Impact case study database

(E= evidence source, lower case letter = section 3 grant)

Global feedback [evidence E1]

RLOs produced using ASPIRE methodology have been created by the University of Nottingham team and their collaborators for use by the target group of users. However, they have also been released for non-commercial reuse with a Creative Commons licence so they can be freely accessed by anyone. Our multiple award-winning open repository ‘HelmOpen’ houses over 200 RLOs [E1.1 and E1.2]. The expertise and insights from stakeholders harnessed within each RLO is accessible to all. Users can choose to return an online evaluation form for each RLO (estimates from comparison with server logs suggest on average 1-2% of users return evaluations) enabling us to gather data about use, reach and significance. Google analytics allow us to identify trends in usage over time and density of use in different countries indicating approximately 5,000,000 users of the RLOs [E1.3].

Based on data from 49,030 feedback forms (35,813 completed since 2014) [E1.4], we know that global usage of HelmOpen RLOs has increased from 50 to 140 countries (a threefold increase since 2014) [E1.5]. An independent report published in 2018 showed that users came from a range of institutions including universities, health care settings and schools as well as the general public. 97% of survey respondents rated the RLO they accessed as ‘very helpful or helpful’ when learning their subject, with little variation by user type or country of origin. 96% of respondents would recommend the RLO to others [E1.6 pp 3, 5, 11].

A wealth of feedback has evidenced the role of RLOs in enhancing knowledge and behaviours in patients/carers and health/education professionals. Here are three examples:

Patient education and self-management – C2Hear [evidence E2]

The C2Hear RLOs were distributed first on Youtube and in 2019, on a dedicated C2HearOnline website [E2.1]. C2Hear has obtained national and international reach for clinical and research impact, with over 104,000 online views (average >7,000/month) with a spike in use during the Covid pandemic [E2.2] when clinics were closed. C2Hear RLOs have received accolades from patients, family members and audiologists [E2.3]. A hearing aid user said “ If I did not have C2Hear I might have given up wearing my hearing aids”, and a family member remarked “ C2Hear helped us at a time when getting help from an audiologist would have been very difficult”. In a follow up project called m2Hear, a more individualised service is provided to patients with hearing aids through their tablet or mobile phone [E2.4].

In a survey of UK audiologists in 2019 (n=52) 90% believed that C2Hear helps patients to troubleshoot basic repairs independently; 90% said that C2Hear helps family members become involved in learning about hearing aid care; and 64% said they had created educational materials for first-time hearing aid users within their local department, of which 27% had been inspired to do so after watching C2Hear. 42% (22/52) of audiologists surveyed had made C2Hear materials available to patients in their clinic [E2.5].

Healthcare and professionals training [evidence E3 and E4]

Pre-term birth RLOs (PRISM) - since released in May 2019, the PRISM RLOs have been accessed by over 13,800 people from 54 countries. Approximately two thirds are educational professionals, 20% parents and 13% are health professionals [E3.1]. Evidencing the value of our ASPIRE methodology the RLOs have not only benefited the target group, teachers, but also other groups who contributed to the co-design process. The multi-stakeholder input in ASPIRE allows hard to reach voices to influence the RLO content and design as shown in their use of the RLOs and the benefits they gain from them. A parent said, *“I've felt FOREVER that I wanted a resource like this for the teachers of my Former Micro Preemie Daughter (born at 26 weeks with a 126 day NICU stay). Thank you so much!!!*”. (Parent from the US, May 2019) [E3.3]

6 months after use [E3.2, p232], 84% (95% CI 73 to 96) of teachers still felt adequately equipped and confident to support the learning of children born preterm. 2 primary school teachers comment on how they are making real changes to support children in the classroom: “ I am more aware of the issues a child born prematurely could have. If a child is struggling with certain areas of maths I now always think if the child could have been born premature.” and “ My enhanced knowledge of preterm birth has encouraged me to give more time to explaining, instructing and supporting these children.”

Dementia RLOs - healthcare professionals caring for those with dementia are using a suite of our RLOs as outputs of research funded by the NIHR. This research developed and evaluated a specialist medical and mental health unit (MMHU) which provided care to cognitively impaired older patients admitted to the acute hospital as a medical emergency. The RLOs, developed in 2014, use excerpts from the award-winning documentary Today is Monday , which illustrates the evidence-based care provided by the MMHU [E4.1]. Between June 2015 and November 2020, the feedback [E4.2-E4.4] from the RLOs has been:

User’s commented on what they liked about the RLOs: ‘ It was clear and precise’ and ‘ compassionate and easy to understand’. The value of these RLOs is demonstrated in the user comments which suggest that at least one NHS Hospital Trust has adopted them within their training.

Capacity Building in the use of the ASPIRE methodology [Evidence E5]

The team’s capacity building projects are transforming the delivery of digital education and healthcare training and practice in Europe and in low and middle income countries. Our MOOC on RLOs and ASPIRE was delivered in 2016, 2017 and 2018 attracting a total of over 13,000 participants globally [E5.1]. Participants said “ Picked up approaches which will influence my future practice” and “ in top 5 of all courses I have taken (whether online or in person)”. For some, participating in the MOOC influenced their own health behaviour, “ I myself have hearing loss and I'm supposed to wear a hearing aid, however, as mentioned in the video ... after using the RLOs I might go back to using it.” [E5.1].

Following the MOOC, other countries have adopted the ASPIRE methodology to develop RLOs across the globe. This demonstrates a shift from global usage of the RLOs themselves, to requesting training on the methodology and skills to create them. For example, there are growing numbers of ASPIRE-trained academics and technologists in Malaysia; the Deputy Dean (Research) and Professor of Primary Care Medicine University of Malaya says “ As a result of this collaboration, the Faculty of Medicine has set up an e-learning unit which comprises academicians, instructional designer and technical team, most of whom have undergone training by Professor Wharrad and her team at the University of Nottingham. RLOs have been developed across six disciplines namely, geriatric medicine, primary care, nursing, paediatrics, nutrition and library science, all of which have champions who have been trained by the ACoRD members. Currently, the RLOs are being used by the medical and nursing students as part of their curricula” [E5.2](e).

