1 (edited by PCL1029 Sun, 09 Dec 2012 11:22:12)

Topic: Need everyone' input before 12/11/0700, not just patient,caregiver too

Hi, everyone.
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.
God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Please note that the questions presented by Percy are of great value and have potential impact on our disease.  Patient-reported outcome (PRO) measures provide an important perspective on how patients feel and function
that cannot be adequately captured by clinical measures. A PRO is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient’s response by a clinician or anyone else.

Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Hi Percy,

Many many thanks indeed for doing this and for all of the work that you do on our behalf and for everything that you are involved with as well. I know that this is a lot of work and takes up so much of your time, and I so hope that you will get a lot of responses and input here from patients that will help with this FDA meeting.

Thank you very much indeed Percy.

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Many of us could contribute to this but you are asking for just patients, am I right?

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Lainy, anyone can answer this patient or caregiver.

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

6 (edited by Pamela Sun, 09 Dec 2012 11:39:51)

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Ok Percy. Here goes. The first is mine. The second is Lauren's.

Understanding The Condition

1. I give it a 3 because I don't understand the meaning of clinical manifestation. I think a simpler term should be used.

2. 5 because you list examples, which helps.

3. 3 because again, I don't understand the term clinical manifestation and would need further explanation.

4.  3 because I think an example like in question 2 would be helpful.

Assessment Of Treatment Options

5. 3 because I think it should say "your" disease instead of "the" disease.

6. 3 because I don't like nor understand the term clinical manifestation and I'm not sure if you are asking about the patient or in general.

7. 2 because I don't understand what therapies you are talking about and what other aspects you mean. Would need examples. Sorry, I don't understand the question.

8. 0 because I don't understand what the question is asking of me.

9. 0 because I don't understand the question at all.

I will go and ask Lauren now. I will put her answers in a separate post.

-Pam

Thanks for all you do, Percy. You are the best.

My beautiful daughter, Lauren Patrice, will live on in my heart forever.

My comments, suggestions, and opinions are based on my experience as a caretaker for my daughter, Lauren and from reading anything I can get my hands on about Cholangiocarcinoma. Please consult a physician for professional guidance.

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Here are Lauren's answers.

1. 0 doesn't understand clinical manifestations.

2. 0 doesn't understand the word aspects.

3. 0

4. 0

5. 5

6. 3 doesn't understand clinical manifestations and would like examples.

7. 3

8. 5

9. 3 If it means per person, I understand. Don't really know what sub-population means.

Lauren said you need to "dumb it down" a lot. Give more examples and use words that are understood by the general public.

My beautiful daughter, Lauren Patrice, will live on in my heart forever.

My comments, suggestions, and opinions are based on my experience as a caretaker for my daughter, Lauren and from reading anything I can get my hands on about Cholangiocarcinoma. Please consult a physician for professional guidance.

Re: Need everyone' input before 12/11/0700, not just patient,caregiver too

Pamela...Lauren is making a good point.  Patient directed literature is to be written at 8th grade level.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER