Staff perceptions of military chemical-biological-radiological-nuclear (CBRN) air-purifying masks during a simulated clinical task in the context of SARS-CoV-2.

Air-purifying full-face masks, such as military chemical-biological-radiological-nuclear masks, might offer superior protection against severe acute respiratory syndrome coronavirus 2 compared to disposable polypropylene P2 or N95 masks. In addition, disposable masks are in short supply, while military chemical-biological-radiological-nuclear masks can be disinfected then reused. It is unknown whether such masks might be appropriate for civilians with minimal training in their use. Accordingly, we compared the Australian Defence Force in-service chemical-biological-radiological-nuclear Low Burden Mask (AirBoss Defense, Newmarket, Canada) with polypropylene N95 masks and non-occlusive glasses worn during simulated tasks performed by civilian clinicians in an Australian tertiary referral hospital intensive care unit. After brief training in the use of the Low Burden Mask, participants undertook a simulated cardiac arrest scenario. Previous training with polypropylene N95 masks had been provided. Evaluation of 10 characteristics of each mask type were recorded, and time to mask application was assessed. Thirty-three participants tested the Low Burden Mask, and 28 evaluated polypropylene N95 masks and glasses. The Low Burden Mask was donned more quickly: mean time 7.0 (standard deviation 2.1) versus 18.3 (standard deviation 6.7) seconds; P = 0.0076. The Low Burden Mask was rated significantly higher in eight of the 10 assessed criteria, including ease of donning, comfort (initially and over a prolonged period), fogging, seal, safety while removing, confidence in protection, and overall. Visibility and communication ability were rated equally highly for both systems. We conclude that this air-purifying full-face mask is acceptable to clinicians in a civilian intensive care unit. It enhances staff confidence, reduces waste, and is likely to be a lower logistical burden during a prolonged pandemic. Formal testing of effectiveness is warranted.

Evaluation of the effectiveness, implementation and cost-effectiveness of the Stay One Step Ahead home safety promotion intervention for pre-school children: a study protocol.

BACKGROUND: Unintentional injuries in children under the age of 5 years commonly occur in the home and disproportionately affect those living in disadvantaged circumstances. Targeted home safety promotion should be offered to families most at risk but there is a paucity of standardised evidence-based resources available for use across family-support practitioners. OBJECTIVE: To assess the effectiveness, implementation and cost-effectiveness of a 2-year home safety programme (Stay One Step Ahead) developed by parents, practitioners and researchers, and delivered by a range of family support providers in inner-city localities, compared with usual care in matched control localities. METHODS: Parents of children aged 0 to 7 months will be recruited to a controlled before and after observational study. The primary outcome is home safety assessed by the proportion of families with a fitted and working smoke alarm, safety gate on stairs (where applicable) and poisons stored out of reach, assessed using parent-administered questionnaires at baseline, 12 and 24 months.Secondary outcomes include: the impact on other parent-reported safety behaviours, medically-attended injuries, self-efficacy for home safety and knowledge of child development and injury risk using questionnaires and emergency department attendance data; implementation (reach, acceptability, barriers, facilitators) of home safety promotion assessed through interviews and observations; and cost-effectiveness using medically-attended injury costs ascertained from healthcare records. CONCLUSION: If shown to be effective and cost-effective this study will provide a practical resource to underpin national guidance. The study could inform public health prevention strategies to reduce home injury in children most at risk, while delivering cost savings to health and care services. TRIAL REGISTRATION NUMBER: ISRCTN31210493; Pre result.

Systematic review and meta-analysis of association between cognitive tests and on-road driving ability in people with dementia.

OBJECTIVES: To assess the strength of association between cognitive tests and on-road driving ability in people with dementia by conducting a systematic review and meta-analysis. METHODS: A literature search strategy was developed using terms related to dementia and driving. Fifteen databases were searched. Studies were selected if they investigated the predictive ability of cognitive tests and on-road fitness to drive in people with dementia. The primary author performed the initial screening of title and abstract of each paper. Two reviewers then independently checked whether the abstracts met the inclusion and exclusion criteria. The primary author also hand searched included studies, reference lists and conducted citation searches. Studies were quality assessed using Newcastle-Ottawa Quality Assessment Scale for Cohort and Case-Control Studies. A random effect model was employed to analyse effect size. RESULTS: The initial search identified 6734 articles, of which 47 full-text articles were screened for inclusion. Thirty articles were included in the review and sixteen articles were included in the meta-analysis. Analysis showed statistically significant weak to moderate (0.3-0.4) relationships between cognitive measures and on-road driving for all cognitive domains except language. CONCLUSION: All cognitive domains apart from language showed a statistically significant moderate association with on-road driving outcome in patients with mild dementia. A composite cognitive battery is likely to be better than testing single cognitive domains in assessing fitness to drive in patients with dementia.

