Intake of Blueberries, Anthocyanins, and Risk of Eye Disease in Women.

BACKGROUND: Blueberries and anthocyanins, their key bioactive component, may improve eye health. However, few long-term studies have examined blueberries and anthocyanins with cataract and age-related macular degeneration (AMD). OBJECTIVES: To investigate the prospective association between blueberry and anthocyanin intake with incident cataract, total AMD, and visually significant AMD among middle-aged and older women. METHODS: A total of 36,653 and 35,402 women initially free of AMD and cataract, respectively, aged ≥45 y from the Women's Health Study provided semiquantitative food frequency questionnaire data on blueberry intake categorized as none, 1-3 servings/mo, 1 serving/wk, or ≥2 servings/wk, plus a combined category of ≥1 serving/wk. Total anthocyanin intake and major subclasses were energy-adjusted and categorized into quintiles. Self-reported risk factors of eye disease were adjusted in multivariable hazard ratios (HRs) (95% confidence intervals [CIs]) of confirmed cataract, AMD, and visually significant AMD with mean follow-up of 11 y. RESULTS: Among the participants, 10.5% consumed ≥1 serving/wk of blueberries, with mean total anthocyanin intake of 11.2 mg/d. Compared to no blueberry intake, women consuming 1-3 servings/mo, 1 serving/wk, and ≥2 servings/wk had corresponding multivariable HRs of total AMD of 0.90 (95% CI: 0.73, 1.11), 0.71 (95% CI: 0.50, 1.00), and 0.36 (95% CI: 0.14, 0.93) (Ptrend = 0.011); those consuming ≥1 servings/wk had an HR of 0.68 (95% CI: 0.47, 0.98). A similar magnitude of HRs were found for visually significant AMD (Ptrend = 0.012) but not for cataract. There were no significant associations between increasing total anthocyanin quintiles and total and visually significant AMD, but there was a modest inverse association with cataract (Ptrend = 0.022), driven by a 10% reduction in cataract in the upper 2 quintiles. CONCLUSIONS: Greater blueberry intake significantly reduced total AMD, but not visually significant AMD or cataract. However, the magnitude of effect for visually significant AMD was similar to total AMD. There was a modest but significant inverse association between dietary anthocyanin intake with cataract but not AMD.

Plasma bile acids in association with Crohn's disease.

BACKGROUND: In addition to facilitating lipid digestions, bile acids (BA) are signalling molecules acting on receptors on immune cells and along the gastrointestinal (GI) tract. The aim of this study was to assess if altered bile acid profiles in plasma are associated with Crohn's disease (CD). METHOD: This cross-sectional study included individuals (aged ≥18 years) referred for colonoscopy at a tertiary centre in Stockholm between 2016 and 2019. All participants received bowel preparation, completed a lifestyle questionnaire and provided blood samples for analysis. During colonoscopy, severity of disease was graded, and biopsies were taken from colonic mucosa. In the current substudy, 88 individuals with CD and 88 age-matched controls were selected for analysis of BA in plasma with ultra performance liquid chromatography (UPLC). Linear regression models were then used to compare mean bile acid concentrations and concentration ratios between CD and controls. RESULTS: Individuals with CD had lower plasma concentrations of the majority of secondary BA compared to controls, in total CD/CC ratio 0.60 (SE 0.12), p = 0.001. The most prominent observations were lower levels of deoxycolic acid derivates and lithocolic acid derivates among participants with CD. Moreover, plasma concentration for secondary BA among participants with active CD was significantly lower compared to those with CD in remission, CD active/CD remission ratio 0.65 (SE 0.11), p < 0.002. CONCLUSION: Crohn's disease may be associated with altered plasma bile acid composition. The significance of colonic bacterial diversity in this context needs to be investigated in further studies.

It is known that Crohn's disease is associated with dysbiosis in the gut microbiota and that primary bile acids are transformed to secondary bile acids by bacterial enzymes in the gut before reabsorbed and transported back to the liver.In this cross-sectional study, Crohn's disease was associated with lower concentrations of secondary bile acids in blood plasmaThe findings should encourage further studies the role of the gut microbiome and bile acid metabolism in development of Crohn's disease and bile acid profile as a biomarker for bowel inflammation.

The use, adherence, and evaluation of interactive text-messaging among women admitted to prevention of mother-to-child transmission of HIV care in Kenya (WelTel PMTCT).

