Comparacion de la efectividad y coste de la cura en ambiente humedo frente a la cura tradicional: ensayo clinico en pacientes de atencion primaria con ulceras vasculares y por presion [A comparison of the effectiveness and cost of moist environment dressings treatment as compared to traditional dressings treatment: randomized clinical trial on patients suffering venous leg ulcers or pressure ulcers treated by primary health care nurses] Capillas Perez R, Cabre Aguilar V, Gil Colome A M, Gaitano Garcia A G, Torra i Bou J 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 use of moist environment dressings (MED) for patients with venous leg ulcers or pressure ulcers. Type of intervention Treatment. Economic study type Cost-effectiveness analysis. Study population The study population included patients suffering from venous leg ulcers or stage II to III pressure ulcers. Patients with infected wounds were excluded from the analysis. Setting The setting was primary care. The economic study was conducted in the district health authority of Hospitalet del Llobregat in Catalonia, Spain. Dates to which data relate The effectiveness and resource use data were collected from June 1996 to July 1999. No price year was reported. Source of effectiveness data The effectiveness data were derived from a single study. Link between effectiveness and cost data The costing was conducted prospectively on the same sample of patients as that used in the effectiveness analysis. Study sample An initial sample of 79 patients was included in the analysis. Nine patients were subsequently excluded due to a change in treatment (3 patients), change of residence (2 patients), and death (4 patients). The final sample comprised 70 patients. There were 41 patients with venous ulcers of which 26.8% were men. The mean age was 69.3 (+/- 9.2) years. There were 29 patients with pressure ulcers of which 89.7% were women. The mean age was 80.3 (+/- 6.6) years. In the Page: 1 / 5
group of patients with venous leg ulcers, 21 lesions were treated with MED and 20 lesions with TC. In the group of patients with pressure ulcers, 15 lesions were treated with MED and 14 with TC. Power calculations to determine the sample size were not performed. The method of sample selection was not stated. Study design This was a blind, randomised clinical trial. The patients were randomised to the study groups on the basis of the sequence of inclusion in the study. The study was carried out in the district health authority of Hospitalet del Llobregat. Four nurses attended all patients, who remained in the study until full cicatrisation of the wounds. However, the length of follow-up was not explicitly stated. The study analysts were blinded to the allocation of the patients to the study groups. Analysis of effectiveness The basis of the clinical study appears to have been treatment completers only. The primary health outcomes were: the time required to cicatrise an initial 1-cm2 wound, the percentage of surface healed daily, the nurse's time required to cicatrise an initial 1-cm2 wound, the total number of treatments required to cicatrise an initial 1-cm2 wound, and the frequency of daily treatments. The study groups were shown to be similar at baseline. Effectiveness results In the group of patients with venous leg ulcers, the median (first and third quartiles) time required to cicatrise an initial 1-cm2 wound was 18.22 (8.25-36.5) days in the MED group and 18.33 (7.54-28) days in the TC group, (p=0.593); the median percentage of surface healed daily was 1.75% (0.98-2.7) in the MED group and 1.51% (0.84-2.85) in the TC group, (p=0.958); the median nurse time required to cicatrise an initial 1-cm2 wound was 40.59 (19.73-73.81) minutes in the MED group and 175.22 (82.12-295.26) minutes in the TC group, (p<0.05); the median number of treatments required to cicatrise an initial 1-cm2 wound was 4.54 (2.81-7.91) in the MED group and 16.33 (7.54-28) in the TC group, (p<0.05); and the median frequency of treatments was every 3.52 (2.91-5.13) days in the MED group and every 1 (1-1) day in the TC group, (p<0.05). In the group of patients with pressure ulcers, the median (first and third quartiles) time required to cicatrise an initial 1-cm2 wound was 7.12 (5.33-11) days in the MED group and 12.18 (5.85-39.58) days in the TC group, (p=0.172); the median percentage of surface healed daily was 1.42% (0.56-2.5) in the MED group and 1.19% (0.59-1.55) in the TC group, (p=0.445); the median nurse time required to cicatrise an initial 1-cm2 wound was 67.5 (32.24-135) minutes in the MED group and 400 (129.9-2,041) minutes in the TC group, (p<0.018); the median number of treatments required to cicatrise an initial 1-cm2 wound was 1.86 (0.71-2.29) in the MED group and 12.1 (5.71-29.86) in the TC group, (p<0.05); and Page: 2 / 5
