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The issue of informed consent
SURVEY OF OPHTHALMOLOGY
VOLUME 27 - NUMBER 2 * SEPTEMBER-OCTOBER
1982
MEDICOLEGALITIES JEROME W. BETTMAN, M.D.
The Issue of Informed Consent JEROME W. BETTMAN,
M.D.
Department of Ophthalmology at Pacific nia, and Department of Ophthalmology,
Medical Center and iJniversi[y of California. Stanford L;niversi[v, Stanford, California
San Francisco,
Califor-
Abstract. Informed consent is rarely the principle issue that brings a case to trial, but it is paramount in the prevention ofsuits. Disadvantages of printed forms and tapes are discussed and a method of documenting the informed consent for the litigious patient is presented. The final criterion for deciding whether certain information should have been conveyed is whether it would have altered the decision of a prudent person. Take the patient into your confidence in the decision-making process, and document that you have done so. (Surv Opthalmol 27:133-135, 1982)
informed consent Key words. prevention of malpractice suit
P
roblems
associated
consent
have
been
with
conveying
discusssed
l
documentation
consent
l
little patients remember after being informed. They especially forget the more serious complications such as endophthalmitis and loss of the eye. Every physician who is threatened with suit should be aware of these references.2” Nevertheless, informed consent is possibly the most important factor in the prevention ofmedicolegal suits for two reasons: First, it is the essence of rapport. Physicians who properly inform a patient have taken that patient into their confidence in the decision-making process. This usually creates a bond that makes a patient willing to accept an unfortunate outcome. Secondly, it eliminates surprise. The unpleasant surprise produces anger and it is anger that most often causes the patient to sue. For these reasons, the prophylactic value of thoroughly informing the patient cannot be overstated. Though informed consent is rarely the principle issue that brings the case to trial, it is a frequent
informed and
of informed
written
extensively since the landmark case of versus Grant ( 1972). ’ The routine discussion regarding this topic will not be reiterated here, but there are many aspects that are not well understood and those are the subject of this paper. The issue of informed consent is rarely the principle cause of a malpractice action. This is because of the long period of time between the alleged substandard act and the resolution of the case (averaging five years in many areas). Neither the patient nor the physician remembers what was actually said, and juries are aware of this. Usually the two sides have diametrically opposite versions but the jury accepts the physician’s word more frequently, especially if there is any indication in the record that information was conveyed. In addition, there are now three controlled studies that document how about
Cobbs
133
134
Surv Ophthalmol
27 (2) September-October
1982
ancillary issue, and the physician who fails to document it is unwise. The best method of conveying the information and documenting it has been the subject of much discussion and considerable disagreement. There is no question but that the information should be imparted by the surgeon or principai physician. Even if extensive printed forms, tapes, brochures or movies are used, the surgeon must always inquire personally as to whether patients understand what they have read, heard, or seen, whether there are any questions, and ask questions to be certain patients do understand. My personal bias is against the use of printed forms, tapes, brochures and movies, except as ancillary devices. Unless the surgeon checks to be certain that the patient understands and there is documented feedback, the patient will usually say, “I might have been shown that, but I didn’t understand it,” or “It wasn’t that tape,” or “I was so nervous I didn’t remember a thing about it.” A printed form may convey the impression that the surgeon is “runthe routine consent ning a factory.” Certainly, forms signed on admission to the hospital and before surgery offer no protection to the surgeon. Another reason that I do not use routine forms is that no form can include all possible complications. If such a complication does occur, there is evidence that it was not discussed. I have two methods of documenting the informed consent. The one used for the routine situation is a simple statement, “The procedure, the complication, the alternatives, and the anesthetic risks were explained to (patient’s name), and he appeared to If there should be disproportionate understand.” risks, such as the possibility of a retinal attachment occurring in a high myope with lattice degeneration before a cataract extraction, these are mentioned. If the foregoing is written in the physician’s own hand in the record and dated, the jury will almost always accept the fact that it was done. The second method is used for the obvious litigious patient, for example, a one-eyed individual with a neovascular membrane encroaching upon the fovea who enters for laser therapy and has a history of having sued another physician. I first thoroughly explain the problems, I then ask for feedback to provide an indication that the patient understands. After this, I hand such patients their own record and ask that they write in it their understanding of the procedure, risks and alternatives. This is documentation that cannot be denied! It is too time-consuming and unnecessary for the routine case. The process of informing the patient should be straightforward. All information that might influence the decision of a prudent person should be
BETTMAN
