Effect of Salt Substitution on Cardiovascular Events and Death.

BACKGROUND: Salt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and safety outcomes are uncertain. METHODS: We conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China. The participants had a history of stroke or were 60 years of age or older and had high blood pressure. The villages were randomly assigned in a 1:1 ratio to the intervention group, in which the participants used a salt substitute (75% sodium chloride and 25% potassium chloride by mass), or to the control group, in which the participants continued to use regular salt (100% sodium chloride). The primary outcome was stroke, the secondary outcomes were major adverse cardiovascular events and death from any cause, and the safety outcome was clinical hyperkalemia. RESULTS: A total of 20,995 persons were enrolled in the trial. The mean age of the participants was 65.4 years, and 49.5% were female, 72.6% had a history of stroke, and 88.4% a history of hypertension. The mean duration of follow-up was 4.74 years. The rate of stroke was lower with the salt substitute than with regular salt (29.14 events vs. 33.65 events per 1000 person-years; rate ratio, 0.86; 95% confidence interval [CI], 0.77 to 0.96; P = 0.006), as were the rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years; rate ratio, 0.87; 95% CI, 0.80 to 0.94; P<0.001) and death (39.28 events vs. 44.61 events per 1000 person-years; rate ratio, 0.88; 95% CI, 0.82 to 0.95; P<0.001). The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years; rate ratio, 1.04; 95% CI, 0.80 to 1.37; P = 0.76). CONCLUSIONS: Among persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt. (Funded by the National Health and Medical Research Council of Australia; SSaSS ClinicalTrials.gov number, NCT02092090.).

Cost-Effectiveness of a Household Salt Substitution Intervention: Findings From 20 995 Participants of the Salt Substitute and Stroke Study.

BACKGROUND: SSaSS (Salt Substitute and Stroke Study), a 5-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium, added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events, and premature death among individuals with previous stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention. METHODS: A within-trial economic evaluation of SSaSS was conducted from the perspective of the health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models. RESULTS: Mean follow-up of the 20 995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio, 0.86 [95% CI, 0.77-0.96]; P=0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving and a >99.9% probability of being cost-effective. CONCLUSIONS: Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life among SSaSS participants.

Experience with 2 years' intervention to progressively reduce salt supply to kitchens in elderly care facilities-challenges and further research: post hoc analysis of the DECIDE-Salt randomized clinical trial.

BACKGROUND: Progressive reduction of sodium intake is an attractive approach for addressing excessive salt intake, but evidence for this strategy in real practice is limited. We aimed to determine the feasibility, effectiveness, and safety of a progressive sodium intake reduction intervention in real-world setting. METHODS: We randomized 48 residential elderly care facilities in China, with 1612 participants aged 55 years and older, to either progressive reduction (PR, 24 facilities) or no reduction (NR, 24 facilities) of the supply of study salt to the kitchens of these facilities for 2 years. The primary efficacy outcome was systolic blood pressure (SBP) at any scheduled follow-up visit. Secondary efficacy outcomes included diastolic blood pressure (DBP) at any scheduled follow-up visit, and major adverse cardiovascular events (comprising non-fatal stroke, non-fatal myocardial infarction, hospitalized non-fatal heart failure, or vascular death) and total mortality. The perception of food saltiness, the addition of out-of-study salt in meals, and 24-h urinary sodium excretion were used as process indicators. RESULTS: Pre-specified analysis per randomization found no effect of the intervention on the 2-year overall mean systolic and diastolic blood pressure (SBP, DBP) and any other outcomes. However, post hoc analysis showed that the intervention effect on blood pressure varied over multiple follow-up visits (p for interaction < 0.046) and presented favorable differences at the 24-month visit (SBP = - 3.0 mmHg, 95%CI = - 5.6, - 0.5; p = 0.020; DBP = - 2.0 mmHg, 95%CI - 3.4, - 0.63; p = 0.004). The effect on 24-h sodium was non-significant (- 8.4 mmol, 95%CI = - 21.8 to 4.9, p = 0.216), though fewer participants with NR than with PR reported food tasting bland (odds ratio 0.46; 95%CI 0.29 to 0.73; p = 0.001). Reporting of bland food taste and other process measures indicated that intervention delivery and adherence were not fully achieved as designed. CONCLUSIONS: The experience of this real-world study demonstrated that achieving acceptability and sustainability of the progressive sodium intake reduction strategy among older adults was challenging, but it has shown potential for effectiveness in these and potentially other residential settings if the lessons of DECIDE-Salt are applied in further studies. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03290716).

Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population.

As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major issue involves validating more HPV tests. In recent years, some HPV tests are used for clinical performance verification in China. The purpose of this study was to explore whether the BD Onclarity (Becton, Dickinson and Company)HPV assay differs from the Roche cobas (Roche Molecular Systems)HPV assay, as determined using 944 cervical samples, including 588 with sequencing results. In the nucleic acid assay accuracy verification, the assays showed excellent concordance for detection of HPV16 (κ = 0.93, 95% confidence interval [CI]: 0.89-0.97) and HPV18 (κ = 0.90, 95% CI: 0.83-0.97), and very good concordance for the 12 other high-risk types (HPV31/33/35/39/45/51/52/56/58/59/66/68, κ = 0.79, 95% CI: 0.75-0.83). The overall agreement for HPV DNA detection between Onclarity and cobas was very good (κ = 0.7755). No difference for ≥CIN2 sensitivity was observed between Onclarity and cobas (both 96.5%), whereas the ≥CIN2 specificity for detection of Onclarity (16.6%, 95% CI: 13.7-19.9) was higher than that of cobas (11.5%, 95% CI: 9.1-14.5). Onclarity exhibited comparable screening performance and triage efficiency compared to cobas in the detection of cervical disease in Chinese women.

Impact of salt substitute and stepwise reduction of salt supply on blood pressure in residents in senior residential facilities: Design and rationale of the DECIDE-Salt trial.

BACKGROUND: High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed. METHODS: The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. CURRENT STATUS: The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018. CONCLUSION: The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.

Interim effects of salt substitution on urinary electrolytes and blood pressure in the China Salt Substitute and Stroke Study (SSaSS).

The Salt Substitute and Stroke Study is an ongoing 5-year large-scale cluster randomized trial investigating the effects of potassium-enriched salt substitute compared to usual salt on the risk of stroke. The study involves 600 villages and 20,996 individuals in rural China. Intermediate risk markers were measured in a random subsample of villages every 12 months over 3 years to track progress against key assumptions underlying study design. Measures of 24-hour urinary sodium, 24-hour urinary potassium, blood pressure and participants' use of salt substitute were recorded, with differences between intervention and control groups estimated using generalized linear mixed models. The primary outcome of annual event rate in the two groups combined was determined by dividing confirmed fatal and non-fatal strokes by total follow-up time in the first 2 years. The mean differences (95% CI) were -0.32 g (-0.68 to 0.05) for 24-hour urinary sodium, +0.77 g (+0.60 to +0.93) for 24-hour urinary potassium, -2.65 mmHg (-4.32 to -0.97) for systolic blood pressure and +0.30 mmHg (-0.72 to +1.32) for diastolic blood pressure. Use of salt substitute was reported by 97.5% in the intervention group versus 4.2% in the control group (P<.0001). The overall estimated annual event rate for fatal and non-fatal stroke was 3.2%. The systolic blood pressure difference and the annual stroke rate were both in line with the statistical assumptions underlying study design. The trial should be well placed to address the primary hypothesis at completion of follow-up.

Dietary Sodium Reduction Reduces Albuminuria: A Cluster Randomized Trial.

