Updated position statement draft (01/07/2019)

Quick question:  how attached are we to "chills"?  I feel it is more subjective than fever.  The current babesiosis cases definition seems to agree: https://wwwn.cdc.gov/nndss/conditions/babesiosis/case-definition/2011/

Open to other opinions. 

PSTemplateStandardizedSurveillance2019_SFR_01022019_SS_knh01092019.docx 167 KB • Download

Hi all,

Please use this version to edit. I've added all the CDC SME contact information. That is the only difference between the previous version, in case you've started editing the previous draft.

Thanks,
Kristen

I think we should leave chills out and keep fever (without a measurement) as reported by patient or health care provider. 

Hayley

I like that.  I think that is what Kristen originally suggested on the call on Monday.  Kristen, what do you think?

Hi everyone. I have attempted to update the position statements. The clean one has the instructions omitted. 

PSTemplateStandardizedSurveillance2019_SFR_01022019_SS_knh01092019_cw010919 clean.docx 170 KB • Download

PSTemplateStandardizedSurveillance2019_SFR_01022019_SS_knh01092019_cw010919.docx 181 KB • Download

I should add that you will probably find errors so feel free to edit at will! I just hope they are a little closer to the final version...

Thanks Carl for this update.  Does anyone else have any other updates?  I want to see if I can get a final version to send to the larger working group tomorrow with some brief explanations/summary.  

I don't have any additional comments. 

Hayley

Do you want us to also review the message before you send it to the group? 

Sure!  I'll put it on basecamp later this morning.  Thanks Sally.

PSTemplateStandardizedSurveillance2019_SFR_Final.docx 148 KB • Download

Additional Authors.docx 12.8 KB • Download

Please take a look at the updated "final" position statement and the additional authors page.  Specifically, we added working to section X. Revision History and Kelly added Table VI and VII at the end which we had not tackled.  Please see if you find any errors or have any suggestions for any of these.  Thanks.

Should we modify the synopsis?  We say addition of new lab criteria, but is it more changes to lab criteria since we are proposing removing some types and changing IgG titer cutoff? See my suggestion

This position statement updates the case definition for Spotted Fever Rickettsiosis (including Rocky Mountain spotted fever) (previous position statement 09-ID-16) through the addition of new changes to the laboratory criteria.

Also, my author info is correct - thank you!!

Sure thing.  I revised the synopsis with your change. 

Everything looks great to me, I added my author information to Sally's. See attached and thank you all for the opportunity to participate in this with you.

Additional Authors_sfgr position.docx 13.5 KB • Download

So here is what I want to say to the working group in basecamp (also I reduced some wording to adhere to word counts):

Dear CSTE RMSF Working Group:

The RMSF Core group have developed the attached position statement.  Please take a look and make comments by COB January 18th.  We will consider all your suggestions and then submit the position statement to the CSTE VBD Subcommittee and then present it to ID and SI steering committees before submitting to CSTE. 

To summarize, we:

1. Discuss the non-specificity of certain diagnostic methods.
2.Discuss the burden of case investigations leading to jurisdictions implementing own case definitions.
3. Propose that final SFR case numbers be omitted from weekly MMWR.
4. Added the utilization of standard sources, standardized criteria for case. ascertainment, and standardized criteria for case classification information
5.  Recommend that SFR surveillance data be omitted from weekly MMWR surveillance tables.
6. Updated the goals of surveillance to include the information aboutthe interpretation of laboratory results and their translation into surveillance data, with an emphasis on excluding interpretations that may not reflect current SFGR infections in patients.
7.  Added statement about how the majority of cases are identified though laboratory and healthcare reporting.
8. Require an elevated IgG IFA antibody titer to be at least 1:128 in value as opposed to simply “elevated.” Require the diagnostic serum specimen to be collected within 90 days of illness onset.
9. Required a convalescent serum specimen to be collected 2 – 6 weeks later as opposed to 2 – 4 weeks later. 
10.  Removed elevated IgG antibody reactive with R. rickettsii or other SFG by ELISA, dot-ELISA, or latex agglutination as lab criteria. 
11.  Removed elevated IgM antibody reactive with R. rickettsii or other SFG by IFA, ELISA, dot-ELISA, or latex agglutination as lab criteria.
12. Clarified “fever as reported by the patient or a healthcare provider” as part of the clinical criteria.
13. Required a convalescent serum specimen with a fourfold rise in IgG titer collected 2 – 6 weeks later as confirmatory laboratory evidence.
14. Added an elevated IgG IFA antibody titer to be at least 1:128 in value in a serum specimen collected within 90 days of illness onset as presumptive laboratory evidence.
15. Removed elevated IgG antibody reactive with R. rickettsii or other SFG by ELISA, dot-ELISA, or latex agglutination as laboratory supportive criteria. 
16. Removed elevated IgM antibody reactive with R. rickettsii or other SFG by IFA, ELISA, dot-ELISA, or latex agglutination as laboratory supportive criteria. 17. Added elevated IgG IFA antibody titer of ≥1:64 in a sample taken within 90 days of illness onset as supportive laboratory evidence. 
18. Removed sentence regarding epidemiologic evidence/linkage/exposure and changed it to “none required”. 
19. Updated the suspect case classification to add “a clinically compatible case that has supportive laboratory evidence”. 
20. Added information about what qualifies as a new case, time frame of when a new case should be counted, and criteria that elevated but stable IgG IFA serological results should be classified as probable cases. 
21.  Updated the language regarding when finalized data are published. 

