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Informed consent for invasive procedures in the emergency department
Journal Pre-proof Informed consent for invasive procedures in the emergency department
Max M. Feinstein, Janet Adegboye, Joshua D. Niforatos, Richard M. Pescatore PII:
S0735-6757(20)30035-8
DOI:
https://doi.org/10.1016/j.ajem.2020.01.035
Reference:
YAJEM 158721
To appear in:
American Journal of Emergency Medicine
Received date:
9 December 2019
Accepted date:
18 January 2020
Please cite this article as: M.M. Feinstein, J. Adegboye, J.D. Niforatos, et al., Informed consent for invasive procedures in the emergency department, American Journal of Emergency Medicine(2018), https://doi.org/10.1016/j.ajem.2020.01.035
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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.
© 2018 Published by Elsevier.
Journal Pre-proof Informed consent for invasive procedures in the ED
Full title: Informed consent for invasive procedures in the emergency department Running title: Informed consent for invasive procedures in the ED Max M. Feinstein MD MA1, Janet Adegboye2, Joshua D. Niforatos MD MTS2,3, Richard M. Pescatore DO4
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1. Department of Anesthesiology, Mount Sinai Hospital, New York, NY, USA. Email address: [email protected] 2. Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA Email address: [email protected] 3. Department of Emergency Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA Email address: [email protected] 4. Department of Emergency Medicine, Crozer-Keystone Health System, Chester, PA, USA Email address: [email protected]
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IRB status: None required Financial Support: None
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Word Count: 3,861 Table Count: 1
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Author contributions: MMF and JA designed the study, performed the systematic review, analyzed the results, and contributed to writing the manuscript. JDN and RMP designed the study, acted as consultants for the systematic review, analyzed the results, and contributed to writing the manuscript. MMF takes responsibility for the paper as a whole.
Corresponding Author Joshua D. Niforatos, MD, MTS Address: 1830 E. Monument St., Suite 6-100 Telephone Number: (505)-554-4644 Email: [email protected] Conflict of Interest Disclosure: None to Declare
Journal Pre-proof Informed consent for invasive procedures in the ED Abstract Background: Informed consent for procedures in the emergency department (ED) challenges practitioners to navigate complex ethical and medical ambiguities. A patient‘s altered mental status or emergent medical problem does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced assessment of the situation to determine the appropriate level of participation. Given the complexities involved with informed consent for procedures in the ED, it is important to understand the experience of key stakeholders involved.
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Methods: For this review, we searched Medline, the Cochrane database, and Clinicaltrials.gov for studies involving informed consent in the ED. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient‘s family, or healthcare provider), number of participants, and primary outcomes measured.
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Results: Fifteen articles were included for final review: Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), and patient understanding (4 of 15 studies). The least common theme addressed in the literature was community notification (1 of 15 studies).
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Conclusions: Studies of informed consent for procedures in the ED span many aspects of informed consent. The aim of the present narrative review is to summarize the work that has been done on informed consent for procedures in the ED.
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Introduction Background In 2015, an estimated 136.9 million visits to the emergency department (ED) were made in the United States1. Of those visits, 56.0 million (40.9%) involved one or more procedures being performed in the ED. While procedures vary substantially in nature, ―invasive procedures‖ have been defined by the National Cancer Institute as, ―A medical procedure that invades (enters) the body, usually by cutting or puncturing the skin or by inserting instruments into the body‖2. The American College of Physicians Ethics Manual states that informed consent should be obtained for procedures, except for those that are neither risky nor invasive, or if the patient lacks capacity to make decisions and no surrogate decision-maker is available3.
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Importance Best practices for informed consent for invasive procedures comes from the anesthesiology literature4–6. Informed consent in this clinical setting is frequently perioperative and often for elective procedures rather than emergent procedures. Given the potential complexities involved with informed consent for invasive procedures in the ED setting, it is paramount to understand the perspective of key participants, including patients, providers, and researchers. Specific complexities include time restrictions on the informed consent process due to the emergent nature of medical problems in the ED, as well as variations in a patient‘s level of consciousness that may impact his/her level of understanding and, therefore, the capacity to provide consent.
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Goals The aim of this narrative review is to summarize the work that has been done on informed consent for invasive procedures in the emergency department.
Journal Pre-proof Informed consent for invasive procedures in the ED Methods Information sources Electronic databases Medline, Cochrane, and Clinicaltrials.gov were searched without date or country of origin restrictions. For the Medline component of the systematic review, Medline‘s ―Best Match‖ search algorithm was used, while Cochrane Library searches were limited to titles, abstracts, and keywords. Additionally, the reference list generated from each database was assessed manually by reviewers M.F. and J.A.
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Search The current review was designed and prepared according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines7, and designed using methods previously described4. Succinctly, the search was conducted on February 7, 2019. The following search terms were used in this review:
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emergency AND (medicine OR department OR room) AND (local OR regional OR sedation OR analgesia OR anesthesia OR intubation) AND informed consent
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Selection criteria Articles were considered eligible if they met the following criteria: (a) randomized controlled trials, nonrandomized clinical trials, prospective or retrospective cohort studies, descriptive studies/surveys, case-control studies, or cross-sectional studies; (b) study population included patients, patients‘ family members, and/or healthcare providers; (c) study setting was the ED; (d) study outcomes related directly to informed consent regarding anesthesia care provided by any healthcare provider; (e) article was in English.
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Narrative reviews, case studies/series, commentaries, and hypothetical cases were excluded. Consensus was reached between the two reviewers (M.F., J.A.) to include or exclude any study for full text review. A third reviewer (J.N.) was available to resolve disagreement regarding inclusion or exclusion of articles. Full text review of each included study was independently conducted by the two reviewers, and consensus was reached between M.F. and J.A. for final inclusion of themes to discuss. Data extraction and synthesis The reviewers M.F. and J.A. independently extracted data from the search results. After duplicates were removed, all studies meeting full inclusion criteria and no exclusion criteria were reviewed. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient‘s family, or healthcare provider), number of participants, and primary outcomes measured.
Journal Pre-proof Informed consent for invasive procedures in the ED
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Study registration This systematic review was registered with PROSPERO (https://www.crd.york.ac.uk/PROSPERO). The registration number is CRD42019130410.
Journal Pre-proof Informed consent for invasive procedures in the ED Results Study selection As shown in the PRISMA diagram (Figure 1), 849 records were gathered from the initial database search and citation review. Of those, a total of 841 remained following removal of duplicates. On review of eligibility, 15 studies met all inclusion criteria and no exclusion criteria. The included studies were published between 1991 and 2017. The present literature review is current through February 2019.
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Study characteristics Our results demonstrate that research on informed consent in the ED is variegated. Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), informed consent pertaining to deceased patients (5 of 15 studies), and patient understanding of informed consent (4 of 15 studies). The least common themes addressed in the literature were community notification (1 of 15 studies), pediatric patients (3 of 15 studies), waivers of informed consent (3 of 15 studies), and tools/aids for providing informed consent (3 of 15 studies). A summary of study characteristics is presented in Table 1. Primary outcomes for each study are shown in Figure 2, and the study subjects are shown in Figure 3.
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Surrogate decision-makers The topic of surrogate decision-makers (also known as substitute decision-maker, alternate decision-maker, or health care proxy) is one that came up often when addressing informed consent in the ED8–13. There are many patient populations that are not able to consent for their own procedures, including unconscious patients, intoxicated patients, pediatric patients, and patients who are deceased. According to the Patient Self-Determination Act14, a patient has the right to formally designate a surrogate to make treatment decisions if the patient becomes unable to make their own decisions. In the event that a surrogate decision-maker has not been identified through either a medical power of attorney or a court-appointed legal guardian, such an agent is selected by medical personnel. In the US, the hierarchy of health care surrogates may vary according to the law of the specific state, but an example order of priority is listed here: 1. The patient‘s guardian 2. The patient‘s spouse 3. Any adult son or daughter 4. Either parent 5. Any adult brother or sister 6. Any adult grandchild or an adult relative 7. A close friend of the patient Two studies addressed surrogate decision-making by the families of deceased patients9,10. Olsen et al. and McNamara et al. surveyed family members to ask about consenting on behalf of the
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recently deceased. When given the option to perform invasive procedures on the recently deceased, such as endotracheal intubation or cricothyrotomy, consent was only given about half of the time. For both studies, reasons given by families who consented for the procedure included helping young doctors learn and the potential benefit to a future patient. In contrast, reasons for family refusal of consent included the desire to avoid invasive procedures on the body, religious reasons, and that the deceased had been through enough. In a few cases, the lack of a single spokesperson created an inability for the family to reach a decision regarding consent. Based on the study results, it appears that the family members tried to honor the wishes of the deceased; however, the studies did not include explicit information about whether or not the patient had an advanced directive.
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Three studies focused on how to improve the surrogate decision-making of a parent on behalf of their child11–13. Spencer et al. and Lin et al. achieved this by incorporating a computer-assisted presentation to improve the parent‘s understanding of the procedure, while Yamamoto et al. asked the parent‘s preference for each step of the procedure. Interestingly, none of the studies investigated the children‘s preference or understanding of the procedure. Spencer et al. included assent in one of their parental satisfaction surveys, but did not expand on how much of a choice the child had for undergoing the procedure. Unlike informed consent for the adult patient, assent from pediatric patients is not always required by law. However, even if assent is not required, children may still benefit from going through the assent process because it allows them to feel more engaged and in control of their health15.
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Deceased patients Fourre et al., Morhaim et al., and Denny and Kollek sought to measure the prevalence of practicing invasive procedures on recently deceased patients in the ED8,16,17. Furthermore, they wanted to see how often informed consent was obtained in these situations. Fourre et al. mailed surveys to program directors of all Accreditation Council for Graduate Medical Education (ACGME)-approved residency programs in emergency medicine16. Of the 96 surveys returned, 45 (47%) indicated that procedures were performed on the recently deceased for teaching purposes in their ED. However, there was no consensus among program directors concerning the appropriateness of obtaining informed consent from family members for these procedures. In fact, 34 out of 45 (76%) stated that they ‗‗almost never‘‘ obtain consent from family members for these procedures. Morhaim et al. saw similar results when they sent surveys to every ED director in the country17. Of the 992 responses, 537 (54%) directors reported the practice of endotracheal intubations on recently deceased patients in their ED. In the vast majority of these cases (97%), the families were not informed of this practice and informed consent was not obtained. Although the practice of endotracheal intubations on recently deceased patients was widespread, objections to its
Journal Pre-proof Informed consent for invasive procedures in the ED practice were also common. In the 537 EDs where this was practiced, 134 (25%) reported at least one complaint from a healthcare provider or from the institution itself.
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Denny and Kollek surveyed 162 learners (medical students and residents in emergency medicine) and 45 teachers (emergency physicians and trauma team leaders), and also found similar results8. Of the 303 invasive procedures performed by the learners, 34 (11%) were performed on mannequins, 169 (56%) were performed on conscious patients, 85 (28%) were performed on unconscious patients, and only 15 (5%) were performed on recently deceased patients. None of the participants obtained consent before practicing or teaching a procedure on a recently deceased patient.
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Olsen et al. and McNamara et al. also examined the process of obtaining informed consent for invasive procedures on recently deceased patients9,10. However, unlike the three studies mentioned above, they chose to survey the family members instead of the emergency medicine personnel. Olsen et al. approached the family members of deceased patients for consent to perform a cricothyrotomy as a learning opportunity for physicians10. Of the 51 families included in the study, 20 families (39%) consented to post-mortem cricothyrotomy, 23 families (45%) refused consent, and 8 families (16%) were too distraught to be approached. Six weeks after the death, follow-up phone calls were made to the 43 families who were approached. Only one of these families expressed that they were offended or upset about being approached for the procedure. All felt that they were approached respectfully, had enough information to make a decision, understood what was being asked, and felt they had a choice in the decision. In a similar manner, McNamara et al. approached the family members of deceased patients for consent to perform endotracheal intubations as a learning opportunity9. Of the 44 families approached, 26 families (59%) consented to post-mortem intubation, while 18 families (41%) refused consent. Patient understanding Patient understanding of the risks and benefits of invasive procedures is an important factor in obtaining informed consent3. There are different methods for assessing patient understanding and obtaining informed consent prior to procedures reported in the included studies. One method is community consultation and public disclosure for research studies that are otherwise exempt from informed consent. O‘Malley et. al. successfully disclosed to almost 7,000 patients about an ongoing clinical trial comparing the use of cricoid pressure versus no cricoid pressure and bimanual laryngoscopy18. Patients and family were informed by either a large poster in the waiting room of the ED or approached by a research associate in the waiting room and read the IRB verbal script. Approximately 74% of patients and accompanying family stated they understood and would hypothetically agree to participate in the aforementioned clinical trial.
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For non-emergent procedural sedation and analgesia (PSA), Bellolio et. al. discovered in their ED that patients, caregivers, and clinicians understood the benefits of PSA19; however, all parties were unaware of the magnitude of risk associated with this intervention. Revell et. al. had similar findings in their descriptive exploratory study of face-to-face interviews with patients20. Although only 8 patients were interviewed after PSA, all patients agreed that they did not need information regarding indications for this procedure in written format. However, the patients wanted information related to their safety throughout the ED stay, suggesting a better need regarding both risk of PSA and outcomes of chief complaint. Similarly, patients enrolled in the verbal consent group in Spencer et al.'s study were less likely to know they had a right to refuse PSA and overall scored lower on knowledge of PSA compared to the intervention group11.
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Aided informed consent Three studies were identified that addressed different methods for providing information related to PSA in the ED11,13,19. When Bellolio et al., mentioned previously, discovered that patients, caregivers, and clinicians did not understand the magnitude of risk associated with these procedures, they developed two aids to improve the informed consent process19. First, a pocket card for emergency medicine physicians was created to standardize the language used when communicating benefit and risk information to patients related to PSA. While the physicians were appreciative of this bedside tool, patients still did not understand the risk information or were not able to engage in decision-making based on this information. The pocket card was then transformed into a visual aid modified to the 6th grade reading level; however, the results from the post-implementation evaluation are still pending.
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Similar to Bellolio et. al., Spencer et. al. studied the efficacy of implementing multimedia presentations (MMPs) for informed consent related to ketamine sedation11. The primary outcome was comprehension of ketamine PSA and parental satisfaction of the consent process comparing MMPs to standard practice (verbal consent) in a randomized study. The MMP group scored higher overall in comprehension and parental satisfaction compared to parents enrolled in the verbal consent group. Furthermore, those in the MMP group were more likely ―to feel involved in the decision to use ketamine‖ and to understand ―they had a right to refuse the ketamine‖. When implemented into the daily ED workflow, the results remained stable with increased comprehension and satisfaction with MMPs. Lin et. al. are conducting a randomized trial to assess whether a computed-assisted information program is superior to routine verbal consent informing parents about the risks, benefits, and alternatives to PSA for their children in the ED13. This study is registered in clinicaltrials.gov, but the results are not available at this time. Pediatric patients
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As described above, Spencer et al. and Lin et al. both performed randomized control trials to see if the use of computer-assisted presentations would improve parental satisfaction and comprehension of informed consent11,13. Alternatively, Yamamoto et al. approached 45 parents to inquire how much they wanted to be involved in the decision-making for their child12. Children were included if they presented to the ED with a small laceration and were less than 8 years old. Parents were allowed to decide on the method of local anesthesia (topical or infiltrated) and whether or not to sedate their children during laceration repair. The informed consent process included both the benefits and risks of each choice, and the physician was told to remain neutral. In 44 out of 45 cases, the parents preferred to be included in the medical decision-making. Only one parent (a 37-year-old mother) indicated that she could not decide whether she liked helping the doctor or not.
