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Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
No

1. Summary of the impact

The group’s research has changed Scottish healthcare-associated infection screening policy, leading to a year-on-year decrease of 17.1% in the prevalence of infections, following an increased uptake of the policy from 75% to 87%. A pioneering programme of studies has improved the validity of the European Centre for Disease Prevention and Control’s healthcare-associated infection survey methodology, resulting in an additional 450,000 (10%) infections being estimated across 28 countries. Globally our research has formed the basis of World Health Organization’s guidance that has led to an increase in the proportion of countries, with a national infection prevention programme, from 41% to 63%.

2. Underpinning research

The research team are part of the Scottish Healthcare-associated Infection (HAI) Prevention Institute [G1], a 6-year Scottish Government funded consortium (£4.3M), in which they lead the work-stream generating evidence for the following aspects of infection prevention and control (IPC) practice.

Developing Scottish HAI Screening Practice

In 2016, Currie led the mixed-methods BESH study to investigate why the Scottish Government target of screening 90% of eligible hospitalised patients for carriage or infection with resistant organisms was not being achieved. Funded by Health Protection Scotland (HPS) [G2], BESH identified for the first time barriers and enablers to implementing screening from the perspective of clinical nurses and IPC managers [R1]. Underpinned by the Theoretical Domains Framework and Normalisation Process Theory, this Scottish-wide study produced findings that significantly predicted optimum compliance with the screening policy: i) routinizing screening as part of the admission process; ii) being admitted to some clinical specialities; iii) providing feedback to nurses on their screening compliance.

Developing & Implementing ECDC HAI Survey Methodology

In 2010, Reilly led the first European-wide study [R2] to evaluate optimal methods for validation of HAI point prevalence surveys. Funded by European Centre for Disease Prevention and Control (ECDC) [G3], its recommendations were subsequently incorporated into the ECDC protocol for the 2016 HAI point prevalence survey. Funding of £350K from the Scottish Government [G4] allowed her to develop this programme of research by utilising this protocol in the Scottish HAI point prevalence survey in 2016 [R3]. The results showed that the prevalence of HAI in Scotland was significantly lower in 2016 (4.6%) compared to 2011 (4.9%), however the validation study carried out for the first time in Scotland in 2016, based on the GCU research, demonstrated that the prevalence before adjustment was 4.6% and after adjustment for the estimated under-reporting was 7.7% (95% CI: 5.1 to 15.8) [R4] The study also demonstrated that the population at risk and the most common causative organism had changed: the patients at risk were older and with significantly more co-morbidities, and Escherichia coli had replaced Staphylococcus aureus as the most common causative organism [R4]. These results indicated a need to fundamentally change NHS Scotland policy makers’ and practitioners’ priorities from surveillance of Staphylococcus aureus to that of Escherichia coli, and to the prevention of urinary infections and pneumonia in older people.

Developing WHO’s guidance on national level IPC interventions

A global coordinated approach to IPC by Governments at a national level was found to be lacking during the 2014 Ebola outbreak. To address this fundamental issue, the World Health Organization (WHO) commissioned Price [G5] in 2015, to provide a systematic review of the effectiveness of national level IPC interventions. Using Cochrane’s Effective Practice and Organization of Care methodology, the review findings provided the first global evidence of effectiveness of national level IPC interventions [R5]. Critically, the review recommended that to reduce HAI, countries should incorporate education and training, surveillance, monitoring, audit and feedback into their IPC programmes and introduce the use of multimodal patient focused interventions.

3. References to the research

The research underpinning this impact case study includes new knowledge that has informed NHS Scotland policy from a sequential two-stage mixed-methods study, which applied constructs from normalization process theory and the theoretical domains framework to guide data collection and analysis [R1]. Research that has been instrumental in developing optimum methods for the European Centres for Disease Prevention and Control to measure infection across it member states and applied for the first time across Scotland to provide a more accurate estimate of the prevalence of infection [R2,3,4]. A first systematic review of evidence of effectiveness of global national infection prevention and control interventions for the World Health Organization published in Lancet Infectious Diseases [R5].

  • [R1] Currie K, King C, McAloney-Kocaman K, Roberts NJ, MacDonald J, Dickson A, et al (2019) Barriers and enablers to methicillin-resistant Staphylococcus aureus admission screening in hospitals: a mixed methods study. 2019 Journal of Hospital Infection 101 (1) pp100-108. https://doi.org/10.1016/j.jhin.2018.08.006

  • [R2] Reilly JS, Price L, Godwin J, Cairns S, Hopkins S, Cookson B, et al. A pilot validation in 10 European Union Member States of a point prevalence survey of healthcare-associated infections and antimicrobial use in acute hospitals in Europe, 2011. Eurosurveillance. 2015;20(8):pii=21045. https://doi.org/10.2807/1560-7917.ES2015.20.8.21045

  • [R3] Cairns S, Gibbons C, Milne A, King H, Llano M, MacDonald L, Malcolm W, Robertson C, Sneddon J, Weir J, Reilly JS (2018) Results from the third Scottish national prevalence survey: the changing epidemiology of healthcare-associated infection in Scotland Journal of Hospital Infection 2018 99 (3) pp 312-317. https://doi.org/10.1016/j.jhin.2018.03.038

  • [R4] Health Protection Scotland (Cairns S, Gibbons C, Hay A, King H, Llano M, MacDonald L, Malcolm W, Robertson C, Sneddon J, Weir J, Reilly JS). National Point Prevalence Survey of Healthcare Associated Infection and Antimicrobial Prescribing 2016. Health Protection Scotland, 2017 [Report]. https://hpspubsrepo.blob.core.windows.net/hps-website/nss/2204/documents/1_PPS%20National%20Report%202016.pdf

  • [R5] Price L, MacDonald J, Melone L, Howe T, Flowers P, Currie K, et al Effectiveness of national infection prevention and control interventions: a systematic narrative review. 2018 Lancet Infectious Diseases 18 (5) e159-e171. DOI: https://doi.org/10.1016/S1473-3099(17)30479-6

Key grants

  • G1. Reilly J, Currie K, Flowers P, Lang S, Price L. 2015-2021 Consortium bid Chief Scientist Office/Scottish Infection Research Network. Creation of Scottish Healthcare Associated Infection Prevention Institute led by University of Glasgow. Main Collaborators: GCU; University of St. Andrews; & Strathclyde University. Total £4.3M, £1.1M to GCU.

  • G2. Currie K, Flowers P, Roberts N, Khanna N, Price L. (2015-2017) Factors affecting the acceptability and implementation of hospital screening policy for antimicrobial resistant organisms: a mixed methods study of staff and public perceptions. Health Protection Scotland/Scottish Infection Research Network. £99,827.

  • G3. Reilly J, Godwin J, Price L (2010-13) European Centre Disease Control. Pilot validation study of the ECDC point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals. €150,000.

  • G4. Reilly J (CARC appointment in NHS) (2016-18) Scottish Government Health Directorate, National prevalence survey of HAI. £350,000.

  • G5. Price L, Flowers P, Currie K, Howe T, Reilly J. World Health Organization. (2015-2016) A systematic review of national IPC programmes core components. £14,973.

4. Details of the impact

Impact on Scottish HAI Screening Policy leading to an increase in uptake and a reduction in HAI

Recommendations from the 2016 BESH study [R1] were adopted by HPS to make fundamental changes to the Scottish National HAI screening programme in 2017. The results demonstrated the barriers and enablers to implementation of HAI screening in Scottish hospitals. Recommendations for improving HAI screening were presented by Currie to the Scottish National Antimicrobial Resistance and HAI Committee (August 2017), with Scottish Government HAI policy advisors in attendance [S1]. Consequently, HPS were funded by the Scottish Government to implement the recommendation to enhance feedback to practitioners on their level of compliance with HAI screening policies, across all Scottish Hospitals. This resulted in an increased uptake of MRSA screening policy from 75% in 2017 [S2 figure 19 page 45] to 87% in 2019 [S3 page 4] and an associated year-on-year decrease of 17.1% (p< 0.001) in MRSA infections in Scottish hospitalised patients [S2 page 38] in the year following implementation of the policy.

Impact on ECDC’s HAI Survey Methodology leading to more robust estimates in 28 European countries

For the first time in 2010 Reilly led a validation of the ECDC HAI point prevalence survey involving five countries. As a result of this study [R2] important changes were made to the 2016 protocol requiring all 28 participating countries to perform a concurrent validation study alongside the HAI survey [S4 page 1]. Demonstrating the importance of this, ECDC provided funding of 10,000 euros to each country to support the implementation of the validation studies [S6]. Both the protocols for the 2016 survey [S5 page 37] and the validation studies [S4 pages 1 & 3] were based on Reilly’s 2010 research. The findings of the validation studies were used to adjust the results of each country’s survey resulting in the identification of an additional 10% of infections, or 450,000 HAI [S6], and significantly improved estimates of the number of HAI in the 28 European countries. This is important as the results of these surveys are used to prioritise investment in surveillance and prevention efforts by countries across the European region. A higher and more robust estimate of the burden of HAI supports appropriate allocation of national resources for managing HAI. In addition, the impact of Reilly’s 2010 validation study has extended beyond Europe. Based on this research, Reilly provided methodological expertise [S7 page 7] for the first Australian point prevalence survey in 34 years conducted in 2018. The methodology [S6 page 8] adopted by Australia was based on the ECDC protocol that was informed by Reilly’s research [R2].

Impact on Scottish healthcare policy and practice

Reilly’s 2016 Scottish point prevalence survey [R3, 4] led to a refresh of the Scottish Government Antimicrobial Resistance and HAI Strategy Group strategy to take account of the recommendations in the study report. To address the increase in Escherichia coli infections and prevent urinary tract infections they made prevention of Gram-negative infections a priority [S8 page 40] resulting in a number of changes to Scottish healthcare practice. These included implementation of a hydration campaign (2017) [S8 page 46] and the launch of a national urinary catheter passport (2017) [S8 page 46] and an enhanced surveillance dashboard for Escherichia coli infections (2018) [S8 page 45].

Impact on WHO’s guidance leading an increase in the proportion of countries with national IPC programmes

The research findings from our systematic review on the effectiveness of national level IPC interventions in 2015 [R5] directly informed the WHO’s guidance on “Core Components for National IPC Programmes” [S9 page 22]. Professors Price & Reilly were invited to present the findings (March 2016) to a WHO panel of global IPC experts who fully incorporated the recommendations of the review into the new guidelines (November 2016) The systematic review provided the evidence base that enabled the WHO guidelines for the core components of national level IPC programmes to move from being based on expert opinion to becoming evidence-based [S9 page 29]. These WHO guidelines are now being implemented by countries worldwide to support global action to maximise the prevention of HAI. The implementation of these guidelines has led to an increase in the proportion of countries, across the six WHO regions, with a national IPC programme from 41% in 2015 to 63% in 2018 [S10 page 99].

5. Sources to corroborate the impact

Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
No

1. Summary of the impact

Globally, support for recovery after stroke is substandard. Insights from our original research on priority areas for improving post-stroke recovery have been instrumental for the development of novel educational resources on vision rehabilitation and secondary stroke prevention (including physical activity and sedentary behaviour) for service users and providers in stroke rehabilitation and recovery support. These new resources, used by over 20,000 service users in 134 countries and completed by over 3,100 service providers within the UK and abroad (including Ireland, Australia, New Zealand), have raised educational standards and enabled the development of innovative, evidence-based stroke rehabilitation and recovery support services.

2. Underpinning research

Our research focuses on evidence gaps, prioritised through the James Lind Alliance Priority Setting Partnership on Life after Stroke, led by Pollock and Davis, i.e. vision rehabilitation and secondary stroke prevention.

