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Chaoyang Li, MD, PhD; Earl S. Ford, MD, MPH; Guixiang Zhao, MD, PhD; et al.
free access
Arch Intern Med. 2011;171(6):507-515. doi:10.1001/archinternmed.2010.440
BackgroundMuch research has been conducted relating total carotenoids—and β-carotene in particular—to risk of cancer and cardiovascular disease (CVD). Limited data are emerging to implicate the important role of α-carotene in the development of CVD or cancer.MethodsWe assessed the direct relationship between α-carotene concentrations and risk of death among 15 318 US adults 20 years and older who participated in the Third National Health and Nutrition Examination Survey Follow-up Study. We used Cox proportional hazard regression analyses to estimate the relative risk for death from all causes and selected causes associated with serum α-carotene concentrations.ResultsCompared with participants with serum α-carotene concentrations of 0 to 1 μg/dL (to convert to micromoles per liter, multiply by 0.01863), those with higher serum levels had a lower risk of death from all causes (P < .001 for linear trend): the relative risk for death was 0.77 (95% confidence interval, 0.68-0.87) among those with α-carotene concentrations of 2 to 3 μg/dL, 0.73 (0.65-0.83) among those with concentrations of 4 to 5 μg/dL, 0.66 (0.55-0.79) among those with concentrations of 6 to 8 μg/dL, and 0.61 (0.51-0.73) among those with concentrations of 9 μg/dL or higher after adjustment for potential confounding variables. We also found significant associations between serum α-carotene concentrations and risk of death from CVD (P = .007), cancer (P = .02), and all other causes (P < .001). The association between serum α-carotene concentrations and risk of death from all causes was significant in most subgroups stratified by demographic characteristics, lifestyle habits, and health risk factors.ConclusionsSerum α-carotene concentrations were inversely associated with risk of death from all causes, CVD, cancer, and all other causes. These findings support increasing fruit and vegetable consumption as a means of preventing premature death.
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Terry P. Haines, PhD; Anne-Marie Hill, MS; Keith D. Hill, PhD; et al.
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Arch Intern Med. 2011;171(6):516-524. doi:10.1001/archinternmed.2010.444
Background
Falls are a common adverse event during hospitalization of older adults, and few interventions have been shown to prevent them.Methods
This study was a 3-group randomized trial to evaluate the efficacy of 2 forms of multimedia patient education compared with usual care for the prevention of in-hospital falls. Older hospital patients (n = 1206) admitted to a mixture of acute (orthopedic, respiratory, and medical) and subacute (geriatric and neurorehabilitation) hospital wards at 2 Australian hospitals were recruited between January 2008 and April 2009. The interventions were a multimedia patient education program based on the health-belief model combined with trained health professional follow-up (complete program), multi-media patient education materials alone (materials only), and usual care (control). Falls data were collected by blinded research assistants by reviewing hospital incident reports, hand searching medical records, and conducting weekly patient interviews.Results
Rates of falls per 1000 patient-days did not differ significantly between groups (control, 9.27; materials only, 8.61; and complete program, 7.63). However, there was a significant interaction between the intervention and presence of cognitive impairment. Falls were less frequent among cognitively intact patients in the complete program group (4.01 per 1000 patient-days) than among cognitively intact patients in the materials-only group (8.18 per 1000 patient-days) (adjusted hazard ratio, 0.51; 95% confidence interval, 0.28-0.93]) and control group (8.72 per 1000 patient-days) (adjusted hazard ratio, 0.43; 95% confidence interval, 0.24-0.78).Conclusion
Multimedia patient education with trained health professional follow-up reduced falls among patients with intact cognitive function admitted to a range of hospital wards.Trial Registration
anzctr.org.au Identifier: ACTRN12608000015347
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Andrea Trombetti, MD; Mélany Hars, PhD; François R. Herrmann, MD, MPH; et al.
