Impact case study database

UofG research on the impacts of trawling at different depths on deep-sea fish species provided pertinent and timely evidence to support an EU policy in 2016 to ban trawling at depths of 800m or lower.

Lead-up to policy change

UofG research has played an important role in the long-running debate concerning deep-sea trawling and environmental damage. Bailey was a co-author on a 2011 report [A] that reviewed the implementation of previous UN General Assembly resolutions on deep-sea fisheries, which cited Bailey’s previous deep-sea data [3.1]. This report found that the UN’s resolutions were not being fully implemented, that precious ecosystems were not protected as intended and that the impact on non-commercial species, which were being caught and discarded as bycatch in significant numbers, was not being adequately measured. This and other work kept up the calls for the seabed’s protection. Nevertheless, EU restrictions imposed in December 2013 were not implemented due to lack of approval from some member states.

In 2014, a debate was held at ‘The Future of Scotland’s Deep Sea Fisheries’ (Edinburgh), in which Bailey participated as a panel member and discussed his research [3.1] on the long-term changes to deep-sea fish populations. Speaking on this discussion, the co-founder of the Deep Sea Conservation Coalition highlighted the need for an evidence base to support change: ‘ We don’t know the value of deep sea ecosystems so we don’t know what we might lose’ [B]. As a result of his participation in this event, the Pew Charitable Trust invited Bailey to speak with EU officials in Brussels in late 2014 about this research. This meeting focussed on the need for changes to trawling depth limits, which had been proposed, to be guided by scientific evidence and led Bailey et al. to commence research (ultimately published in 3.2) to address this requirement. Bailey was also invited to present to UK policymakers at Westminster (20 January 2015) about deep-sea fisheries and the conservation of deep water ecosystems. He again discussed his earlier work [3.1] on the impact of deep-sea fishing, and his preliminary findings on conservation impact trends as a result of fishing depth [B]. In January 2015, Bailey also co-authored a letter, alongside other UK and international marine scientists, to the UK Fisheries Minister, which advocated for the UK to play a pro-active role in upcoming EU negotiations on the management of deep-sea fishing [C]. As correspondence between Bailey and the European Commission noted at the time, ‘ We at the European Commission are very much convinced about the benefits of restricting deep sea fishing to shallower depths like 600m. It is mostly some particular Member States in the EU that criticize your paper and of course parts of the fishing industry, but that is not surprising as they do not want to see any depths limitation in the new legislation on deep sea fishing’ [D].

In August 2015, Bailey’s research [3.2] was published, providing evidence of the environmental consequences of seabed trawling, in addition to decreased economic returns for fishermen trawling at then-current depths. This work was extensively covered in the media across Europe [E], given the commercial and political sensitivities of the European fishing industry (the sector is dominated by France, Spain, the UK and Denmark, but all EU members engage to some extent). There was significant pushback on the suggested depth limit, and UofG researchers responded accordingly, citing their findings that the dangers to certain bycatch species’ populations, endangered by trawling practice, increased significantly at depths of 600m and greater [F]. In October 2015, Bailey spoke at a public event at the Zoological Society of London on the conservation value of European deep-sea habitats and met with UK government policymakers in attendance [G]. These public engagements coincided with the European Parliament reopening discussions on fishing limits. The Deep Sea Conservation Coalition co-founder, speaking about the UofG research, stated that not only did ‘ [we make] extensive use of their research in our work with policy-makers in Brussels and in EU Member States advocating for a new and more rigorous regulation for the management of deep-sea fisheries in EU waters’, but also that the ‘ work has…been recognised in numerous discussions amongst Members of European Parliament and their staff, the European Commission and Member States involved in the negotiation of the new legislation’ [H].

On 14 December 2016, the European Parliament passed Regulation (EU) 2016/2336 ‘establishing specific conditions for fishing for deep-sea stocks’, which stated that ‘ In order to mitigate the potential damaging impacts of bottom trawling, it is appropriate to permit fishing with bottom trawls only at, or above, a depth of 800 metres’ [I]. Adopting an 800m limit was seen as ‘ a compromise between those rejecting any limit and scientific evidence supporting a shallower 600m limit’ [J]. Reflecting the significance of the research, the Marine Scotland collaborator Dr Francis Neat joined an EU delegation to a UN workshop on sea-floor bottom fishing (held in New York, USA); he stated that, “… our study was highlighted by the EU as being an important piece of evidence in their decision to prohibit bottom trawling at depths > 800m. So, it was rewarding to see our efforts being acknowledged at that level” [K]. The EU legislation was also welcomed in the UK by the The Scottish White Fish Producers’ Association, UK’s largest fishing association [L].

