Belgian Pulmonary Function Study (BPFS)

Belgian Pulmonary Function Study : the Belgian Thoracic Society

Pulmonary function tests including spirometry, lung volumes, measurements of resistance and diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests are an integral part of the diagnosis and treatment of lung diseases, but until now there is no clear evidence for the use of many of the pulmonary function tests because of a lack of adequate studies. The obscurity largely pertains to the conditions under which combinations of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all pulmonologists and the pneumology LOK/GLEM"s, will investigate this matter.

Study Overview

• Status: Completed
• Conditions: Respiratory Symptoms

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Leuven, Flanders, Belgium
      • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Caucasian outpatients with respiratory symptoms but without diagnosis

Description

Inclusion Criteria:

• Males and females
• Age between 18 and 75 years old
• New outpatients with respiratory symptoms as dyspnoea, cough, sputum, but without firm diagnosis
• Results of the tests are available and acceptable
• Standardized list of complaints
• Capability of patient for doing pulmonary function tests
• Seen by a Pneumologist
• Written informed consent

Exclusion Criteria:

• Patients with diagnosed respiratory disease
• Younger than 18 and older than 75 years old
• Recent heart attack
• Pneumothorax
• hemoptoic
• Suspicion of Tuberculosis
• Not capable to do pulmonary function tests

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Caucasian outpatients with respiratory symptoms; all consecutive new Caucasian outpatients with respiratory symptoms like dyspnoea, cough, sputum but without diagnosis who are being examined for the first time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis.	To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis and its reflection of the gold standard (final diagnosis), a statistical score will be calculated based on 1/n differential diagnoses after every pulmonary function test. The score will contain corrections for a high number of differential diagnoses and a wrong preferential diagnosis and compared with Linear mixed model after logistic transformation.	end of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% correct preferential diagnoses	To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on preferential diagnoses and their reflection of the gold standard (final diagnosis), the number and percentage of correct preferential diagnoses will be analysed after every pulmonary function test and compared by a generalized estimating equation model (GEE)	end of study
N differential diagnoses in the subgroup with correct preferential diagnosis	To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the number of differential diagnoses and their reflection of the gold standard (final diagnosis), the number of differential diagnoses in patients with correct preferential diagnosis will be analysed after each pulmonary function test and compared with Poisson GEE	end of study
subgroup analyses	The primary endpoint (1/n differntial diagnoses) and 2 secondary endpoints (% correct preferential diagnoses, n differential diagnoses within correct preferential diagnosis) will be analysed in subgroups with final gold standard diagnosis of COPD, asthma, interstitial lung disease and " no pulmonary abnormality"	end of study
Sensitivity analysis	Primary endpoint (1/n differntial diagnoses) and 2 secondary endpoints (% correct preferential diagnoses, n differential diagnoses within correct preferential diagnosis) and subgroup analyses (asthma, COPD, interstitial lung disease and no primary pulmonary abnormality) will be evaluated not only considering final diagnosis as standard but als correct side diagnosis	end of study

Collaborators and Investigators

• Sponsor: Marc Decramer
• Collaborators: Belgian Pulmonary Society
• Investigators: Principal Investigator: Marc MD Decramer, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• Decramer M, Janssens W, Derom E, Joos G, Ninane V, Deman R, Van Renterghem D, Liistro G, Bogaerts K; Belgian Pulmonary Function Study Investigators. Contribution of four common pulmonary function tests to diagnosis of patients with respiratory symptoms: a prospective cohort study. Lancet Respir Med. 2013 Nov;1(9):705-13. doi: 10.1016/S2213-2600(13)70184-X. Epub 2013 Oct 4.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 5, 2013
• Last Update Submitted That Met QC Criteria: March 4, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: sputum; cough; dyspnea; Caucasian outpatients; undiagnosed respiratory symptoms
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory
• Other Study ID Numbers: S52460