60 research outputs found
Efficacy of enteral nutrition in treatment of patients with acute pancreatitis
Cilj istraživanja: usporediti uÄinkovitost i Å”tetnost pojedinih vrsta pripravaka enteralne prehrane, kao i usporediti enteralnu prehranu u odnosu na totalnu parenteralnu prehranu i pristup lijeÄenja bez nutritivne potpore u bolesnika s akutnim pankreatitisom. Dodatni cilj ukljuÄuje i procjenu uÄinkovitosti i Å”tetnosti enteralne prehrane u ovisnosti o težini bolesti. Materijali i metode: temeljem opsežne i sustavne pretrage literature, ovaj sustavni pregled obuhvaÄa sva randomizirana kliniÄka istraživanja u kojima se odreÄeni oblik enteralne prehrane usporeÄuje s drugim oblikom nutritivnog pristupa lijeÄenju (druga enteralna formula, totalna parenteralna prehrana ili pristup bez nutritivne potpore) akutnog pankreatitisa kao kontrolom. Iz studija koje ispunjavaju ukljuÄne kriterije prikupljeni su podaci o karakteristikama istraživanja te primarnim i sekundarnim ishodima. Primarni ishodi obuhvaÄaju mortalitet bilo kojeg uzroka, sindrom sustavnog upalnog odgovora, organsko zatajenje i nuspojave, dok sekundarne ishode Äine lokalne septiÄne komplikacije, ostale lokalne komplikacije, ostale infektivne komplikacije, serumska koncentracija C-reaktivnog proteina i duljina trajanja hospitalizacije. Analiza je provedena raÄunalnim programom Review Manager inaÄica 5.2, primjenom fixed-effect i random-effects modela meta-analize. Rezultati su izraženi kao relativni rizik (RR) za dihotomne podatke i razlika aritmetiÄkih sredina (MD) za kontinuirane podatke, u oba sluÄaja s 95% intervalima pouzdanosti. Analiza je provedena po intention-to-treat principu. Rezultati: pretraživanjem literature je ukupno pronaÄeno 1308 publikacija. Izostavljanjem dvostrukih rezultata i publikacija koje nisu randomizirana istraživanja ili nisu povezane s tematikom sustavnog pregleda, preostala je 41 studija, od kojih je temeljem ukljuÄnih kriterija 25 ukljuÄeno u sustavni pregled i meta-analizu. Imunonutricija u odnosu na kontrolu znaÄajno smanjuje mortalitet bolesnika (RR 0, 49 ; 95% CI 0, 29 do 0, 80), dok znaÄajna razlika u ostalim ishodima s obzirom na manjak prikaza podataka u studijama nije dokazana. SliÄan je uÄinak utvrÄen i za podgrupu bolesnika s teÅ”kim akutnim pankreatitisom. Analiza enteralne prehrane s probioticima ukazala je na znaÄajno manju uÄestalost organskog zatajenja (RR 0, 77 ; 95% CI 0, 62 do 0, 97) i lokalnih septiÄnih komplikacija (RR 0, 60 ; 95% CI 0, 41 do 0, 89), ali iskljuÄivo primjenom fixed-effect modela zbog znaÄajne heterogenosti meÄu studijama. Pojavnost ostalih infektivnih komplikacija bila je znaÄajno manja u skupini lijeÄenoj probioticima (RR 0, 56 ; 95% CI 0, 32 do 0, 98). U jednoj studiji ove analize utvrÄen je znaÄajno veÄi broj ozbiljnih nuspojava, koje su rezultirale znaÄajno veÄom uÄestaloÅ”Äu organskog zatajenja i smrtnosti. Zbog visokog rizika pristranosti i manjkavosti u dizajnu studije, provedena je post hoc analiza s iskljuÄenjem rezultata iste. Time je utvrÄen dodatni blagotvorni uÄinak probiotika na spomenute ishode. Primjena semielementarnih formula znaÄajno je smanjila smrtnost (RR 0, 33 ; 95% CI 0, 20 do 0, 54), uÄestalost organskog zatajenja (RR 0, 42 ; 95% CI 0, 32 do 0, 56), broj lokalnih septiÄnih komplikacija (RR 0, 40 ; 95% CI 0, 30 do 0, 55) i ostalih lokalnih komplikacija (RR 0, 48 ; 95% CI 0, 34 do 0, 67). Ostali su ishodi bili sliÄni u obje grupe ispitanika. Procjenu uÄinkovitosti polimernih enteralnih formula bilo je moguÄe provesti na temelju samo dvije studije, bez utvrÄenog znaÄajnog uÄinka na sve analizirane ishode. SliÄni rezultati na veÄinu kliniÄkih ishoda bolesti dobiveni su analizom dvije studije koje su enteralnu prehranu obogaÄenu vlaknima usporeÄivale s kontrolom, uz statistiÄki znaÄajno kraÄe vrijeme hospitalizacije (MD -9, 28 ; 95% CI -13, 21 do -5, 35) i manji broj ostalih lokalnih komplikacija (11/28 