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

OBJECTIVES: To develop a patient-reported outcome (PRO) questionnaire for symptoms of Clostridium difficile infection (CDI) following the US Food and Drug Administration PRO guidelines. METHODS: Patients' experiences of CDI symptoms were elicited in open-ended discussions with patients and nurses at five US sites (stage 1). A draft PRO measure was developed after demonstration of concept saturation. Two rounds of cognitive interviews were conducted with patients at three US sites (stage 2), with revision of the draft measure after each round. All patients were 18 years or older, with confirmed CDI. The study was conducted with input from a panel of five CDI experts in Europe and North America. RESULTS: Stage 1 included interviews with 18 patients and supplementary interviews with 6 nurses; 16 additional patients were interviewed in stage 2. Patients were representative of the general CDI population and were diverse in age, sex, and disease severity. Concept saturation was reached in stage 1. Items were organized in a draft conceptual framework with five hypothesized domains: diarrhea, abdominal discomfort, tiredness, lightheadedness, and other symptoms. Stage 2 demonstrated initial content validity of the 13-item draft daily diary (CDI-DaySyms). Participants reported that the questions were clear, relevant, and comprehensive. They were able to use the instructions to complete the diary correctly and considered the 24-hour recall period appropriate. CONCLUSIONS: The CDI-DaySyms captures symptoms relevant to patients undergoing CDI, demonstrating initial content validity. Final content and psychometric validity are being evaluated in a substudy comprising patients from two ongoing international clinical trials (ClinicalTrials.gov identifiers NCT01987895 and NCT01983683).

[Diagnostic difficulties in foodborne botulism--case reports and literature review]. / Trudnosci diagnostyczne w zatruciu jadem kielbasianym--opis przypadków i przeglad pismiennictwa.

Food borne botulism is a relatively rare clinical syndrome, which symptomatology is generally highly distinctive. The physicians of various specialties should be familiar with the symptoms of botulism because its sings concern the nervous system, the organ of sight and the gastrointestinal system. In older persons with coexisting chronic diseases some symptoms of botulism may be not distinctive or may mimic exacerbation of early existing diseases. The handbook descriptions present the food borne botulism as dramatic and often deadly disease. However in some cases this disease can have mild course and poor symptomatology. Two cases of food borne botulism with different clinical course are presented in this paper, when the correct diagnosis was established with delay. A 78-year-old man was admitted with the symptoms of pneumonia and dizziness of uncertain aetiology. The diagnosis of food borne botulism was established in 10th day of hospital stay, when the most symptoms were not present. Despite of such late diagnosis and relatively good patient's condition a therapy with antitoxin was administrated. The second case reports a 70-year-old man with chronic heart failure, diabetes and obesity, when the delay of correct diagnosis was about of 24 hours. Despite of relatively early antitoxin administration and intensive supportive care patient died in 11th day of hospital stay.