Impact case study database

Newcastle research found a substantial benefit of breath control therapy on the intelligibility of young people with CP affected by dysarthria. Since breath control is fundamental to clear, intelligible speech, Newcastle recommended this as the first line of therapy before, for example, improving articulation.

Impact on NICE guidance

At the outset of research, there was little guidance on effective therapies. Newcastle research underpinned the chapter on improving speech intelligibility in the January 2017 full NICE guideline NG62 (EV1). For example, R2 and R3 are cited on pages 232-5 as the only studies that investigated improvement of speech production and intelligibility for both single words and connected speech when rated by both familiar and unfamiliar listeners. The guideline also highlighted the finding of R3 that treatment improved children’s communicative participation in interactions at home and school. This evidence led to the following recommendation in the accompanying concise guideline on assessment and management (EV2, page 20):

1.9.6: “Offer interventions to improve speech intelligibility, for example targeting posture, breath control, voice production and rate of speech, to children and young people with cerebral palsy…”

Impact on practice

In 2019, a survey was distributed via the Royal College of Speech and Language Therapists with the same question set as the initial survey (R4, carried out in 2012) to assess change in practice (EV3). Overall, the results suggest a reduction in provision of two types of therapy that Newcastle found to be ineffective or inappropriate (R1-3). The first type is non-speech oromotor interventions (e.g. blowing, moving the tongue in different directions on command); since neural control is specific, this therapy should not improve speech production. The second is articulation therapy, which can only be provided once breath control is sufficient to support speech. Specifically, there was a significant reduction in the proportion of therapists providing these interventions compared to 2012: from 70% to 43% for non-speech oromotor interventions and from 87% to 77% for articulation interventions, indicating a reduction in the use of interventions with limited effectiveness. The proportion of therapists stating that they targeted the speech functions specified by NICE was over 90% in both 2012 and 2019, indicating that therapists now focus their limited time on more effective methods.

In addition, the therapy has been found to improve children’s confidence, allowing them to have more successful conversations, with a wider range of partners in more environments, thereby increasing their social participation (EV4).

Impact on Australian online guidance

In June 2016, the Australian Cerebral Palsy Alliance included R1-3 as evidence on their webpage “Speech therapy for children with dysarthria” (EV5), which has around 250 hits/month, with the recommendation:

“Intensive dysarthria therapy appears to be effective for children with cerebral palsy… the studies concluded that these children’s speech was easier to understand after the therapy.”

Impact on textbook resources

Newcastle research (R1-3) extensively informed the widely-used 2016 textbook “Children’s Speech: An Evidence-Based Approach to Assessment and Intervention” by McLeod and Baker. As of July 2020, this had Amazon sales rankings in the top 5% across Anatomy, Pre-clinical Medicine and Family, and Lifestyle Paediatrics; and sales of over 800 in Europe and over 3,500 in the US (EV6). Citations of Newcastle work include:

• Page 379 “[R2] found that intensive intervention… using the systems approach… was associated with improvements in speech intelligibility for older children with cerebral palsy and dysarthria.”

• Page 514 “Across the evidence on a systems approach to intervention, procedures involving practice of a particular motor skill are usually based on principles of motor learning e.g.… [R2, R3].

• Page 515: “[R2] reported that… intervention sessions 3 times per week for 6 weeks resulted in improvements in both word level and conversational speech intelligibility in children aged 12 to 18 years. A similar finding was reported for younger children aged 5 to 11 years [R3].

Impact on undergraduate teaching

The research (particularly R1-4) has informed national and international university speech therapy courses. For example, at Manchester Metropolitan University the research was crucial in developing their courses and has been adopted on publication into undergraduate teaching to 50 students per year since 2015 (EV7). The University of Strathclyde has included the research into undergraduate teaching since 2017, and R4 is compulsory reading for all 35 students as preparation for class-based discussion (EV8).

Internationally, the University of Sydney confirmed (EV9) that undergraduate teaching has included R1-4 as they have been published since 2014, including specific reference to the systems approach. The course is undertaken by around 90 students per year. At the University of Melbourne, R1-4 were crucial to developing the course, which is undertaken by up to 90 students per year (EV10). The papers also informed a two-year Masters of Speech Pathology degree. Finally, Radboud University Medical Center (Netherlands) confirmed that R1-4 have been included into their undergraduate teaching to 50 students a year since 2013 (EV11).

In summary, Newcastle research found a substantial effect of breath control therapy on the intelligibility of children with CP who are affected by dysarthria. The results informed UK guidance, worldwide use in textbooks and international teaching practice.

