The Research for Complex Treatment of Food Allergies has been Carried out through Multi-Criteria Interview Method Ph.D. Theses Erzsébet Pálfi Semmelweis University Ph.D. School of Pathology Supervisor: Dr. Mária Barna M.D., D.Sc Official reviewers: Dr. András Arató M.D., D.Sc Dr. Lajos Kósa M.D., Ph.D. President of PhD theoretical exam comittee: Dr. Tamás Szamosi M.D., D.Sc Members of PhD theoretical exam comittee: Dr. Magda Antal M.D., Ph.D. Dr. Gábor Mikala M.D., Ph.D. Budapest 2010
1. Introduction Food allergy is defined as a reproductible adverse immune reaction to food proteins. The prevalence of food allergy has been estimated to be around 1% in adults and 4-6% in children in Europe. There has been recent increase in the prevalence of atopy in western countries. The prevalence of food allergy changes with age and so do the specific allergies. For example, egg and milk allergy are most common in infants and are most often outgrown. Peanut allergy is common among children as well as adults. The allergen avoidance diet is based on the accurate allergy diagnosis. The gold standard in food allergy diagnosis is the DBPCFC (double blind placebo control food challenge). The safe allergen free diet is difficult, because the allergens and the allergic symptoms are most diverse. The allergen avoidance diet affects the quality of life and social activities of food allergic patients. The safe allergen avoidance diet includes dietetic counselling and the patients management that concentrated in the health system. However, the further follow-up and management are affected beyond the health system. The information about allergen free products is part of the food safety. In the food allergy management the standardized allergen label is the most preferred method of information delivery. The European Parliament and Council regulate the allergen labelling in Directive of 2000/13/EC (2003/89/EC modification) in connection with the food components. Recited allergens are the cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, cow s milk and dairy products including lactose, nuts, sesame seeds, celery, mustard, and sulphite at concentration of 10 mg/kg and lupin. 1
The European Union regulates the allergen labelling in the national food labelling law, too. In Hungary there is regulation 19/2004 and its modification (40/2008) about the food and allergen labelling. 2. The objective of dissertation The aims of research were finding the best intervention strategies in the management of food allergy. Furthermore, this study tried to develop a complex view of key stakeholders from different sectors connected to food allergy in Hungary. 3. Material and method I used a multi- criteria technique which is a computer background interview method to provide an integrative and comparative analysis of the differing perspectives of key stakeholders on a broad range of possible types of interventions. 30 interviews were involved in current research from 6 different areas which were in connection with food allergy management. The key stakeholders were identified from Hungarian patient organisations (A), health system and scientific research sector (B), industries, commerce and catering (C), consumer protection (D), national food legislation (E) and publicity, media, marketing sector (F). One personal interview took approximately 1.5±0.50 (1-2.5 hours) hours. The interview subjects are selected from the following issues: food allergic patient management and therapy, food safety, consumer protection, food regulation, food trade, public catering, education, dietetic counselling. The interview contains twenty ahead defined judgements, called options and some viewpoints of their evaluation. These twenty options showed the complex situation of 2
management of food allergy in Hungary. The following options were included in the interview: food labelling (1), food regulation in general (2), control of labelling (3), truth of claim(4), function of Food Allergy Databank (5), assortment of product (6), subsidy of food industries and food trade (7), role of food trade (8), education of professionals and patients (9, 10), food allergy diagnosis (11), therapy and protocol using (12, 20), prevention (13), dietician counselling (14), subsidy of health system (15), charge of diet (16), social impact of food allergy (17), subsidy of family concerned food allergy(18), research of allergy (19). The viewpoints of judgement evaluations, called criteria were the feasibility, the