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1.  Measuring anticholinergic drug exposure in older community-dwelling Australian men: a comparison of four different measures 
Anticholinergic drug exposure is associated with adverse outcomes in older people. While a number of tools have been developed to measure anticholinergic drug exposure, there is limited information about the agreement and overlap between the various scales. The aim of this study was to investigate the agreement and overlap between different measures of anticholinergic drug exposure in a cohort of community-dwelling older men.
A cross-sectional study was used to compare anticholinergic drug exposure calculated using the Anticholinergic Risk Scale (ARS), the Anticholinergic Drug Scale (ADS), the Anticholinergic Cognitive Burden (ACB) and the Drug Burden Index anticholinergic subscale (DBI-ACH) in a cohort of community-dwelling men aged 70 years and older (n = 1696). Statistical agreement, expressed as Cohen's kappa (κ), between these measurements was calculated.
Differences were found between the tools regarding the classification of anticholinergic drug exposure for individual participants. Thirteen percent of the population used a drug listed as anticholinergic on the ARS, 39% used a drug listed on the ADS and the ACB, and 18% of the population used one or more anticholinergic drugs listed on the DBI-ACH. While agreement was good between the ACB and ADS (κ = 0.628, 95% CI 0.593, 0.664), little agreement was found between remaining tools (κ = 0.091–0.264).
With the exception of the ACB and ADS, there was poor agreement regarding anticholinergic drug exposure among the four tools compared in this study. Great care should be taken when interpreting anticholinergic drug exposure using existing scales due to the wide variability between the different scales.
PMCID: PMC4631189  PMID: 25923961
anticholinergic burden; anticholinergic drug exposure; drug utilization; methodology; older people
2.  Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial 
PLoS Medicine  2016;13(8):e1002112.
The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors.
Methods and Findings
A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. Main outcomes: falls during the 12 mo trial and Trail Making Tests. Secondary outcomes: The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control participants (82%, p = 0.04). Mean attendance at dance classes was 51%. During the period, 444 falls were recorded; there was no significant difference in fall rates between the control group (0.80 per person-year) and the dance group (1.03 per person-year). Using negative binomial regression with robust standard errors the adjusted Incidence Rate Ratio (IRR) was 1.19 (95% CI: 95% CI = 0.83, 1.71). In exploratory post hoc subgroup analysis, the rate of falls was higher among dance participants with a history of multiple falls (IRR = 2.02, 95% CI: 1.15, 3.54, p = 0.23 for interaction) and with the folk dance intervention (IRR = 1.68, 95% CI: 1.03, 2.73). There were no significant between-group differences in executive function test (TMT-B = 2.8 s, 95% CI: −6.2, 11.8). Intention to treat (ITT) analysis revealed no between-group differences at 12-mo follow-up in the secondary outcome measures, with the exception of postural sway, favouring the control group. Exploratory post hoc analysis by study completers and style indicated that ballroom dancing participants apparently improved their gait speed by 0.07 m/s relative to control participants (95% CI: 0.00, 0.14, p = 0.05). Study limitations included allocation to style based on logistical considerations rather than at random; insufficient power to detect differential impacts of different dance styles and smaller overall effects; variation of measurement conditions across villages; and no assessment of more complex balance tasks, which may be more sensitive to changes brought about by dancing.
Social dancing did not prevent falls or their associated risk factors among these retirement villages' residents. Modified dance programmes that contain "training elements" to better approximate structured exercise programs, targeted at low and high-risk participants, warrant investigation.
Trial Registration
The Australian New Zealand Clinical Trials Registry ACTRN12612000889853
In a cluster-randomized trial, Dafna Merom and colleagues have studied the potential for provision of social dancing classes to reduce the incidence of falls in elderly people.
Author Summary
Why Was This Study Done?
Activities that challenge balance are recognized as efficacious fall prevention strategies.
Pilot studies have demonstrated that a variety of dance styles can improve balance and gait speed of older adults, but no studies have examined whether dance interventions can reduce the number of falls.
What Did the Researchers Do and Find?
We invited all adults who lived independently in 23 retirement villages across Sydney, Australia, to participate in social dance classes (folk dance or ballroom) twice weekly over 12 mo, in total 80 h; 12.3% of the residents expressed interest in the program.
We randomly assigned the retirement villages to receive the social dancing, (12 villages, 279 participants) or to a “wait-listed” comparison group (11 villages, 251 participants).
We found that social dancing was not effective in reducing the number of falls; nor did it improve a variety of fall-related risk factors (e.g., balance, lower leg strength, cognitive processing speed, or task shifting), apart from a small apparent improvement in gait speed, particularly among ballroom participants.
We also found that older adults who had multiple falls in the year prior to the study and received the dance program seemed to fall more often than their counterparts in the comparison group.
What Do These Findings Mean?
This large-scale pragmatic trial suggests that social dance, as delivered in this trial, should not be considered as a fall prevention strategy.
