1

Introduction

Informed consent is a legal document. It requires physicians to disclose the benefits, risks, and alternatives to the proposed treatment, nontreatment, or procedure. It is the method by which fully informed, rational persons may be involved in choices about their health care.

Historically, the concept of consent to treatment goes back at least as far as ancient Greece, with Hippocrates stating that “I will ensure patients receive the information and support they want to make decisions about disease prevention and improvement of their health” . Before 1980, the standard for informed consent was more “physician centred.” In this model, risks disclosed to the patient were based on what would normally be disclosed by other physicians within the specialty. In a decision in 1980, however, the Supreme Court of Canada changed the standard for disclosure to that of what a “reasonable patient” would wish to know about a procedure and its risks . Today, all of the 50 United States have legislation that delineates the required standards for informed consent. For example, the State of Washington uses the second approach outlined as the reasonable patient standard (what an average patient would need to know to be an informed participant in the decision). This approach ensures that a doctor fulfills all professional responsibilities and provides the best care possible and that patients have choices in decisions about their health care. However, the patient’s competence in making a decision is considered . This points to the issue of the patient’s mental capacity. Anyone having an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety. It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient’s understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.

The process of securing informed consent has 3 phases, all of which involve information exchange between the physician and patient and are part of patient education . First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and must ascertain that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the individual must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies, during which consent is taken with provision for the surgeon to do what is considered the best for the patient’s life.

Impairments to reasoning and judgement, which may make it impossible for someone to give informed consent, include such factors as severe mental retardation, severe mental illness, intoxication, severe sleep deprivation, Alzheimer disease, or being in a coma. This term was first used in a 1957 medical malpractice case by Paul G. Gebhard.

Surgical procedures are routine for surgeons, who may forget that for their patients, these procedures and the risks associated with them often evoke profound anxiety. Invasive surgical procedures are certainly never normal or “routine” when it comes to the patient’s personal autonomy. In any context other than medicine, the personal invasion that occurs with a surgical procedure would certainly be construed as battery . When viewed in this light, the importance of the surgical consent process becomes clear.

In accordance with the ethics committee of the American Academy of Otolaryngology-Head and Neck Surgery, the consent process consists of 4 elements: disclosure, comprehension, competence, and voluntary choice . It is largely the second of these elements, comprehension, and the potential for improving it that the present study aims to investigate.

The literature is little and extant regarding timing of consent, and in fact, some believe that there is no right answer about ideal time and place to sign consent; each unit should determine the best local practice. However, it is important that patient be given sufficient chance to absorb the information necessary for them to make their decision.

In developing country like ours, what is legally acceptable (and being practiced in most centers) is a signature, and statement suggesting that risks were discussed suffices. However, the authors of this article consider a handout specific to each case with signatures a better option.

Specifically, the goal of this study was to evaluate how much patients remember of the risks discussed with them regarding their otorhinolaryngologic surgeries and whether a simple intervention, the addition of an information handout, could improve their recall. Previous studies have looked at recall of consent information . Because previous studies (eg, Hekkenberg et al ) have shown some effect of educational level on recall of surgical risks, our study was designed to minimize the impact of this parameter as a confounding variable by stratifying the patients into a postsecondary education and a no-postsecondary education group in relation to those with only verbal and verbal + written consents.

2

Patients and methods

This was a prospective study carried out between January and December 2009 in the Department of Otorhinolaryngology, University of Ilorin teaching hospital. Fifty patients undergoing a variety of otorhinolaryngologic procedures, including mastoidectomy, tympanoplasty, nasal polypectomy, rhinotomy, maxillectomy, and laryngoscopy, were verbally consented by the operating surgeon with a standard checklist of potential surgical complications and adverse effects. Patients were stratified into 2 groups: a higher education group and a lower education group. Within each group, patients were randomized to either a control group, consisting of a verbal explanation only, or an intervention group, which added a written handout to the verbal explanation.

A standard checklist of surgical risks appropriate for each procedure, as well as the degree of risk, was drawn up for each procedure. This was then used during all verbal discussions so that all patients undergoing a particular procedure received the same risk warning and a consistent message irrespective of surgeon or date of consent.

The specific risks discussed with each patient varied according to the procedure but included several or all of the following: facial nerve injury, loss of hearing, tympanic membrane perforation vertigo, infection, hemorrhage, CSF rhinorrhea, facial disfigurement, nasal adhesion, hoarseness, and anesthetic reactions. Additional demographic information, including age, sex, education, type of procedure, and date of consent, was recorded on the same data sheet.

The educational level was divided into 2 groups. Group 1 consisted of those with a high school education or less, whereas group 2 was limited to those who had obtained additional postsecondary education. Within each group, a binary randomized list was used to assign patients to either a control group, consisting of a verbal explanation only, or an intervention group, which added a written handout to the process. The written handout was specific to each procedure and explained the same risks and degree of risk as presented verbally.

Patients with multiple previous surgeries were excluded because of possible confounding recall from previous consenting procedures.

A follow-up telephone interview was conducted, by a separate investigator, at an average of 21 days (range, 14–53), to survey for recall of the complications discussed. Overall recall for each patient was calculated as the percentage of the risks discussed with them.

Statistical analysis was performed with SPSS version 11.0 (SPSS, Chicago, IL). The t -test was used to analyze the impact of education, surgeon, age, sex, and intervention on overall recall. Fisher’s exact test was used to analyze the importance of these factors on recall of the specific risks individually.