Supporting Statement B

Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance

Supporting Statement B

Contact Information

Project Officer: Delicia Carey, PhD

Chief (Acting), Statistics and Data Management Branch

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Division of STD Prevention/ Statistics and Data Management Branch

Centers for Disease Control and Prevention

1600 Clifton Road NE, Mailstop

Atlanta, GA 30333.

Voice: (404) 639-6035

Fax: (404) 639-8611

Email: dcarey@cdc.gov

October 24, 2012

B. Statistical Methods

1. Respondent Universe and Sampling Methods

As with all passive notifiable disease surveillance systems, all residents of a jurisdiction (e.g., state) represent the universe of individuals under surveillance and therefore, the individuals for whom data may be collected when they are diagnosed with a notifiable STD. The local and state health departments, STD care providers, and private health care providers providing care to persons with STD, constitute the respondents who collect the information needed to monitor STDs in the community. Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance case definitions are used to standardize reporting and to aid data interpretation. State health departments define the information content and format that should be collected, as designated by local or state law or regulation. In addition, public health and private laboratories who conduct diagnostic testing for STDs are required by local or state law or regulation to report positive notifiable STD laboratory findings to the local or state public health department. Local, territorial, and state STD prevention and control programs transmit case-patient’s demographics in their weekly electronic reporting to CDC’s National Notifiable Disease Surveillance System. The 60 data elements defining STD Morbidity Surveillance is a part of the routine weekly submission by the local, territorial, and state health agencies.

Personally identifiable information is maintained by the reporting health jurisdictions and are not transmitted to CDC.

The dissemination of national notifiable STD surveillance information is accomplished through publication of an annual STD-specific surveillance summary and supplements in hard copy on CD-ROM and on the Internet (http://www.cdc.gov/std/Stats/ ).

2. Procedures for the Collection of Information

Persons with one or more of the notifiable STDs seek care from health care providers either at public clinics or private health care settings. When a clinical diagnosis is confirmed by laboratory tests for STDs, the case is reported by the provider to the local health department. The information is elicited from the patient in settings where the confidentiality of the client is assured. Data collected by the provider during a clinical encounter or counseling session are reported to state and local public health departments either by phone or by means of a standardized paper form.

In addition, clinical specimens obtained from case-patients to confirm their STD diagnosis, are submitted to private or public diagnostic laboratories with laboratory requisition forms. These forms include information on the provider as well as the case-patient. In accordance with state and local laws and regulations, the Health Information Portability Act (HIPAA), is a public health notification exemption. Both the health care providers and the laboratories are required to report demographic, risk, and clinical information to the local or state public health system. The laboratories may also report positive assays directly to the state health departments.

A subset of the information reported to state health departments is reported electronically as a case report e-record to CDC’s NNDSS on a weekly basis.

Surveillance case definitions for STDs are jointly developed and approved by the Council of State and Territorial Epidemiologists (CSTE) and CDC. Currently, CSTE has designated chancroid, genital Chlamydia trachomatis infection, gonorrhea, and all stages of syphilis as nationally notifiable conditions. Case definitions specify the certainty with which the diagnosis is made and are categorized as confirmed, probable, or suspect cases dependent on available data.

STD case reports are submitted to local and State health departments by telephone, fax, or secure web-based systems. At the state health departments, data elements needed by CDC are submitted electronically via a secure channel (CDC’s Secure Data Network) to NNDSS.

The STD case report for the STD Morbidity Surveillance includes 1) demographic and case report information and 2) risk behavior, source of case detection and selected clinical information specific to STD prevention needs

The STD morbidity surveillance does not require any new procedures at the state health departments in the collection or the process used for transmitting the STD case reports. The processes supporting transmission of the information to CDC will remain unchanged. At CDC, the Division of STD Prevention (DSTDP) will access the data elements needed for the STD Morbidity Surveillance from the weekly STD case report, via CDC’s mainframe.

Completeness of reporting and the quality of data submitted for the STD morbidity surveillance will be monitored directly by the DSTDP.

Race and ethnicity data will be collected in compliance with the two-question format described in the 1997 Office of Management and Budget’s (OMB) Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, also know as Statistical Policy Directive 15.

3. Methods to Maximize Response Rates and Deal with Nonresponse

Response rates by definition do not relate to passive population-based notifiable disease surveillance methods. This section is not applicable to surveillance systems because U.S. Code Section 301 of the Public Health Service Act (42 USC 241) authorizes public health collection of information in order to reduce disease burden in the communities.(Attachment 1) Nevertheless, DSTDP will monitor the content and quality of the data elements needed for the STD morbidity surveillance submitted by the jurisdictions receiving federal funds to participate in the STD morbidity surveillance.

4. Test of Procedures or Methods to be Undertaken

No new diagnostic tests, clinical procedures or laboratory methods will be evaluated or tested. Reported STD surveillance data are reviewed monthly at CDC (DSTDP). Local and state jurisdictions periodically conduct evaluations of their notifiable disease systems. Additionally, DSTDP has begun assessing completeness of reporting data variables needed for STD morbidity surveillance, and the timeliness of case reporting as performance measures.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

By definition, no sampling method is used during the conduct of passive population-based notifiable STD surveillance. Therefore, statistical methods are not employed during analysis of the data.

External consultants and persons from the Division of STD Prevention will be involved in the analysis and reporting segments of the STD Morbidity Surveillance.

External consultants from local and state STD programs: Charlie Rabins, STD Project Director, Illinois State Health Department; Jim Lee, STD Program Manager, Texas State Health Department; Michael Samuel, Epidemiologist, STD Program, San Diego County, CA; CDC staff: Hillard Weinstock, MD, MPH, Team Leader, Surveillance and Special Studies, Eloisa Llata, MD, MPH, Scientific Program Officer, Elizabeth Torrone, PhD, Epidemiologist, Mark Stenger, MA, Epidemiologist, John Su, MD, PhD, MPH, Medical Officer, Guoyu Tao PhD, STD health services researcher, Marvin Fleming, Public Health Advisor, Delicia Carey, PhD, Chief (Acting), Statistics and Data Management Branch.

Local and state STD prevention program staff currently conducts STD surveillance in their jurisdictions. Health care providers and clinical laboratories are required by state law, statute, or regulation to collect and report information on cases of notifiable STDs to local and state health departments. Demographic, risk behavior, and time of event information describing the STD case is reported as part of state notifiable STD case report.

Data analysts in the Statistics and Data Management Branch, DSTDP and epidemiologists in the Epidemiology and Surveillance Branch, DSTDP review the data each week for data quality issues and analyze the data monthly, quarterly, annually, and on an ad hoc basis.

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