Informed Consent

Original Editor - Mariam Hashem

Top Contributors - Mariam Hashem, Tony Lowe and Tarina van der Stockt

A brief background

We can track the history of informed consent back to the early years of last century. A doctor in New York was sued for performing a hysterectomy without obtaining patient's consent. The operation initially aimed to investigate an abdominal mass. When the surgeon suspected fibroid he decided to remove the uterus. When informed about the outcome, the patient wasn't pleased and decided to sue the doctor[1].
Justice Benjamin Cordozo, commented “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.”[1]

Simply, informed concept refers to the patient's right to be informed about their condition, and the risks and benefits of treatment options. It requires healthcare professionals to include their patients in their clinical reasoning process to reach a shared decision. Roles and regulations are different from one country to another and in some circumstances you will find yourself challenged by the available resources, culture and your patient's capacity to make their own decisions.

Ethical and Legal frameworks

The four pillars of ethical medical practice are:

  • Respect for autonomy
  • Non maleficence
  • Beneficence
  • Justice[2]

Ethically, informed consent is at the core of moral practice that justifies autonomy, dignity and respect for our patients. It is based on the theories of the philosopher Immanuel Kant which emphasize on doing what is known and recognized as the right thing to do and considering the consequences of actions [3]. He describes autonomy as a ‘ property of the wills of virtually all adult sane human beings, not as a special feature of the most perfectly rational or morally conscientious persons’[4][5]

Historically, doctors and medical professionals weren't required to obtain patients' approval to perform a specific treatment as long as it was justified against the professional medical opinion which became known as the Bolam test. Patients weren't expected to understand their conditions or to be given a choice regarding risks and benefits. People trusted their doctors and thought they know the best for them. But what happens when the outcomes are not ultimately the best for the patient? Think about the woman who wasn't given a choice on the removal of her uterus? Or a patient who was recommended an amputation but declined this option, following which the surgeon decided to perform the operation anyway given her husband's approval and consent?

An example of legal support for informed consent is the UK law stating that medical and healthcare professionals are obliged to inform the patient on risks and benefits of the given treatment and also alternatives and it's up to the patient to choose freely without controlling influence. This is attributed to the famous legal case ''Montgomery Vs Lankarkshire, 2015'', when a short stature woman with type I diabetes was not informed about the risks of vaginal delivery for her condition and as a result her macrosomic baby sustained shoulder dystocia and brachial plexus injury. The court concluded that she should've been advised on cesarean section and informed on the risks of vaginal birth[6].

Why informed consent?

Informed consent is an essential element of good patient-physiotherapy relationship and a respect for patients' rights. Communicating clinical information effectively and educating patients are correlated with compliance with treatment and cooperation[7]

The practice of moral principals in the application of good patient-physician/physiotherapist relationship out weigh the benefits of a paternalistic approach[8].

The emphasis on self-management is widely supported in the evidence[9]. Patients have to show motivation, willingness and active cooperation to the treatment. Adapting patient-centered practice cannot be validated unless a patient has consented on every aspect of treatment.

Informed consent in practice

Effective communication skills are an essential component of informed consent. Listening carefully and giving opportunities for discussion and questions are great tools to empower patients to make their own decisions. It should not be delivered as a bureaucratic process, instead it's a process of exercising good communication and showing empathy.

Understanding the proposed options and voluntarily giving permission without controlled influence are necessities of informed consent[5].

Depending on the nature of intervention and the risks involved, a written consent may be required, such as when deciding to do a grade 5 manipulation[10].

The following points need to be covered to ensure patient's dignity and autonomy[11]:

  • Discussing clinical condition
  • Discussing suggested intervention(s)
  • Alternatives and the related risks and benefits.
  • Assessment of the patient’s understanding and asking them to state their preference.

This information should be delivered in a simple way to the patient. You may choose to support this with written materials, involve the relatives and ask the patients some questions that will check their understanding.