stated. This must include informafion about the procedure, about alternatives and their value or risks in comparison with the recommended procedure, and the complications, including anesthetic risks. If there is an unusual incidence of a specific complication, this must be clearly stated with an approximation of the incidence. If the patient does not accept the surgeon’s recommendations, the appropriate decision should be urged and the reasons for disagreement clearly stated. The need for thorough discussion of information is increased enormously in elective procedures. Problems of informed consent rarely arise in the emergency Circumstance. In oculoplastic procedures the patient must be told to compare the postoperative state with the pre-operative, not with the contralateral normal. The surgeon usually compares the result with the preoperative state and is pleased; the patient often compares it with the normal and may be displeased. This can lead to problems. In spite of what has been said, one does not have to give a miniature course in medicine. If question arises as to whether certain information should have been conveyed to the patient, the jury will be asked to decide whether that information would have influenced the decision of a prudent person. The possibility of blindness should be mentioned before almost every eye operation for two reasons. First, it is a risk in every procedure, with the possible exception of a minor operation, such as a pterygium that does not require regional injections or excision of orbital fat; second, if the patient accepts the risk of blindness, one may infer that lesser hazards are also accepted. The statement that there is a risk of death does not convey the same impact, because death is not a meaningful1 risk to the average eye patient, who would say, “Of course I might die, but this could happen in my bed or crossing the street, and I don’t worry about it.” Blindness is a meaningful hazard. Other significant hazards should nonetheless be discussed. The method of conveying such information requires some tact. One might say,“The law requires that we discuss all these complications even though some are unusual.” There are three situations in which informed consent is not required: (1) if the patients say they do not want to hear the information. In this circumstance, one must have a witness. If there is a significant incidence of a particular serious complication, I tell patients regardless; (2) if there is a true emergency. This is unusual in ophthalmology; (3) if the patient is psychologically unfit to hear it. One should have the concurrence of a psychiatrist or family physician in this circumstance.
OFFICE
PERSONNEL
AND MEDICOLEGAL
135
CLAIMS
The procedure of informing patients should occur before they enter the hospital, some time before, if at all possible, The stress of entering the hospital understandably diminishes a patient’s ability to concentrate and to be prudent. Although much has been said about problems of informed consent, far fewer problems would occur if the physicians communicated freely with their patients, took them into their confidence in the decision-making process, and documented the communication.
References 1, Cobbs v. Grant. 8C 229:104 2. Leeb D, et al: Observations 3, Plast Reconst Surg 58:28&282,
CAL RPTR. 505, 502 P. 2d 1 on the myth of %formed consent.” 1976 Priluck IA, et al: What patients recall of the preoperative discussion after retinal detachment surgery. Am J O,bhtha/mol 87:62& 623. 1979 4. Robinson G and Merav A: Informed consent: Recall by patients tested postoperatively. Ann Thorac Surx ?2;209. 1976
Reurints
are not available.
VOLUME 27 - NUMBER 2 * SEPTEMBER-OCTOBER
1982
MEDICOLEGALITIES JEROME W. BETTMAN, M.D.
The Issue of Informed Consent JEROME W. BETTMAN,
M.D.
Department of Ophthalmology at Pacific nia, and Department of Ophthalmology,
Medical Center and iJniversi[y of California. Stanford L;niversi[v, Stanford, California
San Francisco,
Califor-
Abstract. Informed consent is rarely the principle issue that brings a case to trial, but it is paramount in the prevention ofsuits. Disadvantages of printed forms and tapes are discussed and a method of documenting the informed consent for the litigious patient is presented. The final criterion for deciding whether certain information should have been conveyed is whether it would have altered the decision of a prudent person. Take the patient into your confidence in the decision-making process, and document that you have done so. (Surv Opthalmol 27:133-135, 1982)
informed consent Key words. prevention of malpractice suit
P
roblems
associated
consent
have
been
with
conveying
discusssed
l
documentation
consent
l
little patients remember after being informed. They especially forget the more serious complications such as endophthalmitis and loss of the eye. Every physician who is threatened with suit should be aware of these references.2” Nevertheless, informed consent is possibly the most important factor in the prevention ofmedicolegal suits for two reasons: First, it is the essence of rapport. Physicians who properly inform a patient have taken that patient into their confidence in the decision-making process. This usually creates a bond that makes a patient willing to accept an unfortunate outcome. Secondly, it eliminates surprise. The unpleasant surprise produces anger and it is anger that most often causes the patient to sue. For these reasons, the prophylactic value of thoroughly informing the patient cannot be overstated. Though informed consent is rarely the principle issue that brings the case to trial, it is a frequent
informed and
of informed
written
extensively since the landmark case of versus Grant ( 1972). ’ The routine discussion regarding this topic will not be reiterated here, but there are many aspects that are not well understood and those are the subject of this paper. The issue of informed consent is rarely the principle cause of a malpractice action. This is because of the long period of time between the alleged substandard act and the resolution of the case (averaging five years in many areas). Neither the patient nor the physician remembers what was actually said, and juries are aware of this. Usually the two sides have diametrically opposite versions but the jury accepts the physician’s word more frequently, especially if there is any indication in the record that information was conveyed. In addition, there are now three controlled studies that document how about
Cobbs
133
134
Surv Ophthalmol
27 (2) September-October
1982
