Impact case study database

King’s research was central to the development of two new classes of drugs which can prevent migraine, addressing a huge unmet clinical need. These drugs are highly effective, well-tolerated (a significant issue for previous therapies), and effective in patients who failed to respond to generic therapies. As a direct result of our research, five new therapies have been licensed in the US and EU, and made available to 500,000 patients in the US (5,300 in the UK). The significance of this work in transforming the treatment of migraine and the lives of migraine sufferers, has been recognised with the 2021 Brain Prize – the world’s largest neuroscience prize – and the 2021 ABF Scientific Breakthrough Award, to Professor Goadsby.

The FDA and EMA approve novel, effective migraine therapies for use in the US and Europe based on King’s clinical trials. Large phase 2 and 3 clinical trials, in which King’s researchers played a major role, of the drugs Aimiovig (Erenumab; Amgen), Ajovy (Fremanezumab; TEVA Pharmaceuticals) and Emgality (Galcanezumab; Eli-Lilly), showed that these novel drugs are safe to use in humans and effectively treat and prevent migraine. These trials provided primary evidence upon which, in 2018, regulatory approval for use of these drugs was granted by two of the largest regulatory bodies globally, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Securing regulatory approval from the FDA is a legal requirement for the sale and use of drugs in the US, and from the EMA for the sale and use of drugs in Europe [A-C]. To date, these novel medicines have been approved in more than 40 countries [C]. In 2020, King’s clinical trials also provided the critical evidence for the further approval of Emgality as the first in class treatment for cluster headache by the FDA and EMA [C].

First tailored migraine therapies are recommended for use in UK clinical guidelines based on King’s research. The National Institute for Health and Care Excellence (NICE) in England and Wales, and the Scottish Medical Council (SMC) in Scotland, are the UK bodies providing evidence-based guidance on the best and most cost-effective drugs and treatments available. Any new drug must be recommended by NICE or the SMC for use in the NHS. In 2019 NICE recommended Fremanezumab for the treatment of chronic migraine in patients who have not responded to 2-4 other treatments; King’s research was central to appraisal of the drug [D]. Further to this, in 2020 NICE recommended another of the novel treatments, Galcanezumab, for the treatment of both chronic and episode migraine, also drawing on King’s research [D]. In 2019 the SMC advised the use of Erenumab and Fremanezumab for chronic migraine sufferers, citing the trials led and co-ordinated by King’s [E]. Anyone who has suffered at least 8 migraine days per month and has not responded to three different treatments can now benefit from these drugs, which NICE initially estimates as 5,300 people. These are the first drugs of their kind available to patients in the UK.

Enabling effective, evidence-based campaigning by the Migraine Trust. King’s research has informed the work of the Migraine Trust charity which provides information and support to migraine sufferers, and campaigns on their behalf. The work directly influenced the Migraine Trust’s response to NICE consultations on the novel antibody therapies, as the MT Chief Executive explains: “Our collaboration with King’s researchers facilitated our comprehensive understanding of the importance of the treatment. This knowledge fed into our design of a patient survey, for our submission as part of the NICE technology appraisal process, allowing us to successfully contribute to the March 2020 decision by NICE to bring this drug [Fremanezumab] to the NHS” [F]. The charity welcomed the NICE decision influenced by King’s work: “We are delighted that for the first time chronic migraine patients in England and Wales will be able to access an effective drug on the NHS that has been specifically designed to prevent migraine attacks. Migraine is a painful, debilitating, and exhausting brain disease and it is vital that people living with this awful condition have access to the best treatments available” [F].

King’s research has led to financial benefit for pharmaceutical companies Amgen, Eli-Lilly, TEVA. Following the 2018 approvals, the three novel antibody drugs have been marketed by these companies, creating millions of dollars in revenue: In the last quarter of 2019 alone, company accounts report revenues between 25 and 90 million USD, with an estimated 1 billion USD per annum market [G].

First FDA approvals for new small molecule class of migraine drugs, crucially shown to be free of medication overuse headache [H]. While earlier in development than CGRP antibody therapies, the first drugs from the second novel class – the small molecule-based gepants – are now available. In December 2019 the FDA approved the first-in-class drug Ubrogepant for the treatment of migraine, followed in February 2020 by approval for the drug Rimegepant; King’s research provided evidence supporting the latter decision. Importantly, a 2020 King’s study showed that this class of drugs does not have the side-effect of medicine-overuse headache common to other treatments; for migraine sufferers, this is in itself a game-changer. The significance of these approvals – with others in the pipeline – is that when this class of drugs comes off-patent, they will be incredibly inexpensive to produce – unlike the antibody drugs, which are complicated and expensive to make. This means that these early steps pave the way for phenomenal impact through migraine treatments which will have far greater reach, and can be made available to everyone, around the world.

New drugs are already being used to treat thousands of migraine patients in the US, and allowing clinicians to treat patients more effectively. In the US more than 500,000 patients are already being treated with the new drugs [I]. A consultant neurologist of the Mayo Clinic in Arizona – which sees 2500 patients a year of whom 80% suffer with chronic migraine – explained that over 60% of patients have responded to the drugs. He notes other benefits, most notably, that these therapies do not restrict blood vessels, or cause severe headaches when overused, unlike previous treatments, saying: “as a result of this ground-breaking research, we have witnessed a wholly unprecedented breakthrough in this field with the FDA-approval of 6 new CGRP targeted biologics and drugs for the acute and preventive treatment of migraine. These new therapies have completely transformed our practice as clinicians” [I1]. The President of the American Brain Foundation (ABF) also explained that it is the impact of King’s research for treatment and patient benefit which is recognised by the ABF’s Scientific Breakthrough Award 2021: “within the past three years only… approximately 1 million patients in over 40 countries around the world have been treated with these therapeutics” [I2] .

New drugs improve the quality of life of migraine sufferers in the UK: “I have been given my life back”. According to NICE estimates, of the 58,900 people who experience chronic migraine in the UK, only 9% currently receive the best existing generic treatment (Botulinum Toxin A), with 53,500 people receiving only ‘best supportive care’ – not treating the migraine itself, but supporting patients to cope with its effects as far as possible. NICE predict that 11,700 people in the UK can now receive Fremanezumab [J] and, based on trials showing the drug to be effective in 45% of patients, predict that 5,300 migraine sufferers will therefore benefit. With the recent further recommendation by NICE for the use of Galcanezumab for not just chronic, but also episodic migraine, many more migraine sufferers in the UK will benefit.

