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ICVTS on-line discussion A Cost-benefit success rates are mandatory for SCS

University Hospital Sestre Milosrdnice, Zagreb 10000, Croatia

Spinal cord stimulation for lower limb ischemic pain treatment

eComment: In the discussion section of the article on spinal cord stimulation (SCS) for critical limb ischemia (CLI) by Pedrini et al. [1], the authors point out the problem of the high cost of SCS treatment compared with best medical treatment (BMT). In the article by Klomp et al. [2], cited by authors, the authors concluded that a treatment regimen of BMT and SCS was no more effective than BMT treatment alone in preventing amputations in patients with critical limb ischemia and was more expensive. But this study has some limitations in estimation of costs. For example, quantities were not reported separately from the costs and insufficient details of the methods of cost estimation were provided. Results may not be generalisable to other settings or countries, although comparisons were made with other studies. That is the main reason that the conclusion stated by the authors, and recently suggested by some other authors, that the repeat prostanoid treatment reduces the difference of cost between the SCS and BMT is not free of charge. It must be stated that in the recent studies conducted to assess clinical and economic implications of SCS compared to BMT, readers could find some limitations:

1. The perspective from which the studies were conducted was not stated;
   
2. The choice of the comparator was made to reflect patients in a steady state;
   
3. There were no comparisons with an alternative strategy;
   
4. The basis of the analysis of effectiveness was a within-group comparison, which was not appropriate for the external comparison;
   
5. Blinding was not conducted and presumably would not have been feasible due to the nature of the intervention;
   
6. It was unclear whether the studies' samples were representative of the studies' populations;
   
7. Power calculations were not performed and there was no evidence that the samples were appropriate;
   
8. It is unclear whether all the relevant categories of costs were considered;
   
9. The sources of the cost data were not provided;
   
10. The costs were treated deterministically and were specific to the study setting since no statistical tests were conducted.
    

Therefore, the external validity of the analysis was low. The studies referred to the general group of patients suffering from CLI and this was reflected in the author's conclusion. Moreover, the complications have to be explicitly incorporated in the probabilistic model, although, of course, patient choice (SCS vs. BMT) is a separate matter and should be taken into consideration before taking a decision.

It is clear that all mentioned circumstances underlines the need for continued quality improvement efforts to provide valid and timely measures of SCS and/or BMT.

	References

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1. Pedrini L, Magnoni F. Spinal cord stimulation for lower limb ischemic pain treatment. Interact CardioVasc Thorac Surg 2007; 6:495–500.[Abstract/Free Full Text]
2. Klomp HM, Spincemaille GHJJ, Steyerberger EW, Habbema JDF, van Urk H. NHS Economic Evaluation Database (NHS EED) – Short record display. Lancet 1999; 353:1040–1044.[CrossRef][Medline]

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