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Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden?

  • Datos identificativos

    Identificador: imarina:9385423
    Autores:
    de la Vega, RocioSakulsriprasert, PrasertMiro, JordiJensen, Mark P
    Resumen:
    Pain intensity is the most commonly used outcome domain in pain clinical trials. To minimize the chances of type II error (ie, concluding that a treatment does not have beneficial effects, when in fact it does), the measure of pain intensity used should be sensitive to changes produced by effective pain treatments. Here we sought to identify the combination of pain intensity ratings that would balance the need for reliability and validity against the need to minimize assessment burden. We conducted secondary analyses using data from a completed 4 -arm clinical trial of psychological pain treatments (N = 164 adults). Current, worst, least, and average pain intensity in the past 24 hours were assessed 4 times before and after treatment using 0 to 10 numerical rating scale -11. We created a variety of composite scores using these ratings and evaluated their reliability (Cronbach's alphas) and validity (ie, associations with a gold standard score created by averaging 16 ratings and sensitivity for detecting between -group differences in treatment efficacy). We found that for each measure, reliability increased as the number of ratings used to create the measures increased and that ratings from 3 or more days were needed to have adequately strong associations with the gold standard. Regarding sensitivity, the findings suggest that composite scores made up of ratings from 4 days are needed to maximize the chances of detecting treatment effects, especially with smaller sample sizes. In conclusion, using data from 3 or 4 days of assessment may be the best practice. Perspective: Composite scores made up of at least 3 days of pain ratings appear to be needed to maximize reliability and validity while minimizing the assessment burden.
  • Otros:

    Autor según el artículo: de la Vega, Rocio; Sakulsriprasert, Prasert; Miro, Jordi; Jensen, Mark P
    Departamento: Psicologia
    Autor/es de la URV: DE LA VEGA CARRANZA, ROCÍO / Miró Martínez, Jordi
    Palabras clave: Adults Assay sensitivity Clinical trial Outcomes Pain assessment Powe Program Reliability Single Therapy Validit Validity
    Resumen: Pain intensity is the most commonly used outcome domain in pain clinical trials. To minimize the chances of type II error (ie, concluding that a treatment does not have beneficial effects, when in fact it does), the measure of pain intensity used should be sensitive to changes produced by effective pain treatments. Here we sought to identify the combination of pain intensity ratings that would balance the need for reliability and validity against the need to minimize assessment burden. We conducted secondary analyses using data from a completed 4 -arm clinical trial of psychological pain treatments (N = 164 adults). Current, worst, least, and average pain intensity in the past 24 hours were assessed 4 times before and after treatment using 0 to 10 numerical rating scale -11. We created a variety of composite scores using these ratings and evaluated their reliability (Cronbach's alphas) and validity (ie, associations with a gold standard score created by averaging 16 ratings and sensitivity for detecting between -group differences in treatment efficacy). We found that for each measure, reliability increased as the number of ratings used to create the measures increased and that ratings from 3 or more days were needed to have adequately strong associations with the gold standard. Regarding sensitivity, the findings suggest that composite scores made up of ratings from 4 days are needed to maximize the chances of detecting treatment effects, especially with smaller sample sizes. In conclusion, using data from 3 or 4 days of assessment may be the best practice. Perspective: Composite scores made up of at least 3 days of pain ratings appear to be needed to maximize reliability and validity while minimizing the assessment burden.
    Áreas temáticas: Anesthesiology and pain medicine Biotecnología Ciências biológicas i Ciências biológicas ii Clinical neurology Educação física Enfermagem Farmacia Interdisciplinar Linguística e literatura Medicina i Medicina ii Medicina iii Neurology Neurology (clinical) Neurosciences Odontología Psicología Saúde coletiva
    Acceso a la licencia de uso: https://creativecommons.org/licenses/by/3.0/es/
    Direcció de correo del autor: jordi.miro@urv.cat
    Identificador del autor: 0000-0002-1998-6653
    Fecha de alta del registro: 2024-10-12
    Versión del articulo depositado: info:eu-repo/semantics/publishedVersion
    Enlace a la fuente original: https://www.sciencedirect.com/science/article/pii/S152659002400350X?via%3Dihub
    Referencia al articulo segun fuente origial: Journal Of Pain. 25 (7): 104474-
    Referencia de l'ítem segons les normes APA: de la Vega, Rocio; Sakulsriprasert, Prasert; Miro, Jordi; Jensen, Mark P (2024). Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden?. Journal Of Pain, 25(7), 104474-. DOI: 10.1016/j.jpain.2024.01.339
    URL Documento de licencia: https://repositori.urv.cat/ca/proteccio-de-dades/
    DOI del artículo: 10.1016/j.jpain.2024.01.339
    Entidad: Universitat Rovira i Virgili
    Año de publicación de la revista: 2024
    Tipo de publicación: Journal Publications
  • Palabras clave:

    Anesthesiology and Pain Medicine,Clinical Neurology,Neurology,Neurology (Clinical),Neurosciences
    Adults
    Assay sensitivity
    Clinical trial
    Outcomes
    Pain assessment
    Powe
    Program
    Reliability
    Single
    Therapy
    Validit
    Validity
    Anesthesiology and pain medicine
    Biotecnología
    Ciências biológicas i
    Ciências biológicas ii
    Clinical neurology
    Educação física
    Enfermagem
    Farmacia
    Interdisciplinar
    Linguística e literatura
    Medicina i
    Medicina ii
    Medicina iii
    Neurology
    Neurology (clinical)
    Neurosciences
    Odontología
    Psicología
    Saúde coletiva
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