[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 74996-74998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24057]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Healthcare Delivery of 
Clinical Preventive Services for People With Disabilities

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

ACTION: Request for supplemental evidence and data submission.

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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 
Delivery of Clinical Preventive Services for People with Disabilities, 
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 Access to published and unpublished 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 December 1, 2023.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#2742574467464f5556094f4f5409404851"><span class="__cf_email__" data-cfemail="89ecf9eac9e8e1fbf8a7e1e1faa7eee6ff">[email protected]</span></a>.
    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: Kelly Carper, Telephone: 301-427-1656 
or Email: <a href="/cdn-cgi/l/email-protection#3a5f4a597a5b52484b14525249145d554c"><span class="__cf_email__" data-cfemail="7217021132131a00035c1a1a015c151d04">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Healthcare Delivery of 
Clinical Preventive Services for People with Disabilities. AHRQ is 
conducting this 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 Delivery of Clinical Preventive Services for 
People with Disabilities. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/people-with-disabilities/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Healthcare Delivery of Clinical Preventive 
Services for People with Disabilities helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this topic. 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

[[Page 74997]]

summary, including the following elements, if relevant: 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 topic. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including, if relevant, 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 topic 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 topics 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 review will answer the following questions. This information is 
provided as background. AHRQ is not requesting that the public provide 
answers to these questions.

Key Questions

    Key Question 1. What are the primary barriers and facilitators\a\ 
to the receipt of clinical preventive services among people with 
disabilities?
    a. How do these barriers/facilitators vary according to preventive 
service?
    b. How do these barriers/facilitators vary according to type and/or 
severity of disability?
    c. How do these barriers/facilitators vary according to 
characteristics such as: gender, race/ethnicity, economic status, 
LGBTQ+ status, or geographic location?
    Key Question 2. What is the effectiveness of interventions to 
improve the receipt of clinical preventive services among people with 
disabilities?
    a. How does the effectiveness vary according to preventive service?
    b. How does the effectiveness vary according to type and/or 
severity of disability?
    c. How does the effectiveness vary according to characteristics 
such as: gender, race/ethnicity, economic status, LGBTQ+ status, or 
geographic location?
    Key Question 3. What are the characteristics and/or components of 
interventions that contribute to their effectiveness (or lack of 
effectiveness) in mitigating barriers to the receipt of clinical 
preventive services among people with disabilities?
    a. How does the effectiveness vary according to preventive service?
    b. How does the effectiveness vary according to type and/or 
severity of disability?
    c. How does the effectiveness vary according to characteristics 
such as: gender, race/ethnicity, economic status, LGBTQ+ status, or 
geographic location?
    Key Question 4. What are the harms of intervention programs to 
mitigate barriers to the receipt of clinical preventive services among 
people with disabilities?
    a. How do the harms vary according to preventive service?
    b. How do the harms vary according to type and/or severity of 
disability?
    c. How do the harms vary according to characteristics such as: 
gender, race/ethnicity, economic status, LGBTQ+ status, or geographic 
location?
    \a\ Categories of barriers and facilitators may include but are not 
limited to:
    <bullet> Environment-level (e.g., transportation; need/availability 
of guardian or caregiver)
    <bullet> Person-level (e.g., fear; discomfort; functional ability; 
self-efficacy)
    <bullet> Provider-level (e.g., disability knowledge/assumptions; 
bias or ``ableism''; communication skills)
    <bullet> Health system (e.g., insurance; patient functionality 
information in records; procedural accommodations, such as visit length 
and clinician reimbursement)
    <bullet> Accessibility of health facilities (e.g., physical 
facility; equipment; sensory environment; telehealth)
    <bullet> Accessible communication (e.g., within facility; from 
outside of facility)
    <bullet> Policy-level (e.g., Federal or State laws)

