scholarly journals Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials

2020 ◽  
Author(s):  
Alice H Lichtenstein ◽  
Kristina Petersen ◽  
Kathryn Barger ◽  
Karen E Hansen ◽  
Cheryl A M Anderson ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Research Question ◽  
Human Nutrition ◽  
Quality Data ◽  
Scientific Integrity ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Results

ABSTRACT In the field of human nutrition, randomized controlled trials (RCTs) are considered the gold standard for establishing causal relations between exposure to nutrients, foods, or dietary patterns and prespecified outcome measures, such as body composition, biomarkers, or event rates. Evidence-based dietary guidance is frequently derived from systematic reviews and meta-analyses of these RCTs. Each decision made during the design and conduct of human nutrition RCTs will affect the utility and generalizability of the study results. Within the context of limited resources, the goal is to maximize the generalizability of the findings while producing the highest quality data and maintaining the highest levels of ethics and scientific integrity. The aim of this document is to discuss critical aspects of conducting human nutrition RCTs, including considerations for study design (parallel, crossover, factorial, cluster), institutional ethics approval (institutional review boards), recruitment and screening, intervention implementation, adherence and retention assessment, and statistical analyses considerations. Additional topics include distinguishing between efficacy and effectiveness, defining the research question(s), monitoring biomarker and outcome measures, and collecting and archiving data. Addressed are specific aspects of planning and conducting human nutrition RCTs, including types of interventions, inclusion/exclusion criteria, participant burden, randomization and blinding, trial initiation and monitoring, and the analysis plan.

scholarly journals Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

2020 ◽  
Author(s):  
Connie M Weaver ◽  
Naomi K Fukagawa ◽  
DeAnn Liska ◽  
Richard D Mattes ◽  
Gregory Matuszek ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Human Nutrition ◽  
Clinical Nutrition ◽  
Nutrition Intervention ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Nutrition Research ◽  
Human Nutrition Research ◽  
Behavior Issues

ABSTRACT Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled-feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity, and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (institutional review boards, data safety and monitoring boards, US FDA); participant safety; standard operating procedures; training of investigators, staff, and students; and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

scholarly journals Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

2021 ◽  
Vol 14 ◽  
pp. 175628482110106
Author(s):  
Fabio Salvatore Macaluso ◽  
Marcello Maida ◽  
Mauro Grova ◽  
Federica Crispino ◽  
Giulia Teresi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomized Controlled Trials ◽  
Real World ◽  
Bowel Disease ◽  
Quality Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Therapeutic Algorithms ◽  
Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents

2018 ◽  
Vol 23 (2) ◽  
pp. 389-396 ◽  
Author(s):  
Krste Boric ◽  
Antonia Jelicic Kadic ◽  
Matija Boric ◽  
Melissa Zarandi-Nowroozi ◽  
Dora Jakus ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Children And Adolescents ◽  
Outcome Measures ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Pain Outcome

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

scholarly journals A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

2019 ◽  
Vol 145 (1) ◽  
pp. 4-11 ◽  
Author(s):  
Thais Regina Mattos Lourenço ◽  
Vasilis Pergialiotis ◽  
Constantin Durnea ◽  
Abdullatif Elfituri ◽  
Jorge Milhem Haddad ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Prolapse Surgery ◽  
Controlled Trials ◽  
Apical Prolapse ◽  
Randomized Controlled

scholarly journals Nurse Participation in Colonoscopy Observation versus the Colonoscopist Alone for Polyp and Adenoma Detection: A Meta-Analysis of Randomized, Controlled Trials

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Lei Xu ◽  
Yu Zhang ◽  
Haojun Song ◽  
Weihong Wang ◽  
Sijie Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Detection Rate ◽  
Meta Analysis ◽  
Research Question ◽  
Adenoma Detection Rate ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Adenoma Detection ◽  
Significant Difference

The role of nurse participation (NP) in colonoscopy observation for polyp and adenoma detection is unclear. This study aimed to evaluate whether nurse participation can improve polyp and adenoma detection.Patients and Methods. The PUBMED, EMBASE, and Cochrane Library databases were searched for randomized controlled trials (RCTs) published in English. The outcome measurements included (1) the polyp and adenoma detection rate (PDR and ADR); (2) the advanced lesions detection rate; and (3) the mean polyp and adenoma detection rate per colonoscopy.Results. Three RCTs with a total of 1676 patients were included. The pooled data showed a significantly higher ADR in the NP group than colonoscopist alone (CA) (45.7% versus 39.3%; RR 1.16; 95% CI, 1.04–1.30). And it showed no significant difference in the PDR and advanced lesions detection rate between the two groups (RR: 1.14, 95% CI: 0.95–1.37; RR: 1.35, 95% CI: 0.91–2.00; resp.).Conclusions. Nurse participation during a colonoscopy can improve the ADR, whereas no benefit for the PDR and advanced lesions detection rate was observed. All RCTs included in the meta-analysis had high risk of bias. Thus, there is a need for new research that uses sound methodology to definitively address the research question under study.

scholarly journals Effects of rehabilitation programs on heart rate variability after stroke: a systematic review

2021 ◽  
Vol 79 (8) ◽  
pp. 724-731
Author(s):  
Thais Regina Belli ◽  
Luciane Aparecida Pascucci Sande de Souza ◽  
Silméia Garcia Zanati Bazan ◽  
Rodrigo Bazan ◽  
Gustavo José Luvizutto
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Randomized Controlled Trials ◽  
Early Mobilization ◽  
Control Group ◽  
Controlled Trials ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Rehabilitation Programs ◽  
Study Results

ABSTRACT Background: It has been shown that the autonomic nervous system can be modulated by physical exercise after stroke, but there is a lack of evidence showing rehabilitation can be effective in increasing heart rate variability (HRV). Objective: To investigate the effectiveness and safety of rehabilitation programs in modulating HRV after stroke. Methods: The search strategy was based in the PICOT (patients: stroke; interventions: rehabilitation; comparisons: any control group; outcomes: HRV; time: acute, subacute and chronic phases of stroke). We searched MEDLINE, CENTRAL, CINAHL, LILACS, and SCIELO databases without language restrictions, and included randomized controlled trials (RCTs), quasi-randomized controlled trials (quasi-RCTs), and non-randomized controlled trials (non-RCTs). Two authors independently assessed the risk of bias and we used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to rate the certainty of the evidence for each included study. Results: Four studies (two RCTs with low certainty of the evidence and two non-RCTs with very low certainty of the evidence) were included. Three of them showed significant cardiac autonomic modulation during and after stroke rehabilitation: LF/HF ratio (low frequency/high frequency) is higher during early mobilization; better cardiac autonomic balance was observed after body-mind interaction in stroke patients; and resting SDNN (standard deviation of normal R-R intervals) was significantly lower among stroke patients indicating less adaptive cardiac autonomic control during different activities. Conclusions: There are no definitive conclusions about the main cardiac autonomic repercussions observed in post-stroke patients undergoing rehabilitation, although all interventions are safe for patients after stroke.

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