Patient-Formulated Lyme Disease Survey Draft

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
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duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Patient-Formulated Lyme Disease Survey Draft

Post by duncan » Mon 28 Jul 2014 23:00

We can start with basic demographics and then build...Or we can settle in on definitions first.

Regardless, this is the beginning of a patient-centered effort to help better characterize the Lyme community through the creation of an innovative survey and, perhaps, survey process.

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Patient-Formulated Lyme Disease Survey Draft

Post by duncan » Tue 29 Jul 2014 16:59

PATIENT-FORMULATED LYME DISEASE SURVEY

Date: __/__/____
First Name:_____________________
Last Name: ______________________
DOB:_____________
Gender: __________
Marital Status____________
Address: Street_________________________
City_______________________________
Zip________________________________
Phone Number: _______________________
Cell: ______________________
Email Address: ______________________________________________

Question 1) Have you ever been diagnosed with Lyme disease? Yes___No___
Question 1a) If yes, what Species of Lyme (Borrelia)? ____Borrelia Burgdorferi sensu stricto
____Borrelia Afzellii
____Borrelia Garinii
___Other

Question 2) Have you ever been bitten by a tick? Yes___No___Unknown___
Question 2a )IF YES, When?___ Where, i.e.Geographic location?_________________________________
Was the tick species identified? If yes, pls specify:_____________________Was the tick tested for Borrelia? Yes__No__
If Yes, was the genotype identified, and if so, please specify:__________________
Was the tick tested for Outer Surface Protein C type? Yes__No__
If Yes, what was the OspC type?:_______________
Can you estimate how long the tick was attached? Yes?__No__If Yes, approximately how long (hours)?____
Question 2b) IF NO, what explanation was given for source of Lyme disease?_______________________

Question 3) Have you ever had a bull's eye rash, i.e. Eythema Migrans, Yes___No___Unknown____
Not all EM's look like a bull's eye rash. Have you ever a rash of unknown origin approximately 5 cm or larger? Yes__No__Unknown___
Did a doctor examine the rash, and was he aware of any bite history? Yes__No__
Have you ever had a secondary rash that was or might have been associated with Lyme? Yes__No__Unknown__
Have you ever had a skin condition called Borrelia Lymphocytoma? Yes__No__Unknown__
Have you ever had a skin condition called Achrodermititis Chronica Atrophicans? Yes__No__Unknown__
If you had any of the above skin conditions, did you show it to your doctor? Yes__No__
Were you diagnosed with Lyme based solely on the skin condition? Yes__No__
Were you diagnosed based on the skin condition with laboratory tests? Yes__No__

Question 4) Was your diagnosis of Lyme disease made by a doctor? Yes___ No___
If Yes, When?:____ Please identify the State/Province/Country where diagnosis was made:___________________________

Question 5) Did you ever have laboratory tests for Lyme? Yes__No__
Question 5a) If yes:
Did you test positive by an ELISA test? Yes___No___Indeterminate___
Did you test positive by Western Blot to CDC standards? Yes___No____
Did you test positive by Western Blot by another standard? Yes__No__ If yes, what standard?___________________
Were the Western Blot results reported with the results of each of the bands? __Yes__No
Did you have any IgM bands positive on the Western Blot test? Yes__No___
If yes, please list which bands_____________________________
Did you have any IgG bands positive on the Western Blot test? Yes___No__
If yes, please list which bands:____________________________
Were you tested with the Western Blot more than once? Yes___No___
If Yes, please note dates and IgM/IgG bands positive for each instance:________________________________________________________
Please provide the dates, results, and laboratory name for each test:_______________________________________________________________________________________________________________________________________________________________________________
Have you ever had a C6 Peptide test? Yes__No__Unknown__
Was it ever positive? Yes__No__ If yes, do you know its value?___
If you were tested with a C6 Peptide more than once, can you specify their values each time tested?____
Please provide the dates, results and laboratory name for each C6 test:_________________________________________________________________________________________________________________________________________________________________________________
Were you tested with any other Lyme test? __Yes__No
If yes, please provide the dates, results and laboratory name for each result:______________________________________________________________________________________________________________________________________________________________________________________
Which elements of the diagnosis convinced you you had Lyme?____________________________________________________________________________________________
Do you follow mainstream medical Websites and/or peer-reviewed Lyme research to educate yourself about your Lyme diagnosis) Yes__No__
Do you rely of Forums for some of your Lyme information needs? __Yes___No
How many doctors did you see before receiving a Lyme diagnosis that you trusted?_____
What other conditions were you diagnosed with prior to your Lyme diagnosis (pls list approximate dates)?_______________________________________________________________________________________
Were you diagnosed by a PCP, ID doctor, a doctor considered Lyme literate or experienced or other?____________
Were you diagnosed with, or do you believe you have Post Treatment Lyme Disease Syndrome?___Yes __No
Were you diagnosed with, or do you believe you have Chronic Lyme? __Yes ___No
Do you have friends or family that have been diagnosed with Lyme? __Yes ___No Did any help you find a physician that would diagnosis and treat you?
On a scale of 1 to 10 (with 10 meaning very trustworthy), rate your relevant government agency (e.g., in the U.S. it is the CDC), to provide accurate and useful information about Lyme disease:_______


