Topic: Need everyone' input before 12/11/0700, not just patient,caregiver too
Sorry for the short notice, I got the question just yesterday.
For example, Below for questions 1-4, that, if I am your doctor or nurse, and you are on oxaliplatin, and I ask you those four questions in the exact way, word for word, Do you understand the questions completely? Or need more assistance and explanation . Can you right away ,for question 1,for example, give me the answer peripheral neuropathy or [ cannot touch cold surfaces].
Or for question 9,if your tumor grown into the portal vein and after you read the question, Will you ask yourself whether the oxaliplatin works for my canner which is grown into the portal vein or not? Even you know your diagnosis is cholangiocarcinoma ?
If you can do that, that means the question is understandable for the patients when ask . If not, then the FDA will rephrase the question and make them more user friendly by the patient in order to assess the outcome of the treatment
At this meeting ( patient-focused Drug Development ) at FDA to discuss proposed questions that are geared towards eliciting the burden of disease "from a patient’s point of view." These questions are listed below. We are interested in hearing your feedback on these draft questions; for instance, are the questions are worded in a way that makes sense to you?
Understanding the Condition
1. What are the clinical manifestations of the disease that have the greatest impact on patients?
2. Are there other aspects of the disease that have a significant impact on a patient’s daily life? (e.g., impaired mobility, sleep problems, etc.)
3. How do the clinical manifestations change with disease progression?
4. How do the other aspects of the disease change with disease progression?
Assessment of Treatment Options
5. What therapies are currently used to treat the disease?
6. How effective are available therapies at treating the clinical manifestations of the disease?
7. How well do available therapies work in treating the other aspects of the disease?
8. How does the effectiveness of available therapies change with progression of the disease?
9. Does therapy effectiveness vary by patient sub-population?
Please give your ideas and further feedback on this message page before
12/11/0700.(ie: you can substitute that question with the way you would like to be asked and write it down here, or at least give each question a score between 0-5; 5 meaning you understand the question completely WITHOUt further additional explanation by medical professionals. and 0 being COMPLETELY do not know what the question means to you. And 3 being half and half and need more clarification by the doctor or nurse or need to look it up on the internet before COMPLETELY understand the question.
Just give the rating from 0-5 is ok too.
And I will try to communicate your feedback to the FDA meeting on 12/11/2012.