Transcript of Web-assisted Audioconference (continued)

Jeffrey Levine: Is that the kind of thing that is viable on paper but in effect harder to demonstrate until you have to demonstrate it?

Dr. Hupert: Well, the nice thing is that you can basically do this for any type of diagram that you have. In fact, the diagrams can get quite complex. So at Weill Cornell, we have spent the last half-year thinking up what we think is a viable smallpox vaccination model. What you can see is the patient flow plans for this vaccination model. I should add that it differs in some key ways from the CDC model, which is now available on the Internet. All the numbers that you will see coming up have to do with this model and not with the CDC model.

An advantage of creating a flow plan like this is that it can be used for both a pre-event and a post-event scenario. You can set up one basic plan and then have different parts of it apply, depending on the scenario that occurs. So you can see the arrow at the upper left where people enter into this flow plan and then you can follow the different arrows down the various pathways. The parts that are in gray would only be used in a post-event plan, according to this model. The rest of it could be used in a pre-event plan and in a post-event plan.

The basic idea behind this model is that people need to be screened off very quickly in either a pre-event or post-event setting if they are actually sick. Of course in a post-event setting that is much more critical. What we have in the gray is a note that you can put a mask, for example, an N-95 mask which many people in the audience will be familiar with, on people who might come into the clinic and say that they have either come in contact with someone who may have smallpox or who feel sick.

The next steps after the entry in a pre-event setting would be that they would get forms for example, they would get their briefing, that they would go through triage, and then perhaps even testing for things like pregnancy or HIV and that of course can be done on-site or off-site. Then people would go back and get their vaccine, and of course as we now know, there is a great deal of exit counseling that needs to be done after people have gotten their vaccination.

Jeffrey Levine: You have got different models then for different scenarios?

Dr. Hupert: That's right. In the post-event setting you can see that one of the added complications is this whole issue of what to do with people who may actually have contact and who may not want a vaccination so you can see that there is a little component there for quarantine counseling, which may come up, and there are different boxes for exit counseling for people who may be affected and who may not be affected.

Jeffrey Levine: What then are some examples that you have got?

Dr. Hupert: Well, the nice thing is that once you come up with the floor plan and with the schematic and you turn it into an Excel spreadsheet, you can actually generate real numbers that are reflections of how this model would work in a realistic scenario.

So, for example, you can have a scenario where you have got 500 people who could be working in your health clinic across your entire community and you have got 14 days in which to vaccinate a million people. What we did was come up with a couple of baseline scenarios. So we have got a pre-event scenario, a small-scale scenario and a large-scale scenario and we have got generalizations about how quickly things would go in the clinic. Here you can see it is listed as slow, baseline and fast. From the output that you see there, you can see that if you have what we considered our baseline time estimates, if you had 14 days in which to vaccinate these one million people, you could actually do it with 500 staff. In fact, we estimate that it would only take 12 days to do that. These are numbers that are based on the experience with the CDC and with other live exercises that we have witnessed from our research group.

On the other hand, you can imagine that there would be a large-scale event and we have created some outputs for the following scenario, which would be a large-scale event with five million people affected. The question here for example would be how many staff would you need in order to actually prophylax those people? The answer according to this model would be you would need about 6,700 core staff to do that. You can see that in the middle box there.

Now one problem with making outputs like this is that they are very hard to visualize. So it would be easier for people to get a sense of how many staff would be required to do these things if we could generate some graphs. Luckily, since we can automate some of this we actually have the ability to make some interesting graphs. So here you can see that for a wide range of different populations, going from 100,000 to eight million, you can see the number of staff that this model anticipates that you will need in order to complete your mass-vaccination campaign in a certain amount of time. The little line across the bottom is four days because a lot of people have talked about four days as a critical benchmark for how long that would take. So for example if you look at the yellow line for one million people, you could see that you would need somewhere between 4,000 and 5,000 people to vaccinate a million people in four days.

Furthermore, you can come up with some very specific numbers relating to the clinics. So this graph shows that the number of people you can actually process through each clinic per day will depend obviously on the hours of operation of the clinic and the flow of patients through the clinic. But the advantage of actually modeling it out is that you can come up with a specific number for an estimated amount of time that you would like your clinic open and then calculate back and see whether or not that would actually give you the appropriate coverage for your population.