The health and wealth of the nation has been improved by enabling community pharmacy to reduce non-adherence to medicines. The initial time-limited pilot of NMS between 2011 and 2013 was evaluated by University of Nottingham researchers, the results of which were instrumental to the adoption and funding of the service from 2014 to the present day [A]. This has allowed for the substantial expansion of NMS across England resulting in significant impacts, highlighted below:

Policy Impact

The formal academic evaluation of NMS commissioned by the DH was done so with the explicit reason to inform decisions on the longer-term future of the service following the initial pilot. In August 2014, the Chief Executive of the Pharmaceutical Services Negotiating Committee (PSNC) stated that they “ will be using the outcomes of the pilot *to inform our ongoing negotiations with NHS employers (who are acting on behalf of NHS England)*”. On 22^nd September 2014, the PSNC announced the finalised Pharmacy Contractual Framework for 2014/15, “ Following the positive outcome of the DH commissioned evaluation of the New Medicine Service, this will continue as an Advanced Service.” [B]

The expertise of Elliott, Boyd and the wider research team to conduct a high-quality evaluation of the NMS was pivotal for the inclusion of the NMS in the DH budget in 2014/15, without which, the health and economic impacts detailed below would not have been realised.

Impact on Health

Over 5,348,000 NMS consultations have been delivered between September 2014 and September 2020 to patients starting new medicines in the four target groups (Table 1). Each consultation for a newly prescribed medicine increases the likelihood of the patient adhering to the medicine by 10%, compared to those not receiving the service, leading to long-term health gain (R1). This is equivalent to an estimated 213,952 Quality Adjusted Life Years (QALY’s) saved since September 2014 [0.04 QALY per consultation R4, D].

The NMS review is recognized as an important opportunity to health promotion. For example, the NICE Guidance NG103 highlights where “ People visit community pharmacies for … a New Medicine Service” to “ Use every opportunity throughout the flu vaccination season to identify people in eligible groups and offer them the flu vaccination.” [C]

Economic impact

Implementation of the NMS has saved the NHS an estimated GBP558,201,000 in costs since September 2014 [GPB104.36 per consultation R4, D, E].

Table 1 Data on the provision and delivery of the New Medicine Service in England [C, R6]

*Based on total number (11,539) of contracted pharmacies in 18/19 period

Impact on Pharmacy

NMS participation from pharmacies and patients has increased since September 2014 (Table 1) with 87% of community pharmacies delivering NMS in 2019/2020. Pharmacists are remunerated for delivery of the intervention, which has generated GBP131,580,500 of income for community pharmacy since September 2014 [D, E].

Since the publication of the evaluation, NMS has become embedded within community pharmacy services: In 2016 NMS delivery became a requirement to achieve ‘Healthy Living Pharmacy’ status - a highly successful scheme to promote public health and wellbeing campaigns through community pharmacy services; in 2017 NMS was announced as one of four gateway criteria for the Pharmacy Quality Payments Scheme; from 2015 NMS episodes are recorded on the medicines optimisation dashboard, as part of the Pharmaceutical Price Regulation Scheme (PPRS)/Medicines Optimisation Programme [F].

Medicines Optimisation and Safety is a key priority in the landmark five-year Community Pharmacy Contractual Framework published in July 2019, and the NMS is highlighted as a key service with expansions into further therapeutic areas to be discussed and agreed in 2021/22 [G]. NMS delivery will continue to be a key gateway criterion for the Pharmacy Quality Scheme highlighting how intrinsically embedded NMS has become within Pharmacy. In September 2020, NMS was outlined as one of seven service requirements for delivery of Structured Medication Reviews (SMR) by Primary Care Networks as part of the Network Contract Directed Enhanced Service [H].

International impact

This study has been replicated internationally and directly influenced NMS pilot projects and subsequent integration into healthcare systems in Norway and Australia. Detailed below are two such cases:

Australia: UoN researchers advised the Evaluation Officer at the National Prescribing Service (NPS) Medicinewise, Australia between January and December 2016 on the NMS evaluation, specifically sharing study patient questionnaires and advising on optimal data collection methods to be applied to a pilot for an equivalent study in Australia [I]. They state on their website “ The New Medicine Support Service is adapted from a successful program widely implemented by the NHS England’ and was cited in a federal budget recommendation in 2017/18.” [J]

Norway: In 2012, pharmacists from the Norwegian pharmacy organisation, Apokus, visited the UK and PSNC to find out more about the NMS service in England and the planned evaluation by University of Nottingham researchers. Email contact between the CEO of Apokus and Boyd and Elliott following the visit facilitated further exchange of expertise [K]. Following a pilot study in 2015, ‘Medisinstart’, influenced by UK NMS [L], was approved in the budget (NOK4,000,000) for patients with cardiovascular disease starting a new medicine. The service was launched in May 2018, and as of the end of 2018 5,000 consultations had been completed [M].

In summary, research from the University of Nottingham has increased patient medicine adherence in chronic illness and led to improved patient health and substantial cost savings.

Research at the University of Nottingham has led to the implementation of new clinical interventions, changes to patient care practices, mitigation of potential harm, and significant improvements in the health outcomes of patients suffering falls across the UK.

Ambulance services

Our research (R1) demonstrated that appropriate referral to the community-based Falls Prevention Service reduced the rate of falls by 55%. This led to the implementation across the East Midlands of the first-of-its-kind clinical pathway - the “Falls Ambulance”, staffed by a paramedic and specialist nurse [A]. The Associate Clinical Director of the East Midlands Ambulance Service NHS Trust stated: “ In direct response to the RCT a falls rapid response team (FRRT) was set up in Nottingham in 2013 […] the service won awards as it was the first of its kind in the UK and a number of other ambulance services followed the Nottingham lead.” [A]. The Kings Fund has included our research as an example of good practice in their 2014 report ‘ Making our health and care systems fit for an ageing population’ [B], which sets out a framework and tools to help local service leaders improve the care they provide for older people. Subsequently, 8 of the other 12 UK Ambulance Trusts have implemented a similar falls referral pathway. The reduction in pressure on over stretched emergency departments is demonstrated with examples of cost savings of GBP197,500 and a decrease of 552 attendances at A&E (a decrease of 75%) seen in East Lancashire alone between April 2016 and March 2017 [A, Royal College of Occupational Therapists report]. Data from our ambulance study has been used nationally to develop a Return on Investment (ROI) resource to help commissioners and communities provide cost-effective falls prevention activities. England’s local authorities and Clinical Commissioning Groups (CCGs) can use results from the tool to protect and improve the health of their local populations when making commissioning decisions [C].

