A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

Relevant literature was identified in PubMed, Picarta, PsycINFO, and Google using the keywords/Mesh terms “informed consent,” “surgical procedures,” “operative,” “patient education,” “mental competency,” and “history.” Searches were performed by two surgical trainees (WL and BK) independently. All selected articles were scanned for relevant references or “related articles” (PubMed). Selection criteria included language (English publications or abstracts) and time period (January 1993–January 2009, with the exception of the legal cases).

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.

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 (Fig. 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 (Fig. 2) [6, 7].

The fundamentals of today’s practice of SIC gained more structure at the beginning of 20th century, especially after the development of anesthesia and more invasive surgery (Fig. 1). In Mohr vs. Williams in 1905, a woman agreed to an operation on her right ear [8]. However, during the operation the surgeon found her left ear in the need of a repair. He was subsequently sued and convicted because he had not proceeded according to the preoperative agreement. The judge called this agreement a contract that authorizes the physician to operate only to the extent of the consent given [9]. In Schoendorff vs. Society of New York Hospital in 1914, Justice Benjamin Cardozo (Fig. 3) became famous for his judgment in the following case. A woman had consented to an abdominal examination under anesthesia but not to an operation [10]. Nevertheless, the surgeon removed a tumor that eventually led the patient to file a law suit. Cardozo’s opinion has become one of the most basic elements in the concept of SIC development: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without the patient’s consent commits an assault for which he is liable in damages” [11‐13]. A patient should be viewed as a person who has the right of bodily self-determination [5, 12].

After the Second World War, there was a strong public reaction to the cruelties committed by Nazi concentration camp “doctors” who performed horrible tests on “patients” without prior information or approval. A code was written as a direct result of the Nuremberg trials (U.S.A. vs. Karl Brandt et al.). This “Nuremberg Code” was an important step in the development of the IC process in trials (Fig. 4). It consisted of ten preconditions any human research study had to fulfill. Interestingly, the first governmental instruction for IC in trials originated in Germany and was written in 1900 [14]. Later on in 1964, The World Health Organization set the Declaration of Helsinki with 22 preconditions for human research. The 1957 case Salgo vs. Leland Stanford, Jr. University Board of Trustees introduced the term “informed consent,” and this term was accepted in Natanson vs. Kline in 1960 [12, 15, 16].

At the same time, a development occurred in the domain of “information.” The 1957 UK case Bolam vs. Friern Hospital Management Committee focused on which risks should be discussed with a surgical patient [17]. This doctor-centered view resulted in a reasonable standard: Any surgeon should tell what other surgeons also tell their patients, a principle known as the Bolam principle [11]. However, the 1972 Canterbury vs. Spence case determined that all risks and alternatives of a procedure have to be explained [18]. This trial clearly demonstrated a shift from the doctors’ point of view toward the patients’ point of view as the standard of IC: the “reasonable patient standard” [11, 12, 19, 20]. Subsequently, the Australian High Court overruled the Bolam principle in the 1992 Roger vs. Whittaker case of a woman losing sight in her good eye after being operated on her diseased eye [21]. Although the risk of this happening was a mere 1:14,000, the court ruled that the surgeon should have informed the woman of the risk as she had apparently asked for this information. On the other hand, the doctor had considered this low risk not relevant [11, 20]. Although not totally abandoned, the “reasonable doctor standard” has become a secondary standard next to the “reasonable patient standard” in most countries [21]. Since the 1980 Truman vs. Thomas case, information provided in an IC process must also include the risks of “not acting or postponing” [22]. In this case, a Pap smear was refused by a woman who claimed not to know the associated risks, i.e., not detecting cancer in time for curative treatment [7].

Dutch legislators as well as governments from various other Western countries have realized that their legislation was out of date. Based on cases such as those mentioned above, several adjustments have led to the 1995 Dutch Medical Treatment Contract Act in which all elements of IC are present, including preconditions, information, and consent. Although legislation differs widely between countries, these “basic elements” are consistent in the Western world.

Based on historical cases and legislation, IC is supported by three cornerstones: “preconditions,” “information,” and “consent” (Fig. 5).

Preconditions include competence and voluntariness. A patient is a person who has a right of self-determination. He/she must be able to make decisions about his/her own body and must be able to decide freely without being influenced by others.

