[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76042-76044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Patient and Provider 
Level Strategies To Address Racial/Ethnic 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

[[Page 76043]]

the public. Scientific information is being solicited to inform our 
review on Patient and Provider Level Strategies to Address Racial/
Ethnic Disparities in Health and Healthcare, which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. 
Access to published and unpublished pertinent scientific information 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 Patient and Provider 
Level Strategies to Address Racial/Ethnic 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 Patient and Provider Level Strategies to Address Racial/
Ethnic 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 Patient and Provider Level Strategies to 
Address Racial/Ethnic 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 strategies targeted at patients 
and provider/health professionals and designed to reduce racial and 
ethnic disparities and improve health outcomes in the treatment of 
common chronic conditions in adults?
    a. What interventions have been studied?
    b. What racial and ethnic populations have been studied?
    c. What common (multiple and single) chronic conditions have been 
studied?
    d. What primary outcomes have been studied?
    e. What are the reported effects of the strategies used in studies 
of interventions to reduce disparities?
    f. What are the reported unintended consequences, harms, or adverse 
events of the strategies used in studies of interventions to reduce 
disparities?
    g. Within race/ethnic groups, what other intersectional influences 
(e.g., disability status, income status, sexual identity and 
orientation, income, geographic location, language etc) have been 
targeted in studies of interventions to reduce disparities?
    h. What study designs have been used?
    i. What information is available on the applicability and 
sustainability of interventions?
    j. What gaps exist in the current research?

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

    a. What patient-level and health professional-level efforts has 
your organization, institution or practice employed to reduce racial 
and ethnic disparities in chronic conditions healthcare and health 
outcomes?
    i. Can you describe the rationale for this effort, for instance 
what problem was driving the decision to implement the solution/
intervention? Was the intervention successful or not? What were the 
challenges? How are you measuring disparities and evaluating 
interventions and outcomes as a result of them?
    b. Do you engage community partnerships in your approach? If so, 
how?
    i. Are there similar approaches you are aware of? Which other 
practice or provider is trying similar approaches?
    c. Are there concepts, or conceptual frameworks, that are important 
in understanding the patient-level and health professional-level 
interventions to reduce racial/ethnic disparities in health and 
healthcare?
    d. How do you identify special groups that are not being served, 
and how do you prioritize which groups for designing interventions for? 
What are the challenges?
    e. How does your organization tailor the patient-level and health 
professional-level approach to reach racial and ethnic minorities that 
may be

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marginalized due 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?
    f. What concerns do you have about the sustainability of patient-
level and health professional-level strategies/interventions intended 
to address racial and ethnic disparities in health and healthcare?
    g. Gray literature: What are prominent sources where you obtain 
information on patient-level and health professional-level strategies/
interventions? Who has conducted such interventions?
    h. What information and resource does your organization or 
institution need to be more effective in incorporating patient-level 
and health professional-level interventions in reducing racial and 
ethnic disparities in health and healthcare?
    i. 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 for chronic diseases. 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 health provider (that is doctor and 
nurse) 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 
etc) in the program(s)?
    d. Are you aware of community collaboration efforts 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 your health provider (that is 
doctor or nurse) 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? Are there things you could do as well? Give 
example(s).
    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       Pediatric
                          ethnic minority adults   populations.
                          with common chronic      Non-U.S
                          conditions.              populations.
                          Health
                          Professionals
                          providing healthcare
                          for racial and ethnic
                          minority adults with
                          common chronic
                          conditions.
Interventions..........   Strategies       Exploratory
                          specifically targeted    sub-group analysis
                          to reduce racial and     where the aims of the
                          ethnic minority health   studies are not
                          and healthcare           relevant to racial/
                          disparities at patient-  ethnic health
                          level and health         disparities.
                          professional-level,      Public health/
                          with relevant links to   policy-based
                          healthcare system.       interventions without
                          Strategies       relevant links to
                          with community           healthcare system.
                          involvement with         Interventions
                          relevant links to        aimed at medical
                          healthcare system.       school students,
                                                   pharmacy students,
                                                   and other allied
                                                   health students.
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 (e.g.,
                          referrals to mental
                          healthcare, cultural
                          relevance).
                          Care
                          utilization outcome
                          measures (e.g., rates
                          of readmission for
                          long-term
                          complications of
                          diabetes).
                          Financial/re-
                          imbursement measures..
                          Harms (e.g.,
                          unintended negative
                          consequences,
                          including
                          misallocation of
                          effort, decreased
                          patient satisfaction,
                          etc.).
                          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 7, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-26930 Filed 12-9-22; 8:45 am]
BILLING CODE 4160-90-P