Supplemental Evidence and Data Request on The Effect of Protein Intake on Health, 38867-38869 [2023-12678]
Download as PDF
<![CDATA[
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on The Effect of Protein Intake
on Health
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
The Effect of Protein Intake on Health,
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published and unpublished pertinent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 July 14, 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 06E53A, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for The Effect of Protein Intake
on Health. 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 The Effect of Protein
Intake on Health, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/effect-protein-intake/protocol.
This is to notify the public that the
EPC Program would find the following
information on The Effect of Protein
Intake on Health helpful:
D 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.
D 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.
D 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
38867
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.
D 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 systematic 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 (KQ)
KQ 1: What is the association between
dietary protein intake and risk of bone
disease?
KQ 2: What is the association between
dietary protein intake and risk of kidney
disease?
KQ 3: What is the association between
dietary protein intake and risk of
sarcopenia?
E:\FR\FM\14JNN1.SGM
14JNN1
38868
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)
Element
Inclusion
Exclusion
Population KQ1 ....................
Participants who are healthy and/or have chronic diseases or chronic disease risk factors, including those
with obesity.
Participants who are pregnant and lactating.
Age of participants (at intervention or exposure):
Æ Infants, children, and adolescents (0–18 years).
Æ Adults (19–64 years).
Æ Older adults (65 years and older).
Population KQ2&3 ...............
Participants who are healthy and/or have chronic diseases or chronic disease risk factors, including those
with obesity.
Participants who are pregnant and lactating.
Age of participants (at intervention or exposure):
Æ Adults (19–64 years).
Æ Older adults (65 years and older).
Interventions KQ1–3 ............
Total dietary protein intake from food, beverages, and
dietary supplements.
Comparison KQ1–3 .............
• Consumption of different levels of total dietary protein
intake.
• No comparator.
Bone outcomes:
Æ Osteoporosis.
Æ Osteopenia.
Æ Fracture.
Æ Bone mass including bone mineral density, bone
mineral content.
Kidney outcomes:
Æ Incidence of kidney stones or ureteral stones.
Æ Incidence of CKD (including evaluations from estimated glomerular filtration (eGFR) rate with or without a parameter for race).
Æ Kidney insufficiency.
Aging associated sarcopenia and its diagnostic indicators, including but not limited to muscle mass, muscle
function, muscle strength.
All duration and follow up.
All settings.
Participants sample exclusively diagnosed with a disease or hospitalized or in a long-term care facility
with an illness or injury.
Participants who have already been diagnosed with
bone disease.
Participants with existing conditions that clearly are
known to alter nutrient metabolism or requirements,
or those being treated with medications that alter nutrient metabolism.
Participant sample exclusively undernourished.
Participant sample exclusively with a baseline diet deficient in protein.
Participant sample exclusively pre-term infant.
Participant sample exclusively post-bariatric surgery
subjects.
Participant sample exclusively elite athletes.
Non-human participants (e.g., animal studies, in-vitro
models).
Participants sample exclusively diagnosed with a disease or hospitalized or in a long-term care facility
with an illness or injury
Participants who have already been diagnosed with kidney disease and/or sarcopenia.
Participants with existing conditions that clearly are
known to alter nutrient metabolism or requirements,
or those being treated with medications that alter nutrient metabolism.
Participant sample exclusively undernourished.
Participant sample exclusively with a baseline diet deficient in protein.
Participant sample exclusively post-bariatric surgery
subjects.
Participant sample exclusively elite athletes.
Non-human participants (e.g., animal studies, in-vitro
models).
No specification on the amount of protein intake (e.g.,
only the type of protein or source of protein reported).
Assessment of %AMDR, but no description of the entire macronutrient distribution of the diet (i.e., examination a single macronutrient in relation to outcomes).
Protein intake via infusions (rather than the GI tract).
Food products or dietary supplements not widely available to U.S. consumers.
Protein intake evaluated with exercise.
Comparison of different sources of protein (i.e., animal
versus plant protein) without specification on the levels of total dietary protein intake
Outcomes KQ1 ....................
ddrumheller on DSK120RN23PROD with NOTICES1
Outcomes KQ2 ....................
Outcomes KQ3 ....................
Timing KQ1–3 ......................
Setting KQ1–3 ......................
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
E:\FR\FM\14JNN1.SGM
14JNN1
Federal Register / Vol. 88, No. 114 / Wednesday, June 14, 2023 / Notices
38869
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)—Continued
Element
Inclusion
Exclusion
Study design KQ1–3 ............
• Randomized controlled trials (RCTs) ..........................
• Non-randomized controlled trials, including quasi-experimental and controlled before-and-after studies.
• Prospective cohort studies with or without comparison group with appropriate analytic technique.
• Nested case-control studies. .......................................
• Narrative reviews.
• Systematic reviews, meta-analyses, umbrella reviews, scoping reviews.
