Generic Information Collection under Formative Research and Tool Development
OMB #0920-0840
Virtual Focus Groups with Primary Care Physicians and
OBGYNs:
Attitudes about Proposed Hepatitis C Screening
Guidelines
DVH 2019
Section A: Supporting Statement
November 18, 2019
CONTACT
Cynthia Jorgensen, DrPH
Alycia Downs, MPH
NCHHSTP/DVH/OD Communication Team
Lead
Co-Principal Investigators
NCHHSTP/DVH/OD Communication Team
Lead
Principal Investigator
Centers for Disease Control and
Prevention
National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP)
Division
of Viral Hepatitis
1600
Clifton Road, NE, Mailstop G-37
Atlanta,
GA 30333
Phone:
404-718-8534
E-mail: [email protected]
TABLE OF CONTENTS
Circumstances Making the Collection of Information Necessary 3
Purpose and Use of the Information Collection 4
Use of Improved Information Technology and Burden Reduction 5
Efforts to Identify Duplication and Use of Similar Information 5
Impact on Small Businesses or Other Small Entities 6
Consequences of Collecting the Information Less Frequently 6
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 6
Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency 6
Explanation of Any Payment or Gift to Respondents 6
Protection of the Privacy and Confidentiality of Information Provided by Respondents 6
Institutional Review Board (IRB) Review and Justification for Sensitive Questions 7
Estimates of Annualized Burden Hours and Costs 7
12A. Estimated Annualized Burden Hours 8
12B. Estimated Annualized Burden Costs 8
Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers 8
Annualized Cost to the Federal Government 8
Explanation for Program Changes or Adjustments 9
Plans for Tabulation and Publication and Project Time Schedule 9
Reason(s) Display of OMB Expiration Date is Inappropriate 9
Exceptions to Certification for Paperwork Reduction Act Submissions 9
EXHIBITS
Exhibit 12.1: Estimated Annualized Burden Hours 8
Exhibit 12.2: Estimated Annualized Burden Costs 8
LIST OF ATTACHMENTS
Attachment 1 Authorizing Legislation
Attachment 2 Initial Recruitment Email
Attachment 3 Recruitment Screener
Attachment 4 Consent Form
Attachment 5 Focus Group Participation Confirmation Letter
Attachment 6 Focus Group Recruitment Spreadsheet
Attachment 7 Discussion Guide
Attachment 8 IRB Approval Certification
Attachment 9 Data Management Plan
Attachment 10 Privacy Impact Assessment
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Supporting Statement
A. Justification
The Centers for Disease Control and Prevention’s (CDC) Division of Viral Hepatitis, (DVH) requests OMB approval for a qualitative research study entitled, “Virtual Focus Groups with Primary Care Physicians and OBGYNs: Attitudes about Proposed Hepatitis C Screening Guidelines ” under the Formative Research and Tool Development Generic Clearance (OMB #0920-0840, expires 1/31/2019). CDC sponsors this current data collection activity. Data collection will be carried out by the CDC’s contractor, KRC Research (KRC), in conjunction with its subcontracting partners. CDC will not receive any personally identifiable information.
There are an estimated 2.4 million people living with hepatitis C in the United States, about 50% of whom are unaware they are currently infected. Hepatitis C is a liver infection caused by the hepatitis C virus. Hepatitis C can range from a mild illness lasting a few weeks to a serious, lifelong illness. Approximately 75%–85% of people who become infected with hepatitis C virus will develop a chronic infection that, if untreated, can lead to liver damage, cirrhosis (scarring of the liver), liver cancer, and even death.
Testing identifies people living with hepatitis C, which is the first step in the linkage to care and treatment. There have been tremendous advancements in hepatitis C treatment over the last decade; improved treatments can cure the disease for over 90% of people within 8-12 weeks. This effort will help identify barriers and motivators to hepatitis C testing by physicians, and will inform CDC’s educational efforts and campaign activities, as well as help inform other potential interventions.
To identify people with chronic hepatitis C, CDC currently recommends the following people be tested:
Everyone born from 1945 to 1965;
Anyone who received clotting factor concentrates made before 1987;
Recipients of blood transfusions or solid organ transplants prior to July 1992;
Long-term hemodialysis patients;
People with known exposures to the hepatitis C virus, such as health care workers or public safety workers after needle sticks involving blood from someone infected with hepatitis C virus, and recipients of blood or organs from a donor who tested positive for the hepatitis C virus;
People with HIV infection;
Children born to mothers with hepatitis C; and
Current or former injection drug users, including those who injected only once many years ago.
