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 Cronbach's 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).


CONCLUSIONS
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.


CONCLUSIONS
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.
Department of Otorhinolaryngology, University Hospital Merkur, Zagreb, Croatia. Electronic address: lukavucemilo@yahoo.com.
Luka
L
Vučemilo
University of Zagreb, School of Medicine, Andrija Štampar School of Public Health, Zagreb, Croatia.
Milan
M
Milošević
Department of Radiology, University Hospital Centre Rijeka, Rijeka, Croatia.
Doris
D
Dodig
Department of Gynaecology and Obstetrics, General Hospital Zabok, Zabok, Croatia.
Bruno
B
Grabušić
Department of Neurology, General Hospital Zadar, Zadar, Croatia.
Biljana
B
Đapić
University of Zagreb, School of Medicine, Andrija Štampar School of Public Health, Zagreb, Croatia.
Ana
A
Borovečki
D000328:Adult; D032962:Consent Forms; D017523:Croatia; D003430:Cross-Sectional Studies; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010817:Physician-Patient Relations; D011594:Psychometrics / Q000295:instrumentation*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires / Q000592:standards*
Clinical practice; Countries in transition; Croatia; Hospital; Informed consent; Instrument; Quality