Research objectives | Outcome | Covariates | Analytical approach |
To determine incidence of diarrhoea and consistency of bowel movements during critical illness To determine the frequency of diarrhoea defined as the proportion of patients with new ICU-acquired diarrhoea | Primary outcome | NA | The incidence of diarrhoea will be computed as the number of new cases during ICU stay divided by the person-time at risk. Descriptive statistics (proportion of patients with diarrhoea) and corresponding 95% CI |
WHO-defined diarrhoea | |||
Different definitions of primary outcome | |||
Bristol Stool Chart-defined diarrhoea | |||
Bliss Stool Classification System-defined diarrhoea | |||
To determine risk factors associated with diarrhoea during critical illness | Primary outcome | Age, sex, APACHE II score, drugs (motility modifiers, opiates, stool softeners), prior gastrointestinal disease, centre | Logistic regression |
Dependent variable | |||
WHO-defined diarrhoea | |||
Secondary outcomes | |||
Research objective | Secondary outcome | Covariates | Analytic approach |
To determine the consequences of diarrhoea | Dependent variable | WHO-defined diarrhoea, age, sex, APACHE II score | Cox regression |
Time to ICU discharge | |||
Time to hospital discharge | |||
Mortality | Logistic regression | ||
Research objective | Secondary outcome | Covariates | Analytical approach |
To determine the incidence of Clostridium difficile-associated diarrhoea (CDAD) during critical illness | IDSA-defined CDAD | NA | Descriptive statistics (proportion of cases with diarrhoea during study period) |
ESCMID-defined CDAD | |||
ACG-defined CDAD | |||
To determine agreement between WHO and Bristol and Bliss scores | Chance corrected agreement (kappa score) | NA | Kappa statistic with 95% CI |
APACHE II, Acute Physiology and Chronic Health Evaluation II; ACG, American College of Gastroenterology ; ESCMID, European Society of Clinical Microbiology and Infectious Diseases ; ICU, intensive care unit; IDSA, Infectious Disease Society of America ; NA, not applicable; CDAD, Clostridium-difficile associated diarrhoea.