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I BEFORE E

Inform Before Engaging: Considerations in Informed Consent


Every human being of adult years and sound mind has a right to determine what shall be done with their own body.

- Justice Benjamin Cardozo, in Schloendorff v. Society of New York Hospital (Monks, 1988)


Whenever someone attends an appointment with a healthcare provider, be that a physiotherapist, a doctor, an optometrist or any other service, that patient receives medical care, and care is provided, following consent to that service. Consent in the medical professions is a deeply-studied and broadly-considered element of the process of delivering care, and it is the gateway to the consultation. Clinical work cannot happen if the patient revokes consent at the beginning or at any stage of the process of providing care. This extends to activities that occur outside of the clinic, such as the provision of reports, the sharing or requesting of information, and the discussion of progress. The patient must consent to their involvement, either directly, indirectly, or in increasing degrees of tangentiality in order for management of the patient and their problems to be undertaken.


However, consent itself is a state that is arrived at only after consideration of other factors. For someone to say yes or no, they need to be oriented to the decision they are actually making. This is an element of consideration that sets healthcare apart from other businesses like retail or manufacturing. In healthcare, a patient needs to be appraised of the nature of the service in which they are going to engage, the benefits and risks, as well as other factors that may influence the likelihoods of success or failure of treatment as well as the broader impact this may have on the individual. Additionally, consent needs to be arrived at properly - a person cannot be compelled to provide their consent to receive treatment or participate in a procedure, nor can consent be provided when a person is not of sound mind. From these understandings, we arrive at the concept of informed consent: consent that is provided having fulfilled a few basic criteria: that the patient or their advocate have the legal capacity to make decisions, that consent has been given voluntarily and not under duress, that the consent provided has been done so with respect to the specific treatment and adjacent actions being performed, that the patient is oriented not only to their condition but to the potential outcomes that may arise during the course of treatment, and that the patient does not withdraw consent during that treatment (ACSHQHC, 2020). It is an absolute barrier - a hurdle which if not attended to, stops the process entirely.



These bases form the foundational considerations of consent for clients - that not only must a person consent to the treatment they are undertaking, but that they must understand what they are undertaking. This is such a fundamental element of healthcare that to provide treatment without a patient's consent is for a provider to put themselves at risk of legal and professional liability. Treatment provided without consent constitutes assault and battery, and this is why treatment is most often provided in environments where the risk is controlled either spatially in terms of the clinic or procedurally through other means (Shah, Thornton, Turrin & Hipskind, 2023).


It should be noted that there are factors that can potentially affect a clinician's ability to provide appropriate information to a patient for them to make an appropriately informed decision.


Firstly, there is the problem of pain. Even if pain isn't being considered, the problem becomes one of discomfort. Even if the discomfort is experienced by someone for whom another person is responsible, the problem becomes one of empathy and adjacency. Pain, discomfort, and distress are all disorienting experiences, especially when they occur in a medical context (Bester, Cole & Kodish, 2016). These experiences are disorienting because they affect our attention, our concentration, and our emotions (Lin, Zhuo & Peng, 2022). Emotional and attentional disturbances alter the means by which people make decisions and perform in assessments (Schwarz, 2000): these disturbances affect how people interpret information, assess their situation, receive language and how they interact in turn with other people (Walteros et. al, 2011). The greater the disturbance, the greater the deviation from the norm. Pain is such a ubiquitous factor in clinical consultations that an entire clinical aesthetic of calming and reassurance needs to be developed in order to ground the patient, both for theirs and the clinician's benefit (Kraft-Todd et. al, 2017). A person in pain needs to be met at their level, because, quite simply, pain affects peoples' ability to comprehend what is going on, (Vessey & Siriwardena, 1998). It is safe to assume that presentations to healthcare clinics lie on a spectrum of discomfort: from mild inconvenience to debilitating severity. A patient at the latter end of the scale needs to be handled deftly, both because of their sensitivity and irritability but also because their desire for relief and their distress at their current situation can drive them to make decisions out of desperation rather than in a considered manner.