naspram 24/32 ; P=0, 008). Samo je jedna studija istraživala imunonutriciju obogaÄenu probioticima i vlaknima, zbog Äega meta-analizu nije bilo moguÄe provesti, a opisuje znaÄajno kraÄe vrijeme hospitalizacije (P=0, 01). Analizom podgrupa utvrÄeno je da je primjena bilo kojeg oblika enteralne prehrane znaÄajno uÄinkovitija od totalne parenteralne prehrane u smanjenju smrtnosti (RR 0, 33 ; 95% CI 0, 21 do 0, 54) i organskog zatajenja (RR 0, 39 ; 95% CI 0, 30 do 0, 52), uz podjednak broj nuspojava lijeÄenja. Enteralna prehrana pokazala se boljom od pristupa bez nutritivne potpore u smanjenju mortaliteta (RR 0, 50 ; 95% CI 0, 29 do 0, 86), dok zbog manjka prikazanih podataka nije bila moguÄa meta-analiza preostalih primarnih ishoda. Sekvencijskom analizom studija za one analize ishoda mortaliteta koje su pokazale statistiÄki znaÄajan rezultat, utvrÄena je dovoljna koliÄina i snaga dokaza u sluÄaju usporedba semielementarnih formula i kontrole te bilo koje enteralne prehrane i totalne parenteralne prehrane. ZakljuÄak: izradom Cochrane sustavnog pregleda i provedbom meta-analize dostupnih literaturnih dokaza prikazani su podatci uÄinkovitosti i Å”tetnosti primjene razliÄitih oblika enteralne prehrane u bolesnika s akutnim pankreatitisom, s posebnim osvrtom na bolesnike s teÅ”kim oblikom bolesti, kao i prednosti, odnosno nedostatci pojedinih nutritivnih terapijskih pristupa. Dodatkom imunomodulatornih tvari enteralnoj prehrani ustanovljeno je znaÄajno smanjenje smrtnosti, ali zbog relativno ograniÄenog broja ukljuÄenih bolesnika potrebna su daljnja istraživanja. Primjena probiotika je kontroverzna i potenijalno povezana s poveÄanim rizikom razvoja ozbiljnih komplikacija te se njihova rutinska primjena ne može preporuÄiti. MeÄutim, zbog heterogenosti i nekonzistentnosti rezultata dodatne strogo kontrolirane i dobro dizajnirane studije su potrebne s ciljem odreÄivanja njihove stvarne Å”tetnosti, odnosno dobrobiti. Semielementarne formule predstavljaju najÅ”ire istraživani i primjenjivani oblik enteralne prehrane u akutnom pankreatitisu s jasnom znaÄajnom prednoÅ”Äu u odnosu na prvenstveno totalnu parenteralnu prehranu u poboljÅ”anju kliniÄkog ishoda i preživljenja bolesnika. OpÄenito, enteralna prehrana pokazala se uÄikovitijom u odnosu na totalnu parenteralnu prehranu, kao i pristup bez nutritivne potpore u bolesnika a akutnim pankreatitisom.Objectives: this thesis aimed to compare the beneficial and harmful effects of specific enteral nutrition formulations, as well as to compare enteral nutrition to total parenteral nutrition and no nutritional intervention in patients with acute pancreatitis. An additional aim was to evaluate the beneficial and harmful effects of enteral nutrition depending on disease severity. Materials and methods: based on extensive and systematic database searches this systematic review comprises randomized clinical trials comparing a specific type of enteral nutrition formulation to a control consisting of another type of nutritive therapeutical approach (ie, other type of enteral formulation, total parenteral nutrition or no nutritional intervention) in acute pancreatitis. From trials fulfilling the inclusion criteria, characteristics of studies and data regarding primary and secondary outcomes were extracted. Primary outcomes include all-cause mortality, systemic inflammatory response syndrome, organ failure, and adverse events, while secondary outcomes refer to local septic complications, other local complications, other infective complications, C-reactive protein concentrations, and length of hospital stay. The analysis was carried out using Review Manager 5.2, with both the fixed-effect and random-effects model. Results were expressed as risk ratios (RR) for dichotomous data, and mean difference (MD) for continuous data, both with a 95% confidence interval (CI). The analysis was based on an intention-to-treat principle.
