Supplemental Evidence and Data Request on Evidence Map on Home and Community Based Services, 69186-69188 [2023-22131]
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69186
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
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HISTORY:
84 FR 70191.
Approved: September 28, 2023.
Shelley K. Finlayson,
Acting Director, U.S. Office of Government
Ethics.
[FR Doc. 2023–22168 Filed 10–4–23; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Evidence Map on Home
and Community Based Services
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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
Evidence Map on Home and Community
Based Services, which is currently being
conducted by the AHRQ’s Evidencebased 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Access to published and unpublished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 November 6, 2023.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
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: epc@ahrq.hhs.gov.
SUMMARY:
E:\FR\FM\05OCN1.SGM
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69187
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Evidence Map on Home
and Community Based Services. 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 Evidence Map on Home
and Community Based Services. The
entire research protocol is available
online at: https://effectivehealthcare.
ahrq.gov/products/evidence-map/
protocol. This is to notify the public that
the EPC Program would find the
following information on Evidence Map
on Home and Community Based
Services helpful:
D 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.
D For completed studies that do not
have results on ClinicalTrials.gov, a
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.
D A list of ongoing studies that your
organization has sponsored for this
SUPPLEMENTARY INFORMATION:
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.
D 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.
Guiding Questions
1. Describe the available research on
the effectiveness of person-centered
HCBS interventions, for adults aged 60
or older with a functional limitation in
home and community-based settings.
a. What HCBS interventions have
been studied in relation to personcentered approaches?
1. For which person-centered HCBS
interventions are systematic reviews
available?
2. For which person-centered HCBS
interventions are sufficient primary
research studies available to justify a
new systematic review?
b. What populations have been
studied with person-centered HCBS
interventions?
c. What primary outcomes of personcentered HCBS interventions have been
studied?
d. What mediating factors have been
identified in the literature that could
affect outcomes such as the presence of
unpaid family caregivers as part of the
overall care team?
e. What study designs have been used
to evaluate the effectiveness of personcentered approaches to HCBS
interventions?
2. What quality measures related to
person-centered HCBS interventions
exist or are under development (See
NCQA measures of person-centered
outcomes (https://www.ncqa.org/hedis/
reports-and-research/pco-measures/)
under development, including the
University of Minnesota’s efforts
(https://acl.gov/sites/default/files/
news%202022-11/ACL%20HCBS
%20Outcome%20Measurement
%20Webinar%20Slides%2005.26.22_
AR%20%28002%29.pdf))?
3. Describe the gaps that exist in the
current research.
a. Which person-centered HCBS
interventions identified by experts as
currently relevant have no or inadequate
evidence?
b. Which patient populations and
outcome measures have no or
inadequate evidence?
c. Are there gaps in evidence related
to taking person-centered planning
approaches to these interventions?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTINGS)
ddrumheller on DSK120RN23PROD with NOTICES1
PICOTS elements
Inclusion criteria
Exclusion criteria
Population ..................
• Adults aged 60 years or older with a functional limitation, requiring assistance with
activities of daily living, regardless of payer source.
Interventions ..............
Person-centered HCBS, including the following person-centered approach, used
alone or in combination:
• Occupational, speech, and physical therapy.
• Durable medical equipment.
• Case management (in home or via phone).
• Caregiver and client training (training on skills to take care of a patient at home).
• Health promotion and disease prevention (training to enabling people to increase
control over, and to improve, their health like cook a healthier meal, or doing
stretches to maintain flexibility again to prevent falls).
• Hospice care.
• Senior centers and adult daycares.
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•
•
•
•
Animals.
Children.
Adults without disabilities.
Adults aged <60 years, exclusively.
• None.
69188
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTINGS)—Continued
PICOTS elements
Comparators ..............
Outcomes ..................
Timing ........................
Settings ......................
Subgroup analysis .....
Study design ..............
Publications ...............
Inclusion criteria
Exclusion criteria
• Congregate meal sites and home-delivered meal programs.
• Personal assistance such as dressing, bathing, toileting, eating, transferring to or
from a bed or chair, etc.