cost-benefit and the group of patients concerned. The interview consisted four parts built upon each other. The interview included: 1. the identification of the options and the criteria, 2. evaluating each option with numerical scores, 3. assigning a quantitative weighting each criterion, 4. overview of formed judgement. The interviewers estimated all of the options with a score system (between 1-10 score), so they developed a pessimistic (negative) and an optimistic (positive) score-interval. The stakeholders took written commentaries that completed the score system. Data were analysed by using the variance-analysis and t-test to determine the changes for all comparisons. A P value less than 0.05 were considered significant. 3
4. Results In the study I compared the viewpoints of key stakeholders, in this manner developing comprehensive and multidisciplinary opinion spectrum. There was no significant difference between options on the basis varianceanalysis (p=0.05). The interview method itself and commentaries made it possible to develop a ranking of all the opinion of the stakeholdersperspectives (SH-perspectives). The importance of three criteria was considered identical in each single perspective. It could say that it was not possible to emphasize one of the criteria in the judgement of the options; there was need for all three criteria to develop a comprehensive opinion spectrum. The stakeholders from different areas ranked similarly the options by right of relevance. They made allowance for three criteria equally in adjudgment of the options relevance. The first intervention point was the patient education in this gradiation by stakeholders of division of market, policy maker and scientific-health care sector and consumer organisation. The key stakeholders suggested that the education of consumers is the most relevant intervention strategy. Education of professionals was the second relevance option in policy makers area and scientific-health care sector; it was third in patient organisation. Dietitian counselling as patient education method was ranked good position by consumer protection and media/marketing sector. Furthermore, the representatives of media, policy makers, the consumer protections specialists and the patient organisations' representatives found the relevant allergen labelling for second intervention strategy. Food allergic patients are very conscious consumers who take into consideration 4
the most seriously the labelling legible information. The allergic consumers cannot understand the information on the labelling. Accordingly, the allergic consumers' education is necessary. The patients establish a claim to adequate allergen information. Although, the allergen information as patients' information on the labelling are not sufficient and they do not replace the dietician counselling and patient management, full and reliable labelling is very important. In addition, the results of food legislation in general option were similar. The stakeholders from industries and policy maker agreed that the mandatory food regulation is the third in gradiation. The policy maker ranked the Databank sixth position. The other stakeholders group did not find its work an important intervention point. Although the Databank is an alternative way to know the information about allergen free products and it functions side by side the labelling regulation in Hungary. Consequently, the options formed a picture about what measures may be effective to change the social environment to make it safer for consumers suffering from food allergy. Overall, in the patient management the relevant and reliable allergen labelling is very important. Although, most stakeholders underlined that allergen information is intended as consumers' information on the label it is not sufficient and the dietician counselling and patient management are not replaced, and necessary the allergic consumers' education. 5
