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Spanish and English Video-Assisted Informed Consent for Intravenous Contrast Administration in the Emergency Department: A Randomized Controlled Trial
ETHICS/ORIGINAL RESEARCH
Spanish and English Video-Assisted Informed Consent for Intravenous Contrast Administration in the Emergency Department: A Randomized Controlled Trial Ethan A. Cowan, MD, MS Yvette Calderon, MD, MS Paul Gennis, MD Ruth Macklin, PhD Carlos Ortiz, MD Stephen P. Wall, MD, MS
From the Department of Emergency Medicine, Jacobi Medical Center (Cowan, Calderon, Gennis, Ortiz, Wall), and the Department of Epidemiology and Population Health (Gennis, Macklin, Wall), Albert Einstein College of Medicine, Bronx, NY.
Study objective: This study determined whether Spanish and English educational videos are superior to routine discussion for informing emergency department (ED) patients about risks, benefits, and alternatives to receiving intravenous contrast for computed tomography (CT). Methods: A prospective randomized controlled trial was performed on a convenience sample of adult ED patients scheduled to receive intravenous contrast for CT. Patients randomized to the intervention group watched a video in Spanish or English explaining the procedure and its risks, benefits, and alternatives. The control group underwent routine discussion, receiving intravenous contrast information from their emergency physician. After their educational sessions, all participants completed a 10-question intravenous contrast knowledge measure and 1 question rating satisfaction with the informed consent process. Mean scores were compared to assess whether the videos were superior to routine discussion for educating patients about intravenous contrast. Secondary outcomes included the proportion of satisfied patients and refusals to sign consent. Results: Of the 112 patients enrolled, 56 were randomized to the video group and 56 to routine discussion. Five patients withdrew from the study, leaving 107 for analysis (video N⫽53; control N⫽54). Mean knowledge scores were higher in the video group (68.1%) compared to routine discussion (47.8%) (95% confidence interval [CI] for the difference 12.6% to 28.1%). Video-group patients exhibited greater satisfaction than routine-discussion patients (86.8% [95% CI 74.6% to 94.5%] versus 77.4% [95% CI 63.8% to 87.7%]). All patients signed consent to receive intravenous contrast. Conclusion: Using Spanish and English educational videos yielded higher intravenous contrast knowledge scores compared with routine informed consent procedures. [Ann Emerg Med. 2007;49: 221-230.] 0196-0644/$-see front matter Copyright © 2007 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2006.07.934
SEE EDITORIAL, P. 231. INTRODUCTION Background More than 8 million computed tomography (CT) studies are performed annually in US emergency departments (EDs), many of which require the administration of intravenous contrast.1 Though the safety profile of new intravenous contrast agents has improved, patients are still exposed to significant risk from potentially severe life-threatening reactions. Rare instances of Volume , . : February
death have also been reported.2,3 Previous studies demonstrate that physicians inconsistently obtain informed consent before the administration of intravenous contrast, and, when consent is obtained, there is wide variability in the quality of the process.4-7 Studies have also demonstrated that patients want to know about the risks of intravenous contrast before receiving it.8,9 Importance The ethical imperative of informed consent requires physicians to provide information about invasive procedures, Annals of Emergency Medicine 221
Informed Consent for IV Contrast Administration Editor’s Capsule Summary
What is already known on this topic Intravenous contrast is not without risk. Emergency department (ED) patients may not receive the information required to make an informed decision about radiographic tests that use contrast. What question this study addressed The authors determined whether Spanish and English educational videos are superior to routine education and discussion by the emergency physician for informing ED patients about risks, benefits, and alternatives to receiving intravenous contrast for computed tomography. What this study adds to our knowledge This 107-person randomized trial demonstrated that patients who viewed the English or Spanish version of the video were more satisfied and performed better on a knowledge test than those who received routine information from their emergency physician. How this might change clinical practice Video information about consent for intravenous contrast is more effective than traditional methods and, although not studied here, probably saves time for those EDs that have prepared video. Not all hospitals require consent for intravenous contrast, nor do all require that the ED perform that task.
including a discussion about their risks benefits and alternatives. Patient understanding of this information facilitates individual choice.10,11 Obtaining adequate informed consent for intravenous contrast administration in the ED is a timeconsuming procedure. Providers must convey complex medical information needed for patients to make an informed decision. Obtaining informed consent from non–English-speaking patients offers additional challenges, requiring even more provider time and greater use of ancillary resources. Video-assisted informed consent for intravenous contrast administration may be a practical solution. Previous studies demonstrate that patients offered video-assisted consent acquire the same if not better understanding of the proposed procedure as patients who receive oral information from their physician; however, these studies were confined to English-speaking patients.12-16 Video-assisted informed consent in multiple languages has the potential to deliver clear and consistent information efficiently to all patients undergoing invasive procedures, regardless of primary language spoken. Goals of This Investigation Despite the challenges that exist in obtaining informed consent, it is necessary for emergency physicians to meet the 222 Annals of Emergency Medicine
Cowan et al ethical imperative of informed consent, which requires sound understanding by all patients regardless of primary language spoken. Our hypothesis was that video-assisted informed consent would produce a 10% difference in mean intravenous contrast knowledge scores compared with those undergoing routine informed consent. A 10% better performance in intravenous contrast knowledge scores before a patient signs informed consent for intravenous contrast administration was considered clinically and ethically important. In secondary analysis, we estimated whether better performance in intravenous contrast knowledge is more pronounced in non– English-speaking patients, in which the challenges of language barriers lead to greater deficiencies in patient understanding. We also explored whether using videos would lead to greater satisfaction with the informed consent process and reduce the number of patients who refuse to sign consent for this procedure.
MATERIALS AND METHODS Study Design We conducted a nonblinded randomized controlled trial with 2 arms: the control group received information about the risks, benefits, and alternatives of intravenous contrast administration from their emergency physician, and the intervention group viewed a video offered in Spanish or English, conveying the same information. The study protocol was reviewed and approved by the institutional review boards of the medical school and the hospital participating in the study. Patients and physicians signed written informed consent before enrollment. Setting The study was carried out in the ED of an academic innercity Level I trauma center with approximately 90,000 annual adult visits. Twenty-four ED attending physicians supervise 54 residents, providing instruction and supervising patient care. Selection of Participants All English- and Spanish-speaking ED patients 18 years of age or older and scheduled to receive a CT scan with intravenous contrast were eligible for enrollment if a trained research associate was available. Research associates collected eligibility data 7 days a week between 8 AM and midnight from August 30, 2005, to February 28, 2006. Patients who were clinically unstable, refused to participate, had known hypersensitivity to the contrast agent, or were unable to understand the consent process for this study were excluded. Patients were also excluded if their emergency physician had previously informed the patient about the risks, benefits, and alternatives to intravenous contrast before being approached by the research associate. If a research associate missed an eligible patient, the research associate subsequently recorded the reason for the missed opportunity in a study log book. Volume , . : February
Cowan et al In our ED, emergency medicine residents are responsible for obtaining informed consent for intravenous contrast administration. No physicians were excluded from the process of obtaining informed consent for intravenous contrast administration. Physicians were blinded to the content of the intravenous contrast videos and the intravenous contrast knowledge measure. Interventions A panel of experts, including 4 emergency physicians, developed the script for the intravenous contrast video (E.C., Y.C., P.G., S.W.). Content was based on expert opinion, pharmaceutic package inserts, and current radiology literature. A physician fluent in Spanish and English was used as the actor for the videos. The final videos were approximately 5 minutes long and contained information on the risks, benefits, and alternatives of intravenous contrast. The language of the video was at an eighth-grade level, as determined by Microsoft Word’s Flesh-Kincade grade level instrument (Microsoft Corp., Redmond, WA). The routine informed consent group included patients who received information about intravenous contrast from their emergency physician. As an element of standard practice, all emergency physicians annually attend a 1-hour lecture in July on the risks, benefits, and alternatives of intravenous contrast and the proper procedure for obtaining informed consent. The expert panel that created the intravenous contrast video also established the lecture content. A brief reference handout reviewing risks, benefits, and alternatives of intravenous contrast is also distributed annually to all emergency physicians. Physicians in this study did not use a prepared template or standard script when discussing intravenous contrast with their patients. At the physician’s request, a certified telephone or institutional translator was used for Spanish-speaking patients. Use of a translator was recorded by the research associate. Spanish-speaking physicians who believed they were proficient enough in Spanish to explain the risks, benefits, and alternatives of intravenous contrast were allowed to obtain informed consent for the IV contrast procedure without the aid of a certified translator. Data Collection and Processing Research associates used a prescripted approach to describe the study to eligible patients and obtain written informed consent in either Spanish or English (Appendix E1, available online at http://www.annemergmed.com). Individuals who declined to participate were asked to provide demographic information. Patients who agreed to participate were randomized to either routine informed consent or video, with the patient as the unit of randomization. The randomization allocation schedule was generated with a standard computergenerated block randomization routine (available online at http://www.randomization.com). Group assignments were placed in sealed opaque envelopes that were sequentially opened after patients signed informed consent for the study. After Volume , . : February