BACKGROUND: To improve future mobile health (mHealth) interventions in resource-limited settings, knowledge of participants' adherence to interactive interventions is needed, but previous studies are limited. We aimed to investigate how women in prevention of mother-to-child transmission of HIV (PMTCT) care in Kenya used, adhered to, and evaluated an interactive text-messaging intervention. METHODS: We conducted a cohort study nested within the WelTel PMTCT trial among 299 pregnant women living with HIV aged ≥ 18 years. They received weekly text messages from their first antenatal care visit until 24 months postpartum asking "How are you?". They were instructed to text within 48 h stating that they were "okay" or had a "problem". Healthcare workers phoned non-responders and problem-responders to manage any issue. We used multivariable-adjusted logistic and negative binomial regression to estimate adjusted odds ratios (aORs), rate ratios (aRRs) and 95% confidence intervals (CIs) to assess associations between baseline characteristics and text responses. Perceptions of the intervention were evaluated through interviewer-administered follow-up questionnaires at 24 months postpartum. RESULTS: The 299 participants sent 15,183 (48%) okay-responses and 438 (1%) problem-responses. There were 16,017 (51%) instances of non-response. The proportion of non-responses increased with time and exceeded 50% around 14 months from enrolment. Most reported problems were health related (84%). Having secondary education was associated with reporting a problem (aOR:1.88; 95%CI: 1.08-3.27) compared to having primary education or less. Younger age (18-24 years) was associated with responding to < 50% of messages (aOR:2.20; 95%CI: 1.03-4.72), compared to being 35-44 years. Women with higher than secondary education were less likely (aOR:0.28; 95%CI: 0.13-0.64), to respond to < 50% of messages compared to women with primary education or less. Women who had disclosed their HIV status had a lower rate of non-response (aRR:0.77; 95%CI: 0.60-0.97). In interviews with 176 women, 167 (95%) agreed or strongly agreed that the intervention had been helpful, mainly by improving access to and communication with their healthcare providers (43%). CONCLUSION: In this observational study, women of younger age, lower education, and who had not disclosed their HIV status were less likely to adhere to interactive text-messaging. The majority of those still enrolled at the end of the intervention reported that text-messaging had been helpful, mainly by improving access to healthcare providers. Future mHealth interventions aiming to improve PMTCT care need to be targeted to attract the attention of women with lower education and younger age.

Evaluation of plasma Short chain fatty acid levels as markers for Inflammatory bowel disease.

BACKGROUND: Specific variations of short chain fatty acids in fecal samples have been shown for patients with inflammatory bowel disease. The aim of this study was to assess if Crohn's disease and ulcerative colitis are associated with altered concentrations of short chain fatty acids also in blood plasma. METHOD: Between 2016-2019, Swedish adults referred to a tertiary center for colonoscopy were asked to participate in a cross-sectional study. Individuals with Crohn's disease or ulcerative colitis as well as individuals with no findings on the colonoscopy (defined as clean colon) were included in the study. Data on colonoscopy findings, blood samples (including haemoglobin, C-reactive protein and short chain fatty acid analysis) as well as a validated lifestyle questionnaire including 277 questions were collected from all participants. Linear regression was used to compare mean concentrations of short chain fatty acids between Crohn's disease, ulcerative colitis and clean colon. RESULTS: The cohort consisted of 132 individuals with Crohn's disease, 119 with ulcerative colitis and 205 with clean colon. In the crude model, succinic acid was significantly lower (p < 0.05) among patients with Crohn's disease (mean 3.00 µM SE 0.10) and ulcerative colitis (mean 3.13 µM SE 0.10) in comparison to clean colon (mean 3.41 µM SE 0.08), however when adjusting for sex, age and diet the results did not remain statistically significant. No differences in plasma concentration of the other measured short chain fatty acids were detected. CONCLUSION: Crohn's disease and ulcerative colitis are not associated with altered short chain fatty acid concentrations in plasma. Further research is needed to confirm or refute our findings.

In this cross-sectional study including individuals with inflammatory bowel disease and healthy subjects we found no association between Crohn's disease and ulcerative colitis and short chain fatty acid concentrations in plasma.

Fruit, vegetable and dietary antioxidant intake in school age, respiratory health up to young adulthood.

