The two main criteria are failure of or unacceptable side-effects from conventional therapy such as oral or subcutaneous opioids. A number of screening tests and trials of intrathecal therapy are used prior to actual pump implantation. Some information from cost modelling and projections may indicate that the cost of this treatment is comparable or advantageous when compared with existing therapies, but this depends on individual patient circumstances. This non-random sample contrasted with the generally positive reports in the published literature. No randomised, controlled or comparator data were found while carrying out this review.
All information is therefore suboptimal.
These variables make analysis very difficult. However, such data as are available indicate a generally positive effect of the therapy, with side-effects and complications occurring in about a quarter of the recipients, but it is difficult to draw definite conclusions because the quality of the data is so poor. The opinions from UK experts were not of such an overwhelmingly positive nature as the published reports. A database or registry of intrathecal pump usage needs to be established to gather basic information collected when utilising standardised outcome measures for pumps used in patients in the second category, in whom randomisation may be inappropriate. The HTA Programme will continue to commission both primary and secondary research.