Physical activity

Our free online and downloadable resources for commissioners to use to plan, implement and monitor the Falls Management Exercise (FaME) programme following our PHISICAL study have been downloaded 884 times (between June 2019 and May 2020). NICE endorsement of the Toolkit (October 2019) acknowledges its accurate reflection of the NICE falls guideline and quality standard [D]. Two counties in England have commissioned the programme enabling over 1,500 people access to effective falls prevention intervention [E]. The PrAISED programme led to an innovative exercise class, in the University of Nottingham’s sports centre, for people with dementia and their carers. This exercise class received BBC press coverage [F] and was attended by up to 30 people per week (between September 2017 and March 2020) (R6). This valued activity is currently paused due to COVID-19.

Care Homes

The GtACH intervention used in 87 care homes showed a significant (43%) reduction in falls in the 3-6 month period post randomisation (R8). 80% of staff in a caring role were trained. The research is impacting people’s lives: One care home manager reports “ one gentleman’s falls have reduced, he is much safer to mobilise, he’s gained confidence and that has improved and had an impact on his quality of life.” [G]. Another care home manager states “ our care home continues to use the GtACH screening and assessment tool, as we have seen the benefits in preventing, reducing and managing falls, increasing staff awareness. The tool has enabled us to communicate more effectively with our allied health care professionals and it has become an integral part of our daily practice.” [H]. A lead community research nurse states “ We have seen a positive reaction from care home personnel about the use of the GtACH programme and the falls resources by listening to feedback from care home managers” [H]. This intervention is now being rolled out nationally through a programme designed to empower care home staff to lead its adoption [h].

Free online and downloadable ‘React to Falls’ resources have been co-developed with a production company for care home staff which include a training resource, pocket sized guides, and a smartphone app, available on Android and Apple platforms [J], developed as a direct result of care homes evaluation of the paper resources [I]. The online resource has had 1,799 unique views (between April and August 2019) with approximately 10% completing all five videos in the resource [J]. 770 care homes across the UK have received ‘React to Falls’ resources developed by the UoN, and 173 have so far provided feedback via survey with 96% (161/168) saying that they are likely or very likely to use the resource in their workplace [K].

The impact described in this case study has been recognised through the award of an MBE for services to occupational therapy, to Robertson, who worked across the NHS and the University of Nottingham on this falls research [L].

(R=research reference; E=evidence source)

Research from the University of Nottingham has led to significantly reduced unintentional injuries in the home for children under the age of five. This has been achieved through influencing national (England, Wales and Scotland) and international (Australia, New Zealand and Canada) policy and home safety strategies including local authority provision of home safety equipment; and by informing and training practitioners.

a. Influencing policy in England, Scotland and Wales on provision of home safety equipment (E1-E4)

University of Nottingham research has provided evidence of effectiveness of home safety education and equipment provision in improving home safety and reducing child injuries. This research [R1,R2] has informed the National Institute for Health and Care Excellence (NICE) PH29/30 “Preventing unintentional injuries among under 15s: Strategies (PH29) and Home (PH30)” and the evidence review of this guidance in 2015 [R4] (E1). The Chief Medical Officer in October 2013 cited our research [R3] as evidence of effectiveness and cost-effectiveness of education and safety equipment provision, making a new policy recommendation for implementing home safety recommendations in NICE PH29/30 (E2). This research also informed Public Health England’s (PHE) 2018 local authority guidance “Reducing unintentional injuries in and around the home among children under five years” [R3,R6,R7] (E3). The PHE 2018 guidance uses evidence from the Cochrane review [R3] stating “ Research shows that providing safety education and free or low-cost safety equipment is effective in improving home safety and can reduce inequalities in some home safety practices.” (pg19, E3). Our Cochrane review [R3] also informed NHS Health Scotland’s 2017 “Unintentional injuries and home safety guidance” (E4). Our 2015 survey [R6] shows wide use of these documents by local authorities with 75% using NICE PH29/30 and 57% using the PHE guidance in decision making about child injury prevention work.

b. Influencing national and international (England, Scotland, Wales and Canada) provision of home safety equipment (E5-E7)

National Hospital Episode Statistics show a decrease of 18% in England’s child home injury admission rates between 2013/2014 (NHS year, unable to disaggregate further, n=46,895) and 2019/2020 (n=38,571). Home safety equipment schemes contributed substantially to this reduction, as shown by our independent evaluation of the national scheme which demonstrated a significant reduction in hospital admission rates following the scheme (E5). Home safety equipment schemes are widely implemented, with 43% of local authorities in England and Wales having a scheme in 2015 [R6]. Many schemes cite our research [R3,R4] as underpinning evidence, e.g. the Scottish home safety equipment scheme. The Royal Society for the Prevention of Accidents (RoSPA) confirmed “ research carried out by Nottingham University on home safety education, home safety checks and home safety equipment provided much of the UK evidence on which the Scottish home safety equipment scheme was based.” (E6.1). Between April 2013 and June 2014, 900 families benefitted from the scheme (unable to disaggregate further) (E6.2). A similar scheme in Ontario, Canada, provided equipment to 3,458 families, from April 2013 to March 2015 (unable to disaggregate), resulting in a significant reduction in emergency department attendances for home injuries (p=0.01) (E7). This ongoing programme was explicitly based on our Cochrane systematic review [R3] “interventions providing safety equipment seem to be more effective than those not doing so. Based on these findings we developed a home safety program*” (p533, E7).

c. Informing national (England and Wales) and international (Canada) practitioner guides and developing resources for practitioners (E8-E13)

Our research has informed influential national and international practitioner guides.

i) The Injury Prevention Briefing (IPB) (E8), an output of the Keeping Children Safe programme of research, [R3,R4,R6] is a guide aimed at practitioners who can help families improve home safety. The IPB has been endorsed by NICE https://www.nice.org.uk/guidance/ph29/resources/endorsed-resource-injury-prevention-briefing-2430498925 and linked to NICE guidance PH29/30 (E1).

ii) The Guide for Commissioners of Child Health Services on Preventing Unintentional Injuries Among the Under-Fives (E9) was another output from the Keeping Children Safe programme of research [R3,R4] and informed home safety recommendations in international and national practitioner guides. This has been distributed to upper tier local authorities in England and health boards in Wales in 2016 and by the Child Accident Prevention Trust via targeted mailing to their subscribers.

