Legacy benefits of blood pressure treatment on cardiovascular events are primarily mediated by improved blood pressure variability: the ASCOT trial.

BACKGROUND AND AIMS: Visit-to-visit systolic blood pressure variability (BPV) is an important predictor of cardiovascular (CV) outcomes. The long-term effect of a period of blood pressure (BP) control, but with differential BPV, is uncertain. Morbidity and mortality follow-up of UK participants in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure-Lowering Arm has been extended for up to 21 years to determine the CV impact of mean systolic blood pressure (SBP) control and BPV during the trial, and amongst those allocated to amlodipine- and atenolol-based treatment. METHODS: Eight thousand five hundred and eighty hypertensive participants (4305 assigned to amlodipine ± perindopril-based and 4275 to atenolol ± diuretic-based treatment during the in-trial period (median 5.5 years) were followed for up to 21 years (median 17.4 years), using linked hospital and mortality records. A subgroup of participants (n = 2156) was followed up 6 years after the trial closure with a self-administered questionnaire and a clinic visit. In-trial mean SBP and standard deviation of visit-to-visit SBP as a measure of BPV, were measured using >100 000 BP measurements. Cox proportional hazard models were used to estimate the risk [hazard ratios (HRs)], associated with (i) mean with SBP and BPV during the in-trial period, for the CV endpoints occurring after the end of the trial and (ii) randomly assigned treatment to events following randomization, for the first occurrence of pre-specified CV outcomes. RESULTS: Using BP data from the in-trial period, in the post-trial period, although mean SBP was a predictor of CV outcomes {HR per 10 mmHg, 1.14 [95% confidence interval (CI) 1.10-1.17], P < .001}, systolic BPV independent of mean SBP was a strong predictor of CV events [HR per 5 mmHg 1.22 (95% CI 1.18-1.26), P < .001] and predicted events even in participants with well-controlled BP. During 21-year follow-up, those on amlodipine-based compared with atenolol-based in-trial treatment had significantly reduced risk of stroke [HR 0.82 (95% CI 0.72-0.93), P = .003], total CV events [HR 0.93 (95% CI 0.88-0.98), P = .008], total coronary events [HR 0.92 (95% CI 0.86-0.99), P = .024], and atrial fibrillation [HR 0.91 (95% CI 0.83-0.99), P = .030], with weaker evidence of a difference in CV mortality [HR 0.91 (95% CI 0.82-1.01), P = .073]. There was no significant difference in the incidence of non-fatal myocardial infarction and fatal coronary heart disease, heart failure, and all-cause mortality. CONCLUSIONS: Systolic BPV is a strong predictor of CV outcome, even in those with controlled SBP. The long-term benefits of amlodipine-based treatment compared with atenolol-based treatment in reducing CV events appear to be primarily mediated by an effect on systolic BPV during the trial period.

Mortality and re-fracture rates in low trauma hip fracture.

OBJECTIVES: This study aimed to estimate the incidence rate of re-fracture and all-cause mortality rate in patients with hip fractures caused by minor trauma in the first year following the event. MATERIALS AND METHODS: This is a retrospective cohort study of patients over 50 years of age conducted in a referral hospital located in Tehran (Shafa-Yahyaian). Using the hospital information system (HIS), all patients hospitalized due to hip fractures caused by minor trauma during 2013-2019 were included in the study. We investigated the occurrence of death and re-fracture in all patients one year after the primary hip fracture. RESULTS: A total of 945 patients with hip fractures during a 307,595 person-days of follow-up, were included. The mean age of the participants was 71 years (SD = 11.19), and 533 (59%) of them were women. One hundred forty-nine deaths were identified during the first year after hip fracture, resulting in a one-year mortality rate of 17.69% (95% CI: 15.06-20.77). The one-year mortality rate was 20.06% in men and 15.88% in women. Out of all the participants, 667 answered the phone call, of which 29 cases had experienced a re-fracture in the first year (incidence rate = 5.03%, 95% CI: 3.50-7.24). The incidence rates in women and men were 6.07% and 3.65%, respectively. CONCLUSION: Patients with low-trauma hip fractures have shown a high rate of mortality in the first year. Considering the increase in the incidence of hip fractures with age, comprehensive strategies are needed to prevent fractures caused by minor trauma in the elderly population.

Optimizing cardiovascular disease mortality prediction: a super learner approach in the tehran lipid and glucose study.

