Evidence map›Paper›PMID 29615035›Full record

ArticleBMC medicine2018

Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?

Rafael Dal-Ré, Perrine Janiaud, John P A Ioannidis

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06719245 (Prevention of PostAmputation Pain With Targeted Muscle Reinnervation), which is not on this map. Cited by 96 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 14 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.

NCT06719245 narecruitingnot on this mapstarted 2024, after this paper: background citation

Prevention of PostAmputation Pain With Targeted Muscle Reinnervation: A National, Multicenter, Randomized, Sham-controlled Superiority Trial, Comparing Standard Neurectomy With Targeted Muscle Reinnervation in Amputations of the Lower Extremities

TypeinterventionalSponsorLeiden University Medical CenterRan2024 to 2028Enrolled203ConditionsAmputation, Surgical, Phantom Limb Pain, Neuroma Amputation, SurgeryArmsTargeted Muscle Reinnervation (TMR), Standard neurectomy
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 14 syntheses or guidelines pooled it.

  1. A systematic review of the methodological quality of randomised trials in IBD surgery.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026
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  3. PRECIS-2 analysis of pragmatic acupuncture trials: a systematic review.BMC complementary medicine and therapies · 2024
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  5. Use of pragmatic randomized trials in multiple sclerosis: A systematic overview.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
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  11. Recall intervals for oral health in primary care patients.The Cochrane database of systematic reviews · 2020
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  14. Routine scale and polish for periodontal health in adults.The Cochrane database of systematic reviews · 2018
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36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors.

Rafael Dal-RéEpidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, E-28040, Madrid, Spain.
Perrine JaniaudMeta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, 94305, USA.
John P A IoannidisDepartments of Medicine, Health Research and Policy, Biomedical Data Science, Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, 94305, USA. jioannid@stanford.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical to inform decision-making by patients, clinicians and policy-makers in real-world settings. Pragmatic RCTs assess effectiveness of available medicines, while explanatory RCTs assess efficacy of investigational medicines. Explanatory and pragmatic are the extremes of a continuum. This debate article seeks to evaluate and provide recommendation on how to characterize pragmatic RCTs in light of the current landscape of RCTs. It is supported by findings from a PubMed search conducted in August 2017, which retrieved 615 RCTs self-labeled in their titles as "pragmatic" or "naturalistic". We focused on 89 of these trials that assessed medicines (drugs or biologics). DISCUSSION: 36% of these 89 trials were placebo-controlled, performed before licensing of the medicine, or done in a single-center. In our opinion, such RCTs overtly deviate from usual care and pragmatism. It follows, that the use of the term 'pragmatic' to describe them, conveys a misleading message to patients and clinicians. Furthermore, many other trials among the 615 coined as 'pragmatic' and assessing other types of intervention are plausibly not very pragmatic; however, this is impossible for a reader to tell without access to the full protocol and insider knowledge of the trial conduct. The degree of pragmatism should be evaluated by the trial investigators themselves using the PRECIS-2 tool, a tool that comprises 9 domains, each scored from 1 (very explanatory) to 5 (very pragmatic).

conclusionsTo allow for a more appropriate characterization of the degree of pragmatism in clinical research, submissions of RCTs to funders, research ethics committees and to peer-reviewed journals should include a PRECIS-2 tool assessment done by the trial investigators. Clarity and accuracy on the extent to which a RCT is pragmatic will help understand how much it is relevant to real-world practice.

Indexed as

Randomized Controlled Trials as TopicHumansPragmatic Clinical Trials as TopicResearch DesignEditorsEffectivenessExplanatory trialsPragmatic trialsPRECIS-2Real-world dataUsual clinical practice

Identifiers

PMID29615035
PMCPMC5883397

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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.