5. The new scientific results of research 1 st I used first time a multi-criteria interview method to provide an integrative and comparative analysis of the differing perspectives of key stakeholders on a broad range of possible types of interventions in food allergy management in Hungary. 2 nd The multi-criteria interview method is workable to find the strategies and the best intervention points in food allergy management. 3 rd The study formed a picture about what measures may be effective to change the social environment to make it safer for consumers suffering from food allergy. The various fields on the basis of the opinion I formed of the most effective method of intervention strategies. These intervention strategies are multidimensional and multidisciplinary. 4 th The importance of three criteria was considered identical in each single perspective. It was not possible to emphasize one of the criteria in the judgement of the options; there was need for all three criteria to develop a comprehensive opinion spectrum. 5 th It was found that the best intervention point was the education of patients suffering food allergy and professional stuff. The quality of life of patients is affected by the knowledge of professionals from different areas. 6 th The results show that the allergen avoidance diet will be only achieved with long-term patients managment and allergen information. 7 th The key treatment of the food allergy is the allergen aviodance diet that should be feasible only with dietetic counselling and adequate information about allergen content. Based on all of the representatives I suggested the 6
importance of allergy expert training, because the adequate dietician counselling is not efficient without the knowledge and the allergen avoidance diet, so thus the counselling are the main therapy in food allergy management. Dietician can give the missing information to food allergic consumers for their diet and the explanation of labelling. 8 th The results confirm the need of communication between various areas. 9 th On the grounds of opinion spectrum of the stakeholders I can say the standardised allergen labelling as intervention point is also preferred in the comlex management of food allergic patients, but it is inpossible without education. 10 th The results suggested that the funcion of Food Allergy Databank is necessary in food allergy managent. 7
6. Publications 6.1. Publications related to the topic of the dissertation International periodicals 1. Pálfi E, Barna M. Food allergen labelling it s role in the food safety of food allergic consumers. Journal on Processing and Energy in Agriculture 2010;14(1):19-22. 2. Pálfi E, Horváth Z, Veresné Bálint M, Németh K, Barna M. Dietary management of food allergy different channels of education of patients in Hungary. New Medicine in press. National periodicals 1. Pálfi E. Klinikai tápszerek bevezetése a táplálékallergiák diagnosztikájába és kezelésébe. Étrend 2000;(4): 8-10. 2. Ciboly Á, Pálfi E, Nékám K, Bárdos Gy. A placebohatás vizsgálata táplálékallergiás és táplálékaverziós betegeknél. Magyar Pszichológiai Szemle 2003;58(4):495-516. 3. Pálfi E. A táplálékallergiás betegek tájékoztatásának jogszabályi szintű lehetőségei. Új Diéta 2004;(4):18-20. 4. Pálfi E, Gillingerné Pankotai M. Táplálékallergia és Táplálékintoletancia Adatbank. AgrárUnió 2005;(6):22. 5. Pálfi E. A dietetikus szerepe a táplálékallergiás betegek tájékoztatásában. Élelmiszer-Biztonsági Közlemények, 2005;51(2):46-47. 6. Pálfi E, Horváth Z, Barna M. Gondolatok a táplálékallergia megelőzéséről és diétájáról. Hippocrates 2006;8(4):196-9. 8
7. Klicsu N, Pálfi E. A gluténmentes diéta költségei. Új Diéta 2007;(6):4-6. 8. Pálfi E, Barna M, Horváth Z, Veresné Bálint M. The Techniques Used for Information and Education of Consumers Suffering from Food Allergy and Intolerance in Hungary. Élelmiszerfizikai Közlemények 2008;21:163-169. 9. Pálfi E, Barna M. A táplálékallergia és táplálékintolerancia komplex kezelése helyzetének kutatása Magyarországon MCM módszerrel. Allergológia és Klinikai Immunológia 2009;11(1):34-38. 10. Pálfi E. A táplálékallergia előfordulási gyakorisága. Élelmiszerbiztonság 2009;7(1):14-15. 11. Barna M, Pálfi E, Horváth Z. A táplálékallergiás fogyasztók táplálkozási biztonsága közös ügy. Élelmiszervizsgálati Közlemények 2009;55(2):83-104. Popular books and chapters 1. Pálfi E. Van, akinek étel, van, akinek méreg. Diétás receptektáplálékallergia. Budapest, Focus Vitalitás, 2003. 80p. 2. Horváth Z, Pálfi E. A diéta receptek. In: Bodánszky H., Horváth Z., Pálfi E., Bárdos Gy. Laktózérzékenyek könyve. Budapest, Anonymus, 2003. p. 29-154. Scientific books and chapters 1. Pálfi E. A táplálkozási napló szerepe a táplálékallergiák és táplálékintoleranciák diagnosztikájában és kezelésében. In: Barna M (szerk.), Magyar Táplálékallergia és Táplálékintolerancia Adatbank. Budapest, Tempus-Phare, 2000. p. 138-140. 9