OBJECTIVES: The objective of the study was to assess the impact of sustained dietary salt reduction on albuminuria in nearly 2000 community-dwelling adults. DESIGN AND METHODS: The present study is a prespecified secondary analysis of the China Rural Health Initiative Salt Reduction Study cluster randomized trial undertaken in 120 villages in rural China. Villages were randomized to a sodium reduction program of education and access to reduced-sodium salt substitute or control. Urinary albumin-to-creatinine ratio (uACR) and albuminuria (uACR ≥22.1 or 31.0 mg/g for men and women, respectively) were assessed at 18 months in a stratified random sample of predominantly older individuals living in participating rural villages. RESULTS: A total of 2,566 participants from 119 villages provided 1,903 eligible urine samples. The sodium reduction program reduced sodium intake by an equivalent of 0.82g of salt/day (0.06-1.68 g) (322 [24-661] mg sodium/day). The mean uACR was 8.85 (8.05-9.82) mg/g (1.00 [0.91-1.11] mg/mmol) in intervention participants compared with 10.53 (9.73-11.33) mg/g (1.19 [1.10-1.28] mg/mmol) in control participants (p=0.008). The corresponding odds ratio for albuminuria was 0.67 (0.46-0.99). CONCLUSIONS: Dietary sodium reduction was associated with significantly lower uACR and less albuminuria after 18 months. Whether CKD progression can be slowed by dietary sodium reduction should be a global research priority. CLINICALTRIALS.GOV: NCT01259700.

Sodium and potassium content of 24 h urinary collections: a comparison between field- and laboratory-based analysers.

OBJECTIVE: Measurement of mean population Na and K intakes typically uses laboratory-based assays, which can add significant logistical burden and costs. A valid field-based measurement method would be a significant advance. In the current study, we used 24 h urine samples to compare estimates of Na, K and Na:K ratio based upon assays done using the field-based Horiba twin meter v. laboratory-based methods. DESIGN: The performance of the Horiba twin meter was determined by comparing field-based estimates of mean Na and K against those obtained using laboratory-based methods. The reported 95 % limits of agreement of Bland-Altman plots were calculated based on a regression approach for non-uniform differences. SETTING: The 24 h urine samples were collected as part of an ongoing study being done in rural China. SUBJECTS: One hundred and sixty-six complete 24 h urine samples were qualified for estimating 24 h urinary Na and K excretion. RESULTS: Mean Na and K excretion were estimated as 170·4 and 37·4 mmol/d, respectively, using the meter-based assays; and 193·4 and 43·8 mmol/d, respectively, using the laboratory-based assays. There was excellent relative reliability (intraclass correlation coefficient) for both Na (0·986) and K (0·986). Bland-Altman plots showed moderate-to-good agreement between the two methods. CONCLUSIONS: Na and K intake estimations were moderately underestimated using assays based upon the Horiba twin meter. Compared with standard laboratory-based methods, the portable device was more practical and convenient.

Rationale, design, and baseline characteristics of the Salt Substitute and Stroke Study (SSaSS)-A large-scale cluster randomized controlled trial.

Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater relative risk reduction for stroke. The power estimate assumes a primary outcome event rate of 3.5% per year and a systolic blood pressure difference of 3.0mm Hg between randomized groups. Recruitment is complete and there are 20,996 participants (about 35 per village) that have been enrolled. Mean age is 65years and 49% are female. There were 73% enrolled on the basis of a history of stroke. The trial is well placed to describe the effects of salt substitution on the risks of vascular disease and death and will provide important policy-relevant data.

Population-wide impact of a pragmatic program to identify and manage individuals at high-risk of cardiovascular disease: a cluster randomized trial in 120 villages from Northern China.

