- Email: [email protected]
Pediatric Resident Preparedness and Educational Experiences With Informed Consent
Accepted Manuscript Pediatric resident preparedness and educational experiences with informed consent Andrew S. Nickels, MD, Jon C. Tilburt, MD, Lainie Friedman Ross, MD, PhD PII:
S1876-2859(15)00309-5
DOI:
10.1016/j.acap.2015.10.001
Reference:
ACAP 768
To appear in:
Academic Pediatrics
Received Date: 23 April 2015 Revised Date:
2 October 2015
Accepted Date: 5 October 2015
Please cite this article as: Nickels AS, Tilburt JC, Ross LF, Pediatric resident preparedness and educational experiences with informed consent, Academic Pediatrics (2015), doi: 10.1016/ j.acap.2015.10.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: Pediatric resident preparedness and educational experiences with informed consent
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Authors: Andrew S. Nickels, MDa,b,c,1 a Department of Medicine, Vanderbilt University Medical Center, Nasvhille, TN b Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN c Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, TN 2611 West End Ave, Suite 200, Nashville, TN 37203 Email: [email protected]
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Jon C. Tilburt, MDd,e. f d Division of General Internal Medicine, Department of Medicine, Mayo Clinic Rochester, MN, e Division of Healthcare Policy and Research, Department of Health Services Research , Mayo Clinic Rochester, MN f Program for Bioethics, Mayo Clinic, Rochester, MN 200 First St. SW Rochester MN 55905 Email: [email protected]
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Lainie Friedman Ross, MD, PhDg,h,i,j g Department of Pediatrics University of Chicago, Chicago, IL h Department of Medicine University of Chicago i MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL j Department of Surgery University of Chicago 5841 S. Maryland Avenue, MC 6082 Chicago, IL 60637 Email: [email protected]
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Corresponding Author: Andrew S Nickels, MD 2611 West End Ave Suite 200 Nashville, TN 37203 Phone: 865-607-3087 Fax: 615-936-2757 Email: [email protected]
Keywords: Informed consent, graduate medical education, ethics, pediatrics Running title: Pediatric residents and informed consent Abstract word count: 250 Manuscript word count: 3195
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Number of Tables: 4 Number of Figures: 1
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Funding source: MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL provided incentives for survey participants. The MacLean Center was not involved in study design, data collection, analysis, or interpretation of the results. Conflict of Interest/Financial Disclosure: All authors have no relevant financial conflicts to this study or preparation of this manuscript. There was no industry funding for this study.
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Abbreviations: AAP = American Academy of Pediatrics, ACGME= Accreditation Council of Graduate Medical Education, EPA = Entrustable Professional Activities; IC = informed consent; PGY= post graduate year, SD = standard deviation, SMSRF= Section on Medical Students, Residents, and Fellows,
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Abstract:
Objectives: Informed consent is an essential component of optimal patient care. Scant data exist
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about pediatric residents’ experiences, comfort level, and educational exposure to informed consent discussions.
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Methods: Electronic survey of a random selection of members of the American Academy of Pediatrics Section for Medical Students, Residents, and Fellows regarding consent practices and
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processes for five commonly encountered pediatric procedures/situations: lumbar puncture, neonatal central line, pediatric sedation, intubation, and administration of blood products. Results: Overall response rate was 34.7% (1071 participants/3084 invited). Responses from active categorical pediatric residents (n=622 respondents) were analyzed. Almost all respondents
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(99%) endorsed the importance of informed consent for best patient care. Observation was the most frequently reported educational modality. Over 90% had obtained consent for lumbar puncture and blood products but only 27.6% for intubation. Between 9 -31% of respondents
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reported obtaining consent for specific procedures in which they were not expected to actively participate. Depending on the procedure, a variable number of respondents reported not feeling
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prepared to discuss the benefits (1- 23%) or risks (2 -31%) of these procedures with patients and/or parents. Respondents felt significantly less prepared to discuss risks (p < 0.05 for each procedure).
Conclusion: A significant percentage of respondents reported not feeling comfortable with discussing key components of informed consent. A minority of respondents reported being engaged in obtaining consent for procedures in which they are not expected to actively
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participate. Best practices for resident involvement in informed consent discussions need to be
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defined and incorporated into resident education.
What’s New: Informed consent is frequently obtained by pediatric residents, yet a significant percentage report not feeling prepared to discuss risks and benefits and also report obtaining
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consent for procedures in which they are not expected to actively participate.
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Introduction: Informed consent is the process by which a provider discusses the indications, benefits, risks, and alternatives of a specific proposed action with a patient or patient’s surrogate.1 Ideally,
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in the clinical context, informed consent is part of an ongoing shared decision-making process that starts when a procedure is believed to be indicated and continues until the procedure is completed.2
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Graduate medical education is actively evolving.3,4 During the 1990s, the Accreditation
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Council for Graduate Medical Education (ACGME) formally identified six core competencies: patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and system based practice.5 New educational frameworks for trainee evaluation and education have been introduced recently including the “Entrustable Professional Activities (EPAs)” in primary medical education and the “Next Accreditation
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System/Milestones” for graduate medical education.3,4,6-9 Both new systems directly address informed consent discussions as an important skill for trainees to master.10,11
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Given the importance of informed consent in patient care and the evolving landscape of medical education, we elected to study informed consent within the context of pediatric graduate
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medical education. We designed a survey to investigate in-training categorical pediatric residents’ perceptions about and experiences with the informed consent process. There were four main areas of interest: 1) experiences with obtaining informed consent for common procedures, 2) comfort level/feelings of preparedness with different aspects of informed consent discussions, 3) beliefs about the importance of informed consent, and 4) educational exposure to different methods used to teach informed consent. Methods:
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A random selection of members of the American Academy of Pediatrics (AAP) Section on Medical Students, Residents, and Fellows (SMSRF) with active email accounts were invited to participate in an on-line survey using SurveyMonkey (www.surveymonkey.com, Palo Alto,
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CA). Questions focused on four areas related to informed consent: experience, comfort level, education, and perceived importance. For items inquiring about experience and comfort level, five common clinical procedures were used throughout the survey: 1) lumbar puncture; 2)
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neonatal central line placement; 3) pediatric sedation; 4) intubation; and 5) administration of
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blood products.
Participants’ experiences with obtaining informed consent were gauged using three survey items. First, participants were asked “At your institution, do you get specific informed consent for the following procedures…” with each of the procedures of interest following. Response categories was “Yes”, “No” or “Not Sure”. Second, participants were asked: “How
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often have you been responsible for obtaining specific informed consent for the following specific procedures?” Response categories for this question were: Once, 1-10 times, 10-25 times, >25 times, Never, and Does Not Apply. Third, participants were asked “Have you ever obtained
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consent for procedures in which you were not expected to actively participate?” with response
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categories of “Yes”, “No” or “Not Sure” for each of the procedures/situations of interest. Respondents’ comfort level with the essential components of informed consent
discussions was addressed by asking the extent to which they agreed or disagreed with the following statements: “I feel prepared to adequately answer patient/parental question regarding the benefits of” [each of the five procedures/situations of interest]. The same question was repeated for risks. General attitude regarding the importance of informed consent and perceived need for further education were explored by asking respondents their level of agreement or
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disagreement with the following statements: (1) Informed consent is important for providing the best patient care, (2) informed consent is important to protect physician liability, (3) I need more education and training in how to obtain a valid informed consent, and (4) I feel comfortable
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responding to parental concerns and refusal (at least initially) of the clinically indicated
procedure . The response categories for these agree/disagree questions were a four point Likert scale (completely agree, somewhat agree, somewhat disagree, and completely disagree). The
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four point scale eliminates the neutral mid-point of a five point Likert scale, compelling
respondents to express an opinion and has previously been used in similar survey studies
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regarding graduate medical education. 12,13
Respondents’ perception of the frequency at which alternatives were being offered for each procedure was explored by asking: “To what extent are patients/parents offered alternatives
Sometimes, Rarely, Never.