BACKGROUND: Dietary antioxidants may protect the lung against oxidative damage and prevent chronic respiratory disease. We aimed to investigate fruit, vegetable and antioxidant intake (measured as total antioxidant capacity, TAC) at age 8 years in relation to asthma and lung function up to 24 years. METHODS: In this study of 2506 participants from a Swedish birth cohort, diet was assessed using food frequency questionnaires. Information on asthma was collected by questionnaires, and lung function was measured by spirometry at ages 8, 16 and 24 years. Generalized estimating equations and mixed effect models were used to assess overall, age- and sex-specific associations. RESULTS: After adjustment for confounders, a higher fruit intake at age 8 years was associated with a tendency to reduced odds of prevalent asthma (T3 vs. T1, OR 0.78; 95% CI 0.60-1.01, p-trend .083), with reduced odds of incident asthma and increased odds of remittent asthma (≥median, OR 0.76; 95% CI 0.58-0.99 and OR 1.60; 95% CI 1.05-2.42, respectively) up to 24 years. Comparable, but non-significant, odds ratios were observed in analyses of long-term fruit intake (mean intake at ages 8 and 16 years). In contrast, no association was observed with vegetable intake. A higher dietary TAC (T3 vs. T1) at 8 years was associated with reduced odds of prevalent asthma (OR 0.73; 95% CI 0.58-0.93, p-trend .010) and improved lung function development (FEV1 -z +0.11; 95% CI 0.01-0.21, p-trend .036 and FVC-z +0.09; 95% CI -0.01-0.20, p-trend .072) up to 24 years. Associations were more pronounced among males, and regarding asthma, participants sensitized to aeroallergens. CONCLUSIONS: Antioxidant intake in school age may improve asthma and lung function up to young adulthood. Although our results should be interpreted with caution, they emphasize the importance of following current dietary guidelines regarding consumption of antioxidant-rich foods as part of a balanced diet.

Neonatal sepsis prediction through clinical decision support algorithms: A systematic review.

AIM: To systematically summarise the current evidence of employing clinical decision support algorithms (CDSAs) using non-invasive parameters for sepsis prediction in neonates. METHODS: A comprehensive search in PubMed, CENTRAL and EMBASE was conducted. Screening, data extraction and risk of bias were performed by two authors. The certainty of the evidence was assessed using GRADE. PROSPERO ID: CRD42020205143. RESULTS: After abstract and full-text screening, 36 studies comprising 18,096 infants were included. Most CDSAs evaluated heart rate (HR)-based parameters. Two publications derived from one randomised-controlled trial assessing HR characteristics reported significant reduction in 30-day septicaemia-related mortality. Thirty-four non-randomised studies found promising yet inconclusive results. CONCLUSION: Heart rate-based parameters are reliable components of CDSAs for sepsis prediction, particularly in combination with additional vital signs and demographics. However, inconclusive evidence and limited standardisation restricts clinical implementation of CDSAs outside of a controlled research environment. Further experimentation and comparison of parameter combinations and testing of new CDSAs are warranted.

Dietary antioxidant intake in school age and lung function development up to adolescence.

Dietary antioxidant intake has been hypothesised to influence lung function. The association between total antioxidant capacity (TAC) of the diet at age 8 years and lung function development up to 16 years in 2307 participants from the Swedish population-based birth cohort BAMSE (Children, Allergy, Milieu, Stockholm, Epidemiology) was investigated.Information on TAC was obtained from a food frequency questionnaire at 8 years. Lung function was measured by spirometry at 8 and 16 years, impulse oscillometry (IOS) and exhaled nitric oxide fraction (F eNO) at 16 years. Low lung function was defined as forced expiratory volume in 1 s (FEV1) z-score below the 25th percentile. Longitudinal associations between TAC and lung function were analysed by mixed effect models adjusted for potential confounders. Stratification by asthma at 8 years was performed to examine effect modification.The median TAC intake was 10 067 µmol Trolox equivalents (TE)·g-1, with males having a lower mean compared to females (9963 versus 10 819 µmol TE·g-1). In analyses of lung function change between 8 and 16 years, there were no statistically significant associations between TAC in tertiles and spirometry results for the total study population. Among children with asthma at 8 years (prevalence 7%), higher TAC was associated with higher mean FEV1 (0.46 sd, 95% CI 0.11-0.80) and decreased odds of low lung function at 16 years (OR 0.28, 95% CI 0.12-0.65). There were no associations between TAC and forced vital capacity or IOS/F eNO results.High dietary antioxidant intake in school age may be associated with improved lung function development from school age to adolescence among children with asthma.

Social concerns related to HIV status disclosure and participation in the prevention of mother-to-child transmission of HIV care among pregnant women in Kenya.

