Evidence map›Paper›PMID 24314401›Full record

ArticleJournal of clinical epidemiology2014

In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials.

Jim McCambridge, Kypros Kypri, Diana Elbourne

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical epidemiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 4 pooled it
12.6field-weighted citation impact, top 1% of its field
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

60 citing papers in PubMed, 4 syntheses or guidelines pooled it, 136 citations in OpenAlex.

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  5. Successfully Reducing Sitting Time Can Improve Metabolic Flexibility.Scandinavian journal of medicine & science in sports · 2025
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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

3 authors at 3 institutions in 2 countries.

Jim McCambridgeDepartment of Social & Environmental Health, Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: Jim.McCambridge@lshtm.ac.uk.
Kypros KypriCentre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.
Diana ElbourneDepartment of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Faculty of Public Health · GBLondon School of Hygiene & Tropical Medicine · GBUniversity of Newcastle Australia · AU

Funding

Wellcome Trust WT086516MA
6 · The paper itself

Abstract

objectivesBehavioral intervention trials may be susceptible to poorly understood forms of bias stemming from research participation. This article considers how assessment and other prerandomization research activities may introduce bias that is not fully prevented by randomization. STUDY DESIGN AND

settingThis is a hypothesis-generating discussion article.

resultsAn additivity assumption underlying conventional thinking in trial design and analysis is problematic in behavioral intervention trials. Postrandomization sources of bias are somewhat better known within the clinical epidemiological and trials literatures. Neglect of attention to possible research participation effects means that unintended participant behavior change stemming from artifacts of the research process has unknown potential to bias estimates of behavioral intervention effects.

conclusionStudies are needed to evaluate how research participation effects are introduced, and we make suggestions for how research in this area may be taken forward, including how these issues may be addressed in the design and conduct of trials. It is proposed that attention to possible research participation effects can improve the design of trials evaluating behavioral and other interventions and inform the interpretation of existing evidence.

Indexed as

Behavior TherapyHealth BehaviorTherapeutic Human ExperimentationBiasHumansRandomized Controlled Trials as TopicResearch DesignBehaviorBiasHawthorne effectInterventionResearch participationTrials

Identifiers

PMID24314401
PMCPMC3969092
OpenAlexW2135062760

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.