Wouter Leclercq

A decade of litigation regarding surgical informed consent in the Netherlands 129 8 Table 8.2 Variables of interest. Patient characteristics Gender, age, type of surgery Doctor characteristics Medical specialty, specialist or trainee status Lead-time (in days) Time between the incident and the actual complaint Informed consent is: Main complaint / part of the complaint Association of SIC aspect The doctor’s behaviour and communication with Insufficient documentation in the medical file Patient’s allegations Insufficient information about: - Diagnosis - Treatment - In general - Characteristics - Aims - Risks / complications - Alternatives - Health status / prognosis - No explicit consent was given Case outcome Judgment (recognition, settlement, rejection) of SIC complaint by the: - Medical advisor - Accused doctor - Lawyer of Medirisk - MDB SIC = surgical informed consent. Statistical analysis Due to a limited time frame to access the Medirisk database a random sample was taken of the medical claims about surgical informed consent. In order to have a balanced sample over the total time frame a random sample per year was taken. An employee of Medirisk who was not involved in the research, did this randomization with a computer. Analyses were descriptive and outcomes depicted as whole numbers and percentages. Continuous variables for group comparison were tested using Student’s T-tests or Mann Whitney U tests. Significance of categorical variables and proportions were analysed using a two- sided Fisher’s exact test. The sign test, which can be used to identify differences between paired observations on an ordinal scale, was used to identify differences between the judgment of the doctor, the medical advisor, the lawyer or the medical court. 14 P-values (two-tailed) of <0.05 were considered as statistically significant. Data analysis was performed using SPSS statistics data 22.