PSTemplateStandardizedSurveillance2019_SFR_Final.docx 148 KB • Download

Here is the additional authors page I meant to send: 

Additional Authors SFR Position Statement.docx 15 KB • Download

PSTemplateStandardizedSurveillance2019_SFR_FINAL_knh01112019.docx 138 KB • Download

Hi all,

I've gone through Abelardo's version and removed the bright blue instructions and made sure all of our responses were in the same navy blue. This will hopefully make the review a little easier for the working group.

Thanks,
Kristen

Excellent!  Thanks Kristen.

I like it!  Thanks Sally.  I'll send to the larger group momentarily.

I like the additions that Sally has made to the introduction as far as the aim and bullet points, but am not sure about making the suggestion that we consider another PS revision. 

While I agree it may be the appropriate direction, I think we would want the other CSTE members to focus on what we are currently proposing and not worry about what we might propose in the future. 

Just a thought...

True.  I'll revise it a bit.

That makes a lot of sense. I am not tied either way, just a thought. I know our lab is using PCR on certain SFGR samples and it has been a huge benefit for us.

Hayley

Thanks Hayley and Sally.  I left it simple.  I imagine there may be other things the larger group will want clarification on too.  We'll see what comments they make and then regroup.  Thanks for everyone's help with this!  

Hi all -

I don't know why, but I suddenly stopped getting Campfire notifications to my inbox and I'm just now seeing all this. I'm looking into fixing this since I live out of my inbox. If there is anything remaining that I can do, please let me know, and don't be afraid to nag me at shawna.stuck@dph.ga.gov. 

I also wanted to let the group know that I will be going on maternity leave soon. This is a double edged sword in that I have a lot of time free at work (since I'm handing off responsibilities), but I'm also a ticking time bomb with no clue of how much longer I'll be working this month. I anticipate helping as much as I can until I go on leave.

Thanks all for pulling everything together and getting it out to the larger group!

Hi Kristen -

I was so happy to see your post come in as an email! :).

I'm on the list of authors already. Thank you to whoever added me. The only thing I updated was the address line 2 which went from "Floor 15" to "14-202"

Additional Authors SFR Position Statement (1).docx 14.8 KB • Download

Hi Kristin! Yep! I created the additional authors page that Dr. Moncayo previously uploaded with everyone's information. 

I have attached it here again in case it was missed. 

Thanks!

-Kelly

Additional Authors SFR Position Statement.docx 15 KB • Download

Hey guys - I think it would be good to reply to Hanna's and David's comments.  I am happy to do so, but would like your thoughts on these replies:

To Hanna:  "Hi Hanna, the core group considered scenarios such as what you are describing.  The current case definition from 2010 words this as: "paired serum specimens (one taken in the first week of illness and a second 2-4 weeks later)". We loosened it to read "paired serum specimens (one taken in the first two weeks of illness and a second 2–6 weeks later."  We felt that this loosened the guidance while providing standardization.  The current arboviral case definition states "four-fold or greater change in virus-specific quantitative antibody titers in paired sera" so does not give a specific timeline as you are suggesting.  However, in CDC's reference manual (https://www.cdc.gov/lyme/resources/TickborneDiseases.pdf), they give the timeline we see in the 2010 case definition.  We feel that loosening the guidance as we have allows for some leeway (giving a little more time for sample acquisition)."

I will work on one for David tomorrow. 

Good morning all,

I will second the thanks. David raises many good points, but in your response I would add a  reminder that the epidemiology of spotted fever group rickettsiosis, particularly RMSF, differs from state to state. Yes, it’s a plug for Arizona where we do not have the lone star tick (at least not any established populations spreading disease that I know of). Our goal is to capture as many true cases as possible given the variation of SFGR across the US and we hope the new proposed case definition will help with that.

Just my miscellaneous thoughts...

Hayley 

Abelardo, I also want to say thanks for taking this whole process on! There are clearly a lot of thoughts. I think one of the key messages, as others have stated, is that this is an incremental improvement to the case definition and as more/better(?) molecular tests become widely available we would hope to again update the case definition. 

I agree with some of David's points including what is the value of counting these highly questionable results. I think that by raising the titer threshold the percentage of cases we identify that are "true" sfr infections will likely increase. I know NC has not published this but of our cases those with an initial reported titer of at least 1:128 are six times more likely to have a more serious illness or be hospitalized. I would not be surprised if that is true elsewhere and I think that is really what we are after with this change...Identifying what is more likely a true infection. 

Regarding tick and pathogen presence Chuck Apperson at NCSU has recently published on this in NC: https://www.ncbi.nlm.nih.gov/pubmed/29771344. The tick vector and various rickettsias are present here...I suppose any number of them could be causing our observed "cases." 

