Supplemental Evidence and Data Request on Nutrition as Prevention for Improved Cancer Outcomes, 59718-59720 [2021-23456]
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Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
The Board also received comments on
the implementation timeline and, in
particular, how coordinating with
FINRA on its own proposed changes
would be beneficial. Commenters noted
the importance of enough lead time
prior to reporting to allow for systems
to be implemented or updated as
needed. The Board understands the
balance between minimizing
compliance burdens on depository
institutions as well as the critical need
to gain insight into this segment of the
Treasury securities and agency-issued
debt and MBS markets. As a result, the
Board intends to provide appropriate
lead time to permit depository
institutions the necessary time to
prepare before the initial reporting
under this collection will be required. In
addition, the Board anticipates that any
modifications adopted by FINRA and
incorporated in the Board’s reporting
requirement in the future will also
provide ample lead time to prepare to
comply with any proposed
modifications. In response to these
comments, the Board is adopting an
implementation timeline for first
reporting under this collection of
September 1, 2022.
Board of Governors of the Federal Reserve
System, October 21, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–23432 Filed 10–27–21; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Nutrition as Prevention for
Improved Cancer Outcomes
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
Nutrition as Prevention for Improved
Cancer Outcomes, 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unpublished pertinent scientific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 29, 2021.
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SUMMARY:
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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:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
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 Nutrition as Prevention for
Improved Cancer Outcomes. AHRQ is
conducting this technical brief 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 Nutrition as Prevention
for Improved Cancer Outcomes,
including those that describe adverse
events. The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
improved-cancer-outcomes/protocol.
This is to notify the public that the
EPC Program would find the following
information on Nutrition as Prevention
for Improved Cancer Outcomes 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.
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Fmt 4703
Sfmt 4703
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
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: In adults diagnosed with cancer
who have or are at risk for cancerassociated malnutrition, what is the
effect of nutritional interventions prior
to cancer treatment in preventing
negative treatment outcomes such as
effects on dose tolerance, hospital
utilizations, adverse events and
survival?
a. Do the effects of nutritional
interventions on preventing the negative
outcomes associated with cancer
treatment vary by cancer type, treatment
type (chemotherapy, radiation, surgery)
and stage of disease?
b. Do the effects of nutritional
interventions vary across the lifespan
(e.g., adults aged ≥65 years vs. <65
years)?
c. KQ1c: Compared to adults without
muscle wasting, do nutritional
interventions prevent the negative
outcomes associated with cancer
E:\FR\FM\28OCN1.SGM
28OCN1
Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
treatment in adults with muscle
wasting?
d. KQ1d: Do the effects of nutritional
interventions on preventing the negative
outcomes associated with cancer
treatment vary across special
populations (e.g., individuals with
multiple comorbid conditions)?
KQ 2: In adults diagnosed with cancer
who have or are at risk for cancerassociated malnutrition, what is the
effect of nutritional interventions during
cancer treatment in preventing negative
treatment outcomes such as effects on
dose tolerance, hospital utilizations,
adverse events and survival?
a. Do the effects of nutritional
interventions on preventing the negative
outcomes associated with cancer
treatment vary by cancer type, treatment
type (chemotherapy, radiation, surgery)
and stage of disease?
b. Do the effects of nutritional
interventions vary across the lifespan
(e.g., adults aged ≥65 years vs. <65
years)?
c. Compared to adults without muscle
wasting, do nutritional interventions
prevent the negative outcomes
associated with cancer treatment in
adults with muscle wasting?
d. Do the effects of nutritional
interventions on preventing the negative
outcomes associated with cancer
treatment vary across special
populations (e.g., individuals with
multiple comorbid conditions)?
KQ 3: In adults diagnosed with cancer
who have or are at risk for cancerassociated malnutrition, what is the
effect of nutritional interventions prior
to or during cancer treatment on
associated symptoms such as fatigue,
nausea and vomiting, appetite, physical
and functional status (e.g., frailty), and
quality of life?
a. Do the effects of nutritional
interventions on symptoms associated
with cancer treatment vary by cancer
type, treatment type (chemotherapy,
radiation, surgery) and stage of disease?
b. Do the effects of nutritional
interventions vary across the lifespan
59719
(e.g., adults aged ≥65 years vs. <65
years)?
c. Compared to adults without muscle
wasting, do nutritional interventions
differentially effect symptoms
associated with cancer treatment in
adults with muscle wasting?
d. Do the effects of nutritional
interventions on symptoms associated
with cancer treatment vary across
special populations (e.g., individuals
with multiple comorbid conditions)?
