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Although we conclude that exercise or physical therapy interventions and vitamin D supplementation reduce the risk for falling among community-dwelling older adults, it is unclear whether comprehensive multifactorial assessment and management interventions reduce the number of fallers. Overall, we found no major clinical harms for these effective interventions to prevent falls in older adults.
Most trials of vitamin D were not adequately designed to assess long-term adverse effects. On the basis of a recent AHRQ evidence report, we found limited evidence (based on 19 vitamin D trials in adults) that vitamin D intake above the current dietary reference amount may be harmful (17). The Women's Health Initiative reported a 17% increased risk for kidney stones in postmenopausal women aged 50 to 79 years whose daily vitamin D3 supplementation was 400 IU combined with 1000 mg of calcium (17). In most trials, reports of hypercalcemia and hypercalciuria were not associated with clinically relevant events.
We found evidence of possible minor harms for vision correction, an intervention without evidence of effectiveness. In a recent USPSTF report evaluating the harms of vision screening and early vision correction in older adults, a single small observational study showed an association between multifocal lens use and an increased risk for falls (adjusted odds ratio, 2.09 [CI, 1.06 to 4.92]) (18). Other treatments for uncorrected refractive errors showed limited evidence of harm.
Our results are similar to those of previous systematic evidence reviews and meta-analyses (16, 77-79), but they differ in some ways. Relevant recent systematic evidence reviews evaluating specific types of interventions (for example, multifactorial assessment and exercise) also included institutional and hospitalized populations (79-80). The purpose of our review was to evaluate outpatient approaches to falls prevention that are relevant to primary care to support the USPSTF recommendation process; thus, our review has a narrower focus than other reviews have had.
The most current review before ours, and the one that is most similar to ours, is a 2009 Cochrane Collaboration review (78). Like that review and meta-analyses, we found no statistically significant reduction in fall risk when all of the multifactorial assessment and management trials were pooled. Another recent systematic review and meta-analysis of multifactorial clinical assessment programs addressing fall risk also reported a lack of overall benefit (79), and a review addressing a broader grouping of complex interventions and outcomes reported a reduction in fall risk associated with these interventions (81). Although the lack of a consistent finding for an overall benefit may result from analyses combining studies that provide direct intervention with those studies that primarily provide referral (82-83), comprehensiveness did not seem to be a predictor of successful interventions in our analysis or in the 2009 Cochrane review (78). However, the current body of literature is sensitive to changes as new trials are published. For example, a recent good-quality trial from the United Kingdom (204 participants) that was published after our review search period ended evaluated comprehensive multifactorial falls assessment and management among community-dwelling older adults who called an ambulance after a fall but were not taken to the emergency department (84). After 12 months, the relative risk for falling between the intervention group and usual care was 0.86 (CI, 0.78 to 0.94). Although the addition of this trial does not affect the pooled estimate of risk for falling, it does affect the overall statistical significance for comprehensive interventions (relative risk, 0.88 [CI, 0.78 to 0.98]; number of active study groups, 7; I2 = 70.2%). The characteristics of a comprehensive multifactorial assessment and management intervention have not been clearly defined, and different approaches to classification may also lead to different results, although our coding of level of comprehensiveness was internally valid.
We conclude that exercise programs are effective overall, as did other reviews (77-78, 80). Like the 2009 Cochrane review (78), we did not find any evidence for differences in the results of fall prevention interventions on the basis of fall risk at baseline, although the intensity of the physical activity interventions was associated with greater reductions in the risk for falling (78, 80).
Unlike the recent Cochrane review and meta-analyses, we found that vitamin D supplementation was consistent with a reduced risk for falling. Our review, however, included data from 4 trials that were not included in the Cochrane review (65-66, 68, 71); these data were generally protective. One large null study (85) included in the Cochrane review was excluded from our review owing to problems with the outcome reporting. After our search period ended, a good-quality trial evaluating a single large oral dose of vitamin D (500,000 IU) showed a paradoxical effect, in which the intervention group had an increase in fallers compared with the placebo control group at 12 months (74% vs. 68%; P = 0.003) (86). After we included this study in the meta-analysis, the relative risk reduction was attenuated but remained statistically significant (relative risk, 0.83 [CI, 0.71 to 0.97]). It was hypothesized that the mega-dose of oral vitamin D in the trial conducted by Sanders and colleagues (86) may have up-regulated CYP24, the enzyme that catabolizes 1,25-dihydroxyvitamin D, leading to decreased levels of vitamin D and increased falling in the intervention group (87). Only 1 other small trial included in this review administered a single mega-dose of vitamin D to vitamin D-deficient participants and reported no difference in risk for falling over 6 months (64).
Our review has limitations. First, we included only English-language RCTs with a true control group that were conducted in community-dwelling older adults and tested outpatient interventions most applicable to primary care clinicians. Second, the heterogeneity of interventions to prevent falling—from the identification of an at-risk population to intervention approaches to the different methods of assessing relevant outcomes—is an inherent limitation in the conduct and interpretation of statistical syntheses of this research. Third, among the intervention trials, we identified no consistent method of identifying people at increased risk for falls. Most studies (68%) enrolled participants who were preselected for increased risk factors for falls, including history of falls, gait and balance impairment, clinical history (for example, stroke, Parkinson disease, recent hospitalization, or medication use), and clinical examination findings (for example, frailty). Fourth, the interventions are heterogeneous even within intervention categories. In particular, the exercise intervention and the multifactorial assessment and management interventions vary considerably in terms of focus and components of care. Fifth, published studies use diverse terms to describe trial components, creating difficulty in categorizing studies. Sixth, very few trials replicated the same intervention, and none of the study-level characteristics helped to explain study effects or reduce heterogeneity. This makes providing clear clinical recommendations with regard to details of successful interventions difficult. Seventh, measurement of outcomes was variable in terms of the method of data collection (prospective vs. retrospective) and the specific measures that were collected (fallers vs. falls). Finally, we report here the proportion of fallers as our primary outcome, but in the full report, we describe other outcomes, including the rate of fallers and health outcomes (injury and fractures, quality of life, disability, and mortality). However, these outcomes were much less commonly reported: only 20 of the included trials reported outcomes of fall-related fractures. In general, we found scant and inconclusive evidence on changing true health outcomes.
Recently, the Prevention of Falls Network Europe published a consensus document describing a common data set for fall prevention interventions; the routine use of these assessment instruments and procedures will enhance the quality and comparability of future trials and expand the available data on health outcomes and other positive outcomes (88). Although the consensus document does not address harms reporting, this is a critical need, particularly because harms were not systematically evaluated in the majority of fall prevention interventions in this review.
In conclusion, current research suggests that clinical interventions, such as vitamin D supplementation, exercise or physical therapy programs, and some comprehensive multifactorial fall assessment and management interventions, can reduce falls and are safe for community-dwelling older adults.
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Source: This article was first published in Annals of Internal Medicine (Ann Intern Med 2010;153:815-825).
Requests for Single Reprints: Yvonne L. Michael, ScD, SM, Epidemiology and Biostatistics, Drexel University School of Public Health, 1505 Race Street, 6th Floor, MS 1033, Philadelphia, PA 19102; e-mail, firstname.lastname@example.org.
Current author addresses and author contributions are available at http://www.annals.org.
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Current as of December 2010
Michael YL, Whitlock EP, Lin JS et al. Primary Care–Relevant Interventions to Prevent Falling in Older Adults: A Systematic Evidence Review for the U.S. Preventive Services Task Force. December 2010. http://www.uspreventiveservicestaskforce.org/uspstf11/fallsprevention/fallsprevart.htm