Those migraine sufferers who have already received the treatment say that they have been given their life back: “My family no longer have to see me in the depths of depression and with no hope that life will ever get better again" [F]. These novel therapies improve quality of life, particularly for migraine sufferers who have previously tried 2–4 unsuccessful treatments. Migraine is debilitating, leaving many sufferers unable to work, as one patient reports to the NICE consultation on Fremanezumab: “It [chronic migraine] defines what I am able to do, how I am able to function, how I’m perceived by the world and disables me beyond belief” [K]. Patients who received one of the new therapies trialled by King’s, report being able to return to employment, reduced side effect and improved mental health: “(I) have been taking Aimovig [Fremanezumab] for 6 months and it has helped so much I can’t even put it into words” [K].

“I’ve now been on Aimovig [Fremanezumab] for the last 6 months and all I can say is that it’s been life changing. I no longer live in fear of the next migraine and I no longer have a permanent headache. Gone is the gastroparesis and the nausea. Gone is my hyperosmia. I no longer have debilitating fatigue. Bright lights no longer bother me, and I can drive at night. I’ve started to volunteer with a view to returning to work. It’s amazing” [K].

“I received 3 months Fremanezumab… as part of the FOCUS trial at King's and have been taking Erenumab for the last 12 months as part of the free-access scheme. These medications have been more effective than any others for me and have allowed me a significant reduction in pain and an increase in functional ability. I no longer want to die.” [K].

King’s research brings an innovative treatment option to women for a problem which has been historically overlooked or trivialised. Women need non-pharmacological treatment options to manage not only the impact of vasomotor symptoms, but also to alleviate depression and anxiety that so often accompany and exacerbate night sweats and hot flushes.

King’s research into the use of CBT for the treatment of menopausal symptoms has shaped national and international policy and guidelines. King’s CBT research (3) was the only work of this kind cited to support the inclusion of CBT as an effective treatment for anxiety and depressed mood during menopause, in the first menopause NICE Guideline in 2015, NG23: Menopause: Diagnosis and Management [A1]. This work also influenced NICE guidance in recommending that GPs and health professionals should provide menopausal women with information and advice about CBT [A2]. Based on her body of research, King’s researcher Professor Myra Hunter was appointed Expert Advisor on the NICE Guideline [A3]. Moreover, based on King’s research the Chief Medical Officer’s 2015 report recommended CBT for symptoms in working women: ‘Non-pharmaceutical treatments such as cognitive behavioural therapy are helpful in reducing the impact of menopausal symptoms .' [A4].

The North American Menopause Society (2015) is the authoritative US source advising healthcare workers and patients. In their position statement (2015) it recommends CBT as one of the few effective non-hormonal treatments available for menopausal women, referencing King’s research. This is a level 1 recommendation, i.e. the strongest possible [A5].

King’s research on CBT for menopausal symptoms has been recommended to healthcare professionals in the UK and is being implemented. In a partnership with the British Menopause Society (BMS), King’s academics produced a factsheet for healthcare professionals [B1], which was endorsed by NICE in 2017. This has changed practice by providing high quality evidence supporting drug free treatment. It has been on the BMS website since 2017, but download figures are only available for February 2019 – November 2020, during which it had 7,162 page views and 565 downloads [B2]. Furthermore, an annual two-day course set-up in collaboration with the British Menopause Society has been run four times since 2018 and has trained 86 health professionals such as GPs, clinical psychologists, CBT therapists, counsellors, and breast cancer nurses to run CBT groups for women, and there has been further training of breast care teams in hospitals [B2, B3]. A treatment manual published by Routledge in 2015 [B4] has been bought by over 300 health professionals to date as part of their training, to enable them to use the treatment in their practice [B5]. A BMJ Practice paper on non-hormonal treatments for menopausal symptoms recommends CBT for menopause, based on King’s research [B6].

King’s research has supported tens of thousands of women with affordable and easy to access CBT treatments. Healthcare workers who have taken the BMS two-day course [B2] have successfully reached thousands of women both directly and through other healthcare workers, for example one practitioner in Scotland estimates she has reached 1,850 people [C1]. In partnership with the BMS King’s researchers produced an easily accessible fact sheet for women, hosted on the patient arm of its website, Women’s Health Concern (WHC) [C2]. Between November 2017 and November 2020 this had 59,184 page views, and 1,291 downloads [B2], being used beyond the UK: “For many women who utilise our service, Myra, your work has changed their lives. We have a wait of approximately 4 months for a new patient appointment… I routinely send out your Women’s Health Concern factsheet prior to their appointment to assist with managing their symptoms ” [C3, C4]. In 2014 King’s researchers launched a self-help book ‘Managing Hot Flushes and Night Sweats’ [C5] to empower women to use the treatments themselves, and in their practices. Now in its second edition, almost 2,000 copies of the book have been sold [B5].

CBT for menopause has also captured the imagination of the media with in-depth coverage by several national outlets [C6]. A 2018 BBC1 documentary The Truth about the Menopause presented by Mariella Frostrup featured King’s research, with feedback from those who used CBT during this programme including comments such as “transformational,” “very useful” and “I’m just Miss Chill now” [C7].

The Australasian Menopause Society also recommends and links to the resources hosted by the WHC [C8].

King’s CBT for menopause has been used in marginalised communities. King’s researchers worked with Handsinc charity in Hackney to develop the “Reclaim the menopause” group sessions for BAME women in the community who might not otherwise easily access services. Around 200 women have attended sessions [D1] and they report: ‘Strategies that we learn here, we pass on to other women who are interested. I’m telling my sisters, who are all over 50 and going through it’ [D2].

King’s research has helped women in the workplace manage their menopausal symptoms.

The Chartered Institute of Personnel and Development (CIPD) now recommends CBT treatment in their 2019 report ‘The menopause at work: a practical guide for people managers’ [E1] based on NICE recommendations and King’s research in the workplace (3,4,6). The BMS also have a factsheet for employers [E2]. The charity Henpicked is one of the UK's largest, fastest growing communities for women over 40, and has created online resources [E3] based on King’s research. It also runs seminars in the workplace on menopause, and King’s CBT and research is an important element in their training. Over the past four years hundreds of employers have attended their training sessions, most recently 120 in the three months from September - November 2020 [E4]. Feedback from the Department of Education after a seminar included “never seen such positive feedback after any session” [E5]. TUC Wales has produced a toolkit for trade unionists ‘The menopause in the workplace’ [E6] which also draws on many of the resources King’s research has informed [e.g. A1, A4, E2].