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to [the specific procedure].” Respondents could choose one of the following responses: Always,
To understand the educational experience of pediatric residents, respondents were asked
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which format(s) had been used to teach them how to discuss procedures with patients and parents and obtain informed consent: lectures on the topic during medical school, lectures on the topic
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during residency, self-directed learning (i.e. reading), actively taught by fellows, actively taught by peers (i.e. residents), actively taught by attending, observed peers (i.e. residents), observed fellows, observed attending, or not having received any of these regarding informed consent. Demographic data were collected regarding age, gender, year in training, residency type
(categorical vs combined training), and residency setting (academic vs community). The survey instrument was presented at a research workshop at the MacLean Center for Clinical Medical Ethics where a convenience sample of approximately 20 residents, attending physicians, and
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ethics fellows piloted the survey and discussed each question for clarity and content/meaning. The questions and survey introduction were modified based on feedback provided. Average time of completion of the survey was between 5-10 minutes. A complete survey is available from the
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corresponding author.
Enrollment in this study occurred from January 1, 2013 to April 30, 2013. Recruitment was accomplished via direct e-mail invitation. After the initial invitation, four further email
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invitations were sent for recruitment. Each invitation email introduced the potential recipient to
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the lead investigator (AN), outlined the general research goal (investigating pediatric resident’s experience with informed consent during training), and summarized the participating’s commitment (length of survey and time commitment). The invitation also explained the voluntary nature of the survey, the IRB approved status of the study, and that written informed consent had been waived for this low risk study. As an incentive, ten $25 Amazon.com
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(Amazon.com, Inc, Seattle, WA) gift cards and two iPads (Apple, Inc, Cupertino, CA) were raffled off to participants who completed the survey and elected to provide their email address.
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All data were de-identified prior to analysis.
Microsoft Excel version 14 (Microsoft Corporation, Redmond, WA) and JMP version
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10.0 (SAS Institute Inc, Cary, NC) were used for quantitative statistical analysis. For percentage reporting, we excluded responses that were left blank by the respondent. For analysis purposes, completely and somewhat agree were combined into “agree” and completely and somewhat disagree were combined into “disagree”. The ordinal response categories regarding frequency of obtaining consent for each procedure were converted into a nominal data set “Never” versus “one or more times”. Responses were subsequently stratified by year in training, interns (postgraduate year 1) versus upper level resident (post-graduate years 2 and 3) in order to better
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understand how stage in training effects reported experience. Chi-square and student t-tests were used with significance set at P < 0.05.
participation in this survey implied consent. Results
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The institutional review board at the University of Chicago granted exempt status and
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A total of 3097 members of the AAP SMSRF were invited to enroll in an online survey. Thirteen had opted out of invitations from surveymonkey.com previously and did not receive the
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invitation. From the 3084 potential respondents, 1071 (998 completed and 73 partially completed) surveys were returned for an overall response rate of 34.7%. Six hundred and twenty-two respondents self-identified as categorical pediatric residents within their first 3 years of training (post-graduate years 1, 2 and 3) and were included in the study population for this
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analysis.
Demographics and training characteristics of the respondents are shown in Table 1. Respondents were predominately female (72.9%), United States medical graduates (79.5%), and
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held MD degree (87.2%). According to the ACGME 2012-2013 Data Resource Book, 73.4% (5802/7910) of pediatric residents were female and 89.2% (7736/8669) held an MD versus
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10.8% (933/8669) held a DO degree. 14 There was no statistical difference between the study population and the national ACGME data for gender (P=0.86) or degree type (P=0.46). For two of the five common procedures (lumbar puncture and the administration of
blood), over 90% of respondents reported that, at their institution, informed consent was specifically obtained (Table 2). Specific informed consent for intubation was least frequently reported as being obtained at the respondents’ institution at 41.1%. Similarly, when asked if the
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respondents themselves had obtained consent for the specific procedure in question, over 90% reported having obtained consent for a lumbar puncture and blood product administration at least once. Intubation was the procedure the least amount of respondents reported ever obtaining
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consent (27.6%). Notably, approximately one-fifth of respondents reported obtaining consent for three of the procedures even though they were “not expected to actively participate” in the
procedure: neonatal central line placement (23.2%), pediatric sedation (22.6%), and lumbar
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puncture (19.3%). Respondents overwhelmingly agreed with statements regarding the
importance of informed consent discussions. Ninety-nine percent (614/620) completely or
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somewhat agreed that “informed consent is important for providing best patient care” and 98.9% (614/621) agreed that “informed consent is important to protect physicians from liability”. Overall, most (88.3% or 546/618) of the residents stated that they “feel comfortable responding to parental concerns and refusals”. Importantly, the rate of reporting feeling
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“comfortable responding to parental concerns and refusals” increased with training with 83.5% (172/206) of interns stating they felt prepared versus 90.8% (374/412) of upper level resident (P=0.01). However, a minority of respondents reported not feeling prepared to adequately
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answer patient /parent questions regarding the benefit and risks of the procedures/situations in
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question. Residents reported that they felt least prepared to discuss the benefits and risks of pediatric sedation (20.6% and 31.0%, respectively). For all procedures, respondents were more likely to report not feeling prepared to answer questions about risks compared to benefits (Table 3).
According to our respondents, whether patients and parents were offered alternatives depended on the procedure in question. For pediatric sedation, 27.7% of respondents reported that alternatives were never or rarely offered whereas 59.6% reported lack of alternatives being
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offered for intubation. The extent to which respondents perceived that patients and parents were being offered alternatives for the five common pediatric procedures is shown in Table 4.
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Respondents reported learning about how to conduct an informed consent discussion from an average of 4.3 (SD ±2.0) different educational modalities. Figure 1 shows the percent of respondents who reported learning about how to conduct an informed consent discussion from each different modality asked in the survey. The most frequent modalities reported were
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observing peers (66.7%) and being actively taught by peers (61.9%). Only 26.0% reported
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having lectures on the topic during residency teaching. When asked if they needed more education and training in how to obtain a valid informed consent, 77.6% (546/618) of respondents either completely or somewhat agreed. Importantly, more interns respondents thought they needed more education than did upper level resident respondents (86.1% versus
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73.3%).
In comparing the survey responses between interns versus upper level residents, we found many differences in their experience and in the preparedness to discuss risks and benefits.
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Table 5 summarizes these results. Upper level residents reported having more experience with obtaining informed consent, were more likely to report having obtained consent for procedures
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for which they were not expected to actively participate (except for pediatric sedation), and were more likely to agree with the statements that they “feel prepared to adequately answer patient/parental questions regarding the” benefits and risks for all of the procedures in question.
Discussion: In pediatrics, there is emerging interest in improving shared decision making in clinical
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practice.15 Training pediatric residents to engage patients and their parents in informed consent discussions is a critical component of ensuring effective shared decision-making.2,16 This exploratory study provides a novel cross sectional assessment of active US pediatric residents’
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experiences, comfort level, beliefs, and educational exposure surrounding informed consent. Both undergraduate and graduate medical education programs have introduced new
frameworks for trainee evaluation and education. At the undergraduate level, the AAMC has
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developed professional tasks that medical student should be able to perform prior to initiating
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residency, known as EPAs.8,10,17 These are intended to help translate the ACGME core competencies into clinical practice. The ability to obtain informed consent is amongst the EPAs and embodies a number of the core competencies such as patient care, professionalism, interpersonal and communication skills, and systems based practice.10,18 At the graduate medical education level, the ACGME introduced the “Next Accreditation System” that has advanced
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graduate medical education from competency-based to the “Milestones”-based system of educational development.19,20 The Pediatric Milestones includes learning how to obtain informed
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consent as an important part of patient care and education.11 Entrustable Professional Activity 11, “Obtain informed consent for test and/or
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procedures”, states that “From day one residents may be in a position to obtain informed consent for interventions, tests, or procedures they order or perform”, but then acknowledges that “residents on day one should not be expected to obtain informed consent for procedures or tests for which they do not know the indications, contraindications, alternatives, risks, and benefits.”10 This study confirms that pediatric residents commonly obtain informed consent and perceive it as important for patient care, but that they need to be educated to perform it correctly. Our findings that interns reported feeling less prepared to answer questions about risks and benefits
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than upper level residents for all procedures underscore a concern with the common practice of having trainees obtain consent for specialty specific procedures without supervision, particularly
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early in their training. Providers who lead consent discussions should be prepared to discuss the risks, benefits, and alternatives of a proposed procedure. We found that it is not only interns who reported not feeling adequately prepared. For each procedure/situation except lumbar puncture, we found that
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some upper level resident respondents also reported that they did not feel prepared to discuss the
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benefits and risks. More concerning, we found that respondents of all levels of training were more likely to report being more comfortable with discussing the benefits of each procedure than the risks. How choices are framed is an important part of decision making and being more prepared to discuss the benefits than the risks may alter the conversation.21-23 Additionally, providing alternatives is a critical component of the informed consent
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discussion, even in the face of a disease with high morbidity and mortality.16,24 For each procedure, over one-quarter of respondents stated that parents were rarely or never told about
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alternatives. If the provider is not fully aware of the alternatives, or not comfortable discussing them, patients and their surrogates will not be able to fully engage in a robust shared decision
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making process.