Results: searches identified a total of 1308 publications. By eliminating duplicates, as well as non-randomized trials and trials not related to the topic of the review, 41 trials were assessed for eligibility and eventually 25 were included in the systematic review and meta-analysis. Immunonutrition compared to control significantly decreased mortality (RR 0.49; 95% CI 0.29 to 0.80), while no significant difference was shown for other outcomes due to a smaller number of studies included. A similar effect was determined in the subgroup of patients with severe acute pancreatitis. Analysis of enteral nutrition with probiotics showed a significantly lower incidence of organ failure (RR 0.77; 95% CI 0.62 to 0.97) and local septic complications (RR 0.60; 95% CI 0.41 to 0.89), but only by the fixed-effect model due to significant heterogeneity between studies. The occurrence of other infective complications was significantly lower in the probiotics group (RR 0.56; 95% CI 0.32 to 0.98). One study from this analysis found a significantly higher number of serious adverse events, which resulted in higher mortality and number of organ failure. Because of a high risk of bias and possible study design flaws, a post-hoc analysis with exclusion of data from this trial was performed. An additional beneficial effect of probiotics on the above mentioned outcomes was noted. The use of semi-elemental formulas significantly reduced mortality (RR 0.33; 95% CI 0.20 to 0.54), occurrence of organ failure (RR 0.42; 95% CI 0.30 to 0.55) and other local complications (RR 0.48; 95% CI 0.34 to 0.67). Other outcomes were similar in both groups. Efficacy assessment of polymeric enteral formulations was possible for only two trials, with no significant effects regarding all assessed outcomes. Similar results on the majority of clinical outcomes were obtained by the analysis of two trials comparing fiber-enriched enteral nutrition to control, with a significantly shorter length of hospital stay (MD -9.28; 95% CI -13.21 to -5.35) and a lower number of other local complications (11/28 versus 24/32; P=0.008). Only one trial assessed the use of immunonutrition enriched with probiotics and fibers, therefore a meta-analysis was not plausible, showing a significantly shorter length of hospital stay (P=0.01). Subgroup analysis confirmed that any type of enteral nutrition used is significantly more effective than total parenteral nutrition in reduction of mortality (RR 0.33; 95% CI 0.21 to 0.54) and organ failure (RR 0.39; 95% CI 0.30 to 0.52), with a similar number of adverse events. Enteral nutrition has proven better than no nutritional intervention in reduction of mortality (RR 0.50; 95% CI 0.29 to 0.86), while meta-analysis of other primary outcomes was not possible due to lack of data. Trial sequential analysis for meta-analyses of mortality which showed significant difference, confirmed a sufficient amount and power of evidence in case of comparing semi-elemental formulations to control, and any type of enteral nutrition to total parenteral nutrition.
