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Meta-Analysis of Incidence Rate Data in the Presence of Zero-Event and Single-Arm Studies Pages 57-66

Romain Piaget-Rossel and Patrick Taffé

https://doi.org/10.6000/1929-6029.2019.08.08

Published: 10 October 2019


Abstract: Unlike the classical two-stage DerSimonian and Laird meta-analysis method, the one-stage random-effects Poisson and Negative-binomial models have the great advantage of including the information contained in studies reporting zero event in one or both arms and in studies with one missing arm. Since the Negative-binomial distribution relaxes the assumption of equi-dispersion made by the Poisson, it should perform better when data exhibit over-dispersion. However, the superiority of the Negative-binomial model with rare events and single-arm studies is unclear and needs to be investigated. Moreover, to the best of our knowledge, this model has never been investigated in the context of a meta-analysis of incidence rate data with heterogeneous intervention effect. Therefore, we assessed the performance of the univariate and bivariate random-effects Poison and Negative-binomial models using simulations calibrated on a real dataset from a study on the surgical management of phyllodes tumors. Results suggested that the bivariate random-effects Negative-binomial model should be favored for the meta-analysis of incidence rate data exhibiting over-dispersion, even in the presence of zero-event and single-arm studies.

Keywords: Incidence rate, Meta-analysis, Negative-binomial model, Poisson model, Rare events, Random effects.

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Property of Melatonin of Acting as an Antihypertensive Agent to Antagonize Nocturnal High Blood Pressure: A Meta-Analysis Pages 67-71

Renato De Vecchis, Andrea Paccone and Marco Di Maio

https://doi.org/10.6000/1929-6029.2019.08.09

Published: 18 October 2019


Abstract: Therapy of hypertension persisting in the course of nocturnal sleep has yielded rather disappointing results . Therefore, the research has focused on drugs such as melatonin acting in such a way so as to counteract the lack of fall in blood pressure during night time sleep.

A meta-analysis has been planned by gathering only randomized controlled trials( RCTs), where melatonin was administered as a single dose at bedtime and compared with placebo.

The efficacy was the "night time variation in systolic blood pressure" and the "night time variation in diastolic blood pressure". Safety endpoint was the possible occurrence of serious adverse events.

Seven studies with 221 participants were pooled in the meta-analysis. Melatonin use was a predictor of significant decrease in nocturnal systolic blood pressure[SBP]( difference in means[MD]= -5.74 mm Hg; 95% CI: -6.07 to- 5.41 mm Hg; p<0.00001).This change was generated by the very steep decrease in nocturnal SBP detected in patients treated with controlled-release(CR) melatonin ( MD=-8.42 mm Hg; 95% CI: -8.82 to- 8.02 mm Hg; p<0.00001); whereas the mean change in nocturnal SBP, found in patients taking fast -release (FR)melatonin, was nonsignificant (MD=-0.06 mm Hg; 95% CI: -0.64 to 0.52 mm Hg; p=0.84). Likewise, use of melatonin was associated with a fall in DBP( MD= -0.60 mm Hg; 95% CI=-1.12 to -0.08 mm Hg), driven by the pressure changes attained by the CR melatonin. No major adverse events occurred in the examined trials. Evening administration of CR melatonin has been shown to cause a significant pressure decrease over the nocturnal sleep. Thus, the CR melatonin preparations could find a place in the antihypertensive armamentarium for promoting the physiological fall of blood pressure levels during night time sleep.

Keywords: Non-dipping, ambulatory blood pressure monitoring, melatonin.

