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Columbia University, College of Physicians and Surgeons, New York.
Address correspondence to Mathew S. Maurer, MD, Columbia University, Clinical Cardiovascular Research Lab for the Elderly, Allen Pavilion, 5141 Broadway, 3 Field West, Room 035, New York, NY 10034. E-mail: msm10{at}columbia.edu
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Methods. Ours was a prospective cohort study of 139 elderly (88 ± 7 years, range 70105 years), Caucasian (97%) residents (women, 84%) of a long-term care facility. Inclusion criteria were age
60 years, ability to rise from a seated position, informed consent obtained from participant or guardian. Multiple domains were assessed for the association with falls including: clinical diagnoses; medication use; orthostatic changes in blood pressure, gait, or balance; cognitive/mental status; general well being; activities of daily living; affect/behavior; range of motion and/or ambulation; and communication. Diabetes mellitus was determined by use of hypoglycemic agents. Time to first fall was determined by review of daily New York State mandated "Incident and Accident" reports.
Results. Over the follow-up period (mean 299 days), 49 participants (35%) experienced a fall. The fall incidence rate for the participants with and without diabetes mellitus was 78% and 30%, respectively (p <.001). The significant unadjusted hazard ratios of fall risk factors included diabetes mellitus, Berg Balance Scale score <45, number of medications, angiotensin-converting enzyme (ACE) inhibitors, hypertension, use of assistive device, inability to independently move a wheelchair, and use of antidepressants, with the latter two factors being protective. In multivariate analysis, only diabetes (adjusted hazard ratio 4.03; 95% confidence interval, 1.968.28) and gait and balance (adjusted hazard ratio 5.26; 95% confidence interval, 1.2622.02) were significantly and independently associated with an increased risk of falls.
Conclusions. Our results suggest that diabetes mellitus is an independent fall risk factor among elderly nursing home residents.
| METHODS |
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60, ability to rise from a seated position, and informed consent obtained from participant or guardian. Trained research coordinators collected chart data including age, sex, race, comorbidities, and medication use. Falls were determined prospectively by review of daily New York State-mandated "Incident and Accident" reports (12). Other variables known to affect risk for falls were assessed as follows.
Clinical Diagnoses
Relevant diagnoses were abstracted from the patient's medical record. The diagnosis of hypertension was based on either a clinical history of hypertension, an average blood pressure of >140/90 mmHg with beat-to-beat monitoring during sitting position for 10 minutes, or an active prescription of an antihypertensive agent. Diabetes was determined by prescription of oral hypoglycemic agent or insulin therapy.
Medications
Medications were determined from computerized pharmacy records with confirmation by review of the participant's medical chart to ensure active prescription of the particular drug at the time of the measurement of orthostatic changes in blood pressure; medication information gathered included name, dosage, and route of administration, and frequency and timing of dosage administration. Medications were categorized into specific groups that have been previously reported to increase the risk of falls including sedativehypnotics (13), antidepressants (14,15), antipsychotics (16), vasodilators (17), and diuretics (18).
Orthostatic Changes in Blood Pressure
Participants underwent a determination of orthostatic changes in blood pressure by using noninvasive beat-to-beat monitoring as the participant arose from a seated position. This determination was made in each participant in the morning between 9:00 AM and 12:00 PM. Each participant had blood pressure and heart rate measured while sitting and after standing for up to 5 minutes with the use of a real time, noninvasive, beat-to-beat vital signs monitor as has been described previously (11). Blood pressure changes were evaluated in 111 participants (80%). Twenty-eight participants did not undergo evaluation because of scheduling conflicts (n = 5), refusal (n = 3), severe/extreme cognitive impairment (n = 11) limiting ability to cooperate, or inability to stand with the dominant arm in a sling (n = 9).
Institutional Comprehensive Assessment and Referral Evaluation
The Institutional Comprehensive Assessment and Referral Evaluation (INCARE), is an assessment tool, using a semistructured interview technique, that was developed by the staff at the Columbia University Center of Geriatrics and Gerontology and the New York Office of Mental Health and has been validated by the staff of the HHAR (1921). The INCARE evaluates major health and social problems in individuals aged 65 or older who are admitted to an institutional setting. It includes items of information covering the evaluation of demographics and work history, cognitive and/or mental status, general well being, activities of daily living, affect and behavior, range of motion and/or ambulation, and communication. The answers, variables, or symptoms that are collected during the interview of the participants can be combined to give different indicator scales of various health and social problems such as depression, cognitive impairment, or arthritis. The INCARE contains indicator scales that combine several symptoms or indicators of a particular problem so that the measurement is less fallible. Several commonly used geriatric assessment scales are included in the INCARE (19,20). For our study, we were interested in certain indicator scales for the risk factors of falls. We evaluated indicator scales from the INCARE for the following risk factors: cognitive impairment, poor vision, depression, and mobility and/or use of an assistive device. Each participant underwent evaluation using the INCARE by personnel trained in the administration of the interview. One hundred thirty-six (98%) participants underwent evaluation with the INCARE.
