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Biomedical subjects

W A Ray

Publications and source records attributed to W A Ray.

At least 37 records · Page 2Linked to original sources
PubMed1998

Perinatal outcomes following implementation of TennCare.

CONTEXT: The abrupt initiation of capitated Medicaid care in Tennessee (TennCare) in 1994 prompted many questions about changes in quality of care. OBJECTIVE: To evaluate the effect on perinatal outcomes of the transition to TennCare in 1994. DESIGN: Before and after retrospective cohort analysis. SETTING AND POPULATION: Births to women residing in Tennessee between 1990 and 1995 with complete demographic information on birth certificates, with a focus on women enrolled in Medicaid giving birth in 1993 (before TennCare) and 1995 (after TennCare). OUTCOME MEASURES: Late prenatal care (after the fourth month of pregnancy) or inadequate prenatal visits, low and very low birth weight, and death in the first 60 days of life. RESULTS: Tennessee residents had 72014 study births in 1993 and 72278 in 1995, of which 37543 (52.1%) and 35707 (49.4%) were to women enrolled in Medicaid at delivery. For these Medicaid births, there were no changes after TennCare in the proportions with late prenatal care (16.2% in 1993 vs 15.8% in 1995), inadequate prenatal visits (5.9% vs 5.6%), low birth weight (9.4% vs 9.0%), very low birth weight (1.6% vs 1.5%), and death in the first 60 days (0.6% both years). These findings were unchanged in multivariate analysis, in analysis of high-risk subgroups, and in analysis of women with demographics characteristic of Medicaid women. CONCLUSION: Study perinatal outcomes did not change among Medicaid births following the transition to TennCare.

Birth Weight↗
PubMed1998

Predictors of mortality from fires in young children.

BACKGROUND: In the United States in 1994, fires claimed 3.75 lives per 100 000 child years and accounted for 17.3% of all injury deaths in children <5 years of age. OBJECTIVES: To conduct a historical cohort study that uses maternal demographic characteristics to identify young children at high risk of fire-related deaths, thus defining appropriate targets for prevention programs. METHODS: The cohort consisted of children born to mothers who resided in the state of Tennessee between 1980 and 1995. Information was obtained by linking birth certificates, 1990 census data, and death certificates. Children were eligible for the study if they were <5 years of age at any time within the study period and if key study variables were present (99.2% of births). Birth certificates provided information on maternal characteristics including age, race, education, previous live births, use of prenatal care, and residence (in standard metropolitan statistical area). Child characteristics included gender, gestational age, and birth type (singleton/multiple gestation). Neighborhood income was estimated by linking the mother's address at the time of birth to the 1990 census (block group mean per capita income). The study outcome was a fire resulting in at least one fatality (fatal fire event) during the study period, identified from death certificates (coded E880 through E889 in the International Classification of Diseases, 9th rev). We calculated the fatal fire event rate corresponding to each stratum of maternal/child characteristics. We assessed the independent association between each characteristic and the risk of a fatal fire event from a Poisson regression multivariate analysis. RESULTS: During the study period, 1 428 694 children contributed 5 415 213 child years to the cohort: there were 270 deaths from fire (4.99 deaths per 100 000 child years) and 231 fatal fire events. In the multivariate analysis, factors associated with greater than a threefold increase in fatal fire events included maternal education, age, and number of other children. Compared with children whose mothers had a college education, children whose mothers had less than a high school education had 19.4 times (95% confidence interval [CI], 2.6-142.4) an increased risk of a fatal fire event. Children whose mothers had more than two other children had 6.1 times (95% CI, 3.8-9.8) an increased risk of a fatal fire event compared with children whose mothers had no other children. Children of mothers <20 years of age had 3.9 times (95% CI, 2.2-7.1) increased risk of a fatal fire event compared with children whose mothers were >/=30 years old. Although both maternal neighborhood income and race were associated strongly with increased rates of fatal fire events in the univariate analysis, this association did not persist in the multivariate analysis. Other factors that were associated with increased risk of fatal fire events in the multivariate analysis were male gender and having a mother who was unmarried or who had delayed prenatal care. The three factors associated most strongly with fire mortality were combined to create a risk score based on maternal education (>/=16 years, 0 points; 13 to 15 years, 1 point; 12 years, 2 points; <12 years, 3 points); age (>/=30 years, 0 points; 25 to 29 years, 1 point; 20 to 24 years, 2 points; <20 years, 3 points); and number of other children (none, 0 points; one, 1 point; two, 2 points; three or more, 3 points). The lowest-risk group (score <3) included 19% of the population and had 0.19 fatal fire events per 100 000 child years. In contrast, highest-risk children (score >7) comprised 1.5% of the population and had 28.6 fatal fire events per 100 000 child years, 150 times higher than low-risk children. Children with risk scores >5 contributed 26% of child years but experienced 68% of all fatal fire events. If the fatal fire event rate for all children had been equal to that of the low-risk group (risk score <3), then 95% of deaths from