BACKGROUND: Social concerns about unintentional HIV status disclosure and HIV-related stigma are barriers to pregnant women's access to prevention of mother-to-child transmission of HIV (PMTCT) care. There is limited quantitative evidence of women's social and emotional barriers to PMTCT care and HIV disclosure. We aimed to investigate how social concerns related to participation in PMTCT care are associated with HIV status disclosure to partners and relatives among pregnant women living with HIV in western Kenya. METHODS: A cross-sectional study, including 437 pregnant women living with HIV, was carried out at enrolment in a multicentre mobile phone intervention trial (WelTel PMTCT) in western Kenya. Women diagnosed with HIV on the day of enrolment were excluded. To investigate social concerns and their association with HIV disclosure we used multivariable-adjusted logistic regression, adjusted for sociodemographic and HIV-related characteristics, to estimate odds ratios (OR) and 95% confidence intervals (CI). RESULTS: The majority (80%) had disclosed their HIV status to a current partner and 46% to a relative. Older women (35-44 years) had lower odds of disclosure to a partner (OR = 0.15; 95% CI: 0.05-0.44) compared to women 18-24 years. The most common social concern was involuntary HIV status disclosure (reported by 21%). Concern about isolation or lack of support from family or friends was reported by 9%, and was associated with lower odds of disclosure to partners (OR = 0.33; 95% CI: 0.12-0.85) and relatives (OR = 0.37; 95% CI: 0.16-0.85). Concern about separation (reported by 5%; OR = 0.17; 95% CI: 0.05-0.57), and concern about conflict with a partner (reported by 5%; OR = 0.18; 95% CI: 0.05-0.67), was associated with lower odds of disclosure to a partner. CONCLUSIONS: Compared to previous reports from Kenya, our estimated disclosure rate to a partner is higher, suggesting a possible improvement over time in disclosure. Younger pregnant women appear to be more likely to disclose, suggesting a possible decreased stigma and more openness about HIV among younger couples. Healthcare providers and future interventional studies seeking to increase partner disclosure should consider supporting women regarding their concerns about isolation, lack of support, separation, and conflict with a partner. PMTCT care should be organized to ensure women's privacy and confidentiality.

Multivitamin Use and the Risk of Cardiovascular Disease in Men.

BACKGROUND: Although multivitamins are widely used by US adults, few prospective studies have investigated their association with the long- and short-term risks of cardiovascular disease (CVD). OBJECTIVE: The aim of this study was to investigate how multivitamin use is associated with the risk of CVD in initially healthy men at baseline. METHODS: We studied 18,530 male physicians aged ≥40 y from the Physicians' Health Study I cohort who were free of CVD and cancer at baseline (1982). All men provided a wide range of self-reported lifestyle and clinical factors plus intake of selected foods and dietary supplements. Cox proportional hazards models were used to calculate multivariable-adjusted HRs (95% CIs). RESULTS: During a mean follow-up of 12.2 y (total of 225,287 person-years), there were 1697 incident cases of major CVD (defined as nonfatal myocardial infarction, nonfatal stroke, and CVD death). In multivariable-adjusted analyses, no significant associations were observed among baseline multivitamin users compared with nonusers for the risk of major CVD events (HR: 0.94; 95% CI: 0.84, 1.05), whereas a self-reported duration of ≥20 y at baseline was associated with lower risk (HR: 0.56; 95% CI: 0.35, 0.90; P-trend = 0.05). Baseline multivitamin use was also significantly inversely associated with the risk of cardiac revascularization (HR: 0.86; 95% CI: 0.75, 0.98). Baseline use of multivitamins was not significantly associated with other CVD endpoints. CONCLUSION: In this long-term prospective study in initially healthy men, multivitamin use for ≥20 y was associated with a lower risk of major CVD events.

A prospective study of erythrocyte polyunsaturated fatty acid, weight gain, and risk of becoming overweight or obese in middle-aged and older women.

PURPOSE: ω3 and ω6 fatty acids (FA) may have divergent effects on the development of obesity. We examined the association of baseline erythrocyte ω3 and ω6 FA composition with body weight change and the risk of becoming overweight or obese in the Women's Health Study (WHS) participants. METHODS: We identified 534 women who had baseline erythrocyte FA measured and a baseline body mass index (BMI) of 18.5-<25 kg/m(2). Body weight was updated at a total of six time points during follow-up. RESULTS: Weight gain during a mean of 10.4-year follow-up increased with increasing quartiles of baseline erythrocyte cis ω6 FA, ω6/ω3 ratio, and trans FA while decreased with increasing cis ω3 FA. After multivariable adjustment including total energy intake and physical activity, the weight gain (kg) in the highest versus the lowest quartile was 3.08 versus 2.32 for erythrocyte cis ω6 FA (p trend 0.04), 2.07 versus 2.92 for cis ω3 FA (p trend 0.08), 2.93 versus 2.05 for ω6/ω3 ratio (p trend 0.046), and 3.03 versus 2.27 for trans FA (p trend 0.06). Among individual FA, the associations were significant for 18:2ω6, 18:3ω6, and trans 18:1 and marginally significant for 20:3ω6 and trans 18:2. The risk of becoming overweight or obese (defined as BMI ≥25 kg/m(2) at any follow-up time point) increased across increasing ω6/ω3 ratio (multivariable model p trend 0.04). CONCLUSIONS: In this prospective study, we found suggestive evidence that erythrocyte cis ω6 FA may be positively associated, and cis ω3 FA inversely associated with weight gain in initially normal-weight women.

