28 research outputs found
15 godina osnutka Časopisa Croatian Medical Journal: nastavljamo s dobrim radom.
In 2007 the Croatian Medical Journal (CMJ) celebrated its 15th anniversary as a peer-reviewed, non-for-profit scientific journal (1).
Over the years, the Journal has become internationally visible through being included in MEDLINE/PubMed, EMBASE/Excerpta
Medica, Scopus, and Thomson Scientific’s databases Current Contents/Clinical Medicine and Science Citation Index – Expanded (2-
4). From the 2007 volume on, it has been also available in PubMed Central, a free digital archive of biomedical and life science journal literature. The Journal’s content has been freely available from www.cmj.hr since 1999. During the last 15 years, its quality and international visibility have notably increased, as evidenced
by the analysis of its impact factor (5). The aim of this article is to provide a brief overview of the CMJ′s major activities in the research community at the so-called scientific periphery
ADVERSE DRUG REACTIONS
Nuspojava je svaka štetna, neželjena reakcija na lijek koji je primijenjen u ispravnoj indikaciji i u uobičajenoj dozi u terapijsku, profilaktičku ili dijagnostičku svrhu. Sve veći broj djelotvornih lijekova, dostupnost lijekova velikom broju ljudi i starenje sveukupne populacije povećavaju mogućnost nastanka nuspojava. Svaki lijek koji može izazvati terapijski učinak, može izazvati i nuspojavu. Jedan od uvjeta za racionalnu primjenu lijekova jest i poznavanje njihovih nuspojava. Usprkos tome što spontana, dobrovoljna prijava nuspojava lijekova i medicinskih proizvoda nije optimalna, jo{ uvijek nema niti jednoga boljeg sustava koji bi prije i pouzdanije otkrivao te pojave. U ~čanku su razjašnjeni osnovni pojmovi koji se upotrebljavaju pri opisu nuspojava, njihova klasifikacija te način na koji se dijagnosticiraju, liječe, prate i prijavljujuAdverse drug reaction (ADR) is a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man. Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. The knowledge about ADRs should lay a basis for a rational drug use. The more drugs there are on the market, and their increasing availability to more and more people, as well as the aging of the population increase the possibility of developing an ADR. Despite the fact that spontaneous, voluntary reporting of ADRs is far from being ideal, at present there is no better way of detecting them. Here we define the terms used to describe ADRs, explain their classification, and discuss the way they can be diagnosed, managed, monitored and reporte
National vs. international journals: views of medical professionals in Croatia
Scholarly journals, especially in non-English-speaking countries, may perform very different functions depending on whether they are published for national or international audiences. Four hundred and sixty-six academic physicians and non-academic general practitioners in Croatia were surveyed on their knowledge about two Croatian medical journals: Liječnički vjesnik (published in Croatian) and Croatian Medical Journal (published in English). The physicians were also surveyed about the importance of all national and international journals published in Croatia, and the types of articles they thought should be published in these journals. More respondents rated national (n = 329, 72.6%) than international journals (n = 275, 63.5%, P < 0.001, Wilcoxon test) as very important for the medical profession. On the other hand, publishing in international journals was more often rated as important than publishing in national journals (n = 184, 42.5% vs. n = 125, 27.8%; P < 0.001, Wilcoxon test). Guidelines for clinical practice were rated as the most important publication item in national journals, and original scientific articles in international journals
Drugs in Pregnancy
Na području kliničke farmakologije trudnoće
vrlo je malo pravih, kontroliranih kliničko-farmakoloških
istraživanja zbog etičkih razloga. Budući da potrošnja lijekova
u trudnoći raste, racionalna farmakoterapija nameće se kao
imperativ. Većina lijekova može proći kroz placentu uz
mogućnost farmakološkog i teratogenog učinka na embrio i
fetus. Uzrok malformacija nepoznat je u 70% slučajeva, a
lijekovi, kemikalije i zračenje čine 2% uzroka. Danas je poznato
manje od 30 teratogena. Lijekovi mogu djelovati štetno
na plod u bilo kojem razdoblju trudnoće. Budući da je čak
50% trudnoća neplanirano, tu je činjenicu važno imati na umu
prilikom propisivanja lijekova ženama generativne dobi. Pri
izboru lijeka treba se odlučiti za lijekove koji su do sada
često propisivani u trudnoći i za koje se pokazalo da su
neškodljivi. Takvim lijekovima treba dati prednost pred novim
ili neispitanim lijekovima, a uvijek treba primijeniti najnižu
djelotvornu dozu. Trudnice treba upozoriti da ne uzimaju
lijekove bez recepta i bez prethodnog dogovora s liječnikom.