Objectives: To explore the population-wide impacts of an evidence-based high-risk strategy for prevention of cardiovascular diseases in resource-poor populations. Methods: A cluster randomized controlled trial was conducted among 120 villages in rural China, with 60 on intervention and 60 on usual care as controls, for 2 years. The intervention emphasized training village doctors to identify high-risk individuals and administering standardized treatments focusing on hypertension management. A random sample of 20 men aged ≥50 years and 20 women aged ≥60 years was drawn from each village before randomization for the baseline survey, and another independent random sample with the same age and sex distribution was drawn at 2 years for the post-intervention survey. The primary outcome was the population mean systolic blood pressure (SBP). Secondary outcomes included the proportions of patients who received regular primary care, antihypertensive medications, aspirin, or lifestyle advice. Results: A total of 5,654 high cardiovascular risk individuals were identified and managed by village doctors in intervention villages for 15 months on average, with mean SBP lowered by 19.8 mmHg and the proportion with blood pressure under control increased from 22.1% to 72.7%. The primary analysis of the two independent samples (5,050 and 4,887 participants each) showed that population-wide mean SBP in intervention villages did not differ from that in control villages at 2 years (mean difference = 1.0 mmHg, 95% CI: -2.19, 4.26; P = 0.528), though almost all secondary outcomes concerning primary care indicators significantly increased in intervention villages. Conclusions: In our study, the pragmatic cardiovascular risk management program targeting on high-risk individuals significantly improved the quality of primary care. However, its impact on population blood pressure level and the burden of hypertension-related diseases appeared very limited. Clinical Trial Registration: ClinicalTrial.gov identifier, NCT01259700.

Effect of a Salt Substitute on Incidence of Hypertension and Hypotension Among Normotensive Adults.

BACKGROUND: Reports on the effects of salt substitution among individuals with normal blood pressure are scarce and controversial. OBJECTIVES: This study sought to assess the effects of a salt substitute (62.5% NaCl, 25% KCl, and 12.5% flavorings) on incidence of hypertension and hypotension among older adults with normal blood pressure. METHOD: A post hoc analysis was conducted among older adults with normal blood pressure participating in DECIDE-Salt, a large, multicenter, cluster-randomized trial in 48 elderly care facilities for 2 years. We used the frailty survival model to compare risk of incident hypertension and the generalized linear mixed model to compare risk of hypotension episodes. RESULTS: Compared with usual salt group (n = 298), the salt substitute group (n = 313) had a lower hypertension incidence (11.7 vs 24.3 per 100 person-years; adjusted HR: 0.60; 95% CI: 0.39 to 0.92; P = 0.02) but did not increase incidence of hypotension episodes (9.0 vs 9.7 per 100 person-years; P = 0.76). Mean systolic/diastolic blood pressure did not increase from the baseline to the end of intervention in the salt substitute group (mean changes: -0.3 ± 11.9/0.2 ± 7.1 mm Hg) but increased in the usual salt group (7.0 ± 14.3/2.1 ± 7.5 mm Hg), resulting in a net reduction of -8.0 mm Hg (95% CI: -12.4 to -3.7 mm Hg) in systolic and -2.0 mm Hg (95% CI: -4.1 to 0.1 mm Hg) in diastolic blood pressure between intervention groups. CONCLUSIONS: In Chinese older adults with normal blood pressure, replacing usual salt with a salt substitute may reduce the incidence of hypertension without increasing hypotension episodes. This suggests a desirable strategy for population-wide prevention and control of hypertension and cardiovascular disease, deserving further consideration in future studies. (Diet Exercise and Cardiovascular Health [DECIDE]-Salt Reduction Strategies for the Elderly in Nursing Homes in China [DECIDE-Salt]; NCT03290716).

Effect of salt substitute and antihypertensive medications among high cardiovascular risk patients: A sub-study of Salt Substitute and Stroke Study (SSaSS).

The relationship between the differential protective effect of salt substitute between hypertensive and normotensive individuals and the use of cardiovascular medications remains unclear. This study involved 4211 individuals with a history of stroke or hypertension who participated in the Salt Substitute and Stroke Study (SSaSS) from 120 villages in Shanxi Province. The aim of this study was to investigate the differences in major adverse cardiovascular events and blood pressure changes between the salt substitute and the regular salt group in the subgroups of participants taking different antihypertensive medications. Mixed models were employed and adjusted for the cluster effect (village) and potential confounding variables. During the average follow-up period of 4.66 years, a significantly protective effect of salt substitute on reducing the risk of cardiovascular events was observed in the participants who taking antihypertensive medications (rate ratio: 0.81, 95% CI: 0.68 to 0.95. p = 0.011), whereas no significant effect in participants not taking antihypertensive medications (rate ratio: 0.91, 95% CI: 0.62 to 1.32, p = 0.612). Significant effects to lower systolic blood pressure of the salt substitutes were observed in the participants who took different antihypertensive medications. This study emphasized that the use of salt substitutes might enhance the efficacy of anti-hypertensive medications in lowering blood pressure and reducing the risk of adverse cardiovascular events.

