Validation of the Behavioural Observation Scale 3 for the evaluation of pain in adults.

BACKGROUND: Many behavioural scales are available to assess pain but none are suitable for a quick evaluation of non-sedated and non-geriatric adults. The Behavioural Observation Scale 3 (BOS-3) is short, composed of five items. This study examined its feasibility and diagnostic performances. METHODS: Adult patients were included from medical and surgical departments of the University Hospital of Bordeaux. In a cross-sectional study, BOS-3 was compared to Numerical Rate Scale (NRS) with communicating patients (CP) and Behavioural Scale for the Elderly Person (ECPA2) with non-communicating patients (NCP). Each time, BOS-3 and reference scale were performed by an internal caregiver and an external expert. RESULTS: We included 447 patients: 395 communicating and 52 non-communicating. All patients were assessed by the BOS-3 and the reference test. All BOS-3 were carried out in less than one minute with only four missing data. Its reproducibility (ICC = 0.77 [95% CI 0.73-0.81] with CP and 0.93 [95% CI 0.89-0.97] with NCP) and its internal consistency (Cronbach α = 0.67 with CP and 0.70 with NCP) were good. In non-communicating patients, ROC analysis set a threshold at 3 on 10. Sensitivity was 0.87 [95% CI 0.77-0.96], specificity 0.97 [95% CI 0.93-1.00], positive predictive value 0.93 [95% CI 0.86-0.99] and negative predictive value 0.95 [95% CI 0.89-1.00]. In communicating patients, sensitivity decreased to 0.34 [95% CI 0.28-0.38] but specificity reached 0.96 [95% CI 0.94-0.98] and positive predictive value 0.75 [95% CI 0.70-0.79]. CONCLUSIONS: BOS-3 had good metrological properties in non-communicating adults. With communicating patients, a positive BOS-3 could be an additional tool to confirm pain, when underestimated on the NRS. SIGNIFICANCE: This study describes the diagnostic performances of a behavioral pain assessment scale designed for non-geriatric and non-sedated adults. The results show its validity in non-communicating patients and suggest its usefulness as an ancillary tool in communicating patients in whom simple numerical scales are often insufficient.

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).

BACKGROUND: Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. MATERIALS AND METHODS: FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. TRIAL STATUS: Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015. TRIAL REGISTRATION: Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237.