KQ 4: In adults with cancer who are
overweight or obese, what is the effect
of nutritional interventions intended for
weight loss prior to or during cancer
treatment in preventing negative
treatment outcomes such as effects on
dose, hospital utilizations, adverse
events and survival?
Contextual Question (CQ)
CQ 1: What evidence is available on
the cost-effectiveness of nutritional
interventions for preventing negative
outcomes associated with cancer
treatment?
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)
KQ1: pre-treatment
nutritional interventions
(PNIs)
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KQ2: nutritional interventions during treatment (NIDTs)
KQ3: pre- or during treatment nutritional interventions (NIs) and patient-centered outcomes
KQ4: weight loss in overweight/obese adults
with cancer
Population ...........
Adults diagnosed with cancer at or after age 18 who have or are at risk for cancer-associated
malnutrition.
Subgroups:
• Cancer and treatment characteristics (cancer type, treatment type (systemic therapy, radiation,
surgery), stage of disease).
• Adults ≥65y vs younger.
• Muscle wasting (e.g., sarcopenia, cachexia, pre-cachexia) vs. no muscle wasting.
• Special populations (individuals with multiple co-morbid conditions).
Overweight (BMI 25–<30)/obese (BMI ≥30)
adults ≥18y of age diagnosed with cancer.
Interventions ........
Nutritional interventions under the supervision of a nutrition professional (e.g., dietician, nutritionist, or other licensed clinicians).
• Diet or nutrition therapy (via oral or enteral (e.g., nasogastric, gastrostomy, jejunostomy) feeding.
Æ Special diets (e.g., fasting (intermittent or short-term), calorie restriction, ketogenic, Mediterranean diet, high calorie, high protein).
Æ Supplements.
• Total parenteral therapy.
• Nutritional counseling.
• Combined nutritional interventions (e.g., nutritional counseling with nutrition therapy).
Nutritional Interventions intended for weight
loss (includes both PNIs and NIDTs).
Comparators ........
Standard of care vs
PNIs or PNIs vs
PNIs.
Standard of care vs PNIs or NIDTs, NIDTs
vs. NIDTs, PNIs vs. PNIs, PNIs vs NIDTs.
Outcomes ............
Intermediate Outcomes
BMI, Body composition, Weight (loss, gain).
PICOTS
Standard of care vs
NIDTs, NIDT vs
NIDT or PNIs vs.
NIDTs.
Final Outcomes.
Cancer treatment tolerance: treatment interruptions, reductions, or delays.
Hospital utilizations: ER visits, Admissions,
Length of stay.
Adverse events.
• Chemotherapy/radiation therapy limiting toxicity.
• Post-op complication.
• NI-related AEs.
• Unintended harms.
Survival.
Nutritional status.
Malnutrition (underweight, wasting, overweight).
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Standard of care vs PNIs or NIDTs, NIDTs
vs. NIDTs, PNIs vs. PNIs, PNIs vs NIDTs.
Fatigue, nausea and vomiting, appetite, physical/functional status (e.g., frailty).
Quality of life ...................................................
Fmt 4703
Sfmt 4703
E:\FR\FM\28OCN1.SGM
Intermediate Outcomes.
BMI, Body composition, Weight (loss, gain).
Final Outcomes.
Cancer treatment tolerance: treatment interruptions, reductions, or delays.
Hospital utilizations: ER visits.
Admissions, Length of stay.
Adverse events.
• Chemotherapy/radiation therapy limiting
toxicity.
• Post-op complication.
• NI-related AEs.
• Unintended harms.
Survival.
Nutritional Status.
Malnutrition (underweight, wasting, overweight).
28OCN1
59720
Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)—Continued
KQ1: pre-treatment
nutritional interventions
(PNIs)
PICOTS
KQ2: nutritional interventions during treatment (NIDTs)
KQ3: pre- or during treatment nutritional interventions (NIs) and patient-centered outcomes
KQ4: weight loss in overweight/obese adults
with cancer
Timing ..................
Nutritional interventions delivered pre- cancer treatment (KQ1, KQ3, KQ4) and during cancer treatment (KQ2, KQ3, KQ4).
Setting .................
