Supplemental Evidence and Data Request on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, 12605-12610 [2017-04193]
Download as PDF
<![CDATA[
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
identification number or foreign country
equivalent, passport number, financial
account number, or credit or debit card
number. You are also solely responsible
for making sure that your comment does
not include any sensitive health
information, like medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which is . . .
privileged or confidential’’ as provided
in Section 6(f) of the FTC Act 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c).16 Your
comment will be kept confidential only
if the FTC General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
is posted, as legally required by FTC
Rule 4.9(b), we cannot redact or remove
your comment from the FTC’s public
record, including the FTC’s Web site,
unless you submit a confidentiality
request that meets the requirements for
such treatment under FTC Rule 4.9(c),
and the General Counsel grants that
request in accordance with the law and
the public interest, as explained above.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
funeralrulepra, by following the
instructions on the web-based form. If
this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Funeral Rule PRA Comment:
FTC File No. P084401’’ on your
comment and on the envelope, and mail
your comment to the following address:
Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue
NW., Suite CC–5610 (Annex J),
Washington, DC 20580, or deliver your
16 In particular, the written request for
confidential treatment that accompanies the
comment must include the factual and legal basis
for the request, and must identify the specific
portions of the comment to be withheld from the
public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
comment to the following address:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW., 5th Floor, Suite 5610
(Annex J), Washington, DC 20024. If
possible, submit your paper comment to
the Commission by courier or overnight
service.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before May 5, 2017. For information on
the Commission’s privacy policy,
including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/ftc/
privacy.htm.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2017–04289 Filed 3–3–17; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Effects of Dietary Sodium
and Potassium Intake on Chronic
Disease Outcomes and Related Risk
Factors
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 of
Effects of Dietary Sodium and
Potassium Intake on Chronic Disease
Outcomes and Related Risk Factors,
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. AHRQ is
conducting this systematic review
pursuant to Section 902(a) of the Public
Health Service Act, 42 U.S.C. 299a(a).
DATES: Submission Deadline on or
before April 5, 2017.
ADDRESSES: Email submissions:
SEADS@epc-src.org.
Print submissions: Mailing Address:
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
12605
Coordinator, P.O. Box 69539, Portland,
OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503–220–
8262 ext. 51723 or Email: SEADS@epcsrc.org.
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 Effects of Dietary Sodium
and Potassium Intake on Chronic
Disease Outcomes and Related Risk
Factors.
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 Effects of Dietary Sodium
and Potassium Intake on Chronic
Disease Outcomes and Related Risk
Factors, including those that describe
adverse events. The entire research
protocol, including the key questions, is
also available online at: https://
www.effectivehealthcare.AHRQ.gov/
index.cfm/search-for-guides-reviewsand-reports/?pageaction=display
product&productid=2428.
This is to notify the public that the
EPC Program would find the following
information on Effects of Dietary
Sodium and Potassium Intake on
Chronic Disease Outcomes and Related
Risk Factors 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,
please provide 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,
and analyzed; as well as effectiveness
and efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
E:\FR\FM\06MRN1.SGM
06MRN1
12606
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
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 will be very
beneficial to the EPC Program. The
contents of all submissions will be made
available to the public upon request.
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 Web site 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.effective
healthcare.ahrq.gov/index.cfm/join-theemail-list1/.
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.
The Key Questions
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Sodium
1. Among adults and children of all
age groups (including both sexes and
pregnant and lactating women), what is
the effect (benefits and harms) of
interventions to reduce dietary sodium
intake on blood pressure at the time of
the study and in later life?
I. Do other minerals (e.g., potassium,
calcium, magnesium) modify the effect
of sodium?
II. Among subpopulations defined by
sex, race/ethnicity, age (children,
adolescents, young adults, older adults,
elderly), and for women (pregnancy and
lactation).
III. Among subpopulations defined by
hypertension, diabetes, and obesity
health status.
2. Among adults and children, what is
the association between dietary sodium
intake and blood pressure?
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
I. Among subpopulations defined by
sex, race/ethnicity and age (children,
adolescents, young adults, older adults,
elderly).
II. Among subpopulations defined by
hypertension, diabetes, and obesity
health status.
3. Among adults, what is the effect
(benefits and harms) of interventions to
reduce dietary sodium intake on
cardiovascular disease (CVD) and
kidney disease morbidity and mortality
and on total mortality?
I. Do other minerals (e.g., potassium,
calcium, magnesium) modify the effect
of sodium?
II. Among subpopulations defined by
sex, race/ethnicity, age (adults, older
adults, elderly), and for women
(pregnancy and lactation).
III. Among subpopulations defined by
hypertension, diabetes, obesity and
renal health status.
4. Among adults, what is the
association between dietary sodium
intake and CVD, coronary heart disease
(CHD), stroke and kidney disease
morbidity and mortality and between
dietary sodium intake and total
mortality?
I. Do other minerals (e.g., potassium,
calcium, magnesium) modify the
association with sodium?
II. Among subpopulations defined by
sex, race/ethnicity, age (adults, older
adults, elderly), and for women
(pregnancy and lactation).
III. Among subpopulations defined by
hypertension, diabetes, obesity and
renal health status.
Potassium
5. Among children and adults, what is
the effect of interventions to increase
potassium intake on blood pressure and
kidney stone formation?
I. Do other minerals (e.g., sodium,
calcium, magnesium) modify the effect
of potassium?
II. Among subpopulations defined by
sex, race/ethnicity, age (children,
adolescents, young adults, older adults,
elderly), and for women (pregnancy and
lactation).
III. Among subpopulations defined by
hypertension, diabetes, obesity and
renal health status.
6. Among children and adults, what is
the association between potassium
intake and blood pressure and kidney
stone formation?
I. Among subpopulations defined by
sex, race/ethnicity, and age (children,
adolescents, young adults, older adults,
elderly).
II. Among subpopulations defined by
hypertension, diabetes, and obesity
health status.
7. Among adults, what is the effect of
interventions aimed at increasing
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
potassium intake on CVD, and kidney
disease morbidity and mortality, and
total mortality?
I. Do other minerals modify the effect
of potassium (e.g., sodium, calcium,
magnesium)?
II. Among subpopulations defined by
sex, race/ethnicity, age (young adults,
older adults, elderly), and for women
(pregnancy and lactation).
III. Among subpopulations defined by
hypertension, diabetes, obesity and
renal health status.
8. Among adults, what is the
association between dietary potassium
intake and CVD, CHD, stroke and
kidney disease morbidity and mortality
and between dietary potassium and total
mortality?
I. Do other minerals (e.g., sodium,
calcium, magnesium) modify the
association with potassium?
II. Among subpopulations defined by
sex, race/ethnicity, age (young adults,
older adults, elderly), and for women
(pregnancy and lactation).