Interventions for visual problems were investigated by Pollock and Hazelton in the first high quality Cochrane systematic review evidence synthesis on the topic [R1, G1]. It demonstrated that specific eye movement training was a promising intervention and could improve stroke survivors’ quality of life - but existing clinical practice did not reflect the available evidence [R2]. Pollock, Hazelton and Brady conducted the first nation-wide survey (with a response rate of 90%) of treatments for stroke-related visual problems in 2011 [R2]. They identified important gaps and variations in care across Scottish inpatient clinical settings and key barriers to evidence-based practice, particularly a lack of training, guidelines and pathways.

Secondary prevention lifestyle interventions after stroke were investigated by Lawrence et al. in their 2015 systematic review and meta-analysis [R3, G2]. Using Cochrane methodology, this high quality review highlighted that these interventions improved lifestyle behaviours and physiological outcomes. In particular, behavioural interventions reduced blood pressure, waist circumference and increased compliance with medication (anti-thrombotics, statins), thereby significantly reducing the odds of subsequent cardiac events. An accompanying qualitative review [R4, G2] highlighted important benefits of group-based secondary prevention interventions from the perspectives of stroke survivors and family members: feeling supported by others, acquiring new knowledge, and gaining confidence. This breakthrough in understanding provided new insights into how self-management of secondary stroke prevention by people affected by stroke could be optimised.

Further research on lifestyle interventions focused on physical activity and sedentary behaviour; the systematic review by van Wijck et al. in 2013 [R5] on physical activity was the first to comprehensively investigate stroke survivors’ perceptions on psychosocial, physical and environmental barriers and facilitators to physical activity, following robust methodology. Findings highlighted that stroke-specific concerns (e.g. fear of subsequent stroke, post-stroke fatigue, embarrassment in a gym environment), lack of motivation (e.g. through depression, anxiety) and environmental factors were the main barriers, and that social support and the desire to get back to valued activities were the most important facilitators to post-stroke physical activity. These insights were essential for the development of specialist educational resources to better engage stroke survivors in physical activity. Sedentary behaviour, independently associated with high mortality and morbidity, was investigated by Tieges, van Wijck and Chastin in 2015 [R6, G3]. Utilising state-of-the-art objective activity monitoring, it investigated behaviour patterns in the largest cohort and longest follow-up period (i.e. one year) of studies published at the time. A key finding was that sedentary behaviour was independent of stroke survivors’ mobility levels and did not improve spontaneously – even in those able to walk independently. These surprising new findings highlighted the need to develop novel behaviour change interventions specifically to reduce sedentary behaviour after stroke.

Taken together, insights from this body of work were instrumental for designing novel, evidence-based educational resources and services to address important evidence gaps affecting service users and providers.

3. References to the research

  • [R1] Pollock A, Hazelton C, Henderson CA, Angilley J, Dhillon B, Langhorne P, Livingstone K, Munro FA, Orr H, Rowe FJ, Shahani U. Interventions for visual field defects in patients with stroke. Cochrane Database of Systematic Reviews 2011, Issue 10. Art. No.: CD008388. https://doi.org/10.1002/14651858.CD008388.pub2. This review, part of a suite of four Cochrane systematic reviews addressing visual problems in stroke, was the first to systematically identify, appraise and meta-analyse the data relating to interventions for this population, addressing an important gap in the literature – a gap, known to be a barrier to clinicians’ ability to provide evidence-based care. Using Cochrane methods, internationally known for their rigour, this review has been used to underpin national stroke guidelines in the UK, USA and Australia. It is very widely read, with an attention score within the top 5% of all research outputs (Altmetric, 11.12.20). This review has provided evidence for the most promising treatment approaches to use with stroke survivors with visual field loss – specifically scanning training approaches.

  • [R2] Pollock A, Hazelton C, Brady M. Visual problems after stroke: a survey of current practice in UK stroke inpatient settings. Topics in Stroke Rehabilitation 2011; 18: 643–651. https://doi.org/10.1310/tsr18s01-643. This robust survey study, which achieved a 90% response rate through the use of evidence-based survey design principles, was the first to address service provision for those with visual problems after stroke across Scottish inpatient clinical settings. It provided the first evidence of assessment methods, their frequency of use and the management approaches across the spectrum of different post-stroke visual impairments. By focussing on Occupational Therapists based in all the acute stroke wards, it provided a ground-breaking and comprehensive picture of clinical practice. The survey identified important variations and gaps in care provision after stroke (especially in relation to eye movement disorders). Importantly, it also enabled us to identify the main barriers to improving care, which included the lack of clinical guidance and poor access to specialist training.

  • [R3] Lawrence M, Pringle J, Kerr S, Booth J, Govan L, Roberts NJ. Multimodal secondary prevention behavioral interventions for TIA and stroke: a systematic review and meta-analysis. PLoS One 2015; 10: e0120902. https://doi.org/10.1371/journal.pone.0120902. This review and meta-analysis made a significant contribution to the evidence base for stroke secondary prevention lifestyle interventions, an under-researched area. The work was conducted using contemporaneous evidence synthesis methods internationally acknowledged as being of the highest quality.

  • [R4] Lawrence M, Pringle J, Kerr S, Booth J. Stroke survivors’ and family members’ perspectives of multimodal lifestyle interventions for secondary prevention of stroke and transient ischaemic attack: a qualitative review and meta-aggregation. Disability & Rehabilitation 2016 38(1):11-21 https://doi.org/10.3109/09638288.2015.1031831. This ground-breaking evidence synthesis, employing rigorous review methods, was the first to be conducted on the topic and as such makes a unique contribution to the evidence base for stroke secondary prevention lifestyle interventions. The review is complemented by contemporaneous quantitative review work [R3]. The review work was conceived to establish a robust and rigorous evidence base to underpin subsequent primary and secondary research, and clinical practice.

  • [R5] Nicholson SL, Sniehotta F, van Wijck F, Greig CA, Mead GE. A systematic review of perceived barriers and motivators to physical activity after stroke. International Journal of Stroke 2013 Jul 8(5): 357-64. https://doi.org/10.1111/j.1747-4949.2012.00880.x. This comprehensive and methodologically robust systematic review made an original contribution to the field of physical activity after stroke, as it was the first to synthesise quantitative and qualitative evidence on psychosocial, physical and environmental barriers and facilitators to post-stroke physical activity. Its contribution was significant as this area was poorly understood and this evidence gap limited the ability of healthcare and exercise professionals to take into consideration a wide range of factors, including stroke survivors’ perceptions, when designing person-centred physical activity interventions. Findings from this review made an important contribution to our insight into a wide range of stroke-specific factors that need to be addressed to better engage stroke survivors in physical activity.

  • [R6] Tieges Z, Mead GE, Allerhand M, Duncan F, van Wijck F, Fitzsimons C, Greig C, Chastin S. Sedentary behaviour in the first year after stroke: a longitudinal cohort study with objective measures. Archives of Physical Medicine and Rehabilitation 2015 Jan 96(1): 15-23. https://doi.org/10.1016/j.apmr.2014.08.015. This observational study made an original contribution to our understanding of enduring sedentary behaviour patterns after stroke, as it was the first to follow a cohort of stroke survivors for 12 months– the longest follow-up period investigated at the time. Utilising state-of-the-art objective activity monitoring devices, this rigorously conducted repeated measures study provided an essential point of reference in the field, by demonstrating not only the amount, fragmentation and diurnal time curve of sedentary behaviour, but also its lack of change over time in the largest cohort of stroke survivors investigated at the time. These findings generated the insight that novel lifestyle interventions after stroke were needed that specifically targeted sedentary behaviour patterns after stroke.

Peer-reviewed grants awarded to team for stroke rehabilitation research:

  • [G1] Royal National Institute of Blind People (RNIB). Evidence of effectiveness of interventions for visual problems after stroke: a series of systematic reviews, 2009 - 2013: £67,166 to Pollock.

  • [G2] Stroke Association Senior Research Training Fellowship: A family-centred approach to the management of lifestyle risk factors for recurrent stroke, 2012-2016: £139,989 to Lawrence.

  • [G3] Edinburgh and Lothian Health Foundation, 2013-2014: £21,284 to Chastin (co-PI), van Wijck (co-I)

4. Details of the impact

Our research has been instrumental in the development of novel educational resources for the benefit of healthcare professionals (including nurses, therapists, psychologists, GPs, paramedics, optometrists), social care workers and specialist exercise professionals, and people affected by stroke within the UK, Ireland, Australia, New Zealand, Canada, US, India, Brazil, and the Philippines. These resources have raised educational standards and enabled the development of innovative, evidence-based stroke rehabilitation and recovery support services. The need for high-quality stroke workforce education is highlighted in the Scottish Government’s Stroke Improvement Plan, the European Stroke Organisation’s Action Plan for Stroke in Europe 2018-2030 and the World Stroke Organisation, as specialist education is essential for delivering stroke-specific care to improve outcomes.

Impact 1: Resource and service development for professionals: evidence-based practice

Vision rehabilitation after stroke

Based on the systematic review by Pollock et al. (2011) [R1], Hazelton was invited to contribute to the Stroke Training and Awareness Resources ‘Vision’ module, an innovative online professional education resource hosted by Chest Heart Stroke Scotland and commissioned by the Scottish Government as part of their Stroke Education Pathway. Over the impact period, an average of 395 module completion certificates per year were issued to health and social care professionals across the UK, North America, Australia, and the Middle East [C1].

Evidence from the Cochrane review [R1] and UK-wide practice survey [R2] also inspired a new GCU-led collaboration between Hazelton, GCU Vision Science faculty (Seidel) and low vision service providers (Visibility UK), which initiated the UK’s first specialist Optometry Neuro-Vision Rehabilitation clinic at GCU in 2017. Providing specialist assessment, diagnosis and rehabilitation post-stroke, it has seen approximately 50 people from across Scotland [C2]. Hazelton’s survey [R2] was also instrumental in initiating and informing the first Best Practice Statement for stroke-related visual impairment in Scotland (2013) [C3]. Alongside evidence-based recommendations [R1], this Statement underpinned a new Stroke and Vision Pathway in NHS Lanarkshire in 2015 [C3]. This subsequently led to post-stroke visual impairment being recognised as a clinical priority in the Scottish Government’s Stroke Improvement Plan (2019), which requires specialist services to be available to all people with post-stroke visual impairment across NHS Scotland and audits their delivery [C3].

Physical activity after stroke

Research by Tieges, Chastin, van Wijck on post-stroke physical activity and sedentary behaviour [R5-6] has been embedded in the Exercise after Stroke Specialist Instructor Course, the first Higher Education Institution-validated course of its kind in the UK, led by van Wijck and delivered by Later Life Training (LLT). LLT provides evidence-based specialist training for health and exercise professionals. A total of 401 LLT professionals have been qualified since the inclusion of R5 in course updates (of which 383 since the inclusion of R6), to deliver novel, evidence-based exercise after stroke services across UK communities [C4]. LLT-qualified professionals were selected by the Stroke Association to deliver their new Moving Forward after Stroke service in 2017, which was rolled out to 9 sites across the UK, reaching over 800 stroke survivors [C6]. This service resulted in perceived benefits in physical recovery, mental health and confidence [C5-6]. Attendees reported engaging in moderate exercise on 5 days on average, compared to 3 days per week before the programme, and many joined a gym following the programme [C5-6].

