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Pulmonary Environmental Epidemiology Unit, CNR Institute of Clinical Physiology, Via Trieste, 41 – 56126 Pisa, ItalyCNR Institute of Biomedicine and Molecular Immunology “A. Monroy”, Via U. La Malfa, 153 – 90146 Palermo, Italy
d UO Pisa: Istituto di Fisiologia Clinica CNR, Pisa: Anna Antonietta Angino [email protected], Sandra Baldacci [email protected], Marco Borbotti [email protected], Laura Carrozzi [email protected], Sonia Cerrai [email protected], Francesco Di Pede [email protected], Sara Maio [email protected], Maurizio Mangione [email protected], Franca Martini [email protected], Anna Paola Pala [email protected], Bona Barbara Piegaia [email protected], Francesco Pistelli [email protected], Giuseppe Sarno [email protected], Patrizia Silvi [email protected], Giovanni Viegi [email protected]; Sezione di Fisiopatologia Respiratoria, Dipartimento Cardio-Toracico e Vascolare, Università degli Studi di Pisa: Elena Bacci [email protected], Lorenza Bancalari (U.O. Pneumologia, ASL La Spezia), Federico Dente [email protected], Maria Pia Foschino (Clinica Malattie Respiratorie, Università di Foggia), Gianna Moscato (Fondazione Maugeri, Pavia), Pierluigi Paggiaro [email protected], Andrea Pelucchi (U.O. Fisiopatologia Respiratoria, Sesto San Giovanni). UO Roma: Istituto di Neurobiologia e Medicina Molecolare CNR, Roma: Megon Bresciani [email protected], Pasquale Pierimarchi [email protected]; Istituto Superiore di Sanità: Barbara Brunetto [email protected], Patrizia Iacovacci [email protected], Carlo Pini [email protected], Raffaella Tinghino [email protected]; Dipartimento di Epidemiologia, Servizio Sanitario Regionale, Regione Lazio: Francesco Forastiere [email protected], Carlo Alberto Perucci [email protected], Riccardo Pistelli (Complesso Integrato Columbus, Università Cattolica del Sacro Cuore, Roma) [email protected], Daniela Porta [email protected], Laura Ancona, Sara Protasi, Barbara Lazazzera, Valentina Ziroli, Eleonora D’Armini, Sabella Festa Campanile, Monica Ferri, Paola Lorusso; Società Italiana di Farmacia Ospedaliera e dei Servizi Farmaceutici delle Aziende Sanitarie (SIFO): Rita Salotti [email protected], Marco Santagati [email protected]. UO Perugia: Sezione di Medicina Interna e Scienze Oncologiche, Dipartimento di Medicina Clinica e Sperimentale dell’Università degli Studi di Perugia: Elisabetta Agea [email protected], Chiara Casciari [email protected], Nicola Murgia [email protected], Fabrizio Spinozzi [email protected]. UO Ancona: Servizio di Allergologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona: Floriano Bonifazi [email protected], Leonardo Antonicelli [email protected], Maria Chiara Braschi [email protected]. UO Napoli: Sez. Farmacologia, Dipartimento di Medicina Sperimentale, Seconda Università degli Studi di Napoli: Valeria Conti [email protected], Amelia Filippelli [email protected], Grazia Maria Corbi [email protected], Giusy Russomanno [email protected]. UO Genova: Clinica Tisiologica e Pneumologica, Dipartimento di Medicina Interna e Specialità Mediche, Università degli Studi di Genova: Fulvio Braido [email protected], Walter Canonica [email protected], Ilaria Baiardini (per papers inerenti Qualità della vita) [email protected], Balbi Francesco [email protected]. UO Pavia: Sezione di Fisiopatologia Respiratoria, Dipartimento di Scienze Ematologiche, Pneumologiche, Cardiovascolari Mediche e Chirurgiche dell’Università degli Studi di Pavia: Isa Cerveri [email protected], Angelo Corsico [email protected], Amelia Grosso [email protected].
To evaluate the impact of a medical education course (MEC) on the behaviour of general practitioners (GPs) to treat asthma and allergic rhinitis (AR).