III. Among subpopulations defined by
hypertension, diabetes, and obesity
health status.
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Key Question 1
I. Population
A. Studies in human participants will
be eligible for inclusion in the review,
with the exception of studies
exclusively reporting on patients with
end stage renal disease, heart failure,
HIV, or cancer.
II. Interventions
A. Studies evaluating interventions to
reduce dietary sodium intake that
specify the oral consumption from food
or supplements of quantified amounts of
sodium and sodium chloride (salt) or
sodium-to-potassium ratio will be
eligible, with the exception of trial arms
in which participants demonstrate a
weight change of +/¥ 3% or more.
Interventions simultaneously addressing
sodium and potassium intake that
document sodium/potassium ratio are
eligible; all other multicomponent
interventions in which the effect of
sodium reduction cannot be
disaggregated from other intervention
components will be excluded.
III. Comparators
A. Studies comparing interventions to
placebo or control diets will be eligible.
Studies comparing an experimental diet
to usual diet, studies comparing levels
of sodium intake, or studies that alter
sodium/potassium ratio in other ways
E:\FR\FM\06MRN1.SGM
06MRN1
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
will be included if they control for other
nutrient levels.
without reported prediction equation
will be excluded.
intervention components will be
excluded.
IV. Outcomes
A. Studies reporting on blood
pressure outcomes (e.g., systolic blood
pressure, diastolic blood pressure, rate
of hypertensive/non-hypertensive
participants, incident hypertension,
percent of participants at blood pressure
goal, and change in blood pressure) will
be eligible.
III. Comparator
A. Studies comparing groups with
different documented sodium intake or
biomarker values for sodium will be
eligible. Studies where differences in
sodium intake or values are confounded
with alteration of other nutrient levels
will be excluded.
III. Comparators
V. Timing
A. Studies reporting on an
intervention period of at least four
weeks will be eligible.
VI. Setting
A. Studies in outpatient settings will
be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs
with a washout period of two weeks or
more will be eligible.
Key Question 2
I. Population
A. Studies in community-dwelling
(non-institutionalized) human
participants will be eligible for
inclusion in the review with the
exception of studies exclusively
reporting on patients with pre-existing
conditions specific to the clinical
outcome of interest, as well as studies
exclusively reporting on patients with
end stage renal disease, heart failure,
HIV, or cancer.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
12607
II. Exposure
A. Studies that measure the intake
(oral consumption from food or
supplements of quantified amounts of
sodium and sodium chloride [salt] or
sodium-to-potassium ratio) with
validated measures or that use
biomarker values to assess sodium level
(at least one 24-hour urinary analysis
with or without reported quality control
measure, chemical analysis of diet with
intervention/exposure adherence
measure, composition of salt substitute
with intervention/exposure adherence
measure, and food diaries with reported
validation [adherence check, electronic
prompts]) will be eligible. Observational
studies that report a weight change of
+/¥ 3% or more (in any exposure
group) among adults; multicomponent
studies that do not properly control for
confounders; and studies relying only
on serum sodium levels, composition of
salt substitute without intervention/
exposure adherence measure, food
diaries without reported validation, use
of a published food frequency
questionnaire, or partial or spot urine
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
IV. Outcomes
A. Studies reporting on blood
pressure outcomes (e.g., systolic blood
pressure, diastolic blood pressure, rate
of hypertensive/non-hypertensive
participants, incident hypertension,
percent of participants at blood pressure
goal, change in blood pressure) will be
eligible. Studies that do not report
baseline blood pressure status will be
excluded.
V. Timing
A. Studies reporting on an
intervention period of at least four
weeks will be eligible.
VI. Setting
A. Studies in community-dwelling
participants will be eligible.
VII. Study Design
A. Prospective cohort studies and
nested case-control studies, where at
least two groups are compared based on
measured sodium intake or biomarker
values will be eligible. Retrospective
studies, case series, cross-sectional
studies or surveys, and case reports will
be excluded.
Key Question 3
I. Population
A. Studies in human adults will be
eligible for inclusion in the review.
Studies exclusively reporting on
patients with end stage renal disease,
heart failure, HIV, or cancer will be
excluded.
II. Intervention
A. Studies evaluating interventions to
reduce dietary sodium intake that
specify the oral consumption from food
or supplements of quantified amounts of
sodium and sodium chloride (salt) or
sodium-to-potassium ratio will be
eligible. Studies with trial arms in
which participants demonstrate a
weight change of +/¥ 3% or more will
be excluded. Interventions
simultaneously addressing sodium and
potassium intake with documents
sodium/potassium ratio are eligible. All
other multicomponent interventions in
which the effect of sodium reduction
cannot be disaggregated from other
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
A. Studies comparing interventions to
placebo or control diets will be eligible.
Studies comparing an experimental diet
to usual diet, studies comparing levels
of sodium intake, or studies that alter
sodium/potassium ratio in other ways
will be included if they control for other
nutrient levels.
IV. Outcomes
A. Studies reporting on mortality (allcause, CVD, CHD, or renal);
cardiovascular disease morbidity,
including acute coronary syndrome
(unstable angina and myocardial
infarction), stroke, myocardial infarction
(ST-segment elevation myocardial
infarction [STEMI] and non-ST
elevation myocardial infarction
[NSTEMI]), requiring coronary
revascularization procedures
(angioplasty, coronary stent placement,
coronary artery bypass), other
atherosclerotic revascularization
procedures (carotid endarterectomy),
left ventricular hypertrophy,
hospitalization for heart failure,
hospitalization for any cause of
coronary heart disease or cardiovascular
disease, or combined CVD morbidity
and mortality; or reporting on renal
function intermediary and clinical
outcomes including creatinine clearance
(CrCl), serum creatinine (SCr),
glomerular filtration rate (GFR), end
stage renal disease, chronic kidney
disease (CKD), albuminuria or
proteinuria (including urine albumin-tocreatinine ratio, urine albumin dipstick
level, urine protein-to-creatinine ratio,
albumin excretion rate), kidney stone
incidence, or acute kidney injury will be
eligible.
V. Timing
A. Only interventions of two years or
longer will be included for kidney
disease outcomes; only interventions of
three months or longer will be included
for cardiovascular disease outcomes; all
other studies need to report on an
intervention period of at least four
weeks to be eligible.
VI. Setting
A. Studies in outpatient settings will
be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs
with a washout period of two weeks or
more will be eligible.
E:\FR\FM\06MRN1.SGM
06MRN1
12608
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
Key Question 4
I. Population
A. Studies in community-dwelling
(non-institutionalized) adults will be
eligible for inclusion in the review with
the exception of studies exclusively
reporting on patients with pre-existing
conditions specific to the clinical
outcomes of interest, as well as studies
exclusively reporting on patients with
end stage renal disease, heart failure,
HIV, or cancer.