Higher Intake of Fruit, but Not Vegetables or Fiber, at Baseline Is Associated with Lower Risk of Becoming Overweight or Obese in Middle-Aged and Older Women of Normal BMI at Baseline.

BACKGROUND: Fruit, vegetable, and dietary fiber intake have been associated with lower risk of cardiovascular disease (CVD); however, little is known about their role in obesity prevention. OBJECTIVE: Our goal was to investigate whether intake of fruits, vegetables, and dietary fiber is associated with weight change and the risk of becoming overweight and obese. METHODS: We studied 18,146 women aged ≥45 y from the Women's Health Study free of CVD and cancer with an initial body mass index (BMI) of 18.5 to <25 kg/m². Fruit, vegetable, and dietary fiber intakes were assessed at baseline through a 131-item food-frequency questionnaire, along with obesity-related risk factors. Women self-reported body weight on annual questionnaires. RESULTS: During a mean follow-up of 15.9 y, 8125 women became overweight or obese (BMI ≥25 kg/m²). Intakes of total fruits and vegetables, fruits, and dietary fiber were not associated with the longitudinal changes in body weight, whereas higher vegetable intake was associated with greater weight gain (P-trend: 0.02). In multivariable analyses, controlling for total energy intake and physical activity along with other lifestyle, clinical, and dietary factors, women in the highest vs. lowest quintile of fruit intake had an HR of 0.87 (95% CI: 0.80, 0.94; P-trend: 0.01) of becoming overweight or obese. No association was observed for vegetable or dietary fiber intake. The association between fruit intake and risk of becoming overweight or obese was modified by baseline BMI (P-interaction: <0.0001) where the strongest inverse association was observed among women with a BMI <23 kg/m² (HR: 0.82; 95% CI: 0.71, 0.94). CONCLUSION: Our results suggest that greater baseline intake of fruit, but not vegetables or fiber, by middle-aged and older women with a normal BMI at baseline is associated with lower risk of becoming overweight or obese.

Who uses multivitamins? A cross-sectional study in the Physicians' Health Study.

PURPOSE: The aim of this study was to examine the prevalence of self-reported multivitamin use in the Physicians' Health Study (PHS) cohort and its association with various lifestyle, clinical, and dietary factors to improve our understanding of who tends to use multivitamins. METHODS: Among 18,040 middle-aged and older men, information on lifestyle and clinical factors was collected from a baseline enrollment questionnaire, and supplement use and dietary factors were assessed through a food-frequency questionnaire. Four categories of multivitamin use were considered: (1) no supplement use, (2) use of multivitamins only, (3) use of multivitamins with other individual vitamin/mineral supplements, and (4) use of other supplements only. We used logistic regression to calculate multivariate odds ratios and 95% confidence intervals of taking multivitamin supplements for various lifestyle, clinical and dietary factors. RESULTS: Overall, 36% of men reported current multivitamin use. Men who were older, current smokers, and currently using aspirin were 143, 43, and 74% more likely to use multivitamins only. Men having a history of hypercholesterolemia were 16% more likely to use multivitamins only. A 14, 24, and 26% greater likelihood of using multivitamins was also observed among men consuming more fruits and vegetables, whole grains, and tea, respectively. Similar associations were observed for the likelihood of using multivitamins with other supplements; however, men with higher physical activity, history of cancer, hypertension, higher consumption of nuts, and lower consumption of red meat and coffee were also more likely to use multivitamins with other supplements (all P < 0.05). CONCLUSION: Self-reported multivitamin use associated with lifestyle, clinical and dietary factors may be an indicator of healthy behaviors. These results provide important information for the interpretation of the recent findings from the PHS II trial and consideration of results from observational studies of multivitamin use and chronic disease.

High-dose supplements of vitamins C and E, low-dose multivitamins, and the risk of age-related cataract: a population-based prospective cohort study of men.