Conclusion: by conducting a Cochrane systematic review and meta-analysis of available literature data, evidence of the beneficial and harmful effects of different enteral nutrition formulations in patients with acute pancreatitis was analyzed. Addition of immunomodulatory agents to enteral nutrition showed significant decrease in mortality, but because of a relatively limited number of patients included further research is required. The use of probiotics is controversial and potentially associated with an increased risk of developement of serious adverse events, therefore their routine application cannot be recommended. However, due to significant heterogeneity and incosistency of results additional rigorously controlled and well-designed trials are needed to determine their potential efficacy or harms. Semi-elemental formulations represent the most widely researched and used type of enteral nutrition in acute pancreatitis with a clear significant benefit over mainly total parenteral nutrition in improving patients clinical outcome and survival. Generally, results showed that enteral nutrition is more effective than total parenteral nutrition, as well as no nutritional support in patients with acute pancreatitis
Random errors in research and the importance of sample size
SluÄajne pogreÅ”ke sastavni su dio svakog eksperimenta, odnosno kliniÄkog istraživanja i posljedica su varijabilnosti uzorkovanja. Rezultati istraživanja trebaju biti primjenjivi na Äitavu populaciju zbog Äega su reprezentativnost i adekvatna veliÄina ispitivanog uzorka izuzetno bitne. ProvoÄenjem odreÄenog mjerenja na uzorku populacije, nastojimo utvrditi s kojom vjerojatnoÅ”Äu je opažena razlika izmeÄu mjerenih varijabli posljedica sluÄajnosti, odnosno postojanja stvarne razlike u populaciji. Navedena vjerojatnost izražava se P-vrijednoÅ”Äu. SluÄajnost se oÄituje u istraživanjima kao pogreÅ”ka tipa I i pogreÅ”ka tipa II. Rizik sluÄajne pogreÅ”ke u istraživanjima umanjuje se poveÄanjem broja mjerenja, odnosno veliÄine istraživanog uzorka. Zbog toga je u fazi planiranja istraživanja nužno izraÄunati i definirati potreban broj ispitanika na temelju prethodno definiranog primarnog ishoda istraživanja. Time se omoguÄuje provoÄenje vjerodostojnih i metodoloÅ”ki Ävrstih istraživanja koja rezultiraju solidnim dokazima.Random errors are essential parts of every experiment and clinical research resulting from sampling variability. Research results should be applicable to the entire population, which is why the representativeness and adequate sample size are of crucial importance. By conducting a specific measurement on a population sample, we try to determine the probability of the observed difference between measured variables being the result of chance or acutal difference in the population. This probability is known as the P-value. Chance in research manifest itself as error type I and error type II. The risk of random error diminishes by increasing the number of measurements or enlarging the sample size. Therefore, it is necessary to calculate and define the required sample size based on a priorly defined primary outcome. This enables the implementation of credible and methodologically strong research resulting in solid evidence
Cochrane group from Rijeka ā review of activities and results
DugogodiÅ”nja suradnja rijeÄkih gastroenterologa sa specifiÄnim grupama u sklopu Cochrane kolaboracije rezultirala je znaÄajnim napretkom na polju znanstveno-istraživaÄke djelatnosti i brojnim publikacijama. Spoznaje i zakljuÄci dosegnuti u Cochrane sustavnim pregledima predstavljaju pouzdane struÄne dokaze u raznim podruÄjima gastroenterologije, posebno kroniÄne hepatitis C infekcije, kolestatskih bolesti jetre i akutnog pankreatitisa. Navedene publikacije visoko su citirani radovi, koji su implementirani i u nekim meÄunarodnim smjernicama, odnosno preporukama lijeÄenja. Doprinosom rijeÄke Cochrane grupe otvorena su vrata suradnje s brojnim inozemnim struÄnjacima i suradnicima, pokrenuto je organiziranje teÄajeva medicine temeljene na dokazima i unaprijeÄena je suradnja s Hrvatskim Cochrane centrom te drugim domaÄim znanstvenicima. Ovaj pregledni Älanak predstavlja pregled dosadaÅ”njih postignuÄa rijeÄkih autora u sklopu Cochrane kolaboracije uz sažeti prikaz najznaÄajnijih rezultata i zakljuÄaka u objavljenim Cochrane sustavnim pregledima s ciljem upoznavanja javnosti s moguÄnostima rada