The mixture of participants with a variety of fall-risk levels, the inclusion of active participants, and the relatively low attendance, on average 51% of the classes prescribed, may explain these results.
We suggest that a modified social dance program that contains “training elements” of structured exercise, particularly balance, targeting low and high risk groups separately, should be tested to ascertain whether dance is an effective fall prevention strategy.
PMCID: PMC5004860  PMID: 27575534
3.  A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy 
Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people.
ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture—vertebral, hip and non-vert-non-hip—occurring post randomisation. Fall-related hospital presentations are a secondary outcome.
This substudy will determine whether a widely available, simple and inexpensive health intervention—aspirin—reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention.
Trial registration number
The protocol for this substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561).
PMCID: PMC4879092  PMID: 26002770
4.  A cross-sectional study of hyponatraemia among elderly patients with heart failure in Uganda 
BMJ Open  2016;6(5):e009775.
Hyponatraemia is a common electrolyte disturbance among older patients. We determined the prevalence of and factors associated with hyponatraemia among older patients with predominantly acute decompensated heart failure attending a tertiary hospital in Kampala, Uganda.
Main study aim: (1) to determine the prevalence of hyponatraemia among patients aged 60 years and above with heart failure attending Mulago National Referral Hospital; (2) to describe the factors associated with hyponatraemia among patients aged 60 years and above with heart failure attending Mulago National Referral Hospital.
The study was conducted in one tertiary hospital located in the northeast of Kampala, Uganda.
400 adults aged 60 years and above were identified for the study. Of these, 188 were excluded as they did not fulfil the inclusion criteria and one declined to participate, leaving a final study group of 211 older adults aged 60 years and above, with a clinical diagnosis of heart failure using Framingham's criteria.
The prevalence of hyponatraemia was 24.2% (51/211). Hyponatraemia was mainly found in patients with mild-to-moderate heart failure, New York Heart Association classes 2 and 3. Of the 51 patients with hyponatraemia, 27 (52.9%) had mild hyponatraemia, while 24 (47.1%) had moderate to severe hyponatraemia of 130–125 mmol/L. History of vomiting (OR=2.94, 95% CI 1.29 to 6.70, p=0.010) and use of loop diuretics (OR=2.71, 95% CI 1.13 to 6.52, p=0.026) were identified as independent factors associated with hyponatraemia among older patients with heart failure.
Our study revealed a relatively high prevalence of hyponatraemia among older patients with mild to moderate heart failure. Patients presenting with a history of vomiting from any cause or use of loop diuretics were more likely to have hyponatraemia.
PMCID: PMC4874129  PMID: 27188802
5.  Effect of Frailty and Age on Platelet Aggregation and Response to Aspirin in Older Patients with Atrial Fibrillation: A Pilot Study 
Cardiology and Therapy  2016;5(1):51-62.
Frailty is associated with changes in inflammation, coagulation, and possibly platelet function. Aspirin is still prescribed for stroke prevention in older patients with atrial fibrillation, although not recommended by current guidelines. In frail older people, it is unclear whether platelet aggregability and response to aspirin are altered. This study aims to investigate the effects of frailty and chronological age on platelet aggregability and on responses to aspirin in older patients with atrial fibrillation.
Inpatients with atrial fibrillation aged ≥65 years were recruited from a tertiary referral hospital in Sydney, Australia. Frailty was determined using the Reported Edmonton Frail Scale. Platelet aggregation studies were performed using whole blood impedance aggregometry.
Data from 115 participants were analyzed (mean age 85 ± 6 years, 41% female, 52% frail). Spearman correlation coefficients found no significant associations of platelet aggregation with chronological age or with frailty score. Comparison between frail and non-frail groups showed that there was no impact of frailty status on aggregation assays amongst participants who were not taking any antiplatelet drugs. Amongst participants taking aspirin, the frail had higher adjusted arachidonic acid agonist (ASPI) test measures (AU per platelet) than the non-frail (0.11 ± 0.11 vs. 0.05 ± 0.04; p = 0.04), suggesting that in frail participants, platelet aggregation is less responsive to aspirin than in non-frail.
We found no effect of chronological age or frailty status on platelet aggregation amongst older patients with atrial fibrillation in this pilot study. However, frailty could be associated with reduced aspirin responsiveness among older patients with atrial fibrillation.
PMCID: PMC4906083  PMID: 26843016
Ageing; Aspirin; Atrial fibrillation; Frailty; Platelet aggregation
6.  Cross-sectional and longitudinal associations between the active vitamin D metabolite (1,25 dihydroxyvitamin D) and haemoglobin levels in older Australian men: the Concord Health and Ageing in Men Project 
Age  2015;37(1):8.
