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

Kleinman, Leah; Talbot, George H.; Hunsche, Elke; Schüler, R.; Nord, Carl Erik

doi:10.1016/j.jval.2017.08.3017

Cited by 5 publications

(9 citation statements)

References 30 publications

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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%

“…Current CDI and prior CDI missed more work and greater impairment while working and more activity impairment than never having CDI. Current CDI and prior CDI had significantly greater percentage of work missed, degree of impairment while working, degree of overall work impairment, and degree of activity impairment due to health than never CDI Kleinman et al [ 28 ] 2018 34 USA, Switzerland, Sweden CDI-DaySyms, PROMIS-GH item Patients with active CDI (pCDI or rCDI) Development of the CDI-DaySyms: 13-item, CDI-specific PRO designed to measure symptoms relevant to the general CDI population Kao et al [ 40 ] 2017 116 Canada SF-36 Survey developed to assess patient perceptions of FMT treatment Adults (18–90 years of age) with rCDI at 3 academic medical centers FMT via oral capsule vs colonoscopy FMT administered orally was not inferior to colonoscopy in preventing rCDI at 12 weeks. Prevention of rCDI after a single FMT treatment was 96.2% in both groups.…”

Section: Resultsmentioning

confidence: 99%

“…For the purposes of this review, the term CDI encompasses primary CDI (pCDI), rCDI, or current history of CDI. HRQoL data differentiated by CDI recurrence have been presented where available, see for example Han et al [ 25 ] and Garey et al [ 22 ]; however, data were frequently pooled without differentiating by CDI recurrence (see for example, Wilcox et al [ 26 ], Talbot et al [ 27 ], Kleinman et al [ 28 ]) or CDI status (current, prior, or no CDI) (see Heinrich et al [ 29 ] and Paul et al [ 30 ]). Excluded were papers solely measuring treatment efficacy, economic outcomes, clinician-reported outcomes, reviews, or commentaries.…”

Section: Methodsmentioning

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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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

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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“…The CDI-DaySyms™ is the first daily symptom diary measuring the broad range of CDI symptoms, which patients in a prior study reported as relevant and meaningful [18]. The development and validation of the questionnaire were rigorously completed in accordance with the FDA’s PRO Guidance for Industry [11].…”

Section: Discussionmentioning

confidence: 99%

“…In response to the lack of an adequate disease-specific daily diary (PRO) covering relevant patient-reported symptoms, the CDI-Daily Symptoms (CDI-DaySyms™) was developed. It measures the broad range of local and systemic CDI symptoms that patients report as meaningful [18].…”

Section: Introductionmentioning

confidence: 99%

Clostridium difficile Infection–Daily Symptoms (CDI-DaySyms™) questionnaire: psychometric characteristics and responder thresholds

Talbot

Kleinman

Davies

et al. 2019

Health Qual Life Outcomes

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Background The purpose of the current study was to determine the final content validation, psychometric characteristics, clinically meaningful improvement, and responder thresholds of the Clostridium difficile infection (CDI)–Daily Symptoms (CDI-DaySyms™) patient-reported outcome (PRO) questionnaire. Methods This validation study was part of two phase III studies (NCT01987895 and NCT01983683) conducted in patients with mild-to-moderate or severe CDI who completed the CDI-DaySyms™ daily throughout the treatment period. The questionnaire was evaluated in three stages: final PRO item content validation (Stage I); psychometric evaluation of reliability and construct validity (Stage II); and determination of clinically meaningful improvement and responder thresholds using distribution-based methods (Stage III). Results The analysis included 168 patients. Most patients were female and Caucasian with mild-to-moderate CDI. The mean age was 57.1 years. Initial item analysis supported by confirmatory factor analysis demonstrated the relevance of 10 items grouped into three distinct domains (Diarrhea Symptoms, Abdominal Symptoms, and Systemic/Other Symptoms). Domain scores demonstrated acceptable internal consistency and test-retest reliability, were sensitive to change, and correlated in expected directions with other relevant symptom and disease-severity measures. Responder thresholds were defined as score changes of − 1.00, − 0.80, and − 0.70 in the Diarrhea Symptoms, Abdominal Symptoms, and Systemic/Other Symptoms domains, respectively. Conclusions The CDI-DaySyms™ is a valid measure of patient-reported CDI symptoms, with good measurement properties, which supports its utility as an endpoint in clinical studies. Further studies confirming responder thresholds based on anchor-based methods are required. Trial registration NCT01987895 , registered November 20, 2013; NCT01983683 , registered November 14, 2013. Electronic supplementary material The online version of this article (10.1186/s12955-019-1142-9) contains supplementary material, which is available to authorized users.

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Choosing the right outcomes in infectious diseases clinical research—putting patients front and centre

Ong,

Patel,

Reinblatt

et al. 2024

Clinical Microbiology and Infection

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

Cited by 5 publications

References 30 publications

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

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

Clostridium difficile Infection–Daily Symptoms (CDI-DaySyms™) questionnaire: psychometric characteristics and responder thresholds

Choosing the right outcomes in infectious diseases clinical research—putting patients front and centre

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