u Cochrane kolaboraciji i vrstom znanstveno-istraživaÄke djelatnosti koja se u sklopu iste provodi te promocije i popularizacije medicine temeljene na dokazima u Å”iroj znanstvenoj i struÄnoj zajednici.The long-term cooperation of gastroenterologists from Rijeka with specific groups within the Cochrane Collaboration has resulted in significant progress in the field of scientific research and numerous publications. The findings and conclusions reached in the published Cochrane systematic reviews represent reliable evidence in various gastroenterology fields, particularly chronic hepatitis C infection, cholestatic liver disease and acute pancreatitis. The aforementioned publications are highly quoted papers, which are cited in different international guidelines and treatment recommendations. With the contribution of authors from Rijeka, a door to cooperation with several foreign experts and associates has been opened, courses in evidence-based medicine have been organized, and the collaboration with the Croatian Cochrane Center and other domestic scientists has been enhanced. This review article presents an overiew of the achievements of authors from Rijeka within the Cochrane Collaboration with a summary of the most important results and conclusions from the systematic reviews aiming to inform the public of the opportunities given by the Cochrane Collaboration and the type of scientific research implemented by it, as well as, to promote and popularize evidence-based medicine in a broad scientific and professional community
Systematic search of databases
Baza podataka je organizirana i ureÄena cjelina meÄusobno povezanih podataka spremljenih bez nepotrebne redundancije. Razlikujemo tri vrste baza podataka: bibliografske, citatne i baze podataka s cjelovitim tekstom. Neke od najpoznatijh baza podataka u podruÄju biomedicine i prirodnih znanosti su: Medline, EMBASE, Web of Science, Cochrane library. Pristup pretraživanju baza podataka vrlo je individualan i gotovo da ne postoji jedinstveni model pretrage. Kod pretrage je bitno koriÅ”tenje kljuÄnih rijeÄi i indeksa, odnosno predmetnih pojmova. KljuÄne rijeÄi pomažu u bržem i kvalitetnijem pretraživanju. Nedostatno pretraživanje može za posljedicu imati sustavne pogreÅ”ke u sustavnom preglednom Älanku te umanjiti vjerodostojnost rezultata i zakljuÄaka. Problem mogu predstavljati brojne neobjavljene studije, kao i one koje nisu navedene na najÄeÅ”Äim mjestima pretrage poput PubMed-a. Struktura strategije pretraživanja trebala bi se temeljiti na glavnim pojmovima koji se ispituju u pregledu. KoriÅ”tenje Booleanove logike primjenom operatora \u27AND\u27, \u27OR\u27 ili \u27NOT\u27 i PICO strategije pretraživanja pokazuje najbolje rezultate. Ako postoji ograniÄenje za pronalaženje specifiÄnih vrsta studija (npr. randomiziranih kontroliranih studija) mogu se koristiti \u27filteri\u27 za pronalaženje upravo takvih studija. Generalne baze podataka poput MEDLINE-a za identificiranje studija za Cochrane sustavne pregledne radove ukljuÄuju tri glavna uvjeta: a) pojmovi za pretragu zdravstvenog stanja od interesa, b) uvjeti za traženje intervencije, c) uvjeti za traženje vrste studija koje Äe biti ukljuÄene ("filter").A database is an organized and systematized set of connected data saved without unnecessary redundancy. There are three types of databases: bibliographic, quotation and full text databases. Some of the most known databases in the field of biomedicine and natural sciences are: Medline, EMBASE, Web of Science, Cochrane Library. Access for database search is highly individual and almost no single search model exists. Crucial part of the search is using keywords and indexes or subject terms. Keywords make search faster and more accurate. Insufficient search can result in systematic errors in a systematic review and reduce the credibility of results and conclusions. The issue can be unpublished studies, as well as those not listed on the most common search sites like PubMed. The search strategy structure should be based on the main terms that are being examined in the review. Using Boolean logic by using the operator \u27AND\u27, \u27OR\u27 or \u27NOT\u27 and the PICO search strategy gives the best results. If there is a limit for finding specific types of studies (eg. randomized controlled studies), \u27filters\u27 can be used to find such studies. General databases such as MEDLINE for Cochrane systematic review include three main conditions: a) terms for searching of a health status of interest, b) conditions for searching intervention, c) conditions for types of studies to be included
