The informed consent questionnaire,which was given to patients after they underwent a standardized informed consentprocedure.
Pointing specifically to a moresevere risk changed the patients' awareness of the possible complicationsthat could occur during cataract surgery. Seventy-six percent of patientsbelieved that there was no risk of any complication (A), whereas only 60%continued to maintain that there was no such risk if asked to estimate thelikelihood of a severe complication during the surgery (B).
Patients tended to prefer a physician-dominateddecision for cataract surgery (A) and surgical method (B).
Most of the patients stated thatthe informed consent information did not alter their decision. All patientsstating that the information had some influence said their decision to havecataract surgery was highly confirmed by informed consent.
Kiss CG, Richter-Mueksch S, Stifter E, Diendorfer-Radner G, Velikay-Parel M, Radner W. Informed Consent and Decision Making by Cataract Patients. Arch Ophthalmol. 2004;122(1):94-98. doi:10.1001/archopht.122.1.94
Copyright 2004 American Medical Association. All Rights Reserved.Applicable FARS/DFARS Restrictions Apply to Government Use.2004
To investigate decision making by patients on the day before cataractsurgery and to evaluate to what extent the informed consent process influencesthe patients' decision regarding consent.
On the day before surgery, 70 patients (mean ± SD age, 70.3 ±10.3 years) underwent a standardized informed consent procedure. They werealso invited to answer 15 questions established in interdisciplinary cooperationamong clinical psychologists, lawyers, and ophthalmologists.
Main Outcome Measures
We assessed presurgical information and personal estimation of risksin cataract surgery; the patient-physician relationship regarding surgery-relateddecisions; and evaluations of the informed consent procedure and the patients'decision.
Questionnaire answers indicated that 28 (40%) of the 70 participatingpatients arrived for surgery without any information; 16 (23%) believed thatthere were surgical procedures without risks; and 53 (76%) estimated thatthere were no risks for their cataract surgery. A physician-dominated decisionfor surgery was preferred by 31 patients (44%); 16 (26%) wanted to decidetogether with their ophthalmologist. Possible risks of a sight-threateningcomplication did not influence 54 patients' (77%) decisions, and 55 patients(78%) said the informed consent process did not influence their decision.The remaining 15 (22%) stated that the informed consent process positivelyconfirmed their decision.
Informed consent 1 day preoperatively does not seem to influence thedecision for cataract surgery. Cognitive dissonance as part of a decision-makingprocess makes changes in an already chosen option unlikely. The resultinglimited decisive potential is very important for credibility in a trial andhas to be considered in ophthalmologic surgery.
MEDICOLEGAL ISSUES ARE gaining interest as the threshold for suing aphysician or hospital declines worldwide.1In ophthalmology,cataract surgery is the most frequently performed surgery and, as such, isthe most common cause of ophthalmologic malpractice litigation, representingone third of all cases against ophthalmologists.2 Inthe majority of cases, no adverse events happen, since cataract surgery hasbecome more controlled and the risk of complications is relatively low.3,4 Nevertheless, the number of claimsin this field is still constantly increasing.2,5
For a malpractice claim to be initiated, negligence, injury, and theproximate cause have to be evident2. However,malpractice in this sense is often hard to prove, and therefore inadequateor lack of informed consent is used as a secondary cause in more than 90%of all ophthalmologic malpractice cases.5,6 Incontrast, it is the primary reason in only 5% to 6% of claims.6,7
Supreme courts in the United States as well as in Europe have statedthe requirements for patient information in several decisions.8- 10 Thedescription of the treatment and the alternatives, inherent risks (if theyare material), and the postoperative period must be covered.8 Thesituation is similar in the United States and Austria, as the guidelines publishedby Lanckton8 match the requirements in Austria.10 Jurisprudence expects physicians to thoroughly informthe patients about inherent risks, but patients may refrain from necessarytreatment because of an excess of information. Thus, by being legally obligatedto obtain informed consent prior to medical treatment, physicians in the UnitedStates and Europe have to walk a tightrope between informing patients sufficientlyand frightening them. Informed consent, however, is an essential element ofcommunication with the patient that is traditionally one of the most importantparts of medical treatment.
Communication with patients is the physician's tool in anamnesis toidentify, with the patient, the best possible treatment. Because of medicolegaldevelopments in the past few years, this communication requirement for treatmentis at risk of degenerating into merely fulfilling the legal requirements andserving as evidence in a physician's defense.9 Thephysician's communication with the patient is, and has always been, a verysensitive element in successful treatment. Thus, legal influences in thisimportant domain of medical treatment have the potential to adversely affectthe quality of the patient's treatment.
Although failure to obtain informed consent does not constitute malpractice,claims by patients that they would not have consented to the procedure hadthey received sufficient information have often resulted in condemnation bythe court and a judgment of liability on the part of the physician. This situationis particularly unfortunate because it has been well documented in severalclinical studies that very little of the information given during the informedconsent procedure can be retained and recalled correctly by the patients even1 day after the surgery.11- 14 Thisconnection between patients' inability to remember and their allegation ofnot having been sufficiently informed once they have experienced an adverseeffect has focused our interest on the patient's decision-making process duringthe informed consent procedure.