II. Exposure
A. Studies that measure the intake
(oral consumption from food or
supplements of quantified amounts of
sodium and sodium chloride [salt] or
sodium-to-potassium ratio) with
validated measures or use biomarker
values to assess sodium level (at least
one 24-hour urinary analysis with or
without reported quality control
measure, chemical analysis of diet with
intervention/exposure adherence
measure, composition of salt substitute
with intervention/exposure adherence
measure, and food diaries with reported
validation [adherence check, electronic
prompts]) will be eligible. Observational
studies that report a weight change of
+/¥ 3% or more (in any exposure
group) among adults; multicomponent
studies that do not properly control for
confounders; and studies relying only
on serum sodium levels, composition of
salt substitute without intervention/
exposure adherence measure, food
diaries without reported validation, use
of a published food frequency
questionnaire, or partial or spot urine
without reported prediction equation
will be excluded.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
III. Comparator
A. Studies comparing groups with
different documented sodium intake or
biomarker values for sodium will be
eligible. Studies where differences in
sodium intake or values are confounded
with alteration of other nutrient levels
will be excluded.
IV. Outcomes
A. Studies reporting on mortality (allcause, CVD, CHD, or renal);
cardiovascular mortality; cardiovascular
disease morbidity, including coronary
heart disease (CHD), acute coronary
syndrome (unstable angina and
myocardial infarction), stroke,
myocardial infarction (ST-segment
elevation myocardial infarction [STEMI]
and non-ST elevation myocardial
infarction [NSTEMI]), requiring
coronary revascularization procedures
(angioplasty, coronary stent placement,
coronary artery bypass), other
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
atherosclerotic revascularization
procedures (carotid endarterectomy),
left ventricular hypertrophy,
hospitalization for heart failure, or
hospitalization for any cause of
coronary heart disease or cardiovascular
disease, or combined CVD morbidity
and mortality; or reporting on renal
function intermediary and clinical
outcomes including creatinine clearance
(CrCl), serum creatinine (SCr),
glomerular filtration rate (GFR), end
stage renal disease, chronic kidney
disease (CKD), albuminuria/proteinuria
(including, urine albumin-to-creatinine
ratio, urine albumin dipstick level,
urine protein-to-creatinine ratio,
albumin excretion rate), acute kidney
injury will be eligible. Studies that do
not report baseline data for the
outcomes of interest will be excluded.
V. Timing
A. Studies reporting exclusively on
kidney disease outcomes need to report
follow up periods of at least two years,
studies reporting exclusively on
cardiovascular disease outcomes or
stroke need to report on follow up
periods of at least 12 months duration;
studies reporting on other outcomes
need to evaluate exposure lasting at
least four weeks to be eligible.
VI. Setting
A. Studies in community-dwelling
participants will be eligible.
VII. Study Design
A. Prospective cohort studies and
nested case-control studies, where at
least two groups are compared based on
measured sodium intake or biomarker
values will be eligible. Retrospective
studies, case series, cross-sectional
studies or surveys, and case reports will
be excluded.
Key Question 5
I. Population
A. Studies in human participants will
be eligible for inclusion in the review;
studies exclusively reporting on patients
with end stage renal disease, heart
failure, HIV, or cancer will be excluded.
II. Interventions
A. Studies evaluating interventions to
increase dietary potassium intake that
specify the oral consumption from food
or supplements of quantified amounts of
potassium, potassium supplements, salt
substitutes such as potassium chloride,
or sodium-to-potassium ratio will be
eligible, with the exception of trial arms
in which participants demonstrate a
weight change of +/¥ 3% or more
among adults. Interventions
simultaneously addressing sodium and
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
potassium intake with documents
sodium/potassium ratio are eligible; all
other multicomponent interventions in
which the effect of sodium reduction
cannot be disaggregated from other
intervention components will be
excluded.
III. Comparators
A. Studies comparing interventions to
placebo or control diets will be eligible.
Studies comparing an experimental diet
to usual diet, studies comparing levels
of potassium intake, or studies that alter
sodium/potassium ratio in other ways
will be included if they control for other
nutrient levels.
IV. Outcomes
A. Studies reporting on blood
pressure outcomes (e.g., systolic blood
pressure, diastolic blood pressure, rate
of hypertensive/non-hypertensive
participants, hypertension incidence,
percent of participants at blood pressure
goal, change in blood pressure) and
incident kidney stones or kidney stone
regrowth will be eligible.
V. Timing
A. Studies reporting exclusively on
kidney stone formation need to report
on an intervention period of two years;
all other studies need to report on an
intervention period of at least four
weeks to be eligible.
VI. Setting
A. Studies in outpatient settings will
be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs
with a washout period of two weeks or
more will be eligible.
Key Question 6
I. Population
A. Studies in community-dwelling
(non-institutionalized) human
participants will be eligible for
inclusion in the review; studies
reporting exclusively on patients with
pre-existing conditions specific to the
clinical outcomes of interest, as well as
studies exclusively reporting on patients
with end stage renal disease, heart
failure, HIV, or cancer will be excluded.
II. Exposure
A. Studies that measure intake (oral
consumption from food or supplements
of quantified amounts of potassium,
potassium supplements, salt substitutes
such as potassium chloride, or sodiumto-potassium ratio) with validated
measures or use biomarkers values to
assess potassium level (at least one 24hour urinary analysis with or without
E:\FR\FM\06MRN1.SGM
06MRN1
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
reported quality control measure,
chemical analysis of diet with
intervention/exposure adherence
measure, composition of potassium
supplement with intervention/exposure
adherence measure, use of a published
food frequency questionnaire, and food
diaries) will be eligible. Observational
studies that report a weight change of
+/¥ 3% or more (in any exposure
group) among adults; multicomponent
studies that do not properly control for
confounders; and studies measuring
potassium intake by reporting chemical
analysis of diet without intervention/
exposure adherence measures,
composition of potassium supplement
without intervention/exposure measure,
or serum potassium will be excluded.
III. Comparator
A. Studies comparing groups with
different documented potassium intake,
serum potassium levels, or urinary
potassium excretion will be eligible.
Studies where differences in potassium
intake or values are confounded with
alteration of other nutrient levels will be
excluded.
IV. Outcomes
A. Studies reporting on blood
pressure outcomes (e.g., systolic blood
pressure, diastolic blood pressure, rate
of hypertensive/non-hypertensive
participants, hypertension incidence,
percent of participants at blood pressure
goal, change in blood pressure), and
kidney stone incident or kidney stone
regrowth will be eligible. Studies that
do not report baseline blood pressure
status and the presence or absence of
kidney stones will be excluded.
V. Timing
A. Studies exclusively reporting on
kidney stone formation need to follow
participants for at least five years; all
other studies need to report on exposure
of at least four weeks to be eligible.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
VI. Setting
A. Studies in community-dwelling
participants will be eligible.
