randomized control trials
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Nutrients ◽  
2022 ◽  
Vol 14 (2) ◽  
pp. 374
Author(s):  
Genevieve Milesi ◽  
Anna Rangan ◽  
Sara Grafenauer

Whole grain foods are rich in nutrients, dietary fibre, a range of antioxidants, and phytochemicals, and may have potential to act in an anti-inflammatory manner, which could help impact chronic disease risk. This systematic literature review aimed to examine the specific effects of whole grains on selected inflammatory markers from human clinical trials in adults. As per the Preferred Reporting Items for Systematic Reviews (PRISMA) protocol, the online databases MEDLINE, Embase, Cochrane, CINAHL, and Scopus were searched from inception through to 31 August 2021. Randomized control trials (RCTs) ≥ 4 weeks in duration, reporting ≥1 of the following: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor (TNF), were included. A total of 31 RCTs were included, of which 16 studies recruited overweight/obese individuals, 12 had pre-existing conditions, two were in a healthy population, and one study included participants with prostate cancer. Of these 31 RCTs, three included studies with two intervention arms. A total of 32 individual studies measured CRP (10/32 were significant), 18 individual studies measured IL-6 (2/18 were significant), and 13 individual studies measured TNF (5/13 were significant). Most often, the overweight/obese population and those with pre-existing conditions showed significant reductions in inflammatory markers, mainly CRP (34% of studies). Overall, consumption of whole grain foods had a significant effect in reducing at least one inflammatory marker as demonstrated in 12/31 RCTs.


2022 ◽  
Author(s):  
Timo Gnambs ◽  
Ulrich Schroeders

Meta-analyses of treatment effects in randomized control trials are often faced with the problem of missing information required to calculate effect sizes and their sampling variances. Particularly, correlations between pre- and posttest scores are frequently not available. As an ad-hoc solution, researchers impute a constant value for the missing correlation. As an alternative, we propose adopting a multivariate meta-regression approach that models independent group effect sizes and accounts for the dependency structure using robust variance estimation or three-level modeling. A comprehensive simulation study mimicking realistic conditions of meta-analyses in clinical and educational psychology suggested that the prevalent imputation approach works well for estimating the pooled effect but severely distorts the between-study heterogeneity. In contrast, the robust meta-regression approach resulted in largely unbiased fixed and random effects. Based on these results recommendations for meta-analytic practice and future meta-analytic developments are provided.


2022 ◽  
Author(s):  
Tanya Maria Paes ◽  
Michelle Renee Ellefson

There is a need for more evidence-based research in education and research involving the use of randomized control trials (RCTs) to examine the efficacy of interventions. However, the difficulty of conducting interventional research in educational settings is often less acknowledged. This article provides practical examples of the issues encountered when implementing a cognitive science informed intervention and the solutions that were successfully implemented. This article will also highlight the importance of designing a multifaceted intervention while considering the cost of the intervention itself, especially when working with hard-to-reach families. It is helpful to make use of existing classroom resources in the intervention to lower costs. Additionally, being consistent and attentive to the developmental stage of the children and supporting parental engagement are two aspects that are crucial to the implementation of the intervention. Researchers would benefit from conducting workshops and public engagement events and can use these opportunities to provide practical strategies about how to support the development of children’s skills in the home environment. In-person interactions are key as parents can ask any questions that they may have, and it can help to dispel any mistrust that they may have with the research process. The article also provides suggestions for building the researcher-practitioner relationship from study onset, including being flexible and accommodating towards the changes in the school context and communicating effectively with teachers. Lastly, the article outlines the benefit of using scaffolding, positive reinforcement, and play-based learning over the course of the intervention to support child outcomes.


2022 ◽  
Vol 21 (1) ◽  
Author(s):  
Dawit Getachew Assefa ◽  
Eden Dagnachew Zeleke ◽  
Wondwosen Molla ◽  
Nebiyu Mengistu ◽  
Ahmedin Sefa ◽  
...  

