10 Key Questions for Medical Decision-making and Informed Consent

  1. Why is this therapy/drug/procedure indicated for my situation?

  2. What is supposed to do for me?

  3. How does it work - what is the mechanism by which it works?

  4. What is the expected benefit?

    • This should be expressed as a number –

      • Relative benefit [example “a 10% improvement”]

      • Absolute benefit [example: improve from 10% to 15%]

  5. In which measurement(s) are/is the benefit: overall survival (OS), progression-free survival, disease-free survival, all-cause mortality etc.

    • Overall survival is the “gold standard” benefit area in oncology, so listen carefully for outcomes listed in another area.

  6. Over what time frame is the benefit to be expected?

    • 1 year? 5 years? Etc...

  7. What are the most common side effects?

    • For those side effects, in what % of patients do they occur?

  8. What are the alternatives to this treatment?

    • This question can often lead to a conversation about therapies that this intervention was directly compared to.

    • It can also open the conversation to other treatments that have more or less effectiveness but have a different side-effect profile

    • The other conversational line from this question is “what do you know of the course of my disease if I choose not to take this therapy or choose something else.”

  9. Can you name the key studies that support this therapy?

    • Oncology professionals should be able to recite the seminal study names, lead author and publication so you can look them up.

  10. If this is a more experimental or less-well studied therapy, questions could include:

    • What studies have been done on this therapy for my situation (the kind of tumor you have)? Listen very carefully to this answer in particular.

    • What kind/phase trials have been performed? Cell, animal, pre-clinical, I, II, III?

    • Where were the studies performed?

    • Has any part of the therapy received regulatory approval from a medical regulatory body in the US, Canada, Western Europe, Japan, or Australia?

    • Where is the data published?

      • At a minimum look for publications in reputable North American or European journals.

      • In the absence of prospective trials, a case report, case study series or even retrospective studies can be supportive if they are written in a scientifically and statistically acceptable manner.

    • What is the proposed mechanism by which it works?

    • What are the known or expected side effects?

    • If the treatment is offered outside the US, ask why that is.