Informed Consent for IV Contrast Administration randomization, a research associate interviewed study subjects to collect demographic information on age, sex, primary language spoken, self-reported ethnicity, self-reported level of education, and whether they had previously received intravenous contrast. Research associates also recorded a unique physician identifier that was used to track the number of patients from whom each provider obtained consent. The control group included patients who received information about intravenous contrast from their emergency physician by patient-physician discussion, as described previously. After discussion with their physician, participants completed a 10-question multiple-choice measure of intravenous contrast knowledge and 1 question assessing their satisfaction with the informed consent process. For patients who requested that the examination be administered orally, a research associate or translator read the questions and marked off the patient’s response on the examination. Research associates were trained to read the questions in an unbiased manner and were unaware of the correct answers. If the examination was orally administered, this was recorded on the data collection instrument. The intervention group included patients who obtained information about intravenous contrast from a Spanish or English video viewed at their bedside on a 5½-inch portable DVD player. At the conclusion of the video, patients were given the opportunity to speak with their physician if they had any questions about the video content. This question-and-answer session was included to create equivalency with the control group, which was able to ask questions during routine informed consent. At the conclusion of the question-and-answer session, patients in the video group were administered the same intravenous contrast knowledge and satisfaction measures as patients in the routine informed consent group. Outcome Measures Study participants were administered an intravenous contrast knowledge measure designed to assess their understanding of the risks, benefits, and alternatives of intravenous contrast administration. To create this measure, the same 4 emergency physicians who developed the intravenous contrast video script (E.C., Y.C., P.G., S.W.) reviewed the current literature on the risks of intravenous contrast, with a special focus on randomized controlled clinical trials.16-22 Development of the measure and video script were done concurrently. Questions were multiplechoice format, readable at a sixth-grade level, as determined by Microsoft Word’s Flesh-Kincade grade level instrument (Microsoft Corp., Redmond, WA). The measure was created in English, professionally translated into Spanish, and then piloted on the first 20 patients enrolled in the study. Data from these patients were then unblinded and analyzed to identify problematic questions. One question was revised according to the pilot data because 19 of 20 patients answered the question incorrectly because of ambiguous wording. The records of the 20 patients in the pilot study were discarded and are not included in the final analysis. The final intravenous contrast Annals of Emergency Medicine 223
Informed Consent for IV Contrast Administration knowledge measure is shown in Appendix E2 (available online at http://www.annemergmed.com). The primary outcome, patient understanding of the risks, benefits, and alternatives of intravenous contrast administration, was determined by quantitative scores on the written examination (0% to 100%). The primary outcome was stratified by preferred language. Secondary outcomes included patient satisfaction with the informed consent process, determined by a 4-point ordinal satisfaction scale, and the proportion of patients who refused to sign consent for the intravenous contrast procedure. Primary Data Analysis Data were recorded in an electronic database using Microsoft Access (Microsoft Corp., Redmond, WA). Data obtained from patients were entered according to patient subject number, without any specific identifiers. This method of data management was selected to ensure patient confidentiality. Baseline characteristics of the routine informed consent and video groups were analyzed using descriptive statistics. Mean and SDs were calculated for normally distributed continuous variables and proportions for categorical variables. The 4-point ordinal satisfaction scale was dichotomized into satisfied (good and excellent) or not-satisfied (poor and fair) categories for analysis. Normality of intravenous contrast knowledge scores was assessed using the Shapiro-Wilk normality test and graphic methods. Mean scores on the intravenous contrast knowledge measure were compared using Student’s t test. Secondary analysis included a comparison of mean scores among Spanish- and English-speaking subgroups. To account for unobserved physician characteristics, including baseline intravenous contrast knowledge, race and ethnicity, and communication skills, the generalized, mixed, linear, randomeffects model was used to adjust for the correlation of patients within consenting physician clusters.23 All statistical data were analyzed using Stata version 8.2 (StataCorp, College Station, TX). Graphs and figures were created using Stata version 8.2 (StataCorp, College Station, TX) and SigmaPlot version 8.0 (Systat Software, Point Richmond, CA). Sample size was determined a priori according to an estimated 10% difference in mean intravenous contrast knowledge scores. The 10% effect size on the intravenous contrast measure was chosen because the authors believed that every question concerning intravenous contrast risks, benefits, and alternatives had equal significance and that any improvement in knowledge that patients attained before signing informed consent for intravenous contrast administration was both clinically and ethically important. To account for the unobservable physician characteristics, we used sample-size estimation for clustered continuous data. A 2-sided t test with a significance level of 0.05 and an intracluster correlation of 0.05 demonstrated that a sample size of 23 clusters per group, with 2 individuals per cluster, achieved 80% power to detect a difference of 10 between-group means. Assuming a 15% 224 Annals of Emergency Medicine
Cowan et al dropout rate, we required 106 total patients. Sample size requirements were calculated using PASS 2004 (NCSS, Utah).
RESULTS Figure 1 summarizes enrollment and patient flow. A total of 424 CT scans with intravenous contrast were performed during the study period. A research associate was available to enroll 202 of the 424 patients. Of the 202 patients, 49 (24.3%) were not eligible, 41 (20.3%) were eligible but refused to participate, and 112 (55.4%) agreed to participate. Of the 41 refusals, 51.2% (21/41) of patients completed a demographic questionnaire. Problems not listed in Figure 1 that resulted in patient exclusion were a broken DVD player (4), patient immobilization in a rigid cervical neck collar (3), respiratory isolation precautions (3), and no available Spanish translator (2). Five of the 112 patients randomized withdrew before completing the intravenous contrast knowledge and satisfaction measures. One patient was unable to hear the video, 1 patient was allergic to contrast dye and was inappropriately enrolled, and 4 patients decided they did not want to complete the measures. Data analysis of the primary and secondary endpoints was performed on the final sample of 107 patients. Forty-four physicians had interactions with 94 of the 107 patients. Physician identification was missing for 13 subjects. For the study population in which physician identification was available, the median number of patients who discussed intravenous contrast administration with their physician was 1 (range 1 to 9). The median number of patients who discussed intravenous contrast administration with their physician in both the routine informed consent and video group was also 1 (routine informed consent range 1 to 4; video range 1 to 6). The P calculated using the generalized, mixed, linear, randomeffects model in Stata was 0, so no adjustment for unobserved physician characteristics was required. The mean age of the study population was 41.5⫾16.3, and 63.2% were female. Latinos accounted for 58.5% of the total population, blacks 28.3%, and non-Latino whites 3.8%. The remaining 9.4% of the population included Asians, Middle Easterners, and Pacific Islanders. Sixty-three percent of the population had at least a high school diploma. The majority of patients (60.2%) had no previous exposure to intravenous contrast. Patients in the routine informed consent and video group were similar with regard to age, sex, ethnicity, preferred language, grade level achieved, previous exposure to intravenous contrast, and oral administration of the postconsent measure (Table 1). Patients who refused to participate or withdrew from the study had similar demographic characteristics to patients enrolled into the study (Table 2). Main Results The main outcomes for all study participants are summarized in Figures 2 though 5. Individual test question performance stratified by mode of consent and preferred language is shown Volume , . : February
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Figure 1. Profile of randomized controlled trial. RA, Research assistant.
in Figures E1-E3 (available online at http://www.annemergmed. com). Mean intravenous contrast knowledge scores were higher in the video compared with the routine informed consent group (68.1% and 47.8.7% respectively; difference of 20.3%; 95% confidence interval [CI] for the difference 12.6% to 28.1%). The analysis stratified by language demonstrated that both English- and Spanish-speaking patients who received video-assisted informed consent scored higher than English and Spanish speakers who discussed intravenous contrast administration with their physician (English video 68.6% versus English routine informed Volume , . : February
consent 50.2%; 95% CI for the difference 9.8% to 27%; Spanish video 65.6% versus Spanish routine informed consent 38.2%; 95% CI for the difference 8.5% to 46.2%). Patients who watched the Spanish video and completed the Spanish knowledge measure scored similar to patients who watched the English video and completed the English knowledge measure (65.6% versus 68.6%; difference of 3%; 95% CI for the difference ⫺11.4% to 17.6%). Spanish-speaking patients who engaged in an informed consent discussion with their physician scored lower than English speakers who engaged in an informed consent discussion with their Annals of Emergency Medicine 225
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Table 1. Baseline characteristics of patients randomized to each group.* Video (nⴝ53)
Patient-Physician Discussion (nⴝ54)
42.7⫾2.1 53.8 (21/52)
40.3⫾2.3 46.2 (28/54)
54.7 (29/53) 1.9 (1/53) 34.0 (18/53) 9.4 (5/53)
62.3 (33/53) 5.7 (3/53) 22.6 (12/53) 9.4 (5/53)
83.0 (44/53) 17.0 (9/53)
79.6 (43/54) 20.4 (11/54)
11.5 (6/52) 25.0 (13/52) 34.6 (18/52) 28.9 (15/52) 42.0 (21/50) 24.4 (11/45)
14.8 (8/54) 22.2 (12/54) 29.6 (16/54) 33.3 (18/54) 37.7 (20/53) 21.7 (10/46)
Characteristics Age, years Male Ethnicity Spanish/Hispanic/Latino White/non-Hispanic Black Other Language of routine informed consent/video and examination English Spanish Grade level achieved 0–8th Grade Some high school High school diploma Beyond high school Previous intravenous contrast Verbal administration of examination
*Continuous variables are reported as mean values (⫾SD), and categorical variables are reported as percentages (n/N). Denominators vary because of missing data.
