Razionale del progetto dimostrativo di AIMAR per GARD (Global Alliance against Chronic Respiratory Diseases)

GARD Demonstration project- Italy E-DIAL (Early DIAgnosis of obstrutive Lung disease)

Background

The Global Alliance against Chronic Respiratory Diseases (GARD) is a voluntary alliance of National and International Organisations, Institutions and agencies with the goal of reducing the global burden of chronic respiratory diseases.
In Italy Chronic Respiratory Diseases (CRDs) are the third cause of death (second if lung cancers are considered) causing more than 20,000 deaths from COPD and asthma and many million Italians suffer from disability caused by CRDs. Since 2006, the Italian Government has included CRDs in the four priorities of public health of the National Health Plan and in 2008 launched a plan to cope with chronic diseases by helping people to change lifestyles, with particular attention to tobacco control.
The Italian Multidisciplinary Association for the study of Respiratory Diseases (AIMAR) is a multidisciplinary society, born in 2003, composed of all professionals involved in any type of assistance to pulmonary patients (including GPs). AIMAR’s major aim is the development of chest medicine by advocacy and health education as well as professional education and research on pulmonary topics. AIMAR joined GARD in 2005 and since then has carried out some projects to implement it: observational (“SOS BPCO”- SOS COPD (1) as well as pharmaco-economic studies on COPD (“ICE” STUDY (2,3) and also a study on office spirometry (SPACE STUDY” (4). For professional education, AIMAR has published in its scientific journals the Italian edition of the ERS-ATS guidelines on pulmonary rehabilitation (5), the Italian guidelines on home ventilation of children with respiratory diseases (6), the Italian charts of respiratory risk (7) and the statements coming from the National Consensus conference on CRDs organised by AIMAR in Rome in 2007 ( 8). Concerning this latter event, the statements were then disseminated through 1+16 simultaneous conferences at local level in April, 2008 (9).
In order to implement the GARD strategy in Italy, AIMAR developed the Project “SOS-Respiro” (“SOS-Breath”). Forty-two respiratory units were recruited and reached a consensus on standardisation of pulmonary function tests, based on International Guidelines. A mass media campaign then started on newspapers/magazines and TV spots (the latter featuring the Coach of the 2006 World soccer cup National Team, Marcello Lippi - forecast for 1 week on a National TV network and for 4 months on local networks), inviting people who experience symptoms suggesting CRDs to refer to their General Practitioner (where educational materiall - poster and leaflet - was made available in some 10,000 GPs’ offices) or to the telephone line (1,709 calls received) or the website and eventually to undergo a spirometry in a Respiratory Unit. Results from this project evidenced a substantial underdiagnosis of COPD and asthma in Italy (10). Reports on all these actions carried out in Italy have been presented at successive GARD Assemblies, in Beijing (2006) (11), Seoul 2007 (12) and Istanbul 2008 (13). AIMAR is currently collaborating with the Italian Ministry of Health in preparing GARD-Italy, launching of which is planned this coming June, in Rome.

The GARD Demonstration Project E-DIAL

Continuing its actions for implementing the GARD strategy in Italy, AIMAR is now launching the GARD Demonstration Project which is named E-DIAL (Early DIAgnosis of obstructive Lung disease) aimed at reducing the underdiagnosis of CRDs in Italy.

Methods and actors

To carry out the project, use will be made of the protocol with the questionnaire and the procedures implemented in the frame of the PROTOCOL FOR ASSESSMENT OF BURDEN OF MAJOR RESPIRATORY DISEASES AT THE PHC LEVEL (14): this consists of a questionnaire that will be either administrated or self-completed and of lung function tests in a randomly selected sub-sample of patients. Lung function values will allow to confirm the diagnosis and screening of sub-clinical respiratory diseases. A total of 25 Respiratory Units will be enrolled throughout Italy. Each Unit will be a reference centre for 10 to 20 GPs. The questionnaire will be administered to the first 20 outpatients, attending the GP clinic on the first day of two consecutive weeks. The questionnaires will be self-administered by the nurse in the waiting room prior to the medical visit, whatever the reason for this visit: a leaflet will explain the reasons behind the questionnaire. The questionnaire will be collected and checked for answers by the GP at the end of the consultation. The GP will also complete a section of the questionnaire. The GP will then check the collected answers and indicate if the patient is known by him to be suffering from a CRD. If not, and if answers are suggestive of CRD, he will address the patient to the Respiratory Unit where the patient will be visited and will undergo a respiratory function test, including a reversibility test with salbutamol. The name, age and sex of the patients having been evaluated for respiratory problems will be written in a list by the GP who will also retain it. The GP will also collect the questionnaire and send it to the Respiratory Unit together with the request for a consultation. At the respiratory consultation, the patient will fill in the same questionnaire as phase I. The Chest Physician, to whom the patient is addressed, will evaluate the patient and fill a diagnostic form on management of the respiratory condition (diagnosis, treatment, exams) as recommended by the protocol. After and only after the medical visit, the patient will undergo a measurement of lung function. This will be performed by a technician, who at the end will fill out a Lung Function Tests (LFT) form. The name, age and sex of the patients having been visited for respiratory problems will be written in a list. Finally, the Chest Physician will deliver a diagnosis to the patient and a letter to the GP who sent the patient.