 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                                Setting)
------------------------------------------------------------------------
           Element                   Include               Exclude
------------------------------------------------------------------------
Population..................  <bullet> People with  <bullet> Studies
                               disabilities          that do not include
                               (including:           people with
                               physical; cognitive/  disabilities or do
                               intellectual/         not report outcomes
                               developmental;        according to
                               sensory; serious      disability status
                               psychiatric/mental
                               illness)
                              <bullet> Adults and
                               children
                              <bullet> Specific
                               populations of
                               interest:
                              --Age
                              --Gender
                              --Race/ethnicity
                              --Economic status
                              --LGBTQ+ status
                              --Geographic
                               location (regional
                               and urban/rural)
                              --Immigration status
                              --Incarcerated
                              --Unhoused
                              --Language spoken
                              --Use of a guardian/
                               proxy for
                               healthcare
                               decisions

[[Page 74998]]

 
Intervention................  <bullet>              <bullet>
                               Interventions to      Interventions that
                               mitigate barriers     do not address
                               and/or improve the    barriers to receipt
                               receipt of clinical   of clinical
                               preventive services   preventive services
                               among people with     for people with
                               disabilities (e.g.,   disabilities
                               modification in
                               policies,
                               practices, and
                               procedures;
                               effective
                               communication; the
                               physical
                               accessibility of
                               facilities;
                               educational/
                               training programs
                               for healthcare
                               providers)
                              <bullet>              <bullet> Preventive
                               Characteristics/      services not listed
                               components of         in Appendix B
                               interventions (KQ3)
                               may include
                               elements such as:
                               staffing, funding,
                               facilities,
                               equipment, training
                              <bullet> Clinical     ....................
                               preventive services
                               listed in Appendix
                               B, derived from
                               USPSTF
                              Grade A and Grade B   ....................
                               recommendations:
                              --Screening (anxiety
                               disorders, breast
                               cancer, cervical
                               cancer, colorectal
                               cancer, depression,
                               HIV infection,
                               hypertension,
                               intimate partner
                               violence,
                               osteoporosis,
                               diabetes, unhealth
                               drug or alcohol
                               use).
                              --Interventions or    ....................
                               behavioral
                               counseling
                               (breastfeeding,
                               falls prevention,
                               perinatal
                               depression, tobacco
                               use/cessation,
                               weight loss,
                               healthy diet and
                               physical activity,
                               sexually
                               transmitted
                               infections)
Comparator..................  <bullet> Another      ....................
                               intervention
                              <bullet> No           ....................
                               intervention
Outcome.....................  <bullet> Receipt of   <bullet> Cost-
                               clinical preventive   effectiveness
                               service
                              <bullet> Quality of   <bullet> Outcomes
                               receipt of clinical   not related to
                               preventive service    included clinical
                              <bullet> Health        preventive services
                               outcomes related to   listed in Appendix
                               clinical preventive   B
                               service.
                              <bullet> Patient      ....................
                               satisfaction
                              <bullet> Patient      ....................
                               well-being
                              <bullet> Harms of     ....................
                               the intervention
                               program
Timing......................  <bullet> All          ....................
Setting.....................  <bullet> Primary      ....................
                               care outpatient
                               clinics
                              <bullet> Community    ....................
                               health clinics
                              <bullet> Settings     ....................
                               referable from
                               primary care
                               settings
                              <bullet> Emergency    ....................
                               departments
                              <bullet> Other        ....................
                               settings (e.g.,
                               home, residence,
                               mobile care units)
                              <bullet> United       ....................
                               States or countries
                               with a ``very
                               high'' United
                               Nations Human
                               Development Index
------------------------------------------------------------------------
Abbreviations: HIV = Human Immunodeficiency Virus; KQ = Key Question;
  LGBTQ+ = Lesbian Gay Bisexual Transgender Queer/questioning plus/
  others; USPSTF = United States Preventive Services Task Force.


    Dated: October 26, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-24057 Filed 10-31-23; 8:45 am]
BILLING CODE 4160-90-P


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