Anaemia and low 25 hydroxyvitamin D (25D) and 1,25 dihydroxyvitamin D (1,25D) levels are common in older people and may adversely affect morbidity and mortality. While there is some evidence for an association between low serum 25D levels and anaemia, there are limited studies among community-dwelling older people. In addition, the relationship between anaemia and the active vitamin D metabolite, 1,25D, has not been investigated. The aim of this study was to examine the associations between serum 25D and 1,25D with anaemia in community-living men aged ≥70 years. Population-based, cross-sectional analysis of the baseline phase and longitudinal analysis of the Concord Health and Ageing in Men Project (CHAMP), a large epidemiological study conducted in Sydney among men aged 70 years and older, were performed; 1666 men were seen at baseline (2005–2007), 1314 men at a 2-year follow-up (2007–2009) and 917 at a 5-year follow-up (2012–2013). The main outcome measurement was haemoglobin levels as a continuous measure. Covariates included 25D and 1,25D, estimated glomerular filtration rate, demographic information, lifestyle measures, health conditions and medication information. The prevalence of anaemia (Hb < 13.0 g/dL, WHO definition) was 14.6 %. In cross-sectional analysis, serum 25D concentrations were positively associated with haemoglobin levels in unadjusted analysis (β value 0.004; 95 % confidence interval (CI) 0.0009, 0.007; p = 0.01), but the associations were no longer significant after multivariate adjustment. The association between 1,25D levels and haemoglobin levels was significant in unadjusted analysis (β value 0.003; 95 % CI 0.002, 0.004; p < 0.0001) and remained significant in adjusted analysis (β value 0.001; 95 % CI 0.004, 0.003; p = 0.01). Serum 1,25D (but not 25D) levels at baseline were significantly associated with changes in haemoglobin over 2 and 5 years in unadjusted (β value 0.002; 95 % CI 0.0009, 0.003; p < 0.0001) and in fully adjusted analyses (β value 0.001; 95 % CI 0.0004, 0.002; p = 0.001). Serum 1,25D, but not 25D, concentrations are independently associated with haemoglobin levels in older men in both cross-sectional and longitudinal analyses. This raises the question whether vitamin D metabolites may influence anaemia states, mediated through different biological pathways, or represent a time-dependent biomarker of chronic ill health.
PMCID: PMC4315774  PMID: 25649710
Vitamin D; Calcitriol; Anaemia older men; Population study
7.  6-PACK programme to decrease fall injuries in acute hospitals: cluster randomised controlled trial 
The BMJ  2016;352:h6781.
Objective To evaluate the effect of the 6-PACK programme on falls and fall injuries in acute wards.
Design Cluster randomised controlled trial.
Setting Six Australian hospitals.
Participants All patients admitted to 24 acute wards during the trial period.
Interventions Participating wards were randomly assigned to receive either the nurse led 6-PACK programme or usual care over 12 months. The 6-PACK programme included a fall risk tool and individualised use of one or more of six interventions: “falls alert” sign, supervision of patients in the bathroom, ensuring patients’ walking aids are within reach, a toileting regimen, use of a low-low bed, and use of a bed/chair alarm.
Main outcome measures The co-primary outcomes were falls and fall injuries per 1000 occupied bed days.
Results During the trial, 46 245 admissions to 16 medical and eight surgical wards occurred. As many people were admitted more than once, this represented 31 411 individual patients. Patients’ characteristics and length of stay were similar for intervention and control wards. Use of 6-PACK programme components was higher on intervention wards than on control wards (incidence rate ratio 3.05, 95% confidence interval 2.14 to 4.34; P<0.001). In all, 1831 falls and 613 fall injuries occurred, and the rates of falls (incidence rate ratio 1.04, 0.78 to 1.37; P=0.796) and fall injuries (0.96, 0.72 to 1.27; P=0.766) were similar in intervention and control wards.
Conclusions Positive changes in falls prevention practice occurred following the introduction of the 6-PACK programme. However, no difference was seen in falls or fall injuries between groups. High quality evidence showing the effectiveness of falls prevention interventions in acute wards remains absent. Novel solutions to the problem of in-hospital falls are urgently needed.
Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000332921.
PMCID: PMC4727091  PMID: 26813674
8.  Multiple, but not traditional risk factors predict mortality in older people: the concord health and ageing in men project 
Age  2014;36(6):9732.
