Presentation of my MBE capstone in which I discuss the issues with using technology to engage in 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.

4. Dr. Prognostication

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

6. Definitions
Informed
Consent
Goals of Care
Shared
Decision
Making

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

28. Dr. Prognostication

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