Outcome analysis of the asthma therapy

Átírás

1 SEMMELWEIS UNIVESITY DOCTORAL SCHOOL of PHARMACEUTICAL AND PHARMACOLOGICAL SCIENCES Ph.D. Thesis Outcome analysis of the asthma therapy By: Mészáros Ágnes Ph.D. candidate Tutor: Dr. Vincze Zoltán Ph.D. Semmelweis University University Pharmacy Institute of Pharmacy Administration Budapest,

2 Introduction Asthma is a condition that was first observed in China something like 4,000 years ago. Yet it s hardly been four decades since people in this part of the world started getting serious about what it is and how to treat it. Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role, in particular mast cells, eosinophiles and T-lymphocytes. In susceptible individuals this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and cough in particularly at night and/or in the early morning. These symptoms are usually associated with widespread but variable airflow limitation that is at least partly reversible either spontaneously or with treatment. The inflammation also causes an associated increase in airway responsiveness to a variety of stimuli. Economics is about trade-offs and choices between wants, needs and the scarcity of resources to fulfil these wants. Outcome studies differ significantly from conventional clinical trials. Clinical trials are efficacy studies that classically evaluate a medication or procedure by the scientific method, usually in a prospective, randomised, doubleblind fashion. Outcome analysis are "real-world" projects in which physicians may not know all of the details regarding a treatment or procedure, the patients may or may not be adherent to therapy, and comorbidities in individual subjects may exist. Chronic diseases that affect a large part of the population and have a significant cost to society are perfect candidates for outcome analysis. As several recent review articles have discussed, asthma is one such condition. Interest in health economic analyses in asthma may be grouped into three broad categories. The first includes the perspective of governments and pharmaceutical industry. The second includes those organisations, which are involved in providing the health care. The third is the patient, who has to meet direct and indirect costs of their disease and the clinician who has to work within a certain budget. Objectives of this study were the following: To focus on the economic burden of asthma in connection to the epidemiological data. The drug consumption, drug cost and other costs related to asthma were analysed. To evaluate patients quality of life with general quality of life instruments, the visual analogue scale, the Euro-QoL questionnaire, the SF-36 and disease specific instruments, the St George s Respiratory Questionnaire. The quality of life examinations were focusing on the evaluation of the quality of life of asthmatics and non-asthmatics in Hungary, to assess the relationship between the severity and the quality of life scores, to evaluate the possible use of psychometric and utility-based measures in asthma, to measure the correlation between the general and disease specific quality of life instruments, to evaluate the influential factors on asthma quality of life. Furthermore the objective of the study was to assess the quality of life of asthmatic patients and to study the influence of age and severity of the disease, as independent variables, on the patient s quality of life. A 2-factor, 3-level face-centred central composite design was applied to construct a second-order polynomial model describing the effect of age and that of the severity of asthma on the patient's quality of life. As well as to develop an educational instrument to assess it s impact as an intervention instrument and to examine quality of life. Results? Although the number of asthma patents is increasing year by year in Hungary. the overall drug consumption between 1989 and 2001 has not increased in compliance with that rate. Our results show no correlation between the increasing number of asthma patients and the overall drug use. 2

3 ? Mild intermittent: 641 Forint? 477,87, mild 1283 Forint? 1355,99, moderate 1730 Forint? 1379,67, sever 1866 Forint? 1292,76. The results emphasise, that preventive therapy should be introduced at an early stage of the cores of the disease to prevent deterioration, as the majority of the costs are spent on the severe patients.? The results of the quality of life studies suggest the reliable application of the Euro-Qol and SF-36 among asthmatics. The gained correlation rates between the VAS and the SGRQ provides the opportunity to use the VAS in every-day clinical practice instead of the SGRQ, and still gain important information.? The findings point out that patients might have bad quality of life results but good FEV1 rates at the same time, as there was only a moderate correlation between the QoL data and FEV1. This suggests that, clinicians can no longer be confident if there are improvements in the clinical parameters, that means the patient has a better QoL.? The obtained polynomial model was successfully applied to the analysis of patient's QoL and its influential factors. The results suggest that QoL may be used as a non-invasive patient monitoring system if measured regularly.? The results indicate that it is necessary to regularly refresh asthma knowledge, to assess patients self-management plans to achieve long-term effectiveness of asthma-management. The effectiveness of a newly developed education instrument was confirmed. The optimal control of asthma means that people lead a high quality of life and in the majority of instances they do not feel compromised by their condition. References: Articles? Mészáros Ágnes, Vincze Zoltán: Életminoség vizsgálatok jelentosége krónikus betegeknél. Orvosi Hetilap Közlés alatt? Agnes Meszaros, M Orosz, P Magyar, A Mesko, Z Vincze: Evaluation of asthma knowledge and quality of life in Hungarian asthmatics. Allergy? A. Meszaros, Z. Bartfai, T. Major, P Magyar, A Mesko, Z Vincze : Assessing quality of life of asthmatics with a visual analogue scale and the St George s Respiratory Questionnaire. Allergologie? A Meszaros, R Zelko, A Mesko, Z Vincze: Factorial design for the analysis of patient s quality of life in asthma. Quality of Life research? Mészáros Ágnes: Az asthma gondozása. Gyógyszertár 2002; 3, 16-18? Mészáros Ágnes, Major Tamás, Bártfai Zoltán, Meskó Andrea, Vincze Zoltán: Az asthmás betegek életminoségének vizsgálata. ACTA Pharmaceutica 2001; 71, ? A. Mészáros, Z. Vincze: Costs, cost-effectivness and asthma. Journal of Social and Administrative Pharmacy 2000; 17, ? Mészáros Ágnes és Dr. Vincze Zoltán: Költségek, költség hatékonyság és az asthma, Gyógyszerészet: ? Mészáros Ágnes, Dr. Vincze Zoltán: Farmakoökonómiai vizsgálatok és az asthma. Kórház 1999; 4,

