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, 2002
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Introduction Objectives of this study were the following:
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
To focus on the economic burden of asthma in connection to the epidemiological data.
getting serious about what it is and how to treat it.
The drug consumption, drug cost and other costs related to asthma were analysed.
Asthma is a chronic inflammatory disorder of the airways in which many cells and
To evaluate patients quality of life with general quality of life instruments, the visual
cellular elements play a role, in particular mast cells, eosinophiles and T-lymphocytes.
analogue scale, the Euro-QoL questionnaire, the SF-36 and disease specific
In susceptible individuals this inflammation causes recurrent episodes of wheezing,
instruments, the St George’s Respiratory Questionnaire.
breathlessness, chest tightness and cough in particularly at night and/or in the early
The quality of life examinations were focusing on the evaluation of the quality of life
morning. These symptoms are usually associated with widespread but variable airflow
of asthmatics and non-asthmatics in Hungary, to assess the relationship between the
limitation that is at least partly reversible either spontaneously or with treatment. The
severity and the quality of life scores, to evaluate the possible use of psychometric and
inflammation also causes an associated increase in airway responsiveness to a variety
utility-based measures in asthma, to measure the correlation between the general and
of stimuli.
disease specific quality of life instruments, to evaluate the influential factors on
Economics is about trade-offs and choices between wants, needs and the scarcity of
asthma quality of life.
resources to fulfil these wants. Outcome studies differ significantly from conventional
Furthermore the objective of the study was to assess the quality of life of asthmatic
clinical trials. Clinical trials are efficacy studies that classically evaluate a medication
patients and to study the influence of age and severity of the disease, as independent
or procedure by the scientific method, usually in a prospective, randomised, double-
variables, on the patient’s quality of life. A 2-factor, 3-level face-centred central
blind fashion. Outcome analysis are "real-world" projects in which physicians may
composite design was applied to construct a second-order polynomial model
not know all of the details regarding a treatment or procedure, the patients may or may
describing the effect of age and that of the severity of asthma on the patient's quality
not be adherent to therapy, and comorbidities in individual subjects may exist.
of life.
Chronic diseases that affect a large part of the population and have a significant cost
As well as to develop an educational instrument to assess it’s impact as an
to society are perfect candidates for outcome analysis. As several recent review
intervention instrument and to examine quality of life.
articles have discussed, asthma is one such condition. Interest in health economic analyses in asthma may be grouped into three broad
Results
categories. The first includes the perspective of governments and pharmaceutical
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industry. The second includes those organisations, which are involved in providing
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
the health care. The third is the patient, who has to meet direct and indirect costs of
compliance with that rate. Our results show no correlation between the increasing
their disease and the clinician who has to work within a certain budget.
number of asthma patients and the overall drug use.
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References:
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
Articles
preventive therapy should be introduced at an early stage of the cores of the
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disease to prevent deterioration, as the majority of the costs are spent on the ?
severe patients.
krónikus betegeknél. Orvosi Hetilap
The results of the quality of life studies suggest the reliable application of the
Közlés alatt ?
Euro-Qol and SF-36 among asthmatics. The gained correlation rates between the
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Mészáros Ágnes, Vincze Zoltán: Életminoség vizsgálatok jelentosége
Agnes Meszaros, M Orosz, P Magyar, A Mesko, Z Vincze: Evaluation of
VAS and the SGRQ provides the opportunity to use the VAS in every-day
asthma knowledge and quality of life in Hungarian asthmatics. Allergy
clinical practice instead of the SGRQ, and still gain important information.
Közlésre elfogadva ?
The findings point out that patients might have bad quality of life results but good
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
FEV1 rates at the same time, as there was only a moderate correlation between
Respiratory Questionnaire. Allergologie the QoL data and FEV1. This suggests that, clinicians can no longer be confident
Közlésre elfogadva ?
if there are improvements in the clinical parameters, that means the patient has a
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
better QoL.
Közlésre elfogadva ?
The obtained polynomial model was successfully applied to the analysis of
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Mészáros Ágnes: Az asthma gondozása. Gyógyszertár 2002; 3, 16-18
patient's QoL and its influential factors. The results suggest that QoL may be used
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Mészáros Ágnes, Major Tamás, Bártfai Zoltán, Meskó Andrea, Vincze Zoltán:
as a non-invasive patient monitoring system if measured regularly. ?
Az
asthmás
betegek
életminoségének
vizsgálata.
ACTA
Pharmaceutica 2001; 71, 196-200 The results indicate that it is necessary to regularly refresh asthma knowledge, to
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assess patients’ self-management plans to achieve long-term effectiveness of
A. Mészáros, Z. Vincze: Costs, cost-effectivness and asthma. Journal of Social and Administrative Pharmacy 2000; 17, 130-135
asthma-management. The effectiveness of a newly developed education
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instrument was confirmed.
Mészáros Ágnes és Dr. Vincze Zoltán: Költségek, költség hatékonyság és az asthma, Gyógyszerészet: 44. 151-155. 2000.
