[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 Access to published and unpublished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: [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: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
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:
Environment-level (e.g., transportation; need/availability
of guardian or caregiver)
Person-level (e.g., fear; discomfort; functional ability;
self-efficacy)
Provider-level (e.g., disability knowledge/assumptions;
bias or ``ableism''; communication skills)
Health system (e.g., insurance; patient functionality
information in records; procedural accommodations, such as visit length
and clinician reimbursement)
Accessibility of health facilities (e.g., physical
facility; equipment; sensory environment; telehealth)
Accessible communication (e.g., within facility; from
outside of facility)
Policy-level (e.g., Federal or State laws)
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
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Element Include Exclude
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Population.................. People with 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)
Adults and
children
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................
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)
Preventive
Characteristics/ services not listed
components of in Appendix B
interventions (KQ3)
may include
elements such as:
staffing, funding,
facilities,
equipment, training
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.................. Another ....................
intervention
No ....................
intervention
Outcome..................... Receipt of Cost-
clinical preventive effectiveness
service
Quality of Outcomes
receipt of clinical not related to
preventive service included clinical
Health preventive services
outcomes related to listed in Appendix
clinical preventive B
service.
Patient ....................
satisfaction
Patient ....................
well-being
Harms of ....................
the intervention
program
Timing...................... All ....................
Setting..................... Primary ....................
care outpatient
clinics
Community ....................
health clinics
Settings ....................
referable from
primary care
settings
Emergency ....................
departments
Other ....................
settings (e.g.,
home, residence,
mobile care units)
United ....................
States or countries
with a ``very
high'' United
Nations Human
Development Index
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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