scholarly journals A Primer on Repeated Sitting Exposure and the Cardiovascular System: Considerations for Study Design, Analysis, Interpretation, and Translation

2021 ◽  
Vol 8 ◽  
Author(s):  
Lee Stoner ◽  
Bethany Barone Gibbs ◽  
Michelle L. Meyer ◽  
Simon Fryer ◽  
Daniel Credeur ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Design ◽  
Guideline Development ◽  
Strong Association ◽  
Controlled Trials ◽  
Public Health Agencies ◽  
Randomized Controlled ◽  
Health Agencies ◽  
Reduction Strategies ◽  
Systems Physiology

Sedentary behavior, particularly sitting, is ubiquitous in many contemporary societies. This is a major societal concern considering the evidence for a strong association between sitting behavior and cardiovascular disease morbidity and mortality. Unsurprisingly, leading public health agencies have begun to advocate “reduction” in sitting behavior. Though, the guidelines are typically vague and non-specific. The lack of specific guidelines for prolonged sitting is attributable to the absence of available evidence to facilitate guideline development. To inform policy, well-designed randomized controlled trials are required to test the efficacy of specific and translatable sitting reduction strategies. To guide the design of randomized controlled trials, this review postulates that several gaps in the literature first need to be filled. Following a general discussion of the importance of sitting behavior to contemporary societies, each of the following are discussed: (i) acute sitting exposure and systems physiology; (ii) recommendations for a systems physiology toolbox; (iii) study design considerations for acute sitting exposure; and (iv) translation of sitting-focused research.

scholarly journals Mediterranean Diet Increases Endothelial Function in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 150 (5) ◽  
pp. 1151-1159 ◽  
Author(s):  
Oliver M Shannon ◽  
Inês Mendes ◽  
Christina Köchl ◽  
Mohsen Mazidi ◽  
Ammar W Ashor ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Status ◽  
Endothelial Function ◽  
Randomized Controlled Trials ◽  
Study Design ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Duration

ABSTRACT Background The endothelium plays a key role in the maintenance of vascular health and represents a potential physiological target for dietary and other lifestyle interventions designed to reduce the risk of cardiovascular diseases (CVD) including stroke or coronary heart disease. Objective To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effects of the Mediterranean dietary pattern (MedDiet) on endothelial function. Methods Medline, Embase, and Scopus databases were searched from inception until January 2019 for studies that met the following criteria: 1) RCTs including adult participants, 2) interventions promoting the MedDiet, 3) inclusion of a control group, and 4) measurements of endothelial function. A random-effects meta-analysis was conducted. Metaregression and subgroup analyses were performed to identify whether effects were modified by health status (i.e., healthy participants versus participants with existing comorbidities), type of intervention (i.e., MedDiet alone or with a cointervention), study duration, study design (i.e., parallel or crossover), BMI, and age of participants. Results Fourteen articles reporting data for 1930 participants were included in the meta-analysis. Study duration ranged from 4 wk to 2.3 y. We observed a beneficial effect of the MedDiet on endothelial function [standardized mean difference (SMD): 0.35; 95% CI: 0.17, 0.53; P <0.001; I2 = 73.68%]. MedDiet interventions improved flow-mediated dilation (FMD)—the reference method for noninvasive, clinical measurement of endothelial function—by 1.66% (absolute change; 95% CI: 1.15, 2.17; P <0.001; I2 = 0%). Effects of the MedDiet on endothelial function were not modified by health status, type of intervention, study duration, study design, BMI, or age of participants (P >0.05). Conclusions MedDiet interventions improve endothelial function in adults, suggesting that the protective effects of the MedDiet are evident at early stages of the atherosclerotic process with important implications for the early prevention of CVD. This study has the PROSPERO registration number: CRD42018106188.

