The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial.

Scoring the severity of a diabetic foot wound infection may help assess the severity, determine the type and urgency of antibiotic and surgical treatment needed, and predict clinical outcomes. We developed a 10-item diabetic foot infection wound score (results could range from 3 to 49 [least to most severe]) incorporating semi-quantitative grading of both wound measurements and various infection parameters. Using data from a prospective diabetic foot infection antibiotic trial (SIDESTEP), we evaluated the score's accuracy in predicting outcome, analyzed its components and tested it for consistency, construct, and validity. Wound scores for 371 patients significantly correlated with the clinical response; it was favorable at the follow-up assessment in 94.8% with a baseline score 19. Scores demonstrated good internal consistency (Cronbach's alpha >0.70 to <0.95). Patients with more severe wounds had higher scores, supporting construct validity. Excluding scores for wound discharge (purulent and nonpurulent), leaving an eight-item score, provided better measurement statistics. This easily performed wound score appears to be a reliable, valid, and useful tool for predicting clinical outcomes. Further validation studies in different patient populations should refine the items included.

Efficacy and safety of pegylated liposomal Doxorubicin in combination with bortezomib for multiple myeloma: effects of adverse prognostic factors on outcome.

INTRODUCTION: Bortezomib with pegylated liposomal doxorubicin (PLD) is superior to bortezomib alone in the relapsed and/or refractory setting, based on the results of a randomized, parallel-group, open-label, multicenter phase III study. To identify patients who might most benefit from this new standard of care, we performed retrospective analyses evaluating the effects of clinically defined, high-risk features on the outcomes with this regimen. PATIENTS AND METHODS: Patients received either bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of an every-21-day cycle with PLD 30 mg/m2 on day 4 (n=324) or bortezomib alone (n=322). Four high- and low-risk subgroup categories were identified, including age≥65, ≥2 previous therapies, International Staging System stage II/III, and disease refractory to last previous therapy. RESULTS: Compared with bortezomib alone, PLD plus bortezomib significantly prolonged the time to progression and duration of response in all of these subgroups. PLD plus bortezomib was well tolerated in all subgroups, and had a safety profile that was not affected by response to previous therapy. CONCLUSION: Treatment of relapsed/refractory myeloma with the combination of PLD plus bortezomib provides better outcomes over bortezomib alone, even in the presence of high-risk prognostic factors. These results suggest that PLD plus bortezomib may represent an additional standard of care for this population of patients with multiple myeloma.