Beyond taking the pulse of informed consent activity amongst pediatric residents, this
study also found that pediatric residents are being asked to obtain consent despite not always being expected to be actively involved in the procedure. Depending on the procedure, up to 20% of responding pediatric residents reported obtaining consent for procedures in which they were not expected to actively participate. This practice is contrary to the guidelines provided by the Pediatric Milestone Project which state: “informed consent elements may be known but the
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actual informed consent must take place by the primary operator for the procedure.” 25 Our respondents reported that they were mainly taught how to engage in informed
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consent discussions through peer learning (observation and actively teaching). This finding is consistent with a previous survey study that showed over half of recently graduated pediatric residents described their ethics/professionalism curriculum as “ad hoc”.12 The low percentage of respondents who reported having had lectures during residency training on how to obtain
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informed consent further supports this claim. This contrasts with a previous study of pediatric
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residency program directors, 80% of whom reported that their program’s ethics curriculum was taught in a lecture format.26 While the question posed to the pediatric residency program directors was not specific to instruction on how residents are taught to engage in an informed consent discussion, the difference between the program directors’ report and the residents’ recall in the current study is notable and deserves greater study. Research is needed to investigate best
consent discussions.
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educational practices for teaching pediatric residents the skills involved in engaging in informed
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This study has several limitations. First is the potential concern for nonresponse bias. While the response rate for this survey was modest (34.7%), it is consistent with other physician
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surveys.27-29 Several factors reduce the concern for bias. According to the AAP, 99% of residency programs sponsor membership in the AAP for their residents and residents are automatically enrolled into the SMSRF section, reducing the risk of selection bias.30 Importantly, the demographics of our respondents match the demographics of the ACGME pediatric resident population in terms of gender and type of graduate degree.14,30 A second limitation relates to the inherent weakness of survey research for exploring topics such as ethics. Using a survey tool may lead to emphasizing the operational notion of “obtaining consent”, putting more importance
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on the medico-legal role of documenting that permission was obtained rather than on the aspirational concept of engaging in a bi-directional discussion of shared decision-making that culminates with an informed patient or surrogate authorizing consent.16 It is possible, then, that
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residents interpreted informed consent to require a written consent document and as such
respondents may have underestimated the procurement of consent at their institution (Table 2, question 1). A third limitation is the potential ambiguity of some of the survey items. For
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example, we asked if respondents obtained consent for procedures in which they were “not
expected to actively participate”. The intention of the phrase “actively participate” was to denote
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a situation in which the resident felt that they obtained consent for a procedure which they were not expected to be present or, if present, perceived they were not meaningfully engaged. A fourth limitation is that our study focused on resident perception of parental interactions surrounding the informed consent process. We did not address the issue of assent for children who, while
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lacking full decisional capacity, may be old enough to voice preferences and interests. Future studies exploring resident training addressing the role of assent in the pediatric informed consent process would be of value.
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Despite these limitations, we believe that our findings are useful for understanding the
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perception of current trainees regarding current educational efforts and opportunities to engage meaningfully in the informed consent process. Qualitative research studying how to best teach engagement in informed consent and shared decision making more broadly is needed and should also involve other stakeholders, including parents and children. Observing and analyzing actual consent discussions for these procedures/situations may also help identify best practices.
Conclusion
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Primary medical education on how to engage in informed consent discussions should focus on common procedures/situations. Residency programs should be aware that obtaining informed consent for specialty specific procedures may not be within the skill set of incoming
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interns. The responsibility for obtaining informed consent should only occur after the resident has demonstrated an understanding of all the key components of the procedure (i.e. risks,
benefits, and alternatives). Special attention should be given to improving residents’ comfort
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level with discussing risks of procedures. Furthermore, residency programs should be aware that trainees may be obtaining consent for procedures in which they are not expected to actively
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participate which is inconsistent with current educational recommendations.
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Figure Legend:
Figure 1. Percent of 622 US pediatric residents reporting having received education regarding
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informed consent from each of several educational modalities.
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References: 1. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 2013.
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2. Milestones. Accerditation Council for Graduate Medical Education.
http://www.acgme.org/acgmeweb/tabid/430/ProgramandInstitutionalAccreditation/NextA ccreditationSystem/Milestones.aspx Accessed August 24, 2015
accreditation system". Acad Med. 2014; 89:27-9.
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3. Nasca TJ, Weiss KB, Bagian JP, Brigham TP. The accreditation system after the "next
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4. Teherani A, Chen HC. The next steps in competency-based medical education: milestones, entrustable professional activities and observable practice activities. J Gen Intern Med. 2014; 29:1090-2.
5. Swing SR. The ACGME outcome project: retrospective and prospective. Med Teach.
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6. Philibert I, Nasca TJ. The next accreditation system: stakeholder expectations and dialogue with the community. J Grad Med Educ. 2012;4:276-8.
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7. Rushton JL, Hicks PJ, Carraccio CL. The next phase of pediatric residency education: the partnership of the Milestones Project. Acad Pediatr. 2010;10:91-2.
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8. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013;5:157-8.
9. Aschenbrener CA. Creating a continuum of learning. Acad Pediatr. 2014; 14:S4-S5. 10. Core Entrustable Professional Activities for Entering Residency: Faculty and Learners Guide. Association of American Medical Colleges. Published 2014.
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https://members.aamc.org/eweb/upload/Core%20EPA%20Faculty%20and%20Learner% 20Guide.pdf Accessed August 24, 2015.
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11. The Pediatrics Milestone Working Group. The Pediatrics Milestone Project.
http://acgme.org/acgmeweb/Portals/0/PDFs/Milestones/320_PedsMilestonesProject.pdf Accessed August 24, 2015.
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12. Cook AF, Sobotka SA, Ross LF. Teaching and assessment of ethics and professionalism: a survey of pediatric program directors. Acad Pediatr. 2013;13:570-576.
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13. Waz WR, Henkind J. The adequacy of medical ethics education in a pediatrics training program. Acad Med. 1995;70:1041-3.
14. Accrediation Council for Graduate Medical Education. ACGME Data Resource Book Academic Year 2012-2013. Accrediation Council for Graduate Medical Education.
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Published 2013.
http://www.acgme.org/acgmeweb/tabid/259/Publications/GraduateMedicalEducationData ResourceBook.aspx. Accessed August 24, 2015.
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15. Wyatt KD, List B, Brinkman WB, et al. Shared Decision Making in Pediatrics: A Systematic Review and Meta-analysis. Acad Pediatr. E-pub ahead of print. 2015.
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16. Paterick TJ, Carson GV, Allen MC, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc.2008;83:313-319.
17. Core Entrustable Professional Activities for Entering Residency: Curriculum Developers' Guide. Association of American Medical Colleges. Published 2014. https://members.aamc.org/eweb/upload/Core%20EPA%20Curriculum%20Dev%20Guide .pdf Accessed August 24, 2015.
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18. Ludwig S. Domain of competence: Professionalism. Acad Pediatr. 2014; 14:S66-S69. 19. Nasca TJ, Philibert I, Brigham T, Flynn TC. The next GME accreditation system-rationale and benefits. N Engl J Med. 2012;366:1051-6.