How many times have the words, "I just want you to stop the pain," been spoken and heard? Those words, expressed wither verbatim or by paraphrased quote, express an intense, visceral and existential desire. Stop the pain. Is that statement alone an example of informed consent on the patient's part? It could be argued that this statement gives the clinician carte-blanche to do what is necessary to manage the patient's presenting discomfort, based on consideration of qualitative and quantitative factors and on weighing up the evidence. However, it is necessary to consider that this statement is expressing an understanding of capability nested in a broadly paternalistic notion of health (Cody, 2023). Visceral and emotionally-driven statements that act as entreaties to the managing clinician show a complete trust in the clinician-driven power structure (Eliassen, 2016). While it could be argued that such statements not only suggest implicit consent, they also place the patient's trust entirely in the clinician, externalising the patient's locus of control on an outside provider to such extent as to make the patient passive in the process. If consent cannot be provided under duress, and a person in pain wants to relieve their discomfort, is that pain and the threat of its continuity not a complicating factor in the elicitation of consent? Externalisation of control to this extent is to make the patient dependent on the clinician (Starr, 1982) and affects the ability of the clinician to clearly communicate information for the patient's benefit. Consent is the basis of collaboration between the clinician and the patient, and while there are times that the outcome depends wholly on clinical practice and the skill of the practitioner, a patient's emotional and pain-driven state must be considered when engaging with someone in distress, especially if a person believes or is led to believe that skills that lie solely within the purview of the clinician are the means to address or eliminate a patient's presenting complaint.


Pain and distress themselves are experiential states that are as multidimensional as the people who find themselves in those situations. Because pain and distress are multidimensional, addressing and managing that individual nuance needs to be done in a manner that is multidimensional and bespoke (Waisel et. al, 2020). This means that how information is presented, conveyed and received will change between patients and even between consultations for the same patient, as a person's orientation to their condition, the severity of their presenting complaint, and their relationship with their practitioner changes over time (Beisecker & Beisecker, 1993). It can be difficult to take time during a session to interrogate factors that contribute to patient understanding of their condition - to review what they have read, what they have heard, the information they have been given and the impact they believe this may have on their lives (Greenhalgh et. al, 2018,) but without taking this time, it can be difficult to estimate or assess the impact of intervention on a person's life aside from evaluating that impact at a superficial level. The societies in which healthcare is delivered are increasingly multicultural, multiethnic, multiracial, distributed over a broad range of ages, levels of education and literacy, and social and personal identity. Each of these individual markers interacts with other markers, in the individual, in their community, and in their society at large. All of these factors impose demands on the healthcare system to deliver care and disseminate information in a manner that meets people as they are and in a means that they can access (Garrett, Whyte, Whelan & Dickinson, 2010). Effective communication of information relies on someone's orientation to their body, their orientation to their condition, and their orientation to the intervention. This communication then needs to be delivered in such a manner that accommodates for patient biases, addresses areas of potential compromise or difficulty, and engages with culturally appropriate and oriented factors to build strength in communication and in the therapeutic relationship (Eliassen, 2016).


The context in which physiotherapy exists and provides services is informed by a society that is increasingly diverse, and the bounds of best practice within that space are defined by legislation. Sometimes patients can be too unwell to attend clinics, and sometimes their level of function is high enough that they can be referred on to a more appropriate service. This boundary of capacity and legislation forms a volume within which all professional interactions with patients occur. The patients who occupy that space are increasingly oriented to their own rights, able to seek, acquire and consider information in advance of ever presenting to a clinic (Rees, Knight & Wilkinson, 2017). Interactions within that space are also characterised by the relationship of the patient with the clinician along an axis of power that can be used to empower or disempower the patient, either deliberately or indirectly based on therapist consideration of individual context (Goodyear-Smith & Buetow, 2001). Conversations about health are increasingly driven by patients, and those conversations cannot occur without consideration and discussion of consent as the necessary facilitating step to begin interventions. Consent is the beginning of collaboration, and collaboration relies on communication (Sinclair et. al, 2016). There are numerous situational and individual biases such as externalisation of control, paternalisation of the process, and failure to engage with individual context that have the potential to affect the trajectory of care and the quality of an individual outcome (Sumsion & Law, 2006.) It is important to meet the patient in their state, be that proactivity, vulnerability, or whatever state of disorientation they are in, and provide a gentle guiding curation to ensure the safe and effective delivery of care (Street, Makoul, Agora & Epstein, 2009).


