Informed Consent in Anesthesia


Anesth Analg 1997 Feb;84(2):299-306

Parental desire for perioperative information and informed consent: a two-phase study.

Kain ZN, Wang SM, Caramico LA, Hofstadter M, Mayes LC

Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut 06510-8051, USA.

The purpose of this investigation was to identify the perioperative anesthetic information parents want from the anesthesiologist, and to determine whether the provision of detailed anesthetic risk information is associated with increased parental anxiety. The investigation consisted of a cross-sectional study followed by a randomized controlled trial. In Phase 1, baseline and situational anxiety, coping strategy, and temperament were obtained from parents of children undergoing surgery (n = 334). A questionnaire examining the desire for perioperative information was administered to all parents. In Phase 2, 47 parents were randomly assigned to receive either routine anesthetic risk information (control) or detailed anesthetic risk information (intervention). The effect of the intervention on parental anxiety was assessed over four time points: prior to the intervention, immediately after the intervention, day of surgery in the holding area, and at separation to the operating room. For Phase 1, the majority of parents (> 95%) preferred to have comprehensive information concerning their child's perioperative period, including information about all possible complications. For selected items, increased parental educational level was associated with increased desire for information (P < 0.05). For Phase 2, when the intervention group was compared with the control group, there were no significant differences in parental anxiety over the four time points [F(1,45) = 0.6, P = 0.4]. Also, the interaction between time and group assignment was not significant [F(3,135) = 1.66, P = 0.18]. We conclude that parents of children undergoing surgery desire comprehensive perioperative information. Moreover, when provided with highly detailed anesthetic risk information, the parental anxiety level did not increase.

Anaesth Intensive Care 1996 Oct;24(5):594-598

Anaesthesia information--what patients want to know.

Garden AL, Merry AF, Holland RL, Petrie KJ

Green Lane Hospital, Auckland, New Zealand.

We developed and introduced into clinical practice a leaflet to improve the delivery of information to patients before obtaining their consent to anaesthesia. The amount of information needs to be what a "reasonable" patient thinks appropriate; therefore we tested patients' responses to three levels of information: "full" disclosure, "standard" disclosure (as contained in our leaflet) and "minimal" disclosure. Forty-five patients scheduled to undergo cardiac surgery were enrolled in the study. None of the information sheets caused a significant change in state anxiety score and only the "full" disclosure significantly increased knowledge about anaesthesia (P = 0.016). All leaflets were easy to understand. When only one leaflet was provided 64-73% of patients thought the content was "just right", whereas when all three leaflets were viewed together, 63% of patients thought the "minimal" leaflet withheld too much information.


J Clin Anesth 1995 May;7(3):200-204

The benefits of the explanation of the risks of anesthesia in the day surgery patient.

Waisel DB, Truog RD

Department of Anesthesia, Children's Hospital, Boston, MA, USA.

STUDY OBJECTIVE: To ascertain the benefits of the preoperative discussion of the risks of anesthesia with parents of ASA status I or II pediatric day surgery patients. DESIGN: Survey analysis. SETTING: Pediatric day surgery unit. PATIENTS: 54 parents of ASA status I or II pediatric day surgery patients between the ages of 7 months and 16 years. INTERVENTIONS: After informed consent for the anesthetic was obtained by a member of the anesthesiology team, the parent(s) were given a questionnaire on their feelings about the explanation of the risks of anesthesia. MEASUREMENTS AND MAIN RESULTS: The questionnaire evaluated how parents felt about their understanding of the risks of anesthesia, the effect of hearing the risks of anesthesia on their anxiety levels, and the benefits of hearing the risks of anesthesia. Over 90% of the parents felt that they understood the risks of anesthesia, that the discussion of the risks would have no effect on their decision to proceed with surgery, and that the explanation of the risks is desirable; 92% considered the explanation desirable either out of a sense of responsibility or because they welcomed better understanding. CONCLUSIONS: Our study suggests the benefits of the explanation of the risks of anesthesia appear to be rooted in satisfying parental responsibility and understanding, and not in providing information for decision making or anxiety relief. Anesthesiologists should not feed compelled to always detail all the risks, but should seek to satisfy individual parental needs.


