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      The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT)

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          Abstract

          Background

          This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT).

          Methods

          A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England.

          Results

          Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of ‘red flags’; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting.

          Conclusion

          This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and fractures, will be reported at the conclusion of the trial.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12877-017-0492-6) contains supplementary material, which is available to authorized users.

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          Most cited references19

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          Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test.

          This study examined the sensitivity and specificity of the Timed Up & Go Test (TUG) under single-task versus dual-task conditions for identifying elderly individuals who are prone to falling. Fifteen older adults with no history of falls (mean age=78 years, SD=6, range=65-85) and 15 older adults with a history of 2 or more falls in the previous 6 months (mean age=86.2 years, SD=6, range=76-95) participated. Time taken to complete the TUG under 3 conditions (TUG, TUG with a subtraction task [TUGcognitive], and TUG while carrying a full cup of water [TUGmanual]) was measured. A multivariate analysis of variance and discriminant function and logistic regression analyses were performed. The TUG was found to be a sensitive (sensitivity=87%) and specific (specificity=87%) measure for identifying elderly individuals who are prone to falls. For both groups of older adults, simultaneous performance of an additional task increased the time taken to complete the TUG, with the greatest effect in the older adults with a history of falls. The TUG scores with or without an additional task (cognitive or manual) were equivalent with respect to identifying fallers and nonfallers. The results suggest that the TUG is a sensitive and specific measure for identifying community-dwelling adults who are at risk for falls. The ability to predict falls is not enhanced by adding a secondary task when performing the TUG.
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            Meta-analysis of the impact of 9 medication classes on falls in elderly persons.

            There is increasing recognition that the use of certain medications contributes to falls in seniors. Our objective was to update a previously completed meta-analysis looking at the association of medication use and falling to include relevant drug classes and new studies that have been completed since a previous meta-analysis. Studies were identified through a systematic search of English-language articles published from 1996 to 2007. We identified studies that were completed on patients older than 60 years, looking at the association between medication use and falling. Bayesian methods allowed us to combine the results of a previous meta-analysis with new information to estimate updated Bayesian odds ratios (ORs) and 95% credible intervals (95% CrIs) Of 11 118 identified articles, 22 met our inclusion criteria. Meta-analyses were completed on 9 unique drug classes, including 79 081 participants, with the following Bayesian unadjusted OR estimates: antihypertensive agents, OR, 1.24 (95% CrI, 1.01-1.50); diuretics, OR, 1.07 (95% CrI, 1.01-1.14); beta-blockers, OR, 1.01 (95% CrI, 0.86-1.17); sedatives and hypnotics, OR, 1.47 (95% CrI, 1.35-1.62); neuroleptics and antipsychotics, OR, 1.59 (95% CrI, 1.37-1.83); antidepressants, OR, 1.68 (95% CrI, 1.47-1.91); benzodiazepines, OR, 1.57 (95% CrI, 1.43-1.72); narcotics, OR, 0.96 (95% CrI, 0.78-1.18); and nonsteroidal anti-inflammatory drugs, OR, 1.21 (95% CrI, 1.01-1.44). The updated Bayesian adjusted OR estimates for diuretics, neuroleptics and antipsychotics, antidepressants, and benzodiazepines were 0.99 (95% CrI, 0.78-1.25), 1.39 (95% CrI, 0.94-2.00), 1.36 (95% CrI, 1.13-1.76), and 1.41 (95% CrI, 1.20-1.71), respectively. Stratification of studies had little effect on Bayesian OR estimates, with only small differences in the stratified ORs observed across population (for beta-blockers and neuroleptics and antipsychotics) and study type (for sedatives and hypnotics, benzodiazepines, and narcotics). An increased likelihood of falling was estimated for the use of sedatives and hypnotics, neuroleptics and antipsychotics, antidepressants, benzodiazepines, and nonsteroidal anti-inflammatory drugs in studies considered to have "good" medication and falls ascertainment. The use of sedatives and hypnotics, antidepressants, and benzodiazepines demonstrated a significant association with falls in elderly individuals.
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              A multifactorial intervention to reduce the risk of falling among elderly people living in the community.