Cost-Effectiveness of Salt Substitute and Salt Supply Restriction in Eldercare Facilities: The DECIDE-Salt Cluster Randomized Clinical Trial.

Importance: Salt substitution has been reported to be a cost-saving sodium reduction strategy that has not yet been replicated in different contexts. Objective: To estimate the cost-effectiveness of sodium reduction strategies within the DECIDE-Salt trial. Design, Setting, and Participants: The DECIDE-Salt trial cluster randomized in a 1:1:1:1 ratio 48 eldercare facilities in China into 4 groups for evaluation of 2 sodium reduction strategies for 2 years: 1 with both strategies, 2 with either strategy, and 1 with neither strategy. The trial was conducted from September 25, 2017, through October 24, 2020. Interventions: The 2 intervention strategies were replacing regular salt with salt substitute and progressively restricting salt supply to kitchens. Main Outcomes and Measures: The main outcomes included per-participant costs of intervention implementation and medical treatments for hypertension and major adverse cardiovascular events (MACEs) against mean reductions in systolic blood pressure, hypertension prevalence, MACE incidence, and mortality. The incremental cost-utility ratio was then assessed as the additional mean cost per quality-adjusted life-year gained. Analyses were conducted separately for each strategy, comparing groups assigned and not assigned the test strategy. Disease outcomes followed the intention-to-treat principle and adopted different models as appropriate. One-way and probabilistic sensitivity analyses were conducted to explore uncertainty, and data analyses were performed between August 13, 2022, and April 5, 2023. Results: A total of 1612 participants (1230 males [76.3%]) with a mean (SD) age of 71.0 (9.5) years were enrolled. Replacing regular salt with salt substitute reduced mean systolic blood pressure by 7.14 (95% CI, 3.79-10.48) mm Hg, hypertension prevalence by 5.09 (95% CI, 0.37-9.80) percentage points, and cumulative MACEs by 2.27 (95% CI, 0.09-4.45) percentage points. At the end of the 2-year intervention, the mean cost was $25.95 less for the salt substitute group than the regular salt group due to substantial savings in health care costs for MACEs (mean [SD], $72.88 [$9.11] vs $111.18 [$13.90], respectively). Sensitivity analysis showed robust cost savings. By contrast, the salt restriction strategy did not show significant results. If the salt substitution strategy were rolled out to all eldercare facilities in China, 48 101 MACEs and 107 857 hypertension cases were estimated to be averted and $54 982 278 saved in the first 2 years. Conclusions and Relevance: The findings of this cluster randomized clinical trial indicate that salt substitution may be a cost-saving strategy for hypertension control and cardiovascular disease prevention for residents of eldercare facilities in China. The substantial health benefit savings in preventing MACEs and moderate operating costs offer strong evidence to support the Chinese government and other countries in planning or implementing sodium intake reduction and salt substitute campaigns. Trial Registration: ClinicalTrials.gov Identifier: NCT03290716.

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

BACKGROUND: Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. DESIGN: This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine. TRIAL STATUS: The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. DISCUSSION: The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide.

Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey.

OBJECTIVES: Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions. DESIGN: A cross-sectional study conducted from September 2017 to March 2018. SETTING: 48 residential elderly care facilities in northern China. PARTICIPANTS: Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia. EXPOSURE: Potassium intake is measured by 24-hour urinary potassium. OUTCOMES: Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect. RESULTS: Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted ß=0.0040/L; p=0.017) and high (adjusted ß=0.0078/L; p=0.003) but not low (adjusted ß=0.0018/L; p=0.311) risk of hyperkalaemia. CONCLUSIONS: A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns. TRIAL REGISTRATION NUMBER: NCT03290716; Post-results.