Impact 2: Resource development for people affected by stroke: evidence-based self-management

Secondary stroke prevention

Based on her programme of research on family-centred secondary stroke prevention [R3-R4, G2], Lawrence was invited in 2014 as a topic expert on the Steering group of SelfHelp4Stroke, the first free, online self-management resource hosted by Chest, Heart and Stroke Scotland to support people affected by stroke. This innovative resource, developed in collaboration with the Interactive Content Team at the University of Edinburgh, was highly commended in the British Medical Association Patient Information Awards 2016. Lawrence led the multi-professional team that developed the content for the stroke secondary prevention module ‘Keeping Well’, and contributed subject expertise to the ‘Getting Started’ module [C1]. Based on her research on barriers and motivators to post-stroke physical activity [R5] and sedentary behaviour [R6], van Wijck was also invited in 2014 to contribute to SelfHelp4Stroke. This research was instrumental in designing the ‘Being Active’ module, which encouraged stroke survivors to be less sedentary, and to address their barriers to progress to a more active lifestyle [C1]. From launch in 2015 to May 2020, more than 21,000 people affected by stroke from 134 countries (including the UK, Ireland, Australia, New Zealand, Canada, US, India, Brazil, the Philippines) have used SelfHelp4Stroke to support them in their self-management [C1].

5. Sources to corroborate the impact

  • [C1] Testimonial (Jan 2021) from Chest Heart Stroke Scotland e-Learning Manager regarding, (1) Stroke Training and Awareness Resources and (2) SelfHelp4Stroke: “Taken together, thousands of people affected by stroke as well as professionals in stroke care from around the world have benefited from educational resources, based on the evidence contributed by the scientists from Glasgow Caledonian University named above. Being able to provide these online resources has contributed to the ability of our organisation to meet its strategic aim of addressing the unmet needs of people affected by stroke through better-informed care and self-management.”

  • [C2] Testimonial from Visibility Scotland Acting CEO (Dec 2020): “I cannot say strongly enough how positive the experience was and how important it was to improving the state of my mental health – feedback from a service user (stroke survivor) who has been supported both by GCU and Visibility Scotland.”

  • [C3] Testimonial (Jan 2021) from NHS-Lanarkshire Stroke Physician and Geriatrician, and Scottish Stroke Care Audit Lead Clinician and Chair confirming the incorporation of GCU research in the following strategies, (1) NHS Lanarkshire Stroke and Vision Pathway and (2) Scottish Government’s Stroke Improvement Plan 2019 (page 60): “…their 2011 Cochrane Review … was important in creating the Best Practice Statement for Screening, Assessment and Management of Vision Problems in the First 30 Days after an Acute Stroke, and this was key to underpinning the Stroke Vision Pathway within NHS Lanarkshire...research at Glasgow Caledonian University… has clearly been essential in raising awareness of the need for vision rehabilitation after stroke, and enabling the development of evidence-based stroke rehabilitation services for people with visual impairment after stroke across Scotland.”

  • [C4] Testimonial from Later Life Training Directorate (Jan 2021): “…we pride ourselves on keeping the course up to date and research from Professor Frederike van Wijck at Glasgow Caledonian University has been instrumental in ensuring this.”

  • [C5] Moving Forward After Stroke: programme evaluation. Stroke Association (2019).

  • [C6] Testimonial from Stroke Association Associate Director Systems engagement (Jan 2021): confirming incorporation of GCU research in [C5]. “On behalf of our charity, I am writing to confirm that research undertaken at Glasgow Caledonian University on physical activity and sedentary behaviour after stroke… has played a key role in enabling our charity to develop and deliver an evidence-based physical activity programme for people affected by stroke in the community. A programme known as Moving Forward after Stroke.”

Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
No

1. Summary of the impact

Professor Brady’s GCU research was instrumental in changing aphasia rehabilitation policy and standards for stroke survivors with problems speaking, understanding, reading and writing language across 23 countries including Australia, Brazil, Canada, Germany, Morocco, Norway, South Korea and the UK. National stroke service-delivery guidance was informed by GCU-led Cochrane systematic reviews, providing ground-breaking, conclusive evidence that speech and language therapy (SLT) benefits aphasia recovery, informing specialist aphasia service development within the emergent Croatian, Iranian, Lithuanian and Turkish SLT profession. GCU-led data-syntheses established that high intensity, acute-stroke SLT, where tolerated, was beneficial and mobilising technology and trained non-professionals effectively augments rehabilitation services.

2. Underpinning research

Despite greater rehabilitation resource use, stroke survivors with aphasia experience more functional impairments, with fewer returning home or to work than those without aphasia. Enhancing aphasia rehabilitation services is a research priority. Since 2010, GCU researchers (Brady, Ali and Campbell) have delivered high quality, award winning research, which significantly impacted on international aphasia rehabilitation policy and practices [G1-6].

In a research context characterised by small scale studies, our world leading GCU-led Cochrane systematic reviews and meta-analyses [R1,2] addressed three priority questions: comparing the effectiveness of SLT to (i) no therapy, (ii) social support or (iii) alternative SLT approaches. Led by Prof Brady the 2012 systematic review (last search date July 2011) included 39 randomised controlled trials (RCTs) and 2518 people with aphasia [R1, G1] providing the first definitive systematic review evidence that SLT benefits recovery, specifically functional communication, reading, writing, and expressive language, compared to no access to therapy, vital high-quality research evidence supporting the existence (or establishment) of specialist SLT aphasia rehabilitation services.

Prof Brady also led the 2016 review update (last search September 2015), undertaken concurrently with the UK Intercollegiate Stroke Working Party Stroke Rehabilitation Guideline update, reducing research waste, and ensuring the currency of the evidence synthesis informing the clinical recommendations. Based on 57 trials (3002 participants [R2, G1,2]), new meta-analyses highlighted that high intensity SLT (up to 15 hours weekly) benefited functional communication and exclusively identified that benefits were only observed amongst people within three months after stroke, who were significantly less likely to tolerate intensive regimens [R2, G1,2]. Delivering high intensity SLT within service resource constraints is challenging. The GCU-led review meta-analysis also concluded that therapist-directed interventions using technology (telerehabilitation or software), or trained non-professionals (family members, volunteers, or assistants) was as effective as face-to-face SLT with a therapist [R1,2, G1,2].

Increasingly, technology-based SLT delivery models augment aphasia rehabilitation services to support high intensity SLT. In 2013, collaborating with Chief Investigator Dr Palmer (University of Sheffield), the NIHR Health Technology Assessment funded a definitive RCT which demonstrated that self-managed, specialist software supported word-finding recovery in people with aphasia [R3, G6]. In collaboration with Dr Øra and Associate Professor Becker from Sunnaas Rehabilitation Hospital, Norway an RCT demonstrated the clinical and research feasibility of an aphasia telerehabilitation service [R4, G3,4]. Both remote SLT delivery models proved feasible, with clinical engagement accelerating in the UK, Norway and internationally in the context of the COVID-19 pandemic and restrictions on face-to-face therapy.

GCU’s aphasia research is a primary reference point in the establishment of new aphasia rehabilitation services in regions where none previously existed [R1-2,5; G1-5]. A GCU-led collaboration, currently involving >200 aphasia researchers from 36 countries, led to several collaborative research projects, including the development of an international aphasia research database [G5]. The dataset supported a one-stage meta-analysis of 5928 individual participants data, highlighting the SLT interventions associated with the greatest language recovery (speaking, understanding, reading and writing outcomes), directly informing the design and development of novel aphasia services [R5, G5].

3. References to the research

The selected research publications (of approximately 30) include the first high quality systematic review evidence of the effectiveness of SLT for aphasia, therapy delivery models, intensity, timing and acceptability [R1,2]. Regularly amongst the Cochrane Stroke Group’s Top 5 downloads they made a significant contribution to international policy and services which was recognised in 2017 with the international Robin Tavistock Award to Prof Brady for “establishing a rigorous and strong evidence base … [which] has influenced the provision of SLT services locally, nationally and internationally” for people with aphasia [R1-3]. Nationally funded, multicentered, clinical RCTs of technologically innovative SLT delivery models provide vital evidence of clinical and cost effectiveness, feasibility and patient acceptability [R4,5, G3,4,6]

Research:

  • [R1] Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database of Systematic Reviews 2012, Issue 5. Art. No.: CD000425. DOI: https://doi.org/10.1002/14651858.CD000425.pub3

  • [R2] Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD000425. https://doi.org/10.1002/14651858.CD000425.pub4

  • [R3] Palmer R, Dimairo M, Cooper C, Enderby P, Brady M, Bowen A, Latimer N, Julious S, Cross E, Alshreef A, Harrison M, Bradley E, Witts H, Chater T. Self-managed, computerised speech and language therapy for people with chronic aphasia post-stroke compared to usual care or attention control (Big CACTUS): a single-blind multi-centre randomised, controlled trial in a health-care setting. Lancet Neurology 2019;18(9):821-833. https://doi.org/10.1016/S1474-4422(19)30192-9

  • [R4] Øra Prag H, Kirmess M, Brady MC, Partee I, Hognestad Bjor R, Johannessen Bertheau B, Bente T, Becker F. The effect of augmented speech-language therapy delivered by telerehabilitation on post stroke aphasia – a pragmatic pilot randomized controlled trial. Clinical Rehabilitation 2020;34(3);369-381. https://doi.org/10.1177/0269215519896616

  • [R5] The RELEASE Collaboration: Brady MC, Ali M, VandenBerg K, Williams LJ, Williams LR, Abo M, Becker F, Bowen A, Brandenburg C, Breitenstein C, Bruehl S, Copland DA, Cranfill TB, di Pietro-Bachmann M, Enderby P, Fillingham J, Galli FL, Gandolfi M, Glize B, Godecke E, Hawkins N, Hilari K, Hinckley J, Horton S, Howard D, Jaecks P, Jefferies E, Jesus LMT, Kambanaros M, Kang EK, Khedr EM, Kong AP-H, Kukkonen T, Laganaro M, Lambon Ralph MA, Laska AC, Leemann B, Leff AP, Lima RR, Lorenz A, MacWhinney B, Marshall RS, Mattioli F, Maviş İ, Meinzer M, Nilipour R, Noé E, Paik N-J, Palmer R, Papathanasiou I, Patricio BF, Pavão Martins I, Price C, Prizl Jakovac T, Rochon E, Rose ML, Rosso C, Rubi-Fessen I, Ruiter MB, Snell C, Stahl B, Szaflarski JP, Thomas SA, van de Sandt-Koenderman M, van der Meulen I, Visch-Brink E, Worrall L & Wright HH. REhabilitation and recovery of peopLE with Aphasia after StrokE (RELEASE): A protocol for a systematic review-based Individual Participant Data (IPD) meta- and network meta-analysis. Aphasiology 2020;34(2):137-157. https://doi.org/10.1080/02687038.2019.1643003

Grants:

  • [G1] Chief Scientist Office core-funding grant Nursing, Midwifery and Allied Health Professions Research Unit at Glasgow Caledonian University Brady MC £ 2,514,534 [Jan 2011-Dec 2016].

  • [G2] Clinical Academic Careers for Scotland Grant, Campbell P (Co-I) Scottish Government Health and Social Care Directorates £480,980 [Aug 2014-Jun 2017].

  • [G3] Collaboration of Aphasia Trialists. Brady MC (PI) European Cooperation in Science and Technology (COST) €500,000 [May 2013-April 2017].

  • [G4] Collaboration of Aphasia Trialists Phase 2. Tavistock Trust for Aphasia. Brady MC (PI) 3 years £93,608 [May 2017-Jan 2021]

  • [G5] REhabilitation and recovery of peopLE with Aphasia after StrokE (RELEASE) Brady MC (PI) Ali M (Co-I), National Institute for Health Research (NIHR), Health Services and Delivery Research. £446,158 [Nov 2015-Oct 2017].