Burns↗
PubMed1997

Policy and program analysis using administrative databases.

Administrative policies and programs play an important and growing role as determinants of the use of medical care. Although some policies and programs may be harmful or ineffectual, randomized, controlled trials or prospective evaluations are rarely done for political or logistic reasons. Most evaluations are retrospective and often use administrative databases. Major problems with such evaluations include poor data quality, lack of concurrent controls, inability to ascertain important study outcomes, and incomplete data on case mix. This article uses published evaluations to illustrate these problems and suggests strategies that can minimize their impact. Such strategies include thorough assessment of data quality, interrupted time-series or policy gradient analysis, restriction of studies to those clinical outcomes that reliably result in medical care, and use of data on medical encounters as surrogates for determining case mix. However, even when these strategies are used, adequate evaluation of the effects of many policies and programs may continue to be impossible. Prospective evaluations need to be used more frequently to ensure that changes are held to the same standard used for other therapeutic interventions.

Data Collection↗
PubMed1997

A randomized trial of a consultation service to reduce falls in nursing homes.

CONTEXT: Falls are a major health problem in nursing homes, but no interventions have been shown to prevent falls in nursing home residents. OBJECTIVE: To evaluate an intervention program designed to prevent falls and associated injuries in high-risk nursing home residents. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: Seven pairs of middle Tennessee nursing homes with 1 facility in each pair randomly assigned to the intervention. Facilities had 482 (261 control, 221 intervention) residents who qualified for the study because they had high risk of falls and a potential safety problem that could be addressed by the intervention. INTERVENTION: Comprehensive structured individual assessment with specific safety recommendations that targeted suboptimal practices for environmental and personal safety, wheelchair use, psychotropic drug use, and transferring and ambulation. Facility staff were encouraged to implement the individual recommendations and to improve overall facility safety. MAIN OUTCOME MEASURES: The mean proportion of recurrent fallers and incidence rate of injurious falls in the facility in the year following the intervention. RESULTS: The mean proportion of recurrent fallers in intervention facilities (43.8%) was 19.1% (95% confidence interval, 2.4%-35.8%) lower than that in control facilities (54.1%, P=.03). Intervention facilities had a nonsignificant trend toward a lower mean rate of injurious falls (13.7 vs 19.9 per 100 person-years, reduction of 31.2%, P=.22). Subgroup analyses suggested greatest benefits for residents for whom the recommended interventions were carried out or who had 3 or more falls in the preceding year. CONCLUSION: The high rate of falls and related injuries in nursing homes should not be viewed as inevitable, but as outcomes that can be substantially improved through structured safety programs.

Accident Prevention↗
PubMed1997

Antihypertensives and the risk of serious hypoglycemia in older persons using insulin or sulfonylureas.

