INFORMED CONSENT

Informed consent is the usual way in which patient preferences are expressed

IC is the practical application of respect patient’s autonomy

When a patient consults a physician for a suspected medical problem, the physician makes a diagnosis and recommends treatment

He explains those steps to the patient, giving reasons for the recommended treatment, the option of alternate treatments and the benefits and risks of all options

The patient understands the information, assess the treatment choices and expresses a preference for one of the options proposed by the physician

This is the essence of the Informed Consent

IC constitutes a central feature of an encounter characterized by mutual participation, good communication, mutual respect and shared decision making

IC required a dialogue between the physician and patient leading to an agreement about the course of medical care

IC establishes a reciprocal relationship between physician and patients

After initial consent to treatment has occurred, an ongoing dialogue between patient and physician concerning the patient’s continuing medical needs reinforces the original consent

A properly negotiated IC benefits both the physician and patient. A therapeutic alliance is forged in which the physician’s work is facilitated because the patient has realistic expectations about results of the treatment and is prepared for possible complications and more likely to be a willing collaborator in the treatment

The sad part is that, many studies reveal that physicians often fail to observe the practice and the spirit of informed consent

IC: Standard And Disclosure

Q: How should the adequacy of disclosure of information by a physician be determined?

A: 3 approaches

i. Ask what a reasonable and prudent physician would tell a patient? [PHYSICIAN centered]

ii. What information would a reasonable patient need to know to make an rational decision? [PATIENT centered]

iii. Whether the information provided is specifically tailored to particular patients need for information and understanding [SUBJECTIVE or PATIENT SPECIFIC]

The trend is now going towards; [SUBJECTIVE or PATIENT SPECIFIC]

The reasonable - patient centered standard may be ethically sufficient, but the subjective standard is ethically ideals

Scope Of Disclosure

Many studies show that patient desire information from their physicians

In recent years, candid disclosure even of ‘bad news’ has become the norm

Disclosure should includes the following things:

i. the patient’s current medical status, including the likely course if no treatment is provided

ii. the interventions that might improve prognosis including risks and benefits of procedures and estimation of probabilities and uncertainties associated with these procedures

iii. a professional opinion about alternative modalities of treatment open to the patient

iv. a recommendation that is based on the physician best clinical judgement

In carrying this information, physician should:

i. avoid technical termsii. attempt to translate statistical data

into everyday probabilitiesiii.enquire whether patient

understand the information

(con’t)

iv. invite questions

v. interpret other information that patient has to ascertain its relevance

It is ethically appropriate to disclose levels of experience and it is obligatory to do so in situation where the procedure is serious and elective

The moral and legal obligations of disclosure vary with the situation, they become more stringent as the treatment situation moves from emergency through elective to experimental

COMPREHENSION

The comprehension of the patient is fully as important as the provision of the information

The physician has an ethical obligation to make reasonable efforts to ensure comprehension

Explanation should be given clearly and simply and questions asked to assess understanding

written instructions or printed materials should be provided

CD or video given if necessary

Documentation of Consent

The process of IC concludes with the patient’s consent (or refusal). This consent is documented in a signed ‘consent form’ that is entered in the patients medical record

Difficulties With Informed Consent

Many studies reveal that physicians consistently fail to conduct ethically and legally satisfactory consent negotiation

Physician’s may be having the following problems

i. use of technical language

iii.uncertainties intrinsic to all medical information

iv.worried about harming or alarming the patient

v. hurried and pressed by multiple duties

Patient may be having:

i. limited understandingii. may be inattentive or distractediii.overcome by fear and anxietyiv. selective hearing because of

denial, fear, or preoccupation with illness

Decisional Capacity

Consent to treatment is complicated not only by the difficulty of disclosure but also by the fact that some patients lack the mental capacity to understand or to make choices

In law, the term ‘competence’ or ‘incompetence’ are used to indicate whether persons have the legal authority to make personal choices

Only a judge, can rule whether a person is legally incompetent and to appoint a guardian

In medical care, persons who are legally competent may have their mental capacities compromised by illness, anxiety, pain or hospitalisation

This is referred to a decisional capacity or incapacity

Determining the decisional capacity of a patient is an essential part of a informed consent process

Determining Decisional Capacity

DC refers to the specific acts of comprehending, evaluating and choosing among realistic options

Determining decisional capacity is a clinical judgement

This is done through engaging the patient in conversation, to observe the patient’s behavior and to talk to 3rd parties e.g. family, friends

Assessment tools e.g. (Macc CAT-T) is a commonly used clinical assessment tool