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Appendix E: Supplemental Literature Searches
Pages 485-522

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From page 485...
... This appendix also includes the committee's search for studies that would have qualified for the AHRQ Systematic Review, but were published after the last literature search conducted by the AHRQ Systematic Review investigators. SUPPLEMENTAL LITERATURE SEARCH FOR POTASSIUM AND SODIUM BALANCE STUDIES In order to minimize the duplication of resources, the committee's supplemental literature search for balance studies drew from the references presented in three sources: Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate (2005 DRI Report)
From page 486...
... SUPPLEMENTAL LITERATURE SEARCHES FOR EVIDENCE ON THE RELATIONSHIP BETWEEN SODIUM INTAKE AND HEADACHES In its search for evidence to inform the sodium Tolerable Upper Intake Level, the committee identified headache as a potentially informative indicator. Evidence of the potential relationship was presented to the committee during its March 2018 public workshop (Whelton, 2018)
From page 487...
... ; catecholamines; type 2 diabetes, glucose intolerance, and insulin sensitivity; and plasma renin activity. Identifying High-Quality Systematic Reviews To minimize the duplication of resources, the committee's supplemental literature searches began with a search for recent, high-quality systematic reviews on all indicators of interest.
From page 488...
... Searching for Primary Studies Because no high-quality, recent systematic reviews were identified on the relationship between sodium and potassium intakes and bone health or type 2 diabetes, glucose tolerance, and insulin sensitivity, a literature search to identify primary studies was conducted in Ovid MEDLINE to identify relevant randomized controlled trials and prospective cohort studies published since January 1, 2003, up to April 2018. The committee searched back to 2003 in order to include anything published since the 2005 DRI Report.
From page 489...
... The AMSTAR 2 criteria for quality assessment is available at https://amstar.ca/docs/AMSTAR-2.pdf (accessed August 15, 2018)
From page 490...
... The complete inclusion/exclusion criteria are outlined in Tables E-2 through E-5 for sodium and potassium intakes and bone health outcomes, and in Tables E-6 through E-9 for sodium and potassium intakes and type 2 diabetes, glucose tolerance, and insulin sensitivity outcomes. The inclusion/exclusion criteria for population, intervention/ intake, comparators, setting, and study design were generally aligned with criteria used in the AHRQ Systematic Review.
From page 491...
... Outcomes Studies reporting on bone health outcomes (including fractures, falls, or performance measures of strength, and bone mineral density) will be eligible for inclusion.
From page 492...
... Observational studies that report a weight change of +/− 3 percent 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.
From page 493...
... Studies comparing an experimental diet to usual diet, studies comparing levels of potassium intake, or studies that alter sodium-to-potassium ratio in other ways will be included if they control for other nutrient levels. Outcomes Studies reporting on bone health outcomes (including fractures, falls, or performance measures of strength, and bone mineral density)
From page 494...
... with validated measures or use biomarker 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.
From page 495...
... Comparators 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-to-potassium ratio in other ways will be included if they control for other nutrient levels.
From page 496...
... Observational studies that report a weight change of +/− 3 percent 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.
From page 497...
... Studies comparing an experimental diet to usual diet, studies comparing levels of potassium intake, or studies that alter sodium-to-potassium ratio in other ways will be included if they control for other nutrient levels. Outcomes Studies reporting on type 2 diabetes mellitus, glucose intolerance, or insulin sensitivity will be eligible for inclusion.
From page 498...
... with validated measures or use biomarker 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.
From page 499...
... Control Duration Results Parallel Arm Randomized Controlled Trial Ilich et al., 97 healthy, Dietary advice to Received dietary 3 years No statistical difference observed in mean BMD 2010 postmenopausal, lower sodium intake advice to maintain of the forearm (p = .417)
From page 500...
... Comparison Group Duration Results Gregory 83 Received 40 Received daily 12 • Mean BMD remained stable over the  et al., 2015 postmenopausal mmol/d K placebo capsules and months 12-month study period in subjects treated (United States) women, with citrate plus daily supplementation with with K citrate and control.
From page 501...
... Comparison Group Duration Results Diet group received additional 300 g/d fruit and vegetables NOTE: aBMD = areal bone mineral density; BMD = bone mineral density; CI = confidence interval; g/d = grams per day; IU/d = International Units per day; K citrate = potassium citrate; mg/d = milligram per day; mmol/d = millimoles per day. aDefined as a T-score at the lumbar spine or hip between −1.0 and −2.5.
From page 502...
... healthy women, • In analysis of all women, no evidence of association between  50–59 years of nutrient intake and BMD. age at follow-up NOTE: BMD = bone mineral density; BUA = broadband ultrasound attenuation; FFQ = food frequency questionnaire; vBMD = volumetric bone mineral density.
From page 503...
... iAnalyses adjusted for age, height, weight, annual percentage change in weight, physical activity level, smoking status, socioeconomic status, and baseline femoral neck BMD.
From page 504...