King’s researchers partnered with Turning Point, a UK charity that delivers mental health care to over 100,000 people with addictions and severe mental health problems. Its Rightsteps initiative supports over 7,000 people in a workplace health and wellbeing programme that benefitted from King’s research. King’s academics were contracted to develop and launch an online version of CBT for menopause. This was launched on World Menopause Day, 18 October 2020 [E7], and is already available to all Turning Point staff. It is currently being rolled out to service users who wish to know more about menopause, as well as being incorporated in Rightsteps wellbeing packages.

King’s research has underpinned partnerships with cancer charities. Breast Cancer Care (the main UK charity for breast cancer patients), has run 12 CBT group workshops since 2014 in NHS facilities across the UK, attended by 150 women (2019) [B3].

Maggie's is a charity providing free cancer support and information in centres across the UK and online and has partnered with King’s to make King’s CBT for menopause available to women accessing their services. King’s staff are currently training clinical staff to deliver online CBT in 6 centres, with a further 18 centres planned [F1].

Women report life-changing impact from King’s CBT. Women report King’s CBT brings a restored sense of control: “I've found it to be a godsend - hot flushes don't last for as long as you think, you can learn what triggers a hot flush and … at least be prepared that it's likely to happen”, with some reporting benefits that extended beyond their menopausal symptoms: “I've found it to be a very interesting, useful read, and some of the skills I've learnt I'm now using in other areas of my life .... with my stressful job for example. Thank you Professor Hunter and Ms Smith - just wish I had been told about these coping skills sooner” [G1].

Since 2014 King’s researchers have continued to help the UK Government prepare for potential emergencies and major incidents. Working to understand how the public behave in a crisis, they have considered both specific scenarios and broader principles. As a result they have also become ‘go to’ advisers when such events occur, and are called upon to support the national emergency response in real time, most recently during the COVID-19 pandemic.

Improving the UK Government’s preparations: contingency planning and emergency response policy. King’s expertise has been used by the UK Government, Local Authorities and Executive Agencies in developing policy and contingency plans that better prepare the country to handle major national incidents. Notably, this has led to the impact of emergencies on public behaviour and to mental health being considered more fully within this process.

(i) Advising the Civil Contingencies Secretariat (CCS). The CCS (an executive department of the Cabinet Office) is responsible for UK emergency planning, ensuring resilience in the face of major incidents and disasters. This includes risk assessment, contingency planning and the emergency response – supporting the Civil Contingencies Committee (COBR), formed during major incidents and national emergencies. King’s worked with the CCS on the 2014-2017 National Risk Assessments, used to plan for future crises [A]. An Assistant Director said this input was “crucial to ensuring that the government and local emergency responders are able to anticipate and plan for the behavioural impacts of emergencies”, and explains that “the work…has reached over 200 policymakers across HM Government, ranging from permanent secretaries and chief scientists of most government departments to specialists and analysts within executive agencies. Over 700 specialists from local authorities, police forces, fire and rescue services, ambulance services and utility providers have used (this) work to inform local preparations for dealing with emergencies; this figure equates to approximately 50% of all risk specialists in the local responder community”.

(ii) Informing contingency planning for a national power outage. King’s review of how people were likely to respond to a national power outage (2) informed contingency planning for this scenario, one of the most significant risks identified in the UK National Security Assessment. A CCS Assistant Director said this “directly influenced the shape of work across government to improve the UK’s resilience and preparedness for a widespread power outage… Your findings on the value of early and consistent communication with the public in the wake of a power outage have been especially valuable, and have been directly incorporated into a post-incident national communications strategy which was tested by Ministers in a table-top exercise last year…” [B, C] .

Flooding: Opening a 2017 House of Lords debate on climate change and health, Baroness Walmsley highlighted King’s research (2): “Although relatively few people die from drowning during UK floods, the psychological trauma and effects on mental health… are considerable. A UK study found that flood victims were more than six times more at risk of depression and anxiety and seven times more at risk of PTSD than the general population.” [D1]. The Parliamentary Committee on Climate Change progress report highlighted that “successful flood recovery includes dealing with impacts on mental health and wellbeing… (which) are significant, prolonged, and extend beyond those whose homes are flooded” [D2]. King’s collaborators at PHE briefed DEFRA, leading to a strategic commitment ‘to improve people’s understanding of the impact of flooding and coastal change and the need to take action’ in the Environment Agency’s 2020 Flooding Strategy [D3; E].

Fostering resilience: King’s finding that most people have considerable mental health resilience (4) was important in the immediate aftermath of the 2017 London Bridge terrorist attack. Southwark Council’s Humanitarian Assistance Steering Group coordinated support for those affected, with a subgroup focused on the multi-agency response for psychosocial and psychological interventions including public facing communications. The Consultant in Public Health Medicine for Southwark Council on mental health explained that King’s research “informed and guided our thinking about managing the psychological sequalae of the major incident – both at population and clinical levels… (including) the decision to advise people to make active use of their existing social support networks” – noting that this work has since been picked up nationally, and revisited locally to help mitigate mental health impact of the COVID-19 pandemic [F].

Helping public officials and emergency responders communicate more effectively during an emergency. The way that information is communicated in an emergency can influence how people behave and, if done effectively, can reduce the risk of harm to them.

(i) Giving information not reassurance. King’s findings on the counterproductive nature of reassurance (5) informed the public health response to the 2018 Novichok incident in Salisbury. It informed PHE communication to the public and “training materials for PHE staff deploying into public spaces in Salisbury and Amesbury to answer questions and provide public health information related to the risks associated with the Novichok incident, for the general public” [E,G]. The Government Office for Science turned to King’s for advice on framing communication about the incident, drawing on the polonium 210 research [C]. This work was also drawn upon after the fire at Grenfell Tower; the Government Chief Scientific Advisor (GCSA) explained: “Dr Rubin was… a core contributor to the Scientific Advisory Group for Grenfell in 2019, which I chaired... (He) brought his expertise to bear in particular on the approach to community engagement taken by government departments on the Grenfell environmental testing programme… (He) provided valuable insight into the potential unintended effects of using ‘reassurance’ as the rationale for action, and promoted clarity in the communication of any technical results of this testing; this helped to inform messaging to local communities” [C].

(ii) Monitoring public reactions effectively, in order to communicate better. Following King’s work with the DHSC (1), NIHR awarded the King’s team ‘sleeper’ funding to enable them to quickly activate and support deployment of this tool at DHSC’s request [H]. In 2018, DEFRA and PHE used an adapted form of the survey tool to inform their communication with the local community following the Novichok incident [E,G].