  • [G6]. Clinical and cost effectiveness of aphasia computer therapy compared with usual stimulation or attention control long term post stroke (Big CACTUS). NIHR Health Technology Assessment. Brady (Co-I) £1,640,038 over 54 months [Sep 2013-Feb 2018]

4. Details of the impact

Introduction

Prof Brady’s aphasia research significantly impacted international stroke rehabilitation policies and practice across 23 countries (including Australia, Brazil, Canada, Croatia, Germany, Italy, Lithuania, Norway, Portugal, South Korea, Spain, Sweden, the US and UK). People with stroke-related aphasia, therapists and national health services benefited from high-quality evidence of SLT-related recovery, particularly early, intensive therapy, informing rehabilitation guidelines, driving clinical standards, delivery, (and internationally) reimbursement and the foundation of new aphasia services.

Impact 1: International Stroke-Related Aphasia Rehabilitation Policy

Brady’s ground-breaking Cochrane systematic review evidence, that SLT benefits stroke-related aphasia recovery compared to no therapy [R1], continues to underpin international multidisciplinary rehabilitation guidelines, informing service provision in Korea and the USA [C1]. Prior to Brady’s research, this high-quality evidence was absent.

The Action Plan for Stroke in Europe 2018-2030 [C2] by the Stroke Alliance for Europe (international stroke survivor voluntary groups) and multidisciplinary European Stroke Organization, utilised expanded Cochrane evidence [R2] demonstrating the benefits of SLT across multiple language modalities (everyday communication, reading and writing) to establish new aphasia rehabilitation “targets for implementation of evidence based … stroke services to 2030” [C2 p309]. Evidence of SLT benefits, particularly high intensity treatment, was endorsed by several country-specific multidisciplinary stroke clinical guidelines (Australia, Canada, Norway, Republic of Korea, Sweden, USA [C1- pages numbers in section 5]). A Norwegian Stroke Guideline Working Group Lead confirmed that Prof Brady’s research [R2] was ‘highly influential’ in changing their 2017 aphasia rehabilitation policy which was consequently “more informed, offered more practical advice to healthcare professionals” [C3].

Impact 2: International aphasia rehabilitation practice

Internationally, SLT is an emerging profession. Aphasia rehabilitation improvements reflect evidence-informed innovation [R3,4] and multidisciplinary decision-making across disparate service environments [C1]. Professional resources including the Australian Rehabilitation Best Practice Statements, direct therapists to optimal practice and the underpinning evidence [C1, R1,2]. Globally, informed by Brady’s research, BMJ Best Practice and Cochrane Clinical Answers are accessible, trustworthy, up-to-date rehabilitation evidence-summaries supporting evolving services [C4-5, R2]. In March 2019, neurologists and linguists in Iran, used Brady’s research findings to inform the design of a “new aphasia service providing aphasia therapy for all stroke patients with aphasia”, reporting that “high intensity therapy has been critical in the recovery of our patients to communicate clearly.” [C6, R2,5].

International survey respondents (including speech and language therapists, doctors, psychologists and neurolinguists) indicated that GCU-led research findings [R1,2] contributed to changes in aphasia rehabilitation between August 2013 and July 2020, which is consequently initiated earlier after stroke (Australia, Croatia, Germany, Ireland, Italy, Lithuania, Morocco, Norway, Portugal, Spain, the Netherlands and UK) at a higher intensity (Australia, Brazil, Canada, Croatia, Cyprus, Germany, Morocco, Norway, Portugal, Spain, Sweden, Switzerland, the Netherlands, UK), at a higher dosage (Brazil, Cyprus, Italy, Morocco, Norway, Spain, Sweden, UK) and over a longer duration (Brazil, Canada, Croatia, Cyprus, Morocco, Spain, UK) [C7]. A clinical director described how the 2016 Cochrane review [R2] was instrumental in changing how Norwegian therapists “deliver aphasia therapy, from typically 1 hr/week every second week … to at least 3 weeks of intensive therapy”, resulting in “improvements in aphasia rehabilitation services, more focused therapy sessions… the opportunity for more group therapy and peer support leading to language improvements and better experience for these patients” [C3].

UK Stroke-Related Aphasia Rehabilitation Policy

Brady’s aphasia research underpinned UK rehabilitation guidelines, whose recommendations directly inform NHS SLT service delivery standards. The 2016 Intercollegiate Stroke Working Party guideline, drawing on updated Cochrane review meta-analyses [R2], highlighted the multi-modality language benefits of SLT and the clinical equipoise relating to optimal theoretical therapeutic approach and the effectiveness of alternative therapy delivery models [C8 p65]. Intensive SLT benefits (for those <3 months after stroke) were emphasized, with therapists urged to consider the acceptability of high-intensity interventions for some stroke survivors [R2, C8 p65]. Prior to Brady’s review, this high-quality evidence was absent.

Brady’s “excellent quality” Cochrane review [R1], highly praised in the 2014 Royal College of Speech and Language Therapists’ resource manual for Clinical Commissioning and Planning Services [C9 p16], supports investment in NHS SLT services. The 2019 National Institute for Health and Care Excellence (NICE) evidence surveillance determined that Brady’s 2016 research [R2] was likely to change existing NICE recommendations (2013) which “makes no recommendations on the intensity of SLT” and the acceptability of high intensity or dose regimens “may need consideration” [C10 p21]. Recently, UK survey respondents (speech and language therapists) indicated that following the GCU-led Cochrane review findings [R2], SLT was now delivered earlier, at a higher intensity, dosage and over a longer duration [C7].

5. Sources to corroborate the impact

  • [C1] Title: Combined international stroke rehabilitation guidelines for the following countries: Date: 2014-2020

- Korea (original language), p71-72 of original document: Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016. Brain Neurorehabilitation 2017; 10(Supp 1): e11. https://dx.doi.org/10.12786/bn.2017.10.e11.

- Sweden (original language), p467-473, 476-478 of original document: Sweden National Clinical guidelines on stroke rehabilitation. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/nationella-riktlinjer/2020-1-6545-kunskapsunderlag-2020.pdf

- Australia, p18, 20, 22-23 of original document: Australian 2014 Aphasia Rehabilitation Best Practice Statement. http://www.aphasiapathway.com.au/flux-content/aarp/pdf/2014-COMPREHENSIVE-FINAL-01-10-2014-1.pdf

- Canada, p1 of selected webpages: Canadian Stroke Best Practices Chapter 10. Rehabilitation to improve language and communication, 2019. https://www.strokebestpractices.ca/recommendations/stroke-rehabilitation/rehabilitation-to-improve-language-and-communication

- Norway, p1-3 of selected webpages: Norwegian Stroke Guidelines Norwegian Department of Health (2017); https://www.helsedirektoratet.no/tema/hjerneslag.

- USA, e123-124 of original document: Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke 2016; 47(6): e98-e169 Jan 2016. DOI: https://dx.doi.org/10.1161/STR.0000000000000098.

Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
Yes

1. Summary of the impact

Suzanne Hagen and team demonstrated that pelvic floor muscle training (PFMT) is effective and cost-effective for prevention and treatment of prolapse, and reduces uptake of subsequent treatment, leading to recommendation of PFMT by NICE, and globally by the International Consultation on Incontinence, who recommend it as first-line treatment. Their discovery of new models of effectively delivering PFMT has provided ways to treat more women than previously possible. Their development, evaluation and translation of the Pelvic Organ Prolapse Symptom Score has resulted in improvements in prolapse care and outcomes in the UK, Australia, Ireland, USA, Ethiopia, India, Brazil, Nepal and Turkey.

2. Underpinning research

Using psychometric evaluation, systematic reviewing, randomised trial and implementation science methodology, Prof Hagen and team undertook ground-breaking research investigating: whether PFMT, traditionally used to treat urinary incontinence, is effective and cost-effective for treating prolapse and for preventing progression of early prolapse symptoms; whether it can be implemented effectively outside a trial context, in the NHS; and whether a brief validated symptom score can be used as part of prolapse management to enhance treatment delivery and outcome.

Providing trial evidence for PFMT for prolapse

Motivated by the lack of any research on the benefits or otherwise of PFMT as a treatment for prolapse, from 2003 to 2011, Hagen and team (DS, AE, SD, JL, LS) carried out a landmark pilot randomised controlled trial (RCT) [G1]. The GCU team then secured £210K from Scottish Government for a definitive full-scale RCT across 25 centre (23 UK, 1 New Zealand, 1 Australian) [G2] evaluating PFMT for the treatment of prolapse which showed that PFMT was effective and cost-effective in reducing women’s prolapse symptoms and the uptake of further treatment [R1,R2]. A further award-winning collaborative RCT led by Prof Hagen (with AE, SD, NS, MC) with centres in New Zealand (Prof Don Wilson), Scotland (Prof Glazener) and England (Prof MacArthur) [G3] was funded by Wellbeing of Women (£148K) from 2010 to 2013 involving women with early signs of prolapse, and found PFMT to be effective and cost-effective for secondary prevention of prolapse symptoms [R3]. The resultant Lancet publications in 2014 and 2017 have become primary references for guiding prolapse care.

Implementing trial evidence nationally

To facilitate uptake of their RCT findings within the UK NHS, Prof Maxwell, Univ of Stirling, and Prof Hagen, and her GCU team (DM, AE, HM, LF), undertook from 2016 to 2019 a multicentre implementation study [G4]. This NIHR-funded (£500K) research including a realist evaluation, an outcome study of three different NHS models of PFMT delivery (involving different staff mixes), and a record linkage study of the long-term outcomes of participants in the previous treatment trial [G2]. Findings showed it is possible to train different non-specialist staff to deliver PFMT effectively, and women’s self-reported outcomes significantly improved across all delivery models; additionally, PFMT reduced the long-term risk of previous trial participants requiring hospital treatment for pelvic floor disorders, over a post-intervention period of more than 10 years [R4].

Improving prolapse symptom measurement internationally

Having accurate information about women’s symptoms is important in order to inform treatment decision-making, and to monitor the effects of treatment. The lack of a brief, reliable and valid measure of prolapse symptoms led Prof Hagen and team (LS, PD, AE) from 2003 to 2016 to develop, test and implement the Pelvic Organ Prolapse Symptom Score (POP-SS) [R5]. This tool can be used by healthcare professionals and researchers working in the field of prolapse, and by women themselves. Its use was reported by 23% of pelvic floor physiotherapists in a UK 2013 survey [R6] and by healthcare professionals and researchers in 12 countries in a 2020 international survey.

3. References to the research

The research comprises the first multicentre trials of PFMT for prolapse [G1,G2,G3], providing evidence previously lacking about effectiveness and cost-effectiveness to inform international guidelines and practice. This was recognised by prizes from the International Continence Society and top 3 BMJ paper status of manuscripts published in the Lancet [R1,R2,R3]. It also includes a novel and comprehensive implementation study funded by NIHR Dept. of Health England [G4] which moved the trial evidence into the NHS and contributed to policy change [R4]. In addition, the first brief validated symptom score for prolapse was developed, which has evidence of high utility for clinical practice globally [R5,R6].