Jeffrey Levine: Now again, what about the key limitations? You have got a model; all models have their limits. What about yours?

Dr. Hupert: That is right. It is very important to note these. The accuracy of any model depends of the quality of the data that you use to make the model. There are a number of elements of these models that we are still trying to pin down, mostly because there has been fairly limited experience with real large-scale mass vaccination campaigns.

One of the critical variables that we are trying to look at is the amount of time it would take. I know that the Department of Health and Human Services has done live vaccine exercises and of course Phase 1 will give us a great deal of information about this.

Second point is that the output of the model has to do with the flow plan that you use for the model. So this is information that is useful for the model that we created. A differently designed vaccination center may give a different result. One of the assumptions that we had with this model is that we would have multiple centers that basically look the same and that we would be able to control the flow. Now Eddie mentioned that one of the key features of all this planning is inter-agency coordination. So, for example, here you would need law enforcement to coordinate with public health to make sure that the flow into the vaccine center was kept under control.

Finally, I would say that these numbers reflect only the critical dispensing staff and not in fact at this point the other ancillary staff or things like law enforcement, sanitation, in order to set up and run these operation centers.

Jeffrey Levine: It is an elegant design. How would you sum up your conclusions?

Dr. Hupert: Well, I think the best thing you can say about models like this is that they will allow planners to think with numbers when designing mass prophylaxis response strategies. What we hope to do is to give people concrete numbers that they can either agree with or disagree with and if they disagree with them they can go back to their plans and figure out how to do things better or differently.

The second thing is that modeling really forces a critical examination of all the assumptions that you have about how you are going to do a really large-scale vaccination plan like this. And it brings to the fore the whole issue of resource availability. So if it looks from the model like the resources are not going to be there in terms of what is available on the public side, it may be that public/private partnerships have to be established.

Finally, I would say that modeling estimates are useful to guide planning but they don't replace the real thing, which is real, live exercises.

Jeffrey Levine: You mentioned the experience with Phase 1 is already being somewhat helpful to you.

Dr. Hupert: That's right, that's right, we are going to hopefully use a lot of the data that we are getting from Phase 1 and validate some of these models.

Jeffrey Levine: Thank you, Nathaniel. We are going to open up the lines for questions in a few minutes, but before we do I would like to go to Tom Terndrup, Director of the Center for Disaster Preparedness and Professor and Chair of the Department of Emergency Medicine at the University of Alabama at Birmingham. With support from AHRQ, Tom and his colleagues have designed a Web site that provides resource information and continuing education about rare infections and potential bioterrorist agents, including anthrax and smallpox, to health care providers.

Tom, what are the challenges of training health care providers to recognize bioterrorist events?

Thomas Terndrup: Thank you, Jeff. The challenges are multiple and some of them are illustrated in the present slide. The backgrounds of the trainees are diverse and run the spectrum from the very beginning public health individual to somebody with a high degree of health care experience. All of these individuals frequently have a full set of current responsibilities so this becomes an add-on to their current activities and creates additional stress.

Also there is a need to illustrate for the trainees the difference between a natural outbreak and that of a bioterrorist attack as we move forward. These events are rare and if we are lucky, hopefully never in a substantial mass-casualty situation. But they are very high risk and so we need to be prepared. Finally, there is limited or no clinical experience with many of these agents and so the health care community needs to struggle with recognition and awareness.

Jeffrey Levine: How was your Web-based educational project designed to approach these problems, because as you indicated, they are complicated.

Dr. Terndrup: Yes. The interactive screensaver, which serves as the front-end to the AHRQ/UAB Web site, is illustrated here. We have a series of six images, which serve as a billboard effect to alert passersby of important topics. In this case, rare infections and bioterrorism. A teaser question illustrated here at the top helps to encourage the passersby to become interested and then active users of the Web site.

Now at the Web site the trainee then selects from the series on the left-hand side of the slide on the menu bar. The menu includes answers to the screensaver teaser questions as well as assistance with complicated differential diagnosis, continuing education modules, related Web links and publications options for the reviewer.

