cluster randomization
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Author(s):  
Ahmed S. Mohammed Metwally ◽  
Sobhy M. Yakout ◽  
Malak N. K. Khattak ◽  
Ghadah Alkhaldi ◽  
Nasser M. Al-Daghri

Studies investigating the association of vitamin D on intelligence is limited. The present study therefore aims to determine the association of vitamin D status with the different domains of intelligence among Saudi Arabian adolescents. This study used relational survey method among 1864 Saudi adolescent, including 549 boys and 1315 girls (mean age 14.7 ± 1.7 years) recruited using a multistage, stratified cluster randomization of 47 public and private schools in Riyadh in Saudi Arabia. A general questionnaire was used to collect demographic information. Intelligence was assessed using multiple intelligence inventory. Anthropometrics were measured and fasting blood samples collected for assessment of glucose and lipid profile. Vitamin D deficiency (25(OH)D <50 nmol/L) was observed in 84.2% of boys and 93.5% of girls. Girls had higher levels of verbal, kinesthetic, musical, naturalist and existential intelligence than boys, while boys have higher logical intelligence than girls (p-values < 0.05). Mixed regression analysis controlled for age, BMI and sex revealed that kinesthetic intelligence was significantly associated with 25(OH)D in boys (β 5.6 (2.8–8.5; p < 0.001)) and inversely associated with musical intelligence (β −1.2 (−2.3–0.1; p = 0.03)) and positively with naturalist (β 2.3 (0.5–4.2; p = 0.01)) in girls. Vitamin D status is associated with several domains of intelligence in adolescents and is sex-specific. Development a specific domain of intelligence may indirectly affect vitamin D status among adolescents, but needs to be proven prospectively.


2021 ◽  
pp. 87-87
Author(s):  
Mirjana Pajcin ◽  
Zoran Bukumiric ◽  
Jelena Tomasevic ◽  
Aleksandra Ilic

Background: Randomization allows study groups to be formed so that they are similar in all characteristics except outcomes. Aim: The aim of this study is to examine the frequency of randomization methods and their effect on achieving baseline balance in cluster randomization studies conducted in schools. Methods: A literature search of MEDLINE bibliographic database shows that the total number of collected articles in full text was 343, out of which 81 were eligible for inclusion. Each publication was reviewed by two independent reviewers, and data was extracted and analyzed. Results: Stratification was the most commonly applied randomization method, reported in 28 trials (34.6 %). There was no statistically significant difference in the number of subjects and clusters, as well as in cluster size between trial?s groups in studies in which simple randomization was used. However, there was a statistically significant difference in number of subjects and clusters between groups in trials in which restricted randomization methods were used. Yet, there was no difference in the cluster size. Conclusion: Although there is no difference in the size of clusters between trial arms, either at the level of the entire sample or in relation to randomization methods applied, additional research should be conducted on larger sample in order to establish the effect of randomization methods on baseline balance, when the size of clusters is in question.


Cancers ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 2550
Author(s):  
Henrik Suttmann ◽  
Jochen Gleissner ◽  
Andreas Huebner ◽  
Tim Mathes ◽  
Werner Baurecht ◽  
...  

Residual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) might be beneficial for mCRPC patients receiving abiraterone acetate plus prednisone (AA + P). This multicenter, prospective, 2-arm trial allocated mCRPC patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization. The primary objective was to assess the influence of AEM on discontinuation rates and medication adherence in mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B. At month 3, the rate of treatment discontinuation, not due to disease progression or the start of new cancer therapy, was low in both arms (A: 9.0% vs. B: 7.3%, OR = 1.230). Few patients had a medium/low Morisky Medication Adherence Scale (MMAS-4) score (A: 6.4% vs. B: 9.1%, OR = 0.685). The results obtained did not suggest any clear adherence difference between Arm A and Arm B. In patients with mCRPC taking AA + P medication, adherence seemed to be generally high.


2020 ◽  
Vol 9 (8) ◽  
pp. 2444 ◽  
Author(s):  
Janet Douglass ◽  
Hayley Mableson ◽  
Sarah Martindale ◽  
Sanya Tahmina Jhara ◽  
Mohammad Jahirul Karim ◽  
...  

Background: Lymphatic filariasis (LF) is a major cause of lymphedema, affecting over 16 million people globally. A daily, hygiene-centered self-care protocol is recommended and effective in reducing acute attacks caused by secondary infections. It may also reverse lymphedema status in early stages, but less so as lymphedema advances. Lymphatic stimulating activities such as self-massage and deep-breathing have proven beneficial for cancer-related lymphedema, but have not been tested in LF-settings. Therefore, an enhanced self-care protocol was trialed among people affected by moderate to severe LF-related lymphedema in northern Bangladesh. Methods: Cluster randomization was used to allocate participants to either standard- or enhanced-self-care groups. Lymphedema status was determined by lymphedema stage, mid-calf circumference, and mid-calf tissue compressibility. Results: There were 71 patients in each group and at 24 weeks, both groups had experienced significant improvement in lymphedema status and reduction in acute attacks. There was a significant and clinically relevant between-group difference in mid-calf tissue compressibility with the biggest change observed on legs affected by severe lymphedema in the enhanced self-care group (∆ 21.5%, −0.68 (−0.91, −0.45), p < 0.001). Conclusion: This study offers the first evidence for including lymphatic stimulating activities in recommended self-care for people affected by moderate and severe LF-related lymphedema.


Author(s):  
Hanumanthappa Kudachi ◽  
Venkatesh Gonibeedu ◽  
Suresh Ramappa ◽  
Sundar Muniswamy

Background: To achieve optimal blood glucose levels educating diabetic patient alone may not be sufficient but the entire family must have access to proven preventive measure. The present study was done to assess the outcome of self-care management practices educational intervention among family member on diabetic individuals.Methods: This prospective interventional cluster randomization study was conducted in rural field practice area, attached to department of Community medicine of Hassan Institute of Medical Sciences. Clusters were formed among the population based on the sub-centres and four clusters were randomly selected. Two clusters were assigned for family intervention and two clusters with individual intervention.Results: Consuming 5 or more serving of fruits and vegetables for more than 5 days a week, increased in the FIC after education and the difference in increase was statistically significant (p<0.02). Physical activity with specific exercise sessions increase after the intervention and the increase was statistically significant in the FIC (p<0.08).  Adherence to medication and testing attained statistically significant increase in the FIC. Also washing of foot daily with luke-warm water increase was statistically significant in both the Intervention Clusters (p<0.0002). On subsequent follow up there was a significant improvement in BMI of family intervention cluster (p<0.03) as compared to individual intervention cluster.Conclusions: Health education intervention activity at the community involving the supportive members of the family can drive-in to bring about behavioural change in the desired direction. 


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