Ethical Issues of Applying Technological Solutions to the Informed Consent Process
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The document discusses the ethical challenges and technological advancements in the informed consent process within healthcare, emphasizing the importance of effective communication and shared decision-making. It highlights the need for health literacy and the risks associated with inadequate consent practices, particularly concerning patients with impaired decisional capacity. Additionally, it compares traditional methods to video and virtual reality solutions aimed at improving patient understanding and involvement in their care decisions.
![Definitions
Informed Consent
• The process in which a health care
provider educates a patient or
their healthcare decision making
surrogate about the risks, benefits,
and alternatives of a given
procedure or intervention.
• Ethically and legally required.
• In practice it is poorly performed
and does not meet the high
standards of its definition
Goals of Care
• The determination of the
endpoints of treatment that are
consistent with a patient’s values
and meaning.
• Ethically required.
Shah P, Thornton I, Turrin D, Hipskind JE. Informed consent. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2021. doi:10.1038/s41415-021-2614-y
Pope TM. Informed Consent Requires Understanding: Complete Disclosure Is Not Enough. Am J Bioeth. 2019;19(5):27-28. doi:10.1080/15265161.2019.1587549](https://image.slidesharecdn.com/21-220516040536-36873937/85/Ethical-Issues-of-Applying-Technological-Solutions-to-the-Informed-Consent-Process-5-320.jpg)
![Teach-Back
A Priori A Posteriori
• Patient has seen a specialist or
been referred from another
physician.
• Minimum: Review documentation.
Ideally speak with other physician.
• “To make sure I provide you with
the best care, it helps me to
understand if you can tell me, in
your own words, what Dr. X, the
[specialty] doctor, explained to
you.”
• You are finishing your visit and
want to assess that the patient has
increased understanding of the
clinic situation.
• “We talked about a lot today and
sometimes I can get a little
technical. For my benefit, if you
were to explain the most important
points of today’s visit to your
family, what would you tell them?”
JBI Database System Rev Implement Rep. 2016 Jan;14(1):210-47](https://image.slidesharecdn.com/21-220516040536-36873937/85/Ethical-Issues-of-Applying-Technological-Solutions-to-the-Informed-Consent-Process-16-320.jpg)
![Non-Maleficence in Informed Consent
• Research has demonstrated that physicians often feel that it is the
responsibility of patients to learn about their prognosis rather than
information that is provided by the physician.
• Two in every three physicians decline providing estimates of
prognosis, particularly regarding life-expectancy.
• As a group, oncologists often use negative and aggressive metaphors
to describe the discussion of prognosis such as
• “hitting [the patient] over the head”
• “dropping a bomb”
• “ambushing [the patient]”
Gordon EJ, Daugherty CK, Gordon E.J, Daugherty C.K. “Hitting you over the head”: Oncologists’ disclosure of prognosis to advanced cancer patients. Bioethics. 2003;17(2):142-168. doi:10.1111/1467-8519.00330
Martin EJ, Widera E. Prognostication in Serious Illness. Med Clin NA. 2020;104(3):391-403. doi:10.1016/j.mcna.2019.12.002
Brennan F, Stewart C, Burgess H, et al. Time to improve informed consent for dialysis: An international perspective. Clin J Am Soc Nephrol. 2017;12(6):1001-1009. doi:10.2215/CJN.09740916](https://image.slidesharecdn.com/21-220516040536-36873937/85/Ethical-Issues-of-Applying-Technological-Solutions-to-the-Informed-Consent-Process-17-320.jpg)
Ethical Issues of Applying Technological Solutions to the Informed Consent Process
- 1. Ethical Issues of Applying Technological Solutions to the Informed Consent Process An Anti-Luddite Discussion Michael Aref, MD, PhD, FACP, FHM, FAAHPM, HMDC @PalliatorMike #CarleBioethxSeminar
- 2. Disclosures • No financial disclosures. • This presentation is my opinion and interpretation of the literature and does not reflect any opinion other than my own.
