Impact case study database

Context

In REF2014 we reported how our research had impacted policy and practice in falls prevention. That underpinning research has continued to be highly influential and has increased in reach and significance.

Pathways to Impact

Since 2014, the EU Prevention of Falls Network for Dissemination (ProFouND- led by UoM, 33 institutions, 14 countries) has extended the reach of impact, through the Falls Action Group: European Innovation Partnership on Active and Healthy Ageing. This group brought together 100 multi-stakeholder commitments/communities from across the EU to promote falls prevention, bringing research evidence to innovation and procurement processes [Ai], [Aii]. Since 2015, we have organised the annual European falls conference, and help organise the Falls World Congress, first held in 2019. Todd wrote briefings for the Department of Health and Social Care and the Chief Medical Officer on fall prevention and activity promotion and attended the House of Lords Select Committee (July 2019), to which UoM also submitted written evidence. Multiple stakeholders have taken up recommendations for practice based on UoM research. We worked with PHE and the Royal Society for the Prevention of Accidents (RoSPA) to influence policy and practice, including recommendations for use of FaME, FES-I, and positively framed messages [Bi]. Similar work was undertaken with the Centre for Ageing Better, AgeUK, British Geriatrics Society and national and international guideline development bodies (e.g NICE, US CDC).

The FaME Implementation Toolkit (developed by East Midlands CLAHRC (Collaboration for Leadership in Applied Health Research and Care), endorsed by NICE and downloaded >800 times) facilitates commissioners’ and providers’ uptake [C].

We worked with Greater Manchester Combined Authority on the devolved falls, fractures and frailty strategies and influenced service configuration, use of FaME and the positively framed “Taking Charge” falls prevention programme [Di].

Reach and significance of the impact

Non-UoM research (Proact65) continues to demonstrate the effectiveness of the FaME intervention at reducing falls by more than a quarter when compared with usual care at 12 month follow-up and increasing the number of participants reaching their physical activity target [E].

Falls interventions

New national and international guidance documents identifying evidence-based strength and balance exercise programmes recommend FaME, e.g NICE 2018 [Fi], US Centers for Disease Control and Prevention (US CDC) 2015 [Fii].

Leading on from the “Taking Charge” falls prevention programme, during 2020 COVID-19 lockdowns, we helped develop Keeping Well at Home and Keeping Well this Winter booklets including FaME exercises, distributed to >260,000 people and recognised as best practice by WHO [Dii].

FaME has been shown to have a financial impact, with PHE recommending the programme as a cost-effective intervention to reduce falls [Bii], estimating that FaME provides a societal return on investment for every GBP1.00 spent of GBP2.28 (1:2.28 ratio), although other estimates are much higher (1:18 and 1:50.5) [Gi], [Gii].

FaME has also been shown to be income-generating. There are 3,264 qualified FaME instructors in the UK (up from 2,000 reported in REF2014), enabling more people to participate in FaME classes, generating GBP813,837 income for Later Life Training, a not for profit training organisation [Giii].

Interim data from a survey undertaken for PHE reveals that 80% of responding falls services in England provided FaME to up to 300 participants per week during 2019-20.

In terms of patient outcomes, some 172,000 people in the UK received the FaME programme in 2019, suggesting that during 2014-2020, up to 424,554 falls and up to 21,000 fractures have been averted by participation in FaME. The Centre for Ageing Better present strong testimonial videos demonstrating FaME’s effect on individuals [H], along with case studies of FaME implementation in the UK.

FaME-based exercises have been implemented in exergames, providing a new cost-effective pathway to impact [I]. The UK company MIRA-Exergaming indicates that approximately 5,000 patients in >200 clinics worldwide have used the games in >67,000 sessions.

The COVID-19 pandemic has given further impetus to our work because of risk of deconditioning and falls resulting from lockdown. Policy briefings to the Department of Health and Social Care on virtual delivery exercise regimens including FaME have been downloaded >1,100 times.

Fear of Falling

FES-I/Short FES-I is now more widely used as a measure of fear-of-falling. It was internationally downloaded 18,274 times in 2020. The website www.fes-i.org alone has >18,000 page views per annum from >120 countries. FES-I is available in 35 languages, an increase of 17% since 2014.

FES-I has been added to the RoSPA “Stay Up Stand Up” core outcomes dataset for falls prevention services and it continues to be recommended by PHE [Bii] as well as by many organisations worldwide (e.g. American Physical Therapy Association, Danish Society for Physiotherapy, SRA-LAb Org USA).

Uptake and adherence

As reported in REF2014, our work published as “ Don’t mention the F-word” resulted in a change of underlying philosophy, with a move away from emphasising the dangers of falls to emphasising positive coping. This continues to influence how services are configured, emphasising the positives of participating in exercise rather than focusing on personal risk from falls. Evidence for this continued impact in the UK is provided in the Centre for Ageing Better Raising the Bar 2019 publication [J], which demonstrates the sustained use and impact of FaME in the UK. Internationally the notion of focusing on the positive rather than emphasising risk, as identified by our research, continues to be a keystone of policy across the EU, North America, Australia and New Zealand and more recently across Asia.

Context

Prior to this work there was a lack of an evidence-base, tools, implementation strategy and principles for consistent end-of-life carer assessment and support. The research team has implemented evidence-based carer assessment and support in healthcare practice via:

1) “pathways” of training development and collaboration;

2) broad reaching national and international roll-out within healthcare organisations;

3) national and international guidelines;

4) direct impact on carers assessed and supported by practitioners.

