Patient Informed Consent Compliance 5 Day Series: Day 5

15 January, 2018

  1. Language used in Consent form should be simple
  2. Words familiar to non-medical readers should be used
  3. Simple, short and direct sentences should be written at all times
  4. Paragraphs should be kept short
  5. Active verbs should be used often
  6. Important points should be highlighted either by making the text bold, underlining it, or by putting them in boxes
  7. Acronyms should be spelled out at their first usage
  8. Usage of "for example," "so forth" instead of e.g. or etc. is recommended
  9. Brand names of drugs/devices, trademark or registered symbol should be capitalized when used for the first time
  10. Generic names of drug/device names should be in lowercase
  11. Abbreviations that have been accepted as standard in the proposed study (such as HIV and DNA) should not be spelled
  1. 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
  2. Discuss all treatment options
    Determining what should be disclosed as a material risk in the consent process can be challenging.
  3. 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
  4. Decide how much medication information the patient needs
  5. 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.
  6. 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.
  7. 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
  8. Documentation
    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.

Read Day 4 Here

Read Day 3 Here

Read Day 2 Here

Read Day 1 Here