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Preference for informed consent Implied informed consent occurs when a patient presents to the ED for treatment and it is understood by both the patient and the health care provider that the patient agrees to be treated at the institution21. To ascertain patient perspectives of implied informed consent, Easton et. al. surveyed 134 patients presenting to their ED regarding the amount of time they perceived necessary to give consent for numerous procedures21. Interestingly, patients perceived 5.6 minutes as enough time for formal consent compared to 7.6 minutes for lumbar puncture and 1 minute for simple blood draw. Though this study was not powered to detect meaningful differences in time allocated for the survey, the signal from this study suggest patients desire more than a cursory overview of risks, benefits, and alternatives prior to receiving PSA.
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Although the aforementioned studies provide valuable information related to preferences for informed consent, Yamamoto et. al.‘s survey study suggests some limits to hypothetical survey questions12. In a pediatric emergency setting, 45 parents were surveyed regarding their preferences for PSA for repair of small lacerations in their children. All 45 parents surveyed preferred non-sedation over sedation. However, in the non-ED setting—i.e., interviews in private offices—only 67 of 94 parents (71%) preferred non-sedation over sedation, suggesting hypothetical encounters may not fully reflect real-time preferences in the emergency setting for PSA. In both settings, parents significantly desired to be involved in medical decisions for their children. In contrast, Revell et. al.‘s descriptive exploratory study—with only 8 patients— suggests that adult patients do not need written information regarding indications for PSA, though they wanted continual confirmation of their safety throughout the ED visit20. In situations in which a patient is not able to provide informed consent, the discretion may rest on the clinician regarding the timing of consent. Denny and Kollek conducted a survey study in Canada that assessed whether physicians or trainees obtained consent from surrogate decisionmakers for procedures on recently deceased patients in the ED8. Among 222 survey respondents disclosing a few hundred procedures on recently deceased patients, no survey respondent
Journal Pre-proof Informed consent for invasive procedures in the ED obtained informed consent prior to practicing the procedure. Barriers to obtaining informed consent, as reported by the respondents, included an inability to identify surrogate decisionmaker at the time of the procedure, a perception that surrogate decision makers were unlikely to consent, and a desire to not upset family members of recently deceased patients. Living patients and surrogate decision-makers were not surveyed to assess non-health care provider perspectives.
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Medical education Medical education was a common theme throughout many of the studies included in the present review 8–10,16,17,22,23. Several studies surveyed the frequency with which deceased and unconscious patients were involved in the teaching of procedural skills8–10,16,17 (CITE Denny, Fourre, McNamara, Morhaim, Olsen), with results as described above under the deceased patients heading. Graber et. al. and Santen et. al. explored patient attitudes regarding medical students performing procedures in the ED22,23. Both studies found that procedure invasiveness correlates with greater patient reluctance to allow students to perform procedures. Santen et. al. specifically explored the question of whether patients would want to be informed if it was a medical resident‘s first time performing an invasive procedure, such as lumbar puncture or intubation, with the vast majority of patients answering in the affirmative22. While unsurprising, these results highlight that patients consider trainee status to be an important consideration in the informed consent process.
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Waiver of informed consent Several included studies assessed circumstances under which informed consent for procedures in the ED should be waived21,24. Easton et. al. surveyed 134 ED patients to define a set of procedures for which informed consent should be waived21. They found that approximately half of survey respondents considered that their consent was implied for minimally-invasive procedures such as blood draws and intravenous line starts. Patients demonstrated a preference for the informed consent process in the context of more invasive procedures such as lumbar punctures and conscious sedation. Fox et. al. assessed how a waiver of informed consent would affect participation rates of clinical trials in the ED24. This research question was designed to address the concern that requiring informed consent can reduce response rates significantly enough to introduce selection bias. To make this assessment, the authors investigated the consent status for patients enrolled in a consent-waived study about blood transfusion after traumatic injury. This investigation was possible because one of the participating clinical sites required that investigators attempt to gain informed consent despite the study‘s consent-waived status. Fox et. al. found that of the 121 eligible subjects, consent for participation in research was obtained only for 55 patients (46%). Thus, the authors concluded that requiring informed consent in clinical studies in the ED has the potential to significantly decrease rates of participation and result in selection bias24.
Journal Pre-proof Informed consent for invasive procedures in the ED
Community notification The emergent nature of medical problems in the ED poses a significant challenge to obtaining ethnically-appropriate informed consent in the conduct of research18. To address this dilemma, community consultation and notification have been used to engage potential participants in ED research. O‘Malley et. al. sought to implement novel strategies to notify community members about ED studies18. As described in more detail in patient understanding, community notification tools such as posters in the ED and discussion with research assistants in the ED waiting room are both viable methods to facilitate informed consent for studies in the ED setting.
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Limitations Several factors limited the scope of this study. First, the criterion to include only articles written in English potentially limits exposure to variation of cultural and ethical norms for informed consent. Additionally, the included studies were published in a large enough time period (19912017) that clinical practices for informed consent may have significantly changed. Specifically, given the implementation of the Patient Self-Determination Act in 1990, it is likely that changes in clinical practice and subsequent research on informed consent evolved over time. Furthermore, most studies were limited to single institution studies, which may not represent trends in EDs across the country. Finally, most of the included studies were retrospective or observational, which makes them at risk for residual and unmeasured confounding.