CONTEXT: Beta-Blockers and angiotensin-converting enzyme (ACE) inhibitors are effective antihypertensive agents for patients with diabetes mellitus. However, beta-blockers attenuate some components of the autonomic response to hypoglycemia and could increase the risk of hypoglycemia. ACE inhibitors may increase insulin sensitivity and predispose users to hypoglycemia. OBJECTIVE: To determine whether use of cardioselective beta-blockers, nonselective beta-blockers, ACE inhibitors, thiazide diuretics, calcium channel blockers, or other antihypertensive drugs alters the risk of developing serious hypoglycemia among older persons prescribed insulin or sulfonylureas. DESIGN: Retrospective cohort study. SETTING: Tennessee Medicaid Program. PATIENTS: A total of 13,559 elderly (mean age, 78+/-7 years) Medicaid enrollees, who were prescribed insulin (n=5171, 38%) or sulfonylureas (n=8368, 62%) from 1985 through 1989. These enrollees contributed a total of 33,107 person-years of insulin or sulfonylurea use for follow-up. MEASUREMENTS: Hospitalization, emergency department admission, or death associated with hypoglycemic symptoms and a concomitant blood glucose determination of less than 2.8 mmol/L (50 mg/dL). RESULTS: We identified 598 persons with an episode of serious hypoglycemia during the study period. The rate of serious hypoglycemia was 2.01 per 100 person-years among those who were not prescribed antihypertensives. Crude rates of serious hypoglycemia were highest among users of ACE inhibitors (2.47 per 100 person-years) and lowest among users of cardioselective beta-blockers (1.23 per 100 person-years). However, when we controlled for demographic characteristics and markers of comorbidity, there was no statistically significant increase or decrease in risk of serious hypoglycemia among users of any class of antihypertensive agents compared with nonusers of antihypertensive drugs. Using nonselective beta-blockers as the reference group, each of these agents was associated with a lower, but not statistically significant, risk of hypoglycemia. CONCLUSIONS: In this population, specific antihypertensive drug therapy had little impact on the risk of hypoglycemia in older diabetic patients. Therapy should be chosen based on other considerations of safety and effectiveness.

Aged↗
PubMed1997

Persistently increased injury mortality rates in high-risk young children.

OBJECTIVE: To study trends in injury mortality for low- and high-risk young children. DESIGN AND METHODS: For Tennessee children 0 to 4 years of age, we used birth certificates to obtain data on maternal education, age, and parity; these risk factors were used to classify children into low- and high-risk groups. The outcome was death from injury, as determined from linked death certificates. Between 1978 and 1995, injury mortality rates were calculated for six 3-year periods for low- and high-risk children. RESULTS: There were 1.5 million children 0 to 4 years of age who contributed 4.9 million child-years. The high-risk group contributed 28% of all child-years. There were 673 injury deaths in the high-risk group, 48.9 deaths per 100,000 child-years, and 586 deaths in the low-risk group, 16.8 deaths per 100,000 child-years. The injury mortality rate for low-risk children decreased from 20.7 to 15.7 per 100,000 child-years between the 1978-1980 and 1981-1983 periods; thereafter it remained relatively stable. For high-risk children, the injury mortality rate decreased from 50.9 to 43.5 per 100,000 between the 1978-1980 and 1981-1983 periods, remained mostly unchanged through 1992, and then increased sharply in the 1993-1995 period to 64.1 per 100,000 child-years. The disparity between high- and low-risk children widened from 29.3 (95% confidence interval, 25.1-33.5) excess deaths per 100,000 for 1978 through 1991 to 46.9 (95% confidence interval, 35.9-57.9) in 1993 through 1995. CONCLUSIONS: In Tennessee, maternal education, age, and parity consistently identified a population of children at increased risk of injury mortality. For these high-risk children, there has been no substantial reduction in injury mortality in high-risk young children during the last 18 years.

Age Factors↗
PubMed1997

Predictors of antipsychotic withdrawal or dose reduction in a randomized controlled trial of provider education.