- 3. Objectives • Review concepts of informed consent, goals of care and shared decision making. • Discuss principlist ethical concepts of autonomy, beneficence, non-maleficence, and justice in terms of informed consent. • Discuss issues of decisional capacity, health literacy, and language as they complicate informed consent. • Compare and contrast video and virtual reality technology solutions for improving informed consent.
- 5. Definitions Informed Consent • The process in which a health care provider educates a patient or their healthcare decision making surrogate about the risks, benefits, and alternatives of a given procedure or intervention. • Ethically and legally required. • In practice it is poorly performed and does not meet the high standards of its definition Goals of Care • The determination of the endpoints of treatment that are consistent with a patient’s values and meaning. • Ethically required. Shah P, Thornton I, Turrin D, Hipskind JE. Informed consent. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2021. doi:10.1038/s41415-021-2614-y Pope TM. Informed Consent Requires Understanding: Complete Disclosure Is Not Enough. Am J Bioeth. 2019;19(5):27-28. doi:10.1080/15265161.2019.1587549
- 7. Choosing a restaurant. Ordering your meal. Deciding how spicy you want it. Shared decision making Goals of care Informed decision making
- 8. Shared Decision Making Choices regarding care that are made jointly by patients or their proxy and their healthcare providers. The application of relational autonomy or the selection of a plan of care from among a clinically viable set of options that is consistent with the patient’s goals. Lenz M, Buhse S, Kasper J, Kupfer R, Richter T, Mühlhauser I. Decision aids for patients. Dtsch Arztebl Int. 2012;109(22-23):401-408. doi:10.3238/arztebl.2012.0401 Elwyn G, Frosch D, Thomson R, et al. Shared decision making: A model for clinical practice. J Gen Intern Med. 2012;27(10):1361-1367. doi:10.1007/s11606-012-2077-6
- 9. Technology and Shared Decision Making • Both informed consent and goals of care are inadequately implemented in practice. • Communications training • Scripting • Websites • Apps • Videos • Augmented and virtual reality Pope TM. Certified patient decision aids: Solving persistent problems with informed consent law. J Law, Med Ethics. 2017;45(1):12-40. doi:10.1177/1073110517703097
- 10. Process of Informed Consent Communication between the provider and the patient or their surrogate in which information is exchanged. The patient or their surrogate elect and authorize an intervention or treatment. Ebbesen M, Sundby M, Pederson F, Andersen S. A Philosophical Analysis of Informed Consent for Whole Genome Sequencing in Biobank Research by use of Beauchamp and Childress’ Four Principles of Biomedical Ethics. J Clin Res Bioeth. 2015;06(06). doi:10.4172/2155-9627.1000244
- 11. Rules of Informed Consent • Respect the privacy of others. • Protect confidential information. • Obtain consent for interventions with patients. • When asked, help others making important decisions. • Telling the truth. Beauchamp T, Childess JF. Principles of Biomedical Ethics. 7th ed. Oxford University Press; 2012.
- 12. Informed Consent in Terms of Ethical Principles •The right to protection from harm •The right to the same treatment regardless of non-disease related factors such as age, sex, gender, sexual orientation, race, religion, finances, or other demographic differences •The right to only be offered options that are helpful •The right of a patient to freely choose among offered clinical options Autonomy Beneficence Non- maleficence Justice
- 13. Autonomy in Informed Consent • Autonomy is the key principle of informed consent. • Majority of patients with serious illness would appreciate prognostication to plan and anticipate their needs, however a majority of physicians are hesitant to do so due to: • lack of training in prognostication and communication regarding prognosis • fear of causing hopelessness • poor estimate models Christakis NA, Lamont EB. Extent and determinants of error in physicians’ prognoses in terminally ill patients: Prospective cohort study. West J Med. 2000;172(5):310-313. doi:10.1136/ewjm.172.5.310 Ranjan P, Kumari A, Chakrawarty A. How can doctors improve their communication skills? J Clin Diagnostic Res. 2015;9(3):1-4. doi:10.7860/JCDR/2015/12072.5712
- 14. Beneficence in Informed Consent • Informed consent requires the appraisal and the disclosure of a patient’s prognosis as well as the interpretation of the disclosed information. • It is important to use evidenced- based interventions that have supportive evidence including positive endpoints of conveying information, risk analysis, and comprehension. • Numerical representations presenting statistics in terms of natural frequencies rather than percentages. • Avoiding linguistic representation of risks without supporting numerical representations. • Graphical representations of information. • SPIKES model • ”Teach-back” Martin EJ, Widera E. Prognostication in Serious Illness. Med Clin NA. 2020;104(3):391-403. doi:10.1016/j.mcna.2019.12.002 Lenz M, Buhse S, Kasper J, Kupfer R, Richter T, Mühlhauser I. Decision aids for patients. Dtsch Arztebl Int. 2012;109(22-23):401-408. doi:10.3238/arztebl.2012.0401 Yen PH, Leasure AR. Use and Effectiveness of the Teach-Back Method in Patient Education and Health Outcomes. Fed Pract. 2019;36(6):284-289. http://www.ncbi.nlm.nih.gov/pubmed/31258322%0Ahttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC6590951.