... uncontrolled follow a moderate reduced-salt diet hypertension reduced-salt diet Crossover Study Design Suckling et 46 men and Received salt Received placebo 12 weeks No significant change in fasting glucose or insulin al., 2016 women, aged tablets to equal tablets and concentration observed from intervention to placebo (United 30–80 years 90 mmol/d and instructed to period. Kingdom)
From page 505...
... aTotal number of participants included in the analysis. bAnalyses adjusted for age, sex, study year, body mass index, physical activity, systolic blood pressure, antihypertensive drug treatment, education, smoking and coffee, alcohol, fruit, vegetable, sausage, bread, and saturated fat consumption.
From page 506...
... Control Duration Results Chatterjee et 27 African Received 40 Received 12 weeks • KCl supplement reduced fasting glucose by 7.2 mg/dL  al., 2017 American mmol/d KCl daily placebo (p = .03)
From page 507...
... aTotal number of participants included in the analysis. bAnalyses adjusted for age, sex, race, clinical center, body mass index, waist circumference, serum magnesium, calcium, and creatinine levels, physical activity, parental history of diabetes, presence of hypertension, systolic blood pressure, fasting glucose and insulin levels, income, and use of β-blockers, diuretics, and angiotensin-converting enzyme inhibitors.
From page 508...
... TABLE E-17 Risk-of-Bias Assessment of Sodium Trials Blinding of Participants and Personnel Selective Reporting of Outcome Data Unequal Distribution Among Groups of Potential Confounders at Baseline Blinding of Outcome Assessment Random Sequence Generation Incomplete Outcome Data Allocation Concealment (Attrition Bias) Author, Year Adherence Meland and Unclear Low Low Low Low Low Low Low Aamland, 2009 risk risk risk risk risk risk risk risk Suckling et al., Low Low Low Low Low Low Unclear Low 2016 risk risk risk risk risk risk risk risk NOTE: BPUK = Blood Pressure U.K.; CASH = Consensus Action on Salt and Health; COI = conflict of interest; N/A = not applicable; WASH = World Action on Salt and Health.
From page 509...
... and Public Public private Other: Funding Source (Author COI) have no declare." competing CASH and F.J.
From page 510...
... 510 DIETARY REFERENCE INTAKES FOR SODIUM AND POTASSIUM TABLE E-18 Risk-of-Bias Assessment for Sodium Observational Studies on the Basis of the Design Comparability of Cohorts Ascertainment of Sodium Representativeness of the Outcome of Interest Not Present at Start of Study Selection of the Non Exposed Cohort Exposed Cohort Author, Year or Analysis Exposure Hu et al., 2005 Moderate risk Low risk High risk Low risk Low risk Illich et al., 2010 Moderate risk Low risk Low risk Low risk Low risk NOTE: COI = conflict of interest; N/A = not applicable; NR = not reported.
From page 511...
... Funding Source Funding Source Low risk High risk Public (Author COI) NR N/A High Low risk High risk Public "The authors declare that "Bayer Moderate they have no conflict of HealthCare interest." LLC, Morristown, NJ, USA"
From page 512...
... 512 DIETARY REFERENCE INTAKES FOR SODIUM AND POTASSIUM TABLE E-19 Risk-of-Bias Assessment of Potassium Trials Incomplete Outcome Data (Attrition Bias) Unequal Distribution Among Groups of Blinding of Participants and Personnel Selective Reporting of Outcome Data Potential Confounders at Baseline Blinding of Outcome Assessment Random Sequence Generation Allocation Concealment Author, Year Adherence Chatterjee et Low risk Low risk Low Low Low Low Low Low risk al., 2017 risk risk risk risk risk Gregory et Low risk Low risk Low Low Unclear Low Low Moderate risk al., 2015 risk risk risk risk Jehle et al., Unclear Unclear Low Low Low Low Low Low risk 2013 risk risk risk risk risk Macdonald Low risk Low risk Low Low Low Low Low Low risk et al., 2008 risk risk risk risk risk NOTE: COI = conflict of interest; N/A = not applicable; NR = not reported.
From page 513...
... Overall Risk of Bias Participants Low risk Low Low N/A Public NR N/A Low risk risk Low risk Unclear Low N/A Public and NR N/A Low risk private incorporationa Low risk Moderate Low N/A Public and "The authors have no Yes Low risk risk private conflicts of interest to incorporationa report." Low risk Low Low N/A Public SLN principal grant N/A Low risk risk holder on a grant from GlaxoSmithKline to examine one of the company's products; HMM involved in interpreting the results of that study; none of the other authors had personal or financial COIb
From page 514...
... 514 DIETARY REFERENCE INTAKES FOR SODIUM AND POTASSIUM TABLE E-20 Risk-of-Bias Assessment for Potassium Observational Studies on the Basis of the Design or Ascertainment of Potassium Comparability of Cohorts Representativeness of the Outcome of Interest Not Present at Start of Study Selection of the Non Exposed Cohort Exposed Cohort Author, Year Exposure Analysis Chatterjee et Moderate Low risk High risk Low risk Low risk al., 2010 risk Chatterjee et Low risk Low risk Moderate risk Low risk Low risk al., 2012 Hayhoe, 2015 Low risk Low risk Moderate risk Low risk Moderate risk Hu et al., 2005 Moderate Low risk High risk Low risk Low risk risk Macdonald et Low risk Low risk Moderate risk Low risk Moderate risk al., 2004 Nieves et al., Low risk Low risk Moderate risk Low risk Moderate risk 2010 Zhu et al., Low risk Low risk High risk Low risk Moderate risk 2009 NOTE: COI = conflict of interest; N/A = not applicable. aIncluded statement of no involvement of the study.