Let us know what else you need. 

Carl

Thanks Carl, Kristen and Hayley for your words of encouragement and ideas of how to reply.  Thanks Carl for this paper.  It is very interesting.  Great to see old friends on it - William, Steve and Chuck.  I think it will help in addressing some of David's concerns.  Working on a response now.

Response to David.  Please review. I don't completely agree with my last sentence of comment 1.  Isn't 60 days better - more consistent with the timeline of 2+6 = 8 weeks = 60 days?:

"Hi David, thanks for your comments.  We agree with many of your comments.  Below is a summary of your concerns and our perspectives:

1.  Concern: Disagree with timeline of 90 days for accepting a positive sample.  Comment: CDC currently uses 90 days.  Our case definition of acute within 2 weeks of onset and convalescent 2-6 weeks later, we need to be able to accept specimens for 8 weeks from onset or 60 days.  Ninety days would allow time for obtaining a convalescent from hard to reach patients.

2.  Concern:  Lone star tick bites are more common and do not transmit R. rickettsii but rather ehrlichia and other rickettsia.  Comment:  The goal of the position statement is to capture as many true cases as possible given the variation of SFGR across the US.  Arizona, for example, does not have established lone star tick populations.  You raise many important questions about ticks that need to be studied.  As an example, this paper https://www.ncbi.nlm.nih.gov/pubmed/29771344 discussed the multiple rickettsia found in dog ticks, adding to the confusion about what rickettiae are responsible for the seroconversions in patients.  Regarding ehrlichia in our endemic states, VA, TN and so on, it may be that it is causing seroconversion as well, but even if we added an exclusion criteria of "and not positive for any other endemic TBDs" or "not positive for ehrlichia" specifically, we would still not be able to distinguish between ehrlichia and SFR.  Even with a PCR positive ehrlichia test, we cannot rule out a SFR infection if there is an antibody response.

3.  Concern: Non-pathogenic R. amblyommii causing seroconversion.  Comment:  There is some evidence that R. amblyommii is not non-pathogenic (https://www.ncbi.nlm.nih.gov/pubmed/27022147; https://www.ncbi.nlm.nih.gov/pubmed/25187639).

4.  Concern:  Seroconversions occurring during acute stage are not an indication of current infection.  Comment:  While most people may develop antibodies 7-10 days after an infection, this may vary on an individual basis and depending on the species, dose, etc.  Some literature regarding seroconversion before 7 days:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC262206/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6311067/.  Further, from a practical perspective, most patients arrive to see the doctor in the acute stage and that is when a sample can be taken.

5.  Concern:  Doctors are not focusing on ehrlichia testing. Comment: We agree that physician education is important.  The position statement serves to guide but even if we include an ehrlichia exclusion as mentioned above, it would not clarify whether there was a SFR infection or not.  We can do PRNTs to discern the most likely etiologic agent in flavivirus infections but we do not have a good test to distinguish SFR vs ehrlichia infections."
 

Abelardo, I think that is an excellent response. I like #4 in particular; we simply cannot dictate when a specimen will be collected even if we may desire the acute to be collected no earlier than 7-10 days post symptom onset. 

Carl

If you can reply to my question about the 90 days, that would be helpful so I can send this to David.  He has entered another 7 paragraphs of comments that I need to reply to...

Thanks Carl.  I just saw your comment.

I just saw that too. I have a few thoughts and correct me I am going on a tangent. 

I think we need to remind everyone that the case definition will never be perfect and correctly identify cases. However it is useful to identify trends which is what I find useful...especially for condition like SFR. Even if things are done consistently wrong (as David suggests) we should still be able to identify trends. 

Speaking for NC, we are not concerned or worried that a new case def will result in fewer cases...we fully expect that! The idea being that those fewer cases are likely to be true. 

Regarding LD, while the incidence is low in NC, it was in VA 15 years ago as well. But diseases emerge and we are now seeing that condition cross over into northwest NC from VA. I suspect this is true for other southeast states. That comment confuses me a little, but seems to warrant a response. 

Thoughts?

I meant to say the case def will never correctly identify ALL cases. 

wow, just catching up on this thread - 
and let me echo what everyone else has said - thank you for tackling this Abelardo!
I very much agree with the big picture things to keep in mind - surveillance is not perfect, and while we can't accurately capture true cases we can look at trends over time.  As better diagnostics are available we can continue to refine the case definition, but until that time, we hope the changes that were made will both better capture true SFGR cases while decreasing work load.

I know in the past there has been a push to get an PH entomologist in every state - but not sure if there was any traction to make this happen.  In NYC I've pushed hard to implement tick surveillance and testing to better understand what ticks are present and what microbes they carry - we've been lucky to get city funding to make this happen and it has been very helpful in understanding our human data.  David is so passionate about tick surveillance - is there a platform for him to advocate for this with the goal of improving our understanding of human tickborne disease data?

