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Immunization Smallpox Vaccination Surveillance Meeting a critical surveillance challenge with an innovative solution Abt Associates Inc. Combining innovative thinking, fast response, and careful monitoring Abt Associates provides unequalled expertise and decades of experience in all aspects of conducting surveys – including collecting and analyzing key immunization data. A critical surveillance project for the Department of Defense serves as a good example of Abt Associates’ innovative surveillance solutions – and our ability to leverage technology and partnerships to deliver complete, accurate data quickly and securely. An acute need for careful surveillance The threat of a smallpox outbreak has been widely discussed in recent months by the government, militar y, and media. In early 2003, these concerns led the U.S. Government to vaccinate selected military personnel and healthcare work- ers against the disease. However, uncer- tainty over the use of the vaccinia vac- cine required careful monitoring of small- pox vaccine recipients, particularly of early cohorts, to ensure the safety of recipients and their contacts. This surveillance needs to serve several functions. It must provide early insights into adverse reactions. It must compile a complete, accurate record of all results – including normal vaccinations, expected symptoms, and unusual adverse events. And it must help streamline the signifi- cant challenges of vaccine administration – particularly among dispersed groups, such as military personnel. Creating an advanced surveillance solution In response to the needs of the Department of Defense, Abt Associates worked with Voxiva, Inc. and Rand to cre- ate an innovative surveillance solution that actively monitors and records events following the administration of the small- pox vaccine. The state-of-the-art electron- ic diary – based on Voxiva’s integrated phone and Web technology and Abt Associates’ call-center capacity – pro- vides a new, efficient way of monitoring and communicating with individuals receiving the smallpox vaccine. Making reporting easier for vaccine recipients Following vaccination, vaccine recipients register and receive a diary repor ting card, which provides instructions on using the system and a list of symptoms. For each day up to four weeks after vacci- nation, vaccine recipients call into a phone-based system or log in to the Web to report any symptoms, or to file nega- tive reports. They may be asked to com- pare their vaccine site to photographs. Vaccine recipients may also be requested to report significant symptoms in mem- bers of their household. By employing easy-to-use, familiar, readily available channels for communication – any phone or a computer with Web access – this solution makes it easy for recipients to report at any time, from almost any place. Active follow-up To assure high levels of compliance, spe- cially trained interviewers are available to call non-reporting vaccine recipients, check for symptoms, and encourage com- pliance. Via active, regular follow-up, interviewers can reach non-compliant vac- cine recipients and gather the informa- tion they need. Vaccine recipients also have access to a Help Desk when they call in, aiding compliance. Thorough analysis of all data All of the data is collected in a database that can be accessed via the Web by authorized users, sorted, and exported to a variety of formats for follow-up, moni- toring, and analysis. Authorized clinic staff members have access to up-to-date information – offering them an ongoing window on current status. This capability enables them to identify special cases, responses that could be associated with particular vaccination situations, and other areas that require immediate attention. Effective communication with vaccine recipients The powerful combination of Abt Associates’ call centers and Voxiva’s technology enables regular communica- tion with vaccine recipients. It offers an opportunity to supply additional informa- tion, broadcast reminders, and send other messages via the phone or the Web. This capability helps reassure vac- cine recipients, and establishes a sim- ple, direct method of communicating – even when the recipients are geographi- cally dispersed. The results: quick progress, careful monitoring Under the first phase of implementation, approximately 2,000 military vaccine recipients located at a US military instal- lation will participate in the electronic monitoring program following vaccination. An ongoing solution for vaccine monitoring The electronic monitoring program pro- vides a reliable, proven solution for moni- toring smallpox vaccine recipients and helping to ensure their ongoing health and safety. In addition to meeting the immediate needs of the Department of Defense, this solution will continue to serve as an effective surveillance method as other groups – from health- care workers at fixed sites to on-the-go deployers – receive the smallpox vaccina- tion. Highlighting the surveillance strengths and capabilities of Abt Associates This high-profile project is just one of hundreds of challenging surveillance efforts undertaken by Abt Associates. It highlights some of the key strengths that Abt