• Systematic reviews or meta-analyses that exclusively
include cross-sectional and/or uncontrolled studies.
• Retrospective cohort studies.
• All other study designs.
Language KQ1–3 .................
Geographic Location KQ1–3
Study size KQ1–3 ................
English only (due to resource limitations) .......................
Locations with food products or dietary supplements
widely available to U.S. consumers, including those
rated very high on the Human Development Index.
..........................................................................................
Publication date KQ1–3 .......
Publication status KQ1–3 ....
2000 to present.
Articles published in peer-reviewed journals ..................
Studies with N < 50 participants (for RCTs—25 participants analyzed per study arm), and without power
calculation.
Articles that have not been peer reviewed and are not
published in peer-reviewed journals (e.g., unpublished data, manuscripts, pre-prints, reports, abstracts, conference proceedings).
Abbreviations: AMDR = Acceptable macronutrient distribution range; GI = gastrointestinal; U.S. = United States; KQ = key question; CKD =
chronic kidney disease; eGFR = estimated glomerular filtration rate; RCT = randomized controlled trial.
Dated: June 8, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–12678 Filed 6–13–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ)
announces a Special Emphasis Panel
(SEP) meeting on ‘‘Implementing and
Evaluating New Models for Delivering
Comprehensive, Coordinated, PersonCentered Care to People with Long
COVID (U18).’’ This SEP meeting will
be closed to the public.
DATES: July 27–28, 2023.
ADDRESSES: Agency for Healthcare
Research and Quality, (Video Assisted
Review), 5600 Fishers Lane, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT:
Jenny Griffith, Committee Management
Officer, Office of Extramural Research,
Education and Priority Populations,
Agency for Healthcare Research and
Quality, (AHRQ), 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone:
(301) 427–1557.
SUPPLEMENTARY INFORMATION: A Special
Emphasis Panel is a group of experts in
fields related to health care research
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:24 Jun 13, 2023
Jkt 259001
who are invited by AHRQ, and agree to
be available, to conduct on an as needed
basis, scientific reviews of applications
for AHRQ support. Individual members
of the Panel do not attend regularly
scheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
a particular review meeting which
requires their type of expertise.
The SEP meeting referenced above
will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. 1009(d), 5 U.S.C. 552b(c)(4),
and 5 U.S.C. 552b(c)(6). Grant
applications for ‘‘Implementing and
Evaluating New Models for Delivering
Comprehensive, Coordinated, PersonCentered Care to People with Long
COVID (U18)’’ are to be reviewed and
discussed at this meeting. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: June 8, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–12675 Filed 6–13–23; 8:45 am]
BILLING CODE 4160–90–P
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
CDC Town Hall Meeting Concerning
Future Directions for the Regional
Centers for Public Health
Preparedness and Response
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces a
town hall meeting regarding the history
and future of CDC-funded public health
preparedness and response centers.
DATES: The town hall meeting will be
held on Wednesday, June 28, 2023, from
1 p.m. to 5 p.m. EDT.
ADDRESSES: The town hall meeting is a
virtual meeting and is open to the
public, limited only by the webcast
lines available. Registration is required.
For information about accessing the
webcast, visit https://www.cdc.gov/orr/
science/research.htm.
FOR FURTHER INFORMATION CONTACT:
Mary Leinhos, Ph.D., Office of
Readiness and Response, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop H21–5,
Atlanta, Georgia 30329–4018; Phone:
(770) 488–8619; Email: CPROAR@
CDC.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The purpose of this town
hall meeting is to provide an overview
SUMMARY:
E:\FR\FM\14JNN1.SGM
14JNN1
]]>Agencies
[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38867-38869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12678]
[[Page 38867]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on The Effect of Protein
Intake on Health
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 The Effect of
Protein Intake on Health, 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 July 14, 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 06E53A, 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 The Effect of Protein
Intake on Health. 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 The Effect of Protein Intake on Health, including those
that describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/effect-protein-intake/protocol.
This is to notify the public that the EPC Program would find the
following information on The Effect of Protein Intake on Health
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 systematic 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 (KQ)
KQ 1: What is the association between dietary protein intake and
risk of bone disease?
KQ 2: What is the association between dietary protein intake and
risk of kidney disease?
KQ 3: What is the association between dietary protein intake and
risk of sarcopenia?
[[Page 38868]]
Population, Intervention, Comparator, Outcome, Timing, Setting/Study
Design (PICOTS)
------------------------------------------------------------------------
Element Inclusion Exclusion
------------------------------------------------------------------------
Population KQ1.............. Participants who are Participants sample
healthy and/or have exclusively
chronic diseases or diagnosed with a
chronic disease disease or
risk factors, hospitalized or in
including those a long-term care
with obesity. facility with an
Participants who are illness or injury.
pregnant and Participants who
lactating.. have already been
Age of participants diagnosed with bone
(at intervention or disease.
exposure):. Participants with
[cir] Infants, existing conditions
children, and that clearly are
adolescents (0-18 known to alter
years).. nutrient metabolism
[cir] Adults (19-64 or requirements, or
years).. those being treated
[cir] Older adults with medications
(65 years and that alter nutrient
older).. metabolism.
