PreFIT trial (Prevention of Falls Injury Trial)

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Objective for processing

This Data Sharing Agreement permits the Warwick Clinical Trials Unit (CTU) to retain the minimum necessary amount of NHS Digital data for archiving purposes in accordance with publishing guidance and the Warwick CTU’s standard operating procedures. The data was supplied for the purpose of the Prevention of Fall Injury Trial (PreFIT). The trial is now complete and the results have been published. Warick CTU wishes to archive the data for 10 years post-trial. This Agreement permits processing of the data for the purpose of secure storage and back up. This Agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the trial by repeating previous analyses described in this Agreement. Following publication of the trial findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Warwick CTU, contact via the publishing journal or an open letter. In such circumstances, Warwick CTU may re-run the previously analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published. Warwick CTU may not undertake different analyses to those undertaken during the original analysis. If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation Warwick CTU must submit an amendment request to NHS Digital before data is accessed. The following provides information on the trial for which the data was originally provided and used: The Warwick CTU were funded by the National Institute for Health Research Health Technology Assessment (NIHR) (HTA) to undertake a large complex intervention trial to investigate alternative strategies to prevent falls and fractures in older adults. The lead applicant was involved with earlier research that identified gaps in evidence; this in turn led to the HTA grant award to investigate alternative interventions to prevent falls: (1) advice alone, versus (2) exercise; versus (3) multifactorial falls prevention (MFFP) intervention in older adults. The aim of the trial is to identify which falls prevention intervention is the most clinical effective and cost-effective, on outcomes of falls and fractures, in adults aged over 70 years. The Pre-FIT trial is the largest trial ever conducted on community based fall prevention on outcomes of fractures. Falls and fractures are common and serious health problems for older people. The UK government recognised this problem, and in 2004, in view of the importance of the problem, elected to develop a guideline through the National Institute of Clinical Excellence (NICE). The guideline was based on the available evidence at that time (up to 2003), which included a high quality review of all of the evidence conducted by the Cochrane Collaboration. Although the amount of evidence available was limited, the Cochrane systematic review concluded that MFFP services are likely to be effective. NICE took this recommendation forward, and undertook some preliminary economic evaluation. Following an evaluation for NICE, it was concluded that there was insufficient data available to determine cost-effectiveness of different options to treatment, including MFFP. NICE also commissioned an update the evidence and determine whether or not it would now be possible to generate economic models. The University of Warwick undertook a rigorous review of the evidence, published in the British Medical Journal (Gates et al). The results of this were surprising, with the accumulation of evidence, it does suggest that MFFP interventions are considerably less effective than originally anticipated, and there is little evidence that fractures can be prevented with these treatments. Concurrently, researchers from New Zealand published a review which suggested that exercise may be just as effective as MFFP, but would be considerably cheaper. This information raised uncertainty, and the need to conduct a large trial to answer several questions which would inform NHS services. The NHS commits £34 million each year to multifactorial falls prevention interventions; these are thought to be conservative estimates. The cost of falls to the NHS and Personal Social Services (PSS) is estimated to be £908.9 million, with 63% of the costs incurred from falls in those aged over 75 years (Scuffham and Chaplin 2002). Although most falls result in no serious injury, approximately 5% of older people living in the community who fall annually experience a fracture (Rubenstein 2001; Tinetti 1988). The total annual cost of fall-related fractures to the NHS is £1.7 billion (Torgerson 2001). The recently updated Cochrane review of interventions to prevent falling in community dwelling older people has suggested that exercise reduces fall rates by approximately 25%, dependent on mode of exercise. Most of the clinical trials conducted to date do not capture fracture as an outcome; fracture is the biggest burden, both to the patient & NHS. Given the money that the NHS invests each year, it is crucial to investigate whether this is an efficient use of scarce resources, exercise may be a cheaper strategy. This is a trial comparing alternative falls prevention interventions to prevent falls and fractures. Peripheral fractures, recorded within diagnosis codes in HES Inpatient, Critical Care, A&E and Outpatient datasets will be accepted as confirmed fracture. This is the primary outcome for the trial. Additional validation work will be conducted to compare ‘HES fractures’ to participant self-reported and fractures recorded in general practice. Other HES variables relating to hospital/episode duration (e.g., length of stay) will be used for economic analyses to determine the cost-effectiveness of alternative interventions. As this is a cohort of older adults aged over 70 years of age, the study team also require mortality data to accurately capture “time to event” outcomes, including fracture rates and falls rates over the duration of the study. The University of Warwick made a final request for HES data in 2017 for this clinical trial. The trial requested interim waves of HES data in 2012-14. The University of Warwick hold full HES data for all participants included in the pilot study (n=1801) and partial HES data for subset of main trial participants (N=8019). These data have been used to calculate number and site of fractures. This was the last PreFIT request for the final wave of HES data for the last three years’ worth of hospital data for those consenting within the relevant timeframe (thus HES years 2013/4, 2014/5 and 2015/6). For the final request in 2017, the University of Warwick excluded those participants for whom they already hold full data (excluded pilot study participants). That request was for data within the three year consented time period, thus from 2014 – 2016 for 8019 participants. For the final 2017 request, the study restricted the request to a HES data download for three years: 2013/4; 2014/5 and 2015/6. This was in addition to the data previously received and covered the period for one year before trial recruitment to the end of follow-up for main trial participants only (n=8019). Participants from the pilot study were not included in that request. The request was restricted to the subset of main trial participants to ensure the timing of individual signed participant consent falls within the approved three year timeline. No new data has been requested since. The trial cohort was selected from five English regions. The trial cohort was carefully selected using the relevant variables for the purposes of analysis. To summarise, the study team require HES data to allow accurate analysis of the trial primary outcome and to generate time to event outcomes (time to first fall; time to fracture etc). The study are unable to report the main trial findings without these HES data. The GDPR legal basis for data processing relied upon in this Agreement are Article 6(1)e (processing is necessary for the performance of a task carried out in the public interest) and Article 9(2)j (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes). The University of Warwick are the sole Data Controller under this Agreement and also process the data. No other organisations have any role in determining the purposes for data processing or have any access to the data disseminated under this Agreement. [1 paragraph unchanged] Other organisations involved in the trial include the University of Leeds Academic Unit of Health Economics. HES data will not be shared with the University of Leeds. A The involvement of University of Leeds extends only to a Professor of Health Economics who holds an honorary contract with the University of Warwick and will provide who has provided the relevant statistical syntax for the economic analysis to be conducted by trial statisticians at the Warwick CTU. In summary, the Warwick CTU were funded by the National Institute for Health Research Health Technology Assessment (NIHR) (HTA) to undertake a large complex intervention trial to investigate alternative strategies to prevent falls and fractures in older adults. Historically, the lead applicant was involved with earlier research that identified gaps in evidence; this in turn led to the HTA grant award to investigate alternative interventions to prevent falls: (1) advice alone, versus (2) exercise; versus (3) multifactorial falls prevention (MFFP) intervention in older adults. The aim of the trial is to identify which falls prevention intervention is the most clinical effective and cost-effective, on outcomes of falls and fractures, in adults aged over 70 years. The Pre-FIT trial is the largest trial ever conducted on community based fall prevention on outcomes of fractures. Further details on the background and rationale are provided below. Falls and fractures are common and serious health problems for older people. The UK government recognised this problem and in 2004, in view of the importance of the problem, elected to develop a guideline through the National Institute of Clinical Excellence (NICE). The guideline was based on the available evidence at that time (up to 2003), which included a high quality review of all of the evidence conducted by the Cochrane Collaboration. Although the amount of evidence available was limited, the Cochrane systematic review concluded that MFFP services are likely to be effective. NICE took this recommendation forward, and undertook some preliminary economic evaluation. Following an evaluation for NICE, it was concluded that there was insufficient data available to determine cost-effectiveness of different options to treatment, including MFFP. NICE also commissioned an update the evidence and determine whether or not it would now be possible to generate economic models. The University of Warwick undertook a rigorous review of the evidence, published in the British Medical Journal (Gates et al). The results of this were surprising, with the accumulation of evidence, it does suggest that MFFP interventions are considerably less effective than originally anticipated, and there is little evidence that fractures can be prevented with these treatments. Concurrently, researchers from New Zealand published a review which suggested that exercise may be just as effective as MFFP, but would be considerably cheaper. This information raised uncertainty, and the need to conduct a large trial to answer several questions which would inform NHS services. Burden of falls The NHS commits £34 million each year to multifactorial falls prevention interventions; these are thought to be conservative estimates. The cost of falls to the NHS and Personal Social Services (PSS) is estimated to be £908.9 million, with 63% of the costs incurred from falls in those aged over 75 years (Scuffham and Chaplin 2002). Although most falls result in no serious injury, approximately 5% of older people living in the community who fall annually experience a fracture (Rubenstein 2001; Tinetti 1988). The total annual cost of fall-related fractures to the NHS is £1.7 billion (Torgerson 2001). The recently updated Cochrane review of interventions to prevent falling in community dwelling older people has suggested that exercise reduces fall rates by approximately 25%, dependent on mode of exercise. Most of the clinical trials conducted to date do not capture fracture as an outcome; fracture is the biggest burden, both to the patient & NHS. Given the money that the NHS invests each year, it is crucial to investigate whether this is an efficient use of scarce resources, exercise may be a cheaper strategy. This is a trial comparing alternative falls prevention interventions to prevent falls and fractures. Peripheral fractures, recorded within diagnosis codes in HES Inpatient, Critical Care, A&E and Outpatient datasets will be accepted as confirmed fracture. This is the primary outcome for the trial. Additional validation work will be conducted to compare ‘HES fractures’ to participant self-reported and fractures recorded in general practice. Other HES variables relating to hospital/episode duration (e.g. length of stay) will be used for economic analyses to determine the cost-effectiveness of alternative interventions. As this is a cohort of older adults aged over 70 years of age, the study team also require mortality data to accurately capture “time to event” outcomes, including fracture rates and falls rates over the duration of the study. The University of Warwick made a final request for HES data in 2017 for this clinical trial. The trial requested interim waves of HES data in 2012-14. The University of Warwick hold full HES data for all participants included in the pilot study (n=1801) and partial HES data for subset of main trial participants (N=8019). These data have been used to calculate number and site of fractures. This was the last PreFIT request for the final wave of HES data for the last three years’ worth of hospital data for those consenting within the relevant timeframe (thus HES years 2013/4, 2014/5 and 2015/6). For the final request in 2017, the University of Warwick excluded those participants for whom they already hold full data (excluded pilot study participants). That request was for data within the three year consented time period, thus from 2014 – 2016 for 8019 participants. For the final 2017 request, the study restricted the request to the subset of main trial participants (excluding pilot study participants) to ensure the timing of individual signed participant consent falls within the approved three year timeline. No new data has been requested since. To summarise, the study team require HES data to allow accurate analysis of the trial primary outcome, to generate time to event outcomes (time to first fall; time to fracture etc). The study are unable to report the main trial findings without these HES data.