Question 6) Did you ever receive treatment for Lyme? Yes__No__
Question 6a)If yes:
Did you receive oral antibiotics? Please specify type, duration, and start/stop dates________________________________________________________________________________________________________________________________________________________________________________________
Did you receive IV antibiotics? Please specify type, duration, and start/stop dates:_____________________________________________________________________________________
Did you receive herbal or supplemental therapies? Please specify type and duration_____
Did symptoms resolve after treatment? Permanently___For a limited time but then returned____
Please note symptoms that permanently resolved:_____________________________________
Please note symptoms that symptoms that partially or temporarily resolved:___________________________________________________________________________________
Please note symptoms that remained unchanged:__________________________________________________
If you were treated and your Lyme was completely resolved, how long did it take from bite to resolution?_________
If you were treated and your Lyme was not completely cured, how long from bite till now? _____________

Did your symptoms worsen at all after treatment (this is sometimes referred to as a Herxheimer Reaction)? __Yes__No

Question 7) Symptoms. The following series of questions will attempt to characterize the nature, intensity and duration of your symptoms.
Question 7a) Please indicate the symptoms which apply to you:
__Fever
__Facial palsy
__Swollen joints
__Arthralgias
__Fatigue
__Cardiac problems
__Cognitive difficulties
__Vertigo/Dizziness/Balance Issues
__Sleep difficulties
__Peripheral Neuropathy (tingling or pain in extremities)
__Optical Problems
__GI Problems
__Other (Please list)____________________________________________________________________________________________________________________________________________________________________________________

Question 7b) On a scale of 1 to 10, with 1 being insignificant and 10 being unbearable, please rate the applicable symptoms' severity (please note the severity before treatment and after treatment):

BEFORE TREATMENT AFTER TREATMENT
__Fever
__Facial Palsy
__Swollen joints
__Joint pain
__Muscle pain
__Fatigue
__Cardiac problems
__Cognitive Difficulties
__Vertigo/Dizziness/Balance issues
__Sleep difficulties
__Peripheral Neuropathy
__Optical Problems
__GI Problems
__Other (Please list)__________________________________________________________________________________________________________________________________________________________________________________________

Question 7c) On a scale of 1 to 10, with one being almost never present, and 10 being always present, please rate the applicable symptom frequency (please note frequency before treatment and after treatment):

BEFORE TREATMENT AFTER TREATMENT
__Fever
__Facial palsy
__Swollen joints
__Joint pain
__Muscle pain
__Fatigue
__Cardiac problems
__Cognitive difficulties
__Vertigo/Dizziness/Balance issues
__Sleep Difficulties
__Peripheral Neuropathy
__Optical Problems
__GI Problems
__Other (Please list)_________________________________________________________________________________________________________________________________________________________________________________

List the five most significant symptoms ever after treatment in order of severity with the first being most severe that were due to Lyme:_______________________________________________________________________
List five most significant symptoms ever after treatment in order of severity that impact on your quality of life that were due to Lyme:__________________________________________________________________________
List the five most significant Lyme symptoms in order of severity that CURRENTLY impact you:_____________________________________________________________________
List the five most significant Lyme symptoms that CURRENTLY impact your quality of life:_________________________________________________________________________





Question 8)Co-infections
Last edited by duncan on Wed 30 Jul 2014 12:59, edited 18 times in total.

