DFWED National Hypothesis Generation and Investigation Module
Contact:
Rudith Vice
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Atlanta, Georgia 30333
Email: nhr9@cdc.gov
1. Respondent Universe and Sampling Methods 2
2. Procedures for the Collection of Information 2
3. Methods to maximize Response Rates and Deal with No Response 2
4. Tests of Procedures or Methods to be Undertaken 2
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 2
There will be no statistical methods used to select respondents for this data collection. Forms 1-4 will be used to conduct interviews during enteric disease outbreak investigations and surveillance. This includes foodborne, waterborne, and zoonotic disease surveillance and outbreak investigations of Campylobacter, Listeria monocytogenes, Salmonella, Shiga-Toxin producing E. coli (STEC), Shigella, Vibrio, and Cronobacter infections in infants. Forms 5-9 will be used to conduct epidemiologic investigations of cases of enteric pathogens that have concerning antimicrobial resistance. Based on the estimated number of cases of enteric disease in the U.S. and the proportion of those cases that are cluster or outbreak associated or have identified antimicrobial resistance, it is estimated that these forms would be administered to approximately 10,610 individual respondents across all jurisdictions each year.
Cluster and Outbreaks: The forms will be administered by state, territorial, local, and tribal (STLT) public health officials via telephone interviews or self-administered web-based surveys with cases or their proxy who are part of an enteric disease cluster or outbreak that meets the following definitions: (1) Multistate cluster or outbreak: Multistate clusters are defined as at least two confirmed illnesses from different states that are genetically related . Multistate clusters and outbreaks are identified in multiple ways, including, but not limited to: through PulseNet, the national molecular subtyping and surveillance network coordinated by CDC, states reaching out to CDC for technical assistance, and through media scans. (2) Single state cluster or outbreak: Single state clusters or outbreaks are defined as at least two cases of an illness from the same state that are either genetically related or epidemiologically related. Single state clusters and outbreaks are identified in multiple ways, including, but not limited to: through PulseNet, state surveillance and cluster detection, states reaching out to CDC for technical assistance, and through media scans.
Antimicrobial Resistance: The forms will be administered by STLT public health officials via telephone interviews or self-administered web-based surveys with cases or their proxy of nontyphoidal Salmonella, STEC, Vibrio, or Campylobacter whose bacterial isolates have concerning antimicrobial resistance. These cases are identified by the National Antimicrobial Resistance Monitoring System (NARMS).
Participants: Respondents will be cases meeting the aforementioned criteria, or their proxy. Participation in the interview or completion of the survey is voluntary.
Recruitment: Officials in STLT public health departments will contact cases that meet the aforementioned criteria, or their proxy, to conduct the interviews. Alternatively, STLT officials may choose to collect information from this questionnaire through a secure Epi Info survey platform, which are sent individually to cases for self-administration.
Form Content: The forms included in this package could contain questions on the following content areas that would allow for the following: (1) characterizing the cluster or outbreak, (2) characterizing the clinical presentation of cases in a cluster or outbreak, (3) describe treatment failure of cases in a cluster or outbreak, (4) identifying mode of transmission, (5) identifying connections between cases, (6) identifying setting of outbreak or cluster, (7) identifying strategies to control and end the cluster or outbreak (8) characterize exposures, risk factors, and sources of illness for resistant enteric infections. The various forms include the following modules: (1) Demographics , (2) Household information and family member event and activity attendance, (3) Clinical signs and symptoms, (4) Medical care and treatment information, (5) Travel history, (6) Contact with international travelers or other ill individuals, (7) Event and activity attendance, (8) Food exposure (9) Water exposure (10) Animal contact history . Form 4 includes sensitive questions including those related to sexual orientation, number of sexual partners, where sexual partners are met, sexualized drug use, and recent diagnosis with an STD. The questions included in this module are essential to the complete investigation of clusters or outbreaks of shigellosis (Form 4) in which sexual contact is suspected as a mode of transmission. The more specific the information on cases, the more specific and tailored the strategies that can be used to control the cluster or outbreak. The questions included in this module have been used before by STLT partners during past investigations of clusters and outbreaks of shigellosis.
Sampling: No sampling will be involved in the administration of these forms. Officials in STLT public health departments will contact cases who meet the aforementioned criteria, or their proxies, to ask if they would be willing to complete the appropriate questionnaire to support the investigation.
Incentives: No incentives will be provided to individuals completing these forms.
Data collection: The forms will be administered by STLT public health officials via telephone interviews or self-administered web-based survey with cases that meet the aforementioned criteria or their proxy. Collection of the data elements will employ quantitative and qualitative methods. Qualitative methods will be used to elicit additional information about potential exposures from ill people. Interviewers will be able to probe further about specific exposures reported by ill people using the open-ended elements included in these forms. For example, when an ill person reports traveling outside their home state, the interviewer would ask about the specific travel destination(s), dates of the travel, and any specific events the ill person participated in while traveling. There are no research questions addressed through this data collection activity. Standardized data will be compiled on recent exposures related to the illness in the context of the investigation. Data will be used to inform outbreak prevention and control activities and inform resistant infection prevention strategies and recommendations. Staff in various programs in DFWED will oversee data collection, data management, analyses and dissemination of information collected with these forms during investigations.