This study aims to identify the common risk factors for mortality in community-dwelling older men. A prospective population-based study was conducted with a median of 6.7 years of follow-up. Participants included 1705 men aged ≥70 years at baseline (2005–2007) living in the community in Sydney, Australia. Demographic information, lifestyle factors, health status, self-reported history of diseases, physical performance measures, blood pressure, height and weight, disability (activities of daily living (ADL) and instrumental ADLs, instrumental ADLs (IADLs)), cognitive status, depressive symptoms and blood analyte measures were considered. Cox regression analyses were conducted to model predictors of mortality. During follow-up, 461 men (27 %) died. Using Cox proportional hazards model, significant predictors of mortality included in the final model (p < 0.05) were older age, body mass index < 20 kg m2, high white cell count, anaemia, low albumin, current smoking, history of cancer, history of myocardial infarction, history of congestive heart failure, depressive symptoms and ADL and IADL disability and impaired chair stands. We found that overweight and obesity and/or being a lifelong non-drinker of alcohol were protective against mortality. Compared to men with less than or equal to one risk factor, the hazard ratio in men with three risk factors was 2.5; with four risk factors, it was 4.0; with five risk factors, it was 4.9; and for six or more risk factors, it was 11.4, respectively. We have identified common risk factors that predict mortality that may be useful in making clinical decisions among older people living in the community. Our findings suggest that, in primary care, screening and management of multiple risk factors are important to consider for extending survival, rather than simply considering individual risk factors in isolation. Some of the “traditional” risk factors for mortality in a younger population, including high blood pressure, hypercholesterolaemia, overweight and obesity and diabetes, were not independent predictors of mortality in this population of older men.
PMCID: PMC4234745  PMID: 25403157
Mortality; Sociodemographic; Economic and lifestyle factors; Health conditions; Physical function; Disability
9.  Prevalence of HIV and chronic comorbidities among older adults 
AIDS (London, England)  2012;26(0 1):S55-S63.
Limited evidence is available on HIV, aging and comorbidities in sub-Saharan Africa. This article describes the prevalence of HIV and chronic comorbidities among those aged 50 years and older in South Africa using nationally representative data.
The WHO’s Study of global AGEing and adult health (SAGE) was conducted in South Africa in 2007–2008. SAGE includes nationally representative cohorts of persons aged 50 years and older, with comparison samples of those aged 18–49 years, which aims to study health and its determinants.
Logistic and linear regression models were applied to data from respondents aged 50 years and older to determine associations between age, sex and HIV status and various outcome variables including prevalence of seven chronic conditions.
HIV prevalence among adults aged 50 and older in South Africa was 6.4% and was particularly elevated among Africans, women aged 50–59 and those living in rural areas. Rates of chronic disease were higher among all older adults compared with those aged 18–49. Of those aged 50 years and older, 29.6% had two or more of the seven chronic conditions compared with 8.8% of those aged 18–49 years (P < 0.0001). When controlling for age and sex among those aged 50 and older, BMI was lower among HIV-infected older adults aged 50 and older (27.5 kg/m2) than in HIV-uninfected individuals of the same age (30.6) (P < 0.0001). Grip strength among HIV-infected older adults was significantly (P=0.004) weaker than among similarly-aged HIV-uninfected individuals.
HIV-infected older adults in South Africa have high rates of chronic disease and weakness. Studies are required to examine HIV diagnostics and treatment instigation rates among older adults to ensure equity of access to quality care, as the number and percentage of older adults living with HIV is likely to increase.
PMCID: PMC4404756  PMID: 22781177
aging; chronic disease; comorbidity; HIV; older adults; South Africa
10.  MultiComponent Exercise and theRApeutic lifeStyle (CERgAS) intervention to improve physical performance and maintain independent living among urban poor older people - a cluster randomised controlled trial 
BMC Geriatrics  2015;15:8.
The ability of older people to function independently is crucial as physical disability and functional limitation have profound impacts on health. Interventions that either delay the onset of frailty or attenuate its severity potentially have cascading benefits for older people, their families and society. This study aims to develop and evaluate the effectiveness of a multiComponent Exercise and theRApeutic lifeStyle (CERgAS) intervention program targeted at improving physical performance and maintaining independent living as compared to general health education among older people in an urban poor setting in Malaysia.
This cluster randomised controlled trial will be a 6-week community-based intervention programme for older people aged 60 years and above from urban poor settings. A minimum of 164 eligible participants will be recruited from 8 clusters (low-cost public subsidised flats) and randomised to the intervention and control arm. This study will be underpinned by the Health Belief Model with an emphasis towards self-efficacy. The intervention will comprise multicomponent group exercise sessions, nutrition education, oral care education and on-going support and counselling. These will be complemented with a kit containing practical tips on exercise, nutrition and oral care after each session. Data will be collected over four time points; at baseline, immediately post-intervention, 3-months and 6-months follow-up.
Findings from this trial will potentially provide valuable evidence to improve physical function and maintain independence among older people from low-resource settings. This will inform health policies and identify locally acceptable strategies to promote healthy aging, prevent and delay functional decline among older Malaysian adults.
Trial registration
PMCID: PMC4334409  PMID: 25887235
Elderly; Exercise; Physical function; Frailty; Randomised controlled trial; Lifestyle
11.  Total hospital stay for hip fracture: measuring the variations due to pre-fracture residence, rehabilitation, complications and comorbidities 
Hospital treatment for hip fracture is complex, often involving sequential episodes for acute orthopaedics, rehabilitation and care of contingent conditions. Most reports of hospital length of stay (LOS) address only the acute phase of care. This study identifies the frequency and mean duration of the component episodes within total hospital stay, and measures the impacts of patient-level and clinical service variables upon both acute phase and total LOS.