Pathways to impact

Face-to-Face (F2F) CSNAT-I training for practitioners

From autumn 2013, F2F training used a train-the-trainer model to cascade CSNAT-I to a wide range of healthcare organisations by training practitioner ‘champions’ to train others within their teams. Added user support was provided by two national conferences (2016, N=100; 2019, N=80) and online group meetings. Some teams further adapted the training materials to deliver CSNAT-I training throughout their region in the UK (Carers Trust/ Peterborough & Cambridge CCGs) and abroad (Canada; Austria). CSNAT has been translated into 15 languages [A].

Online CSNAT-I training for practitioners via Toolkit and support platform

The free online CSNAT-I Training and Implementation Toolkit was launched 11.02.2019 to extend national and international training delivery, further supported by information and resources on the CSNAT website. Organisations obtain a free CSNAT-I practice license following completion of practitioner training, and training is Continuing Professional Development (CPD) accredited. NIHR CLAHRC/ ARC Greater Manchester supported Toolkit development and now hosts the Toolkit.

NHS England Masterclass training of general practitioners 2020

NHS-E commissioned the research team to provide an online four-module Masterclass on improving carer support for general practice to support the Quality Improvement Programme for GPs, fully based on the team’s CSNAT-I training and national recommendations for implementation [B].

Hospice UK collaboration to improve hospice carer provision

The research team worked with the largest UK hospice member organisation to guide, assess and improve hospice support for carers nationally (Hospice UK/ NIHR CLAHRC GM funded) [C].

International drivers for spread

International implementation has been spearheaded by feasibility studies and trials in Australia, Denmark, Netherlands, Austria/Germany, Canada to date (Sweden and Portugal setting up); supported by the research team via e-mail, Skype/ Zoom meetings, annual CSNAT-I network meetings at European Association for Palliative Care Annual Congress (2016, 2017, 2018, 2019) and UK international workshops (2018, 2019).

Reach and significance of the impact

Practitioners trained in CSNAT-I

Face-to-face training in CSNAT-I delivery has been provided to 538 UK practitioners from 134 organisations and to 57 practitioners abroad for cascading within their organisations.

The Online Training and Implementation Toolkit has had 586 registrations and issued 235 certificates from launch 11.02.19 to 31.05.20.

Spread within UK to deliver CSNAT- I to carers within hospices, hospitals, community teams

• 85 UK healthcare organisations hold CSNAT-I Practice Licences [A], including:

• an estimated 20% of Hospice UK member organisations.

• Carers Trust/ Cambs & Peterborough CCG licence for 70 GP practices [D].

• UK’s flagship hospice, St Christopher’s, where CSNAT-I is a central component of their Carer Strategy 2018: “ The person centred focus of CSNAT and the conversations around the 14 domains has transformed social work practice... The questions are empowering for carers… It emphasises what’s strong with people rather than what’s wrong with them… within the very diverse community of South London CSNAT has proven to be culturally relevant and sensitive” [E].

Spread internationally to deliver CSNAT-I to carers within regions or individual healthcare organisations

• 83 healthcare organisations outside the UK hold CSNAT-I Practice Licences (in Australia, Canada, China, Denmark, Germany, Gibraltar, Ireland, New Zealand, Norway, Sweden, Taiwan, USA) [A].

• Canada: Alberta Health Services roll-out of CSNAT-I [F].

• Australia: 42 healthcare organisations have a CSNAT-I license following local trials [3] and Department of Health Victoria State recommendation (2010).

• Austria: roll-out across Austria/ Germany following adaptation of CSNAT-I which won an award from the German Society of Palliative Medicine.

• Denmark: successful trial of CSNAT-I in nine services.

• Netherlands: feasibility testing ongoing.

National and international guidelines promoting carer support/CSNAT-I, with added follow up

• The Royal College of General Practitioners (RCGP)/ Marie Curie recommend CSNAT-I for carer support in their guidelines for end-of-life care in general practice (“Daffodil Standards”, 13.02.19) [D]. Standards provide prominent links to the CSNAT-I Training and Implementation Toolkit and website. 18% of GP practices in England have signed up to the Daffodil Standards.

• The research team’s NHS England carer Masterclass is available to all GP practices nationally and has had nearly 1,000 podcast listeners since February 2020 [B]. The Masterclass coordinates with the Daffodil standards for wider impact.

• Hospice UK promoted to all members the research team’s National Recommendations (2018) for organisational implementation of carer support, and the team’s survey report (2019) on hospices’ performance against national recommendations and launched a Project ECHO (online community of practice network teaching platform) for improvement of carer support (Febrary 2020) [C].

• The Norwegian Government’s May 2020 guidelines for national end-of-life care provision recommend CSNAT-I for all carers: implemented in three of the four Norwegian palliative care regions following the research team’s workshops (February 2019) with regional leads to agree a national CSNAT-I implementation strategy [G, H].

National recognition for the impact of the research awards

The CSNAT-I team received the first NIHR and Charities Consortium Award for practice changing research 2018 and its impact [I].

Impact on carers

Based on implementation data and trial evidence [3, 4] tens of thousands of carers will have had reduced caregiver strain and improved outcomes in bereavement from CSNAT-I. Up to 120,000 carers have been supported through CSNAT-I based on CSNAT-I licensee’s own estimates. Feedback from carers attests to the benefits of CSNAT-I, including being able to reflect on and express their own needs, and gaining reassurance and support “It formalised what I probably knew I needed, but it’s difficult to articulate when you’re going through it…so yes it was very good”; “It gave me the reassurance I needed. It does make you feel less isolated, knowing if anything goes wrong, I’m not the only one making decisions” [J].