VII. Study Design
A. Prospective cohort studies and
nested case-control studies, where at
least two groups are compared based on
measured potassium intake or
biomarker values will be eligible.
Retrospective studies, case series, crosssectional studies or surveys, and case
reports will be excluded.
Key Question 7
I. Population
A. Studies in adults will be eligible
for inclusion in the review; studies
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
reporting exclusively on patients with
heart failure, end stage renal disease,
HIV, or cancer will be excluded.
II. Interventions
A. Studies evaluating interventions to
increase dietary potassium intake that
specify the oral consumption from food
or supplements of quantified amounts of
potassium, potassium supplements, salt
substitutes such as potassium chloride,
or sodium-to-potassium ratio will be
eligible, with the exception of trial arms
in which participants demonstrate a
weight change of +/¥ 3% or more.
Interventions simultaneously addressing
sodium and potassium intake with
documents sodium/potassium ratio are
eligible; all other multicomponent
interventions in which the effect of
sodium reduction cannot be
disaggregated from other intervention
components will be excluded.
III. Comparators
A. Studies comparing interventions to
placebo or control diets will be eligible.
Studies comparing an experimental diet
to usual diet, studies comparing levels
of potassium intake, or studies that alter
sodium/potassium ratio in other ways
will be included if they control for other
nutrient levels.
IV. Outcomes
A. Studies reporting on mortality (allcause, CVD, CHD, or renal);
cardiovascular disease morbidity,
including acute coronary syndrome
(unstable angina and myocardial
infarction), stroke, myocardial infarction
(ST-segment elevation myocardial
infarction [STEMI] and non-ST
elevation myocardial infarction
[NSTEMI]), requiring coronary
revascularization procedures
(angioplasty, coronary stent placement,
coronary artery bypass), other
atherosclerotic revascularization
procedures (carotid endarterectomy),
left ventricular hypertrophy,
hospitalization for heart failure, or
hospitalization for any cause of
coronary heart disease or cardiovascular
disease, or combined CVD morbidity
and mortality; or reporting on renal
function intermediary and clinical
outcomes including creatinine clearance
(CrCl), serum creatinine (SCr),
glomerular filtration rate (GFR), end
stage renal disease, chronic kidney
disease (CKD), albuminuria or
proteinuria (including urine albumin-tocreatinine ratio, urine albumin dipstick
level, urine protein-to-creatinine ratio,
albumin excretion rate), kidney stone
incidence, or acute kidney injury will be
eligible.
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
12609
V. Timing
A. Studies reporting exclusively on
kidney disease outcomes need to report
on an intervention period of two years,
studies reporting on cardiovascular
disease or stroke need to report on an
intervention period of three months; all
other studies need to report on an
intervention period of at least four
weeks to be eligible.
VI. Setting
A. Studies in outpatient settings will
be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs
with a washout period of two weeks or
more will be eligible.
Key Question 8
I. Population
A. Studies in community-dwelling
(non-institutionalized) adults will be
eligible for inclusion in the review with
the exception of studies exclusively
reporting on patients with pre-existing
conditions specific to the clinical
outcomes of interest, as well as studies
exclusively reporting on patients with
end stage renal disease, heart failure,
HIV, or cancer.
II. Exposure
A. Studies that measure intake (oral
consumption from food or supplements
of quantified amounts of potassium,
potassium supplements, salt substitutes
such as potassium chloride, or sodiumto-potassium ratio) with validated
measures or use biomarkers values to
assess potassium level (at least one 24hour urinary analysis with or without
reported quality control measure,
chemical analysis of diet with
intervention/exposure adherence
measure, composition of potassium
supplement with intervention/exposure
adherence measure, use of a published
food frequency questionnaire, and food
diaries) will be eligible. Observational
studies that report a weight change of
+/¥ 3% or more (in any exposure
group) among adults; multicomponent
studies that do not properly control for
confounders; and studies measuring
potassium intake by reporting chemical
analysis of diet without intervention/
exposure adherence measures,
composition of potassium supplement
without intervention/exposure measure,
or serum potassium will be excluded.
III. Comparator
A. Studies comparing groups with
different documented potassium intake,
serum potassium levels, or urinary
potassium excretion will be eligible.
E:\FR\FM\06MRN1.SGM
06MRN1
12610
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
Studies where differences in potassium
intake or values are confounded with
alteration of other nutrient levels will be
excluded.
IV. Outcomes
V. Timing
A. Studies reporting exclusively on
kidney stone formation need to follow
participants for at least five years,
studies reporting exclusively on kidney
disease need to follow participants for at
least two years, studies reporting
exclusively on cardiovascular disease or
stroke need to follow patients for at least
12 months; all other studies need to
report on an exposure period of at least
four weeks to be eligible.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
VI. Setting
A. Studies in community-dwelling
participants will be eligible.
VII. Study Design
A. Prospective cohort studies and
nested case-control studies, where at
least two groups are compared based on
measured potassium intake or
biomarker values will be eligible.
Retrospective studies, case series, cross-
19:24 Mar 03, 2017
Sharon B. Arnold,
Acting AHRQ Director.
[FR Doc. 2017–04193 Filed 3–3–17; 8:45 am]
A. Studies reporting on mortality (allcause, CVD, CHD, or renal);
cardiovascular disease morbidity,
including coronary heart disease (CHD),
acute coronary syndrome (unstable
angina and myocardial infarction),
stroke, myocardial infarction (STsegment elevation myocardial infarction
[STEMI] and non-ST elevation
myocardial infarction [NSTEMI]),
requiring coronary revascularization
procedures (angioplasty, coronary stent
placement, coronary artery bypass),
other atherosclerotic revascularization
procedures (carotid endarterectomy),
left ventricular hypertrophy,
hospitalization for heart failure, or
hospitalization for any cause of
coronary heart disease or cardiovascular
disease, or combined CVD morbidity
and mortality; or reporting on renal
function intermediary and clinical
outcomes including creatinine clearance
(CrCl), serum creatinine (SCr),
glomerular filtration rate (GFR), end
stage renal disease, chronic kidney
disease (CKD), albuminuria/proteinuria
(including urine albumin-to-creatinine
ratio, urine albumin dipstick level,
urine protein-to-creatinine ratio,
albumin excretion rate), kidney stone
incidence, or acute kidney injury will be
eligible. Studies that do not report
baseline data on the outcomes of
interest will be excluded.
VerDate Sep<11>2014
sectional studies or surveys, and case
reports will be excluded.
Jkt 241001
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and
Developmental Disabilities, President’s
Committee for People With Intellectual
Disabilities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
Thursday, March 23, 2017 from
8:30 a.m. to 5:00 p.m.; and Friday,
March 24, 2017 from 9:00 a.m. to 3:00
p.m.