Journal Pre-proof Informed consent for invasive procedures in the ED Table 1: Study Characteristics
Study
2017
Study type
Primary outcomes
Themes
26 EM physicians
-Patient understanding of IC
-Aided informed consent -Patient understandi ng
Intervention al (no control group)
-Procedural sedation
162 learners (students/residen ts) 30 teachers
-Frequency of obtaining IC -Type of procedure -Patient level of awareness / consciousness -Provider preference for IC
-Deceased patients -Medical education -Preference for IC
-Deceased patients -Invasive procedures
-Patient preference for IC
-Preference for IC -Waiver of IC
-Invasive procedures -Procedural sedation
96 EM residency program directors
-Frequency of obtaining IC -Type of procedure -Type of provider
-Deceased patients -Medical education
-Deceased patients -Invasive procedures
121 subjects of multicenter trauma transfusion study
-Frequency of obtaining IC
-Waiver of IC
-Blood product transfusion
-Type of procedure -Type of provider
-Medical education
-Invasive procedures -Trainee status
-Patient understanding of IC -Patient satisfaction with IC
-Aided informed consent -Pediatric patients -Surrogate decisionmakers
-Procedural sedation
Fox
Graber
Lin
2002
2013
2003
2013
Descriptive (survey)
Descriptive
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Descriptive (survey)
134 ED patients
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Fourre
2007
Descriptive (survey)
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Easton
1999
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Denny
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Bellolio
Year
Topic of informed consent
Subject type and total
Descriptive (survey)
150 ED patients
Intervention al (randomize d, with control)
67 parents with patients under 18 years of age receiving procedural sedation and anesthesia in the ED
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1995
992 EM practitioners
-Deceased patients -Medical education
-Deceased patients -Invasive procedures
-Deceased patients -Medical education -Surrogate decisionmakers
-Invasive procedures
6011 ED patients 925 ED patient family members
-Patient willingness to consent -Effectiveness of community notification -Patient understanding of IC
-Community notification -Waiver of IC -Patient understandi ng
-Invasive procedures
5 ED nurses (focus group) 4 EM consultants (focus group) 8 patients (interviews)
-Provider preference for IC -Patient preference for IC -Patient understanding of IC
-Preference for IC -Patient understandi ng
-Procedural sedation
-Medical education
-Invasive procedures -Trainee status
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Descriptive (survey)
-Frequency of practice intubation on deceased patients -Written policy on above practice -Frequency of obtaining IC
51 families of newly deceased adults
Descriptive
-Frequency of obtaining IC -Patient rationale for IC decision
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2017
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OMalley
Descriptive (survey)
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Olsen
1991
Descriptive
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Morhaim
1995
-Frequency of obtaining IC -Patient rationale for IC decision
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McNama ra
44 families of newly deceased adults
-Deceased patients -Medical education -Surrogate decisionmakers
Santen
2017
2004
Jo
Revell
Descriptive (interviews and focus groups)
Descriptive (survey)
202 ED patients
-Type of procedure -Type of provider
-Deceased patients -Invasive procedures
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-Procedural sedation
-Pediatric patients -Surrogate decisionmakers -Preference for IC
-Procedural sedation
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-Patient preference for IC
ro
45 parents of pediatric patients
-Patient understanding of IC -Patient satisfaction with IC
-p
Descriptive (survey)
na
1997
184 parents of pediatric patients
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Yamamo to
2017
Jo
Spencer
Intervention al (randomize d, with control)
-Patient understandi ng -Surrogate decisionmakers -Pediatric patients -Aided informed consent
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Journal Pre-proof Informed consent for invasive procedures in the ED
Journal Pre-proof Informed consent for invasive procedures in the ED Discussion
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The present study represents an initial characterization of the clinical studies that have investigated informed consent for invasive procedures in the ED. The 15 studies included in this review used a range of primary outcomes, most often pertaining to the frequency with which informed consent is obtained. The least common primary outcomes were patient level of awareness/consciousness, effectiveness of community notification, patient willingness to consent, and frequency of practicing intubation on deceased patients. Adult patients were the most common subjects of included studies, while trainees (ie. medical students and residents) were the least common subjects. The most common method for conducting these studies is the use of surveys/questionnaires, with the least common being randomized control trials.
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Future research should continue developing an understanding of the informed consent process. Research that focuses on understanding will facilitate the identification of deficiencies in the informed consent process, which in turn can be used as a basis for designing interventions aimed at improving clinically-important outcome measure. This understanding-based orientation has been used successfully to identify gaps in parental understanding of the concept of randomization in pediatric cancer trials25, which were later used as the basis for an advisory group that was convened to more adequately address patient and family needs for understanding childhood leukemia trials26.
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Informed consent is a foundational aspect of medical decision-making for patients and healthcare providers alike. The informed consent process is made more challenging in the ED where factors such as acute changes in mental status and time-sensitive, emergent medical problems are common. The present study shows that many elements of informed consent for invasive procedures in the ED have been evaluated with a number of different methodologies. To continue improving patient outcomes pertaining to informed consent, future studies will need to focus on gaps in the existing literature.
Journal Pre-proof Informed consent for invasive procedures in the ED References 2015 National Hospital Ambulatory Medical Care Survey [Internet]. National Center for Health Statistics; Available from: https://www.cdc.gov/nchs/data/nhamcs/web_tables/2015_ed_web_tables.pdf
2.
Dictionary of Cancer Terms [Internet]. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/invasive-procedure
3.
Sulmasy LS, Bledsoe TA, for the ACP Ethics, Professionalism and Human Rights Committee. American College of Physicians Ethics Manual: Seventh Edition. Ann Intern Med 2019;170(2_Supplement):S1.
4.
Feinstein MM, Pannunzio AE, Lobell S, Kodish E. Informed Consent in Pediatric Anesthesia: A Narrative Review. Anesth Analg 2018;127(6):1398–405.
5.
Tierney S, Perlas A. Informed consent for regional anesthesia. Curr Opin Anaesthesiol 2018;31(5):614–21.
6.
Sturgess J, Clapp JT, Fleisher LA. Shared decision-making in peri-operative medicine: a narrative review. Anaesthesia 2019;74 Suppl 1:13–9.
7.
Moher D. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. Ann Intern Med 2009;151(4):264.
8.
Denny CJ, Kollek D. Practicing procedures on the recently dead. J Emerg Med 1999;17(6):949–52.
9.
McNamara RM, Monti S, Kelly J. Requesting Consent for an Invasive Procedure in Newly Deceased Adults. JAMA 1995;273(4):310–2.
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1.
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10. Olsen J, Spilger S, Windisch T. Feasibility of Obtaining Family Consent for Teaching Cricothyrotomy on the Newly Dead in the Emergency Department. Ann Emerg Med 1995;25(5):660–5. 11. Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department: Pediatr Emerg Care 2015;31(8):572–6. 12. Yamamoto LG, Young LL, Roberts JL. Informed consent and parental choice of anesthesia and sedation for the repair of small lacerations in children. Am J Emerg Med 1997;15(3):285–9. 13. Lin, Ken-Yo. A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department. 2013;5.
Journal Pre-proof Informed consent for invasive procedures in the ED 14. Levin SM. H.R.4449 - 101st Congress (1989-1990): Patient Self Determination Act of 1990 [Internet]. 1990 [cited 2019 Apr 24];Available from: https://www.congress.gov/bill/101stcongress/house-bill/4449 15. American Academy of Pediatrics Committee on Bioethics. Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics 1995;95(2):314–7. 16. Fourre, Mark. The Performance of Procedures on the Recently Deceased. Acad Emerg Med 2002;9(6):5. 17. Morhaim DK, Heller MB. The practice of teaching endotracheal intubation on recently deceased patients. J Emerg Med 1991;9(6):515–8.
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18. O‘Malley GF, Giraldo P, Deitch K, et al. A Novel Emergency Department-based Community Notification Method for Clinical Research Without Consent. Acad Emerg Med 2017;24(6):721–31.
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19. Bellolio MF, e Silva LOJ, Alencastro Puls H, Hargraves IG, Cabrera D. The research to practice continuum: Development of an evidence-based visual aid to improve informed consent for procedural sedation. J Clin Transl Sci 2017;1(5):316–9.
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20. Revell S, Searle J, Thompson S. The information needs of patients receiving procedural sedation in a hospital emergency department. Int Emerg Nurs 2017;33:20–5.
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21. Easton RB, Graber MA, Monnahan J, Hughes J. Defining the Scope of Implied Consent in the Emergency Department. Am J Bioeth 2007;7(12):35–8.
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22. Santen SA, Hemphill RR, McDonald MF, Jo CO. Patients‘ Willingness to Allow Residents to Learn to Practice Medical Procedures: Acad Med 2004;79(2):144–7.
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23. Graber MA. Patient Opinions and Attitudes toward Medical Student Procedures in the Emergency Department. Acad Emerg Med 2003;10(12):1329–33. 24. Fox EE, Bulger EM, Dickerson AS, et al. Waiver of consent in noninterventional, observational emergency research: The PROMMTT experience. J Trauma Acute Care Surg 2013;75:S3–8. 25. Kodish E, Eder M, Noll RB, et al. Communication of Randomization in Childhood Leukemia Trials. JAMA 2004;291(4):470–5. 26. Yap TY, Yamokoski A, Noll R, et al. A physician-directed intervention: teaching and measuring better informed consent. Acad Med J Assoc Am Med Coll 2009;84(8):1036–42.
