[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76044-76046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Healthcare System Level 
Strategies To Address Racial/Ethnic and Related Disparities in Health 
and Healthcare

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Healthcare 
System Level Strategies to Address Racial/Ethnic and Related 
Disparities in Health and Healthcare, which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. 
Access to

[[Page 76045]]

published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before January 11, 2023.

ADDRESSES:
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Center (EPC) 
Program to complete a review of the evidence for Healthcare System 
Level Strategies to Address Racial/Ethnic and Related Disparities in 
Health and Healthcare. AHRQ is conducting this systematic review 
pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 
299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Healthcare System Level Strategies to Address Racial/
Ethnic and Related Disparities in Health and Healthcare, including 
those that describe adverse events. The entire research protocol is 
available online at: https://effectivehealthcare.ahrq.gov/.
    This is to notify the public that the EPC Program would find the 
following information on Healthcare System Level Strategies to Address 
Racial/Ethnic and Related Disparities in Health and Healthcare helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential, marketing materials, study 
types not included in the review, or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The technical brief will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Guiding Questions

    What is the current evidence for healthcare system-level strategies 
(including components of multifaceted strategies) designed to reduce 
racial, ethnic, and related socioeconomic disparities and improve 
health outcomes?
    a. What interventions have been studied?
    b. What racial and ethnic populations have been studied?
    c. What are the characteristics of the healthcare systems involved 
in studies of interventions to reduce disparities (e.g., size, 
location, private/public, etc.)?
    d. What common (multiple and single) chronic conditions have been 
studied?
    e. What primary outcomes have been studied?
    f. What are the reported effects of the strategies used in studies 
of interventions to reduce disparities?
    g. What are the reported unintended consequences, harms, or adverse 
events of the strategies used in studies of interventions to reduce 
disparities?
    h. Within race/ethnic groups, what other intersectional influences 
(e.g., disability status, income status, sexual identity and 
orientation, income, geographic location, language e.t.c) have been 
targeted in studies of interventions to reduce disparities?
    i. What study designs have been used?
    j. What information is available on the applicability and 
sustainability of interventions?
    k. What gaps exist in the current research?

Questions for Experts/Researchers/Advocacy Organizations/Provider 
Organizations/Practicing Clinicians

    a. What healthcare system-level efforts has your organization or 
institution employed to reduce racial and ethnic disparities in health 
and healthcare?
    i. Can you describe the rationale for this effort, for instance 
what was driving the decision of the problem and the solution/
intervention? Was the intervention successful or not? What were the 
challenges? How are you measuring disparities and evaluating 
interventions and outcomes? How are these efforts funded?
    b. Do you engage community partnerships in your approach? If so, 
how?
    i. Are there similar approaches you are aware of? Which other 
entity is trying similar approaches?
    c. Are there concepts, or conceptual frameworks, that are important 
in understanding the healthcare system-level interventions to reduce 
racial/ethnic disparities in health and healthcare?
    d. Are there elements of healthcare system-level interventions that 
are important and/or preferred for reducing racial/ethnic disparities 
in health and healthcare?
    e. How do you identify social identity groups that are not being 
served at all or not equally served, and how do you prioritize which 
groups for designing interventions? What are the challenges?
    f. How does your organization tailor the healthcare system-level 
approach to reach racial and ethnic groups or minorities that may be 
marginalized due

[[Page 76046]]

to other factors (such as disability status, income status, sexual 
identity and orientation, income, geographic location, language, etc.)? 
Which of these factors have been most challenging to address and why? 
Which factors are relatively easy to address and implement?
    g. What concerns do you have about the sustainability of healthcare 
system-level strategies/interventions intended to address racial and 
ethnic disparities in health and healthcare?
    h. Gray literature: What are prominent sources where you obtain 
information on healthcare system-level strategies/interventions? Who 
has conducted such interventions? Can you give examples of successful 
interventions that have been identified from these sources?
    i. What information and resources does your organization or 
institution need to be more effective in incorporating healthcare 
system-level interventions in reducing racial and ethnic disparities in 
health and healthcare?
    j. What are current gaps in the research and what future research 
is needed most?

Questions for Patient Advocates, Families, Caregivers

    a. Data clearly shows that racial and ethnic minority groups often 
have worse health and care. Why do you think this is the case?
    b. Have you or your loved ones experienced differences in care 
received, are you aware of any healthcare organizational efforts to 
rectify these differences? What are the efforts/programs?
    c. Have you or your loved ones participated in (or are you aware 
of) such program(s)? Was there any effort to consider your race and 
other social factors (such as your disability status, income status, 
sexual identity and orientation, income, geographic location, language 
e.t.c) in the program(s)?
    d. Are you aware of community collaboration efforts (such as social 
service agencies, churches e.t.c) of such programs to rectify the 
differences in your health and care? Should community organizations be 
involved in these efforts? How? What are some barriers that community 
organizations face in collaborating with healthcare organizations?
    e. What types of efforts do you think a healthcare organization 
could do that might reduce these differences in the care received by 
racial and ethnic minority groups? What would be needed for them to 
work?
    f. Are there sources where you obtain information about these 
efforts?

PICOTS (Populations, Interventions, Comparators, Outcomes, and Settings)
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        Element                  Included                Excluded
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Population.............   Racial and       Non-U.S
                          ethnic minority groups.  populations.
                          Healthcare
                          Systems providing
                          healthcare for racial
                          and ethnic minority
                          groups.
Interventions..........   Healthcare       Exploratory
                          system strategies that   sub-group analysis
                          are specifically         where the aims of the
                          targeted to reduce       studies are not
                          racial and ethnic        relevant to racial/
                          minority health and      ethnic health
                          healthcare disparities   disparities.
                          at population-level      Public health/
                          with relevant links to   policy-based
                          healthcare system.       interventions without
                          Strategies       relevant links to
                          specifically targeted    healthcare systems.
                          to reduce racial and     Interventions
                          ethnic minority health   aimed at medical
                          and healthcare           school students,
                          disparities at heath     pharmacy students,
                          care organization-       and other allied
                          level (e.g., structure   health students.
                          of the organization).
                          Strategies
                          with community
                          involvement with
                          relevant links to
                          healthcare system.
Comparators............   Standard care.
                          Alternative
                          strategy/intervention..
Outcomes...............   Health-related
                          outcome measures
                          (e.g., disease
                          specific morbidity and
                          mortality, BP control,
                          Hba1c levels).
                          Process of
                          care measures..
                          Care
                          utilization outcome
                          measures..
                          Barriers to
                          care measures..
                          Financial/re-
                          imbursement measures..
                          Harms (e.g.,
                          unintended negative
                          consequences)..
                          Stigma other
                          related experience of
                          discrimination..
Timing.................  Any....................
Settings...............  Any....................
Study design...........  Randomized controlled    Stand-alone
                          trial, non-randomized    qualitative studies,
                          controlled trial,        systematic reviews,
                          nonrandomized study      narrative reviews,
                          designs, mixed methods.  case reports, case
                                                   series protocols,
                                                   conference abstracts.
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    Dated: December 5, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-26931 Filed 12-9-22; 8:45 am]
BILLING CODE 4160-90-P