These meetings will be open to the
general public.
ADDRESSES: These meetings will be held
in U.S. Department of Health and
Human Services/Hubert H. Humphrey
Building located at 200
IndependenceAvenue SW., Conference
Room 705A, Washington, DC 20201.
Individuals who would like to
participate via conference call may do
so by dialing toll-free #: 1–800–779–
4694, when prompted enter pass code:
4511687. Individuals whose full
participation in the meeting will require
special accommodations (e.g., sign
language interpreting services, assistive
listening devices, materials in
alternative format such as large print or
Braille) should notify Ms. Allison Cruz,
Director, Office of Innovation, via email
at Allison.Cruz@acl.hhs.gov, or via
telephone at 202–795–7334, no later
than Monday, March 6, 2017. The
PCPID will attempt to accommodate
requests made after this date, but cannot
guarantee the ability to grant requests
received after the deadline. All meeting
sites are barrier free, consistent with the
Americans with Disabilities Act (ADA)
and the Federal Advisory Committee
Act (FACA).
AGENDA: The Committee Members will
discuss preparation of the PCPID 2017
Report to the President, including its
content and format, and related data
collection and analysis required to
complete the writing of the Report.
ADDITIONAL INFORMATION: For further
information, please contact Ms. Allison
Cruz, Director, Office of Innovation, 330
C Street SW., Switzer Building, Room
1114, Washington, DC 20201.
DATES:
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Telephone: 202–795–7334. Fax: 202–
795–7334. Email: Allison.Cruz@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: The
PCPID acts in an advisory capacity to
the President and the Secretary of
Health and Human Services on a broad
range of topics relating to programs,
services and support for individuals
with intellectual disabilities. The PCPID
executive order stipulates that the
Committee shall: (1) Provide such
advice concerning intellectual
disabilities as the President or the
Secretary of Health and Human Services
may request; and (2) provide advice to
the President concerning the following
for people with intellectual disabilities:
(A) Expansion of educational
opportunities; (B) promotion of
homeownership; (C) assurance of
workplace integration; (D) improvement
of transportation options; (E) expansion
of full access to community living; and
(F) increasing access to assistive and
universally designed technologies.
Dated: February 27, 2017.
Bob Williams,
Acting Designated Federal Official, PCPID,
Administration on Disabilities (AoD).
[FR Doc. 2017–04165 Filed 3–3–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; Extension of a
Currently Approved Information
Collection (ICR–REV); Centers for
Independent Living Annual
Performance Report (CILPPR);
Correction
Independent Living
Administration, Administration for
Community Living, HHS.
ACTION: Notice of correction.
AGENCY:
The Administration for
Community Living published a
proposed collection of information
document in the Federal Register on
February 23, 2017. (82 FR 11471 and
11472) The document contained an
incorrect date and email address. In
addition under the heading ‘‘New
Requirements’’, the first paragraph was
revised.
FOR FURTHER INFORMATION CONTACT:
Corinna Styles, 202–795–7446.
Corrections:
Under the DATES section, page 11471,
column two, correct the notice to read:
‘‘Submit written or electronic comments
SUMMARY:
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12605-12610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04193]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Effects of Dietary
Sodium and Potassium Intake on Chronic Disease Outcomes and Related
Risk Factors
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 of Effects of
Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and
Related Risk Factors, 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. AHRQ is conducting this systematic review pursuant to
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
DATES: Submission Deadline on or before April 5, 2017.
ADDRESSES: Email submissions: src.org">SEADS@epc-src.org.
Print submissions: Mailing Address: Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, P.O. Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 51723 or Email: src.org">SEADS@epc-src.org.
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 Effects of Dietary
Sodium and Potassium Intake on Chronic Disease Outcomes and Related
Risk Factors.
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 Effects of Dietary Sodium and Potassium Intake on
Chronic Disease Outcomes and Related Risk Factors, including those that
describe adverse events. The entire research protocol, including the
key questions, is also available online at: https://www.effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2428.
This is to notify the public that the EPC Program would find the
following information on Effects of Dietary Sodium and Potassium Intake
on Chronic Disease Outcomes and Related Risk Factors 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, please provide 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, and analyzed; as well as effectiveness and efficacy, and
safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this
[[Page 12606]]
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 will be very beneficial to the EPC Program. The
contents of all submissions will be made available to the public upon
request. 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 Web
site 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/index.cfm/join-the-email-list1/.
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.
The Key Questions
Sodium
1. Among adults and children of all age groups (including both
sexes and pregnant and lactating women), what is the effect (benefits
and harms) of interventions to reduce dietary sodium intake on blood
pressure at the time of the study and in later life?
I. Do other minerals (e.g., potassium, calcium, magnesium) modify
the effect of sodium?
II. Among subpopulations defined by sex, race/ethnicity, age
(children, adolescents, young adults, older adults, elderly), and for
women (pregnancy and lactation).
III. Among subpopulations defined by hypertension, diabetes, and
obesity health status.
2. Among adults and children, what is the association between
dietary sodium intake and blood pressure?
I. Among subpopulations defined by sex, race/ethnicity and age
(children, adolescents, young adults, older adults, elderly).
II. Among subpopulations defined by hypertension, diabetes, and
obesity health status.
3. Among adults, what is the effect (benefits and harms) of
interventions to reduce dietary sodium intake on cardiovascular disease
(CVD) and kidney disease morbidity and mortality and on total
mortality?
I. Do other minerals (e.g., potassium, calcium, magnesium) modify
the effect of sodium?
II. Among subpopulations defined by sex, race/ethnicity, age
(adults, older adults, elderly), and for women (pregnancy and
lactation).
III. Among subpopulations defined by hypertension, diabetes,
obesity and renal health status.
4. Among adults, what is the association between dietary sodium
intake and CVD, coronary heart disease (CHD), stroke and kidney disease
morbidity and mortality and between dietary sodium intake and total
mortality?
I. Do other minerals (e.g., potassium, calcium, magnesium) modify
the association with sodium?
II. Among subpopulations defined by sex, race/ethnicity, age
(adults, older adults, elderly), and for women (pregnancy and
lactation).
III. Among subpopulations defined by hypertension, diabetes,
obesity and renal health status.
Potassium
5. Among children and adults, what is the effect of interventions
to increase potassium intake on blood pressure and kidney stone
formation?
I. Do other minerals (e.g., sodium, calcium, magnesium) modify the
effect of potassium?
II. Among subpopulations defined by sex, race/ethnicity, age
(children, adolescents, young adults, older adults, elderly), and for
women (pregnancy and lactation).
III. Among subpopulations defined by hypertension, diabetes,
obesity and renal health status.
6. Among children and adults, what is the association between
potassium intake and blood pressure and kidney stone formation?