We examined the associations of high-dose supplements of vitamins C and E and low-dose multivitamins with the risk of age-related cataract among 31,120 Swedish men, aged 45-79 years, in a population-based prospective cohort. Dietary supplement use was assessed from a questionnaire at baseline in 1998. During follow-up (January 1998-December 2006), 2,963 incident age-related cataract cases were identified. The multivariable-adjusted hazard ratio for men using vitamin C supplements only was 1.21 (95% confidence interval (CI): 1.04, 1.41) in a comparison with that of non-supplement users. The hazard ratio for long-term vitamin C users (≥10 years before baseline) was 1.36 (95% CI: 1.02, 1.81). The risk of cataract with vitamin C use was stronger among older men (>65 years) (hazard ratio = 1.92, 95% CI: 1.41, 2.60) and corticosteroid users (hazard ratio = 2.11, 95% CI: 1.48, 3.02). The hazard ratio for vitamin E use only was 1.59 (95% CI: 1.12, 2.26). Use of multivitamins only or multiple supplements in addition to vitamin C or E was not associated with cataract risk. These results suggest that the use of high-dose (but not low-dose) single vitamin C or E supplements may increase the risk of age-related cataract. The risk may be even higher among older men, corticosteroid users, and long-term users.

The role of calcium in the prevention of cardiovascular disease--a review of observational studies and randomized clinical trials.

Calcium is a mineral that is important for bone health and has also been suggested to play a role in the prevention of cardiovascular disease (CVD). Lately, the potential effects of both inadequate and excessive calcium intake have received growing attention. In this review, we summarize the evidence from experimental, epidemiologic, and clinical studies investigating the role of calcium intake, either from the diet or from supplements, as well as blood concentrations, in relation to the risk of CVD in adults. In vitro and in vivo laboratory studies suggest that calcium may be involved in CVD development through multiple pathways, including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. Several prospective epidemiologic studies have examined how dietary or supplemental calcium intake is associated with CVD incidence or mortality in middle-aged and older adults, and the results are inconsistent. Prospective studies investigating blood concentrations of calcium have also reported mixed results. However, changes in blood calcium concentrations may reflect a disturbed calcium phosphate balance, which is associated with increased risk of CVD. To date there is no randomized clinical trial that has been designed specifically to test the effect of calcium supplementation on the risk of CVD as the primary end point. Existing trials have performed secondary analyses, and most of them have been conducted among postmenopausal women. These trials suggest that calcium supplementation has no effect on CVD development; however, they do not allow a definitive conclusion to be drawn. The average daily intake of calcium is low in many populations; however, the evidence for a potential role of dietary or supplemental calcium in the prevention of CVD remains insufficient and inconclusive. Only large-scale randomized trials designed to investigate the effects of calcium supplementation on CVD events as the primary end point, as well as short-term trials investigating the effect on coronary biomarkers, can provide a definitive answer.

The effect of an interactive weekly text-messaging intervention on retention in prevention of mother-to-child transmission of HIV care: a randomised controlled trial (WelTel PMTCT).

Retention in prevention of mother-to-child transmission (PMTCT) care is critical to prevent vertical HIV transmission and reduce morbidity and mortality of mother-infant pairs. We investigated whether weekly, interactive text-messaging improved 18-month postpartum retention in PMTCT care. This randomised, two-armed, parallel trial was conducted at six PMTCT clinics in western Kenya. Pregnant women with HIV at least 18 years of age with access to a mobile phone, able to text-message, or had somebody who could text on their behalf, were eligible. Participants were randomly assigned at a 1:1 ratio in block sizes of four to the intervention or control group. The intervention group received weekly text messages asking "How are you?" ("Mambo?" in Swahili) and were requested to respond within 48 h. Healthcare workers called women who indicated a problem or did not respond. The intervention was administered up to 24 months after delivery. Both groups received standard care. The primary outcome was retention in care at 18 months postpartum (i.e., clinic attendance 16-24 months after delivery based on data from patient files, patient registers and Kenya's National AIDS and STI Control Programme database), which was analysed by intention-to-treat. Researchers and data collectors were masked to group assignment, while healthcare workers were not. Between June 25th, 2015, and July 5th, 2016, we randomly assigned 299 women to the intervention and 301 to standard care only. Follow-up concluded on July 26th, 2019. The proportion of women retained in PMTCT care at 18 months postpartum was not significantly different between the intervention (n = 210/299) and control groups (n = 207/301) (risk ratio 1.02, 95% confidence interval 0.92-1.14, p = 0.697). No adverse events related to the mobile phone intervention were reported. Weekly, interactive text-messaging was not associated with improved retention in PMTCT care at 18 months postpartum or linkage to care up to 30 months postpartum in this setting. (ISRCTN No. 98818734).

Total antioxidant capacity of diet and risk of stroke: a population-based prospective cohort of women.

