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This chapter on surveillance and data management is one of nine. With many STDs, such as syphilis, on a downward trend, now is the time to employ new strategies ...
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FOREWARD iii
INTRODUCTION iv Program Operations Guidelines Workgroup Members vi Surveillance and Data Management Subgroup Members vii Surveillance and Data Management Internal/External Reviewers vii
INTRODUCTION S-
OBJECTIVES OF A PUBLIC HEALTH SURVEILLANCE SYSTEM S-
COMPONENTS AND OPERATION OF A SURVEILLANCE SYSTEM (GENERAL PRINCIPLES) S- Legal Authority S- Types of Surveillance Systems S- Case Reporting S- Provider-based case reporting S- Laboratory-Based case reporting S- Electronic reporting of laboratory data S- Reporting by out-of-state laboratories S- Coordination S- Laboratory Visitation S- Laboratory Compliance S- Prevalence Monitoring S-
METHODS OF SURVEILLANCE S- Passive Surveillance S- Active Surveillance S- Sentinel Surveillance S- Special Systems S-
SURVEILLANCE SYSTEM ATTRIBUTES S-
PERSONNEL, TRAINING, AND RESOURCES S-
Surveillance and Data Management i
The development of the Comprehensive STD Prevention Systems (CSPS) program announcement marked a major milestone in the efforts of CDC to implement the recommendations of the Institute of Medicine report, The Hidden Epidemic, Con fronting Sexually Transmitted Diseases, 1997. With the publication of these STD Program Operations Guidelines, CDC is providing STD programs with the guid ance to further develop the essential functions of the CSPS. Each chapter of the guidelines corresponds to an essential function of the CSPS announcement. This chapter on surveillance and data management is one of nine. With many STDs, such as syphilis, on a downward trend, now is the time to employ new strategies and new ways of looking at STD control. Included in these guidelines are chapters that cover areas new to many STD programs, such as com munity and individual behavior change, and new initiatives, such as syphilis elimi nation. Each STD program should use these Program Operations Guidelines when deciding where to place priorities and resources. It is our hope that these guidelines will be widely distributed and used by STD programs across the country in the future planning and management of their prevention efforts.
Judith N. Wasserheit Director Division of STD Prevention
Surveillance and Data Management iii
T
hese guidelines for STD prevention program operations are based on the essential functions contained in the Comprehensive STD Preven tion Systems (CSPS) program announcement. The guidelines are divided into chapters that follow the eight major CSPS sections: Leadership and Program Management, Evaluation, Training and Professional Development, Surveillance and Data Management, Partner Services, Medical and Laboratory Services, Community and Individual Behavior Change, Out break Response, and Areas of Special Emphasis. Ar eas of special emphasis include corrections, adoles cents, managed care, STD/HIV interaction, syphilis elimination, and other high-risk populations. The target audience for these guidelines is public health personnel and other persons involved in man aging STD prevention programs. The purpose of these guidelines is to further STD prevention by providing a resource to assist in the design, implementation, and evaluation of STD prevention and control programs. The guidelines were developed by a workgroup of 18 members from program operations, research, sur veillance and data management, training, and evalua tion. Members included CDC headquarters and field staff, as well as non-CDC employees in State STD Pro grams and university settings. For each chapter, subgroups were formed and as signed the task of developing a chapter, using evidence- based information, when available. Each subgroup was comprised of members of the workgroup plus subject matter experts in a particular field. All subgroups used causal pathways to help determine key questions for literature searches. Literature searches were conducted on key questions for each chapter. Many of the searches found little evidence-based information on particular
topics. The chapter containing the most evidence-based guidance is on partner services. In future versions of this guidance, evidence-based information will be ex panded. Recommendations are included in each chap ter. Because programs are unique, diverse, and locally driven, recommendations are guidelines for opera tion rather than standards or options. In developing these guidelines the workgroup fol lowed the CDC publication “CDC Guidelines—Im proving the Quality”, published in September, 1996. The intent in writing the guidelines was to address appropriate issues such as the relevance of the health problem, the magnitude of the problem, the nature of the intervention, the guideline development methods, the strength of the evidence, the cost effectiveness, implementation issues, evaluation issues, and recom mendations. STD prevention programs exist in highly diverse, complex, and dynamic social and health service set tings. There are significant differences in availability of resources and range and extent of services among different project areas. These differences include the level of various STDs and health conditions in com munities, the level of preventive health services avail able, and the amount of financial resources available to provide STD services. Therefore, these guidelines should be adapted to local area needs. We have given broad, general recommendations that can be used by all program areas. However, each must be used in con junction with local area needs and expectations. All STD programs should establish priorities, examine options, calculate resources, evaluate the demographic distribution of the diseases to be prevented and con trolled, and adopt appropriate strategies. The success of the program will depend directly upon how well