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20. Schumacher DJ, Spector ND, Calaman S, et al. Putting the pediatrics milestones into practice: a consensus roadmap and resource analysis. Pediatrics. 2014;133:898-906. 21. Tversky A, Kahneman D. The framing of decisions and the psychology of choice.
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22. Perneger TV, Agoritsas T. Doctors and patients' susceptibility to framing bias: a
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about complementary and alternative medicine therapies. Pediatrics. 2011;128:S187-192. 25. Accrediation Council of Graduate Medical Education. ACGME Institutional Requirements 2007. Accrediation Council of Graduate Medical Educaiton. Published
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26. Lang CW, Smith PJ, Ross LF. Ethics and professionalism in the pediatric curriculum: a survey of pediatric program directors. Pediatrics. 2009;124:1143-1151.
27. Thorpe C, Ryan B, McLean SL, et al. How to obtain excellent response rates when surveying physicians. Fam Pract. 2009;26:65-68.
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29. Kellerman SE, Herold J. Physician response to surveys. A review of the literature. Am J Prev Med. 2001;20:61-7. 30. Lucke A. Welcome & Letter From Chair. Resident and Fellowship Trainees American
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Academy of Pediatrics. http://www2.aap.org/sections/ypn/r/. Accessed August 24, 2015.
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Table 1. Demographics and training characteristics of 622 responding United States pediatric residents % (n) Female
72.9 (431)
N* = 591
Male
27.1 (160)
Degree Type
MD
87.2 (540)
N* = 619
DO
9.4 (58)
Other
3.4 (21)
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United States
79.5 (492)
International
17.1 (106)
Other
3.4 (21)
Year in Training**
PGY-1
33.4 (208)
N = 622
PGY-2
33.4 (208)
PGY-3
33.1 (206)
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Origin of Degree N* = 568
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Gender
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Mean age N* = 594 (Years [SD])
Abbreviations: PGY = post-graduate year * N varies due to partial non-responders
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Demographic trait
**Percentages do not add up to 100% due to rounding.
29.2 [2.7]
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Table 2. Experience with informed consent for five common procedures/situations among 622 US pediatric residents.
Puncture
Central Line
% (n/N*)
% (n/N*)
93.7
65.3
(582/621)
(404/619)
92.4
Intubation
Products
% (n/N*)
% (n/N*)
% (n/N*)
85.0
41.1
96.3
(527/620)
(256/618)
(596/619)
51.9
52.3
27.6
90.6
(574/621)
(322/621)
(324/619)
(170/616)
(561/619)
19.3
23.2
22.6
9.1
31.2
(120/622)
(144/621)
(140/619)
(56/618)
(194/622)
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obtaining informed consent one or more times for…
were not expected to actively participate…
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*N, Total number of responses. Values vary due to partial non-responders
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Blood
Sedation
their institution gets specific informed consent for…
obtaining consent for procedures in which they
Pediatric
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Neonatal
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Residents reporting….
Lumbar
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Table 3. Self-reported perception of adequate preparation for answering patient/parental questions regarding the benefits and risks of five common procedures/situations
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Respondents disagreeing with the following statements: “I feel prepared to adequately answer patient/parental questions regarding…” % (n)
1.9 (12)
<0.01
13.0 (80)
18.8 (116)
<0.01
20.6 (127)
31.0 (191)
<0.01
5.9 (36)
13.1 (80)
<0.01
2.6 (16)
5.2 (32)
<0.01
0.5 (3)
Neonatal Central Lines (N*=616) Pediatric Sedation (N*=617) Intubation (N*=610)
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Blood Products (N*=616)
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N varies due to partial non-responders
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*
P Value
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Lumbar Puncture (N*=619)
…the risk of…
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…the benefits of...
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Table 4. Self-reported frequency of alternatives being offered to patients/parents for five common procedures/situations among 622 US pediatric residents.
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Extent to which patients/parents are offered alternative to the procedures listed
Neonatal Central Lines**
603
Pediatric Sedation
606
Intubation**
Never
% (n)
% (n)
% (n)
% (n)
36.3 (223)
4.7 (29)
25.7 (158)
33.2 (204)
18.9 (114)
30.3 (183)
40.1 (242)
10.6 (64)
27.6 (167)
44.7 (271)
24.4 (148)
3.3 (20)
602
12.5 (75)
27.9 (168)
44.9 (270)
14.8 (89)
610
23.8 (145)
39.0 (238)
33.6 (205)
3.6 (22)
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Blood Products
Rarely
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614
Sometimes
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Lumbar Puncture**
Always
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N*
* N varies due to partial non-responders.
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**Percentages do not add up to 100% due to rounding error.
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Table 5. Responses to key survey questions broken down by respondents by intern year 1 (post graduate year 1) compared to upper level residents (post-graduate years 2 and 3) Resident (PGY 2&3)
% (n/N*)
% (n/N*)
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Intern (PGY1) Residents reporting they have obtained specific informed consent for the following procedures… Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products
85.6 (178/208) 34.6 (72/208) 37.5 (78/208) 17.6 (36/205) 80.3 (167/208)
Residents reporting they have been responsible for obtaining specific informed consent for the following procedures… Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products Agree with statement "I feel prepared to adequately answer patient/parental questions regarding the benefits of…" Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products
P Value
<0.01 <0.01 <0.01 <0.01 <0.01
15.0 (31/207) 14.1 (29/206) 17.9 (37/207) 4.4 (9/205) 26.1 (54/207)
21.7 (89/411) 28.4 (115/405) 25.3 (103/407) 11.8 (47/400) 34.0 (140/412)
0.05 <0.01 0.42 <0.01 0.05
98.6 (205/208) 76.7 (158/206) 73.9 (153/207) 88.3 (182/206) 93.7 (194/207)
100 (412/412) 92.2 (379/411) 82.3 (339/412) 96.6 (394/408) 93.7 (409/412)
0.04 <0.01 0.02 <0.01 <0.01
Agree with statement "I feel prepared to adequately answer patient/parental questions regarding the risks of…" Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products
95.7 (199/208) 69.7 (145/208) 59.4 (123/207) 77.2 (159/206) 89.3 (184/206)
99.3 (408/411) 87.1 (357/410) 73.9 (303/410) 91.9 (374/407) 97.6 (401/411)
<0.01 <0.01 <0.01 <0.01 <0.01
Educational experience surrounding informed consent Average number of modalities reported Lectures on the topic during medical school Lectures on the topic during residency training Self-directed learning (i.e. reading) Actively taught by fellow Actively taught by peers (residents)
4.18 (3.93-4.44) 49.5 (103/208) 23.1 (48/208) 46.2 (96/208) 21.2 (44/208) 65.9 (137/208)
4.40 (4.22-4.58) 43.0 (178/414) 27.5 (114/414) 43.2 (179/414) 34.8 (144/414) 59.9 (248/414)
0.18 0.13 0.25 0.49 <0.01 0.16
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95.9 (396/413) 60.5 (250/413) 59.9 (246/411) 32.6 (134/411) 95.9 (394/411)
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55.3(229/414) 65.7 (272/414) 44.4 (184/414) 62.3 (258/414)
0.50 0.47 <0.01 0.12
3.4 (7/208)
2.7 (11/414)
0.62
99.5 (207/208 98.6 (205/208)
98.8 (407/412) 99.0 (409/413)
0.67 0.69
86.1 (179/208) 83.5 (172/206)
73.3 (302/412) 90.8 (374/412)
<0.01 0.01
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Agreed with the following statements Informed consent is important for the best patient care Informed consent is important to protect physicians from liability I need more education and training in how to obtain valid informed consent I feel comfortable responding to parental concerns and refusals
52.4 (109/208) 68.8 (143/208) 30.3 (63/208) 55.8 (116/208)
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Actively taught by attending Observed peers (residents) Observed fellows Observed attending I have not received any of the above training regarding informed consent
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* N varies due to partial non-responders. Abbreviations: IC = informed consent; n/N = responses/total number of responses; PGY Post Graduate Year
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S1876-2859(15)00309-5
DOI:
10.1016/j.acap.2015.10.001
Reference:
ACAP 768
To appear in:
Academic Pediatrics
Received Date: 23 April 2015 Revised Date:
2 October 2015
Accepted Date: 5 October 2015
Please cite this article as: Nickels AS, Tilburt JC, Ross LF, Pediatric resident preparedness and educational experiences with informed consent, Academic Pediatrics (2015), doi: 10.1016/ j.acap.2015.10.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: Pediatric resident preparedness and educational experiences with informed consent
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Authors: Andrew S. Nickels, MDa,b,c,1 a Department of Medicine, Vanderbilt University Medical Center, Nasvhille, TN b Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN c Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, TN 2611 West End Ave, Suite 200, Nashville, TN 37203 Email: [email protected]
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Jon C. Tilburt, MDd,e. f d Division of General Internal Medicine, Department of Medicine, Mayo Clinic Rochester, MN, e Division of Healthcare Policy and Research, Department of Health Services Research , Mayo Clinic Rochester, MN f Program for Bioethics, Mayo Clinic, Rochester, MN 200 First St. SW Rochester MN 55905 Email: [email protected]
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Lainie Friedman Ross, MD, PhDg,h,i,j g Department of Pediatrics University of Chicago, Chicago, IL h Department of Medicine University of Chicago i MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL j Department of Surgery University of Chicago 5841 S. Maryland Avenue, MC 6082 Chicago, IL 60637 Email: [email protected]
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Corresponding Author: Andrew S Nickels, MD 2611 West End Ave Suite 200 Nashville, TN 37203 Phone: 865-607-3087 Fax: 615-936-2757 Email: [email protected]
Keywords: Informed consent, graduate medical education, ethics, pediatrics Running title: Pediatric residents and informed consent Abstract word count: 250 Manuscript word count: 3195
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Number of Tables: 4 Number of Figures: 1
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Funding source: MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL provided incentives for survey participants. The MacLean Center was not involved in study design, data collection, analysis, or interpretation of the results. Conflict of Interest/Financial Disclosure: All authors have no relevant financial conflicts to this study or preparation of this manuscript. There was no industry funding for this study.