Associates brings to each project. Unequalled surveillance experience When envisioning and creating the ideal solution for monitoring smallpox vaccine recipients, Abt Associates leveraged its years of experience conducting major, challenging surveys of diverse popula- tions. Our hundreds of survey pro- fessionals, state-of-the-art telephone interviewing facilities, and decades of experience conducting a wide range of surveys helped ensure that best possible solution. The ability to move quickly Abt Associates has a reputation for responding quickly to important chal- lenges. In this case, the entire system was envisioned, designed, demonstrated, approved, and implemented in a matter of weeks. Innovative use of technology Abt Associates recognizes the impor- tance of advanced technology to address the strategic challenges of surveillance. This solution draws on our in-house tech- nical expertise – as well as that of our partners – to leverage the Web, the lat- est advances in telephony, next-genera- tion call centers, and software to create an efficient, flexible solution. The power of partnership Abt works with its partners to create best-in-class solutions to crucial chal- lenges. In this case, our ability to com- bine forces with Rand and Voxiva was crucial to providing a complete surveil- lance solution. Voxiva provided the innov- ative information technology, electronic registration, and other technical exper- tise necessary to provide accurate, secure monitoring. The Rand Center for International and National Health and Security provided technical assistance and meticulous project evaluation. Together, our team provided a complete, integrated solution. Part of our wide-ranging immunization expertise Abt Associates brings more than 30 years of experience and a wide range of capabilities and strengths to the critical area of immunization. As an independent research organization, we take a critical, unbiased view of the many issues related to immunization – and are widely respect- ed for our objectivity. Our capabilities span from clinical research to surveys and registries to financial sustainability analysis. Our team includes hundreds of project managers, bio-statisticians, epidemiologists, social scientists, clinicians, and other experts. And the information and insights we gather help address local, national, and global health challenges. Here are just some of the areas where we offer expertise and experience: Surveillance and registries Abt Associates has conducted a wide range of immunization surveillance, both in the United States and in developing countries. Since 1994, Abt Associates has conducted the National Immunization Survey (NIS) for the Centers for Disease Control and Prevention. The NIS is an extremely large and complex undertaking that screens households throughout the country to find the relatively narrow tar- get population of parents of children ages 19 to 35 months. On an annual basis, over 2,000,000 telephone num- bers are screened and approximately 34,000 interviews are conducted with eli- gible families. Requests for immunization data are mailed to more than 40,000 health care providers. The CDC uses NIS information to monitor vaccination coverage and track the response by parents and health care providers to changes in immunization guidelines and policies. By examining vaccination coverage geographically and for population subgroups, the NIS helps policymakers focus immunization initia- tives where they are most needed. Our surveillance projects specialize in addressing diverse populations – includ- ing young and elderly, individuals with HIV, and racial/ethnic subgroups. For example, since 2000, Abt Associates has conducted surveillance on influenza and pneumonia immunization compliance for adults 65 and older. Current surveil- lance studies are evaluating disparities in compliance between racial and ethnic subgroups. Clinical research Abt Associates Clinical Trials (AACT) pro- vides a broad array of clinical research services – including clinical trials man- agement (Phase I – IV), registries, biosta- tistics, epidemiology, pharmaco-econom- ics and outcomes research, health policy research, and regulatory affairs consult- ing. We help health care organizations, pharmaceutical companies, government agencies, and others collect and analyze key data that helps them evaluate and address a wide range of clinical, quality- of-life, and economic issues. As an exam- ple of our clinical and outcomes research, Abt Associates led and man- aged an 8-year effort to design and con- duct key HIV vaccine efficacy trials. Known as the HIV Network for Prevention Trials (HIVNET), this ambitious project established the infrastructure for the con- duct of Phase I – III clinical trials of vac- cines to prevent HIV infection and non- vaccine prevention interventions – includ- ing microbicides and behavioral counsel- ing. Abt Associates has also conducted studies of vaccines for acellular pertus- sis and strep pneumonia. Our research expertise goes beyond clini- cal trials. For example, we have conduct- ed hundreds of registries, observational studies, and longitudinal surveys to determine the value of health care prod- ucts and services across a wide range of therapeutic areas. We have