- 15. SPIKES Set-up the interview Perception of the patient/surrogate Invitation of the patient/surrogate Knowledge sharing Emotional acknowledgement Strategize and summarize
- 16. Teach-Back A Priori A Posteriori • Patient has seen a specialist or been referred from another physician. • Minimum: Review documentation. Ideally speak with other physician. • “To make sure I provide you with the best care, it helps me to understand if you can tell me, in your own words, what Dr. X, the [specialty] doctor, explained to you.” • You are finishing your visit and want to assess that the patient has increased understanding of the clinic situation. • “We talked about a lot today and sometimes I can get a little technical. For my benefit, if you were to explain the most important points of today’s visit to your family, what would you tell them?” JBI Database System Rev Implement Rep. 2016 Jan;14(1):210-47
- 17. Non-Maleficence in Informed Consent • Research has demonstrated that physicians often feel that it is the responsibility of patients to learn about their prognosis rather than information that is provided by the physician. • Two in every three physicians decline providing estimates of prognosis, particularly regarding life-expectancy. • As a group, oncologists often use negative and aggressive metaphors to describe the discussion of prognosis such as • “hitting [the patient] over the head” • “dropping a bomb” • “ambushing [the patient]” Gordon EJ, Daugherty CK, Gordon E.J, Daugherty C.K. “Hitting you over the head”: Oncologists’ disclosure of prognosis to advanced cancer patients. Bioethics. 2003;17(2):142-168. doi:10.1111/1467-8519.00330 Martin EJ, Widera E. Prognostication in Serious Illness. Med Clin NA. 2020;104(3):391-403. doi:10.1016/j.mcna.2019.12.002 Brennan F, Stewart C, Burgess H, et al. Time to improve informed consent for dialysis: An international perspective. Clin J Am Soc Nephrol. 2017;12(6):1001-1009. doi:10.2215/CJN.09740916
- 18. Non-maleficence in Informed Consent • No clear consensus on diagrams, narratives, or inclusion of cultural characteristics in communicating prognostication. • No studies on layout for communicating prognostication. • No definitive evidence regarding language complexity and level used. • Differing prognostic estimates by different providers involved in care. Martin EJ, Widera E. Prognostication in Serious Illness. Med Clin NA. 2020;104(3):391-403. doi:10.1016/j.mcna.2019.12.002 Siddiqui S, Zhang WW, Platzbecker K, Douglas MJ, Rock LK, Eikermann M. Ethical, legal, and communication challenges in managing goals-of-care discussions in chronically critically ill patients. J Crit Care. 2020;(2020). doi:10.1016/j.jcrc.2020.08.029
- 19. Justice in Informed Consent • Informed consent is typically obtained just prior to the procedure, often after any time of consideration of risks versus benefits. • The time period of the duration of the informed consent is not universally agreed upon setting up conflicts of interest when it comes to the appropriate time to reexplore goals of care. Nusbaum L, Douglas B, Damus K, Paasche-Orlow M, Estrella-Luna N. Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study. Glob Qual Nurs Res. 2017;4. doi:10.1177/2333393617732017 Siddiqui S, Zhang WW, Platzbecker K, Douglas MJ, Rock LK, Eikermann M. Ethical, legal, and communication challenges in managing goals-of-care discussions in chronically critically ill patients. J Crit Care. 2020;(2020). doi:10.1016/j.jcrc.2020.08.029
- 20. Decisional Capacity • Capacity is the provider’s assessment that the patient’s level of attention, cognitive processing, and language comprehension with suitable aids that are sufficient for comprehension and processing of medical information to reach, at worst, an informed and, at best, rational decision • Decisional capacity assessments are at minimum best performed by two independent parties. • May benefit from multiple perspectives in cases of greater complexity such as when the patient is only partially incapacitated. Brennan F, Stewart C, Burgess H, et al. Time to improve informed consent for dialysis: An international perspective. Clin J Am Soc Nephrol. 2017;12(6):1001-1009. doi:10.2215/CJN.09740916 Bernat JL. Ethical issues in the perioperative management of neurologic patients. Neurol Clin. 2004;22(2):457-471. doi:10.1016/j.ncl.2003.12.004