Other experts, including the U.S. Preventive Services Task Force, also recommends testing for:
People in jails or prisons;
People who use drugs snorted through the nose (in addition to people who inject drugs); and
People who get an unregulated tattoo.
Getting tested for hepatitis C is not part of routine prenatal care, except for pregnant woman who have risk factors.
Current recommendations have not been sufficient for identifying all the people living with hepatitis C. Nearly half with chronic hepatitis C are unaware they are currently infected. As a result, CDC is considering recommending one-time hepatitis C antibody testing for all adults including those with no risk factors and for pregnant women during each pregnancy.
If CDC’s universal recommendation is implemented by physicians, more chronic hepatitis C can be identified and the morbidity and mortality associated with hepatitis C can be reduced once those identified get curative treatment. Physicians, and their decision whether or not to implement these recommendations, are the critical element in getting people who are chronically infected tested so they can get treatment and get cured.
CDC wishes to conduct this formative research in order to understand physicians’ attitudes, beliefs and behaviors around hepatitis C testing and get their reaction to a proposed universal testing recommendation. This work falls within the scoop of what is outline for NCHHSTP’s 4 priority diseases, which includes hepatitis C. The methodology of information collection is approved under the generic package and will use qualitative interviewing using volunteer respondents for exploratory and formative research to develop intervention methods and materials. Interviews will consist of groups conducted virtually via the internet (i.e. internet focus groups). Results of qualitative interviews will be used to develop population-appropriate methods, interventions, messages, products, and campaigns.
Thus, DVH requests OMB approval to explore reactions to the universal recommendation, as well as barriers and motivators to physician hepatitis C testing. DVH will use these insights to inform education, outreach, and other strategies as appropriate. CDC is sponsoring this effort to ensure high quality, actionable information is available for health care providers.
Interview data will be gathered from a total of 128 practicing physicians across 16 virtual (online) focus groups comprised of 8 physicians per group. Half of the groups will be comprised of primary care physicians, and half will be comprised of OBGYNs. Physicians will be recruited for virtual focus groups from across the United States and the District of Columbia. Contractor team members and associated vendors involved with this study will screen potential participants for study eligibility with the physician screening tool (Attachment 3). Eligible physicians who choose to participate will be scheduled for a group at a time that is convenient to them.
Participants will be asked to complete an informed consent form (Attachment 4).
We will use a semi-structured qualitative interview guide to collect information (Attachment 7). This research will explore knowledge and attitudes among physicians about hepatitis C screening practices, implementation of CDC’s current hepatitis C testing recommendations, as well and reactions to the new universal hepatitis C screening recommendation from CDC.
The qualitative data collected will be used to prepare a report that summarizes current physician mind states and influences with regard to hepatitis testing, to the current and new universal screening recommendation, and barriers and motivators to screening all U.S. adults.
The purpose is practical and necessary. The findings will be communicated to relevant CDC leadership to use to strengthen its hepatitis C education, outreach, and other strategies as appropriate. Specifically, the information will be used by CDC to inform its communication and education efforts with health care providers in support of the Know More Hepatitis (KMH) educational campaign. The KMH campaign is designed to support CDC hepatitis C testing recommendations among primary care physicians (PCPs) and obstetrician-gynecologists (OBGYNs) whose direct responsibility is patient care among the primary consumer audience.
Information gained from the focus groups will be shared with CDC by the contractor team in aggregate note format and will not contain any names or other personally identifiable information. See response to Question 10 for more information on confidentiality and privacy.
The contracting team will screen potential physician participants by telephone using a screening tool (Attachment 3). Qualifying physicians will all be asked to provide a signed consent form prior to participating in and for recording focus groups (Attachment 4).
After asking for and receiving signed consent forms from participants, staff from the contracting team will conduct the groups virtually using a web-based platform with webcams and voice for phone to allow qualifying physicians to gather virtually from the convenience of their office or home across the fifty states and Washington, D.C., without traveling to a physical location. Furthermore, they will conduct the focus groups at a time that is convenient to participants. These technologies reduce the burden of time and travel.