CRNA 1995 May;6(2):64-69

Informed consent: an essential element of safe anesthesia practice.

McDonough JP, McMullen P, Philipsen N

Generally, health care providers have viewed safety in terms of prevention of patient accidents. However, with the growth of patient consumerism and stress on quality improvement, the concept of "safety" has been expanded. This article examines the legal concept of informed consent and offers practical suggestions on increasing both patient and provider safety and improving quality of care. For reasons dictated by statute, case law, and professional ethics, informed consent should be part of the practice of every CRNA. With proper informed consent, misinformation, dissatisfaction, and subsequent legal action can be diminished. Information should be offered to the patient and family and reinforced with written educational materials and instructions. These procedures should be documented in the medical record to provide verification that the patient was informed of the risks and benefits and agreed to the procedure contemplated. Failure to do so could expose the CRNA to legal actions under legal theories that include not only negligence, but battery, and contract as well.


BMJ 1995 Jan 7;310(6971):43-46

A fundamental problem of consent.

Mitchell J

Clyde and Co, London.

A consultant anaesthetist gave a diclofenac suppository for postoperative pain to a patient having four teeth extracted under general anaesthesia in the dental surgery. He did not seek the patient's specific consent preoperatively for use of the suppository but told her afterwards what he had done. Charged before the professional conduct committee of the General Medical Council with failure to obtain informed consent and assault, the anaesthetist was found guilty of serious professional misconduct and admonished. This decision has far reaching implications and has caused great concern.



Anesth Analg 1996 Mar;82(3):445-451

The Amsterdam Preoperative Anxiety and Information Scale.

Moerman N, van Dam FS, Muller MJ, Oosting H

Department of Anesthesiology, Academic Medical Centre, University of Amsterdam, The Netherlands.

The purpose of the present study was to assess patients' anxiety level and information requirement in the preoperative phase. During routine preoperative screening, 320 patients were asked to assess their anxiety and information requirement on a six-item questionnaire, the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Two hundred patients also completed Spielberger's State-Trait Anxiety Inventory (STAI-State). Patients were able to complete the questionnaire in less than 2 min. On factor analysis, two factors emerged clearly: anxiety and the need for information. The anxiety scale correlated highly (0.74) with the STAI-State. It emerged that 32% of the patients could be considered as "anxiety cases" and over 80% of patients have a positive attitude toward receiving information. Moreover, results demonstrated that 1) women were more anxious that men; 2) patients with a high information requirement also had a high level of anxiety; 3) patients who had never undergone an operation had a higher information requirement than those who had. The APAIS can provide anesthesiologists with a valid, reliable, and easily applicable instrument for assessing the level of patients' preoperative anxiety and the need for information.


Anaesthesia 1994 Feb;49(2):162-164

Patients' desire for information about anaesthesia: Australian attitudes.

Farnill D, Inglis S

University of Sydney, Australia.

Patients in a medium-sized Australian suburban general hospital were asked to complete a pre-operative questionnaire concerning their desire for information about their impending anaesthesia. The results are compared with those of Canadian and Scottish studies published recently. The Australian patients had a higher preference for information about complications, although some patients, mainly elderly, did not want to know about unpleasant aspects of peri-operative procedures or potential complications. As in the other countries, patients under the age of 50 years had a greater desire for information than those who were older (p < 0.05). All national groups accorded highest priority to meeting the anaesthetist before surgery. The results are discussed in relationship to the requirements for informed consent.


Anaesth Intensive Care 1993 Dec;21(6):799-805

The effects of providing preoperative statistical anaesthetic-risk information.

Inglis S, Farnill D

Department of Anaesthesia, Manly General Hospital, New South Wales.