Context

Our research at the UoM has made a significant, direct and global impact in shifting the paradigm of drug development away from ‘one-size-fits-all’ dosing strategies. CAPKR research has enabled exploration of new avenues to address dosage regimen requirements for special populations by integrating information regarding the system attributes (abundance of enzymes/transporters) into PBPK predictive models. In the words of the Deputy Director of the FDA Office of Clinical Pharmacology (OCP):

“The CAPKR group has published several seminal pieces of novel research related to 'stratified medicine' particularly in paediatrics, pregnant women and obese patients undergoing bariatric surgery which have been very informative and led to actionable changes in drug development and patient care.” [Ai].

CAPKR has also delivered economic and ethical benefits via reducing the number of clinical studies. The testimonial by the Vice-President and Global Head of Clinical Pharmacology at Pfizer states:

“We typically conducted 25 to 40 or more clinical pharmacology studies to evaluate all these potential intrinsic and extrinsic factors for each new medicine before requesting regulatory approval. These studies add to the cost and time of developing new medicine and contribute to the escalating cost of new medicines for patients and tax payers around the world. We (now) make extensive use of PBPK models to inform our strategy about the necessity to conduct or avoid particular clinical pharmacology studies.” [Bi].

Pathways to impact involved

• A close collaboration with the FDA (under a Memorandum of Understanding Agreement signed by the Director of Center for Drug Evaluation and Research, FDA [C]), which has helped us translate the latest Drug Metabolism and Pharmacokinetics (DMPK) science into practice under the Model-Informed Drug Development (MIDD) approach.

• Regular site visits, and sabbatical stays at the FDA (Galetin and Rostami).

• Contributions as key opinion leaders in EMA/ FDA internal workshops/discussion panels (Aarons, Galetin, Ogungbenro and Rostami).

• Direct engagement with the senior leadership of Clinical Pharmacology and DMPK operations of pharmaceutical companies [Bi-Bv].

• Practical Pharma interaction via CAPKR membership to carry out pre-competitive research (up to GBP100,000 per annum per member), and currently includes companies Eli Lilly, GSK, AbbVie, Merck-Serono, Janssen, Merck-Sharp & Dohme, Genentech and Takeda.

Reach and significance of the impact

CAPKR’s translational modelling has been widely adopted by pharmaceutical companies and regulatory agencies. The impact can be viewed as follows:

1. Individualized dosing. The ‘one-size-fits-all’ approach in drug development does not consider that individual responses of patients can vary significantly as a result of physiological/biological differences which stem from genetics, environment, ethnicity or age. Recognizing this challenge and to address these issues, the FDA held a workshop in August 2019 on ‘Precision Dosing’, a term first coined by CAPKR in 2016. From this the FDA released new guidance (November 2020) entitled ‘ Enhancing the Diversity of Clinical Trial Populations’ [D]. The guidance acknowledges that in traditional drug development certain populations are often excluded from trials without strong clinical / scientific rationale (e.g. individuals with organ dysfunction). It also indicates that failure to include participants with complex comorbidities in a development program may lead to a failure to discover important safety information.

Global health advocates (Gates Foundation) have also been a beneficiary of our research findings. The research has created the opportunity for developing new rational guidance for drug treatment in orphan disease groups such as pregnant patients in developing countries which are not studied as part of clinical drug development [E].

2. Modernising drug development and changing regulatory perspective. Using PBPK modelling, CAPKR have shown how to evaluate and include individualized factors into a dosage regimen prior to conducting any clinical studies. Many PBPK predictive models are now implemented in commercial software [F] and incorporated into drug development practice within the pharmaceutical industry, encouraged by global regulators. The FDA position paper regarding disparity of the impact of DDI and genetic polymorphism in paediatrics vs. adults [Gi] is based directly on CAPKR’s research on variable ontogeny of drug metabolising enzymes and transporters. Furthermore, 2020 FDA Guidance for patients with renal impairment [Gii] considers the use of PBPK modelling for dose adjustment guidance which also links to CAPKR’s translational modelling in this patient cohort.

The implementation of these approaches as part of MIDD to inform new drug labels necessitated building confidence at a level where regulatory bodies could accept PBPK models in lieu of clinical studies. Between 2008-2017, nearly 100 new drug applications containing PBPK analyses were submitted to the FDA OCP and the drug label for 70 of the approved cases had statements based on PBPK. The role of CAPKR in industrialising PBPK applications is indicated by testimonials from regulatory agencies [Ai], [Aii] and top leadership within global pharmaceutical companies [Bi-v], e.g. Head of Quantitative Pharmacology & Pharmacometrics and Vice President, Merck:

"CAPKR has an outstanding research record and pioneered innovative scientific approaches that have greatly impacted the methodologies for scientific approaches and review recommendations”. [Bii].

CAPKR research had a ‘direct’ impact on adoption of new regulatory practices and development of official guidance documents dealing with PBPK models [Hi], [Hii], indicated by the testimonial from the Pharmacokinetic Group Lead of the MHRA:

“… they (CAPKR) have been influential in leading the outcomes (bottom-up and top-down modelling) which all ultimately contribute to some policy changes and regulatory guidance”. [Aii].

