1. Status of Varicella Surveillance in the United States, 2004
Alison Rue, RN, MPH
Laura Zimmerman, MPH
Dalya Guris, MD, MPH
National Immunization Program
Centers For Disease Control And Prevention

2. Overview Background on varicella surveillance
Case-based reporting (CBR) survey results
Open discussion of case-based reporting
Good morning, today I will present an overview of varicella surveillance in the United States. I will specifically discuss the background for varicella surveillance and case-based reporting; the results of a survey to assess the current status of the varicella case-based surveillance system in the United States, and then we will have time to discuss case-based reporting and lessons learned.

3. Background Pre-vaccine varicella burden (average)
4 million cases
11,000-13,500 hospitalizations
deaths
2005 is 10th anniversary of US varicella vaccination program
Varicella, caused by the varicella zoster virus, is sometimes thought of as a benign disease even though infection can be life-threatening. In the pre-vaccine era, the average annual varicella disease burden was approximately 4 million cases, 11 thousand to 13 thousand hospitalizations, and 100 to 150 deaths.
2005 is the 10th anniversary of the US varicella vaccination program. Since implementation of the vaccination program, varicella morbidity and mortality have declined dramatically.
(EPI slides as background – see extra slides)

4. Vaccine Impact Decline in disease:
87% in active surveillance sites
70-86% in states with consistent passive reporting
Decline in hospitalizations and deaths:
~80% in hospitalizations in active surveillance sites
92% decline in deaths in children and adults <50 yrs
Compared with average levels, by 2004, the decline in disease was 87% in active surveillance sites and 70-86% in states with consistent passive reporting to NNDSS.
There was about an 80% decline in varicella hospitalizations in the active surveillance sites.
Varicella deaths have 92% among children and adults under 50 years of age.

5. Current Varicella Surveillance in the US
Deaths: nationally notifiable
Hospitalizations: variably notifiable
Varicella cases
Active surveillance
Passive surveillance
Outbreak investigation and control
To evaluate the effects of the vaccination program and guide future immunization policy, surveillance for varicella morbidity and mortality is needed. Since 1999, varicella deaths have been nationally notifiable. However, we know from data from the National Center for Health Statistics that there is a substantial underreporting of varicella deaths to the National Immunization Program.
Varicella hospitalizations are notifiable in approximately half of the states.
To estimate national trends in varicella disease, three sites established comprehensive active surveillance in CDC worked with state and local health officials at the three sites in West Philadelphia, Pennsylvania; Antelope Valley, California; and Travis County Texas. From , all three sites participated in active surveillance and two continue to conduct active surveillance today. At the active surveillance sites, each reported case of varicella is thoroughly investigated. The data from these investigations are useful in monitoring vaccine impact and in conducting herpes zoster surveillance.
Nationally, since the vaccination program began, there has been some passive reporting of disease. Most states report aggregate, or total number of cases, without any individual information. In 1995, 23 states reported varicella cases; in 2004, 24 states reported varicella cases.
There has also been an increase in outbreak investigations and control efforts.

6. CSTE Recommendations
States establish statewide, individual case- based reporting systems
Advantages of case-based reporting:
Better understand impact of vaccination program
Guides future policy
With increasing vaccination coverage and rapidly falling incidence, CSTE now recommends that states establish individual case-based reporting systems. CBR data allows states to better understand impact of vaccination program and guides future vaccination policy.

7. Options for implementing CBR
Statewide
All reporting sites add varicella to their list
Sentinel site
Identify sites with varicella cases
Throughout state or in select jurisdictions
Work with associations (school nurse, etc)
Request reports from sites participating in other surveillance networks (e.g., managed care)
Expand sites as system develops
There are 2 options for beginning case-based reporting-- statewide or sentinel site.
…..In statewide case-based reporting, varicella is added to the list of reportable diseases in all state sites that currently report notifiable diseases.
If statewide reporting is currently not an option in your state, sentinel site surveillance is an acceptable alternative.
…..Sentinel reporting is an interim step for states to expand to statewide reporting. For implementation, states identify sentinel sites that report individual case information. Sentinel sites are located either throughout the state or in select jurisdictions. State-wide or local school nurse associations and managed care networks may prove useful in some states.
….. States may consider requesting reports from sites that already participate in other surveillance networks. 
….States may expand their number of sites as they develop their system.

