Supporting Statement B

Identifying Sources of and Risk Factors for Harmful Algal Bloom Exposures through Poison Control Center Follow-up Questionnaires – United States, 2019

GenIC Request

Poison Center Collaborations for Public Health Emergencies

OMB Control No. 0920-1166

(expiration date 02/29/2020)

Supporting Statement Part B –

July 2019

Project Officer

Royal Law, PhD MPH

National Center for Environmental Health

Centers for Disease Control and Prevention

4770 Buford Highway NE, MS F-60

Atlanta, Georgia 30341

Phone: (770) 488-3416

Fax: (770) 488-3450

Email: [email protected]

Table of Contents

B.1. Respondent Universe and Sampling Methods 4

B.2. Procedures for the Collection of Information 4

B.3. Methods to Maximize Response Rates and Deal with Nonresponse 5

B.4. Tests of Procedures or Methods to be Undertaken 5

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 6

List of Attachments

Attachment 1. Consent, Permission, and Assent Forms for HABs GenIC

Attachment 2. Follow-up questionnaire for individuals calling poison control centers (PCCs) regarding exposures to harmful algal blooms (HABs) – Adult

Attachment 3. Follow-up questionnaire for individuals calling poison control centers (PCCs) regarding exposures to harmful algal blooms (HABs) – Adolescent

Attachment 4. Follow-up questionnaire for individuals calling poison control centers (PCCs) regarding exposures to harmful algal blooms (HABs) – Child

Attachment 5. NCEH/ATSDR Human subjects Research Determination Form

Part B. Collections of Information Employing Statistical Methods

B.1. Respondent Universe and Sampling Methods

Poison control centers (PCCs) have seen increases in harmful algal bloom (HAB) related reported exposures in 2019; there have been more than 150 HABs-related exposures from March 1 to April 30, 2019. Federal, state, and local public health officials are aware of the public health threat, but more contextual information is needed about HABs exposures to understand the problem including how individuals were exposed, medical treatments recommended or conducted on the exposed individuals, and awareness of health communication messages surrounding HABs exposures.

This public health emergency has been selected for additional data collection using this Generic Information Collection Request (Generic ICR) and meets the following criteria:

1. The event is a public health emergency causing adverse health effects.

2. Timely data are urgently needed to inform rapid public health action to prevent or reduce injury, disease, or death.

3. The event is characterized by (1) a natural or man-made disaster; (2) contaminated food/water;

4. The event has resulted in calls to a poison center, and the poison center agrees to conduct the call-back data collection.

5. The event is domestic.

6. Data collection will be completed in 60 days or less.

The study population will include any individual calling PCCs reporting HABs exposure, including callers reporting ingesting contaminated shellfish, bathing or swimming in waters contaminated with toxins, or drinking water contaminated with toxins. HABs-related exposures will be identified using PCC substance coding identifiers. Inclusion criteria include human exposures (excluding information calls and animal calls) with at least some clinical effects (excluding exposures with no reported clinical effects). These respondents to this poison center investigation include:

• Adults (18 years and older)

• Adolescents (15 up to 18 years)

• Parents or guardians of children (less than 15 years)

B.2. Procedures for the Collection of Information

Once this event is approved under this Generic ICR, information for the follow-up will be collected by PCC staff using a consent/permission/assent form (Attachment 1) and a questionnaire based on the age of the exposed individual (Attachments 2-4). The consent and the questionnaire will be administered to a convenience sample of callers to participating PCCs, which include all those who called about a HABs exposure within 60 days of the approval for this Generic ICR.

CDC does not expect unusual problems requiring specialized sampling.

The interviewers for this Generic ICR are trained medical and public health professionals who conduct interviews regularly in their roles as PCC representatives. Prior to beginning interviews, PCC staff will be oriented to the consent procedures and the questionnaire forms. Quality control procedures will be implemented to the extent possible given the rapid nature of the data collection to collect high quality data. This will be a one-time data collection.

Data collected by PCC staff will be collated and sent to the American Association of Poison Control Centers (AAPCC), and data will be reviewed by AAPCC staff for accuracy.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

The PCC team will take the following steps to improve the response rates, including:

• Re-contacting potential respondents at least twice more if the first attempt to reach them is unsuccessful

• Rescheduling the interview to a time that is more convenient for the respondent

• Providing a toll-free number for individuals to return calls

The response rates for previous data collections of a similar nature were only tracked at the local poison centers and an overall response rate could not be estimated. However, per their normal operations, PCCs follow up with all exposure calls to ascertain medical outcome following the exposure. Participation rates for these follow ups are high (over 80%) and we estimate participation rates for this data collection to be high as well.

B.4. Tests of Procedures or Methods to be Undertaken

The questionnaires (Attachments 2-4) were derived using questionnaires from two previous data collections (i.e., Hurricane Sandy; Lamp Oil) and with assistance from HABs subject matter experts at CDC. Basic descriptive statistics will be used to analyze the data.

The questionnaires have been reviewed by other CDC staff as well as representatives from local PCCs and the AAPCC.

Limitations to data collection are that all reported exposures and questionnaire responses are self-report, so there is no confirmation of exposure or response information. Not all exposures are reported to PCCs so the information collection lacks representativeness. Conclusions drawn from aggregate data may not be representative of individuals within the affected area.

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

The CDC investigators guiding the PCC data collection and analyzing the data are trained in epidemiology. CDC investigators will collaborate extensively with PCC staff throughout the process of data collection. While CDC staff will supervise the investigation, only poison center staff will actually collect data.

The following CDC staff will be involved in consultation of statistical design and responsible for collection and data analysis.

Table B5-1. Personnel consulted on statistical design and data analysis

Name	Title	Affiliation	Phone		Email
FEDERAL AGENCY
Stephanie Kieszak, MS	Statistician	NCEH	(770) 488-3407	[email protected]

Table 5-2. Personnel responsible for collection and analysis of information

Name	Title	Affiliation	Phone	Email
Royal Law, MPH	Epidemiologist	NCEH	(770)488-3416	[email protected]
Stephanie Kieszak, MS	Statistician	NCEH	(770) 488-3407	[email protected]
Lorrie Backer, PhD	Epidemiologist	NCEH	(770)488-3426	[email protected]

Because the investigations will be public health responses and not planned research studies, the analysis is largely descriptive.

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