Evidence map›Paper›PMID 37963675›Full record

ReviewRegional anesthesia and pain medicine2024

Evaluating the balance of benefits and harms in chronic pain clinical trials: prioritizing individual participants over individual outcomes.

Mahd Nishtar, Remington Mark, Dale J Langford, Michael P McDermott, John D Markman, Scott R Evans, Fallon O France, Meghan Park, Sonia Sharma, Dennis C Turk and 2 more

Open access · greenAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Regional anesthesia and pain medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 11% of its field
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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
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

12 authors at 6 institutions in 1 country.

Mahd NishtarAnesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.
Remington MarkAnesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.ORCID 0000-0002-4702-9738
Dale J LangfordAnesthesiology, Critical Care & Pain Management, Hospital for Special Surgery, New York, New York, USA.
Michael P McDermottDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
John D MarkmanDepartment of Neurosurgery, University of Rochester, Rochester, NY, USA.
Scott R EvansSchool of Medicine and Health Sciences, The George Washington University, Washington, DC, USA.
Fallon O FranceAnesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.
Meghan ParkAnesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.
Sonia SharmaSchool of Medicine and Biomedical Sciences, University at Buffalo Jacobs, Buffalo, New York, USA.
Dennis C TurkAnesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.
Robert H DworkinAnesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.
Jennifer S GewandterAnesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA jennifer_gewandter@urmc.rochester.edu.
University of Rochester · USGeorge Washington University · USHospital for Special Surgery · USJacobs Institute · USUniversity of Rochester Medical Center · USUniversity of Washington · US

Funding

Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01)U01FD007702 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H, EISENACH, JAMES · 2022 to 2023
$1.0M
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD007474 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H, EDWARDS, ROBERT R · 2021 to 2021
$500k
Promoting high-quality pain treatment trials through mentorship of junior investigators: A focus on study conduct and method developmentK24NS126861 · NINDS · UNIVERSITY OF ROCHESTER · PI GEWANDTER, JENNIFER · 2021 to 2021
$306k
FDA HHS U01 FD007474FDA HHS U01 FD007702NINDS NIH HHS K24 NS126861
6 · The paper itself

Abstract

backgroundRandomized clinical trials (RCTs) generally assess efficacy and safety separately, with the conclusion of whether a treatment is beneficial based solely on the efficacy endpoint. However, assessing and combining efficacy and safety domains, using a single composite outcome measure, can provide a more comprehensive assessment of the overall effect of a treatment. Furthermore, composite outcomes can incorporate information regarding the relationship between the individual outcomes. In fact, such outcomes have been suggested in the clinical trials literature for at least 15 years.

objectivesTo (1) identify whether recent primary publications of chronic pain RCTs from major pain journals included a composite outcome measure of benefits and harms and (2) discuss the potential benefits of such outcomes in various stages of treatment development, including as outcome measures in RCTs, and to support decisions of Data and Safety Monitoring Boards and ordering of treatments in the context of treatment guidelines. EVIDENCE REVIEW: RCTs published in 6 major pain journals published between 2016 and 2021 that investigated interventions for chronic pain were reviewed.

findingsOf 73 RCTs identified, only 2 included a composite outcome measure of benefits and harms. Both of these articles compared 2 active treatments.

conclusionsComposite outcomes of benefits and harms are underutilized in chronic pain RCTs. The advantages and challenges of using such outcomes are discussed.

Indexed as

Chronic PainRandomized Controlled Trials as TopicHumansOutcome Assessment, Health CarePain ManagementRisk AssessmentTreatment Outcomechronic painoutcomespain management

Identifiers

PMID37963675
PMCPMC11081843
OpenAlexW4388653111

What OpenQuestion holds

Textmetadata
LicenceTDM
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.