Publications

  • R1. Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. International Urogynecology Journal. 2009 Jan 1;20(1):45-51: cited 138 times (Google Scholar). https://doi.org/10.1007/s00192-008-0726-4

  • R2. Hagen S, Stark D, Glazener C, Dickson S, Barry S, Elders A, Frawley H, Galea MP, Logan J, McDonald A, McPherson G. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. The Lancet. 2014 Mar 1;383(9919):796-806; cited 225 times (Google Scholar), BMJ top 3 Best UK Research Papers 2015, International Continence Society Best Clinical Abstract 2011. https://doi.org/10.1016/S0140-6736(13)61977-7

  • R3. Hagen S, Glazener C, McClurg D, Macarthur C, Elders A, Herbison P, Wilson D, Toozs-Hobson P, Hemming C, Hay-Smith J, Collins M. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial. The Lancet. 2017 Jan 28;389(10067):393-402; cited 58 times (Google Scholar), International Continence Society Best Clinical Abstract 2014, Scottish NMAHP Research Best Paper Award 2017. https://doi.org/10.1016/S0140-6736(16)32109-2

  • R4. Maxwell, M., Berry, K., Wane, S., Hagen, S., McClurg, D., Duncan, E., Abhyankar, P., Elders, A., Best, C., Wilkinson, J., Mason, H., Fennochi, L., Calveley, E., Guerrero, K., Tincello, D. Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation. NIHR Health Services and Delivery Research. 2020 Dec 8:47. https://doi.org/10.3310/hsdr08470

  • R5. Hagen S, Glazener C, Sinclair L, Stark D, Bugge C. Psychometric properties of the pelvic organ prolapse symptom score. BJOG: an International Journal of Obstetrics & Gynaecology. 2009 Jan;116(1):25-31; cited 60 times (Google Scholar). https://doi.org/10.1111/j.1471-0528.2008.01903.x

  • R6. Hagen S, Stark D, Dougall I. A survey of prolapse practice in UK women’s health physiotherapists: what has changed in the last decade?. International Urogynecology Journal. 2016 Apr 1;27(4):579-85; cited 14 times (Google Scholar). https://doi.org/10.1007/s00192-015-2864-9

Grants

  • G1. Hagen S, Stark D, Ramsay I, Glazener C. A feasibility study for a RCT of a pelvic floor muscle training intervention for pelvic organ prolapse; funder: Chief Scientist Office; sponsor: Glasgow Caledonian University; duration: 2003-2005; value: £37K

  • G2. Hagen S, Stark D, Glazener C, Sinclair L, Norrie J, Wilson D. A multi-centre randomised controlled trial of a pelvic floor muscle training intervention for women with pelvic organ prolapse (POPPY); funder: Chief Scientist Office; sponsor: Glasgow Caledonian University; duration: 2007-2011; 2007-2011; value: £210K

  • G3. Hagen S, Glazener C, McClurg, Bain C, MacArthur C, Toozs-Hobson P, Wilson PD, Herbison P, Hay-Smith J. Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women (PREVPROL); funder: Wellbeing of Women; sponsor: Glasgow Caledonian University; duration: 2010-2013; value: £148K

  • G4. Maxwell M, Hagen S (co-CI) et al. Implementation of an evidence-based pelvic floor muscle training intervention for women with pelvic organ prolapse (PROlapse and PFMT: implementing Evidence Locally - PROPEL); funder: NIHR HSDR; sponsor: University of Stirling; duration: 2016-2019; value: £500K

4. Details of the impact

UK and International prolapse policy impact

Five to 10% of women will experience symptomatic prolapse during their lifetime. Two decades ago evidence of effectiveness of PFMT as a treatment for prolapse was lacking, practice varied and no national guidance existed. Since then, guidance recommending PFMT as first-line treatment for prolapse, resulting from our research, was incorporated into the 2013 and 2017 International Consultation on Incontinence reviews [S1]. In 2016 our research was adopted by the German, Swiss and Austrian Societies of Gynaecology and Obstetrics [S2]. Subsequently, NICE in 2019 [S3] incorporated the research results [R1-R3] into their prolapse management guidelines. The implementation of these guidelines means that PFMT should be offered to improve outcomes for women with prolapse. Drawing on the research [G1-G3], the Pelvic Obstetric and Gynaecological Physiotherapy (POGP) network of the Chartered Society of Physiotherapists commenced prolapse courses in 2014, teaching physiotherapists to deliver PFMT (18 courses, 450 participants) [S4]. The POGP Chair said “The findings of the trials have enabled evidence-based practice to be taught on the POGP prolapse courses, which started in 2014. The findings from the studies have enhanced the teaching content with robust evidence-based research” [S4]. The POGP also developed a patient information leaflet in 2016 including instruction in PFMT, based on the research, and to date have distributed this to around 50 UK care settings to share with prolapse patients [S5].

Following the halt in September 2018 of the use of transvaginal mesh in prolapse surgery, our research was influential in Scottish Government decision-making on physiotherapy provision for women with prolapse. Prof Hagen presented evidence of the benefits of PFMT [G1-G4] from December 2018 - February 2019 to the Minister for Public Health Sport and Wellbeing, and the lead Consultant in Public Health Medicine who stated “I think finding ways this work is reflected in any developing pathways/other areas is vital” (emails available). This led to a presentation in April 2019 to the Scottish Government-appointed Transvaginal Mesh Implants Oversight Group who recommended a need to “undertake a detailed scoping of [physiotherapy] capacity, including referral rates and sources, to determine current needs and future workforce requirements” [S6, page 27].

Influencing professional awareness of the benefits of PFMT in the UK

Delivery of PFMT is challenged by the large numbers of women with prolapse and the limited number of specialist physiotherapists who traditionally deliver PFMT: the UK has only around 800 such specialists. Finding alternative ways to make this evidence-based intervention more widely available were identified in the PROPEL study [G4]. Events to disseminate its findings in London and Glasgow (12/19 February 2019, materials available), were attended by 120 UK clinicians and service managers [R4]. On learning that different models of PFMT delivery, involving non-specialist staff, were effective and acceptable, participants shared action plans to implement changes to their services (transcripts available). Action plans contained statements such as: “I have some good ideas and emerging evidence to take to the commissioners”; “[I] feel enthusiastic and determined to participate in providing this effective treatment, improve pathways, developing information leaflets for patients/women”. Implementation of such models allows a wider group of existing staff to treat women, giving better access to PFMT, and freeing up specialist teams for complex prolapse cases. This argument was presented to an Oral Hearing of the Independent Medicines and Medical Devices Safety Review of vaginal mesh by the Chartered Society of Physiotherapists who emphasised the importance of the PROPEL findings [G5] in increasing the workforce for PFMT delivery [S7, page 90].

International clinical practice and patient impact

Clinicians treating women worldwide, recognising the need for a brief validated prolapse symptom score, have adopted the POP-SS, developed and validated by Prof Hagen [R5-R7], and the instrument has been translated into Amharic, Turkish, Nepalese, Chinese, Russian and Samoan (publications and emails available). In Nepal this facilitated research into PFMT delivery during pregnancy [S8]. According to a 2020 survey of POP-SS users [S9], with respondents from the UK, Australia, Republic of Ireland, USA, and countries where there is a significant unmet clinical need such as Ethiopia, India, Brazil, Nepal and Turkey, the respondents used the POP-SS to monitor women’s prolapse symptoms (89%), and to share information with patients (78%) and colleagues (60%). Over 70% included the POP-SS within their patient records. For 40%, the POP-SS was used to inform treatment decisions, e.g. whether or not to proceed to surgery. Respondents reported it improved their clinical practice (73%), and treatment outcome (42%), specifically it “allowed management to be more appropriate” and led to “quicker resolution of issues”.

5. Sources to corroborate the impact

Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
No

1. Summary of the impact

Professors Hutchinson and Goldberg established a research programme on hepatitis C virus (HCV) that has shaped Scotland’s public health response and led to major health benefits. Their epidemiological studies and modelling– addressing the knowledge gap in how to scale-up therapy for greatest health gain– underpinned Scottish Government’s HCV strategy and setting of targets on treatment. HCV treatment targets have been met, and lead to reductions in liver-related failure (67%), cancer (69%) and death (49%). Over 300 cases of liver failure have been averted in the first four years of the national HCV strategy, translating to £30million saving to the NHS.

2. Underpinning research

The research has been led by Professors Hutchinson and Goldberg at GCU, and funded through collaborative research grants with Health Protection Scotland (HPS, a division of NHS Scotland) totalling over £2.5 million during 2013-2020 [G1-G3]. An aim of these grants was to inform Scottish Government’s strategy on HCV through a combination of mathematical modelling and epidemiological studies evaluating interventions to prevent infection and disease. These grants have funded 14 researchers and yielded 115 peer-reviewed journal articles during 2013-20; ten of these researchers are listed above, having either led or contributed to selected papers [R1-R6].

During 2013-15, Hutchinson and Innes employed mathematical modelling to inform Scottish Government’s strategy on new highly-effective HCV interferon-free therapies [R1]. A Markov simulation model was created to forecast the population-level impact of different prioritisation strategies for scaling-up these new but expensive HCV therapies; while the model was parameterised to Scotland, the findings were translatable to other resource rich countries. Key strengths of the work included a) a synthesis of a vast array of observational data from Scotland’s surveillance systems (lacking elsewhere) to parameterise the model, and b) the adoption of a dynamic approach (rarely employed in previous HCV studies due to complexity) modelling both transmission and disease progression simultaneously. Results indicated that treatment of HCV-infected patients with moderate/severe liver disease needed to be increased 3-fold to make a 75% reduction in incidence of HCV-related liver failure within 5 years. This key finding directly informed Government’s policy (2015) on prioritising the new therapies to those with moderate/severe liver disease and new national targets for HCV treatment and disease.

The GCU team have also been at the forefront of research examining the clinical benefit of HCV antiviral therapy. During 2013-15, research led by Innes and Hutchinson involved (i) comprehensive statistical analysis of liver and non-liver related outcomes associated with treatment for a large real-world national cohort, and (ii) a Markov-chain Monte Carlo simulation of the patient-important benefits of treatment [R2,R3]. Evidence from these studies - that the short-term benefit of therapy was greatest for patients with moderate/severe liver disease - further informed Scottish Government’s HCV treatment strategy (2015).

During 2015-20, the GCU team have evaluated the impact of the Scottish strategy to prioritise new HCV therapies to those with moderate/severe liver disease. Through record-linkage and statistical analysis of population-level surveillance data and individual-level clinical cohort data (lacking elsewhere), Hutchinson and Goldberg demonstrated the first country-level evidence of major population impact of the new HCV therapies to reduce (and avert) presentations of liver failure [R4]. Further, McDonald and Hutchinson showed that clearance of HCV infection following treatment with the new therapies was associated with a lower risk of severe liver complications (including liver cancer) and improved survival among patients with cirrhosis [R5].

In recognition of the insights of international relevance from GCU’s research on HCV, Hutchinson was commissioned by the International Journal of Drug Policy to review the Scottish experience of translating research on treatment and management of HCV infection into public health policy and impact [R6].