Jeffrey Levine: Now, the interactive screensaver does promote awareness?

Dr. Terndrup: It does and relevant to images that would capture the attention of individuals who are near the computer screen. The user might then pause the image since this is an interactive screensaver, by clicking on the pause bar they could more closely inspect the image, one that might have further detail than the chest x-ray seen here. In addition they could click to get more information which would then take them again to our Web site. So the screensaver serves to capture the attention and draws potential trainees to the Web site where more information is then obtained. The Web site is updated regularly, especially for smallpox and anthrax. Both summary information as well as more extensive information has been made available.

Jeffrey Levine: Does the screensaver actually serve to improve education on bioterrorist attacks, would you say?

Dr. Terndrup: We believe that it does. We have collected some preliminary data summarized here which shows that senior medical students and first-year house officers in responding to a standard set of bioterrorism and emerging infection questions. Their performance was improved by virtue of the presence of the screensaver in the emergency department. We saw roughly a 20-25% increase in their response rates to these standard questions.

Jeffrey Levine: Which is interesting given the fact that you have a highly educated population of providers in the first place.

Dr. Terndrup: One thing of note here is during the baseline period was actually prior to the events of September 11, 2001 and October and so we sort of have a natural history experience here. So you see that you look at the reddish bars that there is about a 20% increase in sort of baseline knowledge that is just related to the general state of awareness in that population of students.

Jeffrey Levine: Of course we are all aware there has been a lot of discussion in the media about so-called dual-use benefit of enhancing our knowledge of infectious disease and training for recognizing bioterrorist attacks. What is meant by that terminology and what degree of risk do different biological organisms present for a bioterrorist attack?

Dr. Terndrup: The notion of dual use, which you see here now, is to promote public health preparedness and our view of that is that bioterrorism preparations, given that this is a rare and hopefully never very significant event in our country, will result in better public health by establishing mechanisms of better recognition, by clinicians' treatment involvement in public health emergency response authorities we believe that bioterrorism preparation is better public health preparedness.

Jeffrey Levine: Do you think that is already happening, there is already a benefit?

Dr. Terndrup: I think some of the comments made earlier this afternoon by the other panel members clearly indicates a need for getting to know who you are working with and I think there has been a lot of progress in that area by virtue of our preparedness efforts.

Jeffrey Levine: All right now, much has changed obviously since the Web site was posted in October of 2001. How have you kept your information up to date?

Dr. Terndrup: Our information has been kept up to date by regular updates through the Web site. Most especially we have, with the support of AHRQ, included more primary care providers. In mid-December we included a new pediatrics module. We also are working with collaborators from internal medicine and family practice to try to add to our existing, what we term "first points of care contacts" so that we have primary care physicians incorporated into that fold.

An important aspect of this is also our dermatology referral module, which will help clinicians, either hospital-based clinicians or those in the primary care sector, to know when to refer a patient to the dermatology community.

Jeffrey Levine: Tom Terndrup, thank you very much. Let me repeat the address to Tom's very important Web site. It is www.bioterrorism.uab.edu.

In a moment we will open up the discussion for questions from our listening audience but first let me tell you how to communicate with us. There are two ways you can send your questions to us. The first is by telephone. If you are already listening on a phone, press "*1" to indicate that you have got a question. If you are listening through your computer and want to call in with a question, dial 1-888-496-6261 and use the password "bioterrorism". Then press "*1". While asking your question on the air, please do not use a speakerphone or a cell phone to ask your question and if you are listening through your computer it is important that you turn down the volume after speaking with the operator. There is a significant time delay between the Web and telephone audio.

If you want to send a question via the Internet, simply click the button marked "Q&A" on the event window on your computer screen and select the button labeled "Send a Question". Type in your question and then click the "Submit" button. One important thing, if you prefer not to use your name when you speak with us, that is fine. But we would like to know what State you are from and the name of your department or organization so please provide those details regardless of the way in which you transmit your questions.

