Ana Borovečki

Ethics and the structures of health care in the European countries in transition: hospital ethics committees in Croatia

Hospital ethics committees are a recent phenomenon in countries in transition. Croatias example shows they are staffed mainly by older doctors with no specialist knowledge of ethical issues. The importance of professional relationships and the educational function of ethics committees have been ignored

Education of ethics committee members: experiences from Croatia

Objectives: To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. Design: Before/after cross-sectional study using a self administered questionnaire. Setting: Educational workshop for members of hospital ethics committees, Zagreb, 2003. Main outcome measurements: Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. Results: The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions—education, case analysis, guidelines formation—were neglected. Members’ level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. Conclusions: The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members’ knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees’ work in Croatia especially in the hospital setting.

Regulation of healthcare ethics committees in Europe

In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be apt to improve HECs’ accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries.

Readability and content assessment of informed consent forms for medical procedures in Croatia.

Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.

Institutional Challenges for Clinical Ethics Committees

Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the organizational context in which CECs function in Europe focusing on five aspects. We conclude that in Europe clinical ethics committees need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization. CECs, perhaps particularly in transitional countries, must counter the charge of “alibi ethics”. CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges, but the fact that CECs continue to develop suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs.

Developments regarding ethical issues in medicine in the Republic of Croatia.

In Croatia, the subject of medical ethics, or bioethics, was introduced into the curriculum in the early 1990s at the medical schools of the University of Rijeka and the University of Zagreb. Today, bioethics education has become a basic part of undergraduate medical education not only in Rijeka and Zagreb but also in Osijek.

Developing a Model of Healthcare Ethics Support in Croatia

Croatia is a transitional society in that it is a country emerging from a socialist command economy toward a market-based economy with ensuing structural changes of a social and political nature—some extending into the healthcare system. A legacy from our past is that, until now, Croatian healthcare institutions have had no real experience with clinical ethics support services. When clinical cases arise presenting complex ethical dilemmas in treatment options, the challenges presented to the medical team are substantial. The case described below recently occurred on a ward in a university hospital in Croatia. An unexpected request from the patient’s parents created a number of issues that needed to be addressed by the medical team, which was made more difficult by the lack of clinical ethics support services. Such cases press the question currently being debated as to what type of ethics support services would be suitable for Croatia and why.

Croatian National Centre for Biobanking - a new perspective in biobanks governance?

Ethical issues in biobanking, as well as organization and management of biobanks, have become permanent topic of scientific publications in the last 15 years (1). The Expert Group of the European Commission Defines biobanks as collections of various types of biological samples (cells, tissues, blood, DNA) plus related databases. They can be small collections or large national repositories, population-based or disease specific, established for diagnostic, therapeutic (eg, transplantation), forensic, or research purposes (1-3).

Chromosomal abnormalities and DNA image cytometry of haematological neoplasms in fine needle aspirates of lymph nodes

The current diagnostics of haematological neoplasms along with morphological analysis, immunophenotyping and molecular analysis inevitably includes cytogenetic analysis. In this work the possibility of cytomorphological subclassification of haematological neoplasms from lymph node fine needle aspirates was examined without depending upon the referential histological diagnosis and cytogenetic analysis. In addition, the feasibility of cytogenetic analysis of the material obtained by lymph node fine needle aspiration (FNA) was examined. By analysing the findings of cytogenetic analysis and DNA image cytometry, it was decided to examine the possibility of comparing the findings and supplementing diagnostic possibilities of these methods. In 15 cases cytological diagnoses and cytogenetic analysis of haematological neoplasms were performed on the material obtained by lymph node FNA. In 12 of 15 cases histological diagnosis was made separately. A good cytohistological correlation was available in 9 of 12 cases (75%). Cytomorphological diagnoses in 10 of 15 cases (76%) were confirmed by the finding of a specific chromosomal translocation. In two cases cytological diagnosis did not correlate with the histological diagnosis and was confirmed only with specific chromosomal translocations. The lymphocytes obtained by lymph node FNA were adequate material for cytogenetic analysis – in 15 of 18 (83%) cases mitoses in cell cultures were obtained. In 13 of 15 (87%) cases clonal chromosomal abnormalities were detected, whereas in 2 of 15 (13%) cases a normal karyotype was found. DNA image cytometry was performed on nine samples, whereas in six samples the material was not sufficient. Although a small number of samples was analysed in the cases with identical cytomorphological diagnoses, the analysed histograms regarding the DNA index values showed heterogeneity. In conclusion, a cell culture sampled by FNA of lymph nodes is an adequate method for the chromosomal analysis. The specific cytogenetic abnormality associated with cytological diagnosis provides an opportunity to make a definitive diagnosis and provides a powerful approach when reference diagnosis on biopsy material cannot be obtained.

The quality of informed consent in Croatia-a cross-sectional study and instrument development

OBJECTIVE To examine the informed consent process implementation and quality in Croatia using a specially developed instrument. METHODS A cross-sectional questionnaire study was conducted in 300 patients (response rate 73%) from six hospitals in Croatia, along with psychometric evaluation of the questionnaire. RESULTS Signing the informed consent form was a formality for 64% of patients, 54% of patients did not give their written consent, and in 39% of cases physicians made treatment decisions by themselves. The overall informed consent process score was 4.06±0.60 (of 5.00). Physician-patient relationship score was 4.61±0.57, Verbal information 3.99±0.98, Decision making 3.94±0.75, and Written information 3.60±1.42. The overall Cronbachs alpha coefficient was 0.890. Significant correlations were found in relation to Physician-patient relationship and education levels (OR=0.43, 95% CI=0.18-0.99, p=0.048), and Verbal information and duration of health problems (OR=1.83, 95% CI=1.02-3.25, p=0.041). CONCLUSION The developed questionnaire is reliable and valid. The informed consent process quality in Croatia was reasonably high, although insufficient and inadequate written materials represent a weak spot that require enhancement. PRACTICE IMPLICATIONS The study contributes to the development of suitable measuring instrument for assessment of the informed consent process quality in clinical practice. The questionnaire could be of use in the hospital accreditation process.