Sally - that is a very thoughtful suggestion.  David is actually the current President for NAVCO and in charge of setting the agenda.  He is coming to Nashville next week.  I invited him to give the keynote address at our Tennessee Mosquito and Vector Control Association annual meeting.  I can talk to him then.  Also, there is a NAVCO board meeting tomorrow.  Since I am a past president I will be on the call.  Do you want me to bring this up - advocating for PH state entomologist funding?  Kristen, any thoughts about Sally's comment from CDC's perspective? 

That is a good point. I thought there was a CSTE position statement advocating for PH entomologist in each state but I cannot find one. Nonetheless, something similar to the position statement advocating for a PH vet in each state would probably be helpful (https://c.ymcdn.com/sites/www.cste.org/resource/resmgr/PS/1999-ID-2.pdf). 

I agree that in some cases (and probably more I don't even know about) at least entomologic field work (calculating density of infected nymphal Ixodes scapularis) is better at identifying risk areas for human acquisition of disease than our passive surveillance systems for human infection. 

Victoria from Kentucky just stated, "I was under the impression the revised definition would focus more on PCR testing rather than the fourfold increase for confirmatory laboratory evidence." I'm not sure what "focus more" specifically entails, but we did not get rid of PCR as a method of confirmatory testing. Perhaps she can elaborate more on what vision she had for the language surrounding PCR testing?

"Kentucky’s current issue is that no health providers order the second IgG titer, therefore we have hundreds of probable cases and no confirmed." A lot of states are seeing this issue, which is why only 3% of SFR cases are reported as confirmed. Our background and justification has multiple paragraphs on this issue, and I'm not sure if we should just highlight those in a response or expand upon them. We cannot dictate what providers order but we can work to ensure that positive lab results are interpreted correctly, reducing the number of "false positives" we count in our epidemiological data. The key point to drive home is our goal, which states that "improved case definition will update the interpretation of laboratory results and their translation into surveillance data, with an emphasis on excluding interpretations that may not reflect current SFGR infections in patients."

Shawna Stuck
Vectorborne Disease Epidemiologist
Georgia Department of Public Health

Thanks Shawna - really good points.  Is everyone OK with my continuing to respond to these?  It should only last through tomorrow.  My thought is that we discuss as a core group how to respond - as we have been doing - and then I reply to voice our collective opinion.  Does that sound OK?

I also wanted to get your opinions on the 90 day vs. 60 days. Is 60 days better - more consistent with the timeline of 2+6 = 8 weeks = 60 days?  I can defend 60 days by saying it accounts for the time of acute and convalescent sample acquisition (acute within 2 weeks plus 2-6 weeks after the acute sample is taken) but if we go with 90 days I need a better justification than what I have come up with: "Ninety days would allow time for obtaining a convalescent from hard to reach patients."  Please help.

 Hi team, 

I am reviewing all of these comments carefully this morning and will share my thoughts shortly. One thing that will help me is to get a brief understanding on how investigations and case classifications are done in your respective states. ie: Since your states only receive reports of positive lab results, how do you determine confirmed or probable status. Are the reports you are receiving actually convalescent titers, or upon interviewing patients  and reviewing medical records you learn about the negative acutes…

 I’m hoping my question makes sense, but I’m basically trying to understand the scenarios related to spotted fever group rickettsia cases. To put it into perspective, in Arizona, we always see the acute samples because negatives are reported to us. Our probable cases are most commonly elevated acute or unchanged titers (yes with clinically compatible illness so difficult to rule out a past infection that was not previously detected due to patient not getting convalescent drawn at that time). Confirming our cases (when we can) is easy since we have the negative acute to compare already in our surveillance system.

Thanks!
Hayley 

Abelardo, I am OK with you continuing to answer the questions. Thanks again for doing that. 

Regarding 60 vs 90 days I don't really have the knowledge to comment. Is there any publication detailing the primary immune response to Rickettsia spp.? Looking at old publications with animal models the primary immune response seems to remain detectable for a long time...and that could be used to support the 90 day limit (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC262206/).

Hayley, in NC the single specimen we receive is almost always determined to be acute upon investigation, and comparing collection date to symptom onset date. 

Carl

In immediate response to your question Abelardo...

1. I personally have no issues with discussing these inquiries as a group on basecamp as we have been and having you be the person that replies.

2. 60 days still seems like an acceptable timeline and it is already extended from the previous case definition. Of course I think that 90 days gives patients a longer time to have a convalescent sample drawn, however I do wonder if in some scenarios the IgG would start to decline, resulting in an elevated but lower-level titer, and potentially more likely a probable case classification.

Thanks Carl. So are the acutes being collected closer to the 2 week time point resulting in a detectable titer of say 128 or 256? In Arizona, our acute samples are usually in the first 2 to 3 days of symptom onset.

Hayley - that would be ideal if we could get negatives to be able to call these cases confirmed but in TN we got last year, for example, about 4000 positive lab reports, so I imagine we would get maybe 10x as many negatives (?) or more.  That would pose an additional burden for us to get sift those. 

Abelardo,

Indeed the burden is very high since majority of people don’t come back for convalescent titers. In AZ, I rule out hundreds of cases with negative acutes that the tribal health departments don’t even have time to investigate (eg. I don’t get clinical information).

