Overview
Consents taking and documentation is a vital part of legal and medical ethics that guides medical practice. It serves as a tool for effective patient management. It is meant to be taking before any form of treatment simply because all patients capable of understanding of such form of information has the right to receive accurate information regarding his or her illness/condition, the physician treatment plan, associated complications and effect, and other available treatment options. It is the responsibility of the physician to ensure this is achieved and properly documented before any start of treatment.
Improper taking and documentation
The issue of improper taking of consent and documentation has been a major issue in patient management in recent times. A case of ‘Canterbury vs. Spence’ was a related case of issues of informed consent and documentation, and the potential risks of the surgery were not explained to the prospective patients (Lawnix, 2011). This court case revealed the importance of informed consents and documentation in medical practice.
It is very important for the health care provider to ensure proper taking and documentation of the patient's agreement to the information provided on discussions which is related to treatment of choice, side effects and financial implication. Proper documentation which could be done using consent form, or through documentation in patients case note will help provide a legal ethical and legal basis for the clinical treatment the health care provider is planning to institute.
This issue is a legal and ethical problem which impairs patient’s perception and choices. Different factors contribute to the issue. One major factor is that which relates to the approach the health care provider takes to achieve the taking of consent and the documentation method. Seeing the consent form as been the real informed consent is another contributory factor to the issue. This is because it will impair the face-to-face communication that should have been the foundation of the consent. When a patient is fully informed, he or she will be prepared for the potential outcome of the treatment protocols.
Informed consent in oncology especially relating to chemotherapy is a very important aspect of patient’s management that must be taking before any treatment. This is because of the nature of the management, side effects or complications that are usually associated with the chemicals that are being used. Researches have shown this aspect to be very important in achieving an effective chemotherapy that has both legal and ethical background.
Literature review
Blackwell & Boothman (2009) in their article presented the overview of the issue with improper documentation in clinical oncology especially as related to chemotherapy. The issues at hand were highlighted and the need for improved modes of consent taking and documentation were stated. It is important for the health care provider to note that no matter the means of documentation of the informed consent that has been taking, the most important consideration must be focused on ensuring that the patient is completely informed and understand all aspects of the treatments and complications and then signed the consent. The common methods that could be used to take the informed consent are the standardized consent form and the patients note (Blackwell, & Boothman, 2009). The standardized consent forms are usually easier and efficient in recording the consent.
The issue considered by the researchers to be related to this type of documentation is that whenever the form is to be signed by the patient, it is usually presented with so many other forms for the patient to sign together (Blackwell, & Boothman, 2009). The implication of the approach is that the patient might not actually have the time to review the forms considering the present oncology condition of the patient and the patient is still trying to cope. Another important issue with the standardize form is that the form can’t be customized for individual patient. The implication of this is that, changes occurring in oncology and patient management will not have a way of input in such forms (Blackwell, & Boothman, 2009).
Dina & Maura (2005) in a paper on informed consent and chemotherapy focused on the legal and ethical parts of proper documentation of consent for chemotherapy. The authors highlighted the importance of taking and documenting informed consent before chemotherapy administration by an oncologist. The authors also highlighted the state regulation as regards to informed consent requirements simply because different management entails different informed consents. The U.S law court considered every adult human with sound mind has the right to determine what will happen to his body. This law guides the informed consent hence making it encompasses the diagnosis, proposed interventions, likely derived benefits, complications, and alternatives. The authors have highlighted the defect in taking informed content which is related to loss of standards and elements of consent when taking it (Dina & Maura, 2005).
Physician standard or patient standard of materiality has been the standards that guides taking of consent. Initially, it was the physician standard but now, most American states are after the use of patient standard of materiality (Dina & Maura, 2005). This requires the attending physician to disclose all the information that a reasonable patient would deem material towards making an informed decision as regards to treatment choices. This empower all patients to take decide their treatment choice and not based on the physician choice.
In avoiding the problems of defective documentation, the following method may suffice; standardized forms, clinic note, and check list. Each of the listed method of documentation has its pros and cons.
The most important aspect is that the form should document a face-to-face conversation that occurred between the patient and the physician as regards to the informed consent.
Considering the various ethical issues that has occurred in relation to chemotherapy, the following element is best applied when taking informed consent
This provides the relative explanation of the toxic nature of chemotherapy which is usually associated with different levels of risks and side effects. The legal aspect of informed consent requires that "disclosure of those risks and side effects that are either material to the patient's decision or customarily disclosed by physicians” (Dina & Maura, 2005)
Level of uncertainty
"However, when a proposed intervention is innovative, untested, or otherwise outside the standard of care, this probably constitutes a material fact and should generally be disclosed. If chemotherapy is truly experimental, then the federal Common Rule (45 C.F.R. Part 46) applies “(Dina & Maura, 2005).
Alternatives and personal choices
This involves discussion of various reasonable alternatives with their various advantages and disadvantages for the patients to take an informed decision.
Ways to address the problem of informed consent
Identifying options for documenting informed consent as stated above.
Providing the required and complete information that will educate the client.
Ensuring that a competent non-physician takes the consent or the consent is being taking by the attending physician.
Patient must understand all aspect of the consent and opportunity given for the patient to ask questions on various areas that seem unclear.
Giving the patient the opportunity to choose the treatment option after treatment options are provided.
Ensuring that the consent taken was properly documented in a manner that allows any form of revisit if need be.
Conclusion
It is very important for the oncologist to ensure that the patient is fully informed as regards to all aspect of the treatment, the potential risks and side effects and the alternatives. It is after this has been achieved that the oncologist can then go on with the chemotherapy.
References
Blackwell, C., & Boothman, J.D., (2009). Documenting Informed Consent for Chemotherapy. American Society of Clinical Oncology. DOI: 10.1200/JOP.0742501
Dina, M., & Maura, C., (2005). Informed Consent and Chemotherapy. Legal Corner. Journal of Clinical Oncology. Vol.27 Number32 nov. 10 2009
Lawnix, (2011). Canterbury V. Spence- Case Brief.
Retrieved 26 November, 2011 from http://www.lawnix.com/cases/canterbury-spence.html