iv Program Operations Guidelines for STD Prevention
David Byrum Program Development and Support Branch, DSTD Janelle Dixon Health Services Research and Evaluation Branch, DSTD Bob Emerson Training and Health Communications Branch, DSTD Nick Farrell Program Support Office, NCHSTP Melinda Flock Surveillance and Data Management Branch, DSTD John Glover Program Development and Support Branch, DSTD Beth Macke Behavioral Interventions and Research Branch, DSTD Charlie Rabins Illinois Department of Public Health Anne Rompalo Johns Hopkins School of Medicine Steve Rubin Program Development and Support Branch, DSTD, New York City Lawrence Sanders Southwest Hospital and Medical Center, Atlanta Don Schwarz Program Development and Support Branch, DSTD Jane Schwebke University of Alabama Birmingham Kim Seechuk Program Development and Support Branch, DSTD Jerry Shirah Training and Health Communications Branch, DSTD Nancy Spencer Colorado Department of Public Health Kay Stone Epidemiology and Surveillance Branch, DSTD Roger Tulloch Program Development and Support Branch, DSTD, Sacramento, California
vi Program Operations Guidelines for STD Prevention
Susan Blank Epidemiology and Surveillance Branch, DSTD, New York City Scott Danos Statistics and Data Management Branch, DSTD Don Dowda Behavioral Interventions and Research Branch, DSTD Gail Gould Program Development and Support Branch, DSTD, Sacramento, California Sam Groseclose Epidemiology and Surveillance Branch, DSTD Melinda Flock Statistics and Data Management Branch, DSTD Noreen Hynes Epidemiology and Surveillance Branch, DSTD, Baltimore Karl Labes Program Development and Support Branch, DSTD, New York City Jean Montes California Department of Health Services Charlie Rabins Illinois Department of Public Health Steve Rubin Program Development and Support Branch, DSTD, New York City Don Schwarz Program Development and Support Branch, DSTD Roger Tulloch Program Development and Support Branch, DSTD, Sacramento, California
Carol Ciesielski Epidemiology and Surveillance Branch, DSTD, Chicago Marty Goldberg Program Development and Support Branch, DSTD, Philadelphia Robert Gunn Epidemiology and Surveillance Branch, DSTD, San Diego Richard Kahn Program Development and Support Branch, DSTD Steve Kowalewski Program Development and Support Branch, DSTD, Harrisburg, Pennsylvania Anne Major Program Development and Support Branch, DSTD, Austin, Texas Steve Middlekauff Program Development and Support Branch, DSTD Phil Moncrief Program Development and Support Branch, DSTD, Tallahassee, Florida Darien Ogburn Statistics and Data Management Branch, DSTD Dennis Sayers Program Development and Support Branch, DSTD, Columbus, Ohio Cristal Simmons Chicago Department of Public Health Emmett Swint Statistics and Data Management Branch, DSTD
Surveillance and Data Management vii
Legal Authority
Every state has communicable disease laws that give the department of health the authority to determine which diseases are reportable. However, not every dis ease is reportable in every state. For STDs, many states have statutes that define the reportable diseases. The legal authority for deciding which conditions (and which accompanying case data) are reportable in a given jurisdiction can vary by state, territory or local law or regulation, but is usually the state and/or local health department. Every state requires physicians to report diagnosed cases of, and/or laboratories to re port tests indicative of, specific diseases. In most states, other health care or public health professionals (per sons in charge of hospitals, clinics, prisons, detention centers) are also required to report cases of specified diseases to the health department. For more details, see the chapter on LEADERSHIP. Some disease reports are legislatively mandated; oth ers are declared notifiable by the state or local health officer, state epidemiologist, or board of health. The latter is particularly important in the face of a need to act quickly as new conditions arise. Mandated disease reporting requires demographic information, onset date or date of diagnosis, and responsible county. Other data collection requirements are normally left to the local health jurisdiction, but should be consistent with national surveillance case definitions. Reporting re quirements should also be time-specific to provide the best opportunity for disease intervention. For example, the states of California, New York, and New Jersey require that acquired and congenital syphilis infections be reported within 24 hours of diagnosis.
