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author:("masui, Tahir")
1.  Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial 
The British Journal of General Practice  2015;65(640):e731-e738.
Background
Regular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups.
Aim
To evaluate two exercise programmes promoting physical activity among older people.
Design and setting
Pragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby.
Method
Practices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs.
Results
In total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar.
Conclusion
The FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.
doi:10.3399/bjgp15X687361
PMCID: PMC4617267  PMID: 26500320
aged people; exercise promotion; falls; general practice; physical activity
2.  Understanding the theoretical underpinning of the exercise component in a fall prevention programme for older adults with mild dementia: a realist review protocol 
Systematic Reviews  2016;5:119.
Background
Older adults with mild dementia are at an increased risk of falls. Preventing those at risk from falling requires complex interventions involving patient-tailored strength- and balance-challenging exercises, home hazard assessment, visual impairment correction, medical assessment and multifactorial combinations. Evidence for these interventions in older adults with mild cognitive problems is sparse and not as conclusive as the evidence for the general community-dwelling older population. The objectives of this realist review are (i) to identify the underlying programme theory of strength and balance exercise interventions targeted at those individuals that have been identified as falling and who have a mild dementia and (ii) to explore how and why that intervention reduces falls in that population, particularly in the context of a community setting. This protocol will explain the rationale for using a realist review approach and outline the method.
Methods
A realist review is a methodology that extends the scope of a traditional narrative or systematic evidence review. Increasingly used in the evaluation of complex interventions, a realist enquiry can look at the wider context of the intervention, seeking more to explain than judge if the intervention is effective by investigating why, what the underlying mechanism is and the necessary conditions for success. In this review, key rough programme theories were articulated and defined through discussion with a stakeholder group. The six rough programme theories outlined within this protocol will be tested against the literature found using the described comprehensive search strategy. The process of data extraction, appraisal and synthesis is outlined and will lead to the production of an explanatory programme theory.
Discussion
As far as the authors are aware, this is the first realist literature review within fall prevention research and adds to the growing use of this methodology within healthcare. This synthesis of evidence will provide a valuable addition to the evidence base surrounding the exercise component of a fall intervention programme for older adults with mild dementia and will ultimately provide clinically relevant recommendations for improving the care of people with dementia.
Systematic review registration
PROSPERO CRD42015030169
Electronic supplementary material
The online version of this article (doi:10.1186/s13643-016-0212-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13643-016-0212-x
PMCID: PMC4952275  PMID: 27435818
Realist review; Realist synthesis; Accidental falls; Fall prevention; Exercise; Dementia; Cognitive impairment
3.  Randomised controlled trial of the effectiveness of community group and home-based falls prevention exercise programmes on bone health in older people: the ProAct65+ bone study 
Age and Ageing  2015;44(4):573-579.
Background: exercise can reduce osteoporotic fracture risk by strengthening bone or reducing fall risk. Falls prevention exercise programmes can reduce fall incidence, and also include strengthening exercises suggested to load bone, but there is little information as to whether these programmes influence bone mineral density (BMD) and strength.
Objective: to evaluate the skeletal effects of home (Otago Exercise Programme, OEP) and group (Falls Exercise Management, FaME) falls prevention exercise programmes relative to usual care in older people.
Methods: men and women aged over 65 years were recruited through primary care. They were randomised by practice to OEP, FaME or usual care. BMD, bone mineral content (BMC) and structural properties were measured in Nottingham site participants before and after the 24-week intervention.
Results: participants were 319 men and women, aged mean(SD) 72(5) years. Ninety-two percentage of participants completed the trial. The OEP group completed 58(43) min/week of home exercise, while the FaME group completed 39(16) and 30(24) min/week of group and home exercise, respectively. Femoral neck BMD changes did not differ between treatment arms: mean (95% CI) effect sizes in OEP and FaME relative to usual care arm were −0.003(−0.011,0.005) and −0.002(−0.010,0.005) g cm−2, respectively; P = 0.44 and 0.53. There were no significant changes in BMD or BMC at other skeletal sites, or in structural parameters.
Conclusions: falls prevention exercise programmes did not influence BMD in older people. To increase bone strength, programmes may require exercise that exerts higher strains on bone or longer duration.
doi:10.1093/ageing/afv055
PMCID: PMC4476850  PMID: 25906791
osteoporosis; prevention; exercise; bone mineral density; X-ray absorptiometry; men; women; aged; primary care, older people
4.  Frailty predicts trajectories of quality of life over time among British community-dwelling older people 
Quality of Life Research  2016;25:1743-1750.
Purpose
To investigate associations between baseline frailty status and subsequent changes in QOL over time among community-dwelling older people.
Methods
Among 363 community-dwelling older people ≥65 years, frailty was measured using Frailty Index (FI) constructed from 40 deficits at baseline. QOL was measured using Older People’s Quality of Life Questionnaire (OPQOL) six times over 2.5 years. Two-level hierarchical linear models were employed to predict QOL changes over time according to baseline frailty.