Liječnici i trudnice mogu zatražiti konzultaciju kliničkog farmakologa
o uzimanju lijekova u trudnoći. Neobično je važno
da se trudnicama objasni tzv. normalna učestalost malformacija
u trudnoći koja iznosi oko 3% te rizik povezan sa
samom bolešću, kako bi se izbjegao nepotreban pobačaj ili
neliječenje bolesti trudnice.As it is not ethical for pregnant women to be
included in clinical trials there are very few controlled clinical
trials with pregnant women. The fact is that drug consumption
in pregnancy continuously rises, so rational pharmacotherapy
becomes an imperative. Majority of drugs pass the placental
barrier, carrying potential pharmacological and/or teratogenic
activity on embryo and fetus. In 70% of fetal malformations
causative factor remains unknown while drugs, various chemicals
and radiation make just 2% of causes. Generally, in
everyday use are less than 30 drugs with absolutely proved
teratogenic activity. Drugs can harm a fetus in any period of
pregnancy. About 50% of pregnancies are not planned and
that information is very important when prescribing drugs to
the women in generative phase. Drugs which have been widely
prescribed and which have been shown to be safe in pregnancy
should be a first line in prescribing to pregnant women.
Those drugs should, certainly have an advantage in comparison
to the new drugs with incompletely defined safety profile.
It is also recommended to use the lowest efficient dose. Pregnant
women should be warned to contact their physician any
time when they need some drug, despite if the drug is on the
OTC regimen. If dilemma regarding the use of certain drugs in
pregnancy exists physicians and pregnant women should contact
a clinical pharmacologist. Finally, to avoid unnecessary
abortions or lack of adequate treatment, pregnant women
should be informed on, so called, normal frequency of malformations
which is about 3%, and on risk associated with the
disease as well
QUALITY OF HEALTH CARE, ACCREDITATION, AND HEALTH TECHNOLOGY ASSESSMENT IN CROATIA: ROLE OF AGENCY FOR QUALITY AND ACCREDITATION IN HEALTH
U 20. stoljeću Avedis Donabedian, utemeljitelj znanosti o kvaliteti medicinske skrbi, definirao je pojam kvalitete medicinske skrbi, uveo čimbenike usporedbe, preporučio određivanje standarda kvalitete i pokazatelja (indikatora) kvalitete na razini ustroja, provedbe i ishoda skrbi. Počeci akreditacije datiraju iz 1913. godine osnivanjem American College of Surgeons sa svrhom promoviranja koncepta bolničkih standarda; 50.-ih godina prošlog stoljeća osnovana je International Commision on Accreditation of Health Care Organization (JCAHO). Zatim je slijedilo razvijanje kanadskog akreditacijskog sustava (Canadian Council on Health Services Accreditation - CCHSA), danas poznatog kao Accreditation Canada, australskog (Australian Council on Healthcare Standards International - ACHSI), da bi 80-tih i 90-tih godina započeo intenzivniji razvoj akreditacijskih sustava u Europi i svijetu. Proces procjene zdravstvenih tehnologija započeo je prije 30-tak godina u Americi, a u Europi 1980. godine osnutkom prve nacionalne HTA agencije u Švedskoj. Agencija za kvalitetu i akreditaciju u zdravstvu, kao javna, neovisna i neprofitna ustanova osnovana je 2007. godine temeljem Zakona o kvaliteti zdravstvene zaštite kojim je i definirana njena uloga u procesu praćenja kvalitete zdravstvene zaštite, akreditacije nositelja zdravstvene djelatnosti, te postupku provođenja procjene zdravstvenih tehnologija u Republici Hrvatskoj. Cilj je ovoga rada dati pregled dosadašnjih aktivnosti Agencije od ljeta 2009. godine, kao i budućih aktivnosti na navedenim područjima, ukazati na potrebu edukacije osnovnih korisnika i dionika u navedenim procesima te prikazati međunarodnu suradnju i aktivno sudjelovanje u europskim projektima.Avedis Donabedian defined the quality of care as the kind of care, which is expected to maximize an inclusive measure of patient welfare, after taking into account the balance of expected gains and losses associated with the process of care in all its segments. According to the World Medical Assembly, physicians and health care institutions have an ethical and professional obligation to strive for continuous quality improvement of services and patient safety with the ultimate goal to improve both individual patient outcomes as well as population health. Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner, with the aim to formulate safe and effective health policies that are patient focused and seek to achieve the highest value. The Agency for Quality and Accreditation in Health was established in 2007 as a legal, public, independent, nonprofit institution under the Act on Quality of Health Care. The Agency has three departments: Department of Quality and Education, Department of Accreditation, and Department of Development, Research, and Health Technology Assessment. According to the Act, the Agency should provide the procedure of granting, renewal and cancellation of accreditation of healthcare providers; proposing to the Minister, in cooperation with professional associations, the plan and program for healthcare quality assurance, improvement, promotion and monitoring; proposing the healthcare quality standards as well as the accreditation standards to the Minister; keeping a register of accreditations and providing a database related to accreditation, healthcare quality improvement, and education; providing education in the field of healthcare quality assurance, improvement and promotion; providing the HTA procedure and HTA database, supervising the healthcare insurance standards, and providing other services in the field of healthcare quality assurance, improvement, promotion and monitoring, according to the Act. Formal activities of the Agency in the field of HTA actually began in summer 2009. In the field of quality and accreditation, the plan and program of healthcare quality assurance, improvement, promotion and monitoring was finished and published in October 2010; preparation of the healthcare quality standards as well as the accreditation standards is still in process, with the aim to start accreditation process at 10 hospitals in 2011. Education in the field of healthcare quality assurance, improvement and promotion has been established as a continuous process from the beginning. The Agency is member of the International Society for Quality in Health Care (ISQua) and participates in the work of the European Accreditation Network (EAN). In the field of HTA, the Agency has established international collaboration and support, which resulted in its appointment and participation in the European network for Health Technology Assessment (EUnetHTA) Joint Action Project as a EUnetHTA Partner, as well as its membership in the international society, HTAi. TAIEX project has been approved as a two-day workshop in December 2010. The Croatian HTA Guidelines have been issued with the aim to start the HTA process and reports that should serve as recommendations, as a support to policy-makers at the national level, in particular the Croatian Ministry of Health and Social Welfare, and Croatian Institute of Health Insurance, in making evidence-informed decisions on the strategic planning, investment, management and implementation of technologies in health care, on funding (reimbursement) and coverage of health technologies, and at hospital level on the request from hospital directors and policy teams. In conclusion, establishment of all these measures in Croatia is by no means an easy and quick process, however, we do believe that it is feasible through continuous and close collaboration of all those involved
Use of gastroprotective agents in recommended doses in hospitalized patients receiving NSAIDs: a drug utilization study