Are patients who are provided with details about anaesthesia risks on the eve of surgery better informed, and does the information increase their anxiety? Forty (ASA Class I or II) patients scheduled for surgery requiring general anaesthesia were randomly allocated to either a routine or a detailed information group. Levels of anxiety were assessed by the Spielberger State-Trait Anxiety Inventory. Actual knowledge of risks was assessed by a special visual analogue scale. Patients had experienced an average of five previous anaesthetics and so most patients in both groups knew the risks of common complications such as nausea and sore throat and were able to represent them accurately on the visual analogue scale. The detailed group, however, had gained more accurate knowledge of the likelihood of two rare complications, death (P < 0.001) and serious tooth damage (P < 0.05). Notwithstanding, there was no difference between the groups in anxiety. Thus, provision of detailed information about the risks of the complications of general anaesthesia did increase patients' knowledge but did not increase patients' levels of anxiety.


Anesth Analg 1993 Aug;77(2):256-260

Parental knowledge and attitudes toward discussing the risk of death from anesthesia.

Litman RS, Perkins FM, Dawson SC

Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, New York.

There is considerable debate as to the extent of disclosure of risks when obtaining informed consent for anesthesia, especially when discussing with parents the rare risk of death of healthy children about to undergo elective, outpatient surgery. In Part I, we attempted to determine parents' knowledge about the risks of anesthesia as well as their thoughts toward either hearing, or not hearing, about the risk of death. In the first part of our study, 115 parents completed questionnaires before speaking with the anesthesiologist. Ninety-six (87%) wanted to know the chances of death as a result of anesthesia, whereas 14 (13%) did not. Seventy-five (68%) parents knew that this risk was "extremely rare," 21 (19%) believed that it occurs "once in a while," and 14 (13%) thought there was "no chance." Eighty-two (74%) parents wanted to know "all possible risks," 26 (24%) wanted to know only "those that are likely to occur," and 3 (2%) wanted to know only about those that would "result in significant injury." Mothers were more likely to want to hear all possible risks, whereas fathers were more likely to want to know only about those that are likely to occur (P = 0.001). Otherwise, responses were not influenced by the sex of the parents, the age of the child, or whether the child or any siblings had had surgery in the past. In Part II, a separate group of 121 parents were surveyed after participating in the preanesthetic discussion with the anesthesiologist.


Z Orthop Ihre Grenzgeb 1993 Jan;131(1):6-9

Undesirable treatment results from the viewpoint of an expert witness on medical liability problems--an analysis of 142 cases.

[Article in German]

Breitenfelder J

Orthopadischen Klinik, St. Vincenz-Hospitals, Brakel/Westfalen.

Causes of proven medical misconduct were analyzed on the basis of 142 expert testimonies prepared for an advisory committee on medical liability. The principal causes of misconduct identified were: 1. an incorrect indication for surgery; 2. Unsatisfactory surgical technique; 3. Inadequate preoperative patient enlightenment. In many of the cases in which an incorrect indication for therapy or a technical error could not be proved, the patients or their lawyers attempted to assert their claims by declaring that they had been insufficiently informed. The majority of the claims for recourse concerned: a) problems associated with implantation of total hip replacements; b) sequelae of revisional osteotomies of the lower extremity; c) infiltration therapy with a topical anesthetic; d) sequelae of lumbar disc surgery. These four therapeutic categories accounted for almost two-thirds of all proven errors of therapy and in informing patients. A total of 16.26% of the claims were resolved in the plaintiff's favor. Several examples are presented to illustrate the problem of incorrect indication and unsatisfactory surgical technique as a cause of proven therapeutic error.



Dtsch Z Mund Kiefer Gesichtschir 1991 Nov;15(6):449-457

Different information patterns and their influence on patient anxiety prior to dental local anesthesia.

[Article in German]

Lipp M, Dick W, Daublander M, Bertram M

Klinik fur Anasthesiologie Universitatsklinikum Mainz.