^{Figure 1: 932,000 km2 now protected (green)}

The new legislation came into force on 1^st January 2017 and applies across an area of 932,000km² (Fig. 1 green zones, now protected). It has particular impact across the 15% (143,000km²) of EU waters (primarily continental slope) that has traditionally been fished to 1500m depth. The new legislation will benefit ~49 species of deep-sea fish, including roundnose grenadier ( Coryphaenoides rupestris), black scabbardfish ( Aphanopus carbo), birdbeak dogfish ( Deania calceus), orange roughy ( Hoplostethus atlanticus), rabbit fish ( Chimaeridae), blue ling ( Molva dypterygia) and anglerfish ( Lophius piscatorius) [3.1]. In Scottish ports in 2012, 3,737 tonnes of three deep-sea fish species (black scabbardfish, blue ling and Greenland halibut) were landed by all vessels combined. Of this, 94% were landed by foreign vessels, mostly French and Spanish. Since 2016, International Council for the Exploration of the Sea (ICES) data indicate a large drop in landings of ecologically important deep-sea target species, notably of the endangered roundnose grenadier. Catches of this species decreased from 38 to 30 tonnes in ‘Division 5.b.’ (area north of UK); from 725 to 202 tonnes in ‘Division 6’ (area north-west of UK); and from 4 to 0.8 tonnes in ‘Division 7’ (area west of UK) [M]—some fish are still caught as they can move to shallower waters, which aren’t protected. Furthermore, within the ICES report an observation from the French observers at sea programme, which monitor landings and discards, reported that discards as % weight of total catch had decreased from 5% weight in 2016 to an almost negligible 0.7% weight in 2019, and that this was related to, a) a change in the depth of the French fleet towards shallower depths; and 2) attempts to avoid areas where discards are high [M].

Following the United Kingdom’s exit from the EU, the adopted EU regulation 2016/2336 has been converted and preserved in the UK as retained EU law, thus binding UK fisheries to this legislation. Furthermore, in September 2020 the Scottish Government designated a 100,000km² area of national waters in the North-East Atlantic as the West of Scotland Marine Protected Area (MPA). This deep-sea marine reserve provides additional protections to some of the deepest parts of Scotland’s seas. The region falls outwith the area protected in the EU regulation, but the EU regulation was used as the basis for the area, extending protections against trawling at depths below 800m within the MPA, the boundary of which follows the 800m depth contour of the seabed [N].

Additional impacts of the legislation include protection to sea floor cold-water coral reef and sponge ecosystems. Work at Plymouth University has shown that prohibiting trawl fishing below 800m will substantially increase the area of protection for vulnerable cold-water corals (Ireland: from 15% to 43%; UK: from 41% to 53%), sponges (Ireland: from 2% to 100%; UK: from 11% to 100%) and xenophyophore communities (Ireland: from 7% to 99%; UK: from 13% to 99%) [O].

Canine rabies is an infectious viral disease that is universally fatal following the onset of clinical symptoms. Rabies transmitted from domestic dogs is responsible for over 99% of human deaths from the disease. Annually, it causes ~59,000 human deaths worldwide, 3.7 million disability-adjusted life years (DALYs) and costs the global economy USD8.6 billion. Effective and timely rabies PEP is a vitally important tool for reducing rabies deaths while canine rabies remains endemic. But in Africa, it is often unavailable in the communities that need it most, while in Asia it is resourced at great cost and used wastefully to treat all dog bites.

UofG modelling research has delivered vital data for international policy and investment strategies. This work provided a crucial framework that supported new global policy on rabies PEP by the WHO. This policy, together with the models that predict the impacts of PEP investment, provided the basis for a decision by Gavi ( http://www.gavi.org/) to add rabies PEP to their global vaccine investment strategy. Gavi brings together key global stakeholders, including WHO, the World Bank, UNICEF, governments of donor and developing countries, the vaccine industry in developed and developing countries, research agencies and philanthropic organizations, such as the Bill & Melinda Gates Foundation, which are each represented on Gavi’s executive board.

Engagement with Gavi

In 2013, Gavi considered investing in rabies PEP as part of their 2015−2021 vaccine investment strategy (VIS). In an expert consultation, to which UofG’s Prof. Hampson contributed, Gavi considered a range of factors but decided in November not to support rabies PEP. In their decision, they cited key knowledge gaps that limited the feasibility of vaccine implementation, including a lack of consensus on PEP treatment regimens (10 different regimens were recommended and in use at the time), uncertainty about PEP demand and treatment-seeking behaviour, and the cost-effectiveness of different investment scenarios [A]. Gavi instead elected to fund a USD2 million ‘learning agenda’, awarded to WHO, to address these gaps for their next investment decision in December 2018.

Revision of WHO policy on rabies vaccines

A crucial step towards Gavi investing in rabies vaccination was for WHO to develop an updated consensus position statement on rabies PEP to address discrepancies between its earlier recommendations (2010) and how PEP was being used in endemic regions, and to consider evidence for newly proposed regimens that could be evaluated. To facilitate this work, in 2016 the WHO established a Strategic Advisory Group of Experts (SAGE) working group on rabies vaccines whose role was to develop practical and feasible recommendations to prevent human rabies. Concurrently, WHO used Gavi learning agenda funding to commission Hampson and Trotter to undertake two key modelling studies—the vaccine model [3.3] and the impact model [3.5]. In April 2017, WHO convened a meeting of the WHO Modelling Consortium to develop a consensus on the modelling approach and, through SAGE, to commission a portfolio of research from across the consortium, to address Gavi’s learning agenda and to feed data to the modelling studies led by Hampson and Trotter.