OBJECTIVES: To evaluate the effects of an educational program to reduce antipsychotic use in nursing homes that had high use rates post-OBRA-87 and to identify factors that predicted antipsychotic withdrawal or 50% or greater dose reduction. DESIGN/SETTING: A randomized controlled trial (RCT) of the educational program (nursing home the unit of randomization and analysis) was conducted in 12 Tennessee nursing homes (6 education/6 control). Cohort analysis in baseline antipsychotic users identified factors predicting withdrawal or dose reduction. SUBJECTS: The RCT analysis included 1152 patients in the homes at baseline and 6 months. The cohort analysis included 133 baseline antipsychotic users in the five education homes able to implement the recommendations of the educational program. OUTCOME MEASURES: Change in days of antipsychotic use per 100 days of nursing home residence, withdrawal from antipsychotics, reduction in antipsychotic dose by 50% or more. RESULTS: Following the educational intervention, use of antipsychotics in the six education homes decreased from 25.3 days per 100 at baseline to 19.7 days per 100 by month 6, a 23% reduction relative to control homes (P = .014). In the withdrawal analysis, 44 (33%) of 133 baseline antipsychotic users were withdrawn. Factors at baseline predicting successful withdrawal were low antipsychotic dose, no use of benzodiazepines or antidepressants, and behavioral symptoms score below the median. However, although an additional 22 patients had dose reductions > or = 50%, none of the predictors of withdrawal were associated with dose reductions. CONCLUSIONS: Focused provider education programs may facilitate antipsychotic reduction above and beyond that attributable to regulatory changes. Patients who are poor candidates for total antipsychotic withdrawal may tolerate substantial dose reductions, which should reduce their risk of adverse antipsychotic effects.

Aged↗
PubMed1997

Predictors of injury mortality in early childhood.

OBJECTIVE: To study the association between maternal/infant characteristics and mortality from injury for children 0 through 4 years of age. DESIGN: Historical cohort. SETTING: State of Tennessee. PARTICIPANTS: Children 0 through 4 years of age at any time between January 1, 1985 and December 31, 1994. We linked birth certificates and US census data to obtain information on maternal age, race, education, neighborhood income, parity, use of prenatal care, residence location, infant's gender, and gestational age. MAIN OUTCOME MEASURES: The outcome was death from injury, as determined from linked death certificates. The incidence density rates for each stratum (defined by maternal/child characteristics) were calculated by dividing the number of injury deaths by child years in the stratum. We used multivariate analysis to assess the independent contribution of each characteristic to risk of injury death. RESULTS: There were 1 035 504 children 0 through 4 years of age who contributed 3 414 436 child years. There were 803 deaths from injury, ie, 23.5 deaths per 100 000 child years. In the multivariate analysis, children had at least a 50% increased risk of injury mortality if they were born to a mother who had less than a high school education (relative risk [RR] = 2.88; 95% confidence interval [CI]: 1.92-4.34) compared with a college education, was <20 years of age (RR = 2.42; 95% CI: 1.76-3.31) compared with >30 years, or had >2 other children (RR = 2.97; 95% CI: 2.29-3.85) compared with no other children. Neither race nor income was significantly associated with childhood injury mortality in the multivariate analysis. Classification of children by maternal education, age, and parity defined a pronounced risk gradient in which high-risk children had an injury mortality rate >15 times that of low-risk children. The steep risk gradient was present for both infants (24-fold increase for high-risk children) and children 1 through 4 years of age (13-fold increase for high-risk children). If the injury mortality rate for all children were equal to that of the low-risk group, 614/803 (76.3%) of injury deaths would not have occurred. CONCLUSIONS: For young children, maternal education, age, and parity are strongly and independently associated with injury mortality. These factors define a steep gradient of risk, suggesting that many injury deaths could be prevented.

Birth Certificates↗
PubMed1996

Angiotensin converting enzyme inhibitor-associated angioedema: higher risk in blacks than whites.