Pivoting to support the UK response to COVID-19:

Drawing on expertise to give scientific advice to Government. King’s researchers have been members of the Government’s Scientific Advisory Group for Emergencies (SAGE) for COVID-19, which considered the scientific evidence supporting the Government’s pandemic response, reporting to the GCSA; and of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG). Dr Rubin was asked to set up and chair the Independent Scientific Pandemic Insights Group on Behaviours (SPI-B), a COVID-19 SAGE subcommittee providing behavioural science advice to improve adherence to recommended interventions (> 30 leading UK academics) [I]. The GCSA said: “The scientific advice provided by these groups has been pivotal in informing the evidence base supporting policy decisions on the UK’s pandemic response” [I].

**Improving how the Government used data on public behaviour to inform its pandemic response. Following DHSC’s request in February 2020 to activate the pandemic response plan (1), King’s provided advice and analysis in real time using DHSC’s weekly survey data [H, I]. Reports were delivered weekly to DHSC, SPI-B and other Governmental agencies. The team took requests for analysis from SAGE and its subgroups; these informed SAGE papers – King’s work was cited in at least 50 [I] – in turn delivered to COBR and multiple Government departments, ultimately informing urgent policy decisions. PHE said SPI-B outputs “have directly informed a range of policy areas, and specifically have informed how we write gov.uk coronavirus guidance, which receives many millions of unique hits during the pandemic”; and that “we have routinely briefed the internal… teams in the National Covid Response Centre (NCRC) morning Situational Awareness Meetings on the outcomes and implications of Prof Rubin’s work across a range of policy and operational areas, including on symptom attribution/recognition, self-isolation adherence, vaccination uptake and public perceptions and behavioural intentions relating to the COVID-19 pandemic” [E] . We detail three specific significant policy and public health examples.

Providing analysis on improving adherence to self-isolation. Based on CORSAIR and other polling data, SAGE recommended multiple times that adherence to isolation must not be overlooked as the core aspect of any testing and contact tracing strategy. On 16 September 2020, SPI-B was commissioned to produce a report on how to improve rates of adherence to self-isolation which drew on our polling data and review [I]. The GCSA explained: “On September 17 SAGE endorsed a commissioned SPI-B report on improving rates of adherence to self-isolation, delivered immediately to Government Officials; this included a specific focus on the need for financial support, citing King’s analyses. The Government announced new measures on September 19 including the provision of £500 grants to those on low incomes asked to self-isolate and this report continues to inform central Government discussions informing the ongoing UK response” . [I]. PHE said this work “has been widely briefed across the public health system, and is being used to inform the development of pilots designed to improve testing uptake, and self-isolation adherence in a number of localities across England” [E] .

**Improving the mental health and welfare of those in quarantine or isolation. PHE requested Kings review (7) on the impact of self-isolation at an early stage to develop their principles for handling people placed into isolation, to reduce distress. The PHE Head of Behavioural Science said: “From early in the pandemic, Prof Rubin’s rapid systematic reviews on the impact of quarantine on mental health was included in our briefings for staff running the Arrowe Park and Kent’s Hill Park isolation facilities” [E]. It also informed online resources to support self-isolation, and public messages of thanks from the Chief Medical Officer and others to those isolating [I].

Informing the decision to place the UK into full lock-down. The GCSA explained: “Following the Prime Minister’s March 16 2020 announcement that people should avoid non-essential travel and contact, a crucial question was whether this advice sufficiently changed public behaviour. King’s evidence of ‘room for improvement’, along with similar findings from the ONS, were considered by SAGE on March 23rd and adopted as one of five essential findings subsequently reported to central government, and supported briefing for COBR the same day. This contribution from King’s, along with expert input from Dr Rubin in the weeks preceding, contributed to the evidence base behind the decision that the UK would enter a full, compulsory lockdown” [I]**.

King’s research has been central to the continuing global call to address the gap in mental health infrastructure around the world, since underpinning the influential Lancet Call to Action in 2007. The multi-level approach King’s has advocated – combining change at national, governmental level with effective grass roots implementation – has helped instigate changes in policy and strategy at international and national levels, while providing evidence to implement and scale up mental health programmes on the ground. Collectively, this has brought much needed support to empower countries and communities with limited resources to fill the mental health treatment gap.

King’s research underpinned continuing development and updating of the WHO Mental Health Global Action Program (mhGAP). Based on research co-authored by King’s (1), the WHO launched its ongoing mhGAP programme (aimed at scaling up services for mental, neurological and substance use disorders especially in LMICs where healthcare resources are scarce) [A1, A2]. Subsequently, the programme also developed an Intervention Guide (IG) [A3] and Operations Manual (OM) [A4] on the basis of King’s evidence to provide implementation support to primary care staff in limited resource settings. The WHO also developed the mhGAP community toolkit [A5], which was influenced by King’s researcher Hanlon’s co-authored book Where There Is No Psychiatrist [A6, A7]. This toolkit supports progamme managers to identify local mental health needs, and tailor treatment accordingly.

Subsequent updates to these resources [A8] have drawn on the body of King’s research on mental health needs and service provision in low resource settings, for example acknowledging the value of proactive case-finding in the community (5), and the need to consider the differences between countries (1). Now available in online and smartphone app formats, the IG is produced in Arabic, Chinese, French, Greek, Hindi, Russian, and Spanish and is used in over 100 countries worldwide [A1, A3]. Given that this widespread uptake is sometimes in countries which do not provide feedback, measurements or evaluation, it is not possible to give an exact number of healthcare professionals trained, or number of people with mental illness reached. However, a review in 2018 found uptake of the IG in 90 countries, with positive evaluations available from 33 countries in Africa, the Middle East, Asia and South America [A9]. For example, the IG was used during a humanitarian crisis after a military operation in 2014 in Pakistan. 58 non-specialist healthcare workers working with internally displaced people were trained using mhGAP resources to detect mental illness, allowing people at high risk to access support that they would not otherwise have received [A10]. More recently, in 2019 an evaluation in Mozambique found that 177 health professionals and 1161 community health workers were trained to work with people with epilepsy, resulting in 89,869 consultations over four years, an increase of 67% [A11].

Importantly, King’s research has continued to make the case for improved global mental health care, providing new and valuable insights into how to make this happen on the ground for a broader range of resources and projects. For example, as a result of King’s economic analyses in collaboration with WHO on the cost and benefit of implementing mental health care (7), the United Nations introduced an updated MNS module to its OneHealth economic tool, the primary purpose of which is to assess public health investment needs in low and middle income countries [A7, A1].

By showing what works at a local and district level, King’s research has led to investment and scale up nationally of integrated mental health care.

Example (i): Nepal

As a result of King’s research showing successful implementation and evaluation of an integrated mental health care plan and joint working with local partners in Chitwan district in Nepal (6), there have been national policy changes and local initiatives developed beyond Chitwan. For example:

• Underpinned by findings from PRIME, the Nepalese Ministry of Health produced a Community Mental Health Care Package based on the mhGAP IG and standards, [B1].