Outpatient Oncology Care, Ambulatory Care, Cancer Treatment Centers, inpatient, home-based, hospice, telemedicine.
Abbreviations: KQ = key question; BMI = body mass index; ER = emergency room; PICOTS = population, intervention, comparator, outcomes, timing, setting; RCT
= randomized controlled trial; NRCT = non-randomized controlled trial.
Dated: October 22, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–23456 Filed 10–27–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Temporary Extension and Modification
of Framework for Conditional Sailing
Order (CSO) for Cruise Ships
Operating or Intending To Operate in
U.S. Waters
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), a
component of the Department of Health
and Human Services (HHS), announces
a temporary extension and modification
of the Framework for Conditional
Sailing Order (CSO).
DATES: This action is effective
November 1, 2021, at 12:01 a.m. EDT
upon the expiration of the current
Order.
FOR FURTHER INFORMATION CONTACT:
Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H16–4, Atlanta,
GA 30329. Phone: 404–498–1600.
Email: dgmqpolicyoffice@cdc.gov.
SUPPLEMENTARY INFORMATION: This
Order temporarily extends and modifies
the Framework for Conditional Sailing
Order (CSO). This Order only applies to
cruise ship operators in U.S.
jurisdictions where foreign-flagged
ships port or travel on international
itineraries and state and local health
departments do not routinely exercise
public health jurisdiction nor maintain
maritime public health programs that
conduct surveillance, inspections,
investigations, and management for
communicable diseases with potential
for significant morbidity and mortality
onboard foreign-flagged ships. These
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SUMMARY:
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17:34 Oct 27, 2021
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specific jurisdictions are listed below in
the Order.
This Order additionally applies to
foreign-flagged cruise ships operating
outside of U.S. waters if the cruise ship
operator intends for the ship to return
to operating in international, interstate,
or intrastate waterways, subject to the
jurisdiction of the United States during
the period that this Order is in effect.
As per the Preliminary Injunction
Order, entered by the U.S. District Court
for the Middle District of Florida on
June 18, 2021, as of July 23, 2021, the
CSO and accompanying measures, such
as technical instructions, are
nonbinding recommendations for cruise
ships arriving in, located within, or
departing from a port in Florida.
Accordingly, this Order shall not apply
to this subset of ships while this
Preliminary Injunction Order remains in
effect (or in the event the Preliminary
Injunction becomes permanent).
However, CDC will continue to operate
the CSO as a voluntary program for such
ships should they choose to follow the
CSO measures on a voluntary basis.
A copy of the Order is provided below
and a copy of the signed order can be
found at https://www.cdc.gov/
quarantine/cruise/.
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS) CENTERS
FOR DISEASE CONTROL AND
PREVENTION (CDC)
Order Under Sections 361 & 365 of the
Public Health Service Act (42 U.S.C.
264, 268) and 42 Code of Federal
Regulations Part 70 (Interstate) and
Part 71 (Foreign)
Temporary Extension & Modification of
Framework for Conditional Sailing
Order (CSO)
Executive Summary
The Centers for Disease Control and
Prevention is temporarily extending the
Framework for Conditional Sailing
Order (CSO) issued on October 30, 2020.
Since the issuance of the CSO, cruise
lines, with CDC assistance, have
resumed passenger operations and
successfully developed and
implemented health and safety
protocols to manage COVID–19 that
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have averted overwhelming onboard
medical facilities and burdening
shoreside hospital resources. However,
considering the continued spread of the
Delta variant, emergence of other
COVID–19 variants of concern,
breakthrough cases among the fully
vaccinated, and possible additional
surges of cases and deaths, CDC has
determined a temporary extension of the
CSO is necessary for foreign-flagged
cruise ships operating on international
itineraries. After the expiration of this
temporary extension, CDC intends to
transition to a voluntary program, in
coordination with interested cruise ship
operators and other stakeholders, to
assist the cruise ship industry to detect,
mitigate, and control the spread of
COVID–19 onboard cruise ships.
This Order shall remain in effect until
the earliest of (1) the expiration of the
Secretary of Health and Human
Services’ declaration that COVID–19
constitutes a public health emergency;
(2) the CDC Director rescinds or
modifies the Order based on specific
public health or other considerations; or
(3) January 15, 2022 at 12:01 a.m. (EST).
