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Contribution of Four Pulmonary Function Tests to Diagnosis in the Primary Care.

8 février 2018 mis à jour par: Centre Hospitalier Universitaire Saint Pierre

Contribution of Four Pulmonary Function Tests to Diagnosis in Patients With Respiratory Symptoms in the Primary Care.

Contribution of four pulmonary function tests to diagnosis in patients with respiratory symptoms in the primary care.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

Background Pulmonary function tests are routinely used for the diagnosis of respiratory conditions. Few studies have been conducted, assessing the use of the pulmonary function tests and their contribution to the diagnosis in patients with respiratory symptoms. A recent study in 33 chest services from Belgian hospitals have shown that each of the four common pulmonary function tests (spirometry, lung volume, airway resistance and diffusing capacity) contributes significantly to the final diagnosis made by pulmonologists in new patients with respiratory symptoms.

Primary care physicians however treat the majority of patients with respiratory symptoms and often use a symptom-based approach to make a diagnosis (2). Diagnostic spirometry remains largely underused in primary care and is probably mainly performed in the care of patients with asthma and chronic obstructive pulmonary disease (COPD). Drawbacks of home spirometry also include poorly performed tests and incorrect interpretation of the results (3). In addition, primary care physicians have no access to the three other common pulmonary function tests that contribute independently to the diagnosis of respiratory diseases (1).

Since 2015, our chest service localized in the center of Brussels offers a direct and open access to the lung function laboratory to all the patients referred by their general practitioners. The four common tests are performed in their patients with respiratory symptoms but no clear diagnosis and the patients are not evaluated by the chest physicians. A protocol is however performed with potential advice for additional diagnostic tests (provocation tests, exhaled NO measurement, ergospirometry, imaging,…).

In the present study, we will assess the contribution of the four common pulmonary function tests to diagnosis in patients with respiratory symptoms in the primary care.

Methods Prospective single center cohort study. Adult patients, aged more than 18 years, presenting to the general practitioner with respiratory symptoms but without a clear diagnosis and referred by them for pulmonary function tests will be enrolled in the study. Patients will be excluded if they had diagnosed respiratory disease at our institution and if they are not able to perform pulmonary function testing.

The patients will not be seen or examined by a pulmonologist of the chest service. They will return to the referring family physician for further treatment.

Before lung function testing, the patients will be asked to fill in a questionnaire, including short questions about their medical history and respiratory medications, previous referrals to a pulmonologist, symptoms and comorbidities.

All patients, regardless of the suspected respiratory condition, will also be asked to complete the COPD assessment test (CAT test) to better quantify their symptoms.

The tests (spirometry, plethysmography, airway resistance measurement, diffusion capacity measurement) will then be performed by a qualified lung function lab technician. Interpretation of the results will be made by a pulmonologist. The protocol will be given to the patient or sent to the referring family physician and may also include proposals for additional diagnostic tests.

In second time, one month later, the general practitioner will be contacted by one of the investigators to receive more information about the final diagnosis based on all the investigations done and treatment.

The collected data will be processed in a database and analyzed anonymously. The primary outcome will be the increase in the proportion of diagnosis afforded by the four tests in comparison with spirometry alone. Secondary outcomes will be the proportion of patients without clear diagnosis, time to lung function tests and time to diagnosis.

Statistical analysis The present study is mainly descriptive and no hypothesis can be made on the contribution of additional lung function tests to the final diagnosis in a population of patients from general practitioners. The present study will include 100 patients with respiratory symptoms but no clear diagnosis.

Type d'étude

Observationnel

Inscription (Anticipé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

  • all patients, send by a general practitioner to our lung function lab
  • adults patients (older than 18 years and younger than 80 years), both sexes
  • not followed by a pulmonologist
  • no previous diagnosis and established treatment

La description

Inclusion Criteria:

  • all subjects: 18 or older than 18 years old and younger than 80 years old
  • send by a general practitioner for a lung function test

Exclusion Criteria:

  • subjects, younger than 18 years old
  • not able to perform the lung function tests
  • incomplete lung function tests
  • disease already diagnosed
  • already follow up by a pulmonologist
  • preoperative test

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
1 cohort
adult patients of both sexes (>18 and <80 years) with no previous diagnosis or follow up by a pulmonologist, send by a general practitioner to the lung function lab

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
number of cases in which the four lung function tests are contributing to the final diagnosis
Délai: at study completion
number of cases in which the four lung function tests are contributing to the final established diagnosis compared to spirometry alone
at study completion

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
number of cases in which additional tests were performed
Délai: at study completion
number of cases in which additional tests were needed to establish the correct final diagnosis, after the performance of the four lung function tests
at study completion
changes in treatment after the four lung function tests
Délai: at study completion
changes in treatment, prescribed by the primary physician, after the performance of the four lung function tests
at study completion

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Vincent Ninane, M.D., PhD, CHU St Pierre

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 avril 2017

Achèvement primaire (Anticipé)

25 juillet 2018

Achèvement de l'étude (Anticipé)

25 septembre 2018

Dates d'inscription aux études

Première soumission

24 janvier 2018

Première soumission répondant aux critères de contrôle qualité

31 janvier 2018

Première publication (Réel)

6 février 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 février 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 février 2018

Dernière vérification

1 février 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • B076201731685

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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