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Intraoperative ultrasound is associated with clear lumpectomy margins for palpable infiltrating ductal breast cancer |
Moore M M, Whitney L A, Cerilli L, Imbrie J Z, Bunch M, Simpson V B, Hanks J B |
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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 examined was intraoperative ultrasound-guided surgery (IOUS) used for women undergoing lumpectomy for palpable breast cancer. Lumpectomy without intraoperative ultrasound was explicitly stated as the comparator.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised women undergoing lumpectomy for biopsy-proven infiltrating ductal carcinoma of the breast, stage T1 and T2. Only patients who had undergone preoperative core biopsy were eligible.
Setting The setting was secondary care. The economic study was conducted in Charlottesville, Virginia, USA.
Dates to which data relate Effectiveness data were collected between 1 December 1998 and 15 October 2000. Resource years and price years were not stated.
Source of effectiveness data Effectiveness data were derived from a single study.
Link between effectiveness and cost data Costing was undertaken prospectively on the same patient sample as that used in the effectiveness analysis.
Study sample 51 women with breast cancer undergoing lumpectomy for biopsy-proven infiltrating ductal carcinoma of the breast, stage T1 and T2, were recruited for the study and were randomised to undergo IOUS (n=27) or standard surgical excision without ultrasound (n=24). Power calculations related to the sample size were not reported. Baseline characteristics, such as age, and family history were reported to allow comparisons with the study population.
Study design This was a randomised, single-centre, prospective study. Duration of follow-up was not stated.
Analysis of effectiveness The analysis of effectiveness was based on intention to treat. The main health outcomes used in the analysis were surgical accuracy, quantified as the mass of uninvolved breast tissue and margin status, and patient satisfaction with the cosmetic result assessed on a scale of 1-5. Groups were shown to be comparable at analysis in terms of age, family history of breast cancer and tumour stage.
Effectiveness results One (3.5%) of the 27 patients in the IOUS group had a positive margin, compared to 7 (29%) in the conservative surgery group, (p<0.05).
The margin of uninvolved breast tissue was also greater in the IOUS groups compared with the conventional surgery one (7.6 +/- 2mm versus 4.8 +/- 1.4 mm).
Satisfaction with the cosmetic aspect of surgery was equivalent between groups, with 25 of the 27 patients in the IOUS group and 24 and 22 of 24 patients in the conventional surgery group rating the cosmetic outcome at 4 or 5 on a 5-point scale.
Clinical conclusions Surgical accuracy and margin status were improved by using ultrasound-guided surgery. Patient satisfaction was equivalent for IOUS and the conventional surgery. Overall, patients with dense breasts had an increased volume of surgically removed tissue compared to patients with normal breast density, but statistical significance was not reached in either group when this indicator was used.
Measure of benefits used in the economic analysis The authors did not provide a summary measure of benefits. As such, a cost-consequences analysis was conducted and the user is referred to the effectiveness results reported above.
Direct costs Direct hospital costs, such as surgical costs and cost of reexcision, were considered in the analysis. Quantities and costs were not discounted due to the short duration of the study. Also, quantities and costs were not presented separately. Although it is not very clear, it appears that costs data were derived from the authors' setting. The years to which costs and price relate were not reported.
Statistical analysis of costs Data were compared between groups using standard statistical evaluations for means and standard error. Analysis of variance calculations were used and analysis was performed using SPSS-MAC (SPSS Inc, Chicago, IL), with p<0.05 signifying statistical significance.
Indirect Costs Indirect costs were not considered in the analysis.
Sensitivity analysis A sensitivity analysis was not conducted.
Estimated benefits used in the economic analysis The authors did not provide a summary measure of benefits, therefore this study was categorised as a cost-consequences analysis.
Cost results Surgical cost (mean values +/- SD) was $2,191 (+/- 752) for ultrasound and $2,238 (+/- 777) for the conventional procedure.
The average cost for reexcision was $1,778 (+/- 688) per case.
Synthesis of costs and benefits A synthesis of costs and benefits was not conducted due to the cost-consequences approach adopted in the analysis.
Authors' conclusions The authors concluded that the use of ultrasound-guided surgery optimises the surgeon's ability to obtain satisfactory margins for breast-conserving techniques in patients with breast cancer. Patient satisfaction is excellent and cost-savings are most likely realised.
CRD COMMENTARY - Selection of comparators The reason for the choice of the comparators was clear, as both IOUS and conventional breast surgery for palpable ductal cancer were used in the authors' setting. You, as a database user, should consider if this applies to your own setting.
Validity of estimate of measure of effectiveness The analysis was based on a randomised, single-centre, prospective trial that was appropriate for the study question. The study sample seemed to be representative of the study population, with baseline characteristics being presented, but no power calculations were reported to have been used in determining the sample size. Patient groups were shown to be comparable in their baseline characteristics. Appropriate statistical analyses were undertaken on the effectiveness data.
Validity of estimate of measure of benefit The authors did not provide a summary measure of benefits. The analysis was therefore categorised as a cost-consequences study and health benefits are associated with the effectiveness results.
Validity of estimate of costs Cost components were not reported in detail, so it is difficult to judge whether important items were omitted. Costs and quantities were not reported separately. Costs, appropriately, were not discounted due to the short duration of the study. Appropriate statistical analyses were conducted on costs, although no p values were provided to indicate if differences in cost results reached statistical significance. However, a comparison of total costs per treatment alternative was not carried out, making the evidence provided insufficient to make judgements on cost-effectiveness, given the presence of uncertainty.
Other issues Extensive comparisons were conducted with relevant studies dealing with the same topic. The issue of the generalisability of costs was not addressed, there being no sensitivity analysis. The authors did not appear to present their results selectively, although they did not provide an analysis of total costs.
Implications of the study The authors stated that if further studies confirm their conclusion that ultrasound-guide surgery decreases the need for second surgery, IOUS might result in less expensive surgery combined with increased patient satisfaction and reduced emotional turmoil.
Bibliographic details Moore M M, Whitney L A, Cerilli L, Imbrie J Z, Bunch M, Simpson V B, Hanks J B. Intraoperative ultrasound is associated with clear lumpectomy margins for palpable infiltrating ductal breast cancer. Annals of Surgery 2001; 233(6): 761-768 Other publications of related interest Harlow SP et al Intraoperative ultrasound localisation to guide surgical excision of non-palpable breast carcinoma. Journal of the American College of Surgeons 1999;189:241-246.
Indexing Status Subject indexing assigned by NLM MeSH Breast Neoplasms /pathology /surgery /ultrasonography; Carcinoma, Ductal, Breast /pathology /surgery /ultrasonography; Endosonography; Female; Humans; Mastectomy, Segmental /methods; Monitoring, Intraoperative; Neoplasm Staging; Palpation; Patient Satisfaction; Reoperation AccessionNumber 22001001242 Date bibliographic record published 31/10/2002 Date abstract record published 31/10/2002 |
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