ancillary issue, and the physician who fails to document it is unwise. The best method of conveying the information and documenting it has been the subject of much discussion and considerable disagreement. There is no question but that the information should be imparted by the surgeon or principai physician. Even if extensive printed forms, tapes, brochures or movies are used, the surgeon must always inquire personally as to whether patients understand what they have read, heard, or seen, whether there are any questions, and ask questions to be certain patients do understand. My personal bias is against the use of printed forms, tapes, brochures and movies, except as ancillary devices. Unless the surgeon checks to be certain that the patient understands and there is documented feedback, the patient will usually say, “I might have been shown that, but I didn’t understand it,” or “It wasn’t that tape,” or “I was so nervous I didn’t remember a thing about it.” A printed form may convey the impression that the surgeon is “runthe routine consent ning a factory.” Certainly, forms signed on admission to the hospital and before surgery offer no protection to the surgeon. Another reason that I do not use routine forms is that no form can include all possible complications. If such a complication does occur, there is evidence that it was not discussed. I have two methods of documenting the informed consent. The one used for the routine situation is a simple statement, “The procedure, the complication, the alternatives, and the anesthetic risks were explained to (patient’s name), and he appeared to If there should be disproportionate understand.” risks, such as the possibility of a retinal attachment occurring in a high myope with lattice degeneration before a cataract extraction, these are mentioned. If the foregoing is written in the physician’s own hand in the record and dated, the jury will almost always accept the fact that it was done. The second method is used for the obvious litigious patient, for example, a one-eyed individual with a neovascular membrane encroaching upon the fovea who enters for laser therapy and has a history of having sued another physician. I first thoroughly explain the problems, I then ask for feedback to provide an indication that the patient understands. After this, I hand such patients their own record and ask that they write in it their understanding of the procedure, risks and alternatives. This is documentation that cannot be denied! It is too time-consuming and unnecessary for the routine case. The process of informing the patient should be straightforward. All information that might influence the decision of a prudent person should be
BETTMAN
stated. This must include informafion about the procedure, about alternatives and their value or risks in comparison with the recommended procedure, and the complications, including anesthetic risks. If there is an unusual incidence of a specific complication, this must be clearly stated with an approximation of the incidence. If the patient does not accept the surgeon’s recommendations, the appropriate decision should be urged and the reasons for disagreement clearly stated. The need for thorough discussion of information is increased enormously in elective procedures. Problems of informed consent rarely arise in the emergency Circumstance. In oculoplastic procedures the patient must be told to compare the postoperative state with the pre-operative, not with the contralateral normal. The surgeon usually compares the result with the preoperative state and is pleased; the patient often compares it with the normal and may be displeased. This can lead to problems. In spite of what has been said, one does not have to give a miniature course in medicine. If question arises as to whether certain information should have been conveyed to the patient, the jury will be asked to decide whether that information would have influenced the decision of a prudent person. The possibility of blindness should be mentioned before almost every eye operation for two reasons. First, it is a risk in every procedure, with the possible exception of a minor operation, such as a pterygium that does not require regional injections or excision of orbital fat; second, if the patient accepts the risk of blindness, one may infer that lesser hazards are also accepted. The statement that there is a risk of death does not convey the same impact, because death is not a meaningful1 risk to the average eye patient, who would say, “Of course I might die, but this could happen in my bed or crossing the street, and I don’t worry about it.” Blindness is a meaningful hazard. Other significant hazards should nonetheless be discussed. The method of conveying such information requires some tact. One might say,“The law requires that we discuss all these complications even though some are unusual.” There are three situations in which informed consent is not required: (1) if the patients say they do not want to hear the information. In this circumstance, one must have a witness. If there is a significant incidence of a particular serious complication, I tell patients regardless; (2) if there is a true emergency. This is unusual in ophthalmology; (3) if the patient is psychologically unfit to hear it. One should have the concurrence of a psychiatrist or family physician in this circumstance.
OFFICE
PERSONNEL
AND MEDICOLEGAL
135
CLAIMS
The procedure of informing patients should occur before they enter the hospital, some time before, if at all possible, The stress of entering the hospital understandably diminishes a patient’s ability to concentrate and to be prudent. Although much has been said about problems of informed consent, far fewer problems would occur if the physicians communicated freely with their patients, took them into their confidence in the decision-making process, and documented the communication.
References 1, Cobbs v. Grant. 8C 229:104 2. Leeb D, et al: Observations 3, Plast Reconst Surg 58:28&282,
CAL RPTR. 505, 502 P. 2d 1 on the myth of %formed consent.” 1976 Priluck IA, et al: What patients recall of the preoperative discussion after retinal detachment surgery. Am J O,bhtha/mol 87:62& 623. 1979 4. Robinson G and Merav A: Informed consent: Recall by patients tested postoperatively. Ann Thorac Surx ?2;209. 1976
Reurints
are not available.