Context

Venous leg ulcers are the most common type of complex wound: they are painful and unpleasant for those affected and incur high costs for the NHS. Venous ulcers can be treated with compression applied to the leg by bandages or stockings, but there are many compression options since these medical devices come to market rapidly, generally without evidence of clinical and cost-effectiveness. Within this context our research has provided high certainty evidence to support decision-making by all stakeholders.

Pathways to impact

1. 1. Our work has been cited in international guidelines and recommended evidence practice documents including:

2. Systematic review of compression [1] — (i) Management of Chronic Venous Disease Clinical: Practice Guidelines of the European Society for Vascular Surgery (2015). (ii) Management of patients with venous leg ulcers. Wounds Australia and the European Wound Care Association (2016). (iii) Public Health England. Venous leg ulcers: Infection diagnosis and microbiological investigation. Quick reference guide for primary care: For consultation and local adaptation (2016) and (iv) National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summaries (2019)*.

3. VenUS IV [3,4] — (i) NICE Clinical Knowledge Summary (2019)* Wounds UK. Best Practice Statement: Holistic Management of Venous Leg Ulceration. London (2016) and (ii) NHS England Rightcare Scenario: Betty’s story (2017).

4. *The main UK Guideline for venous leg ulcers has not been updated since 2010: discussions are underway with NICE. In the interim and in recognition of key evidence that required recognition this Clinical Knowledge Summary was rapidly updated in 2019.

5. We have undertaken extensive local knowledge mobilisation and implementation work via the NIHR CLAHRC-GM Leg Ulcer Quality Improvement (ILUMIN) Programme, considered a pathway to impact here. This was an evidence-based improvement strategy to enhance delivery of evidence-based quality standards for leg ulcer management which included: use of the highest level of compression therapy possible where clinically appropriate and use of high compression 2-layer stocking kits, where clinically appropriate.

Reach and significance of the impact

**Influencing and sustaining the use of effective modes of compression for venous leg ulceration . There are many compression options for leg ulcer treatment. Our systematic review, which is the main evidence internationally for compression, has been pivotal in promoting compression therapy as the only venous leg ulcer-focused medical device proven to reduce time to ulcer healing. By evidencing the need for compression and by identifying multilayer compression with an elastic layer as the most effective bandage option, our research increased and contributed to promoting and sustaining high levels of optimal compression prescribing in the UK and internationally.

We demonstrate our impact in England using routine NHS community prescribing data (England). In 1998, about 200,000 packs of multi-component elastic-containing bandages were used to treat venous leg ulcers; this increased to approximately 800,000 packs in 2014 [A].

Further support of our positive impact on compression use comes from the Regional Chief Nurse North (NHS England & NHS Improvement) who has formally acknowledged the importance of the research cited in this case study in ‘ promoting and sustaining high levels of optimal compression prescribing in the UK’ [B]. This point is also acknowledged by the Director of the National Wound Care Strategy Programme: our Cochrane review [1] informs the National Wound Care Strategy Programme’s approach for venous leg ulcers and impacted on the decision to include a compression-related indicator in the planned 2020/21 NHS Commissioning for Quality and Innovation (CQUIN) on assessment, diagnosis and treatment of lower leg wounds and forms the evidence base for that indicator [C].

The compression review [1] has also had impact internationally. For example, the review has been “… pivotal in sustaining the promotion of compression therapy to patients and staff in the 4VLU Collaboration in New Zealand, a combined academic and clinical research group. The six clinical centres in the 4VLU Collaboration are located in the major cities across the country (Auckland, South Auckland, Hamilton, [covering the Waikato region], Wellington, Christchurch, Dunedin [covering Otago and Southland regions) and together provide services to 55% of the New Zealand population” [D].

Whilst our work led to the promotion of compression bandages internationally, it also highlighted where there was further potential to evaluate non-bandage compression products which had the potential to be valuable (less reliant on operator skill, less bulky).

**Increasing use of 2-layer compression stockings. In 2013, before publication of VenUS IV findings, there were 25,237 complete 2-layer stocking kits prescribed in England in the community: that figure had been stable for 8 years (Figure 1). Following publication of VenUS IV there was a year-on-year increase in prescribing of 2-layer stockings. In 2018, 46,521 full kits were prescribed: an increase of 21,284 kits from 2013 (an 84% increase; Figure 1).

Figure 1: Quantity of 2-layer compression stocking kits (stocking and liners together) prescribed annually in England Community NHS Services [A].

As each person receives an average of two kits annually, we can estimate that approximately 23,260 people received 2-layer compression stockings in 2018. With a mean annual cost-saving of hosiery (estimated from VenUS IV) of GBP302 per person compared with standard compression this equates to a mean saving for the NHS of approximately GBP7,000,000 in 2018. We are confident in attributing this increase to VenUS IV and subsequent knowledge mobilisation: there was no other significant research or quality improvement activity in the area at the time in the UK or internationally.

Increased used of 2-layer compression stockings is further evidenced by the results of a recent survey of 139 registered nurses in the UK who regularly treat people with venous leg ulcers. Data showed that 2-layer compression stockings are the third most frequently used type of compression, used by most respondents [E]. Whilst similar pre-2014 data are not available we know from working with over 30 trial sites during VenUS IV that 2-layer compression stockings were used infrequently (in total 6.8% of participants were receiving this at baseline) and in many NHS Trusts were not listed in their wound treatment formulary.

**Measurement of increased use of 2-layer compression stockings in local areas. From our local NIHR-CLAHRC-GM ILUMIN implementation work, we have local data demonstrating further impact in terms of increased use of 2-layer compression stockings for venous ulcer treatment. At the start of ILUMIN in East Lancashire in November 2017, 2-layer compression stockings were worn by 8% of people with a venous leg ulcer, compared with 25% on completion of this work in October 2018 [F].