Processing activities

The data was supplied by NHS Digital to the University of Warwick. There will be no subsequent flows of data. The data will be securely stored. The data may be accessed for a purpose specified above only. In all such circumstances, the data must remain on University of Warwick’s servers. The following information describes the processing activites which took place under previous versions of this Data Sharing Agreement: [7 paragraphs unchanged] No further linkage to any other datasets will be undertaken. [3 paragraphs unchanged] In 2017 the study requested a HES data download for three years: 2013/4; 2014/5 and 2015/6. This was in addition to the data previously received and covered the period for one year before trial recruitment to the end of follow-up for main trial participants only (n=8019). Participants from the pilot study were not included in that request. No further linkage to any other datasets will be undertaken. No geographical spread, this is for our trial cohort only, selected from five English regions. The trial have carefully selected the relevant variables for the purposes of analysis. NHS Digital reminds all organisations party to this Agreement of the need to comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data) NHS Digital reminds all organisations party to this agreement of the need to comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data)

Expected output

The following outputs will be produced: have been published: 1. An HTA monograph reporting the overall trial results to the funder (NIHR HTA). The monograph is due for submission in March 2019. - The main PreFIT trial findings were published in the New England Journal of Medicine (impact factor 74). Ref: Lamb S, Bruce J, Hossain A, et al., Screening and intervention to prevent fall and fractures in older people. N Engl J Med, 2020 Nov 5;383(19):1848-1859. 2. In parallel, the study intend to submit a number of peer-reviewed publications to leading medical journals. They expect the results of the trial to be of great interest to the academic community and anticipate publishing the ‘main’ findings in a leading journal eg. The Lancet, The New England Journal of Medicine (NEJM) or equivalent. There will be a number of related papers reporting subsidiary but clinically important research questions. Several subsidiary papers are currently under review. - The HTA monograph was published in May 2021, ref: Bruce J, Hossain A, Lall R, et al., 2021;25(34):1-114. doi: 10.3310/hta25340. This is available full-text on NIHR website. This report includes the description of HES data obtained from NHS Digital and procedures for analyses. 3. The study will publish the trial intervention manuals as open-access on the Warwick Research Archive Portal. The study have published the trial protocol paper (Bruce et al, BMJ Open 2016) and intervention papers are also in the public domain (BMC Geriatrics and Physiotherapy). Other secondary publications are under review. We can provide details of these e.g. forthcoming methodological papers relating to fracture analyses (submitted to Trials); methods paper on falls screening (submitted to PLOS Medicine); also a paper describing exercise intervention findings (in preparation). 4. Trial findings will be summarised on the Warwick Clinical Trials Unit main website with further information within the PreFIT trial website: http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/ The following papers relating to PreFIT have also been published:- - Griffin J, Lall R, Bruce J, et al. Comparison of alternative falls data collection methods in the Prevention of Falls Injury Trial (PreFIT). J Clin Epidemiol 2019; 106: 32-40. - Finnegan S, Bruce J, Skelton DA, Withers EJ, Lamb SE, on behalf of PreFIT Study Group. Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT). Physiotherapy 2018; 104(1): 72-9. - Bruce J, Ralhan S, Sheridan R, et al. The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT). BMC Geriatr 2017; 17(1): 116. - Bruce J, Lall R, Withers EJ, et al. A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT). BMJ Open 2016; 6(1): e009362 In addition, there are other falls-related outputs from a funded PhD studentship, related to PreFIT: - - Finnegan S, Bruce J, Seers K. Life after falls prevention exercise - experiences of older people taking part in a clinical trial: a phenomenological study. BMC Geriatrics 2021; 21(1): 91. - Finnegan S, Seers K, Bruce J. Long-term follow-up of exercise interventions aimed at preventing falls in older people living in the community: a systematic review and meta-analysis. Physiotherapy 2019; 105(2): 187-99. - Finnegan S, Bruce J, Seers K. What enables older people to continue with their falls prevention exercises? A qualitative systematic review. BMJ Open 2019; 9(4): e026074. The study trial intervention manuals are available as open-access on the Warwick Research Archive Portal. These are the full intervention manuals for the exercise and falls prevention interventions, available for researchers and healthcare professionals to see the details of the interventions delivered within the trial. Trial findings are summarised on the Warwick Clinical Trials Unit main website with further information within the PreFIT trial website: http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/ [1 paragraph unchanged] 5. Findings will be disseminated to AgeUK charity and to Public Health England. These websites also explain how data were used for the purposes of the trial. 6. Findings will be submitted to In additional, study findings have been presented at various academic conferences, including geriatric care, physiotherapy and falls prevention conferences (e.g. e.g. British Society of Geriatrics; Geriatrics 2018; World Confederation for Physical Therapy). Preliminary findings of falls outcomes have been presented at Therapy; also the British Geriatric Society 2018 and a forthcoming National Osteoporosis Society meeting (UK, December 2018). UK, 2018; Falls and Fractures Network Meeting 2019. 7. Findings will be disseminated on social media via the Warwick Clinical Trials Unit Twitter page: @WarwickCTU. This website currently has 327 followers (September 2018). Findings will also be disseminated by the Warwick Medical School Twitter account: @warwickmed / N=3651 followers. The trial has had considerable interest online, with findings being disseminated on social media via the Warwick Clinical Trials Unit Twitter page: @WarwickCTU (n=979 followers), Warwick Medical School (n=4880 followers), by trial team members (e.g @jxbruce (n=683); @FinneganSusanne (n=198) and others within the falls community (e.g. British Geriatric Society n=28,600). All outputs are aggregated with small number suppression in line with the HES Analysis Guide. No data will be shared outside the University of Warwick except for aggregated, small number suppressed outputs. NIHR published an alert on 30/09/2021 and highlight that NICE are currently in the process of updating their guidance and will incorporate the findings of PreFIT. See: https://evidence.nihr.ac.uk/alert/postal-advice-prevents-fall-related-fractures/