Mills & Epstein argued about the practicality and consequences of the Montgomery case, when the medical workers find themselves challenged to act in the patient's best interest in an attempt to protect themselves. A good way of applying informed consent is to ask yourself how to think and what to think instead of what to do[6].

Obstacles and Limitations

Del Carmen & Joffe [12] discussed two limitations of informed consent:

  1. Limited resources
  2. Cultural perspectives

Limited resources, when minimizing risks - sometimes by limiting choices - is the priority such as in residential care, emergency departments and intensive care units.

Cultural perspectives where paternalistic approaches are still accepted in some communities. Sharing information and being truthful on the medical condition may be considered offensive for some cultural backgrounds.

Management has to be tailored to individual needs and it's the physiotherapist's responsibility to build a good relationship with their patients and find the right balance in negotiating the treatment plan for the patient's best interest.

Competence, refers to the ability to understand the proposed information, plan of care and actions. Healthcare professionals should be trained on dealing with patients who lack the mental capacity to understand their condition and make decisions for themselves.

The principals of mental capacity assessment state that mental capacity should be assumed unless proven otherwise. If incapacity is identified due to learning disability, psychological or neurological impairment that may influence understanding, judgement or decision making, then the healthcare professional should continue support the patients' autonomy as much as possible[13][14]. Refer to this link for further information on mental capacity assessment.

[15]
[16]

References

  1. 1.0 1.1 Alper J, editor. Informed consent and health literacy: workshop summary. National Academies Press; 2015 Mar 4.
  2. Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford University Press, USA; 2001.
  3. Kant’s Moral Philosophy. Plato.stanford.edu. (Stanford Encyclopedia of Philosophy). [online]. (2019). Available at: https://plato.stanford.edu/entries/kant-moral/ [Accessed 6 Jul. 2019].
  4. Christman JP. The inner citadel: Essays on individual autonomy.
  5. 5.0 5.1 Delany, C. M. (2005). Informed Consent: ethical theory, legal obligationsand the physiotherapy clinical encounter, PhD thesis, Centre for Study of Health and Society, School of Population Health, University of Melbourne.
  6. 6.0 6.1 Mills F, Epstein M. Risk disclosure after Montgomery: Where are we going?. Case reports in women's health. 2019 Jan;21:e00090.
  7. Parry RH. Communication during goal-setting in physiotherapy treatment sessions. Clinical rehabilitation. 2004 Sep;18(6):668-82.
  8. Messer NG. Professional-patient relationships and informed consent. Postgraduate medical journal. 2004 May 1;80(943):277-83.
  9. O’Sullivan PB, Caneiro JP, O’Keeffe M, et al. Cognitive functional therapy: an integrated behavioral approach for the targeted management of disabling low back pain. Phys Ther. 2018;98:408–423.
  10. Refshauge KM, Parry S, Shirley D, Larsen D, Rivett DA, Boland R. Professional responsibility in relation to cervical spine manipulation. Australian journal of Physiotherapy. 2002 Jan 1;48(3):171-9.
  11. Delany C. Cervical Manipulation-How Might Informed Consent be Obtained Before Treatment?. Journal of law and medicine. 2002 Nov;10(2):174-86.
  12. Del Carmen MG, Joffe S. Informed consent for medical treatment and research: a review. The oncologist. 2005 Sep 1;10(8):636-41.
  13. Marshall H, Sprung S. The Mental Capacity Act: a review of the current literature. British journal of community nursing. 2016 Aug 2;21(8):406-10.
  14. Church M, Watts S. Assessment of mental capacity: a flow chart guide. Psychiatric Bulletin. 2007 Aug;31(8):304-7.
  15. Informed Consent: In a patient's shoes. Available from: https://www.youtube.com/watch?v=g_LEAp7_isU
  16. The nurses's role in informed consent. Available from:https://www.youtube.com/watch?v=x3xiwxmZwC4