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Wstęp. W wyniku systematycznego przeglądu literatury przeprowadzonego w ramach wieloośrodkowego, międzynarodowego programu badawczego „Zwiększanie udziału osób starszych w badaniach klinicznych” (PREDICT), finansowanego przez Komisję Europejską z funduszy 7. Projektu Ramowego, wykazano małe uczestnictwo osób w wieku podeszłym w badaniach klinicznych. Materiał i metody. Na podstawie tych rezultatów opracowano kwestionariusz wywiadu w celu zbadania opinii pracowników opieki zdrowotnej, etyków i przedstawicieli przemysłu farmaceutycznego na temat przyczyn małego udziału osób starszych w badaniach klinicznych oraz czynników, które mogą sprzyjać stosownemu zwiększaniu ich reprezentacji w projektach badawczych. Badanie zostało przeprowadzone w 9 krajach: Republice Czeskiej, Hiszpanii, Holandii, Izraelu, Litwie, Polsce, Rumuni, Wielkiej Brytanii i we Włoszech. W niniejszym artykule przedstawiono jednak tylko opinie polskich respondentów, akcentując zasadnicze różnice w porównaniu z poglądami w pozostałych krajach. Wyniki. W opinii polskich respondentów osoby starsze nie są wystarczająco reprezentowane w badaniach klinicznych, a starszy wiek nie powinien stanowić kryterium wykluczającego z badań. Określono listę czynników, które potencjalnie mogą wpływać na proces rekrutacji osób w starszym wieku do badań klinicznych. Najczęściej wskazywanymi przyczynami wykluczania osób starszych były: współistnienie wielu chorób w tej grupie wiekowej, częste występowanie polipragmazji, zaburzeń funkcji poznawczych i obawa przed pojawianiem się zdarzeń niepożądanych. Wnioski. Wyniki tych badań wraz z innymi realizowanymi w ramach projektu posłużyły do opracowania Karty PREDICT zawierającej rekomendacje zmierzające do zapewnienia równoprawnego udziału osób starszych w badaniach klinicznych. Introduction. A systematic review of literature conducted in frame of multicentre, international the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7, indicated that elderly persons are underrepresented in the clinical trials. Material and methods. Basing on those results the interview questionnaire has been elaborated to examine the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of old people in clinical trials and promoters of their higher participation in it. The study has been conducted in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. However this paper presents only opinions of Polish respondents to underline the main differences in views in comparison to other countries. Results. According to respondents in Poland older persons are insufficiently represented in clinical trials, and older age should not be used as a criterion of exclusion. The list of potential factors that might influence the recruitment process to clinical trials has been established. The most frequently indicated reasons of older people exclusion from trials were: more often co-morbidity, polypragmasy, cognitive impairment and fear of adverse effects. Conclusions. The results of this study together with other findings coming out of the project enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials.

In frame of the European Project CHANGE (Care of Health Advertising New Goals for Elderly people) the study of health behaviours regarding healthy nutrition and physical activity was conducted on patients in age of 60 and more covered with care of community nurses. Objectives: To assess association between physical activity and nutritional habits, stages of change of these behaviors among older patients and other psychosocial conditions regarding planning of health education intervention to change their health behaviours. Methods: 108 persons at age avg. 69.6 (SD 60–87) were interviewed by questionnaire (assessing the frequency of intake of particular food products, physical activity, motivation and stage of change these behaviors, satisfaction with physical condition and general wellbeing) by the trained community nurses. Results: Results showed sedentary style of life in most studied patients. Among physical activity the frequency of daily walking was the highest (69%), while 70% of older people did not exercise. In study group 42% were not aware of importance of physical activity for their health. But the awareness of importance of healthy nutrition was high, and about half of study group (48%) reported that they eat meals with reduced fat, and 80% eat high fiber food. The rules of healthy nutrition were not fully respected. Positive correlations were shown between intention to change, stage of change of health behavior and performance of physical activity and healthy eating. Those behaviors were positively related to well- -being and satisfaction with physical condition. Conclusions: Health promotion programs for older patients should be planned in different way depending on their stage of change of health behaviors. There is a need to raise awareness of importance of physical activity, and to educate older patients about recommended types of exercises and recreation. In case of recommendations of healthy nutrition, the awareness is high and performance definitely more frequent, therefore health promotion programs should stimulate development of permanent social support to maintain change of these behaviors.