We compared the incidence of angioedema during exposure to angiotensin converting enzyme inhibitors (ACEIs) in blacks with that in whites in a retrospective cohort study of Medicaid recipients from Michigan, Ohio and Tennessee during 1986- 1992. Medicaid administrative files were used to identify filled prescriptions for ACEIs and calcium channel blockers (CCBs), and to identify first episodes of angioedema that occurred during exposure to an ACEI or CCB. There were 48,776 black and 106,482 white patients with 43,989 and 114,448 person-years of exposure to an ACEI, respectively. For comparison, there were 49,004 black and 110,129 white patients with 43,064 and 117,684 person-years of exposure to a CCB, respectively. The incidence of angioedema in blacks ranged from 3.3 to 4.6 per 1000 person-years of ACEI exposure--three to four times higher than that for whites in each state. Controlling for a slightly greater incidence of angioedema in blacks and other covariates, black users of ACEIs had a 3.1-fold greater incidence than white users. First exposure to ACEIs was associated with a higher risk of angioedema than chronic exposure in blacks, but not whites. Among blacks, the rate of angioedema during the first 30 days of exposure was 11.4 times greater (95% confidence interval [CI], 3.5 to 37.0) among ACEI users than CCB users; for those with at least 1 year of exposure, the rate was 4.5 times higher (95% CI, 2.6 to 8.0). Among whites, the increased risk of angioedema was more modest (rate ratio 1.7, 95% CI, 1.3 to 2.4 compared to CCB users) and did not differ by duration of ACEI use. In an analysis of angioedema cases and randomly selected controls in a subset of the full cohort, the greater risk of ACEI-associated angioedema in blacks was not explained by concurrent exposure to diuretics or antibiotics. Blacks may be at greater risk of angioedema when taking ACEIs than whites. Further study is necessary to confirm these findings, to examine effects of underlying disease on angioedema incidence, and to describe any racial differences in the severity of angioedema occurring with ACEIs.

Journal Article↗
PubMed1996

Excess costs from gastrointestinal disease associated with nonsteroidal anti-inflammatory drugs.

OBJECTIVE: To quantify medical care costs for the diagnosis and treatment of gastrointestinal disorders attributable to use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than aspirin in elderly persons. DESIGN AND SETTING: Retrospective cohort study of 75,350 Tennessee Medicaid enrollees at least 65 years of age. MEASUREMENTS: The cohort was classified by baseline NSAID use as nonusers (no use preceding 1988), occasional users (< 75% of days) or regular users (> or = 75% of days). For the follow-up year (1989), we calculated annual rates of utilization of and Medicare/Medicaid payments for: medical care for NSAID-associated gastrointestinal disorders; hospitalizations/emergency department visits for peptic ulcers, gastritis/duodenitis, and gastrointestinal bleeding; outpatient upper and lower gastrointestinal tract radiologic and endoscopic examinations; and histamine2 (H2)-receptor antagonist, sucralfate, and antacid prescriptions. Rates were adjusted for demographic characteristics and baseline health care utilization. RESULTS: Among nonusers of NSAIDs, the adjusted mean annual payment for all types of medical care for study gastrointestinal disorders was $134. This increased to $180 among occasional users, an excess of $46 (p < .001); and to $244 among regular users, an excess of $111 (p < .001, comparison with both nonusers and occasional users). Cohort members with any baseline year NSAID use had an adjusted mean annual payment of $191, $57 (p < .001) higher than that for nonusers. In both users and nonusers of NSAIDs, medications and inpatient care accounted for the largest component of costs. Among regular NSAID users, excess payments increased with baseline NSAID dose: $56, $120, and $157 for less than 1, 1 to 2, and more than 2 standard units per day, respectively (p < .01, linear trend). CONCLUSIONS: Nonsteroidal anti-inflammatory drug (NSAID) use in elderly patients was associated with substantial excess costs and utilization of medical care for gastrointestinal disorders.

Aged↗
PubMed1996

Black Americans have an increased rate of angiotensin converting enzyme inhibitor-associated angioedema.