Virtual groups work well for the physician audience. The platform is web-based, meaning that it does not download anything to a person’s personal computer (participants and viewers need only have an internet connection and the latest version of Adobe on their computers). Civicom allows for virtual focus groups with webcams to be conducted seamlessly, drawing upon all of the benefits of in-person focus groups without the limitation of geography. Respondents see and hear each other and interact in real-time.
To mitigate any technological complications, the contracting team has a technician virtually present at each of the focus groups to help as needed with any technology (phone, internet, and webcam) challenges for respondents, viewers, and the moderator, should they arise.
The contracting team will record the focus group conversations and transcribe recordings after the interview. This limits the burden on the participant (no additional burden after completing the interview) and allows the interviewer to focus on building and maintaining rapport with participants.
The Agency is considering a universal patient screening recommendation based on expert opinion and scientific evidence.
To the Agency’s knowledge, there is no other available research to guide the agency in its communications related to its proposed universal patient screening recommendation. There is no reason for another Federal Agency to collect this information.
In summary, the Agency has determined that the information it needs is essential, unique, does not exist and is not planned from other sources, and so requests to obtain this information from among physicians using primary research. CDC desires to effectively communicate this universal hepatitis C screening recommendation to physicians to make them aware and motivate them to implement the recommendation.
This information collection does not involve burden to small
businesses or other small entities.
This information collection will provide the primary qualitative data needed to effectively communicate the universal hepatitis C screening recommendation to physicians and to understand any identified barriers so CDC can address those issues in education, outreach and other strategies as appropriate. .
If these groups are not conducted, CDC will be lacking an in-depth
contextual understanding of factors that may affect the success of
implementation of new recommendations.
This data collection effort does not involve any special circumstances.
A 60 day FRN notice to solicit public comments was published for the Generic umbrella collection (0920-0840) in the Federal Register on 04/23/2018, Volume 83, Number 78, Page Number 17663-17664. No public comments were received.
Aside from the official 60 day public comment period for the Generic data collection, there were no other public contacts or opportunities for public comment on this information collection.
Voluntary physician participants will each receive a $100 token of
appreciation. Offering tokens of appreciation is necessary to subject
matter experts, like physicians. This amount is consistent with the
hourly wage rate of physicians. DVH is requesting 75 minutes of
physician time. Although there has been some debate on the necessity
of offering tokens of appreciation, numerous studies have shown that
tokens of appreciation can significantly increase response rates, and
the use of tokens of appreciation is expected to enhance survey
response rates among subject matter experts without biasing
responses. This improves the validity and reliability of
the data, which is of utmost importance in this scientific
study.
The CDC Privacy Officer has assessed this package for applicability of 5 U.S.C. § 552a, and determined that the Privacy Act does apply to the overall information collection. CDC has completed a Privacy Impact Assessment of the data system used by the study contractor team (Attachment 10).
Information gained from the focus groups will be in aggregate narrative note format and will not contain any names or other personally identifiable information. The information gained from the focus groups will be qualitative in nature, and not used to generate statistical information.
Following the groups, a report will be prepared of content from the groups and will analyze the information to identify key themes, insights, and findings. The information will be used by CDC staff to inform education, outreach, and other strategies as appropriate. Information is internal and is not intended for release outside of the agency.
KRC’s recruitment partner is Reckner Healthcare (Reckner). Potentially qualifying study participants will be drawn from the Reckner Healthcare physician panel, a volunteer national panel of physicians. Physician panelists will first be contacted by Reckner via email and invited to participate (Attachment 2). If potential participants are interested in participating, Reckner will screen them by telephone using a screening tool (Attachment 3) to determine if they qualify.
CDC will be identified as the sole sponsor of the activity. Individuals will be advised that participation is voluntary and their responses will be treated with confidentiality. They will be asked to read and sign a consent form (Attachment 4).
Personally identifiable information from qualifying individuals will not be distributed outside of Reckner. Other information gathered by Reckner from qualifying respondents in the screening tool will be summarized in an anonymized spreadsheet which will be distributed to KRC Research and CDC (Attachment 6).
Thus, only Reckner staff will have access to personally identifiable information (full respondent name, phone number, and email). CDC staff will not be involved with sample recruitment and will never know the identities of any study respondents.
IRB Review
This study has been reviewed and approved by the Ethical & Independent Review Services (Attachment 8). The approved IRB protocol is also included as a supplemental document to Part B.