Methods
Data on 1820 patients (mean age 41yrs±17yrs) with asthma or AR were collected by 107 Italian GPs: 50% attended a MEC and 50% didn’t (group B). The adherence for AR and asthma treatment was evaluated according to ARIA and GINA guidelines (GL).
Results
AR and asthma were diagnosed in 78% and 56% of patients; 34% had concomitant AR and asthma. Regardless of the MEC, the adherence to GL was significantly higher for AR than for asthma treatment (52 versus 19%). Group B GPs were more compliant to ARIA guidelines in the treatment of mild AR, whereas group A were more compliant in the treatment of moderate–severe AR; the adherence didn’t differ between the groups for AR patients with comorbid asthma. Adherence to GINA GL for asthma treatment did not differ between GPs of groups A and B, independently from concomitant AR. Though insignificantly, group A were more compliant to GINA GL in the treatment of patients with only severe persistent asthma (63 versus 46%) as group B were for patients with severe persistent asthma and concomitant AR.
Conclusions
GPs often tend to treat patients independently from GL. The impact of a single MEC did not improve adherence to GL in treating less severe AR and asthma patients, while there was a trend towards the opposite attitude in more severe AR patients without concomitant asthma.
Allergic rhinitis (AR) and asthma are inflammatory conditions of the respiratory tract that often coexist. AR affects 10–20% of people from all countries, ethnic groups, conditions and ages, causing major illness and disability worldwide, with substantial socioeconomic impact.
There is well-documented evidence of an important overlap between AR and asthma. It was found that about 40% of AR patients had asthma, and 30–80% of asthmatic patients reported AR.
The correct management of asthma and rhinitis could be ensured by following international GINA (Global Initiative for Asthma) and ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines (GL) published by the World Health Organization. ARIA GL stress the importance of the links between rhinitis and asthma and provide recommendations about best management options for most patients in most situations.
These GL have been developed to help physicians in ameliorating patients management by presenting them with optimal clinical practices based on a systematic review of current evidence about treatment options for asthma and allergic rhinitis. GINA and ARIA GL have been developed to improve the quality of care for patients and reduce the public health burden associated with these diseases. The GL specify that effective long-term control of disease may be achieved for each disease severity level by selecting appropriate medications, treating asthma attacks, identifying and avoiding asthma triggers, educating patients to manage their condition, and by regular monitoring of the disease.
However, there is evidence that GL recommendations are often not applied within the clinical practice
and this might result in under or overtreatment of patients. Difficulty in the implementation of GL in clinical practice may be due to several factors, including poor communication within the doctor–patient relationship, structural limitations of the National Health Systems, treatment duration, or the patients’ own beliefs about medications.
General practitioners (GPs) are among the first healthcare professionals to whom patients with asthma or rhinitis should refer for their symptoms and, therefore, GPs are encouraged to understand and use GL. Programs of Continuing Medical Education (CME) should improve both the medical knowledge and the adherence to GL, although studies on their effectiveness have shown conflicting results.
American College of Chest Physicians Health and Science Policy Committee Continuing medical education effect on physician knowledge application and psychomotor skills: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.
American College of Chest Physicians Health and Science Policy Committee Continuing medical education effect on practice performance: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.
Spreading and impact of the World Health Organization’s Allergic Rhinitis and its Impact on Asthma guidelines in everyday medical practice in France. Ernani survey.
CME programs differ largely around the world. They are established in the U.S. and many European countries since many years; in Italy, they became mandatory by law in 2002.
In spite of the high burden of asthma and AR in the general population and the important role played by GPs in the management of such diseases, there are few evaluations so far concerning data provided directly by GPs.
The ARGA study (the Italian acronym for ‘Allergopatie Respiratorie: studio di monitoraggio delle linee guida GINA e ARIA’), funded by the Italian Drug Agency (AIFA), was carried out between March 2007 and February 2010. The general aim was to monitor correspondence between scientific knowledge based on the World Health Organization GINA
GL for asthma and allergic rhinitis management and applicability in clinical practice.
