A Randomized Controlled Trial on Office Spirometry in Asthma and COPD in Standard General Practice: Study Design and Participants

This prospective, randomized, controlled, comparative trial involving 57 Italian reference specialist centers and 570 GPs (10 for each specialist center, randomly selected) homogeneously distributed throughout the country was designed to evaluate whether office spirometry by GPs may improve diagnostic accuracy in asthma and COPD. A preliminary phase consisted of two meetings of the 57 specialist centers to agree on the conduct of the study, including materials such as the questionnaires for patients and GPs, and the educational plan for primary physicians. Specialists agreed to refer to international Global Initiative for Chronic Obstructive Lung Disease and Global Initiative for Asthma guidelines.
A run-in phase from May to October 2002 was planned in which each specialist center held two educational meetings of 4 h each with GPs centered on international guidelines on asthma and COPD and spirometry, including practical sessions with the instrument selected for the study (Table 1). A simple questionnaire concluded the run-in period to evaluate the opinion of each GP on the feasibility and usefulness of office spirometry and to identify doctors willing to participate in the randomized comparative trial. Reasons for not participating were not formally requested. there

As an alternative to the randomized study, the GPs were also invited to continue for a period of 9 months with the application of office spirometry as part of a parallel observational study on the simple feasibility and self-rated usefulness of the test. The only incentives permitted legally for all doctors participating in the study were as follows: donation of the spirometer for research purposes by the nonprofit scientific association supporting the study, and acquisition of continuous medical education credits for the educational sessions.
Approval of the study by an ethics committee was left to the responsibility of each of the participating specialist centers. Each patient was requested to give informed consent to the processing of personal data.

Table 1—List of Contents of the Educational Meetings Held by Pulmonary Specialists for GPs

Pathophysiology of the respiratory system
Role of spirometry in respiratory medicine
Obstructive lung disorders: natural history, clinical features, and differential diagnosis of asthma and COPD
Discussion of three clinical cases (asthma, COPD, and mixed pattern)
Standard requirements for respiratory function tests according to international guidelines
How to perform spirometry (including reversibility tests): practical indications
The instruction of patients
Interpretation of spirometry results in different clinical situations
Algorithm for the interpretation of spirometry
Practical tests on the interpretation of spirometry: 12 clinical cases (interactive)
Continuing medical education questionnaires for self-evaluation
Practical session fully devoted to the field demonstration on how to use the portable spirometer adopted for the study plus direct testing of the personal device by GPs
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