From June 2017, Hampson and Trotter discussed the findings of the vaccine model study with SAGE during several meetings, with SAGE endorsing a final, clear position on shorter and less costly PEP regimens in October 2017 [B]. The WHO published their position paper in April 2018 [C], ahead of Gavi’s investment shortlisting in June 2018 [C]. The WHO 2018 position paper draws on evidence about the magnitude of the global rabies burden established by Hampson et al. in 2015 (global burden study) [3.2] and the pivotal findings from the Gavi-funded/WHO-commissioned PEP modelling work [3.3], stating: “ ID administration of rabies vaccines provides a cost-saving and dose-sparing alternative to IM vaccination. ID PEP regimens use at least 25% less vaccine vials than IM PEP regimens. As numbers of patients seen in clinics increase, ID regimens become increasingly cost-effective, using up to 85% less vaccine vials” [C]. A summary document published by the chair of SAGE explicitly sets out the updates to WHO’s position on vaccine regimens, stating that, “ WHO now also recommends newer, shorter vaccine regimens that reduce costs, quantity of vaccine, and number of clinic visits…” citing the UofG research [3.1, 3.3, 3.4] throughout as background to changes [B].

Gavi invest in rabies PEP in their 2021–2025 investment strategy

Drawing on the IVIR-AC validated PEP regimens, the impact modelling study [3.4] was able to offer key insights into the health impact (future deaths averted), costs and value for money of various scenarios of investment in these PEP regimens, both with and without additional rabies control programmes. Hampson & Trotter shared these findings iteratively and responsively with Gavi to address the board’s questions [D]. In November 2018, Gavi announced the addition of rabies PEP to their 2021−2025 investment strategy [E]. The Gavi board’s documentation cited as strategic rationale for the investment case: 1) the WHO recommendations on the choice of regimen (2-site, 1-week ID regimen); and, 2) the UofG-Cambridge modelling projections, citing Hampson and Trotter [D, F]. The Head of Policy at Gavi said, “ The estimates that Dr Hampson and Trotter used formed the basis of our projections on future demand for and impact of rabies PEP. This was a critical foundation for determining financial implications for Gavi, the relative cost-effectiveness of rabies PEP and other important criteria to support the Board’s ultimate decision to approve the investment case… The synthesis of research contributed by UofG researchers helped to simplify what had been a complicated investment proposition—contextualising the global burden and identifying a universal and simple strategy” [D].

Rabies PEP is for the first time one of Gavi’s strategic goals, opening an investment window across the 57 countries eligible to apply for Gavi vaccine support for the next five years, which could prevent an estimated 489,000 deaths from rabies.

Emerging secondary impacts on national vaccination policies

Despite significant disruption to international discourse in 2020 ahead of the Gavi investment window, and in response to the WHO position on rabies PEP, several countries have changed, or are in the process of updating, their rabies PEP policies to bring them into line with WHO recommendations. Currently the Philippines, Nepal and Bhutan have revised guidelines; Bangladesh, Côte d'Ivoire, Madagascar and Cambodia are in the process of revising [G]. In India, Pakistan and Tanzania implementation has been more regional. In India the state of Himachal Pradesh issued new guidelines in response to the WHO position statement [H]. UofG researchers led by Hampson have also supported a switch to the 1-week ID regimen in the 28 districts of South Eastern Tanzania and in the Mara region in North West Tanzania.

Tanzania has the third largest livestock population in Africa (~30 million cattle), with up to 70% of households dependent on income generated from livestock and agriculture. Livestock diseases contribute to keeping households in poverty, by causing human illness; increasing costs for livestock owners; and reducing livestock productivity. UofG researchers have adopted a grassroots approach to research on FMD and anthrax in Tanzania over many years. They have collaborated with communities and institutions at local and national levels, to determine the most relevant and effective ways to monitor, prevent and treat these diseases. Their approach of multi-level engagement has alerted policymakers to the community burden of livestock diseases, thereby driving disease control and vaccine policies in Tanzania.

Surveillance and control of livestock diseases at the community and regional levels

UofG research has focused on the health problems of under-served communities in rural Tanzania. As a result, these communities are now equipped with tools to demonstrate the impact of livestock disease, and are better able to monitor and respond to disease. Since August 2013, UofG researchers have provided training in anthrax surveillance and case management to 60 community-based health workers (representing ~66% and 33% of the animal-health and human-health workforce, respectively) in areas of the Ngorongoro District that are at high risk of anthrax. This district has a population of 180,000 people and 1.8 million livestock, distributed across the UNESCO World Heritage Ngorongoro Conservation Area (NCA) and the Loliondo Game Controlled Area.

UofG researchers have also helped to develop protocols and validate diagnostics for anthrax testing of animal carcasses at the Kilimanjaro Clinical Research Institute [3.3]. These tests confirm the epidemiological links between animal and, indirectly, human cases (based on positive tests from animal samples) given that sampling of severely affected people is extremely difficult. Detection of anthrax has increased since implementation of testing in 2017, in turn prompting follow-up and the provision of free antibiotic treatment to affected people, preventing death in the most severe cases [A, C].