• The mental health care training of primary health workers developed in Chitwan district was officially adopted by the Nepalese National Training Institute and Ministry of Health [B2].

• The Nepalese Ministry of Health endorsed the integrated mental health care plan and has included psychotropic medicines on the free drugs list for the first time [B1, B3].

• Similar integrated health care plans as the one used in Nepal have been appropriately adapted and scaled up to 94 facilities across the five countries participating in PRIME in close collaboration with governmental partners [B4].

• The community detection tool evaluated by King’s in Nepal [B5] (6) is now being implemented and tested in countries including Belize, Sri Lanka and South Africa [B6, B7,B8].

Example (ii): Ethiopia

As a result of King’s research on the effectiveness of task-sharing as an approach to integrate mental health care into primary care in the Sodo region of Gurage Zone Ethiopia (4), and by joint working with local partners, there have been a number of developments in the country:

• King’s research findings (4) shaped Ethiopia’s first National Mental Health Strategic Plan [C1].

• King’s researchers developed a participatory, integrated district level plan with key stakeholders, implemented and scaled-up care to the whole of the Gurage Zone [C2].

• More than 100 frontline health workers, 100 community health workers, as well as healthcare managers and pharmacy technicians were trained to support delivery of mental health care. More than 600 people with SMI (4), and 350 people with epilepsy [C3] have received care.

King’s researchers have co-developed mental health services with communities, making implementation more effective, and addressing barriers to treatment caused by stigma, reaching many more of those who need support. By working closely with communities, King’s research has identified and co-developed meaningful and effective routes to provide mental health services such as task-sharing and community detection tools. Based on King’s research around stigma (8) people living with mental illness have been engaged with the planning and delivery of services. In Nepal service users were involved in the training and supervision of primary healthcare workers and in Ethiopia service users shared their stories to teach community members and to train primary care staff.

With a focus on the reduction of stigma around mental health, the INDIGO partnership programme has implemented service user involvement in stigma reduction in 42 villages in Andhra Pradesh in India and showed significant improvements in knowledge, attitude and behaviour [D1]. In Ethiopia, the EMERALD program included experts with lived experience of mental illness into training for primary care workers, based on King’s evidence that social contact is the best approach to reduce stigma (8) [D2].

Service users report the benefit of access to psychological and pharmacological treatment, one saying “the support group taught me to understand myself and accept who I am ”, and another with SMI saying “the treatment has helped… now I can work… the drugs have worked a lot for me. Now my drugs are my food, they are my tea ”. Her mother comments “they no longer shun her. She’s no longer scared in her current state” [D3]**.

King’s researchers produced evidence reports to inform UK public health policy.

Public Health England (PHE) exists to protect and improve the nation’s health and wellbeing by providing evidence-based professional, scientific and delivery expertise. Based on King’s ground breaking work in the area of vaping ( 1,2,3,6), PHE commissioned the research group to undertake analyses and systematic literature reviews, summarising evidence on e-cigarettes to support policy recommendations. Initially commissioned for one report, which received global attention, King’s researchers have subsequently been commissioned for several reports (“King’s PHE Reviews”) [A1], all of which feature King’s primary research, enabling the cycle of evidence-based policy in this area. PHE state the first King’s PHE review “attracted international attention and marked a sea change in policy debate. For the first time national policy was underpinned by a comprehensive assessment of the current evidence. The report recommended a regulatory balance protecting children, ensuring products were safe and effective and maximising the public health opportunities. This balance of managing risks and maximising the opportunities has since become the expressed goal of successive governments. [A2]. King’s PHE Reviews have informed policy and are the means by which the government monitors the use and impact of e-cigarettes among adults and youth, and identifies areas of interest for future research and policy questions. They both underpin and are a requisite of the UK government’s Tobacco Control Plan for England, [A3], authored by the Department of Health and Social Care aiming to support harm reduction with alternative forms of nicotine such as e-cigarettes [A4].

King’s research influenced NICE pathways for stop smoking services.

The National Institute for Health and Care Excellence (NICE) guidance on stop smoking services recommends that health and social care workers in primary care and community settings offer advice to every person over 12 who smokes. NICE advice therefore affects about 7 million smokers in England alone, and all professional stop smoking services and practitioners. The NICE pathway makes recommendations for stop smoking services [B]. It was informed by King’s primary research ( 1) and the King’s 2018 PHE evidence review [A1], now including recommendations on e-cigarettes as a harm-reduction strategy, based on the findings that e-cigarettes are substantially less harmful than smoking and that many people have found them helpful to quit smoking. The recommendations are also underpinned by King’s research into smoking and e-cigarette use in young people which shows that using e-cigarettes was largely confined to those who had ever smoked tobacco, with a low proportion of young people who had never smoked tobacco using e-cigarettes ( 5,6).

National UK training for stop smoking services is underpinned by King’s research.

The National Centre for Smoking Cessation and Training (NCSCT) is the main provider of training to practitioners offering stop smoking support in the UK, following standards which the NICE pathway mandates must be upheld in stop smoking services [B]. Evidence from the 2015 and 2018 King’s reviews underpins the NCSCT stop smoking practitioner training, which now includes a section on e-cigarettes [C1, C2]. Since September 2015, 16,092 health and social care professionals have accessed the online training and passed the assessment. The NCSCT also includes the 2018 King’s PHE Review as a resource for stop smoking service professionals and since 2016 over 55,000 health and social care professionals have accessed it through the NCSCT alone [A1, C2]. The NCSCT have produced guidance on e-cigarettes ‘Electronic cigarettes: A briefing for stop smoking services’ in partnership with PHE, informed by King’s PHE Reviews for PHE [C3]. This briefing recommends that practitioners ‘be open to e-cigarette use in people keen to try them; especially in those who have tried and failed to stop smoking using licensed stop smoking medicines’. It further includes reference to King’s primary research on the characteristics of e-cigarette use associated with reduced smoking, such as daily use of re-fillable tank products (2). The briefing can be freely downloaded from the website and over 2,000 hard copies have been distributed at NCSCT face-to-face training courses for health and social care professionals [C2, C3]. Additionally, in 2018 the NCSCT produced a series of five public health information films for PHE, ‘E-cigarette safety: the facts explained’ to counter misperceptions about the harms of e-cigarettes highlighted in King’s research (3) one of which features King’s researcher McNeill, and has had more than 400,000 views [C4].

