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OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale
BACKGROUND: Chest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease at the emergency department (ED) for years. Recently, ultra-low-dose chest computed tomography (ULD chest CT) has been introduced, which provides substantially more detailed informa...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6460797/ https://www.ncbi.nlm.nih.gov/pubmed/31093568 http://dx.doi.org/10.1186/s41512-018-0038-1 |
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author | van den Berk, Inge A. H. Kanglie, Maadrika M. N. P. van Engelen, Tjitske S. R. Bipat, Shandra Dijkgraaf, Marcel G. W. Bossuyt, Patrick M. M. de Monyé, Wouter Prins, Jan M. Stoker, Jaap |
author_facet | van den Berk, Inge A. H. Kanglie, Maadrika M. N. P. van Engelen, Tjitske S. R. Bipat, Shandra Dijkgraaf, Marcel G. W. Bossuyt, Patrick M. M. de Monyé, Wouter Prins, Jan M. Stoker, Jaap |
author_sort | van den Berk, Inge A. H. |
collection | PubMed |
description | BACKGROUND: Chest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease at the emergency department (ED) for years. Recently, ultra-low-dose chest computed tomography (ULD chest CT) has been introduced, which provides substantially more detailed information on pulmonary conditions that may cause pulmonary disease, with a dose in the order of chest X-ray (0.1 vs. 0.05 mSv). The OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or CT (OPTIMACT) study is a randomized trial designed to evaluate the effectiveness of replacing chest X-ray for ULD chest CT in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED. METHODS: Two thousand four hundred patients presenting at the ED with pulmonary complaints and suspected of non-traumatic pulmonary disease will be enrolled in this multicenter, pragmatic, randomized trial. During randomly assigned periods of one calendar month, either conventional chest X-ray or ULD chest CT scan will be used as the imaging strategy. Randomization will rely on computer-generated blocks of 2 months to control for seasonal effects. Chest X-ray and ULD chest CT will be performed in a standardized way, after obtaining the clinical history and performing physical examination and initial laboratory tests. The primary outcome measure is functional health at 28 days. Secondary outcome measures are mental health, length of hospital stay, mortality within 28 days, quality-adjusted life years (QALYs) during the first 28 days, correct diagnoses at ED discharge as compared to the final post hoc diagnosis, and number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT. In an economic evaluation, we will estimate total health care costs during the first 28 days. DISCUSSION: This pragmatic trial will clarify the effects of replacing chest X-ray by ULD chest CT in daily practice, in terms of patient-related health outcomes and costs, in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED. TRIAL REGISTRATION: The OPTIMACT trial is registered in the Netherlands National Trial Register under number NTR6163. The date of registration is December 6, 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s41512-018-0038-1) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6460797 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-64607972019-05-15 OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale van den Berk, Inge A. H. Kanglie, Maadrika M. N. P. van Engelen, Tjitske S. R. Bipat, Shandra Dijkgraaf, Marcel G. W. Bossuyt, Patrick M. M. de Monyé, Wouter Prins, Jan M. Stoker, Jaap Diagn Progn Res Protocol BACKGROUND: Chest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease at the emergency department (ED) for years. Recently, ultra-low-dose chest computed tomography (ULD chest CT) has been introduced, which provides substantially more detailed information on pulmonary conditions that may cause pulmonary disease, with a dose in the order of chest X-ray (0.1 vs. 0.05 mSv). The OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or CT (OPTIMACT) study is a randomized trial designed to evaluate the effectiveness of replacing chest X-ray for ULD chest CT in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED. METHODS: Two thousand four hundred patients presenting at the ED with pulmonary complaints and suspected of non-traumatic pulmonary disease will be enrolled in this multicenter, pragmatic, randomized trial. During randomly assigned periods of one calendar month, either conventional chest X-ray or ULD chest CT scan will be used as the imaging strategy. Randomization will rely on computer-generated blocks of 2 months to control for seasonal effects. Chest X-ray and ULD chest CT will be performed in a standardized way, after obtaining the clinical history and performing physical examination and initial laboratory tests. The primary outcome measure is functional health at 28 days. Secondary outcome measures are mental health, length of hospital stay, mortality within 28 days, quality-adjusted life years (QALYs) during the first 28 days, correct diagnoses at ED discharge as compared to the final post hoc diagnosis, and number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT. In an economic evaluation, we will estimate total health care costs during the first 28 days. DISCUSSION: This pragmatic trial will clarify the effects of replacing chest X-ray by ULD chest CT in daily practice, in terms of patient-related health outcomes and costs, in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED. TRIAL REGISTRATION: The OPTIMACT trial is registered in the Netherlands National Trial Register under number NTR6163. The date of registration is December 6, 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s41512-018-0038-1) contains supplementary material, which is available to authorized users. BioMed Central 2018-08-08 /pmc/articles/PMC6460797/ /pubmed/31093568 http://dx.doi.org/10.1186/s41512-018-0038-1 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Protocol van den Berk, Inge A. H. Kanglie, Maadrika M. N. P. van Engelen, Tjitske S. R. Bipat, Shandra Dijkgraaf, Marcel G. W. Bossuyt, Patrick M. M. de Monyé, Wouter Prins, Jan M. Stoker, Jaap OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale |
title | OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale |
title_full | OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale |
title_fullStr | OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale |
title_full_unstemmed | OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale |
title_short | OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale |
title_sort | optimal imaging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest x-ray or ultra-low-dose ct (optimact)—a randomised controlled trial chest x-ray or ultra-low-dose ct at the ed: design and rationale |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6460797/ https://www.ncbi.nlm.nih.gov/pubmed/31093568 http://dx.doi.org/10.1186/s41512-018-0038-1 |
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