SSB_NPPTL_Field Package V2

Generic Clearance for CDC/NIOSH/NPPTL

Assessing Respirator Perceptions, Experiences, and Maintenance

OMB Control Number: 0920-XXXX Expiration Date: XX-XX-XXXX

Supporting Statement B

Emily J. Haas, Ph.D.

Research Health Scientist

Tel. 412.386.4627

[email protected]

July 26, 2022

Table of Contents

1. Respondent Universe and Sampling Methods

2. Procedures for the Collection of Information

3. Methods to Maximize Response Rates and Deal with No Response

4. Tests of Procedures or Methods to be Undertaken

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

B. Collection of Information Employing Statistical Methods

1. Respondent Universe and Sampling Methods

Respondents include persons in the general population or from specific subpopulations that are reflective of the full spectrum of the U.S. workforce, from industries that rely heavily on respiratory protection to protect workers (e.g., healthcare and social assistance and public safety and emergency response) to those that more seldomly wear respiratory protection. Expected respondent job roles include industrial hygienists, occupational health professionals, infection control professionals, physicians, nurse practitioners, nurses, infection preventionists, fire department chiefs, battalion chiefs, sheriffs, shift supervisors, firefighters, police officers, paramedics, and those who might choose to wear a respirator at their place of employment. Respondents may also include those who work at smaller businesses that employ fewer than 10 people and therefore, are not held to the same RPP requirements. Because respondents will be recruited from a variety of different workforces and occupations, it is expected that the respondent pool will vary in gender, age, races/ethnicities, persons residing in rural and/or urban locations, and/or in specific regions or health jurisdictions.

Information collection requests for each individual project associated with this generic clearance will clearly define the specific goals, respondent population and sampling method. Populations and sampling methods will vary from project to project. Sampling methodologies will include probability sampling methods such as simple or stratified random sampling, or multi-stage random sampling, or nonprobability methods such as respondent-driven sampling, purposive sampling, and convenience sampling.

2. Procedures for the Collection of Information

Because this generic clearance covers a wide range of studies, each individual project submitted under this generic clearance will clearly define the specific data collection methods and procedures. Individual data collections will be time-limited and generally conducted only once, except when pilot testing of interventions occur, and respondents may have to be approached several times on the same respirator or similar type of respiratory protection under evaluation. No single data collection activity will take longer than 2 years to complete from inception of information collection to the first report of findings.

Potential respondents will be identified through targeted recruitment efforts or purposive selection of key informants selected from the relevant study population. Screening questions may be used to determine eligibility. In some cases, an algorithm may be used to randomly select or ensure a diverse respondent pool. Recruitment methods, whether a convenience sample or randomly identification via an algorithm, will vary by individual project. All recruitment materials will indicate the voluntary nature of the study.

We anticipate that studies under this generic clearance will use mixed methods for data collection. Some data will be collected by using qualitative open-ended questions. Brief structured surveys that include closed-ended questions will be appropriate for collecting information on age, race/ethnicity, sex and gender identity, and statuses of their organization’s RPP relative to respirators being used. Assessments may also collect quantitative data on respirator information, use, and perceptions. Regardless of the mixture of open-ended and closed-ended questions being used, all data collection methods will be implemented by trained personnel. For in-depth interviews and focus groups, questions may be open-ended so respondents can reply freely of their own accord. For these types of interviews, the trained data collector will guide the discussion with probing questions as needed. The content of open-ended questions will vary by each task order. Qualitative interview guides, focus group guides, and brief structured surveys will be submitted with each genIC covered under this generic clearance. Qualitative or structured interviews may involve individuals or groups, and may be conducted in-person, on the telephone, or via the internet (i.e., internet focus groups).

Regardless of methods, projects will comply with all federal regulations for consent based on the nature of the study. Any consent process will inform potential participants of the private and voluntary nature of the study and provide general information about the study, the topics to be covered in the study, potential risks, and the token of appreciation available for completing the study. Screening questions may be asked; the screener includes questions to assess eligibility.

Data collection may be interviewer administered or self-administered. Data collection will generally be computer assisted. Implementers may also collect data with pencil and paper for some studies in certain situations. Data collected will be kept on secure computer servers with access restrictions and/or in locked cabinets in secure locations. Any derived personal identifiable information (PII) required to conduct the study, will be maintained separately from the data collected, either on a server with access restricted to authorized personnel only, or if on paper, in separate locked cabinets from the data or recordings/transcripts. For electronic surveys, eligible individuals will be invited to participate and asked to click on a hyperlink to launch the consent form and survey on a secure website. Individuals will indicate their consent electronically to proceed. Only those who agree to participate will enter the survey. Those who do not consent to be screened will be thanked for their time and asked to close their browser window.

3. Methods to Maximize Response Rates and Deal with No Response

To maximize participation, NIOSH will work with collaborators identified for each individual study. Examples include organizational point of contacts who volunteer to participate in studies, who will be explained the importance of the study for the organizations, their employees, and the occupational industry before the study period begins. Any flyers or other recruitment materials to be used to encourage participation prior to commencing data collection will be included in applicable projects.

Participation in all research under this generic IC is voluntary. In most cases, participants will not receive payment or incentives. In some cases, however, incentives may be provided to respondents to encourage their participation. The amount of the token of appreciation will depend on the preferences and needs of the populations in the local study locations. Incentives generally will not exceed $40 per hour for such intensive interviews like focus groups and cognitive interviews unless compelling evidence is provided that recruitment is difficult for a particular subgroup. If, for some reason, compensation needs to be higher, individual packages will justify the compensation rates by job/occupation being recruited. Tokens of appreciation may include but are not limited to gift certificates to grocery stores or retail pharmacies and cash.

It is important to maximize response rates during information collection. Data collection efforts have not involved so many different health entities and occupations in one effort, so it is difficult to determine workers’ overall willingness to participate in each individual package. However, projects may use follow-up probes to encourage participation and for data collection that will occur via e-survey software, respondents will be able to easily select their answers, facilitating rapid questionnaire completion. For convenience, if participants cannot complete the survey at one sitting, they will be able to stop at any point and pick up where they left off at a later time.

However, CDC NIOSH does not claim that the workers selected for each study are statistically representative of the entire population. It should not be assumed that the findings of individual projects are generalizable to other entities. Due to the diversity of respiratory protection device types and the variety of occupational settings these are not meant to be generalizable. Rather they are meant to be case studies to help professionals make decisions about how to make respirators usable and implemented in their workplace via an RPP or another framework. Generalizability is not the goal. Rather, the goal is for results of individual projects to be utilized by experts in taking the results/lessons learned and adapt them for their specific environment based on their education and training.

4. Tests of Procedures or Methods to Be Undertaken

Depending on the purpose of the individual study covered under this generic IC, tests may be conducted of recruitment and enrollment procedures; health messages, respirator products, interventions or RPP frameworks; and data collection methods and instruments needed to evaluate respiratory protection.

Data collection materials to be used in each individual study will be validated and tested to accurately inform the study outcomes. Specifically, survey items and interview questions will be created based on a thorough literature review of using occupational health and safety, applied psychology and psychosocial health, public health communication, OSHA regulations, and RPP content as well as past practice utilized by NIOSH researchers when developing psychometrically supported data collection materials.

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

This information collection request does not employ statistical methods. Individual studies covered under this generic will provide statistical reviews and design if applicable.