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

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

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

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

Identifying the need for good practices in Health Technology Assessment : summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA

The systematic use of evidence to inform healthcare decisions, particularly health technology assessment (HTA), has gained increased recognition. HTA has become a standard policy tool for informing decision makers who must manage the entry and use of pharmaceuticals, medical devices, and other technologies (including complex interventions) within health systems, for example, through reimbursement and pricing. Despite increasing attention to HTA activities, there has been no attempt to comprehensively synthesize good practices or emerging good practices to support populationbased decision-making in recent years. After the identification of some good practices through the release of the ISPOR Guidelines Index in 2013, the ISPOR HTA Council identified a need to more thoroughly review existing guidance. The purpose of this effort was to create a basis for capacity building, education, and improved consistency in approaches to HTA-informed decision-making. Our findings suggest that although many good practices have been developed in areas of assessment and some other key aspects of defining HTA processes, there are also many areas where good practices are lacking. This includes good practices in defining the organizational aspects of HTA, the use of deliberative processes, and measuring the impact of HTA. The extent to which these good practices are used and applied by HTA bodies is beyond the scope of this report, but may be of interest to future researchers