The ARGA study included several sub-projects related to different cross-sectional or longitudinal studies with specific aims, and it was framed in four research sectors: (1) observational studies; (2) drug surveillance; (3) educational intervention; (4) prescriptive appropriateness and pharmacoeconomy.
The present study relies on the sub-project of the ARGA study titled ‘Observational study on Italian General Practitioners’.
Aim of the present report was to evaluate the impact of an educational program on GPs behaviour concerning: (1) drug prescription, for AR and asthma, and (2) prescription adherence to ARIA and GINA GL.
Methods
Population
This prospective study was performed by the Pulmonary Environmental Epidemiology Unit of the CNR Institute of Clinical Physiology (Pisa, Italy) with randomly enrolled GPs and their patients, residing in 20 Italian provinces distributed in three macro-areas (North, Centre, South-Islands). The number of GPs invited to participate was chosen based on density of the residing Italian population.
Recruitment was performed via mail. Considering a 30% drop out mean rate and a minimum number expected of 120 GPs, 180 GPs were invited to participate in the study. 89% of GPs (n=107) agreed to participate out of the minimum number expected.
GPs were invited to select all their patients with asthma and/or AR, with a pharmacological treatment or presence of asthma-like/AR symptoms in the last 12 months. Since in Italy under the age of 14 years children are in charge of family paediatricians and not of GPs, male and female Italian citizens aged 14 years and over were considered eligible subjects for our study. Subjects deemed unable to collaborate in the survey, and those permanently hospitalized or living in nursery homes, were excluded.
Participating patients provided “ex-ante” written informed consent for the purposes of the study (participation in the study, anonymous management of individual and collective data and anonymous publication of the research results).
Before the beginning of data collection, GPs were randomly divided in two groups (A and B). After the randomization and prior to the beginning of data collection, group A GPs (n=54, 50.5%) attended a medical educational course on ARIA and GINA GL. Group B GPs (n=53, 49.5%) did not participate in the course, and represented the control group. Two editions of the course were held, one at the end of March (Milan) and the other at the beginning of April (Rome), in order to facilitate the participation of GPs residing in the national territory. The course lasted 8 hours and dealt with the following topics: epidemiology of respiratory allergic diseases, ARIA and GINA GL (diagnosis, severity, control and drugs prescription), patients and caregiver education, quality evaluation of allergenic extracts utilized in specific immunotherapy, drug surveillance, prescriptions appropriateness and pharmacoeconomy, methodological aspects of the study.
The study protocol, patient information sheet and consent form were approved by the Ethic Committee of University-Hospital of Pisa (Azienda Ospedaliero-Universitaria Pisana) on October 13, 2006 (Prot. no. 37710 of October 25, 2006).
Data collection
GPs reported information on diagnosis, disease severity and treatment of their patients filling in a specifically formulated questionnaire.
Concerning diagnosis and severity level, we considered the following questions:
1.
‘What kind of diagnosis have you made for your patient?’ (AR, asthma or both).
2.
‘Have you assessed the severity level of AR/ asthma of your patients?’ (Yes, No).
3.
If Yes, ‘What is the diagnosed severity level of AR /asthma?’ (Mild intermittent, mild persistent, moderate–severe intermittent, moderate–severe persistent for AR
For some patients GPs did not answer the first question, even though they provided information on the severity level. Thus, to minimize missing information, a patient was classified as having AR and/or asthma according to the reported diagnosis and/or severity level.
Statistical analyses
Statistical analyses were carried out using the Statistical Package for Social Sciences (SPSS), rel. 13.0. Used routines were frequency distribution, cross tabulations, and non-parametric tests of Mann–Whitney.
The therapeutic groups considered in statistical analyses to assess the correct adherence to the guidelines were those listed in ARIA GL
To assess the impact of the preliminary educational course on prescribing adherence to GL, we compared the behaviour of group A GPs to that of group B GPs. For these comparisons, chi-square test was used. A two-tailed test with a 5% level of significance was used for analysis.