the median frequency of treatments was every 5 (3.46-5.86) days in the MED group and every 1 (1-1.01) day in the TC group, (p<0.05). Clinical conclusions In patients with both groups of ulcers, MED was more effective than TC in terms of the nurse's time required to cicatrise the wound and the number and frequency of treatments required. Measure of benefits used in the economic analysis The health outcomes were left disaggregated and no summary benefit measure was used in the analysis. A costconsequences analysis was therefore conducted. Direct costs The analysis of the costs included the materials required for treatment of the wounds and the nurse's time (cost per hour including salary and social security). Only the unit cost of personnel was reported. The cost/resource boundary was that of the district health authority. The costs of the materials were based on retail prices and the hourly cost of the nurses was derived from average salaries. The effectiveness and resource use data were collected from June 1996 to July 1999. No price year was reported. Discounting was irrelevant as the costs were incurred over a short period of time. Statistical analysis of costs Standard statistical analyses were conducted to test for the statistical significance of the estimated costs. Indirect Costs The indirect costs were not included. Currency Spanish pesetas (Pta). Sensitivity analysis No sensitivity analysis was conducted. Estimated benefits used in the economic analysis See the 'Effectiveness Results' section. Cost results In the group of patients with leg venous ulcers, the median (first and third percentiles) cost of the cicatrisation of an initial 1-cm2 wound was Pta 2,409 (1,396-4,897) with MED and Pta 10,616 (5,903-18,227) with TC; the nurse's time for the cicatrisation of an initial 1-cm2 wound cost Pta 1,489 (723-2,707) with MED and Pta 6,427 (3,012-10,830) with TC; and the materials for the cicatrisation of an initial 1-cm2 wound cost Pta 791 (561-1,797) with MED and Pta 3,465 (2,499-7,548) with TC. In the group of patients with pressure ulcers, the median (first and third percentiles) cost of the cicatrisation of an initial 1-cm2 wound was Pta 4,388 (1,808-7,539) with MED and Pta 17,983 (6,521-87,798) with TC; Page: 3 / 5
the nurse's time for the cicatrisation of an initial 1-cm2 wound cost Pta 2,610 (1,247-5,221) with MED and Pta 15,490 (5,027-78,971) with TC; and the materials for the cicatrisation of an initial 1-cm2 wound cost Pta 1,230 (338-2,754) with MED and Pta 2,619 (1,351-12,086) with TC. All of the differences in the costs between the patients in the MED and the TC groups were statistically significant. Synthesis of costs and benefits Not relevant as a cost-consequences analysis was conducted. Authors' conclusions Moist environment dressings (MED) proved to be more effective in almost all of the outcome measures used in the analysis. In addition, they were generally cheaper than traditional care (TC) for patients with pressure ulcers and venous leg ulcers in a primary care setting in Spain. CRD COMMENTARY - Selection of comparators TC was selected as the comparator since it represented the standard treatment for patients with venous leg ulcers or pressure ulcers. You should decide if it represents a routine treatment in your own setting. Validity of estimate of measure of effectiveness The internal validity of the study was high as a randomised controlled trial was used to assess the effectiveness, although the clinical analysis was conducted on the basis of treatment completers only. The study groups were shown to be comparable at baseline, and the study sample appears to have been representative of the study population. Power calculations were not performed. The method of randomisation was reported. The authors conducted two separate analyses as two distinct study populations of patients were considered. Validity of estimate of measure of benefit No summary benefit measure was used in the economic analysis. The analysis was therefore categorised as a costconsequences study. Validity of estimate of costs It appears that all the relevant categories of costs have been included in the analysis. The unit costs were only reported for personnel. Discounting was not applied since it was irrelevant. No sensitivity analyses were conducted on the costs, which were specific to the study setting. No price year was reported, thus limiting the possibility of reflating the costs in another setting. No indirect costs were included in the analysis, although their impact may have been of some importance in the economic analysis. Other issues The authors compared their findings with those from other studies. However, they did not address the issue of the generalisability of the study results to other settings. Sensitivity analyses were not conducted. The study considered patients with pressure ulcers and venous leg ulcers and this was reflected in the conclusions of the analysis. Implications of the study The authors highlighted that the reduced time required to cicatrise with MED in comparison with TC was an important variable, as it implies that the quality of life of both patients and their caregivers may improve and care resources may be minor. However, the authors noted that the different products available for the MED-based treatment may vary in Page: 4 / 5
Powered by TCPDF (www.tcpdf.org) their efficacy. Source of funding None stated. Bibliographic details Capillas Perez R, Cabre Aguilar V, Gil Colome A M, Gaitano Garcia A G, Torra i Bou J. Comparacion de la efectividad y coste de la cura en ambiente humedo frente a la cura tradicional: ensayo clinico en pacientes de atencion primaria con ulceras vasculares y por presion. [A comparison of the effectiveness and cost of moist environment dressings treatment as compared to traditional dressings treatment: randomized clinical trial on patients suffering venous leg ulcers or pressure ulcers treated by primary health care nurses] Revista ROL de Enfermera 2000; 23(1): 17-24 Indexing Status Subject indexing assigned by NLM MeSH Chronic Disease; Comparative Study; English Abstract; Humans; Humidity; Leg Ulcer /nursing /physiopathology; Occlusive Dressings /economics /standards; Pressure Ulcer /nursing /physiopathology; Primary Health Care /methods; Treatment Outcome; Wound Healing AccessionNumber 22000007526 Date bibliographic record published 31/05/2003 Date abstract record published 31/05/2003 Page: 5 / 5