Case reporting was sporadic within the NCA before these diagnostic protocols were made available in 2018 [3.2–3.4]. For example, during 2015–2017, a mean average of 50 cases were reported annually at the principal hospital within the NCA (Endulen Hospital). In 2018, a total of 276 cases were recorded within the wider Ngorongoro District, with 6.5% mortality (18 deaths); in 2019, there were 299 cases, with 4.7% mortality (14 deaths). The Chief Medical Officer at Endulen Hospital, said, “ The activities of the anthrax project have led to enhanced awareness of the disease amongst clinicians…[and] we have benefited from improvements in case detection as a result of the work the anthrax field team are doing on the ground with community members” [A] . Within the community, the anthrax project has raised awareness of the need to report cases and seek treatment for affected individuals. Speaking to treatment provided at the household level by clinical officers as part of the project, the Chief Medical Officer indicated that is has “ enabled provision of antibiotics to patients who might not have otherwise been able to receive treatment due to their remoteness, and likely prevented the progression of anthrax cases, possibly even preventing deaths” [A].

Communication networks enabled by UofG researchers, including the anthrax WhatsApp working group, allow households to report suspected anthrax and FMD cases to UofG-trained health workers, who liaise with UofG teams and health authorities for follow-up. These networks also disseminate important information, such as infection sources and how to reduce disease spread. A Community Animal Health Worker said, “ The WhatsApp working group and the multiple workshops led by Glasgow researchers have widened the network of stakeholders, enabling connectivity between us in the community and those with decision making power all the way from the local leaders to the NCA authority, district-level authorities and even the Director of Veterinary Services. Through the WhatsApp group we are able to access and share data and information from all corners of the world, wherever the members happen to be” [B]. Improved, community-led surveillance has also resulted in increased numbers of animal disease cases being reported. Prior to 2016, local veterinary records reflected only 5–10 unconfirmed cases of animal anthrax per year [3.2, 3.4]; between April 2016 and October 2018, 491 anthrax-suspected livestock carcasses were tested. Of these, 75% were confirmed positive by molecular methods, indicating that communities accurately recognise anthrax [C]. These communities often have little choice to avoid grazing their cattle in such areas, highlighting the value of livestock vaccination as a strategy to prevent and control anthrax in Ngorongoro District.

National policy for surveillance and control of livestock diseases

The findings of UofG research have also heightened recognition among national officials and policymakers of the impact of livestock diseases on affected communities.

UofG research on FMD [3.1] has underpinned policy briefings for the Tanzanian Ministry of Livestock and Fisheries, and also Ministry workshops (in Oct 2013 and 2015), through which findings were shared; for example, the role of wildlife in FMD transmission and offering recommendations on vaccination programmes. In addition, UofG research provided key evidence to facilitate Tanzania joining the United Nations Food and Agriculture Organisation’s (FAO) ‘Progressive Control Pathway for FMD’ (PCP-FMD)—a globally-accepted framework for countries tackling this disease [D, E]. Before the UofG research, Tanzania lacked key data necessary to join Stage One of this pathway (identifying risk and control options). The Tanzanian Chief Veterinary Officer said, “ The [UofG] team has provided us with essential baseline socio-economic and epidemiological data to enter the PCP-FMD pathway and start developing country-specific disease management policies, including our own national FMD control plan in line with PCP-FMD” [E]. The ultimate goal of progression to the final stages of the PCP-FMD pathway would allow Tanzania to acquire official FMD-free status and trade cattle internationally. UofG research showing limited wildlife-to-cattle transmission risk in Tanzania also revealed that separating livestock and wildlife was unnecessary and ineffective in preventing FMD [3.1]. This work shaped the 2015 Tanzania Livestock Modernization Initiative, on whose steering committee Prof. Cleaveland sat, which set out the government’s commitment to improving the livestock industry. This initiative noted that Tanzania would not adopt veterinary fences to contain grazing land (as has been done in other African countries), thus avoiding the environmental and economic costs of such approaches [F].

UofG research and engagement on anthrax also led the Tanzanian government to identify this disease as a ‘priority’ zoonosis. In 2017, in recognition of her research expertise in this area, the FAO country office in Tanzania requested support from Dr Tiziana Lembo for the development of anthrax control plans with the Tanzanian One Health Coordination Unit. During August 2017–January 2018, Dr Lembo provided evidence-based input into the resulting ‘National Strategy for the Prevention and Control of Anthrax in Humans and Animals 2018–2023’ [G]. The Tanzanian Chief Veterinary Officer highlighted the contribution, pointing out that the document ‘ greatly benefited from the input of the anthrax research project led by the University of Glasgow and colleagues in northern Tanzania’ [H].

In December 2018, district-level authorities from the Ngorongoro District, engaged by the UofG anthrax project, initiated discussions with relevant Tanzanian Ministries about implementing and financing livestock vaccination programmes against anthrax. To provide a framework for this initiative, Drs Lembo and Forde worked closely with the NCA District Veterinary and Medical Officers on a situation analysis; they also developed recommendations for surveillance and prevention measures that would be strategic, locally specific and economical [C]. This strategy was submitted to the NCA Authority in January 2020. In April 2020, the NCA Authority agreed to provide TSH270 million (approx. GBP88,000) to the District Veterinary Office, which used the budget to operationalise and implement anthrax campaigns to vaccinate 273,000 small ruminants during July–August 2020; this targeted ‘at-risk’ areas and species identified by the UofG research [I]. The Tanzanian Chief Veterinary Officer said, “ The approach of the anthrax team has brought the voice of the communities to the attention of local- and national-level authorities, which is to be congratulated given that this is a well-known gap that often compromises our ability to act in response to the needs of affected communities” [H].