4 ? Mészáros Ágnes, Dr. Soós Gyöngyvér, Dr. Mezei Györgyi, Dr. Vincze Zoltán: Az asthma gyógyszerterápiájának költség-hatékonyság elemzése. Kórház 1998; 1, Conference papers:? Mészáros Ágnes, Dr. Zelkó Romána, Meskó Andrea, Dr. Vincze Zoltán: Faktoriális kísérlet alkalmazása asthmás betegek életminoségének vizsgálatában. Magyar Kórházi Gyógyszerész Kongresszus XIII Szeged 2002 szeptember 20-22? A Mészáros, R Zelko, A Mesko, Z Vincze: Factorial design for the analysis of the quality of life as outcome measure in asthma care in Hungary - Pre- Conference Session of the Fourth European Conference of Health Economics 7-10 July 2002 Paris? Mészáros Ágnes: Életminoség vizsgálatok jelentosége a krónikus betegek kezelésében, különös tekintettel az asthma vonatkozásábaneme Konferencia Marosvásárhely, április 4-6? Mészáros Ágnes: Asthma gyógyszerészi gondozás. MOSZ Asthma továbbképzo konferenciája Visegrád 2002 január 24-27? Mészáros Ágnes, Bártfai Zoltán: Az életminoség mérés szerepe a krónikus megbetegedésekben, különös tekintettel az asthma bronchialeban. MTT Allergológiai és Légzéspathológiai Szekció ülése. Sopron 2001 szeptember 7-9? Mészáros Ágnes: Evidenciák a krónikus betegek kezelésében az asthma bronchiale példáján, Gyógyszerészek Országos Konferenciája Siófok 2000 október 4-8? Mészáros Ágnes és Dr. Vincze Zoltán: Asthmás betegek együttmuködo készségének a vizsgálata, Magyar Kórházi Gyógyszerész Kongresszus X, Siófok 2000 május 4-6 4? Mészáros Ágnes, Dr. Vincze Zoltán, Dr. Magyar Pál: Életminoség és költségelemzés vizsgálatok asthma bronhiale-ban, Gyógyszerészek Országos Kongresszusa IX és Congressus Pharmaceuticus XI, Siófok október 6-10.? Mészáros Ágnes és Dr. Vincze Zoltán: Farmakoökonómiai vizsgálatok az asthma terápiájában, Gyógyszerészek Országos Kongresszusa Siófok 1998 október 7-11 Conference poster presentations:? A Meszaros, Z Vincze: Assessment of quality of life in children with asthma, European Respiratory Society Annual Conference 2002 September Stockholm? A Meszaros, G Vincze, A Mesko, M Orosz: Asthma knowledge and quality of life (QoL) of adult asthma International Society for Pharmacoeconomics and Outcome Research Cannes 2001 November 11-13? M Orosz, A Meszaros, G Murakozi, G Galfy: Quality of life of mild and moderate asthmatics, European Respiratory Society Annual Conference 2001 September Berlin? A Meszaros, Z. Vincze, E. Galik: Asthma and anti asthma drug use in Hungary, International Society for Pharmacoeconomics and Outcome Research Antwerp 2000 November 5-7? A Mezraros, Z Bartfai, T Major, Z Vincze, P Magyar: Quality of life and asthma, 1th. Congress of the International Union Against Tuberculosis and Lung Disease, Europe Region, Budapest 2000 April 12-15? T. Major, A Meszaros, P Magyar: Asthma quality of life IUATLD Eastren Regional Conference Hong-Kong 2000 June

5 ? A Meszaros, Z Vincze, P Magyar: Economical effects of asthma and its influance on the patients quality of life, International Society for Pharmacoeconomics and Outcome Research, Edinburgh 1999 November 11-13? A Meszaros, Gy Soos, Z Vincze: Cost-effectiveness of the asthma therapy, Ethical and Economical Aspects of Pharmacotherapy, Hradec Kralove 1998 June 3-6? Mészáros Ágnes, Soós gyöngyvér, Mezei Györgyi, Vincze Zoltán: Asthma gyógyszeres terápiájának költség-hatékonyság elemzése, Magyar Kórházi Gyógyszerészek Kongresszusa Siófok, 1997 április Acknowledgements Many people supported directly and indirectly the efforts of this work. My tutor Dr. Vincze Zoltán PhD, director of the University Pharmacy Institute of Pharmacy Administration, who made it possible to work on this field since 1997, and spent so many years helping me and supporting all efforts on my research. Dr. Magyar Pál PhD, director of the Pulmonology Department, he was who accepted me to work many month in his department, at the Department of Pulmonology and as so kind to support the clinical studies. He has prided me with the most recent literature and further new ideas on my studies. Dr. Orosz Márta PhD, Dr. Bártfai Zoltán who were there to help me at any time in my practical problems, they made it possible to find the study subjects. Mesko Andrea has supported the statistical examinations. Dr. Zelko Romána PhD, who critically reviewed almost all articles and the present work, thank you for the many friendly support. I should have mentioned first Dr. Cserháti Endre PhD, Dr. Mezei Györgyi and Dr. Barcza Lajos PhD who supported my first steps on the field of science during my undergraduate studies as I was research student. Other supports includes all my colleagues and caregivers. At last I have to thank the support of my family and especially the support of my mother. 5