Pradeep Suri, Patrick J Heagerty, Andrew Timmons, Mark P Jensen
{"title":"Description and initial validation of a novel measure of pain intensity: the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use.","authors":"Pradeep Suri, Patrick J Heagerty, Andrew Timmons, Mark P Jensen","doi":"10.1097/j.pain.0000000000003150","DOIUrl":null,"url":null,"abstract":"<p><strong>Abstract: </strong>Although many individuals with chronic pain use analgesics, the methods used in many randomized controlled trials (RCTs) do not sufficiently account for confounding by differential post-randomization analgesic use. This may lead to underestimation of average treatment effects and diminished power. We introduce (1) a new measure-the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use (NRS-UP (A) )-which can shift the estimand of interest in an RCT to target effects of a treatment on pain intensity in the hypothetical situation where analgesic use was not occurring at the time of outcome assessment; and (2) a new pain construct-an individuals' perceived effect of analgesic use on pain intensity (E A ). The NRS-UP (A) may be used as a secondary outcome in RCTs of point treatments or nonpharmacologic treatments. Among 662 adults with back pain in primary care, participants' mean value of the NRS-UP (A) among those using analgesics was 1.2 NRS points higher than their value on the conventional pain intensity NRS, reflecting a mean E A value of -1.2 NRS points and a perceived beneficial effect of analgesics. More negative values of E A (ie, greater perceived benefit) were associated with a greater number of analgesics used but not with pain intensity, analgesic type, or opioid dose. The NRS-UP (A) and E A were significantly associated with future analgesic use 6 months later, but the conventional pain NRS was not. Future research is needed to determine whether the NRS-UP (A), used as a secondary outcome may allow pain RCTs to target alternative estimands with clinical relevance.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":null,"pages":null},"PeriodicalIF":5.9000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11189761/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"PAIN®","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/j.pain.0000000000003150","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/2 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Abstract: Although many individuals with chronic pain use analgesics, the methods used in many randomized controlled trials (RCTs) do not sufficiently account for confounding by differential post-randomization analgesic use. This may lead to underestimation of average treatment effects and diminished power. We introduce (1) a new measure-the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use (NRS-UP (A) )-which can shift the estimand of interest in an RCT to target effects of a treatment on pain intensity in the hypothetical situation where analgesic use was not occurring at the time of outcome assessment; and (2) a new pain construct-an individuals' perceived effect of analgesic use on pain intensity (E A ). The NRS-UP (A) may be used as a secondary outcome in RCTs of point treatments or nonpharmacologic treatments. Among 662 adults with back pain in primary care, participants' mean value of the NRS-UP (A) among those using analgesics was 1.2 NRS points higher than their value on the conventional pain intensity NRS, reflecting a mean E A value of -1.2 NRS points and a perceived beneficial effect of analgesics. More negative values of E A (ie, greater perceived benefit) were associated with a greater number of analgesics used but not with pain intensity, analgesic type, or opioid dose. The NRS-UP (A) and E A were significantly associated with future analgesic use 6 months later, but the conventional pain NRS was not. Future research is needed to determine whether the NRS-UP (A), used as a secondary outcome may allow pain RCTs to target alternative estimands with clinical relevance.
期刊介绍:
PAIN® is the official publication of the International Association for the Study of Pain and publishes original research on the nature,mechanisms and treatment of pain.PAIN® provides a forum for the dissemination of research in the basic and clinical sciences of multidisciplinary interest.