Seventeen GPs of group A and 17 GPs of group B should be enrolled to yield a 80% of power to detect, at the 5% level of significance, a 10% difference between the groups in the proportion of disease control obtained with the GL application; a higher number of GPs participated (54 GPs of group A and 53 GPs of group B) permitting us to yield 90% of power to detect, at the 5% level of significance, a 10% difference between the groups in the proportion of disease control obtained with the GL application.
Results
GPs participating in the study (n=107) were 79.3% male; 43.1% resided in the North macro-area, 18.6% in the Centre, and 38.2% in the South-Islands area.
Table 2 reports general characteristics, diagnosis, and severity level of patients enrolled in this study. GPs collected data on 1820 patients aged 14–90 (median age 40 yrs), 835 male (46%). Of these, 78% had AR, 56% had asthma and 34% had asthma+AR. In 13% of patients GPs reported they had not assessed severity level of the disease (12% of AR patients and 7% of asthmatics). As for disease severity, most of the patients with AR (72.8%) were diagnosed by GPs as having a mild form (46.2% mild intermittent and 26.6% mild persistent) and most asthma patients (73.8%) had an intermittent/mild persistent form. Only 7% of patients had moderate–severe persistent AR and 3.6% had severe persistent asthma.
Antihistamines (anti-H) and nasal corticosteroids (NCS) were the most prescribed drugs for AR treatment, regardless of GPs group, and whether these drugs were prescribed as single or combined therapy (Table 3).
Table 3Prescriptions for allergic rhinitis (AR) treatment as reported by general practitioners (GPs) attending (group A) and not attending (group B) the preliminary medical educational course. Percent prevalence by AR classification based on ARIA guidelines.
Prescribing patterns differed significantly in patients with only AR. In patients with mild intermittent AR, group B mostly prescribed anti-H as monotherapy; in mild persistent AR, group A prescribed other drugs (sistemyc corticosteroids) as monotherapy; in moderate–severe intermittent AR, group B GPs mostly prescribed anti-H as monotherapy, while group A GPs prescribed the combination of anti-H+NCS.
Prescribing patterns in patients with AR+asthma did not differ significantly in group A and B GPs with the exception of anti-H+other drug/s that were more prescribed in patients with mild intermittent AR by group A GPs.
Asthma treatment
Generally, inhaled corticosteroids (ICS)+long-acting β2-agonists (LABA) or short-acting β2-agonists (SABA) as monotherapy were the most frequently prescribed medicines in patients with asthma (Table 4).
Table 4Prescriptions for asthma treatment as reported by general practitioners (GPs) attending (group A) and not attending (group B) the preliminary medical educational course. Percent prevalence by asthma classification based on GINA guidelines.
There were significant differences between the two groups in the treatment of mild or moderate persistent asthma without AR co-morbidity. Group A GPs were more likely to treat these patients with combined therapies of LABA+ICS or LABA+other; instead, group B GPs more frequently prescribed LABA as monotherapy and associations of LABA with SABA.
Prescribing patterns for the treatment of asthma+AR did not differ significantly between group A GPs and group B GPs, except for the few patients with severe persistent asthma: both GPs prescribed a polipharmacy treatment with LABA, but group B GPs included also SABA prescription.
Prescription adherence to GL
In general, prescription adherence to GL was significantly higher for AR than for asthma (52.4 versus 19.4%, p<0.001) regardless of the educational course.
In general, GPs who did not attend the educational course were significantly more compliant to ARIA GL than those who did (Fig. 1). Sensitivity analysis for severity levels showed that group B GPs treated patients with mild AR more appropriately, reaching a significant difference in the mild intermittent subgroup. Group A GPs were instead more compliant to ARIA GL regarding prescriptions for persistent AR, significantly for the moderate–severe subgroup. Considering patients with asthma co-morbidity, there was no difference in the prevalence of adherence to ARIA GL for AR treatment between the two GPs groups.
Figure 1Prevalence of appropriate prescriptions according to ARIA guidelines for allergic rhinitis treatment. Comparison between general practitioners (GPs) attending (group A) and not attending (group B) the preliminary medical educational course. Mod–sev, moderate–severe. Statistical significance: ** p<0.01, ***p<0.001.