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Abbreviations: AAP = American Academy of Pediatrics, ACGME= Accreditation Council of Graduate Medical Education, EPA = Entrustable Professional Activities; IC = informed consent; PGY= post graduate year, SD = standard deviation, SMSRF= Section on Medical Students, Residents, and Fellows,
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Abstract:
Objectives: Informed consent is an essential component of optimal patient care. Scant data exist
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about pediatric residents’ experiences, comfort level, and educational exposure to informed consent discussions.
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Methods: Electronic survey of a random selection of members of the American Academy of Pediatrics Section for Medical Students, Residents, and Fellows regarding consent practices and
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processes for five commonly encountered pediatric procedures/situations: lumbar puncture, neonatal central line, pediatric sedation, intubation, and administration of blood products. Results: Overall response rate was 34.7% (1071 participants/3084 invited). Responses from active categorical pediatric residents (n=622 respondents) were analyzed. Almost all respondents
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(99%) endorsed the importance of informed consent for best patient care. Observation was the most frequently reported educational modality. Over 90% had obtained consent for lumbar puncture and blood products but only 27.6% for intubation. Between 9 -31% of respondents
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reported obtaining consent for specific procedures in which they were not expected to actively participate. Depending on the procedure, a variable number of respondents reported not feeling
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prepared to discuss the benefits (1- 23%) or risks (2 -31%) of these procedures with patients and/or parents. Respondents felt significantly less prepared to discuss risks (p < 0.05 for each procedure).
Conclusion: A significant percentage of respondents reported not feeling comfortable with discussing key components of informed consent. A minority of respondents reported being engaged in obtaining consent for procedures in which they are not expected to actively
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participate. Best practices for resident involvement in informed consent discussions need to be
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defined and incorporated into resident education.
What’s New: Informed consent is frequently obtained by pediatric residents, yet a significant percentage report not feeling prepared to discuss risks and benefits and also report obtaining
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consent for procedures in which they are not expected to actively participate.
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Introduction: Informed consent is the process by which a provider discusses the indications, benefits, risks, and alternatives of a specific proposed action with a patient or patient’s surrogate.1 Ideally,
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in the clinical context, informed consent is part of an ongoing shared decision-making process that starts when a procedure is believed to be indicated and continues until the procedure is completed.2
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Graduate medical education is actively evolving.3,4 During the 1990s, the Accreditation
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Council for Graduate Medical Education (ACGME) formally identified six core competencies: patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and system based practice.5 New educational frameworks for trainee evaluation and education have been introduced recently including the “Entrustable Professional Activities (EPAs)” in primary medical education and the “Next Accreditation
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System/Milestones” for graduate medical education.3,4,6-9 Both new systems directly address informed consent discussions as an important skill for trainees to master.10,11
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Given the importance of informed consent in patient care and the evolving landscape of medical education, we elected to study informed consent within the context of pediatric graduate
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medical education. We designed a survey to investigate in-training categorical pediatric residents’ perceptions about and experiences with the informed consent process. There were four main areas of interest: 1) experiences with obtaining informed consent for common procedures, 2) comfort level/feelings of preparedness with different aspects of informed consent discussions, 3) beliefs about the importance of informed consent, and 4) educational exposure to different methods used to teach informed consent. Methods:
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A random selection of members of the American Academy of Pediatrics (AAP) Section on Medical Students, Residents, and Fellows (SMSRF) with active email accounts were invited to participate in an on-line survey using SurveyMonkey (www.surveymonkey.com, Palo Alto,
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CA). Questions focused on four areas related to informed consent: experience, comfort level, education, and perceived importance. For items inquiring about experience and comfort level, five common clinical procedures were used throughout the survey: 1) lumbar puncture; 2)
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neonatal central line placement; 3) pediatric sedation; 4) intubation; and 5) administration of
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blood products.
Participants’ experiences with obtaining informed consent were gauged using three survey items. First, participants were asked “At your institution, do you get specific informed consent for the following procedures…” with each of the procedures of interest following. Response categories was “Yes”, “No” or “Not Sure”. Second, participants were asked: “How
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often have you been responsible for obtaining specific informed consent for the following specific procedures?” Response categories for this question were: Once, 1-10 times, 10-25 times, >25 times, Never, and Does Not Apply. Third, participants were asked “Have you ever obtained
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consent for procedures in which you were not expected to actively participate?” with response
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categories of “Yes”, “No” or “Not Sure” for each of the procedures/situations of interest. Respondents’ comfort level with the essential components of informed consent
discussions was addressed by asking the extent to which they agreed or disagreed with the following statements: “I feel prepared to adequately answer patient/parental question regarding the benefits of” [each of the five procedures/situations of interest]. The same question was repeated for risks. General attitude regarding the importance of informed consent and perceived need for further education were explored by asking respondents their level of agreement or
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disagreement with the following statements: (1) Informed consent is important for providing the best patient care, (2) informed consent is important to protect physician liability, (3) I need more education and training in how to obtain a valid informed consent, and (4) I feel comfortable
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responding to parental concerns and refusal (at least initially) of the clinically indicated
procedure . The response categories for these agree/disagree questions were a four point Likert scale (completely agree, somewhat agree, somewhat disagree, and completely disagree). The
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four point scale eliminates the neutral mid-point of a five point Likert scale, compelling
respondents to express an opinion and has previously been used in similar survey studies
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regarding graduate medical education. 12,13
Respondents’ perception of the frequency at which alternatives were being offered for each procedure was explored by asking: “To what extent are patients/parents offered alternatives
Sometimes, Rarely, Never.
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to [the specific procedure].” Respondents could choose one of the following responses: Always,
To understand the educational experience of pediatric residents, respondents were asked
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which format(s) had been used to teach them how to discuss procedures with patients and parents and obtain informed consent: lectures on the topic during medical school, lectures on the topic
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during residency, self-directed learning (i.e. reading), actively taught by fellows, actively taught by peers (i.e. residents), actively taught by attending, observed peers (i.e. residents), observed fellows, observed attending, or not having received any of these regarding informed consent. Demographic data were collected regarding age, gender, year in training, residency type
(categorical vs combined training), and residency setting (academic vs community). The survey instrument was presented at a research workshop at the MacLean Center for Clinical Medical Ethics where a convenience sample of approximately 20 residents, attending physicians, and
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ethics fellows piloted the survey and discussed each question for clarity and content/meaning. The questions and survey introduction were modified based on feedback provided. Average time of completion of the survey was between 5-10 minutes. A complete survey is available from the
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corresponding author.