Association of Peer Network with Childhood Obesity in DECIDE-Children Program.

Some studies have found associations between the peer network and childhood obesity. The present study aimed to analyze the association of the peer network with obesity-related cognition, behaviors and adiposity indicators, and explore whether peer network influences the effect of a childhood-obesity intervention. Based on DECIDE-Children, 1392 children's friendship nominations within the class were collected and peer network indicators including the network size, network density, and in- and out-degree centrality were calculated. The linear mixed model was used to analyze the association between peer network indicators and children's cognition, behaviors and adiposity indicators (body mass index (BMI), BMI z score, the prevalence of overweight and obesity). Children with a higher in-degree centrality had 34.4% (95%CI: 17.4% to 48.1%) lower risk of overweight or obesity. The baseline degree centrality was inversely associated with the BMI and BMI z score at the end of the trial. For each unit increase in in-degree centrality at baseline, the BMI at the end of the trial decreased by 0.047 (95%CI: 0.015 to 0.080), and the BMI z score decreased by 0.015 (95%CI: 0.003 to 0.028). Children's popularity reflected by centrality in their peer network was associated with cognition, behaviors, and adiposity indicators. Future childhood-obesity intervention research could pay more attention to socially inactive children.

Effect of a Multifaceted Intervention on Children's Body Image and the Mediating Role of Body Image in Changes in Adiposity Indicators.

Besides genetic factors and energy-related behaviors, psycho-cultural factors are also important in obesity etiology. Previous studies have suggested that improving body image might be an effective method for managing body weight. Thus, this study aimed to evaluate the effects of a multifaceted intervention on the body image of children and explore whether body image played a mediating role in changes in adiposity indicators. This study was embedded in a cluster randomized controlled trial, involving 1287 children from 24 primary schools in three cities in China (Beijing, Changzhi and Urumqi). The 9-month multifaceted intervention on childhood obesity included five components (three targeted children and two targeted environments), and randomization was performed by an independent person who was blinded to the schools. Two indicators (body size perception and body size expectation) were chosen to characterize body image and were measured by Ma figural stimuli at baseline and the end of the trial. Changes in body image indicators were classified as conducive to weight loss or not. Other anthropometric measures and self-reported behaviors were also collected at both time points. Generalized linear mixed models were used in the analyses. Compared to the controls (n = 648), the proportion of body size perception conducive to weight loss increased in the intervention group (n = 639), with an odds ratio of 2.42 (95%CI: 1.70~3.45, p < 0.001). The proportion of body size expectation conducive to weight loss also increased more in the intervention group than in the controls (OR = 1.74, 95%CI: 1.14~2.66, p = 0.010). In children whose baseline nutritional status was "normal weight with higher BMI" or "overweight/obese", the improvements in body size perception and body size expectation partly mediated the association between the intervention and changes in BMI, BMI Z score, waist circumference and body fat percentage (p < 0.05). This multifaceted study effectively improved the body image of children, which, in turn, led to beneficial changes in adiposity indicators. For the first time, body size perception and body size expectation have been confirmed to be important factors associated with the beneficial effect of a childhood obesity intervention, suggesting that body image components should be generalized in the future.

Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial.

