Hengel Richard L, Schroeder Claudia P, Jo Jinhee, Ritter Timothy E, Nathan Ramesh V, Gonzales-Luna Anne J, Obi Engels N, Dillon Ryan J, Van Anglen Lucinda J, Garey Kevin W
Atlanta ID Group, 275 Collier Rd, Suite 450, Atlanta, GA, 30309, USA.
Healix Infusion Therapy, LLC, 14140 Southwest Freeway, Suite 400, Sugar Land, TX, 77478, USA.
J Patient Rep Outcomes. 2022 May 14;6(1):49. doi: 10.1186/s41687-022-00456-9.
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.
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.
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.
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.
艰难梭菌感染(CDI)与高复发率相关,影响健康相关生活质量(HrQOL)。然而,患者报告的数据尤其是门诊环境下的数据匮乏。我们评估了在美国输液中心接受贝佐妥单抗治疗的患者随时间推移的HrQOL变化,并确定了与HrQOL变化相关的临床因素。
对在美国25个门诊输液中心接受贝佐妥单抗治疗的成年CDI患者进行了HrQOL调查。该调查改编自Cdiff32工具,以评估与焦虑相关的HrQOL变化,并在输液当天(基线)和贝佐妥单抗治疗后90天(随访)完成。收集了人口统计学、疾病史、CDI危险因素以及90天随访时的CDI复发(rCDI)情况。计算了HrQOL得分的变化,并使用多变量线性回归模型评估结果,P < 0.05被定义为具有统计学意义。
共纳入144例患者(平均年龄:68±15岁,63%为女性,Charlson指数中位数为4, 15.9%有rCDI)。总体平均基线和随访时的HrQOL得分分别为26.4±11.5和56.4±25.0。在随访时,原发性CDI患者的该得分(34.5±21.7)显著高于多次rCDI患者(24.7±21.0;P = 0.039)。与有rCDI的患者(增加6.7±19.5)相比,无rCDI的患者随访时HrQOL的平均变化显著更高(增加34.1±28.8;P < 0.001),表明焦虑有所改善。
使用Cdiff32工具,我们证明了进一步发生rCDI的患者的HrQOL显著恶化。这些发现支持使用Cdiff32评估与CDI相关的人文结局。