The patient then again becomes the necessary focus of consideration, first in their presentation, then in their relationship to the clinician and the process of receiving healthcare, and in their capacity as thinking, acting beings. It must be said that even though patients who present may be well-oriented to their conditions, they may be poorly oriented to their rights and the information that substantiates those rights. There are significant discrepancies in what people understand about aspects of consent: crucial information including risks and benefits, and voluntariness are not clearly understood (Pietrzykowski & Smilowska, 2021). This is further compounded by the health literacy of the patient – those with lower health literacy display poorer understanding of and engagement with healthcare practice as well as poorer adherence to management (Australian Institute of Health and Welfare, 2022). It is entirely possible for patients to agree to participate in and receive healthcare on defective grounds, and it is difficult for a therapist to assess present deficits in detail in the span of the average clinical consultation. Health literacy is not something that can be addressed through in-session patient education (Convie et. al, 2020): it is a structural population-level and demographic outcome that arises through the crystallisation of health inequalities and inequities that are present in and a result of societal systems (Kickbusch, Maag & Wait, 2006). How can a therapist assess a patient’s ability to read and comprehend consent documents once the signature has already been provided, with the understanding that the language used in many patient educational tools may be too difficult for patients to comprehend (Barton & Janis, 2020)? This can be controlled for in redundant clinical process but that takes time, and time is money. How can a therapist be confident that a patient understands what they are consenting to? There is no clear answer because this presents a wicked question whose short answer is a charitable assumption and whose longer answer lies beyond the scope of an individual author to interrogate.


It is tempting to say that because of these issues that the elicitation of informed consent and the means by which that is achieved are moot or otherwise less useful than contemporarily understood. That is not the case. Consideration of the necessity of informed consent on moral, proprietary, ethical and legal axes in isolation and in combination supports the conclusion that informed consent is a necessary binary to achieve in clinical practice. From a moral perspective, informed consent is a necessary step in acknowledging, but more importantly deferring to, the autonomy of the patient (Pugh, 2020). Even if the autonomy of the patient is compromised, negotiable or unreliable, elicitation of informed consent is appropriate as it indicates a mutuality of intent on the part of the patient and their clinician. The legal argument for the necessity of informed consent has already been articulated, and this in combination with its other rationalised arms of argumentation crystallise the notion of informed consent into something in line with the contention proposed by O'Neill in 2003, that for all its opacity and compartmentalisation, consent in the medical context is necessary to ensure that patients have not been deceived or coerced, or that as much effort as is reasonably practicable has been used to ensure that care is being undertaken in line with understood and applied best practice.


Managing consent in a clinical context is complicated because people are complicated. No two people are the same, no two presentations are the same, and no two plans of management will produce reliable or similar results. That's the challenge and also the beauty of the work done in clinic - by asking questions, confirming understanding, educating, empowering and guiding, clinicians have the opportunity to add definite, significant and sustainable value to the lives of their clients. It's easy to say that people are different and so their expectations of treatment will be different. It's harder to understand that that difference imposes a burden of labour and consideration on the clinician to consider if not understand how those same differences can be leveraged or need to be overcome. That's the challenge, but it's a worthwhile one, because what is the heart of healthcare if not the process of helping others overcome the challenges they face in their lives?


References:


Australian Commission on Safety and Quality in Health Care. 2020. Informed Consent in Health Care. Retrieved 2023/04/17 from https://www.safetyandquality.gov.au/sites/default/files/2020-09/sq20-030_-_fact_sheet_-_informed_consent_-_nsqhs-8.9a.pdf


Australian Institute of Health and Welfare. (2022, July 7). Health Literacy. Retrieved 2023/04/17 from https://www.aihw.gov.au/reports/australias-health/health-literacy


Barton, N., & Janis, J. E. (2020). Missing the mark: the state of health care literacy in plastic surgery. Plastic and Reconstructive Surgery Global Open, 8(5).


Beisecker, A. E., & Beisecker, T. D. (1993). Using metaphors to characterize doctor--patient relationships: Paternalism versus consumerism. Health Communication, 5(1), 41-58.


Bester, J., Cole, C. M., & Kodish, E. (2016). The limits of informed consent for an overwhelmed patient: clinicians’ role in protecting patients and preventing overwhelm. AMA journal of ethics, 18(9), 869-886.


Cody, W. K. (2003). Paternalism in nursing and healthcare: central issues and their relation to theory. Nursing Science Quarterly, 16(4), 288-296.


Convie, L. J., E. Carson, D. McCusker, R. S. McCain, N. McKinley, W. J. Campbell, S. J. Kirk & M. Clarke. (2020). The patient and clinician experience of informed consent for surgery: a systematic review of the qualitative evidence. BMC medical ethics, 21(1), 1-17.