OBJECTIVE: To study the association of race and other patient characteristics associated with angiotensin converting enzyme (ACE) inhibitor-associated angioedema. METHODS: This was a retrospective cohort study of participants in the Tennessee Medicaid Program ( >or= 15 years of age) to whom ACE inhibitors had been prescribed from 1986 through 1992. RESULTS: We identified 82 patients with confirmed angioedema during 51,752 person-years of ACE inhibitor use, giving an overall rate of angioedema of 1.6 per 1000 person-years of ACE inhibitor use. After potential confounding factors were controlled for, the adjusted relative risk (RR) of angioedema among black American users of ACE inhibitors was 4.5 (95% confidence interval [CI] 2.9 to 6.8) compared with white subjects. In addition to race, other factors associated with a significantly increased relative risk in the entire population were the first 30 days of ACE inhibitor use (RR, 4.6; 95% CI, 2.5 to 8.5) compared to > 1 year of use, use of either lisinopril (RR, 2.2; 95% CI, 1.2 to 3.9) or enalapril (RR, 2.2; 95% CI, 1.4 to 3.5) compared to captopril, and previous hospitalization for any diagnosis within 30 days (RR, 2.0; 95% CI, 1.1 to 3.6). Neither ACE inhibitor dose nor concurrent diuretic use was associated with the risk of angioedema. CONCLUSIONS: These data suggest that black Americans have a substantially increased risk of ACE inhibitor-associated angioedema compared with white subjects and that this increased risk cannot be attributed to an effect of dose, specific ACE inhibitor, or concurrent medications.

Adolescent↗
PubMed1996

Clinical and biomechanical measures of balance as fall predictors in ambulatory nursing home residents.

BACKGROUND: We evaluated the capacity of biomechanical and clinical measures of balance to predict future risk of recurrent falls in a cohort of frail, elderly ambulatory residents of 12 Tennessee community nursing homes. METHODS: Baseline measurements of balance and other potential fall risk factors were obtained in 303 ambulatory nursing home residents. Balance measures included biomechanics force platform measurements of postural sway (area ellipse and mean velocity) and clinical measures, which included functional reach, Tinetti balance subscale (adapted from Tinetti's Performance Oriented Mobility Index), timed chair stands, and 10-foot walk. Residents who fell two or more times during follow-up (mean of 11 months) were identified from nursing home incident reports and nursing notes. The predictive value of the balance measures was evaluated by the incidence density ratio (IDR) estimated from proportional hazards models. RESULTS: There were 118 recurrent fallers (54.2 per 100 person-years). Rates of recurrent falls increased with increasing quintiles of both the biomechanical and clinical measures of balance, with unadjusted IDRs (95% CI) per quintile change of 1.22 (1.07-1.39) for area ellipse, 1.12 (0.98-1.27) for mean velocity of postural sway, 1.29 (1.13-1.47) for the Tinetti balance subscale, 1.24 (1.08-1.41) for timed walk, 1.24 (1.09-1.42) for timed chair stands, and 1.12 (0.98-1.28) for functional reach. Controlling for age, gender, height, and weight did not materially affect the linear relationship between the balance measure quintiles and subsequent recurrent falls. However, after controlling for additional fall risk factors, only area ellipse of postural sway and the Tinetti balance subscale remained independently predictive of subsequent recurrent fall rates, with IDRs of 1.16 (1.02-1.36) and 1.17 (1.01-1.34), respectively. In an analysis where subjects were stratified by tertiles of each of these two measures, each measure appeared to independently predict future rates of recurrent falls. The independent predictive capacity of each measure persisted after controlling for other fall risk factors in a multivariate analysis with IDRs of 1.15 (1.00-1.32) for area ellipse and 1.15 (1.00-1.32) for the Tinetti balance subscale. Inclusion of both balance measures in a model with other fall risk factors to evaluate their relationship did not materially alter IDR point estimates of these risk factors. CONCLUSIONS: In this cohort of frail, nursing home residents, both area ellipse of postural sway and the Tinetti balance subscale independently predicted risk of future recurrent falls. However, the predictive value of other independent fall risk factors on risk of future recurrent falls persisted and was not explained by these two measures. Thus, assessment of patient fall risk based on surrogate endpoints, for either research or clinical practice, may need to include multiple measurements.

