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lOw-dose CT cOmPared to Lung UltraSonography vs standard care for the diagnosis of pneumonia in the elderly: a multicentre randomized controlled study (OCTOPLUS)

English title lOw-dose CT cOmPared to Lung UltraSonography vs standard care for the diagnosis of pneumonia in the elderly: a multicentre randomized controlled study
Applicant Prendki Virginie
Number 197398
Funding scheme Project funding
Research institution Service de gériatrie Département réhabilitation et gériatrie Hôpitaux Universitaires de Genève
Institution of higher education University of Geneva - GE
Main discipline Internal Medicine
Start/End 01.04.2021 - 31.03.2024
Approved amount 885'908.00
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All Disciplines (2)

Discipline
Internal Medicine
Geriatrics

Keywords (7)

lung ultrasonography; computed tomography; chest X-ray; diagnosis; aged; pneumonia; accuracy

Lay Summary (French)

Lead
La pneumonie est une des premières causes de maladie et de décès de cause infectieuse chez les patients âgés, et une source importante de prescription d'antibiotiques. Les trois stratégies actuelles d’imagerie, qui sont primordiales dans le diagnostic, n’ont jamais fait l’objet d’études comparatives (essai randomisé). Le projet OCTOPLUS apporte sa contribution à ce domaine de recherche.
Lay summary

Contenu et objectifs du travail de recherche

Le diagnostic de pneumonie repose sur des arguments cliniques et l’apparition d’un infiltrat sur la radiographique thoracique. Cependant il est difficile chez la personne âgée car la pneumonie peut ressembler à d’autres maladies fréquentes et la radiographie peut être compliquée à réaliser et interpréter, même par des spécialistes. Le scanner thoracique à faible irradiation est une autre modalité qui semble plus performante, mais plus coûteuse et pas toujours disponible dans un contexte d’urgence. Enfin, l’échographie pulmonaire, non irradiante et facile d’accès, pourrait s’avérer être un outil diagnostique utile et pratique.

Dans l’étude, les patients de plus de 65 ans hospitalisés aux urgences pour une pneumonie bénéficieront des trois stratégies d’imagerie et seront répartis en trois groupes selon le tirage au sort. Seule une des trois imageries sera accessible au médecin en charge, qui fera son diagnostic sur la base des résultats de la clinique, la biologie et l’imagerie à laquelle il aura accès. Son diagnostic sera comparé à la fin de l’étude au diagnostic de référence (appelé gold standard) qui sera donné par des experts ayant accès à toutes les données recueillies. Il sera ainsi possible de voir si le scanner est supérieur en efficacité à la radiographie et d’évaluer également la performance de l’échographie.

Contexte scientifique et social du projet de recherche

Le projet relève de la recherche clinique, et s’intéresse à la pneumonie du sujet âgé, maladie fréquente dans le contexte actuel de vieillissement de la population mondiale. Pour mieux prendre en charge cette maladie, il est important d’en évaluer le diagnostic, sur le plan de l’efficacité mais également du coût pour la société. Si le scanner était supérieur à la radiographie, cela modifierait les pratiques médicales actuelles.


Direct link to Lay Summary Last update: 01.12.2020

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Associated projects

Number Title Start Funding scheme
167079 COMPASS study (COMPuterized Antibiotic Stewardship Study) 01.03.2017 NRP 72 Antimicrobial Resistance
182918 2nd European Conference on Diagnostic Error in Medicine (EuroDEM) 01.07.2018 Scientific Exchanges
196615 Mixed-method evaluation of an online forward triage tool within the COVID-19 pandemic 01.06.2020 Special Call on Coronaviruses
187284 The digital diagnostician: how information technology affects medical diagnoses 01.04.2020 NRP 77 Digital Transformation

Abstract

Background and rationale: Pneumonia is the leading cause of morbidity and mortality from infection in elderly patients, and an important cause of antibiotic prescription. Its diagnosis is challenging in elderly patients, because of the lack of sensitivity and specificity of signs, symptoms and chest x-ray (CXR) findings, and the high incidence of alternative diagnoses. Hence, new strategies are needed to improve the diagnosis of pneumonia and their impact should be assessed. CT scan findings have recently shown to impact both diagnosis and clinical management and point-of-care ultrasonography (US) is frequently used for patients admitted with respiratory symptoms.Overall aim: To compare the diagnostic, therapeutic, clinical and cost outcomes of three diagnostic strategies based on CXR (standard care), low-dose CT scan (LDCT) or lung US (LUS) in elderly patients with suspected community or nursing-home acquired pneumonia in the emergency room (ER).Primary objective: To evaluate whether a diagnostic strategy using LDCT compared with CXR leads to a more accurate diagnosis in suspected pneumonia in elderly patients (difference in accuracy between LDCT and CXR).Main secondary objectives: To evaluate 1) whether a diagnostic strategy using LUS compared with CXR leads to a more accurate diagnosis, 2) the sensitivity and specificity of CXR, LDCT and LUS, 3) whether a diagnostic strategy leads to a decrease in antibiotic consumption and 4) in the number of diagnostic tests ordered and 5) in a change in clinical outcomes (length of hospital stay, transfer to intensive care unit, intra-hospital mortality, 1 and 3-month readmission, 1 and 3-month mortality) and 6) cost outcomes; 7) to evaluate concordance between physicians at the ER and experts and 8) the association of biomarkers and the presence of an infiltrate. Methods: Swiss multicentric individual-level randomized superiority clinical trial with 3 parallel arms, conducted on opening hours. Patients will be screened for eligibility since their arrival to the ER; CXR, LDCT, and LUS (by a certified ultrasonographist not in charge of the patient) will be performed in all patients within 4 hours. Patients will be randomized 1:1:1 and according to the allocation arm, the results of 2 imaging modalities will be registered on a dedicated secured research picture archiving and communication system and masked to the patients, the treating physician, and the investigators assessing the outcomes. The imaging available to the treating physician will be obtained first no later than 2 hours after randomization ensure prompt clinical diagnosis and treatment decisions. Unblinding of the images will be done on day 5. In case of subsequent clinical deterioration, the physician will be able to order new imaging and in case of an emergency finding, the concealed results will be unblinded earlier. At the end of the study, all 3 imaging methods will be interpreted by 2 experts in chest Imaging and then the reference diagnosis will be determined by a panel of experts using all available patient data, including all imaging modalities and the consensus reached by previous experts. We plan to enrol 165 patients in each arm, for a total of 495 with a power of 0.9, based on a previous study. We expect 2 years of recruitment. The total follow-up will be 3 months.Expected results: Superiority of LDCT over CXR, and of LUS over CXR for the diagnosis of pneumonia. Impact of this study: Confirmed superiority of LDCT over CXR could affect recommendations for the diagnosis of pneumonia in elderly patients, where LDCT should be preferred to CXR. Higher diagnostic accuracy could lead to a reduction in the overuse of antibiotics and better clinical and cost outcomes. The same should apply if LUS shows superiority over CXR, with the advantage over LDCT that it is more easily available and non-irradiating (approval by the ethic committee of Geneva (number 2019-01288).
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