Factors associated with falls among community-dwelling older people in Taiwan

<p><b>INTRODUCTION</b>Falls are common among older people. Previous studies have shown that falls were multifactorial. However, data regarding community-dwelling Chinese population are minimal. We aimed to study factors associated with falls among community-dwelling older Chinese people.</p><p><b>MATERIALS AND METHODS</b>We conducted a cross-sectional study in a community hospital in Taiwan in 2010. Our sample included 671 elders from the 3680 examinees of the free annual Senior Citizens Health Examination. Participants were interviewed with a detailed questionnaire, and 317 elders were further invited for serum vitamin D tests. The main outcome was falls in the previous 12 months. Predictor variables included sociodemographic characteristics, lifestyle risk factors, body stature, frailty, serum 25 (OH) D levels, and medications.</p><p><b>RESULTS</b>The mean age of the 671 participants was 75.7 ± 6.4 years old, and 48.7% of which were female. Fallers comprised 21.0% of the study population. In multivariate models, female gender (adjusted odds ratio (aOR): 2.32), loss of height in adulthood (aOR: 1.52), low body weight (aOR: 2.69), central obesity (aOR: 1.67), frailty (aOR: 1.56), polypharmacy (aOR: 2.18) and hyperglycaemia (aOR: 1.56) were factors associated with falls. Vitamin D insufficiency (serum 25 (OH) D levels <30 ng/mL) was not associated with falls (OR: 0.78; 95% CI, 0.38 to 1.60) (n = 317) in this study.</p><p><b>CONCLUSION</b>Among community-dwelling older people in Taiwan, falls were mainly associated with female gender, polypharmacy, frailty, reduced body height, low body weight or central obesity, and hyperglycaemia. In addition to other risk factors, body stature should be considered as a novel risk factor when screening elders at risk for falls.</p>

Rethinking Statistical Approaches to Evaluating Drug Safety

PURPOSE: The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. MATERIALS AND METHODS: Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to be inadequate. Therefore, based on the concept of proof of safety, the non-inferiority hypothesis is employed to prove that the risk of new drugs does not exceed a pre-specified allowable safety margin, hence proving that a drug has no excessive risk. The results from papers published on Vioxx(R) and Avandia(R) are used to illustrate the difference between the traditional approach for proof of hazard and the non-inferiority approach for proof of safety. RESULTS: The p-values from traditional hypotheses were greater than 0.05, and failed to demonstrate that Vioxx(R) and Avandia(R) are of cardiovascular hazard. However, these results cannot prove that both Vioxx(R) and Avandia(R) are of no cardiovascular risk. On the other hand, the non-inferiority approach can prove that they are of excessive cardiovascular risk. CONCLUSION: The non-inferiority approach is appropriate to prove the safety of drugs.