8. Varicella Surveillance: Variables to Collect
Three most important variables:
Age
Varicella vaccination
Severity of disease
Future: additional variables
Currently, it may not be feasible to complete a comprehensive case investigation form for each case of varicella. However, each varicella case report should include, at a minimum, the following three variables:  age, varicella vaccination history, and severity of disease.
These variable are key to monitor varicella vaccination program and assess need and provide guidance for future policy change.
As CBR programs mature and the incidence of varicella continues to decline, jurisdictions will want to consider collecting additional variables about the source case and laboratory testing results.
In the interim though, we wanted to see what states are doing now to implement CBR. I will next discuss the survey results.

9. National Varicella CBR Survey
September 2004
In September 2004 NIP conducted a survey about case-based reporting practices to immunization grantees.

10. Background States enhancing surveillance
Need to understand nationwide surveillance activities to:
Accurately interpret data
Evaluate trends
Compare incidence across jurisdictions
Objective: to characterize case-based reporting activities
We wanted to conduct this survey because we knew that during the last few years states have been enhancing varicella surveillance using a variety of approaches. At the national level, in order to accurately interpret data, evaluate trends, and compare incidence across geographic boundaries or jurisdictions, it is crucial that we have a good understanding of surveillance activities conducted by each state, and how case-based surveillance is being implemented.  
The recent national case-based reporting survey characterized what states are doing or plan to do, to implement case-based surveillance.

11. Methods September 2004 survey
Sent to Immunization Program Managers of all the CDC grantees (n=65)
For the purposes of analysis, combined the geographic boundaries of state, city, and DC responses
Referred to as “jurisdictions”
n=57
In September 2004, NIP sent a questionnaire to the Immunization Program Managers in all 65 immunization grantee areas. The immunization grantees include all 50 states, the District of Columbia, 6 city immunization programs, and 8 territories and commonwealths.
For this presentation, we combined the geographic boundaries of state, city, and District of Columbia results only, and referred to them as “jurisdictions”. This yields a total number of 57.

12. Results: Survey responses received from: 89% response rate
46 states and DC
4 city immunization programs
89% response rate
Survey responses were received from 46 states, District of Columbia, and 4 city immunization programs. The response rate totaled 51 of 57 jurisdictions or 89%.

13. Results: Reporting Laws & Practices
59% (30/51) mandate varicella reporting
Reporting time frame:
Same day through 3 days (17 jurisdictions)
5-7 days (13 jurisdictions)
Varicella reporting sources
67% - Physicians, nurses, laboratories, hospitals
61% - Schools
52% - Daycares
This slide shows information on varicella reporting laws and practices. 59% or 30 of the 51 responding jurisdictions have mandated varicella as a reportable disease.
17 jurisdictions require varicella reports to public health officials on the same day or within 3 days of case identification; and 13 jurisdictions require case notification within 5-7 days.
Jurisdictions accept case reports from a variety of sources including physicians, schools & daycares, parents, and laboratories. 67 percent of Jurisdictions receive varicella reports from the healthcare sector including physicians, nurses, laboratories, and hospitals. 61 percent of Jurisdictions receive reports from schools, and 52 percent of Jurisdictions receive reports from daycares.

14. Results: Laws & Practices
(Continued)
Jurisdictions with mandated reporting (n=30):
90% report varicella outbreaks
83% report varicella deaths
46% have case-based reporting
Jurisdictions that do not mandate reporting (n=21):
81% report varicella outbreaks
81% report varicella deaths
19% have case-based reporting
Among the 30 jurisdictions with mandated reporting, 90 percent receive outbreak notifications, 83 percent receive varicella death reports, and 46 percent receive individual case reports.
Among the 21 jurisdictions who do not mandate reporting, 81 percent indicated that they receive outbreak notification, 81 percent receive varicella death reports, and 19 percent have case-based reporting.

15. Types of varicella cases reported to state and city public health officials (n=51)
Case reporting is correlated with varicella reporting requirements. Yet regardless of case-based reporting requirements, states do have outbreak or death reporting systems in place. In general, among states without mandated CBR (orange bars), few receive case-based reports.
These results illustrate that previous CSTE recommendations to institute a reporting mechanism for varicella deaths is being put in place, and a higher percentage of states that have legislation requiring reporting of varicella cases, have case-based reporting.

