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Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study

BACKGROUND: Common disease-specific outcomes are vital for ensuring comparability of clinical trial data and enabling meta analyses and interstudy comparisons. Traditionally, the process of deciding which outcomes should be recommended as common for a particular disease relied on assembling and surv...

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Autores principales: Elghafari, Anas, Finkelstein, Joseph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899806/
https://www.ncbi.nlm.nih.gov/pubmed/33460388
http://dx.doi.org/10.2196/18298
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author Elghafari, Anas
Finkelstein, Joseph
author_facet Elghafari, Anas
Finkelstein, Joseph
author_sort Elghafari, Anas
collection PubMed
description BACKGROUND: Common disease-specific outcomes are vital for ensuring comparability of clinical trial data and enabling meta analyses and interstudy comparisons. Traditionally, the process of deciding which outcomes should be recommended as common for a particular disease relied on assembling and surveying panels of subject-matter experts. This is usually a time-consuming and laborious process. OBJECTIVE: The objectives of this work were to develop and evaluate a generalized pipeline that can automatically identify common outcomes specific to any given disease by finding, downloading, and analyzing data of previous clinical trials relevant to that disease. METHODS: An automated pipeline to interface with ClinicalTrials.gov’s application programming interface and download the relevant trials for the input condition was designed. The primary and secondary outcomes of those trials were parsed and grouped based on text similarity and ranked based on frequency. The quality and usefulness of the pipeline’s output were assessed by comparing the top outcomes identified by it for chronic obstructive pulmonary disease (COPD) to a list of 80 outcomes manually abstracted from the most frequently cited and comprehensive reviews delineating clinical outcomes for COPD. RESULTS: The common disease-specific outcome pipeline successfully downloaded and processed 3876 studies related to COPD. Manual verification indicated that the pipeline was downloading and processing the same number of trials as were obtained from the self-service ClinicalTrials.gov portal. Evaluating the automatically identified outcomes against the manually abstracted ones showed that the pipeline achieved a recall of 92% and precision of 79%. The precision number indicated that the pipeline was identifying many outcomes that were not covered in the literature reviews. Assessment of those outcomes indicated that they are relevant to COPD and could be considered in future research. CONCLUSIONS: An automated evidence-based pipeline can identify common clinical trial outcomes of comparable breadth and quality as the outcomes identified in comprehensive literature reviews. Moreover, such an approach can highlight relevant outcomes for further consideration.
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spelling pubmed-78998062021-03-02 Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study Elghafari, Anas Finkelstein, Joseph JMIR Med Inform Original Paper BACKGROUND: Common disease-specific outcomes are vital for ensuring comparability of clinical trial data and enabling meta analyses and interstudy comparisons. Traditionally, the process of deciding which outcomes should be recommended as common for a particular disease relied on assembling and surveying panels of subject-matter experts. This is usually a time-consuming and laborious process. OBJECTIVE: The objectives of this work were to develop and evaluate a generalized pipeline that can automatically identify common outcomes specific to any given disease by finding, downloading, and analyzing data of previous clinical trials relevant to that disease. METHODS: An automated pipeline to interface with ClinicalTrials.gov’s application programming interface and download the relevant trials for the input condition was designed. The primary and secondary outcomes of those trials were parsed and grouped based on text similarity and ranked based on frequency. The quality and usefulness of the pipeline’s output were assessed by comparing the top outcomes identified by it for chronic obstructive pulmonary disease (COPD) to a list of 80 outcomes manually abstracted from the most frequently cited and comprehensive reviews delineating clinical outcomes for COPD. RESULTS: The common disease-specific outcome pipeline successfully downloaded and processed 3876 studies related to COPD. Manual verification indicated that the pipeline was downloading and processing the same number of trials as were obtained from the self-service ClinicalTrials.gov portal. Evaluating the automatically identified outcomes against the manually abstracted ones showed that the pipeline achieved a recall of 92% and precision of 79%. The precision number indicated that the pipeline was identifying many outcomes that were not covered in the literature reviews. Assessment of those outcomes indicated that they are relevant to COPD and could be considered in future research. CONCLUSIONS: An automated evidence-based pipeline can identify common clinical trial outcomes of comparable breadth and quality as the outcomes identified in comprehensive literature reviews. Moreover, such an approach can highlight relevant outcomes for further consideration. JMIR Publications 2021-02-08 /pmc/articles/PMC7899806/ /pubmed/33460388 http://dx.doi.org/10.2196/18298 Text en ©Anas Elghafari, Joseph Finkelstein. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 08.02.2021. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on http://medinform.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Elghafari, Anas
Finkelstein, Joseph
Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study
title Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study
title_full Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study
title_fullStr Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study
title_full_unstemmed Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study
title_short Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study
title_sort automated identification of common disease-specific outcomes for comparative effectiveness research using clinicaltrials.gov: algorithm development and validation study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899806/
https://www.ncbi.nlm.nih.gov/pubmed/33460388
http://dx.doi.org/10.2196/18298
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