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• W166568560 endingPage "6112" @default.
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• W166568560 abstract "6112 Background: The BPI-SF is a widely used patient-reported outcome measure for assessing pain and has become the standard for use in clinical and research studies. The rating of worst pain is often selected as the primary outcome of interest; however, there are no published data available on its MID, particularly as a change score. The data presented in this analysis can help to enhance interpretation of the assessment. Methods: Patients with advanced breast cancer who enrolled in a randomized, double-blind, phase 3 study comparing denosumab vs. zoledronic acid in the treatment of bone metastases completed the BPI-SF, FACT-B, and EQ-5D questionnaires at baseline, week 5, and every 4 weeks thereafter until the end of the study. After assessing the correlation between change in the BPI worst pain rating with several potential anchors using the interval from baseline to week 25, we computed both anchor-based and distribution-based MID estimates for the BPI worst pain rating in both treatment arms combined. Results: Data from 1,564 of 2,049 patients (mean [SD] age 57 [11] yrs) who participated in the study and had valid baseline and end-of-interval BPI ratings and anchors were used in these analyses. Spearman correlation coefficients ranged from 0.33 to 0.42 for the anchors. Mean change scores in BPI worst pain rating for 1 category of improvement in each anchor and distribution-based results appear in the Table. Combining results from anchor and distribution-based approaches resulted in an MID estimate of 2 points. Conclusions: An MID estimate of 2 points can be clinically useful for interpreting BPI-SF baseline scores as well as changes in worst pain rating over time. Additional work should be done in other populations and over different time intervals to finalize this initial estimate. Mean change scores in BPI worst pain rating for 1 category change in each anchor EQ-5D pain item FACT-B* FACT-G physical** FACT-G total* Distribution-based method 1.71–1.98 1.07–1.59 1.13–1.83 0.66–1.28 1 SEM 0.5 effect size Guyatt's statistic 1.6 1.4 1.4 * For FACT-B and FACT-G total assessments, 1 category = 10 points. ** For the FACT-G assessment, 1 category = 5 points. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen Amgen" @default.
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• W166568560 date "2010-05-20" @default.
• W166568560 modified "2023-09-26" @default.
• W166568560 title "Estimating minimally important differences (MID) for the worst pain rating of the brief pain inventory (BPI)-short form (SF)." @default.
• W166568560 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.6112" @default.
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