Articles: outcome-assessment-health-care.
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 spinal muscular atrophy: a randomised, double-blind, placebo-controlled phase 2 trial.
Spinal muscular atrophy (SMA) is a progressive motor neuron disease causing loss of motor function and reduced life expectancy, for which limited treatment is available. We investigated the safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 SMA. ⋯ AFM Téléthon and Trophos SA.
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Randomized Controlled Trial
Subcutaneous Injection of Triamcinolone and Lidocaine to Prevent Postherpetic Neuralgia.
Herpes zoster (HZ) is associated with inflammation of the peripheral nerves, which is considered to be an important cause of postherpetic neuralgia (PHN). Interventions aimed at reducing this inflammation could prevent PHN. One option is the epidural administration of corticosteroid and local anesthetic. However, several authors have reported a risk of arachnoiditis with epidural corticosteroids. Subcutaneous injection in an outpatient setting is a safer option. However, there is limited evidence of the effectiveness of this alternative for preventing PHN. ⋯ Subcutaneous injection, lidocaine, triamcinolone, postherpetic neuralgia, prevention.
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Randomized Controlled Trial
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population. We aimed to substantiate this post-hoc result and assess safety and efficacy of edaravone in a phase 3 trial that focused on patients with early stage ALS who met the post-hoc analysis inclusion criteria. ⋯ Mitsubishi Tanabe Pharma Corporation.
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Randomized Controlled Trial Comparative Study
Cost-utility of Group Acceptance and Commitment Therapy for Fibromyalgia versus recommended drugs: An economic analysis alongside a 6-month randomised controlled trial conducted in Spain (EFFIGACT study).
The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. ⋯ Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM.
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Randomized Controlled Trial
Normal saline versus balanced-salt solution as intravenous fluid therapy during neurosurgery: Effects on acid-base balance and electrolytes.
This prospective, randomized controlled study compared the changes in acid-base balance and serum electrolytes with the use of intravenous balanced and non-balanced crystalloid solutions intraoperatively during elective neurosurgery. ⋯ A balanced solution (Sterofundin®ISO) provided significantly better control over acid-base balance, sodium and chloride levels when used as intraoperative fluid maintenance and replacement during elective neurosurgery.