Henry
Posts: 1108
Joined: Thu 10 Nov 2011 18:49

Re: Patient-Formulated Lyme Disease Survey Draft

Post by Henry » Tue 29 Jul 2014 18:16

Duncan: Good start. However, you need to differentiate between the IgM Western blot (unreliable; most experienced investigators recommend not using it anymore) and the IgG Western blot which is quite reliable in patients after 4-5 weeks of infection. I suggest referring only to the results of an IgG Western blot, along with a statement on how the results were evaluated, i.e., according to the criteria recommended by the CDC, or IGenex. There is a BIG difference between the two.

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Patient-Formulated Lyme Disease Survey Draft

Post by duncan » Tue 29 Jul 2014 18:29

Aach, my brain. Good catch, Henry. Not sure will add the definitional distinction between CDC and Igenex as ultimately it's the bands that matter, and each school can derive what it wants from the data. Maybe. If it needs to be added, we will add.

Henry
Posts: 1108
Joined: Thu 10 Nov 2011 18:49

Re: Patient-Formulated Lyme Disease Survey Draft

Post by Henry » Tue 29 Jul 2014 22:55

Duncan: In Immunochemistry 101, one learns that IgM antibody is the first class of antibody made during the immune response. So, early in infection, it is the only type of antibody that can be detected. The IgG antibody response matures later and reaches detectable levels at about 4-5 weeks after infection. These two class of antibody, though specific for the antibodies they react with, differ in valency; IgM is pentavalent, whereas IgG is divalent. Although the difference of 3 in valency seems small, it is an exponential function, which therefore amounts to a difference of 1,000-fold in reactivity. Thus, only slight similarities in structure between unrelated bacterial antigens might not be recognized by IgG antibodies; however, they may be recognized by the more reactive IgM antibody, thereby resulting in a high percentage of false positive tests. That is why the results for IgG Western blots have greater diagnostic significance. Many experts on diagnosis recommend not doing IgM Western blots at all for that reason. This phenomenon is not peculiar to antibody responses against Borrelia antigens. It is true for ALL antibody responses. Some like to use the short-hand terminology that IgM antibody is very "sticky" and thus not as specific as IgG antibody for that reason. But, the immunochemistry tells you why.

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Patient-Formulated Lyme Disease Survey Draft

Post by duncan » Tue 29 Jul 2014 23:18

Understood. Well, maybe not so much. But thanks, Henry, anyway for trying to explain it.

Let me ask you this, though: If this survey can demonstrate a statistically significant correlation between persistently elevated IgM's and persistent symptom presentation, wouldn't that potentially be meaningful, especially if the sample size is large enough - statistically speaking - to re-enforce the inference?

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LHCTom
Posts: 341
Joined: Mon 22 Oct 2012 4:18

Re: Patient-Formulated Lyme Disease Survey Draft

Post by LHCTom » Wed 30 Jul 2014 2:28

Some ideas in bold...

PATIENT-FORMULATED LYME DISEASE SURVEY

Date: __/__/____
First Name:_____________________
Last Name: ______________________
DOB:_____________
Gender: __________
Marital Status____________
Address: Street_________________________
City_______________________________
Zip________________________________
Phone Number: _______________________
Cell: ______________________
Email Address: ______________________________________________

Question 1) Have you ever been diagnosed with Lyme disease? Yes___No___

Question 2) Have you ever been bitten by a tick? Yes___No___Unknown___
Question 2a )IF YES, When?___ Where, i.e.Geographic location?_________________________________
Was the tick species identified? If yes, pls specify:_____________________Was the tick tested for Borrelia? Yes__No__
If Yes, was the genotype identified, and if so, please specify:__________________
Was the tick tested for Outer Surface Protein C type? Yes__No__
If Yes, what was the OspC type?:_______________
Can you estimate how long the tick was attached? Yes?__No__If Yes, approximately how long (hours)?____
Question 2b) IF NO, what explanation was given for source of Lyme disease?_______________________

Question 3) Have you ever had a bull's eye rash, i.e. Eythema Migrans, Yes___No___Unknown____
Not all EM's look like a bull's eye rash. Have you ever a rash of unknown origin approximately 5 cm or larger? Yes__No__Unknown___
Did a doctor examine the EM and was he aware of any bite history?
Have you ever had a secondary rash that was or might have been associated with Lyme? Yes__No__Unknown__
Have you ever had a skin condition called Borrelia Lymphocytoma? Yes__No__Unknown__
Have you ever had a skin condition called Achrodermititis Chronica Atrophicans? Yes__No__Unknown__
If you had any of the above skin conditions, did you show it to your doctor? Yes__No__
Were you diagnosed with Lyme based solely on the skin condition? Yes__No__
Were you diagnosed based on the skin condition with laboratory tests? Yes__No__