A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT.

BACKGROUND: People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI. DESIGN: Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken. SETTING: Community settings in nine sites in England. PARTICIPANTS: Participants were aged 18-69 years, had undergone a TBI > 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent. RANDOMISATION AND BLINDING: Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded. INTERVENTIONS: In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only. MAIN OUTCOME MEASURES: Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire - patient version (EMQ-p) at 6 months' follow-up. Secondary outcomes: Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied. RESULTS: We randomised 328 participants (memory rehabilitation, n = 171; usual care, n = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5; p = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months' follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months' follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be £26.89 cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported. LIMITATIONS: As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the sample. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation. CONCLUSIONS: The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN65792154. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 16. See the NIHR Journals Library website for further project information.

People with brain injuries often report memory problems. These difficulties can continue long after the injury, causing complications in daily life. Many people do not receive specific help for these memory problems after leaving hospital. Our study explored whether receiving 'memory rehabilitation' (a group treatment to help people deal with memory difficulties) was better than the treatment that people usually receive to help reduce the frequency of forgetting in daily life. We recruited 328 people who had memory problems following brain injury. About half were allocated at random to receive memory rehabilitation and half did not have any extra memory treatments, but everyone continued to receive their usual care. Those who had memory rehabilitation were offered 10 group sessions at which strategies were taught to help them cope with memory problems. We asked all participants to complete memory tests and questionnaires at the start of the study and again 6 and 12 months afterwards to find out whether the memory rehabilitation had any effect. Some participants were also interviewed about the study. At the 6- and 12-month assessments, there were no differences between those who received memory rehabilitation and those who did not in terms of how often participants reported memory problems in their daily lives or how well they performed on memory tests. We also did not find any differences in participants' mood or quality of life. However, individual goals set by the participants at the start of the study were a little better met by those who received memory rehabilitation than by those who did not. The memory rehabilitation did not represent value for money. In interviews, participants reported positive experiences of taking part in the study and of attending the group sessions. This group memory rehabilitation programme is unlikely to help people with memory problems following a brain injury more than the usual treatment that people receive. Some people may benefit more from memory rehabilitation than others, but this needs further investigation.

PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL): study protocol.

BACKGROUND: Falls in older people are a leading causes of unintentional injury. Due to an ageing population, injuries are likely to increase unless more is done to reduce older people's falls risk. In clinical trials, the Falls Management Exercise (FaME) programme has reduced the rate of falls and falls-related injuries in community-dwelling older adults. However, the commissioning of FaME is inconsistent across England, potentially due to a lack of evidence that FaME can be delivered effectively in a 'real world' setting. The PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL) study is designed to study the implementation of FaME in a range of different settings in England. METHODS: The PHISICAL study will use a mixed-methods, triangulation, multilevel design to explore the implementation of FaME. Framework analysis of semistructured interviews with up to 90 stakeholders (exercise programme users, service providers, referrers and commissioners) and observational data from locally led communities of practice will identify the factors that influence FaME's implementation. Quantitative, anonymised, routine service data from up to 650 exercise programme users, including measures of falls and physical activity, will allow assessment of whether the benefits of FaME reported in clinical trials translate to the 'real world' setting. CONCLUSION: The findings from this study will be used to develop a toolkit of resources and guidance to inform the commissioning and delivery of future FaME programmes. This study has the potential to inform public health prevention strategies, and in doing so may reduce the number of falls in the older population while delivering cost savings to health and social care services.

Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. DESIGN: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. SETTING: Participants' homes or hospital. PARTICIPANTS: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. INTERVENTION: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). MAIN MEASURES: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. RESULTS: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2-8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small ( d = 0.005) to moderate ( d = 0.74), and significant differences in physical function between intervention and usual care groups ( d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. CONCLUSION: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

Exercise for reducing fear of falling in older people living in the community: Cochrane systematic review and meta-analysis.