Hayley, Let me get back to you on that. I want to make sure I am as accurate as possible. 

Carl

I am also fine (and more than happy!) to have you Abelardo, respond to the inquiries.  
As for identifying acute negative specimens - when we investigate a single positive titer, we contact the provider to ask if additional testing was done, and if so to report the information - this can be done by phone or by fax.

For the 60 vs 90 days -  I'd prefer going with 60 days, unless other feel strongly that by doing so we will miss true cases.  

But honestly OK with either as don't think by making it 60 it will make much of an impact in number of cases we exclude.

Am I wrong in thinking that Ehrlichia and Rickettsia can cross react on an IFA?
This article (https://www.cdc.gov/MMWR/PREVIEW/MMWRHTML/rr5504a1.htm) says that "Little cross-reactivity of Rickettsia with Ehrlichia or Anaplasma species exists."  David says that the Rickettsia cases out there may be Ehrlichia but I think he means that in terms of symptoms rather than tests cross-reacting.  

Also, is there an article to back up the 90 day (or 60 day) cut-off?  It would be good to point to an article showing how long IgG titers are maintained.  I imagine the answer is over a year, but it would be good to justify this as well as our convalescent range of 2-6 weeks which should coincide with our cut-off, right?

Thanks Abelardo. I think your response is very well-formulated.
I think part of the rationale for the 90 day period over the 60 day period was in relation to the spotted fevers other than RMSF. We know it can take much longer for antibodies to rise as a result of R. africae, R. conorii with seroconversion at 28 days, but high level persistence of antibodies past 6 weeks. 
https://cvi.asm.org/content/cdli/9/2/324.full.pdf
shorter time to seroconversion for RMSF cases
https://academic.oup.com/jid/article/148/5/876/976240
That being said, I do not have a problem with making this 60 days rather than 90, and agree it is not likely to have a significant impact on case exclusion. 

As for the cross reactivity, generally we feel there is limited cross reactivity between Ehrlichia and Rickettsia species (more within group cross-reactivity). As far as I am aware, a couple studies have found some cross reactivity using IFA between Ehrlichia and Rickettsia species, but the level of fluorescence was generally less substantial and the possibility of dual infections were not able to be eliminated.
I will ask around and double check with members of our group to make sure that is their understanding.
Thanks,
Naomi

Thanks Naomi.  Kelly and I are putting together an FAQ for this position statement to submit to the VBD subcommittee along with the position statement.  Thanks for the articles about seroconversion.  Any additional  information on the cross-reactivity would be great. 

Aside from possibly changing 90 to 60, is there any other change we should make to the position statement based on comments by the working group? 

Jordan is working on scheduling a VBD subcommittee call as well as a Surveillance Practice and Implementation (SPIS) subcommittee call where we can present the PS.   

Naomi,
In the Clements et al (1984) article (attached), Fig 2 shows the IgG antibody responses of 6 unvaccinated volunteers who developed clinical RMSF after intradermal challenge with R. rickettsii.  The response is up to 1:320 by day 7 (I'm sure there is individual variation around this titer) and it goes down by day 12 to about 1:160 and stays steady after that.  Does this support both our contentions that getting a sample within 7 days of illness is OK (and that we may be not missing as many true cases by not counting 1:64 single titer cases as probable)?

Abelardo

Clements et al 1983.pdf 928 KB • Download

Please take a look at the FAQ.  Specifically need input on Q1 bullet 1, Q2 bullet 1, Q3 bullet 1 and Q4 bullet 3.   I highlighted these in yellow.  

I think the most challenging questions we get will be regarding:
1. Accepting results from samples acquired within a week of infection. See responses for Q1 in FAQ.
2. Why a 1:128 cut-off.  See responses for Q2 in FAQ.
3. Why 60 days (do we all agree with 60 days?).  See responses for Q3 in FAQ.
4.  Could SFR really be Ehrlichia.  See responses for Q4 in FAQ.

Spotted Fever Rickettsiosis Case Def FAQs.docx 19 KB • Download

Hello Abelardo,

I apologize for the delayed response on these FAQ's. I think the document is going to be a great resource for the other jurisdictions in addressing their inquiries moving forward. 

In regards to Q#2, you may also consider adding that low-pathogenic or non-pathogenic rickettsial species may cause a slight elevation in titer. Additionally,  an non-specific antibody response could occur in a multitude of scenarios and the higher the titer, the more confident we can be that the elevation was in response to the actual pathogen in question. 

Past exposure is also something really important, which you do highlight. In Arizona, we have the hyper-endemic areas where people may be getting re-exposed to either RMSF or these low-pathogenic species and that of course complicates interpretation of the titers.

My final 2-cents  that should be considered throughout this entire position statement is that although the primary focus is RMSF, we are not JUST doing surveillance for that morbidity. Spotted fever group rickettsioses covers parkeri, africae and others that we DO want to know about and classify appropriately.  