Question 4) Was your diagnosis of Lyme disease made by a doctor? Yes___ No___
If Yes, When?:____State/Province/Country where diagnosis was made:___________________________

Question 5) Did you ever have laboratory tests for Lyme? Yes__No__
Question 5a) If yes:
Did you test positive by an ELISA test? Yes___No___
Did you test positive by Western Blot? Yes___No____
Did you have any IgM bands positive on the Western Blot test? Yes__No___
If yes, please list which bands_____________________________
Did you have any IgG bands positive on the Western Blot test? Yes___No__
If yes, please list which bands:____________________________
Were you tested with the Western Blot more than once? Yes___No___
If Yes, please note dates and IgM/IgG bands positive for each instance:________________________________________________________
Please provide the dates, results and Laboratory name for each test?________________________________
Have you ever had a C6 Peptide test? Yes__No__Unknown__
Was it ever positive? Yes__No__ If yes, what was its value?___
If you were tested with a C6 Peptide more than once, can you specify their values each time tested?____
Could you provide the dates, values and Laboratory name for each C6 test?___________________
Were you tested with any other Lyme test? Yes____ No____
Please list these tests with dates, results and laboratory names? _________________________
What elements of the diagnosis convinced you that you had Lyme?______________
Do you follow mainstream medical Websites and or peer reviewed Lyme research yourself in order to educate yourself in undersytanding your diagnosis? yes___ no___
How much do you count on Forums and Forum post advice for your information from 1 minimum to 10 maximum? yes___no___
Question 6) Did you ever receive treatment for Lyme? Yes__No__
Question 6a)If yes:
Did you receive oral antibiotics? Please specify type, duration and start stop dates:_____
Did you receive IV antibiotics? Please specify type and duration with start and stop dates:_____
Did you receive herbal or supplemental therapies? Please specify type and duration_____
Did symptoms resolve after treatment? Permanently___For a limited time but then returned____
Which symptoms permanently resolved if any and which partially resolved and which were unaffected?______
If you were treated and completely resolved, how long from bite to resolution?
If you were treated but not fully resolved, how long from bite to now?___________

Question 7) Symptoms. The following series of questions will attempt to characterize the nature, intensity and duration of your symptoms.
Question 7a) Please indicate the symptoms which apply to you:
__Fever
__Facial palsy
__Swollen joints
__Arthralgias
__Fatigue
__Cardiac problems
__Cognitive difficulties
__Vertigo/Dizziness/Balance Issues
__Sleep difficulties
__Peripheral Neuropathy (tingling or pain in extremities)
__Other - please list

Question 7b) On a scale of 1 to 10, with 1 being insignificant and 10 being unbearable, please rate the applicable symptoms' severity. Please indicate the severity before treatment and after treatment and any variation?
__Fever
__Facial Palsy
__Swollen joints
__Joint pain
__Muscle pain
__Fatigue
__Cardiac problems
__Cognitive Difficulties
__Vertigo/Dizziness/Balance issues
__Sleep difficulties
__Peripheral Neuropathy
__Other - please list

Question 7c) On a scale of 1 to 10, with one being almost never present, and 10 being always present, please rate the applicable symptom frequency:
__Fever
__Facial palsy
__Swollen joints
__Joint pain
__Muscle pain
__Fatigue
__Cardiac problems
__Cognitive difficulties
__Vertigo/Dizziness/Balance issues
__Sleep Difficulties
__Peripheral Neuropathy
__Other - please list

An easy to read table showing symptoms with the characterization numbers, dates, tests, results and everything asked might be a very clean way to very accurately charaterize all the details in time. Then they fill in the blanks.

just a thought.
The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

User avatar
LHCTom
Posts: 341
Joined: Mon 22 Oct 2012 4:18

Re: Patient-Formulated Lyme Disease Survey Draft

Post by LHCTom » Wed 30 Jul 2014 2:49

A few more ideas that might provide some valuable information. If its possible to get data, I think it should be as thorough as possible and include things like beliefs. If such a survey is ccreated, I suggest putting it out and trying to get as many filled out as possible. There are many questions that peoplem like the CDC might prefer not to ask but are valuable in understanding all the issues.

On a scale of 1 to 10 with 10 meaning very trustworthy, rate your trust in the CDC to provide good Lyme Disease information?_____

How many doctors did you see before getting a Lyme diagnosis you trusted?_____

Did you have friends or family that had Lyme? yes____no____ Did they help you with finding a doctor and the diagnosis?