Contemporary approach to chronic hepatitis C treatment
KroniÄni hepatitis C jedan je od najznaÄajnijih uzroka kroniÄnih bolesti jetre i globalni zdravstveno-ekonomski problem danaÅ”njice od kojeg boluje gotovo 3 % svjetske populacije. Eliminacija virusa i uspjeÅ”no izljeÄenje povezani su sa smanjenjem uÄestalosti razvoja hepatocelularnog karcinoma, smanjenjem smrtnosti zbog komplikacija bolesti jetre i opÄe smrtnosti oboljelih. Napredak na podruÄju istraživanja genetskih karakteristika virusa i patofizioloÅ”kih mehanizama bolesti rezultirao je tijekom posljednjih desetak godina znaÄajnim poboljÅ”anjem farmakoterapije i ishodima lijeÄenja s poveÄanjem moguÄnosti trajnog izljeÄenja. No prava evolucija, odnosno revolucija na podruÄju medikamentozne terapije, dogaÄa se unatrag otprilike dvije godine, razvojem novih direktnih antivirusnih lijekova kojima se u velikoj mjeri olakÅ”ava naÄin lijeÄenja i skraÄuje njegovo trajanje uz postizanje boljeg terapijskog odgovora. Odobrenjem i dostupnoÅ”Äu tzv. inteferon-free terapije na podruÄju Europske unije, SAD-a i Japana sve se viÅ”e smanjuje uloga dosadaÅ”njih modaliteta lijeÄenja, Äime se znaÄajno poboljÅ”ava sigurnosni profil lijeÄenja ovih pacijenata. Daljnji razvoj novih oblika terapije zasigurno vodi k tome da Äe se u relativno bliskoj buduÄnosti izljeÄenje kroniÄnog hepatitisa C postizati joÅ” uÄinkovitijom terapijom uz kraÄe trajanje lijeÄenja. Ovaj pregledni Älanak prikazuje suvremene terapijske modalitete i preporuke lijeÄenja kroniÄnog hepatitisa C uz osvrt na odreÄene specifiÄnosti, prednosti i nedostatke pojedinih lijekova.Chronic hepatitis C is one of the major causes of chronic liver disease and a global health and economic burden of our time, which affects almost 3 % of the worldās population. Virus elimination and effective treatment are associated with a decreased incidence of hepatocelullar carcinoma, liver-related mortality and all-cause mortality in affected patients. The progress of the research in the field of viral genetics and pathophysiologic mechanisms in the last decade has resulted in significant improvements in pharmacotherapy and treatment outcomes with increased possibilities of a permanent cure. However, the real evolution, or better, revolution in pharmacotherapy is happening in the last two years with the development of new direct antiviral agents, which greatly facilitate treatment and shorten its duration with a better end-result. By approving and making interferon-free modalities available in the EU, USA and Japan the role of previous treatment approaches is being all the more reduced, which significantly improves the safety profile of treatment of these patients. Further advance of new forms of therapy certainly leads to the fact that in the relatively near future hepatitis C eradication will be achieved by single-tablet regimens used for a shorter period of time. This review article presents contemporary therapeutic approaches and treatment recommendations for chronic hepatitis C with reference to certain features, advantages and disadvantages of specific drugs
Bias in clinical trials
Bias ili sistemska pogreÅ”ka koja se javlja u istraživanjima u danaÅ”nje je vrijeme veliki teret za Evidence based medicine (EBM). Takve pogreÅ”ke se mogu javiti u bilo kojoj fazi istraživanja i uvelike utjeÄu na rezultate i vjerodostojnost neke terapije ili postupka. Postoje razne metode kojima se može na vrijeme prepoznati i izbjeÄi bias te je njihovo koriÅ”tenje preporuÄljivo.Bias or systematic error which occurs during trials is a heavy load on Evidence based medicine (EBM). Such errors can occur in any trial phase and they can greatly impact the results and credibility of a certain trial or procedure. Various metods exist which can help identify and avoid bias. The use of these metods is highly recommended
Cochrane collaboration: history and development
