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An economic analysis of patients with active arterial peptic ulcer hemorrhage treated with endoscopic heater probe, injection sclerosis, or surgery in a prospective, randomized trial |
Gralnek I M, Jensen D M, Kovacs T O, Jutabha R, Jensen M E, Cheng S, Gornbein J, Freeman M L, Machicado G A, Smith J, Sue M, Kominski G |
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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 authors examined the use of heater probe and injection sclerosis for emergency endoscopic treatment of patients with active, arterial ulcer bleeding.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients aged at least 18 years requiring emergency endoscopic treatment for active, arterial ulcer bleeding.
Setting The setting was hospital. The economic study was carried out in the USA.
Dates to which data relate The effectiveness and resource use data were collected between 1 April 1989 and 31 March 1994. The price year was 1995 to 1996.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was performed prospectively on the same patient sample as that used in the effectiveness analysis.
Study sample Power calculations were not used to determine the sample size. The study sample consisted of 31 patients randomly allocated to either the heater probe group (n=9), the injection sclerosis group (n=10) or the medical-surgical group (n=12). The mean ages of the three groups were 63.6 (standard deviation, SD=4.8), 69.7 (SD=3.2) and 57.5 (SD=4.3) years, respectively. Among the 134 patients enrolled in the study, 103 (77%) did not fulfil the inclusion criteria and were therefore excluded from the analysis.
Study design This was a multicentre, randomised, controlled, double-masked trial carried out in 6 centres. The duration of the follow-up was 30 days after randomisation. No loss to follow-up was reported. The members of staff involved were blinded to the endoscopic treatment, except for the medical-surgical group.
Analysis of effectiveness The analysis of effectiveness was performed on an intention to treat basis. The clinical outcomes were primary haemostasis rate, rate of emergency surgery, and severe ulcer rebleeding. The study groups were found to be comparable in terms of clinical background variables or endoscopic characteristics.
Effectiveness results The primary haemostasis rate was 100 and 90% in the heater probe and injection sclerosis groups, respectively, compared with 8% in the medical-surgical group (p<0.0001 for the differences between each of the two former groups versus the latter; p=0.33 for the difference between the two former groups).
The values for rate of emergency surgery were 0% for the heater probe group, 10% for the injection sclerosis group, and 75% for the medical-surgical group (p<0.0001 for the differences between each of the two former groups versus the latter).
The values in terms of severe ulcer rebleeding were 11% for the heater probe group, 30% for the injection sclerosis group, and 75% for the medical-surgical group (p<0.009 for the differences between each of the two former groups versus the latter; p=0.31 for the difference between the two former groups).
Clinical conclusions Endoscopic heater probe and injection sclerosis have similar efficacy for the treatment of active, arterial peptic ulcer haemorrhage, and they are both significantly more effective than the medical-surgical approach. There was a trend towards a better clinical outcome with the heater probe than with injection sclerosis.
Measure of benefits used in the economic analysis No summary benefit measure was identified in the economic analysis, and only separate clinical outcomes were reported. The study should, therefore, be considered as a cost-consequences analysis.
Direct costs The costs were not discounted due to the 30-day follow-up period considered for the cost analysis. The quantities of resource use were reported separately from the costs in terms of the duration of hospital stay and the transfusion rates of packed red blood cells. The cost items were reported separately from the costs. The cost analysis covered the following: the total cost of the hospital room, i.e. for stay in both the intensive care unit and non-intensive care unit; endoscopy; surgery; total transfusion costs for packed red blood cells, fresh frozen plasma and "pooled" platelets; and consultation. The cost analysis was conducted from a hospital perspective. The cost data were obtained from one of the study institutions' (UCLA) estimated combined fixed and variable costs for each of the procedures involved, and from the Medicare reimbursement rates for physician fees. The price year was 1995 to 1996.
Statistical analysis of costs Kruskal-Wallis nonparametric methods were used to compare the groups in terms of median costs.
Indirect Costs Indirect costs were not considered.
Sensitivity analysis No sensitivity analysis was conducted.
Estimated benefits used in the economic analysis Cost results The heater probe and injection sclerosis groups had median total direct costs of $4,153 and $5,247, respectively, versus $11,149 in the medical-surgical group (p=0.00001 for the difference between heater probe and medical-surgery, and p=0.0051 for the difference between injection sclerosis and medical-surgery).
Synthesis of costs and benefits The costs and benefits were not combined since the use of heater probe or injection sclerosis was the dominant strategy.
Authors' conclusions Heater probe and injection sclerosis are similarly efficacious treatments for active ulcer haemorrhage. Both treatments yield significantly lower direct costs of medical care and cost-savings with respect to medical-surgical treatment.
CRD COMMENTARY - Selection of comparators The rationale for the choice of comparator was likely to have been based on the fact that medical-surgical treatment is the traditional strategy used for the treatment of patients with active ulcer haemorrhage. You, as a database user, should, therefore, consider whether this is a widely used health technology in your own setting.
Validity of estimate of measure of benefit Appropriate statistical analyses were performed to assess the significance of the difference between the results of the three treatments. However, the internal validity of the effectiveness results should be judged in the light of the trade-off between the randomised design adopted and the small sample size.
Validity of estimate of costs Given the perspective of the analysis, all direct costs were included. Unit costs were based on the data and were reported in detail from reliable sources. The small sample size and the short follow-up period may have adversely affected the internal validity of the cost results.
Other issues The issue of generalisability to other settings or countries was not addressed, although appropriate comparisons were made with other studies. The authors emphasised the fact that this is one of the few published randomised controlled trials of heater probe and injection. Moreover, the study included a detailed assessment of direct costs of hospital care for endoscopic haemostasis of active ulcer using cost data and not charges. The authors pointed out some limitations of their investigation as a result of the small sample size and the short period of follow-up.
Implications of the study More accurate calculations of true cost-effectiveness need to be determined. This will require national, multicentre cooperative trials of larger numbers of patients, with a greater duration of follow-up.
Source of funding Randomised controlled trial supported by NIH-NIDDK, grant number RO1-AM33273; economic analysis partially funded by the American Society for Gastrointestinal Endoscopy via an Endoscopic Outcomes and Effectiveness Developmental Research Award (1996).
Bibliographic details Gralnek I M, Jensen D M, Kovacs T O, Jutabha R, Jensen M E, Cheng S, Gornbein J, Freeman M L, Machicado G A, Smith J, Sue M, Kominski G. An economic analysis of patients with active arterial peptic ulcer hemorrhage treated with endoscopic heater probe, injection sclerosis, or surgery in a prospective, randomized trial. Gastrointestinal Endoscopy 1997; 46(2): 105-112 Indexing Status Subject indexing assigned by NLM MeSH Aged; Cost Savings; Direct Service Costs; Double-Blind Method; Duodenal Ulcer /complications; Electrocoagulation /economics; Endoscopy, Digestive System /economics; Epinephrine /therapeutic use; Ethanol /therapeutic use; Female; Hemostasis, Endoscopic /economics /methods; Hospital Costs; Humans; Male; Middle Aged; Outcome Assessment (Health Care); Peptic Ulcer Hemorrhage /economics /therapy; Prospective Studies; Sclerosing Solutions /therapeutic use; Sclerotherapy /economics; Stomach Ulcer /complications; United States AccessionNumber 21997001239 Date bibliographic record published 28/02/2002 Date abstract record published 28/02/2002 |
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