POINTS TO REMEMBER
- Language used in Consent form should be simple
- Words familiar to non-medical readers should be used
- Simple, short and direct sentences should be written at all times
- Paragraphs should be kept short
- Active verbs should be used often
- Important points should be highlighted either by making the text bold, underlining it, or by putting them in boxes
- Acronyms should be spelled out at their first usage
- Usage of "for example," "so forth" instead of e.g. or etc. is recommended
- Brand names of drugs/devices, trademark or registered symbol should be capitalized when used for the first time
- Generic names of drug/device names should be in lowercase
- Abbreviations that have been accepted as standard in the proposed study (such as HIV and DNA) should not be spelled
MEASURES TO IMPROVE THE INFORMED CONSENT PROCESS
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- Work on your Rapport
The importance of good rapport between the patient and doctor cannot be overemphasized. The level of rapport is a better predictor of the risk of litigation than the actual content of any particular discussion
- Discuss all treatment options
Determining what should be disclosed as a material risk in the consent process can be challenging.
- Use the ABCDEF mnemonic which is useful for guiding and documenting your discussion with the patient:
Alternative therapies available
Benefits of the therapy proposed
Common but not devastating risks
Devastating but not common risks
Extra considerations specific to this patient
Facial expressions, body language, and questions
- Decide how much medication information the patient needs
- Discuss how test results will be communicated Laboratory or radiology investigations and their results introduce a unique set of issues. Particularly for non-routine lab work, it is prudent to discuss the advantages, disadvantages, and limitations of the test being ordered or recommended.
- Keep a record of referrals
A patient generally has the right to refuse speciality treatment or referral to a specialist, once informed of the risks of delay or lack of treatment after making such a decision. If a patient still refuses referral document the decision in case it results in a delayed diagnosis or an adverse outcome.
- Avoid making guarantees about procedure
All procedures, including associated anaesthesia, require a discussion of risks and benefits. If appropriate, also discuss available alternative procedures and your reasons for not recommending them
It is a necessary, final step. It records the process that is vital to good patient care and it may be the only proof that a discussion took place. Legal case opinions shed little light on what represents adequate documentation.