Participant sample
exclusively
undernourished.
Participant sample
exclusively with a
baseline diet
deficient in
protein.
Participant sample
exclusively pre-
term infant.
Participant sample
exclusively post-
bariatric surgery
subjects.
Participant sample
exclusively elite
athletes.
Non-human
participants (e.g.,
animal studies, in-
vitro models).
Population KQ2&3............ Participants who are Participants sample
healthy and/or have exclusively
chronic diseases or diagnosed with a
chronic disease disease or
risk factors, hospitalized or in
including those a long-term care
with obesity. facility with an
Participants who are illness or injury
pregnant and Participants who
lactating.. have already been
Age of participants diagnosed with
(at intervention or kidney disease and/
exposure):. or sarcopenia.
[cir] Adults (19-64 Participants with
years).. existing conditions
[cir] Older adults that clearly are
(65 years and known to alter
older).. nutrient metabolism
or requirements, or
those being treated
with medications
that alter nutrient
metabolism.
Participant sample
exclusively
undernourished.
Participant sample
exclusively with a
baseline diet
deficient in
protein.
Participant sample
exclusively post-
bariatric surgery
subjects.
Participant sample
exclusively elite
athletes.
Non-human
participants (e.g.,
animal studies, in-
vitro models).
Interventions KQ1-3......... Total dietary No specification on
protein intake from the amount of
food, beverages, protein intake
and dietary (e.g., only the
supplements. type of protein or
source of protein
reported).
Assessment of %AMDR,
but no description
of the entire
macronutrient
distribution of the
diet (i.e.,
examination a
single
macronutrient in
relation to
outcomes).
Protein intake via
infusions (rather
than the GI tract).
Food products or
dietary supplements
not widely
available to U.S.
consumers.
Protein intake
evaluated with
exercise.
Comparison KQ1-3............ Consumption Comparison of
of different levels different sources
of total dietary of protein (i.e.,
protein intake. animal versus plant
No protein) without
comparator.. specification on
the levels of total
dietary protein
intake
Outcomes KQ1................ Bone outcomes: ....................
[cir] Osteoporosis..
[cir] Osteopenia....
[cir] Fracture......
[cir] Bone mass
including bone
mineral density,
bone mineral
content..
Outcomes KQ2................ Kidney outcomes: ....................
[cir] Incidence of
kidney stones or
ureteral stones..
[cir] Incidence of
CKD (including
evaluations from
estimated
glomerular
filtration (eGFR)
rate with or
without a parameter
for race)..
[cir] Kidney
insufficiency..
Outcomes KQ3................ Aging associated ....................
sarcopenia and its
diagnostic
indicators,
including but not
limited to muscle
mass, muscle
function, muscle
strength.
Timing KQ1-3................ All duration and ....................
follow up.
Setting KQ1-3............... All settings. ....................
[[Page 38869]]
Study design KQ1-3.......... Randomized Narrative
controlled trials reviews.
(RCTs). Systematic
Non- reviews, meta-
randomized analyses, umbrella
controlled trials, reviews, scoping
including quasi- reviews.
experimental and Systematic
controlled before- reviews or meta-
and-after studies. analyses that
Prospective exclusively include
cohort studies with cross-sectional and/
or without or uncontrolled
comparison group studies.
with appropriate
analytic technique. Retrospective
Nested case- cohort studies.
control studies.. All other
study designs.
Language KQ1-3.............. English only (due to ....................
resource
limitations).
Geographic Location KQ1-3... Locations with food ....................
products or dietary
supplements widely
available to U.S.
consumers,
including those
rated very high on
the Human
Development Index.
Study size KQ1-3............ .................... Studies with N < 50
participants (for
RCTs--25
participants
analyzed per study
arm), and without
power calculation.
Publication date KQ1-3...... 2000 to present. ....................
Publication status KQ1-3.... Articles published Articles that have
in peer-reviewed not been peer
journals. reviewed and are
not published in
peer-reviewed
journals (e.g.,
unpublished data,
manuscripts, pre-
prints, reports,
abstracts,
conference
proceedings).
------------------------------------------------------------------------
Abbreviations: AMDR = Acceptable macronutrient distribution range; GI =
gastrointestinal; U.S. = United States; KQ = key question; CKD =
chronic kidney disease; eGFR = estimated glomerular filtration rate;
RCT = randomized controlled trial.
Dated: June 8, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-12678 Filed 6-13-23; 8:45 am]
BILLING CODE 4160-90-P
