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Selective intestinal decontamination in multiple trauma patients: prospective, controlled trial |
Lingnau W, Berger J, Javorsky F, Lejeune P, Mutz N, Benzer 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 Selective intestinal decontamination in multiple trauma patients.
Economic study type Cost-effectiveness analysis.
Study population Patients (male and female) 18 years of age or older (mean age 38, +
Setting Hospital. The economic study was carried out in Innsbruck, Austria.
Dates to which data relate The main effectiveness data were taken from a single trial conducted between 1989 and 1994. Resource and cost data were mainly derived from 1989-1994 sources. The price year was not stated.
Source of effectiveness data The estimates for final outcomes were derived from a single study.
Link between effectiveness and cost data The costing was undertaken prospectively on the same patient sample as that used in the effectiveness study.
Study sample A feasibility and pilot study was conducted using 26 patients. A cohort of 310 patients (243 male) was included in the analysis. Patients were randomly assigned to different regimes. Patients were divided into 3 groups: PTA (80, 77.5% male), PCA (82, 74.4% male), and placebo (148, 81.1% male). Intubation was carried out at the following locations: site of accident (38.8%, 35.4% and 40.5% in the PTA, PCA and placebo group, respectively), primary care hospital (18.8%, 26.8% and 20.3% in the PTA, PCA and placebo group, respectively) and emergency room (42.4%, 37.8% and 39.2 in the PTA, PCA and placebo group, respectively). The type of airway was mainly orotracheal (97.5%, 93.9% and 99.3% in the PTA, PCA and placebo group, respectively). Power calculations to determine the sample size were not undertaken. The numbers of excluded patients were 10 (zero deaths) for PTA, 8 (3 deaths) for PCA and 29 (1 death) in the placebo group.
Study design Randomized controlled trial. The duration of the follow-up was not explicitly stated, however it was likely to be 3 days or longer after ICU admission. The loss to follow-up included 47 patients. The reasons were: violations regarding intravenous prophylaxis (14), early extubation or discharge from the ICU within 48 hours (29), severity of injuries and missing bacteriologic data (2).
Analysis of effectiveness The analysis of the clinical study was based on treatment completers only. The primary health outcomes used in the analysis were: colonization during total ICU treatment and complication rate.
Effectiveness results Results for the PTA, PCA, PTA+PCA and placebo groups were:
Total oropharynx colonization during total ICU treatment: 205, 187, 392 and 622
Total rectum colonization during total ICU treatment: 604, 564, 1168 and 1241
Total trachea colonization during total ICU treatment: 274, 234, 508 and 634
Total urine colonization during total ICU treatment: 47, 48, 95 and 79
Incidence of pneumonia: 47.5%, 39%, 43.7% and 45.3%
Incidence of sepsis: 47.5%, 37.8%, 42.6% and 42.6%
Incidence of multiple organ failure (MOF): 56.3%, 52.4%, 54.3% and 58.1%
Incidence of death: 11.3%, 12.2%, 11.7% and 10.8%.
Clinical conclusions Selective decontamination reduced intestinal bacterial colonization. No differences were found for complication rate among the PTA, PCA, PTA+PCA and placebo groups.
Measure of benefits used in the economic analysis The outcome measures used in the analysis were colonization during total ICU treatment and complication rate.
Direct costs Costs for topical prophylaxis and for treatment of complications were included in the analysis. The quantities were analysed separately from costs. Discounting was not applied. The quantity/cost boundary adopted was the hospital. The price year was not stated.
Statistical analysis of costs Chi-squared test, t-test, Kaplan-Meier method, log-rank-test in a two-sided approach, means+/-SD or proportions.
Sensitivity analysis No sensitivity analysis was conducted.
Estimated benefits used in the economic analysis Results for the PTA, PCA, PTA+PCA and placebo groups were:
Total oropharynx colonization during total ICU treatment: 205, 187, 392 and 622
Total rectum colonization during total ICU treatment: 604, 564, 1168 and 1241
Total trachea colonization during total ICU treatment: 274, 234, 508 and 634
Total urine colonization during total ICU treatment: 47, 48, 95 and 79
Incidence of pneumonia: 47.5%, 39%, 43.7% and 45.3%
Incidence of sepsis: 47.5%, 37.8%, 42.6% and 42.6%
Incidence of multiple organ failure (MOF): 56.3%, 52.4%, 54.3% and 58.1%
Incidence of death: 11.3%, 12.2%, 11.7% and 10.8%.
Cost results The average cost of the antibiotics used for topical prophylaxis per patient was $745 (+/- 47) and $329 (+/- 6) for the PTA and PCA group, respectively. The cost for additional antibiotics used for treatment of infectious complications was $335 (+/- 95), $299 (+/-70) and $450 (+/- 73) in the PTA, PCA and placebo group, respectively. Discounting was not applied.
Synthesis of costs and benefits A synthesis of the estimated benefits and costs was not provided. An incremental cost analysis was not performed.
Authors' conclusions Selective decontamination in trauma patients reduced intestinal bacterial colonization, however, no benefit was found in terms of complication rates.
CRD COMMENTARY - Selection of comparators The reason for the choice of the comparator was clear. Reduction of potential pathogens by selective intestinal decontamination has been widely considered as a mean of improving intensive care. You, as a user of this database, should consider whether these technologies are relevant to your own setting.
Validity of estimate of measure of benefit The estimate of measure of benefit used in the economic analysis is likely to be internally valid. The data have not been used selectively.
Validity of estimate of costs The resource quantities were reported separately from the prices. Adequate details of methods of quantity/cost estimation were given. No important cost items were omitted.
Other issues The authors' conclusions were justified, given the uncertainties in the data. The issue of generalisability to other settings or countries was not addressed. Appropriate comparisons were not made with other studies. The results were not presented selectively.
Source of funding Funded in part by research grant BAY q 3939/0454 and by grants of the Leopold-Franzens-University of Innsbruck, Austria.
Bibliographic details Lingnau W, Berger J, Javorsky F, Lejeune P, Mutz N, Benzer H. Selective intestinal decontamination in multiple trauma patients: prospective, controlled trial. Journal of Trauma 1997; 42(4): 687-694 Indexing Status Subject indexing assigned by NLM MeSH Adult; Amphotericin B /therapeutic use; Anti-Bacterial Agents /therapeutic use; Anti-Infective Agents /therapeutic use; Bacterial Translocation; Ciprofloxacin /therapeutic use; Colistin /therapeutic use; Double-Blind Method; Drug Therapy, Combination /therapeutic use; Female; Humans; Intestines /microbiology; Male; Multiple Trauma /complications; Pneumonia /etiology /prevention & Prospective Studies; Respiration, Artificial /adverse effects; Tobramycin /therapeutic use; control AccessionNumber 21997000650 Date bibliographic record published 31/10/1998 Date abstract record published 31/10/1998 |
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