Journal Pre-proof Informed consent for invasive procedures in the ED
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Figure 1
Max M. Feinstein, Janet Adegboye, Joshua D. Niforatos, Richard M. Pescatore PII:
S0735-6757(20)30035-8
DOI:
https://doi.org/10.1016/j.ajem.2020.01.035
Reference:
YAJEM 158721
To appear in:
American Journal of Emergency Medicine
Received date:
9 December 2019
Accepted date:
18 January 2020
Please cite this article as: M.M. Feinstein, J. Adegboye, J.D. Niforatos, et al., Informed consent for invasive procedures in the emergency department, American Journal of Emergency Medicine(2018), https://doi.org/10.1016/j.ajem.2020.01.035
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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.
© 2018 Published by Elsevier.
Journal Pre-proof Informed consent for invasive procedures in the ED
Full title: Informed consent for invasive procedures in the emergency department Running title: Informed consent for invasive procedures in the ED Max M. Feinstein MD MA1, Janet Adegboye2, Joshua D. Niforatos MD MTS2,3, Richard M. Pescatore DO4
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1. Department of Anesthesiology, Mount Sinai Hospital, New York, NY, USA. Email address: [email protected] 2. Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA Email address: [email protected] 3. Department of Emergency Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA Email address: [email protected] 4. Department of Emergency Medicine, Crozer-Keystone Health System, Chester, PA, USA Email address: [email protected]
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IRB status: None required Financial Support: None
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Word Count: 3,861 Table Count: 1
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Author contributions: MMF and JA designed the study, performed the systematic review, analyzed the results, and contributed to writing the manuscript. JDN and RMP designed the study, acted as consultants for the systematic review, analyzed the results, and contributed to writing the manuscript. MMF takes responsibility for the paper as a whole.
Corresponding Author Joshua D. Niforatos, MD, MTS Address: 1830 E. Monument St., Suite 6-100 Telephone Number: (505)-554-4644 Email: [email protected] Conflict of Interest Disclosure: None to Declare
Journal Pre-proof Informed consent for invasive procedures in the ED Abstract Background: Informed consent for procedures in the emergency department (ED) challenges practitioners to navigate complex ethical and medical ambiguities. A patient‘s altered mental status or emergent medical problem does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced assessment of the situation to determine the appropriate level of participation. Given the complexities involved with informed consent for procedures in the ED, it is important to understand the experience of key stakeholders involved.
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Methods: For this review, we searched Medline, the Cochrane database, and Clinicaltrials.gov for studies involving informed consent in the ED. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient‘s family, or healthcare provider), number of participants, and primary outcomes measured.
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Results: Fifteen articles were included for final review: Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), and patient understanding (4 of 15 studies). The least common theme addressed in the literature was community notification (1 of 15 studies).
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Conclusions: Studies of informed consent for procedures in the ED span many aspects of informed consent. The aim of the present narrative review is to summarize the work that has been done on informed consent for procedures in the ED.
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Introduction Background In 2015, an estimated 136.9 million visits to the emergency department (ED) were made in the United States1. Of those visits, 56.0 million (40.9%) involved one or more procedures being performed in the ED. While procedures vary substantially in nature, ―invasive procedures‖ have been defined by the National Cancer Institute as, ―A medical procedure that invades (enters) the body, usually by cutting or puncturing the skin or by inserting instruments into the body‖2. The American College of Physicians Ethics Manual states that informed consent should be obtained for procedures, except for those that are neither risky nor invasive, or if the patient lacks capacity to make decisions and no surrogate decision-maker is available3.
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Importance Best practices for informed consent for invasive procedures comes from the anesthesiology literature4–6. Informed consent in this clinical setting is frequently perioperative and often for elective procedures rather than emergent procedures. Given the potential complexities involved with informed consent for invasive procedures in the ED setting, it is paramount to understand the perspective of key participants, including patients, providers, and researchers. Specific complexities include time restrictions on the informed consent process due to the emergent nature of medical problems in the ED, as well as variations in a patient‘s level of consciousness that may impact his/her level of understanding and, therefore, the capacity to provide consent.
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Goals The aim of this narrative review is to summarize the work that has been done on informed consent for invasive procedures in the emergency department.
Journal Pre-proof Informed consent for invasive procedures in the ED Methods Information sources Electronic databases Medline, Cochrane, and Clinicaltrials.gov were searched without date or country of origin restrictions. For the Medline component of the systematic review, Medline‘s ―Best Match‖ search algorithm was used, while Cochrane Library searches were limited to titles, abstracts, and keywords. Additionally, the reference list generated from each database was assessed manually by reviewers M.F. and J.A.
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Search The current review was designed and prepared according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines7, and designed using methods previously described4. Succinctly, the search was conducted on February 7, 2019. The following search terms were used in this review:
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emergency AND (medicine OR department OR room) AND (local OR regional OR sedation OR analgesia OR anesthesia OR intubation) AND informed consent
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Selection criteria Articles were considered eligible if they met the following criteria: (a) randomized controlled trials, nonrandomized clinical trials, prospective or retrospective cohort studies, descriptive studies/surveys, case-control studies, or cross-sectional studies; (b) study population included patients, patients‘ family members, and/or healthcare providers; (c) study setting was the ED; (d) study outcomes related directly to informed consent regarding anesthesia care provided by any healthcare provider; (e) article was in English.
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Narrative reviews, case studies/series, commentaries, and hypothetical cases were excluded. Consensus was reached between the two reviewers (M.F., J.A.) to include or exclude any study for full text review. A third reviewer (J.N.) was available to resolve disagreement regarding inclusion or exclusion of articles. Full text review of each included study was independently conducted by the two reviewers, and consensus was reached between M.F. and J.A. for final inclusion of themes to discuss. Data extraction and synthesis The reviewers M.F. and J.A. independently extracted data from the search results. After duplicates were removed, all studies meeting full inclusion criteria and no exclusion criteria were reviewed. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient‘s family, or healthcare provider), number of participants, and primary outcomes measured.
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Study registration This systematic review was registered with PROSPERO (https://www.crd.york.ac.uk/PROSPERO). The registration number is CRD42019130410.
Journal Pre-proof Informed consent for invasive procedures in the ED Results Study selection As shown in the PRISMA diagram (Figure 1), 849 records were gathered from the initial database search and citation review. Of those, a total of 841 remained following removal of duplicates. On review of eligibility, 15 studies met all inclusion criteria and no exclusion criteria. The included studies were published between 1991 and 2017. The present literature review is current through February 2019.
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Study characteristics Our results demonstrate that research on informed consent in the ED is variegated. Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), informed consent pertaining to deceased patients (5 of 15 studies), and patient understanding of informed consent (4 of 15 studies). The least common themes addressed in the literature were community notification (1 of 15 studies), pediatric patients (3 of 15 studies), waivers of informed consent (3 of 15 studies), and tools/aids for providing informed consent (3 of 15 studies). A summary of study characteristics is presented in Table 1. Primary outcomes for each study are shown in Figure 2, and the study subjects are shown in Figure 3.