- 21. Decisional Capacity Clear Incapacity • Coma • Severe, non-verbal, dementia Occult Incapacity • Verbal patients particularly those with good “defense” mechanisms. • Conversant but lack the executive functioning or short-term memory to make complex, informed, medical decisions • Waxing and waning cognition. • Delirium, encephalopathy • Acute due to emotional impact of new diagnostic or prognostic information. Forte DN, Kawai F, Cohen C. A bioethical framework to guide the decision-making process in the care of seriously ill patients. BMC Med Ethics. 2018;19(1):78-78. doi:10.1186/s12910-018-0317-y Requarth JA. Informed consent challenges in frail, delirious, demented, and do-not-resuscitate adult patients. J Vasc Interv Radiol. 2015;26(11):1647-1651. doi:10.1016/j.jvir.2015.08.011 Bernat JL. Ethical issues in the perioperative management of neurologic patients. Neurol Clin. 2004;22(2):457-471. doi:10.1016/j.ncl.2003.12.004
- 22. Relationships in Informed Consent Patient Provider Surrogate If patients perceive their physician as being integral to decision-making and value their expertise, the more likely they will accept counsel regarding their decisions and remain adherent with recommendations. Separating the patient’s voice from the proxy’s wishes Labrie NHMM, Schulz PJ. The effects of general practitioners’ use of argumentation to support their treatment advice: results of an experimental study using video-vignettes. Health Commun. 2015;30(10):951-961. doi:10.1080/10410236.2014.909276 It is appropriate to include patients with impaired decisional capacity in informed consent to the level of their incapacity, proxies may not understand or accept that the patient’s decisional capacity as impaired.
- 23. Health Literacy and Language in Informed Consent • In first world countries nearly half the population has suboptimal or inadequate health literacy, simultaneously due to the desire to allow for self-determination, there is a drive toward patients and their families making choices amongst increasingly complex options in their healthcare. • Dichotomy between intended and received meaning likely arises from dissimilar life experience and assumptions before, during, and after conversations: • literal meaning • intended meaning • received meaning. Perrenoud B, Velonaki V-S, Bodenmann P, Ramelet A-S. The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol. JBI database Syst Rev Implement reports. 2015;13(10):82-94. doi:10.11124/jbisrir-2015-2304 Batten JN, Wong BO, Hanks WF, Magnus DC. Treatability statements in serious illness: The gap between what is said and what is heard. Cambridge Q Healthc Ethics. 2019;28(3):394-404. doi:10.1017/S096318011900029X
- 24. Health Literacy and Language in Informed Consent Highly contextual words can impair communication: •Treatable •Comfort Provider factors can further complicate communication •provider discomfort with prognostication due to inaccurate tools •fear of inaccurate prediction •discomfort with disclosure of serious news •inadequate communication skills •fear of diminishing hope •fear of causing distress •fear of disrupting the clinical relationship •fear of patient dissatisfaction •provider guilt over not being able to provide curative treatment Martin EJ, Widera E. Prognostication in Serious Illness. Med Clin NA. 2020;104(3):391-403. doi:10.1016/j.mcna.2019.12.002
- 25. Development of Technology for Informed Consent • Development of informed consent technology: • systematic literature review • establishing a theoretical framework • assessing patient attitudes and preferences • pilot phase • evaluation phase • implementation • This is an ethical quagmire as biases carried by developers of tools to assist with informed consent can impact the literature review, theoretical framework, and assessment of patient preferences. Lenz M, Buhse S, Kasper J, Kupfer R, Richter T, Mühlhauser I. Decision aids for patients. Dtsch Arztebl Int. 2012;109(22-23):401-408. doi:10.3238/arztebl.2012.0401
