EDUCATIONAL ADVANCES
The Need for Emergency Medicine Resident Training in Informed Consent for Procedures Theodore Gaeta, DO, MPH, Rafael Torres, MD, Radha Kotamraju, MD, Carly Seidman, BS, Joel Yarmush, MD, MPA
Abstract Objectives: To determine emergency medicine (EM) residents’ perceptions and reported practices of obtaining informed consent for emergency department procedures. Methods: The authors performed a cross-sectional observational study of EM residents. A brief, shortanswer survey was distributed that covered the following topics related to informed consent: training, confidence and comfort levels, and current practices. Data were analyzed using basic frequency displays, and descriptive statistics are reported. Results: Of the 20 programs contacted, 16 responded and agreed to distribute the invitation to their residents. A total of 402 of 490 eligible residents (82%) in the participating programs responded. The majority of EM residents (56%) had never received formal training on obtaining informed consent, and those who had reported that their primary exposure to formal training occurred during their medical school years (79%). More than half of the residents (56%) have felt uncomfortable obtaining consent for a procedure. Few residents (32%) felt very confident that they provide comprehensive information to patients, while 9% were not very confident that they disclose all pertinent risks, benefits, and alternatives to their patients. Sixty-three percent of all EM residents believed formal training is necessary, and half (52%) reported interest in receiving training (i.e., listings of risks, benefits, and alternatives as well as standards for determining which procedures need consent). The residents’ current perceptions of consent requirements for commonly performed emergency department procedures (emergent and nonemergent) are also reported. Conclusions: Few residents have had formal training in informed consent, and there is wide variability in the perception of which procedures require informed consent. Residents are not confident in their knowledge of all risks and benefits of common procedures, and comfort levels in obtaining informed consent are low. Residents can benefit from additional resources that provide standardized information and formal training on the issue. ACADEMIC EMERGENCY MEDICINE 2007; 14:785–789 ª 2007 by the Society for Academic Emergency Medicine Keywords: informed consent, resident training, emergency procedures
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s legal issues have come to play an increasingly large role in medical decision-making, the concept of informed consent has been continually reexamined and remains an imperfect and controversial process. To make a truly informed decision, the risks, benefits, and alternatives for an invasive procedure must be clearly explained to the patient. This responsibility lies with the treating physician. In the emergency department (ED), resident physicians are frequently required to obtain informed consent for a vast spectrum of procedures under stressful conditions and within a
From the Department of Emergency Medicine, New York Methodist Hospital (TG, RT, RK, CS, JY), Brooklyn, NY. Received March 8, 2007; revisions received May 9, 2007, and May 15, 2007; accepted May 26, 2007. Contact for correspondence and reprints: Theodore Gaeta, DO, MPH; e-mail:
[email protected].
ª 2007 by the Society for Academic Emergency Medicine doi: 10.1197/j.aem.2007.05.012
limited time frame. Moreover, there are special challenges to obtaining informed consent in the ED setting, including impairments in patients’ cognitive abilities during emergencies, inadequate levels of health literacy, and language barriers. ED patients are therefore a vulnerable population. There are also federal rules allowing exemptions from consent under certain circumstances, further complicating the informed consent process.1 Therefore, emergency medicine (EM) residents require a thorough understanding of the informed consent process to ensure that patients’ ethical and legal rights are upheld. Previous studies that have examined patients’ perspectives on informed consent have suggested that patients have not felt adequately educated about the risks and benefits of procedures and potential alternatives.2 Studies have also examined the content of consent documents and proposed changes to these forms.3,4 Specific to the ED, one study examined the inadequacy of the general
ISSN 1069-6563 PII ISSN 1069-6563583
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consent form that is signed on arrival to the hospital.5 However, although the existing practices pertaining to informed consent have been criticized, few studies have examined the perspectives of those who actually obtain the consent. Because resident physicians often obtain informed consent in the ED, acquiring more information about residents’ perceptions could potentially improve the quality of this process. The Society for Academic Emergency Medicine Ethics Committee has stated that although the informed consent process faces unique challenges in the ED, if extra precautions are taken, the best interests of subjects can be protected. In fact, the Model of the Clinical Practice of Emergency Medicine curriculum describes consent as an educational component in the practice of medicine that can be evaluated through the Accreditation Council on Graduate Medical Education (ACGME) core competencies in professionalism and procedural competency.6 This study was designed to assess EM residents’ awareness and perceptions of informed consent policies and procedures. Specifically, a survey of EM residents was conducted to determine 1) residents’ understanding of policies and protocols, 2) the current extent of informed consent training practices, and 3) residents’ perceptions of the need for further training. METHODS Study Design and Population A cross-sectional observational study of EM residents was performed in the 2003–2004 academic year. The residency directors and program coordinators of 20 New York State ACGME–accredited EM residency training programs were invited via e-mail to participate in an online survey. Response to the survey implied consent to participate. This study was approved by our institutional review board. Survey Content and Administration The researchers developed a short-answer survey based on a