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

• Reliable and valid questionnaire was developed.
• Contributes to the development of suitable measuring instrument for informed consent.
• Assessed quality of the informed consent process in Croatia was reasonably high.
• Four factors were analyzed and Written information was rated with the lowest score.
• Provides patient related determinants of the quality of the informed consent process.

ObjectiveTo examine the informed consent process implementation and quality in Croatia using a specially developed instrument.MethodsA cross-sectional questionnaire study was conducted in 300 patients (response rate 73%) from six hospitals in Croatia, along with psychometric evaluation of the questionnaire.ResultsSigning 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).ConclusionThe 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 implicationsThe 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.