Results
At baseline, mean age was 73.1 (range 65–90) and 62.0 % were women. Mean FI was 0.17 (range 0.00–0.66), and mean OPQOL was 130.80 (range 93–163). The hierarchical linear model adjusted for age, gender, ethnicity, education, and enrollment site predicted that those with higher FI at baseline have lower QOL than those with lower FI (regression coefficient = −47.64, p < 0.0001) and that QOL changes linearly over time with slopes ranging from 0.80 (FI = 0.00) to −1.15 (FI = 0.66) as the FI increases. A FI of 0.27 is the cutoff point at which improvements in QOL over time change to declines in QOL.
Conclusions
Frailty was associated with lower QOL among British community-dwelling older people. While less frail participants had higher QOL at baseline and QOL improved over time, QOL of frailer participants was lower at baseline and declined.
Electronic supplementary material
The online version of this article (doi:10.1007/s11136-015-1213-2) contains supplementary material, which is available to authorized users.
doi:10.1007/s11136-015-1213-2
PMCID: PMC4893360  PMID: 26747318
Frailty; Quality of life; Well-being; Community-dwelling older people
5.  Novel Use of the Nintendo Wii Board for Measuring Isometric Lower Limb Strength: A Reproducible and Valid Method in Older Adults 
PLoS ONE  2015;10(10):e0138660.
Background
Portable, low-cost, objective and reproducible assessment of muscle strength in the lower limbs is important as it allows clinicians to precisly track progression of patients undergoing rehabilitation. The Nintendo Wii Balance Board (WBB) is portable, inexpensive, durable, available worldwide, and may serve the above function.
Objective
The purpose of the study was to evaluate (1) reproducibility and (2) concurrent validity of the WBB for measuring isometric muscle strength in the lower limb.
Methods
A custom hardware and software was developed to utilize the WBB for assessment of isometric muscle strength. Thirty older adults (69.0±4.2 years of age) were studied on two separate occasions on both the WBB and a stationary isometric dynamometer (SID). On each occasion, three recordings were obtained from each device. For the first recording, means and maximum values were used for further analysis. The test-retest reproducibility was examined using intraclass correlation coefficients (ICC), Standard Error of Measurement (SEM), and limits of agreement (LOA). Bland-Altman plots (BAP) and ICC’s were used to explore concurrent validity.
Results
No systematic difference between test-retest was detected for the WBB. ICC within-device were between 0.90 and 0.96 and between-devices were from 0.80 to 0.84. SEM ranged for the WBB from 9.7 to 13.9%, and for the SID from 11.9 to 13.1%. LOA ranged for the WBB from 20.3 to 28.7% and for the SID from 24.2 to 26.6%. The BAP showed no relationship between the difference and the mean.
Conclusions
A high relative and an acceptable absolute reproducibility combined with a good validity was found for the novel method using the WBB for measuring isometric lower limb strength in older adults. Further research using the WBB for assessing lower limb strength should be conducted in different study-populations.
doi:10.1371/journal.pone.0138660
PMCID: PMC4596703  PMID: 26444554
6.  Novel use of the Nintendo Wii board as a measure of reaction time: a study of reproducibility in older and younger adults 
BMC Geriatrics  2015;15:80.
Background
Reaction time (RT) has been associated with falls in older adults, but is not routinely tested in clinical practice. A simple, portable, inexpensive and reliable method for measuring RT is desirable for clinical settings. We therefore developed a custom software, which utilizes the portable and low-cost standard Nintendo Wii board (NWB) to record RT. The aims in the study were to (1) explore if the test could differentiate old and young adults, and (2) to study learning effects between test-sessions, and (3) to examine reproducibility.
Methods
A young (n = 25, age 20–35 years, mean BMI of 22.6) and an old (n = 25, age ≥65 years, mean BMI of 26.3) study-population were enrolled in this within- and between-day reproducibility study. A standard NWB was used along with the custom software to obtain RT from participants in milliseconds. A mixed effect model was initially used to explore systematic differences associated with age, and test-session. Reproducibility was then expressed by Intraclass Correlation Coefficients (ICC), Coefficient of Variance (CV), and Typical Error (TE).
Results
The RT tests was able to differentiate the old group from the young group in both the upper extremity test (p < 0.001; −170.7 ms (95%CI −209.4;-132.0)) and the lower extremity test (p < 0.001; −224.3 ms (95%CI −274.6;-173.9)). Moreover, the mixed effect model showed no significant learning effect between sessions with exception of the lower extremity test between session one and three for the young group (−35,5 ms; 4.6 %; p = 0.02). A good within- and between-day reproducibility (ICC: 0.76-0.87; CV: 8.5-12.9; TE: 45.7-95.1 ms) was achieved for both the upper and lower extremity test with the fastest of three trials in both groups.
Conclusion
A low-cost and portable reaction test utilizing a standard Nintendo wii board showed good reproducibility, no or little systematic learning effects across test-sessions, and could differentiate between young and older adults in both upper and lower extremity tests.
doi:10.1186/s12877-015-0080-6
PMCID: PMC4496937  PMID: 26155934
Reaction time; Older adults; Young adults; Reproducibility; Nintendo wii board
7.  “Keeping Moving”: factors associated with sedentary behaviour among older people recruited to an exercise promotion trial in general practice 
BMC Family Practice  2015;16:67.