small focus group of EM residents (two residents from each level of training in an EM three-year program). The instrument was piloted on the full complement of EM residents at our institution (n = 30) to test face validity. Sample participants were asked to provide feedback as to the quality of the overall intent of the questionnaire and participate in an item-by-item discussion of the questions. This ‘‘practice run’’ allowed us to assess the time demand and readability of the questions and to identify any potential misunderstanding of the content before distributing the survey. The instrument underwent minimal revision with respect to grammar and formatting and was made available online for the study institutions. To assist in establishing the reliability of the instrument, the sample residents were asked to retake the survey online. All 30 residents surveyed at our institution responded the same way on the online version with respect to primary outcome questions. Program directors were asked to forward a link to our Web-based survey to their residents. A second reminder message was sent to each of the residency programs one month after the initial contact was made. The survey site
was closed three months after the first program query, and data were analyzed. The anonymous, Web-based survey (available as an online Data Supplement at http://www.aemj.org/cgi/ content/full/j.aem.2007.05.012/DC1) covered the following topics relating to informed consent: previous training and interest in additional training, confidence and comfort levels, and current practices. Residents were also asked to report their current practices in providing informed consent for a selected number of ED-related procedures and asked their opinions regarding whether there should be a hospital policy requiring consent for these procedures. Data Analysis The data were entered into a Microsoft Excel spreadsheet (Microsoft Corp., Redmond, WA). Data were analyzed using basic frequency displays, and descriptive statistics are reported. RESULTS Twenty EM residency programs were contacted; 16 responded and agreed to distribute the invitation to their residents. A total of 402 of 490 residents (82%) in the participating programs responded. Demographic characteristics of the survey population and general results are reported in Table 1. A baseline measure of sample error was performed on the response to question 3, ‘‘Do you feel formal training is necessary for learning how to obtain consent?’’ At the 95% confidence level, the margin of error was 4.9%. The great majority of the EM residents surveyed (365/ 402; 91%) did not have formal training during their EM residency on obtaining informed consent. Most of these residents had either no training (56%) or nonspecific training during medical school (35%). Two thirds (63%) of the EM residents believed that formal training is necessary, and approximately half (52%) expressed an interest in receiving this training. Residents who received previous training were more likely than those who had not to believe that formal training is necessary for learning how to properly obtain informed consent for procedures (134/179 [65%] vs. 117/223 [53%]). The majority (69%) of residents obtained written informed consent in ‘‘75% of cases’’ for nonemergent procedures but did not obtain it in ‘‘75% of cases’’ for emergent procedures (87%). When asked about specific procedures, the EM residents were varied in how often they obtained written informed consent (Table 2). The range varied from 93% for blood product transfusion and 87% for procedural sedation to 1.5% for repair of laceration, in general, and 2.2% for repair of facial laceration. For seven of the 13 procedures, the residents obtained written informed consent parallel to what they believed was appropriate (i.e., informed consent is within 5% of what the hospital should require). These procedures included laceration repair, lumbar puncture, blood product transfusion, procedural sedation, closed reduction of a fracture, joint aspiration, and peritoneal aspiration. In all of the remaining seven procedures, the residents obtained written informed consent less often than they believed was appropriate. For five of these
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Table 1 Demographic Characteristics of Survey Population and General Results
Level of training EM 1 EM 2 EM 3 EM 4 Gender Male Female Residents aware of the presence of a hospital policy regarding informed consent for procedures Residents familiar with their hospital policy regarding informed consent for procedures Residents who have received formal training in obtaining informed consent for procedures In medical school In residency Residents who believe that formal training in informed consent for procedures is necessary Residents who reported ‘‘ever feeling uncomfortable’’ providing informed consent for procedures Did not understand all risks, benefits, and alternatives Did not agree with the necessity of the procedure Not sure consent was necessary Residents interested in receiving further training or additional resources regarding informed consent for procedures Preferred format of educational resource Pocket guide/handbook Lecture series with handout Video or Web-based learning module
procedures, the difference between how often informed consent was obtained and how often it should be required was 10%–20%. These procedures included nerve block, central line, photographs/video, chest tube insertion, and repair of a facial laceration. Finally, the difference between how often informed consent was obtained and whether it should be required was slightly greater than 20% for administration of intravenous contrast material. Overall, the EM residents believed that they provide sufficiently comprehensive information to patients; 32%
Table 2 Residents’ Report of Their Current Practice of Providing Informed Consent for Procedures in Contrast to Their Belief That There Should Be Formal Guidelines Requiring Informed Consent
Procedure Lumbar puncture Blood/blood products Conscious sedation Laceration repair Closed reduction of fracture Joint aspiration Peritoneal aspiration Nerve block Central line Photographs/video Intravenous contrast Chest tube Facial laceration
Informed Consent Obtained (%)
Informed Consent Should Be Required (%)
80 93 87 1.5 34
77 95 90 6 34
34 70 5 64 67 18 59 2.2
44 72 20 74 85 40 72 16
No.