Cochrane kolaboracija je meÄunarodna i neprofitna organizacija, Äiji je temeljni cilj promicanje medicine temeljene na dokazima (engl. Evidence based medicine; EBM) te stvaranje i Å”irenje pouzdanih, visokokvalitetnih dokaza o intervencijskim i dijagnostiÄkim postupcima u zdravstvenoj zaÅ”titi. Archibald Cochrane bio je Å”kotski lijeÄnik te jedan od idejnih zaÄetnika medicine temeljene na dokazima, u Äiju je Äast organizacija je dobila ime. Organizacija je osnovana 1993. godine u Oxfordu (UK) pod vodstvom Sir-a Iaina Chalmersa. Danas Cochrane kolaboracija okuplja viÅ”e od 40 tisuÄa suradnika i volontera iz viÅ”e od 130 zemalja. Cochrane kolaboracija se sastoji od nekoliko razliÄitih radnih skupina, koje podržavaju rad organizacije. Glavni proizvod Cochrane kolaboracije je baza sustavnih pregleda (engl. Cochrane Database of Systematic Reviews; CDSR), koja predstavlja glavni dio Cochrane knjižnice (engl. Cochrane Library). Cochrane knjižnica sadrži razliÄite vrste visokokvalitetnih, neovisnih dokaza za donoÅ”enje odluka u zdravstvu. Svakodnevni razvoj Cochrane kolaboracije, oÄituje se poveÄanjem broja Cochrane sustavnih pregleda te broja suradnika. Cochrane kolaboracija ima nekoliko ciljeva za buduÄnost, meÄu kojima se istiÄu želja da se visokokvalitetni dokazi uÄine dostupnima svakome diljem svijeta te etabliranje kolaboracije kao glavnog zagovornika zdravstvene zaÅ”tite temeljene na dokazima.Cochrane Collaboration is an international and non-profit organization which main goal is to promote Evidence-Based Medicine (EBM) and to create and disseminate reliable, high-quality evidence on interventional and diagnostic procedures in a health care. Archibald Cochrane was a Scottish physician and one of a founders of evidence-based medicine. The organization got named after him, in his honour. The organization was found in 1993. in Oxford (UK), under the leadership of Sir Iain Chalmers. Nowadays, Cochrane Collaboration brings together over 40,000 associates and volunteers from more than 130 countries. Cochrane Collaboration consists of a several different working groups that are supporting work of the organization. The main product of Cochrane Collaboration is the Cochrane Database of Systematic Reviews (CDSR), which is the main part of the Cochrane Library. The Cochrane Library contains various types of high-quality, independent evidence for decision-making in healthcare. The daily development of Cochrane Collaboration is reflected on increasing of the number of Cochrane systematic reviews and the number of collaborators. Cochrane Collaboration has several goals for the future, including a desire to make high-quality evidence available to anyone around the world and to establish collaboration as the main evidence-based health advocate
Contemporary approach to chronic hepatitis C treatment
KroniÄni hepatitis C jedan je od najznaÄajnijih uzroka kroniÄnih bolesti jetre i globalni zdravstveno-ekonomski problem danaÅ”njice od kojeg boluje gotovo 3 % svjetske populacije. Eliminacija virusa i uspjeÅ”no izljeÄenje povezani su sa smanjenjem uÄestalosti razvoja hepatocelularnog karcinoma, smanjenjem smrtnosti zbog komplikacija bolesti jetre i opÄe smrtnosti oboljelih. Napredak na podruÄju istraživanja genetskih karakteristika virusa i patofizioloÅ”kih mehanizama bolesti rezultirao je tijekom posljednjih desetak godina znaÄajnim poboljÅ”anjem farmakoterapije i ishodima lijeÄenja s poveÄanjem moguÄnosti trajnog izljeÄenja. No prava evolucija, odnosno revolucija na podruÄju medikamentozne terapije, dogaÄa se unatrag otprilike dvije godine, razvojem novih direktnih antivirusnih lijekova kojima se u velikoj mjeri olakÅ”ava naÄin lijeÄenja i skraÄuje njegovo trajanje uz postizanje boljeg terapijskog odgovora. Odobrenjem i dostupnoÅ”Äu tzv. inteferon-free terapije na podruÄju Europske unije, SAD-a i Japana sve se viÅ”e smanjuje uloga dosadaÅ”njih modaliteta lijeÄenja, Äime se znaÄajno poboljÅ”ava sigurnosni profil lijeÄenja ovih pacijenata. Daljnji razvoj novih oblika terapije zasigurno vodi k tome da Äe se u relativno bliskoj buduÄnosti izljeÄenje kroniÄnog hepatitisa C postizati joÅ” uÄinkovitijom terapijom uz kraÄe trajanje lijeÄenja. Ovaj pregledni Älanak prikazuje suvremene terapijske modalitete i preporuke lijeÄenja kroniÄnog hepatitisa C uz osvrt na odreÄene specifiÄnosti, prednosti i nedostatke pojedinih lijekova.Chronic hepatitis C is one of the major causes of chronic liver disease and a global health and economic burden of our time, which affects almost 3 % of the worldās population. Virus elimination and effective treatment are associated with a decreased incidence of hepatocelullar carcinoma, liver-related mortality and all-cause mortality in affected patients. The progress of