The second cornerstone is information. According to the 1995 WHO declaration on the promotion of patients rights, patients have the right to be fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures, together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of nontreatment; and about the diagnosis, prognosis, and progress of treatment [23]. All this information must be disclosed by the surgeon to enable the patient his/her right of self-determination. A well-defined care plan incorporating the surgeon’s advice should be discussed and it must be verified that the patient understands this information.

The third cornerstone is consent: registration of the patient’s decision and (written) consent [11, 24, 25].

Informed consent is often given by the patient during a preoperative consult with a consultant, a resident, or a specialized nurse. The information associated with a surgical procedure can be exchanged verbally, in writing, by video, or by computer technology. In this respect, large differences exist between countries. The US demands a patient signature, whereas a note in the patient chart is sufficient in the UK. In the Netherlands, doctors are not strictly required to obtain written consent [26].

As a routine, the patient’s competence is only “checked” in a general sense and deemed appropriate if communication with a patient is “normal” [27]. Only if the patient is officially “incompetent” will a legally appointed surrogate decision maker or an other representative in accordance with the law be allowed to decide for the patient [27]. However, a normal intelligence per se does not necessarily mean that a patient is really competent. Recently, Appelbaum [28] reviewed the literature on patient competence. A group of patients with known cognitive disease and patients with cancer demonstrated variable outcomes on competence tests. Lower scores were found in people of older age and limited education. The number of “incompetent” patients was higher than expected. Surprisingly, the doctor’s ability to differentiate between competent and incompetent was not better than throwing a dice [28].

On the other hand, even patients who are objectively deemed competent may be ignorant. They frequently do not know the process of SIC and do not know their rights, which results in wrong beliefs [29, 30]. Only 40% of the patients think that the IC paper confirms their wishes [29]. Interestingly, they usually do not feel the need for more information and their actual knowledge of the benefits and risks involved remains poor [31‐35]. In contrast, when asked what information they would like to have, they indicate that they would like more information than they actually receive [36].

Several misconceptions also exist with respect to voluntariness. One study reveals that 46% of patients in the study were under the impression that the major goal of an IC is to protect the hospital from litigation. In addition, 68% of the patients were convinced that the IC process gives the doctor control of what is going to happen [29].

Literature on patient education is extensive and is usually focused on informing patients in a general sense. On the other hand, studies on information in relation to the IC process are scarce. Results consistently demonstrate that neither doctors nor patients are well prepared for all elements of the IC process [19, 20, 30, 37‐42]. Residents are frequently “in charge” of the IC process but do not know what to tell a patient and do not perform well in tests on IC and medical law [25, 37, 43]. In contrast, they are more capable in informing the patient of benefits of the surgical procedure than they are giving information about risks or alternatives [37]. Interestingly, 21% of patients in one study reported that they received most information from sources outside the hospital [44].

The way information is presented greatly influences what a patient remembers. Oral information is retained very poorly, and patients tend to forget crucial parts of information such as alternative treatment options [41, 45]. This will lead to false-negative feelings, particularly in patients with a IQ below average, age over 60, a tendency to somatization, or a poor perceived control [44]. On the other hand, better-informed patients will have more realistic expectations, higher satisfaction, and demonstrate more treatment cooperation [46]. A recent study reveals that a great difference exists between the points of view of surgeons and patients regarding relevance of information and what should be told or not told [36]. Another study demonstrates that patients are not interested in the IC form that is used, and two thirds of the patients do not read it carefully [44].

Studies on the patient’s comprehension of information are rare. Analyses of tapes of IC indicate that various elements of the surgical procedure are discussed in 71% of the cases. The assessment of whether the patients actually understand this information is performed in only 1.5% of the cases [41, 47]!

Studies focusing on the consent element indicate that consent forms are not composed very well [48, 49]. Readability is poor, and only a minority are written on a 12-year-old reading level, which is best practice [48‐50]. More than half of all IC forms are filled out incorrectly [19, 51]. One retrospective study shows that the consent forms cannot be retrieved in 7.7% of the cases [19].

Check your patient’s competence and do not count on your clinical insight.

Register the SIC process in detail using an adequate IC form, and check that it is filled in correctly and store it in a safe place.

Check for more research to be published as SIC is not a fixed format but a developing area of medicine.