A description of the UK NHS hospital resource use and patient quality of life associated with hospitalisations for recurrent Clostridium difficile infection

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Clostridium difficile infection

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  180

Study design details

• Main study objective:
  To describe the cost of hospital resource use of patients with a recurrence of CDI
• Outcomes:
  Difference in total hospital resource (£) (including prescribing, infection control measures, diagnostic tests, supplementary nutrition, multidisciplinary team review, stay per ward/side room) between patients with and without recurrent CDI hospitalisation and stratified for patients with a mild/moderate recurrence of CDI and for those with a severe recurrence of CDI. Difference in no. days hospitalised between patients with (cases) and without (controls) CDI recurrence, stratified by severity of recurrence, total hospital resource (£) for the period between first and recurrent CDI, stratified by severity of recurrence, mean EQ5D score for patients with CDI hospitalisations, overall and stratified by age/disease severity, patient/disease characteristics.
• Data analysis plan:
  This study is designed to be descriptive of recurrent CDI overall and not to detect differences between different treatment regimens for CDI, although descriptive sub-group analyses will be conducted according to patient and disease characteristics. Both distributions and descriptive statistics of both central tendency (medians and arithmetic or geometric means) and dispersion (standard deviation, interquartile range) will be presented for quantitative variables. Nominal variables will be described with frequencies, percentages and modes, while ordinal variables will also have medians and interquartile ranges described.