The IPB and Commissioners guide are extensively cited by PHE’s practitioner guide (2017) (E10). Their usefulness is evidenced by the Child Accident Prevention Trust stating in 2017 “Our links with public health, health visiting and early years services, for example via our advice, in-house training and consultancy, show that all three of the outputs mentioned above [IPB, commissioners guide and PHE practitioners guide] are useful to practitioners and commissioners, enabling them to easily integrate evidence-based approaches into their work. We continue to promote them as key resources to support child injury prevention in the UK.” (E11).

In disadvantaged areas of Nottingham, our research [R3,R4] has informed evidence-based home safety checklists, monthly safety messages and safety weeks for families. Between October 2017 and June 2020, 4,451 families completed checklists, 24,400 home safety messages were distributed, 440 families attended safety week sessions and 950 received home safety visits from family mentors (E12).

Our research informed the Institute of Health Visiting Local Authority Child Public Health Briefing: The Health Visiting contribution to Child Accident Prevention (2016) [R3] (E13.1) and The Canadian Injury Prevention Resource (2015) [R1,R3] (E13.2).

d. Informing national and international injury prevention strategies (E14)

Our research has informed national and international public health strategies, including the 2018 National Accident Prevention Strategy (England) [R3,R6,R7] (E14.1), the 2015 Child Unintentional Deaths and Injuries in New Zealand and Prevention Strategies [R2,R3] (E14.2) and the 2016 New South Wales Child Safety Good Practice Guide: Good investments in unintentional child injury prevention and safety promotion [R1, R2, R3] (E14.3).

e. Training health and social care professionals (E15-E16)

We have developed and delivered child home safety training focussing on use of the IPB for 550 health and social care practitioners and family mentors in four sites in England (Nottingham, Bristol, Newcastle, Norwich) between 2014 and 2016. The 2015 Nottingham evaluation shows 90% of practitioners (health visitors and children centre staff) learnt something new from the session and 87% felt more confident about presenting child injury prevention. Three months later at least 50% had used 9 of the 11 home safety activities and between 100 and 250 families had undertaken each of the 11 activities (E15).

The 2016 Bristol evaluation (p6, E16) showed that practitioners found using the IPB enabled discussions with parents about home safety, e.g. *“nice easily adaptable activities and guidance which get parents to think about dangers through the eyes of a child”’ and “encouraging parents to be aware of child development … promoting parental observation and encouraging them to be one step ahead” and increased practitioner confidence, e.g. “it has filled me with confidence in advising parents and families on how to prevent injury/accidents”.

Researchers at the University of Nottingham have directly increased the safety of patients across England. The pharmacist-led IT-based intervention (PINCER), developed and tested by researchers at Nottingham, reduces clinically important medication errors in primary care, a long-standing global patient safety challenge. The clinical and economic evaluation led to PINCER being selected by the AHSN Network for national adoption and spread ( https://www.ahsnnetwork.com/about-academic-health-science-networks/national-programmes-priorities). PINCER has been included in NICE Guidelines and implemented widely across NHS England.

Clinical impact of PINCER

As of 7 December 2020, 2,688 general practices located within 104 (77%) CCGs had uploaded baseline data to the online comparative analysis service, CHART Online, showing that 25,545,538 patient records had been searched to identify instances of potentially hazardous prescribing using 13 prescribing safety indicators. In total, 206,109 at-risk patients were identified of being at risk of at least one prescribing error at baseline giving an overall prevalence of 8.07 patients at risk of medication error per 1,000 registered patients prior to the PINCER intervention. Analysis of follow-up data from 1,060 practices showed a reduction in the absolute number of at-risk patients identified in at least one prescribing safety indicator of 13,387 patients (from 92,762 to 79,375 patients; -14.4%). Greatest reductions were seen for those indicators associated with GI bleed, which showed a decrease of 10,559 at-risk patients (from 40,720 to 30,161 patients; -25.9%) [A, B].

One of the key strengths of the national rollout of PINCER has been the ability for general practices, pharmacists and named individuals at CCGs to access comparative views of numbers of at-risk patients using an Online comparative analysis service, CHART, including time-trended analyses [B]. Over time, as more and more practices have been participating in the national rollout of PINCER and uploading their summative data, the facility has been providing a national picture of medication safety thus enabling localities to prioritise areas for improvement and evaluate the impact of the PINCER implementation. For example, the Clinical Lead for Medicines Optimization with Wessex AHSN stated “… we successfully deployed PINCER in 236 practices, which is 94% of all of the practices in Wessex. This has given us a robust baseline measure of medication safety but more importantly, when practices implemented the PINCER intervention, we had 3,441 fewer patients at risk from clinically significant medication errors compared to baseline.” [C]

Upskilling the primary care pharmacy workforce

To date, at total of 2,032 individuals (1,505 primary care pharmacists, 153 primary care pharmacy technicians, 176 GPs, 48 practice managers and 150 CCG/other primary care staff) have been trained to deliver the PINCER intervention through a combination of eLearning tools, online resources, live webinars and face-to-face action learning set sessions [D].

Incorporation of PINCER into national Medicines Optimisation policy and guidance

Since 2015, PINCER has been incorporated into the NICE ‘Medicines Optimisation Clinical Guideline’ published 04 March 2015 [E]. This means that general practices throughout the country are encouraged to use the intervention. In 2017, the World Health Organisation identified ‘Medication Without Harm’ as the theme for their third Global Patient Safety Challenge which aims to reduce severe avoidable medication-related harm by 50% globally in the next 5 years. In response to this challenge, the NHS Business Services Authority produced a Medication Safety Dashboard drawing on the PINCER indicators for GI bleed and Acute Kidney Injury [F]. The system links prescribing data in primary care to hospital admissions to help the NHS monitor and prevent errors.