2. Nékám K, Pálfi E. A táplálékallergiás betegek kezelése és gondozása. In: Barna M (szerk.), Magyar Táplálékallergia és Táplálékintolerancia Adatbank. Budapest, Tempus-Phare, 2000. p. 149-152. 3. Pálfi E. Dietetikai szempontok a táplálékallergiák kezelésében. In: Czirják L (szerk.), Klinikai Immunológia. Budapest, Medicina Könyvkiadó, 2006. p. 490-494. Chapter of coursebook 1. Pálfi E. Táplálkozási allergiák és intoleranciák. In: Veresné Bálint M (szerk.), Gyakorlati dietetika. Budapest, Semmelweis Egyetem Egészségügyi Főiskolai Kar, 2004. p. 231-251. Conference abstracts 1. Horváth Z, Pálfi E, Barna M. Experiences on Management of Hungarian Food Allergy and Food Intolerance Databank. 2nd CEFood Congress. Budapest, 2004. április 26-28. 2. Pálfi E, Horváth Z. Comparative Assessment of Techniques and Chanels Used for Information and Education of Consumers with Food Allergy and Food Intolerance in Hungary. EFAD 6th Forum-Nutrition. Genf, Svájc, 2005. június 2-5. 3. Pálfi E, Horváth Z. A táplálékallergiás beteg információhoz juttatásának szükségessége Magyarországon. Magyar Gasztroenterológiai Társaság 47. Nagygyűlés. Balatonaliga, 2005. június 07-11. 4. Pálfi E, Barna M. The Hungarian Food Allergy and Food Intolerance Databank One of the Techniques Used for Information and Education of Consumers with Food Allergy and Intolerance in Hungary. The SAFE Consortium International Congress on Food Safety. Budapest, 2006. 10
5. Pálfi E, Barna M, Tarczy T. A táplálékallergia és táplálékintolerancia prevenciójának és komplex kezelés helyzetének kutatása Magyarországonprogram háttér fejlesztése. Táplálkozástudományi Társaság XXXII. Vándorgyűlése. Kecskemét, 2007. október 18-20. 6. Pálfi E, Barna M. A táplálékallergia és táplálékintolerancia prevenciójának és komplex kezelés helyzetének kutatása Magyarországon. Táplálkozástudományi Társaság XXXIII. Vándorgyűlése. Pécs, 2008. október 2-4. 7. Pálfi E, Barna M. A táplálékallergia és táplálékintolerancia komplex kezelésének kutatása több kritériumos leképezés módszerrel. Táplálkozástudományi Társaság XXXIV. Vándorgyűlése. Székesfehérvár, 2009. október 8-10. 8. Mester Á, Pálfi E, Gilingerné Pankotai M. Tejtermékek és tejhelyettesítő készítmények kalciumtartalmának összehasonlítása, tejfehérje allergiás gyermekek kalcium bevitelének felmérése. Táplálkozástudományi Társaság XXXIV. Vándorgyűlése. Székesfehérvá,r 2009 október 8-10. 9. Pálfi E, Barna M. The Management of Food Allergy and Food Intolerance Searching with Multi-Criteria Method in Hungary. The SAFE Consortium 2nd International Congress on Food Safety. Girona, Catalunya, Spain, 2009. április 27-29. 11
6.2. Publications unrelated to the topic of the dissertation National periodicals 1. Pálfi E. A dializált beteg étrendje. Új Diéta 2003;(2):8. 2. Pálfi E. A Norbi-Update-étrend kritikája. Új Diéta 2005;(3):10-11. 3. Gilingerné Pankotai M, Varga Zs, Pálfi E, Weismann A V. Comparison of the Antioxidant Activity in Berries and Fruit Products Made from Berries. Élelmiszerfizikai Közlemények 2008;21:181-187. Chapters of coursebook 1. Pálfi E. Mozgásszervi betegségek. In: Veresné Bálint M (szerk.), Gyakorlati dietetika. Budapest, Semmelweis Egyetem Egészségügyi Főiskolai Kar, 2004. p. 200-205. 2. Pálfi E. Poliszisztémás autoimmun kórképek. In: Veresné Bálint M (szerk.), Gyakorlati dietetika. Budapest, Semmelweis Egyetem Egészségügyi Főiskolai Kar, 2004. p. 206-212. 3. Horváth Z. Pálfi E, Veresné Bálint M. Egyéb Kórképek. In: Veresné Bálint M (szerk.), Gyakorlati dietetika. Budapest, Semmelweis Egyetem Egészségügyi Főiskolai Kar, 2004. p. 270-285. 4. Pálfi E. Gyógyszer-diéta interakció. In: Veresné Bálint M (szerk.), Gyakorlati dietetika. Budapest, Semmelweis Egyetem Egészségügyi Főiskolai Kar, 2004. p. 285-288. 5. Horvát Z, Pálfi E, Veresné Bálint M. Diétás ételkészítési gyakorlatok. Budapest, Semmelweis Egyetem Egészségügyi Főiskolai Kar, 2005. 348 p. 12
Conference abstracts 1. Veresné Bálint M, Gilingerné Pankotai M, Pálfi E. Change in content of leaf vegetable crops during the storage. The 5-th European Forum for Dietitians. Budapest. 2003. május 4-7. 2. Pálfi E, Gilingerné Pankotai M, Veresné Bálint M, Ignáth T, Felföldi J. Change in vitamin C content and firmness of sweet pepper types during the storage. The 5-th European Forum for Dietitians. Budapest. 2003. május 4-7. 3. Pálfi E, Gilingerné Pankotai M, Veresné Bálint M. Storability of Paprika Types. 2nd CEFood Congress. Budapest. 2004. április 26-28. 4. Veresné Bálint M, Gilingerné Pankotai M, Pálfi E, Komsa I. Change in Nutritive value in leaf vegetable types during the storage. 2nd CEFood Congress. Budapest. 2004. április 26-28. 13