Treatment with cladribine tablets significantly reduced relapse rates, the risk of disability progression, and MRI measures of disease activity at 96 weeks. The benefits need to be weighed against the risks. (ClinicalTrials.gov number, NCT00213135.)
IFNbeta-1a 44 micro g subcutaneously tiw was more effective than IFNbeta-1a 30 micro g IM qw on all primary and secondary outcomes investigated after 24 and 48 weeks of treatment.
Objective
To establish a score threshold that constitutes a clinically relevant change for each domain of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26). While its use in clinical practice and clinical trials has increased worldwide, the clinical interpretation of this 26-item disease-specific patient-reported quality of life questionnaire for men with localized prostate cancer would be facilitated by characterization of score thresholds for clinically relevant change (the minimally important differences, or MID).
Methods
We used distribution- and anchor-based approaches to establish the MID range for each EPIC-26 domain (urinary, sexual, bowel, hormonal) based on a prospective, multi-institutional cohort of 1,201 men treated for prostate cancer between 2003 and 2006 and followed for 3 years after treatment. For the anchor-based approach, we compared within/between subject score changes for each domain to an external “anchor” measure of overall cancer treatment satisfaction.
Results
We found the bowel and vitality/hormonal domains to have the lowest MID range (a 4–6 point change should be considered clinically relevant), while the sexual domain had the greatest MID values (10–12). Urinary incontinence appeared to have a greater MID range (6–9) compared with the urinary irritation/obstruction domain (5–7).
Conclusions
Using two independent approaches, we established the minimally important differences for each EPIC-26 domain. Definition of these MID values is essential for the researcher or clinician to understand when changes in symptom burden among prostate cancer survivors are clinically relevant.
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