Local data from NHS Wakefield Clinical Commissioning Group show 100 2-layer compression stocking kits used in year 2013/14, increasing to more than 450 stocking kits in 2018/19 (only 8 months of data available for this last year). Activity by local clinical teams that supported this increase was driven by the findings of VenUS IV [G, H].

Context

Fluoride has been used for several decades to prevent tooth decay through a variety of different methods including toothpaste, water, milk, mouthrinses, tooth gels and varnish. Despite being a largely preventable disease, dental caries remains widespread, affecting billions of people worldwide. It is one of the most common reasons for hospital admissions in children. Within this context, our research provides clear evidence that is directly informing national and international healthcare policy on the most effective methods of delivering fluoride.

Pathways to impact

Our synthesised evidence produced by Cochrane Oral Health has had a positive impact through both health professional and patient facing materials. The research played a significant role in ensuring appropriate knowledge transfer from primary studies through to clinical guidelines and policy.

Reach and significance of the impact

Optimising patient care through clinical recommendations

Our systematic reviews and their findings have been cited in national and international guidelines by developers, including:

• Public Health England (Delivering Better Oral Health) [A].

• Scottish Dental Clinical Effectiveness Programme (Prevention and Management of Dental Caries in Children) [B].

• American Dental Association (Topical fluoride for caries prevention) [C].

• American Academy of Pediatric Dentistry (Guideline on fluoride therapy) [D].

• National Health and Medical Research Council (NHMRC), Australia (Water fluoridation) [E].

• Royal Australian College of General Practitioners (Guidelines for preventive activities in general practice) [F].

Guidelines and their recommendations, underpinned by our research, have had and continue to have direct impact on patient care. For example, our research underpinned many of the recommendations of Public Health England’s ‘Delivering Better Oral Health (DBOH): an Evidence-Based Toolkit for Prevention’ (2014, updated 2017), including recommendations around what age to start toothbrushing, how often to brush, the fluoride concentration in toothpaste, the role of fluoride varnish and the role of fluoride mouthrinses. DBOH is given to every General Dental Practitioner in England and Wales and as such influences clinical practice in primary care. DBOH is also informing revisions to the dental contract.

NHMRC, Australia, has utilised our review on water fluoridation to develop advice for the Australian community, health professionals and government [E]. It acknowledged the review to be the highest quality evidence synthesis included in their technical report.

Influencing industry

Following the recommendations on toothpaste fluoride concentrations within DBOH, many major manufacturers have increased the concentration of fluoride in children's toothpastes from 550 ppm or less to 1,000 ppm fluoride or more [G]. By 2014, only four types of children's toothpaste could be found that contained low levels of fluoride and none that were fluoride free, reducing access to fluoride toothpastes with sub-optimal fluoride concentrations. Industry stakeholder involvement in the ongoing update of DBOH has confirmed the influence the publication continues to have on product manufacturing [H].

Informing political debate

Our research has informed and continues to inform debate regarding the possible (re) introduction of community water fluoridation in the UK. We were consulted to prepare a parliamentary debate (Lord Baldwin, 2015), and were asked to speak at a closed meeting to inform Irish parliamentary decision making (2015).

In 2015, Cochrane Oral Health were asked by the UK Department of Health to provide information about the review and its implications in two UK Parliamentary Questions:

• why systematic scientific reviews, such as Cochrane reviews, adopt ‘specific and relatively narrow criteria’ (HL395).

• what plans the government had to commission further studies that might meet the criteria of the 2015 Cochrane review Water fluoridation for the prevention of dental caries, in the light of findings that “the applicability of the results to current lifestyles is unclear because the majority of the studies were conducted before fluoride toothpastes and the other preventative measures were widely used” (HL396).

Our review on water fluoridation has also been directly cited by decision makers in local authorities (e.g. Hull [I]). Discussions are ongoing.

Informing national programmes to improve the oral health of children

In the Eradicating Child Poverty in Wales strategy (2006), the Welsh Government set a target to address oral health inequalities in children by 2020. Their ‘Designed to Smile Programme’ (based on the Scottish initiative, ChildSmile) has been key to reaching this target. Designed to Smile explicitly cite our research on fluoride concentration in toothpastes [4] to inform their daily toothbrushing schemes [Ji].  In 2018/2019 alone, 1,398 primary schools and nurseries participated in daily toothbrushing schemes, with appropriate fluoride toothpaste [Jii]. Over the past 10 years Designed to Smile has helped achieve a 10% reduction in tooth decay in five-year-old Welsh children, with a 35% (>3,200) reduction in the number of children undergoing dental procedures under general anaesthesia.

Context

It is recognised that good oral health is important in supporting general health. Our research focused on the care of medically compromised patients.

Before our research there was an absence of robust synthesised evidence of large, complex bodies of evidence. Existing reviews were of low quality and/or restricted to particular subsets of interventions or cancer types, resulting in sub-optimal recommendations being promoted.

Pathways to impact

Our research focused on providing robust evaluations of the comparative effectiveness of different measures to promote health via oral hygiene. These findings are included in multiple national and international clinical guidelines informing recommendations that are key to the planning and provision of oral health care world-wide.

