Wouter Leclercq

Chapter 8 128 in which the patient had a complaint about his or her IC procedure were included. A second reviewer re-reviewed some of the files to reduce the risk of bias. A random sample of claims and a total of MDB decisions concerning SIC were to be included for analysis. The study focused on four major surgical disciplines: general surgery, orthopaedic surgery, plastic surgery and gynaecology. Because our study was based on retrospective analysis of existing databases, the rules laid down in the Medical Research lnvolving Human Subjects Act do not apply to this study. Figure 8.1 Flowchart of our study sample. Data, variables and study instrument All data were anonymized. Of all claims and MDB decisions, the following data were extracted: patient and doctor characteristics, the patient’s allegations and the legal outcome of claims and MDB decisions (Table 8.2). The patient’s allegations were coded into 9 predefined categories based on the description of informed consent in the Dutch law. 8 The reasonableness or legitimacy of the patient’s allegations was not evaluated in this study. The judicial outcome of claims was not specifically focused on SIC, therefore statistics were only performed on cases in which the lack of informed consent was the main issue (n=95) In case of a MDB decision, two different sentences were imposed in our study: a caution or a reprimand. We analysed how often the accused doctors recognized the patient’s complaint about SIC in comparison to medical advisors, lawyers of Medirisk or the MDB.