In February 2018, the Short Life Working Group of the DHSC published a report stating that “ In primary care settings, the use of interventions such as pharmacist-led information technology intervention (PINCER) should be employed.” and that a “ key priority is the “roll-out of proven interventions in primary care such as PINCER.” [G]

In January 2019, NHS England published “Investment and evolution: A five-year framework for GP Contract Reform to implement the NHS Long Term Plan”. Prescribing safety was a new quality improvement domain in the contract, with practices incentivised to demonstrate continuous quality improvement in relation to prescribing safety. The Framework stated (Section 3.16, page 22) “the nationally-backed rollout of the pharmacist-led information technology intervention for medical errors (PINCER or equivalent) by the AHSNs” as one of four key areas for Quality Improvement. PINCER provided a mechanism for practices to achieve this, as well as providing CCGs with a process for verifying GP practice achievement [H].

PINCER has also been identified as an evidence-based approach to reducing a range of medication errors as part of the mandatory QI project in the new GMS Contract Wales: QI Framework 2019-20, and discussions about the rollout of PINCER to general practices in Wales are ongoing [I]. In July 2019, the NHS Patient Safety Strategy highlighted PINCER as one of its Medicines Safety Improvement Programmes to support work to reduce prescribing error rates by 50%, improving safety and reducing costs. More recently, in September 2020, the Primary Care Network (PCN) Service Specifications highlighted PINCER as a tool to help clinicians to identify patients who would benefit most from receiving a Structured Medication Review (SMR) [J].

In summary, research from the University of Nottingham has led to a significant increase in the protection of patients across England from harmful prescribing errors.

(number=research reference in section 3, letter=evidence source)

Research at Nottingham has transformed delivery of community-based stroke care and rehabilitation improving the efficiency of service and quality of care, nationally and internationally. The identification of core components of service provision, evaluation of Early Supported Discharge services in practice, and creation of the Post-Stroke Checklist has resulted in significant impacts, highlighted below:

Regional Impact

Improved provision and access to services

Our two-year quality improvement programme in the East Midlands, funded by the East Midlands Academic Health Science Network (EMAHSN) using the consensus findings and evidence-based core components of services [1,2], facilitated the commissioning and provision of community stroke services. The programme’s ‘Provision of care pathways’ 2015 report [a] identified gaps and inequities in community-based service provision in the East Midlands (n=5,063 patients-per-annum, 2015-16 Sentinel Stroke National Audit Programme (SSNAP) data), which informed regional Chief Executive Officers, East Midlands Clinical Commissioning Groups, and 36 UK Strategic Clinical Networks [a]. Between April 2014 and October 2016, adoption of our Early Supported Discharge and Community Stroke Rehabilitation service specifications [a] were promoted to providers and commissioners of nine teams (n=1,200 patients, 2015-16 SSNAP data) across the East Midlands. As reported by the Chartered Society of Physiotherapists, the adopted model was based on our evaluation of Nottinghamshire based services that showed substantial benefits to stroke patients, including improved activities of daily living [b]. Our work also informed other regional specifications (London and Cheshire & Merseyside) [c], and provided evidence-based guidance and performance monitoring to a further 29 ESD teams treating a total of 2,272 stroke patients-per-annum according to 2015-16 SSNAP data.

Improvements in care practices

In 2015, we delivered a bespoke series of multidisciplinary training workshops for 9 community stroke teams across the East Midlands. Workshop topics included collection and sharing of data to monitor performance and improving communication between services, addressing challenges highlighted by our research [2,3]. The vast majority of participants (94% of n=66 community stroke team staff) reported that they were able to significantly apply their learning to their work [a – Stroke Rehabilitation Programme Impact Report p11]. Staff implemented specific evidence-based service improvement goals, as evidenced in multidisciplinary team project reports from Derbyshire, Leicestershire, Lincolnshire, and Northamptonshire [a], directly impacting on provision of care.

National Impact

Development of policy and practice: NHS England rehabilitation pilots

In April 2020, Fisher was appointed the National Rehabilitation and Life After Stroke Workstream lead, with NHS England & NHS Improvement (NHS E&I) Clinical Policy Unit. This was in recognition of Fisher being an established national leader in stroke care. She was a member of the commissioning guidance for rehabilitation working group and her team’s research has informed the national commissioning guidance [d], clinical guidelines [d] and national and regional stroke care improvement [e,f]. Fisher and Walker led a task and finish group to produce a National Integrated Community Stroke Rehabilitation service specification [e], detailing team composition, intervention delivery and performance monitoring informed by the research [3,4,5]. In August 2020, this specification was circulated to 20 new Integrated Stroke Delivery Networks (n=29,773 stroke patients from 2019-20 SSNAP data) covering all CCGs in England [f]. The National Clinical Director for Stroke, NHS E&I, confirmed that “Dr Fisher’s research has informed gap analysis and improvement plans as part of implementation of the NHS Long Term plan.” [f] The NHS Long Term Plan sets out the actions to improve care, with stroke services being one area of focus.

Findings from the NIHR ‘WISE’ study (n=6,222 patients), providing further evidence for the importance of adopting evidence-based core components [5,6,7], have also been critical in developing plans for the NHS England rehabilitation pilot initiative. Launched in November 2020, this programme has supported evidence-based community stroke rehabilitation service provision across England [f]. Our research “ will inform evaluation of the effectiveness of the rehabilitation pilots and ultimately how the performance of services across the country are monitored” […]“ This will have a beneficial effect on outcomes for stroke survivors and, crucially, will address geographical inequities.” National Clinical Director for Stroke, NHS E&I [f]. In October 2020, Fisher was appointed Associate Director of the Stroke Audit Programme to implement improved national performance monitoring informed by our research [5,7].

Reducing the impact of Covid-19

To support community stroke services across England during COVID-19, since April 2020, Fisher chaired a weekly, (now monthly) national community stroke on-line meeting with 60 regional stroke care leads to maintain evidence-based stroke services. Fisher also co-authored guidance on the restoration and recovery of stroke services during the pandemic [g]. Fisher, Walker and others produced a UK and Ireland statement on provision of evidence-based ESD and community stroke services during COVID-19 [g], highlighted in global and national webinars and endorsed by the World Health Organisation [g]. These activities emphasised the importance of continued stroke therapy provision [g].

