Evidence map›Paper›PMID 33200182›Full record

ArticleAdvances in nutrition (Bethesda, Md.)2021

Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials.

Alice H Lichtenstein, Kristina Petersen, Kathryn Barger, Karen E Hansen, Cheryl A M Anderson, David J Baer, Johanna W Lampe, Helen Rasmussen, Nirupa R Matthan

Abstract read
In one paragraph

Article in Advances in nutrition (Bethesda, Md.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Alice H LichtensteinCardiovascular Nutrition Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.
Kristina PetersenPennsylvania State University, University Park, PA, USA.
Kathryn BargerJean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.
Karen E HansenSchool of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.
Cheryl A M AndersonDivision of Preventive Medicine, Department of Family Medicine of Public Health, University of California, San Diego, La Jolla, CA, USA.
David J BaerFood Components and Health Laboratory, Beltsville Human Nutrition Research Center, USDA Agricultural Research Service, Beltsville, MD, USA.
Johanna W LampePublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Helen RasmussenJean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.
Nirupa R MatthanJean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.

Funding

Tufts Clinical and Translational Science Institute (Pilot Supplement)UL1TR002544 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2018 to 2022
$50.2M
Penn State Clinical and Translational Science InstituteUL1TR002014 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KRASCHNEWSKI, JENNIFER L. · 2016 to 2025
$33.7M
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
NCATS NIH HHS UL1 TR002014NCATS NIH HHS UL1 TR002529NCATS NIH HHS UL1 TR002544
6 · The paper itself

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.

Indexed as

Randomized Controlled Trials as TopicResearch DesignHumansNutritional StatusNutrition TherapyOutcome Assessment, Health Careadherencedesigndietnutritionrandomized controlled trialsrecruitmentretentionscientific integrityscreening

Identifiers

PMID33200182
PMCPMC7849995

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.