scholarly journals Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Connie M. Weaver ◽  
J. Kalina Hodges
Keyword(s):  
Best Practices ◽  
Randomized Controlled Trials ◽  
Evidence Base ◽  
Human Nutrition ◽  
Controlled Trials ◽  
Dietary Recommendations ◽  
Regulatory Policies ◽  
Randomized Controlled ◽  
Carry Over ◽  
Intervention Trials

Best practices for designing, conducting, documenting, and reporting human nutrition randomized controlled trials were developed and published in Advances in Nutrition. Through an example of the randomized clinical trial on blueberries and bone health funded by the National Institutes of Health, this paper will illustrate the elements of those best practices that apply specifically to plant-based intervention clinical trials. Unique study design considerations for human feeding interventions with bioactive plant compounds include the difficulty of blinding the intervention, background nutritional status of participants, carry-over effects of the intervention, benefits of a run-in period, lack of safety/tolerability data, and nutrition-specific regulatory policies. Human nutrition randomized controlled trials are the gold standard for establishing causal relations between an intervention and health outcome measures. Rigorous studies and documentation define the quality of the evidence-base to inform public health guidelines and to establish personalized dietary recommendations for the health-promoting plant components.

scholarly journals Are Randomized Controlled Trials Controlled? Patient Preferences and Unblind Trials

1997 ◽  
Vol 90 (12) ◽  
pp. 652-656 ◽  
Author(s):  
Klim Mcpherson ◽  
Annie R Britton ◽  
John E Wennberg
Keyword(s):  
Randomized Controlled Trials ◽  
Patient Preferences ◽  
Treatment Effects ◽  
Evidence Base ◽  
Modern Medicine ◽  
Treatment Preferences ◽  
Controlled Trials ◽  
True Nature ◽  
Randomized Controlled ◽  
Catch 22

The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions—for example, between treatment preferences and treatment effects—is generally subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments through poorly understood (psychological) pathways, then RCTs, particularly when unblinded, may wrongly attribute effects solely to a treatment's physiological/pharmacological properties. To interpret the RCT evidence base it is important to know whether any preference effects exist and, if so, by how much they affect outcome. Reliable measurement of these effects is difficult and will require new approaches to the conduct of trials. In view of the fanciful image with which such effects are portrayed and the uncertainties about their true nature and biological mechanisms, existing evidence is unlikely to provide sufficient justification for investment in trials. This is a Catch 22. Until an escape is found we might never know, even approximately, how much of modern medicine is attributable to psychological processes.

scholarly journals Pork consumption and its relationship to human nutrition and health: a scoping review

2021 ◽  
Author(s):  
Laura Paige Penkert ◽  
Ruogu Li ◽  
Jing Huang ◽  
Anil Gurcan ◽  
Mei Chun Chung ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Scoping Review ◽  
Case Control ◽  
Human Nutrition ◽  
Controlled Trials ◽  
Case Control Studies ◽  
Nutrition And Health ◽  
Randomized Controlled ◽  
Scoping Reviews ◽  
Pork Consumption

Pork is a frequently consumed red meat that provides substantial amounts of energy, macronutrients, and micronutrients to the diet. Its role in human nutrition and health is controversial and a plethora of data exist in the peer-reviewed scientific literature. Therefore, we conducted a scoping review of clinical and population-based studies to assess the effects of pork consumption on human nutrition and health. Results are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews. Data were extracted from 86 studies, including 16 randomized controlled trials, 1 uncontrolled trial, 7 cohort studies, 4 nonrandomized controlled trials, 4 case-cohort and nested case-control studies, 33 case-control studies, and 21 cross-sectional studies. Intervention studies were conducted in healthy individuals and were short to moderate in duration. The effect of pork intake on patients’ nutrient status was the most commonly assessed outcome. The majority of observational studies assessed the effect of pork on cancer incidence, but no studies assessed the effects of pork on inflammation or oxidative stress. No interventional studies explored diabetes mellitus risk, and only one study assessed cancer risk associated with pork consumption. Several micronutrients in pork, including zinc, iron, selenium, choline, thiamin, and vitamins B6 and vitamin B12, are thought to influence cognitive function and may prove to be a unique area of research. To date, there is a dearth of high-quality randomized controlled trials assessing the effects of pork intake on disease risk factors and outcomes. This review helps highlight the many research gaps that future studies should be designed to address.