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Surrogate decision-makers The topic of surrogate decision-makers (also known as substitute decision-maker, alternate decision-maker, or health care proxy) is one that came up often when addressing informed consent in the ED8–13. There are many patient populations that are not able to consent for their own procedures, including unconscious patients, intoxicated patients, pediatric patients, and patients who are deceased. According to the Patient Self-Determination Act14, a patient has the right to formally designate a surrogate to make treatment decisions if the patient becomes unable to make their own decisions. In the event that a surrogate decision-maker has not been identified through either a medical power of attorney or a court-appointed legal guardian, such an agent is selected by medical personnel. In the US, the hierarchy of health care surrogates may vary according to the law of the specific state, but an example order of priority is listed here: 1. The patient‘s guardian 2. The patient‘s spouse 3. Any adult son or daughter 4. Either parent 5. Any adult brother or sister 6. Any adult grandchild or an adult relative 7. A close friend of the patient Two studies addressed surrogate decision-making by the families of deceased patients9,10. Olsen et al. and McNamara et al. surveyed family members to ask about consenting on behalf of the
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recently deceased. When given the option to perform invasive procedures on the recently deceased, such as endotracheal intubation or cricothyrotomy, consent was only given about half of the time. For both studies, reasons given by families who consented for the procedure included helping young doctors learn and the potential benefit to a future patient. In contrast, reasons for family refusal of consent included the desire to avoid invasive procedures on the body, religious reasons, and that the deceased had been through enough. In a few cases, the lack of a single spokesperson created an inability for the family to reach a decision regarding consent. Based on the study results, it appears that the family members tried to honor the wishes of the deceased; however, the studies did not include explicit information about whether or not the patient had an advanced directive.
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Three studies focused on how to improve the surrogate decision-making of a parent on behalf of their child11–13. Spencer et al. and Lin et al. achieved this by incorporating a computer-assisted presentation to improve the parent‘s understanding of the procedure, while Yamamoto et al. asked the parent‘s preference for each step of the procedure. Interestingly, none of the studies investigated the children‘s preference or understanding of the procedure. Spencer et al. included assent in one of their parental satisfaction surveys, but did not expand on how much of a choice the child had for undergoing the procedure. Unlike informed consent for the adult patient, assent from pediatric patients is not always required by law. However, even if assent is not required, children may still benefit from going through the assent process because it allows them to feel more engaged and in control of their health15.
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Deceased patients Fourre et al., Morhaim et al., and Denny and Kollek sought to measure the prevalence of practicing invasive procedures on recently deceased patients in the ED8,16,17. Furthermore, they wanted to see how often informed consent was obtained in these situations. Fourre et al. mailed surveys to program directors of all Accreditation Council for Graduate Medical Education (ACGME)-approved residency programs in emergency medicine16. Of the 96 surveys returned, 45 (47%) indicated that procedures were performed on the recently deceased for teaching purposes in their ED. However, there was no consensus among program directors concerning the appropriateness of obtaining informed consent from family members for these procedures. In fact, 34 out of 45 (76%) stated that they ‗‗almost never‘‘ obtain consent from family members for these procedures. Morhaim et al. saw similar results when they sent surveys to every ED director in the country17. Of the 992 responses, 537 (54%) directors reported the practice of endotracheal intubations on recently deceased patients in their ED. In the vast majority of these cases (97%), the families were not informed of this practice and informed consent was not obtained. Although the practice of endotracheal intubations on recently deceased patients was widespread, objections to its
Journal Pre-proof Informed consent for invasive procedures in the ED practice were also common. In the 537 EDs where this was practiced, 134 (25%) reported at least one complaint from a healthcare provider or from the institution itself.
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Denny and Kollek surveyed 162 learners (medical students and residents in emergency medicine) and 45 teachers (emergency physicians and trauma team leaders), and also found similar results8. Of the 303 invasive procedures performed by the learners, 34 (11%) were performed on mannequins, 169 (56%) were performed on conscious patients, 85 (28%) were performed on unconscious patients, and only 15 (5%) were performed on recently deceased patients. None of the participants obtained consent before practicing or teaching a procedure on a recently deceased patient.
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Olsen et al. and McNamara et al. also examined the process of obtaining informed consent for invasive procedures on recently deceased patients9,10. However, unlike the three studies mentioned above, they chose to survey the family members instead of the emergency medicine personnel. Olsen et al. approached the family members of deceased patients for consent to perform a cricothyrotomy as a learning opportunity for physicians10. Of the 51 families included in the study, 20 families (39%) consented to post-mortem cricothyrotomy, 23 families (45%) refused consent, and 8 families (16%) were too distraught to be approached. Six weeks after the death, follow-up phone calls were made to the 43 families who were approached. Only one of these families expressed that they were offended or upset about being approached for the procedure. All felt that they were approached respectfully, had enough information to make a decision, understood what was being asked, and felt they had a choice in the decision. In a similar manner, McNamara et al. approached the family members of deceased patients for consent to perform endotracheal intubations as a learning opportunity9. Of the 44 families approached, 26 families (59%) consented to post-mortem intubation, while 18 families (41%) refused consent. Patient understanding Patient understanding of the risks and benefits of invasive procedures is an important factor in obtaining informed consent3. There are different methods for assessing patient understanding and obtaining informed consent prior to procedures reported in the included studies. One method is community consultation and public disclosure for research studies that are otherwise exempt from informed consent. O‘Malley et. al. successfully disclosed to almost 7,000 patients about an ongoing clinical trial comparing the use of cricoid pressure versus no cricoid pressure and bimanual laryngoscopy18. Patients and family were informed by either a large poster in the waiting room of the ED or approached by a research associate in the waiting room and read the IRB verbal script. Approximately 74% of patients and accompanying family stated they understood and would hypothetically agree to participate in the aforementioned clinical trial.
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For non-emergent procedural sedation and analgesia (PSA), Bellolio et. al. discovered in their ED that patients, caregivers, and clinicians understood the benefits of PSA19; however, all parties were unaware of the magnitude of risk associated with this intervention. Revell et. al. had similar findings in their descriptive exploratory study of face-to-face interviews with patients20. Although only 8 patients were interviewed after PSA, all patients agreed that they did not need information regarding indications for this procedure in written format. However, the patients wanted information related to their safety throughout the ED stay, suggesting a better need regarding both risk of PSA and outcomes of chief complaint. Similarly, patients enrolled in the verbal consent group in Spencer et al.'s study were less likely to know they had a right to refuse PSA and overall scored lower on knowledge of PSA compared to the intervention group11.
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Aided informed consent Three studies were identified that addressed different methods for providing information related to PSA in the ED11,13,19. When Bellolio et al., mentioned previously, discovered that patients, caregivers, and clinicians did not understand the magnitude of risk associated with these procedures, they developed two aids to improve the informed consent process19. First, a pocket card for emergency medicine physicians was created to standardize the language used when communicating benefit and risk information to patients related to PSA. While the physicians were appreciative of this bedside tool, patients still did not understand the risk information or were not able to engage in decision-making based on this information. The pocket card was then transformed into a visual aid modified to the 6th grade reading level; however, the results from the post-implementation evaluation are still pending.
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Similar to Bellolio et. al., Spencer et. al. studied the efficacy of implementing multimedia presentations (MMPs) for informed consent related to ketamine sedation11. The primary outcome was comprehension of ketamine PSA and parental satisfaction of the consent process comparing MMPs to standard practice (verbal consent) in a randomized study. The MMP group scored higher overall in comprehension and parental satisfaction compared to parents enrolled in the verbal consent group. Furthermore, those in the MMP group were more likely ―to feel involved in the decision to use ketamine‖ and to understand ―they had a right to refuse the ketamine‖. When implemented into the daily ED workflow, the results remained stable with increased comprehension and satisfaction with MMPs. Lin et. al. are conducting a randomized trial to assess whether a computed-assisted information program is superior to routine verbal consent informing parents about the risks, benefits, and alternatives to PSA for their children in the ED13. This study is registered in clinicaltrials.gov, but the results are not available at this time. Pediatric patients
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As described above, Spencer et al. and Lin et al. both performed randomized control trials to see if the use of computer-assisted presentations would improve parental satisfaction and comprehension of informed consent11,13. Alternatively, Yamamoto et al. approached 45 parents to inquire how much they wanted to be involved in the decision-making for their child12. Children were included if they presented to the ED with a small laceration and were less than 8 years old. Parents were allowed to decide on the method of local anesthesia (topical or infiltrated) and whether or not to sedate their children during laceration repair. The informed consent process included both the benefits and risks of each choice, and the physician was told to remain neutral. In 44 out of 45 cases, the parents preferred to be included in the medical decision-making. Only one parent (a 37-year-old mother) indicated that she could not decide whether she liked helping the doctor or not.