NICE recommendation of hyoscine and generic GBr

The 2017 NICE guidance NG62 (EV 1, page 262-4) recommended that both GBr and hyoscine be considered as single first-line treatments for drooling in children with CP. This guidance was informed largely by R3, the only RCT carried out in the UK and the only one to inform “Consideration of economic benefits and harms” (page 263). The guidance noted that although hyoscine was more cost-effective than GBr, it was associated with more problematic side-effects and greater risk of treatment cessation.

Approval of proprietary GBr across Europe

Newcastle research (R3) also informed the licensing of two proprietary GBr drugs for drooling in children with wider neurodevelopmental conditions. First, data from R3 were provided pre-publication under a confidentiality agreement to Proveca, a UK-based pharmaceutical company who manufacture the GBr drug Sialanar. These data allowed Proveca to fulfil the requirements for the European Medicines Agency (EMA) to grant a paediatric use marketing authorisation for Sialanar in September 2016 (EV2), covering all EU member states. Proveca confirmed the essential role played by Newcastle research (EV3): “Newcastle University were kind enough to share with us the results from [R3] prior to its publication. Early access to these data was essential for us to meet one of the required criteria necessary to validate the application within the strict timetable set by the EMA.” Following the EMA approval, Proveca received MHRA marketing authorisation for Sialanar in the UK in September 2016 (EV4). In July 2017, the Scottish Medicines Consortium specifically approved Sialanar for use in Scotland (EV5). In April 2019, the Zorginstituut Nederland (National Health Care Institute of the Netherlands) used R3 as essential evidence in the documentation approving Sialanar for use in the Netherlands (EV3, EV6).

A second pharma company, Company A [name redacted for publication], received an MHRA additional indication for their GBr Drug A [name redacted for publication] in February 2019. This decision was largely informed by R3, as confirmed by the company (EV7): “This approval was a direct result of a body of evidence we submitted to the MHRA. This evidence included seven studies, of which [R3]… was the largest and most relevant.”

Impact on number of prescriptions

Since its approval by NICE in January 2017, the number of prescriptions for Sialanar in England has increased to around 800 per month (EV8, see graph below). Sialanar is only licensed for drooling in children with neurodisability and therefore prescription numbers are a more accurate representation of use in practice than generic GBr, which is licensed for a variety of conditions. In Scotland, prescriptions in primary care have increased to around 70 a month (EV9, see graph below), and the supply of Sialanar in secondary care increased from a total of 250 ml in 2017 (approximately 21 doses) to 4,250 ml in 2019 (approximately 354 doses). Between January and July 31^st 2020 alone, 4,330 ml (approximately 361 doses) was supplied (EV10). The number of prescriptions of Drug A specifically for this condition increased from 2,268 in January 2019 to 2,568 in July 2020, as confirmed by Company A (EV7) .

Impact on use in practice

To investigate the preferential use of GBr over hyoscine in practice, a survey of clinicians was conducted in August 2020 and received 77 responses (EV11). Medications accounted for 58.3% of all interventions; as absolute percentages, 16.6% were GBr prescriptions (of which 9.1% Sialanar, 3.5% Drug A and 4.0% as a specially-prepared unlicensed product), and 20.7% hyoscine. The proportion of GBr prescriptions was approximately similar to the previous rate of 14.3% (of which Sialanar 7.1%, Drug A 3.6% and as a special 3.6%). However, there was a substantial fall in the prescription of hyoscine from its previous rate of 64.2%. The main reasons for changing practice were: 42.8% due to the Newcastle trial (R3), 25.7% because families prefer it, 14.2% because of guidelines from their local Trust and 8.6% due to NICE guidelines. In addition, the survey found that 23 clinicians started children on Sialanar each month. Of the children switched to Sialanar, 27.9% were switched from generic GBr and 59.5% from hyoscine. Taken together, these results show increasing use of a well-researched and licensed drug instead of either an unlicensed drug or one with greater side effects.

In summary, Newcastle research into the effectiveness and side effects of medications for drooling in children with neurodevelopmental conditions informed UK and European licensing of one generic and two proprietary drugs. As a result, international prescribing practice has changed, offering children and their parents a treatment for this distressing and potentially dangerous condition.