Improved monitoring and access to services: NHS Scotland

In a successful collaboration with the Scottish Stroke Care Audit (SSCA) team and the Scottish Stroke Improvement Programme, in 2018 University of Nottingham-led researchers mapped services for stroke survivors in Scotland using consensus and evaluation findings [1,2,5]. Findings from the project were written up in the Implementation of Community Stroke Rehabilitation in Scotland report and “ were discussed at the National Advisory Committee for Stroke (NACS in April 2019) […]. As a consequence of this work, community rehabilitation services were featured in the SSCA national audit report for the first time, raising awareness of service provision. The report was circulated to stroke managed clinical networks in Scotland and used to stimulate service improvements e.g. addressing inequality in access to services.” Strategic Lead, Scottish Stroke Allied Health Professionals Forum [h].

International Impact

Our research has also informed stroke guidelines issued by the Health Quality Ontario Ministry of Long-Term Care in 2016, and the American Stroke Association in 2019, informing international recommendations for ESD provision in Canada and USA [i].

International impact improved delivery of care: Post-Stroke Checklist

The Post-Stroke Checklist (PSC) [8], published in 2012 and subsequently endorsed by the World Stroke Organisation (a global network of over 3,200 individuals from 92 countries and scientific and stroke support organizations from 49 countries) and the Canadian Stroke Network, is used by clinicians worldwide to improve stroke survivor follow-up and care. The PSC helps stroke survivors and professionals identifying changes and problems so that they can be effectively treated [j]. The PSC has been shown to have particular utility in offering a standardised approach to delivery of six-month reviews after stroke (as recommended by NHS England [j]) to ensure longer term support for stroke survivors. The PSC has been translated into other languages including Malay, Chinese, German and Finnish.

Use in Malaysia (2016) and Singapore (2018) has demonstrated the feasibility and utility of the PSC in identifying long-term stroke care needs in clinical practice, with feedback from patients and clinicians indicating a high level of satisfaction. Email contact with a Rehabilitation Medicine Specialist, Universiti Kebangsaan Medical Centre, Malaysia (2016) confirmed “We use it on our stroke patients during most follow-up outpatient clinics… I find that the checklist is useful to train the new medical officers in our team so as not to miss out any main important points in post-stroke care” [j]. A further email exchange with an Advanced Practice Nurse, National University of Singapore stated “We use this checklist in our outpatient stroke clinic. The Singapore National Stroke Association advocate the use of this tool to empower patients and family members to self-monitor for post-stroke complications” [j].

In summary, our research in developing specifications for service delivery, raising awareness of gaps in service delivery, and creation of improvement initiatives is transforming the lives of survivors of stroke.

“Oh, yes. Yeah. Far better. …The thing about the hospital, you did probably half an hour a day ... with the physio, which wasn’t enough” “And certainly I wouldn’t be where I am now as far as improvement if it wasn’t for the ESD team.”

(Stroke survivor receiving ESD (2019) [6]).

The provision of influenza vaccination through community pharmacy in England, France and Australia has been transformed by Anderson’s research.

England - Impact on services

In England, Anderson’s research supported the Pharmaceutical Services Negotiating Committee (PSNC) negotiations for the NHS pharmacy service, whereby from 2015 the delivery of influenza vaccinations by pharmacists was nationalised across England: Public Health England’s report ‘Influenza Vaccine Uptake amongst GP Patient Groups in England’ for the 2012/13 Winter season highlighted that “ … just over 50% of people aged six months to under 65 years in a clinical risk group, had been vaccinated against flu. Despite continued efforts to improve uptake … the remaining half of the clinical risk group population eligible to receive the vaccine, are still not getting immunised.” There was considerable interest within the public health community, and the policy leads for influenza vaccination at Public Health England, in a role for community pharmacists as part of the annual flu campaign to widen and ease access to vaccination. Those officials were interested specifically in three issues in consideration of a nationally commissioned service from community pharmacy:

• were community pharmacists capable of delivering the service?

• did they have capacity to deliver it such to make a difference to the under 65 at-risk groups?

• would the public see community pharmacies as a legitimate place for receiving an influenza vaccination?

The chief executive for the Company Chemists’ Association (2007 – 2015) and Pharmacy Voice (2010 – 2017), who was involved in these discussions through the Pharmacy Public Health Advisory group [A], confirmed that Anderson’s “ research contributed to the weight of evidence that resulted in the commissioning of the national flu service in 2015.” “ *At the time when officials were actively considering the extension of the national scheme into pharmacy, these data … were significant in the commissioning of the national scheme.*” [A]

The Chief Pharmacist at Boots UK Ltd “ *confirm[ed] that the work carried out by Professors Claire Anderson ... on influenza vaccinations provided by community pharmacists in the UK has been instrumental in supporting the evidence case for widening access to such services across the NHS.*” [B]

Uptake of NHS funded influenza vaccinations in pharmacies between September and March has increased from 595,467 in 2015/16 to 1,721,705 in 2019/20. The number of pharmacies offering the service has increased by 29% over this period (from 7,195 to 9,310), and pharmacy contractors have received GBP56,502,440 in fees directly for the delivery of influenza vaccinations from the NHS [C]. The 2018 ‘Economic Analysis of Flu Vaccination’ notes that “ costs of delivering a vaccine through a pharmacy is £2 cheaper than through a GP.” Vaccination in pharmacy was estimated to have saved the NHS around GBP3,000,000 in 2017/18 [D]. Provision of influenza vaccination is one of the gateway criteria to access the Pharmacy Quality Payment scheme since 2016, and will continue to be so as outlined in The Community Pharmacy Contractual Framework 2019/20 to 2023/24. Since 2015, Anderson’s research has been used in annual briefings provided by PSNC to pharmacy contractors to help promote the influenza vaccination service to patients and local stakeholders [E].

England - Impact on patients

The results of the annual patient questionnaire for the Flu Vaccination Service delivered by community pharmacy, managed by NHS England, demonstrate patients highly value the service. In 2016/17 and 2017/18, at least 98% of patients were very satisfied with the service, 99% would be willing to have an influenza vaccination at pharmacy again, and 99% would recommend the service. 15% (2016/17) and 7% (2017/18) of patients said they might not have had the vaccination if the service had not been available in pharmacy, equating to 236,727 vulnerable patients not receiving the best protection against the influenza virus [F]. It was concluded that the results were sufficiently consistent and positive to not have to run the questionnaire thereafter.