Background
Sedentary behaviour is detrimental to health, even in those who achieve recommended levels of physical activity. Efforts to increase physical activity in older people so that they reach beneficial levels have been disappointing. Reducing sedentary behaviour may improve health and be less demanding of older people, but it is not clear how to achieve this. We explored the characteristics of sedentary older people enrolled into an exercise promotion trial to gain insights about those who were sedentary but wanted to increase activity.
Method
Participants in the ProAct65+ trial (2009–2013) were categorised as sedentary or not using a self-report questionnaire. Demographic data, health status, self-rated function and physical test performance were examined for each group. 1104 participants aged 65 & over were included in the secondary analysis of trial data from older people recruited via general practice. Results were analysed using logistic regression with stepwise backward elimination.
Results
Three hundred eighty seven (35 %) of the study sample were characterised as sedentary. The likelihood of being categorised as sedentary increased with an abnormal BMI (<18.5 or >25 kg/m2) (Odds Ratio 1.740, CI 1.248–2.425), ever smoking (OR 1.420, CI 1.042–1.934) and with every additional medication prescribed (OR 1.069, CI 1.016–1.124). Participants reporting better self-rated physical health (SF-12) were less likely to be sedentary; (OR 0.961, 0.936–0.987). Participants’ sedentary behaviour was not associated with gender, age, income, education, falls, functional fitness, quality of life or number of co-morbidities.
Conclusion
Some sedentary older adults will respond positively to an invitation to join an exercise study. Those who did so in this study had poor self-rated health, abnormal BMI, a history of smoking, and multiple medication use, and are therefore likely to benefit from an exercise intervention.
Trial registration
ISRCTN reference: ISRCTN43453770
doi:10.1186/s12875-015-0284-z
PMCID: PMC4446807  PMID: 26018127
Older people; Physical activity; Sedentary behaviour; Exercise promotion
8.  Does the timed up and go test predict future falls among British community-dwelling older people? Prospective cohort study nested within a randomised controlled trial 
BMC Geriatrics  2015;15:38.
Background
Falling is common among older people. The Timed-Up-and-Go Test (TUG) is recommended as a screening tool for falls but its predictive value has been challenged. The objectives of this study were to examine the ability of TUG to predict future falls and to estimate the optimal cut-off point to identify those with higher risk for future falls.
Methods
This is a prospective cohort study nested within a randomised controlled trial including 259 British community-dwelling older people ≥65 years undergoing usual care. TUG was measured at baseline. Prospective diaries captured falls over 24 weeks. A Receiver Operating Characteristic curve analysis determined the optimal cut-off point to classify future falls risk with sensitivity, specificity, and predictive values of TUG times. Logistic regression models examined future falls risk by TUG time.
Results
Sixty participants (23%) fell during the 24 weeks. The area under the curve was 0.58 (95% confidence interval (95% CI) = 0.49-0.67, p = 0.06), suggesting limited predictive value. The optimal cut-off point was 12.6 seconds and the corresponding sensitivity, specificity, and positive and negative predictive values were 30.5%, 89.5%, 46.2%, and 81.4%. Logistic regression models showed each second increase in TUG time (adjusted for age, gender, comorbidities, medications and past history of two falls) was significantly associated with future falls (adjusted odds ratio (OR) = 1.09, 95% CI = 1.00-1.19, p = 0.05). A TUG time ≥12.6 seconds (adjusted OR = 3.94, 95% CI = 1.69-9.21, p = 0.002) was significantly associated with future falls, after the same adjustments.
Conclusions
TUG times were significantly and independently associated with future falls. The ability of TUG to predict future falls was limited but with high specificity and negative predictive value. TUG may be most useful in ruling in those with a high risk of falling rather than as a primary measure in the ascertainment of risk.
doi:10.1186/s12877-015-0039-7
PMCID: PMC4403843  PMID: 25887660
Timed up and go test; Falls; Older people
9.  Calcaneal quantitative ultrasound and Phalangeal radiographic absorptiometry alone or in combination in a triage approach for assessment of osteoporosis: a study of older women with a high prevalence of falls 
BMC Geriatrics  2014;14:143.
Background
The objective of this study was to investigate if application of United Kingdom National Osteoporosis Society (UK-NOS) triage approach, using calcaneal quantitative ultrasound (QUS), phalangeal radiographic absorptiometry (RA), or both methods in combination, for identification of women with osteoporosis, would reduce the percentage of women who need further assessment with Dual Energy X-ray Absorptiometry (DXA) among older women with a high prevalence of falls.
