Evidence mapPaperPMID 33521483Full record

Trial reportPain reports

Essential statistical principles of clinical trials of pain treatments.

Robert H Dworkin, Scott R Evans, Omar Mbowe, Michael P McDermott

Abstract readClinical TrialReview
In one paragraph

Trial report in Pain reports. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
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

29 citing papers in PubMed.

  1. Trial
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  8. Tecovirimat for the Treatment of Mpox.The New England journal of medicine · 2026
    Article
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  12. Review
  13. Review
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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

4 authors.

Robert H DworkinDepartments of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Center for Health + Technology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Scott R EvansDepartment of Biostatistics and Bioinformatics and the Biostatistics Center, George, Washington University, Washington DC, USA.
Omar MboweDepartment of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Michael P McDermottDepartments of Biostatistics and Computational Biology and Neurology, and Center for Health + Technology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article presents an overview of fundamental statistical principles of clinical trials of pain treatments. Statistical considerations relevant to phase 2 proof of concept and phase 3 confirmatory randomized trials investigating efficacy and safety are discussed, including (1) research design; (2) endpoints and analyses; (3) sample size determination and statistical power; (4) missing data and trial estimands; (5) data monitoring and interim analyses; and (6) interpretation of results. Although clinical trials of pharmacologic treatments are emphasized, the key issues raised by these trials are also directly applicable to clinical trials of other types of treatments, including biologics, devices, nonpharmacologic therapies (eg, physical therapy and cognitive-behavior therapy), and complementary and integrative health interventions.

Indexed as

Acute painChronic painClinical trialsEndpointsMissing dataOutcomesResearch designStatistical analysis

Identifiers

PMID33521483
PMCPMC7837867

What Socratic 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 Socratic graph.