In 240 patients the correlation between different patterns of pretreatment verbal information on local anesthesia and perioperative patient anxiety was studied. Emphasis has been placed on the importance of "local anesthesia" itself as an anxiety factor as compared with other dental treatment measures and on legal aspects. The 240 patients were randomized into 3 groups of 80 patients each receiving minimum, basic, or extended information on local anesthesia. Anxiety was measured using the STAI test before and after the delivery of information, after local anesthesia, and finally after dental treatment. The significance of different anxiety factors was assessed with a questionnaire. Local anesthesia, pain sensation, and drilling were found to be the main anxiety factors. Higher STAI scores were observed in women and prior to surgical treatment, and the scores increased after minimum and extended information. Anxiety decreased after basic information, and significantly so in patients with high preoperative STAI scores. Disregarding the forensic aspects, our results suggest that basic information prior to dental treatment could be a useful method for reducing anxiety and improving the patients' confidence in the dentist or surgeon.


Anaesthesia 1991 May;46(5):410-412

Patients' desire for information about anaesthesia. Scottish and Canadian attitudes.

Lonsdale M, Hutchison GL

Department of Anaesthesia, Ninewells Hospital and Medical School, Dundee.

Patients in Canada and Scotland were asked to complete a pre-operative questionnaire examining their desire for information relating to anaesthesia. In both Canada and Scotland, patients under the age of 50 years had a greater wish to receive information than those who were older (p less than 0.0001). In Canada, female patients were found to be more keen to receive pre-operative information than males of the same age group (p less than 0.05). The priority given to individual pieces of information was remarkably similar in both countries. Details of dangerous complications of anaesthesia and surgery were consistently rated of low priority, with high priority going to postoperative landmarks such as eating and drinking. Both countries rated meeting the anaesthetist before surgery as the highest priority of all.



J Clin Anesth 1991 Jan;3(1):11-13

A risk-specific anesthesia consent form may hinder the informed consent process.

Clark SK, Leighton BL, Seltzer JL

Department of Anesthesiology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA.

STUDY OBJECTIVE: To evaluate the effect of a preprinted, risk-specific consent form on the amount of anesthetic risk information patients retain from the preoperative interview. DESIGN: Postoperative survey of consecutive inpatients to determine risk information retained before and after implementation of a preprinted anesthesia consent form, using standard preoperative risk discussions. SETTING: Inpatient units of a university medical center. PATIENTS: Two groups of patients, both of whom received a standard oral discussion of anesthetic risk information, were compared. Patients in the control group (125 consecutive inpatients) received this information only orally and were interviewed two weeks prior to implementation of a preprinted anesthesia consent form. Patients in the study group (92 consecutive inpatients) received this information orally and via a preprinted consent form and were interviewed between the fourth and sixth weeks after implementation of a preprinted anesthesia consent form. INTERVENTIONS: Anesthesia residents discussed five standard anesthetic risks with elective, adult inpatients (n = 233) during a two-week period immediately before and between the fourth and sixth weeks after instituting the mandatory use of a risk-specific anesthesia consent form. These patients were interviewed postoperatively by one of the authors to determine the amount of anesthesia risk information they retained. MEASUREMENTS AND MAIN RESULTS: Results of the postoperative survey showed that patients in the control group retained more information concerning anesthetic risks than did those in the study group (33% vs 19%, p less than 0.01). CONCLUSIONS: To improve the informed consent process, either a better method of presenting the preprinted, risk-specific consent form or another method of simultaneously conveying and documenting risk information is needed.


Br J Hosp Med 1990 Nov;44(5):326

Patient consent for gynaecological examination.

Lawton FG, Redman CW, Luesley DM

King's College Hospital, London.

Pelvic examination of women patients under general anaesthesia has long been practised by gynaecologists in order to teach clinical findings to medical students. Although this practice may spare patients discomfort and embarrassment, a recent survey has shown that it should not be carried out without patient consent. Consent, however, is rarely withheld.


BMJ 1993 Jan 30;306(6873):298-300

Who's afraid of informed consent?

Kerrigan DD, Thevasagayam RS, Woods TO, Mc Welch I, Thomas WE, Shorthouse AJ, Dennison AR

Royal Hallamshire Hospital, Sheffield.