              Since falling is associated with serious morbidity among elderly people, we investigated whether the risk of falling could be reduced by modifying known risk factors. We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling: postural hypotension; use of sedatives; use of at least four prescription medications; and impairment in arm or leg strength or range of motion, balance, ability to move safely from bed to chair or to the bathtub or toilet (transfer skills), or gait. These subjects were given either a combination of adjustment in their medications, behavioral instructions, and exercise programs aimed at modifying their risk factors (intervention group, 153 subjects) or usual health care plus social visits (control group, 148 subjects). During one year of follow-up, 35 percent of the intervention group fell, as compared with 47 percent of the control group (P = 0.04). The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 (95 percent confidence interval, 0.52 to 0.90). Among the subjects who had a particular risk factor at base line, a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of reassessment, as follows: at least four prescription medications, 63 percent versus 86 percent, P = 0.009; balance impairment, 21 percent versus 46 percent, P = 0.001; impairment in toilet-transfer skills, 49 percent versus 65 percent, P = 0.05; and gait impairment, 45 percent versus 62 percent, P = 0.07. The multiple-risk-factor intervention strategy resulted in a significant reduction in the risk of falling among elderly persons in the community. In addition, the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group, as compared with the control group. Thus, risk-factor modification may partially explain the reduction in the risk of falling.
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                Author and article information

                Contributors
                02476 151128 , julie.bruce@warwick.ac.uk
                shvaita_ralhan@yahoo.co.uk
                ray.sheridan@nhs.net
                k_westacott@hotmail.co.uk
                emma.withers@warwick.ac.uk
                s.k.finnegan@warwick.ac.uk
                John.Davison@nuth.nhs.uk
                finbarr.martin@gstt.nhs.uk
                sarah.lamb@ndorms.ox.ac.uk
                Journal
                BMC Geriatr
                BMC Geriatr
                BMC Geriatrics
                BioMed Central (London )
                1471-2318
                1 June 2017
                1 June 2017
                2017
                : 17
                : 116
                Affiliations
                [1 ]ISNI 0000 0000 8809 1613, GRID grid.7372.1, Warwick Clinical Trials Unit, Division of Health Sciences, , University of Warwick, ; Coventry, CV4 7AL UK
                [2 ]ISNI 0000 0001 2306 7492, GRID grid.8348.7, Oxford University Hospitals NHS Trust, , The John Radcliffe Hospital, ; Headley Way, Headington, Oxfordshire, OX3 9DU UK
                [3 ]ISNI 0000 0000 8527 9995, GRID grid.416118.b, , Royal Devon & Exeter Hospital, ; Barrack Road, Exeter, EX2 5DW UK
                [4 ]GRID grid.15628.38, , University Hospitals of Coventry and Warwickshire, ; Clifford Bridge Road, Coventry, CV2 2DX UK
                [5 ]ISNI 0000 0004 0444 2244, GRID grid.420004.2, Falls and Syncope Service, , Newcastle upon Tyne Hospitals NHS Foundation Trust, ; Newcastle, NE1 4LP UK
                [6 ]GRID grid.425213.3, Guys and St Thomas’ NHS Foundation Trust, , St Thomas’ Hospital, ; London, SE1 7EH UK
                [7 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Botnar Research Centre, Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, , University of Oxford, ; Windmill Road, Oxford, OX3 7LD UK
                Author information
                http://orcid.org/0000-0002-8462-7999
                Article
                492
                10.1186/s12877-017-0492-6
                5455136
                28571563
                ddd556a4-5dcc-4dda-b985-c740616b137d
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 24 June 2016
                : 25 April 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000664, Health Technology Assessment Programme;
                Award ID: 08/14/41
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Geriatric medicine
                falls,falls prevention,multifactorial assessment,older adults,trial intervention

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