Improving Power and Accuracy in Randomized Controlled Trials of Pain Treatments by Accounting for Concurrent Analgesic Use.

Humans Analgesics, Opioid Randomized Controlled Trials as Topic Analgesics / therapeutic use Pain Management / methods Pain / drug therapy Pain, Postoperative / drug therapy
Pain low back pain opioids outcomes power

Journal

The journal of pain
ISSN: 1528-8447
Titre abrégé: J Pain
Pays: United States
ID NLM: 100898657

Informations de publication

Date de publication:
02 2023
Historique:
received: 30 08 2021
revised: 17 09 2022
accepted: 19 09 2022
pmc-release: 01 02 2024
pubmed: 12 10 2022
medline: 7 2 2023
entrez: 11 10 2022
Statut: ppublish

Résumé

The 0 to 10 numeric rating scale of pain intensity is a standard outcome in randomized controlled trials (RCTs) of pain treatments. For individuals taking analgesics, there may be a disparity between "observed" pain intensity (pain intensity with concurrent analgesic use) and pain intensity without concurrent analgesic use (what the numeric rating scale would be had analgesics not been taken). Using a contemporary causal inference framework, we compare analytic methods that can potentially account for concurrent analgesic use, first in statistical simulations, and second in analyses of real (non-simulated) data from an RCT of lumbar epidural steroid injections. The default analytic method was ignoring analgesic use, which is the most common approach in pain RCTs. Compared to ignoring analgesic use and other analytic methods, simulations showed that a quantitative pain and analgesia composite outcome based on adding 1.5 points to pain intensity for those who were taking an analgesic (the QPAC

Identifiants

DOI: 10.1016/j.jpain.2022.09.017 PMID: 36220482 PMC: PMC9898095
pubmed: 36220482
pii: S1526-5900(22)00417-5
doi: 10.1016/j.jpain.2022.09.017
pmc: PMC9898095
mid: NIHMS1841575
pii:
doi:

Substances chimiques

Analgesics, Opioid 0
Analgesics 0

Types de publication

Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

332-344

Subventions

Organisme : NIAMS NIH HHS
ID : P30 AR072572
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002319
Pays : United States

Informations de copyright

Published by Elsevier Inc.

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Auteurs

Pradeep Suri (P)

Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, Washington; Division of Rehabilitation Care Services, VA Puget Sound Health Care System, Seattle, Washington; Clinical Learning, Evidence, and Research Center, University of Washington, Seattle, Washington; Department of Rehabilitation Medicine, University of Washington, Seattle, Washington. Electronic address: pradeep.suri@va.gov.

Patrick J Heagerty (PJ)

Department of Biostatistics, University of Washington, Seattle, Washington.

Anna Korpak (A)

Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, Washington.

Mark P Jensen (MP)

Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.

Laura S Gold (LS)

Clinical Learning, Evidence, and Research Center, University of Washington, Seattle, Washington; Departments of Radiology and Neurological Surgery, University of Washington, Seattle, Washington.

Kwun C G Chan (KCG)

Department of Biostatistics, University of Washington, Seattle, Washington.

Andrew Timmons (A)

Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, Washington.

Janna Friedly (J)

Clinical Learning, Evidence, and Research Center, University of Washington, Seattle, Washington; Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.

Jeffrey G Jarvik (JG)

Clinical Learning, Evidence, and Research Center, University of Washington, Seattle, Washington; Departments of Radiology and Neurological Surgery, University of Washington, Seattle, Washington.

Aaron Baraff (A)

Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, Washington; Department of Statistics, University of Washington, Seattle, Washington.

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