the research in the field of viral genetics and pathophysiologic mechanisms in the last decade has resulted in significant improvements in pharmacotherapy and treatment outcomes with increased possibilities of a permanent cure. However, the real evolution, or better, revolution in pharmacotherapy is happening in the last two years with the development of new direct antiviral agents, which greatly facilitate treatment and shorten its duration with a better end-result. By approving and making interferon-free modalities available in the EU, USA and Japan the role of previous treatment approaches is being all the more reduced, which significantly improves the safety profile of treatment of these patients. Further advance of new forms of therapy certainly leads to the fact that in the relatively near future hepatitis C eradication will be achieved by single-tablet regimens used for a shorter period of time. This review article presents contemporary therapeutic approaches and treatment recommendations for chronic hepatitis C with reference to certain features, advantages and disadvantages of specific drugs
Importance of conducting randomised clinical trials
KliniÄko ispitivanje (pokus ili studija) smatra se jedinim znanstvenim dokazom djelotvornosti nekog lijeka, terapijskog ili kirurÅ”kog zahvata. U posljednjih 50 godina, dominantan oblik istraživanja u medicinskoj znanosti postala su randomizirana kliniÄka istraživanja (eng. Randomised clinical trials; RCT) te danas predstavljaju kamen temeljac medicine temeljene na dokazima (engl. Evidence based medicine; EBM) RijeÄ je o kvantitativno komparativnom obliku istraživanja pomoÄu kojeg se usporeÄuje uÄinak dvaju ili viÅ”e postupaka na ispitanike, koji su nasumiÄno podijeljeni u viÅ”e istraživaÄkih skupina. Stupanj dokaza, dobivenih pomoÄu randomiziranih kliniÄkih istraživanja, predstavlja najviÅ”i stupanj dokaza u medicinskoj znanosti, a smjernice koje predstavljaju sistematizirane principe lijeÄenja uglavnom se temelje na najboljim dostupnim podacima iz kliniÄkih istraživanja. Smjernice omoguÄuju lijeÄnicima da uz pomoÄ svog iskustva i znanja, vodeÄi pritom raÄuna o osobitostima i stavovima bolesnika, najbolje lijeÄe bolesnika. Pouzdanost i kvaliteta rezultata RCT-a, ovise o odreÄenim karakteristikama samog istraživanja poput adekvatno provedenog postupka randomizacije, āzaslijepljenostiā istraživaÄa i ispitanika, te pravilno oblikovanom protokolu istraživanja. Usprkos velikom broju prednosti, postoje i odreÄene negativne karakteristike randomiziranih kliniÄkih istraživanja, poput etiÄkih pitanja opravdanosti istraživanja, cijene, nemoguÄnoti provedbe samog istraživanja te nedovoljno dobre informiranosti pacijenata o važnosti njihova provoÄenja,kako za medicinsku znanost tako i za njih same.Clinical trial (experiment or study) is considered to be the only scientific evidence of the efficiency of a drug, therapeutic or surgical procedure. In the last 50 years, randomized clinical trials (RCTs) have become the dominant form of research in medical science and today they represent the base of Evidence Based Medicine (EBM). RCTs are quantitative comparative controlled experiments in which the effect of two or more clinical procedures is compared on subjects randomly divided into several research groups. The level of evidence, obtained through randomized clinical trials, represents the highest level of evidence in medical science, and the guidelines that represent systematized principles of medical treatment are mainly based on the best available clinical data. Guidelines allow physicians, in combination with their own experience and knowledge, while simultaneously taking care of personality and charateristics of patients, providing patients the best available treatment. Quality of RCT results depends on certain characteristics of the research itself, such as the adequately conducted randomization procedure, the "blindness" of researchers and subjects and properly designed research protocol. Despite the great number of advantages, there are certain negative characteristics of randomized clinical trials, such as ethical questions of justification of the research, price of the research, impossibility to carry out the research itself, and inadequate knowledge of patients about the importance of their implementation, both for medical science and them
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