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Related Experiment Videos

Defining the clinically important difference in pain outcome measures.

John T Farrar1, Russell K Portenoy, Jesse A Berlin

  • 1University of Pennsylvania School of Medicine, Philadelphia, PA, USA Beth Israel Medical Center, New York, NY, USA.

Pain
|November 9, 2000
PubMed
Summary

Clinically important pain relief from breakthrough cancer pain is best indicated by a 33% change on percentage pain intensity difference scales. This study identified key thresholds on various pain scales for adequate pain relief, improving clinical trial validity.

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Area of Science:

  • Pain Management
  • Clinical Pharmacology
  • Oncology

Background:

  • Interpreting analgesic study results is challenging due to difficulties in quantifying clinically important pain differences.
  • Mean group differences in pain scores may not accurately reflect individual patient experiences or clinical relevance.
  • Establishing clear benchmarks for pain improvement is crucial for evaluating treatment efficacy.

Purpose of the Study:

  • To determine specific thresholds on standard pain scales that signify clinically important pain relief for patients.
  • To re-analyze data from a trial of oral transmucosal fentanyl citrate (OTFC) for breakthrough cancer pain to identify these thresholds.
  • To enhance the interpretability and clinical applicability of future pain therapy clinical trials.

Main Methods:

Related Experiment Videos

  • Re-analysis of data from a randomized clinical trial involving oral transmucosal fentanyl citrate (OTFC) for cancer-related breakthrough pain.
  • Evaluation of various pain scales including absolute pain intensity difference (PID), percentage pain intensity difference (PID%), pain relief (PR), sum of pain intensity difference (SPID), percentage of maximum total pain relief (% Max TOTPAR), and global medication performance.
  • Adequate pain relief was defined by the patient's decision not to use rescue opioid medication.

Main Results:

  • Percentage change scales (% Max TOTPAR and PID%) demonstrated the highest accuracy in predicting adequate pain relief, with an optimal cut-off point of 33%.
  • For absolute scales, clinically important cut-off points were identified as a PID of 2, PR of 2 (moderate), and SPID of 2.
  • A global medication performance rating of 2 (good) also indicated excellent outcomes.

Conclusions:

  • This study provides data-derived cut-off points for several pain scales that represent clinically important improvement in breakthrough cancer pain.
  • The identified thresholds, particularly the 33% threshold for % Max TOTPAR and PID%, can improve the validity and comparability of pain clinical trials.
  • Further validation in diverse patient populations and pain conditions is recommended to establish consistent clinically important outcome measures.