BACKGROUND & AIM: Cardiovascular disease (CVD) is the most important cause of death in the world and has a potential impact on health care costs, this study aimed to evaluate the performance of machine learning survival models and determine the optimum model for predicting CVD-related mortality. METHOD: In this study, the research population was all participants in Tehran Lipid and Glucose Study (TLGS) aged over 30 years. We used the Gradient Boosting model (GBM), Support Vector Machine (SVM), Super Learner (SL), and Cox proportional hazard (Cox-PH) models to predict the CVD-related mortality using 26 features. The dataset was randomly divided into training (80%) and testing (20%). To evaluate the performance of the methods, we used the Brier Score (BS), Prediction Error (PE), Concordance Index (C-index), and time-dependent Area Under the Curve (TD-AUC) criteria. Four different clinical models were also performed to improve the performance of the methods. RESULTS: Out of 9258 participants with a mean age of (SD; range) 43.74 (15.51; 20-91), 56.60% were female. The CVD death proportion was 2.5% (228 participants). The death proportion was significantly higher in men (67.98% M, 32.02% F). Based on predefined selection criteria, the SL method has the best performance in predicting CVD-related mortality (TD-AUC > 93.50%). Among the machine learning (ML) methods, The SVM has the worst performance (TD-AUC = 90.13%). According to the relative effect, age, fasting blood sugar, systolic blood pressure, smoking, taking aspirin, diastolic blood pressure, Type 2 diabetes mellitus, hip circumference, body mss index (BMI), and triglyceride were identified as the most influential variables in predicting CVD-related mortality. CONCLUSION: According to the results of our study, compared to the Cox-PH model, Machine Learning models showed promising and sometimes better performance in predicting CVD-related mortality. This finding is based on the analysis of a large and diverse urban population from Tehran, Iran.

The relationship between diet quality indices and odds of breast cancer in women: a case-control study.

Dietary quality is an important factor in the etiology of breast cancer (BrCa), but further studies are required to better elucidate this relationship. Accordingly, we sought to analyze if diet quality, assessed using the Diet Quality Index-International (DQI-I), Mean Adequacy Ratio (MAR), and Dietary Energy Density (DED), was related to BrCa. In this Hospital-based case-control study, 253 patients with BrCa and 267 non BrCa controls were enrolled. Individual food consumption data from a food frequency questionnaire was used to calculate the Diet Quality Indices (DQI). Employing a case-control design, odds ratios (ORs) and 95% confidence intervals (CIs) were obtained, and a dose-response analysis investigated. After adjusting for potential confounders, those in the highest quartile of the MAR index had significantly lower odds of BrCa than those in the lowest (OR = 0.42, 95% CI 0.23-0.78; P for trend = 0.007). Although there was no association between individual quartiles of the DQI-I and BrCa, there was evidence of a significant trend across all the quartile categories (P for trend = 0.030).There was no significant association was found between DED index and the odds of BrCa in the crude and fully adjusted models. We found that higher MAR indices were associated with decreased odds of BrCa, Therefore, the dietary patterns reflected by these scores may serve as a possible guide to preventing BrCa in Iranian women.

Effect of sumac powder on clinical symptoms, hyperandrogenism, inflammation, blood glucose, lipid profiles in women with polycystic ovary syndrome: A double-blind randomized clinical trial.

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders associated with a high risk of diabetes, atherosclerosis, and cardiovascular disease. The purpose of this study was to determine the effect of sumac powder on clinical symptoms and laboratory parameters in women with PCOS. The double-blind randomized controlled clinical trial was conducted on 88 women with PCOS randomly assigned to the intervention and control groups. The intervention group received three capsules each containing 1 g of sumac powder for 12 weeks. All data and serum levels of sex hormone, hs-CRP, glucose, and lipid profiles were measured at the baseline and at the end of the study. Data were analyzed using SPSS version 25 software. The ANCOVA test results showed that hs-CRP level was significantly reduced in the intervention group (p = .008). Blood glucose and lipid profiles in the intervention group were significantly reduced compared to the placebo group (p < .05). Insulin sensitivity and HDL levels were increased significantly in the Sumac group after the intervention (p < .05). Sumac powder can reduce the inflammatory effects, and glycemic status and lipid profile of polycystic ovaries in affected women, but has no significant effect on anthropometric parameters and sex hormones.

Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial.