Hayley

All - I am presenting our PS on the SPIS call on Friday.  The SPIS group is generally more focused on the mechanics of surveillance so I will focus on the reporting criteria and tables.  I will send them our PS and make some ppt slides to go through it clearly.  The call is this Friday at 1:30PM ET and I will be talking in the beginning for 20 min with a Q/A of 10 min.  Is anyone interested in joining the call?

Abelardo 

I updated the PS with only one change: changing 90 days to 60 days throughout the document.  I also updated slightly the FAQ.  Let me know if you have any thoughts. I am going to send the PS to the SPIS group today.  I'll send you my powerpoint today so you can see it.  Let me know if anyone is interested in attending and I can forward the call-in information. 

Abelardo

PSTemplateStandardizedSurveillance2019_SFR_FINAL.docx 139 KB • Download

Spotted Fever Rickettsiosis Case Def FAQs.docx 19 KB • Download

Hi everyone,

Here is a ppt slide of what I am thinking of presenting to the SPIS group on Friday.  Please take a look and let me know what you think.  It might be good to use a similar approach when we talk to the CSTE VBD subcommittee.  

Thanks,

Abelardo

SPIS Presentation.pptx 432 KB • Download

These are great slides Abelardo!

Hi Abelardo - I'm looking at the slides now and will let you know if I have any thoughts - but not sure what SPIS stands for - can you enlighten me :)?
thanks!

Sure!  This is the CSTE Surveillance Practice and Implementation Subcommittee and they indicated they are most interested on the mechanics of surveillance, specifically the reporting criteria.  Here is a newer version of the ppt.  I saw that the second table did not have the confirmed column in the previous version.

SPIS Presentation.pptx 433 KB • Download

got it, thanks. I made a few edits to statement of the problem - but not sure if I changed the meaning - so feel free to ignore.  
Would it be helpful to audience to provide the original language and show the specific changes?  Am happy to help do that if you think its worth the time.
looks great!!  Good luck!

972d4ae0-2505-11e9-b79b-a0369f740dfa SAS.pptx 432 KB • Download

Hi Sally - Sure!  If you want to make a slide on the original language and the specific changes, that would be great!   I need to get this to the organizer before noon ET tomorrow.  Do you think you can get something to me before then?

Thanks,

Abelardo

Here is the call-in information if anyone wants to join tomorrow:

This is a reminder that the CSTE Surveillance Practice and Implementation Subcommittee (SPIS) call will be held on Friday, February 2nd, at 1:30-3:00 pm ET. The calendar invite is attached, and the agenda and webinar information are below:

1.       1:30-1:35: Roll call & CSTE updates

2.       1:35-1:40: Data Standardization Workgroup Update- Gillian Haney (MA), Molly Crockett (MA), Laura Erhart (AZ)

3.       1:40-2:15: Spotted Fever Group Rickettsioses Position Statement Overview + Q & A - Abelardo Moncayo (TN)

4.       2:15-2:50: NMI Message Mapping Guide (MMG) Implementation Experience in Jurisdictions: Challenges with data collection and prioritization of data elements + Discussion/ Q & A- Rachelle Boulton (UT)

5.       2:50-3: Request for feedback on data collection methods for Whole Genome Sequencing (WGS) data- Gillian Haney (MA)

6.       Adjourn

To join by phone only: 
Call-in toll-free number (US/Canada):1-877-668-4490 
Access code: 791 659 537 

To add this call to your calendar program, click this link:  https://cste.webex.com/cste/k2/j.php?MTID=t8fc32633128a347fc4d9d8bcff96d7d2

Can someone double check me on Table VII on the second to last page here? I updated it to what I think is correct:

PSTemplateStandardizedSurveillance2019_SFR_FINAL.docx 139 KB • Download

No worries.  Good luck with your pipes!

I love those 3 slides - thanks!  Here is the updated presentation.  I changed the wording on tables in the PS slightly and the S and Os.  They are similar to the last PS from 2010 so they should be OK.  Let me know if anyone has any thoughts about those tables.  I'm going to send the ppt to SPIS now but we can modify those tables if we need to later.  Thanks.

SPIS Presentation.pptx 441 KB • Download

Thoughts about the SPIS call?  Should we have a call next week to discuss?

Monday 1PM CT?  Does that work for most?

Yes that is fine for me too. Abelardo you did a great job presenting our thoughts and intent. 

Thanks Carl.  I'm still thinking about the call.  What if we were to change the clinical to something like what is in the McQuiston paper:

"Suspected RMSF cases included patients with a fever
( >=100.4°F or 38°C), for whom no other clear alternative diagnosis was present and who had at least one of the following: 1) a history of a tick bite in the 2 weeks before illness onset; 2) non-pruritic skin manifestations (petechial rash, maculo- papular rash, or eschar); or, 3) two or more of the following: headache, myalgia, nausea, vomiting, abdominal pain [, anemia, thrombocytopenia, or any hepatic transaminase elevation]."  Just a thought.

I do not feel comfortable with changing the recommendation about timing of samples taken to only those greater than 7 days of illness, however, for all the reasons we have discussed.  I think the confirmatory lab evidence already addresses that and we should to keep the presumptive lab evidence as is.