Table 2. Characteristics of patients enrolled versus those who refused to participate or withdrew.* Characteristics Age, years Male, % Ethnicity Spanish/Hispanic/Latino Black Preferred language English Spanish Grade level achieved 0–8th Grade Some high school High school diploma Beyond high school Previous intravenous contrast
Enrolled (nⴝ107)
Refused/Withdrew (nⴝ26)
41.5⫾16.3 36.8 (39/106)
45.8⫾17.5 26.9 (7/26)
58.5 (62/106) 28.3 (30/106)
69.2 (18/26) 30.8 (8/26)
81.3 (87/107) 18.7 (20/107)
73.1 (19/26) 26.9 (7/26)
13.2 (14/106) 23.6 (25/106) 32.1 (34/106) 31.1 (33/106) 39.8 (41/103)
26.1 (6/23) 13.0 (3/23) 21.8 (5/23) 39.1 (9/23) 34.6 (9/26)
*Continuous variables are reported as mean values (⫾SD), and categorical variables are reported as percentages (n/N). Denominators vary because of missing data.
physician (38.2% versus 50.2%; difference of 12%; 95% CI for the difference ⫺1.7% to 25.8%). The difference in scores between the routine informed consent group and video group was greater among Spanish speakers than English speakers (difference of 27.4% for Spanish speakers; 95% CI for the difference 8.5% to 46.2% versus difference of 18.4% for English speakers; 95% CI for the difference 9.8% to 27.0%). 226 Annals of Emergency Medicine
Figure 2. Box plot of intravenous contrast knowledge scores by mode of consent and language. The middle bars are the medians, and the boxes include the interquartile range. Filled dots represent outlying data points. The whisker bars represent the 10th and 90th percentile of the data.
Of the 53 patients randomized to the video, 86.8% (95% CI 74.6% to 94.5%) were satisfied with the way they were informed about intravenous contrast, whereas 77.4% (95% CI 63.8% to 87.7%) of patients randomized to routine informed consent were satisfied with their experience. None of the patients in either group refused to sign consent for intravenous contrast administration.
LIMITATIONS There is no valid and reliable measure to evaluate understanding of the risks, benefits, and alternatives of intravenous contrast. The intravenous contrast knowledge measure used in this study has face validity and contains content the authors believed patients should know before signing consent for intravenous contrast administration. The survey was also piloted on a subset of patients to identify and rephrase problematic questions. Patients’ preconsent intravenous contrast knowledge was not formally tested using a preintervention/postintervention design. Randomization yielded balanced groups with respect to previous exposure to intravenous contrast, thus limiting this potential bias. The difference in scores between the routine informed consent group and video group was greater among Spanish speakers than English speakers; however, the 95% CI for the difference for Spanish speakers (8.5% to 46.2%) well overlaps that obtained for English speakers (9.8% to 27.0%). This study did not have the power to detect a difference in language subgroups, and thus more data are necessary to confirm these preliminary findings. Volume , . : February
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Figure 3. Test performance by mode of consent. The x axis represents the total percentage correct on the intravenous contrast knowledge test (0% to 100%).
Figure 4. Test performance by mode of consent: English language. The x axis represents the total percentage correct on the intravenous contrast knowledge test (0% to 100%).
To promote uniformity of information given to patients in the control and video groups, all resident and attending physicians responsible for obtaining informed consent for intravenous contrast are given an hour-long lecture annually on Volume , . : February
intravenous contrast risks, benefits, and alternatives; however, the information physicians conveyed to patients was not standardized or recorded. It is conceivable that there was variability in the information provided by physicians to patients Annals of Emergency Medicine 227
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Figure 5. Test performance by mode of consent: Spanish language. The x axis represents the total percentage correct on the intravenous contrast knowledge test (0% to 100%).
in the control group. This inconsistency in information dissemination likely mimics the actual practice of physicians who obtain informed consent for any invasive procedure in the ED. Physicians were not blinded to the intervention, and, as a result, may have altered their informed consent discussion during the study. Physicians might have been more diligent in providing intravenous contrast information if they were concerned about being labeled as a poor educator. Alternatively, the physicians could have performed their job in the routine manner, which may provide valuable information about patient education during these informed consent sessions. The study population was predominantly Latino and black, limiting generalizability of the study conclusions to white nonLatinos and others. However, the preponderance of Latino and black patients satisfied the study’s purpose to address the challenges of conveying complex medical information to multiethnic and non–English-speaking patient populations. Additionally, this study examined patients and physicians at a public hospital in one urban academic institution; the results may not generalize to other ED settings.
DISCUSSION Our results suggest that using educational videos offered in Spanish and English yields higher intravenous contrast knowledge scores in patients requiring informed consent for intravenous contrast administration in the ED. In our sample, mean scores on the postconsent intravenous contrast knowledge 228 Annals of Emergency Medicine
measure were higher in the video group compared with the routine informed consent group. Our findings are consistent with a previous study of an interactive media tool used to educate patients about intravenous contrast risks, benefits, and alternatives in an outpatient setting.16 Despite demonstrating that video education yields higher intravenous contrast knowledge, our patients in both the video and routine informed consent groups achieved low mean intravenous contrast knowledge scores (47.8% routine informed consent group, 68.1% video group). One reason for low mean scores in the routine informed consent group may be variability in the intravenous contrast information given by physicians to patients. Other potential reasons for low mean scores in both groups may be the inclusion of non–English-speaking patients and patients having, on average, lower educational achievement than those in previous studies. Another possibility for lower mean scores in our patient population may be related to the difficulty of the questions on the intravenous contrast knowledge measure. Alternatively, low intravenous contrast knowledge scores in this study may reflect an inherent difficulty with obtaining adequate informed consent in the ED. Previous studies have shown that patients with acute medical conditions have little understanding of study aims, risks, and benefits.24 ED patients may also have unrecognized cognitive impairment that makes them less capable of understanding the informed-consent process.25 Another problem leading to variability may be the time required for ED providers to convey the complex information necessary to obtain adequate informed consent. Volume , . : February
Cowan et al Obtaining informed consent for non–English-speaking patients is even more challenging because it requires additional provider time and greater use of ancillary resources. More than 46 million people in the United States do not speak English as their primary language, and more than 21 million speak English less than “very well.”26 Most health care organizations provide either inadequate interpreter services or no services at all.27-32 In many settings, providers use untrained interpreters, including family members, friends, nonclinical employees, or nonfluent health care professionals.33-35 Previous studies have identified the use of unqualified interpreters as a source of medical errors and poor health outcomes, primarily because of miscommunications between patients and providers.36-41 Although having qualified translators has been shown to reduce health disparity for non–English-speaking patients, few provider centers have the resources to offer 24-hour translation services in all languages.42 Telephone translation services are an alternative, but often, time and awkward pauses during lengthy conversation prohibit its use in the consent process. Videoassisted informed consent for non–English-speaking patients may be a feasible alternative. Our subgroup analysis suggests that Spanish-speaking patients who watched the video and completed the intravenous contrast knowledge measure in their language may achieve a level of understanding comparable to their English-speaking counterparts (65.6% versus 68.6%). The difference in scores between the routine informed consent group and the video group was greater in Spanish speakers than English speakers (27.4% versus 18.4%); however, this study was not powered to detect a difference in language subgroups, and thus more data are necessary to confirm these preliminary findings. Continued research is required to determine the causes of differences in knowledge acquisition between English- and non–English-speaking patients in the ED. One possibility is that language barriers and lack of translation services lead to differences in patients’ understanding of diagnosis and treatments.43-45 Spanish language proficiency was not measured among the providers who believed their skills were adequate to educate patients about intravenous contrast. If these providers were not effective communicators, this may in part explain why non–English-speaking patients achieved limited understanding of intravenous contrast’s risks, benefits, and alternatives during their ED visit. In the future, we plan to produce intravenous contrast informational videos in additional languages, perform a qualitative analysis of intravenous contrast knowledge to test the reliability of our quantitative measure, and determine the costeffectiveness of video-assisted informed consent for intravenous contrast administration. We also plan to investigate the applicability of educational videos to other ED invasive procedures for which informed consent is required. In Retrospect We would like to have had a validated scale to measure intravenous contrast knowledge. To reduce bias from physician Volume , . : February
Informed Consent for IV Contrast Administration behavior, we could have devised a mechanism to blind the physicians. Using a stratified sampling strategy would have assisted in recruiting non-Latino white patients. Measuring patient competency to consent for intravenous contrast, measuring provider Spanish-language proficiency, and tracking patient receiving of sedating medications would have improved our understanding of the reasons for low mean knowledge scores. In summary, the use of Spanish and English educational videos was superior to routine informed consent in educating patients about the risks, benefits, and alternatives to intravenous contrast administration in the ED. Videoassisted informed consent may also increase patient satisfaction with the informed consent process and the understanding of intravenous contrast in non–Englishspeaking patients, but future studies are necessary to confirm the results of these preliminary findings. Video-assisted informed consent does not seem to discourage patients from signing consent to receive intravenous contrast for CT. Supervising editor: Robert K. Knopp, MD Author contributions: EAC, PG, and SPW conceived the study and designed the trial. EAC, RM, and SPW received research funding. All authors supervised the conduct of the trial and data collection. EAC managed the data, including quality control. EAC, CO, and SPW produced the Spanish and English intravenous contrast video. RM provided ethical consultation and feedback on study design and protocol implementation. EAC and SPW provided statistical expertise and analyzed the data. EAC drafted the article, and all authors contributed substantially to its revision. EAC takes responsibility for the paper as a whole. Funding and support: Ethan Cowan, MD, MS, is funded by an F32 Ruth L. Kirschstein National Research Service Award from the National Institute of General Medical Sciences (NIGMS 1 F 32 GM075589-01). Publication dates: Received for publication April 13, 2006. Revisions received June 30, 2006. Accepted for publication July 24, 2006. Available online September 28, 2006. Reprints not available from the authors. Address for correspondence: Ethan A. Cowan, MD, MS, Jacobi Medical Center, Albert Einstein College of Medicine, 1400 Pelham Parkway South, Room 1W20, Bronx, NY 10461; 718918-3050, fax 718-918-7459; E-mail [email protected].