Types of Surveillance Systems Surveillance data are usually collected and used ex plicitly for a specific surveillance purpose.
Case Reporting Incidence is defined as the number of newly developed cases of disease in a specified time period. The inci dence rate is the number of new cases of disease di vided by the number of persons at risk during a speci fied time period. Case-reporting is the process of reporting cases of notifiable STDs by providers and/ or laboratories to local and state health departments and from state health departments to CDC. Case re ports remain the most common source of STD sur veillance data for state and local health departments.
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In addition, the reporting areas share data from case reports with the Centers for Disease Control and Pre vention (CDC) via the National Electronic Telecom munications System for Surveillance (NETSS). NETSS collects information on a number of notifiable diseases and injuries that are nationally reportable in the United States for control of these conditions. The Council of State and Territorial Epidemiologists (CSTE) determines which conditions should be nationally reportable to the CDC. Reporting from states and other reporting areas to the CDC is voluntary (except for reports of quarantinable disease, which are required by interna tional regulation). For more information, including record layouts and the NETSS implementation plan, contact CDC’s Division of STD Prevention, Statistics and Data Management Branch. Although most jurisdictions accept a gonorrhea or chlamydia case report from either a clinician or a labo ratory, some require that each case be reported from both sources, and reject case reports from a single source. While laboratory-based reporting is essential and more complete, reporting by clinicians should continue to be encouraged to obtain office-based, point-of-care tests for gonorrhea and chlamydia used by providers. Reporting by providers also affords lo cal health departments an opportunity to establish ongoing relationships with community medical pro viders who serve at-risk populations. These relation ships can result in better reporting, expanded demo graphic and treatment information, identification of problems with the current laboratory reporting sys tems, and identification of opportunities for additional STD prevention. These data can be used to better de fine and then target at-risk populations. All cases of disease should be reported regardless of treatment status. If a program only reports cases of disease that have been treated, they will be under re porting the true number of cases and the incidence rate will be lower.