Enrollment in this study occurred from January 1, 2013 to April 30, 2013. Recruitment was accomplished via direct e-mail invitation. After the initial invitation, four further email
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invitations were sent for recruitment. Each invitation email introduced the potential recipient to
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the lead investigator (AN), outlined the general research goal (investigating pediatric resident’s experience with informed consent during training), and summarized the participating’s commitment (length of survey and time commitment). The invitation also explained the voluntary nature of the survey, the IRB approved status of the study, and that written informed consent had been waived for this low risk study. As an incentive, ten $25 Amazon.com
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(Amazon.com, Inc, Seattle, WA) gift cards and two iPads (Apple, Inc, Cupertino, CA) were raffled off to participants who completed the survey and elected to provide their email address.
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All data were de-identified prior to analysis.
Microsoft Excel version 14 (Microsoft Corporation, Redmond, WA) and JMP version
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10.0 (SAS Institute Inc, Cary, NC) were used for quantitative statistical analysis. For percentage reporting, we excluded responses that were left blank by the respondent. For analysis purposes, completely and somewhat agree were combined into “agree” and completely and somewhat disagree were combined into “disagree”. The ordinal response categories regarding frequency of obtaining consent for each procedure were converted into a nominal data set “Never” versus “one or more times”. Responses were subsequently stratified by year in training, interns (postgraduate year 1) versus upper level resident (post-graduate years 2 and 3) in order to better
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understand how stage in training effects reported experience. Chi-square and student t-tests were used with significance set at P < 0.05.
participation in this survey implied consent. Results
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The institutional review board at the University of Chicago granted exempt status and
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A total of 3097 members of the AAP SMSRF were invited to enroll in an online survey. Thirteen had opted out of invitations from surveymonkey.com previously and did not receive the
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invitation. From the 3084 potential respondents, 1071 (998 completed and 73 partially completed) surveys were returned for an overall response rate of 34.7%. Six hundred and twenty-two respondents self-identified as categorical pediatric residents within their first 3 years of training (post-graduate years 1, 2 and 3) and were included in the study population for this
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analysis.
Demographics and training characteristics of the respondents are shown in Table 1. Respondents were predominately female (72.9%), United States medical graduates (79.5%), and
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held MD degree (87.2%). According to the ACGME 2012-2013 Data Resource Book, 73.4% (5802/7910) of pediatric residents were female and 89.2% (7736/8669) held an MD versus
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10.8% (933/8669) held a DO degree. 14 There was no statistical difference between the study population and the national ACGME data for gender (P=0.86) or degree type (P=0.46). For two of the five common procedures (lumbar puncture and the administration of
blood), over 90% of respondents reported that, at their institution, informed consent was specifically obtained (Table 2). Specific informed consent for intubation was least frequently reported as being obtained at the respondents’ institution at 41.1%. Similarly, when asked if the
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respondents themselves had obtained consent for the specific procedure in question, over 90% reported having obtained consent for a lumbar puncture and blood product administration at least once. Intubation was the procedure the least amount of respondents reported ever obtaining
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consent (27.6%). Notably, approximately one-fifth of respondents reported obtaining consent for three of the procedures even though they were “not expected to actively participate” in the
procedure: neonatal central line placement (23.2%), pediatric sedation (22.6%), and lumbar
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puncture (19.3%). Respondents overwhelmingly agreed with statements regarding the
importance of informed consent discussions. Ninety-nine percent (614/620) completely or
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somewhat agreed that “informed consent is important for providing best patient care” and 98.9% (614/621) agreed that “informed consent is important to protect physicians from liability”. Overall, most (88.3% or 546/618) of the residents stated that they “feel comfortable responding to parental concerns and refusals”. Importantly, the rate of reporting feeling
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“comfortable responding to parental concerns and refusals” increased with training with 83.5% (172/206) of interns stating they felt prepared versus 90.8% (374/412) of upper level resident (P=0.01). However, a minority of respondents reported not feeling prepared to adequately
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answer patient /parent questions regarding the benefit and risks of the procedures/situations in
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question. Residents reported that they felt least prepared to discuss the benefits and risks of pediatric sedation (20.6% and 31.0%, respectively). For all procedures, respondents were more likely to report not feeling prepared to answer questions about risks compared to benefits (Table 3).
According to our respondents, whether patients and parents were offered alternatives depended on the procedure in question. For pediatric sedation, 27.7% of respondents reported that alternatives were never or rarely offered whereas 59.6% reported lack of alternatives being
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offered for intubation. The extent to which respondents perceived that patients and parents were being offered alternatives for the five common pediatric procedures is shown in Table 4.
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Respondents reported learning about how to conduct an informed consent discussion from an average of 4.3 (SD ±2.0) different educational modalities. Figure 1 shows the percent of respondents who reported learning about how to conduct an informed consent discussion from each different modality asked in the survey. The most frequent modalities reported were
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observing peers (66.7%) and being actively taught by peers (61.9%). Only 26.0% reported
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having lectures on the topic during residency teaching. When asked if they needed more education and training in how to obtain a valid informed consent, 77.6% (546/618) of respondents either completely or somewhat agreed. Importantly, more interns respondents thought they needed more education than did upper level resident respondents (86.1% versus
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73.3%).
In comparing the survey responses between interns versus upper level residents, we found many differences in their experience and in the preparedness to discuss risks and benefits.
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Table 5 summarizes these results. Upper level residents reported having more experience with obtaining informed consent, were more likely to report having obtained consent for procedures
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for which they were not expected to actively participate (except for pediatric sedation), and were more likely to agree with the statements that they “feel prepared to adequately answer patient/parental questions regarding the” benefits and risks for all of the procedures in question.
Discussion: In pediatrics, there is emerging interest in improving shared decision making in clinical
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practice.15 Training pediatric residents to engage patients and their parents in informed consent discussions is a critical component of ensuring effective shared decision-making.2,16 This exploratory study provides a novel cross sectional assessment of active US pediatric residents’
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experiences, comfort level, beliefs, and educational exposure surrounding informed consent. Both undergraduate and graduate medical education programs have introduced new
frameworks for trainee evaluation and education. At the undergraduate level, the AAMC has
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developed professional tasks that medical student should be able to perform prior to initiating
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residency, known as EPAs.8,10,17 These are intended to help translate the ACGME core competencies into clinical practice. The ability to obtain informed consent is amongst the EPAs and embodies a number of the core competencies such as patient care, professionalism, interpersonal and communication skills, and systems based practice.10,18 At the graduate medical education level, the ACGME introduced the “Next Accreditation System” that has advanced
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graduate medical education from competency-based to the “Milestones”-based system of educational development.19,20 The Pediatric Milestones includes learning how to obtain informed
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consent as an important part of patient care and education.11 Entrustable Professional Activity 11, “Obtain informed consent for test and/or
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procedures”, states that “From day one residents may be in a position to obtain informed consent for interventions, tests, or procedures they order or perform”, but then acknowledges that “residents on day one should not be expected to obtain informed consent for procedures or tests for which they do not know the indications, contraindications, alternatives, risks, and benefits.”10 This study confirms that pediatric residents commonly obtain informed consent and perceive it as important for patient care, but that they need to be educated to perform it correctly. Our findings that interns reported feeling less prepared to answer questions about risks and benefits
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than upper level residents for all procedures underscore a concern with the common practice of having trainees obtain consent for specialty specific procedures without supervision, particularly
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early in their training. Providers who lead consent discussions should be prepared to discuss the risks, benefits, and alternatives of a proposed procedure. We found that it is not only interns who reported not feeling adequately prepared. For each procedure/situation except lumbar puncture, we found that
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some upper level resident respondents also reported that they did not feel prepared to discuss the
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benefits and risks. More concerning, we found that respondents of all levels of training were more likely to report being more comfortable with discussing the benefits of each procedure than the risks. How choices are framed is an important part of decision making and being more prepared to discuss the benefits than the risks may alter the conversation.21-23 Additionally, providing alternatives is a critical component of the informed consent
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discussion, even in the face of a disease with high morbidity and mortality.16,24 For each procedure, over one-quarter of respondents stated that parents were rarely or never told about
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alternatives. If the provider is not fully aware of the alternatives, or not comfortable discussing them, patients and their surrogates will not be able to fully engage in a robust shared decision
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making process.
