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      Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation

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          Abstract

          Objectives

          To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes.

          Design

          Multicentre, parallel, cluster randomised controlled trial.

          Setting

          Long term care homes in the UK, registered to care for older people or those with dementia.

          Participants

          1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care.

          Interventions

          Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care.

          Main outcome measures

          Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation.

          Results

          Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval −£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (−0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively.

          Conclusions

          The GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency.

          Trial registration

          ISRCTN34353836.

          Related collections

          Most cited references28

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          Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

          Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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            Multiple imputation using chained equations: Issues and guidance for practice

            Multiple imputation by chained equations is a flexible and practical approach to handling missing data. We describe the principles of the method and show how to impute categorical and quantitative variables, including skewed variables. We give guidance on how to specify the imputation model and how many imputations are needed. We describe the practical analysis of multiply imputed data, including model building and model checking. We stress the limitations of the method and discuss the possible pitfalls. We illustrate the ideas using a data set in mental health, giving Stata code fragments. 2010 John Wiley & Sons, Ltd.
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              Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets.

              A five-level version of the EuroQol five-dimensional (EQ-5D) descriptive system (EQ-5D-5L) has been developed, but value sets based on preferences directly elicited from representative general population samples are not yet available. The objective of this study was to develop values sets for the EQ-5D-5L by means of a mapping ("crosswalk") approach to the currently available three-level version of the EQ-5D (EQ-5D-3L) values sets. The EQ-5D-3L and EQ-5D-5L descriptive systems were coadministered to respondents with conditions of varying severity to ensure a broad range of levels of health across EQ-5D questionnaire dimensions. We explored four models to generate value sets for the EQ-5D-5L: linear regression, nonparametric statistics, ordered logistic regression, and item-response theory. Criteria for the preferred model included theoretical background, statistical fit, predictive power, and parsimony. A total of 3691 respondents were included. All models had similar fit statistics. Predictive power was slightly better for the nonparametric and ordered logistic regression models. In considering all criteria, the nonparametric model was selected as most suitable for generating values for the EQ-5D-5L. The nonparametric model was preferred for its simplicity while performing similarly to the other models. Being independent of the value set that is used, it can be applied to transform any EQ-5D-3L value set into EQ-5D-5L index values. Strengths of this approach include compatibility with three-level value sets. A limitation of any crosswalk is that the range of index values is restricted to the range of the EQ-5D-3L value sets. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Role: professor of rehabilitation research
                Role: research fellow
                Role: professor of the medicine of older people
                Role: professor of the care of older people,
                Role: professor of health economics
                Role: senior lecturer
                Role: research associate
                Role: professor of medical statistics
                Role: statistician
                Role: associate professor of applied health services research
                Role: research fellow
                Role: research fellow
                Role: senior research fellow
                Role: health economist
                Role: professor of clinical psychiatry
                Role: professor of geriatric medicine
                Role: professor of applied dementia studies
                Role: research fellow
                Role: patient and public involvement representative
                Role: operations manager
                Journal
                BMJ
                BMJ
                BMJ-UK
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2021
                07 December 2021
                : 375
                : e066991
                Affiliations
                [1 ]School of Medicine, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK
                [2 ]Nottingham CityCare Partnership, Nottingham, UK
                [3 ]NIHR Applied Research Collaboration – East Midlands, Nottingham, UK
                [4 ]NIHR Nottingham Biomedical Research Centre, Nottingham, UK
                [5 ]Nottingham University Hospitals NHS Trust, Nottingham, UK
                [6 ]University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
                [7 ]Norwich Medical School, University of East Anglia, Norwich, UK
                [8 ]University of Hertfordshire, Hatfield, UK
                [9 ]Exeter Medical School, University of Exeter, Exeter, UK
                [10 ]University College London, London, UK
                [11 ]University of Bradford, Bradford, UK
                [12 ]Nottingham, UK
                Author notes
                Correspondence to: P A Logan pip.logan@ 123456nottingham.ac.uk (or @loganpip on Twitter)
                Author information
                https://orcid.org/0000-0002-6657-2381
                Article
                bmj-2021-066991.R1 logp066991
                10.1136/bmj-2021-066991
                8649897
                34876412
                64673e6a-333a-4e6d-b5d5-6f5e5b99b92e
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

                History
                : 12 November 2021
                Categories
                Research

                Medicine
                Medicine

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