BACKGROUND: Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT). METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY)control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130. FINDINGS: Between June 1 and June 30, 2021, 3498 people were screened. 2878 participants met eligibility criteria and received COVID-19 vaccine or control. The median ages of ChAd/ChAd-primed participants were 53 years (IQR 44-61) in the younger age group and 76 years (73-78) in the older age group. In the BNT/BNT-primed participants, the median ages were 51 years (41-59) in the younger age group and 78 years (75-82) in the older age group. In the ChAd/ChAD-primed group, 676 (46·7%) participants were female and 1380 (95·4%) were White, and in the BNT/BNT-primed group 770 (53·6%) participants were female and 1321 (91·9%) were White. Three vaccines showed overall increased reactogenicity: m1273 after ChAd/ChAd or BNT/BNT; and ChAd and Ad26 after BNT/BNT. For ChAd/ChAd-primed individuals, spike IgG geometric mean ratios (GMRs) between study vaccines and controls ranged from 1·8 (99% CI 1·5-2·3) in the half VLA group to 32·3 (24·8-42·0) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·1 (95% CI 0·7-1·6) for ChAd to 3·6 (2·4-5·5) for m1273. For BNT/BNT-primed individuals, spike IgG GMRs ranged from 1·3 (99% CI 1·0-1·5) in the half VLA group to 11·5 (9·4-14·1) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·0 (95% CI 0·7-1·6) for half VLA to 4·7 (3·1-7·1) for m1273. The results were similar between those aged 30-69 years and those aged 70 years and older. Fatigue and pain were the most common solicited local and systemic adverse events, experienced more in people aged 30-69 years than those aged 70 years or older. Serious adverse events were uncommon, similar in active vaccine and control groups. In total, there were 24 serious adverse events: five in the control group (two in control group A, three in control group B, and zero in control group C), two in Ad26, five in VLA, one in VLA-half, one in BNT, two in BNT-half, two in ChAd, one in CVn, two in NVX, two in NVX-half, and one in m1273. INTERPRETATION: All study vaccines boosted antibody and neutralising responses after ChAd/ChAd initial course and all except one after BNT/BNT, with no safety concerns. Substantial differences in humoral and cellular responses, and vaccine availability will influence policy choices for booster vaccination. FUNDING: UK Vaccine Taskforce and National Institute for Health Research.

The Effects of Synbiotic Supplementation on Serum Anti-Inflammatory Factors in the Survivors of Breast Cancer with Lymphedema following a Low Calorie Diet: A Randomized, Double-Blind, Clinical Trial.

BACKGROUND AND AIM: Breast cancer-related lymphedema (BCRL) is a treatment-related inflammatory complication in breast cancer survivors (BCSs). This study was aimed to evaluate the effect of synbiotic supplementation on serum concentrations of IL-10, TGF-ß, VEGF, adiponectin, and edema volume among overweight or obese BCSs with lymphedema following a low-calorie diet (LCD). METHOD: In a randomized double-blind, controlled clinical trial, 88 obese and overweight BCSs women were randomized to synbiotic supplement (n = 44) or placebo (n = 44) groups and both groups followed an LCD for 10 weeks. Pre- and post-intervention comparisons were made regarding the anti-inflammatory markers which included IL-10, TGF-ß, VEGF, adiponectin, edema volume, and anthropometric measurements. Also, the same factors were analyzed to find inter-group disparities. RESULTS: There were no significant differences among participants in the baseline, except for IL-10 and adiponectin. Post-intervention, no significant differences were observed regarding the anti-inflammatory markers, including IL-10, VEGF, adiponectin, and TGF-ß between the groups. After 10 weeks of intervention edema volume significantly decreased in the synbiotic group; additionally, anthropometric measurements (body weight, BMI, body fat percent, and WC) decreased in both groups significantly (P < 0.001 and P < 0.005; respectively). CONCLUSION: Synbiotic supplementation coupled with an LCD in a 10-week intervention had beneficial effects on increasing the serum TGF-ß, IL-10, and adiponectin levels in women with BCRL. It also reduced arm lymphedema volume. Therefore, synbiotic supplementation can be effective in improving health status in BCRL patients.

The impact of probiotic yogurt versus ordinary yogurt on serum sTWEAK, sCD163, ADMA, LCAT and BUN in patients with chronic heart failure: a randomized, triple-blind, controlled trial.