- 26. Video Informed Consent Aids • Video does show benefit in the decision-making process, offering different modalities of patient education beyond brochures increases patient knowledge and satisfaction. • For example, in the CPR-VDA study video • appeared to be feasible • accepted by all parties involved • positively affected decision-making by improving knowledge • clarifying patient values and self-determination • improved congruence between patient’s choices and physician orders • improved communication regarding CPR • reduced uncertainty between involved parties Rothwell E, Johnson E, Wong B, et al. Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial. J Empir Res Hum Res Ethics. 2020;15(4):252-260. doi:10.1177/1556264620913455 Kapell Brown C, Kryworuchko J, Martin W, Brown CK, Kryworuchko J, Martin W. Evaluation of the CPR video decision aid with patients with end stage renal disease. BMC Nephrol. 2018;19(1). doi:10.1186/s12882-018-1018-y
- 27. Video Informed Consent Aids Video modalities allow for standardization of the information transmission portion of informed consent but are likely only useful in cases where the options are relatively binary, e.g. CPR. Video does not allow for the option of assessing knowledge, so even the highest-level information about prognosis will not necessarily be understood and assessment of understanding not obtained. Informed consent improvement is most needed for people with low health literacy which cannot be assessed by the video decision making aid. When families are integrated into conversations and empowered to assist with shared decision making the process is improved, particularly when a patient has impaired decisional capacity. Perrenoud B, Velonaki V-S, Bodenmann P, Ramelet A-S. The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol. JBI database Syst Rev Implement reports. 2015;13(10):82-94. doi:10.11124/jbisrir-2015-2304 Kalocsai C, Amaral A, Piquette D, et al. “It’s better to have three brains working instead of one”: a qualitative study of building therapeutic alliance with family members of critically ill patients. BMC Health Serv Res. 2018;18(1):533-533. doi:10.1186/s12913-018-3341-1
- 29. Augmented and Virtual Reality • Insubstantial literature on the use of augmented and virtual reality in informed consent. • Virtual reality would allow a patient to literally see themselves undergo the treatment without having to bear the burden of direct experience and allow the highest likelihood or best and worst-case scenario’s play out. • Only with minimal risk procedures, such as hemodialysis, patients can trial the intervention before committing to treatment. • Even with strict oversight and guidelines, the rich presentation of suboptimal information leads to significant ethical issues. • Even if we could make the experience indistinguishable from real life it would be unethical to have a patient experience the suffering of an intervention for an imaginary benefit just to assist them in their choices regarding whether to pursue intervention. Scherer JS, Holley JL. The role of time–limited trials in dialysis decision making in critically ill patients. Clin J Am Soc Nephrol. 2016;11(2):344-353. doi:10.2215/CJN.03550315
- 30. Augmented and Virtual Reality • Perhaps the way forward is to make virtual reality simulations of our patients and allow physicians to practice their conversations with these simulacra first before having to engage the patient and their surrogates.
- 31. Thank You Questions • Comments • Discussion
Editor's Notes
- #15: SPIKES takes a good deal of training to be done well. Difficult to replicate this with technology ‘Teach back” requires high level executive functioning assess effectiveness, also difficult to be done by technology In addition, poor health literacy, innumeracy15, and early cognitive impairment in dementia16 may all be patient limiting factors in understanding and comprehension that technology cannot solve.