OBJECTIVE: In recent years, studies investigated to what extend recommendations for co-prescribing gastroprotective agents in prevention of NSAID-induced gastrointestinal complications are followed in clinical practice. However, only a few studies have also taken into consideration the recommended dose of gastroprotectives prescribed in NSAID-induced ulcer prophylaxis. The aim of our study was to evaluate the prevalence of concomitant use of gastroprotectives with NSAIDs in hospitalized patients, with emphasis on the recommended dose of gastroprotectives for ulcer prophylaxis. - - - - - METHOD: This observational, cross-sectional, drug utilization study included all adult patients receiving NSAIDs hospitalized in the Clinical Hospital Center Zagreb on the day of the study. Data on age, sex, comorbidities, indications for NSAID use, type/dose of NSAIDs and gastroprotectives, history of gastrointestinal events, active gastrointestinal symptoms and risk factors were evaluated. - - - - - MAIN OUTCOME MEASURE: Study outcomes were: (1) prevalence of prescription of gastroprotectives among NSAID-users at risk; (2) prevalence of prescription of gastroprotective in recommended dose; (3) association between risk factors and prescription of GPAs. - - - - - RESULTS: The rates of gastroprotectives prescription were significantly higher in NSAID-users with concomitant risk factors as compared to patients without risk factors [47/70 (67.1%) and 8/22 (36.4%), respectively; p = 0.01072]. However, gastroprotection in recommended ulcer-preventive dose was low in both groups [8/70 (11.4%) and 9/92 (9.8%), respectively]. The number of concomitant risk factors did not increase the odds of receiving anti-ulcer therapy (odds ratio 0.7279). Thirty-three percent of patients with concomitant risk factors were not prescribed gastroprotectives. Ibuprofen, NSAID with the lowest risk of inducing gastrointestinal complications, was prescribed in only two patients. - - - - - CONCLUSION: The results indicate high awareness among hospital physicians about possible NSAID-induced gastrointestinal complications, but insufficient knowledge about risk factors related to NSAID-induced gastrointestinal toxicity, recommended dose of gastroprotectives in NSAID-induced ulcer prophylaxis and gastrointestinal toxicity of different types of NSAIDs
ADVERSE DRUG REACTIONS
Nuspojava je svaka štetna, neželjena reakcija na lijek koji je primijenjen u ispravnoj indikaciji i u uobičajenoj dozi u terapijsku, profilaktičku ili dijagnostičku svrhu. Sve veći broj djelotvornih lijekova, dostupnost lijekova velikom broju ljudi i starenje sveukupne populacije povećavaju mogućnost nastanka nuspojava. Svaki lijek koji može izazvati terapijski učinak, može izazvati i nuspojavu. Jedan od uvjeta za racionalnu primjenu lijekova jest i poznavanje njihovih nuspojava. Usprkos tome što spontana, dobrovoljna prijava nuspojava lijekova i medicinskih proizvoda nije optimalna, jo{ uvijek nema niti jednoga boljeg sustava koji bi prije i pouzdanije otkrivao te pojave. U ~čanku su razjašnjeni osnovni pojmovi koji se upotrebljavaju pri opisu nuspojava, njihova klasifikacija te način na koji se dijagnosticiraju, liječe, prate i prijavljujuAdverse drug reaction (ADR) is a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man. Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. The knowledge about ADRs should lay a basis for a rational drug use. The more drugs there are on the market, and their increasing availability to more and more people, as well as the aging of the population increase the possibility of developing an ADR. Despite the fact that spontaneous, voluntary reporting of ADRs is far from being ideal, at present there is no better way of detecting them. Here we define the terms used to describe ADRs, explain their classification, and discuss the way they can be diagnosed, managed, monitored and reporte
Nationale und europäische Identität sowie Einstellungen zur Integration in europäische Strukturen bei Bürgern aus Zagreb und Novi Sad