Administrative datasets for 2552 subjects hospitalised between 1 July 2008 and 30 June 2009 were linked. Associations between LOS, pre-fracture accommodation status, age, sex, fracture type, hospital separation codes, selected comorbidities and complications were examined in regression models for acute phase and total LOS for patients from residential aged care (RAC) and from the community.
Mean total LOS was 30.8 days, with 43 per cent attributable to acute fracture management, 37 per cent to rehabilitation and 20 per cent to management of contingent conditions. Community patients had unadjusted total LOS of 35.4 days compared with 18.8 days for RAC patients (p <0.001). The proportion of transfers into rehabilitation (57 per cent vs 17 per cent, p <0.001) was the major determinant for this difference. In multivariate analyses, new RAC placement, discharge to other facilities, and complications of pressure ulcer, urinary or surgical site infections increased LOS by at least four days in one or more phases of hospital stay.
Pre-fracture residence, selection for rehabilitation, discharge destination and specific complications are key determinants for acute phase and total LOS. Calculating the dimensions of specific determinants for LOS may identify potential efficiencies from targeted interventions such as orthogeriatric care models.
PMCID: PMC4308914  PMID: 25609030
Hip fracture; Length of stay; Complications; Residential aged care; Rehabilitation
12.  A Post-Hospital Home Exercise Program Improved Mobility but Increased Falls in Older People: A Randomised Controlled Trial 
PLoS ONE  2014;9(9):e104412.
Home exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known. The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital.
Methods and Findings
This randomised controlled trial (ACTRN12607000563460) was conducted among 340 older people. Intervention group participants (n = 171) were asked to exercise at home for 15–20 minutes up to 6 times weekly for 12 months. The control group (n = 169) received usual care. Primary outcomes were rate of falls (assessed over 12 months using monthly calendars), performance-based mobility (Lower Extremity Summary Performance Score, range 0–3, at baseline and 12 months, assessor unaware of group allocation) and self-reported ease of mobility task performance (range 0–40, assessed with 12 monthly questionaries). Participants had an average age of 81.2 years (SD 8.0) and 70% had fallen in the past year. Complete primary outcome data were obtained for at least 92% of randomised participants. Participants in the intervention group reported more falls than the control group (177 falls versus 123 falls) during the 12-month study period and this difference was statistically significant (incidence rate ratio 1.43, 95% CI 1.07 to 1.93, p = 0.017). At 12-months, performance-based mobility had improved significantly more in the intervention group than in the control group (between-group difference adjusted for baseline performance 0.13, 95% CI 0.04 to 0.21, p = 0.004). Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups (0.49, 95% CI −0.91 to 1.90, p = 0.488).
An individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital.
Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12607000563460
PMCID: PMC4152130  PMID: 25180702
13.  Statin use and clinical outcomes in older men: a prospective population-based study 
BMJ Open  2013;3(3):e002333.
The aim of this analysis was to investigate the relationship of statins with institutionalisation and death in older men living in the community, accounting for frailty.
Prospective cohort study.
Community-dwelling men participating in the Concord Health and Ageing in Men Project, Sydney, Australia.
Men aged ≥70 years (n=1665).
Data collected during baseline assessments and follow-up (maximum of 6.79 years) were obtained. Information regarding statin use was captured at baseline, between 2005 and 2007. Proportional hazards regression analysis was conducted to estimate the risk of institutionalisation and death according to statin use (exposure, duration and dose) and frailty status, with adjustment for sociodemographics, medical diagnosis and other clinically relevant factors. A secondary analysis used propensity score matching to replicate covariate adjustment in regression models.
At baseline, 43% of participants reported taking statins. Over 6.79 years of follow-up, 132 (7.9%) participants were institutionalised and 358 (21.5%) participants had died. In the adjusted models, baseline statin use was not statistically associated with increased risk of institutionalisation (HR=1.60; 95% CI 0.98 to 2.63) or death (HR=0.88; 95% CI 0.66 to 1.18). There was no significant association between duration and dose of statins used with either outcome. Propensity scoring yielded similar findings. Compared with non-frail participants not prescribed statins, the adjusted HR for institutionalisation for non-frail participants prescribed statins was 1.43 (95% CI 0.81 to 2.51); for frail participants not prescribed statins, it was 2.07 (95% CI 1.11 to 3.86) and for frail participants prescribed statins, it was 4.34 (95% CI 2.02 to 9.33).
These data suggest a lack of significant association between statin use and institutionalisation or death in older men. These findings call for real-world trials specifically designed for frail older people to examine the impact of statins on clinical outcomes.
