OBJECTIVES: Limited Patient Reported Outcomes (PRO) data exists for obese patients with ABSSSI.  This study sought to evaluate health-related quality of life (HRQL) in obese patients (BMI >30) with a positive clinical response (cured, complete resolution of all baseline signs and symptoms and improved, some symptoms remain, but no further antibiotics are necessary) patients during an ABSSSI trial.  METHODS: Adult patients diagnosed with ABSSSI were enrolled in a prospective phase 3, randomized, double-blind study to evaluate antibiotic treatment.  An analysis of PRO was conducted to understand the difference between cured obese patients (COP) and improved obese patients (IOP) with respect to patient reported HRQL at End of Treatment (EOT) and late follow up (LFU, study day 21-28).  HRQL was measured by Extremity Soft Tissue Infection (ESTI) Score[i], a 20 question survey using a 5-point Likert scale (5 equals highest degree of importance/impairment to the patients) measured symptoms, daily functioning, emotional functioning, and social interactions.  RESULTS: Obese patients compromised 29% of the study (660 patients, 589 included in analysis, 193 obese).  IOP at EOT were less likely to proceed to cure than non-obese patients (26%, 16%) at LFU.  The ESTI Score was higher at LFU in IOP than COP (46.4, 26.3, p=0.029).    At LFU, IOP were more likely than COP to report having continued difficulty performing a job (29.0%, 9.6%, p=0.008) and earning an income (32.3%, 14.0%, p=0.032).  CONCLUSIONS: IOP had more difficulty than COP with HRQL measures at LFU.  IOP at EOT may have persistent HRQL issues that require further utilization of health care resources.  Additional research is needed to determine the potential economic impact of this data.

[i] Storck et al, Development of a Health-Related Quality of Life Questionnaire (HRQL) for patients with Extremity Soft Tissue Infections (ESTI), BMC Infectious Diseases