Percent
98 114 155 35
24 28 39 9
246 156 338 62 179 142 37 253 227 177 21 17 208
61 49 84 15 44 79 21 63 56 78 9 7 52
324 290 178
81 72 44
of the residents felt very confident and an additional 60% felt somewhat confident. Those residents with previous training were more likely to feel somewhat or very confident in their disclosure of risks and benefits (173/ 179; 97%) than those without training (196/223; 76%). While most felt confident in providing information, more than half of the residents (56%) felt uncomfortable in obtaining the informed consent. Nearly two thirds of the residents who felt uncomfortable felt this way because they did not understand all the risks, benefits, and alternatives to be disclosed. In addition to utilizing the standard consent form and procedure note, 36% attested to always writing a progress note, 45% to sometimes writing a progress note, and 19% to never writing a progress note detailing the informed consent process. The survey results suggested that residents interested in formal informed consent training believe they would benefit from education with regard to the following: comprehensive listings of risks, benefits, and alternatives that need to be conveyed in the acquisition of informed consent (72%); standards delineating which procedures need consent (30%); and information regarding the legal ramifications of obtaining or failing to obtain informed consent (12%). Eighty-one percent of the residents expressed that they would be interested in having access to a pocket manual or handbook describing the most common procedures requiring consent, as well as listings of all risks, benefits, and alternatives that should be explained to patients. A similar number of residents believed the material could be easily communicated in a lecture-style format. Fewer were interested in the electronic versions of selfeducation.
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DISCUSSION Variability in Informed Consent Practices According to the American Medical Association’s guidelines for informed consent, ‘‘The physician’s obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice.’’7 The existing literature points to significant variability and deficiency in informed consent practices across specialties and institutions. Chadha and Repanos measured health care providers’ (n = 118) knowledge of informed consent practices in the United Kingdom via a 12-question ‘‘true or false’’ survey and found the overall percentage answered correctly was only 50.9%. It was suggested that ‘‘consent is incompletely understood by most health care professionals.’’8 Brown discovered tremendous variability in informed consent practices pertaining to emergency psychiatry research in the United States.9 McClean and Card found Canadian internal medicine residents to be deficient in their knowledge and practice of informed consent. Moreover, it was seldom reported that the residents received assessment or feedback on their skills.10 Our data collected from the New York State EM residency training programs is consistent with the existing research in that it suggests that many EM residents do not believe they are equipped with the information necessary to adequately follow informed consent guidelines. In addition, these data are suggestive of remarkable variability in the residents’ informed consent practices. There appears to be little consensus as to which procedures require consent, how risks and benefits should be explained, and how these events should be documented. Protocols and Practices A major issue is thus deciding which procedures require formal consent. Ideally, the physician should always document that the management plan was explained to and accepted by the patient. How does this practice translate into the acquisition of signatures on specific consent forms? Of the residents who alleged that their hospitals have formal policies regarding which procedures require consent, only a small proportion expressed that they were very familiar with these policies. Familiarity with institutional informed consent policies was not found to increase with number of years in training. In addition, familiarity with informed consent practices was highest among those who had prior formal training (81% of those trained expressed that they were very or somewhat familiar with their hospital’s practices). Those without previous training were less likely to be aware of hospital policy on informed consent and less likely to practice in accordance with hospital-defined standards of care. According to our survey, most residents attested to obtaining consent for blood transfusions, lumbar punctures, procedural sedations, and laceration repairs. A majority (81%) of residents agreed that they do not routinely obtain consent for emergent procedures. The American Medical Association’s guidelines state that informed consent should be obtained for every procedure excluding those situations where the physician feels