Reach and significance of the impact

Prevention and treatment of oral conditions in patients receiving treatment for cancer

Our research has been used to inform several major guidelines, underpinning recommendations, reducing the advocation of ineffective interventions (e.g. nystatin and chlorhexidine) and improving health outcomes in medically compromised patients. The impact of our research is illustrated by the number, scope and reputation of the guidelines our work has informed. For example:

• UK NICE Clinical Knowledge Summary Palliative Care makes recommendations for those receiving chemotherapy and radiotherapy based entirely on our research findings (2018) [A].

• Mucositis Prevention Guideline Development Group makes international recommendations for the prevention of oral and oropharyngeal mucositis in children receiving treatment for cancer (2015) [B].

• Association of the Scientific Medical Societies in Germany presents guidelines for supportive therapy for oncological patients (2016) [C].

Alongside the clinical implications of preventing oral complications of cancer treatment, there are also significant financial implications associated with mouth care management. One recent publication found that the incremental cost of manging oral mucositis was approximately USD5,000 to USD30,000 among patients receiving radiation therapy and USD3,700 per cycle among patients receiving chemotherapy (Elting LS, Chang YC. Costs of Oral Complications of Cancer Therapies: Estimates and a Blueprint for Future Study. J Natl Cancer Inst Monogr. 2019 Aug 1;2019(53):lgz010. doi: 10.1093/jncimonographs/lgz010).

Our research is being used to directly inform patients about aspects of their clinical care including: Lymphoma action [Di] and Oncolink patient information on side-effects of treatment [Dii].

Prevention of VAP in critically ill patients receiving mechanical ventilation

Again, our research underpins international Guidelines, including:

• Valvular Disease Working Group of the French Society of Cardiology, Society of Oral Surgery, Society of Periodontology and Oral Implantology, Society of Endodontics and Society of Infectious Pathology provide recommendations on management of oral status in patients with valvular disease (2017) [E].

• Korean Nursing Practice Guidelines for Oral Care provide national evidence-based guidelines for clinical nursing care settings (2020) [F].

Further integration of our research has been supported by NHS Improvement Saving Lives guidance, supporting healthcare providers to reduce healthcare-associated infections and variation in care (2017) [G]. Our review is the single systematic review source supporting oral hygiene measures as a high impact intervention in the reduction of VAP. Inclusion of oral care as one of six core elements of the care process enhances the impact of evidence in this area. Quality improvement studies showed that implementing a VAP care bundle, with an evidence-based oral hygiene component, resulted in a significant, sustained improvement in resident oral health (2018) [H]. It also significantly reduced the incidence rate of VAP (a reduction of 21% in days intubated), duration of invasive ventilation (12.8 to 12.4 days), ICU length of stay (3 days) and mortality rate (8%) (2019) [I].

There has been further impact on practice through the integration of evidence into practitioner educational material. NHS Health Education England have developed teaching aids that seek to address shortcomings in oral care often observed in hospital and community care. Our research provides the evidence-base for oral care measures for ventilated patients. Subsequently, a Mouthcare Matters MOOC has used our research to inform their training. The author states: “ Alongside clinical expertise, evidence from the Cochrane reviews has been key to informing the development of MCM educational materials for reducing the incidence of ventilator-associated pneumonia and for preventing and treating mucositis in people being treated for cancer.” [J].

Context

Although unequal access to health/social care provision, poor health outcomes and the lack of linguistically and culturally appropriate service provision for Deaf signers were already recognised, the development of evidence-based interventions was hampered by the lack of appropriate clinical research tools, minimal involvement of cultural insiders in research design and service execution, and little data on effectiveness of BSL-specific service provisions. Our work has impacted all of these areas of development.

Pathways to impact - capacity building

Barriers in access to education at all ages through BSL means there is not a readily available Deaf signing academic workforce who are skilled to lead health and social care research within and about their own cultural community. Over 10 years we have built a critical mass of pre- and post- doctoral Deaf (and hearing) signers with specialist cultural-linguistic (BSL) research skills specifically in applied health and social care research which increase the salience and impact of current research and builds future capacity. Awards to SORD’s Deaf academics who are BSL users include 3 MRes (ESRC/NIHR); 3 PhD (NIHR and Alzheimer’s Society), 2 post-doctoral fellowships (NIHR and Alzheimer’s Society) and currently 2 PhDs (ESRC and NIHR) as well as a further 1 MRes (NIHR), 1 MPhil (NIHR), 2 PhDs (ESRC/AHRC) and 3 current PhDs (ESRC and International award) to hearing signers. In 2016 SORD group lead Young won the Times Higher Outstanding Postgraduate Research Supervisor of the Year award for her specific supervisory practice in promoting the achievements of deaf and hearing academics in this specialist field. “ *Appointed a fellow of the Academy of Social Sciences in 2015, Professor Young has been described as a ‘one-off’ whose supervisions, support and research have had a global impact, making her a worthy winner of Times Higher Education’s very first award for Outstanding Research Supervisor of the Year.*” [A].

Reach and significance of the impact

(i) Impact on clinical practice

IAPT is the Department of Health’s frontline clinical service treating depression/anxiety and serves 1,000,000 people annually. Linguistically and culturally valid standardised self-assessments used within this service are now available for the first time in BSL for use by either Deaf or hearing practitioners delivered in an online format. National IAPT does not collect national data on the language used in assessment/therapy, only the outcome scores. However, SignHealth, who deliver specialist BSL IAPT and use the BSL IAPT tools we developed and validated, report between 01 January 2011 and 31 December 2019 there were 1,518 Deaf clients who attended where the tools would have been used as per service protocol within a total number of 12,888 sessions within the same period [B]. Additionally, Mayden who administer the online data collection system for IAPT confirm that an additional five NHS service providers have used the BSL versions and recorded data from them into the national database [C]. The EQ5D5L BSL is the first signed language version anywhere in the world to be admitted to the Euroqol Group suite of instruments (the Euroqol Group is an international foundation established to improve decisions about health and health care worldwide by developing, promoting and supporting the use of instruments with the widest possible applicability for the measurement and valuation of health) for assessment of health-related quality of life in clinical practice and is described by the Executive Director of Euroqol as “ a real step forward in health evaluation studies for this minority Deaf population.” [D].

