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]

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[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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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]


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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