Methods
We assessed 286 women with DXA of hip and spine (Hologic Discovery) of whom 221 were assessed with calcaneal QUS (Achilles Lunar), 245 were assessed with phalangeal RA (Aleris Metriscan), and 202 were assessed with all three methods. Receiver operator characteristics (ROC) curve for QUS, RA, and both methods in combination predicting osteoporosis defined by central DXA were performed. We identified cutoffs at different sensitivity and specificity values and applied the triage approach recommended by UK-NOS. The percentage of women who would not need further examination with DXA was calculated.
Results
Median age was 80 years (interquartile range [IQR]) [75–85], range 65–98. 66.8% reported at least one fall within the last 12 months. Prevalence of osteoporosis was 44.4%. Area under the ROC-curve (AUC) (95% confidence interval (CI)) was 0.808 (0.748-0.867) for QUS, 0.800 (0.738-0.863) for RA, and 0.848 (0.796-0.900) for RA and QUS in combination. At 90% certainty levels, UK-NOS triage approach would reduce the percentage of women who need further assessment with DXA by 60% for QUS, and 43% for RA. The false negative and false positive rates ranged from 4% to 5% for QUS and RA respectively. For the combined approach using 90% certainty level the proportion of DXAs saved was 22%, the false negative rate was 0% and false positive rate was 0.5%. Using 85% certainty level for the combined approach the proportion of DXAs saved increased to 41%, but false negative and false positive values remained low (0.5%, and 0.5% respectively).
Conclusions
In a two-step, triage approach calcaneal QUS and phalangeal RA perform well, reducing the number of women who would need assessment with central DXA. Combining RA and QUS reduces misclassifications whilst still reducing the need for DXAs.
doi:10.1186/1471-2318-14-143
PMCID: PMC4289572  PMID: 25526670
10.  Developing the principles of chair based exercise for older people: a modified Delphi study 
BMC Geriatrics  2014;14:65.
Background
Chair based exercise (CBE) is suggested to engage older people with compromised health and mobility in an accessible form of exercise. A systematic review looking at the benefits of CBE for older people identified a lack of clarity regarding a definition, delivery, purpose and benefits. This study aimed to utilise expert consensus to define CBE for older people and develop a core set of principles to guide practice and future research.
Methods
The framework for consensus was constructed through a team workshop identifying 42 statements within 7 domains. A four round electronic Delphi study with multi-disciplinary health care experts was undertaken. Statements were rated using a 5 point Likert scale of agreement and free text responses. A threshold of 70% agreement was used to determine consensus. Free text responses were analysed thematically. Between rounds a number of strategies (e.g., amended wording of statements, generation and removal of statements) were used to move towards consensus.
Results
16 experts agreed on 46 statements over four rounds of consultation (Round 1: 22 accepted, 3 removed, 5 new and 17 modified; Round 2: 16 accepted, 0 removed, 4 new and 6 modified; Round 3: 4 accepted, 2 removed, 0 new and 4 modified; Round 4: 4 accepted, 0 removed, 0 new, 0 modified).
Statements were accepted in all seven domains: the definition of CBE (5), intended users (3), potential benefits (8), structure (12), format (8), risk management (7) and evaluation (3).
The agreed definition of CBE had five components: 1. CBE is primarily a seated exercise programme; 2. The purpose of using a chair is to promote stability in both sitting and standing; 3. CBE should be considered as part of a continuum of exercise for frail older people where progression is encouraged; 4. CBE should be used flexibly to respond to the changing needs of frail older people; and 5. Where possible CBE should be used as a starting point to progress to standing programmes.
Conclusions
Consensus has been reached on a definition and a set of principles governing CBE for older people; this provides clarity for implementation and future research about CBE.
doi:10.1186/1471-2318-14-65
PMCID: PMC4039312  PMID: 24884392
Chair based exercise; Older people; Physical activity; Consensus development
11.  European undergraduate curriculum in geriatric medicine developed using an international modified Delphi technique 
Age and Ageing  2014;43(5):695-702.
Introduction: the rise in the number of older, frail adults necessitates that future doctors are adequately trained in the skills of geriatric medicine. Few countries have dedicated curricula in geriatric medicine at the undergraduate level. The aim of this project was to develop a consensus among geriatricians on a curriculum with the minimal requirements that a medical student should achieve by the end of medical school.
Methods: a modified Delphi process was used. First, educational experts and geriatricians proposed a set of learning objectives based on a literature review. Second, three Delphi rounds involving a panel with 49 experts representing 29 countries affiliated to the European Union of Medical Specialists (UEMS) was used to gain consensus for a final curriculum.
Results: the number of disagreements following Delphi Rounds 1 and 2 were 81 and 53, respectively. Complete agreement was reached following the third round. The final curriculum consisted of detailed objectives grouped under 10 overarching learning outcomes.
Discussion: a consensus on the minimum requirements of geriatric learning objectives for medical students has been agreed by European geriatricians. Major efforts will be needed to implement these requirements, given the large variation in the quality of geriatric teaching in medical schools. This curriculum is a first step to help improve teaching of geriatrics in medical schools, and will also serve as a basis for advancing postgraduate training in geriatrics across Europe.
doi:10.1093/ageing/afu019
PMCID: PMC4143490  PMID: 24603283
European; undergraduate curriculum; geriatric medicine; consensus; Delphi
12.  UK medical teaching about ageing is improving but there is still work to be done: the Second National Survey of Undergraduate Teaching in Ageing and Geriatric Medicine 
Age and Ageing  2013;43(2):293-297.
