Evidence mapPaperPMID 32520773Full record

ArticlePain2020

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations.

Shannon M Smith, Robert H Dworkin, Dennis C Turk, Michael P McDermott, Christopher Eccleston, John T Farrar, Michael C Rowbotham, Zubin Bhagwagar, Laurie B Burke, Penney Cowan and 27 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Pain, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 90 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing 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.

NCT07731256 phase2not yet recruitingstarted 2027, after this paper: background citation

A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity

Ran2027Enrolled250Registered outcomes13Posted comparisons0ConditionsChronic Lower Back Pain, glp1 Agonist, Lower Back Pain, Obesity (BMI>30)ArmsPlacebo (administered by PDS290 pen-injector), Semaglutide (administered by PDS290 pen-injector)
Open the trial in the graph
NCT05581472 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Examining Different Components of Online Acceptance and Commitment Therapy for Chronic Pain in a Sample of People With Chiari Malformation

TypeinterventionalSponsorKent State UniversityRan2023 to 2024Enrolled113ConditionsChronic Pain, Chiari MalformationArmsOnline Acceptance and Commitment Therapy Intervention + Phone Coaching, Online Acceptance and Commitment Therapy Intervention without phone coaching
NCT05983159 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2024 to 2027Enrolled50ConditionsSlow-Flow Vascular Malformation, Fast-Flow Vascular Malformation, Vascular Malformations, Venous MalformationArmsAlpelisib, Mirdametinib
3 · Its place in the literature

Who cites it

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

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  9. Psychological therapies for temporomandibular disorders (TMDs).The Cochrane database of systematic reviews · 2022
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30 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

37 authors.

Shannon M SmithDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States.
Robert H DworkinDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States.
Dennis C TurkAnesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States.
Michael P McDermottDepartment of Neurology, University of Rochester Medical Center, Rochester, NY, United States.
Christopher EcclestonCentre for Pain Research, The University of Bath, Bath, United Kingdom.
John T FarrarDepartments of Epidemiology, Neurology, and Anesthesia, University of Pennsylvania, Philadelphia, PA, United States.
Michael C RowbothamCPMC Research Institute, Sutter Health, San Francisco, CA, United States.
Zubin BhagwagarDepartment of Psychiatry, Yale School of Medicine, New Haven, CT, United States.
Laurie B BurkeSchool of Pharmacy, University of Maryland, Baltimore, MD, United States.
Penney CowanAmerican Chronic Pain Association, Rocklin, CA, United States.
Susan S EllenbergCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, United States.
Scott R EvansDepartment of Epidemiology and Biostatistics, The George Washington University, Washington, DC, United States.
Roy L FreemanDepartment of Neurology, Harvard Medical School, Boston, MA, United States.
Louis P GarrisonDepartment of Pharmacy, University of Washington, Seattle, WA, United States.
Smriti IyengarEli Lilly and Company, Indianapolis, IN, United States.
Alejandro JadadDepartment of Anesthesia, Faculty of Medicine, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Mark P JensenDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States.
Roderick JunorEisai Ltd, Hatfield, United Kingdom.
Cornelia KampCenter for Health and Technology, University of Rochester Medical Center, Rochester, NY, United States.
Nathaniel P KatzTufts University School of Medicine, Boston, MA, United States.
James Patrick KesslakRevance Therapeutics, Newark, CA, United States.
Ernest A KopeckyCollegium Pharmaceutical, Inc, Stoughton, MA, United States.
Dmitri LissinScilex Pharmaceuticals, Palo Alto, CA, United States.
John D MarkmanNeuromedicine Pain Management and Translational Pain Research, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States.
Philip J MeaseRheumatology Clinical Research, Swedish Medical Center, Seattle, WA, United States.
Alec B O'ConnorDepartment of Medicine, University of Rochester Medical Center, Rochester, NY, United States.
Kushang V PatelAnesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States.
Srinivasa N RajaDepartment of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Cristina SampaioFaculdade Medicinda de Lisboa, Universidade de Lisboa, Lisboa, Portugal.
David SchoenfeldDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Jasvinder SinghDepartments of Medicine and Epidemiology, University of Alabama at Birmingham School of Medicine, Birmingham, AB, United States.
Ilona SteigerwaldNeumentum, Inc, Palo Alto, CA, United States.
Vibeke StrandDivision of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States.
Leslie A TivePfizer, Inc, New York, NY, United States.
Jeffrey TobiasAquila Consulting Group, LLC, Petaluma, CA, United States.
Ajay D WasanDepartments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
Hilary D WilsonBoehringer Ingelheim, Seattle, WA, United States.

Funding

FDA HHS U01 FD005936
6 · The paper itself

Abstract

Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit-risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used.

Indexed as

AnalgesicsChronic PainHumansPain MeasurementRandomized Controlled Trials as TopicResearch DesignTranslationsAnalgesics

Identifiers

PMID32520773
PMCPMC7572524

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.