In general, STLT public health officials will make every effort to contact cases identified as part of an outbreak, as resources allow. Policies vary, but many jurisdictions attempt to contact a case at least three times before deeming them ‘lost to follow-up’. The forms are designed to be administered in an average of 25 minutes via telephone interview, so the burden on cases to complete the interview should be sufficiently low to maximize response rates. Alternatively, health officials may choose to collect information from the questionnaire through a self-administered web-based survey, which may reduce the burden of administering the questionnaire by phone for partners that do not have the capacity to conduct interviews for every case in a cluster or outbreak. Web-based surveys also provide cases with an additional format to complete forms.
The estimate for burden hours is based on the previous three years of data collection using the previously approved forms (Form 1 and Form 4), and user testing. Based on previous experience, the average time to complete the instruments including time for reviewing instructions, gathering needed information, and completing the instrument, was approximately 25 minutes (range: 10 to 45 minutes). For the purposes of estimating burden hours, the average time to complete each instrument was used.
Forms 1-2. Individuals consulted on statistical aspects of the design: not applicable. The NHGQ was created collaboratively with public health officials who will be conducting the interview. Voluntary use of the NHGQ among STLT public health officials has resulted in positive feedback indicating that the content is appropriate. Additionally, internal testing used fabricated exposure data to be sure that data elements will be ascertained and recorded accurately when using the NHGQ.
Because information collected on the NHGQ is for hypothesis generation in multistate outbreak investigations, analytic work will focus on generating frequency distributions for demographic variables as well as food and other exposure variables included in the NHGQ. These frequency distributions will also be cross tabulated across demographic and exposure variables. The primary objective of the descriptive analyses is to identify food and other exposures with high reported frequency among cases and to describe the demographic characteristics of ill people.
Once exposures of interest are identified through descriptive analysis, the reported frequencies among cases are compared to frequencies from other data sources to assess whether reported exposure frequency among cases is higher than expected. This can be accomplished by comparing reported exposure frequency among cases to the proportion of healthy people in the general population reporting these same exposures using the FoodNet Population survey, a population-based survey of healthy people in ten states. The comparison of reported exposure frequency among cases to the exposure frequency of the general population is accomplished using a binomial distribution and estimates the probability of observing the exposure frequency among cases by chance alone given the population exposure frequency. As more NHGQ data are reported to ORPB over time, a similar calculation may be performed comparing current outbreak-related cases to exposures reported among cases in past multistate outbreak investigations. Any additional analyses required to understand the relationship between exposures and illness in a multistate outbreak investigation exceed the scope of the NHGQ.
Form 3. Individuals consulted on statistical aspects of the design: not applicable. The Animal Contact Focus Questionnaire was created collaboratively with public health officials who will be conducting the interview. Voluntary use of the elements included in the Animal Contact Focus Questionnaire among some state and local public health officials has resulted in positive feedback indicating that the content is appropriate. Additionally, internal testing used fabricated exposure data to be sure that data elements will be ascertained and recorded accurately when using the Animal Contact Focus Questionnaire.
Descriptive analysis will be conducted on variables of interest from the Animal Contact Focus Questionnaire. Frequencies of exposure to vehicles of interest from the Animal Contact Focus Questionnaire will be compared to frequencies of the same exposures from the FoodNet Population survey, using the same method described for the NHGQ. Frequencies of animal or animal product purchase locations and brand and lot numbers of feed will be calculated to identify potential common sources.
Forms 4-9
Individuals consulted on statistical aspects of the design: not applicable. The NARMS SIRI questionnaire is based on the NHGQ and was created collaboratively with public health officials who will be conducting the interview. Voluntary use of the elements included in the NARMS SIRI Questionnaires among some State and local public health officials has resulted in positive feedback indicating that the content is appropriate. Additionally, internal testing used fabricated exposure data to be sure that data elements will be ascertained and recorded accurately when using the NARMS SIRI Questionnaires.
Descriptive analysis will be conducted on variables of interest from the NARMS SIRI Questionnaires. Frequencies of demographic variables and health outcomes will be calculated and may be compared with non-resistant strains, and exposure to vehicles of interest from the NARMS SIRI questionnaire will be calculated and may be compared to frequencies of the same exposures from the FoodNet survey, using the same method described for the NHGQ. Frequencies of travel, food, animal, or environmental exposures will be calculated to identify potential common sources of resistant infection.
Individuals collecting and/or analyzing data:
The Division for Foodborne Waterborne and Environmental diseases will be responsible for managing and reviewing submitted data. The principal investigator and project director for Forms 1-3 is Dr. Laura Gieraltowski. She can be reached by phone at 404.639.3868 or by email at lax2@cdc.gov.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Samuel, Lee (CDC/OID/NCEZID) |
| File Modified | 0000-00-00 |
| File Created | 2025-06-30 |