Introduction: in 2008, a UK national survey of undergraduate teaching about ageing and geriatric medicine identified deficiencies, including failure to adequately teach about elder abuse, pressure ulcers and bio- and social gerontology. We repeated the survey in 2013 to consider whether the situation had improved.
Method: the deans of all 31 UK medical schools were invited to nominate a respondent with an overview of their undergraduate curriculum. Nominees were invited by email and letter to complete an online questionnaire quantifying topics taught, type of teaching and assessment undertaken, and the amount of time spent on teaching.
Results: one school only taught pre-clinical medicine and declined to participate. Of the 30 remaining schools, 20 responded and 19 provided analysable data. The majority of the schools (95–100%) provided teaching in delirium, dementia, stroke, falls, osteoporosis, extra-pyramidal disorders, polypharmacy, incontinence, ethics and mental capacity. Only 68% of the schools taught about elder abuse. Thirty-seven per cent taught a recognised classification of the domains of health used in Comprehensive Geriatric Assessment (CGA). The median (range) total time spent on teaching in ageing and geriatric medicine was 55.5 (26–192) h. There was less reliance on informal teaching and improved assessment:teaching ratios compared with the 2008 survey.
Conclusions: there was an improvement in teaching and assessment of learning outcomes in ageing and geriatric medicine for UK undergraduates between 2008 and 2013. However, further work is needed to increase the amount of teaching time devoted to ageing and to improve teaching around elder abuse and the domains of health used in CGA.
doi:10.1093/ageing/aft207
PMCID: PMC3927775  PMID: 24375323
undergraduate medical education; geriatrics; medical education; curriculum; elder abuse; older people
13.  Chair-Based Exercises for Frail Older People: A Systematic Review 
BioMed Research International  2013;2013:309506.
Introduction. Frail older people are often unable to undertake high-intensity exercise programmes. Chair-based exercises (CBEs) are used as an alternative, for which health benefits are uncertain. Objective. To examine the effects of CBE programmes for frail older people through a systematic review of existing literature. Method. A systematic search was performed for CBE-controlled trials in frail populations aged ≥65 years published between 1990 and February 2011 in electronic databases. Quality was assessed using the Jadad method. Results. The search identified 164 references: with 42 duplicates removed, 122 reviewed, 116 excluded, and 6 analysed. 26 outcome measures were reported measuring 3 domains: mobility and function, cardiorespiratory fitness, mental health. All studies were of low methodological quality (Jadad score ≤2; possible range 0–5). Two studies showed no benefit, and four reported some evidence of benefit in all three domains. No harmful effects were reported; compliance was generally good. Conclusion. The quality of the evidence base for CBEs is low with inconclusive findings to clearly inform practice. A consensus is required on the definition and purpose of CBEs. Large well-designed randomised controlled trials to test the effectiveness of CBE are justified.
doi:10.1155/2013/309506
PMCID: PMC3782120  PMID: 24089670
14.  Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial 
Trials  2013;14:192.
Background
Failure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses, and inaccurate capture of risks to participants can influence reporting of intervention harms and benefits.
In this paper we describe how challenges of recruitment and retention of participants, standardisation and quality control of interventions and capture of adverse events were overcome in the ProAct65+ cluster RCT. This trial compared class-based and home-based exercise with usual care in people aged 65 years and over, recruited through general practice. The home-based exercise participants were supported by Peer Mentors.
Results
(1) Organisational factors, including room availability in general practices, slowed participant recruitment so the recruitment period was extended and the number invited to participate increased. (2) Telephone pre-screening was introduced to exclude potential participants who were already very active and those who were frequent fallers. (3) Recruitment of volunteer peer mentors was difficult and time consuming and their acceptable case load less than expected. Lowering the age limit for peer mentors and reducing their contact schedule with participants did not improve recruitment. (4) Fidelity to the group intervention was optimised by introducing quality assurance observation of classes by experienced exercise instructors. (5) Diaries were used to capture data on falls, service use and other exercise-related costs, but completion was variable so their frequency was reduced. (6) Classification of adverse events differed between research sites so all events were assessed by both sites and discrepancies discussed.
Conclusions
Recruitment rates for trials in general practice may be limited by organisational factors and longer recruitment periods should be allowed for. Exercise studies may be attractive to those who least need them; additional screening measures can be employed to avoid assessment of ineligible participants. Enrolment of peer mentors for intervention support is challenging and needs to be separately tested for feasibility. Standardisation of exercise interventions is problematic when exercise programmes are tailored to participants’ capabilities; quality assurance observations may assure fidelity of the intervention. Data collection by diaries can be burdensome to participants, resulting in variable and incomplete data capture; compromises in completion frequency may reduce missing data. Risk assessments are essential in exercise promotion studies, but categorisation of risks can vary between assessors; methods for their standardisation can be developed.