Previous Orders and Incorporation by
Reference
The findings and other evidence
relied upon in issuing the CSO are
incorporated herein by reference. Any
ambiguity between the October 30, 2020
Order, as further modified and extended
by the current Order, shall be resolved
in favor of the current Order.
Applicability
This temporary renewal and
modification of the CSO shall apply
only to the subset of carriers 1 described
below and hereinafter referred to as
‘‘cruise ships’’:
All commercial, non-cargo,2 foreignflagged,3 passenger-carrying vessels operating
1 Carrier is defined by 42 CFR 71.1 to mean, ‘‘a
ship, aircraft, train, road vehicle, or other means of
transport, including military.’’
2 Given the substantial risk of person-to-person
transmission of COVID–19, as opposed to
transmission via indirect contact, this Order is
currently limited to passenger, non-cargo vessels.
3 This Order modifies the CSO so that it is
applicable only to foreign-flagged vessels that per
46 U.S.C. 55103 may not travel between U.S. ports
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59718-59720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23456]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Nutrition as Prevention
for Improved Cancer Outcomes
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 Nutrition as
Prevention for Improved Cancer Outcomes, 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 29, 2021.
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: Jenae Benns, Telephone: 301-427-1496
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 Nutrition as
Prevention for Improved Cancer Outcomes. AHRQ is conducting this
technical brief 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 Nutrition as Prevention for Improved Cancer Outcomes,
including those that describe adverse events. The entire research
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/improved-cancer-outcomes/protocol.
This is to notify the public that the EPC Program would find the
following information on Nutrition as Prevention for Improved Cancer
Outcomes 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: In adults diagnosed with cancer who have or are at risk for
cancer-associated malnutrition, what is the effect of nutritional
interventions prior to cancer treatment in preventing negative
treatment outcomes such as effects on dose tolerance, hospital
utilizations, adverse events and survival?
a. Do the effects of nutritional interventions on preventing the
negative outcomes associated with cancer treatment vary by cancer type,
treatment type (chemotherapy, radiation, surgery) and stage of disease?
b. Do the effects of nutritional interventions vary across the
lifespan (e.g., adults aged >=65 years vs. <65 years)?
c. KQ1c: Compared to adults without muscle wasting, do nutritional
interventions prevent the negative outcomes associated with cancer
[[Page 59719]]
treatment in adults with muscle wasting?
d. KQ1d: Do the effects of nutritional interventions on preventing
the negative outcomes associated with cancer treatment vary across
special populations (e.g., individuals with multiple comorbid
conditions)?
KQ 2: In adults diagnosed with cancer who have or are at risk for
cancer-associated malnutrition, what is the effect of nutritional
interventions during cancer treatment in preventing negative treatment
outcomes such as effects on dose tolerance, hospital utilizations,
adverse events and survival?
a. Do the effects of nutritional interventions on preventing the
negative outcomes associated with cancer treatment vary by cancer type,
treatment type (chemotherapy, radiation, surgery) and stage of disease?
b. Do the effects of nutritional interventions vary across the
lifespan (e.g., adults aged >=65 years vs. <65 years)?
c. Compared to adults without muscle wasting, do nutritional
interventions prevent the negative outcomes associated with cancer
treatment in adults with muscle wasting?
d. Do the effects of nutritional interventions on preventing the
negative outcomes associated with cancer treatment vary across special
populations (e.g., individuals with multiple comorbid conditions)?
KQ 3: In adults diagnosed with cancer who have or are at risk for
cancer-associated malnutrition, what is the effect of nutritional
interventions prior to or during cancer treatment on associated
symptoms such as fatigue, nausea and vomiting, appetite, physical and
functional status (e.g., frailty), and quality of life?
a. Do the effects of nutritional interventions on symptoms
associated with cancer treatment vary by cancer type, treatment type
(chemotherapy, radiation, surgery) and stage of disease?
b. Do the effects of nutritional interventions vary across the
lifespan (e.g., adults aged >=65 years vs. <65 years)?
c. Compared to adults without muscle wasting, do nutritional
interventions differentially effect symptoms associated with cancer
treatment in adults with muscle wasting?
d. Do the effects of nutritional interventions on symptoms
associated with cancer treatment vary across special populations (e.g.,
individuals with multiple comorbid conditions)?
KQ 4: In adults with cancer who are overweight or obese, what is
the effect of nutritional interventions intended for weight loss prior
to or during cancer treatment in preventing negative treatment outcomes
such as effects on dose, hospital utilizations, adverse events and
survival?