provided vac- cine policy research for Herpes Simplex Virus (HSV) and pneumococcal pneumo- nia. We have provided economic research assessing the economic value of pertus- sis, diphtheria, and tetanus booster vaccines for hospital staff. These studies are just a few of the hundreds of key efforts where Abt Associates and AACT have provided independent clinical research capabilities. Financial sustainability Abt Associates is also active in research- ing and analyzing the financial sustain- ability of vaccination efforts around the world. Our research provides valuable information and insights that help guide policymaking. Internationally, Abt Associates strives to improve financing for immunization by working with the Global Alliance for Vaccines and Immunization (GAVI) and with individual country governments. Abt Associates has contributed to GAVI policy development, conducted global and regional training for immunization program officials, and has a staff member on the GAVI Financing Task Force. Abt Associates has also worked with the governments of many countries to assist them in improving the financial sustain- ability of their immunization programs. This work is funded by a variety of clients, including the Children’s Vaccine Program, the U.S. Department of Health and Human Services, U.S. Agency for International Development, World Health Organization, and others. Similarly, Abt Associates has worked for several years with a global vaccine com- pany to better understand the clinical and economic impact of childhood dis- eases, the barriers to preventing those diseases with vaccines, and how to pro- mote vaccine delivery and financing. We have investigated the implications of adult as well as childhood immunization. Our economic analyses have helped iden- tify population groups that would most benefit clinically and economically from immunization initiatives. About Abt Associates Immunization is just one of the many important global issues where Abt Associates applies its extensive research services. Abt Associates is one of the largest government and business research and consulting firms in the world. Founded in 1965, we have gained a reputation for providing our clients with sound information and careful analysis – providing the best possible foundation for decision-making. We are dedicated to providing practical, measurable, high- value solutions to a wide range of chal- lenges. Our practice spans four broad lines of endeavor: domestic public policy, international development, Abt Associates Clinical Trials (AACT), and business research and consulting. A global organization known for innovation Abt Associates is a private, employee- owned company with a full-time perma- nent staff of approximately 1,000 in offices throughout the world. Approximately 50 percent of our staff has graduate degrees; one in six has a doctorate. Our staff includes nationally and internationally recognized experts known for excellence in their respective disciplines, innovative research tech- niques, and insightful and often ground- breaking analyses and recommendations. Unequalled expertise with survey research projects Abt Associates designs and conducts complex survey research projects to eval- uate public policy and programs and to provide statistical information to support decision-making in both government and business. Abt Associates has developed innovative approaches to computer- assisted data collection, including appli- cations in personal screening and inter- viewing, record abstraction in institutional settings, and telephone surveys. Experience with a full range of clients Our principal work is conducting research for government clients. We have success- fully assisted numerous Federal depart- ments and agencies, including the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), United States Agency for International Development (USAID), Center for Medicare and Medicaid Services, the Department of Defense (DoD), and many more. We also work with leading private sector organizations in biotechnology, pharmaceutical, medical devices, diagnostics and other areas. And our clients include a wide range of foundations focused on world health and other pressing issues. Managing complex projects and partnering with leading companies Abt Associates is particularly skilled in project management of complex projects, as well as bringing together the key resources necessary to meet the require- ments of each project. For the smallpox surveillance project, partnering with Voxiva, Inc. (www.voxiva.net) and Rand (www.rand.org) – both leaders in their fields – enabled us to develop an innova- tive solution that met and exceeded our client’s expectations. For more information on Abt Associates, go to www.abtassociates.com. Abt Associates Inc. Smallpox Vaccination Surveillance Abt Associates Inc. 55 Wheeler Street Cambridge, MA 02138 617 492 7100 617 492 5219 fax www.abtassociates.com . more information on Abt Associates, go to www.abtassociates.com. Abt Associates Inc. Smallpox Vaccination Surveillance Abt Associates Inc. 55 Wheeler Street Cambridge,. initiatives. About Abt Associates Immunization is just one of the many important global issues where Abt Associates applies its extensive research services. Abt Associates