I. Among subpopulations defined by sex, race/ethnicity, and age
(children, adolescents, young adults, older adults, elderly).
II. Among subpopulations defined by hypertension, diabetes, and
obesity health status.
7. Among adults, what is the effect of interventions aimed at
increasing potassium intake on CVD, and kidney disease morbidity and
mortality, and total mortality?
I. Do other minerals modify the effect of potassium (e.g., sodium,
calcium, magnesium)?
II. Among subpopulations defined by sex, race/ethnicity, age (young
adults, older adults, elderly), and for women (pregnancy and
lactation).
III. Among subpopulations defined by hypertension, diabetes,
obesity and renal health status.
8. Among adults, what is the association between dietary potassium
intake and CVD, CHD, stroke and kidney disease morbidity and mortality
and between dietary potassium and total mortality?
I. Do other minerals (e.g., sodium, calcium, magnesium) modify the
association with potassium?
II. Among subpopulations defined by sex, race/ethnicity, age (young
adults, older adults, elderly), and for women (pregnancy and
lactation).
III. Among subpopulations defined by hypertension, diabetes, and
obesity health status.
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Key Question 1
I. Population
A. Studies in human participants will be eligible for inclusion in
the review, with the exception of studies exclusively reporting on
patients with end stage renal disease, heart failure, HIV, or cancer.
II. Interventions
A. Studies evaluating interventions to reduce dietary sodium intake
that specify the oral consumption from food or supplements of
quantified amounts of sodium and sodium chloride (salt) or sodium-to-
potassium ratio will be eligible, with the exception of trial arms in
which participants demonstrate a weight change of +/- 3% or more.
Interventions simultaneously addressing sodium and potassium intake
that document sodium/potassium ratio are eligible; all other
multicomponent interventions in which the effect of sodium reduction
cannot be disaggregated from other intervention components will be
excluded.
III. Comparators
A. Studies comparing interventions to placebo or control diets will
be eligible. Studies comparing an experimental diet to usual diet,
studies comparing levels of sodium intake, or studies that alter
sodium/potassium ratio in other ways
[[Page 12607]]
will be included if they control for other nutrient levels.
IV. Outcomes
A. Studies reporting on blood pressure outcomes (e.g., systolic
blood pressure, diastolic blood pressure, rate of hypertensive/non-
hypertensive participants, incident hypertension, percent of
participants at blood pressure goal, and change in blood pressure) will
be eligible.
V. Timing
A. Studies reporting on an intervention period of at least four
weeks will be eligible.
VI. Setting
A. Studies in outpatient settings will be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs with a washout period of two
weeks or more will be eligible.
Key Question 2
I. Population
A. Studies in community-dwelling (non-institutionalized) human
participants will be eligible for inclusion in the review with the
exception of studies exclusively reporting on patients with pre-
existing conditions specific to the clinical outcome of interest, as
well as studies exclusively reporting on patients with end stage renal
disease, heart failure, HIV, or cancer.
II. Exposure
A. Studies that measure the intake (oral consumption from food or
supplements of quantified amounts of sodium and sodium chloride [salt]
or sodium-to-potassium ratio) with validated measures or that use
biomarker values to assess sodium level (at least one 24-hour urinary
analysis with or without reported quality control measure, chemical
analysis of diet with intervention/exposure adherence measure,
composition of salt substitute with intervention/exposure adherence
measure, and food diaries with reported validation [adherence check,
electronic prompts]) will be eligible. Observational studies that
report a weight change of +/- 3% or more (in any exposure group) among
adults; multicomponent studies that do not properly control for
confounders; and studies relying only on serum sodium levels,
composition of salt substitute without intervention/exposure adherence
measure, food diaries without reported validation, use of a published
food frequency questionnaire, or partial or spot urine without reported
prediction equation will be excluded.
III. Comparator
A. Studies comparing groups with different documented sodium intake
or biomarker values for sodium will be eligible. Studies where
differences in sodium intake or values are confounded with alteration
of other nutrient levels will be excluded.
IV. Outcomes
A. Studies reporting on blood pressure outcomes (e.g., systolic
blood pressure, diastolic blood pressure, rate of hypertensive/non-
hypertensive participants, incident hypertension, percent of
participants at blood pressure goal, change in blood pressure) will be
eligible. Studies that do not report baseline blood pressure status
will be excluded.
V. Timing
A. Studies reporting on an intervention period of at least four
weeks will be eligible.
VI. Setting
A. Studies in community-dwelling participants will be eligible.
VII. Study Design
A. Prospective cohort studies and nested case-control studies,
where at least two groups are compared based on measured sodium intake
or biomarker values will be eligible. Retrospective studies, case
series, cross-sectional studies or surveys, and case reports will be
excluded.
Key Question 3
I. Population
A. Studies in human adults will be eligible for inclusion in the
review. Studies exclusively reporting on patients with end stage renal
disease, heart failure, HIV, or cancer will be excluded.
II. Intervention
A. Studies evaluating interventions to reduce dietary sodium intake
that specify the oral consumption from food or supplements of
quantified amounts of sodium and sodium chloride (salt) or sodium-to-
potassium ratio will be eligible. Studies with trial arms in which
participants demonstrate a weight change of +/- 3% or more will be
excluded. Interventions simultaneously addressing sodium and potassium
intake with documents sodium/potassium ratio are eligible. All other
multicomponent interventions in which the effect of sodium reduction
cannot be disaggregated from other intervention components will be
excluded.
III. Comparators
A. Studies comparing interventions to placebo or control diets will
be eligible. Studies comparing an experimental diet to usual diet,
studies comparing levels of sodium intake, or studies that alter
sodium/potassium ratio in other ways will be included if they control
for other nutrient levels.
IV. Outcomes
A. Studies reporting on mortality (all-cause, CVD, CHD, or renal);
cardiovascular disease morbidity, including acute coronary syndrome
(unstable angina and myocardial infarction), stroke, myocardial
infarction (ST-segment elevation myocardial infarction [STEMI] and non-
ST elevation myocardial infarction [NSTEMI]), requiring coronary
revascularization procedures (angioplasty, coronary stent placement,
coronary artery bypass), other atherosclerotic revascularization
procedures (carotid endarterectomy), left ventricular hypertrophy,
hospitalization for heart failure, hospitalization for any cause of
coronary heart disease or cardiovascular disease, or combined CVD
morbidity and mortality; or reporting on renal function intermediary
and clinical outcomes including creatinine clearance (CrCl), serum
creatinine (SCr), glomerular filtration rate (GFR), end stage renal
disease, chronic kidney disease (CKD), albuminuria or proteinuria
(including urine albumin-to-creatinine ratio, urine albumin dipstick
level, urine protein-to-creatinine ratio, albumin excretion rate),
kidney stone incidence, or acute kidney injury will be eligible.