Sensitive Questions
This study among physicians will not involve questions considered
sensitive.
The recruitment period is six weeks. This data collection will include 128 physicians. We expect to screen 400 physicians, and we expect 32% to be eligible and to participant in the data collection, which yields a final client sample size of 128. Contractor staff will screen potential physician participants for eligibility by phone, which will take approximately ten minutes (Attachment 3). The consent form (Attachment 4) will take approximately 3 minutes to complete and will be administered once. The focus group discussion (Attachment 7) will take 75 minutes to complete and will be administered once.
Exhibits 12.1 and 12.2 provide further details about how the estimates of burden hours and costs were calculated. The estimated annualized burden is 233.4 hours.
Exhibit 12.1: Estimated Annualized Burden Hours
Category of Respondent Activity |
No. of Respondents |
Participation Time (min.) |
Burden Hours |
Physicians – Screener |
400 |
10 |
67 |
Physicians – Consent Form |
128 |
3 |
6 |
Physicians – Focus Group |
128 |
75 |
160 |
Total |
528 |
85 |
233 |
The annualized costs to the participants are described in Exhibit 12.2. To estimate the hourly wage rate of those involved in this study, we have used information from the United States Bureau of Labor Statistics (BLS). Results from the latest BLS Occupational Employment Statistics survey (conducted in May 2018) were released on March 29, 2019 and form the basis of the estimates below. (Source: https://www.bls.gov/news.release/ocwage.t01.htm)
The mean hourly wage for “family and general practitioners,” the best available analogue for this study’s primary care physician audience, is $101.82. The mean hourly wage for obstetricians and gynecologists is $114.58. Because an equal number of respondents from both groups will participate in this study, and because we anticipate no differences in their rate of qualification, we have used the average of these two hourly wages ($108.20) below.
The total estimated cost of the burden to participants is approximately $25,253.88, which represents the total burden hours multiplied by the average hourly wage rate ($108.20).
Exhibit 12.2: Estimated Annualized Burden Costs
Category of Respondent Activity |
Burden Hours |
Hourly Wage Rate |
Respondent Costs |
Physicians – Screener |
67 |
$108.20 |
$7,249.40 |
Physicians – Consent Form |
6 |
$108.20 |
$649.20 |
Physicians – Focus Group |
160 |
$108.20 |
$17,312.00 |
Totals |
233 |
|
$25,210.60 |
There are no other costs to respondents or record keepers for participating in this research.
Exhibit 14.1 provides the annualized cost to the government, which totals $25,253 using the 2019 Atlanta locality salary schedule. CDC supports costs for hepatitis C task orders using funds budgeted for these purposes. Managing the project, providing technical assistance, monitoring and analyzing the submitted data, and generating assorted reports will require the expertise of two CDC staff.
Exhibit 14.1: Annualized Cost to the Government (2019 scale)
Expense Type |
Expense Explanation |
Annual Costs (dollars) |
Direct Costs |
CDC, Health Education Specialist (GS-13, 0.10 FTE) |
$9,328.20 |
|
CDC Health Scientist (GS-14, 0.05 FTE) |
$5,511.55 |
|
Subtotal, Direct Costs |
$14,839.75 |
Contract Costs |
Annual Contract Costs (200-2016-F-90427) |
$107,000 |
|
TOTAL COST TO THE GOVERNMENT |
$ 121,839.75 |
This is a new genIC request under Generic request 0920-0840.
Tabulation will include descriptive characteristics and feedback from participants in narrative form. Data collection will occur between 2-4 months after OMB approval with analysis carried our 5-8 months after OMB approval, and the final report will be submitted 10-12 months after OMB approval. The project timeline is detailed in exhibit 16.1.
Exhibit 16.1: Project Time Schedule
Activity |
Time Schedule |
Develop data collection tools, sampling and data plans, study protocol |
March to September 2019 |
OMB Submission |
October 2019 |
Recruitment |
1 months after OMB Approval |
Data Collection |
2-4 months after OMB Approval |
Data analysis finalized |
5-8 months after OMB Approval |
Draft report and final report written |
7-9 months after OMB approval |
Final data set and final report submitted to CDC |
10-12 months after OMB Approval |
We do not seek approval to eliminate the expiration date.
The activities comply with the requirements in 5 CFR 1320.9.
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