REFERENCES 1. McCaig LF, Burt CW. National Hospital Ambulatory Medical Care Survey: 2002 emergency department summary. Adv Data. 2004; 340:1-34. 2. Nakamura I, Hori S, Funabiki T, et al. Cardiopulmonary arrest induced by anaphylactoid reaction with contrast media. Resuscitation. 2002;53:223-226. 3. Health A. Omnipaque. Available at: http://www.amershamhealthus.com. Accessed February 22, 2006.
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Informed Consent for IV Contrast Administration 4. Spring DB, Akin JR, Margulis AR. Informed consent for intravenous contrast-enhanced radiography: a national survey of practice and opinion. Radiology. 1984;152:609-613. 5. Lambe HA, Hopper KD, Matthews YL. Use of informed consent for ionic and nonionic contrast media. Radiology. 1992;184: 145-148. 6. Hopper KD, Tyler HN Jr. Informed consent for intravascular administration of contrast material: how much is enough? Radiology. 1989;171:509-514. 7. Hopper KD, Lambe HA, Shirk SJ. Readability of informed consent forms for use with iodinated contrast media. Radiology. 1993; 187:279-283. 8. Hopper KD, Houts PS, McCauslin MA, et al. Patients’ attitudes toward informed consent for intravenous contrast media. Invest Radiol. 1992;27:362-366. 9. Spring DB, Winfield AC, Friedland GW, et al. Written informed consent for i.v. contrast-enhanced radiography: patients’ attitudes and common limitations. AJR Am J Roentgenol. 1988;151: 1243-1245. 10. Applebaum P, Lidz CW, Meisel A. Informed Consent Legal Theory and Clinical Practice. New York, NY: Oxford University Press; 1987. 11. Barber B. Informed Consent in Medical Therapy and Research. New Brunswick, NJ: Rutgers University Press; 1980. 12. Gagliano ME. A literature review on the efficacy of video in patient education. J Med Educ. 1988;63:785-792. 13. Fisher L, Rowley PT, Lipkin M Jr. Genetic counseling for betathalassemia trait following health screening in a health maintenance organization: comparison of programmed and conventional counseling. Am J Hum Genet. 1981;33:987-994. 14. Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointest Endosc. 1994;40:271-276. 15. Meade CD, McKinney WP, Barnas GP. Educating patients with limited literacy skills: the effectiveness of printed and videotaped materials about colon cancer. Am J Public Health. 1994;84: 119-121. 16. Hopper KD, Zajdel M, Hulse SF, et al. Interactive method of informing patients of the risks of intravenous contrast media. Radiology. 1994;192:67-71. 17. Barrett BJ, Parfrey PS, McDonald JR, et al. Nonionic lowosmolality versus ionic high-osmolality contrast material for intravenous use in patients perceived to be at high risk: randomized trial. Radiology. 1992;183:105-110. 18. Bettmann MA, Heeren T, Greenfield A, et al. Adverse events with radiographic contrast agents: results of the SCVIR Contrast Agent Registry. Radiology. 1997;203:611-620. 19. Barrett BJ, Carlisle EJ. Meta-analysis of the relative nephrotoxicity of high- and low-osmolality iodinated contrast media. Radiology. 1993;188:171-178. 20. Moore RD, Steinberg EP, Powe NR, et al. Frequency and determinants of adverse reactions induced by high-osmolality contrast media. Radiology. 1989;170:727-732. 21. Cochran ST, Bomyea K, Sayre JW. Trends in adverse events after IV administration of contrast media. AJR Am J Roentgenol. 2001; 176:1385-1388. 22. Katayama H, Yamaguchi K, Kozuka T, et al. Adverse reactions to ionic and nonionic contrast media: a report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990; 175:621-628. 23. Wears RL. Advanced statistics: statistical methods for analyzing cluster and cluster-randomized data. Acad Emerg Med. 2002;9: 330-341. 24. Williams BF, French JK, White HD. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent
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substudy): a prospective observational study. Lancet. 2003;361:918-922. Smithline HA, Mader TJ, Crenshaw BJ. Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? Acad Emerg Med. 1999;6: 776-780. US Census Bureau. Profile of selected social characteristics. Available at: http://www.factfinder.census.gov. Accessed August 24, 2005. Robert Wood Johnson Foundation. New survey shows language barriers causing many Spanish-speaking Latinos to Skip Care. Available at: http://www.rwjf.org. Accessed September 27, 2004. Association of State and Territorial Offices. ASTHO Bilingual Health Initiative: Report and Recommendations. Washington, DC: Association of State and Territorial Offices; 1992. Jacobs EA, Lauderdale DS, Meltzer D, et al. The impact of interpreter services on delivery of health care to limited Englishproficient patients. J Gen Intern Med. 2001;16:468-474. Baker DW, Parker RM, Williams MV, et al. Use and effectiveness of interpreters in an emergency department. JAMA. 1996;275: 783-788. Ginsberg C, Martin D, Andrulis D, et al. Interpretation and Translation Services in Health Care: A Survey of US Public and Private Teaching Hospitals. Washington, DC: National Public Health and Hospital Institute; 1995. Schmidt R, Ahart A, Shur G. Limited English Proficiency as a Barrier to Health and Social Services. Washington, DC: Macro Interaction, Inc; 1995. Brach C, Fraser I, Paez K. Crossing the language chasm. Health Aff (Millwood). 2005;24:424-434. Carrasquillo O, Orav EJ, Brennan TA, et al. Impact of language barriers on patient satisfaction in an emergency department. J Gen Intern Med. 1999;14:82-87. Morales LS, Cunningham WE, Brown JA, et al. Are Latinos less satisfied with communication by health care providers? J Gen Intern Med. 1999;14:409-417. Putsch RW 3rd. Cross-cultural communication: the special case of interpreters in health care. JAMA. 1985;254:3344-3348. Vasquez C, Javier RA. The problem with interpreters: communicating with Spanish-speaking patients. Hosp Community Psychiatry. 1991;42:163-165. Ebden P, Carey OJ, Bhatt A, et al. The bilingual consultation. Lancet. 1988;1:347. Marcos LR. Effects of interpreters on the evaluation of psychopathology in non-English-speaking patients. Am J Psychiatry. 1979;136:171-174. Flores G, Laws MB, Mayo SJ, et al. Errors in medical interpretation and their potential clinical consequences in pediatric encounters. Pediatrics. 2003;111:6-14. Cohen AL, Rivara F, Marcuse EK, et al. Are language barriers associated with serious medical events in hospitalized pediatric patients? Pediatrics. 2005;116:575-579. Jacobs EA, Shepard DS, Suaya JA, et al. Overcoming language barriers in health care: costs and benefits of interpreter services. Am J Public Health. 2004;94:866-869. Flores G, Rabke-Verani J, Pine W, et al. The importance of cultural and linguistic issues in the emergency care of children. Pediatr Emerg Care. 2002;18:271-284. Brach C, Fraser I. Can cultural competency reduce racial and ethnic health disparities? a review and conceptual model. Med Care Res Rev. 2000;57(suppl 1):181-217. Richardson LD, Babcock Irvin C, Tamayo-Sarver JH. Racial and ethnic disparities in the clinical practice of emergency medicine. Acad Emerg Med. 2003;10:1184-1188.
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Appendix E1. Recruiting Script: Post-consent Measure. Hello, my name is ____________________ and I am a research assistant working with the emergency physicians today. Your doctor has recommended that you get a Computed Tomography (CT) scan with Intravenous (IV) contrast to help figure out what is wrong with you today. We are studying how to improve the way doctors get permission to perform this test. Normally, a doctor would come to your bedside and tell you about the risks, benefits, and alternatives of IV contrast, and then ask you to sign a consent form. We are studying whether a video can improve your understanding of the same information. If you agree to participate in the study you will be assigned by chance (like flipping a coin) to one of two groups.