The study was performed at the Department of Ophthalmology and Optometryof the University of Vienna, Austria, and followed the requirements of theDeclaration of Helsinki.
A consecutive series of 70 patients (mean ± SD age, 70.3 ±10.3 years) who were scheduled to undergo cataract surgery was asked to participatein a study about informed consent.
Patients who had previously had eye surgery were not included in thestudy. A written informed consent document was established and used as a templatefor our standardized informed consent procedure. The written information includedan explanation of the word cataract; the method ofsurgery (ie, phacoemulsification with posterior chamber lens implantation);the risks, including an estimation of their likeliness; the postoperativeperiod; possible refractive outcomes and the rate of surgical success; andalternatives. We explained all medical expressions using layperson's terms.Informed consent was then documented, and the patients signed the form.
Fifteen questions were established in interdisciplinary collaborationamong ophthalmologists, lawyers, and clinical psychologists (Figure 1). Two types of possible answers were used: answers gradedon a scale of 1 to 5 and yes or no answers. Patients were introduced to theprocedure, and we evaluated their education (highest degree earned), occupation,and regional provenance (rural, town, or city).
The questionnaire was administered in 3 parts: preoperative information,the patient-physician relationship, and evaluations about the informed consentprocedure and the patient's decision. Parts 1 and 2 were performed beforeand part 3 was performed after informed consent was obtained.
Of the 70 patients who participated, 44 (63%) lived in a city, 20 (29%)came from towns, and 6 (8%) lived in a rural area. Only 12 (17%) had graduatedfrom high school or had received any higher education, representing the usualeducational distribution in this age group. The other 58 had graduated aftera minimum of 9 years of schooling from junior high or vocational school. Therewere no significant education-related differences in the response patternsor attitudes of our patients.
The questionnaire revealed that 28 (40%) of our patients came to theward without having informed themselves about the surgery (question 1). Theremaining 42 (60%) had at least some information, mostly from their ophthalmologist,but they had also quite frequently obtained information only from friends,family, or neighbors. None of those surveyed had used the Internet or othersources to receive information (question 2). Of the 70 patients, 16 (23%)believed that there were surgical procedures that have no risk of complications(question 3); all of these 16 respondents belonged to the low-education group.
Cataract surgery was thought to be a relatively easyprocedure, with 69 patients (99%) choosing answers between 1 and 3 on a scalewhere 1 was easy and 5 was difficult (mean ± SD, 1.97 ± 0.90).
Regarding patients' estimation of adverse events occurringduring their cataract surgery, 53 patients (76%) said they believed that therewas no risk at all of any complication (question 5; mean ± SD, 1.34± 0.72). However, if they were then asked to estimate thelikelihood of a severe complication occurring during their surgery, only 42(60%) continued to maintain that there was no such risk (question 6). Thus,it appears that pointing specifically to a more striking event changed thepatients' awareness of the risk (Figure 2).
The risk of a severe and probably sight-threatening complication didnot influence the decision of 54 patients (77%) about whether they wantedthe surgery (mean ± SD, 1.27 ± 0.56). At this point, most ofthe patients clearly stated that since cataract surgery was indicated, theyhad come to have their cataract removed and were not willing to refrain fromthe procedure just because of possible complications.
Thirty-one patients (44%) wanted the physician alone to decide for oragainst surgery, 12 (17%) preferred a physician-dominated decision, 18 (26%)wanted to come to a decision together with their ophthalmologist, and 9 (13%)wanted to come to a decision by themselves. The mean ± SD score of2.20 ± 1.36 (Figure 3A) indicatedthat the patients wished to have a more physician-dominated decision. Amongthe 70 patients, 23 (33%) said that their ophthalmologist had made the decisionfor surgery; 22 (31%) said the decision was made consensually; and 25 (36%)said they had decided alone (question 11; mean ± SD, 2.90 ±1.63).
Sixty-seven patients (97%) (Figure 2B) wished to leave the decision about the choice of surgical procedureto the physician alone. They said that they knew nothing about it and thereforedid not want to be involved or to interfere.
The patients not only expected that their physician would choose theappropriate surgical method, but they also had a very high level of confidencein their physicians in general, since 66 (94%) said that they were ratherconfident or very confident (mean ± SD, 4.70 ± 0.62). The rangeof answers, between 2 and 5 on a scale of 1 to 5, showed that people werenot afraid to be honest.
Of the 70 patients responding, 55 (78%) stated thatthe given information did not influence their decision (mean ± SD,1.63 ± 1.34) (Figure 4).The other patients who indicated an influence were asked whether this influencewas positive or negative. All of them said that the informed consent highlyconfirmed their decision, because it was a sign of competence for them. Thus,it appears that patients are glad to be informed but do not want to rethinktheir decision.
