We conducted a cross-sectional study to determine attending physicians’ understanding of laws regarding informed consent and confidentiality. The study was conducted in nine hospitals in Dolj County, Romania between November 2021 and March 2022. Dolj county is located in the southwestern part of Romania, with over 700,000 residents (7th place among Romanian counties) and a monthly net income of approximately 630 euros (16th place in Romanian counties). The local healthcare system includes thirteen public hospitals (one of which is a psychiatric facility that was excluded from the study due to different legislation applicable to patients). The healthcare system in Romania is built on a modified version of the Bismark model, and although it includes both public and private facilities, it remains highly centralized. Because resources and employees are primarily concentrated in the public sector, we focused our research on the public hospitals in the region. Six out of the twelve public hospitals agreed to our invitation to participate in the study. We also sent invitations to the three private hospitals with the largest number of physicians in the region, of which two participated in the study. To ensure a diverse range of healthcare practices and county coverage, we included different local hospitals: one tertiary university hospital, one secondary community hospital, two specialty hospitals, two primary hospitals, and two private day hospitals.
Participants and data collection
The study was conducted on a convenience sample consisting of physicians working in hospital settings from Dolj county on a voluntary base. To approach the participants, we sought administrative consent from the hospital management. On the basis of their affirmative responses, we approached the hospital ward heads to seek second approval for each ward. Due to the pandemic, the ward heads deposited printed copies of the questionnaire in on-call rooms, where physicians could easily access them. After a week or two, depending on the circumstances, we collected all of the filled-in questionnaires. We have distributed 418 printed questionnaires in accordance with the information provided by the hospital ward heads. We included all available attending physicians. However, psychiatric physicians were not included due to their distinct legal responsibilities. Additionally, physicians who worked solely in laboratories and had no contact with patients were also excluded from the cohort. Considering the particularities and similarities across specialties, we opted to group physicians into five categories: surgical specialties (cardiovascular, general, oral and maxillofacial, pediatric, plastic, thoracic, neurosurgery, ophthalmology, orthopedic, otolaryngology, urology), non-surgical specialties (allergy and immunology, dermatology, gastroenterology, hematology, internal medicine, neonatology, neurology, nephrology, radiotherapy, pediatrics, physical medicine and rehabilitation, pulmonology, rheumatology, oncology), obstetrics-gynecology, emergency, and anesthesia and intensive care.
The questionnaire was adapted from one previously published by Nanu et al.  in light of the findings of the previously cited research. We added three more scenarios regarding informed consent and one self-assessment question to the initial questionnaire, validated in 2007. All additional questions were validated by a panel of five experts. We asked the experts to evaluate if the additional questions were essential, relevant, and intelligibly formulated. After calculating the index of content validity and ratio, we retained all additional questions.
We divided the questionnaire into three sections:
Section 1: Information on the research participants concerning medical specialty, age, years in practice, workplace sector, and location.
Section 2: Multiple choice scenario-based questions on informed consent and confidentiality (n = 10 questions). We provided physicians with ten distinct scenarios, seven of them referring to informed consent and three to confidentiality. To each scenario, we offered three alternative answers, only one of which was in accordance with the law. We instructed the participants to choose the responses that most accurately reflected their regular practice. Respondent’s knowledge of informed consent was tested by scenarios number 3, 4, 5, 6, 7, 9, and 10, while confidentiality knowledge was addressed by questions number 1, 2, and 8.
Section 3: Self-assessment (n = 1 question). Finally, we asked them to self-assess their practice and respond to the question of whether they engaged in any medical acts that could be considered a breach of medical laws in the preceding 3 years.
The questionnaire was applied in the Romanian language to the Romanian physicians. An additional file presents the English translation of the questionnaire in more detail (see Additional file 1).
The question asking physicians to self-assess their compliance with the law also represented the exclusion criteria. To calculate physicians’ legal knowledge ratings, we included those respondents who answered negatively to the self-assessment question and declared that they did not engage in potentially illegal medical acts. Their responses to the ten scenario-based questions were compared to the applicable legal standards. The correct answer was the legally acceptable one, and each scenario-based question was weighted equally (one point for each correct answer and zero points for incorrect answers). Additionally, we calculated the compliance score for the physicians who admitted to having committed a legal breach and compared the results. We decided that a high Kuder–Richardson Reliability Coefficient was not desirable, as the study relates to education knowledge, and each question evaluates an aspect on an entirely different scale, loading onto different factors .
We used Microsoft Excel (Microsoft Corp., Redmond, WA, USA), together with the XLSTAT add-on for MS Excel (Addinsoft SARL, Paris, France) and IBM SPSS Statistics 20.0 (IBM Corporation, Armonk, NY, USA) for processing the data. Descriptive analysis of the study group was performed with MS Excel. Normality tests (Anderson-Darling) and complex statistical tests (Chi-Square, Kruskal–Wallis, Friedman, etc.) were performed using the XLSTAT add-on or SPSS. We used the Anderson-Darling test to verify the normality of the data. None of the numerical variables investigated had a normal distribution of data, globally or inside each studied group. Because the study involved numerical comparisons between more than two groups that did not have a standard (Gaussian) distribution, the nonparametric Kruskal-Wallis test was primarily used, followed by a posthoc analysis using the Dunn method for multiple pairwise comparisons with Bonferroni correction. Categorical data were compared using the Chi-square test (χ2), which is a statistical test that shows if there is a connection (association or influence) between two factors. It was used to interpret incidence tables generated by cross-tabulation of two categorical variables recorded in the study.