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

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.

Impaired Quality of Life, Work, and Activities Among Adults with Clostridium difficile Infection: A Multinational Survey.

BACKGROUND: Evidence of humanistic detriments of Clostridium difficile infection (CDI) remains limited. AIMS: To assess humanistic burden associated with CDI. METHODS: Self-reported National Health and Wellness Survey data between 2013 and 2016 were analyzed for the USA, five European countries, China, and Brazil. Outcome measures included SF-36v2® for health-related quality of life (HRQoL) and Work Productivity and Activity Impairment questionnaire. Respondents (≥ 18 years old) were classified as (1) currently treated doctor-diagnosed CDI (C-CDI), (2) doctor-diagnosed prior CDI (P-CDI), or (3) never experienced CDI (NO-CDI). Regression modeling assessed the association between CDI status and outcomes, adjusting for potential confounders. RESULTS: Of 352,780 respondents, 299, 2111, and 350,370 met the criteria for C-CDI, P-CDI, and NO-CDI, respectively, with 45% of the total from the USA. C-CDI and P-CDI respondents were older, were less often employed and had more comorbidities than those with NO-CDI. After adjustment for covariates, C-CDI and P-CDI had significantly lower HRQoL relative to NO-CDI for mental (MCS 39, 43 vs. 46) and physical (PCS 39, 41 vs. 46) component summary scores, and health utility (SF-6D 0.58, 0.64 vs. 0.71) (all p < 0.05), meeting common thresholds for minimally important differences. Those with C-CDI and P-CDI reported missing more work (21, 16 vs. 8%), greater impairment while working (43, 34 vs. 22%), and more activity impairment (61, 49 vs. 34%) than those with NO-CDI (all p < 0.05), respectively. CONCLUSIONS: CDI is associated with meaningfully worse HRQoL and greater impairment to work and activities compared with NO-CDI. The impairment directly attributable to CDI requires further evaluation.

Patients' experience and perception of hospital-treated Clostridium difficile infections: a qualitative study.

BACKGROUND: Clostridium difficile is the leading cause of antibiotic-associated diarrhea and an important source of nosocomial infection. Clinical manifestations can range from mild diarrhea to lethal pseudomembranous colitis. Little is known about the burden of C. difficile infections (CDI) in patients. OBJECTIVE: This qualitative study explored the impact of hospital-treated CDI on patients' lives from the first occurrence of CDI symptoms, through their hospital stay, and after discharge. METHODS: Semi-structured interviews with 12 US and 12 French patients who had experienced CDI were conducted using an interview guide that was developed on the basis of a thorough literature review. Transcripts from these interviews were analyzed to identify concepts related to the research question. FINDINGS: CDI affected numerous aspects of patients' lives. Patients reported that the continuous, watery, and uncontrollable diarrhea characteristic of CDI had the most impact on their daily lives. Diarrhea prevented them from participating in usual daily activities; this caused the collapse of their social lives. Patients felt humiliated and embarrassed. Patients' emotional distress worsened once hospitalized; they reported feelings of loneliness and worry when placed in isolation. From discharge to the time of the interview, patients reported both psychological and physical improvement. However, despite continuing improvement, most patients reported persistent worry and fear of recurrent episodes, and they were thus more careful about their diet and hygiene. CONCLUSION: As one patient in this study explained, CDI is "the worst of everything that I've had." The emotional distress and extreme physical exhaustion associated with CDI result in a traumatic and frightening experience for patients. This trauma persists after recovery and includes lingering fears of a recurrent episode.

Faecal microbiota transplantation for Clostridium difficile infection.

PURPOSE: To review the current clinical literature regarding the use of fecal microbiota transplantation (FMT) for severe and recurrent Clostridium difficile disease (CDAD). BACKGROUND: Clostridium difficile (C. difficile) is a gram positive, spore forming bacteria, and an important nosocomial pathogen causing healthcare associated diarrhoea in hospitalized patients in developed and developing countries. During the past several years, CDAD has become more frequent, severe, refractory, and more likely to relapse. It has become apparent that C. difficile is no longer just a nosocomial infection, with a rising rate of infection in populations not previously affected. Standard treatment regimens and new medications exist, but recurrence rates are high. METHODS: Using PubMed, we conducted a Boolean search with the following medical subject headings (MeSH): Clostridium difficile infection and fecal transplantation or recurrent C. difficile infection. We restricted the search to human studies, published in English, between 2011 through June 1, 2013. RESULTS: There were 104 publications identified. Of those related to FMT, there were 20 clinical reviews, 6 case reports, 3 clinical trials (one, a randomized control trial), and 1 meta-analysis. Since 1958 there have been 36 published reports of FMT for C. difficile infection (CDI) representing 583 patients. Success rates were higher when FMT was administered via colonoscopy (representing the majority of patients, 79.2%). The overall success rate for FMT, regardless of administration method, was 80-98%. CONCLUSION: Fecal microbiota transplantation attempts to restore the normal microbiome of the colon, and has achieved a cure rate reaching more than 90%. Mounting evidence supports the utility of FMT for severe and recurrent cases of CDI. Barriers that will need to be addressed are patient perceptions and fears, standard protocol development, and further clinical trials.