that ‘‘harm from failure to treat is imminent.’’11 Our study used the terms ‘‘emergent’’ and ‘‘nonemergent’’ without any further definition, due to the fact that the emergent nature of any given procedure varies based on the clinical situation. The issue of documentation was also addressed by the survey. Many residents averred to either ‘‘always’’ or ‘‘sometimes’’ writing an additional progress note documenting consent, in addition to completing the standard consent form. There was not a large difference in this practice among those with previous formal training versus those without. Overall, as residents are exposed to the increasingly legal atmosphere of medical practice, further education on informed consent and documentation practices seems to be of benefit. Need for Training At present, there are no consistent, universally accepted approaches to the teaching or evaluation of informed consent skills in the United States. Existing literature has suggested that health care personnel, often residents, frequently lack adequate informed consent training; this results in insufficient knowledge and skills. Based on Canadian residents’ poor performance upon evaluation, McClean and Card called for ‘‘the urgent need for enhanced teaching of informed consent skills in postgraduate training programs,’’ as well as ‘‘an effective strategy for regular formative feedback and accurate summative evalution.’’10 Chadha and Repanos similarly noted that ‘‘improvements in practice and knowledge should be possible with targeted educational sessions aimed at those involved in the consent process.’’8 Our study also uncovered a need for formal informed consent training, and our results indicate that the EM residents often lacked the confidence in their knowledge of risks, benefits, and alternatives to properly relay this information to patients. Patients cannot be expected to make an informed decision if their provider is functionally uninformed. Residents who had no previous training made up the majority of the sample who felt ‘‘not very confident’’ or ‘‘not at all confident’’ in their skills in obtaining consent. Inversely, those who had previous training felt more familiar with existing hospital policies and, in general, more confident in obtaining consent. A recent study of pediatrics residents suggested that provision of formal education and training in informed consent via lecture, video, and discussion ‘‘positively affects residents’ knowledge and attitudes.’’12 Other research found the use of standardized patient feedback to be an effective means of teaching informed consent to surgical residents; it was recommended that similar training methods be implemented within other medical specialties as well.13 Consent and refusal of care is an educational component of practice in the Model of the Clinical Practice of Emergency Medicine. It is the responsibility of training programs to provide the structured education of their residents in these practices. There are many options for curriculum development and implementation. When residents were asked to choose their preferred method of further training, the most common response was in the form of a pocket guide or manual that provides easy access to the risks, benefits, and alternatives to
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common procedures. A formal lecture series with appropriate handouts was also a desirable option. Regardless of the educational method, evaluation of competency in informed consent should be a part of a resident’s overall assessment of procedural competency, as well as the interpersonal skills and communication and the professionalism core competencies. By providing mentorship in the ED, clinical faculty can both participate in the education of the resident and provide feedback through direct observation. LIMITATIONS This survey was distributed only to EM residents receiving their training in the state of New York. Because informed consent protocol is known to vary from state to state, the results of this study cannot be generalized to reflect the practices and attitudes of EM residents as a whole. In addition, our query was only related to the resident’s knowledge of and familiarity with their institution’s policy regarding consent. We did not attempt to confirm the content of these policies. Therefore, some of the variability on response may be accounted for by the variability in actual institutional requirements. Many residents reported not having formal training in obtaining informed consent for procedures. It may be the residents did not remember it or considered it inadequate. This survey did not include the program directors’ verification of the educational exposure of residents, and therefore there may be a mismatch between resident recall and their actual presented curriculum. Finally, as might occur in any survey-based research, residents’ self-evaluations of their informed consent practices were subjective and may not have reflected their actual performance. However, we found a consistent theme of inadequate educational exposure, knowledge, and confidence among our sampled EM residents. Unfortunately, the survey instrument was not designed to evaluate whether the residents’ comfort level improved over time. Questions were geared toward identifying the reasons for unease. CONCLUSIONS Relatively few residents have formal training in providing informed consent. Residents’ confidence and comfort levels in obtaining informed consent were not high; few believed that they had full knowledge of all risks and benefits before obtaining patients’ consent, and there was wide variability in residents’ selection and documentation of procedures requiring informed consent. Many residents asserted that they would benefit from more formal training on the subject, and nearly all demonstrated interest in a pocket manual or booklet providing standardized information on the issue. Educational mod-
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ules addressing basic guidelines might be of great value. Evaluation of the impact of informed consent training programs is certainly worthy of future investigation.
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