OBJECTIVE--To test the assumption that patients will become unduly anxious if they are given detailed information about the risks of surgery in an attempt to obtain fully informed consent. DESIGN--Preoperative anxiety assessed before and after patients were randomly allocated an information sheet containing either simple or detailed descriptions of possible postoperative complications. SETTING--Four surgical wards at two Sheffield hospitals. SUBJECTS--96 men undergoing elective inguinal hernia repair under general anaesthesia. MAIN OUTCOME MEASURE--Change in anxiety level observed after receiving information about potential complications. RESULTS--Detailed information did not increase patient anxiety (mean Spielberger score at baseline 33.7 (95% confidence interval 31.3 to 36.2), after information 34.8 (32.1 to 37.5); p = 0.20, paired t test). A simple explanation of the facts provided a statistically significant degree of reassurance (mean score at baseline 34.6 (31.5 to 37.6), after information 32.3 (29.8 to 34.9); p = 0.012), although this small effect is likely to be clinically important only in those whose baseline anxiety was high (r = 0.27, p = 0.05). CONCLUSIONS--In men undergoing elective inguinal hernia repair a very detailed account of what might go wrong does not increase patient anxiety significantly and has the advantage of allowing patients a fully informed choice before they consent to surgery, thus reducing the potential for subsequent litigation.




J R Soc Med 1994 Mar;87(3):149-152

Informed consent: what do patients want to know?

Dawes PJ, Davison P

Sunderland Royal Infirmary, UK.

Informed consent is an important aspect of surgery, yet there has been little inquiry as to what patients want to know before their operation. This study has questioned 50 patients within 3 months of an ENT (ear, nose and throat) operation. We found that most were happy to allow doctors to determine their treatment but they wanted to know about their condition, the treatment, and the important side effects. Fifty per cent of patients admitted worrying about some aspect of their recent surgery. More than two-thirds thought signing a consent form primarily signified agreement to undergo treatment and that it was a legal document; 54% thought there was an important medico-legal aspect. Over half thought information sheets would be reassuring, one-third thought they would provoke anxiety and 8% thought they would frighten them from having surgery. Closer examination of the answers to our questions showed that those who were most worried about aspects of their surgery had a higher mean anxiety score, as did those who thought an information sheet would be either frightening or anxiety provoking. However, a higher anxiety score was not associated with a desire to know less about the proposed treatment.


Gastrointest Endosc 1994 May;40(3):271-276

A randomized trial using videotape to present consent information for colonoscopy.

Agre P, Kurtz RC, Krauss BJ

Memorial Sloan-Kettering Cancer Center, New York, New York 10021.

A randomized controlled trial was conducted to determine if a videotaped presentation by a physician conveys information more effectively than an in-person discussion by the same physician using the identical script. Two hundred one patients undergoing colonoscopy were enrolled in the study. Patients were randomly assigned to one of three groups: video plus discussion, video alone, and discussion alone. A validated, 13-item knowledge test and the State-Trait Anxiety Inventory were administered to all patients. Mean number of correct test answers for video plus discussion was 11.04; for video alone, 10.70; and for discussion alone, 9.61. ANOVA with planned orthogonal comparisons showed that the patients in the two video groups had significantly better scores (p < 0.001) than those in the discussion-only group. No difference was noted between the two video groups (p = 0.32). Anxiety did not increase with increased understanding of the risks and benefits of colonoscopy. This approach may work as well for other invasive medical procedures and could save physician time while laying a foundation for a more personalized discussion.


Semin Dermatol 1991 Jun;10(2):123-128

Making your own videotapes for patient instruction.

Guin JD, Donaldson R

Department of Dermatology, University of Arkansas for Medical Sciences, Little Rock 72205.

Producing your own videotapes can be both fun and clinically helpful. They are extremely effective for patient instruction and for obtaining informed consent. This article discusses the production, presentation, and effective use of videotapes in office practice.