Person-Centered Research: A novel approach to Randomized Controlled Trials

2018 ◽  
Vol 6 (2) ◽  
pp. 209
Author(s):  
Reza A Badian ◽  
Brendan McCormack ◽  
Vibeke Sundling
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Study Design ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Centered Care ◽  
Based Medicine ◽  
Novel Design

Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we intend to introduce a novel design to fill such a gap.Aims and objectives: The aim of this paper is to introduce a novel study design where essential values of person-centered care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design termed a person-centered randomized controlled trial (PC-RCT).Methods: In this paper we discuss the importance and role of evidence in clinical research, levels of evidence, as well as the significance of study design in evidence-based medicine. Moreover, we discuss randomized controlled trials that are considered the gold standard to achieve high quality evidence. In this paper we will explain what the concept of person-centered care is and discuss the values associated with person-centeredness.The theoretical and methodological considerations that are relevant in applying this concept will be discussed before presenting how we intend to incorporate person-centered values into a randomized controlled trial in a novel study design that is both person-centered and randomized controlled (PC-RCT). Different aspects of this proposed novel study design will be discussed, including the theory and methods underlying this new proposed design, its novelty, different stages and practical steps involved in this proposed design. Challenges, drawbacks and possible solutions for addressing challenges of this novel design will be explored, focusing on the construct, dynamics, advantages, disadvantages and novelty of PC-RCT design.Conclusion: This paper presents how person-centered values and traditional randomised controlled trial principal values are integrated into one study design where the strengths of both concepts are merged into one. The proposed novel study design has stronger person-centered characteristics and is solid in its RCT features. This design ensures that participants have much more active participation in decision-making and gain more choice in their treatment. The proposed novel study design in this paper has clearly an important role to play in satisfying the need for a study design that can address both the need for rendering higher levels of evidence as well as simultaneously securing greater integration of person-centered values in the same study design.

scholarly journals MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials

2019 ◽  
Vol 236 (9) ◽  
pp. 2735-2745 ◽  
Author(s):  
Michael C. Mithoefer ◽  
Allison A. Feduccia ◽  
Lisa Jerome ◽  
Anne Mithoefer ◽  
Mark Wagner ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Design ◽  
Pooled Analysis ◽  
Controlled Trials ◽  
Phase 2 ◽  
Phase 3 ◽  
Randomized Controlled

scholarly journals Microbiome research in general and business newspapers: How many microbiome articles are published and which study designs make the news the most?

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249835
Author(s):  
Andreu Prados-Bo ◽  
Gonzalo Casino
Keyword(s):  
New York ◽  
Randomized Controlled Trials ◽  
Study Design ◽  
Observational Studies ◽  
New York Times ◽  
Environmental Studies ◽  
Controlled Trials ◽  
Academic Journals ◽  
News Stories ◽  
Randomized Controlled

The microbiome is a matter of interest for science, consumers and business. Our objective is to quantify that interest in academic journals and newspapers, both quantitatively and by study design. We calculated the number of articles on the microbiome from the total number of biomedicine articles featured in both PubMed and Spanish science news agency SINC, from 2008 to 2018. We used the Factiva database to identify news stories on microbiome papers in three general newspapers (The New York Times, The Times and El País) and three business newspapers (The Wall Street Journal, the Financial Times and Expansión), from 2007 to 2019. Then, we compared news stories with microbiome papers in PubMed, while also analyzing the frequencies of five study design types, both in the newspapers and in the papers themselves. Microbiome papers represented 0.8% of biomedicine papers in PubMed from 2008 to 2018 (increasing from 0.4% to 1.4%), while microbiome news published by SINC represented 1.6% of total biomedical news stories during the same period (increasing from 0.2% to 2.2%). The number of news stories on microbiome papers correlated with the number of microbiome papers (0.91, p < 0.001) featured in general newspapers, but not in business ones. News stories on microbiome papers represented 78.9% and 42.7% of all microbiome articles in general and business newspapers, respectively. Both media outlet types tended to over-report observational studies in humans while under-reporting environmental studies, while the representation of systematic reviews of randomized controlled trials, randomized controlled trials and animal/laboratory studies was similar when comparing newspapers and PubMed. The microbiome is receiving increasing attention in academic journals and newspapers. News stories on the microbiome in general and business newspapers are mostly based on research findings and are more interested in observational studies in humans and less in environmental studies compared to PubMed.

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