Luka Vučemilo1, Milan Milošević2, Doris Dodig3, Bruno Grabušić4, Biljana Đapić5, Ana Borovečki2. 1. Department of Otorhinolaryngology, University Hospital Merkur, Zagreb, Croatia. Electronic address: lukavucemilo@yahoo.com. 2. University of Zagreb, School of Medicine, Andrija Štampar School of Public Health, Zagreb, Croatia. 3. Department of Radiology, University Hospital Centre Rijeka, Rijeka, Croatia. 4. Department of Gynaecology and Obstetrics, General Hospital Zabok, Zabok, Croatia. 5. Department of Neurology, General Hospital Zadar, Zadar, Croatia.
Abstract
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). 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.
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). 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.
Authors: George Bazoukis; Jennifer Hall; Joseph Loscalzo; Elliott Marshall Antman; Valentín Fuster; Antonis A Armoundas Journal: Cell Rep Med Date: 2022-01-18