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Cost-effectiveness of early living related segmental bowel transplantation as therapy for trauma-induced irreversible intestinal failure |
Cicalese L, Sileri P, Gonzales O, Asolati M, Rastellini C, Abcarian H, Benedetti E |
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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 health technology under investigation was living-related small bowel transplantation (LRSBTx). This was compared with total parenteral nutrition (TPN).
Economic study type Cost-effectiveness analysis.
Study population The study population comprised trauma patients who had subsequent total eneterectomy and irreversible intestinal failure.
Setting The setting was tertiary care. The study was conducted in Chicago, USA.
Dates to which data relate The dates to which the effectiveness, resource or cost data for the intervention referred, were not reported. The price data used for the comparator were from 1992.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was carried out on the same sample of patients from whom the effectiveness data were collected. The effectiveness and cost data were collected retrospectively.
Study sample Power calculations to determine an appropriate sample size were not reported, and neither was the method of sample selection. The patients included had undergone total enterectomies and experienced irreversible intestinal failure. Thus, the study sample seems appropriate for the study question. The sample size was 6 (3 patients and 3 donors).
Study design The study was a case series of patients and donors for the LRSBTx procedure. No patient sample was defined to collect data for the comparator (TPN). The study was conducted at a single centre. The mean follow-up for the LRSBTx sample was 26.3 months (range: 11 - 40). There was no loss to follow-up.
Analysis of effectiveness The data analysis included all the LRSBTx patients and donors identified for the retrospective sample. The primary health outcome for this sample was not stated. The authors reported a number of outcomes that comprised the postoperative course for recipients and donors. These included survival and health state, return to oral diets, reversal of liver dysfunction, biopsy test for rejection of transplant, and infection.
Effectiveness results All of the LRSBTx recipients survived and were well at follow-up (mean follow-up 26.3 months, range: 11 - 40). There was a 100% return to oral diets. Liver dysfunction was reversed in 100% of the recipients, and all of the biopsies for transplant rejection were negative. Apart from two patients who developed CMV infections, no other bacterial or fungal infections were documented.
None of the donors experienced any adverse postoperative events or complications.
Clinical conclusions The authors concluded that isolated LRSBTx is effective for patients with irreversible intestinal failure from trauma. The risks of acute rejection and infections are reduced in comparison with SBTx. The procedure has minimal impact on the lifestyles of the donors.
Measure of benefits used in the economic analysis No measure of benefit was used in the economic analysis. This study was therefore categorised as a cost-consequences analysis.
Direct costs The number of hospital admissions and length of stay was reported for LRSBTx recipients and donors. The authors did not report separate resource use and cost data for donor workup, outpatient visits, other procedures or interventions and tests. The unit costs were not reported for any of the resource items. The resource quantities and the costs were not reported separately for the comparator (TPN). The direct costs to the hospital were included in the analysis. These were for donor workup and hospitalisation, recipient hospitalisation, outpatient follow-up (including routine visits, endoscopies and laboratory tests), hospital readmission and chronic immunosuppression. The source of the cost data was not reported, and neither were the methods used to estimate the costs. The costs were not discounted even though the mean follow-up was longer than one year. The average costs were reported. The authors did not report the year of the price data, whether the data were adjusted for inflation, or whether any costs were excluded from the analysis. They also did not report whether the observed data were adjusted to account for centre-specific protocol-driven resource use and costs.
Statistical analysis of costs The mean values for resource use and cost data were reported, while ranges were reported for the length of stay. Variations in mean costs were reported as the mean plus or minus a measure of variance (e.g. standard deviation, or the range between confidence intervals, percentiles or minimum and maximum), which was not reported. They also did not report any statistical analysis of the cost data. This was appropriate given the sample size.
Indirect Costs The indirect costs were not included in the analysis since they were not relevant to the implicit perspective of the study.
Currency US dollars ($). No currency conversions were reported
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results For LRSBTx recipients, the average cost of hospitalisation was $113,000 (+/- 26,000), the yearly average cost per outpatient follow-up was $3,900 (+/- 750), the mean cost of readmission per patient was $2,200 (+/- 600), and chronic immunosuppression cost approximately $14,000 per year per patient.
For LRSBTx donors, the average cost of donor workup and hospitalisation was $16,000 (+/- 2,000).