BACKGROUND: To date, no study has investigated the effects of probiotic yogurt as a functional food in patients with chronic heart failure (CHF). Therefore, the aim of this study was to compare the impact of probiotic yogurt versus ordinary yogurt on inflammatory, endothelial, lipid and renal indices in CHF patients. In this randomized, triple-blind clinical trial, 90 patients with CHF were randomly allocated into two groups to take either probiotic or ordinary yogurt for 10 weeks. Serum levels of soluble tumor necrosis factor-like weak inducer of apoptosis (sTWEAK), soluble cluster of differentiation 163 (sCD163), asymmetric dimethylarginine (ADMA), and lecithin cholesterol acyltransferase (LCAT) were measured by using ELISA kits, and blood urea nitrogen (BUN) was measured by calorimetry method at baseline and at the end of trial. The P-value <0.05 was defined as statistically significant. RESULTS: Seventy-eight patients completed the study. At the end of the intervention, the levels of sTWEAK in both groups increased significantly, and this increase was greater in the probiotic yogurt group [691.84 (335.60, 866.95)] compared to control group [581.96 (444.99, 929.40)], and the difference between the groups was statistically significant after adjusting for confounders (P-value: 0.257, adjusted P-value: 0.038). However, no significant differences were found between the groups in the cases of other study indices. CONCLUSION: Probiotic yogurt may be useful for improving the inflammatory status in patients with CHF through increasing sTWEAK levels, however, further studies are needed in this area. © 2022 Society of Chemical Industry.

Dimensions of Preparation for Aging: A Systematic Review.

Background: A deeper understanding of the dimensions of preparation for aging at the personal level may provide new perspectives for healthy aging promotion policies. Therefore, the present study was conducted to investigate the dimensions of preparation for old age and retirement. Methods: This was a systematic review. The search was performed in the following databases: PubMed, Embase, Scopus, Web of Science, PsycINFO, and Google Scholar up to June 2020. This search was done based on the following keywords: "prepare*", "preparation", "plan* ", "Aged", "Ageing", "Aging", "older people", "senior", "retirement", "older adults", and "elderly" through the AND/OR operators. In the preliminary search, 2032 papers were identified. After removing the duplicated articles and screening the title and abstract, the full text of 141 papers were investigated. Finally, 42 papers were eligible for inclusion in the systematic review. Results: The results indicated that preparation for aging is propounded in the 6 dimensions: (1) health preparation; (2) psychological preparation; (3) financial preparation; (4) housing; (5) social preparation; and (6) active leisure. Conclusion: The findings of the present study indicated that planning for aging requires coverage of all dimensions of old age preparations to achieve healthy aging. The preparation planning should be performed before later life and during the young or middle-age years.

Information System Success of the Iranian Integrated Health Record System Based on the Clinical Information System Success Model.

Background: The Integrated Health Record System, locally known as the "SIB," is the most used information system for recording public health services provided to the Iranian population. The objective of this study was to evaluate the success rate of the SIB using the Clinical Information System Success Model (CISSM). Methods: This is a psychometric and evaluation study. The CISSM has a 26-item instrument that assesses 7 constructs in 3 following stages: (1) the socio-technical stage (facilitating conditions, social influence, information quality, and system performance(; (2) the integrated stage (system use dependency and user satisfaction); and (3) success outcome stage (net benefit). A Persian version of the CISSM instrument was validated and applied in this study. Based on this instrument, the reliability and the validity of the CISSM were assessed. The SIB success rate was evaluated using a validated CISSM. The study participants were 758 SIB users from different disciplines and different levels. Results: Assessment of content validity, construct validity, internal consistency, and test-retest reliability showed acceptable psychometric properties of the CISSM instrument. The results demonstrated that the SIB success rate was in the moderate range (59.6%). Facilitating conditions and information quality were strong predictors of use dependency and user satisfaction, while both of these 2 constructs significantly influenced net benefit. Conclusion: The SIB success was in the moderate range, and it needs to be enhanced. Therefore, Iranian healthcare policymakers should consider working on the most important factors influencing SIB success (facilitating conditions, information quality, use dependency, and user satisfaction) to improve SIB success.

Cigarette Smoking Behavior a Gateway to Opium Use Disorder: A Mendelian Randomization Analysis.