There were no significant differences in prescription adherence to GINA GL for asthma among group A GPs and group B GPs, even in patients with concomitant AR (Fig. 2). Although insignificantly, group A GPs were more compliant to GINA GL than group B GPs for patients with only severe persistent asthma (63 versus 46%), whereas an opposite trend was shown for severe persistent asthma patients with concomitant AR (57 versus 67%).
Figure 2Prevalence of appropriate prescriptions according to GINA guidelines for asthma treatment. Comparison between general practitioners (GPs) attending (group A) and not attending (group B) the preliminary medical educational course.
The time lapse between the educational course and data collection did not affect in any way prescriptive appropriateness by group A GPs (Mann–Whitney non-parametric test p=0.44 for AR and 0.54 for asthma).
Discussion
Regardless of the preliminary medical education course (MEC), GPs were more adherent to ARIA GL for AR treatment than GINA GL for asthma treatment. The adherence to GL significantly increased according to disease severity, in both groups A and B GPs.
There has been considerable debate and widespread skepticism about the impact of continuing medical education on physicians’ performance in the practice setting. In the U.S., disseminating multidisciplinary GL showed no clear effect on prescribing behaviour, even though GPs were more intensely involved in their development.
Does a joint development and dissemination of multidisciplinary guidelines improve prescribing behaviour: a pre/post study with concurrent control group and a randomised trial.
In Mexico, 40% of physicians did improve their prescribing practices after an interactive educational workshop on rhino-pharyngitis treatment, however more than 40% did not.
A study performed in France to determine the impact on medical practices of ARIA GL knowledge, found that there was no significant difference of first-line treatment strategy for asthma between physicians claiming to know ARIA GL and those who did not.
Spreading and impact of the World Health Organization’s Allergic Rhinitis and its Impact on Asthma guidelines in everyday medical practice in France. Ernani survey.
Accordingly, in our study we noted only few differences in prescription behaviour among group A GPs (attending the educational course) and group B GPs (not attending the course); in particular, group B GPs were more compliant to ARIA GL in the treatment of mild AR, whereas group A GPs tended to be more compliant in the treatment of moderate–severe AR. This behaviour might have been influenced by pre-existing knowledge about asthma and rhinitis management of both groups A and B GPs and by the attendance to other past educational initiatives. Short term period between the MEC and data collection might also have negatively affected GL adherence of group A GPs: in fact, there is evidence that prescribing habits of individual physicians are quite firmly established and changes might occur slowly depending on various factors like scientific papers, specialist recommendations, meetings, colleagues and patients.
Thus, exposure to a single educational course did not improve adherence to GL in treating less severe allergic rhinitis and asthma patients, while there was a trend towards the opposite in more severe allergic rhinitis patients without concomitant asthma.
Indeed, a recent review, concluded that multiple CME exposures are more effective to maximize retention and improve physician application of knowledge.
American College of Chest Physicians Health and Science Policy Committee Continuing medical education effect on physician knowledge application and psychomotor skills: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.
However, another recent review which evaluated the impact of CME on short- and long-term physician practice performance, indicated that the amount of frequency of exposure to CME activities appeared to have little effect on behaviour change.
American College of Chest Physicians Health and Science Policy Committee Continuing medical education effect on practice performance: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.
Regardless of the education course, the adherence to ARIA GL was quite low, in accordance with marketing studies, which show that the majority of GPs do not completely follow ARIA GL.
We noted a large use of antihistamines, even as monotherapy, to treat patients with moderate–severe persistent AR, although ARIA GL suggest NCS. Anti-H are more effective in seasonal than perennial AR, and the treatment with NCS is preferentially indicated for more severe form of AR with persistent nasal congestion.
GL adherence increased as AR severity augmented and reached its peak for moderate–severe persistent AR. This is a promising finding, since GL-based approach has been demonstrated more effective than freeform treatment
for such severity level. Overall, it is a good result that group A GPs were more compliant than group B GPs to treat more severe AR. This may indicate a limited validity of the medical education course in improving adherence to ARIA GL, regardless of asthma co-morbidity.
