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.

Fluconazole compared with endoscopy for Human Immunodeficiency Virus (HIV)-infected patients.

Treatment.

Cost-effectiveness analysis.

HIV-infected patients with esophageal symptoms. No further details were given.

Hospital. The economic study was carried out in Atlanta, Georgia, USA.

The main effectiveness data were taken from a clinical trial conducted in the period 1990-94. Resource and cost data were mainly derived from data collection forms. The price year was not stated.

Estimates of fluconazole efficacy, and endoscopic findings responding to empirical antifungal therapy,were derived from a single randomized trial.

The costing was undertaken prospectively on the same patient sample as that used in the economic study.

A cohort of 134 HIV-infected patients with esophageal symptoms. The patients were randomized prospectively to groups receiving either standard doses of fluconazole or endoscopy. The patients in the fluconazole group (68) had a mean age of 34.0 (+/- 5.7) years (P=0.095), 85.3% were male (P=0.444), 48.5 were homosexual of bisexual (P=0.287), 27.9% were intravenous drug users (P=0.776) and 44.1% were AIDS carriers (P=0.463). The patients in the endoscopy group (66) had a mean age of 35.9 (+/- 7.7) years (P=0.095), 80.3% were male(P=0.444), 39.4% were homosexual or bisexual (P=0.287), 25.8% were intravenous drug users (P=0.776) and 37.9% were AIDS carriers (P=0.463). Power calculations to determine the sample size were not given.

The study was a randomized controlled trial. The duration of the follow-up was 53 months. The loss to follow-up was onepatient from the endoscopy group (the patient failed to return for the final procedure and could not be contacted).

The analysis of the clinical study was based on treatment completers only. The primary health outcomes used in the analysis were estimates of fluconazole efficacy and endoscopic findings responding to empirical antifungal therapy.

Of 68 patients in the fluconazole group, 82% were estimated to have a complete resolution within the first week of therapy and 12 patients were estimated to have no response. Of the patients with no response, 10 were estimated to have esophageal ulcers. Of 65 patients in the endoscopy group, 65% were estimated to have Candida esophagitis, 15% esophageal ulcer and 14% both Candida esophagitis and esophageal ulcer. Patients responding to empirical antifungal therapy, or who had Candida esophagitis alone at endoscopy, were less likely to have severe symptoms (P=0.027) or odynophagia as the only symptom (P<0.001), but more frequently had odynophagia and dysphagia (P=0.007) and thrush (P=0.002).

Empirical oral antifungal therapy with fluconazole is highly efficacious and safe for HIV-infected patients with new-onset esophageal symptoms.

The authors did not derive a summary benefit measure and as such the benefits are assumed to be equal to the effectiveness measures.

The costs of fluconazole therapy and endoscopy were included in the analysis. Quantities were analysed separately from costs. Discounting was not applied. The quantity/cost boundary adopted was the hospital. The price date was not stated.

US dollars ($).

No sensitivity analysis was reported.

Of 68 patients in the fluconazole group, 82% were estimated to have a complete resolution within the first week of therapy and 12 patients were estimated to have no response. Of the patients with no response, 10 were estimated to have esophageal ulcer. Of 65 patients in the endoscopy group, 65% were estimated to have Candida esophagitis, 15% esophageal ulcer and 14% both Candida esophagitis and esophageal ulcer. Patients responding to empirical antifungal therapy, or who had Candida esophagitis alone at endoscopy, were less likely to have severe symptoms (P=0.027) or odynophagia as the only symptom (P<0.001), but more frequently had odynophagia and dysphagia (P=0.007) and thrush (P=0.002).

The fluconazole therapy was estimated to have an average saving of $738.16 per patient. The average cost per patient in the endoscopy group was estimated to be $977.77 compared with $239.61 in the fluconazole group (P<0.0001).

A synthesis of the estimated benefits and costs was not given. No incremental analysis wasperformed.

Empirical oral antifungal therapy with fluconazole is highly efficacious, safe and cost-effective for HIV-infected patients with new-onset esophageal symptoms.

The reason for the choice of comparator is clear. Empirical antifungal treatment has been recommended for HIV-infected patients with new-onset esophageal symptoms, reserving endoscopy for those in whom empirical therapy fails. You, as a user of this database, should consider whether these are widely used health technologies in your own setting.

The estimate of measure of benefit used in the economic analysis is likely to be internally valid. The data have not been used selectively to assess the safety and cost/effectiveness of fluconazole.

Adequate details of methods of quantity/cost estimation were not given. Important cost items do not appear to have been omitted.

The authors' conclusionswere justified, given the uncertainties in the data. The issue of generalisability to other settings or countries was not addressed although appropriate comparisons were made with other studies. The results do not appear to have been presented selectively.

Further research is needed to include in the study population patients who had previously been using oral-systemic agents on a long-term basis, and patients with a prior history of esophageal disease and being unable to eat.

None stated.