Beyond taking the pulse of informed consent activity amongst pediatric residents, this
study also found that pediatric residents are being asked to obtain consent despite not always being expected to be actively involved in the procedure. Depending on the procedure, up to 20% of responding pediatric residents reported obtaining consent for procedures in which they were not expected to actively participate. This practice is contrary to the guidelines provided by the Pediatric Milestone Project which state: “informed consent elements may be known but the
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actual informed consent must take place by the primary operator for the procedure.” 25 Our respondents reported that they were mainly taught how to engage in informed
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consent discussions through peer learning (observation and actively teaching). This finding is consistent with a previous survey study that showed over half of recently graduated pediatric residents described their ethics/professionalism curriculum as “ad hoc”.12 The low percentage of respondents who reported having had lectures during residency training on how to obtain
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informed consent further supports this claim. This contrasts with a previous study of pediatric
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residency program directors, 80% of whom reported that their program’s ethics curriculum was taught in a lecture format.26 While the question posed to the pediatric residency program directors was not specific to instruction on how residents are taught to engage in an informed consent discussion, the difference between the program directors’ report and the residents’ recall in the current study is notable and deserves greater study. Research is needed to investigate best
consent discussions.
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educational practices for teaching pediatric residents the skills involved in engaging in informed
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This study has several limitations. First is the potential concern for nonresponse bias. While the response rate for this survey was modest (34.7%), it is consistent with other physician
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surveys.27-29 Several factors reduce the concern for bias. According to the AAP, 99% of residency programs sponsor membership in the AAP for their residents and residents are automatically enrolled into the SMSRF section, reducing the risk of selection bias.30 Importantly, the demographics of our respondents match the demographics of the ACGME pediatric resident population in terms of gender and type of graduate degree.14,30 A second limitation relates to the inherent weakness of survey research for exploring topics such as ethics. Using a survey tool may lead to emphasizing the operational notion of “obtaining consent”, putting more importance
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on the medico-legal role of documenting that permission was obtained rather than on the aspirational concept of engaging in a bi-directional discussion of shared decision-making that culminates with an informed patient or surrogate authorizing consent.16 It is possible, then, that
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residents interpreted informed consent to require a written consent document and as such
respondents may have underestimated the procurement of consent at their institution (Table 2, question 1). A third limitation is the potential ambiguity of some of the survey items. For
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example, we asked if respondents obtained consent for procedures in which they were “not
expected to actively participate”. The intention of the phrase “actively participate” was to denote
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a situation in which the resident felt that they obtained consent for a procedure which they were not expected to be present or, if present, perceived they were not meaningfully engaged. A fourth limitation is that our study focused on resident perception of parental interactions surrounding the informed consent process. We did not address the issue of assent for children who, while
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lacking full decisional capacity, may be old enough to voice preferences and interests. Future studies exploring resident training addressing the role of assent in the pediatric informed consent process would be of value.
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Despite these limitations, we believe that our findings are useful for understanding the
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perception of current trainees regarding current educational efforts and opportunities to engage meaningfully in the informed consent process. Qualitative research studying how to best teach engagement in informed consent and shared decision making more broadly is needed and should also involve other stakeholders, including parents and children. Observing and analyzing actual consent discussions for these procedures/situations may also help identify best practices.
Conclusion
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Primary medical education on how to engage in informed consent discussions should focus on common procedures/situations. Residency programs should be aware that obtaining informed consent for specialty specific procedures may not be within the skill set of incoming
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interns. The responsibility for obtaining informed consent should only occur after the resident has demonstrated an understanding of all the key components of the procedure (i.e. risks,
benefits, and alternatives). Special attention should be given to improving residents’ comfort
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level with discussing risks of procedures. Furthermore, residency programs should be aware that trainees may be obtaining consent for procedures in which they are not expected to actively
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participate which is inconsistent with current educational recommendations.
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Figure Legend:
Figure 1. Percent of 622 US pediatric residents reporting having received education regarding
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informed consent from each of several educational modalities.
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References: 1. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 2013.
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2. Milestones. Accerditation Council for Graduate Medical Education.
http://www.acgme.org/acgmeweb/tabid/430/ProgramandInstitutionalAccreditation/NextA ccreditationSystem/Milestones.aspx Accessed August 24, 2015
accreditation system". Acad Med. 2014; 89:27-9.
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3. Nasca TJ, Weiss KB, Bagian JP, Brigham TP. The accreditation system after the "next
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4. Teherani A, Chen HC. The next steps in competency-based medical education: milestones, entrustable professional activities and observable practice activities. J Gen Intern Med. 2014; 29:1090-2.
5. Swing SR. The ACGME outcome project: retrospective and prospective. Med Teach.
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6. Philibert I, Nasca TJ. The next accreditation system: stakeholder expectations and dialogue with the community. J Grad Med Educ. 2012;4:276-8.
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7. Rushton JL, Hicks PJ, Carraccio CL. The next phase of pediatric residency education: the partnership of the Milestones Project. Acad Pediatr. 2010;10:91-2.
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8. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013;5:157-8.
9. Aschenbrener CA. Creating a continuum of learning. Acad Pediatr. 2014; 14:S4-S5. 10. Core Entrustable Professional Activities for Entering Residency: Faculty and Learners Guide. Association of American Medical Colleges. Published 2014.
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https://members.aamc.org/eweb/upload/Core%20EPA%20Faculty%20and%20Learner% 20Guide.pdf Accessed August 24, 2015.
Accreditation Council for Graduate Medical Education.
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11. The Pediatrics Milestone Working Group. The Pediatrics Milestone Project.
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12. Cook AF, Sobotka SA, Ross LF. Teaching and assessment of ethics and professionalism: a survey of pediatric program directors. Acad Pediatr. 2013;13:570-576.
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13. Waz WR, Henkind J. The adequacy of medical ethics education in a pediatrics training program. Acad Med. 1995;70:1041-3.
14. Accrediation Council for Graduate Medical Education. ACGME Data Resource Book Academic Year 2012-2013. Accrediation Council for Graduate Medical Education.
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15. Wyatt KD, List B, Brinkman WB, et al. Shared Decision Making in Pediatrics: A Systematic Review and Meta-analysis. Acad Pediatr. E-pub ahead of print. 2015.
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16. Paterick TJ, Carson GV, Allen MC, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc.2008;83:313-319.
17. Core Entrustable Professional Activities for Entering Residency: Curriculum Developers' Guide. Association of American Medical Colleges. Published 2014. https://members.aamc.org/eweb/upload/Core%20EPA%20Curriculum%20Dev%20Guide .pdf Accessed August 24, 2015.
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18. Ludwig S. Domain of competence: Professionalism. Acad Pediatr. 2014; 14:S66-S69. 19. Nasca TJ, Philibert I, Brigham T, Flynn TC. The next GME accreditation system-rationale and benefits. N Engl J Med. 2012;366:1051-6.
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20. Schumacher DJ, Spector ND, Calaman S, et al. Putting the pediatrics milestones into practice: a consensus roadmap and resource analysis. Pediatrics. 2014;133:898-906. 21. Tversky A, Kahneman D. The framing of decisions and the psychology of choice.
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22. Perneger TV, Agoritsas T. Doctors and patients' susceptibility to framing bias: a
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randomized trial. J Gen Intern Med. 2011;26:1411-1417.