BACKGROUND AND PURPOSE: Consumption of antioxidant-rich foods may reduce the risk of stroke by inhibition of oxidative stress and inflammation. Total antioxidant capacity (TAC) takes into account all antioxidants and the synergistic effects between them. We examined the association between dietary TAC and stroke incidence in cardiovascular disease (CVD)-free women and in women with CVD history at baseline. METHODS: The study included women (31,035 CVD-free and 5680 with CVD history at baseline), aged 49 to 83 years, from the Swedish Mammography Cohort. Diet was assessed with a food frequency questionnaire. Dietary TAC was calculated using oxygen radical absorbance capacity values. Stroke cases were ascertained by linkage with the Swedish Hospital Discharge Registry. RESULTS: During follow-up (September 1997 to December 2009), we identified 1322 stroke cases (988 cerebral infarctions, 226 hemorrhagic strokes, and 108 unspecified strokes) among CVD-free women and 1007 stroke cases (796 cerebral infarctions, 100 hemorrhagic strokes, and 111 unspecified strokes) among women with a CVD history. The multivariable hazard ratio of total stroke comparing the highest with the lowest quintile of dietary TAC was 0.83 (95% CI, 0.70-0.99; P for trend=0.04) in CVD-free women. Among women with a CVD history, the hazard ratios for the highest versus lowest quartile of TAC were 0.90 (95% CI, 0.75-1.07; P for trend=0.30) for total stroke and 0.55 (95% CI, 0.32-0.95; P for trend=0.03) for hemorrhagic stroke. CONCLUSIONS: These findings suggest that dietary TAC is inversely associated with total stroke among CVD-free women and hemorrhagic stroke among women with CVD history.

Multivitamins in the prevention of cancer and cardiovascular disease: the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial.

BACKGROUND: Although older adults commonly take multivitamin-multimineral (MVM) supplements to promote health, evidence on the use of daily MVMs on invasive cancer is limited. OBJECTIVES: The study objective was to determine if a daily MVM decreases total invasive cancer among older adults. METHODS: We performed a randomized, double-blind, placebo-controlled, 2-by-2 factorial trial of a daily MVM and cocoa extract for prevention of cancer and cardiovascular disease (CVD) among 21,442 US adults (12,666 women aged ≥65 y and 8776 men aged ≥60 y) free of major CVD and recently diagnosed cancer. The intervention phase was from June 2015 through December 2020. This article reports on the MVM intervention. Participants were randomly assigned to daily MVM or placebo. The primary outcome was total invasive cancer, excluding nonmelanoma skin cancer. Secondary outcomes included major site-specific cancers, total CVD, all-cause mortality, and total cancer risk among those with a baseline history of cancer. RESULTS: During a median follow-up of 3.6 y, invasive cancer occurred in 518 participants in the MVM group and 535 participants in the placebo group (HR: 0.97; 95% CI: 0.86, 1.09; P = 0.57). We observed no significant effect of a daily MVM on breast cancer (HR: 1.06; 95% CI: 0.79, 1.42) or colorectal cancer (HR: 1.30; 95% CI: 0.80, 2.12). We observed a protective effect of a daily MVM on lung cancer (HR: 0.62; 95% CI: 0.42, 0.92). The composite CVD outcome occurred in 429 participants in the MVM group and 437 participants in the placebo group (HR: 0.98; 95% CI: 0.86, 1.12). MVM use did not significantly affect all-cause mortality (HR: 0.93; 95% CI: 0.81, 1.08). There were no safety concerns. CONCLUSIONS: A daily MVM supplement, compared with placebo, did not significantly reduce the incidence of total cancer among older men and women. Future studies are needed to determine the effects of MVMs on other aging-related outcomes among older adults. This trial is registered at www.clinicaltrials.gov as NCT02422745.

Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS).

Background Cocoa extract and multivitamins have been proposed to reduce the risk of cardiovascular disease (CVD) and cancer, respectively. However, few randomized clinical trials have tested their long-term effects on these outcomes. Methods The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a randomized, double-blind, placebo-controlled, 2 × 2 factorial trial of a cocoa extract supplement and a multivitamin supplement to reduce the risk of CVD and cancer. Here we describe the pragmatic, hybrid design of the trial and baseline characteristics of the trial participants. Results The nationwide study population includes 21,442 U.S. women aged ≥65 years and men aged ≥60 years without baseline myocardial infarction (MI), stroke, or a recent (within the past 2 years) cancer diagnosis. Participants were randomized in a 2 × 2 factorial design to one of four groups: (1) cocoa extract (containing 500 mg/d flavanols, including 80 mg (-)-epicatechin) and a multivitamin (Centrum Silver©); (2) cocoa extract and multivitamin placebo; (3) multivitamin and cocoa extract placebo; or (4) both placebos. Randomization successfully distributed baseline demographic, clinical, behavioral, and dietary characteristics across treatment groups. Baseline biospecimens were collected from 6867 participants, with at least one follow-up biospecimen from 2142 participants. The primary outcome for the cocoa extract intervention is total CVD (a composite of MI, stroke, cardiovascular mortality, coronary revascularization, unstable angina requiring hospitalization, carotid artery surgery, and peripheral artery surgery); the primary outcome for the multivitamin intervention is total invasive cancer. Conclusion COSMOS will provide important information on the health effects of cocoa extract and multivitamin supplementation in older U.S. adults. Clinical Trials Registration: clinicaltrials.gov #NCT02422745.