Gateway hypothesis presumes that using a psychotropic drug can increase the probability of using another drug. The study was to assess whether cigarette smoking is a gateway drug for subsequent opium use. Mendelian randomization (MR) analysis was applied to test and estimate the size of causal effect of cigarette smoking on opium use. The CHRNA3 rs1051730 polymorphism was used as an instrumental variable. A population-based case control study in the setting of Fasa Cohort Study was carried out using 477 cases and 531 controls based on their opium use status at the baseline of cohort study. The logistic two stage estimator method was applied. The Number of cigarettes smoked per day was associated with opium use (OR 1.17, 95% CI 1.15-1.19). In the MR analysis, rs1051730 T alleles were associated with increased risk of opium use among ever smokers (OR 5.73, 95% CI 1.72-19.07) however there found no evidence of association among never smokers. In instrumental variable analysis, showed that on average smoking every 1 more cigarette per day increases the odds of opium use by 1.17 (OR 1.17, 95%CI:1.14-1.19). The MR analysis found a positive finding on the relationship between cigarette smoking and opium use which supports the gateway hypothesis. It adds new information to the gateway theory regarding the relation of cigarette smoking and drug use, and increases our understanding of the importance of tobacco control for prevention of opium addiction.

Effects of different invitation strategies on participation in a cohort study of Iranian public sector employees: a cluster randomized trial.

BACKGROUND: Identifying strategies to optimize participation in health studies is one of the major concerns for researchers. The purpose of this study was to evaluate the efficiency of different invitation strategies on participation rate in the Employees' Health Cohort Study of Iran (EHCSIR). METHODS: Two cluster-randomized trials were carried out to assess the outcomes of different invitation strategies. In the first phase, 7 units with 1880 employees (3 hospitals, 3 health centers, and 1 office) were assigned to the three parallel modes of invitation: 1) invitation letter, 2) phone call and 3) Short Message Service (SMS). In the second phase, 6 hospitals with 1633 employees were allocated to two invitation methods: 1) invitation letter, 2) invitation letter plus EHCSIR project introduction video. All groups were followed up by phone calls. A logistic mixed-effects model was used to compare the effectiveness of the strategies. The cost-effectiveness of the interventions was also compared. RESULTS: In the first phase, the participation rates in the invitation letter, phone call, and SMS groups were 27.04% (182/673), 21.55% (131/608), and 22.54% (135/599), respectively. Using an invitation letter was significantly more successful than SMS (Adjusted Odds Ratio = 1.80, 95% CI =1.14 to 2.85). Average Cost-Effectiveness Ratios (ACER) were $1.37, $1.42, and $1.55 for the invitation letter, phone call, and SMS, respectively. In the second phase, adding a project introduction video to the invitation letter did not significantly influence the participation rate (Adjusted OR = 0.58, 95% CI =0.24 to 1.36). The ACER was $1.21 for the invitation letter only and $2.01 for the invitation letter plus the introduction video. CONCLUSIONS: In comparison with the phone call and SMS, the invitation letter is the most effective invitation method for public sector employees to participate in a cohort study. Sending an introduction video did not significantly increase the participation rate compared to sending an invitation letter only.

The effects of Chlorella supplementation on glycemic control, lipid profile and anthropometric measures on patients with type 2 diabetes mellitus.

BACKGROUND: Diabetes is a chronic disease and the prevalence of it is rapidly increasing. Recently, the use of natural products in chronic diseases such as diabetes has gained more attention. Chlorella, a single-celled green alga, is one of them. There have been some studies on the effects of chlorella supplementation in chronic diseases such as NAFLD, prediabetes, and diabetic mice, but none of them examined the effects of chlorella in patients with T2DM. The present study was designed to evaluate the effects of chlorella supplementation on glycemic control, lipid profile, and anthropometric indices in type 2 diabetic patients. METHODS: This study is a double-blind, randomized controlled trial. 84 patients with T2DM assigned into two groups, receiving 1500 mg/day C. vulgaris or placebo for 8 weeks. Anthropometric information, blood pressure, 24-h food intake recall, and blood samples were collected at the beginning and end of the study to determine the changes of FBS, HbA1c, insulin concentration, insulin resistance, and lipid profile. RESULTS: None of the variables investigated in this study showed a significant change after 8 weeks of intervention with C. vulgaris. CONCLUSION: According to the findings of this study, supplementation with C. vulgaris with a dosage of 1500 mg/day for 8 weeks, does not improve the anthropometric measurements, glycemic status, and lipid profile as well. Thus, it cannot be considered as a complementary therapeutic approach to common medications at this dosage and duration. However, future studies with a higher dosage of C. vulgaris and more prolonged than 8 weeks are needed to be done.

