Chest
Volume 129, Issue 4, April 2006, Pages 844-852
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Original Research
A Randomized Controlled Trial on Office Spirometry in Asthma and COPD in Standard General Practice: Data From Spirometry in Asthma and COPD: a Comparative Evaluation Italian Study

https://doi.org/10.1378/chest.129.4.844Get rights and content

Study objectives

To evaluate whether office spirometry by general practitioners (GPs) is feasible and may improve the diagnosis of asthma and COPD.

Methods

A prospective, randomized, comparative trial was planned involving 57 Italian pulmonology centers and 570 GPs who had to enroll consecutive subjects aged 18 to 65 years with symptoms of asthma or COPD without a previous diagnosis. Patients were randomized 1:1 into two groups with an interactive voice responding system: conventional evaluation alone vs conventional evaluation and spirometry. Office spirometry was performed by GPs who were trained by reference specialists using a portable electronic spirometer (Spirobank Office; MIR; Rome, Italy). Diagnosis was confirmed by the reference specialist center in blind fashion.

Results

Seventy-four GPs complied to the trial. Of 333 patients enrolled, 136 nonrandom violators completed the protocol. Per-protocol analysis showed a concordant diagnosis between GPs and specialists in 78.6% of cases in the conventional evaluation-plus-spirometry group vs 69.2% in the conventional evaluation group (p = 0.35). In the intention-to-treat analysis, the respective percentages of concordant diagnosis were 57.9 and 56.7 (p = 0.87).

Conclusions

Office spirometry by GPs is feasible, but frequent protocol violation and inadequate sample size did not allow us to prove a significant advantage of office spirometry in improving the diagnosis of asthma and COPD in standard general practice as organized at present in Italy, thus reinforcing the need for close cooperation between GPs and specialists in respiratory medicine.

Section snippets

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

Results

The vast majority of GPs attended the educational meetings (95% attended both sessions, and 99% attended at least one). No GP coworkers attended, since most Italian GPs work individually without staff support. Approximately 13% of GPs had postgraduate training in respiratory medicine, but none had ever used a spirometer regularly in their activity as GP.

Eighty-eight percent of GPs had from 1,000 to 1,500 patients registered at their practice; the remaining 12% had < 1,000 patients. Each GP

Discussion

Subjects with chronic respiratory disorders frequently have delayed access to diagnostic evaluation and treatment, in many cases because patients themselves minimize their symptoms and do not consult their GP.4 An ongoing debate in respiratory medicine focuses on whether the performance of spirometry by the GP may help in identifying asthma or COPD patients earlier, offering them a correct treatment even though specialist assessment is not readily available. The aim of our study was to verify

Appendix

The following physicians and Italian Pulmonary Medicine Centers participated in the study: Angelo Adovasio, Ospedale Pieve di Coriano, Pieve di Coriano MN; Vincenzo Albano, Casa di Cura Bernardini, Taranto; Goffredo Alviano, Glaviano, ASL CE/1 - D.S. n.25, Caserta; Saverio Amoroso, Ospedale Civico, Palermo; Antonio Areopagita, Ospedale “Moscati”, Avellino; Giovanni Azzarà, Ambulatorio A.S.L., Reggio Calabria; Guido Basetti, Sani, Ex I.O.T. ASL 10, Firenze; Gianbattista Bottino, Università di

Acknowledgment

We are indebted to OPIS DATA, Milan, Italy (Drs. A. Poli and S. Amigoni) for statistical support.

References (19)

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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

Supported by an unrestricted grant by SIMESA SpA (AstraZeneca Group), Milan, Italy.

The Spirometry in Asthma and COPD: a Comparative Evaluation (SPACE) study is a project of Associazione Scientifica Interdisciplinare per lo Studio delle Malattie Respiratorie, a scientific association for the multidisciplinary study of respiratory disorders.

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