As you are formatting your questions or queuing up on the phone lines, I want to say a few words about our sponsors. The mission of AHRQ is to support and conduct health services research designed to improve the outcomes and quality of health care, reduce its cost, address patient safety and medical errors and broaden access to effective services. Two of AHRQ's operating components helped to produce this series of audio conferences. First, AHRQ's User Liaison Program serves as a bridge between researchers and State and local policymakers. ULP not only brings research-based information to policymakers so you are better informed, but we also take your questions back to AHRQ researchers so they are aware of priorities at the State and local level. Hundreds of State and local officials participate in the ULP workshops every year.

Second, AHRQ's Center for Primary Care Research provides expertise and leadership on primary care practice and research, both within AHRQ and throughout the Department of Health and Human Services. The Center supports extramural and intramural research that informs a wide range of issues related to primary care practice and policy.

I would like to take a quick moment to thank Dr. Sally Phillips, Director of AHRQ's Bioterrorism Preparedness Research Program in the Center for Primary Care Research, who has been instrumental in helping to produce this series. The ULP and the Center for Primary Care Research hope that today's Web-assisted audio conference and the four other events in this series will provide a forum for a productive discussion between our audience of policymakers and researchers.

We would appreciate any feedback you have on this Web-assisted audio conference. At the end of today's broadcast, a brief evaluation form will appear on your screen. Easy to follow instructions are included on how to fill it out. Please be sure to take the time to fill out the form. Your comments on this audio conference will provide us with a valuable tool in planning future events that better suit your needs. Alternatively, please E-mail your comments to the AHRQ User Liaison Program at https://info.ahrq.gov. Now, let's go to the questions from the audience.

This one is from David Rutger. The question is, "I was vaccinated as a child. My understanding is that it is no longer effective. If I receive the vaccine now, how long will it be good before I need another?" Good straightforward question. Who wants to handle that? Nancy, do you want to take a wag at that?

Ms. Ridley: Based on what we have been led to believe is that if you have been vaccinated within the last three years that is sufficient. However, any longer than that, and I think it is a matter of we are just not sure how much residual protection there is from people like us who were vaccinated many, many years ago, 30 and 40 years ago.

Dr. Terndrup: If I could add to that Jeff, this is Tom, I think the data that I have seen indicates that there is even some evidence of long-lasting immunity, albeit it is not quite as good as the 3-5 year interval which we have been recommended.

Jeffrey Levine: All right. We have got a caller, Chris Snook from Cincinnati, Ohio. If you are there, go ahead with your question, Sir.

Chris Snook: OK. In smallpox vaccination campaigns without furlough, how are concerns regarding contact between vaccinees and immunocompromised individuals being addressed?

Ms. Ridley: The general recommendation is that this is one area where we are recommending that hospital workers be reassigned to an area and not work with immunocompromised individuals. That is a pretty clear directive and recommendation. Those individuals should not be working during the period of this activity with immunocompromised individuals.

Jeffrey Levine: This one, I'm sorry. Dr. Raub?

Dr. Raub: I can just add that one of the reasons that Phase 1 is moving as deliberately as it is ensuring that individuals who are to be vaccinated get sufficient briefing and understanding that they need about everything from how to care for the vaccination site to the nature of the contacts that they should avoid.

Jeffrey Levine: This one is for Nathaniel Hupert. It is from Skip Payne at Seneca County General Health District in Colorado. The question is, "Is your program available online for downloading?"

Dr. Hupert: That is a very good question. We have actually just sent out the guidelines which are 57 pages to our advisory board members who include people from New York City, from the Federal government, from CDC and from at least some counties around the country who have been doing a great deal of bioterrorism preparedness work. We anticipate that in a short amount of time, once we have gotten comments on this from the advisory board members and once the model that we have has been vetted, that it will become available either through AHRQ on the Web or through another means. It is an Excel model and it could easily be put on a Web site in a downloadable form.

Jeffrey Levine: All right. This one is a call from Janet Murray in Missouri. Go ahead.

Janet Murray: Thank you. My real simple question. Can you repeat that Web site on the bioterrorism. I don't think I got it copied down correctly. Thank you.

Dr. Hupert: Yeah. It is going to go up on the screen but it is www.bioterrorism.uab.edu.

Janet Murray: Thank you.

Dr. Hupert: You are welcome.