ECG Abnormalities and Arterial Stiffness by HIV Status among High-Risk Populations in Rakai, Uganda: A Pilot Study.

Background: People living with HIV are at increased risk for cardiovascular disease (CVD). In sub-Saharan Africa, population-based data on major CVD events such as stroke and myocardial infarction are difficult to collect. The use of proxy measures could be a feasible way to better study CVD in such settings. This study aimed to determine the acceptance of incorporating ECG and arterial function measurements into a population-based cohort study and to assess the prevalence of ECG abnormalities and arterial stiffness. Methods: A pilot study was conducted within the Rakai Community Cohort Study in Uganda on two high-risk CVD populations; one determined by age (35-49) and Framingham CVD risk scores and the other by age alone (50+). Data on ECG, arterial function, blood pressure, and HIV status were collected. The acceptability of incorporating ECG and arterial function measurements was established as an acceptance rate difference of no more than 5% to blood pressure measurements. Results: A total of 118 participants were enrolled, 57 participants living with HIV and 61 HIV-negative participants. Both ECG measurements and arterial function were well accepted (2% difference). Left ventricular hypertrophy (LVH) and arterial stiffness (>10 m/s) were common in both participants living with HIV and HIV-negative participants across the two high-risk populations. Prevalence rates ranged from 30% to 53% for LVH and 25% to 58% for arterial stiffness. Arterial stiffness at the 11 m/s cutoff (p = 0.03) was found to be more common among participants living with HIV in the 35-49 population. Conclusions: The incorporation of ECG and arterial function measurements into routine activities of a population-based cohort was acceptable and incorporating these proxy measures into cohort studies should be explored further. LVH and arterial stiffness were both common irrespective of HIV status with arterial stiffness potentially more common among people living with HIV.

The effect of weekly interactive text-messaging on early infant HIV testing in Kenya: a randomised controlled trial (WelTel PMTCT).

Mother-to-child transmission of HIV remains a significant concern in Africa despite earlier progress. Early infant diagnosis (EID) of HIV is crucial to reduce mortality among infected infants through early treatment initiation. However, a large proportion of HIV-exposed infants are still not tested in Kenya. Our objective was to investigate whether weekly interactive text-messages improved prevention of mother-to-child transmission (PMTCT) of HIV care outcomes including EID HIV testing. This multicentre, parallel-group, randomised, open-label trial included six antenatal care clinics across western Kenya. Pregnant women living with HIV, aged 18 years or older, with mobile phone access, were randomised in a 1:1 ratio to weekly text messages that continued until 24 months postpartum, asking "How are you?" ("Mambo?") to which they were asked to respond within 48 h, or a control group. Healthcare workers contacted participants reporting problems and non-responders by phone. Participants in both groups received routine PMTCT care. The prespecified secondary outcome reported in this paper is EID HIV testing by eight weeks of age (blinded outcome assessment). Final 24-months trial results will be published separately. We estimated risk ratios using Poisson regression with robust standard errors. Between June 2015-July 2016, we screened 735 pregnant women, of whom 600 were enrolled: 299 were allocated to the intervention and 301 to the control group. By eight weeks of age, the uptake of EID HIV testing out of recorded live births was 85.5% in the intervention and 84.7% in the control group (71.2% vs. 71.8% of participants randomised, including miscarriages, stillbirths, etc.). The intention-to-treat risk ratio was 0.99; 95% CI: 0.90-1.10; p = 0.89. The proportion of infants diagnosed with HIV was 0.8% in the intervention and 1.2% in the control group. No adverse events were reported. We found no evidence to support that the WelTel intervention improved EID HIV testing. A higher uptake of EID testing than expected in both groups may be a result of lower barriers to EID testing and improved PMTCT care in western Kenya, including the broader standard use of mobile phone communication between healthcare workers and patients. (ISRCTN No. 98818734. Funded by the European-Developing Countries Clinical Trial Partnership and others).