V. Timing
A. Only interventions of two years or longer will be included for
kidney disease outcomes; only interventions of three months or longer
will be included for cardiovascular disease outcomes; all other studies
need to report on an intervention period of at least four weeks to be
eligible.
VI. Setting
A. Studies in outpatient settings will be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs with a washout period of two
weeks or more will be eligible.
[[Page 12608]]
Key Question 4
I. Population
A. Studies in community-dwelling (non-institutionalized) adults
will be eligible for inclusion in the review with the exception of
studies exclusively reporting on patients with pre-existing conditions
specific to the clinical outcomes of interest, as well as studies
exclusively reporting on patients with end stage renal disease, heart
failure, HIV, or cancer.
II. Exposure
A. Studies that measure the intake (oral consumption from food or
supplements of quantified amounts of sodium and sodium chloride [salt]
or sodium-to-potassium ratio) with validated measures or use biomarker
values to assess sodium level (at least one 24-hour urinary analysis
with or without reported quality control measure, chemical analysis of
diet with intervention/exposure adherence measure, composition of salt
substitute with intervention/exposure adherence measure, and food
diaries with reported validation [adherence check, electronic prompts])
will be eligible. Observational studies that report a weight change of
+/- 3% or more (in any exposure group) among adults; multicomponent
studies that do not properly control for confounders; and studies
relying only on serum sodium levels, composition of salt substitute
without intervention/exposure adherence measure, food diaries without
reported validation, use of a published food frequency questionnaire,
or partial or spot urine without reported prediction equation will be
excluded.
III. Comparator
A. Studies comparing groups with different documented sodium intake
or biomarker values for sodium will be eligible. Studies where
differences in sodium intake or values are confounded with alteration
of other nutrient levels will be excluded.
IV. Outcomes
A. Studies reporting on mortality (all-cause, CVD, CHD, or renal);
cardiovascular mortality; cardiovascular disease morbidity, including
coronary heart disease (CHD), acute coronary syndrome (unstable angina
and myocardial infarction), stroke, myocardial infarction (ST-segment
elevation myocardial infarction [STEMI] and non-ST elevation myocardial
infarction [NSTEMI]), requiring coronary revascularization procedures
(angioplasty, coronary stent placement, coronary artery bypass), other
atherosclerotic revascularization procedures (carotid endarterectomy),
left ventricular hypertrophy, hospitalization for heart failure, or
hospitalization for any cause of coronary heart disease or
cardiovascular disease, or combined CVD morbidity and mortality; or
reporting on renal function intermediary and clinical outcomes
including creatinine clearance (CrCl), serum creatinine (SCr),
glomerular filtration rate (GFR), end stage renal disease, chronic
kidney disease (CKD), albuminuria/proteinuria (including, urine
albumin-to-creatinine ratio, urine albumin dipstick level, urine
protein-to-creatinine ratio, albumin excretion rate), acute kidney
injury will be eligible. Studies that do not report baseline data for
the outcomes of interest will be excluded.
V. Timing
A. Studies reporting exclusively on kidney disease outcomes need to
report follow up periods of at least two years, studies reporting
exclusively on cardiovascular disease outcomes or stroke need to report
on follow up periods of at least 12 months duration; studies reporting
on other outcomes need to evaluate exposure lasting at least four weeks
to be eligible.
VI. Setting
A. Studies in community-dwelling participants will be eligible.
VII. Study Design
A. Prospective cohort studies and nested case-control studies,
where at least two groups are compared based on measured sodium intake
or biomarker values will be eligible. Retrospective studies, case
series, cross-sectional studies or surveys, and case reports will be
excluded.
Key Question 5
I. Population
A. Studies in human participants will be eligible for inclusion in
the review; studies exclusively reporting on patients with end stage
renal disease, heart failure, HIV, or cancer will be excluded.
II. Interventions
A. Studies evaluating interventions to increase dietary potassium
intake that specify the oral consumption from food or supplements of
quantified amounts of potassium, potassium supplements, salt
substitutes such as potassium chloride, or sodium-to-potassium ratio
will be eligible, with the exception of trial arms in which
participants demonstrate a weight change of +/- 3% or more among
adults. Interventions simultaneously addressing sodium and potassium
intake with documents sodium/potassium ratio are eligible; all other
multicomponent interventions in which the effect of sodium reduction
cannot be disaggregated from other intervention components will be
excluded.
III. Comparators
A. Studies comparing interventions to placebo or control diets will
be eligible. Studies comparing an experimental diet to usual diet,
studies comparing levels of potassium intake, or studies that alter
sodium/potassium ratio in other ways will be included if they control
for other nutrient levels.
IV. Outcomes
A. Studies reporting on blood pressure outcomes (e.g., systolic
blood pressure, diastolic blood pressure, rate of hypertensive/non-
hypertensive participants, hypertension incidence, percent of
participants at blood pressure goal, change in blood pressure) and
incident kidney stones or kidney stone regrowth will be eligible.
V. Timing
A. Studies reporting exclusively on kidney stone formation need to
report on an intervention period of two years; all other studies need
to report on an intervention period of at least four weeks to be
eligible.
VI. Setting
A. Studies in outpatient settings will be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs with a washout period of two
weeks or more will be eligible.
Key Question 6
I. Population
A. Studies in community-dwelling (non-institutionalized) human
participants will be eligible for inclusion in the review; studies
reporting exclusively on patients with pre-existing conditions specific
to the clinical outcomes of interest, as well as studies exclusively
reporting on patients with end stage renal disease, heart failure, HIV,
or cancer will be excluded.
II. Exposure
A. Studies that measure intake (oral consumption from food or
supplements of quantified amounts of potassium, potassium supplements,
salt substitutes such as potassium chloride, or sodium-to-potassium
ratio) with validated measures or use biomarkers values to assess
potassium level (at least one 24-hour urinary analysis with or without
[[Page 12609]]
reported quality control measure, chemical analysis of diet with
intervention/exposure adherence measure, composition of potassium
supplement with intervention/exposure adherence measure, use of a
published food frequency questionnaire, and food diaries) will be
eligible. Observational studies that report a weight change of +/- 3%
or more (in any exposure group) among adults; multicomponent studies
that do not properly control for confounders; and studies measuring
potassium intake by reporting chemical analysis of diet without
intervention/exposure adherence measures, composition of potassium
supplement without intervention/exposure measure, or serum potassium
will be excluded.
III. Comparator
A. Studies comparing groups with different documented potassium
intake, serum potassium levels, or urinary potassium excretion will be
eligible. Studies where differences in potassium intake or values are
confounded with alteration of other nutrient levels will be excluded.