PMCID: PMC3612783  PMID: 23474793
Clinical Pharmacology; Geriatric Medicine
14.  The study design and methodology for the ARCHER study - adolescent rural cohort study of hormones, health, education, environments and relationships 
BMC Pediatrics  2012;12:143.
Adolescence is characterized by marked psychosocial, behavioural and biological changes and represents a critical life transition through which adult health and well-being are established. Substantial research confirms the role of psycho-social and environmental influences on this transition, but objective research examining the role of puberty hormones, testosterone in males and oestradiol in females (as biomarkers of puberty) on adolescent events is lacking. Neither has the tempo of puberty, the time from onset to completion of puberty within an individual been studied, nor the interaction between age of onset and tempo. This study has been designed to provide evidence on the relationship between reproductive hormones and the tempo of their rise to adult levels, and adolescent behaviour, health and wellbeing.
The ARCHER study is a multidisciplinary, prospective, longitudinal cohort study in 400 adolescents to be conducted in two centres in regional Australia in the State of New South Wales. The overall aim is to determine how changes over time in puberty hormones independently affect the study endpoints which describe universal and risk behaviours, mental health and physical status in adolescents. Recruitment will commence in school grades 5, 6 and 7 (10–12 years of age). Data collection includes participant and parent questionnaires, anthropometry, blood and urine collection and geocoding. Data analysis will include testing the reliability and validity of the chosen measures of puberty for subsequent statistical modeling to assess the impact over time of tempo and onset of puberty (and their interaction) and mean-level repeated measures analyses to explore for significant upward and downward shifts on target outcomes as a function of main effects.
The strengths of this study include enrollment starting in the earliest stages of puberty, the use of frequent urine samples in addition to annual blood samples to measure puberty hormones, and the simultaneous use of parental questionnaires.
PMCID: PMC3496596  PMID: 22950846
Puberty; Hormones; Adolescent; Cohort studies; Rural health; Behaviour; Wellbeing; Public health; Protocol; Paediatrics
15.  Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial 
The BMJ  2012;345:e4547.
Objectives To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home.
Design Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website.
Setting Residents in metropolitan Sydney, Australia.
Participants Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran’s Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises.
Interventions Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months.
Main outcome measures Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass.
Results After 12 months’ follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. The overall incidence of falls in the LiFE programme was 1.66 per person years, compared with 1.90 in the structured programme and 2.28 in the control group. We saw a significant reduction of 31% in the rate of falls for the LiFE programme compared with controls (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99)); the corresponding difference between the structured group and controls was non-significant (0.81 (0.56 to 1.17)). Static balance on an eight level hierarchy scale, ankle strength, function, and participation were significantly better in the LiFE group than in controls. LiFE and structured groups had a significant and moderate improvement in dynamic balance, compared with controls.
Conclusions The LiFE programme provides an alternative to traditional exercise to consider for fall prevention. Functional based exercise should be a focus for interventions to protect older, high risk people from falling and to improve and maintain functional capacity.
Trial registration Australia and New Zealand Clinical Trials Registry 12606000025538.
PMCID: PMC3413733  PMID: 22872695
16.  Determinants of Serum-Induced SIRT1 Expression in Older Men: The CHAMP Study 
Circulating factors that have an effect on SIRT1 expression are influenced by caloric restriction. To determine the association between frailty and such circulating factors, we measured serum-induced SIRT1 expression from a nested cohort of frail (n = 77) and robust (n = 82) participants from Concord Health and Ageing in Men Project, a population-based study of community-dwelling men older than 70 years. Serum-induced SIRT1 expression was not different between frail and robust men (103.1 ± 17.0 versus 100.4 ± 19.3 μg/L). However, subsequent analyses showed that men with the lowest values (first quartile) were less likely to be frail (odds ratio = 0.5, 95% confidence interval = 0.2–1.0, p = .04) and had higher total body lean mass (p = .001) than the other participants. Serum-induced SIRT1 expression did not correlate with age, diseases, medications, albumin, fasting glucose, or lipids. Overall, there was no association between frailty and serum-induced SIRT1 expression; however, post hoc analysis suggested that there might be a paradoxical association between low serum-induced SIRT1 expression and robustness.
PMCID: PMC4007825  PMID: 20819794
SIRT1 expression; Frailty
17.  How fast does the Grim Reaper walk? Receiver operating characteristics curve analysis in healthy men aged 70 and over  
The BMJ  2011;343:d7679.
Objective To determine the speed at which the Grim Reaper (or Death) walks.
Design Population based prospective study.
Setting Older community dwelling men living in Sydney, Australia.
Participants 1705 men aged 70 or more participating in CHAMP (Concord Health and Ageing in Men Project).
Main outcome measures Walking speed (m/s) and mortality. Receiver operating characteristics curve analysis was used to calculate the area under the curve for walking speed and determine the walking speed of the Grim Reaper. The optimal walking speed was estimated using the Youden index (sensitivity+specificity−1), a common summary measure of the receiver operating characteristics curve, and represents the maximum potential effectiveness of a marker.