McQuiston_IgM RMSF 2014.pdf 442 KB • Download

Kristen - thanks for working on rebuttals.  

Potential times for the VBD subcommittee call are: 

February 19 at 1pm or 2pm

February 20 at 2pm

February 21 at 1pm or 2pm

Which one is best for all of you?  I am fine with all of them.

Jordan, do we need to present again to SPIS?  Do they need to approve the final product?

Thanks,
Abelardo

Hi Abelardo,

No, you don't have to present to the SPIS group again. They don't have to approve the PS prior to submission but you can send a new draft to the subcommittee chair if you would like additional feedback.

Thanks,
Jordan

Thanks Jordan.

All, I think we need to address this message from David in our discussion today.  I imagine he will bring this up again when we present to the VBD subcommittee:  "I personally would not want to count any titer registered before seven days after onset, and I doubt that even in the event that a true SFR patient did develop a detectable titer in the first seven days of illness, that it would reach as high as 1:128.  Therefore, I have proposed that no titer should be countedunlessit was measured in the time-frame from 7 to 60 days post onset because I think that any patient with a titer as high as 1:128 measured before 7 days post-onset would likely have a residual titer from an old (likely low pathogenic or non-pathogenic) exposure to an SFR agent.  In past years in Virginia, we have seen at least one patient with a 1:512 titer who had no fever and could not meet the case definition, and seen quite a few cases that did not meet the clinical criteria in the case definition who had titers of 1:128 or 1:256].   

 

In any case, I think Abelardo's proposed case definition would certainly be a great improvement to the current definition as it would weed out a lot of what are likely to be bogus SFR cases.  Abelardo's proposed case definition will look for both Probable and Confirmed cases, and with any Confirmed case, there would have to be at least, a four-fold rise in titer from the acute to convalescent sera.   I am assuming that it would be 4-fold a rise in titer starting from a base value of 1:128  to at least  1:512, but that might need some further clarification."

Here is an email regarding the tables:

Good morning. Abelardo,

Thank you for recognizing a need for an improved SFR case definition and moving forward.  

I agree with the states that requested a more refined symptomatology; I feel that  would be most beneficial. 

Additionally, I'll be happy to help with the Tables when you are closer to a finished product.  I notice in the Reporting table, according to your narrative, all the letters should be an 'S' because each is sufficient to report.  In the second table, you are missing a Suspect column to distinguish between the different variations, one with clinical criteria, the other without.  You will also need to add a row in the clinical criteria that state 'No clinical information is attainable' and list it as Necessary for one of the Suspects.

Thank you,

Sherri



*********************************************
Sherri L. Davidson, Ph.D., M.P.H.
Interim State Epidemiologist
Epidemiology, Surveillance, & Informatics 
Infectious Diseases & Outbreaks Division
Alabama Department of Public Health
Phone 334-206-2050 or 334-206-5971

Here is an email about the philosophy of PS:

Yes, thank you! It was pretty animated today!

 

Abelardo, nice presentation. I do have some strong opinions on the “philosophy” behind case definitions! I don’t think having the expansive symptom criteria because CDC can’t get the information is a good rationale for not have a “strict” confirmed case definition. Leslieanne’s point around using the suspect, probable and confirmed criteria was a good one.

 

Gillian

Here are the most updated documents:

PSTemplateStandardizedSurveillance2019_SFR_FINAL.docx 139 KB • Download

SPIS Presentation.pptx 441 KB • Download

Spotted Fever Rickettsiosis Case Def FAQs.docx 19.1 KB • Download

That's correct.  I don't think it has been sent out to the VBD subcommittee yet, but, yes, it is likely to be on 2/21 at 12MST/1CST/2EST.

Kristen - thanks for running this by your division.  I would be interested in getting their thoughts about how to address the after 7 days of onset issue in a way other than to say it is not practical because patients come in within 7 days.  I tried to address that in the FAQ but if there are any other papers (esp. about R. rickettsia), that would be helpful.  

I think it would be best to share everything with RZB staff. I am sure they can provide some constructive criticism. 

Carl

Hi all,

Quick update: the FAQ is being reviewed by members of RZB. The revised FAQ, small position statement suggestions, and slides will be uploaded to Basecamp by COB Friday.

We had an internal RZB meeting on Friday and we are all now on the same page. There were some helpful suggestions on rewording some of the position statement, so those suggestions will be in the version I upload on Friday.

Please let me know if you have any questions.

Thanks,
Kristen

Hi Kristen - any major changes being suggested?  Thanks for coordinating this input from RZB colleagues. 

Abelardo

Happy Friday all!

Attached, please find an updated version of the FAQ as well as the position statement with tracked changes. The position statement edits are mostly small (grammar edits, using abbreviations for SFR and RMSF throughout the document, etc.). Please let me know if you have any questions.

I'm finishing the slides now and plan to upload them before Monday.

Have a great weekend!

Thanks,
Kristen

Spotted Fever Rickettsiosis Case Def FAQs_knh_02152019.docx 22.1 KB • Download

PSTemplateStandardizedSurveillance2019_SFR_FINAL_knh02152019.docx 153 KB • Download

I thought it was going to take longer to finish the slides...here they are! Please let me know if you have any questions. These are just suggestions, so feel free to remove any.