Trial registration
ISRCTN43453770
doi:10.1186/1745-6215-14-192
PMCID: PMC3707765  PMID: 23815878
Randomised controlled trial; General practice; Recruitment; Adverse events; Exercise; Peer mentors; Postural stability instructors; Data collection; Quality assurance
15.  Functional level at admission is a predictor of survival in older patients admitted to an acute geriatric unit 
BMC Geriatrics  2012;12:32.
Background
Functional decline is associated with increased risk of mortality in geriatric patients. Assessment of activities of daily living (ADL) with the Barthel Index (BI) at admission was studied as a predictor of survival in older patients admitted to an acute geriatric unit.
Methods
All first admissions of patients with age >65 years between January 1st 2005 and December 31st 2009 were included. Data on BI, sex, age, and discharge diagnoses were retrieved from the hospital patient administrative system, and data on survival until September 6th 2010 were retrieved from the Civil Personal Registry. Co-morbidity was measured with Charlson Co-morbidity Index (CCI). Patients were followed until death or end of study.
Results
5,087 patients were included, 1,852 (36.4%) men and 3,235 (63.6%) women with mean age 81.8 (6.8) and 83.9 (7.0) years respectively. The median [IQR] length of stay was 8 days, the median follow up [IQR] 1.4 [0.3; 2.8] years and in hospital mortality 8.2%. Mortality was greater in men than in women with median survival (95%-CI) 1.3 (1.2 -1.5) years and 2.2 (2.1-2.4) years respectively (p < 0.001). The median survivals (95%-CI) stratified on BI groups in men (n = 1,653) and women (n = 2,874) respectively were: BI 80-100: 2.6 (1.9-3.1) years and 4.5 (3.9-5.4) years; BI 50-79: 1.7 (1.5-2.1) years and 3.1 (2.7-3.5) years; BI 25-49: 1.5 (1.3-1.9) years and 1.9 (1.5-2.2) years and BI 0-24: 0.5 (0.3-0.7) years and 0.8 (0.6-0.9) years. In multivariate logistic regression analysis with BI 80-100 as baseline and controlling for significant covariates (sex, age, CCI, and diseases of cancer, haematology, cardiovascular, respiratory, infectious and bone and connective tissues) the odds ratios for 3 and 12 months survival (95%-CI) decreased with declining BI: BI 50-79: 0.74 (0.55-0.99) (p < 0.05) and 0,80 (0.65-0.97)(p < 0.05); BI 25-49: 0.44 (0.33-0.59)(p < 0.001) and 0.55 (0.45-0.68)(p < 0.001); and BI 0-24: 0.18 (0.14-0.24)(p < 0.001) and 0.29 (0.24-0.35)(p < 0.001) respectively.
Conclusion
BI is a strong independent predictor of survival in older patients admitted to an acute geriatric unit. These data suggest that assessment of ADL may have a potential role in decision making for the clinical management of frail geriatric inpatients.
doi:10.1186/1471-2318-12-32
PMCID: PMC3462125  PMID: 22731680
ADL; Barthel Index; Charlson Index; Co-morbidity; Elderly; Functional assessment; Geriatric; Mortality; Survival
16.  Determinants of fracture risk in a UK-population-based cohort of older women: a cross-sectional analysis of the Cohort for Skeletal Health in Bristol and Avon (COSHIBA) 
Age and Ageing  2011;41(1):46-52.
Background: identification of individuals with high fracture risk from within primary care is complex. It is likely that the true contribution of falls to fracture risk is underestimated.
Methods: cross-sectional analysis of a population-based cohort of 3,200 post-menopausal women aged 73 ± 4 years. Self-reported data were collected on fracture, osteoporosis clinical risk factors and falls/mobility risk factors. Self-reported falls were compared with recorded falls on GP computerised records. Multivariable logistic regression was used to identify independent risk factors for fracture.
Results: a total of 838 (26.2%) reported a fracture after aged 50; 441 reported falling more than once per year, but 69% of these had no mention of falls on their computerised GP records. Only age [odds ratios (OR): 1.37 per 5 year increase, 95% confidence interval (CI): 1.23–1.53], height (1.02 per cm increase, 95% CI: 1.01–1.04), weight (OR: 0.99 per kg increase, 95% CI: 0.98–0.99) and falls (OR: 1.49 for more than once per year compared with less, 95% CI: 1.13–1.94) were independent risk factors for fracture. Falls had the strongest association.