IV. Outcomes
A. Studies reporting on blood pressure outcomes (e.g., systolic
blood pressure, diastolic blood pressure, rate of hypertensive/non-
hypertensive participants, hypertension incidence, percent of
participants at blood pressure goal, change in blood pressure), and
kidney stone incident or kidney stone regrowth will be eligible.
Studies that do not report baseline blood pressure status and the
presence or absence of kidney stones will be excluded.
V. Timing
A. Studies exclusively reporting on kidney stone formation need to
follow participants for at least five years; all other studies need to
report on exposure of at least four weeks to be eligible.
VI. Setting
A. Studies in community-dwelling participants will be eligible.
VII. Study Design
A. Prospective cohort studies and nested case-control studies,
where at least two groups are compared based on measured potassium
intake or biomarker values will be eligible. Retrospective studies,
case series, cross-sectional studies or surveys, and case reports will
be excluded.
Key Question 7
I. Population
A. Studies in adults will be eligible for inclusion in the review;
studies reporting exclusively on patients with heart failure, end stage
renal disease, HIV, or cancer will be excluded.
II. Interventions
A. Studies evaluating interventions to increase dietary potassium
intake that specify the oral consumption from food or supplements of
quantified amounts of potassium, potassium supplements, salt
substitutes such as potassium chloride, or sodium-to-potassium ratio
will be eligible, with the exception of trial arms in which
participants demonstrate a weight change of +/- 3% or more.
Interventions simultaneously addressing sodium and potassium intake
with documents sodium/potassium ratio are eligible; all other
multicomponent interventions in which the effect of sodium reduction
cannot be disaggregated from other intervention components will be
excluded.
III. Comparators
A. Studies comparing interventions to placebo or control diets will
be eligible. Studies comparing an experimental diet to usual diet,
studies comparing levels of potassium intake, or studies that alter
sodium/potassium ratio in other ways will be included if they control
for other nutrient levels.
IV. Outcomes
A. Studies reporting on mortality (all-cause, CVD, CHD, or renal);
cardiovascular disease morbidity, including acute coronary syndrome
(unstable angina and myocardial infarction), stroke, myocardial
infarction (ST-segment elevation myocardial infarction [STEMI] and non-
ST elevation myocardial infarction [NSTEMI]), requiring coronary
revascularization procedures (angioplasty, coronary stent placement,
coronary artery bypass), other atherosclerotic revascularization
procedures (carotid endarterectomy), left ventricular hypertrophy,
hospitalization for heart failure, or hospitalization for any cause of
coronary heart disease or cardiovascular disease, or combined CVD
morbidity and mortality; or reporting on renal function intermediary
and clinical outcomes including creatinine clearance (CrCl), serum
creatinine (SCr), glomerular filtration rate (GFR), end stage renal
disease, chronic kidney disease (CKD), albuminuria or proteinuria
(including urine albumin-to-creatinine ratio, urine albumin dipstick
level, urine protein-to-creatinine ratio, albumin excretion rate),
kidney stone incidence, or acute kidney injury will be eligible.
V. Timing
A. Studies reporting exclusively on kidney disease outcomes need to
report on an intervention period of two years, studies reporting on
cardiovascular disease or stroke need to report on an intervention
period of three months; all other studies need to report on an
intervention period of at least four weeks to be eligible.
VI. Setting
A. Studies in outpatient settings will be eligible.
VII. Study Design
A. Parallel RCTs and cross-over RCTs with a washout period of two
weeks or more will be eligible.
Key Question 8
I. Population
A. Studies in community-dwelling (non-institutionalized) adults
will be eligible for inclusion in the review with the exception of
studies exclusively reporting on patients with pre-existing conditions
specific to the clinical outcomes of interest, as well as studies
exclusively reporting on patients with end stage renal disease, heart
failure, HIV, or cancer.
II. Exposure
A. Studies that measure intake (oral consumption from food or
supplements of quantified amounts of potassium, potassium supplements,
salt substitutes such as potassium chloride, or sodium-to-potassium
ratio) with validated measures or use biomarkers values to assess
potassium level (at least one 24-hour urinary analysis with or without
reported quality control measure, chemical analysis of diet with
intervention/exposure adherence measure, composition of potassium
supplement with intervention/exposure adherence measure, use of a
published food frequency questionnaire, and food diaries) will be
eligible. Observational studies that report a weight change of +/- 3%
or more (in any exposure group) among adults; multicomponent studies
that do not properly control for confounders; and studies measuring
potassium intake by reporting chemical analysis of diet without
intervention/exposure adherence measures, composition of potassium
supplement without intervention/exposure measure, or serum potassium
will be excluded.
III. Comparator
A. Studies comparing groups with different documented potassium
intake, serum potassium levels, or urinary potassium excretion will be
eligible.
[[Page 12610]]
Studies where differences in potassium intake or values are confounded
with alteration of other nutrient levels will be excluded.
IV. Outcomes
A. Studies reporting on mortality (all-cause, CVD, CHD, or renal);
cardiovascular disease morbidity, including coronary heart disease
(CHD), acute coronary syndrome (unstable angina and myocardial
infarction), stroke, myocardial infarction (ST-segment elevation
myocardial infarction [STEMI] and non-ST elevation myocardial
infarction [NSTEMI]), requiring coronary revascularization procedures
(angioplasty, coronary stent placement, coronary artery bypass), other
atherosclerotic revascularization procedures (carotid endarterectomy),
left ventricular hypertrophy, hospitalization for heart failure, or
hospitalization for any cause of coronary heart disease or
cardiovascular disease, or combined CVD morbidity and mortality; or
reporting on renal function intermediary and clinical outcomes
including creatinine clearance (CrCl), serum creatinine (SCr),
glomerular filtration rate (GFR), end stage renal disease, chronic
kidney disease (CKD), albuminuria/proteinuria (including urine albumin-
to-creatinine ratio, urine albumin dipstick level, urine protein-to-
creatinine ratio, albumin excretion rate), kidney stone incidence, or
acute kidney injury will be eligible. Studies that do not report
baseline data on the outcomes of interest will be excluded.
V. Timing
A. Studies reporting exclusively on kidney stone formation need to
follow participants for at least five years, studies reporting
exclusively on kidney disease need to follow participants for at least
two years, studies reporting exclusively on cardiovascular disease or
stroke need to follow patients for at least 12 months; all other
studies need to report on an exposure period of at least four weeks to
be eligible.
VI. Setting
A. Studies in community-dwelling participants will be eligible.
VII. Study Design
A. Prospective cohort studies and nested case-control studies,
where at least two groups are compared based on measured potassium
intake or biomarker values will be eligible. Retrospective studies,
case series, cross-sectional studies or surveys, and case reports will
be excluded.
Sharon B. Arnold,
Acting AHRQ Director.
[FR Doc. 2017-04193 Filed 3-3-17; 8:45 am]
BILLING CODE 4160-90-P
