[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]]
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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.
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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 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published and unpublished pertinent scientific information will improve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?
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Population, Intervention, Comparator, Outcome, Timing, Setting/Study
Design (PICOTS)
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Element Inclusion Exclusion
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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).
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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