Studied population

As stated above, a total of 25 Respiratory Units will be enrolled throughout Italy to participate in the survey. Each Unit will be a reference centre for 10 to 20 GPs. In each GP’s clinic, 20 outpatients will be included each week. Thereafter 250 to 500 GPs will contribute to the survey for a total of 5000-10000 outpatients each week. The expected number of CRDs patients referred to each respiratory unit is between 40 and 120 for each week (based on the assumption of respiratory symptoms in 20-30% of all recruited patients per day). This means between 1000 and 3000 CRDs patients in total.

Consensus and Training

A one-day seminar will be organised by AIMAR, to present the project and its goals to the Respiratory Unit. Existing guidelines on respiratory function tests and their reports will also be discussed and a consensus reached. In addition, each Respiratory Unit will organise a meeting to brief their GPs on the project and discuss local topics.

Expected Results

The goal of the project is to measure the underdiagnosis of CRDs in Italy in a randomly selected population sample. The objectives are to optimise diagnosis and treatment of respiratory diseases by disseminating and implementing guidelines of reference. Other objectives include the creation of a local network able to manage CRDs and to implement a multidisciplinary approach to the diagnosis and treatment of CRDs, comparing also different local situations and promoting excellence, wherever possible. The results will be submitted to indexed journals for publication.

Involved Professionals

AIMAR Steering committee
Fernando De Benedetto
Claudio F. Donner
Stefano Nardini
Claudio M. Sanguinetti

Warranty Committee
Isabella Annesi- Maesano (INSERM- Paris)
Nikolai Khaltaev (WHO- Geneva)
Paola Pisanti (Ministry of Health- Rome)

References

1) Lusuardi M, Blasi F, Allegra L, Donner CF. Il management delle riacutizzazioni del paziente ospedalizzato in Italia. Multidisciplinary Respiratory Medicine 2007;4:54-56.
2) Lusuardi M, Lucioni C, Donner CF. Costs related to COPD exacerbations in Italy. Multidisciplinary Respiratory Medicine 2008 ;3(1):60-62.
3) Lusuardi M, Lucioni C, De Benedetto F, Mazzi SD, Sanguinetti CM, Donner CF. GOLD severity stratification and risk of hospitalization for COPD exacerbations. Monaldi Arch Chest Dis 2008,69: 164-169.
4) Lusuardi M, De Benedetto F, Paggiaro P, Sanguinett CM, Brazzola G, Ferri P, Donner CF . 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. Chest 2006;129(4):844-52.
5) Documento dell’American Thoracic Society American Thoracic Society / European Respiratory Society: rapporto ufficiale sulla riabilitazione respiratoria Linda Nici, et al. Traduzione a cura di Francesco Ioli. American Journal of Respiratory and Critical Care Medicine – Italian translation of Selected Articles - 2006 n.3 pag 87-116
6) Racca F, Gregoretti C, Cordola G, Bignamini E, Ranieri VM, Maspoli. M Linee guida per la ventilazione meccanica a pressione positiva domiciliare e le dimissioni protette del paziente pediatrico con insufficienza respiratoria cronica Multidisciplinary Respiratory Medicine 2006 n. 2 pag 46-83:
7) Zuccaro P, Pichini S, Mortali C, Pacifici R, Viegi G, Baldacci S, Angino A, Martini F, Borbotti M, Scognamiglio A, Simoni M, Silvi P, Di Pede F, Carrozzi L, Porta D, Simonato L, Crispo A, Merletti F, Forastiere. Fumo e patologie respiratorie: le carte del rischio per BPCO e tumore al polmone Multidisciplinary Respiratory Medicine 2007 n.2 pag 14-21: http://www.iss.it/binary/ofad/cont/carte%20del%20rischio.1229944649.pdf
8) Proceedings of the Consensus Conference in Respiratory Medicine, Rome, October 2007. Multidisciplinary Respiratory Medicine 2008; 3:105-162
9) Sanguinetti CM, De Benedetto F, Nardini S, Polverino M, Donner CF. “Primavera AIMAR” dissemination of the consensus in respiratory medicine to improve clinical practice. Multidisciplinary Respiratory Medicine 2008;3: 356-376
10) Nardini S, De Benedetto F, Sanguinetti CM, Donner CF. The “SOS breath” project- First fruit of AIMAR’ s collaboration in the WHO alliance of GARD Multidisciplinary Respiratory Medicine 2006; 1 (3):8-12
11) Donner CF, Nardini S. The WHO Global Alliance against chronic Respiratory Diseases (GARD) launched in Beijing March 2006. Multidisciplinary Respiratory Medicine 2006; 1(2):8-10.
12) http://www.who.int/gard/news_events/NARDINI_GARD_ITALY_(DEF). Pdf
13) http://www.who.int/gard/news_events/6_nardini.pdf
14) Martins P, Pinto JR, do Céu Teixeira M, Neuparth N, Silva O, Tavares H, Spencer JL, Mascarenhas D, Papoila AL, Khaltaev N, Annesi-Maesano I. Under-report and underdiagnosis of chronic respiratory diseases in an African country. Allergy 2009 DOI: 10.1111/j.1398-9995.2009.01956.