The authors reported the Medicare cost of TPN as over $150,000 per patient (1992). This excluded the costs of frequent hospitalisation, medical equipment and nursing care.
Synthesis of costs and benefits The costs and benefits were not combined.
Authors' conclusions Living-related small bowel transplantation (LRSBTx) becomes cost-effective from the first year post-transplant and, when successful, provides complete rehabilitation for these patients.
CRD COMMENTARY - Selection of comparators The authors reported two possible comparators, TNP and cadaveric SBTx, but did not state whether these represented routine practice in their own setting. The costs of the intervention were only compared with one of the reported comparators, TPN. The authors' justification for this was that there were no data to assess the relative cost-effectiveness of LRSBTx and TPN. The authors also noted that there were differences between LRSBTx and SBTx. It is unclear why SBTx was not chosen as a comparator, and the authors did not justify this exclusion. The authors did not report whether there were other possible comparators. You should decide if TPN is a widely used technology in your own setting.
Validity of estimate of measure of effectiveness The effectiveness data were derived from a single study. The study was a small, retrospective case series, which provided data on the effectiveness and cost of the intervention for three LRSBTx recipients and their donors. No justification for the sample size was given. It was not possible to assess whether the intervention sample was chosen selectively. These factors and the retrospective case series design could introduce bias and random variation, which would lead to an incorrect estimation of the effectiveness.
The characteristics of the study sample were described. The disease state was representative of the study population, but the authors did not report whether the recipients were representative of the study population in terms of other characteristics. There was no defined comparison sample for the assessment of relative effectiveness, so it is not possible to assess whether the patient groups were comparable at analysis. No effectiveness data were reported for the comparator group. There was also no statistical analysis or control for confounding factors.
Validity of estimate of measure of benefit The authors did not derive a measure of health benefit. There was no evidence reported to indicate therapeutic equivalence between the intervention and comparator. The analysis was therefore categorised as a cost-consequences analysis.
Validity of estimate of costs The authors did not report the perspective adopted in the analysis. The categories of cost data reported implied that the perspective was that of the hospital. For the intervention, all of the categories of cost relevant to the hospital perspective were included in the analysis. However, there was insufficient information for each category of cost to assess whether all the relevant costs were included in the analysis. For the comparator, the authors reported that some costs (frequent hospitalisation, medical equipment and nursing care) were omitted. The authors did not specify which resource and cost items were included in the cost estimate for TPN. The costs and the quantities were not reported separately. Resource use for the intervention was obtained from a single study of three LRSBTx recipients and their donors. A statistical analysis of the quantities or costs was not conducted, but this may not have been appropriate given the sample size. The authors did not report the source of the unit costs, nor did they report whether charges were used to proxy prices. The date to which the prices related was reported for the comparator, but not for the intervention. Discounting was not undertaken even though the costs were incurred over more than one year.
Other issues The authors did not make appropriate comparisons of their results with the findings from other studies. The issue of generalisability to other settings was not addressed. The authors did not present their results selectively. The study enrolled patients with extensive intestinal resection leading to irreversible intestinal failure and this was reflected in the authors' conclusions. The authors did not report any limitations of their study.
Implications of the study The authors state that LRSBTx recipients have shorter hospital stays and fewer hospital readmissions than those reported after cadaveric SBTx. The procedure has minimal impact on the lifestyle of donors and is not associated with short- or long-term morbidity. The authors also state that compared with TPN, LRSBTx becomes cost-effective from the first year post-transplant and provides complete rehabilitation in these patients. However, these conclusions are drawn from a small study of a retrospective case series of patients.
Bibliographic details Cicalese L, Sileri P, Gonzales O, Asolati M, Rastellini C, Abcarian H, Benedetti E. Cost-effectiveness of early living related segmental bowel transplantation as therapy for trauma-induced irreversible intestinal failure. Transplantation Proceedings 2001; 33(7-8): 3581-3582 Indexing Status Subject indexing assigned by NLM MeSH Adult; Chicago; Cost-Benefit Analysis; Humans; Intestinal Diseases /economics /etiology /surgery; Intestines /injuries; Living Donors AccessionNumber 22002000218 Date bibliographic record published 30/11/2003 Date abstract record published 30/11/2003 |
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