Cilj ovog istraživanja bio je ispitati je li moguće paralelno egzi-stiranje nacionalnih i europskog identiteta ili su oni međusobno isključivi. U istraživanju su sudjelovali građani Hrvatske i Srbije i Crne Gore. Ispitivanje je obuhvatilo po 400 sudionika iz Zagreba i Novog Sada, oba spola, u dobi od 15 do 46 godina. Primijenjeno je nekoliko instrumenata za ispitivanje istih konstrukata: Skala nacionalnog identiteta (Cinnirella, 1997.), Skala europskog identiteta (Cinnirella, 1997.), Skala nacionalnog identiteta - NAIT (Čorkalo i Kamenov, 1998.), Skala stavova prema europskim integracijama - STEIN (Franceško i sur., 2002.). Rezultati upućuju na ortogonalni odnos nacionalnog i europskog identiteta mjerenih Cinnirellinim skalama te umjereno negativnu povezanost kad su isti konstrukti mjereni NAIT-om i STEIN-om. Potonji rezultat potvrđuje hipotezu da europski identitet i stav prema europskim integracijama nisu isti konstrukt. Dodatno su analizirani rezultati po dimenzijama primijenjenih instrumenata i njihov međusobni odnos. Sudionici iz oba uzorka imaju izraženiji nacionalni nego europski identitet, što je u skladu s očekivanjima, jer je salijentnost nacionalnog identiteta poznata i često dokumentirana posljedica poratnoga razdoblja.The aim of this study was to find out if national and
European identity exist simultaneously, or are they mutually
exclusive. Citizens from two European countries, not yet
members of the European Union, Croatia and Serbia and
Montenegro, participated in this study. Participants from
Zagreb and Novi Sad, 400 from each town, were selected
according to their gender, age and educational level. The
questionnaire consisted of various measures of the same
psychological constructs: Cinnirella\u27s European Identity Scale
and National Identity Scale (1997), NAIT (^orkalo and
Kamenov, 1998) and STEIN (France{ko et al., 2002). Results
suggest an orthogonal relation between national and
European identity when measured with Cinnirella\u27s scales
and a moderate negative correlation when measured with
NAIT and STEIN scales. The latter result confirms our
hypothesis that European identity and attitude toward
European integrations are not the same construct. Results on
extracted dimensions of the STEIN scale and their
correlations with other applied instruments were examined.
Participants from both countries express a higher level of
national than European identity, which was expected because
national identity salience is one of the well-documented
consequences in the aftermath of war.Mit dieser Untersuchung wollte man herausfinden, ob die
parallele Existenz nationaler Identitäten einerseits und der
europäischen Identität andererseits möglich ist, oder ob
diese beiden Identitäten einander ausschließen. An der
Untersuchung nahmen Bürger aus Kroatien sowie Serbien
und Montenegro teil, zwei europäischen Ländern, die noch
keine EU-Mitglieder sind. Die insgesamt 400 befragten
Männer und Frauen kommen aus Zagreb und Novi Sad und
sind zwischen 15 und 46 Jahre alt. Es kamen mehrere
verschiedene Instrumente zur Untersuchung der angeführten
Konstrukte zum Einsatz: Skala zur nationalen Identität
(Cinnirella, 1997), Skala zur europäischen Identität
(Cinnirella, 1997), Skala zur nationalen Identität – NAIT
(^orkalo und Kamenov, 1998), Skala der Einstellungen zu
europäischen Strukturen – STEIN (France{ko et al., 2002).
Ermittelt anhand der Skalen von Cinnirelli, verweisen die
Ergebnisse auf das Bestehen eines orthogonalen
Verhältnisses zwischen nationaler und europäischer Identität;
gemäß NAIT und STEIN ist dieses Verhältnis gemäßigt
negativ. Letzteres Resultat bestätigt die Hypothese, dass es
sich bei der europäischen Identität und der Einstellung zu
europäischen Strukturen nicht um dasselbe Konstrukt
handelt. Zusätzlich analysierte man die Resultate gemäß den
Dimensionen der angewandten Instrumente sowie ihr
gegenseitiges Verhältnis. Bei den Umfrageteilnehmern beider
Länder ist die nationale Identität ausgeprägter als die
europäische. Dies entspricht den Erwartungen der Autoren,
denn die Salienz der nationalen Identität ist in
Nachkriegszeiten eine notorische und viel dokumentierte
Erscheinung
Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy
We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data.RCTs were mostly registered before 13 September 2005 deadline (n = 101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (χ(2) (1) = 7.255, P = 0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size.ICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials