Policy makers and clinical practice guidelines recognize patient-reported outcomes as important endpoints in clinical research and practice [8]. Consequently, health-related quality of life (HrQOL) measures seem particularly important in patients with CDI [3, 5, 10]. There are different generic tools created for patient-reported outcomes [11] and quality of life [4,5,6,7], however, Cdiff32 is the only instrument specifically developed to assess HrQOL in patients with CDI [3]. A recently conducted real-world experience study of bezlotoxumab in outpatient infusion centers [9] provided an opportunity to assess CDI patient-reported quality of life changes from baseline to follow-up using an adapted Cdiff32 survey. Our findings indicate that patients with primary CDI had significantly higher HrQOL scores at baseline indicating less anxiety compared to patients with multiple prior CDI recurrences. At follow-up, anxiety-related HrQOL worsened significantly in patients with further rCDI regardless of baseline number of CDI episodes, whereas HrQOL improved in patients without rCDI. The findings of HrQOL worsening in patients with further rCDI was confirmed by multivariable analysis.
The strength of this study includes a sizeable cohort as this is the second largest study to date demonstrating quantitative changes of patient-reported HrQOL in CDI [3,4,5,6, 10]. In addition, the current study had rigorous individual patient follow-up providing HrQOL data at two different time points. Prospective changes in anxiety-related HrQOL with further episodes of rCDI also suggest this humanistic outcome is important and should be incorporated into future intervention studies designed to prevent rCDI.
Our findings are consistent with previous reports showing decreased HrQOL in patients with CDI recurrences. Han et al. demonstrated low quality of life scores for patients hospitalized with CDI using the Cdiff32 and PROMIS Global Health surveys (10). The Cdiff32 survey was particularly sensitive to HrQOL changes in patients with recurrent and/or severe disease. Others have used various instruments to quantify quality of life in CDI patients [4,5,6,7]. Barbut et al. demonstrated the impact of the infection on patients’ quality of life using the EQ-5D-3L and EQ-VAS instruments, which showed an association between HrQOL and CDI severity [6]. Similar results were observed using the EQ-5D-3L questionnaire in patients who were hospitalized with CDI [5]. A multinational study used SF-36v2 to compare the impact of CDI on quality of life and work productivity in patients with current or prior CDI and patients without rCDI [4]. A Canadian study highlighted the long-lasting effect and emotional impact on patients with CDI [12]. All studies have consistently shown decreased HrQOL scores in patients with rCDI, with prevention of rCDI expected to improve HrQOL. The current study findings add to the understanding of the burden associated with CDI and underscore the long-lasting nature of this infectious disease.
The study has limitations. For ease of survey completion, a limited number of questions from the Cdiff32 instrument were used including one question from the general physical sub-domain and six questions from the anxiety sub-domain. Although we were able to demonstrate significant differences between recurrent and non-recurrent CDI patients using this subset of HrQOL questions, future validation of the adapted Cdiff32 survey will be required. This real-world cohort consisted of an older population of CDI patients receiving bezlotoxumab in the outpatient setting. Changes to HrQOL in younger patients and those receiving other treatments will require further research. Nevertheless, the prospective changes of HrQOL scores observed in patients with rCDI suggest that reducing the likelihood of further CDI episodes will likely improve HrQOL. Providing clinically meaningful thresholds that define improvement in HrQOL for patients with CDI should be a focus for future research.