Development and Validation of a Clostridium difficile Health-related Quality-of-Life Questionnaire

Garey, Kevin W.; Aitken, Samuel L; Gschwind, Liliane; Goddu, Sumana; Xie, Yang; Duff, Catherine; Barbut, Frédéric; Shah, Dhara N.; DuPont, Herbert L.

doi:10.1097/mcg.0000000000000473

Cited by 45 publications

(71 citation statements)

References 34 publications

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“…In that particular study, the direct treatment costs of CDI recurrence were estimated at €73,898 per patient with one or more recurrence [ 69 ]; this is four times greater than the incremental cost estimates for recurrent CDI reported in the US-based systematic review mentioned above [ 13 ]. It has also been shown that recurrent CDI has a greater impact on patients’ quality of life than the initial episode [ 70 ]. Taken together, these data suggest that fidaxomicin may be more cost-effective than suggested by the results of our systematic literature review of EEs.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Literature Review of Economic Evaluations of Antibiotic Treatments for Clostridium difficile Infection

Burton¹,

Mitchell²,

Watt

2017

PharmacoEconomics

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Background and Objective Clostridium difficile infection (CDI) is associated with high management costs, particularly in recurrent cases. Fidaxomicin treatment results in lower recurrence rates than vancomycin and metronidazole, but has higher acquisition costs in Europe and the USA. This systematic literature review summarises economic evaluations (EEs) of fidaxomicin, vancomycin and metronidazole for treatment of CDI.MethodsElectronic databases (MEDLINE®, Embase, Cochrane Library) and conference proceedings (ISPOR, ECCMID, ICAAC and IDWeek) were searched for publications reporting EEs of fidaxomicin, vancomycin and/or metronidazole in the treatment of CDI. Reference bibliographies of identified manuscripts were also reviewed. Cost-effectiveness was evaluated according to the overall population of patients with CDI, as well as in subgroups with severe CDI or recurrent CDI, or those at higher risk of recurrence or mortality.ResultsOverall, 27 relevant EEs, conducted from the perspective of 12 different countries, were identified. Fidaxomicin was cost-effective versus vancomycin and/or metronidazole in 14 of 24 EEs (58.3%), vancomycin was cost-effective versus fidaxomicin and/or metronidazole in five of 27 EEs (18.5%) and metronidazole was cost-effective versus fidaxomicin and/or vancomycin in two of 13 EEs (15.4%). Fidaxomicin was cost-effective versus vancomycin in most of the EEs evaluating specific patient subgroups. Key cost-effectiveness drivers were cure rate, recurrence rate, time horizon, drug costs and length and cost of hospitalisation.ConclusionsIn most EEs, fidaxomicin was demonstrated to be cost-effective versus metronidazole and vancomycin in patients with CDI. These results have relevance to clinical practice, given the high budgetary impact of managing CDI and increasing restrictions on healthcare budgets.OtherThis analysis was initiated and funded by Astellas Pharma Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s40273-017-0540-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

A Systematic Literature Review of Economic Evaluations of Antibiotic Treatments for Clostridium difficile Infection

Burton¹,

Mitchell²,

Watt

2017

PharmacoEconomics

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“…The only other disease-specific PRO questionnaire developed for this patient population is the Cdiff32, a 32-item instrument that has recently been reported to measure HRQOL in patients with CDI [31]. Unlike the CDI-DaySyms, the Cdiff32 is not a CDIsymptom-specific daily diary but rather a measure of the bother and/or impact of CDI on patients' daily activities, anxiety, diet, sleep, discomfort, health perception, dysphoria, relationships, and social interactions, with a recall period of the past 7 days.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the two instruments were developed differently. Although the symptoms included in the CDI-DaySyms were elicited from patients with CDI until saturation was reached, the items in the Cdiff32 were identified through a literature research, and although clinicians and patients assessed the relevance of these items, no attempts were apparently made to elicit additional HRQOL items from patients or to document via a saturation grid that all relevant concepts were included [31]. The present qualitative research study to develop the CDI-DaySyms had several strengths.…”

Section: Discussionmentioning

confidence: 99%

The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium difficile Infection

et al. 2018

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“…In the past, Wilcox et al used the EQ-5D-3 L questionnaire and the EQ visual analogue scale to explore HRQoL changes in CDI participants [23] and Garey et al developed a health-related quality of life instrument (Cdiff32) based on the RAND Short-Form 36 (SF-36). Garey et al demonstrated that there was no consensus towards assessment of CDI participants' quality of life [20]. Therefore, our survey did not include these previously considered questionnaires.…”

Section: Survey Questions (See Electronic Supplementary Materials A1)mentioning

confidence: 99%

“…Despite a scarcity of quality of life data in those with CDI, chronic diarrhea in patients with HIV or those having received a kidney transplant has shown significant reductions in health-related quality of life, including decreased general well-being, social, and physical functioning [18,19]. Only one study by Garey et al [20] has attempted to develop and validate a questionnaire of quality of life taking into account the specificities of CDI. To date, the specific impact of CDI on patient-reported Health-Related Quality of Life (HRQoL) has not been thoroughly studied [19,21,22].…”

Section: Introductionmentioning

confidence: 99%

Perception of quality of life in people experiencing or having experienced a Clostridioides difficile infection: a US population survey

Lurienne

Bandinelli

Galvain

et al. 2020

J Patient Rep Outcomes

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Background: Although the incidence, severity and mortality of Clostridioides (Clostridium) difficile infection (CDI) have been increasing, patients' quality of life changes resulting from CDI have not been studied thoroughly. This study aimed at exploring the consequences of CDI on quality of life through patients' perspective. Methods: An observational, cross-sectional study involving 350 participants with a self-reported CDI diagnosis was conducted through an online self-administered survey. Participants were grouped into those who had active disease ("Current CDI") and those who had a history of CDI ("Past CDI"). Results: One hundred fifteen participants (33%) reported Current CDI and 235 (67%) reported Past CDI. A large majority of participants admitted that their daily activities were impacted by the infection (93.9% and 64.7% of Current and Past CDI respondents respectively, p < 0.05). Physical and psychological consequences of CDI were experienced by 63.5% and 66.1% of participants with active CDI. Despite the infection being cleared, these consequences were still frequently experienced in Past CDI cohort with similar rates (reported by 73.2% of respondents for both, physical consequences p = 0.08; psychological consequences p = 0.21). After the infection, 56.6% of respondents noted that post-CDI symptoms remained; 40.9% believed they would never get rid of them. Conclusions: While the societal burden of CDI is well described in the literature, our study is one of the first aimed at understanding the major burden of CDI on quality of life. Our results highlight the long-lasting nature of CDI and further reinforce the need for enhanced therapeutics in the prevention and treatment of this devastating infection.

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Development and Validation of a Clostridium difficile Health-related Quality-of-Life Questionnaire

Abstract: Supplemental Digital Content is available in the text.

Cited by 45 publications

References 34 publications

A Systematic Literature Review of Economic Evaluations of Antibiotic Treatments for Clostridium difficile Infection

A Systematic Literature Review of Economic Evaluations of Antibiotic Treatments for Clostridium difficile Infection

The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium difficile Infection

Perception of quality of life in people experiencing or having experienced a Clostridioides difficile infection: a US population survey

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