2019-26864. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Agency for Healthcare Research and Quality, HHS.

ACTION:

Notice.

SUMMARY:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project “Evaluation of Patient-Centered Outcomes Research Trust Fund—Training Program.”

DATES:

Comments on this notice must be received by 60 days after date of publication.

ADDRESSES:

Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [e-mail].

Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports Clearance Officer, [phone], or by emails at [e-mail].

SUPPLEMENTARY INFORMATION:

Proposed Project

Evaluation of Patient-Centered Outcomes Research Trust Fund—Training Program

AHRQ Authorization To Provide Researcher Training in Comparative Effectiveness Research/Patient-Centered Outcomes Research (CER/PCOR) Methods

Section 6301(b) of the Patient Protection and Affordable Care Act, Public Law 111-148 (the “Affordable Care Act”), enacted section 937(e) of the Public Health Service Act (“PHS Act”), which authorizes AHRQ to build capacity for comparative effectiveness research (CER) by establishing grant programs that provide training for researchers in methods used to conduct research. It also notes that, “[at] a minimum, such training shall be in methods that meet the methodological standards adopted [by the Patient Centered Outcomes Research Institute (PCORI)] under section 1181(d)(9) of the Social Security Act.” In addition, section 937(a) of the PHS Act charges AHRQ with disseminating patient-centered outcomes research (PCOR) and CER findings into practice. AHRQ's PCOR Trust Fund Training Program (PCORTF-TP) invests in training grants that build researchers' skills and enhance research capacity in these practice areas.

PCOR is research that assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions. This research helps clinicians, patients, and caregivers make decisions about health care choices by highlighting comparisons and outcomes that matter to people, such as survival, function, symptoms, and health-related quality of life. The AHRQ PCORTF-TP supports individuals and academic institutions to train researchers and clinicians in CER methods applied within the context of CER/PCOR via mentored career development award mechanisms for emerging independent investigators, as well as targeted skill development and applied experiences via research grant mechanisms for independent researchers. PCORTF-TP grants support training for recent graduates, mid-career professionals, and established professionals in research and clinical settings. The program prioritizes expanding capacity in underserved and predominantly minority communities.

AHRQ recognizes the importance of ensuring that its training activities are useful, well implemented, and effective in achieving their intended goals. Therefore, the PCORTF-TP evaluation reflects AHRQ's commitment to ensuring responsible stewardship. The PCORTF-TP evaluation comprises analysis of grantee progress reports, a bibliometric analysis of grantee publications, key informant interviews with AHRQ program staff responsible for managing PCORTF-TP grants, focused discussions with the PCORTF-TP evaluation Stakeholder Working Group, and surveys of grantees and mentors.

The purpose of this evaluation is to assess the outputs, outcomes, and impact of AHRQ's PCORTF-TP. The evaluation will address the following questions:

• What is the nature of PCORTF-TP activities for scholar/investigator development?
• Which activities for PCORTF-TP scholars/investigators have the greatest influence on intended outcomes (e.g., PCOR careers)?
• How have PCORTF-TP and partner institutions developed the capacity for PCOR training and mentoring, and in what ways is this sustainable?
• What do mentors and mentees perceive to be the most important ways that the program has contributed to the field of CER/PCOR?

This evaluation is being conducted by AHRQ through its contractor, AFYA, Inc., pursuant to AHRQ's authority to carry out the activities described in section 937 of the PHS Act. 42 U.S.C. 299b-37.

Method of Collection

To achieve the goals of this project, the evaluator will survey PCORTF-TP awardees, scholars, and mentors. Online surveys: K Awardee Survey/K12 Scholar Survey and K Awardee/K12 Scholar Primary Mentor Survey will be used to: (1) Collect non-identifying demographic information; and (2) ask respondents about their training activities and outcomes. Key informant interviews: Key Informant Interview Guide will be used to collect qualitative data about program processes, outcomes, and lessons learned from K12 scholar program directors.

AHRQ will use the information collected through this Information Collection Request to assess progress toward achieving the PCORTF-TP aims. The information collected will facilitate program planning. Results will indicate whether grantees are conducting activities relevant to CER/PCOR training and whether those activities are increasing CER/PCOR capacity. Two surveys, each tailored for four respective PCORTF-TP respondent groups as well as key informant interviews will yield data on training activities, trainees' career plans, trainees' research and clinical activities relevant to CER/PCOR, and primary mentor experiences. The surveys are designed to capture primarily quantitative data with some qualitative data. The interview guide is designed to collect qualitative data.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in this evaluation. The survey will be completed by approximately 288 awardees, scholars, principal investigators (PI), and mentors. The surveys will each require approximately 30 minutes to complete. The key informant interview will be conducted with approximately 13 PIs. These interviews are expected to take one hour each. The total hour burden is expected to be 150.5 hours for this participant data collection effort.

Exhibit 1—Estimated Annualized Burden Hours

Form name	Number of respondents	Number of responses per respondent	Hours per response	Total burden hours
K Awardee/K12 Scholar * Survey	147	1	0.5	73.5
K Awardee/K12 Primary Mentor Survey	128	1	0.5	64
Key Informant Interview Guide for K12 Program Directors	13	1	1	13
Total	288			150.5
* K Awardee/K12 Scholar survey = K01/K08/K99/K18 Awardees and K12 Scholars.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to participate in this project. The total cost burden is estimated to be $11,134.34.

Exhibit 2—Estimated Annualized Cost Burden

Form name	Number of respondents	Total burden hours	Average hourly wage rate*	Total cost burden
K Awardee/K12 Scholar Survey	147	73.5	* $74.43	$5,434.59
K Awardee/K12 Primary Mentor Survey	128	64	* $74.43	4,732.16
Key Informant Interview Guide for K12 Program Directors	13	13	* $74.43	967.59
	288	150.5		11,134.34
* Average hourly wage ($73.94) based on the average annual salary for three categories of Health Specialties Teachers, Postsecondary (25-1071; Scientific Research and Development Services—$178,090; General Medical and Surgical Hospitals—$153,790; and Colleges, Universities, and Professional Schools—$126,890). Data Source: National Occupational Employment and Wage Estimates in the United States, May 2018, “U.S. Department of Labor, Bureau of Labor Statistics” (available at http://www.bls.gov/​oes/​current/​naics4_​621400.htm).

Request for Comments

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Dated: December 9, 2019.

Virginia L. Mackay-Smith,

Associate Director.