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The first group will hear information about the risks, benefits, and alternatives of IV contrast from their doctor. The second group will hear about the risks, benefits, and alternatives of IV contrast from the videotape. After watching the videotape your doctor will return to your bedside and answer any questions that you have. Both groups will answer a few questions about themselves and then take a short 10-question quiz about the risks, benefits, and alternatives of IV contrast. We will not collect any information that can be used to identify you. Neither group will have their care for their emergency problem affected in any way. Your care will not change if you choose not to participate. If you have any questions I’d be happy to answer them. Would you like to participate? If yes, RANDOMIZE patient If no, GO TO REFUSAL FORM
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Appendix E2. Spanish and English video consenting for IV contrast administration in the emergency department: post consent measure. 1. What is the chance of the IV contrast dye causing serious side effects like heart problems? a. None b. Common (1 person in 10) c. Rare (1 person in 20,000) d. Extremely rare (1 person in a million) 2. Which of the following is a minor side effect to the IV contrast dye? a. Death b. Kidney damage c. Rash d. Heart Attack 3. Which of the following is a more serious side effect to the IV contrast dye? a. Rash b. Cough c. Fever d. Kidney damage 4. Which of the following make you more likely to have a side effect from the IV contrast dye? a. Recent surgery b. Eating before the test c. Previous side effect to contrast dye d. Fever 5. Which of the following is one of the most common side effects of IV contrast dye? a. Death b. Nausea c. Kidney Damage d. Heart attack 6. Which medical problem can increase the chance of having kidney damage after getting IV contrast dye? a. Prior kidney disease b. High blood pressure c. Arthritis d. Thyroid disease 7. How long do you need to worry about side effects from the IV contrast dye? a. Always b. 7 days c. 6 hours d. 5-10 minutes 8. What is the benefit of getting IV contrast dye for your CAT scan? a. Helps X-rays get into your body b. Makes your pain go away c. Makes it easier for doctors to find out what is wrong with you d. Keeps you calm and relaxed for the CAT scan 9. Minor side effects to the IV contrast dye require? a. Medications b. Admission to the hospital c. Kidney transplant d. No treatment is required 10. By signing the informed consent form, you are telling your doctor that you understand________________? a. the risks of getting IV contrast b. the benefits of getting IV contrast c. the alternatives of getting IV contrast d. All of the above 11. Please rate your overall satisfaction with the way you were informed about IV contrast dye. a. Poor b. Fair c. Good d. Excellent
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Figure E1. Test question performance by mode of consent. The x axis represents the percentage of participants who answered the question correctly (0% to 100%). The y axis represents the question number.
Figure E3. Test question performance stratified by language: Video group. The x axis represents the percentage of participants who answered the question correctly (0% to 100%). The y axis represents the question number.
Figure E2. The question performance stratified by language: Physician group. The x axis represents the percentage of participants who answered the question correctly (0% to 100%). The y axis represents the question number. Volume 49, . : February
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Spanish and English Video-Assisted Informed Consent for Intravenous Contrast Administration in the Emergency Department: A Randomized Controlled Trial Ethan A. Cowan, MD, MS Yvette Calderon, MD, MS Paul Gennis, MD Ruth Macklin, PhD Carlos Ortiz, MD Stephen P. Wall, MD, MS
From the Department of Emergency Medicine, Jacobi Medical Center (Cowan, Calderon, Gennis, Ortiz, Wall), and the Department of Epidemiology and Population Health (Gennis, Macklin, Wall), Albert Einstein College of Medicine, Bronx, NY.
Study objective: This study determined whether Spanish and English educational videos are superior to routine discussion for informing emergency department (ED) patients about risks, benefits, and alternatives to receiving intravenous contrast for computed tomography (CT). Methods: A prospective randomized controlled trial was performed on a convenience sample of adult ED patients scheduled to receive intravenous contrast for CT. Patients randomized to the intervention group watched a video in Spanish or English explaining the procedure and its risks, benefits, and alternatives. The control group underwent routine discussion, receiving intravenous contrast information from their emergency physician. After their educational sessions, all participants completed a 10-question intravenous contrast knowledge measure and 1 question rating satisfaction with the informed consent process. Mean scores were compared to assess whether the videos were superior to routine discussion for educating patients about intravenous contrast. Secondary outcomes included the proportion of satisfied patients and refusals to sign consent. Results: Of the 112 patients enrolled, 56 were randomized to the video group and 56 to routine discussion. Five patients withdrew from the study, leaving 107 for analysis (video N⫽53; control N⫽54). Mean knowledge scores were higher in the video group (68.1%) compared to routine discussion (47.8%) (95% confidence interval [CI] for the difference 12.6% to 28.1%). Video-group patients exhibited greater satisfaction than routine-discussion patients (86.8% [95% CI 74.6% to 94.5%] versus 77.4% [95% CI 63.8% to 87.7%]). All patients signed consent to receive intravenous contrast. Conclusion: Using Spanish and English educational videos yielded higher intravenous contrast knowledge scores compared with routine informed consent procedures. [Ann Emerg Med. 2007;49: 221-230.] 0196-0644/$-see front matter Copyright © 2007 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2006.07.934
SEE EDITORIAL, P. 231. INTRODUCTION Background More than 8 million computed tomography (CT) studies are performed annually in US emergency departments (EDs), many of which require the administration of intravenous contrast.1 Though the safety profile of new intravenous contrast agents has improved, patients are still exposed to significant risk from potentially severe life-threatening reactions. Rare instances of Volume , . : February
death have also been reported.2,3 Previous studies demonstrate that physicians inconsistently obtain informed consent before the administration of intravenous contrast, and, when consent is obtained, there is wide variability in the quality of the process.4-7 Studies have also demonstrated that patients want to know about the risks of intravenous contrast before receiving it.8,9 Importance The ethical imperative of informed consent requires physicians to provide information about invasive procedures, Annals of Emergency Medicine 221
Informed Consent for IV Contrast Administration Editor’s Capsule Summary
What is already known on this topic Intravenous contrast is not without risk. Emergency department (ED) patients may not receive the information required to make an informed decision about radiographic tests that use contrast. What question this study addressed The authors determined whether Spanish and English educational videos are superior to routine education and discussion by the emergency physician for informing ED patients about risks, benefits, and alternatives to receiving intravenous contrast for computed tomography. What this study adds to our knowledge This 107-person randomized trial demonstrated that patients who viewed the English or Spanish version of the video were more satisfied and performed better on a knowledge test than those who received routine information from their emergency physician. How this might change clinical practice Video information about consent for intravenous contrast is more effective than traditional methods and, although not studied here, probably saves time for those EDs that have prepared video. Not all hospitals require consent for intravenous contrast, nor do all require that the ED perform that task.
including a discussion about their risks benefits and alternatives. Patient understanding of this information facilitates individual choice.10,11 Obtaining adequate informed consent for intravenous contrast administration in the ED is a timeconsuming procedure. Providers must convey complex medical information needed for patients to make an informed decision. Obtaining informed consent from non–English-speaking patients offers additional challenges, requiring even more provider time and greater use of ancillary resources. Video-assisted informed consent for intravenous contrast administration may be a practical solution. Previous studies demonstrate that patients offered video-assisted consent acquire the same if not better understanding of the proposed procedure as patients who receive oral information from their physician; however, these studies were confined to English-speaking patients.12-16 Video-assisted informed consent in multiple languages has the potential to deliver clear and consistent information efficiently to all patients undergoing invasive procedures, regardless of primary language spoken. Goals of This Investigation Despite the challenges that exist in obtaining informed consent, it is necessary for emergency physicians to meet the 222 Annals of Emergency Medicine
Cowan et al ethical imperative of informed consent, which requires sound understanding by all patients regardless of primary language spoken. Our hypothesis was that video-assisted informed consent would produce a 10% difference in mean intravenous contrast knowledge scores compared with those undergoing routine informed consent. A 10% better performance in intravenous contrast knowledge scores before a patient signs informed consent for intravenous contrast administration was considered clinically and ethically important. In secondary analysis, we estimated whether better performance in intravenous contrast knowledge is more pronounced in non– English-speaking patients, in which the challenges of language barriers lead to greater deficiencies in patient understanding. We also explored whether using videos would lead to greater satisfaction with the informed consent process and reduce the number of patients who refuse to sign consent for this procedure.