- #18: Given the underlying rules for informed consent it seems likely that however well-intentioned a new tool would be to assist in informed consent there is an increased risk of further removing physicians from their ethical responsibility of prognostication and communication. That stated there also remains the opportunity with both video and virtual reality aids to empower patients to ask more questions, pulling clinicians from their place of discomfort and promoting ethically responsible, patient-focused, informed consent.
- #19: Different estimates, particularly emotionally distressing information such as prognostic estimates, will impair shared decision making and with differing information make informed consent impossible. Until this divide is traversed it seems non-beneficial to add a separate opinion in the glossy packaging of a video or virtual reality to the mix.
- #20: Many of the issues regarding justice and informed consent appear to be temporal. The patient presents for the procedure or treatment and consent is signed, that is the patient is likely already committed, somewhat in a sunk cost fallacy, to proceeding and no further decision making will be made at that time. Thus, even the best technological aid to informed consent will need to be implemented in a timely fashion to optimize robust reflection on the decisions regarding an intervention well before it would begin. Furthermore, patients and their families may feel that informed consent is for a specific procedure and the time during which the patient undergoes the procedure. However, proceduralists and surgeons may view informed consent as being inclusive of the pre-, peri- post-procedural and recovery from the intervention while other members of the healthcare team will have different opinions regarding the time period for which the informed consent is valid. Clearly any technological solution to informed consent would be biased by the creators to their perceived appropriate duration of the informed consent. Use of ideological rather than scientific considerations in informed consent can derail the shared decision making required because the information provided is inaccurate. This would remain an existential threat to any technological platform to enhance informed consent unless clear standards, such as those used in evidenced-based clinical recommendations, were used.
- #22: Here, again, issues will arise with using technological aids to informed consent. Presenting more information via either video or through virtual reality to an incapacitated patient would only heighten distress for patient and family.
- #23: There are essentially three parties involved in informed consent: the patient, healthcare usually represented by the person obtaining informed consent, and the patient’s support network, e.g. their significant other, family, close friends, or caregivers, typically represented by the patient’s healthcare surrogate or power of attorney. These parties must communicate, i.e. patient-provider, provider-surrogate, and patient-surrogate, in order for informed consent to be truly obtained. There are issues with all these interactions that may potentially complicate technological adjuncts to informed consent. Technological interventions of whatever kind may be able to help provide and frame information. Videos are well suited for providing information and basic computer or web applications may be able to assess rudimentary knowledge but are likely not able to frame information in context of individual patient goals. Short of artificial intelligence that can pass the Turing test (where an artificial intelligence’s answers are indistinguishable from a human)21, provide empathy, and translate goals into definitive clinical plans of care, technology will not be able to assist with decision making and adherence in the same way as an engaged healthcare provider.
- #26: The way that an oncologist, a palliative care physician, and a critical care physician view chemotherapy or cardiopulmonary resuscitation (CPR) is significantly different
- #28: This is a limitation of deferring or delegating informed decision making to a tool like video, apps, or virtual reality as conversation will likely suffer given baseline discomfort with prognostication and conversations about poor prognosis.
- #31: Medicine has suffered morally because of the adoption of more technological solutions when a more human one was required. Each technological advance in medicine has not improved quality of life nor decreased provider burnout and stress. When we look to technology to solve issues that we are fundamentally uncomfortable with such as fear of the unknown and of being cruel we run the risk of making the problem worse and not better. The best way forward in using technology is not by allowing it to address our weaknesses in communication and collaboration but in finding ways to make them our strengths. Perhaps the way forward is to make virtual reality simulations of our patients and allow physicians to practice their conversations with these simulacra first before having to engage the patient and their surrogates.
- #32: Medicine has suffered morally because of the adoption of more technological solutions when a more human one was required. Each technological advance in medicine has not improved quality of life nor decreased provider burnout and stress. When we look to technology to solve issues that we are fundamentally uncomfortable with such as fear of the unknown and of being cruel we run the risk of making the problem worse and not better. The best way forward in using technology is not by allowing it to address our weaknesses in communication and collaboration but in finding ways to make them our strengths. Perhaps the way forward is to make virtual reality simulations of our patients and allow physicians to practice their conversations with these simulacra first before having to engage the patient and their surrogates.