International impact

France: The international status of Walgreens Boots Alliance facilitated the influence of Anderson’s research on the development of national pharmacy influenza vaccination services in France for at-risk patients. This is corroborated in statements of the Contract Framework and Outcomes Senior manager at Boots UK Ltd and the Chief Pharmacist at Boots UK Ltd [B]. In 2016, the French regulator (Conseil National de l’Ordre des Pharmaciens) featured Anderson’s publication (R1) as supporting evidence in their successful campaign to change legislation to allow pharmacists to deliver influenza vaccinations [G]. In July 2018, a Haute Autorité de Santé (French national authority for health) guideline was published ‘Extension des competences des professionnels de santé en matière de vaccinations’. This guideline recommends the development of influenza vaccination services in pharmacy in France using the UK as a successful case study, and Anderson’s findings on patients’ attitudes to pharmacy vaccination as supporting evidence [pages 38, 39, 51, G]. In 2018/19, 22,000 pharmacists delivered over 650,000 influenza vaccinations across 13,000 pharmacy sites in four pilot regions [H]. In 2019/20, the service was expanded countrywide with almost 2,000,000 patients vaccinated by a pharmacist [H].

Australia: Anderson’s research informed the pilot Australia ‘Queensland Pharmacist Immunisation Pilot (QPIP)’ project that allowed Australian pharmacists to vaccinate for the first time in 2014. The chair of the steering committee for the pilot commented “ *we utilized the evidence and data from Claire Anderson’s work in the UK and used this to influence and change policy in Australia around influenza vaccinations in community pharmacy. It formed the basis of large practice base studies in community pharmacy.*” [I]

Following the success of the pilot, private influenza vaccinations have been delivered nationwide by community pharmacy since 2016. In 2018, over 1,000,000 Australians were vaccinated in pharmacy, and this rose to over 2,000,000 in 2019 [J]. Greg Hunt, Minister for Health, Australia, stated in a press release regarding record vaccinations in Australia in December 2018, “ Australia experienced the lowest rates of the influenza since 2013 after a record 11 million Australians got a flu jab, nearly a third more than the previous year. Delivering vaccines to people in most need of protection would not have been possible without the collaboration between GPs and other vaccination providers across Australia, as well as community pharmacies which encouraged and administered the uptake of this important, lifesaving vaccination.” [J]

The second stage of the pilot, launched in 2015, expanded the Pharmacy vaccination program, for MMR, diphtheria, pertussis and tetanus. Pharmacy is now commissioned to deliver the National Immunisation Programme for at high-risk groups in three territories; Victoria, Australia Capital Territory and Western Australia. As of January 2019, 7 out of 8 Australian states and territories offer vaccination services additional to influenza [K].

Transforming vaccinations globally

The International Pharmaceutical Federation (FIP) is the global federation of more than 150 national associations representing over 4,000,000 pharmacists and pharmaceutical scientists, and 170 universities. Since 2016, FIP have been working globally to develop the role of pharmacy in provision of vaccination services. The FIP Chief Executive Officer confirms Anderson’s research has contributed significantly to their publication of Transforming Vaccination Globally report and set of global commitments and regional action plans [L].

Impact on reducing the double threat - Covid-19 and Influenza

In 2020, a double threat of COVID-19 and influenza risked further burdening healthcare systems worldwide. In Sept 2020, Public Health England published research that linked prevalence of death with patients suffering from COVID-19 and influenza to be twice those suffering with COVID-19 alone. Australia, England and France launched ambitious plans to expand their influenza vaccination programmes for maximum population uptake. In Australia, influenza vaccination uptake increased by 5,000,000 compared to 2019 and delivery by pharmacy was expanded to include children from 10 years of age. In England, a record 30,000,000 patients were eligible for free NHS influenza vaccinations, with over 950,000 patients vaccinated in pharmacy in September 2020 alone; 2.5 times that of the same period in 2019. Pharmacy gave over 2,397,788 influenza vaccinations in 2020, 890,000 more than in 2019 [C, M]. France ordered 30% more influenza vaccinations this year than previously.

In November 2020, the PSNC confirmed it was working with NHS England and NHS Improvement (NHSE&I) and the Department of Health and Social Care to agree how pharmacies could play a part in the COVID-19 vaccination programme. Alastair Buxton, Director of NHS Services at PSNC, stated “ Community pharmacy teams have had a central role in the response to the pandemic so far, and this should continue as new treatments and vaccinations become available.” “ The success of the flu vaccinations service highlights just how effective community pharmacies are in delivering key public health initiatives and means the majority of pharmacists are already trained in administering vaccines.” At the end of November, pharmacy contractors were contacted by the NHSE&I Chief Commercial Officer and SRO Vaccine Programme, the Director of Primary Care, and the Chief Pharmaceutical Officer for England with details of the commissioning of community pharmacy-led designated vaccination sites, highlighting that “ *The UK has one of the world’s highest levels of public support for making a safe COVID-19 vaccine available and community pharmacy is currently doing an outstanding job of increasing coverage under the expanded winter flu programme.*” [M], and echo those of the Chief Pharmacist at Boots UK Ltd [B]. The first pharmacy-commissioned COVID-19 vaccination sites will be active from January 11^th 2021.

Thanks to Claire Anderson’s research influencing the provision of influenza vaccination in Pharmacy, thereby increasing service capacity, England, France and Australia have been able to deliver record numbers of flu vaccinations in 2020. Pharmacy provision of this service has helped to protect millions of people and their healthcare systems.

Fundamental, discovery research led by Alexander has resulted directly in the development, translation and commercialisation of a Bacteriaphobic^® urinary catheter through the collaboration with a specialist medical device company Camstent Ltd. This discovery and the commercial product offers a superior strategy to prevent CAUTI’s over current methods, which focus on antibiotics to kill the attached organisms.

