Wouter Leclercq

A decade of litigation regarding surgical informed consent in the Netherlands 125 8 INTRODUCTION Medical claims and malpractice lawsuits are the final stage of a clinical process where a patient feels aggrieved, maltreated, disappointed, dissatisfied or had expectations that were not lived up to. 1-3 An important reason for patients to file a medical malpractice suit or complaint at a medical disciplinary board (MDB) is an inadequate surgical informed consent (SIC) process. 4,5 Until now the frequency, characteristics, clinical circumstances and legal outcome of malpractice claims and MDB decisions concerning SIC (in the Netherlands) have not been systematically analysed and described. Informed consent is an evolving concept in history. The oldest document establishing rules for the conduct of medical professionals is the Hippocratic oath, stating that doctors should conceal most information from patients as they could not be trusted with making intelligent health decisions. 6 Only in the 19th century this paternalistic approach shifted towards a patient-centred approach, in which a patient agrees to a health intervention based on an understanding of it. 7 Patients should be educated by their physicians to make informed choices concerning their health. A properly conducted surgical informed consent process (SIC) allows patients to authorize an invasive procedure with full comprehension of relevant information including involved risks and benefits. 8 A sound SIC process consists of three important elements: preconditions, information and consent. 6 Preconditions include a determination of the cognitive competence of a patient to make a voluntary decision about his or her own body. 9 The second element is SIC information consists of seven sub elements. 9 In most common-law countries, patients must be ‘reasonably’ informed on the purpose, possible risks and complications of a treatment, alternative treatment options and prognosis, completed with a sound advice from the medical team involved. 9 The last element of SIC is consent. 9 The patient’s decision and consent must be registered. Although a written consent in the patient’s medical file is highly recommended, in the Netherlands a patient’s signature is not legally obliged. 10 An adequate SIC process serves a number of purposes. The patient’s autonomy is respected and the patient is protected against potential harm. Better informed patients have more realistic expectations, higher satisfaction rates and become more compliant with their treatment objectives. 11-19 Conversely, SIC violation undermines the patient’s right of self- determination and jeopardizes the patient-doctor relationship resulting in an increased risk for disappointed or aggrieved patients filing a malpractice claim or a complaint at an MDB. 20-23 According to annual reports of European, United States and Australian health services the number of malpractice claims and MDB complaints and the associated costs have risen in the past years. 24-27 A substantial number of these claims and complaints is due to omissions during the informed consent process. 28-32 In the Netherlands 6 , one in every six surgeons and one in seven orthopaedic or plastic surgeons was faced with an official SIC related complaint in the previous 5 years. 33 The purpose of this study was