The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.
Neuromodulation
; 19(1): 60-70, 2016 Jan.
Article
em En
| MEDLINE
| ID: mdl-26387883
ABSTRACT
BACKGROUND:
Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS 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 SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting.METHODS:
RA patients deemed suitable were randomized in a 11 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization.RESULTS:
We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants 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 SCS group.CONCLUSIONS:
While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Resultado do Tratamento
/
Análise Custo-Benefício
/
Estimulação da Medula Espinal
/
Angina Pectoris
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article