Conclusion: when identifying individuals with high fracture risk we estimate that more than one fall per year is at least twice as important as height and weight. Furthermore, using self-reported falls data is essential as computerised GP records underestimate falls prevalence.
doi:10.1093/ageing/afr132
PMCID: PMC3234077  PMID: 22107913
fractures; falls; COSHIBA; FRAX; cohort study; elderly
17.  Pharmacological Treatments for Osteoporosis in Very Elderly People 
Only a few randomized controlled trials investigating antiosteoporotic agents with fracture endpoints have included participants over the age of 80 years. The pivotal trial with alendronic acid had an upper age range of 80 years, although a separate trial that showed a significant reduction in nonvertebral fractures included some participants up to age of 84 years. Risedronate and zoledronic acid are the only bisphosphonates to show a significant reduction in new vertebral, hip and nonvertebral fractures during a 3-year period in those over 80 years of age. In addition, zoledronic acid was associated with a reduction in the rate of new clinical fractures and improved survival in elderly subjects after hip fracture. More recently, denosumab was found to significantly reduce the risk of new radiographic vertebral, hip and nonvertebral fractures in women up to the age of 89 years with osteoporosis. Strontium ranelate and teriparatide have shown fracture reductions in populations that have included subjects over the age of 80 years. There has been evidence to show that a combination of calcium and vitamin D reduces nonvertebral fracture in older populations. The role of vitamin D alone is less clear, although there is the suggestion that it may be effective at higher doses. The burden of osteoporosis is unquestionably rising within our ageing population. More emphasis is therefore required on researching the benefits of these pharmacological agents in very elderly people.
doi:10.1177/2040622311409972
PMCID: PMC3513886  PMID: 23251755
bisphosphonates; calcium; denosumab; elderly; fracture; fracture prevention; osteoporosis; strontium ranelate; teriparatide; vitamin D
18.  Not at the expense of osteoporosis care 
BMJ : British Medical Journal  2008;336(7640):343.
doi:10.1136/bmj.39486.653009.3A
PMCID: PMC2244764  PMID: 18276674
19.  Cost-effectiveness of a day hospital falls prevention programme for screened community-dwelling older people at high risk of falls 
Age and Ageing  2010;39(6):710-716.
Background: multifactorial falls prevention programmes for older people have been proved to reduce falls. However, evidence of their cost-effectiveness is mixed.
Design: economic evaluation alongside pragmatic randomised controlled trial.
Intervention: randomised trial of 364 people aged ≥70, living in the community, recruited via GP and identified as high risk of falling. Both arms received a falls prevention information leaflet. The intervention arm were also offered a (day hospital) multidisciplinary falls prevention programme, including physiotherapy, occupational therapy, nurse, medical review and referral to other specialists.
Measurements: self-reported falls, as collected in 12 monthly diaries. Levels of health resource use associated with the falls prevention programme, screening (both attributed to intervention arm only) and other health-care contacts were monitored. Mean NHS costs and falls per person per year were estimated for both arms, along with the incremental cost-effectiveness ratio (ICER) and cost effectiveness acceptability curve.
Results: in the base-case analysis, the mean falls programme cost was £349 per person. This, coupled with higher screening and other health-care costs, resulted in a mean incremental cost of £578 for the intervention arm. The mean falls rate was lower in the intervention arm (2.07 per person/year), compared with the control arm (2.24). The estimated ICER was £3,320 per fall averted.
Conclusions: the estimated ICER was £3,320 per fall averted. Future research should focus on adherence to the intervention and an assessment of impact on quality of life.
doi:10.1093/ageing/afq108
PMCID: PMC2956532  PMID: 20833862
cost-effectiveness; accidental falls; screening; comprehensive geriatric assessment; randomised controlled trial; elderly
20.  A multicentre randomised controlled trial of day hospital-based falls prevention programme for a screened population of community-dwelling older people at high risk of falls 
Age and Ageing  2010;39(6):704-710.
Objective: to determine the clinical effectiveness of a day hospital-delivered multifactorial falls prevention programme, for community-dwelling older people at high risk of future falls identified through a screening process.
Design: multicentre randomised controlled trial.
Setting: eight general practices and three day hospitals based in the East Midlands, UK.
Participants: three hundred and sixty-four participants, mean age 79 years, with a median of three falls risk factors per person at baseline.
Interventions: a day hospital-delivered multifactorial falls prevention programme, consisting of strength and balance training, a medical review and a home hazards assessment.
Main outcome measure: rate of falls over 12 months of follow-up, recorded using self-completed monthly diaries.
Results: one hundred and seventy-two participants in each arm contributed to the primary outcome analysis. The overall falls rate during follow-up was 1.7 falls per person-year in the intervention arm compared with 2.0 falls per person-year in the control arm. The stratum-adjusted incidence rate ratio was 0.86 (95% CI 0.73–1.01), P = 0.08, and 0.73 (95% CI 0.51–1.03), P = 0.07 when adjusted for baseline characteristics. There were no significant differences between the intervention and control arms in any secondary outcomes.
Conclusion: this trial did not conclusively demonstrate the benefit of a day hospital-delivered multifactorial falls prevention programme, in a population of older people identified as being at high risk of a future fall.
doi:10.1093/ageing/afq096
PMCID: PMC2956530  PMID: 20823124
accidental falls; screening; primary care; comprehensive geriatric assessment; randomised controlled trial; elderly
21.  Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial 
Trials  2010;11:6.
Background
Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention.
Design/Methods
Pragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial.
Discussion
The ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk.
