The role of the research nurse at conducting clinical trials

Uvod: Izsledki kliničnih preskušanj spreminjajo ustaljene načine zdravljenja in so podlaga za napredek znanosti na področju medicine. Medicinske sestre so bile pomemben del raziskovalnih timov vse od pričetka modernega kliničnega preskušanja, vidnejšo vlogo pa so pridobile v osemdesetih letih prejšnjega stoletja, ko so se pojavili prvi opisi del in nalog, ki jih medicinska sestra pri izvajanju kliničnih preskušanj opravlja, in hkrati tudi nov naziv – raziskovalna medicinska sestra. Namen: Namen diplomskega dela je preučiti in opisati vlogo medicinske sestre, ki je vključena v izvajanje kliničnih raziskav v svetu s pomočjo pregleda objavljenih izvirnih raziskav, in odgovoriti na vprašanje, kako so te vloge urejene in priznane. Metode: Uporabili smo opisno metodo dela s pregledom in analizo literature. Strokovno in znanstveno literaturo smo iskali v slovenskem in angleškem jeziku od 12. januarja do 1. februarja 2020 v bibliografskih podatkovnih bazah CINAHL, PubMED, DiKUL in sistemu COBIB.SI. Iskalni pojmi so bili »research nurse role«, »clinical trials nurse role«, »clinical research nurse role«, »clinical research coordinator role«, »raziskovalna medicinska sestra«, »klinične raziskave«, »koordinator kliničnih raziskav«, »vloga medicinske sestre pri izvajanju kliničnih raziskav«. Rezultati: Med 41 izbranimi objavami za izdelavo diplomskega dela je bilo v končno analizo vključenih 9 izvirnih raziskav. Tri od teh raziskav so naredili v Veliki Britaniji, dve v Združenih državah Amerike, po eno pa v Avstraliji, Kanadi, Južni Koreji in Italiji. Prepoznanih je pet vlog raziskovalne medicinske sestre: izvajalka zdravstvene nege, informatorka, koordinatorka kliničnih raziskav, pacientova zastopnica, upravljalka s podatki »data manager«. Združene države Amerike so edina država, kjer imajo raziskovalne medicinske sestre priznano specializacijo na področju izvajanja kliničnih raziskav. Razprava in zaključek: V večini držav se raziskovalne medicinske sestre posebnosti dela učijo izkustveno ali pod mentorstvom izkušene raziskovalne medicinske sestre. Na področju opredeljevanja vlog je največ literature dostopne v angleškem jeziku, prav tako so večino raziskav o vlogi raziskovalne medicinske sestre opravili v angleško govorečih državah. Kljub prepoznani vlogi raziskovalne medicinske sestre in dodatnih znanjih, ki jih za izvajanje kliničnih raziskav potrebuje, področje izobraževanja in usposabljanja ni urejeno. Z nadaljnjimi znanstvenimi raziskavami o vlogah raziskovalne medicinske sestre in promocijo dela in nalog le-te, bi klinična preskušanja približali medicinskim sestram, ki bi jih morda to področje delovanja zanimalo.Introduction: Clinical trial findings are changing the established treatments and are the basis for advances in medical science. Nurses have always been an important part of research teams since the beginning of modern clinical trials, and they gained a more prominent role in the 1980s, when the first descriptions of the work and tasks performed by the nurse in clinical trials emerged, including a new job title - research nurse. Purpose: The purpose of the thesis is to examine and describe the role of the nurse involved in conducting clinical trials in the world by reviewing the published original research, and to answer the question of where the nurses’ roles are regulated and recognized. Methods: A descriptive method of work with literature review and analysis was used. Professional and scientific literature was searched in Slovene and English from 12 January to 1 February 2020 in the bibliographic databases CINAHL, PubMED, DiKUL and COBIB.SI. The search terms were: "research nurse role", "clinical trials nurse role", "clinical research nurse role", "clinical research coordinator role", "research nurse", "klinične raziskave", "koordinator kliničnih raziskav", "vloga medicinske sestre pri izvajanju kliničnih raziskav". Results: Of the 41 selected publications, 9 research papers were included in the final analysis. Three researches were conducted in the UK, two in the United States and one in Australia, Canada, South Korea and Italy respectively. Five research nurse roles were identified: direct care provider, informant, clinical research coordinator, patient advocate, data manager. The United States of America is the only country where research nurses have a recognized specialization in conducting clinical research. Discussion and Conclusion: In most countries, research nurses learn the specifics while working or under the guidance of an experienced research nurse. In the field of role delineation, most literature is available in English, and most research on the role of the research nurse has been conducted in English-speaking countries. Despite the recognized role of the research nurse and the advanced knowledge required to conduct clinical trials, the field of education and training is not regulated. Through further scientific research into the role of the research nurse and the promotion of the research nurse\u27s work and tasks, clinical trials would be brought closer to the nurses who may be interested in this field of activity