Articles: outcome-assessment-health-care.
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Randomized Controlled Trial
Effect of high-dose simvastatin on cognitive, neuropsychiatric, and health-related quality-of-life measures in secondary progressive multiple sclerosis: secondary analyses from the MS-STAT randomised, placebo-controlled trial.
In the 24-month MS-STAT phase 2 trial, we showed that high-dose simvastatin significantly reduced the annualised rate of whole brain atrophy in patients with secondary progressive multiple sclerosis (SPMS). We now describe the results of the MS-STAT cognitive substudy, in which we investigated the treatment effect on cognitive, neuropsychiatric, and health-related quality-of-life (HRQoL) outcome measures. ⋯ The Moulton Foundation, the Berkeley Foundation, the Multiple Sclerosis Trials Collaboration, the Rosetrees Trust, a personal contribution from A W Pidgley CBE, and the National Institute for Health Research University College London Hospitals Biomedical Research Centre and University College London.
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J Am Acad Child Adolesc Psychiatry · Aug 2017
Randomized Controlled TrialEstablishing Clinical Cutoffs for Response and Remission on the Screen for Child Anxiety Related Emotional Disorders (SCARED).
To determine optimal percent reduction and raw score cutoffs on the parent- and child-report Screen for Child Anxiety Related Emotional Disorders (SCARED) for predicting treatment response and remission among youth with anxiety disorders. ⋯ Results serve as guidelines for operationalizing treatment response and remission on the SCARED, which could help clinicians systematically monitor treatment outcomes of youth with anxiety disorders in a cost- and time-efficient manner. Clinical trial registration information-Child and Adolescent Anxiety Disorders (CAMS); http://clinicaltrials.gov/; NCT00052078.
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J. Med. Internet Res. · Jul 2017
Randomized Controlled Trial Multicenter StudyMy Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.
The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. ⋯ The results of this study show that implementation of Loop was feasible. It provides useful information for planning future studies further examining effectiveness and team collaboration. Numerically higher scores were observed for the Loop arm relative to the control arm with respect to continuity of care. Future work is required to understand the incentives and barriers to participation so that the implementation of tools like Loop can be optimized.
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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
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.