• Transportation and access including physical access to their homes (ramps, rails,
etc.) or access to places (doctor’s offices, etc.) or could also be access to
healthcare setting (ride to the doctor’s office).
• Home repairs and modifications.
• Home safety assessments.
• Homemaker and chore services.
• Information and referral services (to clinical care or other community-based services).
• Community integration services and day support.
• Behavioral health services.
• Financial services.
• Legal services, such as help preparing a will.
• Telephone reassurance.
• Institutional care (nursing care, long-term care) without HCBS ..................................
• No HCBS while living in the home or community.
• Mortality ........................................................................................................................
• Time to nursing home placement.
• Patient satisfaction.
• Person-centered outcomes.
• Hospitalization, rehospitalization.
• Clinical outcomes (falls, disease-related outcomes).
• Social isolation.
• Quality of life (see NQF HCBS Quality Domains Report).
• Harms of the intervention.
• All .................................................................................................................................
• Home settings ..............................................................................................................
• Independent living.
• Assisted living.
• Studies conducted in the United States.
• Geography ....................................................................................................................
• Race/ethnicity.
• Sex.
• Comorbidities.
• Social situations (community, home).
• Clinical needs (includes activities of daily living as well as other needs to care for a
person).
• Guiding Question 1:
Æ RCTs.
Æ Comparative observational studies.
Æ Systematic reviews or meta-analyses.
• Guiding Questions 2–3:
Æ RCTs.
Æ Comparative observational studies.
Æ Surveys.
Æ Qualitative studies.
Æ Mixed-method studies.
Æ Narrative reviews.
Æ Systematic review or meta-analysis.
• Studies published in English as peer reviewed full-text articles .................................
• Studies published after Year 2000.
• Studies conducted outside of the United States.
• None.
• None.
• None.
• Nursing home.
• Healthcare setting.
• None.
•
•
•
•
•
In vitro studies.
Erratum.
Editorials.
Letters.
Case reports/series.
• Foreign language studies.
• Conference abstracts.
Abbreviations: HCBS = Home and Community Based Services; NQF = National Quality Forum; RCT = randomized clinical trials.
ddrumheller on DSK120RN23PROD with NOTICES1
Dated: September 29, 2023.
Marquita Cullom,
Associate Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–22131 Filed 10–4–23; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4160–90–P
Reorganization of the National Center
for Chronic Disease Prevention and
Health Promotion
Centers for Disease Control and
Prevention (CDC), the Department of
Health and Human Services (HHS).
AGENCY:
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ACTION:
Notice.
CDC has modified its
structure. This notice announces the
reorganization of the National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP). NCCDPHP has
realigned the Division of Adolescent
and School Health from the National
Center National Center for HIV, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP).
SUMMARY:
E:\FR\FM\05OCN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69186-69188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22131]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Evidence Map on Home
and Community Based Services
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
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 Evidence Map on
Home and Community Based Services, 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 November 6, 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].
[[Page 69187]]
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 Evidence Map on Home
and Community Based Services. 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 Evidence Map on Home and Community Based Services. The
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/evidence-map/protocol. This is to
notify the public that the EPC Program would find the following
information on Evidence Map on Home and Community Based Services
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 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.
Guiding Questions
1. Describe the available research on the effectiveness of person-
centered HCBS interventions, for adults aged 60 or older with a
functional limitation in home and community-based settings.
a. What HCBS interventions have been studied in relation to person-
centered approaches?
1. For which person-centered HCBS interventions are systematic
reviews available?
2. For which person-centered HCBS interventions are sufficient
primary research studies available to justify a new systematic review?
b. What populations have been studied with person-centered HCBS
interventions?
c. What primary outcomes of person-centered HCBS interventions have
been studied?
d. What mediating factors have been identified in the literature
that could affect outcomes such as the presence of unpaid family
caregivers as part of the overall care team?
e. What study designs have been used to evaluate the effectiveness
of person-centered approaches to HCBS interventions?