(ii) Impact on health policy and practice guidelines

SORD’s evidence of the cost effectiveness of direct IAPT provision through Deaf signing therapists is directly cited within the Royal College of Psychiatry’s clinical commissioning guidelines in primary mental health care for deaf people [E]. This is significant because Clinical Commissioning Groups [CCGs] were hitherto reluctant to fund such a specialist therapy assuming that standard therapy with an interpreter was better value for money which had constrained Deaf signers’ choices of preferred treatment. We co-wrote the NHS England commissioning guidelines on interpreting and translation in primary care which incorporated in full the 8 quality practice principles we wrote, derived directly from our data analysis. The guidelines, published in September 2018, were distributed directly to all 195 CCGs in England at the time and have been downloaded over 150 times per month up to January 2020 [F, G].

(iii) Impact on inclusion of Deaf signers’ needs in social care practice innovations

Innovations in dementia care on an international basis have overlooked deaf signers’ specific requirements because they are different from those of older people who have acquired hearing loss. Policy and practice addressing the needs of cultural-linguistic minorities with dementia also usually overlook them, seeing them instead as disabled people. The impact and challenge of our work in spotlighting this neglected group and inspiring new and innovative care practices in many countries has been recognised by the Executive Director of Alzheimer’s Europe: “ I was happy to provide these dissemination opportunities to the work carried out by the Social Research with Deaf People Group, as I found their work to have the potential to be truly transformative for a minority population often forgotten or excluded in research and policy developments in the field of dementia” [H]. Third sector organisations in the UK have used our research evidence to lever social care practice development funds for new bespoke services for deaf BSL users living with dementia, for example the BDA (British Deaf Association) in Scotland “ We greatly value the many years of work that SORD has carried out to make the unique needs of this population (Deaf BSL users with dementia and their care partners) more visible. Their approach to seeking solutions for Deaf people from Deaf people’s experience and in BSL has been particularly helpful and matches with our own philosophy” [I]. SORD is relied upon in the Deaf community to provide evidence-based advice and support for Deaf people living with dementia in the community, as demonstrated through a live-streamed broadcast in BSL “Coronavirus: Supporting elderly and vulnerable people” given on 22 April 2020 during the coronavirus crisis that reached 8,064 people. There were 2,070 engagements and subsequently 1,100 further views since it was uploaded to the broadcaster website [J].

Context

Asthma is a life-threatening disease requiring drug-delivery into the lungs via devices known as inhalers. Younger children can find taking the inhaler difficult and so it is often attached to one end of a cylindrical chamber, or spacer, and then pressed to release the drug into this spacer. A mask on the other end of the spacer allows the child to breathe in the drug more easily from the chamber through several breaths. However, this technique is associated with poor adherence and reduced drug delivery to the lungs. Treatments are missed or given with poor technique, which is exacerbated by children being distressed. Poor adherence with spacers in children is a major health and socio-economic problem, with an estimated 14% of all children globally experiencing symptoms, and levels of adherence to treatment reported to be as low as 28%.

Pathway to impact – new technology

The Rafi-tone system, developed in 2016, uses a mask designed to produce a specific whistle which provides an auditory cue when breathing is correct. Software provides entertaining visual encouragement to a child when this is heard (Figure 1) and logs correct treatment in a digital calendar. The mask whistle improves carer and children’s confidence that the drug has been inhaled, and the additional app is used by educators to train carers and children in whistle spacer use, especially if there are known compliance issues.

Figure 1. Illustration of the mask, spacer and inhaler, with mask whistle activating the Rafi-tone games.

Aslam’s research is novel in providing an accessible system, combining animation type games to motivate treatment compliance and providing reassurance to parents/ carers that optimum treatment has been given.

Reach and significance of the impact

Clinical impact on asthmatic children worldwide

The mask and associated app make inhaler use more fun, transforming perceptions and improving adherence and breathing technique in children.

An independent, international randomised controlled trial of 371 children was conducted, comparing app use with standard verbal instructions [A]. The trial found that lung functions of children using the app were significantly (p<0.001) improved. The percentage of patients improved according to an asthma control test was higher in the app group compared to the verbal instruction group. Compliance also improved subjectively and objectively.

An independent post-marketing survey of 6-10 weeks’ use of the mask and app was conducted on 112 asthmatics (aged 1-11) and their parents. Survey results showed that use of doctor/hospital services reduced from 16/6 at baseline to 4/1 respectively at follow-up [B]. All of the 10 independent healthcare practitioners surveyed stated that their patients were better controlled using the Rafi-tone system [B]. This evidence implies significant benefit to children who have used the system. There have been over 112,000 international mask sales since its inception in 2016. App use is steadily rising, with over 4,000 maintained downloads, currently 250 per month (as at July 2020). The mask and app are available in the UK, France, Norway, Sweden and Australia.

