10 Key Questions for Medical Decision-making and Informed Consent
Why is this therapy/drug/procedure indicated for my situation?
What is supposed to do for me?
How does it work - what is the mechanism by which it works?
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%]
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.
Over what time frame is the benefit to be expected?
1 year? 5 years? Etc...
What are the most common side effects?
For those side effects, in what % of patients do they occur?
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.”
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.
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.