Evidence map›Paper›PMID 27184269›Full record

ArticleAdvances in nutrition (Bethesda, Md.)2016

Perspective: Randomized Controlled Trials Are Not a Panacea for Diet-Related Research.

James R Hébert, Edward A Frongillo, Swann A Adams, Gabrielle M Turner-McGrievy, Thomas G Hurley, Donald R Miller, Ira S Ockene

Abstract read
In one paragraph

Article in Advances in nutrition (Bethesda, Md.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 7 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

63 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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3 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

7 authors.

James R HébertCancer Prevention and Control Program, Departments of Epidemiology and Biostatistics, and jhebert@sc.edu.
Edward A FrongilloHealth Promotion, Education and Behavior, Arnold School of Public Health.
Swann A AdamsCancer Prevention and Control Program, Departments of Epidemiology and Biostatistics, and College of Nursing, University of South Carolina, Columbia, SC;
Gabrielle M Turner-McGrievyHealth Promotion, Education and Behavior, Arnold School of Public Health.
Thomas G HurleyCancer Prevention and Control Program, Departments of.
Donald R MillerDepartment of Health Policy and Management, Boston University School of Public Health, Boston, MA; Center for Healthcare Organization and Implementation Research, Bedford Veterans Administration Medical Center, Bedford, MA; and.
Ira S OckeneDivision of Cardiovascular Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA.

Funding

Training ProgramU54CA153461 · NCI · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · PI HEBERT, JAMES R · 2010 to 2015
$4.8M
DIDACTIC: Dissemination and Implementation of a Diet and Activity Community TrialR01HL122285 · NHLBI · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · PI BRANDT, HEATHER M, HEBERT, JAMES R · 2014 to 2017
$2.1M
Developing the Dietary Inflammatory Index for Clinical ApplicationR44DK103377 · NIDDK · CONNECTING HEALTH INNOVATIONS, LLC · PI SHIVAPPA, NITIN, WIRTH, MICHAEL DAVID · 2014 to 2016
$1.8M
NCI NIH HHS U54 CA153461NHLBI NIH HHS R01 HL122285NIDDK NIH HHS R44 DK103377
6 · The paper itself

Abstract

Research into the role of diet in health faces a number of methodologic challenges in the choice of study design, measurement methods, and analytic options. Heavier reliance on randomized controlled trial (RCT) designs is suggested as a way to solve these challenges. We present and discuss 7 inherent and practical considerations with special relevance to RCTs designed to study diet: 1) the need for narrow focus; 2) the choice of subjects and exposures; 3) blinding of the intervention; 4) perceived asymmetry of treatment in relation to need; 5) temporal relations between dietary exposures and putative outcomes; 6) strict adherence to the intervention protocol, despite potential clinical counter-indications; and 7) the need to maintain methodologic rigor, including measuring diet carefully and frequently. Alternatives, including observational studies and adaptive intervention designs, are presented and discussed. Given high noise-to-signal ratios interjected by using inaccurate assessment methods in studies with weak or inappropriate study designs (including RCTs), it is conceivable and indeed likely that effects of diet are underestimated. No matter which designs are used, studies will require continued improvement in the assessment of dietary intake. As technology continues to improve, there is potential for enhanced accuracy and reduced user burden of dietary assessments that are applicable to a wide variety of study designs, including RCTs.

Indexed as

DietNutritional SciencesRandomized Controlled Trials as TopicResearch DesignHumansbehavioral interventionsblindingdietary assessment methodsepidemiologic studiesinformed consentobservational studiesrandomized controlled trialsstudy design

Identifiers

PMID27184269
PMCPMC4863268

What OpenQuestion holds

Textmetadata
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.