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Clinically important changes in acute pain outcome measures: a validation study.

John T Farrar1, Jesse A Berlin, Brian L Strom

  • 1University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA.

Journal of Pain and Symptom Management
|May 3, 2003
PubMed
Summary
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This study validates pain scale cut-off points for measuring clinically important differences in acute pain relief. These validated measures, including pain intensity and relief scales, are crucial for future pain therapy clinical trials.

Area of Science:

  • Pain Management
  • Clinical Trial Methodology
  • Pharmacology

Background:

  • Pain intensity and relief measures are vital in clinical trials.
  • Defining clinically important differences in pain is essential for therapeutic assessment.
  • Previous studies identified potential cut-off points for acute pain measures.

Purpose of the Study:

  • To validate established cut-off points for acute pain measurement scales against a patient-determined indicator of clinical importance.
  • To assess the association between specific pain scale thresholds and the need for rescue medication in cancer breakthrough pain.
  • To confirm the utility of these validated pain scale cut-offs in future pain therapy trials.

Main Methods:

  • Utilized data from the titration phase of a randomized controlled trial comparing oral transmucosal fentanyl citrate (OTFC) and immediate release morphine sulfate (MSIR).

Related Experiment Videos

  • Collected data on pain intensity, pain relief, and global medication performance every 15 minutes for 60 minutes.
  • Employed receiver operating characteristic (ROC) curve analysis to compare pain scale cut-offs with the need for rescue medication in 134 patients experiencing 1307 pain episodes.
  • Main Results:

    • Validated cut-off points were identified: 33% for pain intensity difference, >=2 for raw pain intensity difference, >=2 for pain relief, >=33% for maximum total pain relief, and >=2 for global medication performance.
    • ROC analysis demonstrated strong associations between these pain measures and the absence of rescue medication need, with area under the curve ranging from 0.839 to 0.862.
    • The findings closely approximated those of an earlier study, reinforcing their reliability.

    Conclusions:

    • The validated pain scale cut-off points serve as reliable surrogates for patient-determined clinically important pain responses.
    • These findings support the use of these specific cut-off values in future clinical trials for pain therapy.
    • The study confirms the robustness of these measures in distinguishing clinically meaningful pain relief.