Towards developing a vaccination strategy for FMD

UofG research has showed that monovalent vaccines containing existing FMD virus strains can prevent outbreaks caused by the four serotypes circulating in Tanzania [3.1]. Since March 2015, MSD Animal Health has provided GBP73,408 in funding to support collaborative research with Lembo and Reeve to strengthen FMD surveillance and prevention in Tanzania at the community level (see section 3) [3.1]. The Associate Director at MSD said, “ We were interested in establishing a presence in Africa and contributing to FMD control in the most affected communities… UofG research has provided data and community-level expertise to inform our future strategy development at MSD Animal Health with regards to FMD in Africa—building capacity for surveillance, which has provided a level of strain-level surveillance that doesn’t exist elsewhere in Africa. Furthermore, the learnings from such research are being factored into how we can help in rolling out effective vaccination programs in the region…Through the partnerships the University of Glasgow have in Tanzania we have been able to contribute to a dialogue with relevant national authorities to define what the entry point to this market might be” [J].

The Tanzanian Chief Veterinary Officer said, “ We recognize that major hurdles to FMD vaccination still exist, particularly in relation to the availability of high-quality polyvalent vaccines that would be efficacious against the multiple virus serotypes and strains we have in Tanzania. Work by the University of Glasgow with industrial partners showing that some of the existing vaccine strains are protective against the four serotypes circulating in Tanzania offers great promise in this area. We look forward to working with colleagues at Glasgow to improve policies and strategies for FMD vaccine sourcing, importation and delivery, and to trial high-potency vaccine formulations on the ground” [E].

UofG expertise in veterinary epidemiology identified risk factors for injury and fatality among horses participating in flat racing and endurance riding, which in turn has raised awareness of the risks and driven improvements in equine welfare across these sports.

Benefits for flat racing in North America

Flat racing is a popular spectator sport, with prestigious races such as the 2019 Kentucky Derby attracting considerable interest in terms of track attendance (150,729 people); TV coverage (16.5 million viewers on US network NBC); and betting (USD165.5 million wagered). Racing also contributes USD15.6 billion directly to the US economy and supports more than 241,000 jobs across the sector. However, in 2008, a US Congressional committee called on the racing industry to improve its equine welfare record following three high-profile deaths, leading to creation of the EID. An average of 1.91 deaths per 1,000 race starts was recorded during 2009–2014 ( 4,165 deaths in total). With the average cost of a racehorse approximately USD80,000, and annual stud fees for a single elite male potentially worth more than USD10 million, racehorse welfare is of considerable economic importance to the sport.

Parkin has been the EID epidemiological consultant since 2008 [5.A], with the outcomes of his analyses reported annually [5.B]. His research revealed key risk factors associated with track deaths and catastrophic injuries leading to death [3.1, 3.2], which have evolved as the amount of information available in the EID grows each year. The value of this work is highlighted by the Executive Vice President, The Jockey Club of North America: “ Parkin’s guidance, direction and research have been mission critical in positioning the EID as the nation’s go-to resource for understanding and mitigating factors associated with increased risk of injury or fatality. Many of the safety procedures now in place at racetracks across the US can trace roots to Parkin’s research. He has materially reduced the incidence of injury and fatality to race horses in North America as evidenced by the national statistics” [5.A].

Although The Jockey Club of North America lacks the power to enforce regulation change directly, it acknowledges that Parkin’s findings have contributed to a considerable attitudinal shift in the racing industry: “ A culture of safety has been seeded in the US and germinated into an environment where stakeholders have all raised their level of focus upon the health, safety and welfare of the horse. His messages effectively distil a very complex and statistically sophisticated analysis into language everyone involved in the business of breeding, raising and racing horses can understand and execute upon” [5.A]. Other racing organisations concur [5.C]: “ The public has no tolerance for the deaths of racing horses and the entire industry has had to perform serious self-examination to identify ways to improve racing safety and health outcomes. Parkin’s identification of risk factors allowed for understanding of where and how risk could be mitigated and offered the opportunity for rational discussions and mindful decision making” (Executive Director, Racing, Medication & Testing Consortium; RMTC); “ Risk analysis allows horseracing to better focus their safety efforts [through] understanding that there are horse factors and racecourse management factors that put horses more at risk of injury. Parkin’s research using EID data has received much greater public and policy attention than most other academic research related to horseracing” (Equine Medical Director, California Horse Racing Board; CHRB).