MATERIALS AND METHODS Study Design We conducted a nonblinded randomized controlled trial with 2 arms: the control group received information about the risks, benefits, and alternatives of intravenous contrast administration from their emergency physician, and the intervention group viewed a video offered in Spanish or English, conveying the same information. The study protocol was reviewed and approved by the institutional review boards of the medical school and the hospital participating in the study. Patients and physicians signed written informed consent before enrollment. Setting The study was carried out in the ED of an academic innercity Level I trauma center with approximately 90,000 annual adult visits. Twenty-four ED attending physicians supervise 54 residents, providing instruction and supervising patient care. Selection of Participants All English- and Spanish-speaking ED patients 18 years of age or older and scheduled to receive a CT scan with intravenous contrast were eligible for enrollment if a trained research associate was available. Research associates collected eligibility data 7 days a week between 8 AM and midnight from August 30, 2005, to February 28, 2006. Patients who were clinically unstable, refused to participate, had known hypersensitivity to the contrast agent, or were unable to understand the consent process for this study were excluded. Patients were also excluded if their emergency physician had previously informed the patient about the risks, benefits, and alternatives to intravenous contrast before being approached by the research associate. If a research associate missed an eligible patient, the research associate subsequently recorded the reason for the missed opportunity in a study log book. Volume , . : February
Cowan et al In our ED, emergency medicine residents are responsible for obtaining informed consent for intravenous contrast administration. No physicians were excluded from the process of obtaining informed consent for intravenous contrast administration. Physicians were blinded to the content of the intravenous contrast videos and the intravenous contrast knowledge measure. Interventions A panel of experts, including 4 emergency physicians, developed the script for the intravenous contrast video (E.C., Y.C., P.G., S.W.). Content was based on expert opinion, pharmaceutic package inserts, and current radiology literature. A physician fluent in Spanish and English was used as the actor for the videos. The final videos were approximately 5 minutes long and contained information on the risks, benefits, and alternatives of intravenous contrast. The language of the video was at an eighth-grade level, as determined by Microsoft Word’s Flesh-Kincade grade level instrument (Microsoft Corp., Redmond, WA). The routine informed consent group included patients who received information about intravenous contrast from their emergency physician. As an element of standard practice, all emergency physicians annually attend a 1-hour lecture in July on the risks, benefits, and alternatives of intravenous contrast and the proper procedure for obtaining informed consent. The expert panel that created the intravenous contrast video also established the lecture content. A brief reference handout reviewing risks, benefits, and alternatives of intravenous contrast is also distributed annually to all emergency physicians. Physicians in this study did not use a prepared template or standard script when discussing intravenous contrast with their patients. At the physician’s request, a certified telephone or institutional translator was used for Spanish-speaking patients. Use of a translator was recorded by the research associate. Spanish-speaking physicians who believed they were proficient enough in Spanish to explain the risks, benefits, and alternatives of intravenous contrast were allowed to obtain informed consent for the IV contrast procedure without the aid of a certified translator. Data Collection and Processing Research associates used a prescripted approach to describe the study to eligible patients and obtain written informed consent in either Spanish or English (Appendix E1, available online at http://www.annemergmed.com). Individuals who declined to participate were asked to provide demographic information. Patients who agreed to participate were randomized to either routine informed consent or video, with the patient as the unit of randomization. The randomization allocation schedule was generated with a standard computergenerated block randomization routine (available online at http://www.randomization.com). Group assignments were placed in sealed opaque envelopes that were sequentially opened after patients signed informed consent for the study. After Volume , . : February
Informed Consent for IV Contrast Administration randomization, a research associate interviewed study subjects to collect demographic information on age, sex, primary language spoken, self-reported ethnicity, self-reported level of education, and whether they had previously received intravenous contrast. Research associates also recorded a unique physician identifier that was used to track the number of patients from whom each provider obtained consent. The control group included patients who received information about intravenous contrast from their emergency physician by patient-physician discussion, as described previously. After discussion with their physician, participants completed a 10-question multiple-choice measure of intravenous contrast knowledge and 1 question assessing their satisfaction with the informed consent process. For patients who requested that the examination be administered orally, a research associate or translator read the questions and marked off the patient’s response on the examination. Research associates were trained to read the questions in an unbiased manner and were unaware of the correct answers. If the examination was orally administered, this was recorded on the data collection instrument. The intervention group included patients who obtained information about intravenous contrast from a Spanish or English video viewed at their bedside on a 5½-inch portable DVD player. At the conclusion of the video, patients were given the opportunity to speak with their physician if they had any questions about the video content. This question-and-answer session was included to create equivalency with the control group, which was able to ask questions during routine informed consent. At the conclusion of the question-and-answer session, patients in the video group were administered the same intravenous contrast knowledge and satisfaction measures as patients in the routine informed consent group. Outcome Measures Study participants were administered an intravenous contrast knowledge measure designed to assess their understanding of the risks, benefits, and alternatives of intravenous contrast administration. To create this measure, the same 4 emergency physicians who developed the intravenous contrast video script (E.C., Y.C., P.G., S.W.) reviewed the current literature on the risks of intravenous contrast, with a special focus on randomized controlled clinical trials.16-22 Development of the measure and video script were done concurrently. Questions were multiplechoice format, readable at a sixth-grade level, as determined by Microsoft Word’s Flesh-Kincade grade level instrument (Microsoft Corp., Redmond, WA). The measure was created in English, professionally translated into Spanish, and then piloted on the first 20 patients enrolled in the study. Data from these patients were then unblinded and analyzed to identify problematic questions. One question was revised according to the pilot data because 19 of 20 patients answered the question incorrectly because of ambiguous wording. The records of the 20 patients in the pilot study were discarded and are not included in the final analysis. The final intravenous contrast Annals of Emergency Medicine 223
Informed Consent for IV Contrast Administration knowledge measure is shown in Appendix E2 (available online at http://www.annemergmed.com). The primary outcome, patient understanding of the risks, benefits, and alternatives of intravenous contrast administration, was determined by quantitative scores on the written examination (0% to 100%). The primary outcome was stratified by preferred language. Secondary outcomes included patient satisfaction with the informed consent process, determined by a 4-point ordinal satisfaction scale, and the proportion of patients who refused to sign consent for the intravenous contrast procedure. Primary Data Analysis Data were recorded in an electronic database using Microsoft Access (Microsoft Corp., Redmond, WA). Data obtained from patients were entered according to patient subject number, without any specific identifiers. This method of data management was selected to ensure patient confidentiality. Baseline characteristics of the routine informed consent and video groups were analyzed using descriptive statistics. Mean and SDs were calculated for normally distributed continuous variables and proportions for categorical variables. The 4-point ordinal satisfaction scale was dichotomized into satisfied (good and excellent) or not-satisfied (poor and fair) categories for analysis. Normality of intravenous contrast knowledge scores was assessed using the Shapiro-Wilk normality test and graphic methods. Mean scores on the intravenous contrast knowledge measure were compared using Student’s t test. Secondary analysis included a comparison of mean scores among Spanish- and English-speaking subgroups. To account for unobserved physician characteristics, including baseline intravenous contrast knowledge, race and ethnicity, and communication skills, the generalized, mixed, linear, randomeffects model was used to adjust for the correlation of patients within consenting physician clusters.23 All statistical data were analyzed using Stata version 8.2 (StataCorp, College Station, TX). Graphs and figures were created using Stata version 8.2 (StataCorp, College Station, TX) and SigmaPlot version 8.0 (Systat Software, Point Richmond, CA). Sample size was determined a priori according to an estimated 10% difference in mean intravenous contrast knowledge scores. The 10% effect size on the intravenous contrast measure was chosen because the authors believed that every question concerning intravenous contrast risks, benefits, and alternatives had equal significance and that any improvement in knowledge that patients attained before signing informed consent for intravenous contrast administration was both clinically and ethically important. To account for the unobservable physician characteristics, we used sample-size estimation for clustered continuous data. A 2-sided t test with a significance level of 0.05 and an intracluster correlation of 0.05 demonstrated that a sample size of 23 clusters per group, with 2 individuals per cluster, achieved 80% power to detect a difference of 10 between-group means. Assuming a 15% 224 Annals of Emergency Medicine
Cowan et al dropout rate, we required 106 total patients. Sample size requirements were calculated using PASS 2004 (NCSS, Utah).
RESULTS Figure 1 summarizes enrollment and patient flow. A total of 424 CT scans with intravenous contrast were performed during the study period. A research associate was available to enroll 202 of the 424 patients. Of the 202 patients, 49 (24.3%) were not eligible, 41 (20.3%) were eligible but refused to participate, and 112 (55.4%) agreed to participate. Of the 41 refusals, 51.2% (21/41) of patients completed a demographic questionnaire. Problems not listed in Figure 1 that resulted in patient exclusion were a broken DVD player (4), patient immobilization in a rigid cervical neck collar (3), respiratory isolation precautions (3), and no available Spanish translator (2). Five of the 112 patients randomized withdrew before completing the intravenous contrast knowledge and satisfaction measures. One patient was unable to hear the video, 1 patient was allergic to contrast dye and was inappropriately enrolled, and 4 patients decided they did not want to complete the measures. Data analysis of the primary and secondary endpoints was performed on the final sample of 107 patients. Forty-four physicians had interactions with 94 of the 107 patients. Physician identification was missing for 13 subjects. For the study population in which physician identification was available, the median number of patients who discussed intravenous contrast administration with their physician was 1 (range 1 to 9). The median number of patients who discussed intravenous contrast administration with their physician in both the routine informed consent and video group was also 1 (routine informed consent range 1 to 4; video range 1 to 6). The P calculated using the generalized, mixed, linear, randomeffects model in Stata was 0, so no adjustment for unobserved physician characteristics was required. The mean age of the study population was 41.5⫾16.3, and 63.2% were female. Latinos accounted for 58.5% of the total population, blacks 28.3%, and non-Latino whites 3.8%. The remaining 9.4% of the population included Asians, Middle Easterners, and Pacific Islanders. Sixty-three percent of the population had at least a high school diploma. The majority of patients (60.2%) had no previous exposure to intravenous contrast. Patients in the routine informed consent and video group were similar with regard to age, sex, ethnicity, preferred language, grade level achieved, previous exposure to intravenous contrast, and oral administration of the postconsent measure (Table 1). Patients who refused to participate or withdrew from the study had similar demographic characteristics to patients enrolled into the study (Table 2). Main Results The main outcomes for all study participants are summarized in Figures 2 though 5. Individual test question performance stratified by mode of consent and preferred language is shown Volume , . : February
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Figure 1. Profile of randomized controlled trial. RA, Research assistant.