Expected measurable benefits

The PreFIT trial findings will be considered by NICE when deciding whether to continue to recommend funding selected falls prevention activities; specifically whether to recommend exercise to prevent falls and fractures or whether resources are best directed at multifactorial strategies e.g. in those who are at greatest risk of falling. Trial findings will be incorporated into Cochrane systematic review updates. The majority of trials published to date have sample sizes of less than 200 participants. This trial has 9821 participants and will contribute a great deal of certainty with regards to findings. Falls are common in people aged over 70 years of age. Given the ageing population, trial findings impact upon older adults at risk of falling. Study findings will inform clinical and public health policy decision making and are being considered by NICE. This is the largest ever RCT of community dwelling older adults and provides valuable information on whether NHS funding should be reallocated to other areas of care. Trial researchers were invited by Public Health England to present at a falls prevention event in 2016, to report on trial methods and to raise awareness of the near completion of the trial. PHE are awaiting the trial findings. The University of Warwick are also contacted regularly by consultant clinicians and falls prevention experts asking for updates on when the trial findings will be released. The findings from PreFIT will undoubtedly inform clinical and public health policy decision making. This is the largest ever RCT of community dwelling older adults and will provide valuable information on whether NHS funding should be reallocated to other areas of care. Falls are common in people aged over 70 years of age. Given the ageing population, the study expect the impact from this trial to be significant as will potentially affect a large number of older adults. It is likely that national guidance will be updated on the basis of the findings from this large clinical trial.

Benefits reported

Benefits to date include recruitment of a large representative cohort of older adults aged 70 to 101 years. This is one of the largest cohort studies of older adults in England and will provide valuable data on falls, fractures and health status over time. The study have published three papers relating to the trial to date and more publications are planned (two are currently under review). The PreFIT trial findings are being considered by NICE as no evidence was found to support multifactorial falls prevention activities on fracture outcomes. An interim benefit was found from the exercise programme on reducing falls (at 8 months), but this was not sustained over time by 18 months follow-up. Trial findings will be incorporated into the next Cochrane systematic review updates. The majority of falls trials published to date had sample sizes of less than 200 participants. PreFIT is the large trial in the UK and one of the largest globally, with findings based on 9803 people aged from 70 to 101 years. As fractures were determined from HES data, the University of Warwick had 100% data completion for the primary outcome. Early PreFIT falls results were presented at the European Falls Festival in July 2018, the Fragility Fracture Network in July 2018, and the British Geriatrics Society (BGS) Falls & Postural Stability meeting in September 2018. Further presentations are scheduled for events in November / December 2018. The study team have been in communication with Public Health England who are awaiting the final paper and Health Technology Assessment (HTA) report for the trial. Other historical activities, prior to trial findings being published, included invitations by Public Health England to present the trial, to describe methods and raise awareness of the scale of the study and how it will contribute to the evidence. The University of Warwick Clinical Trials Unit were contacted regularly by consultants in geriatric medicine, falls prevention experts and those organising conference meetings, requesting updates on progress and anticipated release of study findings.