A randomized controlled trial on the coloprotective effect of coenzyme Q10 on immune-inflammatory cytokines, oxidative status, antimicrobial peptides, and microRNA-146a expression in patients with mild-to-moderate ulcerative colitis.

PURPOSE: Coenzyme Q10 (CoQ10), having potent antioxidant and anti-inflammatory pharmacological properties, has recently been shown to be a safe and promising agent in maintaining remission of ulcerative colitis (UC). This trial was, therefore, designed to determine CoQ10 efficacy on inflammation and antioxidant status, antimicrobial peptides, and microRNA-146a expression in UC patients. METHODS: In this randomized double-blind controlled trial, 88 mild-to-moderate UC patients were randomly allocated to receive CoQ10 (200 mg/day) or placebo (rice flour) for 2 months. At the baseline and at an 8-week follow-up, serum levels of Nrf2, cathelicidin LL-37, ß-defensin 2, IL-10, IL-17, NF-κB p65 activity in peripheral blood mononuclear cells (PBMCs), simple clinical colitis activity index questionnaire (SCCAIQ), and quality of life (IBDQ-32 score), as well as an expression rate of microRNA-146a were measured. RESULTS: A significant reduction was detected in the serum IL-17 level, activity of NF-κB p65 in PBMCs, and also SCCAI score in the CoQ10 group compared to the placebo group, whereas IL-10 serum concentrations and IBDQ-32 score of the CoQ10 group considerably increased versus the control group; the changes of these variables were also significantly different within and between groups at the end of the study. Furthermore, CoQ10 remarkably increased serum levels of cathelicidin LL-37. A significant change in serum cathelicidin LL-37 levels was also observed between the two groups. No statistical difference, however, was seen between the two groups in terms of the serum levels of Nrf2 and ß-defensin 2 and the relative expression of microRNA-146a. CONCLUSIONS: Our results indicate that CoQ10 supplementation, along with drug therapy, appears to be an efficient reducer of inflammation in patients with mild-to-moderate UC at a remission phase. TRIAL REGISTRATION: The research has also been registered at the Iranian Registry of Clinical Trials (IRCT): IRCT20090822002365N17.

Effects of synbiotic supplementation on serum adiponectin and inflammation status of overweight and obese breast cancer survivors: a randomized, triple-blind, placebo-controlled trial.

PURPOSE: Adipokines and inflammatory factors can affect breast cancer (BC) prognosis and recurrence among breast cancer survivors (BCSs). This study was to evaluate the effects of synbiotic supplementation along with a low-calorie diet on some recurrence-related factors such as adiponectin, tumor necrosis factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) among obese and overweight BCSs. METHODS: We performed a randomized, triple-blind, placebo-controlled clinical trial among 76 overweight or obese postmenopausal women with a history of hormone-receptor-positive BC. Participants were randomly divided into 2 groups to intake either 109 CFU/day synbiotic supplement or placebo (n = 38 each group) for 8 weeks. All participants were given a low-calorie diet program. The primary outcome was serum concentration of adiponectin which was measured at baseline and after 8 weeks. RESULTS: Compared with the placebo, synbiotic intake significantly increased adiponectin (+ 13.58 (10.08, 18.17) vs. - 0.42 (- 2.90, 1.98) µg/ml; P < 0.001). In addition, synbiotic supplementation resulted in significant reduction in TNF-α levels (- 17.09 (- 32.05, - 13.60) vs. 0.20 (- 3.97, 2.00) ng/L; P < 0.001) and hs-CRP levels (- 1.14 (- 1.90, - 0.88 vs. - 0.06 (- 0.38, 0.15) mg/L; P < 0.001) compared with the placebo. CONCLUSIONS: In conclusion, 8-week synbiotic consumption by overweight and obese postmenopausal BCSs had beneficial effects on adiponectin, TNF-α, and hs-CRP. TRIAL REGISTRATION: IRCT, IRCT20091114002709N49. Registered 18 May 2018, http://www.irct.ir : IRCT20091114002709N49.

Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity.