in Figures E1-E3 (available online at http://www.annemergmed. com). Mean intravenous contrast knowledge scores were higher in the video compared with the routine informed consent group (68.1% and 47.8.7% respectively; difference of 20.3%; 95% confidence interval [CI] for the difference 12.6% to 28.1%). The analysis stratified by language demonstrated that both English- and Spanish-speaking patients who received video-assisted informed consent scored higher than English and Spanish speakers who discussed intravenous contrast administration with their physician (English video 68.6% versus English routine informed Volume , . : February
consent 50.2%; 95% CI for the difference 9.8% to 27%; Spanish video 65.6% versus Spanish routine informed consent 38.2%; 95% CI for the difference 8.5% to 46.2%). Patients who watched the Spanish video and completed the Spanish knowledge measure scored similar to patients who watched the English video and completed the English knowledge measure (65.6% versus 68.6%; difference of 3%; 95% CI for the difference ⫺11.4% to 17.6%). Spanish-speaking patients who engaged in an informed consent discussion with their physician scored lower than English speakers who engaged in an informed consent discussion with their Annals of Emergency Medicine 225
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Table 1. Baseline characteristics of patients randomized to each group.* Video (nⴝ53)
Patient-Physician Discussion (nⴝ54)
42.7⫾2.1 53.8 (21/52)
40.3⫾2.3 46.2 (28/54)
54.7 (29/53) 1.9 (1/53) 34.0 (18/53) 9.4 (5/53)
62.3 (33/53) 5.7 (3/53) 22.6 (12/53) 9.4 (5/53)
83.0 (44/53) 17.0 (9/53)
79.6 (43/54) 20.4 (11/54)
11.5 (6/52) 25.0 (13/52) 34.6 (18/52) 28.9 (15/52) 42.0 (21/50) 24.4 (11/45)
14.8 (8/54) 22.2 (12/54) 29.6 (16/54) 33.3 (18/54) 37.7 (20/53) 21.7 (10/46)
Characteristics Age, years Male Ethnicity Spanish/Hispanic/Latino White/non-Hispanic Black Other Language of routine informed consent/video and examination English Spanish Grade level achieved 0–8th Grade Some high school High school diploma Beyond high school Previous intravenous contrast Verbal administration of examination
*Continuous variables are reported as mean values (⫾SD), and categorical variables are reported as percentages (n/N). Denominators vary because of missing data.
Table 2. Characteristics of patients enrolled versus those who refused to participate or withdrew.* Characteristics Age, years Male, % Ethnicity Spanish/Hispanic/Latino Black Preferred language English Spanish Grade level achieved 0–8th Grade Some high school High school diploma Beyond high school Previous intravenous contrast
Enrolled (nⴝ107)
Refused/Withdrew (nⴝ26)
41.5⫾16.3 36.8 (39/106)
45.8⫾17.5 26.9 (7/26)
58.5 (62/106) 28.3 (30/106)
69.2 (18/26) 30.8 (8/26)
81.3 (87/107) 18.7 (20/107)
73.1 (19/26) 26.9 (7/26)
13.2 (14/106) 23.6 (25/106) 32.1 (34/106) 31.1 (33/106) 39.8 (41/103)
26.1 (6/23) 13.0 (3/23) 21.8 (5/23) 39.1 (9/23) 34.6 (9/26)
*Continuous variables are reported as mean values (⫾SD), and categorical variables are reported as percentages (n/N). Denominators vary because of missing data.
physician (38.2% versus 50.2%; difference of 12%; 95% CI for the difference ⫺1.7% to 25.8%). The difference in scores between the routine informed consent group and video group was greater among Spanish speakers than English speakers (difference of 27.4% for Spanish speakers; 95% CI for the difference 8.5% to 46.2% versus difference of 18.4% for English speakers; 95% CI for the difference 9.8% to 27.0%). 226 Annals of Emergency Medicine
Figure 2. Box plot of intravenous contrast knowledge scores by mode of consent and language. The middle bars are the medians, and the boxes include the interquartile range. Filled dots represent outlying data points. The whisker bars represent the 10th and 90th percentile of the data.
Of the 53 patients randomized to the video, 86.8% (95% CI 74.6% to 94.5%) were satisfied with the way they were informed about intravenous contrast, whereas 77.4% (95% CI 63.8% to 87.7%) of patients randomized to routine informed consent were satisfied with their experience. None of the patients in either group refused to sign consent for intravenous contrast administration.
LIMITATIONS There is no valid and reliable measure to evaluate understanding of the risks, benefits, and alternatives of intravenous contrast. The intravenous contrast knowledge measure used in this study has face validity and contains content the authors believed patients should know before signing consent for intravenous contrast administration. The survey was also piloted on a subset of patients to identify and rephrase problematic questions. Patients’ preconsent intravenous contrast knowledge was not formally tested using a preintervention/postintervention design. Randomization yielded balanced groups with respect to previous exposure to intravenous contrast, thus limiting this potential bias. The difference in scores between the routine informed consent group and video group was greater among Spanish speakers than English speakers; however, the 95% CI for the difference for Spanish speakers (8.5% to 46.2%) well overlaps that obtained for English speakers (9.8% to 27.0%). This study did not have the power to detect a difference in language subgroups, and thus more data are necessary to confirm these preliminary findings. Volume , . : February
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Figure 3. Test performance by mode of consent. The x axis represents the total percentage correct on the intravenous contrast knowledge test (0% to 100%).
Figure 4. Test performance by mode of consent: English language. The x axis represents the total percentage correct on the intravenous contrast knowledge test (0% to 100%).
To promote uniformity of information given to patients in the control and video groups, all resident and attending physicians responsible for obtaining informed consent for intravenous contrast are given an hour-long lecture annually on Volume , . : February
intravenous contrast risks, benefits, and alternatives; however, the information physicians conveyed to patients was not standardized or recorded. It is conceivable that there was variability in the information provided by physicians to patients Annals of Emergency Medicine 227
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Figure 5. Test performance by mode of consent: Spanish language. The x axis represents the total percentage correct on the intravenous contrast knowledge test (0% to 100%).
in the control group. This inconsistency in information dissemination likely mimics the actual practice of physicians who obtain informed consent for any invasive procedure in the ED. Physicians were not blinded to the intervention, and, as a result, may have altered their informed consent discussion during the study. Physicians might have been more diligent in providing intravenous contrast information if they were concerned about being labeled as a poor educator. Alternatively, the physicians could have performed their job in the routine manner, which may provide valuable information about patient education during these informed consent sessions. The study population was predominantly Latino and black, limiting generalizability of the study conclusions to white nonLatinos and others. However, the preponderance of Latino and black patients satisfied the study’s purpose to address the challenges of conveying complex medical information to multiethnic and non–English-speaking patient populations. Additionally, this study examined patients and physicians at a public hospital in one urban academic institution; the results may not generalize to other ED settings.
DISCUSSION Our results suggest that using educational videos offered in Spanish and English yields higher intravenous contrast knowledge scores in patients requiring informed consent for intravenous contrast administration in the ED. In our sample, mean scores on the postconsent intravenous contrast knowledge 228 Annals of Emergency Medicine
measure were higher in the video group compared with the routine informed consent group. Our findings are consistent with a previous study of an interactive media tool used to educate patients about intravenous contrast risks, benefits, and alternatives in an outpatient setting.16 Despite demonstrating that video education yields higher intravenous contrast knowledge, our patients in both the video and routine informed consent groups achieved low mean intravenous contrast knowledge scores (47.8% routine informed consent group, 68.1% video group). One reason for low mean scores in the routine informed consent group may be variability in the intravenous contrast information given by physicians to patients. Other potential reasons for low mean scores in both groups may be the inclusion of non–English-speaking patients and patients having, on average, lower educational achievement than those in previous studies. Another possibility for lower mean scores in our patient population may be related to the difficulty of the questions on the intravenous contrast knowledge measure. Alternatively, low intravenous contrast knowledge scores in this study may reflect an inherent difficulty with obtaining adequate informed consent in the ED. Previous studies have shown that patients with acute medical conditions have little understanding of study aims, risks, and benefits.24 ED patients may also have unrecognized cognitive impairment that makes them less capable of understanding the informed-consent process.25 Another problem leading to variability may be the time required for ED providers to convey the complex information necessary to obtain adequate informed consent. Volume , . : February
Cowan et al Obtaining informed consent for non–English-speaking patients is even more challenging because it requires additional provider time and greater use of ancillary resources. More than 46 million people in the United States do not speak English as their primary language, and more than 21 million speak English less than “very well.”26 Most health care organizations provide either inadequate interpreter services or no services at all.27-32 In many settings, providers use untrained interpreters, including family members, friends, nonclinical employees, or nonfluent health care professionals.33-35 Previous studies have identified the use of unqualified interpreters as a source of medical errors and poor health outcomes, primarily because of miscommunications between patients and providers.36-41 Although having qualified translators has been shown to reduce health disparity for non–English-speaking patients, few provider centers have the resources to offer 24-hour translation services in all languages.42 Telephone translation services are an alternative, but often, time and awkward pauses during lengthy conversation prohibit its use in the consent process. Videoassisted informed consent for non–English-speaking patients may be a feasible alternative. Our subgroup analysis suggests that Spanish-speaking patients who watched the video and completed the intravenous contrast knowledge measure in their language may achieve a level of understanding comparable to their English-speaking counterparts (65.6% versus 68.6%). The difference in scores between the routine informed consent group and the video group was greater in Spanish speakers than English speakers (27.4% versus 18.4%); however, this study was not powered to detect a difference in language subgroups, and thus more data are necessary to confirm these preliminary findings. Continued research is required to determine the causes of differences in knowledge acquisition between English- and non–English-speaking patients in the ED. One possibility is that language barriers and lack of translation services lead to differences in patients’ understanding of diagnosis and treatments.43-45 Spanish language proficiency was not measured among the providers who believed their skills were adequate to educate patients about intravenous contrast. If these providers were not effective communicators, this may in part explain why non–English-speaking patients achieved limited understanding of intravenous contrast’s risks, benefits, and alternatives during their ED visit. In the future, we plan to produce intravenous contrast informational videos in additional languages, perform a qualitative analysis of intravenous contrast knowledge to test the reliability of our quantitative measure, and determine the costeffectiveness of video-assisted informed consent for intravenous contrast administration. We also plan to investigate the applicability of educational videos to other ED invasive procedures for which informed consent is required. In Retrospect We would like to have had a validated scale to measure intravenous contrast knowledge. To reduce bias from physician Volume , . : February
Informed Consent for IV Contrast Administration behavior, we could have devised a mechanism to blind the physicians. Using a stratified sampling strategy would have assisted in recruiting non-Latino white patients. Measuring patient competency to consent for intravenous contrast, measuring provider Spanish-language proficiency, and tracking patient receiving of sedating medications would have improved our understanding of the reasons for low mean knowledge scores. In summary, the use of Spanish and English educational videos was superior to routine informed consent in educating patients about the risks, benefits, and alternatives to intravenous contrast administration in the ED. Videoassisted informed consent may also increase patient satisfaction with the informed consent process and the understanding of intravenous contrast in non–Englishspeaking patients, but future studies are necessary to confirm the results of these preliminary findings. Video-assisted informed consent does not seem to discourage patients from signing consent to receive intravenous contrast for CT. Supervising editor: Robert K. Knopp, MD Author contributions: EAC, PG, and SPW conceived the study and designed the trial. EAC, RM, and SPW received research funding. All authors supervised the conduct of the trial and data collection. EAC managed the data, including quality control. EAC, CO, and SPW produced the Spanish and English intravenous contrast video. RM provided ethical consultation and feedback on study design and protocol implementation. EAC and SPW provided statistical expertise and analyzed the data. EAC drafted the article, and all authors contributed substantially to its revision. EAC takes responsibility for the paper as a whole. Funding and support: Ethan Cowan, MD, MS, is funded by an F32 Ruth L. Kirschstein National Research Service Award from the National Institute of General Medical Sciences (NIGMS 1 F 32 GM075589-01). Publication dates: Received for publication April 13, 2006. Revisions received June 30, 2006. Accepted for publication July 24, 2006. Available online September 28, 2006. Reprints not available from the authors. Address for correspondence: Ethan A. Cowan, MD, MS, Jacobi Medical Center, Albert Einstein College of Medicine, 1400 Pelham Parkway South, Room 1W20, Bronx, NY 10461; 718918-3050, fax 718-918-7459; E-mail [email protected].