Berg Balance Scale
The Berg Balance Scale (22) was used to measure a participant's degree of balance and strength in standing and walking, and as a diagnostic test for predicting a participant's potential for falling. It was administered by a licensed physical therapist to 117 participants (84%). Twenty-two participants did not undergo evaluation because of scheduling conflicts (n = 7), refusal (n = 4), or severe/extreme cognitive impairment (n = 11).
Statistical Analysis
Risk ratios for risk of falls, among all participants and within subgroups of those with and without diabetes mellitus, were estimated for each of the risk factors. Significance was estimated using Student's t test (for unpaired comparison of continuous variables) and chi square with Fisher's exact test (for dichotomous variables). Using Cox proportional hazard regression, unadjusted and adjusted hazard ratios were estimated for each risk factor. SAS 8.0 (Cary, NC) was used for all analyses.
| RESULTS |
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Eighteen (13%) of the nursing home residents were classified as having diabetes, with two-thirds maintained on oral agents and one-third receiving insulin. The demographic and clinical characteristics of study participants based on the prevalence of diabetes are shown in Table 1. Participants classified as having diabetes were younger, more often obese (40% vs 5%), with a higher prevalence of hypertension (83% vs 51%) and more visual impairment (20% vs 8%), and were prescribed on average almost two more medications per day and almost one additional cardiovascular medication per day than were those participants not classified as having diabetes. However, those participants classified with diabetes did not differ from those without diabetes in sex, race, history of stroke, degree of cognitive impairment, scores on the Berg Balance Scale (27 ± 17 vs 30 ± 18), use of assistive devices, and the prevalence of orthostatic hypotension measured at 1 or 3 minutes after standing. The fall incidence rate for the participants with and without diabetes mellitus was 78% and 30%, respectively, which was very significant (p <.001).
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| DISCUSSION |
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Association of Diabetes with Falls
The multiple and well recognized complications of long-standing diabetes mellitus including peripheral neuropathy, diabetic retinopathy, autonomic neuropathy, diabetic foot ulcer, or hypoglycemia from inappropriate glycemic control can each contribute meaningfully to fall risk through multiple mechanisms(3). Visual impairments either from proliferative diabetic retinopathy or related to poor glycemic control have been associated with an increased rate of falls (24,25). In our data, a global assessment of visual impairment demonstrated a trend toward greater visual impairment in diabetics as compared with nondiabetics (20% vs 8%), but this was not significant and thus may not solely account for the observed difference in fall rate. Additionally, although diabetes is associated with orthostatic hypotension secondary to underlying autonomic neuropathy (2628), and this has been associated with an increased risk for falls in elderly persons (29,30), we did not detect any significant differences in the degree of orthostatic blood pressure changes as measured with continuous beatto-beat technology during active standing (11). Therefore, it is unlikely that the higher fall rate that we observed in diabetics was attributable to differences in orthostatic changes in blood pressure. Previous studies suggested the possible link between falls and diabetes mellitus among the community-dwelling elderly population (6,31), with a significant portion of the risk being attributable to proprioceptive deficits (6,32,33) or reduced strength and work performance of leg muscles (34). Our data cannot definitively establish the reason underlying the empiric observation that elderly diabetic residents of the nursing home experience more falls than their nondiabetic counterparts. The lack of significant difference in prevalence of orthostatic hypotension or visual impairment suggests that other factors, perhaps related to peripheral neuropathies or diabetic foot complications, play a greater causal role. Further studies confirming these findings in larger data sets and evaluating for the putative mechanism would be required.
Gait and Balance
Using the Berg Balance Scale, we found that gait and balance was an independent predictor of falls in our population of elderly nursing home residents. Although numerous previous investigations have emphasized the importance of gait and balance difficulties in manifesting falls in nursing home residents (5,10,35,36), and several studies have documented the utility of the Berg Balance Scale for predicting falls in community-dwelling elderly population (3739) and in acute inpatient rehabilitation (40), to our knowledge these data are the first to suggest a significant predictive value of the Berg Balance Scale for falls risk in elderly nursing home residents. In our data, as in others (5), gait and balance abnormalities were the single most important predictor of falls in this population.
Medications
Medications are often noted to be associated with an increased risk for falls, with several studies supporting a strong and linear association between the number of medications and falls risk in both community dwelling and nursing home populations (16,18,41,42). Whether this association represents a causal relationship or whether medications are simply a marker of falls risk has not been clarified. The association of falls and medication use is based on observational data, with minimal adjustment for confounders, dosage, or duration of therapy (18,42). For example, although observational data suggest a weak but significant association of diuretic use and falls in older individuals (18), data from randomized controlled trials did not reveal an association between diuretic use and falls (41). In our data, medications were associated in univariate analysis with fall risk such that for every medication the risk for falls increased by 10% and the risk was 2.5 times higher in those patients prescribed more than four medications compared with those prescribed fewer than four medications. However, in multivariate analysis, medication use was not a predictor of falls risk, suggesting that the medications may be a marker of other independent risk factors for falls. For example, although we found and previously reported that use of ACE inhibitors was associated with an increased risk for falls (43), ACE inhibitors were prescribed more often in diabetics and the risk attributable to them in multivariate analysis was no longer an independent predictor but was rather subsumed by the diagnosis of diabetes mellitus (Table 2). To ultimately clarify the role of medications in the genesis of falls, randomized controlled trials should add falls as an outcome variable and programs designed to decrease medication use should be evaluated for their impact on fall rates.
We found that antidepressants were associated with lower fall risk in univariate analysis, an unanticipated and unexpected finding that to our knowledge has not been previously reported. Previous studies have demonstrated that antidepressants are associated with an increased risk for falls (15,36,44). While potentially attributable to a beneficial effect of the antidepressants, participants receiving antidepressants had higher scores (i.e., more severe depression) than those patients not receiving antidepressants on the Feeling Tone Questionnaire (33 ± 27 vs 21 ± 24, p =.04); suggesting that this was not a treatment effect. Alternatively, it is possible that participants receiving antidepressants were significantly less likely to fall because of other factors not directly attributed to antidepressants. Further analysis revealed that participants prescribed antidepressants as compared with those not prescribed antidepressants were more often unable to stand alone (44% vs 30%), were more often immobile (42% of patients receiving antidepressants had a Berg Balance Scale score < 10, whereas 15% of participants who did not receive antidepressants had Berg scores <10), were more often in a wheelchair (45% vs 20%), and more often did not ambulate independently (26% vs 7%). These additional analyses suggest that antidepressants in our population were more often prescribed to severely immobile participants who were at baseline of lower risk and that the reduced falls risk associated with antidepressants was confounded by these other factors. Indeed, in multivariate analyses, the protective effect of antidepressants was attenuated (hazard ratio 0.38; 95% CI, 0.151.002, p =.051) and not included in the final model.
Limitations
There are several limitations to our study. First, the diagnostic criteria for diabetes mellitus were based only on the prescription of medications used to treat diabetes, not by standard laboratory criteria. Thus, there may have been misclassification, and we likely identified participants with either more severe or longer standing diabetes mellitus that required treatment. Second, some traditional fall risk factors were not included in our analysis because of the original design including lower extremity weakness and previous falls. Thus, a biased estimation of the risk factors studied cannot be excluded. Finally, some fall risk factors identified in previous studies were not confirmed as independent predictors of falls possibly because of our small sample size and hence limited power. However, by using a prospective study design and using a time-to-event analysis, we were able to improve statistical power because those participants with and without the outcome of interest were evaluated. Additionally, the prospective design can reduce several forms of biasincluding confounding, ascertainment, and recallthat are present in retrospective studies. Prospective study designs tend to reduce these biases and have been used increasingly in studies of fall risk assessment in elderly nursing home residents (36,45,46). However, very few of these used a time-to-event analysis (45). Using such methodology and analyzing multiple domains of function (mobility, cognition, health status, medications, mood) facilitates development of a multivariate risk model for falls and may provide further evidence of causality in that the temporality of the association between a risk factor and outcome (in this case, falls) is incorporated into the association.
Summary
Diabetes mellitus, defined by the use of hypoglycemic agents, is an independent fall risk factor among frail nursing home residents. These results, coupled with the rising prevalence of diabetes, suggest that diabetes mellitus should be considered to be a risk factor for falls in this population. Indeed, identifying such patients as being at higher risk may facilitate preventive measures aimed at reducing the risk for falls.
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Received June 2, 2004
Accepted June 4, 2004
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