The Royal College of General Practitioners (RCGP) position statement on e-cigarettes [D] directs UK GPs to the King’s 2015 PHE Review and to the NCSCT training as means to inform GPs in the use of e-cigarettes as part of a harm-reduction approach.

Better success rates indicated by these new training approaches are underpinned by King’s research. Statistics from NHS Digital showed that in 2018 - 2019, stop smoking services supported 236,175 attempts to stop smoking. Attempts to stop smoking in which clients used e-cigarettes have achieved the highest self-reported quit rates compared with prescription medication, and Nicotine Replacement Therapy, indicating that the revisions of training based on King’s research has saved countless lives [E]. NCSCT said about the impact of King’s research: ‘It is clear that the KCL evidence reviews have made an enormous and valuable contribution to our stop smoking services, and to the NCSCT in terms of the training and resources that we provide. We are very grateful to them, and are confident this has positively impacted and supported a great number of health and social care professionals in this area, and consequently to their patients who smoke’ [C2].

King’s research underpins PHE recommendations and policies on e-cigarettes in public places. Based on King’s PHE Reviews, PHE have issued advice on the use of e-cigarettes in the workplace and public spaces to help employers and organisations develop their own policies. They state that ‘e-cigarettes have significant potential to help reduce tobacco use and the serious harm it causes to smokers, those around them and wider society. Recognition of this should be at the centre of policies on e-cigarette use in public places and workplaces’ [F1]. Hospitals in England, including their grounds, have become smoke-free in line with NICE guidance. Whether to allow e-cigarettes/vaping on hospital sites is not consistent across trusts but the large number that do permit vaping and explicitly support the use of e-cigarettes, have frequently based their decision on the evidence provided by King’s [F2]. In particular, mental health trusts, which have large numbers of patients who smoke, have found smoke free policies allowing vaping very helpful [F3, F4, F5]. A recent survey showed that e-cigarettes are available in 91% of mental health trusts [F6].

King’s research informs UK Government policy.

The 2019 Government Green Paper ‘Advancing our health: prevention in the 2020s’ [G1] cites the 2018 King’s PHE Review, stating that e-cigarettes are a helpful contribution to a harm reduction strategy in smokers, and recommending their use thus ‘We are setting an ambition to go 'smoke-free' in England by 2030. This includes an ultimatum for industry to make smoked tobacco obsolete by 2030, with smokers quitting or moving to reduced risk products like e-cigarettes.’ King’s PHE Reviews are regularly quoted in the House of Lords as being key document for reviewing the impact of current e-cigarette regulations [e.g. G2]. Also, King’s researchers have regularly developed evidence for Parliament with the campaigning charity ASH, an organisation which aims to influence tobacco control policies by understanding and communicating research findings important to the UK policy environment, and which provides the secretariat for the All Party Parliamentary Group on Smoking and Health [F5].

King’s research informed calls for revision of policies on e-cigarettes in New Zealand

New Zealand was one of several countries that originally put in place stringent e-cigarette and vaping restrictions. On the basis of King’s PHE Reviews the New Zealand Ministry of Health recommended that the government support smokers to switch to significantly less harmful nicotine alternatives. This was instrumental in New Zealand legalising nicotine vaping products in 2018. The work is referenced in the Ministry of Health’s recommendation to the consultation [H1] and on the Ministry of Health’s website [H2].

King’s research has contributed to making psychiatric units safe places, where any conflict that may arise can be dealt with in a way that is humane and fair, with containment used as an absolute last resort. King’s research has also ensured that staff should feel safer at work.

Safewards is recommended in the UK by government and healthcare bodies.

King’s research informed the 2015 National Institute for Health and Care Excellence (NICE) Guideline NG10: ‘Violence and aggression. Short-term management in mental health, health and community settings’ (King’s researcher Bowers was a Guideline development group member). Safewards was identified as one of only two conflict and containment management interventions shown to be effective via a randomised controlled trial, and Safewards is mentioned multiple times throughout the Guideline as notable, evidenced, and implemented in many hospitals [A1].

Safewards is also recommended in the 2015 report ‘Positive and Proactive Care: reducing the need for restrictive interventions’ by the then Department of Health as follows: “The Safewards model has demonstrated significant effectiveness in achieving reductions in incidents of conflict and the use of physical restraint, seclusion and rapid tranquillisation in acute UK mental health settings….. all providers should consider the implications of the Safewards model to their context” [A2 p22]. Safewards was also promoted through the Department of Health’s Positive and Safe Champions newsletter in 2015 [A3].

In NHS England (NHSE), the Commissioning for Quality and Innovation (CQUIN) framework supports improvements in the quality of services and the creation of new, improved patterns of care. In MH3 CQUIN, Reducing Restrictive Practices within Adult Low & Medium Secure Services, Safewards is recommended: "Increase positive ward culture by developing conflict reduction practice-based initiatives e.g. positive handovers (Safewards)" [A4 p3]. Safewards has also been recommended by the Head of Quality Improvement Taskforce for Children and Young People inpatient services (Mental Health, Learning Disability and Autism) at NHSE [A5].

The Care Quality Commission (CQC) has repeatedly endorsed Safewards in various reports, e.g. in 2014 it stated “We welcome the new Safewards model” [A6 p49]; and in a report in 2017 stated “quality improvement techniques and evidence-based approaches such as Safewards can help support staff to change their practice” [A7 p1]. The CQC also stated that their biggest concern in mental health was safety, naming Safewards in another 2017 report as a “good initiative to embrace a culture of safety” [A8 p82].

The National Insititue for Health Research (NIHR) also highlighted Safewards in its 2018 report Forward Thinking, targeted at mental health commissioners and provider organisations, saying: “it had many strengths, and a demonstrable impact on conflict and containment rates. Decreased conflict means fewer injuries from violence, suicide and self-harm” [A9 p18].

King’s researchers responded to the real and pressing need to address the issue of managing conflict and containment with swift and strategic rollout of the Safewards model. Having developed a model with strong evidence of effectiveness (4,5) it was immediately disseminated. King’s researchers swiftly went beyond traditional academic publications and conference presentations to reach practitioners quickly, to protect as many staff and patients as possible. A website was launched in 2013, making the Safewards interventions freely and easily available to all, with no registration requirement. It has since been translated into German, Turkish, Dutch, Finnish, Danish, Polish, and Spanish, with thousands of international visitors every year [B1]. Each component part of the approach is presented separately in a way that is practical and comprehensive. In the year Dec 16 2019 – Dec 16 2020, the website had 71,286 users, 69,849 of whom were new, from countries across the world including Germany, Australia, and the USA [B2]. King’s researchers set up dedicated social media channels for practitioners to support, advise and learn from one another including Twitter @Safewards (over 4,000 tweets and 4,700 followers), Youtube where 37 training videos created by King’s researchers are freely available and have had over 31,000 views in total, and Facebook (membership of a dedicated Facebook group is 8,000+ members, predominantly healthcare workers) [B3]. King’s research staff supported the Safewards rollout with meetings and local launch events with leading nurses, managers and influential figures worldwide [B4]. The Safewards team have not only made available a comprehensive and easy to implement set of tools to increase safety on psychiatric units via their website, but in their online forums have also fostered a growing and supportive community of healthcare staff committed to working together to provide advice and guidance to improve standards of care [B1].

