Plos One
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Randomized Controlled Trial
Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies.
To evaluate the effects of study participation per se at the beginning of a sleep extension trial between screening, randomization, and the run-in visit. ⋯ Improvements in biochemical and behavioral parameters between screening and randomization changed the "true" study baseline, thereby potentially affecting outcome. While regression to the mean and placebo effect were considered, these findings are most consistent with the "Hawthorne effect", according to which behavior measured in the setting of an experimental study changes in response to the attention received from study investigators. This is the first time that biochemical changes were documented with respect to the Hawthorne effect. The findings have implications for the design and conduct of clinical research.
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Randomized Controlled Trial
Effects of 1-year intervention with a Mediterranean diet on plasma fatty acid composition and metabolic syndrome in a population at high cardiovascular risk.
Metabolic syndrome (MetS) has become an important public concern due to its increasing prevalence. An altered fatty acid composition has been associated with MetS, but the Mediterranean diet has been shown to have a protective effect. The aim of the present study was to analyze the influence of a Mediterranean dietary pattern, as assessed by the biomarkers of food supplied, on the plasma fatty acid composition and its relation with MetS after 1 year of intervention. ⋯ The nut and olive oil diets induced a fatty acid composition that has been shown to be beneficial in the face of MetS. Therefore, a Mediterranean diet rich in fats of vegetable origin may be a useful tool for the management of MetS without the need for concerns over weight gain due to its high fat content.
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Randomized Controlled Trial
The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.
Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. ⋯ DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method.
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Randomized Controlled Trial
Do post discharge phone calls improve care transitions? A cluster-randomized trial.
The transition from hospital to home can expose patients to adverse events during the post discharge period. Post discharge care including phone calls may provide support for patients returning home but the impact on care transitions is unknown. ⋯ A single post discharge phone call had a small impact on the quality of care transitions and no effect on hospital utilization. Higher intensity post discharge support may be required to improve the patient experience upon returning home.
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Randomized Controlled Trial Clinical Trial
A high dietary glycemic index increases total mortality in a Mediterranean population at high cardiovascular risk.
Different types of carbohydrates have diverse glycemic response, thus glycemic index (GI) and glycemic load (GL) are used to assess this variation. The impact of dietary GI and GL in all-cause mortality is unknown. The objective of this study was to estimate the association between dietary GI and GL and risk of all-cause mortality in the PREDIMED study. ⋯ High dietary GI was positively associated with all-cause mortality in elderly population at high cardiovascular risk.