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Preference for informed consent Implied informed consent occurs when a patient presents to the ED for treatment and it is understood by both the patient and the health care provider that the patient agrees to be treated at the institution21. To ascertain patient perspectives of implied informed consent, Easton et. al. surveyed 134 patients presenting to their ED regarding the amount of time they perceived necessary to give consent for numerous procedures21. Interestingly, patients perceived 5.6 minutes as enough time for formal consent compared to 7.6 minutes for lumbar puncture and 1 minute for simple blood draw. Though this study was not powered to detect meaningful differences in time allocated for the survey, the signal from this study suggest patients desire more than a cursory overview of risks, benefits, and alternatives prior to receiving PSA.
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Although the aforementioned studies provide valuable information related to preferences for informed consent, Yamamoto et. al.‘s survey study suggests some limits to hypothetical survey questions12. In a pediatric emergency setting, 45 parents were surveyed regarding their preferences for PSA for repair of small lacerations in their children. All 45 parents surveyed preferred non-sedation over sedation. However, in the non-ED setting—i.e., interviews in private offices—only 67 of 94 parents (71%) preferred non-sedation over sedation, suggesting hypothetical encounters may not fully reflect real-time preferences in the emergency setting for PSA. In both settings, parents significantly desired to be involved in medical decisions for their children. In contrast, Revell et. al.‘s descriptive exploratory study—with only 8 patients— suggests that adult patients do not need written information regarding indications for PSA, though they wanted continual confirmation of their safety throughout the ED visit20. In situations in which a patient is not able to provide informed consent, the discretion may rest on the clinician regarding the timing of consent. Denny and Kollek conducted a survey study in Canada that assessed whether physicians or trainees obtained consent from surrogate decisionmakers for procedures on recently deceased patients in the ED8. Among 222 survey respondents disclosing a few hundred procedures on recently deceased patients, no survey respondent
Journal Pre-proof Informed consent for invasive procedures in the ED obtained informed consent prior to practicing the procedure. Barriers to obtaining informed consent, as reported by the respondents, included an inability to identify surrogate decisionmaker at the time of the procedure, a perception that surrogate decision makers were unlikely to consent, and a desire to not upset family members of recently deceased patients. Living patients and surrogate decision-makers were not surveyed to assess non-health care provider perspectives.
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Medical education Medical education was a common theme throughout many of the studies included in the present review 8–10,16,17,22,23. Several studies surveyed the frequency with which deceased and unconscious patients were involved in the teaching of procedural skills8–10,16,17 (CITE Denny, Fourre, McNamara, Morhaim, Olsen), with results as described above under the deceased patients heading. Graber et. al. and Santen et. al. explored patient attitudes regarding medical students performing procedures in the ED22,23. Both studies found that procedure invasiveness correlates with greater patient reluctance to allow students to perform procedures. Santen et. al. specifically explored the question of whether patients would want to be informed if it was a medical resident‘s first time performing an invasive procedure, such as lumbar puncture or intubation, with the vast majority of patients answering in the affirmative22. While unsurprising, these results highlight that patients consider trainee status to be an important consideration in the informed consent process.
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Waiver of informed consent Several included studies assessed circumstances under which informed consent for procedures in the ED should be waived21,24. Easton et. al. surveyed 134 ED patients to define a set of procedures for which informed consent should be waived21. They found that approximately half of survey respondents considered that their consent was implied for minimally-invasive procedures such as blood draws and intravenous line starts. Patients demonstrated a preference for the informed consent process in the context of more invasive procedures such as lumbar punctures and conscious sedation. Fox et. al. assessed how a waiver of informed consent would affect participation rates of clinical trials in the ED24. This research question was designed to address the concern that requiring informed consent can reduce response rates significantly enough to introduce selection bias. To make this assessment, the authors investigated the consent status for patients enrolled in a consent-waived study about blood transfusion after traumatic injury. This investigation was possible because one of the participating clinical sites required that investigators attempt to gain informed consent despite the study‘s consent-waived status. Fox et. al. found that of the 121 eligible subjects, consent for participation in research was obtained only for 55 patients (46%). Thus, the authors concluded that requiring informed consent in clinical studies in the ED has the potential to significantly decrease rates of participation and result in selection bias24.
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Community notification The emergent nature of medical problems in the ED poses a significant challenge to obtaining ethnically-appropriate informed consent in the conduct of research18. To address this dilemma, community consultation and notification have been used to engage potential participants in ED research. O‘Malley et. al. sought to implement novel strategies to notify community members about ED studies18. As described in more detail in patient understanding, community notification tools such as posters in the ED and discussion with research assistants in the ED waiting room are both viable methods to facilitate informed consent for studies in the ED setting.
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Limitations Several factors limited the scope of this study. First, the criterion to include only articles written in English potentially limits exposure to variation of cultural and ethical norms for informed consent. Additionally, the included studies were published in a large enough time period (19912017) that clinical practices for informed consent may have significantly changed. Specifically, given the implementation of the Patient Self-Determination Act in 1990, it is likely that changes in clinical practice and subsequent research on informed consent evolved over time. Furthermore, most studies were limited to single institution studies, which may not represent trends in EDs across the country. Finally, most of the included studies were retrospective or observational, which makes them at risk for residual and unmeasured confounding.
