Evaluation of Health-Related Quality of Life in Patients Treated with RBX2660 (Microbiota Suspension) for Recurrent C. difficile Infection

Misra, Bharat; Ramesh, Mayur; Sobcinski, Mary Kay

doi:10.14309/00000434-201410002-00652

Cited by 1 publication

(11 citation statements)

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“…Across the 21 studies, humanistic CDI burden was assessed using four generic and two CDI disease-specific PRO measures designed for use in clinical trials. The generic HRQoL measures were EuroQol EQ-5D-3L (index and visual analogue scale [EQ VAS]) [ 25 , 26 , 30 , 37 ], 36-Item Short Form Health Survey (SF-36)/RAND-36 [ 22 , 29 , 38 – 40 ], Short Form 6-Dimension (SF-6D) [ 29 ], and National Health Institute’s Patient-Reported Outcomes Measurement Information System—Global Health (PROMIS-GH) [ 25 , 27 , 28 , 41 ]. The CDI disease-specific PROs included the C. difficile Health-Related Quality-of-Life Questionnaire (Cdiff32) [ 16 , 22 , 25 ] and the Clostridium difficile Infection–Daily Symptoms (CDI-DaySyms) [ 27 , 28 ].…”

Section: Resultsmentioning

confidence: 99%

“…Nine PRO studies were identified with a primary objective to assess patient perceptions and experiences with CDI treatment. Most (eight of nine) evaluated the impact of different FMT formulations on HRQoL [ 16 , 38 – 40 , 42 , 45 , 47 , 48 ], and one article also included overall physician perceptions toward experimental FMT treatment [ 47 ]. Finally, one additional study assessed the impact of antibiotic treatment on HRQoL in patients with CDI [ 30 ].…”

Section: Resultsmentioning

confidence: 99%

“…Improvement in psychological and physical parameters after discharge. Most patients reported persistent worry and fear of recurrent episodes, and they were more careful about their diet and hygiene Misra et al [ 38 ] 2014 34 USA SF-36 Patients with rCDI FMT (live microbiota suspension) via enema After treatment, mean SF-36 MCS score increased from 43.6 (SD 13.0) at baseline to 51.3 (SD 11.2) at day 60, and mean PCS score increased from 44.9 (SD 10.3) at baseline to 46.0 (SD 11.1) at day 60 Zipursky et al [ 48 ] 2012 192 USA Survey developed to assess attitudes towards FMT treatment for rCDI Hypothetical scenarios of rCDI in lieu of patients When patients were provided with FMT efficacy data only, 85% preferred FMT, while 15% preferred antibiotic treatment. Once patients were informed of the fecal source FMT, the preference for FMT decreased from 85% to 81% ( P = not significant).…”

Section: Resultsmentioning

confidence: 99%

“…FMT preference increased significantly if offered as a pill (90%) or if recommended by their physician (94%). Although FMT was rated as unappealing, women more so than men and older less so than younger, were willing to consider this alternative, with 77% willing to pay out-of-pocket for FMT Madeo et al [ 14 ] 2010 15 USA Qualitative study: interviews conducted to elicit patient experiences with CDI Convenience sample of patients hospitalized with CDI Thematic analysis revealed 4 key themes of CDI: physical suffering, lack of control over bowel function, lack of understanding of CDI, and loss of privacy and dignity ADL, activities of daily living; CDI, Clostridioides difficile infection; CDI-DaySyms, Clostridium difficile Infection–Daily Symptoms; Cdiff32, Clostridioides difficile Health-Related Quality-of-Life Questionnaire; EU, European Union; EQ-5D, EuroQol EQ-5D questionnaire; FMT, fecal microbiota transplantation; GMH, global mental health; GPH, global physical health; GSRS, Gastrointestinal Symptom Rating Scale; HRQoL, health-related quality of life; MCS, mental component summary; NHWS, National Health and Wellness Survey; pCDI, first or primary CDI occurrence; PCS, physical component summary; PRO, patient-reported outcome; PROMIS-GH, Patient-Reported Outcomes Measurement Information System—Global Health; QALY, quality-adjusted life year; rCDI, recurrent CDI; SD, standard deviation; SF-36, 36-Item Short Form Health Survey; SF-6D, Short Form 6-Dimension; UK, United Kingdom; USA, United States; VAS, visual analog scale; WPAI, Work Productivity and Activity Impairment a All 21 studies cited were peer-reviewed articles with 3 being abstracts [ 30 , 38 , 39 ] …”

Section: Resultsmentioning

confidence: 99%

“… ADL, activities of daily living; CDI, Clostridioides difficile infection; CDI-DaySyms, Clostridium difficile Infection–Daily Symptoms; Cdiff32, Clostridioides difficile Health-Related Quality-of-Life Questionnaire; EU, European Union; EQ-5D, EuroQol EQ-5D questionnaire; FMT, fecal microbiota transplantation; GMH, global mental health; GPH, global physical health; GSRS, Gastrointestinal Symptom Rating Scale; HRQoL, health-related quality of life; MCS, mental component summary; NHWS, National Health and Wellness Survey; pCDI, first or primary CDI occurrence; PCS, physical component summary; PRO, patient-reported outcome; PROMIS-GH, Patient-Reported Outcomes Measurement Information System—Global Health; QALY, quality-adjusted life year; rCDI, recurrent CDI; SD, standard deviation; SF-36, 36-Item Short Form Health Survey; SF-6D, Short Form 6-Dimension; UK, United Kingdom; USA, United States; VAS, visual analog scale; WPAI, Work Productivity and Activity Impairment a All 21 studies cited were peer-reviewed articles with 3 being abstracts [ 30 , 38 , 39 ] …”

Section: Resultsmentioning

confidence: 99%

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Patient Experiences with Clostridioides difficile Infection and Its Treatment: A Systematic Literature Review

et al. 2023

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Introduction Clostridioides difficile infection (CDI) is a globally recognized cause of morbidity and mortality with devastating effects on health-related quality of life (HRQoL). The objective of this study was to conduct the first systematic literature review (SLR) to assess the humanistic burden of CDI on patient experiences, including HRQoL and related constructs, and attitudes towards treatment alternatives. Methods An SLR was conducted to identify peer-reviewed articles that assessed CDI, including recurrent CDI (rCDI), and patient-reported outcomes or HRQoL. PubMed, Embase, and the Cochrane Collaboration abstracting services were used to conduct literature searches from 2010 to 2021 in the English language. This SLR was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) criteria. Results Of 511 identified articles, 21 met study inclusion criteria. The SLR showed CDI has a devastating impact on patients’ overall HRQoL that continues well beyond infection clearance. The impact of CDI on physical, emotional, social, and professional well-being rivaled abdominal symptoms of uncontrollable diarrhea, being worse for patients with rCDI. Patients with CDI feel isolated, depressed, lonely, and continue to be frightened of recurrences as well as being contagious to others. Most believe that they will never be free of CDI. Conclusion CDI and rCDI are debilitating conditions affecting physical, psychological, social, and professional functioning of patients’ HRQoL, even long after the event has occurred. The results of this SLR suggest that CDI is a devastating condition in need of better prevention strategies, improved psychological support, and treatments that address the microbiome disruption to break the cycle of recurrence. Additional safe and effective therapies are needed to address this unmet medical need. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00833-x.

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