OBJECTIVE: to determine the effect of exercise interventions on fear of falling in community-living people aged ≥65. DESIGN: systematic review and meta-analysis. Bibliographic databases, trial registers and other sources were searched for randomised or quasi-randomised trials. Data were independently extracted by pairs of reviewers using a standard form. RESULTS: thirty trials (2,878 participants) reported 36 interventions (Tai Chi and yoga (n = 9); balance training (n = 19); strength and resistance training (n = 8)). The risk of bias was low in few trials. Most studies were from high-income countries (Australia = 8, USA = 7). Intervention periods (<12 weeks = 22; 13-26 weeks = 7; >26 weeks = 7) and exercise frequency (1-3 times/week = 32; ≥4 times/week = 4) varied between studies. Fear of falling was measured by single-item questions (7) and scales measuring falls efficacy (14), balance confidence (9) and concern or worry about falling (2). Meta-analyses showed a small to moderate effect of exercise interventions on reducing fear of falling immediately post-intervention (standardised mean difference (SMD) 0.37, 95% CI 0.18, 0.56; 24 studies; low-quality evidence). There was a small, but not statistically significant effect in the longer term (<6 months (SMD 0.17, 95% CI -0.05, 0.38 (four studies) and ≥6 months post-intervention SMD 0.20, 95% CI -0.01, 0.41 (three studies)). CONCLUSIONS: exercise interventions probably reduce fear of falling to a small to moderate degree immediately post-intervention in community-living older people. The high risk of bias in most included trials suggests findings should be interpreted with caution. High-quality trials are needed to strengthen the evidence base in this area.

Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial.

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.

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.

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.

Exercise for reducing fear of falling in older people living in the community.

BACKGROUND: Fear of falling is common in older people and associated with serious physical and psychosocial consequences. Exercise (planned, structured, repetitive and purposive physical activity aimed at improving physical fitness) may reduce fear of falling by improving strength, gait, balance and mood, and reducing the occurrence of falls. OBJECTIVES: To assess the effects (benefits, harms and costs) of exercise interventions for reducing fear of falling in older people living in the community. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2013), the Central Register of Controlled Trials (CENTRAL 2013, Issue 7), MEDLINE (1946 to July Week 3 2013), EMBASE (1980 to 2013 Week 30), CINAHL (1982 to July 2013), PsycINFO (1967 to August 2013), AMED (1985 to August 2013), the World Health Organization International Clinical Trials Registry Platform (accessed 7 August 2013) and Current Controlled Trials (accessed 7 August 2013). We applied no language restrictions. We handsearched reference lists and consulted experts. SELECTION CRITERIA: We included randomised and quasi-randomised trials that recruited community-dwelling people (where the majority were aged 65 and over) and were not restricted to specific medical conditions (e.g. stroke, hip fracture). We included trials that evaluated exercise interventions compared with no intervention or a non-exercise intervention (e.g. social visits), and that measured fear of falling. Exercise interventions were varied; for example, they could be 'prescriptions' or recommendations, group-based or individual, supervised or unsupervised. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently assessed studies for inclusion, assessed the risk of bias in the studies and extracted data. We combined effect sizes across studies using the fixed-effect model, with the random-effect model used where significant statistical heterogeneity was present. We estimated risk ratios (RR) for dichotomous outcomes and incidence rate ratios (IRR) for rate outcomes. We estimated mean differences (MD) where studies used the same continuous measures and standardised mean differences (SMD) where different measures or different formats of the same measure were used. Where possible, we performed various, usually prespecified, sensitivity and subgroup analyses. MAIN RESULTS: We included 30 studies, which evaluated 3D exercise (Tai Chi and yoga), balance training or strength and resistance training. Two of these were cluster-randomised trials, two were cross-over trials and one was quasi-randomised. The studies included a total of 2878 participants with a mean age ranging from 68 to 85 years. Most studies included more women than men, with four studies recruiting women only. Twelve studies recruited participants at increased risk of falls; three of these recruited participants who also had fear of falling.Poor reporting of the allocation methods in the trials made it difficult to assess the risk of selection bias in most studies. All of the studies were at high risk of performance and detection biases as there was no blinding of participants and outcome assessors and the outcomes were self reported. Twelve studies were at high risk of attrition bias. Using GRADE criteria, we judged the quality of evidence to be 'low' for fear of falling immediately post intervention and 'very low' for fear of falling at short or long-term follow-up and all other outcomes.Exercise interventions were associated with a small to moderate reduction in fear of falling immediately post intervention (SMD 0.37 favouring exercise, 95% confidence interval (CI) 0.18 to 0.56; 24 studies; 1692 participants, low quality evidence). Pooled effect sizes did not differ significantly between the different scales used to measure fear of falling. Although none of the sensitivity analyses changed the direction of effect, the greatest reduction in the size of the effect was on removal of an extreme outlier study with 73 participants (SMD 0.24 favouring exercise, 95% CI 0.12 to 0.36). None of our subgroup analyses provided robust evidence of differences in effect in terms of either the study primary aim (reduction of fear of falling or other aim), the study population (recruitment on the basis of increased falls risk or not), the characteristics of the study exercise intervention or the study control intervention (no treatment or alternative intervention). However, there was some weak evidence of a smaller effect, which included no reduction, of exercise when compared with an alternative control.There was very low quality evidence that exercise interventions may be associated with a small reduction in fear of falling up to six months post intervention (SMD 0.17, 95% CI -0.05 to 0.38; four studies, 356 participants) and more than six months post intervention (SMD 0.20, 95% CI -0.01 to 0.41; three studies, 386 participants).Very low quality evidence suggests exercise interventions in these studies that also reported on fear of falling reduced the risk of falling measured either as participants incurring at least one fall during follow-up or the number of falls during follow-up. Very low quality evidence from four studies indicated that exercise interventions did not appear to reduce symptoms of depression or increase physical activity. The only study reporting the effects of exercise interventions on anxiety found no difference between groups. No studies reported the effects of exercise interventions on activity avoidance or costs. It is important to remember that our included studies do not represent the totality of the evidence of the effect of exercise interventions on falls, depression, anxiety or physical activity as our review only includes studies that reported fear of falling. AUTHORS' CONCLUSIONS: Exercise interventions in community-dwelling older people probably reduce fear of falling to a limited extent immediately after the intervention, without increasing the risk or frequency of falls. There is insufficient evidence to determine whether exercise interventions reduce fear of falling beyond the end of the intervention or their effect on other outcomes. Although further evidence from well-designed randomised trials is required, priority should be given to establishing a core set of outcomes that includes fear of falling for all trials examining the effects of exercise interventions in older people living in the community.