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Informed Consent for IV Contrast Administration 4. Spring DB, Akin JR, Margulis AR. Informed consent for intravenous contrast-enhanced radiography: a national survey of practice and opinion. Radiology. 1984;152:609-613. 5. Lambe HA, Hopper KD, Matthews YL. Use of informed consent for ionic and nonionic contrast media. Radiology. 1992;184: 145-148. 6. Hopper KD, Tyler HN Jr. Informed consent for intravascular administration of contrast material: how much is enough? Radiology. 1989;171:509-514. 7. Hopper KD, Lambe HA, Shirk SJ. Readability of informed consent forms for use with iodinated contrast media. Radiology. 1993; 187:279-283. 8. Hopper KD, Houts PS, McCauslin MA, et al. Patients’ attitudes toward informed consent for intravenous contrast media. Invest Radiol. 1992;27:362-366. 9. Spring DB, Winfield AC, Friedland GW, et al. Written informed consent for i.v. contrast-enhanced radiography: patients’ attitudes and common limitations. AJR Am J Roentgenol. 1988;151: 1243-1245. 10. Applebaum P, Lidz CW, Meisel A. Informed Consent Legal Theory and Clinical Practice. New York, NY: Oxford University Press; 1987. 11. Barber B. Informed Consent in Medical Therapy and Research. New Brunswick, NJ: Rutgers University Press; 1980. 12. Gagliano ME. A literature review on the efficacy of video in patient education. J Med Educ. 1988;63:785-792. 13. Fisher L, Rowley PT, Lipkin M Jr. Genetic counseling for betathalassemia trait following health screening in a health maintenance organization: comparison of programmed and conventional counseling. Am J Hum Genet. 1981;33:987-994. 14. Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointest Endosc. 1994;40:271-276. 15. Meade CD, McKinney WP, Barnas GP. Educating patients with limited literacy skills: the effectiveness of printed and videotaped materials about colon cancer. Am J Public Health. 1994;84: 119-121. 16. Hopper KD, Zajdel M, Hulse SF, et al. Interactive method of informing patients of the risks of intravenous contrast media. Radiology. 1994;192:67-71. 17. Barrett BJ, Parfrey PS, McDonald JR, et al. Nonionic lowosmolality versus ionic high-osmolality contrast material for intravenous use in patients perceived to be at high risk: randomized trial. Radiology. 1992;183:105-110. 18. Bettmann MA, Heeren T, Greenfield A, et al. Adverse events with radiographic contrast agents: results of the SCVIR Contrast Agent Registry. Radiology. 1997;203:611-620. 19. Barrett BJ, Carlisle EJ. Meta-analysis of the relative nephrotoxicity of high- and low-osmolality iodinated contrast media. Radiology. 1993;188:171-178. 20. Moore RD, Steinberg EP, Powe NR, et al. Frequency and determinants of adverse reactions induced by high-osmolality contrast media. Radiology. 1989;170:727-732. 21. Cochran ST, Bomyea K, Sayre JW. Trends in adverse events after IV administration of contrast media. AJR Am J Roentgenol. 2001; 176:1385-1388. 22. Katayama H, Yamaguchi K, Kozuka T, et al. Adverse reactions to ionic and nonionic contrast media: a report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990; 175:621-628. 23. Wears RL. Advanced statistics: statistical methods for analyzing cluster and cluster-randomized data. Acad Emerg Med. 2002;9: 330-341. 24. Williams BF, French JK, White HD. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent
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Appendix E1. Recruiting Script: Post-consent Measure. Hello, my name is ____________________ and I am a research assistant working with the emergency physicians today. Your doctor has recommended that you get a Computed Tomography (CT) scan with Intravenous (IV) contrast to help figure out what is wrong with you today. We are studying how to improve the way doctors get permission to perform this test. Normally, a doctor would come to your bedside and tell you about the risks, benefits, and alternatives of IV contrast, and then ask you to sign a consent form. We are studying whether a video can improve your understanding of the same information. If you agree to participate in the study you will be assigned by chance (like flipping a coin) to one of two groups.
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The first group will hear information about the risks, benefits, and alternatives of IV contrast from their doctor. The second group will hear about the risks, benefits, and alternatives of IV contrast from the videotape. After watching the videotape your doctor will return to your bedside and answer any questions that you have. Both groups will answer a few questions about themselves and then take a short 10-question quiz about the risks, benefits, and alternatives of IV contrast. We will not collect any information that can be used to identify you. Neither group will have their care for their emergency problem affected in any way. Your care will not change if you choose not to participate. If you have any questions I’d be happy to answer them. Would you like to participate? If yes, RANDOMIZE patient If no, GO TO REFUSAL FORM
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Appendix E2. Spanish and English video consenting for IV contrast administration in the emergency department: post consent measure. 1. What is the chance of the IV contrast dye causing serious side effects like heart problems? a. None b. Common (1 person in 10) c. Rare (1 person in 20,000) d. Extremely rare (1 person in a million) 2. Which of the following is a minor side effect to the IV contrast dye? a. Death b. Kidney damage c. Rash d. Heart Attack 3. Which of the following is a more serious side effect to the IV contrast dye? a. Rash b. Cough c. Fever d. Kidney damage 4. Which of the following make you more likely to have a side effect from the IV contrast dye? a. Recent surgery b. Eating before the test c. Previous side effect to contrast dye d. Fever 5. Which of the following is one of the most common side effects of IV contrast dye? a. Death b. Nausea c. Kidney Damage d. Heart attack 6. Which medical problem can increase the chance of having kidney damage after getting IV contrast dye? a. Prior kidney disease b. High blood pressure c. Arthritis d. Thyroid disease 7. How long do you need to worry about side effects from the IV contrast dye? a. Always b. 7 days c. 6 hours d. 5-10 minutes 8. What is the benefit of getting IV contrast dye for your CAT scan? a. Helps X-rays get into your body b. Makes your pain go away c. Makes it easier for doctors to find out what is wrong with you d. Keeps you calm and relaxed for the CAT scan 9. Minor side effects to the IV contrast dye require? a. Medications b. Admission to the hospital c. Kidney transplant d. No treatment is required 10. By signing the informed consent form, you are telling your doctor that you understand________________? a. the risks of getting IV contrast b. the benefits of getting IV contrast c. the alternatives of getting IV contrast d. All of the above 11. Please rate your overall satisfaction with the way you were informed about IV contrast dye. a. Poor b. Fair c. Good d. Excellent
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Figure E1. Test question performance by mode of consent. The x axis represents the percentage of participants who answered the question correctly (0% to 100%). The y axis represents the question number.
Figure E3. Test question performance stratified by language: Video group. The x axis represents the percentage of participants who answered the question correctly (0% to 100%). The y axis represents the question number.
Figure E2. The question performance stratified by language: Physician group. The x axis represents the percentage of participants who answered the question correctly (0% to 100%). The y axis represents the question number. Volume 49, . : February
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