Contextual Question (CQ)
CQ 1: What evidence is available on the cost-effectiveness of
nutritional interventions for preventing negative outcomes associated
with cancer treatment?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
----------------------------------------------------------------------------------------------------------------
KQ3: pre- or during
KQ1: pre-treatment KQ2: nutritional treatment nutritional KQ4: weight loss in
PICOTS nutritional interventions interventions (NIs) and overweight/obese adults
interventions during treatment patient-centered with cancer
(PNIs) (NIDTs) outcomes
----------------------------------------------------------------------------------------------------------------
Population............ Adults diagnosed with cancer at or after age 18 who have or are Overweight (BMI 25-<30)/
at risk for cancer-associated malnutrition. obese (BMI >=30)
Subgroups: adults >=18y of age
Cancer and treatment characteristics (cancer type, diagnosed with cancer.
treatment type (systemic therapy, radiation, surgery), stage
of disease).
Adults >=65y vs younger.
Muscle wasting (e.g., sarcopenia, cachexia, pre-
cachexia) vs. no muscle wasting.
Special populations (individuals with multiple co-
morbid conditions).
----------------------------------------------------------------------------------------------------------------
Interventions......... Nutritional interventions under the supervision of a nutrition Nutritional
professional (e.g., dietician, nutritionist, or other licensed Interventions intended
clinicians). for weight loss
(includes both PNIs
and NIDTs).
Diet or nutrition therapy (via oral or enteral (e.g.,
nasogastric, gastrostomy, jejunostomy) feeding.
[cir] Special diets (e.g., fasting (intermittent or short-
term), calorie restriction, ketogenic, Mediterranean diet,
high calorie, high protein).
[cir] Supplements.
Total parenteral therapy.
Nutritional counseling.
Combined nutritional interventions (e.g., nutritional
counseling with nutrition therapy).
----------------------------------------------------------------------------------------------------------------
Comparators........... Standard of care Standard of care Standard of care vs Standard of care vs
vs PNIs or PNIs vs NIDTs, NIDT vs PNIs or NIDTs, NIDTs PNIs or NIDTs, NIDTs
vs PNIs. NIDT or PNIs vs. vs. NIDTs, PNIs vs. vs. NIDTs, PNIs vs.
NIDTs. PNIs, PNIs vs NIDTs. PNIs, PNIs vs NIDTs.
----------------------------------------------------------------------------------------------------------------
Outcomes.............. Intermediate Outcomes Intermediate Outcomes.
BMI, Body composition, Weight (loss, Fatigue, nausea and BMI, Body composition,
gain). vomiting, appetite, Weight (loss, gain).
physical/functional
status (e.g., frailty).
Final Outcomes. Final Outcomes.
Cancer treatment tolerance: treatment Quality of life........ Cancer treatment
interruptions, reductions, or delays. tolerance: treatment
interruptions,
reductions, or delays.
Hospital utilizations: ER visits, Hospital utilizations:
Admissions, Length of stay. ER visits.
Admissions, Length of
stay.
Adverse events. Adverse events.
Chemotherapy/radiation Chemotherapy/
therapy limiting toxicity. radiation therapy
limiting toxicity.
Post-op complication. Post-op
complication.
NI-related AEs. NI-related
AEs.
Unintended harms. Unintended
harms.
Survival. Survival.
Nutritional status. Nutritional Status.
Malnutrition (underweight, wasting, Malnutrition
overweight). (underweight, wasting,
overweight).
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[[Page 59720]]
Timing................ Nutritional interventions delivered pre- cancer treatment (KQ1, KQ3, KQ4) and during
cancer treatment (KQ2, KQ3, KQ4).
----------------------------------------------------------------------------------------------------------------
Setting............... Outpatient Oncology Care, Ambulatory Care, Cancer Treatment Centers, inpatient, home-
based, hospice, telemedicine.
----------------------------------------------------------------------------------------------------------------
Abbreviations: KQ = key question; BMI = body mass index; ER = emergency room; PICOTS = population, intervention,
comparator, outcomes, timing, setting; RCT = randomized controlled trial; NRCT = non-randomized controlled
trial.
Dated: October 22, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-23456 Filed 10-27-21; 8:45 am]
BILLING CODE 4160-90-P