Accidental Falls↗
PubMed1996

Injurious falls in nonambulatory nursing home residents: a comparative study of circumstances, incidence, and risk factors.

OBJECTIVE: To determine the circumstances of, incidence of, and risk factors for falls resulting in serious injuries in nonambulatory nursing home residents compared with those for ambulatory residents. DESIGN: Prospective cohort study with 1-year follow-up. SETTING: Twelve community nursing homes in Tennessee. SUBJECTS: A total of 1228 residents, 65 years of age or older, of whom 725 (59%) were nonambulatory and 503 (41%) were ambulatory. MEASUREMENTS: Baseline data were obtained for potential risk factors for injurious falls. These included demographic characteristics, mental and physical function, vision, hearing, incontinence, and use of mechanical restraints and psychotropic drugs. Data were obtained from direct resident assessment, care provider interview, and the nursing home Minimum Data Set (MDS) (validated in a sample of residents). OUTCOME: There were 111 first falls resulting in serious injury (head injury with altered consciousness, fracture, joint dislocation or sprain, or sutured laceration) that received medical treatment (hospitalization, emergency room visit, physician visit, or on-site radiological examination), ascertained from facility incident reports and nursing home charts. RESULTS: Nonambulatory residents had a substantially greater prevalence of mental and physical impairment. Circumstances of injurious falls in nonambulatory (n = 39 falls) and ambulatory (n = 72 falls) residents differed; those in the former groups were more likely to involve equipment (87% vs 45%, P < .0001), occur while seated or during transferring (82% vs 21%, P < .0001), and from a chair/bed level (54% vs 6%, P < .0001). The incidence of injurious falls in nonambulatory residents (6.7 per 100 person-years) was less than half that in ambulatory residents (17.0 per 100 person-years, P < .0001). After controlling for other factors, the nonambulatory residents at highest risk were those not bed-bound and with capacity for independent transfer (incidence density ratio (IDR) = 2.02, 95% CI = 1.07-7.99); the ambulatory residents at highest risk were baseline users of psychotropic drugs (IDR = 2.49, 95% CI = 1.43-4.33). CONCLUSIONS: In the study cohort, nonambulatory residents had 35% of injurious falls. Because the circumstances and risk factors of these events were substantially different from those for ambulatory residents, separate prevention strategies may be needed for this group. These data suggest that increasing the safety of transferring and of equipment are appropriate targets for interventions.

Accidental Falls↗
PubMed1996

Individual sulfonylureas and serious hypoglycemia in older people.

OBJECTIVE: To compare the risk of serious hypoglycemia associated with the use of individual sulfonylureas in older people. DESIGN: A retrospective cohort study. SETTING: The Tennessee Medicaid Program. PATIENTS: A total of 13,963 Medicaid enrollees, aged 65 years or older, who were prescribed one of six sulfonylureas from 1985 to 1989. MAIN OUTCOME MEASURE: Hospitalization, emergency room admission, or death associated with neuroglycopenic or autonomic symptoms, myocardial infarction, stroke, or injury, with a concomitant blood glucose determination of less than 2.8 mmol/L (50 mg/dL). RESULTS: We identified 255 persons with a first episode of serious hypoglycemia during 20,715 person-years of sulfonylurea use. The crude rate (per 1000 person-years) of serious hypoglycemia was highest in glyburide users, 16.6 (95% confidence interval [CI], 13.2 to 19.9 and lowest among users of tolbutamide, 3.5 (95% CI, 1.2 to 5.9). Users of tolbutamide, tolazamide, and glipizide had lower risks of serious hypoglycemia than users of chlorpropamide, whereas the risk of serious hypoglycemia among glyburide users did not differ from that of chlorpropamide users. Among second generation sulfonylureas, the adjusted relative risk of severe hypoglycemia among glyburide users, compared with glipizide users, was 1.9 (95% CI, 1.2 to 2.9). An increased risk of serious hypoglycemia associated with use of glyburide compared with glipizide occurred in all strata, including those defined by gender, race, nursing home residence, dose, and duration of use. CONCLUSIONS: Significant differences in risk of serious hypoglycemia were observed among users of individual agents. This may be explained by duration, timing, or potency of hypoglycemic action. These data confirm previous findings that chlorpropamide use is associated with high risk of hypoglycemia and indicate that among second generation sulfonylureas, glipizide is less associated with hypoglycemia than is glyburide. More information comparing the effectiveness of glycemic control among individual sulfonylureas is needed to assist prescribers in selecting a specific agent for use in clinical practice.