Safewards has been widely implemented across England and the UK. Safewards was deliberately made freely available without registration via the website in order to minimise barriers and maximise take-up. This means there is no firm number of how many trusts and teams have implemented Safewards. However, we are aware of implementation in South London & Maudsley, Greater Manchester Mental Health (GMMH), Sussex Partnership, Lincolnshire Partnership, West London, Worcestershire, Kent, Berkshire, Derby, Leicester, Oxleas, Merseycare, Fife, and Cumbria, Northumberland and Tyne and Wear (CNTW). Examples include, in GMMH 58 wards have adopted the Safewards philosophy and practice [C1, C2]; and in Sussex Partnership since Safewards was implemented there has been a 63% decrease in seclusion, 45% decrease in restraints, and a 53% decrease in use of rapid tranquilisation medication [C3]. In CNTW all wards within the Trust utilise Safewards, resulting in restraint down 23%, seclusion down 21% and staff assault reduced by 18% [C4]. We are also aware that private UK providers such as Cygnet Healthcare, Elysium and Priory Group are using Safewards.

Safewards has been implemented internationally. In the state of Victoria, Australia, $2.4 million has been invested in Safewards implementation for 58 mental health units initially, with a second phase expected to include emergency departments and acute medical units [D1], and Safewards Victoria is now a recognised resource in the National Quality Health Standards [D2]. In Denmark Safewards has been implemented in around half of all mental health units, reducing forced sedation and mechanical restraints [D3]. In Tasmania [D4], Finland [D5], and Belgium [D6], Safewards interventions are either recommended or are being actively implemented in hospitals in order to drive quality improvements in mental health inpatient care.

Safewards benefits both patients and staff. Less conflict results in fewer injuries and less violence towards staff. Less containment is better for staff as well as patients (5). There are other benefits. Patient Iris reports “it has certainly helped and supported me, to be seen as Iris, and not the badly behaved person I am so often seen as… this wonderful human way of working with very distressed and vulnerable people” [E1]. Paul Sams, Service User Project Coordinator says ”as a former service user I am particularly impressed with the opportunities these interventions offer patients to have a voice in the ward environment” [E2]. The benefits of Safewards for patients and staff are recognised by NHSE [A5] and the Royal College of Nursing, who says “the most important part of Safewards is that patients and their families ‘get it’ and love it” [E3]. Head of Nursing for Acute Care at Sussex Partnership reports that Safewards “has helped the team move away from an “us and them” mentality that previously existed…creating a ward community that is collaborative and safe” [C3].

The unique dynamism of Safewards has enabled the model to be implemented within health and social care settings beyond psychiatry. Care in Mind runs residential care homes in England for young people, and introduced Safewards for Safehomes in March 2015. They report that it has had “an overwhelmingly positive impact. The model allows for a more therapeutic relationship between staff and young people. In fact, in many ways, it allows the young people in our care to see the staff as more human” [F1]. In CNTW NHS Foundation Trust, as well as Adult Acute Services, Safewards has been rolled out across Children’s services, Older People’s services, Psychiatric Intensive Care Units, Forensics, Mother and Baby units, Autism and Learning Disability services, and more recently within community based servies [C4]. In Tasmania Safewards is one of the actions committed to in the Government’s long-term plan for mental health 2015-25, and as well as in healthcare settings, it is being implemented in the Youth Justice sector, where it is known as Safecentres [F2].

King’s evaluations of FREED, MANTRA and ECHO led to national recommendations and guidelines, accompanied by increased large scale funding from the UK Government to scale up eating disorders services. FREED is a cornerstone of NHS England’s (NHSE) commitment to increase community mental health services to reach 370,000 people as part of the NHSE Long Term Plan (2019), supported by UK Government investment of £1 billion [A1,A2]. FREED also features as a Positive Practice Example by NHSE with NICE and the National Collaborating Centre for Mental Health in their Guidance for Commissioners and Providers [A3]. A Royal College of Psychiatrists position paper on eating disorders recommends FREED [A4], and links to the FREED website.

MANTRA is recommended as a first line treatment for adults with AN in the 2017 NICE Guideline 69 Eating disorders: recognition and treatment [A5]. Also on the basis of King’s research, the National Collaborating Centre for Mental Health’s commissioning guidance for adult eating disorders recommended whole team training in FREED, MANTRA and ECHO approaches [A3]. This led to a UK Government contract of almost £2.2 million for a training programme to be delivered by King’s researchers via Maudsley Learning [A6, A7].

Evidence-based implementation established by King’s has enabled the uptake of these approaches. FREED was initially available to young people in South London and Maudsley NHS Foundation Trust, extended to 3 other large eating disorders services, then adopted by the Academic Health Sciences Networks which covers 15 regions in England. FREED is described by the NHS as “gold standard” [A1], and was central to the increased NHS funding for new services for children and young people up to the age of 25 [B1]. King’s work was so compelling that commissioning guidelines and funding were agreed in some cases before findings were published in peer-reviewed journals, with an early independently produced business case from the Health Economics team at the University of York helping accelerate the roll out [B2]. As part of its 2020 investment of £150 million in eating disorder services, NHS England initially named 18 services where FREED would be implemented [A1]. Our records indicate that at the end of December 2020, 10 trusts were actively using FREED, a further 24 were in the process of implementing it, and 6 more were at the early stages of exploring it [B3]. A FREED-like service based on King’s research has also been established in Australia [B4].

There has been a large demand for MANTRA and at King’s alone, 400 therapists in the UK have been trained in the UK since 2016 [B5 - B10]. Two specialist trainers estimate they have reached 500 UK and international therapists [B11, B12], and as one of these trainers provided some of the King’s training, we estimate more than 700 therapists have been trained in the UK in total.

King’s research has benefitted patients and carers, changing and saving lives.

King’s research has been the basis for the development of a suite of innovative approaches for eating disorders that place the person and their carers at the centre and allow flexibility and adaptability to reach as many people as possible. Eating disorders, particularly AN, can be fatal and this approach has enabled patients to be seen, recognised and treated.

