| Abstract | Cilj istraživanja: Ovaj rad analizira kvalitetu i pouzdanost dokaza koji podržavaju kliničke
smjernice Europskog društva za medicinsku onkologiju (engl. The European Society for
Medical Oncology, ESMO). Cilj je procijeniti razinu dokaza i stupanj preporuka unutar ESMO
smjernica, uzimajući u obzir brzi razvoj novih znanja u onkologiji. Analiza sistematski
pregledava ESMO smjernice, istražujući promjene u preporukama i razinama dokaza tijekom
vremena.
Rad također naglašava važnost oslanjanja na visokokvalitetna istraživanja pri formiranju
smjernica, kako bi se osigurala najbolja skrb za pacijente. Poseban naglasak stavlja se na
transparentnost, rigoroznost i redovito ažuriranje kliničkih smjernica, kako bi se osiguralo da
one odražavaju najnovija znanstvena dostignuća u onkologiji.
Materijali i metode: U ovom istraživačkom radu koristile su se ESMO kliničke smjernice
objavljene od svibnja 2005. do listopada 2022. kako bi se ocijenila kvaliteta dokaza koji su
podupirali preporuke za liječenje onkoloških oboljenja. Smjernice su preuzete s mrežne stranice
ESMO, a svaka smjernica temeljito je pregledana s ciljem izvlačenja ključnih preporuka i
odgovarajućih razina dokaza.
Metodologija istraživanja obuhvatila je nekoliko koraka. Najprije su se izdvojile ESMO
smjernice koje su za ocjenu svojih preporuka koristile Američkoga društva za infektivne bolesti
(engl. Infectious Diseases Society of America, IDSA) sustav, kategorizirajući svaku preporuku
od I do IV, gdje I predstavlja najvišu razinu dokaza. Stupanj preporuke za svaku smjernicu bio
je ocijenjen na skali od A do D, pri čemu A predstavlja najviši stupanj preporuke. Također, iz
smjernica su izvučeni podaci o farmakoterapiji, terapiji zračenjem, potpornoj terapiji, kirurgiji,
patologiji tumora i genetskim promjenama, metodama probira, dijagnostičkim postupcima,
praćenju, stadiju bolesti, vrsti raka i transplantaciji. U radu su obrađene 82 smjernice za 41
sijelo maligne bolesti. Trenutne smjernice definirane su kao one objavljene na mrežnoj stranici
ESMO do 10. prosinca 2022. Prethodne verzije tih smjernica našle su se kao reference u
trenutnim smjernicama. Dodatno se pretraživala ESMO mrežna stranica i PubMed baza
podataka kako bi se pronašlo prvo izdanje analiziranih smjernica.
Plan istraživanja uključivao je niz koraka koji su započeli prikupljanjem svih relevantnih
ESMO smjernica i ekstrakcijom potrebnih podataka. Uslijedila je detaljna analiza svake
smjernice, njezinih razina dokaza i stupnjeva preporuke. Usporedba trenutnih smjernica s
prethodnim verzijama omogućila je identifikaciju promjena i trendova.
Pretraživala se svaka smjernica kako bi se identificirale preporuke navedene u sažetoj tablici
preporuka. Ako sažeta tablica nije bila dostupna, uključivale su se preporuke koje su bile jasno
istaknute u svakom dokumentu i odvojene od ostatka teksta. Ako nisu bile jasno odvojene,
pretraživao se cijeli tekst smjernica i izdvajale preporuke s pripadajućom razinom dokaza i
stupnjem preporuke. Ako su uz jednu preporuku bile dvije razine dokaza ili stupnja preporuka,
u analizu se uključivala ona s jačom razinom dokaza, odnosno višim stupnjem preporuke.
Prikupljeni podaci obrađeni su statističkim metodama. Interpretacija rezultata uključivala je
analizu i tumačenje prikupljenih podataka u kontekstu kvalitete i pouzdanosti ESMO smjernica.
Rezultati: Analizirano je ukupno 82 smjernice koje su pokazale značajan porast broja
preporuka tijekom vremena, od prvih, preko prethodnih do trenutnih verzija. Ukupan broj
preporuka povećao se za 106 % između prethodnih i trenutnih verzija.
Usporedba trenutnih i prethodnih smjernica pokazuje blagi pad preporuka s najvišom razinom
dokaza (engl. Level of Evidence, LOE) I i II od 10 %, ali rast preporuka temeljenih na najnižim
razinama dokaza (V) porastao je za 5%. Ovaj trend ukazuje na potrebu za boljim dizajniranim
i rigoroznijim istraživanjima kako bi se ojačali dokazi koji podupiru preporuke.
Farmakoterapija je imala najveći broj preporuka najviše razine dokaza, LOE I, 42%, dok su
dijagnostički postupci i kirurgija pokazali najniži udio preporuka s najvišom razinom dokaza
(16 %).
U analizi različitih izdanja smjernica, primjetne su bitne promjene u preporukama. Unatoč
smanjenju najviših razina dokaza (LOE I) u nekim područjima, zabilježen je rast stupnja
preporuka (engl. Grade of Recommendation, GOR), što ukazuje na veću sigurnost u preporuke.
Ovaj trend ukazuje na to da, iako se može dogoditi smanjenje kvalitete dokaza, povjerenje u
efikasnost preporuka nastavlja rasti.
