The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for XXXX (RASCAL Study): A Pilot Randomized Controlled Trial.

@entity1 @entity9462 @entity602 @entity5749 @entity951
BACKGROUND: @entity1 with " @entity951 " ( @entity951 ) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown @entity602 ( @entity602 ) to be a promising treatment for @entity5749 and @entity951 ; however, none has compared @entity602 with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of @entity602 in @entity951 @entity1 , i.e., recruitment and retention of @entity1 , burden of outcome measures, our ability to standardize UC in a UK @entity9462 setting. METHODS: @entity951 @entity1 deemed suitable were randomized in a 1:1 ratio to @entity602 plus UC ( @entity602 group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of @entity1 ; feasibility and acceptability of @entity602 treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. @entity1 outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. RESULTS: We failed to meet our planned recruitment target (45 @entity1 ) and randomized 29 @entity1 (15 @entity602 group, 14 UC group) over a 42-month period across four sites. None of the study @entity1 chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the @entity602 group. CONCLUSIONS: While @entity1 recruitment was found to be challenging, levels of @entity1 retention, outcome completion, and acceptability of @entity602 therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial.
