Articles: outcome-assessment-health-care.
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Randomized Controlled Trial Comparative Study
Comparison of self-reported knee injury and osteoarthritis outcome score to performance measures in patients after total knee arthroplasty.
To characterize patient outcomes after total knee arthroplasty (TKA) by (1) examining changes in self-report measures (Knee Injury and Osteoarthritis Outcome Score [KOOS]) and performance measures over the first 6 months after TKA, (2) evaluating correlations between changes in KOOS self-report function (activities of daily living [ADL] subscale) and functional performance (6-minute walk [6MW]), and (3) exploring how changes in pain correlate with KOOS ADL and 6MW outcomes. ⋯ Patient self-report by using the KOOS did not reflect the magnitude of performance deficits present after surgery, especially 1 month after TKA. Self-report KOOS outcomes closely paralleled pain relief after surgery, whereas performance measures were not correlated with pain. These results emphasize the importance of including performance measures when tracking recovery after TKA as opposed to solely relying on self-reported measures.
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Randomized Controlled Trial
Annual high-dose vitamin D3 and mental well-being: randomised controlled trial.
Epidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking. ⋯ The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D(3) is a practical intervention to prevent depressive symptoms in older community-dwelling women.
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Health Technol Assess · Mar 2011
Randomized Controlled Trial Multicenter StudyVenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers.
To compare the clinical effectiveness and cost-effectiveness of low-dose ultrasound delivered in conjunction with standard care against standard care alone in the treatment of hard-to-heal venous ulcers. ⋯ Low-dose ultrasound, delivered weekly during dressing changes, added to the package of current best practice (dressings, compression therapy) did not increase ulcer healing rates, affect quality of life (QoL) or reduce recurrence. It was associated with higher costs and more adverse events. There is no evidence that adding low-dose ultrasound to standard care for 'hard-to-heal' ulcers aids healing, improves QoL or reduces recurrence. It increases costs and adverse events. The relationship between ulcer healing rates and patient recruitment is worthy of further study.
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Randomized Controlled Trial
Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials.
Due to resource limitations, few critical care interventions have been rigorously evaluated with adequately powered randomized clinical trials (RCTs). There is a need to improve the efficiency of RCTs in critical care so that more definitive high quality RCTs can be completed with the available resources. The objective of this study was to validate and demonstrate the utility of a novel composite outcome measure, persistent organ dysfunction (POD) plus death, for clinical trials of critically ill patients. ⋯ POD + death may be a valid composite outcome measure and compared to mortality endpoints, may reduce the sample size requirements of clinical trials of critically ill patients. Further validation in larger clinical trials is required.
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Health Qual Life Out · Oct 2010
Randomized Controlled TrialInterpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS).
The PRIMUS is a Multiple Sclerosis (MS)-specific suite of outcome measures including assessments of QoL (PRIMUS QoL, scored 0-22) and activity limitations (PRIMUS Activities, scored 0-30). The U-FIS is a measure of fatigue impact (scored 0-66). These measures have been fully validated previously using an MS sample with mixed diagnoses. The aim of the present study was to validate the measures further in a specifically Relapse Remitting MS (RRMS) sample and to provide preliminary evidence of the responder definitions (RD; also known as minimal important difference) for these instruments. ⋯ The results show that the PRIMUS and U-FIS are valid instruments for use with RRMS patients. The analyses provide preliminary information on how to interpret scores on the scales. These data will be useful for assessing treatment efficacy and for powering clinical studies. TRIAL REFERENCE NUMBER: ClinicalTrials.gov Identifier NCT00340834.