3. References to the research

The research, funded by NHS Scotland via Health Protection Scotland [G1,G2,G3], provided the evidence to inform the national public health response to Hepatitis C in Scotland. The research involved advanced statistical analysis of public health surveillance data, including novel record-linkage and national clinical cohort studies to inform the extent and nature of hepatitis C infection in Scotland, and the effectiveness of antiviral treatments [R2,R4,R5,R6]. Our research is unique in its analysis of national clinical data – covering all clinics across the country, lacking elsewhere – to determine the ‘real-world’ effectiveness of therapies and thus is not subject to selection biases of most other studies confined to specialist academic centres. Our analysis yielded the most comprehensive understanding of clinical benefit of HCV therapies, with a large sample size and in excess of 5 years per-patient follow-up afforded the statistical power for the first examination of a diverse range of outcome events in different patient groups (vis-à-vis mild versus moderate/severe liver disease) [R2]. Major strengths of the mathematical modelling work for Scotland was the synthesis of a vast array of observational data from these surveillance systems and clinical cohort data to parameterise the model [R1,R3]. Further the adoption of a dynamic modelling approach to robustly account for HCV transmission and disease progression simultaneously [R1], in contrast to previous models focussing on one of these outcomes, was a key advancement that provided crucial insight to healthcare policymakers. Our recent research “provided the first evidence of a major population impact of new direct-acting antiviral therapies in averting HCV-related decompensated cirrhosis [liver failure]” [R4], and was selected as part of the Best at the International Liver Congress (involving over 10,000 delegates) in 2018 [C6] and was the subject of a keynote presentation at the First WHO Europe Regional meeting on Viral Hepatitis [C9]. The research has been published in leading hepatology journals (including the BMJ journal Gut and Journal of Hepatology, both with an impact factor of 20).

Peer-reviewed Research Papers:

  • [R1] Innes H, Goldberg D, Dillon J, Hutchinson SJ. Strategies for the treatment of Hepatitis C in an era of interferon-free therapies: what public health outcomes do we value most? Gut. 2015 Nov; 64(11): 1800-9. https://doi.org/10.1136/gutjnl-2014-308166

  • [R2] Innes HA, McDonald SA, Dillon JF, Allen S, Hayes PC, Goldberg D, Mills PR, Barclay ST, Wilks D, Valerio H, Fox R, Bhattacharyya D, Kennedy N, Morris J, Fraser A, Stanley AJ, Bramley P, Hutchinson SJ. Toward a more complete understanding of the association between a hepatitis C sustained viral response and cause-specific outcomes. Hepatology. 2015 Aug; 62(2):355-64. https://doi.org/10.1002/hep.27766

  • [R3] Innes H, Goldberg D, Dusheiko G, Hayes P, Mills PR, Dillon JF, Aspinall E, Barclay ST, Hutchinson SJ. Patient-important benefits of clearing the hepatitis C virus through treatment: a simulation model. J Hepatol. 2014 Jun;60(6):1118-26. https://doi.org/10.1016/j.jhep.2014.01.020

  • [R4] Hutchinson SJ, Valerio H, McDonald SA, Yeung A, Pollock K, Smith S, Barclay S, Dillon JF, Fox R, Bramley P, Fraser A, Kennedy N, Gunson R, Templeton K, Innes H, McLeod A, Weir A, Hayes PC, Goldberg D. Population impact of direct-acting antiviral treatment on new presentations of hepatitis C-related decompensated cirrhosis: a national record-linkage study. Gut. 2020 Dec; 69(12): 2223-2231. https://doi.org/10.1136/gutjnl-2019-320007

  • [R5] McDonald SA, Pollock KG, Barclay ST, Goldberg DJ, Bathgate A, Bramley P, Dillon JF, Fraser A, Innes HA, Kennedy N, Morris J, Went A, Hayes PC, Hutchinson SJ. Real-world impact following initiation of interferon-free hepatitis C regimens on liver-related outcomes and all-cause mortality among patients with compensated cirrhosis. J Viral Hepat 2020 Mar; 27(3): 270-80. https://doi.org/10.1111/jvh.13232

  • [R6] Hutchinson SJ, Dillon JF, Fox R, McDonald SA, Innes HA, Weir A, McLeod A, Aspinall EJ, Palmateer NE, Taylor A, Munro A, Valerio H, Brown G, Goldberg DJ. Expansion of HCV treatment access to people who have injected drugs through effective translation of research into public health policy: Scotland's experience. Int J Drug Policy. 2015 Nov;26(11):1041-9. https://doi.org/10.1016/j.drugpo.2015.05.019

Research Grants awarded to Hutchinson as PI to inform and evaluate Scotland’s strategy on Hepatitis C and other blood borne viruses:

  • [G1] Hutchinson SJ (PI), Goldberg DJ. Analytical research to inform on the effectiveness of services to prevent, diagnose and treat blood borne viruses in Scotland using data collected as part of the Scottish Government’s Sexual Health & BBV Framework (2015-2020). (Funded by Health Protection Scotland, 2015-2020, £1,805,110)

  • [G2] Hutchinson SJ (PI), Goldberg DJ. Research to estimate the number of people in Scotland to be initiated onto antiviral therapy for hepatitis C. (Funded by Health Protection Scotland, 2013-2015, £75,000)

  • [G3] Hutchinson SJ (PI), Goldberg DJ. Analytical research to inform on the effectiveness of services to prevent, diagnose and treat blood borne viruses in Scotland using data collected as part of the Scottish Government’s Sexual Health & BBV Framework. (Funded by Health Protection Scotland, 2013-2015, £709,720)

4. Details of the impact

The GCU research directly informed Scottish Government (SG) health policy on HCV, specifically on the scale-up of new therapies and setting of National Targets on treatment and disease in 2015. This evidence-based strategy led to changes in treatment practice that is estimated to have averted over 300 cases of liver failure in Scotland in the first 4 years, translating to ~£30 million saved by NHS Scotland. Evaluation of the clinical impact of these new therapies by the GCU team has informed the latest SG strategy published in 2019 to eliminate HCV by 2024.

Impact Pathway: In 2014, SG established an expert advisory group– Hepatitis C Treatment and Therapies Group– to provide recommendations on the delivery of new HCV therapies. GCU researchers chaired (Goldberg) and were members (Hutchinson and Innes) of this group [C1, page 14]. Hutchinson was funded by Health Protection Scotland (HPS) to undertake research to inform the group [G2,G3]. In late 2014, key stakeholders (150 service users and providers) were consulted at a National Symposium on the research findings and recommendations of the advisory group [C1 (page 2)]; GCU researchers chaired and presented at the event. The report of the advisory group [C1] was adopted as policy by SG in 2015 (see below). Thereafter, Hutchinson was funded to evaluate the impact of these new therapies on clinical practice and outcomes [G1]; the findings [R4,R5] summarised below underpin Scotland’s latest policy to eliminate HCV by 2024 (see below) [C3].

Impact on Scottish Health Policy (2015): SG first published a report from the Hepatitis C Treatment and Therapies Group in 2015 [C1], which recommended prioritisation of the new therapies to those with moderate/severe liver disease and new national targets on (a) numbers to be treated (50% increase to 1,500 in 2015/16, and rising thereafter to 2,000 by 2018/19) and (b) reductions in new presentations of HCV-related liver failure (75% reduction by 2020). The prioritised approach and new targets were set based on the GCU mathematical modelling [R1]. Government policy documents [C1 pages 10-13; C2 pages 36-37] reference the GCU research [R1,R2,R3,R6] and state: “Modelling work undertaken by GCU estimates that a minimum of 1500 treatment initiates per year during 2015-2020 is required to stand a chance of reducing the number of new liver failure presentations from the current level of nearly 200 to 50 by 2020” and that “of the annual number of people initiated onto antiviral therapy, 1500 should belong to the F2-F4 liver fibrosis category [i.e. moderate/severe liver disease] at time of treatment”.

Impact on Clinical Practice and Outcomes (2015-2018): The SG National Target on treatment, informed by GCU research [R1], has been exceeded each year between 2015/16 and 2018/19 [C3, pages 14-15]. In the four years since the introduction of the new therapies, ~6,900 people were initiated on treatment in Scotland and an estimated 6,100 persons were cured of their HCV infection (i.e. no longer at increased risk of liver disease) [C5,R4]. In line with the Government’s policy [C1], the scale-up in new therapies was greatest for those with severe liver disease (cirrhosis): ~1,800 initiated in the first 4 years with 1,600 estimated to have achieved cure, representing a 3.2-fold and 5.9-fold rise respectively compared to the 4 years prior to the new therapies [C5,R4]. As a result of the major scale-up in therapy among those with severe liver disease and as predicted by the GCU modelling [R1], the numbers presenting to hospital with chronic HCV-related liver failure reduced by 67% between 2014 and 2018 [C5,R4]. Through time-series analysis published in the BMJ journal Gut, an estimated 330 cases of liver failure have been averted in Scotland since the introduction of new therapies [C5,R4]. The life-time cost of managing a case of liver failure is ~£95,000, thus the 330 cases averted translates to ~£30 million expense avoided to the NHS [C3]. Further, surveillance data also shows that presentations of HCV-related liver cancer have reduced by 69% and HCV-related deaths have reduced by 49% [C3].

Impact on Scottish Health Policy (2019): GCU research [R4,R6] demonstrating impact of HCV therapies on clinical outcomes has informed Scotland’s recent HCV Elimination strategy [C3], where SG has endorsed new targets to eliminate HCV infection and disease by the year 2024 [C4], in advance of the WHO global target by 2030. Scotland’s evidenced-based strategy on HCV and associated clinical impact has been recognised as best practice at the International Liver Congress [C6], by the World Innovation Summit on Health [C7,C8] and WHO Europe [C9,C10].

5. Sources to corroborate the impact

Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
No

1. Summary of the impact

Falls in older adults represent an escalating public health concern. The Falls Management Exercise (FaME) programme, in sedentary older people, reduces the rate of falls and increases physical activity close to recommended levels for health. This led to adoption of FaME by multiple Public Health bodies and widespread implementation across the UK and Norway. FaME halves the number of falls, improves quality of life, physical activity and physical function, reduces fear of falls and produces a return on investment of between £2.89-£50.59 for every £1 invested. Community led FaME group programmes reach over 10,700 older people per week in the UK.

2. Underpinning research

Falls and fractures cost the NHS and social care over £2.3billion annually. Over a third of older people are concerned about falls and often restrict physical activity, affecting their physical and mental health. Although FaME was originally developed by Skelton in a small RCT of 100 women with a history of ≧3 falls in the last year (Age Ageing Letter, 2005), it was included in Department of Health guidance (Prevention Package, 2009) and there was some uptake in NHS led outpatient falls programmes (RCP, 2011).

In a problem/solution based model, Skelton, an exercise physiologist, updated the programme (FaME+) with a public health focus that would have wider reach (including more emphasis on progressive strength training, balance challenging exercises, floor work and walking, extra motivational and behaviour change support, and shortened duration). This FaME+ programme has led to collaborations with 10 universities, NHS trusts and local authorities and a technology company, 15 published papers, an implementation manual and shared grant income of nearly £2.8million.

ProAct65+, was a definitive three-arm, parallel-design cluster RCT involving 1256 people aged ≥65 years recruited from 43 general practices in London, Derby and Nottingham with a 2 year follow-up [R1,R2;G1]. The 6 month FaME+ intervention, led by Postural Stability Instructors (PSIs) reduced falls (54%) alongside a health-enhancing increase of 105 mins of moderate physical activity a week (1 year post intervention), bringing participants close to the 150 mins/week recommended by the Chief Medical Officer (CMO, 2011). The mean cost per extra person achieving the physical activity target was £1740 [R1, R2; G1].

In the UK, 1 in 5 people aged 75+ live with sight loss. Visually impaired older people fall more and are nearly twice as likely to experience a hip fracture than sighted older people. VIOLET, a proof of concept study based in Northumbria and Glasgow, found group-based FaME+ [R1] was feasible and safe in people with moderate-severe visual impairment with minor communication delivery changes and in smaller groups. de Jong found that participants and instructors felt that visually impaired older adults could be integrated into existing FaME classes with support [R3; G2].

Working with MIRA Health and the University of Manchester, Skelton, de Jong and Mavroeidi showed that innovative digital solutions (games played on the Kinect platform and a TV using FaME+ [R1] exercises) and physiotherapist supervision (for set up and progression) were cost-effective, reduced falls (69%), fear of falls and pain in older people living in sheltered housing [R4; G3].