From page 515...
... Funding Source Funding Source (Author COI) Low Low risk Public None reported financial N/A High risk disclosure Low Low risk Public "The authors declare N/A Moderate risk that there is no duality of interest associated with this manuscript." Low Unclear Public "None of the authors had N/A Moderate risk a financial or personal conflict of interest relevant to this research at the time of writing." Low High risk Public NR N/A High risk Low Low risk Public "None of the authors had N/A Moderate risk financial or commercial interest in any company or organization sponsoring the research." Low Low risk Public and All authors claimed: nothing No Moderate risk private to disclose incorporationa Low High risk Public "None reported conflict of N/A High risk interest."
From page 516...
... Table E-21 provides a brief summary of the committee's assessment of the applicability of each study to its evidence review. TABLE E-21 References Identified as Meeting the AHRQ Systematic Review Inclusion Criteria, Published Between March 2017 and June 2018 Reference Notes About the Study Lelli et al., • High-risk-of-bias article based on AHRQ quality assessment criteria  2018 • High-risk-of-bias observational studies did not inform the committee's  decision making for the sodium CDRR for adults Lelong et al., • High-risk-of-bias article based on AHRQ quality assessment criteria  2017 • High-risk-of-bias observational studies did not inform the committee's  decision making for the sodium CDRR for adults • High-risk-of-bias observational studies did not inform the committee's  decision making related to blood pressure or incident hypertension for potassium CDRR for adults Mente et al., • High-risk-of-bias article based on AHRQ quality assessment criteria  2018 • High-risk-of-bias observational studies did not inform the committee's  decision making for the sodium or potassium CDRR for adults Mirmiran et • High-risk-of-bias article based on AHRQ quality assessment criteria  al., 2018 • Used a food frequency questionnaire to assess dietary intake; evidence  based on food frequency questionnaires was excluded from the sodium intake-related key questions, but was included in the potassium-related key questions Pathak et al., • Study conducted in patients with chronic kidney disease  2017 • Given insufficient evidence on effect modification of kidney disease,  study did not inform the sodium DRIs
From page 517...
... APPENDIX E 517 TABLE E-21 Continued Reference Notes About the Study Prentice et al., • High-risk-of-bias article based on AHRQ quality assessment criteria  2017 • Used a food frequency questionnaire to assess dietary intake; evidence  based on food frequency questionnaires was excluded from the sodium intake-related key questions, but was included in the potassium-related key questions Saran et al., • Study conducted in patients with stage 3–4 chronic kidney disease  2017 • Given insufficient evidence on effect modification of kidney disease,  study did not inform the sodium DRIs Saulnier et al., • Study conducted in individuals with type 2 diabetes  2017 • High-risk-of-bias article based on AHRQ quality assessment criteria  • High-risk-of-bias observational studies did not inform the committee's  decision making for the sodium CDRR for adults Setayeshgar et • High-risk-of-bias article based on AHRQ quality assessment criteria  al., 2017 • Study was part of a collection of evidence that informed the  committee's rationale regarding extrapolation of the sodium CDRR to children Tabara et al., • Study only reported on sodium-to-potassium ratio; independent  2017 relationship with sodium and potassium not reported Torres et al., • Study conducted in patients with autosomal dominant polycystic  2017 kidney disease • Given insufficient evidence on effect modification of kidney disease,  study did not inform the sodium DRIs Zhao et al., • Study population was adults with suspected coronary heart disease,  2017 and therefore could not be used to estimate relationship with incident cardiovascular disease Chen et al., • Primary analyses of trials already included in the AHRQ Systematic  2016; Cheng Review et al., 2018; Juraschek et al., 2017; Murtaugh et al., 2018 Allaert, 2017; • Studies used salt substitutes; independent effects of sodium and  Hu et al., 2018; potassium could not be determined Janda et al., • Studies did not inform the sodium or potassium DRIs  2018; Yang et al., 2018 NOTE: AHRQ = Agency for Healthcare Research and Quality; CDRR = Chronic Disease Risk Reduction Intake; DRI = Dietary Reference Intake.
From page 518...
... 2013a. Ef fect of increased potassium intake on cardiovascular risk factors and disease: Systematic review and meta-analyses.
From page 519...
... 2015. Dietary mag nesium and potassium intakes and circulating magnesium are associated with heel bone ultrasound attenuation and osteoporotic fracture risk in the EPIC-Norfolk cohort study.
From page 520...
... 2018. Variation in sodium intake and intra-individual change in blood pressure in chronic kidney disease.
From page 521...
... 2009. The effects of high potassium consumption on bone mineral density in a prospective cohort study of elderly postmenopausal women.


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