Provider-based case reporting All states require that certain STDs be reported by physicians and other health care providers when they suspect that a case has occurred or they have labora tory confirmation. Physicians can use confidential morbidity report systems that allow them to enter ba sic demographic information which is sent to the local or state health department by mail, dedicated FAX, or electronically. In some areas, use of FAX to report may pose a confidentiality issue. To provide adequate pro vider reporting and to improve reporting, routine con tact with providers and feedback on disease trends in their area can help them to better understand the uses of data and to be more timely and complete in their case reporting. The relationship between STD prevention program staff and health care providers should focus on com municating useful information on screening, treatment, and partner management for STDs. The provision of information on case-reporting requirements should be viewed as only one aspect of STD prevention program- provider relations. Routine contact with providers and the provision of feedback to providers on reporting may improve the timeliness, completeness, and valid ity of case reports and may also result in improve ments in the quality of STD care. Programs should
Surveillance and Data Management S – 3
should be performed in addition to laboratory-based reporting to capture the growing usage of point of care tests; that is, tests that are rapid, on-site tests for gon orrhea and chlamydia. Surveillance information can be used to trigger labo ratory visits to inform laboratories of their reporting responsibilities, to provide copies of appropriate laws and regulations, to discuss reporting procedures in cluding appropriate mailing address, and to answer any questions the laboratories may wish to raise. In formation to be included on laboratory reports slips and timeliness of reporting should be discussed. Labo ratories must understand their statutory responsibili ties to report all results for which reporting is man dated (e.g., reactive syphilis serologies, treponemal and non-treponemal). Visits can also be used to identify a contact person, both in the laboratory and in the local health jurisdic tion. Local public health laboratory staff should be aware of—and afforded—the opportunity to partici pate in such visits. Programs are further encouraged to provide information on alternative reporting mecha nisms—telephone, dedicated FAX, or electronic—as available and deemed appropriate. One method of gathering information is to survey laboratories. Laboratory survey formats should be con sistent from year to year to allow programs to moni tor levels of testing within the community. The infor mation provided will help programs identify high- volume, high-priority laboratories and may help com pare reports received throughout the year. Programs using surveys to obtain information from clinical labo ratories should establish a mechanism for providing “feedback” to the laboratories. For example, a yearly report could be developed and included with each sur vey packet that presents and analyzes information ob tained from previous surveys. The ability to provide information that spans multiple years would be de pendant on the uniformity of the data being collected over time. Such a format does not preclude questions being added or dropped. Laboratories that report large numbers of positives or serve providers who see high-risk patient popula tions or practice in high-morbidity communities should be closely monitored and targeted for close working relationships. Such relationships can be particularly
useful in identifying and then solving problems. Pro grams should have a computerized laboratory check list that allows the ongoing tabulation of reports from laboratories with the number of cases of disease re ported, date of laboratory receipt, and date reported. This can be used to detect a change in the pattern of reporting and allow the program to rapidly contact the laboratory to discuss reasons why reporting pat terns have changed. STD prevention programs should work with labo ratories to routinely collect gonorrhea and chlamydia testing data from both public and private laborato ries. The number of gonorrhea and chlamydia tests performed, type of test, and the number positive by sex, age, race, ethnicity, zip code, and provider type, along with the number of laboratories providing data during the reporting period, should be recorded and maintained by STD prevention programs.
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Electronic reporting of laboratory data
In general, laboratories are more likely than providers to report STD positive test results. Many clinical labo ratories maintain computerized data systems, and many of those include the minimum data elements needed for STD case reporting. Once STD prevention programs define variables and data formats for case reporting, they should make these data formats avail able to laboratories and begin to ensure complete and timely reporting. STD prevention programs and clini cal laboratories should also be working collaboratively to develop or expand their abilities to transmit and to receive electronic line-listed data on all persons with positive tests for case reporting purposes. STD pre vention programs need to collaborate with other dis ease control programs such as TB and HIV/AIDS to maximize the impact on disease control surveillance operations and avoid duplication.
Reporting by out-of-state laboratories
Large commercial laboratories often receive specimens from many states. Many state STD prevention pro grams have reported that it is difficult to obtain data from out-of-jurisdiction laboratories. With increasing regionalization of commercial laboratories and the centralization of lab services within managed care or ganizations, out-of-jurisdiction testing may become more common. All of these laboratories should be notified of their legal responsibilities to report notifi able diseases to the appropriate state STD prevention program. State programs can assist this process by providing out-of-state laboratories with information regarding their reporting responsibilities, including
accurate mailing addresses and methods to transmit data. When problems continue, programs should re quest the assistance of the STD prevention program in the laboratory’s home state to resolve the matter. The Council of State and Territorial Epidemiolo gists (CSTE) recommends that the following algorithm be used by notifiable disease reporting sources when reporting to public health authorities in multiple ju risdictions (in order of preference): a) the state where the patient resides; b) the state where the provider who ordered the test is located if information on a) is missing; c) the state where the laboratory that received the origi nal specimen is located if information on a) and b) is missing; or d) the state where the laboratory that performed the test is located if information on a), b), and c) is missing. In states where laws require reporting to counties, the state and county health departments need to work with laboratories to establish an algorithm.