16. Results: Case-Based Reporting
Of 51 respondents:
23 (43%) jurisdictions conduct case-based reporting
17 (33%) jurisdictions plan to implement case-based reporting
Most reports come from schools and medical personnel
2 jurisdictions conduct sentinel-site reporting.
In response to The Council of State and Territorial Epidemiologists recommendation for case-based reporting by 2005, of 51 respondents, 23 jurisdictions indicated conducting case-based reporting. 17 additional jurisdictions indicated that they plan to implement case-based reporting, though the time frame for implementation is unknown for most respondents.
For jurisdictions with case-based reporting, most receive reports from schools and medical personnel.
Most jurisdictions have chosen to request all reporting sites to submit reports, versus implementing sentinel surveillance, however two jurisdictions conduct sentinel surveillance.

17. Varicella Case-Based Reporting, 2004
This map shows which states currently conduct CBR. States that are currently conducting case-based reporting are dark green; states that plan to conduct case-based reporting are light green; states that do not have plans to conduct case-based reporting are white; and states for which we have no information are striped.
CBR in place
Planned CBR
No CBR, no plans
No information

18. Results: Implementing CBR – Lessons learned
Health Department (staffing) Resources
Community & Public Health buy-in
Legislation
Programmatic Strategies
Data Quality
There were several key areas of lessons learned – both barriers and successful strategies to implement case-based reporting. These include: health department resources, community and public health buy-in, legislation, programmatic strategies and data quality.

19. Results: Strategies to promote CBR
Meetings and presentations
Provide reporting forms
Newsletters to update reporting requirements
Updated list of reportable diseases
Reporting forms
Provide feedback to:
Reporting sources
Local health departments (LHDs)
Public health meetings
Survey respondents were asked to identify any practices that they have found useful for promoting case-based reporting.
Many jurisdictions responded that face-to-face meetings with the reporting sources - such as presentations to physician groups, or during VFC visits - were powerful tools for developing their reporting systems. These meetings and presentations also provide a forum for distributing any new reporting requirements or requests, as well as reporting forms. Newsletters and websites are useful for distributing updated lists of reportable diseases, reporting forms, and other updates.
Other suggestions included: providing regular written feedback to reporting sources – both community reporters and local health departments that are involved in surveillance.
States can facilitate case-based reporting implementation with local health departments by discussing CBR at state public health conferences and meetings where local public health staff can see both local and state data on trends and review reporting requirements with State personnel.

20. Results: Strategies to promote CBR
(continued)
Provide investigation protocols and other CBR tools to LHDs
Infectious disease training for LHD staff
Respond to community needs
Investigate and respond to outbreaks
Increase availability of laboratory testing
Establish legislation
Enhanced surveillance funding
States can help standardize reporting and minimize local health department work by providing investigation protocols instructional binders and other tools to local health departments.
……..Some respondents indicated that it helped to have state staff do infectious disease in-service training at local health departments.
…..CBR is also facilitated when there is legislation to mandate case-based reporting
…..Jurisdictions also mentioned that part of maintaining good reporting practices among providers included responding to the needs of the reporting community. Services such as investigating outbreaks and facilitating laboratory testing help establish a good relationship with the reporting community.
…..Finally, as a way to programmatically introduce CBR, several jurisdictions mentioned incorporating varicella case-based reporting into their overall bioterrorism response plans for enhancing rash surveillance.

21. Results: Barriers to CBR
Limited staffing resources
Incidence
Buy-in & communicating new reporting requirements
Under-reporting
Lack of legislative support (i.e. reporting is more likely when mandated)
We also asked the grantees to identify key barriers to implementing case-based reporting. The recurring theme was the limited staffing resources – not only at the health department levels, but also among those who submit reports, such as school nurses.
Other concerns include: the relatively high incidence of varicella and the time it takes to collect necessary information on each case; establishing reporter buy-in and the difficulty in communicating new reporting requirements or reporting requests to providers, schools and daycare staff; under-reporting of varicella cases (due to lack of buy-in), and the lack of and difficulty obtaining legislative support.

22. Results: Barriers to CBR (continued)
Incomplete case information
Case confirmation
Low vaccination coverage areas (high case numbers)
Other barriers that respondents indicated include incomplete case information, case confirmation (for example - how do you confirm a parent’s report of disease?), and finally, in areas with low vaccination coverage incidence can be particularly high further challenging the public health system.

