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Resource use associated with hospitalisations for recurrent Clostridium difficile infection
Background
Clostridium difficile infection (CDI) is associated with significant morbidity, mortality and healthcare resource utilisation. Recurrence of CDI, which occurs in approximately 20-30% of patients, presents a major challenge for healthcare providers. Following a prolonged period without innovation in the treatment options for CDI, new therapeutics have been developed recently which reduce the rate of CDI recurrence compared with conventional treatment. A clear understanding of the economic burden of recurrent CDI is important to enable payers and clinical decision makers to evaluate the potential impacts of these interventions on local service provision. There is currently a paucity of data that quantify the resource use and costs associated with recurrent CDI in the United Kingdom (UK).
Objective
The objective of this study was to determine the UK hospital resource use associated with hospitalisations for recurrent CDI.
Method
We conducted a non-interventional, retrospective case-control study in 6 acute National Health Service (NHS) hospitals (5 in England and 1 in Scotland), selected based on likely availability of sufficient study participants, geographic spread, availability of local clinical staff to collect the required data and database systems that would allow identification of eligible patients. Pseudonymised data were gathered from the hospital medical records of 64 patients hospitalised with a CDI recurrence (‘cases’) and 64 ‘matched controls’, with a first episode of CDI but no recurrence. The eligibility criteria are summarised in Figure 1. Local clinical staff collected data on demographics, CDI strain and illness severity at first episode (both groups) and recurrence (cases only) and hospital resource use (including prescribing, hospital attendances and admissions, investigations and procedures, intravenous [IV] / nutritional support). Resource use data were collected from the ‘index event’, defined as the first recorded symptoms of either recurrent (cases) or first episode only (controls) CDI until 28 days post-index or death, whichever was shorter. Data were collected in 2013-2014 covering an observation period of 01 March 2012 (date of first event for the first patient included) to 02 June 2014 (end of post-index observation period for last patient included). The cost of resource utilisation was calculated using UK-specific reference costs and a Market Forces Factor Index applied to the costs for each Hospital Trust. Analyses are presented overall and stratified by CDI severity (severe or mild/moderate). Severe CDI was defined by the presence of white cell count >15×109/L, acutely rising blood creatinine (e.g. >50% increase above baseline), temperature >38.5oC or evidence of severe colitis (abdominal signs, radiology). Where none of the criteria for severe CDI were present, CDI was considered as mild/moderate.
Results: patient characteristics
Table 1 shows the demographic and clinical characteristics of patients with recurrent and first episode only CDI. Six percent (4/64) of the cases (all with mild/moderate CDI) and 14% (9/64) of the matched controls (5 with severe and 4 with mild/moderate CDI) died within the 28 day post-index period. The median duration of the post-index observation period in patients who died was 13 days for cases and 12 days for controls.
Results: resource use
The total cost of treating patients with a recurrent and first episode only CDI during the 28 day post-index observation period is shown in Figure 2. The median cost was £7,539 per patient for recurrent and £6,294 per patient for first episode only CDI (difference, p=0.075). In the subgroup of patients with severe CDI the median cost was £8,542 for recurrent and £5,631 for first episode only CDI (difference, p=0.039). Although most patients had total costs less than £10,000, there was a small number of outliers in the control group (with total costs of greater than £20,000). The difference in costs between individual cases and matched controls ranged from -£38,163 (higher cost for control than case) to £11,841 (higher cost for case than control) with a median difference of £689 (higher cost for case than control, interquartile range [IQR] -£1,873 to £3,954). There was an increased median length of stay of 5.5 days associated with recurrent CDI (p=0.2690); 11 days in the subgroup of patients with severe CDI (p=0.029) (Figure 3) The breakdown of total costs is shown in Figure 4. The costs of hospital stays accounted for the majority of total costs for both groups (86.7% for recurrent and 88.6% for first episode only CDI). The cost of CDI-specific medicines accounted for 5.4% of total costs for recurrent and 0.9% of total costs for first episode only CDI. A similar breakdown was seen when assessed according to CDI severity.
Conclusions
Recurrent CDI is associated with substantial hospital costs, which are similar to those of the first episode. These costs, which are largely driven by the duration of hospital stay, will have a considerable impact on healthcare budgets. The results of this multicentre study provide contemporaneous “real-world” cost burden data to aid decision- making on the use of new CDI therapeutics, particularly those associated with reduced risk of recurrence. The data presented here on the cost of managing CDI according to disease severity are important when considering guidance from Public Health England, which recommends different treatment strategies for patients with severe and mild/moderate disease.
Authors
Mark Wilcox, John Coia, Andrew Dodgson, Susan Hopkins, Martin Llewelyn, Chris Settle, Harblas Ahir, Susan Mclain-Smith
Journal
Presented at the 26th ECCMID
Therapeutic Area
Infectious diseases and vaccines
Center of Excellence
Real-world Evidence & Data Analytics
Year
2016
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