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Effects of a Restricted Water Intake on Clinical and Laboratory Outcomes in Patients with Chronic Heart Failure: A Meta-Analysis Pages 72-80

Renato De Vecchis and Andrea Paccone

https://doi.org/10.6000/1929-6029.2019.08.10

Published: 25 November 2019


Abstract: In chronic heart failure patients (CHF), irrefutable evidence that documents the efficacy of the limitation in fluid consumption on major cardiovascular outcomes is so far lacking. Therefore, we performed a meta-analysis of studies that evaluated the efficacy and safety of the strategy of restricting fluid intake in the diet of CHF patients. The studies included were randomized controlled trials (RCTs) comparing CHF patients undergoing limitation in fluid consumption with patients who had free access to fluid intake. Primary outcomes were heart failure hospitalizations and all-cause mortality. Secondary outcomes were the sensation of thirst as measured by a visual analog scale, the duration of therapy with intravenous diuretics, and the serum levels of creatinine, sodium and B-type natriuretic peptide (BNP). The effect size was expressed as pooled odds ratio (OR) in the case of binary variables, and as weighted mean difference (WMD) in the case of continuous variables. Six RCTs were incorporated into the meta-analysis. Patients subjected to restricted fluid intake compared with those admitted to free fluid intake showed a similar rehospitalization rate (pooled odds ratio (OR)=1.52;95%CI: 0.67 to 3.43; p =0.32) and a similar mortality rate (pooled OR=1.55; 95% CI:0.87 to 2.75;p=0.14). Likewise, there were no differences in regards to patients' sense of thirst (weighted mean difference (WMD) =-0.7; 95% CI: -2.58 to 1.17; p= 0.46), the duration of intravenous diuretic treatment (WMD=0.17 days; 95% CI: -1.26 to 1.6 days; p =0.81), the serum creatinine levels (WMD=0.05 mg/dl; 95% CI: -0.16 to 0.26 mg/dl; p=0.12), and serum sodium levels (WMD= -0.86 mmol/L; 95% CI:-2.92 to 1.2 mmol/L; p=0.41). By contrast, serum BNP levels were significantly higher in the group with free fluid intake(WMD=223.76 pg/ml; 95% CI: 158.8 to 288.72 pg/ml; p<0.001). In CHF patients, liberal fluid consumption does not seem to exert an unfavorable impact on heart failure rehospitalizations or all-cause mortality.

Keywords: Water intake, heart failure, cardiovascular outcomes.

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Determinants of Diarrhea Occurrence among Under-Five Children in Southern Nations, Nationalities, and People’s Region, Ethiopia Pages 81-88

Melkamu Molla Ferede

https://doi.org/10.6000/1929-6029.2019.08.11

Published: 25 November 2019


Abstract: Based on the 2016 Ethiopian Demographic and health Survey report, among nine regions and two administrative Cities in Ethiopia, the second highest prevalence of childhood diarrhea was observed in Southern Nations, Nationalities, and People’s (SNNP) Region. Thus, the purpose of this study was to identify determinants of diarrhea occurrence among under five children in SNNP Region in Ethiopia. The study was conducted based on the 2016 Ethiopia demographic and health survey. A total of 1,197 under-five children were included in the study. In bivariate analysis crude odds ratio was used to assess the relationships between the prevalence of diarrhea and determinant factors. Multivariable logistic regression was employed to analyze the overall effect of determinants of the occurrence of diarrhea among under-five children. Data was analyzed using SPSS_23 and Stata_14. The overall prevalence of diarrhea among under-five children, two weeks before the survey, in the region was 14.2%. The highest magnitude of diarrhea was observed among rural children 13% [COR: 1.127; 95% CI: .601-2.115], who used unimproved sanitation (12.7%) and still breastfeeding children (11.2%). The multivariable logistic regression analysis revealed that child’s age 6-11months (AOR: 4.8; 95% CI: 2.322-10.074) and 12-23 months (AOR: 3.5; 95% CI: 1.736-7.050) were significantly associated with diarrhea. Prevalence of diarrhea was also significantly associated with households with six or more members (AOR = 1.675; 95% CI: 1.026-2.732) and currently breastfeeding children (AOR: 5.609; 95% CI: 1.322-23.799). In order to reduce the occurrence of childhood diarrhea, health care programs and other efforts related to children in SNNP Region should give special attention to children whose age between 6 -11 and 12-23 months, households with six or more members, and currently breastfeeding children since those children had strongly associated with diarrhea.

Keywords: Diarrhea, SNNP Region, Under-five Children, Determinants, Odds ratio, Logistic Regression.

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