Finally, to provide guidance for commissioners of falls prevention services, the ground breaking PHISICAL Study examined the implementation of FaME+ commissioned in three distinct (organisation, geography, ethnicity, socio-demographics) localities (Derby City, Leicestershire and Rutland Counties) using the Consolidated Framework for Implementation Research and the Carroll conceptual framework for implementation fidelity [R5; G4]. PHISICAL followed 29 FaME+ programmes, showing similar reductions in falls and improvements in physical activity seen in ProAct65+ [R1] and produced a FaME+ Implementation Toolkit, including advice on areas of fidelity and quality for improvement, to support future large-scale adoption by public health commissioners.

3. References to the research

  • [R1] Iliffe S, Kendrick D, Morris R, Masud T, Gage H, Skelton D, et al. 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. Health Technol Assess. 2014;18(49):vii-xxvii, 1-105. doi: https://doi.org/10.3310/hta18490

  • [R2] Gawler S, Skelton DA, Dinan-Young S, Masud T, Morris RW, et al; ProAct65+ team. Reducing Falls among older people in general practice: the ProAct65+ exercise intervention trial. Arch Gerontol Geriatr. 2016;67:46-54. doi: https://doi.org/10.1016/j.archger.2016.06.019

  • [R3] Adams N, Skelton D, Bailey C, Howel D, Coe D, Lampitt R, et al. Visually Impaired OLder people’s Exercise programme for falls prevenTion (VIOLET): a feasibility study. Public Health Res. Southampton (UK): NIHR Journals Library. 2019;7(4). doi: https://doi.org/10.3310/phr07040

  • [R4] Stanmore EK, Mavroeidi A, de Jong LD, Skelton DA, et al. The effectiveness and cost-effectiveness of strength and balance Exergames to reduce falls risk for people aged 55 years and older in UK assisted living facilities: A multi-centre, cluster randomised controlled trial. BMC Med. 2019;17(1):49. doi: https://doi.org/10.1186/s12916-019-1278-9

  • [R5] Carpenter H, Audsley S, Coupland C, et al. PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL): Study Protocol. Injury Prevention. 2019 Oct;25(5):453-458. doi: https://doi.org/10.1136/injuryprev-2017-042627

Grants

  • [G1] NIHR HTA – A multi-centre cluster trial in primary care comparing a community group exercise programme with home based exercise and with usual care for people aged 65 and over (ProAct65+). £1.7 million. PI: Iliffe. Co-Is: Kendrick, Skelton, et al. June 2008-June 2014. ISRCTN43453770. Sponsor: University College London.

  • [G2] NIHR PHR - Adapting a falls prevention exercise programme with and for older people with visual impairment: a feasibility study (VIOLET). £463k. PI: Adams. Co-Is: Skelton, Bailey, et al. May 2015-Nov 2017. ISRCTN16949845. Sponsor: Northumbria University.

  • [G3] Innovate UK – Small Business Research Initiative (SBRI) Healthcare Phase 2 award, NHS England. A multi-centre, cluster randomised controlled trial comparing falls prevention Exergames with remote monitoring against standard falls prevention programmes for community dwelling older adults at risk of falls. £354k. PI: Stanmore. Co-Is: MIRA Ltd, Todd, Skelton, et al. July 2016-Dec 2018. NCT02634736. Sponsor: Manchester University.

  • [G4] NIHR CLAHRC - PHysical activity Implementation Study In Community-dwelling AduLts (PhISICAL) Implementation of FaME: A community based programme for falls prevention. £250k. PI: Orton. Co-Is: Kendrick, Skelton et al. Sept 2015-Dec 2018. Sponsor: Nottingham University.

Quality of the Research

ProAct65+, funded by the NIHR HTA, was the first definitive parallel-design multi-centre cluster RCT with a 2 year follow up to show that a group exercise programme could substantially increase physical activity and reduce falls in sedentary older people even a year after intervention cessation [R1, R2; G1] highlighting its utility as a public health initiative. VIOLET, funded by NIHR PHR, was the first proof of concept study to show that group falls exercise was feasible and safe in significantly visually impaired older people [R3; G2]. In a highly competitive Healthcare Phase 2 Award, NHS England funded the development and evaluation of the falls prevention Exergames (MIRA) based on FaME [R4; G3] and is the first Exergame study to show substantial return on investment. In a novel and comprehensive implementation study (PHISICAL), funded by NIHR CLAHRC East Midlands and Leicestershire County Council, FaME was rolled out in 3 distinct localities and barriers and facilitators to implementation were considered when producing the first UK falls prevention implementation manual for commissioners of services [R5; G4]. Research and implementation of FaME into practice was recognised in the conferring of Fellowships to Skelton from the Royal College of Physicians of Edinburgh, the Chartered Society of Physiotherapy and a lifetime achievement award from the British Geriatrics Society.

4. Details of the impact

FaME+, designed to reduce falls and improve the health and physical activity of older people, is delivered by PSIs in community settings in the UK. Independently published service evaluations have demonstrated life changing impacts on physical health, physical activity and confidence in those older people accessing FaME+. This has been achieved through a pathway of impact on falls guidelines and policy, the provision of education and implementation materials and demonstrable return on investment for commissioners of these services.

Life-changing health impacts to older people taking part in FaME+ sessions

FAME+ has a significant reach in the UK. An independent ROSPA impact report showed wide implementation and reach in three areas (Devon, Greater Manchester and Leicestershire, Rutland and Derby) [S1]. A survey of PSIs (n=656, 18% of qualified PSIs) suggested that FaME+ reached 10,729 older adults in an average week and over a one-year period (Jan 2019-Jan 2020) 68,796 people [S2], as sessions run in 12-24 week blocks. Extrapolating to 50% of all trained PSIs and with programmes throughout the year, over 2 million older people a year would be receiving FaME+ [S2]. The MIRA platform has extended the reach of FaME+ with more than 4904 patients using it since its release [S3], and since 2018 there are over 10 licences specifically for falls prevention in older people used in rehab facilities, care homes and sheltered housing facilities.

Significantly, there have been multiple service evaluations of ‘effectiveness’ by independent community and health organisations demonstrating the physical, mental and social health impacts to FaME+ participants. These include reductions in falls of 43-58% [S4;S6], improvements in balance confidence of 55-100% [S2,S5-S7] and quality of life (42%) [S6], >10% reduced fear of falling [S4;S2;S5], improvement in timed up and go (20-50%) [S4-S6;S10], balance [S2;S5;S10], and functional skills such as getting off the floor [S5], increased self-reported physical activity [S2;S5;S7], improved mental wellbeing [S4;S6], and increased social interaction and participation [S2;S4-S6] leading to a reduction in social isolation.

Impact on Falls Guidelines and Policy to increase adoption and improve implementation

Due to the efficacy and cost-effectiveness of FaME+ [R1], it is one of only two structured exercise programmes supported by PHE Cost-effective Commissioning (2018) for falls prevention. Local providers implement FaME+ as evaluations show a greater return on investment than PHE suggested (£2.28 for every £1) (PHE 2018). Dance to Health reported a return on investment of £2.89 for every £1 invested [S4] whereas, Staying Steady (Gateshead) reported that for every £1 spent on FaME+ returned £50.59 [S7] to the public purse and Steady Steps (Edinburgh Leisure) estimated that every £1 used on FaME+ saved £18 [S6].

In 2019, FaME+’s efficacy led to adoption by the CMO Physical Activity Recommendations for Health, Public Health Wales and the National Prudent Healthcare Falls Prevention Taskforce, The Royal Osteoporosis Society in ‘Strong, Steady, Straight’, the Chartered Society of Physiotherapy ‘Physiotherapy Works – Falls: A Community Approach and Prevention and Management of Falls in the Community: A Framework for Action for Scotland (2014/2016). The Centre for Ageing Better report ‘Raising the bar on strength and balance’ (2019) recommended FaME+ as the best public health programme for prevention of falls and maintenance of physical function.

Impact on Education to increase adoption and improve implementation

Skelton is a Founding Director of Later Life Training Ltd (LLT), a not for profit national training provider. Since Aug 2014, LLT has trained 1200 PSIs [S2]) to use FAME+ [R1;R2;S8]. The syllabus, informed by Skelton’s research, was updated in 2017 to reflect the verbal and adapted delivery skills required to work with visually impaired older adults [R3;S8]; allowing inclusion of people with sight loss into FaME+ classes. In 2016-2018, LLT trained 30 Dance Choreographers in the UK in principles and delivery of FaME+ to support the Dance to Health initiative, reaching a wider audience in public health [R1;S4].

Skelton adapted the FaME+ Implementation Toolkit quality assurance (QA) checklist for PSI self-reflection and assessment to improve quality and fidelity to the delivery of FaME+ [R5;S9] and in 2019 LLT provided this to all qualified PSIs [S8]. The FaME+ Implementation Toolkit for Commissioners, endorsed by NICE in October 2019 [R5;S9], has been downloaded >800 times and 94% found it useful and rated it 4/5 for building the case for investment, planning for implementation and monitoring and evaluation [S10].

Beyond LLT, Skelton, with MIRA Health, delivered a webinar on Exergames based on FaME+ to >200 people and the recording attracted over 350 views [R4;S3]. In 2015, she was invited to initiate a strategic rollout of FaME+ [R1] by the Norwegian University of Science and Technology, establishing core trainers for the Norwegian National Falls Prevention Programme, Sterk og stødig, (462 instructors trained in 59 Norwegian municipalities), reaching 4000 older people [S11]. They now have 75 municipalities (out of 422 across Norway) (Oct 2020) signed up for continued strategic roll-out.

5. Sources to corroborate the impact

Submitting institution
Glasgow Caledonian University
Unit of assessment
3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type
Health
Is this case study continued from a case study submitted in 2014?
No

1. Summary of the impact

Research at GCU has been instrumental in reducing transmission of HIV by directly shaping policy in Scotland and the Republic of Ireland, and by changing models of care in Scotland, and by influencing European HIV Pre-exposure prophylaxis (PrEP) guidance. In Scotland, PrEP has reduced by two thirds the overall risk of acquiring HIV in men who have sex with men, and recently acquired infections have decreased by 40% since PrEP was introduced in 2017. People who inject drugs in western Scotland are among the first world-wide to benefit from a PrEP service to prevent HIV transmission.

2. Underpinning research

The interdisciplinary GCU HIV prevention group conducts programmatic, mixed methods research with diverse populations. Approaches and methods span basic social science to addressing wider issues of implementation and policy. The breadth of our research expertise, prominence of our senior researchers in national/international clinical and public health, and strong links to key community-based organisations have enabled very rapid translation of research findings into practice, often ahead of publication.

PrEP is a new biomedical prevention tool in which people take anti-HIV drugs to prevent them acquiring HIV. PrEP had been demonstrated to be highly effective in men who have sex with men (MSM) in clinical trials but by 2015, PrEP had not been implemented at scale and its acceptability in the “real world” context was unknown. Our early Celtic nations survey research (2015/2016 [R1], funded by NHS Lanarkshire [G1], was the first study to accurately assess PrEP acceptability amongst high-risk MSM and showed that willingness to take PrEP rose as HIV risk behaviours increased. A subsequent mixed-methods study [R2], funded by NHS Lanarkshire [G1] and the UK Medical Research Council (MRC) [G2] provided additional granularity, showing that almost half of all MSM at high risk of sexually acquired HIV in Scotland, (those who would benefit most) would use PrEP when available.

