nThere is data available in structured fields in the EHR, however, this is sometimes incomplete and inaccurate. An assessment of the free text clinical notes provides an opportunity to fill in the gaps and provide a much richer dataset for evaluation. We plan to use Natural Language Processing (NLP) (a field of machine learning that allows computers to analyse human language) to review Discharge Summaries of patients admitted to hospital with COVID-19 and convert free text data into structured data for analysis.\n\nThe NLP techniques developed by Dr Collier's team include methods for coding of free texts to SNOMED CT and other biomedical ontologies. These methods, based on statistical machine learning from human annotated texts, have been benchmarked for scientific texts and social media. In this project we intend to adapt these techniques for patient records. The techniques will require a number of human annotated patient records in order to adapt. The NLP output will be combined with structured data from the EHR and undergo statistical analysis to identify the rates of complications in patients with COVID-19 and risk factors associated with these. This may help to guide management decisions by earlier intervention to prevent poor outcomes in these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Cambridge University Hospitals NHS Foundation Trust with confirmed COVID-19', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female\n* Age range: 18 to 100 years\n* Patients admitted to Cambridge University Hospitals with confirmed COVID-19 on lab testing\n\nExclusion Criteria:\n\nChildren and patients with a negative COVID test.'}, 'identificationModule': {'nctId': 'NCT04432961', 'briefTitle': 'Natural Language Processing (NLP) Analysis of Free Text Notes to Investigate Coronavirus (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'A Database and Analytics Study of Free Text Clinical Notes and Structured Data to Investigate Phenotype Associations With Outcomes in Patients With COVID-19', 'orgStudyIdInfo': {'id': 'A095625'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cambridge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dr Sapna Trivedi', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}