Coordination Many laboratories are required to report data to mul tiple public health programs within the same health department. These public health programs may also request that data be reported in different formats and for different time periods. Collaboration and coordi nation between the health department programs that receive data from laboratories would improve effi ciency of laboratory-based surveillance data and sim plify the laboratories’ reporting procedures.
S – 6 Program Operations Guidelines for STD Prevention
to conduct a visit, how to address laboratory non compliance issues, how to arrange follow-up visits, materials that should be left with the laboratory, and how to respond to questions where the health department representative does not immediately have the answer. Responsible staff should be well versed in the various methods available for the labo ratory to report findings, and provide suggestions or alternatives (given resource availability) to com ply with reporting timeliness, i.e., priority mail, FAX, or electronic reporting.
ter information obtained from laboratory visits into computers so that information can be easily followed and updated over time. For this reason, the infor mation collected from laboratories should remain uniform from year to year to simplify analysis.
Laboratory Compliance The following steps should be implemented in an ef fort to ensure proper laboratory compliance with ex isting reporting requirements.
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Prevalence Monitoring
Prevalence of a disease or infection is defined as the proportion of persons in a population who have that disease or infection at a defined point in time. Preva lence monitoring is the observation of trends in preva lence in defined populations over time. In contrast to case-reporting, which is intended to cover all health care providers and laboratories, preva lence-monitoring is most commonly performed using
data obtained on selected populations. These preva lence data are usually systematically collected from routine screening rather than case-based surveillance activities performed for the primary purpose of assess ing overall disease burden. This activity is performed by state and local health departments in collaboration with providers and labo ratories; in many instances these data are also reported to CDC. Prevalence monitoring has been used in the Regional Infertility Prevention Program for the sur veillance of gonococcal and chlamydial infections as well as in GISP for the surveillance of resistant gonorrhea. Because prevalence-monitoring demands more re sources than case-reporting, the participation of pro viders needs to be actively sought by the health de partment, often in collaboration with Regional Infertility Prevention Projects. For percentage of posi tive test results to be a valid estimate of prevalence, providers must routinely screen the target population. If diagnostic testing is included, the estimate will be biased and not reflect the true prevalence of disease in the target population. Laboratories can be the primary source of preva lence monitoring data if the laboratory routinely re ceives data on sex, age, and provider type on persons testing positive and negative for chlamydia or gonor rhea. State and local STD prevention programs should work closely with their surveillance staff to collect these data. The purposes of prevalence monitoring, e.g., monitoring the effectiveness of chlamydia and gonor rhea prevention programs, must be communicated to laboratories. The state and local statutes that provide the authority for public health surveillance, including in some cases the authority for obtaining data on both positive and negative test results, should be provided and discussed with laboratories, and written proce dures for data security and confidentiality should be provided and discussed. As the morbidity of a par ticular disease begins to decrease, negative test infor mation will provide programs an additional indicator to determine if the decrease is real. Unlike chlamydia and gonorrhea, positivity or prevalence of reactive serology for syphilis is not a measure of active disease in the community. Serologic tests for syphilis remain positive for long periods after infection is treated. Clinical information in combina-
Surveillance and Data Management S – 9
Active Surveillance
Active surveillance involves outreach by the public authority, such as regular telephone calls or visits to laboratories, hospitals, and providers to stimulate re porting of specific diseases. Because it places intensive demands on resources, implementation of active sur veillance should be limited to brief or sequential periods of time and for specific purposes. It is a reasonable method of surveillance for:
Operationally, active surveillance includes visits or tele phone calls to such key reporting sources as clinicians or laboratories by public health authorities on a regu lar or episodic basis to elicit (or verify) case reports and/or reviewing medical records and other alterna tive sources to identify diagnoses that may not have been reported. It is generally employed when it is ex pected that more disease is in the community than is shown in the passive surveillance systems.