BACKGROUND: Heparin is an anticoagulant medication that is usually injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma, and pain at the injection site. One of the factors that may affect pain, haematoma, and bruising is injection speed. Several studies have been carried out to determine if speed of injection affects the amount of pain and bruising where the injection is given; however, the results of these studies have differed, and study authors have not reached a clear final conclusion. This is the second update of a review first published in 2014. OBJECTIVES: To assess the effects of duration (speed) of subcutaneous heparin injection on pain and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). We also looked at haematoma at the injection site. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 June 2020. We undertook reference checking of included studies to identify additional studies. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injection of heparin on pain, bruising, and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: For this update, two review authors independently selected studies and extracted data via Covidence software and assessed methodological quality using Cochrane's risk of bias tool. The primary outcomes of interest were pain intensity at injection site and size and incidence of bruising. The secondary outcomes of interest were size and incidence of haematoma at injection site. We calculated the odds ratio (OR), mean difference (MD), or standardised mean difference (SMD) with corresponding 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria. MAIN RESULTS: We identified one new study for this update, resulting in a total of five included studies with 503 participants who received subcutaneous injections of LMWH into the abdomen. Given the nature of the intervention, it was not possible to blind participants and caregivers (personnel) in any of the included studies. Two studies described blinding of outcome assessors. Overall, the methodological quality of included studies was moderate. The duration of the fast injection was 10 seconds, and the duration of the slow injection was 30 seconds in all included studies. Four studies reported site pain intensity after each injection at different time points. Two studies assessed site pain intensity immediately after each injection; meta-analysis showed no evidence of a difference in site pain intensity immediately after slow injection when compared to fast injection (MD -1.52, 95% CI -3.56 to 0.53; 140 participants; low-certainty evidence). Meta-analysis of three studies indicated that site pain intensity may be slightly reduced 48 hours after the slow heparin injection compared to fast injection (MD -1.60, 95% CI -2.69 to -0.51; 103 participants; low-certainty evidence). Five studies assessed bruise size at 48 hours, and two studies assessed bruise size at 60 hours. Meta-analysis showed there may be a reduction in bruise size 48 hours (SMD -0.54, 95% CI -1.05 to -0.02; 503 participants; 5 studies; very low-certainty evidence) and 60 hours (SMD -0.49, 95% CI -0.93 to -0.06; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. There was no evidence of a difference in bruise size 72 hours after slow injection compared to fast injection (SMD -0.27, 95% CI -0.61 to 0.06; 140 participants; 2 studies; low-certainty evidence). Three studies evaluated incidence of bruising and showed there may be a reduction in bruise incidence 48 hours (OR 0.39, 95% CI 0.26 to 0.60; 444 participants; low-certainty evidence) and 60 hours (OR 0.25, 95% CI 0.10 to 0.65; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. We downgraded the certainty of the evidence due to risk of bias concerns, imprecision, and inconsistency. None of the included studies measured size or incidence of haematoma. AUTHORS' CONCLUSIONS: Administering medication safely and enhancing patient comfort are the main aims of clinical nurses. In this review, we identified five RCTs that evaluated the effect of subcutaneous heparin injection duration on pain intensity, bruise size and incidence. We found that pain may be slightly reduced 48 hours after slow injection. Similarly, there may be a reduction in bruise size and incidence after slow injection compared to fast injection 48 and 60 hours postinjection. We downgraded the certainty of the evidence for all outcomes to low or very low due to risk of bias concerns, imprecision, and inconsistency. Accordingly, new trials with a more robust design, more participants, and a focus on different injection speeds will be useful in strengthening the certainty of the available evidence.

The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: a randomized controlled trial.

BACKGROUND: Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence. METHODS: A randomized controlled trial on 90 pregnant women was blocked into two intervention groups (n = 45) and a control (n = 45). The intervention group received six counseling sessions with a solution-focused approach. Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The tools were completed once before the intervention and again 6 weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant. RESULTS: A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps = 0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P = 0.001). CONCLUSION: Solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2017040628352N4 . Date of registration: August 20th 2017.

Rapid review of COVID-19 epidemic estimation studies for Iran.