Forty-eight patients (69%) said they felt fairly or very secure becauseof the informed consent (question 13; mean ± SD, 3.87 ± 1.43).Our informed consent procedure did not increase insecurity, because 63 patients(90%) answered "not at all" when asked if the information made them feel insecure(question 14). Only 10 (14%) of the 70 patients said they had some mild concerns(mean ± SD, 1.14 ± 0.35; range, 1-2) about their operation afterthe information about possible complications was given. These were patientswho came completely uninformed and thought that cataract surgery was a completelyharmless procedure. In summary, the questions concerning the patients' evaluationof the informed consent revealed that it makes patients feel more secure butdoes not influence their decision.
In his numerous publications, Kraushar2,5- 7,9,15,16 haselaborately illustrated the medicolegal jurisdiction in ophthalmology. Inparticular, his work has dealt with litigation regarding the informed consentprocedure. He has concluded, "Litigation for medical malpractice is rarelybased only on lack of informed consent. The informed consent part of a lawsuitmay be the most difficult to defend, however, since it will often depend oncredibility."9 Although failure to obtain informedconsent does not constitute malpractice, a patient's claim that sufficientinformation would have led to not consenting to the treatment often resultsin condemnation. Thus, in the present study, we investigated, on the day ofadmission for cataract surgery, the basic views of patients, their decision-makingprocess, and to what extent informed consent influenced their decision aboutconsent.
When they came to the ward, the patients were generally poorly informedand underestimated the risk of complications. They preferred a physician-dominateddecision process and said that informed consent did not influence their decision.In particular, the information about sight-threatening complications did notinfluence their decision for cataract surgery. This observation is interesting,since many patients in court claim that that they would never have consentedto the surgery if they had known what could happen. To elucidate this biasbetween our results and the allegations of patients in court, the psychologicalbackground of the human decision-making process has to be taken into account,since cognitive dissonance17 might providean explanation for the observed contradiction.18 Communication-relatedchanges in the attitude of a person can occur when the content of a messagecauses inconsistency19 (eg, when somethingthat was originally linked with positive associations becomes connected withnegative objections). This kind of situation causes a cognitive stress situation(ie, cognitive dissonance). Since humans inevitably need to achieve an equilibriumwithin themselves to feel comfortable with a decision, this dissonance canonly be overcome either by enhancing the positive attitude or by devaluatingthe objections. To achieve this equilibrium, a person selects the option withthe least cognitive complexity.19 Furthermore,before a final decision is made, the perception of a given piece of informationis often selective, and information processing is biased in favor of the alreadychosen alternative.20 In accordance with thisobservation, a recent publication21 on dependenciesin the decision-making process between cognitive dissonance and the sequenceof presentation of information has shown that people tend to prefer and togive excessive weight to information that is in favor of their existing decisionwhen the alternatives are presented sequentially and allow a selection. Thesedecision-making processes are, of course, also applicable to our cataractpatients. They came to the ward having made the decision to have cataractsurgery, and then they were confronted with information regarding possiblecomplications, information that was capable of causing them discomfort orcognitive dissonance. To decrease the upcoming dissonance between the decisionalready made (ie, to have cataract surgery) and possible adverse effects,the patients had to relativize the unfavorable information.
Cognitive dissonance also serves as a likely explanation for the findingsof Morgan and Schwab11 and Priluck et al,14 who have shown that their patients could not recallcrucial details of their preoperative conversation as little as 1 day aftersurgery. Thus, if patients in court claim that they have not heard about acertain consequence, they are not necessarily lying, since cognitive dissonancecauses selective perception and cognitive information processing. Thus, cognitivedissonance and the resulting decision-making behavior of human beings makechanges in an already chosen option rather unlikely. This is particularlytrue for patients when the operation is objectively indicated and constitutesa possible solution for their problem. The limited decisive potential causedby cognitive dissonance is very important for the question of credibilityin a trial and has to be taken into account.
Our results have also shown that the patients preferred a physician-dominateddecision-making process; they stated that they were very confident in theirsurgeon, although they had seen that physician for the first time, and onlyfor a short time, on the day of hospital admission. Most patients interpretedour standardized informed consent procedure as a sign of competence that confirmedtheir decision. This once again seems to indicate the typical preoperativemood of believing in and hoping for the best, but it also shows that evenan extensive informed consent document clearly seems to increase the preoperativecomfort of the patients.
Courts in the United States and Europe have stated that the day beforesurgery is an appropriate time to obtain informed consent. However, Leydheckeret al22 have shown that 36% of patients wouldhave preferred hearing the information at the time that their surgery wasscheduled; 65% would have liked it at least a few days before the surgery.Our results are in agreement with the findings of Leydhecker, and we thereforebelieve that the patients can better be reached by providing sufficient informationearlier.
In summary, informed consent 1 day preoperatively does not seem to beeffective in influencing the decision for or against cataract surgery. Cognitivedissonance as part of the decision-making process23 hasto be considered in medicolegal issues, since changes in an already chosenoption can cause difficulties, particularly when surgery is objectively indicated.