Eliassen, A. H. (2016). Power relations and health care communication in older adulthood: educating recipients and providers. The Gerontologist, 56(6), 990-996.


Garrett, P. W., Whyte, L., Whelan, A. K., & Dickson, H. G. (2010). Representations and coverage of non-Englishspeaking immigrants and multicultural issues in three major Australian health care publications. Australia and New Zealand Health Policy, 7(1).


Goodyear-Smith, F., & Buetow, S. (2001). Power Issues in the Doctor Patient Relationship. Health Care Analysis, 9(4), 449–462. doi:10.1023/a:1013812802937


Greenhalgh, J., Gooding, K., Gibbons, E., Dalkin, S., Wright, J., Valderas, J., & Black, N. (2018). How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. Journal of patient-reported outcomes, 2(1), 1-28.


Kraft-Todd, G. T., Reinero, D. A., Kelley, J. M., Heberlein, A. S., Baer, L., & Riess, H. (2017). Empathic nonverbal behavior increases ratings of both warmth and competence in a medical context. PloS one, 12(5)


Kickbusch, I., Maag, D., & Wait, S. (2006). Navigating health: The role of health literacy. Alliance for Health and the Future International Longevity Centre-UK.


Lin, C., Zhuo, S., & Peng, W. (2022). Ongoing pain facilitates emotional decision-making behaviors. Brain Science Advances, 8(1), 38-49.


Monks, S. S. (1993). The concept of informed consent in the United States, Canada, England and Australia: a comparative analysis. The UNIVERSITY OF QUEENSLAND LAW JOURNAL, 17(2), 222-233.


O'Neill, O. (2003). Some limits of informed consent. Journal of medical ethics, 29(1), 4-7.


Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: empirical studies on patient comprehension—systematic review. Trials, 22, 1-8.


Pruchno, R. (2012). Not your mother’s old age: Baby boomers at age 65. The Gerontologist, 52, 149–152. doi:10.1093/geront/gns038


Pugh J. (2020) Autonomy, Rationality, and Contemporary Bioethics. Oxford (UK): Oxford University Press


Rees, C. E., Knight, L. V., & Wilkinson, C. E. (2007). Doctors being up there and we being down here: A metaphorical analysis of talk about student/doctor–patient relationships. Social Science & Medicine, 65(4), 725–737. doi:10.1016/j.socscimed.2007.03.044


Schwarz, N. (2000). Emotion, cognition, and decision making. Cognition & Emotion, 14(4), 433–440.


Shah, P., Thornton, I., Turrin, D., & Hipskind, J. E. (2022). Informed Consent. In StatPearls. StatPearls Publishing.


Sherman, K. A., Kilby, C. J., Pehlivan, M., & Smith, B. (2021). Adequacy of measures of informed consent in medical practice: A systematic review. Plos one, 16(5), e0251485.


Sinclair, S., Torres, M. B., Raffin-Bouchal, S., Hack, T. F., McClement, S., Hagen, N. A., & Chochinov, H. M. (2016). Compassion training in healthcare: what are patients’ perspectives on training healthcare providers?. BMC medical education, 16(1), 1-10.


Starr, P. (1982). The social transformation of American medicine. New York, NY: Basic Books.


Street, R. L., Makoul, G., Arora, N. K., & Epstein, R. M. (2009). How does communication heal? Pathways linking clinician–patient communication to health outcomes. Patient Education and Counseling, 74(3), 295–301.


Sumsion, T., & Law, M. (2006). A Review of Evidence on the Conceptual Elements Informing Client-Centred Practice. Canadian Journal of Occupational Therapy, 73(3), 153–162.


Vessey, W., & Siriwardena, A. (1998). Informed consent in patients with acute abdominal pain. Journal of British Surgery, 85(9), 1278-1280.


Waisel, D. B., Ruben, M. A., Blanch-Hartigan, D., Hall, J. A., Meyer, E. C., & Blum, R. H. (2020). Compassionate and clinical behavior of residents in a simulated informed consent encounter. Anesthesiology, 132(1), 159-169.


Walteros, C., Sánchez-Navarro, J. P., Muñoz, M. A., Martínez-Selva, J. M., Chialvo, D., & Montoya, P. (2011). Altered associative learning and emotional decision making in fibromyalgia. Journal of psychosomatic research, 70(3), 294-301.

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