2. What quality measures related to person-centered HCBS
interventions exist or are under development (See NCQA measures of
person-centered outcomes (https://www.ncqa.org/hedis/reports-and-research/pco-measures/) under development, including the University of
Minnesota's efforts (https://acl.gov/sites/default/files/news%202022-11/ACL%20HCBS%20Outcome%20Measurement%20Webinar%20Slides%2005.26.22_AR%20%28002%29.pdf))?
3. Describe the gaps that exist in the current research.
a. Which person-centered HCBS interventions identified by experts
as currently relevant have no or inadequate evidence?
b. Which patient populations and outcome measures have no or
inadequate evidence?
c. Are there gaps in evidence related to taking person-centered
planning approaches to these interventions?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Settings)
----------------------------------------------------------------------------------------------------------------
PICOTS elements Inclusion criteria Exclusion criteria
----------------------------------------------------------------------------------------------------------------
Population........................... Adults aged 60 years or older with a Animals.
functional limitation, requiring assistance Children.
with activities of daily living, regardless of Adults without
payer source. disabilities.
Adults aged
<60 years,
exclusively.
Interventions........................ Person-centered HCBS, including the following None.
person-centered approach, used alone or in
combination:
Occupational, speech, and physical
therapy.
Durable medical equipment..............
Case management (in home or via phone).
Caregiver and client training (training
on skills to take care of a patient at home).
Health promotion and disease prevention
(training to enabling people to increase
control over, and to improve, their health like
cook a healthier meal, or doing stretches to
maintain flexibility again to prevent falls).
Hospice care...........................
Senior centers and adult daycares......
[[Page 69188]]
Congregate meal sites and home-
delivered meal programs.
Personal assistance such as dressing,
bathing, toileting, eating, transferring to or
from a bed or chair, etc.
Transportation and access including
physical access to their homes (ramps, rails,
etc.) or access to places (doctor's offices,
etc.) or could also be access to healthcare
setting (ride to the doctor's office).
Home repairs and modifications.........
Home safety assessments................
Homemaker and chore services...........
Information and referral services (to
clinical care or other community-based
services).
Community integration services and day
support.
Behavioral health services.............
Financial services.....................
Legal services, such as help preparing
a will.
Telephone reassurance..................
Comparators.......................... Institutional care (nursing care, long- None.
term care) without HCBS.
No HCBS while living in the home or
community.
Outcomes............................. Mortality.............................. None.
Time to nursing home placement.........
Patient satisfaction...................
Person-centered outcomes...............
Hospitalization, rehospitalization.....
Clinical outcomes (falls, disease-
related outcomes).
Social isolation.......................
Quality of life (see NQF HCBS Quality
Domains Report).
Harms of the intervention..............
Timing............................... All.................................... None.
Settings............................. Home settings.......................... Nursing home.
Independent living. Healthcare
setting.
Assisted living........................
Studies conducted in the United States.
Subgroup analysis.................... Geography.............................. None.
Race/ethnicity.........................
Sex....................................
Comorbidities..........................
Social situations (community, home)....
Clinical needs (includes activities of
daily living as well as other needs to care for
a person).
Study design......................... Guiding Question 1: In vitro
studies.
[cir] RCTs................................... Erratum.
[cir] Comparative observational studies...... Editorials.
[cir] Systematic reviews or meta-analyses.... Letters.
Guiding Questions 2-3: Case reports/
series.
[cir] RCTs...................................
[cir] Comparative observational studies......
[cir] Surveys................................
[cir] Qualitative studies....................
[cir] Mixed-method studies...................
[cir] Narrative reviews......................
[cir] Systematic review or meta-analysis.....
Publications......................... Studies published in English as peer Foreign
reviewed full-text articles. language studies.
Studies published after Year 2000. Conference
abstracts.
Studies conducted outside of the United
States.
----------------------------------------------------------------------------------------------------------------
Abbreviations: HCBS = Home and Community Based Services; NQF = National Quality Forum; RCT = randomized clinical
trials.
Dated: September 29, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-22131 Filed 10-4-23; 8:45 am]
BILLING CODE 4160-90-P