Bio-behavioural survey research led by GCU (Drs McAuley, Palmateer, Prof Hutchinson), published in Lancet HIV, 2017-18 showed that prevalence of HIV among people who inject drugs (PWID) in NHS Greater Glasgow & Clyde (NHS GGC) had increased ten-fold from 1% to 11% because of an outbreak [R3, G3]. The study also generated the first empirical evidence of the key individual and environmental factors associated with infection: homelessness, incarceration, and a major shift to injection of cocaine.

The survey findings [R3] led us to explore qualitatively, in one of the first studies worldwide, the acceptability of PrEP among people who inject drugs (PWID) in Glasgow at very high risk of HIV during the ongoing outbreak (2019-2020). We showed that many found PrEP acceptable and would take it if offered [R4, G4].

As other UK countries rolled out PrEP programmes (2017-2020), Prof Estcourt, led a Five Nations (UK & Republic of Ireland) initiative to develop an evidence-based dataset for regular reporting of PrEP clinical activity and outcomes, to develop a harmonised monitoring system for PrEP across five closely related nations, funded within [G3]. We used a modified Delphi Technique to develop and refine the data variables and demonstrated utility with Scottish national data. The dataset has informed the 2021 European (ECDC) guidance on PrEP monitoring, led by Prof Estcourt [G5].

Finally, in 2019-2020 we conducted complex epidemiological analyses of Scottish national datasets to provide the first “real-world” data on impact of PrEP at population level [R5, G3]. We used a retrospective cohort approach with readily available data from over 12,000 MSM, contributing over 20,000 person-years of follow-up. We showed that compared to the pre-PrEP period, risk of HIV in MSM in the PrEP period was reduced by 75% among those prescribed PrEP at least once.

3. References to the research

Our underpinning papers include key new knowledge from a large online survey involving complex statistical analyses [R1], mixed methods studies with integration of several datasets [R2], a large cross-sectional analysis of four cross-sectional, anonymous, bio-behavioural surveys of almost 4000 PWID [R3], one of the first studies to explore acceptability of PrEP use in PWID [R4] and complex epidemiological analysis of large national data sets which reported population impact of routinely implemented PrEP for the first time [R5].

  • [R1] Frankis J, Young I, Lorimer K, Davis M, and Flowers P. Towards preparedness for PrEP: PrEP awareness and acceptability among MSM at high risk of HIV transmission who use sociosexual media in four Celtic nations: Scotland, Wales, Northern Ireland and The Republic of Ireland: an online survey. Sexually Transmitted Infections. 2016 Jun 1;92(4):279-85. https://dx.doi.org/10.1136/sextrans-2015-052101

  • [R2] Frankis J, Young I, Flowers P, McDaid, L. (2016). Who Will Use Pre-Exposure Prophylaxis (PrEP) and Why?: Understanding PrEP Awareness and Acceptability amongst Men Who Have Sex with Men in the UK-A Mixed Methods Study. PloS one, 11(4), e0151385 https://doi.org/10.1371/journal.pone.0151385

  • [R3] McAuley A, Palmateer NE, Goldberg DJ, Trayner KMA, Shepherd SJ, Gunson RN, Metcalfe R, Milosevic C, Taylor A, Munro A, Hutchinson S. Re-emergence of HIV related to injecting drug use despite a comprehensive harm reduction environment: a cross-sectional analysis. Lancet HIV. 2019 May;6(5):e315-e324. https://doi.org/10.1016/S2352-3018(19)30036-0

  • [R4] Smith M, Elliott L, Hutchinson SJ, Metcalfe R, Flowers P, McAuley A. Perspectives on Pre-exposure Prophylaxis for People Who Inject Drugs in the context of an HIV outbreak: a qualitative study. International Journal of Drug Policy: Volume 88, February 2021, published online 26.11.20. https://doi.org/10.1016/j.drugpo.2020.103033

  • [R5] Estcourt C, Yeung A, Nandwani R, Cullen B, Goldberg D, Wallace L, Steedman N, Hutchinson S (last author). Population-level effectiveness of a national HIV pre-exposure prophylaxis programme in men who have sex with men: a retrospective cohort study within real world implementation in Scotland. (AIDS: accepted 30.11.20, published online ahead of print 7.12.20. https://doi.org/10.1097/QAD.0000000000002790

Research Grants

  • [G1] Dr Frankis’ & Prof Flowers’ work was funded as part of NHS Lanarkshire and GCU partnership funding for Blood Borne Viruses research [1.10.12 – 31.5.14] (£20,000 plus 20% salary costs; Title: Social Media, Men who have sex with men and Sexual Health Study).

  • [G2] HIV & the Biomedical- Investigating the Acceptability of Biomedical Interventions for HIV Prevention in Scotland, the qualitative research component, was awarded to Dr Ingrid Young and Prof McDaid, funded by the UK Medical Research Council (MRC) (MC_U130031238/MC_UU_12017/2), as part of core-funding for the Sexual Health Programme (now the Social Relationships and Health Improvement programme) at the MRC/CSO Social and Public Health Sciences Unit, University of Glasgow. Sponsor: GCU and University of Glasgow.

  • [G3] Part of Dr McAuley’s work and Prof Estcourt’s leadership of the national evaluation of PrEP and related work (P5, P6) were both funded as part of Hutchinson SJ (PI), Goldberg DJ. Analytical research to inform on the effectiveness of services to prevent, diagnose and treat blood borne viruses in Scotland using data collected as part of the Scottish Government’s Sexual Health & BBV Framework (2015-2020). (Funded by Health Protection Scotland, 2015-2020, £1,805,110). Sponsor: Health Protection Scotland.

  • [G4] Dr McAuley’s work was also funded by the Needle Exchange Surveillance Initiative (NESI). The initiative was initially funded by the Scottish Government as part of the Hepatitis C Action Plan. More recently the initiative has been funded under the auspices of the Scottish Government’s Sexual Health and Blood Borne Virus Framework. NESI provides information to evaluate and better target interventions aimed at reducing the spread of infection amongst PWID. The GCU team took over the delivery of the NESI study in 2017 as part of a seven-year collaboration and research agreement with Public Health Scotland (then Health Protection Scotland), value £600,000 January 2017 to March 2024.Sponsor: Health Protection Scotland.

  • [G5] Professor Estcourt was invited to present the Five Nations minimum dataset for PrEP monitoring at an HIV prevention workshop at The European Centres for Disease Prevention and Control (ECDC) in November 2018. Following this, she was invited to apply for (and was awarded) the contract from ECDC, Office of Chief Scientist Service, Contract ECD 9879, Support to European Member States on implementation and monitoring of pre-exposure prophylaxis for HIV, NP/2019/OCS/10701, 2020, €49,922, Sponsor: GCU.

4. Details of the impact

Prof Estcourt’s team’s research has impacted on HIV prevention policy and practice in some of the most vulnerable and marginalised groups in Scotland, the UK and the Republic of Ireland. It has also influenced pan-European prevention guidance. In Scotland, this has contributed to a 40% reduction in new diagnoses of HIV in MSM in the last two years (a cost saving of £320,000 per transmission) and provided PrEP for PWID in the context of an uncontrolled outbreak, in the first example of this worldwide.

The Deputy Chief Medical Officer for Scotland is “indebted to Professor Estcourt and the team for their contribution to the national HIV prevention agenda. They are highly regarded in Scottish Government in terms of the quality and importance of their work in the SH and BBV fields” (S1).

Impact on Scottish HIV Prevention Policy:

The Scottish Medicines Committee approved PrEP for people at highest risk of HIV in April 2017 based on the recommendations from Scottish Health Protection Network Working Group [S2]. The Group used data from GCU research [R1, R2] to:

1) provide its estimate of PrEP uptake in MSM at high risk of HIV (58.5%) (R1, S2/page 4/para3), leading to the Group’s recommendation for approval of PrEP and subsequently the estimate on which planning of national clinical PrEP services was based. Subsequently 1855 MSM were protected from acquiring HIV in the first year of roll out.(S3/page17/para3).

2) to determine risk-based eligibility criteria for PrEP. Evidence from [R2] suggesting that condomless anal intercourse with two or more previous partners in the last 12 months was a marker of HIV transmission risk, led to the Working Group recommending that this should be (S2/page4/para3) (and subsequently became, S3/page16/Fig 4.1) one of the eligibility criteria for PrEP. This enabled an additional 2776 MSM, a group at highest risk of HIV and poor sexual health, to be protected from acquiring HIV in the first two years of the PrEP programme (S4/page9/last para).

We improved understanding of HIV transmission in PWID which led to an expansion of targeted HIV testing and PrEP provision during an ongoing HIV outbreak.

Findings from our bio-behavioural and qualitative research [R3, R4] directly informed the public health response to the outbreak:

3) Enhanced testing initiatives were introduced in the “hotspot areas” identified in the research ahead of publication [R3] [S5,S6,S7]. which contributed to 112 PWID being diagnosed with HIV (2016-2019) and linked into effective HIV care. Dr McAuley provided evidence at Scottish Affairs Committee (2016-2019) inquiry on problematic drug use on 7 May 2019 [S5], which was referenced by the Scottish Government when endorsing plans for Scotland’s first safer drug consumption facility [S6]. Ahead of publication, the research also informed the business case for Scotland’s first Heroin Assisted Treatment (HAT) service which opened in November 2019 To date, 10 PWID have been successfully managed on HAT.

4) NHS Greater Glasgow & Clyde established a highly innovative PrEP service for PWID at high risk of HIV through sexual transmission, in identified “hotspot” areas [R3], [S7] Dr Smith’s qualitative study showed PWID would find PrEP acceptable if more widely offered [R4]. To date 37 PWID with concurrent sexual risk (largest cohort in Europe) have been protected from HIV by taking PrEP.

“… the research has undoubtedly had an impact on reducing the potential for onward transmission of the virus thus benefitting the health outcomes of the population most at risk (PWID). In addition, it is likely to have contributed to a major cost saving to the health board…” (S7, Chair of NHS Greater Glasgow & Clyde Outbreak Incident Management Team).

5) The minimum dataset for national reporting of Human Immunodeficiency Virus PrEP-related data has been incorporated into Public Health Scotland’s National Statistics reporting cycle (S8/page3/para1) [G3] helping policy and health planners to drive sustainable PrEP provision for the population.

6) Our national level epidemiological analysis [R6] has underpinned the decision to continue a Scottish national PrEP programme to reduce HIV transmission, widening PrEP eligibility criteria to include the two groups of MSM at very high risk of HIV [R6, S1]. As a result, an additional 1500 MSM are being offered protection from acquiring HIV per year.

“Our close links and joint working across research studies, policy and national strategies creates a unique partnership in which the views and needs of beneficiaries are central to the work from the very start” (S9, CEO HIV Scotland).

Impact on Republic of Ireland PrEP policy:

7) Estimates of PrEP uptake [R1], were used in the Republic of Ireland’s Health Protection Surveillance Report, on which the Irish National programme was based (S10/page7/3.4.3, page12/4.6, page14/5). 2289 people at high risk of HIV have benefitted from the Irish PrEP programme to November 2020.

Impact on Wider European PrEP guidance:

8) Prof Estcourt presented an early version of the minimum dataset at European Centres for Disease Control “PrEP in Europe”, workshops (2018 & 2020). It was so well received that it has been included in new European CDC PrEP Operational Guidance, (led by Prof Estcourt) as an example of a robust monitoring tool for country-level data reporting and European-harmonised reporting to monitor progress against HIV prevention goals [S11, Annex 3] [G5].

5. Sources to corroborate the impact

Showing impact case studies 1 to 7 of 7

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