Trial Registration
Trial Registration: ISRCTN43453770
doi:10.1186/1745-6215-11-6
PMCID: PMC2821309  PMID: 20082696
22.  Falls and health status in elderly women following first eye cataract surgery: an economic evaluation conducted alongside a randomised controlled trial 
The British Journal of Ophthalmology  2007;91(12):1675-1679.
Aim
To evaluate the cost‐effectiveness of first eye cataract surgery compared with no surgery from a health service and personal social services perspective.
Methods
An economic evaluation undertaken alongside a randomised controlled trial of first eye cataract surgery in secondary care ophthalmology clinics. A sample of 306 women over 70 years old with bilateral cataracts was randomised to cataract surgery (expedited, approximately four weeks) or control (routine, 12 months wait); 75% of participants had baseline acuity of 6/12 or better. Outcomes included falls and the EuroQol EQ‐5D.
Results
The operated group cost a mean £2004 (bootstrapped) more than the control group over one year (95% confidence interval (CI), £1363 to £2833) (p<0.001), but experienced on average 0.456 fewer falls, an incremental cost per fall prevented of £4390. The bootstrapped mean gain in quality adjusted life years (QALYs) per patient was 0.056 (95% CI, 0.006 to 0.108) (p<0.001). The incremental cost–utility ratio was £35 704, above the currently accepted UK threshold level of willingness to pay per QALY of £30 000. However, in an analysis modelling costs and benefits over patients' expected lifetime, the incremental cost per QALY was £13 172, under conservative assumptions.
Conclusions
First eye cataract surgery, while cost‐ineffective over the trial period, was probably cost‐effective over the participants' remaining lifetime.
doi:10.1136/bjo.2007.118687
PMCID: PMC2095519  PMID: 17585002
economic evaluation; cataract surgery; falls; elderly
23.  Reducing hip fracture risk with risedronate in elderly women with established osteoporosis 
Background:
There is limited evidence to support the efficacy of current pharmaceutical agents in reducing the risk of hip fracture in older postmenopausal women with established osteoporosis.
Objective:
To clarify the efficacy of risedronate in reducing the risk of hip fracture in elderly postmenopausal women aged ≥ 70 years with established osteoporosis, i.e., those with bone mineral density-defined osteoporosis and a prevalent vertebral fracture.
Methods:
Post hoc analysis of the Hip Intervention Program (HIP) study, a randomized controlled trial comparing risedronate with placebo for reducing the risk of hip fracture in elderly women. Women aged 70 to 100 years with established osteoporosis (baseline femoral neck T-score ≤ −2.5 and ≥1 prior vertebral fracture) were included. The main outcome measure was 3-year hip fracture incidence in the risedronate and placebo groups.
Results:
A total of 1656 women met the inclusion criteria. After 3 years, hip fracture had occurred in 3.8% of risedronate-treated patients and 7.4% of placebo-treated patients (relative risk 0.54; 95% confidence interval 0.32–0.91; P = 0.019).
Conclusion:
Risedronate significantly reduced the risk of hip fracture in women aged up to 100 years with established osteoporosis.
PMCID: PMC2785868  PMID: 19966913
osteoporosis; postmenopausal; hip fracture; risedronate
24.  Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial [ISRCTN46584556] 
Trials  2006;7:5.
Falls in older people are a major public health concern in terms of morbidity, mortality and cost. Previous studies suggest that multifactorial interventions can reduce falls, and many geriatric day hospitals are now offering falls intervention programmes. However, no studies have investigated whether these programmes, based in the day hospital are effective, nor whether they can be successfully applied to high-risk older people screened in primary care.
The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling. This will be tested by a pragmatic parallel-group randomised controlled trial in which the participants, identified as at high risk of falling, will be randomised into either the intervention Day hospital arm or to a control (current practice) arm. Those participants preferring not to enter the full randomised study will be offered the opportunity to complete brief diaries only at monthly intervals. This data will be used to validate the screening questionnaire. Three day hospitals (2 Nottingham, 1 Derby) will provide the interventions, and the University of Nottingham's Departments of Primary Care, the Division of Rehabilitation and Ageing Unit, and the Trent Institute for Health Service Research will provide the methodological and statistical expertise. Four hundred subjects will be randomised into the two arms. The primary outcome measure will be the rate of falls over one year. Secondary outcome measures will include the proportion of people experiencing at least one fall, the proportion of people experiencing recurrent falls (>1), injuries, fear of falling, quality of life, institutionalisation rates, and use of health services. Cost-effectiveness analyses will be performed to inform health commissioners about resource allocation issues. The importance of this trial is that the results may be applicable to any UK day hospital setting.
Sites
General practices across Nottinghamshire and Derbyshire.
Day hospitals:
Derbyshire Royal Infirmary (Southern Derbyshire Acute Hospitals NHS Trust)
Sherwood Day Service (Nottingham City Hospital Trust)
Leengate Day Hospital (Queen's Medical Centre Nottingham University Hospital NHS Trust)
doi:10.1186/1745-6215-7-5
PMCID: PMC1420328  PMID: 16542012

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