Working through an extensive network of participating stakeholders and racecourses, The Jockey Club of North America Thoroughbred Safety Committee has recommended actions based on the risk factors identified by Parkin [3.1, 3.2] to promote an industry-wide improvement in safety records. These recommendations have been re-enforced through racetrack accrediting organisations such as the RMTC and the National Thoroughbred Racing Association (NTRA) Safety and Integrity Alliance, as well as via biennial summits on the Welfare and Safety of the Racehorse co-hosted with the Grayson–Jockey Club Research Foundation (Parkin presented EID findings at this summit in 2015, 2016, 2018 and 2020) [5.A, 5.C]. For example, the 2019 NTRA Code of Standards requires all of its members to report injuries and fatalities to the EID, including the findings of post-mortem veterinary examinations, with protocols in place at racetracks to monitor such events [5.D]. The efforts of these national bodies have led to local and regional changes in North America. In October 2018, the CHRB amended Rule 1588 on race start eligibility to require veterinary checks for all horses that had not raced for 12 months (affecting over 1,700 horses per year) and for first-time racers aged 4 years or older [5.C, 5.D]. This rule change was based on a review of racing-related fatalities that reflected key findings of UofG data analyses [3.2]. In March 2019, all 29 organisations representing the Mid-Atlantic region Thoroughbred racing industry voted to adopt and implement a five-point strategic plan to reduce equine fatalities, including establishment of best practices to identify horses at increased risk of injury and implementation of protective factors to reduce such risk, with all racetracks required to report to the EID [5.D]. This region comprises the largest concentration of Thoroughbred racing in the USA, with around 90,000 race starts at 14 racetracks annually.

Local changes have resulted in a year-on-year decrease in the rate of fatal injuries across North America. The rate dropped by 24% between 2014 and 2019 (equating to approximately 135 fewer racecourse deaths/year) [5.B, 5.E]. Indeed, the 2019 fatality rate (reported in March 2020) was the lowest within the past decade (1.53 per 1,000 race starts versus 2.00 per 1,000 in 2009), with the rate on dirt surfaces also falling to a low of 1.60 per 1,000 race starts (versus 2.10 in 2009) [5.B, 5.E]. These findings were widely reported by the racing and equine media [5.E]. As highlighted above, reductions in fatal injuries have been realised through increasing industry awareness and scrutiny of equine welfare. An EID evaluation presented by Parkin at the Seventh Welfare and Safety of the Racehorse summit (June 2016) demonstrated that approximately 35% of the reported drop in fatal injuries could be attributed to mitigations of risk factors identified through UofG research [3.1, 3.2]; namely, race distance, race intensity, time with same trainer, age at first start, male horses and dirt track in sloppy/muddy condition (‘off-dirt’) [5.E]. The remaining 65% reflected veterinary history, training records, changes to medication regulations, local modification and natural/random variation [5.E].

In August 2020, the Kentucky General Assembly's Interim Joint Committee on Licensing, Occupations, and Administrative Regulations passed a raft of medication rules, including prerace withdrawal time for phenylbutazone extended from 24 to 48 hours [5.F]. This decision was based on Parkin’s demonstration of phenylbutazone as a risk factor for injury and fatality [3.3]. The wider role of medication in race-related risk was acknowledged by the US Congress on passing the Horseracing Integrity and Safety Act to develop and implement a medication control programme (September 2020) [5.F]. Finally, The Jockey Club of North America has launched an electronic equine treatment records system that will enable analysis of medication patterns (type/frequency) for potential associations with increased risk of injury or fatality [5.A].

Global benefits for endurance riding

Each year, approximately 300 endurance rides take place under mandatory FEI rules in 50 countries worldwide. During the period 2010–2017, 32% of all horses participating in these events were eliminated owing to FTQ. Endurance riding had been criticised for an excessive rate of injuries and fatalities. In November 2013, the FEI Endurance Strategic Planning Group called for immediate and sustainable action to provide a permanent solution to this problem [5.G, 5.H]. As a result, the Injuries Surveillance System (ISS) was created to enable a consistent approach to managing the FEI data (February 2014) [5.G, 5.H].

The GEIS uses ISS data to identify risk factors for FTQ during endurance rides [3.4–3.7]. Parkin’s findings were first announced at the FEI Sports and Endurance Forums in 2017 [5.I]. These presentations provided a clear message that speed and insufficient rest periods are key factors for FTQ. The UofG data also provided crucial evidence to substantiate regulatory change by the FEI General Assembly to revise mandatory rest periods and so minimise equine injury (November 2017) [5.I]. The proposed changes added 7 days to between-competition rest periods across all distances for horses with an average ride speed greater than 20 km/hour (even if they do not complete the ride) and where there is evidence of irregular gait or any invasive treatment [5.I]. These changes would prevent up to 10% of FTQs and had been due to take effect in January 2019 [5.I]. However, the FEI decided to postpone as it had plans to go further with the rule changes.

In October 2018, a new five-person FEI Temporary Committee, which included Parkin, was created to review the entire rule book, and re-focus the sport on endurance riding rather than endurance racing [5.G, 5.J]. The key rule changes were presented at the 2019 FEI Sports Forum in April 2019 [5.J]. Substantial changes were made, with many rules altered based on analysis and evidence provided by Parkin and Bennet [3.4–3.7]. These included changes to the penalties for riding fast and not completing; extended mandatory out of competition periods; stricter regulations at veterinary inspections; changes to qualification regulations based on previous successful completion of rides, including as a specific horse–rider combination; and course design. Evidence demonstrating the clear link between his analyses and the most contentious rule changes was presented by Parkin to all national federations prior to the 2019 FEI General Assembly [5.J]. The new set of welfare rules was voted through by the National Federations at the FEI General Assembly meeting in November 2019 [5.J], with some changes coming into force on 1 January 2020, and the remainder introduced on 1 July [5.J]. The 2020 endurance riding season saw many events cancelled owing to COVID-19 lockdown and travel restrictions; therefore, the full benefits of these rule changes will be seen only from 2021.

