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Headline
There was no evidence that ‘screen and treat’ falls prevention strategies in primary care reduce fractures at 18 months.
Abstract
Background:
Falls and fractures are a major problem.
Objectives:
To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions.
Design:
Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice.
Setting:
Primary care.
Participants:
People aged ≥ 70 years.
Interventions:
All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling.
Main outcome measures:
The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit.
Results:
Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported.
Limitations:
The rate of fractures was lower than anticipated.
Conclusions:
Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective.
Future work:
Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects.
Trial registration:
Current Controlled Trials ISRCTN71002650.
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. 25, No. 34. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Chapter 2. Methods
- Trial design and setting
- Eligibility criteria
- Participant exclusions by general practitioner
- Postal invitation and participant consent
- Allocation sequence generation and randomisation
- Blinding
- Trial interventions (advice, exercise and multifactorial falls prevention)
- Screening and referral to active intervention
- Co-interventions
- Baseline data: practices and participants
- Outcomes
- Secondary outcomes
- Data collection: postal questionnaires
- Process evaluation
- Data management
- Data analyses
- Statistical analyses
- Treatment comparisons
- Descriptive analyses
- Secondary outcomes
- Other secondary outcomes and baseline measures
- Missing data
- Adverse event reporting
- Pilot phase and protocol revisions
- Monitoring and approval
- Patient and public involvement
- Trial Steering Committee
- Data Monitoring and Ethics Committee
- Chapter 3. Trial interventions
- Introduction
- Advice intervention
- Rationale and scientific principles for the exercise intervention
- Content of the PreFIT exercise intervention
- Procedures for delivery of the PreFIT exercise intervention
- Exercise adherence
- Data collection
- Exercise quality control assessments
- Multifactorial falls prevention intervention
- Content of PreFIT MFFP assessment
- Culprit medications
- PreFIT medication reviews
- Factors not included in the PreFIT multifactorial falls prevention assessment
- Staff training
- Recommended treatments
- Data collection
- Multifactorial falls prevention quality control assessments
- Chapter 4. Results
- Study timeline
- Cluster (general practice)-level data
- Sociodemographic characteristics of recruited general practices
- Participant recruitment and allocation
- Completeness of primary outcome data
- Completeness of secondary outcome data
- Baseline characteristics of trial participants
- History of falls and fractures in previous year
- Primary outcome: fractures
- Secondary outcomes
- Subgroup analyses
- Health-related quality of life over time by intervention
- Frailty
- Serious adverse events
- Process evaluation
- Time from randomisation to start of treatment
- Process evaluation
- Chapter 5. Health economics
- Overview of health economics analysis
- Measurement of resource use and costs
- Costing of the PreFIT active interventions
- Collection of secondary care use data
- Collection of broader resource use data
- Calculation of utilities and quality-adjusted life-years
- Missing data
- Results
- Cost-effectiveness results
- Discussion
- Chapter 6. Discussion
- Study findings and key messages
- Internal and external validity
- Data collection
- Uptake to trial
- Participant characteristics
- Quality of life
- Screening in primary care
- Referrals and uptake to intervention
- Comparison with other studies
- Interpretation of study findings
- Intervention fidelity
- Medication reviews
- Fracture prevention
- Strengths of the study
- Limitations of the study
- Patient and public involvement
- Cost-effectiveness findings
- Future recommendations
- Conclusions
- Acknowledgements
- References
- Appendix 1. Supplementary tables
- List of abbreviations
- List of supplementary material
About the Series
Declared competing interests of authors: Julie Bruce is chief investigator or co-investigator on multiple current research grants from the UK National Institute for Health Research (NIHR). Julie Bruce reports consultancy fees from Medtronic plc (Medtronic plc, Dublin, Ireland). Julie Bruce has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. Julie Bruce is supported by NIHR Research Capability Funding via University Hospitals Coventry and Warwickshire. Martin Underwood was chairperson of the National Institute for Health and Care Excellence Accreditation Advisory Committee until March 2017, for which he received a fee. He is chief investigator or co-investigator on multiple previous and current research grants from NIHR and Arthritis Research UK and is a co-investigator on grants funded by the Australian National Health and Medical Research Council. He is a NIHR senior investigator. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd (Kent, UK), which provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd (Hart, UK), which is related to return-to-work initiatives. He is a co-investigator on a study receiving support in kind from Orthospace Ltd (Caesarea, Israel). He has accepted an honorarium from Carta (Palo Alto, CA, USA). He is co-investigator on two NIHR-funded research projects receiving additional support from Stryker Ltd (Kalamazoo, MI, USA). He has accepted an honorarium from the Confederation for Advanced Research Training in Africa (CARTA). He is an editor of the NIHR journal series and a member of the NIHR Journals Library Editorial Group (2016–20), for which he receives a fee. Chris Bojke was a member of the NIHR Health Services and Delivery Research (HSDR) Board (2018–present). Roberto Longo was a NIHR HSDR Associate Member (2017–18). Claire Hulme reports being a member of the Health Technology Assessment (HTA) Commissioning Board (2013–17). Dawn A Skelton reports personal fees from Later Life Training Ltd (Killin, UK) during the conduct of the study. She is currently co-investigator on a NIHR HTA grant [ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care Homes), ongoing]. She has received grants from the NIHR Collaborations for Leadership in Applied Health Research and Care [PhISICAL (PHysical activity Implementation Study In Community-dwelling AduLts)], grants from the NIHR Public Health Research programme [REACT (REtirement into ACTION), ongoing; VIOLET (Visually Impaired OLder people’s Exercise programme for falls prevenTion), finished] and grants from the Medical Research Council/NIHR Methodology programme (finished) during the conduct of this study. Sarah E Lamb reports grants from the NIHR HTA programme during the conduct of the study, and was a member of the following: HTA Additional Capacity Funding Board (2012–15), HTA Clinical Trials Board (2010–15), HTA End of Life Care and Add-on Studies Board (2015), HTA Funding Boards Policy Group (formerly the Clinical Studies Group) (2010–15), HTA Post-Board Funding Teleconference (2010–15), HTA Maternal, Neonatal and Child Health Methods Group (2013–15), HTA Primary Care Themed Call Board (2013–14), HTA Prioritisation Group (2012–15) and the NIHR Clinical Trials Unit Standing Advisory Committee (2012–16).
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 08/14/41. The contractual start date was in September 2010. The draft report began editorial review in June 2019 and was accepted for publication in January 2020. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Last reviewed: June 2019; Accepted: January 2020.
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