Results The mean walking speed was 0.88 (range 0.15-1.60) m/s. The highest Youden index (0.293) was observed at a walking speed of 0.82 m/s (2 miles (about 3 km) per hour), corresponding to a sensitivity of 63% and a specificity of 70% for mortality. Survival analysis showed that older men who walked faster than 0.82 m/s were 1.23 times less likely to die (95% confidence interval 1.10 to 1.37) than those who walked slower (P=0.0003). A sensitivity of 1.0 was obtained when a walking speed of 1.36 m/s (3 miles (about 5 km) per hour) or greater was used, indicating that no men with walking speeds of 1.36 m/s or greater had contact with Death.
Conclusion The Grim Reaper’s preferred walking speed is 0.82 m/s (2 miles (about 3 km) per hour) under working conditions. As none of the men in the study with walking speeds of 1.36 m/s (3 miles (about 5 km) per hour) or greater had contact with Death, this seems to be the Grim Reaper’s most likely maximum speed; for those wishing to avoid their allotted fate, this would be the advised walking speed.
PMCID: PMC3240682  PMID: 22174324
18.  Anti-Retroviral Treatment Outcomes among Older Adults in Zomba District, Malawi 
PLoS ONE  2011;6(10):e26546.
There are approximately 3 million people aged 50 and older in sub-Saharan Africa who are HIV-positive. Despite this, little is known about the characteristics of older adults who are on treatment and their treatment outcomes.
A retrospective cohort analysis was performed using routinely collected data with Malawi Ministry of Health monitoring tools from facilities providing antiretroviral therapy services in Zomba district. Patients aged 25 years and older initiated on treatment from July 2005 to June 2010 were included. Differences in survival, by age group, were determined using Kaplan–Meier survival plots and Cox proportional hazards regression models.
There were 10,888 patients aged 25 and older. Patients aged 50 and older (N = 1419) were more likely to be male (P<0.0001) and located in rural areas (P = 0.003) than those aged 25–49. Crude survival estimates among those aged 50–59 were not statistically different from those aged 25–49 (P = 0.925). However, survival among those aged 60 and older (N = 345) was worse (P = 0.019) than among those 25–59. In the proportional hazards model, after controlling for sex and stage at initiation, survival in those aged 50–59 did not differ significantly from those aged 25–49 (hazard ratio 1.00 (95% CI: 0.79 to 1.27; P = 0.998) but the hazard ratio was 1.46 (95% CI: 1.03 to 2.06; P = 0.032) for those aged 60 and older compared to those aged 25–49.
Treatment outcomes of those aged 50–59 are similar to those aged 25–49. A better understanding of how older adults present for and respond to treatment is critical to improving HIV services.
PMCID: PMC3198738  PMID: 22031839
19.  The Association of Alanine Transaminase With Aging, Frailty, and Mortality 
The relationships between blood tests of liver function and injury (alanine transaminase [ALT], gamma-glutamyl transferase, bilirubin, and albumin) with age, frailty, and survival were investigated in 1,673 community-dwelling men aged 70 years or older. ALT was lower in older participants. Those participants with ALT below the median at baseline had reduced survival (hazard ratio 2.10, 95% confidence interval [CI] 1.53–2.87) up to 4.9 years. Older age, frailty, low albumin, low body mass index, and alcohol abstinence also were associated with reduced survival, with age and frailty being the most powerful predictors. Low ALT was associated with frailty (odds ratio 3.54, 95% CI 2.45–5.11), and the relationship between ALT and survival disappeared once frailty and age were included in the survival analysis. Low ALT activity is a predictor of reduced survival; however, this seems to be mediated by its association with frailty and increasing age. ALT has potential value as a novel biomarker of aging.
PMCID: PMC4085878  PMID: 20498223
Alanine transaminase; Aging; Biomarker of aging; Frailty; Liver; Mortality
21.  Estimation of lean body weight in older community-dwelling men 
Lean body weight (LBW) decreases with age while total body fat increases, altering drug pharmacokinetics. The aim of this study was to evaluate the ability of the LBW equation to predict dual-energy X-ray absorptiometry (DXA)-derived fat free mass (FFMDXA) in older community-dwelling males compared with that of two existing FFM equations: the Heitmann and Deurenberg equations.
Data were obtained from 1655 older men enrolled in the Concord Health and Ageing in Men Project. The predictive performance of the LBW and FFM equations to predict FFMDXA accurately was assessed graphically using Bland–Altman plots and quantitatively for precision and bias using the method of Sheiner and Beal in all participants and in frailty and body mass index (BMI) subgroups.
