The surgical consent process is key to patient understanding of the procedures and outcomes as well as legal protection for patient and provider.  It is much more than simply obtaining a subject's signature on the consent form

The term “informed consent” or “legal informed consent” requires providing patients with adequate information to allow for an informed decision about the surgery, facilitating the patient understanding of the information, options and outcomes, as well as providing adequate opportunity for them to ask questions.

Key to providing patients this information is structuring the consent form in such a way that it is easy to read and consistent with other consent forms.  There are also some basic topics (sections) that should be explicitly noted in the form.

In BETTER CONSENTS PART 1, Kasadia has developed a recommended format and content of the consent form.

In nearly all consent forms reviewed, the key topical areas are covered.  Often though, risks, options and outcomes are intermingled.  This makes it difficult for the patient to really understand the key points.  This is why explicitly breaking up and providing headers (sections) for 6 key topics is crucial:

  • What it is
  • How it is treated
  • Options
  • Risks
  • Outcomes
  • Patient Acknowledgement

This section describes the condition in simple straightforward terms.  Avoid delving into the other sections and just concentrate on the condition, symptoms, how it is formed or underlying conditions.  Repeating analogies and examples also used in educational videos is a great way to add cohesiveness to the overall patient educational plan.  When appropriate, include how the doctor forms the diagnosis of the condition.  Some practices describe what life is like with the condition, others leave that description for the outcomes so that they can accentuate the outcome if the patient decides to NOT have the surgery.

Here we focus on the surgical procedure to correct the condition.  It is best to first describe the treatment and alternative treatments (briefly) in general terms, first and then towards the end of this section describe what happens during the surgery.  This is a good section to mention timing of the surgery and any adverse reactions if the surgery is delayed.  If the procedure is going to have periodic follow-ups or additional surgeries, make sure these are spelled out for the patient.

Many consent forms intermingle options when describing the key or recommended treatment procedure.  Start this section linking the procedure from the previous (how is treated) section and then expanding on options and/or alternatives here.  By separating options from procedures the practice can add more clarity to how options provide focus on benefits related to comfort, well-being and quality of life.

Making these important distinctions when describing patient options helps patients and family process ramification of the options:

  • Significant ramifications to quality of life
  • Significant financial differences
  • Are not life-threating but determine major lifestyle differences (a.k.a. correction of near versus far vision)
  • Alternatives to the recommended procedure (and why they may not be recommended)

Of course, even if options exist for the patient, they may not be candidates for some options.  We like putting in some generic statements such as “you will consult with your doctor and care team to determine which option is best for you”.

In some cases, options exist but the patient does not get to choose. In those cases, we simply state that the doctor will have to make the decision on which option is right for you.

No real secret sauce for risks, most consent forms do a good job of listing these.  Ensure that there this section include material risks common to all surgery and risks specific for the proposed surgery, even if they are rare.  It is not possible to list every conceivable risk so it is often left to the providers clinical judgement on what should be included.

The National Institute of Health advises these guidelines:

  • Should warn the patient of anything that poses a substantial risk of grave adverse consequences
  • Should mention significant risk that would affect the decision of a reasonable patient
  • Is under a clear and legal obligation to tell the truth if asked a direct question

In terms where to draw the line in mentioning a risk, common practice to list the risk if the complication is likely to occur more than 1% of the time.

For some conditions, it is appropriate add a paragraph listing the risks of NOT having the surgery.

Patients and familys respond well when communicating outcomes in the “Best Case/Worst Case” style even when the outcomes do not involve difficult treatment decisions or are not life-threatening.

This section should resonate with the patient in terms of “what will my lifestyle be impacted by the various options or even is the surgery is not performed.

Kasadia recommends avoiding “hard” facts and figures here since patients tend to over-focus on these or note understand the underlying statistical meaning.  If the practice feels this information is important for the patient to have, consider placing this information into “fact-sheets” and include as a separate content item on the patient education plan.

Some procures will rely on patient self-care and post-surgical lifestyle choices.  It is critical to provide this information to the patient, even if summarized, so they are aware of the patient responsibility.

Key to this section is to keep it simple and specific.  Use a bulleted list prefaced by text such as “By signing below, you consent (agree) that:”.

There are some specific bullet recommendationsthe practice always include:

  • You read this informed consent form, or someone read it to you
  • You understand the information in this informed consent form
  • The surgeon or staff offered you a paper or digital copy of this informed consent form<
  • The eye surgeon or staff answered your questions about yoursurgery
  • You understand that there may be additional costs if you need more surgery or other treatment

Here are some optional bullets that the practice should consider:

  • You are consenting to have the discussion with your doctor to be video recorded 
  • In the event of an emergency, I hereby give my consent to my transfer from the Surgery Center to a Medicare approved hospital
  • You understand there are no guarantees regarding the results of your surgery and you may have persistent symptoms
  • Possible Observer or Representative (invited & approved by the surgeon) may be present in the operating room

Lastly, adding the SPECIFIC conditions of the procedure and reference the surgery being performed and on the anatomical location (example):

  • You accept that blepharoplasty can change how your eyes or eyelids look
  • You are consenting to have blepharoplasty surgery performed on your RIGHT EYE

Don’t forget to include the consent form TITLE at the top.  Including the words “informed consent” in the title along with the surgical procedure is good practice. This is in addition to the title given when creating the content item in the Kasadia App since the content title does not print with the consent form.

We have opted to keep the formatting elements simple with only 5 options:

  • BOLD
  • Italics
  • Underline
  • Round bullets
  • Numbered lists

This allows consistent formatting when the practice, provider and patient data is automatically rendered to the final consent form.

Check back on the web site for BETTER CONSENTS PART II where we will discuss best practices on recording the VIDEO CONSENT.