23. Conclusions
Jurisdictions have made substantial progress toward meeting CSTE case- based reporting recommendations
Majority of jurisdictions conduct state wide surveillance
Sentinel site case-based reporting is an interim option for states
In conclusion, jurisdictions have made substantial progress towards implementing case-based reporting. The majority of jurisdictions that have implemented case-based reporting conduct it statewide, although sentinel site reporting is an option for states beginning case-based reporting. As an interim step towards state-wide reporting, sentinel site reporting should be expanded as case numbers continue to decline.

24. Conclusions
(continued)
Schools and providers are important sources of varicella reports
Legislation requiring varicella reporting increases case-based reporting practices
Schools and healthcare providers are important and invaluable sources of varicella case reports. And finally, we observe that when there is legislation requiring varicella reporting, case-based reporting practices improve.
(extra slide on Laura’s conclusions – essentially duplicate of points made elsewhere in the presentation)

25. Acknowledgements State and City Health Department Officials
Immunization Services Division (CDC/NIP)
Immunization Program Managers (ISD)
Viral Vaccines Preventable Diseases Branch (CDC/NIP)
Laura Zimmerman
Dalya Guris
Rafael Harpaz
John Zhang
Adriana Lopez
Paul Gargiullo
Sandra Dos Santos Chavez
Mona Marin
Jessica Leung
Jane Seward
- I NEED HELP ON THIS SLIDE. I’m not sure who and how they should be listed here –
I want to particularly thank the state and city health department officials who took the time to complete this survey. And also Laura Zimmerman who worked extensively on this project. Thank you.
For our discussion I would like to urge you to discuss strategies that you have successfully used to implement new surveillance programs. This could be an excellent forum in which to exchange ideas – hopefully between some states with established CBR, states that are in the middle of implementing it and states that are just beginning.
Thank you.

26. THANK YOU

27. EXTRA SLIDES

28. Measuring Severity of Disease
<50 lesions — can be counted within 30 seconds
lesions — patient’s hand can be placed between lesions without touching a lesion
lesions — patient’s hand cannot be placed between lesions without touching one
500+ lesions — difficult to see the skin
Collecting disease severity data can illustrate the impact of reducing severe disease. We recommend measuring disease severity by noting the number of lesions. Using four descriptive categories allows standardized assessment of individual varicella cases.
Less than 50 lesions – in this case, the lesions can be easily counted within 30 seconds
lesions – in this case, the patient’s hand can be placed between the lesions without touching a lesion
lesions – in this case, the patient’s hand cannot be placed between the lesions without touching a lesion
More than 500 lesions – in this case, the lesions are clumped so closely together that it is difficult to see normal skin

29. Acceptable sources of varicella case reports (n=51)
This slide basically shows that all states with mandated varicella case-based reporting (the yellow bars) accept physician, physician assistant, or nurse practitioner varicella case reports.
Consistently, of the states without mandated reporting (orange bars), fewer accept reports of any kind, though it is interesting that many states without mandated CBR still do accept varicella case reports
(DON’T READ NOTE: “accept” has to do with whether or not they will count a case as a case based on who reported it. For example, about 70% will ‘count’ a case as varicella if a parent calls and tells them that their child has varicella. They do not need further medical evaluation, physicians or lab tests aren’t needed to ‘confirm’ the parent’s diagnosis)

30. Sources of case-based reports in state and city jurisdictions currently conducting CBR (n=23)
Among jurisdictions with case-based reporting in place, most receive reports from schools and medical personnel.
Jurisdictions that plan to implement case-based reporting in the future are not included on this slide since they are not yet receiving reports, though many indicated that they expected to receive reports from similar reporting sites.
(don’t read below – REFERENCE ONLY)
Though jurisdictions accept case reports from a variety of sources, most (67%) of the reports actually received come from the healthcare sector, including physicians, nurses, laboratories, and hospitals. 61 percent of Jurisdictions receive reports from schools, and 52 percent of Jurisdictions receive reports from daycares.

31. Background
Healthy People has a goal of varicella disease reduction
CDC has goal of varicella elimination
Surveillance for monitoring program impact
Today, a goal of disease reduction has been established for Healthy People In addition, CDC has a goal of disease elimination. Varicella surveillance is needed to monitor the impact of the varicella vaccination program. Active surveillance in 2-3 communities has been in place since 1995, but resources to support this surveillance may not be available indefinitely. National passive surveillance will be necessary to continue monitoring the program’s impact and to guide policy. Varicella surveillance will ultimately need to be case-based.

