Evidence map›Paper›PMID 14633287›Full record

Trial reportBMC medical research methodology2003

Design, analysis and presentation of factorial randomised controlled trials.

Alan A Montgomery, Tim J Peters, Paul Little

2 registry-linked trialsAbstract readClinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medical research methodology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 148 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 10 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.

NCT03654105 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2019 to 2026Enrolled2,000ConditionsInflammation, Smoking Cessation, Diet Modification, Physical ActivityArmsCytisine, Acetylsalicylic acid, Diet Modification and Physical Activity Increase, early lung cancer detection, spirometry with CO test
NCT05106790 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Efficacy of mHealth and Education-led Peer Counseling of Patients With Hypertension and Coronary Artery Disease: a Double-blinded Pragmatic Randomized Control Trial With Factorial Design, Pakistan

TypeinterventionalSponsorUniversiti Putra MalaysiaRan2022 to 2023Enrolled1,440ConditionsTreatment Adherence and ComplianceArmsEducational support with peer counseling, mHealth intervention, mHealth intervention and Educational support with peer counseling
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Community Health Worker Training Curricula and Intervention Outcomes in African American and Latinx Communities: A Systematic Review.Health education & behavior : the official publication of the Society for Public Health Education · 2021
    Pooled it
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  5. Glucocorticoids for acute viral bronchiolitis in infants and young children.The Cochrane database of systematic reviews · 2013
    Pooled it
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  8. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2008
    Pooled it
  9. Rosiglitazone for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2007
    Pooled it
  10. Pioglitazone for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2006 · on this map
    Pooled it
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  15. Perceived Effectiveness of Cigar Warnings in Discouraging Blunt Use.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2024
    Trial
  16. Secondary prevention of stroke. A telehealth-delivered physical activity and diet pilot randomized trial (ENAbLE-pilot).International journal of stroke : official journal of the International Stroke Society · 2024
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88 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

3 authors.

Alan A MontgomeryDivision of Primary Health Care, University of Bristol, Cotham House, Cotham Hill, Bristol BS6 6JL, UK. alan.a.montgomery@bristol.ac.uk
Tim J Peters
Paul Little

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. DISCUSSION: Using a 2 x 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. SUMMARY: Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

Indexed as

Data Interpretation, StatisticalHumansRandomized Controlled Trials as TopicResearch DesignSample Size

Identifiers

PMID14633287
PMCPMC305359

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.