Wouter Leclercq

A review of surgical informed consent: Past, present, and future. A quest to help patients make better decisions 23 2 MAIN RESULTS A total of 2,952 articles was identified using the Mesh terms ‘‘surgical procedures’’ and ‘‘informed consent,’’ of which 2,567 were in English. Most of these articles were not related to the present study questions listed above, as operative procedures were tested which required an IC. Only a limited number of articles focused on the SIC process itself. Eventually, 175 articles were selected directly, through references, or a related article search. Of this body of literature, 71 articles met our inclusion criteria. Meta-analysis of these articles was not possible because the studies differed in study design, tests used, and outcome measurement. History of surgical informed consent In medieval times doctors asked for a ‘‘hold harmless document’’ aimed at releasing them from any future responsibility to the patient or family in the event anything adverse happened following therapy. This pro corpore mortuoto can be found in Italian, French, and Middle East archives as early as the 14th century and is considered an early precursor of IC, although its purpose was to protect the doctor and not the patient. 1–3 The initial concept of current IC legislation developed in later centuries from case-related litigation into a standard practice (Figure 2.1). Some bizarre landmark cases may be identified and are worth mentioning in the present overview. In the 18th century, a patient sued his doctor for refracturing his leg and experimenting with a novel external fixating mechanism without informing the patient or obtaining approval. This 1767 Slater vs. Baker and Stapleton trial was the first example of an IC case. 4,5 The concept of IC was used in an 1845 novel by Edgar Allen Poe. A patient was asked for permission for an experimental therapy just before his death (Figure 2.2). 6,7 Figure 2.1 Landmarks in the history of the IC process: a timetable.