The LBW and Heitmann equations consistently overestimated FFMDXA for all frailty and BMI subgroups with a mean difference [95% confidence interval (CI)] of 5.5 kg (−0.65, 11.63 kg) and 3.34 kg (−2.84, 9.64 kg), respectively. The Deurenberg equation overestimated FFMDXA for overweight participants but underestimated FFMDXA for not-frail participants, with a mean difference (95% CI) of 1 kg (−7.23, 5.25 kg) for all participants.
LBW and FFM estimated using these equations give results comparable to DXA-derived FFM. The LBW and Heitmann equations provide a more consistent estimate of FFMDXA in all frailty and BMI groups despite the Deurenberg equation having the smallest mean difference. Further studies to determine whether the LBW equation is a clinically useful substitute for weight when determining drug dose in older people appear warranted.
PMCID: PMC2824472  PMID: 20233174
community dwelling; estimation; frailty; lean body weight; older men
23.  Prevalence and correlates of physical disability and functional limitation among community dwelling older people in rural Malaysia, a middle income country 
BMC Public Health  2010;10:492.
The prevalence and correlates of physical disability and functional limitation among older people have been studied in many developed countries but not in a middle income country such as Malaysia. The present study investigated the epidemiology of physical disability and functional limitation among older people in Malaysia and compares findings to other countries.
A population-based cross sectional study was conducted in Alor Gajah, Malacca. Seven hundred and sixty five older people aged 60 years and above underwent tests of functional limitation (Tinetti Performance Oriented Mobility Assessment Tool). Data were also collected for self reported activities of daily living (ADL) using the Barthel Index (ten items). To compare prevalence with other studies, ADL disability was also defined using six basic ADL's (eating, bathing, dressing, transferring, toileting and walking) and five basic ADL's (eating, bathing, dressing, transferring and toileting).
Ten, six and five basic ADL disability was reported by 24.7% (95% CI 21.6-27.9), 14.4% (95% CI 11.9-17.2) and 10.6% (95% CI 8.5-13.1), respectively. Functional limitation was found in 19.5% (95% CI 16.8-22.5) of participants. Variables independently associated with 10 item ADL disability physical disability, were advanced age (≥ 75 years: prevalence ratio (PR) 7.9; 95% CI 4.8-12.9), presence of diabetes (PR 1.8; 95% CI 1.4-2.3), stroke (PR 1.5; 95% CI 1.1-2.2), depressive symptomology (PR 1.3; 95% CI 1.1-1.8) and visual impairment (blind: PR 2.0; 95% CI 1.1-3.6). Advancing age (≥ 75 years: PR 3.0; 95% CI 1.7-5.2) being female (PR 2.7; 95% CI 1.2-6.1), presence of arthritis (PR 1.6; 95% CI 1.2-2.1) and depressive symptomology (PR 2.0; 95% CI 1.5-2.7) were significantly associated with functional limitation.
The prevalence of physical disability and functional limitation among older Malaysians appears to be much higher than in developed countries but is comparable to developing countries. Associations with socio-demographic and other health related variables were consistent with other studies.
PMCID: PMC2933720  PMID: 20716377
24.  Drug Burden Index and physical function in older Australian men 
This study evaluated the associations of physical performance and functional status measures with the Drug Burden Index in older Australian men. The Drug Burden Index is a measure of total exposure to anticholinergic and sedative medications that incorporates the principles of dose–response and maximal effect.
A cross-sectional survey was performed on community-dwelling older men enrolled in The Concord Health and Ageing in Men Project, Sydney, Australia. Outcomes included chair stands, walking speed over 6 m, 20-cm narrow walk speed, balance, grip strength and Instrumental Activities of Daily Living score (IADLs).
The study population consisted of 1705 men (age 76.9 ± 5.5 years). Of the 1527 (90%) participants who reported taking medications, 21% were exposed to anticholinergic and 13% to sedative drugs. The average Drug Burden Index in the study population was 0.18 ± 0.35. After adjusting for confounders (sociodemographics, comorbidities, cognitive impairment, depression), Drug Burden Index was associated with slower walking speed (P < 0.05), slower narrow walk speed (P < 0.05), balance difficulty (P < 0.01), grip weakness (P < 0.01) and poorer performance on IADLs (P < 0.05). Associations with physical performance and function were stronger for the sedative than for the anticholinergic component of the Drug Burden Index.
Higher Drug Burden Index is associated with poorer physical performance and functional status in community-dwelling older Australian men. The Drug Burden Index has broad applicability as a tool for assessing the impact of medications on functions that determine independence in older people.
PMCID: PMC2732944  PMID: 19660007
elderly; function; medications
25.  Exercise intervention to prevent falls and enhance mobility in community dwellers after stroke: a protocol for a randomised controlled trial 
BMC Neurology  2009;9:38.
Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors.
Methods and design
Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars) and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition.
This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if found to be effective, has the potential to be implemented within existing community services.
Trial registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000479505).
PMCID: PMC2719587  PMID: 19624858

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