GenIC Clearance for CDC/ATSDR
Formative Research and Tool Development
Contact:
Rudith Vice
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Phone: (404)718-7292
Email: [email protected]
1. Respondent Universe and Sampling Methods 3
2. Procedures for the Collection of Information 3
3. Methods to Maximize Response Rates and Deal with No Response 3
4. Tests of Procedures or Methods to be Undertaken 4
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 4
To participate in the focus groups, participants must meet the following primary inclusion criteria:
Be a physician or a pharmacist
For physicians, have a specialty in infectious diseases
For pharmacists, have a specialty in infectious diseases or work in a hospital
Have direct patient care as a primary responsibility
Work in a variety of settings except for academic medical centers or teaching hospitals
Be very or somewhat familiar with antifungal therapeutic drug monitoring (TDM)
Potential participants are drawn from a national panel of individuals who have opted in to participate in focus groups or interviews on various topics. The contractor KRC Research will direct a vendor panel provider to distribute an invitation to screen for the focus groups to members of its panel, starting with those individuals whose panel profiles suggest they are most likely to qualify (e.g., known to be physicians or pharmacists, have known specialties). When an individual receives the invitation to screen, they will either complete a screening questionnaire online (Attachment 1) or via the phone in a call with a panel provider staff member. Individuals must pass the screening questionnaire without being disqualified based on their answers or due to quotas reached on certain characteristics.
A total of eight participants will be purposively selected from this pool of eligible participants for each of three focus groups, for a total of 24 participants. Within the parameters of the physician and pharmacist audience, participants will be selected to maximize variability across practice settings, geographic region, age, sex, and race and ethnicity. Because of the qualitative nature of this data collection, findings cannot be generalized and recruitment of participants does not involve statistical methods.
Selected participants will be invited to confirm their interest and availability in participating. Once confirmed, a confirmation message will be sent to the participants with logistical information, as well as the date and time of the focus group. A day or two prior to the scheduled focus group, participants will receive a reminder email. To incentivize participation, participants will be offered a $75 incentive for their time, in line with market research recruitment standards. If, at the time of invitation, the participant declines to participate, a replacement participant will be selected from the pool of eligible participants.
A vendor company will conduct all recruitment and screening activities.
After completing screening and scheduling, three focus groups will be conducted. Each will last 90 minutes. Prior to the focus groups, participants will be required to sign and date a consent form that outlines the details about the interview, such as confidentiality and incentive (Attachment 2). They will be sent the form electronically and required to sign it electronically. Project records will be maintained in accordance with the federal record retention requirements. Additionally, at the start of each focus group, participants are given a brief verbal reminder of the consent form details.
Trained moderators from the contracted firm KRC Research will conduct all focus groups as well as oversee recruitment and screening (described in Section 1). The moderator will use a semi-structured interview guide for all interviews (Attachment 3). The questions in the guide explore the knowledge, experiences, and barriers to antifungal TDM among this professional healthcare audience. The guide also asks about participants’ questions and needs related to this topic and their most common or trusted sources of information.
With the consent of each participant, focus groups will be audio and video recorded to capture the content of the discussion. Recordings will be used to develop written transcriptions which will be used for analytic purposes in the development of a report. Field notes will be taken during the focus groups to capture key quotes or expressions. No recordings or transcripts with personally identifiable information will be shared outside of the KRC Research and DFWED team conducting and analyzing the interviews.
By design, all potential participants in these focus groups will be drawn from a panel of individuals who have opted in to participate in activities like this one. The use of panel sampling helps to maximize the efficiency of recruiting, since all possible participants are familiar with the recruiting contractor and many will have been contacted before. Additionally, to maximize response, the screening questionnaire (Attachment 1) is intentionally designed to collect only the minimum amount of information needed to determine the qualifications and useful mix of participants, and quotas for several demographic variables are “loose,” meaning that there is no exact number of individuals who must be recruited with certain criteria. (For example, recruiting a mix of practice settings within each group rather than an exact number in specialty clinics or hospitals.) This reduces the number of individuals who will be screened.
It is sometimes the case that participants do not sign in on time for their focus group, either for unexpected personal reasons, forgetfulness, or other reasons. To minimize the instances of this occurring, respondents are given several days’ advance notice of the group and are sent reminder emails the day before and day of the discussion. Should they still not appear, the interviewing team at KRC Research has protocols in place so that the recruiting team can quickly email or call the participant to confirm availability or troubleshoot. Additionally, it is a common practice in market research to plan for one or two “no show” participants and to tailor the conversation as needed to adjust for a slightly smaller group.
At the beginning of each focus group itself, participants will be reminded that their participation is voluntary and they do not need to answer any question that they are not comfortable answering.
No pre-tests are planned for this project.
The following individuals are working under contract with DFWED and have been consulted throughout the development and design of this data collection. These individuals will lead the interviews once the package is approved.
Mike Ruddell
Vice
President, KRC
Research Washington, DC 20001 Phone: 202-585-2946 Email: [email protected] |
Lindsay Gutekunst Senior
Vice President, KRC Research Washington, DC 20001 Phone: 202-585-2922 Email: [email protected] |
CDC DFWED – Antifungal TDM – Supporting Statement B
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Samuel, Lee (CDC/OID/NCEZID) |
| File Modified | 0000-00-00 |
| File Created | 2025-05-19 |