The 2012 Nature Biotechnology article detailing the discovery of bacteria-resistant materials gained wide media coverage and considerable interest from industry to develop the discovery into new technology. In 2013, Camstent Ltd changed their business direction from blood resistance to focus on commercialization of the technology discovered at the University of Nottingham. Camstent Ltd secured an exclusive licencing deal to develop the technology into products for urology that commonly lead to HAIs. With continued support from UoN researchers, Camstent have developed their first commercially available, CE mark approved Bacteriaphobic^® urinary catheter [A]. The growth of Camstent during the REF period is intimately linked to the discovery of the materials at the University of Nottingham and the continued research support provided, “ the nature and outcomes of the research collaborations between Camstent Ltd and the University of Nottingham has resulted in the successful development and commercialisation of our first coated urinary catheter product and growth of Camstent Ltd.”, CTO and Founder of Camstent confirms [B]. This can be summarised in several milestones:

1. Licencing milestone

In 2013, the patent of the antibacterial polymer developed by Alexander and colleagues was licensed by the University of Nottingham to Camstent Ltd for their exclusive use to coat urinary tract Foley catheters [C].

1. Investment milestones

To December 2020, Camstent has raised in excess of GBP5,000,000 of investment through a series of funding rounds supported by promising proof-of-concept results established with University of Nottingham support. As indication of the excitement and interest in the technology in June 2017, Camstent exceeded a target investment round by almost three-fold to a total of GBP850,000 from existing and new investors. The investment was pledged towards a CE mark application of the Foley catheter, to develop clinical and marketing partnerships towards sales, and to expand the development of other medical products. In a separate investment round in March 2019, Camstent raised an additional GBP600,000, which was used towards funding clinical evaluations, pursuing regulatory milestones, making key appointments to the Executive Team, and doubling the manufacturing and laboratory space [D].

1. Manufacturing milestones

In 2017, with Alexander and colleagues providing the technical knowhow to set up the polymer manufacturing process, Camstent Ltd established a manufacturing facility in Bedfordshire, UK. The facility is medical devices-compliant and certified for the manufacture of coated urinary Foley catheters (ISO 13485). The opening of the facility was an important milestone that allowed the production of coated catheters for early sales, product trials and regulatory approval, with the maximum capacity of 10,000 catheters per month [B, E].

1. Regulatory research milestones

The Camstent Ltd coated urinary catheter achieved European Union CE mark approval in 2017 (CE 0088, Certificate Number LRQ 00000604/B). The CE mark allows for the catheters to be sold in the UK and across Europe. More recently in November 2019, the catheter achieved the descriptor of Bacteriaphobic^® following claim approval from the notified body, and National UK trade mark following publication of the first-in-man clinical trial that demonstrated the coatings ability to resist bacteria [F].  This was a significant step towards commercialization, as the catheter could now claim to repel bacterial attachment.

1. Clinical milestones

Camstent Ltd secured Innovate UK funding to carry out a qualitative evaluation of the performance of the Bacteriaphobic^® catheters in 31 patients. The evaluation determined the perceived comfort and ease of insertion/withdrawal of the catheters, adequate drainage of urine from the bladder, safety, packaging, labeling, instructions for use, all of which is key for both patients and clinicians. The catheter coating forms a smooth surface that lowers the frictional forces associated with insertion and withdrawal, minimising patient discomfort, acute irritation and reducing tissue trauma. 30 of the 31 patients reported positive comfort experiences on catheter insertion [G].  A UK lead urologist and Honorary Associate Professor at University College London Hospitals NHS Foundation Trust, who trialled the catheters in her patients, said “ The surface of the catheter is very smooth and hardly requires any lubrication for insertion which is great for the patient. Our patients are all satisfied with the new product and we will continue to use Camstent catheters… as the new standard for post-operative urinary diversion after Reconstructive Urological Surgery.” [H]

An intermediate scale first-in-man pilot study during 2018-2021 involving six hospitals in the UK compared biofilm formation in 75 BACTIGON^®-coated versus 75 standard silicon catheters in 150 hospitalised patients. This study concluded the BACTIGON^®-coated catheters reduced the mass of bacteria detected on catheters after use by 65% to 95% compared to uncoated catheters [I]. The Head of Nottingham Colorectal Service at Nottingham Universities Trust who partook in the non-randomised clinical study stated, “ *Attempts to reduce CAUTI infections have really made very little impact so far….reducing infections is essential to prevent complications and reduce length of hospital stay I therefore agreed to run a study of the Camstent catheters…the catheters were deemed easy to insert by clinicians and the results demonstrated a reduction in biofilm formation compared to our standard catheters.*” [J]

1. Sales and agreements milestones

The Camstent Bacteriaphobic^® catheter is available for sale on Camstent’s website: "available in standard and female lengths, and in sizes 12 & 14 Fr” and has recently secured regulatory approval to expand the range of coated catheters to include more sizes and speciality tips [K]. In 2019, Camstent secured a deal with the global distributor of medical devices Pennine Healthcare. Since then, Pennine have secured the placement of the Camstent catheters on NHS procurement of four UK hospitals who are regularly purchasing catheters from Camstent Ltd [B].

1. Company diversification and future outlook

Camstent is making significant progress to secure FDA approval to sell its product in the United States, and is conducting a 300-patient multi-centre clinical trial with the University of Nottingham to document the significant impact the coating is expected to have on infection rates and length of hospital stay [I]. Camstent is currently pursuing partnership and licencing opportunities for wider use of the coating in medical products across global markets. In late 2020, a supplementary trial is beginning in collaboration between Camstent, the University of Nottingham and the Norfolk & Norwich Trust to apply the coating to suprapubic catheters used for patients with trauma of spinal injury. This is evidence of company strategy and future product diversification as a result of their collaboration with the Nottingham research team.

The collaboration between Camstent Ltd and the University of Nottingham research group has been paramount to the success of this commercial venture. Chief Technical Officer at Camstent said “ Professor Morgan Alexander and Professor Paul Williams brought un-matched insight to material chemistry, understanding of clinical microbiology, and comprehensive analytical test facilities that made transfer of the University’s technology to clinical customers possible.” [B]

The UK lead urologist at UCL Hospitals NHS Foundation Trust comments that “ *We are very pleased that there is finally a catheter available with antibacterial surface coating we have been waiting decades for!*” [H]

In summary, researchers at the University of Nottingham have enabled the translation and commercialization of a medical device from their discovery of a new class of biomaterial through to the clinic.