RT Journal Article
T1 Optimizing pain intensity assessment in clinical trials: How many ratings are needed to best balance the need for validity and to minimize assessment burden?
A1 Vega de Carranza, Rocío de la
A1 Sakulsriprasert, Prasert
A1 Miró, Jordi
A1 Jensen, Mark P.
K1 Dolor - Evaluación
K1 Ensayos clínicos
K1 Fidelidad
AB Pain intensity is the most commonly used outcome domain in pain clinical trials. Tominimize 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 byeffective pain treatments. Here we sought to identify the combination of pain intensity ratings thatwould 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 psychologicalpain treatments (N = 164 adults). Current, worst, least, and average pain intensity in the past 24 hourswere assessed 4 times before and after treatment using 0 to 10 numerical rating scale-11. We createda 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 sensitivityfor 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 thatratings from 3 or more days were needed to have adequately strong associations with the goldstandard. Regarding sensitivity, the findings suggest that composite scores made up of ratings from 4days are needed to maximize the chances of detecting treatment effects, especially with smallersample 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
PB Elsevier
YR 2024
FD 2024-07
LK https://hdl.handle.net/10630/31944
UL https://hdl.handle.net/10630/31944
LA eng
NO Rocío de la Vega, Prasert Sakulsriprasert, Jordi Miró, Mark P. Jensen, Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden?, The Journal of Pain, Volume 25, Issue 7, 2024
NO Funding for open access charge: Universidad de Málaga / CBUA
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 22 ene 2026