Jeffrey Levine: All right. This one is for anyone. What is the role of the professional organization in bioterrorism preparedness, i.e., nursing and other specialty organizations? Obviously that is a complicated question. Do they work individually or do they work together? What are they supposed to do?

Ms. Ridley: I'll answer this one. Basically all of the professional organizations, and I think we have about 60 or 70 in Massachusetts, are members of both our CDC and our HRSA Statewide advisory committees that are doing all of the planning. They are active members of every single one of our workgroups and we have at least ten workgroups so that the organizations really play a key role in representing their membership across the board regardless of whether it is fire or police or emergency management or whatever it is. They are very, very active participants in the statewide advisory committees.

Jeffrey Levine: Eddie Gabriel, you are nodding your head. Do you agree with that?

Mr. Gabriel: Oh yeah. It is important that every professional organization look for each other. I am sure that the question was more for the medical professional, the nurse and the physician, but I like Nancy's answer because what it did is it closed that gap between those agencies and the emergency response communities and the other agencies that have professional memberships to get everybody speaking the same language. I think it is absolutely appropriate.

Ms. Ridley: One other point. In many cases it is the first time that these organizations have actually sat down and done joint planning for these initiatives.

Jeffrey Levine: All right. This in effect kind of spins off that question. It is for Bill Raub. What is your view of the fact that several national associations of nurses and nurses practitioners groups are protesting the smallpox vaccination process?

Dr. Raub: Well we have a good deal of respect for those who are concerned and deliberate about the trade-offs associated with the vaccine program. Many of the nursing groups and others have pointed out that not every nurse in this country has health insurance, for example. Therefore, not every one of their members is necessarily in a position to be fully compensated in the event of an adverse reaction, especially if the workman's comp program in the State also doesn't cover it or if the employer itself is not providing the coverage.

I stressed at the beginning that the program is voluntary. We think there are good reasons for this to get serious consideration, but we also respect those who want to move more deliberately and we are hopeful that as the Congress debates a compensation package that we may find a way to move forward more rapidly that will be more comfortable with everyone involved.

Jeffrey Levine: Thank you, Dr. Raub. We have another caller. Peggy Putnam on the line from Tennessee. Go ahead, Peggy.

Peggy Putnam: I would like to ask what type of vaccine-site care do you recommend in the pre-event phase of vaccination and for how long?

Jeffrey Levine: Who wants to handle that one?

Dr. Hupert: The Advisory Committee on Immunization Practices has recommended what is called the semi-occlusive dressing for this site in addition to gauze. The reason they recommend this particular bandage, and you can get the details from the CDC Web site if you just look under "smallpox". The reason they recommend this particular bandage is because in studies that they have cited, the amount of virus that you can actually get from the other side, the outsides of this semi-occlusive dressing, is extremely small. Which is why the ACIP has stated as their official position that people who have gotten vaccinated can actually go back to work under certain circumstances. Of course, Nancy has mentioned one particular circumstance where they should not work directly with immunocompromised individuals. So that is part of the detail of the dressing. Even in the pre-event phase.

Jeffrey Levine: All right, Nancy we have a question for you from Sandra Woods. How does Massachusetts' plan to sustain its vaccination effort over time if the response team members will only be included if they have been previously vaccinated? Those health care workers under 30 may not have been exposed to the vaccine, obviously, before.

Ms. Ridley: Well, I think that our, obviously our plan will eventually stand beyond the 10,000 that we hope to be doing in Phase 1 to additional personnel. I think that once we get a really good handle and have a core staff immunized, we will proceed; under-30 will eventually be added to the ranks. There is no way to get around it at some point. But I think that initially you are better off starting with those who are least likely to have any type of adverse reactions, which are those of us that are over 30. Eventually, people regardless of age will be included on the team.

Jeffrey Levine: We have a call from Dr. Nick Berneer. He is up in Minnesota. Probably one of the few places that is colder than Washington, DC at the moment. He is at St. Joseph's Medical Center. Dr. Berneer, are you up there?

Dr. Berneer: I am.

Jeffrey Levine: Go ahead with your question.