Multicentre cluster randomised trial comparing a community group exercise programme and home-based exercise with usual care for people aged 65 years and over in primary care.

BACKGROUND: Regular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements. OBJECTIVE: To evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years. DESIGN: The ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥ 65 years) in primary care. SETTING: Forty-three UK-based general practices in London and Nottingham/Derby. PARTICIPANTS: A total of 1256 people ≥ 65 years were recruited through their general practices to take part in the trial. INTERVENTIONS: The FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking. MAIN OUTCOME MEASURES: The primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial. RESULTS: In total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants. The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87; p = 0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92; p = 0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99; p = 0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93). CONCLUSION: The FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms. TRIAL REGISTRATION: This trial is registered as ISRCTN43453770. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website for further project information.

Which factors are associated with fear of falling in community-dwelling older people?

BACKGROUND: fear of falling (FOF) is common in older people and associated with serious physical and psychosocial consequences. Identifying those at risk of FOF can help target interventions to both prevent falls and reduce FOF. OBJECTIVE: to identify factors associated with FOF. STUDY DESIGN: cross-sectional study in 1,088 community-dwelling older people aged ≥65 years. METHODS: data were collected on socio-demographic characteristics, self-perceived health, exercise, risk factors for falls, FOF (Short FES-I), and functional measures. Logistic regression models of increasing complexity identified factors associated with FOF. RESULTS: high FOF (Short FES-I ≥11) was reported by 19%. A simpler model (socio-demographic + falls risk factors) correctly classified as many observations (82%) as a more complex model (socio-demographic + falls risk factors + functional measures) with similar sensitivity and specificity values in both models. There were significantly raised odds of FOF in the simpler model with the following factors: unable to rise from a chair of knee height (OR: 7.39), lower household income (OR: 4.58), using a walking aid (OR: 4.32), difficulty in using public transport (OR: 4.02), poorer physical health (OR: 2.85), black/minority ethnic group (OR: 2.42), self-reported balance problems (OR: 2.17), lower educational level (OR: 2.01) and a higher BMI (OR: 1.06). CONCLUSIONS: a range of factors identify those with FOF. A simpler model performs as well as a more complex model containing functional assessments and could be used in primary care to identify those at risk of FOF, who could benefit from falls prevention interventions.

Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial.

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.