There is a paucity of high-quality evidence on the effectiveness and safety of salt reduction strategies, particularly for older people, who have the most to benefit but are at higher risk of adverse effects. Here, we conducted a clinical trial in which 48 residential elderly care facilities in China (1,612 participants including 1,230 men and 382 women, 55 years or older) were cluster-randomized using a 2 × 2 factorial design to provision of salt substitute (62.5% NaCl and 25% KCl) versus usual salt and to a progressively restricted versus usual supply of salt or salt substitute for 2 years. Salt substitute compared with usual salt lowered systolic blood pressure (-7.1 mmHg, 95% confidence interval (CI) -10.5 to -3.8), meeting the primary outcome of the trial, whereas restricted supply compared with usual supply of salt or salt substitute had no effect on systolic blood pressure. Salt substitute also lowered diastolic blood pressure (-1.9 mmHg, 95% CI -3.6 to -0.2) and resulted in fewer cardiovascular events (hazard ratio (HR) 0.60, 95% CI 0.38-0.96), but had no effect on total mortality (HR 0.84, 95% CI 0.63-1.13). From a safety standpoint, salt substitute increased mean serum potassium and led to more frequent biochemical hyperkalemia, but was not associated with adverse clinical outcomes. In contrast, salt restriction had no effect on any study outcome. The results of this trial indicate that use of salt substitute, but not efforts to restrict salt supply, may achieve blood pressure lowering and deliver health benefits to residents of elderly care facilities in China. Clinicaltrials.gov registration: NCT03290716.

Impact of genital warts on health related quality of life in men and women in mainland China: a multicenter hospital-based cross-sectional study.

BACKGROUND: Information on the health-related quality of life (HRQoL) of patients with genital warts (GW) in populations in mainland China is still limited. The aim of the study was to use a generic instrument to measure the impact of genital warts on HRQoL in men and women in this setting. METHODS: A multi-centre hospital-based cross-sectional study across 18 centers in China was conducted to interview patients using the European quality of life-5 dimension (EQ-5D) instrument; respondents' demographic and clinical data were also collected. RESULTS: A total of 1,358 GW patients (612 men, 746 women) were included in the analysis, with a mean age of 32.0 ± 10.6 years. 56.4% of the patients reported some problems in the dimension of Anxiety/Depression (highest), followed by Pain/Discomfort (24.7%) and Mobility (3.5%). The overall visual analogue scale (VAS) score of the study population was found to be 65.2 ± 22.0, and the EQ-5D index score was found to be 0.843 ± 0.129 using Japanese preference weights (the Chinese preference was unavailable yet). Patients with lower VAS means and EQ-5D index scores were more often female, living in urban area, and suffering multiple GW (all p values < 0.05), but the values did not differ notably by age (p values > 0.05). CONCLUSIONS: The HRQoL of patients with GW was substantially lower, compared to a national representative general population in China (VAS = ~80); the findings of different subgroups are informative for future GW prevention and control efforts.

Estimation of the costs of cervical cancer screening, diagnosis and treatment in rural Shanxi Province, China: a micro-costing study.

BACKGROUND: Cost estimation is a central feature of health economic analyses. The aim of this study was to use a micro-costing approach and a societal perspective to estimate aggregated costs associated with cervical cancer screening, diagnosis and treatment in rural China. METHODS: We assumed that future screening programs will be organized at a county level (population ~250,000), and related treatments will be performed at county or prefecture hospitals; therefore, this study was conducted in a county and a prefecture hospital in Shanxi during 2008-9. Direct medical costs were estimated by gathering information on quantities and prices of drugs, supplies, equipment and labour. Direct non-medical costs were estimated via structured patient interviews and expert opinion. RESULTS: Under the base case assumption of a high-volume screening initiative (11,475 women screened annually per county), the aggregated direct medical costs of visual inspection, self-sampled careHPV (Qiagen USA) screening, clinician-sampled careHPV, colposcopy and biopsy were estimated as US$2.64,$7.49,$7.95,$3.90 and $5.76, respectively. Screening costs were robust to screening volume (<5% variation if 2,000 women screened annually), but costs of colposcopy/biopsy tripled at the lower volume. Direct medical costs of Loop Excision, Cold-Knife Conization and Simple and Radical Hysterectomy varied from $61-544, depending on the procedure and whether conducted at county or prefecture level. Direct non-medical expenditure varied from $0.68-$3.09 for screening/diagnosis and $83-$494 for pre-cancer/cancer treatment. CONCLUSIONS: Diagnostic costs were comparable to screening costs for high-volume screening but were greatly increased in lower-volume situations, which is a key consideration for the scale-up phase of new programs. The study's findings will facilitate cost-effectiveness evaluation and budget planning for cervical cancer prevention initiatives in China.