Pain is a vital sign and veterinarians widely recognise its central role in animal care and welfare. However, pain assessment in companion animals is challenging due to the inherent barriers to communication, and the species-specific response to and presentation of pain. The UK companion animal population included an estimated 10.9 million cats and 9.9 million dogs in 2019, up to 80% of which encounter pain through injury or surgery at some point in their lives. Since August 2013, the UofG acute pain tool for dogs (CMPS/CMPS-SF) has continued to broaden its reach geographically as a widely used resource in veterinary practice and to support drug trials within pharmaceutical companies. Within this period this tool is now joined by new tools based on UofG research—to assess acute pain in cats and chronic pain through HRQL in dogs—which have also been further developed and promoted through a new commercial enterprise.

Commercial development of the UofG pain and quality of life assessment tools

In November 2013, Prof. Reid founded NewMetrica Ltd. ( newmetrica.com) to commercialise and support wider adoption within the veterinary community of the tools developed at the UofG. NewMetrica acquired the UofG research through an EasyAccessIP knowledge transfer agreement [5.A1] and continued to build on the core UofG research, to refine the tools. In 2014, NewMetrica launched a discrete website for the 46-item GUVQuest [3.5, 3.6] and re-branded it as VetMetrica-Canine ( vetmetrica.com), for use by veterinary surgeons and pet owners in the UK and Europe to assess HRQL. In 2018, NewMetrica refined VetMetrica-Canine into a shorter (22-item) tool that retains the capacity of the prototype to measure HRQL, but improves owner compliance with completing such assessments [5.B]. NewMetrica also built an alert system into the online tool, which notifies veterinary practices of changes in the health status trend of a canine patient detected through an owner’s use of the tool. In 2017, NewMetrica also produced a definitive version of the CMPS-Feline (acute pain assessment tool for cats) for use in veterinary practice, by integrating the UofG feline pain assessment [3.3] and facial expression scale [3.4] into a single tool [5.B].

NewMetrica currently employs two staff members (increasing to four, as required, to support research operations), and has commercialised the tools within two key markets: 1) providing the pharmaceutical industry with valid, reliable and responsive outcome measures to support their clinical trials for post-marketing and regulatory purposes; and 2) in clinical veterinary practice, where the tools deliver benefits for vets and pet owners through improved clinical monitoring, better communication and decision-making [5.A1]. These activities have led to the following impacts:

Pharmaceutical industry: regulatory changes and medicines approval

A number of pharmaceutical companies have used the acute pain and HRQL tools in clinical trials to support regulatory approval and are included in official documentation that accompanies veterinary products:

1. Elanco Animal Health Inc (Indiana, USA) used CMPS-SF to assess efficacy in two studies for two preparations of the nonsteroidal anti-inflammatory robenacoxib for dogs (oral and injectable), demonstrating their effectiveness for postoperative pain and inflammation. These formed part of the regulatory submission to the US Food & Drug Administration (FDA), approved in May 2016. The same studies were also described in a post-authorisation approval (tablet and injection) from the European Medicines Agency (EMA) for a new indication of postoperative pain and inflammation in dogs (December 2019) [5.C].

2. Aratana Therapeutics (Kansas, USA) used CMPS-SF in field studies to assess product effectiveness of their novel local anaesthetic bupivacaine liposome injectable suspension (NOCITA) for cranial cruciate ligament surgery. These formed part of the regulatory submission to the FDA, approved August 2016. Between 2016–18, Aratana earned USD10.8 million on NOCITA product sales, with year on year growth. The slow-release formula addressed an unmet need for postoperative pain control post-surgery in the home environment. The Massachusetts Society for the Care & Protection of Animals stated, “ The introduction of NOCITA into the veterinary market has allowed us to greatly improve how we provide post-operative analgesia to our patients” [5.D].

3. In November 2015, Royal Canin (Gard, France) launched their Weight Management Programme for vet practices across the UK. Canine obesity affects nearly 60% of dogs in the UK. Royal Canin used the UofG HRQL-canine tool to provide the first scientific evidence that weight loss improves quality of life ( German et al., 2012), which is now one of the key scientific marketing claims for their weight loss programme [5.E].

Since its incorporation Newmetrica has worked closely with the US FDA Center for Veterinary Medicines (CVM) to ensure compliance with the US government’s 21 CFR 11 standard for electronic data capture. This ensures that the data and modelling resulting from the web-based apps meets the FDA CVM’s stringent quality assurance, opening the market for wider use in US clinical trials [5.F].

