Recurrent Clostridioides difficile infection worsens anxiety-related patient-reported quality of life

Abstract

Background Clostridioides difficile infection (CDI) is associated with high recurrence rates impacting health-related quality of life (HrQOL). However, patient-reported data are lacking particularly in the outpatient setting. We assessed changes in HrQOL over time in patients treated with bezlotoxumab at US infusion centers and determined clinical factors associated with HrQOL changes. Methods The HrQOL survey was conducted in adult patients with CDI, who received bezlotoxumab in 25 US outpatient infusion centers. The survey was adapted from the Cdiff32 instrument to assess anxiety-related changes to HrQOL and completed on the day of infusion (baseline) and at 90 days post bezlotoxumab (follow-up). Demographics, disease history, CDI risk factors, and recurrence of CDI (rCDI) at 90-day follow-up were collected. Changes in HrQOL scores were calculated and outcomes assessed using a multivariable linear regression model with P < 0.05 defined as statistically significant. Results A total of 144 patients (mean age: 68 ± 15 years, 63% female, median Charlson index: 4, 15.9% rCDI) were included. The overall mean baseline and follow-up HrQOL scores were 26.4 ± 11.5 and 56.4 ± 25.0, respectively. At follow-up, this score was significantly higher for patients who had primary CDI (34.5 ± 21.7) compared to those with multiple rCDI (24.7 ± 21.0; P = 0.039). The mean HrQOL change at follow-up was significantly higher for patients without rCDI (34.1 ± 28.8 increase) compared to patients with rCDI (6.7 ± 19.5 increase; P < 0.001), indicating improvement in anxiety. Conclusions Using the Cdiff32 instrument, we demonstrated that HrQOL worsened significantly in patients with further rCDI. These findings support the use of Cdiff32 in assessing CDI-related humanistic outcomes.

Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109

“…Another important finding from this study was the performance of the disease-specific Cdiff32 measure in the context of this placebo-controlled randomized trial. In ECOSPOR III, the average baseline Cdiff32 total scores in patients with recurrent CDI were similar between the 2 arms and consistent with previous studies, with a range of approximately 26 to 50 . Importantly, in this Phase 3 trial, the Cdiff32 detected significant change from baseline in HRQOL scores by clinical outcome in the overall population at week 8.…”

“…In ECOSPOR III, the average baseline Cdiff32 total scores in patients with recurrent CDI were similar between the 2 arms and consistent with previous studies, with a range of approximately 26 to 50. 4 , 19 , 20 Importantly, in this Phase 3 trial, the Cdiff32 detected significant change from baseline in HRQOL scores by clinical outcome in the overall population at week 8. Finally, the post hoc analyses of on-study CDI recurrence between study arms clearly differentiate the sensitivity of the Cdiff32 in assessing important patient-related clinical outcomes.…”

“… 1 C difficile infection (CDI) is a debilitating disease with up to 10 to 20 watery bowel movements daily leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression. 2 , 3 , 4 , 5 , 6 HRQOL changes related to CDI are long lasting, deeply affect patients’ lives, including mental, physical, and relational aspects. 2 , 7 , 8 A multicenter study in the UK demonstrated a 46% lower HRQOL measured by the general instrument EuroQol (EQ-5D) index 9 in adults who are hospitalized with CDI as compared with age- and gender-matched population norms.…”

“…Clostridioides difficile ( C difficile ) is the most common health care-associated infectious agent in the US and is estimated to cause more than 460 000 infections and 20 000 deaths annually . C difficile infection (CDI) is a debilitating disease with up to 10 to 20 watery bowel movements daily leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression . HRQOL changes related to CDI are long lasting, deeply affect patients’ lives, including mental, physical, and relational aspects .…”

The burden of CDI in the United States: a multifactorial challenge

“…Various studies have reported that CDI and rCDI have significant detrimental effects on patients' quality of life that can have long-lasting and emotional impacts [70][71][72][73][74][75][76]. For many patients there are various psychological, social, professional, and economic impacts that should not be under-appreciated.…”