The results of initial literature review indicate thai elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the 'lncreasing the PaRticipation of the EIDerly In Clinical Trials' (PREDICD project, financed by the EU within the FP7. The goal of the PREDICT was to study reasons why older people are excluded from clinical trials based on age-related criteria and development of the charter including recommendations to prevent their exclusion. The project gathered investigators from 11 inslitutions in 9 countries: Czech Republic, lsrael, ltaly, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. Within the scope of PREDICT, first, to assess the scope of the problem the systematic review of literature was performed, !hen the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of ald people in trials was examined, !hen finally the opinion of elderly patients and their caregivers were assessed. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials.

Wstęp. Liczne doniesienia wskazują na małą i nierówną reprezentację osób starszych w badaniach klinicznych stanowiących podstawę tworzenia zaleceń dotyczących postępowania. Stało się to przesłanką do przeprowadzenia wieloośrodkowego, międzynarodowego programu badawczego „Zwiększanie udziału osób starszych w badaniach klinicznych” (PREDICT), finansowanego przez Komisję Europejską w ramach VII Projektu Ramowego. Celem projektu było rozpoznanie przyczyn i skali zjawiska oraz stworzenie zaleceń odnośnie do włączania osób w starszym wieku do badań. Materiał i metody. W projekcie uczestniczyło 11 instytucji z 9 krajów: Czech, Hiszpanii, Holandii, Izraela, Litwy, Polski, Rumunii, Wielkiej Brytanii i Włoch. Zastosowano systematyczny przegląd literatury w celu zbadania zagadnienia udziału osób starszych w badaniach klinicznych, czynników sprzyjających ich uczestnictwu i utrudniających to uczestnictwo, przyczyn niskiego uczestnictwa oraz sposobów jego zwiększania. Wyniki. Potwierdzono hipotezę małej i nierównej reprezentacji osób starszych w badaniach klinicznych, a wyniki przeglądu stały się podstawą do przeprowadzenia w 9 krajach badań opinii pracowników opieki zdrowotnej oraz opinii pacjentów w starszym wieku na temat udziału osób starszych w badaniach klinicznych. Wnioski. Ostatecznym rezultatem tych badań jest karta zawierająca rekomendacje zmierzające do zapewnienia równoprawnego udziału osób starszych w badaniach klinicznych. Background. Several research reports indicate that elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7. The goal of the PREDICT was to establish the reasons and extent to which old people are excluded from trials based on age-related criteria. Material and methods. The project gathered investigators from 11 institutions in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. The systematic review of literature has been applied to assess the scope of the problem in terms of participation, predisposing and obstructive factors, reasons of low participation and possible interventions to enhance it. Results. The hypothesis of low and unequal representation of older people in clinical research has been confirmed. The systematic review results became the background for conducting in 9 countries a study of opinion shared by the health care professionals and elderly patients on their participation in clinical research. Conclusions. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to assure the equal rights to older people to participate in clinical trials.

As a result of labour migration to the old EU countries the nursing staff in the residential and social care institutions in Poland is being extensively repalced by care assistants who are less knowledgable and competent in providing care for the elderly. Moreover the in-job education is poorly developed in those institutions and the position of an in-job educator is not clearly defined. It is observed that competences of the injob educator should be defined and promoted to improve the process of in-job education. This problem has been addressed by the muliticenter study conducted in the framework of a European ComPro project (Competence Profiles for Learning Supporters in Elderly Care) funded by Leonardo da Vinici program (2006–2008). The main goal of the project was to develop the self-assessment tool for persons responsible for in-job education of professionals caring for older persons in social care institutions. In order to help them recognize the deficit competencies the in-job educators should be specially trained to effectively detect professionals’ educational needs.