BACKGROUND: To inform researchers about the methodology and results of epidemic estimation studies performed for COVID-19 epidemic in Iran, we aimed to perform a rapid review. METHODS: We searched for and included published articles, preprint manuscripts and reports that estimated numbers of cumulative or daily deaths or cases of COVID-19 in Iran. We found 131 studies and included 29 of them. RESULTS: The included studies provided outputs for a total of 84 study-model/scenario combinations. Sixteen studies used 3-4 compartmental disease models. At the end of month two of the epidemic (2020-04-19), the lowest (and highest) values of predictions were 1,777 (388,951) for cumulative deaths, 20,588 (2,310,161) for cumulative cases, and at the end of month four (2020-06-20), were 3,590 (1,819,392) for cumulative deaths, and 144,305 (4,266,964) for cumulative cases. Highest estimates of cumulative deaths (and cases) for latest date available in 2020 were 418,834 on 2020-12-19 (and 41,475,792 on 2020-12-31). Model estimates predict an ominous course of epidemic progress in Iran. Increase in percent population using masks from the current situation to 95% might prevent 26,790 additional deaths (95% confidence interval 19,925-35,208) by the end of year 2020. CONCLUSIONS: Meticulousness and degree of details reported for disease modeling and statistical methods used in the included studies varied widely. Greater heterogeneity was observed regarding the results of predicted outcomes. Consideration of minimum and preferred reporting items in epidemic estimation studies might better inform future revisions of the available models and new models to be developed. Not accounting for under-reporting drives the models' results misleading.

Analysis of hand-forearm anthropometric components in assessing handgrip and pinch strengths of school-aged children and adolescents: a partial least squares (PLS) approach.

BACKGROUND: The purpose of this study was to examine the influence of hand-forearm anthropometric dimensions on handgrip and pinch strengths among 7-18 years children and adolescents and to investigate the extent to which these variables can be used to predict hand strength. METHODS: Four types of hand strengths including handgrip, tip to tip, key, and three-jaw chuck pinches were measured in 2637 healthy children and adolescents (1391 boys and 1246 girls) aged 7-18 years using standard adjustable Jamar hydraulic hand dynamometer and pinch gauge. A set of 17 hand-forearm anthropometric dimensions were also measured with an accurate digital caliper and tape measure. RESULTS: No significant differences were found between the hand strengths of boys and girls up to the age of 10 years. Gender related differences in handgrip and pinches were observed from the age of 11 years onwards, with boys always being stronger. The dominant hand was stronger than the non-dominant hand (8% for handgrip and by about 10% for all three types of pinches). The strongest correlations were found between the hand length and hand strengths (r > 0.83 for handgrip and three all pinches; p < 0.001, 2-tailed). Based on the partial least squares (PLS) analysis, 8 out of 17 anthropometric indices including hand length, hand circumference, thumb length, index finger length, middle finger length, and forearm length had considerable loadings in the PLS analysis, which together accounted for 46% of the total variance. CONCLUSIONS: These results may be used by health professionals in clinical settings as well as by designers to create ergonomic hand tools.

Psychometric evaluation of the perceived access to health care questionnaire.

BACKGROUND AND OBJECTIVE: Access to health care is a universal concern. Therefore, this study was conducted to develop a questionnaire to assess the Perceived Access to Health care based on Penchansky and Thomas's definition of access and the assessment of its psychometric properties. METHOD: The initial questionnaire contains 31 items developed based on a deductive approach with an extensive review of the related literature. Content validity, face validity, construct validity, internal consistency, and instrument reliability were further examined. Data analysis was conducted using SPSS software version 24, R software version 4, and lavaan package. RESULTS: The initial questionnaire was examined using qualitative content validity, and the necessary modifications were applied to each item. The content validity ratio (CVR) was approved in 30 items with a value greater than 0.78, and one item with a CVR value lower than 0.78 was removed. In the case of the content validity index (CVI), 29 items were approved with a CVI value of greater than 0.79, and one item with a CVI value between 0.70 and 0.79 was revised. In qualitative face validity, all items were approved by a panel of experts and the participants. All 30 items with an impact score index higher than 1.5 were approved for the next steps. The confirmatory factor analysis results showed that the six-factor model of access to health care has an appropriate fit. Cronbach's alpha coefficient for the questionnaire was calculated 0.86. The value of Cronbach's alpha for the dimensions of availability, accessibility, affordability, accommodation, acceptability, and awareness were 0.61, 0.76, 0.66, 0.60, 0.80, and 0.76, respectively. The Intraclass Correlation Index (ICC) value for reliability (test-retest) of the whole instrument was calculated 0.94 using the two-way mixed absolute agreement method. CONCLUSION: The success of health programs depends on eliminating barriers to access to provided health care services. One of the most critical barriers to understanding access is a perception of limited access. This questionnaire might be used further to understand perceived health care access in different global contexts.