Sentinel Surveillance Sentinel surveillance involves the collection of case data from only part of the total population (from a sample of providers) to learn something about the larger popu lation, such as trends in disease. The advantages of sentinel surveillance data are that they can be less ex pensive to obtain than those gained through active surveillance of the total population, and the data can be of higher quality than those collected through pas sive systems. This is because it is logistically easier to obtain higher quality information from a smaller popu lation. A vulnerability of sentinel systems is not being able to ensure the representativeness of the sample se lected. Sentinel surveillance systems may be useful in identifying the burden of disease for conditions that are not reportable, or behavioral characteristics that are of sufficient public health importance to merit monitoring. Candidates for sentinel systems might include: human papilloma virus, herpes simplex pri mary infection, congenital infection, or other adverse outcomes of STDs. One sentinel surveillance system already in place is the Gonococcal Isolate Surveillance System (GISP), which monitors the antibiotic resistance patterns of gonococcal isolates in selected sites by clinic-type, patient characteristics, and changes over time. Sentinel systems for antimicrobial resistance pat terns for chlamydia, herpes, and trichomoniasis may be useful, as would sentinel surveillance of relevant risk behaviors.
Special Systems Special systems are occasionally designed and imple mented to generate surveillance information that is not possible to acquire by any of the other systems already mentioned. Special systems include those designed for chlamydia prevalence monitoring, which consist of collection of information regarding all tests performed— positive or negative—to determine the number of in fections in the population at risk over a particular time interval (period prevalence). Because chlamydia is only diagnosed by testing, the population at risk for a chlamydia diagnosis is defined as those tested for chlamydia.
Surveillance and Data Management S – 11
The MMWR Supplement, dated May 6, 1988, titled: Guidelines for Evaluating Surveillance Systems de scribes surveillance system attributes in detail. Each surveillance system has elements that are designed to meet specific objectives. The combination of these at tributes determines the strengths and weaknesses of the system. The attributes must be balanced against one another (e.g., high sensitivity may be possible only with a complex reporting system from a wide array of providers). Appendix S-E describes these attributes.
Historically, STD prevention programs have put most of their surveillance resources into data collection and data management functions rather than into data analysis, interpretation, and dissemination. Although data collection and data management are the founda tion of surveillance, data alone are not meaningful without appropriate analysis, interpretation, dissemi nation, and application of surveillance data. These surveillance functions are critical to making informed decisions on quality of case report or prevalence data, applying science-based information to local program’s prevention and intervention strategies, and increasing data completeness and quality within and across STD prevention programs. Many state and local STD prevention programs, however, have no one assigned to data analysis and interpretation functions. Every program must have or must develop the capacity to properly collect, assess, analyze, interpret, and disseminate surveillance data.
This requires individuals with specific training or ex pertise. Toward this end, programs should cooperate with local, state, and federal agencies to implement the approaches necessary to have or develop these skills in STD prevention programs. Designation of a surveillance coordinator in each project area provides a focal point for developing ana lytical capacity. The surveillance coordinator should be made responsible for building analytical and data interpretation capacity. Recommendations on build ing capacity and on training recognize the limited re sources that can be allocated to these necessary activi ties. These recommendations thus indicate the use of innovative approaches to staff training that will re quire cooperation between STD prevention programs and all levels of the public health system. Improve ments in a STD prevention program’s capacity to ana lyze and interpret surveillance data will likely save money over time because of improved data quality and availability—allowing for data-based prevention pro gram planning. A variety of options can be explored to help pro grams meet identified training and resource needs as sociated with the development of a surveillance coor dinator position. These may include:
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