Abstract Background The efficacies of artemisinin based combinations have been excellent in Africa, but also comprehensive evidence regarding their safety would be important. The aim of this review was to synthesize available evidence on the safety of dihydroartemisinin-piperaquine (DHA-PQ) compared to artemether-lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria among children in Africa. Methods A systematic literature search was done to identify relevant articles from online databases PubMed/ MEDLINE, Embase, and Cochrane Center for Clinical Trial database (CENTRAL) for retrieving randomized control trials comparing safety of DHA-PQ and AL for treatment of uncomplicated P. falciparum malaria among children in Africa. The search was performed from August 2020 to 30 April 2021. Using Rev-Man software (V5.4.1), the extracted data from eligible studies were pooled as risk ratio (RR) with 95% confidence interval (CI). Results In this review, 18 studies were included, which involved 10,498 participants were included. Compared to AL, DHA-PQ was associated with a slightly higher frequency of early vomiting (RR 2.26, 95% CI 1.46 to 3.50; participants = 7796; studies = 10; I2 = 0%, high quality of evidence), cough (RR 1.06, 95% CI 1.01 to 1.11; participants = 8013; studies = 13; I2 = 0%, high quality of evidence), and diarrhoea (RR 1.16, 95% CI 1.03 to 1.31; participants = 6841; studies = 11; I2 = 8%, high quality of evidence) were more frequent in DHA-PQ treatment arm. Conclusion From this review, it can be concluded that early vomiting, diarrhoea, and cough were common were significantly more frequent in patients who were treated with the DHA-PQ than that of AL, and both drugs are well tolerated. More studies comparing AL with DHA-PQ are needed to determine the comparative safety of these drugs.


2022 ◽  
pp. 53-74
Author(s):  
Duarte Vital Brito ◽  
Hernâni Zão Oliveira

The use of gamification in the health context, especially to trigger behavior change, has assumed a particular relevance. However, the scientific evidence that supports the effectiveness of gamified methodologies has constituted a barrier to the implementation of projects. This chapter draws on a review of this theme, identifying barriers and opportunities for using gamification mechanisms. Results show that digital games are often considered as more enjoyable, engaging, and interesting solutions that are able to increase access, autonomy, self-efficacy, compliance to treatment, and knowledge acquisition. However, most studies reported a high risk of bias due to small-sized samples, short follow-up times, and lack of randomized control trials or more robust study designs. Therefore, future research should target older adults, ensure longer periods of follow-up, bigger samples, and include randomized control trials. Involvement of patients and health professionals is also a key component to ensure a more effective and regulated delivery of such solutions within the healthcare system.


Author(s):  
José Eizayaga

If there were one lacking or insufficient issue which conscious medical orientated homeopaths could regret, it would be probably high quality clinical research. A big part of the homeopathic community still insists in the traditional ways of building knowledge, leading us nowhere. There is now an agreement between clinical researchers that there have been done enough efforts with Randomized Control Trials (RCT). But what we need today is good quality scientific research that could improve our daily practice. This article introduce the REDIMEH, an Ibero-American Integrative Network for Clinical Research in Homeopathy, horizontal in structure, with no political objectives, with the only intention of joining efforts in order to obtain enough clinical data to draw out valid conclusions. Keywords: REDIMED, atopic dermatitis, clinical research.  Projeto REDIMED: Red Integrada Ibero-Americana para Pesquisa Clínica em Homeopatia ResumoSe pudermos apontar uma questão, a qual os verdadeiros médicos homeopatas podem se lamentar, esta deveria ser a falta ou insuficiéncia de pesquisas clínicas de alta qualidade. Uma grande parte da comunidade homeopática ainda insiste nas formas tradicionais de construção de conhecimento, levando-nos a lugar algum. Existem pontos bem estabelecidos pelos pesquisadores clínicos que tem se esforçado muito com a realização de Ensaios Controlados Randomizados (RCT). O que mais precisamos hoje é de investigação científica de boa qualidade, que possa melhorar a nossa prática diária. Este artigo apresenta o projeto REDIMEH, uma Rede Integrada Ibero-Americana para Pesquisa Clínica em Homeopatia, de estrutura horizontal, sem objetivos políticos, com a intenção de unir esforços no sentido de obter dados clínicos suficientes para chegarmos a conclusões válidas para a prática clínica diária. Palavras-chave: REDIMED, dermatite atópica, investigação clínica.  Proyecto REDIMEH: Red Iberoamericana Integrativa de Investigación Clínica en Homeopatía ResumenSi hubiera uma cuestión de la cual los médicos homeopatas podrían pesar, sería probablemente la investigación clínica de alta calidad. Una gran parte de la comunidad homeopática sigue insistiendo en las formas tradicionales de construcción del conocimiento, que nos conduce a ninguna parte. En la actualidad, existe un acuerdo entre los investigadores clínicos, que ya se han hecho lo suficiente con los esfuerzos de control de ensayos aleatorios (RCT). Pero lo que necesitamos hoy es la investigación científica de buena calidad que pueda mejorar nuestra práctica diaria. Este artículo presentará el REDIMEH, uma Red Iberoamericana Integrativa de Investigación Clínica en Homeopatía, con una estructura horizontal, sin objetivos políticos, con la única intención de unir esfuerzos con el propósito de obtener datos clínicos suficientes para sacar conclusiones válidas. Palabras-clave: REDIMED, dermatitis atópica, investigación clínica  Correspondence author: Jose Eizayaga, [email protected], www.maimonides.edu How to cite this article: Eizayaga J. REDIMEH Project: Ibero-American Integrative Network for Clinical Research in Homeopathy. Int J High Dilution Res [online]. 2009 [cited YYYY Month dd]; 8(27): 50-52. Available from: http://journal.giri-society.org/index.php/ijhdr/article/view/340/392.  