Zaključak: Ova analiza ESMO kliničkih smjernica otkriva da je jedna trećina trenutnih
preporuka podržana najvišom razinom dokaza (LOE I), iako je opća razina LOE I blago
smanjena u odnosu na prethodne verzije. Postoje varijacije u razinama dokaza i stupnjevima
preporuka među različitim vrstama raka, s visokim stopama preporuka na temelju nižih razina
dokaza (LOE III-V), što izaziva zabrinutost zbog smanjene pouzdanosti smjernica. Potrebno je
provoditi više kvalitetno dizajniranih studija za povećanje visokokvalitetnih dokaza i
poboljšanje ishoda liječenja raka, uz redovito ažuriranje smjernica kako bi se odgovorilo na
brze promjene u terapijskim mogućnostima. |
| Abstract (english) | Objective: This paper analyzes the quality and reliability of the evidence supporting the clinical
guidelines of the European Society for Medical Oncology (ESMO). The goal is to assess the
level of evidence and the grade of recommendations within ESMO guidelines, considering the
rapid development of new knowledge in oncology. The analysis systematically reviews ESMO
guidelines, exploring changes in recommendations and levels of evidence over time.
The paper also highlights the importance of relying on high-quality research when forming
guidelines to ensure the best care for patients. Particular emphasis is placed on transparency,
rigor, and regular updates of clinical guidelines to ensure they reflect the latest scientific
achievements in oncology.
The abstract underscores the significance of this research in the context of improving clinical
guidelines and healthcare, emphasizing the need for precise and up-to-date guidelines that
reflect the current state of scientific knowledge.
Materials and Methods: This research utilized ESMO clinical guidelines published from May
2005 to October 2022 to assess the quality of evidence supporting oncological treatment
recommendations. Guidelines were downloaded from the ESMO website, and each guideline
was thoroughly reviewed to extract key recommendations and corresponding levels of
evidence.
The research methodology involved several steps. Initially, ESMO guidelines that used the
IDSA system to assess their recommendations were selected, categorizing each
recommendation from I to IV, where I represents the highest level of evidence. The grade of
recommendation for each guideline was assessed on a scale from A to D, with A representing
the highest level of recommendation. Additionally, data about pharmacotherapy, radiation
therapy, supportive therapy, surgery, tumor pathology and genetic changes, screening methods,
diagnostic procedures, monitoring, disease stages, cancer types, and transplantation were
extracted from the guidelines. The study processed 82 guidelines for 41 malignant disease
topics. Current guidelines were defined as those published on the ESMO website
(www.esmo.org/guidelines) by December 10, 2022. Previous versions of these guidelines were
identified as references in the current guidelines. Further searches were conducted on the ESMO
website and the PubMed database to find the first edition of the analyzed guidelines.
The research plan included a series of steps starting with the collection of all relevant ESMO
guidelines and the extraction of necessary data. This was followed by a detailed analysis of each
guideline, its levels of evidence, and grades of recommendation. Comparing current guidelines
with previous versions enabled the identification of changes and trends.
Each guideline was searched to identify recommendations listed in the summary table of
recommendations. If no summary table was available, recommendations that were clearly
highlighted in each document and separated from the rest of the text were included. If they were
not clearly separated from the rest of the text, the entire text of the guidelines was searched, and
recommendations with their associated levels of evidence and grades of recommendation were
extracted. If a recommendation was associated with two levels of evidence or grades of
recommendation, the one with the stronger level of evidence or higher grade of
recommendation was included in the analysis.
Collected data were processed using statistical methods. The interpretation of the results
involved analyzing and interpreting the collected data in the context of the quality and reliability
of ESMO guidelines.
Results: A total of 82 guidelines were analyzed, showing a significant increase in the number
of recommendations over time, from the first through previous to current versions. The total
number of recommendations increased by 106% between the previous and current versions. A
comparison of the current and previous guidelines shows a slight decrease in recommendations
with the highest levels of evidence (LOE I and II) by 10%, but an increase in recommendations
based on the lowest levels of evidence (V) by 5%. This trend indicates a need for better designed
and more rigorous research to strengthen the evidence supporting the recommendations.
Pharmacotherapy had the highest number of recommendations at the highest level of evidence,
LOE I, at 42%, while diagnostic procedures and surgery showed the lowest proportion of
recommendations with the highest level of evidence (16%). In analyzing different versions of
the guidelines, significant changes in recommendations are noticeable. Despite a decrease in
the highest levels of evidence (LOE I) in some areas, there is an increase in the grade of
recommendations (GOR A), indicating enhanced confidence in the recommendations. This
trend suggests that, even though the quality of evidence may decrease, the confidence in the
effectiveness of the recommendations continues to grow.
Conclusion: This analysis of ESMO clinical guidelines reveals that one-third of current
recommendations are supported by the highest level of evidence (LOE I), although the overall
level of LOE I has slightly decreased compared to previous versions. Variations in levels of
evidence and grades of recommendations among different types of cancer, with high rates of
recommendations based on lower levels of evidence (LOE III-V), raise concerns about
decreased reliability of guidelines. An increase in GOR A recommendations has also been
noted, despite a decrease in LOE I in some areas, suggesting a trend towards increasing
unfounded security in recommendations. More high-quality studies are needed to increase highquality evidence and improve cancer treatment outcomes, along with regular updates to
guidelines to respond to rapid changes in therapeutic options. |
