Development of the Common Data Base for the FICSIT trials

Department of Health Services, University of Washington, Seattle 98195.
Journal of the American Geriatrics Society (Impact Factor: 4.57). 04/1993; 41(3):297-308. DOI: 10.1111/j.1532-5415.1993.tb06708.x
Source: PubMed


The eight FICSIT (Frailty and Injuries: Cooperative Studies of Intervention Techniques) sites test different intervention strategies in selected target groups of older adults. To compare the relative potential of these interventions to reduce frailty and fall-related injuries, all sites share certain descriptive (risk-adjustment) measures and outcome measures. This article describes the shared measures, which are referred to as the FICSIT Common Data Base (CDB). The description is divided into four sections according to the four FICSIT committees responsible for the CDB: (1) psychosocial health and demographic measures; (2) physical health measures; (3) fall-related measures; and (4) cost and cost-effectiveness measures. Because the structure of the FICSIT trial is unusual, the CDB should expedite secondary analyses of various research questions dealing with frailty and falls.

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Available from: Marcia G Ory, Jul 25, 2014
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    • "• Buchner 1993 [55] “unintentionally coming to rest on the ground, floor or some other lower level”. "
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    ABSTRACT: The Timed Up and Go test (TUG) is a commonly used screening tool to assist clinicians to identify patients at risk of falling. The purpose of this systematic review and meta-analysis is to determine the overall predictive value of the TUG in community-dwelling older adults. A literature search was performed to identify all studies that validated the TUG test. The methodological quality of the selected studies was assessed using the QUADAS-2 tool, a validated tool for the quality assessment of diagnostic accuracy studies. A TUG score of >=13.5 seconds was used to identify individuals at higher risk of falling. All included studies were combined using a bivariate random effects model to generate pooled estimates of sensitivity and specificity at >=13.5 seconds. Heterogeneity was assessed using the variance of logit transformed sensitivity and specificity. Twenty-five studies were included in the systematic review and 10 studies were included in meta-analysis. The TUG test was found to be more useful at ruling in rather than ruling out falls in individuals classified as high risk (>13.5 sec), with a higher pooled specificity (0.74, 95% CI 0.52-0.88) than sensitivity (0.31, 95% CI 0.13-0.57). Logistic regression analysis indicated that the TUG score is not a significant predictor of falls (OR = 1.01, 95%CI 1.00-1.02, p = 0.05). The Timed Up and Go test has limited ability to predict falls in community dwelling elderly and should not be used in isolation to identify individuals at high risk of falls in this setting.
    Full-text · Article · Feb 2014 · BMC Geriatrics
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    • "Falls (most commonly defined as “an unintentional/inadvertent/involuntary or accidental coming to rest on a lower level”) [1] are a significant burden to society [2]. Each year, approximately 30% of community-dwelling individuals aged 65 and older and 50% of community dwellers aged 85 and older fall [3]. "
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    ABSTRACT: Background: Falls are a leading cause of morbidity and mortality in older adults. Although numerous trials of falls prevention interventions have been completed, there is extensive variation in their intervention components and clinical context, such that the key elements of an effective falls prevention program remain unclear to patients, clinicians, and policy-makers. Our objective is to identify the most effective interventions and combinations of interventions that prevent falls though a systematic review and meta-analysis, including a network meta-analysis. Methods/design: We will search for published (e.g., MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Ageline) and unpublished (e.g., trial registries, dissertations) randomised clinical trials (RCTs) in all languages examining interventions to prevent falls compared to usual care or other falls prevention interventions among adults aged ≥65 years from all settings (e.g., community, acute care, long-term care, and rehabilitation). The primary outcomes are number of injurious falls and number of hospitalizations due to falls. Secondary outcomes include falls rate, number of fallers, number of emergency room visits due to falls, number of physician visits due to falls, number of fractures, costs, and number of intervention-related harms (e.g., muscle soreness related to exercise).We will calibrate our eligibility criteria amongst the team and two independent team members will screen the literature search results in duplicate. Conflicts will be resolved through team discussion. A similar process will be used for data abstraction and quality appraisal with the Cochrane risk of bias tool.Our results will be synthesized descriptively and a random effects meta-analysis will be conducted if the studies are deemed methodologically, clinically, and statistically (e.g., I²<60%) similar. If appropriate, a network meta-analysis will be conducted, which will allow the comparison of interventions that have not been compared in head-to-head RCTs, as well as the effectiveness of interventions. Discussion: We will identify the most effective interventions and combinations of interventions that prevent falls in older people. Our results will be used to optimize falls prevention strategies, and our goal is to ultimately improve the health of seniors internationally. Trial registration: PROSPERO registry number: CRD42013004151.
    Full-text · Article · Jun 2013 · Systematic Reviews
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    • "A fall was defined as unintentionally coming to the ground or some lower level, excluding causes such as sustaining a violent blow, loss of consciousness, or sudden onset of paralysis, such as during a stroke or epileptic seizure (Gibson, Andres, Isaacs, Radebaugh, & Wormpetersen, 1987). Neither ''coming to rest against a wall or other structure'' nor ''high-trauma falls (e.g., falling from a ladder) or falling as a consequence of sustaining a violent blow'' were included as falls (Buchner et al., 1993). "
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    ABSTRACT: The aim of this study was to test the reliability and validity of a preferred-standing test for measuring the risk of falling. The preferred-standing position of elderly fallers and non-fallers and healthy young adults was measured. The maximal BSW was measured. The absolute and relative reliability and discriminant validity were assessed. The expanded timed get-up-and-go test (ETGUG), one-leg stance test (OS), tandem stance (TS), and falls efficacy scale international version (FES-I) were used to determine criterion validity. In total, 146 persons (102 females, 44 males; mean age 55±22 years, range 20-94) were recruited. Forty elderly community dwellers (8 fallers) and 26 young adults were tested twice to determine the test-retest reliability. The BSW showed acceptable test-retest reliability (Intraclass correlation coefficient, ICC2,1=0.77-0.83) and inter-rater reliability (ICC3,1=0.77-0.95) for all groups. The standard error of measurement (SEM) was between 0.77 and 1.87, and the smallest detectable change (SDC) was between 2.14cm and 5.19cm. The Bland-Altman plot revealed no systematic errors. There was significant difference between elderly fallers and non-fallers (F(1/75)=11.951; p=0.001. Spearman's rho coefficient values showed no correlation between the BSW and the ETGUG (-0.17, p=0.47), OLS (-0.04, p=0.65), TS (-0.11, p=0.21), and FES-I (-0.10; p=0.27). Only the BSW was a significant predictor for falling (odds ratio=0.736, p=0.007). The reliability and validity of the BSW protocol were acceptable overall. Prospective studies are warranted to evaluate the predictive value of the BSW for determining the risk of falling.
    Full-text · Article · May 2013 · Archives of gerontology and geriatrics
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