ICR Statement B cocci enhanced surveillance 5.7.15

ICR Statement B cocci enhanced surveillance 5.7.15.docx

Enhanced Surveillance of Coccidioidomycosis in Low- and Non-Endemic States

OMB: 0920-1087

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Enhanced Surveillance of Coccidioidomycosis in Low- and Non-Endemic States

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Contact:

Amy McMillen

Office of Policy and Planning

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E., MS C-12

Atlanta, Georgia 30333

Phone: (404) 639-1045

Fax: (404) 639-3039

Email: [email protected]


5/7/2015




Table of Contents

SECTION B: Collections of Information Employing Statistical Methods

  1. Respondent Universe and Sampling Methods p. 2

  2. Procedures for the Collection of Information p. 2

  3. Methods to Maximize Response Rates and Deal with No response p. 2

  4. Tests of Procedures or Methods to be Undertaken p. 2

  5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data p. 2


  1. Respondent Universe and Sampling Methods

The data collection does not involve statistical methods. In states participating in this enhanced surveillance project, all coccidioidomycosis cases reported to state public health authorities that meet the Council of State and Territorial Epidemiologists (CSTE) case definition are eligible for inclusion.



  1. Procedures for the Collection of Information

Cases will be identified through routine state-based coccidioidomycosis surveillance; cases meeting the CSTE definition of a confirmed case are eligible to be interviewed by state health department personnel. All cases reported in the year following the project start date will be contacted by telephone and invited to participate in the interview. Ideally, cases should be contacted within four to six weeks after they are first identified as meeting the CSTE case definition. A log will be provided to record phone call attempts. A total of five attempts should be made for each valid phone number. At least one attempt should be made in the morning (8 am – 12 pm) and one in the afternoon (12 – 5 pm) on weekdays. If there is no response after three attempts during the day, at least one attempt should be made on a weekday evening (5 – 8 pm), and at least one attempt should be made on a weekend (Saturday or Sunday, 10 am – 9 pm). A parent or guardian will be interviewed for cases under 13 years old. For cases aged 13–17 years old, the adolescent can be interviewed if permission from the parent or guardian is obtained. State health departments routinely contact patients and their caregivers to collect information about reportable diseases such as coccidioidomycosis. Therefore, each state health department will use their existing processes for gaining voluntary participation from patients with reportable conditions (or their guardians).

Participating states may choose to take a retrospective approach instead of or in addition to the prospective approach described above. With the retrospective approach, cases reported in the year preceding the project start date meeting the CSTE case definition will be contacted by telephone and invited to complete the interview by telephone. Interviews will be conducted using the same methods described in the prospective approach.

A standardized case report form (Attachment 4) to will be used to collect information on demographics, underlying medical conditions, travel history, symptom type and duration, healthcare-seeking behaviors, diagnosis, treatment, and outcomes. The interview is expected to take approximately 20 minutes. Each case who chooses to participate in the surveillance project will be interviewed only once.

  1. Methods to Maximize Response Rates and Deal with No response

Participation in this surveillance project is voluntary. The case report form has been streamlined to ensure the ease of response and to minimize the public burden. A total of five attempts will be made for each valid phone number as described in the Supporting Statement A. The following script will be used to introduce the project:



I’m calling because (name of your state health department) and the CDC are doing a public health investigation about Valley Fever to better understand how it affects the health of people in (your state). We’d like to talk to you because your healthcare provider ordered a Valley Fever test for you. This doesn’t necessarily mean that you have Valley Fever. As you may already know, Valley Fever is a fungal infection that usually affects the lungs and is not contagious. Your participation is voluntary, but we were hoping you could complete a brief phone interview that will take about 20 minutes. May I ask you a few questions?”



  1. Tests of Procedures or Methods to be Undertaken

The case report form has not been used before in other OMB-approved data collections, but a similar data collection instrument was used very successfully in Arizona as part of their routine surveillance efforts.


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

Individuals consulted on statistical aspects of the design: not applicable.


The data collection was designed by CDC’s Mycotic Diseases Branch in collaboration with state health department personnel in states that are low- and non-endemic for coccidioidomycosis. State health department personnel will collect the data. Data will be analyzed by CDC’s Mycotic Diseases Branch and state health department personnel.





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