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Arch Intern Med. 2011;171(6):525-533. doi:10.1001/archinternmed.2010.446
Background
Falls occur mainly while walking or performing concurrent tasks. We determined whether a music-based multitask exercise program improves gait and balance and reduces fall risk in elderly individuals.Methods
We conducted a 12-month randomized controlled trial involving 134 community-dwelling individuals older than 65 years, who are at increased risk of falling. They were randomly assigned to an intervention group (n = 66) or a delayed intervention control group scheduled to start the program 6 months later (n = 68). The intervention was a 6-month multitask exercise program performed to the rhythm of piano music. Change in gait variability under dual-task condition from baseline to 6 months was the primary end point. Secondary outcomes included changes in balance, functional performances, and fall risk.Results
At 6 months, there was a reduction in stride length variability (adjusted mean difference, −1.4%; P < .002) under dual-task condition in the intervention group, compared with the delayed intervention control group. Balance and functional tests improved compared with the control group. There were fewer falls in the intervention group (incidence rate ratio, 0.46; 95% confidence interval, 0.27-0.79) and a lower risk of falling (relative risk, 0.61; 95% confidence interval, 0.39-0.96). Similar changes occurred in the delayed intervention control group during the second 6-month period with intervention. The benefit of the intervention on gait variability persisted 6 months later.Conclusion
In community-dwelling older people at increased risk of falling, a 6-month music-based multitask exercise program improved gait under dual-task condition, improved balance, and reduced both the rate of falls and the risk of falling.Trial Registration
clinicaltrials.gov Identifier: NCT01107288
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Connie E. Chen, BA; Sanket S. Dhruva, MD; Lisa A. Bero, PhD; et al.
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Arch Intern Med. 2011;171(6):534-539. doi:10.1001/archinternmed.2010.445
BackgroundTraining patients are the first individuals in whom a physician uses an investigational device. There is great variability in the use of data from training patients in the absence of guidelines. The prevalence and extent of data reporting from training patients in cardiovascular device studies submitted for US Food and Drug Administration (FDA) approval has not been characterized.MethodsInformation on training patients was abstracted from the Summary of Safety and Effectiveness Data summarizing cardiovascular device premarket applications approved by the FDA from 2000 through 2007. We examined the numbers and characteristics of training patients and the inclusion of their results in end-point analyses.ResultsThere were 78 cardiovascular device summaries in this 8-year period, of which 17 (22%) involved training patients. Of the 123 studies in the summaries, 20 (16%) used training patients. All studies excluded training patients from efficacy analyses and 19 of 20 (95%) excluded them from safety analyses. Sixteen of 20 (80%) did not provide any outcome data, and 15 of 20 (75%) did not check for outcome differences between training and nontraining treatment patients. Eighteen of 20 (90%) did not provide demographic information on training patients, and 14 of 20 (70%) did not prespecify guidelines for their enrollment.ConclusionsTraining patients comprise a considerable proportion of patients receiving investigational cardiovascular devices, but their results are excluded from FDA submissions. Their exclusion from analyses means that safety and efficacy outcomes may look better than actual results. Guidelines on the use and inclusion of results for training patients would improve accuracy on results reporting.
Marc J. Claeys, MD, PhD; Antoine de Meester, MD; Carl Convens, MD; et al.
free access
Arch Intern Med. 2011;171(6):544-549. doi:10.1001/archinternmed.2011.57
Antonio Cherubini, MD, PhD; Joaquim Oristrell, MD, PhD; Xavier Pla, MD; et al.
free access
Arch Intern Med. 2011;171(6):550-556. doi:10.1001/archinternmed.2011.31
S. Michael Gharacholou, MD; Renato D. Lopes, MD, PhD; Karen P. Alexander, MD; et al.
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Arch Intern Med. 2011;171(6):559-567. doi:10.1001/archinternmed.2011.36
Health Care Reform
Cyrus K. Yamin, BS; Srinivas Emani, PhD; Deborah H. Williams, MHA; et al.
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Arch Intern Med. 2011;171(6):568-574. doi:10.1001/archinternmed.2011.34
Health Care Reform
Todd B. Mendelson, MD, MBE; Michele Meltzer, MD, MBE; Eric G. Campbell, PhD; et al.
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Arch Intern Med. 2011;171(6):577-584. doi:10.1001/archinternmed.2011.96