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The optimal control of asthma means that people lead a high quality of life and in the
Mészáros Ágnes, Dr. Vincze Zoltán: Farmakoökonómiai vizsgálatok és az asthma. Kórház 1999; 4, 26-29
majority of instances they do not feel compromised by their condition.
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Mészáros Ágnes, Dr. Soós Gyöngyvér, Dr. Mezei Györgyi, Dr. Vincze
Mészáros Ágnes, Dr. Vincze Zoltán, Dr. Magyar Pál: Életminoség és
Zoltán: Az asthma gyógyszerterápiájának költség-hatékonyság elemzése.
költségelemzés vizsgálatok asthma bronhiale-ban, Gyógyszerészek Országos
Kórház 1998; 1, 31-33
Kongresszusa IX és Congressus Pharmaceuticus XI, Siófok 1999. október 610. ?
Conference papers: ?
Mészáros Ágnes és Dr. Vincze Zoltán: Farmakoökonómiai vizsgálatok az
Mészáros Ágnes, Dr. Zelkó Romána, Meskó Andrea, Dr. Vincze Zoltán:
asthma terápiájában, Gyógyszerészek Országos Kongresszusa – Siófok 1998
Faktoriális
október 7-11
kísérlet
alkalmazása
asthmás
betegek
életminoségének
vizsgálatában. Magyar Kórházi Gyógyszerész Kongresszus XIII Szeged 2002 szeptember 20-22 ?
Conference poster presentations: ?
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-
asthma, European Respiratory Society Annual Conference 2002 September
Conference Session of the Fourth European Conference of Health Economics
14-18 Stockholm ?
7-10 July 2002 Paris ?
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of life (QoL) of adult asthma International Society for Pharmacoeconomics
kezelésében, különös tekintettel az asthma vonatkozásábanEME Konferencia
and Outcome Research Cannes 2001 November 11-13 ?
moderate asthmatics, European Respiratory Society Annual Conference 2001
továbbképzo konferenciája Visegrád 2002 január 24-27
September 22-26 Berlin ?
Mészáros Ágnes, Bártfai Zoltán: Az életminoség mérés szerepe a krónikus
A Meszaros, Z. Vincze, E. Galik: Asthma and anti asthma drug use in
megbetegedésekben, különös tekintettel az asthma bronchialeban. MTT
Hungary, International Society for Pharmacoeconomics and Outcome
Allergológiai és Légzéspathológiai Szekció ülése. Sopron 2001 szeptember
Research Antwerp 2000 November 5-7 ?
A Mezraros, Z Bartfai, T Major, Z Vincze, P Magyar: Quality of life and
Mészáros Ágnes: Evidenciák a krónikus betegek kezelésében az asthma
asthma, 1th. Congress of the International Union Against Tuberculosis and
bronchiale példáján, Gyógyszerészek Országos Konferenciája Siófok 2000
Lung Disease, Europe Region, Budapest 2000 April 12-15 ?
október 4-8 ?
M Orosz, A Meszaros, G Murakozi, G Galfy: Quality of life of mild and
Mészáros Ágnes: Asthma gyógyszerészi gondozás. MOSZ Asthma
7-9 ?
A Meszaros, G Vincze, A Mesko, M Orosz: Asthma knowledge and quality
Mészáros Ágnes: Életminoség vizsgálatok jelentosége a krónikus betegek
Marosvásárhely, 2002. április 4-6 ?
A Meszaros, Z Vincze: Assessment of quality of life in children with
Mészáros Ágnes és Dr. Vincze Zoltán: Asthmás betegek együttmuködo
T. Major, A Meszaros, P Magyar: Asthma quality of life IUATLD Eastren Regional Conference Hong-Kong 2000 June
készségének a vizsgálata, Magyar Kórházi Gyógyszerész Kongresszus X, Siófok 2000 május 4-6
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Acknowledgements
A Meszaros, Z Vincze, P Magyar: Economical effects of asthma and its influance on the patients quality of life, International Society for
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Pharmacoeconomics and Outcome Research, Edinburgh 1999 November 11-
Many people supported directly and indirectly the efforts of this work.
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My tutor Dr. Vincze Zoltán PhD, director of the University Pharmacy Institute of
A Meszaros, Gy Soos, Z Vincze: Cost-effectiveness of the asthma therapy,
Pharmacy Administration, who made it possible to work on this field since 1997, and
Ethical and Economical Aspects of Pharmacotherapy, Hradec Kralove 1998
spent so many years helping me and supporting all efforts on my research.
June 3-6
Dr. Magyar Pál PhD, director of the Pulmonology Department, he was who accepted
Mészáros Ágnes, Soós gyöngyvér, Mezei Györgyi, Vincze Zoltán: Asthma
me to work many month in his department, at the Department of Pulmonology and as
gyógyszeres terápiájának költség-hatékonyság elemzése, Magyar Kórházi
so kind to support the clinical studies. He has prided me with the most recent
Gyógyszerészek Kongresszusa Siófok, 1997 április 17-20
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.
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