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Influence of prolonged use of intravenous administration sets in paediatric cancer patients on CVAD-related bloodstream infection rates and hospital resources |
Simon A, Fleischhack G, Wiszniewsky G, Hasan C, Bode U, Kramer M H |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The study examined the effects of extending the routine intravenous administration set (IVAS) change interval from 72 hours to 7 days for the prevention of central venous access device (CVAD)-related bloodstream infections (BSIs) in paediatric cancer patients. In practice, the IVAS may be changed prior to the routine change interval because of discharge, or following the administration of blood products for example.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised all patients receiving anti-cancer chemotherapy in a paediatric oncology ward. The patient population had implanted ports in place for 55% of all inpatient treatment days, and double-lumen Broviac catheters in place for 25% of all inpatient days.
Setting The setting was tertiary care. The economic study was carried out in Bonn, Germany.
Dates to which data relate The effectiveness and resource use data related to April 2001 to March 2003. The price year was not stated.
Link between effectiveness and cost data The resource use data were obtained prospectively from the same patient sample as that used in the effectiveness study.
Study sample The authors did not report any power calculations. All eligible patients were recruited into the study. Patients recruited between April 2001 and March 2002 were assigned to an IVAS change interval of 72 hours (group 1), whilst those recruited between April 2002 and March 2003 were assigned to an IVAS change interval of 7 days (group 2). Of the 175 patients eligible over the study period, 96 were recruited to group 1 and 79 to group 2.
Study design The study design was a prospective, non-randomised controlled trial that compared groups before and after a change of practice at the single study centre. Although the study was not blinded, it is likely that blinding was impossible given the nature of the intervention. The authors did not report the length of follow-up.
Analysis of effectiveness The primary health outcome was the incidence of CVAD-related BSIs. A CVAD-related BSI was defined as clinical signs of infection plus one positive blood culture taken from a CVAD in a patient with a CVAD in place and with no other evidence of another primary focus of infection. The analysis of effectiveness accounted for all patients included in the study sample. The authors reported that the basic clinical characteristics of the patients were similar between groups, and reported no statistically significant differences at baseline.
Effectiveness results The incidence density for CVAD-related BSIs per 1,000 device utilisation days decreased by 33.4% in group 2 compared with group 1. The incidence per 100 admissions decreased by 51.8% in group 2 compared with group 1. The differences were not found to be statistically significant.
Clinical conclusions The authors concluded that increasing the IVAS change interval from 72 hours to 7 days in their study did not increase the incidence density of CVAD-related BSIs. However, they stated that they could not attribute the observed reduction in infections to the intervention because of the unrandomised pre/post-intervention protocol.
Measure of benefits used in the economic analysis The authors did not derive a summary measure of benefit. In effect, a cost-consequences analysis was performed.
Direct costs The study included the direct costs to the hospital. These included material costs (devices) and nursing time. The resource use data were measured by primary data collection on the same patient sample as that used in the effectiveness analysis. The unit cost per hour of nursing time was derived from a published study. The source of the unit cost per device was not specified. The price year was not reported. The authors reported the average costs. The resource use quantities and the costs were reported separately. The costs were not discounted, but the timeframe for the analysis was unclear.
Statistical analysis of costs The cost data were analysed deterministically.
Indirect Costs The indirect costs were not included in the analysis.
Currency US dollars ($). The conversion rate (year unspecified) was EUR 1 = $1.157.
Sensitivity analysis The authors did not conduct any sensitivity analysis.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The total cost in group 1 was $35,410, compared with $26,857 in group 2. Hence, the extension of the IVAS change interval from 72 hours to 7 days was associated with a $7,425 reduction in costs. The costs of infections were not included in the analysis.
Synthesis of costs and benefits The costs and benefits were not combined.
Authors' conclusions Extending the routine intravenous administration set (IVAS) change interval from 72 hours to 7 days in a paediatric oncology unit with high infection control standards would appear to be safe and cost-effective.
CRD COMMENTARY - Selection of comparators The comparator was selected to represent current practice in the study setting. The authors noted that the study setting was characterised by continuous high-quality surveillance for CVAD-related infections. You must consider whether the comparator is representative of current practice in your own setting.
Validity of estimate of measure of effectiveness The estimate of effectiveness was derived from a prospective, non-randomised, comparative study design in which patients were recruited before and after a change of practice at the study centre. The authors stated that the study was undertaken as a pilot study, and acknowledged that the design allowed for changes in patient and nursing characteristics between groups. The authors reported details of the patients included in the study and recruited all eligible patients from the participating centre. The authors appear to have conducted an unadjusted analysis of infection rates. The authors did not perform power calculations as this was a pilot study. They stated that, in order to detect an increase from 1.3 to 2.6 in the incidence of CVAD-related infections per 100 admissions with a statistical power of 80% and a significance level of 5%, 1,000 patients would need to be randomised to each group and would have to consistently complete the routine change interval. Hence, a fully powered randomised design was not practicable for the pilot study.
Validity of estimate of measure of benefit The authors did not derive a summary measure of benefit. They stated that the study design impeded an attribution of changes in infection rates to the intervention. However, they claimed that the study results may be sufficient to support the conclusion that extending the routine change interval is not harmful.
Validity of estimate of costs The authors did not specify a study perspective. The study included direct costs related to the intervention (i.e. device costs and nursing time related to changing the devices). The study omitted the costs of medication and infections but, as infection rates were lower in the intervention group, this omission is unlikely to have affected the authors' conclusions. The resource use data were obtained from the authors' setting, while the unit cost of nursing time was derived from a published study. The precise nature of the unit costs employed was unclear. However, the resource use costs and quantities were reported separately, which enables the generalisability of the study results to be assessed. Discounting was not applied and the timeframe for the analysis was unclear. The authors did not investigate uncertainty in the cost data.
Other issues The authors did not compare their findings with those from other studies. The issue of generalisability to other settings was addressed in that the authors stressed that the results may only apply to centres with the same features as the study setting. The authors presented the results of the analysis in detail and their conclusions reflected the scope of the analysis.
Implications of the study The authors recommend that a prospective, randomised controlled trial with sufficient power be conducted to determine whether extending the routine IVAS change interval reduces the number of CVAD-related BSIs.
Source of funding Supported by a grant from the German Society of Paediatric Infective Diseases and funding from GILEAD Sciences GmbH and Wyeth Pharma GmbH.
Bibliographic details Simon A, Fleischhack G, Wiszniewsky G, Hasan C, Bode U, Kramer M H. Influence of prolonged use of intravenous administration sets in paediatric cancer patients on CVAD-related bloodstream infection rates and hospital resources. Infection 2006; 34(5): 258-263 Indexing Status Subject indexing assigned by NLM MeSH Adolescent; Adult; Catheterization, Central Venous /adverse effects /instrumentation; Child; Child, Preschool; Cost Savings; Cross Infection /etiology; Female; Humans; Infant; Infusions, Intravenous; Male; Neoplasms /therapy; Prospective Studies; Sepsis /etiology; Time Factors AccessionNumber 22006002232 Date bibliographic record published 31/07/2007 Date abstract record published 31/07/2007 |
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