Author(s):  
Praveen Uppu ◽  
M. Manickavasagam ◽  
Nalini Sirala Jagadeesh ◽  
K. Ramesh Babu

Abstract Background To establish the evidence related to the efficacy of mobile phone technology for managing side effects of chemotherapy and improved quality of life among patients with cancer. Methods Articles published in peer-reviewed journals were included in this review. Randomized control trials (RCTs) and non-randomized control trials (non-RCTs) consisting of mobile-based interventions (mobile application, smart phone App-based interventions or guidelines to manage side-effects of chemotherapy or mobile health services), and adult cancer patients (aged 18 or above years) as participants who were undergoing chemotherapy and received mobile phone-based interventions as an interventional group versus control/comparator group who were getting routine or usual care were included in this systematic review. Databases such as Scopus, Science Direct, Cochrane library, PubMed, and Google Scholar were systematically searched between 2007 and 2020. Using the Cochrane risk of bias tool, the methodological quality of the included studies was evaluated by two independent authors. Results We included 10 trials, involving 1467 cancer patients and the number of participants ranged from 50 to 457. All trials measured the side effects of chemotherapy as the main outcome and three trials measured the quality of life as the main outcome.Ten trials included for narrative synthesis showed a significant decrease in chemotherapy side effects and considerable improvement in the quality of life in the interventional group than in the comparison group. Meta-analysis of four RCTs containing 803 subjects concluded a significant improvement (p < 0.0001) in the quality of life.A significant improvement in the quality of life was revealed by random effects model (SMD = 0.31, 95% CI: 0.17, −0.46) and a significant difference (Z = 4.37, p < 0.001) was identified between experimental and control groups. Conclusion Current review strengthens the evidence that utilizing mobile-phone based technology has favorable effects on improving the quality of life by minimizing side-effects associated with chemotherapy among cancer patients.


2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Emily Shockley ◽  
Aliya Amin ◽  
Dennis Savaiano

Background/Objective: Six out of ten deaths in the United States are caused by chronic diseases. There are multiple approaches to prevention and/or early detection of chronic diseases through screenings, nutrition, physical activity, and more. Unfortunately, a large portion of the US population have low rates of preventative care. Community health coalitions have the potential to improve preventative health outcomes by partnering with key members of communities to design programs that best fit community needs. In this systematic review, we examine evidence that community health coalitions can improve preventative health outcomes. Methods: PubMed, WebofScience, CINAHL, and PsycINFO were searched for (outcome OR health outcome) AND (prevention) AND (diabetes OR hypertension OR cancer OR prenatal) AND (community-based participatory research OR community coalition OR coalition OR health coalition). After screening 490 articles, 30 full-text, peer-reviewed, English articles meeting inclusion criteria of health coalition, prevention, health outcomes reported, and conducted in the United States were reviewed. Results: 27 of the 30 studies showed community health coalitions having a positive impact. Roughly half of the articles were randomized control trials. Community members and academia were represented in 80% and 77%, respectively, of the coalitions described, while other representations included faith-based organizations, health care, public health, industry, and education. Diabetes and cancer represented 74% of the targeted preventions addressed. 90% of the interventions focused on educating the community, and 33% focused on increasing health screening rates. 60% utilized trained community members to deliver interventions. 60% reported health measurements, 33% reported screening rates, and 30% reported knowledge and awareness. Conclusion, Impact, & Implications: While the evidence suggests community health coalitions are effective in improving preventative health outcomes, the quality of the studies remain low. There is a need for increased rigor of study design and assessment in order to determine the true efficacy of community health coalitions. The majority of the randomized-control trials in this review were rated as low-quality, highlighting the difficulty of designing a randomized, controlled study in a community. Inadequate funding, lack of rigorous design, or ethical challenges can limit the quality of the assessment. Further, although prenatal care was included as a search term, there were no coalitions found that addressed this type of preventative care. This points to a future need for the creation of or increased publications from prenatal health coalitions.  


Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 100570
Author(s):  
Deborah Lai ◽  
Daniel Wang ◽  
Matthew McGillivray ◽  
Shadi Baajour ◽  
Ali S Raja ◽  
...  

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