What other conditions were you diagnosed with prior to your Lyme dignosis? Please list with approximate dates?

Were you diagnosed by a PCP, ID doctor, a doctor considered Lyme Literate or experienced, or other?

What do you believe convinced your doctor your condition was Lyme that resulted in treatment?

Were you diagnosed with or do you believe you have chronic Lyme or PTLD and for how long as opposed to being bitten and treated with resolution fairly quickly?
The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

dlf
Posts: 294
Joined: Sun 7 Apr 2013 15:36

Re: Patient-Formulated Lyme Disease Survey Draft

Post by dlf » Wed 30 Jul 2014 3:51

Hi LHCTom!

Glad to see you joining in! I had been working on the other thread to feed into this one and had sort of been trying to work in some kind of order to expand stuff that Duncan started with. I like all the additions you've made but think this will all have to be re-arranged and sorted into categories to make it flow. I hadn't started on testing, but so far the only things I think are missing are:
Did you test positive by an ELISA test? Yes___No___ Indeterminate__________
Were the Western blot tests reported with the results for each of the bands? Yes________No________

(In Canada, the provincial labs won't report individual bands, so unless the patient had other testing done they won't have a record of them and may not even realize that they are reported differently elsewhere. This may also be the case for other areas and commercial labs).

Did you test positive by Western Blot to CDC standards?

Did you test positive by Western Blot to another laboratory standard?


I also think we should include a section on clinical symptoms consistent with the diagnosis, ie what were the early symptoms or more precisely the symptoms that were present at diagnosis. That could go along with the other questions about diagnosis that you added in and were also in the section I posted when we started off in the other thread, and that post was not done ALL tongue in cheek. Some of that could be dragged over to this thread. I think it would be useful to break those symptoms away from symptoms and the burden later on after treatment and if the patient is still treating or even if not, their current symptoms. For example, I had recurring fevers between 101 and 104 for a year and a half.....then my body temperature dropped suddenly and ranges from 96.5 up with now a high temp for me being 98.0. So a way to capture differences over time may also be useful.
Maybe also questions along the lines of:
List your five most significant symptoms after treatment in order of severity with the first being the most severe.
List your five most significant symptoms after treatment that impacted on your quality of life.
List your current five most significant symptoms in order of severity with the first being the most severe.
List your current five most significant symptoms that impact on your quality of life today.

Charts might work better.

I would also like to see a section created on immune dysfunction after symptom onset.

velvetmagnetta
Posts: 469
Joined: Sun 23 Feb 2014 22:47

Re: Patient-Formulated Lyme Disease Survey Draft

Post by velvetmagnetta » Wed 30 Jul 2014 5:46

Some of us - I have no idea how many - got worse after antibiotics than we were before due to - who knows? Is it the Herxheimer Reaction and some of us got a bigger herx than others?

I want us to be sure to include these people. We don't hear much from them because they are really really sick. I am one of those people and am only recently able to use the computer! Well, I guess we still might not be able to count these people. But we can try!

Perhaps we may be able to include the forever-herxers if we keep the format as simple and clean as possible - lots of spaces between questions and, if the questionnaire can be filled out online, include as many check boxes (non-fill-in) as possible. This will also help with maintaining a database for all the answers as well as calculating statistics.

For instance, the positive, negative, and indeterminate bands from the ELISA and Western Blot can be listed in a check-off format. If I recall, some of the numbers come back with one plus (+) and some two (++), so perhaps we can create a table where someone could simply check off all this information.

Also, we can list all the known ELISA and Western Blot laboratories - including an "other" box for any we missed.

And what about the Advanced Labs culture test? This would be a great way of testing the accuracy and validity of that test. What if it really does work and the CDC has been trying to shut it down this whole time? Or what if it doesn't?

I think the "endemic" question is a good one especially because the CDC has been using it against us for so long. We will now have more data for them to make that kind of serious determination.

Also, because the herx is so mysterious, especially for those for whom it never ends, this questionnaire would be the first actual research into it. People have had lots of theories of what it's all about, but no real hard analysis has ever been done to my knowledge.

Like the other questions, we will need intensity and duration of herx. I will try to come up with as many herx symptoms as I can - some are the same as Lyme symptoms, but some are completely different - at least as far as I know.

I'll be back later! Great job everybody - I'm so inspired by you all!

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