Aged↗
PubMed1996

Clinical studies of drug effects in humans.

Many important drug properties cannot be predicted from in vitro or animal studies but must be quantified from studies of clinically relevant endpoints in humans. Clinical study designs include the randomized controlled trial (RCT) and a variety of observational designs. In RCTs, randomization usually ensures treatment group comparability with respect to other factors, so outcome differences reflect treatment differences per se. Properly conducted RCTs thus are the strongest study design, the mainstay of mandatory premarketing studies, and essential for evaluation of therapeutic efficacy. RCT limitations include frequent use of surrogate endpoints, limited power, short-term follow-up, and cross-contamination of study groups. For ethical reasons, some questions cannot be studied with RCTs. The simplest observational design, the case series, has limited value because it lacks a denominator. Limitations of cohort and case-control studies include misclassification, selection bias, and confounding. Despite their limitations, properly conducted experimental and observational clinical studies provide essential data for clinical practice.

Aspirin↗
PubMed1995

Psychotropic drugs and risk of recurrent falls in ambulatory nursing home residents.

Although psychotropic drug use has been associated with increased risk of falls in long-term care settings; this association may be confounded by the high prevalence of dementia and depression and other fall risk factors. This question was addressed in a prospective cohort study of recurrent falls among 282 ambulatory residents of 12 Tennessee nursing homes during 1991-1992. Eligible subjects were > or = 65 years of age, ambulatory, able to provide study data, and expected to remain in the nursing home for > or = 3 months. Baseline data collected for each cohort member included symptoms of dementia (cognitive impairment and behavior problems) and depression, medication use, and other potential fall risk factors. Falls were ascertained from facility incident reports and nursing home charts. During follow-up, 111 residents had > or = 2 falls, an incidence rate of 54.9 recurrent falls per 100 person-years. With the use of Cox proportional hazards modeling, the authors found incidence density ratios (95% confidence intervals (Cl)) showing that the following risk factors were independently associated with recurrent falls: age > or = 75 years (1.66 (1.01-2.72)); > or = 4 assisted activities of daily living (1.94 (1.09-3.47)); middle (2.08 (1.20-3.61)) and upper (2.54 (1.44-4.49)) tertiles of balance impairment; fall in the 90 days preceding assessment (2.01 (1.32-3.06)); and upper tertile of behavior problems (1.65 (1.03-2.64)). The rate of recurrent falls increased tenfold as the number of these risk factors increased from 0 to 5 (21.4 to 231.5 per 100 person-years, p < 0.0002). After controlling for symptoms of dementia and depression and other fall risk factors, the incidence density ratio for recurrent falls in baseline regular psychotropic drug users (n = 178) compared with nonusers (n = 104) was 1.97 (95% Cl 1.28-3.05). Within groups defined by number of other independent fall risk factors present, regular psychotropic users had a recurrent fall rate that was greater than that for nonusers: 44.1 versus 22.9 per 100 person-years (p = 0.03) in the low risk (< or = 2 factors) group and 98.7 versus 64.3 (p = 0.08) in the high risk (> 2 factors) group. The attributable risk of recurrent falls for regular psychotropic drug users was 36%, which suggests optimal management of psychopharmacotherapy is an essential component of fall prevention programs for ambulatory nursing home residents.

Accidental Falls↗