32. Varicella Vaccine Surveillance United States, 1995-2003
Before we begin discussing aspects of varicella case-based reporting, I would like to show you some information on varicella vaccine. Let’s take a look at varicella vaccine surveillance data in the United States since the beginning of the vaccination program in 1995.

33. Varicella Vaccine Distribution, 1995-2003
US Births
This chart shows varicella vaccine distribution. Vaccine distribution increased in the early years of the vaccination program, and since 1997, the doses distributed have remained fairly stable and exceed the US annual birth cohort of approximately 4 million. This indicates that catch-up vaccination has been occurring along with vaccination of children months of age.

34. Estimated Varicella Vaccination Coverage Among Children Months Of Age – National Immunization Survey, United States,
Vaccination coverage among children months of age has increased from 26% in 1997 to 85% in We are close to achieving the 2010 national coverage target of 90%.
Vaccination coverage varies by state. In 2003, the range was 67% to 93%. 32 states had coverage of 80% or higher, and 18 states had less than 80% coverage.
Much of the increased coverage was driven by school entrance laws (extra slide)
Goal

35. Vaccine Impact
(continued)
Varicella deaths declined in children and adults under 50 years of age
Disease declines tend to be lower in states with lower coverage
Varicella deaths have declined dramatically among children and adults under 50 years of age.
As one would expect, disease declines tend to be lower in states with lower vaccination coverage.

36. State Requirements: Varicella Vaccination for Child Care or School Entry as of November 2004
By November 2004, 44 states had implemented child care or school entry varicella vaccination requirements. The breakdown of school requirements included 17 states with childcare, elementary, and middle or high school requirements; 19 states with childcare and elementary school requirements; 4 states with a childcare only requirement; and 4 states with an elementary school only requirement.

37. CSTE Recommendations Sentinel site reporting (continued)
Identify sites with varicella cases
Throughout state or in select jurisdictions (schools, childcare centers, MD offices)
Work with associations (school nurse, etc)
Expand sites as system develops
If statewide reporting is currently not an option in your state, sentinel site surveillance is an acceptable alternative.
Sentinel reporting is an interim step to expand to statewide reporting. To implement sentinel site reporting, states identify sentinel sites that report individual case information. Sentinel sites are located either throughout the state or in select jurisdictions. Sentinel sites may include schools, child care centers, physicians’ offices, hospitals, colleges, and other institutions. State-wide or local school nurse associations and managed care networks may prove useful in some states.
States may expand their number of sites as they develop their system.
(note: duplicate slide – info put on same slide as state-wide guidance)

38. Future: Additional Variables to Collect
Information on source cases
Contact information
Vaccination status
Severity of disease
Laboratory information on cases
As incidence declines, additional variables are required to understand the epidemiology of remaining disease.  In the future, states will want to include variables that reveal information about source cases such as contact information, vaccination status and severity of disease of the source case.
Laboratory information on suspected cases will be a very important component of varicella surveillance in the future.

39. Reporting Varicella Cases to CDC
CDC building reporting capacity for varicella via a national electronic reporting system
States should report cases to CDC in 2005
CDC is developing recommendations for surveillance indicators
Currently, CDC is developing an updated case report form and the ability to receive individual case information via the national electronic reporting system.  In the interim, states should maintain their own databases and assess case reports to determine the need for public health action.
We anticipate that CDC will be able to receive case-based reports in 2005.  When the electronic reporting capability is operational, states will observe that many variables are included.  Be aware that the reporting system will expand over time to include other variables that add to the collection of age, vaccine history, and severity of disease.  
Over the next several years, CDC will develop recommendations for surveillance indicators and timeliness of reporting. 

40. Conclusion
Establishing and maintaining case-based reporting is crucial
Implementation may be challenging
Reporting is feasible through sentinel sites and by limiting the number of variables collected
Establishing case-based reporting takes time
In conclusion, establishing and maintaining case based reporting is crucial due to the number of cases still in the US.
We acknowledge that implementation of varicella case-based reporting may be challenging.
We encourage keeping case-based reporting systems feasible by beginning with sentinel site surveillance and by limiting the number of variables to collect for each case.
Case-based surveillance will expand over time in order to meet the needs of each vaccination program.