scholarly journals External Validity and Worksite Wellness: Lessons From China and Illinois

2020 ◽  
Vol 35 (1) ◽  
pp. 9-12
Author(s):  
Paul E. Terry
Keyword(s):  
Best Practices ◽  
Randomized Controlled Trials ◽  
External Validity ◽  
Careful Consideration ◽  
Controlled Trials ◽  
Worksite Wellness ◽  
Randomized Controlled ◽  
Negative Findings ◽  
New Evidence ◽  
Internal And External Validity

This editorial describes recent randomized controlled trials of worksite wellness interventions and argues that fidelity to intervention designs should be contingent on careful consideration of internal and external validity. A China based hypertension management study which achieved impressive outcomes across 60 workplaces using a comprehensive approach is contrasted with the traditional wellness practices employed in other randomized controlled trials conducted in America. Why studies with negative findings receive more media and professional scrutiny than studies with positive findings is discussed. Three reasons are posited for why bad is stronger than good when it comes to capturing attention. Adoption of new evidence is discussed along with what health promotion professionals can do to advance best practices by considering adoption as an ongoing process.

The Clinical Effects of Red Blood Cell Transfusions: An Overview of the Randomized Controlled Trials Evidence Base

2011 ◽  
Vol 25 (2) ◽  
pp. 145-155.e2 ◽  
Author(s):  
Kirstin L. Wilkinson ◽  
Susan J. Brunskill ◽  
Carolyn Dorée ◽  
Sally Hopewell ◽  
Simon Stanworth ◽  
...  
Keyword(s):  
Blood Cell ◽  
Randomized Controlled Trials ◽  
Red Blood Cell ◽  
Evidence Base ◽  
Controlled Trials ◽  
Clinical Effects ◽  
Randomized Controlled ◽  
Red Blood Cell Transfusions

The Cochrane Skin Group: Promoting the Best Evidence

2005 ◽  
Vol 9 (6) ◽  
pp. 324-331
Author(s):  
Avanta Collier ◽  
Kathryn R. Johnson ◽  
Finola Delamere ◽  
Tina Leonard ◽  
Robert P. Dellavalle ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Cochrane Collaboration ◽  
Evidence Base ◽  
Therapeutic Interventions ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Cochrane Collaboration ◽  
Evidence Summaries

Background: The international Cochrane Skin group, established in 1997, organizes, writes and disseminates systematic reviews of therapeutic interventions in dermatology. ObjectiveTo introduce the Cochrane Skin Group and what it offers to cutaneous medicine and surgery providers. Methods: Descriptive review of the structure and output of the Cochrane Collaboration Library and the Cochrane Skin Group. Results: Systematic reviews of randomized controlled trials produced through the Cochrane Skin Group provide a benchmark for evidence summaries for informing clinical decisions in dermatology. Conclusion: The work performed by the Cochrane Skin Group is an important component for informing the evidence base for the clinical practice of cutaneous and surgical dermatology.

scholarly journals An update around the evidence base for the lower extremity ultrasound regional block technique

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 104 ◽  
Author(s):  
Andrea Fanelli ◽  
Daniela Ghisi ◽  
Rita Maria Melotti
Keyword(s):  
Lower Extremity ◽  
Randomized Controlled Trials ◽  
Regional Anesthesia ◽  
Current Literature ◽  
Gold Standard ◽  
Ultrasound Guidance ◽  
Evidence Base ◽  
Controlled Trials ◽  
Modest Improvement ◽  
Randomized Controlled

Ultrasound guidance currently represents the gold standard for regional anesthesia. In particular for lower extremity blocks, despite the heterogeneity and the lack of large randomized controlled trials, current literature shows a modest improvement in block onset and quality compared with other localization techniques. This review aims to present the most recent findings on the application of ultrasound guidance for each single lower extremity approach.

scholarly journals What is the evidence base for atopic eczema treatments? A summary of published randomized controlled trials

2017 ◽  
Vol 176 (4) ◽  
pp. 910-927 ◽  
Author(s):  
H. Nankervis ◽  
K.S. Thomas ◽  
F.M. Delamere ◽  
S. Barbarot ◽  
S. Smith ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Atopic Eczema ◽  
Evidence Base ◽  
Controlled Trials ◽  
Randomized Controlled
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