A GP practice pharmacist stated that she “ had the most amazing experience” with the Rafi-tone system and that this technology was a “ game changer” for her practice and patients [C]. Other quotes from health carers have included “ Great idea. Easy to use and good distraction for children—makes inhaler delivery so much easier” [D]. Example quotes from parents have included “ Good distraction and improved technique. New to inhalers so made him less scared”; ‘‘Yes, it has definitely helped in breathing technique. T was previously taking shallow breaths but with the game managed to focus on deeper breaths and concentrated on playing the game.’’; “… helps to direct the child’s attention and focus on breathing. Enjoyable activity. No bad points - a really good idea. A good way to introduce inhalers” [D].

Economic impact of Clin-e-cal, a new technology company

Clin-e-cal, an innovative digital health company, arose entirely from the research for Rafi-tone. Founded by Aslam through a partnership with doctors, researchers and hospital teams, it has been established now for six years [E]. Clin-e-cal’s collaboration with Clement Clarke International directly led to the whistle that activates the Rafi-tone app. The app successfully qualified for the prestigious NHS apps store [F]. The mask is produced by Clement Clarke and is available via prescription [G], meaning that it is readily available.

Clin-e-cal has two full-time members of staff, a board of six members and robust and increasing income streams of approximately currently GBP20,000 per month. The company has attracted GBP250,000 external venture capital funding, allowing expansion and diversification.

In summary, research studies, testimonials and sales indicate that the easily accessible Rafi-tone technology has transformed clinical care for tens of thousands of children internationally, improving adherence and addressing the serious morbidity associated with asthma and viral induced wheeze.

Context

When this project was conceived there were significant concerns about NHS oral surgery referrals [A]. The 2006 England and Wales NHS dental contract significantly increased referrals, as practices were paid the same fee to refer a patient or undertake the procedure themselves. Costs spiralled, as hospital care was expensive with few alternative options for NHS commissioners. Quality was also a concern due to inappropriate referrals, tortuous referral pathways, long waits and lack of care close to home. A web-based referral system was developed collaboratively between UoM and local NHS staff in Manchester but there was uncertainty about remote triage, the quality of Tier 2 services and the cost-effectiveness of a managed referral system. At that time NHS dental commissioners had no experience in such systems and little activity in this area until this research was conducted.

Pathways to impact

Impact was managed though collaboration with NHS decision-makers in an agreed implementation strategy. The sequential implementation of the system as a ‘live’ NHS service meant that impact would be both measurable and cumulative during the project. When the research was completed and prior to publication, the system in Sefton was retained and rapidly expanded across the North West through local commissioning networks [B]. Sefton provided a live, rigorously evaluated working implementation model, which attracted interest from NHS dental commissioners leading the rapid adoption across England [B], [C], [D].

Reach and significance of the impact

Although only completed in 2017 the research has had a rapid and transformative impact on management of care pathways in NHS dentistry. After the North West, the system was rolled out across the Midlands, Thames Valley, Kent, Surrey and Sussex, East Midlands [C], and most recently across the whole of Wales [D]. The recommendations from our work have been embedded within the service specifications used in tenders for new referral management and Tier 2 contracts. Here we use data made available by FDS Consultants, a consortium of dental and medical NHS consultants based in the North West of England and one of two companies providing referral management services based on the research model. Table 1 summarises the rapid growth in use, and the geographical spread of the oral surgery system across England. The average cost of an acute trust minor oral surgery referral in the North West region is approximately GBP650; our research showed a GBP108 saving for a referral to a Tier 2 service and this price difference has been used to estimate cost savings. These savings are primarily used to expand Tier 2 capacity for specialist dental care. An appraisal of the implementation of a managed oral surgery referral service in a Strategic Transformation Plan in the Midlands demonstrated cost savings of GBP 4,192,444 in one year [C].

The figures presented are an underestimate of the full impact of the research as they are solely for oral surgery, only apply to England and only apply to one referral provider. The other main provider has a similar coverage to FDS and hence, if extrapolated, a doubling of the numbers would be appropriate. Concerns about providing cost savings at the expense of a reduction in quality were dispelled by our research and reinforced by findings from on-going evaluations. In 2018/19 94% of patients treated reported their problem was resolved and 99.7% assessed the service providing their care as good or better [B], [D]. This is supported by the experience in Wales where the new referral service, embedding our research findings, has been reported as having “ a significant impact in improving the quality, content and validity of referrals to dental specialties” [D]. It is also reported to have, importantly, improved access to specialist services and patient experience for the population of Wales.

Adaptation and expansion

Referral management systems have now expanded to orthodontics (another high referral speciality), starting in NHS Cheshire and Mersey which from 2017-2020 has seen a growth of 3,500 referrals to Tier 2 services whilst keeping secondary care referrals at the same level [B]. Oral Medicine is now included with the inclusion of clinical photographs in the online system [E]. Most recently the referral systems across England were able to rapidly adapt to the COVID19 crisis by triage and directing patients in pain to Urgent Dental Care centres. Over 34,000 patient episodes of care were delivered via this route between March and August 2020 [B]. The referral system was adapted to support thousands of urgent optometry referrals via COVID19 Urgent Eyecare Services [4]. This demonstrates the far-reaching impact of the work beyond dentistry and the possibility of using the system to support other referral pathways in the future.

Overall for all dental specialties across England and Wales, approximately 10,000 referrals per day are now processed from general dental practices with 70% of referrals diverted to primary care-based Tier 2 services, producing estimated savings for the NHS of over GBP210,000,000 per year.