Journal Pre-proof Informed consent for invasive procedures in the ED Table 1: Study Characteristics
Study
2017
Study type
Primary outcomes
Themes
26 EM physicians
-Patient understanding of IC
-Aided informed consent -Patient understandi ng
Intervention al (no control group)
-Procedural sedation
162 learners (students/residen ts) 30 teachers
-Frequency of obtaining IC -Type of procedure -Patient level of awareness / consciousness -Provider preference for IC
-Deceased patients -Medical education -Preference for IC
-Deceased patients -Invasive procedures
-Patient preference for IC
-Preference for IC -Waiver of IC
-Invasive procedures -Procedural sedation
96 EM residency program directors
-Frequency of obtaining IC -Type of procedure -Type of provider
-Deceased patients -Medical education
-Deceased patients -Invasive procedures
121 subjects of multicenter trauma transfusion study
-Frequency of obtaining IC
-Waiver of IC
-Blood product transfusion
-Type of procedure -Type of provider
-Medical education
-Invasive procedures -Trainee status
-Patient understanding of IC -Patient satisfaction with IC
-Aided informed consent -Pediatric patients -Surrogate decisionmakers
-Procedural sedation
Fox
Graber
Lin
2002
2013
2003
2013
Descriptive (survey)
Descriptive
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Descriptive (survey)
134 ED patients
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Fourre
2007
Descriptive (survey)
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Easton
1999
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Denny
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Bellolio
Year
Topic of informed consent
Subject type and total
Descriptive (survey)
150 ED patients
Intervention al (randomize d, with control)
67 parents with patients under 18 years of age receiving procedural sedation and anesthesia in the ED
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1995
992 EM practitioners
-Deceased patients -Medical education
-Deceased patients -Invasive procedures
-Deceased patients -Medical education -Surrogate decisionmakers
-Invasive procedures
6011 ED patients 925 ED patient family members
-Patient willingness to consent -Effectiveness of community notification -Patient understanding of IC
-Community notification -Waiver of IC -Patient understandi ng
-Invasive procedures
5 ED nurses (focus group) 4 EM consultants (focus group) 8 patients (interviews)
-Provider preference for IC -Patient preference for IC -Patient understanding of IC
-Preference for IC -Patient understandi ng
-Procedural sedation
-Medical education
-Invasive procedures -Trainee status
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Descriptive (survey)
-Frequency of practice intubation on deceased patients -Written policy on above practice -Frequency of obtaining IC
51 families of newly deceased adults
Descriptive
-Frequency of obtaining IC -Patient rationale for IC decision
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2017
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OMalley
Descriptive (survey)
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Olsen
1991
Descriptive
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Morhaim
1995
-Frequency of obtaining IC -Patient rationale for IC decision
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McNama ra
44 families of newly deceased adults
-Deceased patients -Medical education -Surrogate decisionmakers
Santen
2017
2004
Jo
Revell
Descriptive (interviews and focus groups)
Descriptive (survey)
202 ED patients
-Type of procedure -Type of provider
-Deceased patients -Invasive procedures
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-Procedural sedation
-Pediatric patients -Surrogate decisionmakers -Preference for IC
-Procedural sedation
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-Patient preference for IC
ro
45 parents of pediatric patients
-Patient understanding of IC -Patient satisfaction with IC
-p
Descriptive (survey)
na
1997
184 parents of pediatric patients
ur
Yamamo to
2017
Jo
Spencer
Intervention al (randomize d, with control)
-Patient understandi ng -Surrogate decisionmakers -Pediatric patients -Aided informed consent
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Journal Pre-proof Informed consent for invasive procedures in the ED Discussion
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The present study represents an initial characterization of the clinical studies that have investigated informed consent for invasive procedures in the ED. The 15 studies included in this review used a range of primary outcomes, most often pertaining to the frequency with which informed consent is obtained. The least common primary outcomes were patient level of awareness/consciousness, effectiveness of community notification, patient willingness to consent, and frequency of practicing intubation on deceased patients. Adult patients were the most common subjects of included studies, while trainees (ie. medical students and residents) were the least common subjects. The most common method for conducting these studies is the use of surveys/questionnaires, with the least common being randomized control trials.
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Future research should continue developing an understanding of the informed consent process. Research that focuses on understanding will facilitate the identification of deficiencies in the informed consent process, which in turn can be used as a basis for designing interventions aimed at improving clinically-important outcome measure. This understanding-based orientation has been used successfully to identify gaps in parental understanding of the concept of randomization in pediatric cancer trials25, which were later used as the basis for an advisory group that was convened to more adequately address patient and family needs for understanding childhood leukemia trials26.
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Informed consent is a foundational aspect of medical decision-making for patients and healthcare providers alike. The informed consent process is made more challenging in the ED where factors such as acute changes in mental status and time-sensitive, emergent medical problems are common. The present study shows that many elements of informed consent for invasive procedures in the ED have been evaluated with a number of different methodologies. To continue improving patient outcomes pertaining to informed consent, future studies will need to focus on gaps in the existing literature.
Journal Pre-proof Informed consent for invasive procedures in the ED References 2015 National Hospital Ambulatory Medical Care Survey [Internet]. National Center for Health Statistics; Available from: https://www.cdc.gov/nchs/data/nhamcs/web_tables/2015_ed_web_tables.pdf
2.
Dictionary of Cancer Terms [Internet]. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/invasive-procedure
3.
Sulmasy LS, Bledsoe TA, for the ACP Ethics, Professionalism and Human Rights Committee. American College of Physicians Ethics Manual: Seventh Edition. Ann Intern Med 2019;170(2_Supplement):S1.
4.
Feinstein MM, Pannunzio AE, Lobell S, Kodish E. Informed Consent in Pediatric Anesthesia: A Narrative Review. Anesth Analg 2018;127(6):1398–405.
5.
Tierney S, Perlas A. Informed consent for regional anesthesia. Curr Opin Anaesthesiol 2018;31(5):614–21.
6.
Sturgess J, Clapp JT, Fleisher LA. Shared decision-making in peri-operative medicine: a narrative review. Anaesthesia 2019;74 Suppl 1:13–9.
7.
Moher D. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. Ann Intern Med 2009;151(4):264.
8.
Denny CJ, Kollek D. Practicing procedures on the recently dead. J Emerg Med 1999;17(6):949–52.
9.
McNamara RM, Monti S, Kelly J. Requesting Consent for an Invasive Procedure in Newly Deceased Adults. JAMA 1995;273(4):310–2.
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1.
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10. Olsen J, Spilger S, Windisch T. Feasibility of Obtaining Family Consent for Teaching Cricothyrotomy on the Newly Dead in the Emergency Department. Ann Emerg Med 1995;25(5):660–5. 11. Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department: Pediatr Emerg Care 2015;31(8):572–6. 12. Yamamoto LG, Young LL, Roberts JL. Informed consent and parental choice of anesthesia and sedation for the repair of small lacerations in children. Am J Emerg Med 1997;15(3):285–9. 13. Lin, Ken-Yo. A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department. 2013;5.
Journal Pre-proof Informed consent for invasive procedures in the ED 14. Levin SM. H.R.4449 - 101st Congress (1989-1990): Patient Self Determination Act of 1990 [Internet]. 1990 [cited 2019 Apr 24];Available from: https://www.congress.gov/bill/101stcongress/house-bill/4449 15. American Academy of Pediatrics Committee on Bioethics. Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics 1995;95(2):314–7. 16. Fourre, Mark. The Performance of Procedures on the Recently Deceased. Acad Emerg Med 2002;9(6):5. 17. Morhaim DK, Heller MB. The practice of teaching endotracheal intubation on recently deceased patients. J Emerg Med 1991;9(6):515–8.
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18. O‘Malley GF, Giraldo P, Deitch K, et al. A Novel Emergency Department-based Community Notification Method for Clinical Research Without Consent. Acad Emerg Med 2017;24(6):721–31.
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19. Bellolio MF, e Silva LOJ, Alencastro Puls H, Hargraves IG, Cabrera D. The research to practice continuum: Development of an evidence-based visual aid to improve informed consent for procedural sedation. J Clin Transl Sci 2017;1(5):316–9.
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20. Revell S, Searle J, Thompson S. The information needs of patients receiving procedural sedation in a hospital emergency department. Int Emerg Nurs 2017;33:20–5.
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21. Easton RB, Graber MA, Monnahan J, Hughes J. Defining the Scope of Implied Consent in the Emergency Department. Am J Bioeth 2007;7(12):35–8.
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22. Santen SA, Hemphill RR, McDonald MF, Jo CO. Patients‘ Willingness to Allow Residents to Learn to Practice Medical Procedures: Acad Med 2004;79(2):144–7.
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23. Graber MA. Patient Opinions and Attitudes toward Medical Student Procedures in the Emergency Department. Acad Emerg Med 2003;10(12):1329–33. 24. Fox EE, Bulger EM, Dickerson AS, et al. Waiver of consent in noninterventional, observational emergency research: The PROMMTT experience. J Trauma Acute Care Surg 2013;75:S3–8. 25. Kodish E, Eder M, Noll RB, et al. Communication of Randomization in Childhood Leukemia Trials. JAMA 2004;291(4):470–5. 26. Yap TY, Yamokoski A, Noll R, et al. A physician-directed intervention: teaching and measuring better informed consent. Acad Med J Assoc Am Med Coll 2009;84(8):1036–42.
Journal Pre-proof Informed consent for invasive procedures in the ED
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Figure 1