Impact on guidance and policy

Newcastle research (PISTE and PEARS 2) has directly informed national guidance and commissioning policy for the provision of stroke services and implementation of MT. Preliminary PEARS 2 work informed recommendations in the 2016 National Clinical Guideline for Stroke (NCGS, EV1). This is a highly influential publication with a proven track record of influencing stroke service provision in the UK for more than 15 years. On page 41 (section 3.5) the guidelines state “ *mechanical thrombectomy (MT) is an effective acute stroke treatment for selected patients with proximal large artery occlusions as an adjunct to IVT … Centres that provide endovascular treatment should meet the professional standards set out by the joint societies’ working group (National Institute for Health and Care Excellence, 2015b, [R2]*”. Furthermore the joint editor of the guidelines confirms that as well as R2, the committee “ had information on the time metrics of MT performance from PISTE, a UK based trial, that matched international comparator trials”, referring to R1 data (EV2a).

The 2018 NICE guideline (NG128, EV3) explicitly references R3 when considering the cost effectiveness of MT on ischaemic stroke treatment. It states “ The committee was informed by a published modelling study [R3]… [which] indicates that 40% of people … are potentially eligible for thrombectomy [MT]”. The guidance also says “ The committee was confident that the economic evidence accurately demonstrates that offering thrombectomy alongside intravenous thrombolysis … is cost-effective compared with current practice… and would therefore be a good use of NHS resources”, and recommends that MT be offered to ischaemic stroke patients as soon as possible after the onset of symptoms (EV3).

Impacts on stroke service provision, stroke specialists and healthcare providers

Following the 2016 NCGS policy decision to commission MT, NHS England published service specifications in 2017 (EV4, EV5). Newcastle research (R2) is one of only 3 national standards informing this document. One of the others is NICE guidance IPG548, which is directly informed by the 2018 NICE guidance (EV3) referenced above and underpinned by Newcastle research.

This MT service specification was rolled out across NHS England in April 2018 and led to substantial changes in the national provision of MT services. The primary change was an increase in the number of large CSCs to implement hyperacute thrombectomy services (EV5). This change is indicated as larger units have better performance metrics for patient outcomes in national audit data (SSNAP) and can provide all treatments including MT. There are currently 24 centres in the UK that provide MT (EV6).

Impacts on patients

Restructuring stroke services and commissioning MT services have directly increased the number of patients receiving MTs as part of routine stroke care. Before PEARS research, figures voluntarily submitted to SSNAP showed that just over 150 MTs were carried out in 2015 (EV2b). Following restructuring, this number has grown annually with approximately 800 MTs carried out in 2017 and >1,200 in 2018 (EV7). As of July 31^st 2020, MT numbers had increased markedly in England to an annual rate of >1,600 (EV5, EV7) or from <5% of those eligible to ~20% (EV2a). This was expected to be 1,800-2,000 (EV2a), but due to the COVID-19 pandemic, the number of referrals dropped by 27.7% compared to the first 3 months of 2020 (EV6).

MT has a very powerful treatment effect, as shown in PISTE and other clinical trials (R1, EV8). Given the median age of stroke is around 70 years, functional independence has been the focus of investigation in most studies. A 2019 NHS England Clinical Priorities Advisory Group recognised the benefits of MT, stating that “ 63% of patients treated with thrombectomy [MT] *will be independent or mobile without assistance; with usual care this would be only 43%*”. Additionally, “ 20% more stroke patients treated with thrombectomy will be independent after stroke than those treated using current standard care” (EV9). This Advisory Group was supported by an additional NHS service specification (EV10), itself informed by R2 and NICE guidance NG128 (EV3). The specification has been available online since 2019 through public consultation, although due to the COVID-19 pandemic, it was not published until January 2021.

As stroke is the UK’s leading cause of acquired disability, it has major repercussions amongst families of stroke patients and wider society. LAO stroke is disproportionately responsible for poor outcomes after stroke. Given that 8,000 English patients per annum are eligible for MT treatment, an estimated 1,600 patients per annum will make a good recovery after stroke with a further 1,300 left less disabled than they would have been without MT. Reducing long-term disability in these 3,000 people per annum will have clear societal gains (R6).

In summary

Newcastle research identified that 10% of LAO stroke patients are eligible for MT treatment and modelled the changes required to stroke service centres to optimise care. This led to optimal implementation of thrombectomy care in England and approximately 1,600 MTs performed in 2019-20, quadruple the number in 2016 before PISTE/PEARS, subsequently improving patient recovery and reducing disability.