Dr. Berneer: I just had a question about any to-date summary had on experience of vaccinees? Many institutions in Minnesota have been very conservative and very reluctant to do a pre-event vaccination because of the inability to reassign nurses to other departments in small communities. Do any of you have any data on the east coast?

Jeffrey Levine: Nancy Ridley, do you want to take that?

Ms. Ridley: Data on the East Coast in terms of, I'm not sure I understand the question.

Dr. Berneer: Experience of the vaccinees. How many have missed work?

Ms. Ridley: Oh, so far I think if you look at last Friday's MMWR report, the results on the first 7,400 vaccinees across the country, civilian vaccinees, show that the numbers of adverse reactions including minor ones was extremely low. I think it was one serious reaction, one moderate reaction that was linked to the type of reactions you could see from the vaccination and 23 minor rashes or aches or pains. We in Massachusetts, with our small numbers, we only did about 26 so far, have not had any loss of work. As I said before, the only side effect we have seen has been a hypersensitivity that appears to be due to the tape on the bandage.

Jeffrey Levine: Actually this would be kind of a follow-up to that. This is from Robert Helfridge for either Nancy Ridley or Bill Raub. How has recent vaccination history of side effects compared to historical data? Are we being overly cautious in preventing volunteers from being vaccinated?

Ms. Ridley: So far it seems like the precautions have been successful in terms of keeping the side effects or the potential for having an adverse effect to a very, very low minimum. Yes, maybe we have been over cautious here, but I think it was wise to start with this type of a process. As we have seen so far, we have got about 7,500 civilians that been vaccinated. Which is, it may not have been as fast as the Federal government wanted to see it go, but I think it is going to prove in the long run to be successful.

Dr. Raub: Just to reinforce Nancy's point, the pattern so far is about what we would have predicted given the kinds of precautions that are in place. It is confirming what we had learned from the historical experience and therefore we are optimistic that as the program evolves that we will have that continued good result.

Jeffrey Levine: We have got a question for Tom Terndrup. Do you have any evidence that your Web site usage reflects national bioterrorism concerns? In other words, can you see spikes, ebbs and flows, that kind of thing?

Dr. Terndrup: Sure, Jeff. We have been concerned about the utility of the Web site and so we recently looked at our data on the number of Web hits at the AHRQ/UAB bioterrorism Web site. What we found is that beginning in November of 2001, if you look at the red stipple bars, that is anthrax hits. And the blue ones, the blue boxes if you will, are smallpox hits. Of course what you see is ending up in mid-January this year is an increasing number of hits regarding smallpox. Our interpretation of this data is that this is consistent with the Web site reflecting national interest and trends.

Jeffrey Levine: Here is one for Eddie Gabriel. In times of crisis, how can local agencies better coordinate with State and Federal partners that always seems to be one of those issues? It was handled, well how was it handled on 9/11, let's say and how do you think it could be better handled?

Mr. Gabriel: Well, the example of 9/11 is certainly the extreme, but clearly it brought emergency management and the coordination of emergency management does at the local level and at the State level and at the Federal level to a new level. The emergency management agencies throughout the country have now been moving more aggressively, I think, to work with their local health departments, the State health departments and their Federal homeland security as well as the CDC and HHS on just this kind of planning.

To do that the best way is to plan and do drills. The way to do those kinds of drills and exercises that bring people to the table and show you those contact points that allow you to go up and down the chain. Knowing what resources are available is essentially making this work when the crisis hits. So you need to know who the contact points are if you want a disaster medical assistance team, a DMAT team through the CDC or HHS. You need to know where to go for what resources, how to get them and how your chain works from the lower level to the State level to the Federal level to get those resources to help you in the time of crises.

Jeffrey Levine: Bill Raub is the representative of the Federal government. Do you have some thoughts on this?

Dr. Raub: Yes I do. There is the clich‚ that all politics is local but all terrorism is local as well. Therefore, one of the highest priorities of the Department of Health and Human Services is helping to ensure that the local capabilities are there not only to make the initial response but also to be able to connect with the assets and other assistance that the State or the Federal government might provide. That connectivity is so important. The comments that he made before about incident management and having planned out well in advance the relationships for response are extremely critical.

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