Thanks,
Kristen

SPIS Presentation_knh02152019.pptx 6.24 MB • Download

Thanks Kristen!  Will take a look at this over the weekend.  
Have a good weekend,  
Abelardo

What do you all think of this message re: table VI and VII?  I asked CSTE positionstatements@cste.org but haven't gotten a response yet about if we have filled the tables out correctly.

Good morning. Abelardo,

Thank you for recognizing a need for an improved SFR case definition and moving forward.  

I agree with the states that requested a more refined symptomatology; I feel that  would be most beneficial. 

Additionally, I'll be happy to help with the Tables when you are closer to a finished product.  I notice in the Reporting table, according to your narrative, all the letters should be an 'S' because each is sufficient to report.  In the second table, you are missing a Suspect column to distinguish between the different variations, one with clinical criteria, the other without.  You will also need to add a row in the clinical criteriathat state 'No clinical information is attainable' and list it as Necessary for one of the Suspects.

Thank you,

Sherri



*********************************************
Sherri L. Davidson, Ph.D., M.P.H.
Interim State Epidemiologist
Epidemiology, Surveillance, & Informatics 
Infectious Diseases & Outbreaks Division
Alabama Department of Public Health
Phone 334-206-2050 or 334-206-5971

Hi all,

I have been thinking a lot about these tables, as I am now also involved in the plague position statement. I agree with Sherri that we should add to the "suspect" column for table VII. 

For table VI, I wonder if we are missing some other categories. Should we consider "physician suspicion based on clinical syndrome [with exposure] as sufficient or even necessary to report? I say this because I was thinking about infections of R. parkeri or R. africae. Since there are no commercially available tests, wouldn't public health want to know about these suspected infections?

Also, I think we would want to add all the types of lab evidence that would generate a lab report to public health. Examples: Demonstration of  antigen in a biopsy or autopsy specimen by IHC, or PCR. Lastly, wouldn't ALL these positive lab scenarios be sufficient to report. 

If we change the table, the above text will need to be updated.

Finally, where are the co-authors listed in the final position statement.

I look forward to the call tomorrow. 

Thanks,
Hayley

Position Statement 2019_SFR_FINAL.docx 149 KB • Download

Additional Authors SFR Position Statement.docx 15 KB • Download

Hi Hayley,

Thanks for the reminder about the additional authors.  Uploaded are the PS and the additional authors pages.  

I think tables VI and VII are correct.  The tables in the previous case definition were filled out in a similar way.  I believe that the public health authority referred to in the tables is CDC rather than states.  I'll see if I can call the CSTE office about the tables to make sure.

Also, Hayley, did you find someone to present the plague PS at CSTE?

Thanks,
Abelardo

I just realized that it was Jennifer House asking for help on the plague PS.  I thought it was you when you mentioned that PS above.  Great that you will be able to be at CSTE!

Here are the changes based on the call (from my perspective):

1.  Change the supportive lab evidence to:
·      Has serologic evidence of elevated IgG antibody at a titer <1:128 reactive with SFGR, including R. rickettsii,antigen by IFA in a sample taken within 60 days of illness onset.

2.  Change the timing requirement to:
·      Serological evidence of a fourfold increase in IgG-specific antibody titer reactive with SFGR, including R. rickettsii,antigen by IFA between paired serum specimens (one taken in the first two weeks of illness and a second up to 6 weeks later),

3.  Not make changes changes on symptoms.  Lyme disease has an onset limit of 30 for IgM but nothing for IgG.  Since we are dealing with IgG and multiple pathogens, I don't think we should change anything.

That sounds all right to me, thanks!

Great question Kristen. I can ask our state epidemiologist.

I look forward to seeing you there. 

Hayley

Not sure I understood Katie Brown's comment about >=1:64 on supportive lab evidence but it did lead me to change that to <1:128.  I think we are capturing her concern in the first part of the suspect definition: "A case with laboratory evidence of past or present infection but no clinical information available (e.g., a laboratory report) or ..."

Hi Kristen,

Before the voting sessions, there will be a roundtable to present the position statement and have an open discussion. During the voting session, members can ask questions and, if necessary and time permitting, authors can make changes live prior to voting.

Jordan

Are CDC subject matter experts able to chime in during the discussion?  I understand they are not voting members but hopefully they can participate in discussion.

Yes, SMEs listed on the PS can join the discussion.

Hi all. I wanted to say I thought you all did a good job on the call yesterday, there were a lot of questions. 

I was not sure about Katie's comment either but I think what you suggest makes sense Abelardo. 

Carl

Thanks Carl.  That's great that the SMEs can join the discussion at CSTE.  Attached is the revised version of the PS with the change in the supportive lab evidence of <1:128.  I have not made any change to the timing of the second titer yet.

Position Statement 2019_SFR_FINAL.docx 149 KB • Download

Hi Kristen,

Has Chris or William gotten back to you about the paired serology wording?  

Thanks,

Abelardo