National Impacts on security

The “Watching eyes” signs have been used by several police forces in the UK to combat cycle theft, including North East London, the West Midlands and Leicestershire Police. In December 2013, as part of the OPERATION OWL neighbourhood watch scheme, the Waltham Forest Borough police force collaborated with Newcastle University to install posters at the top 6 cycle theft locations in the borough. In 2013 police in Waltham Forest Borough (as of 2018, part of the North East Command Unit in London), needed cheap and simple strategies for combating cycle crime which did not distract from their other duties, such as implementing traffic safety initiatives. As such the “Watching eyes” posters were recognised as offering “ the perfect solution to both tackle cycle theft yet still allow police to commit their time to other life saving deployments” (EV1). The posters were supplemented with home visits to known cycle thieves but the officer in charge of the project at the time commented that “ the posters were able to police the problem, even when we were committed elsewhere” (EV1). Between December 2013 and June 2014, there was a 25% decrease in cycle theft at the 6 cycle racks, compared to the same time frame the year before. Notably, one cycle rack saw a decrease of 75%. The drop in cycle theft extended to the rest of the borough which experienced a 14% drop in cycle theft incidents across the borough and an 81% drop around the area of Central Walthamstow between December 2013 and June 2014.

The success of the project led to the use of the posters in other London boroughs and for the posters to be adapted into small flyers to be displayed in front windows to tackle burglary (EV1). The officer in charge of the project noted that “ The staring eyes posters did not do the investigative work for us, but they assisted in creating a brand, which was recognisable to members of the public and criminals alike. This no doubt increased the flow of intelligence we received and elevated the profile of cycle theft as a crime type” (EV1).

Furthermore, 20 posters were put up at cycle theft hotspots at the University of East Anglia between 2013 and 2019 (EV2). The University reports that there were 40% fewer cycle thefts reported on campus than in 2013 and that there was “ a rise in awareness from users of cycle racks. More sightings were reported of suspicious behaviour and a sense of ‘community spirit’ was felt in tackling cycle theft” (EV2).

International impacts on security

In August 2014, the police force of Delmenhorst/Oldenburg-Land/Wesermarsch in Germany became aware of the Newcastle research through press coverage and carried out their own investigation of the effectiveness of the “Watching eyes” posters. After consultation with Newcastle University the police force installed 10 “Watching eyes” posters in 3 cycle locations around the city on 1^st August 2014. Signs adapted to include an equivalent “Cycle thieves. We are watching you” phrase in German and were placed in locations which were identified to be difficult or impossible to monitor. Reported cycle thefts were recorded both before (2012-2013, 2013-2014) and after installation (2014-2015) and showed a 40-65% drop in cycle theft numbers after the posters were introduced depending on the location (Table 1, EV3).

Table 1 – Cycle theft numbers from 3 locations in Delmenhorst.

Impacts on public spaces

The ‘Keep Britain Tidy’ campaign used the “Watching eyes” posters in an anti-dog-fouling measure. The posters, based on Newcastle original design, were piloted in 2014 at 120 testing sites across 17 local authorities. The pilot recorded an average decrease in dog fouling of 46% which encouraged further implementation of the posters in 152 local authorities, parish councils and community groups across England. In some of these locations, dog-fouling has been reduced by as much as 90% (EV4). Furthermore, the ‘Keep Britain Tidy’ campaign has won numerous awards including the 2015 Nudge Award, the Guardian Best Ads of 2015, the 2015 Local Government Chronicle Award – High Commendation and the 2016 Charity Award in the Environment and Conservation Category. These have helped to further increase the awareness of the work of the ‘Keep Britain Tidy’ campaign (EV4).

The “Watching eyes” posters have also been used by Boston Borough Council to directly combat fly-tipping and littering. Boston Town Centre was recognised as a significant hotspot for fly-tipping, and littering which negatively impacted local businesses and residents. The area was not protected by CCTV and regular patrols had been unsuccessful in deterring fly-tipping. The incidence of fly-tipping was reduced by 50% for the 3 months that posters were in place at the start of 2014, compared to the same time the year before (EV5).

Economic impacts

Following these implementations and success, the use of “Watching eyes” has become mainstream with the eyes seen extensively within stores and companies producing safety and security signage incorporating watching eyes imagery independent of involvement from Newcastle University. For example, the UK company [Company X] developed a range of signage after seeing reports of the Newcastle University research. They provide this signage through their distributors to construction, safety and security, fire and PPE supplies sectors across the UK [redacted for publication] (EV6).

In summary

Newcastle research found that the presence of Watching eye imagery prompts positive behavioural changes. This simple and effective intervention has been used in the UK to tackle littering and fly tipping and in the UK and Germany to reduce bicycle thefts. The concept of “Watching eye” imagery has now extended into the public space, most obviously by companies developing effective safety and security signage with these designs.