Setting The setting was community. The economic study was carried out in Madrid, Spain.

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1 Analisis coste-efectividad del tratamiento de la hiperplasia prostatica benigna de grado moderado [Cost-effectiveness analysis of the treatment of moderate benign prostatic hyperplasia] Meseguer Barros C M, Fidalgo Garcia M L, Rubio Cebrian S 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 Three treatment strategies for patients suffering from moderate benign prostatic hyperplasia (MBPH) were analysed: watchful waiting (reducing liquids before sleeping, no coffee or alcohol before sleeping, avoiding diuretics or antidepressants); pharmacological treatment with doxazosin (2 mg daily as initial treatment and 4 mg daily as maintenance treatment) as first-line therapy and with finasteride (5 mg daily) as second-line treatment; and transurethral resection of the prostate (TURP). Type of intervention Treatment. Economic study type Cost-effectiveness analysis. Study population The study population comprised patients suffering from MBPH, according to the classification of the symptom scale of the American Association of Urology (score between 8 and 18 points on the basis of a questionnaire filled in by the patient). Setting The setting was community. The economic study was carried out in Madrid, Spain. Dates to which data relate The effectiveness evidence was derived from data obtained in No dates for resources were reported. The price year was Source of effectiveness data The effectiveness evidence was derived from a review of the literature and from experts' opinion. Modelling A decision tree model was constructed to assess costs and effectiveness of the three treatments over a time horizon of two years. A hypothetical cohort of 1,000 eligible patients was considered. If there was no response to a treatment, the patients were switched to the next treatment, which was pharmacological therapy after watchful waiting and TURP after pharmacological treatment, until the patient improved. Adverse events related to the pharmacological therapy were not considered as they did not result in additional costs and consisted of a switch to an alternative drug. On the contrary, adverse effects of TURP were included in the model, as they appeared to be quite severe and expensive. Page: 1 / 5

2 Outcomes assessed in the review The outcomes assessed in the review were the effectiveness rates of watchful waiting and pharmacological treatment, considered as clinical improvement and based on a 3-point reduction in the symptom scale of the American Association of Urology. Study designs and other criteria for inclusion in the review Sources searched to identify primary studies Criteria used to ensure the validity of primary studies Methods used to judge relevance and validity, and for extracting data Number of primary studies included Several studies were used to construct the decision model, but a single published study was used to derive the effectiveness evidence. Methods of combining primary studies Not relevant. Investigation of differences between primary studies Not relevant. Results of the review The effectiveness rate (90% confidence interval) of watchful waiting ranged from 31% to 55%, while the effectiveness rate of pharmacological treatment ranged from 59% to 86% for doxazosin and from 54% to 78% for finasteride. Methods used to derive estimates of effectiveness Experts' opinions were used to derive the effectiveness rate of TURP, using a structured questionnaire. Estimates of effectiveness and key assumptions The effectiveness rate of TURP ranged from 77.5% to 80.0% for improvement without complications and from 75% to 85% for improvement with complications. Measure of benefits used in the economic analysis The benefit measure was the percentage of patients experiencing clinical improvement after two years, which was obtained from the decision model. A 3% discount rate was used. Page: 2 / 5

3 Direct costs The costs included in the analysis referred to costs of the pharmacological treatment with doxazosin and finasteride, costs of TURP, and costs of physician visits. Unit costs and quantities of resources used were reported separately. Costs related to the diagnostic assessment of the disease were not included as they were similar for all treatments. The estimation of the cost of TURP was based on actual data derived from a Spanish hospital on the basis of the DRG system. The source of other costs was not stated. Discounting was carried out, although the time frame of the study was only two years. The price year was Statistical analysis of costs No statistical analysis of costs was carried out. Indirect Costs Indirect costs were not included. Currency Spanish pesetas (Pta). Sensitivity analysis One-way sensitivity analyses were carried out to assess the impact of variations of effectiveness rates of both watchful waiting and pharmacological treatment and costs of both TURP and pharmacological treatment on the estimated costeffectiveness ratios. For the effectiveness rates, 90% confidence intervals were used, while for the costs, a +/-20% variation was carried out. Estimated benefits used in the economic analysis The overall effectiveness rate was 94.2% for watchful waiting, 92.0% for pharmacological treatment, and 76.6% for TURP. Cost results Total costs for each strategy were not reported. Synthesis of costs and benefits Costs and benefits were combined by performing an average cost-effectiveness analysis. The cost per improved patient was Pta 72,300 with watchful waiting, Pta 109,564 with pharmacological treatment, and Pta 349,557 with TURP. The cost-effectiveness of watchful waiting was robust to variations carried out in the sensitivity analyses. Authors' conclusions The authors concluded that watchful waiting represented the most cost-effective strategy for the management of patients with MBPH. CRD COMMENTARY - Selection of comparators The authors stated that the three treatments analysed in the study represented strategies currently used in the management of patients with MBPH and that they were widely discussed in the literature. You, as a user of this database, should determine whether they are treatments implemented in your own setting. Page: 3 / 5

4 Validity of estimate of measure of effectiveness The benefit measure was mainly derived from a single study, which was based on American experts' data. A review of the literature was not carried out. Further data were obtained from a questionnaire compiled by other experts. To overcome the problems related to the data obtained from these sources, sensitivity analyses were carried out on some effectiveness estimates. Validity of estimate of measure of benefit The benefit measure, represented by the number of improved patients was obtained from the decision model. The authors stated that quality-of-life issues were not considered, due to the lack of such data in the available literature. Validity of estimate of costs It appears that all costs relevant to the perspective adopted in the study were included in the analysis. Some costs were not included as they were common to the three strategies. The price year was reported and discounting was carried out. The authors stated that the inclusion of indirect costs would not have changed the study results. Other issues The authors made some comparisons of their findings with those from other studies but the generalisability of the study results to other settings and contexts was limited as few sensitivity analyses were carried out. However, unit costs and quantities of resources were reported separately. The study considered patients' suffering from MBPH and this was reflected in the authors' conclusions. The authors did not present the study results in detail, especially as regards costs. Implications of the study The authors suggested that the study results should be used to support decision-making at different levels of health care. Further studies with a longer follow-up period should be carried out. Source of funding None stated. Bibliographic details Meseguer Barros C M, Fidalgo Garcia M L, Rubio Cebrian S. Analisis coste-efectividad del tratamiento de la hiperplasia prostatica benigna de grado moderado. [Cost-effectiveness analysis of the treatment of moderate benign prostatic hyperplasia] Atencion Primaria 2000; 25(8): PubMedID Indexing Status Subject indexing assigned by NLM MeSH Cost-Benefit Analysis; Decision Trees; Health Care Costs; Humans; Male; Prostatic Hyperplasia /economics /therapy; Severity of Illness Index AccessionNumber Date bibliographic record published 30/11/2002 Page: 4 / 5

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