Asthma treatment
In general, adherence to GINA GL was low, independently of the education course. This is not surprising. Several authors continue to show poor physician’s compliance with asthma management guidelines in clinical practice,
Asthma pharmacotherapy prescribing in the ambulatory population of the United States: evidence of nonadherence to national guidelines and implications for elderly people.
Lack of awareness or familiarity to GL recommendations, disbelief that a recommendation will lead to an improved outcome, difficulties in reconciling patient’s preferences with guideline recommendations, lack of reminder systems/counseling materials/consultant support, as well as poor reimbursement or increased practice costs, and even increased liability may be self-reported barriers that undermine the adherence of physicians to clinical practice GL.
In the present study, LABA were prescribed as single therapy to treat at least a few patients, although LABA should only be used in combination with an appropriate dose of ICS, because the risk of asthma-related adverse events, including deaths, increases if LABA are taken as single medicine. We also found that less than one third (24–30%) of patients with intermittent or mild persistent asthma were prescribed ICS+LABA, regardless of asthma symptoms in the past year. A study performed in the U.S. on more than 16,000 asthmatics found that slightly less than 40% of patients met the criteria for appropriate prescription of ICS+LABA, and these patients were significantly more likely to be treated by pulmonologists and allergists than by GPs.
Association between previous health care use and initiation of inhaled corticosteroid and long-acting beta2-adrenergic agonist combination therapy among US patients with asthma.
On the other hand, our GPs did not use ICS to treat a large number of patients with persistent asthma. Recent studies have shown that only a small percentage of patients received appropriate treatment with ICS.
Although the use of SABA is recommended only for relief of symptoms, we found that SABA, in association with other drugs, were often used as controller medications to treat persistent asthma.
Similarly to ARIA GL, the adherence to GINA GL tended to improve as asthma severity increased. In general, the educational course did not affect prescriptive adherence to GINA GL, even though other authors have shown effectiveness.
The only possible indication of an effect of the MEC comes from the treatment of severe persistent asthma without concomitant AR, in which group A GPs were more compliant to GINA GL than group B GPs, although not significantly (Fig. 2).
Limitations of the study
Data on drug prescription patterns only provide limited information for judging their quality.
When we started the study, use of leukotriene receptor antagonists (LTRA) was recommended only for treating AR patients with concomitant asthma. During the course of our study, ARIA GL were updated and LTRA were added to the list of recommended drugs for rhinitis regardless of asthma co-morbidity.
Thus, our results on the adherence to GL have to be evaluated with caution.
Conclusion
Our results confirm similar studies showing that GPs often tend to ignore GL. However, there was a trend to improve adherence to GL when treating more severe patients.
A single medical educational course did not improve adherence to GL in treating less severe patients.
These findings underscore the need to implement clinical practice guidelines by more effective and innovative interventions aimed at improving physicians’ compliance.
Conflict of interest
All authors have no competing interests to declare.
Acknowledgements
The authors are indebted to the General Practitioners without whom the study would not have been possible.
This work was supported by the Italian Agency of Drug (AIFA), project no. FARMJY5SA “Respiratory allergic diseases: monitoring study of GINA and ARIA guidelines (ARGA)”.
American College of Chest Physicians Health and Science Policy Committee
Continuing medical education effect on physician knowledge application and psychomotor skills: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.
American College of Chest Physicians Health and Science Policy Committee
Continuing medical education effect on practice performance: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.
Spreading and impact of the World Health Organization’s Allergic Rhinitis and its Impact on Asthma guidelines in everyday medical practice in France. Ernani survey.
Does a joint development and dissemination of multidisciplinary guidelines improve prescribing behaviour: a pre/post study with concurrent control group and a randomised trial.
Asthma pharmacotherapy prescribing in the ambulatory population of the United States: evidence of nonadherence to national guidelines and implications for elderly people.
Association between previous health care use and initiation of inhaled corticosteroid and long-acting beta2-adrenergic agonist combination therapy among US patients with asthma.
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