Change in veterinary professional practice

The acute pain dog tool (CMPS-SF) has been translated into Italian, German, Spanish, Norwegian, French and Swedish, addressing the absence of validated pain assessment tools in these languages. Each translation required cross-cultural validation (e.g. Italian in 2018 [5.G]) to define behavioural expressions. The CMPS-SF tool and GUVQuest (now ‘VetMetrica-Canine’) are available online via NewMetrica and are also described in the WSAVA Guidelines for the Recognition, Assessment and Treatment of Pain, which was published in May 2014 and is endorsed by veterinary associations in 67 countries [5.H1]. The full text of the WSAVA pain guidelines have been accessed 38,595 times (with 13,842 PDF downloads) since publication [5.H2]. Furthermore, the British Small Animal Veterinary Association (BSAVA) re-printed the CMPS-SF in their BSAVA Pocketbook for Vets (2^nd Ed., February 2019) and BSAVA Guide to Pain Management in Small Animal Practice (March 2019) with 2,497 and 6,256 copies issued, respectively, either through direct sales or provided through member benefits [5.I].

Veterinary practice and owner engagement with the pain and quality of life assessment toolsThe UofG-research based acute pain tools are widely used in clinical practice. Between January 2016 and December 2020, Newmetrica issued online licenses to 2,455 practices in 76 countries, permitting use of the CMSF-SF tool (dogs), with the greatest volume in the UK, USA, Spain, Australia and Canada [5.A2]. Over the same period, Newmetrica issued online licenses to 2,206 practices in 67 countries for the CMPS-Feline tool, primarily in the USA, UK, Spain and Canada [5.A3]. These numbers reflect changing practice in veterinary clinics. The President of the European College of Veterinary Anaesthesia and Analgesia said, “ The short form of the GCMPS has allowed us to considerably raise the bar in terms of quality of analgesia in dogs. However, cats are a very different matter. Assessing pain in cats has always been difficult… the Glasgow group has given the acute pain scale for cats the robustness required for it to succeed in practice and be used after many different procedures” [5.J]. Meanwhile, Newmetrica’s online chronic pain tools platform vetmetrica.com has raised awareness among pet owners of subtle changes in behaviours related to pain and welfare issues, thus extending the reach beyond veterinary practice. Since launch in January 2014, vetmetrica.com has registered 169 veterinary practices and 2,179 owners (N.B. pharmaceutical companies also count as a single owner). The tool allows vets to involve owners with clinical follow-up, or to monitor an otherwise healthy pet and alert the vet to a change in health status. To date, 12,194 owner assessments and 2,428 vet assessments have been completed [A], showing active engagement with the tool. Referring to owner-reporting on their pets, the Director of a veterinary practice stated, “ *[VetMetrica’s] real time monitoring allows for early identification of problems leading to quicker intervention and the results can be used to help guide owners’ decisions and monitor responses to treatment” [5.K]. This change in collaborative vet-owner pet monitoring is recognised by the pharmaceutical industry. On their Rimadyl^® (carprofen) product page, Zoetis Inc. describe the value of helping owners to work collaboratively with vets to understand, monitor and manage their dog’s osteoarthritis to improve their quality of life [5.L1]. This claim cites a 2018 study, undertaken with NewMetrica, in which owners used the VetMetrica-Canine tool to monitor the improvement in chronic pain of their dogs while on long-term treatment [5.L2]. Zoetis have licensed the tool from Newmetrica (November 2013–present) and use it in their Osteoathritis Checklist—a tool designed to facilitate collaboration between vets and owners for this purpose [5.L3]. Zoetis partnered with the National Association of Veterinary Technicians of America (NAVTA) in 2018 to create a professional training course to introduce the tool [5.L4]. Zoetis have also incorporated the VetMetrica tool into their PetDialog mobile app, which is offered via veterinary practices to allow owners to assess quality of life, build a pet profile and monitor health [5.L5].

Professional education and supporting prescribing

A key impact pathway for the tool uptake into clinical practice has been through continuing professional development (CPD) delivered to drug companies and their partner veterinary practices. Five veterinary pharmaceutical companies have licenced the CMPS or HRQL tools for marketing and educational purposes since November 2013 (Boehringer Ingleheim, Germany; Zoetis Inc., USA; Animalcare Ltd., UK; Ceva Animal Health, UK; and Dechra Pharmaceuticals, UK) [5.A4]. Between January–December 2016, Boehringer Ingelheim partnered with NewMetrica to deliver CPD on CMPS-Feline in 630 veterinary practices and to 3,779 professionals (vets and vet nurses); the tool was well-received, with the majority of attendees adopting it for use in their practices. Boehringer also offer an online white-label version of the tool to support prescribing of their Metacam® (meloxicam) drug in cats ( www.metacam-painscale.co.uk), which has been loaded 5,171 times since launch in March, 2020—even though Covid-19 has interfered with marketing of the app. Accompanying this were five education webinars on using the CMPS-Feline tool, viewed collectively 2,800 times as part of the Boehringer Academy [5.M1]. Similarly, AnimalCare Ltd. offer their own branded versions of the Glasgow CMPS tools for cats and dogs within ‘The PAC’—their ‘Practice Assistance Centre’. The PAC is available to their network of veterinary practices, and has registered 540 users since launch in April 2020 [5.M2].