Evidence map›Paper›PMID 28254585›Full record

ReviewThe journal of pain2017

The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations.

Shannon M Smith, Robert H Dworkin, Dennis C Turk, Ralf Baron, Michael Polydefkis, Irene Tracey, David Borsook, Robert R Edwards, Richard E Harris, Tor D Wager and 26 more

Abstract readReview
In one paragraph

Review in The journal of pain, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 4 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

71 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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11 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

36 authors.

Shannon M Smith
Robert H Dworkin
Dennis C Turk
Ralf Baron
Michael Polydefkis
Irene Tracey
David Borsook
Robert R Edwards
Richard E Harris
Tor D Wager
Lars Arendt-Nielsen
Laurie B Burke
Daniel B Carr
Amy Chappell
John T Farrar
Roy Freeman
Ian Gilron
Veeraindar Goli
Juergen Haeussler
Troels Jensen
Nathaniel P Katz
Jeffrey Kent
Ernest A Kopecky
David A Lee
William Maixner
John D Markman
Justin C McArthur
Michael P McDermott
Lav Parvathenani
Srinivasa N Raja
Bob A Rappaport
Andrew S C Rice
Michael C Rowbotham
Jeffrey K Tobias
Ajay D Wasan
James Witter

Funding

Brain Mechanisms Underlying CBT-Related Reductions in FibromyalgiaR01AR064367 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI EDWARDS, ROBERT R, NAPADOW, VITALY · 2014 to 2018
$4.0M
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
Analgesic Clinical Trial Innovations,Opportunities,and Networks(ACTION)U01FD004187 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2011 to 2014
$1.8M
FDA HHS U01 FD004187FDA HHS U01 FD005936Medical Research Council G0700399NIAMS NIH HHS R01 AR064367
6 · The paper itself

Abstract

Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. PERSPECTIVE: The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability.

Indexed as

BiomarkersBrainSkinChronic PainHumansSensory ThresholdsBiomarkersBiomarkersbrain imagingIMMPACTsensory testingskin punch biopsy

Identifiers

PMID28254585
PMCPMC5484729

What OpenQuestion holds

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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.