Background
Invasive Escherichia coli disease (IED) comprises a diverse range of severe infections caused by E. coli, mainly affecting neonates and older adults, and is associated with severe and sometimes fatal outcomes. This study aimed to evaluate signs and symptoms associated with IED, and to assess the impact of IED on health-related quality of life (HRQoL) among older patients. Furthermore, we examined how generic patient-reported outcomes questionnaires capture experiences of patients with IED.
Methods
A cross-sectional qualitative study consisting of semi-structured interviews was conducted. Participants aged ≥ 60 years who met the IED clinical case definition were enrolled within 2 weeks after the disease episode and asked to describe IED signs and symptoms and HRQoL impact through open-ended questions. The interview transcripts were analyzed using NVivo 12 and a conceptual model was built. The concepts for impacts identified by participants with IED were then compared with the concepts routinely assessed by two generic HRQoL instruments: the 36-Item Short Form Survey (SF-36) and EuroQol 5-Dimension (EQ-5D).
Results
Of 80 patients screened, 43 met inclusion criteria and 16 consented to participate in the study. The interviews showed that IED affected daily routines and activities (n = 13), ability to move and sleep (both n = 11), and caused exhaustion (n = 10) as well as constant pain (n = 9). Most HRQoL impacts identified were also measured in SF-36 and EQ-5D, but concepts specific for patients with IED, not measured in SF-36 and EQ-5D, were also recognized.
Conclusions
IED was shown to cause substantial physical, social, and psychological impacts in patients. This burden was especially apparent in review of patient self-reports for concepts that are part of generic HRQoL instruments (SF-36, EQ-5D), and patients also frequently reported neurological/mental impacts. Further, this study provides valuable qualitative data that may be useful for future research in developing a disease-specific instrument for the assessment of HRQoL in patients with IED.
Funding
This work was supported by Johnson & Johnson.
Keywords
Escherichia coli, Patient-reported outcomes, Quality of life, Bacteremia, Invasive E. coli disease (IED)
Authors
Mark A. Schmidt, Inga Gruß, James V. Davis, Judy Donald, Kelly McQuarrie, Michal Sarnecki, Joachim Doua, Luis Hernandez Pastor, Jeroen Geurtsen, Cristina Valencia, Elvira Carrió, Thomas Verstraeten, Antoine C. El Khoury
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