23. Levin IP, Schneider SL, Gaeth GJ. All Frames Are Not Created Equal: A Typology and Critical Analysis of Framing Effects. Organ Behav Hum Decis Process.1998;76:149-188. 24. Gilmour J, Harrison C, Asadi L et al. Informed consent: advising patients and parents
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about complementary and alternative medicine therapies. Pediatrics. 2011;128:S187-192. 25. Accrediation Council of Graduate Medical Education. ACGME Institutional Requirements 2007. Accrediation Council of Graduate Medical Educaiton. Published
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July 1, 2007. https://www.acgme.org/acgmeweb/Portals/0/irc_IRCpr07012007.pdf. Accessed August 24, 2015.
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26. Lang CW, Smith PJ, Ross LF. Ethics and professionalism in the pediatric curriculum: a survey of pediatric program directors. Pediatrics. 2009;124:1143-1151.
27. Thorpe C, Ryan B, McLean SL, et al. How to obtain excellent response rates when surveying physicians. Fam Pract. 2009;26:65-68.
28. Asch DA, Jedrziewski MK, Christakis NA. Response rates to mail surveys published in medical journals. J Clin Epidemiol. 1997;50:1129-1136.
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29. Kellerman SE, Herold J. Physician response to surveys. A review of the literature. Am J Prev Med. 2001;20:61-7. 30. Lucke A. Welcome & Letter From Chair. Resident and Fellowship Trainees American
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Academy of Pediatrics. http://www2.aap.org/sections/ypn/r/. Accessed August 24, 2015.
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Table 1. Demographics and training characteristics of 622 responding United States pediatric residents % (n) Female
72.9 (431)
N* = 591
Male
27.1 (160)
Degree Type
MD
87.2 (540)
N* = 619
DO
9.4 (58)
Other
3.4 (21)
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United States
79.5 (492)
International
17.1 (106)
Other
3.4 (21)
Year in Training**
PGY-1
33.4 (208)
N = 622
PGY-2
33.4 (208)
PGY-3
33.1 (206)
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Origin of Degree N* = 568
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Gender
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Mean age N* = 594 (Years [SD])
Abbreviations: PGY = post-graduate year * N varies due to partial non-responders
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Demographic trait
**Percentages do not add up to 100% due to rounding.
29.2 [2.7]
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Table 2. Experience with informed consent for five common procedures/situations among 622 US pediatric residents.
Puncture
Central Line
% (n/N*)
% (n/N*)
93.7
65.3
(582/621)
(404/619)
92.4
Intubation
Products
% (n/N*)
% (n/N*)
% (n/N*)
85.0
41.1
96.3
(527/620)
(256/618)
(596/619)
51.9
52.3
27.6
90.6
(574/621)
(322/621)
(324/619)
(170/616)
(561/619)
19.3
23.2
22.6
9.1
31.2
(120/622)
(144/621)
(140/619)
(56/618)
(194/622)
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obtaining informed consent one or more times for…
were not expected to actively participate…
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*N, Total number of responses. Values vary due to partial non-responders
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Blood
Sedation
their institution gets specific informed consent for…
obtaining consent for procedures in which they
Pediatric
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Neonatal
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Residents reporting….
Lumbar
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Table 3. Self-reported perception of adequate preparation for answering patient/parental questions regarding the benefits and risks of five common procedures/situations
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Respondents disagreeing with the following statements: “I feel prepared to adequately answer patient/parental questions regarding…” % (n)
1.9 (12)
<0.01
13.0 (80)
18.8 (116)
<0.01
20.6 (127)
31.0 (191)
<0.01
5.9 (36)
13.1 (80)
<0.01
2.6 (16)
5.2 (32)
<0.01
0.5 (3)
Neonatal Central Lines (N*=616) Pediatric Sedation (N*=617) Intubation (N*=610)
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Blood Products (N*=616)
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N varies due to partial non-responders
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*
P Value
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Lumbar Puncture (N*=619)
…the risk of…
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…the benefits of...
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Table 4. Self-reported frequency of alternatives being offered to patients/parents for five common procedures/situations among 622 US pediatric residents.
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Extent to which patients/parents are offered alternative to the procedures listed
Neonatal Central Lines**
603
Pediatric Sedation
606
Intubation**
Never
% (n)
% (n)
% (n)
% (n)
36.3 (223)
4.7 (29)
25.7 (158)
33.2 (204)
18.9 (114)
30.3 (183)
40.1 (242)
10.6 (64)
27.6 (167)
44.7 (271)
24.4 (148)
3.3 (20)
602
12.5 (75)
27.9 (168)
44.9 (270)
14.8 (89)
610
23.8 (145)
39.0 (238)
33.6 (205)
3.6 (22)
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Blood Products
Rarely
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Sometimes
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Lumbar Puncture**
Always
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N*
* N varies due to partial non-responders.
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**Percentages do not add up to 100% due to rounding error.
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Table 5. Responses to key survey questions broken down by respondents by intern year 1 (post graduate year 1) compared to upper level residents (post-graduate years 2 and 3) Resident (PGY 2&3)
% (n/N*)
% (n/N*)
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Intern (PGY1) Residents reporting they have obtained specific informed consent for the following procedures… Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products
85.6 (178/208) 34.6 (72/208) 37.5 (78/208) 17.6 (36/205) 80.3 (167/208)
Residents reporting they have been responsible for obtaining specific informed consent for the following procedures… Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products Agree with statement "I feel prepared to adequately answer patient/parental questions regarding the benefits of…" Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products
P Value
<0.01 <0.01 <0.01 <0.01 <0.01
15.0 (31/207) 14.1 (29/206) 17.9 (37/207) 4.4 (9/205) 26.1 (54/207)
21.7 (89/411) 28.4 (115/405) 25.3 (103/407) 11.8 (47/400) 34.0 (140/412)
0.05 <0.01 0.42 <0.01 0.05
98.6 (205/208) 76.7 (158/206) 73.9 (153/207) 88.3 (182/206) 93.7 (194/207)
100 (412/412) 92.2 (379/411) 82.3 (339/412) 96.6 (394/408) 93.7 (409/412)
0.04 <0.01 0.02 <0.01 <0.01
Agree with statement "I feel prepared to adequately answer patient/parental questions regarding the risks of…" Lumbar Puncture Neonatal Central Line Pediatric Sedation Intubation Blood Products
95.7 (199/208) 69.7 (145/208) 59.4 (123/207) 77.2 (159/206) 89.3 (184/206)
99.3 (408/411) 87.1 (357/410) 73.9 (303/410) 91.9 (374/407) 97.6 (401/411)
<0.01 <0.01 <0.01 <0.01 <0.01
Educational experience surrounding informed consent Average number of modalities reported Lectures on the topic during medical school Lectures on the topic during residency training Self-directed learning (i.e. reading) Actively taught by fellow Actively taught by peers (residents)
4.18 (3.93-4.44) 49.5 (103/208) 23.1 (48/208) 46.2 (96/208) 21.2 (44/208) 65.9 (137/208)
4.40 (4.22-4.58) 43.0 (178/414) 27.5 (114/414) 43.2 (179/414) 34.8 (144/414) 59.9 (248/414)
0.18 0.13 0.25 0.49 <0.01 0.16
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95.9 (396/413) 60.5 (250/413) 59.9 (246/411) 32.6 (134/411) 95.9 (394/411)
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55.3(229/414) 65.7 (272/414) 44.4 (184/414) 62.3 (258/414)
0.50 0.47 <0.01 0.12
3.4 (7/208)
2.7 (11/414)
0.62
99.5 (207/208 98.6 (205/208)
98.8 (407/412) 99.0 (409/413)
0.67 0.69
86.1 (179/208) 83.5 (172/206)
73.3 (302/412) 90.8 (374/412)
<0.01 0.01
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Agreed with the following statements Informed consent is important for the best patient care Informed consent is important to protect physicians from liability I need more education and training in how to obtain valid informed consent I feel comfortable responding to parental concerns and refusals
52.4 (109/208) 68.8 (143/208) 30.3 (63/208) 55.8 (116/208)
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Actively taught by attending Observed peers (residents) Observed fellows Observed attending I have not received any of the above training regarding informed consent
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* N varies due to partial non-responders. Abbreviations: IC = informed consent; n/N = responses/total number of responses; PGY Post Graduate Year
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