FREED allows young people with eating disorders access to evidence-based treatment, tailored to their needs, as early as possible. One FREED service user says “I feel like such a different person. My confidence has risen, my control has risen, every element of my life, I feel more comfortable and happier in”, where another says “The best thing to ever happen to me was this, I don’t know where I would have been, genuinely don’t know where I would have been, if I hadn’t got the support when I did” [C1]. Parallel separate resources for individuals and healthcare professionals provide a holistic approach which can be used flexibly, depending on need. This has enabled FREED to be used across a diversity of patients and in a number of settings. It aims to reach all young people who need support, including those not typically captured by eating disorders services, and since 2018 our own records show that FREED has been used to treat over 1,100 patients. Impact and equality assessments are being made available nationally as part of the FREED rollout to ensure all groups are reached [C2].

Rooted in King’s research, MANTRA has been developed to be an accessible and user-friendly form of treatment that allows patients to understand their role in eating disorders. Therapists can be trained at different levels depending on how closely they work with patients, allowing training to be relevant for both specialist and more general services. A process evaluation revealed that MANTRA is positive for patients, e.g. “Absolutely, definitely feel a bit more comfortable within myself, you know I was feeling very hopeless going back to sort of this time last year… but sort of since working through those issues I’ve managed, I’m actually in a different job now… and I’m a lot happier there and I’m going out and doing more things… ” [C3].

ECHO has been used by several services to support carers of those with eating disorders for example through the New Maudsley Carers group, with over 1,000 carers reached [C4]. One carer of a family member with AN says “I cannot emphasize strongly enough, my belief in the importance and inclusion of carer guidance resources and psychoeducational skills in the treatment of eating disorders… [to] equip carers with skills that empower them and give them the confidence to provide the best possible support to their loved one on their quest towards recovery ” [C5]. The ECHO approach has been taken up in a peer-coaching format by the UK’s largest eating disorder charity BEAT [C6]. Two books have also been published using the ECHO methods: Skills-based Caring for a Loved One with an Eating Disorder (Treasure et al [C7], and Caring for a Loved One with an Eating Disorder (Langley et al) [C8]. The former has sold 42,000 copies over two editions, and the latter 700 copies [C9].

King’s evidence-based approaches have alleviated pressure on services and carers and enabled cost savings. An economic analysis of FREED showed that although FREED requires initial investment, there is a shorter duration of High Intensity Treatment (HIT) for FREED patients, compared to standard care, resulting in savings of between £2,998 and £261,097 per year in one local area, depending on the amount of HIT that is inpatients and how much is day care [B2]. King’s researchers carried out health economics assessments of ECHO and showed training for carers reduces admission length on average by 20 days with a saving of £10,000 to £14,500 per case (8). In another analysis a combination of ECHO and MANTRA, the length of inpatient stay for the intervention group was 4.5 weeks less than the comparison group, representing a considerable cost saving [D1].

King’s research has been influential at every step of the process leading to the Government’s White Paper published in January 2021 (publication delayed by COVID-19). King’s researchers engaged in the IRMHA, chaired by King’s Professor Sir Simon Wessely, and conducted work specifically commissioned to inform IRMHA’s recommendations and subsequent proposed changes to the MHA.

King’s research shifted the recommendations of the IRMHA towards recognising mental capacity and patient involvement in care. King’s researchers, including those with lived experience, were key advisors to the Autonomy Group of the IRMHA, addressing a key service user concern: “I felt a lot of things were done to me rather than with me” [A1 p71, A2]. This Group used King’s research (1,2,3,5; published subsequent to IRMHA meetings) to support recommendations on the provision of Advance Choice Documents (ACDs). These allow people to say how they want to be treated in the future and require doctors to record why treatment preferences are not followed. They were one of the IRMHA’s key recommendations [A3]. The approach of King’s MHJ project to conducting research which includes the voice of service users was noted in the IRMHA as an example of interdisciplinary working [A1]. Kings’ research on CTOs (8), which were first implemented in the 2007 revision of the 1983 MHA, indicated that they were unlikely to improve key outcomes, including hospitalisations. This evidence informed the IRMHA’s recommendation to put the CTO policy “in the last chance saloon” [A1 p28]. King’s research underpinning this IRMHA recommendation has ensured that CTOs will continue to be scrutinised for their effectiveness.

Government committed to a new mental health legislation, a key component of which is King’s recommendations on advance decision making. The Government responded to the IRMHA’s final report on 6^th Dec 2018, committing to bring forward new mental health legislation, and immediately accepting two of the IRMHA’s recommendations based on King’s research (1,2,3,5; published subsequent to IRMHA final report) [B1]. Both relate to advance planning: firstly that persons detained under the MHA would be able to nominate a person to make decisions about their care, to replace previous legislation that this role automatically fell to nearest relative; and secondly, that statutory ACDs would be introduced to allow patients, whilst in periods of mental capacity, to outline their preferences for care during periods of incapacity. The recommendation that ACDs should be used appeared in every stage of the parliamentary debate concerning the reform of the MHA [B2, B3, B4]. King’s also conducted two “Policy Labs” during which ADM was discussed [B5, B6, B7] bringing the MHJ project members together with policy advisors from key Government departments and the NHS, alongside service users, representatives from various bodies involved in criminal justice, social work and charities, and other stakeholders.

King’s researchers have worked proactively with policymakers to ensure the Government followed through on these recommendations. Kings’ researchers effectively helped Government translate their research findings into law, building on earlier engagement with Government (Owen was a Parliamentary Office of Science and Technology research fellow on the Mental Capacity Act in 2011; Ruck Keene was a consultant at the Law Commission for the report on Mental Capacity and Deprivation of Liberty in 2017). This has involved King’s organising an evidence session for parliamentarians and senior civil servants in the Westminster Parliament on 21^st May 2019 [B8] chaired by the Rt Hon Baroness Margaret Jay, for which they provided a policy briefing document resulting from the Policy Labs on ADM [B9]. King’s researchers have subsequently directly engaged with the civil servants responsible for drafting the White Paper in a series of meetings. A Senior Policy Advisor at the Department of Health and Social Care says: “the advice was very helpful in informing our proposal on ‘advance choice documents’ in the White Paper ” [B10].

King’s work on the IRMHA has provided a framework contributing to one of the goals of the NHS Long Term Plan. The NHS Long Term Plan states: “It (the IRMHA) has examined rising detention rates, racial disparities in detention and concerns that the Act is out of step with a modern mental health system. The government is now considering the findings of the review in detail, including the need for better crisis services and improved community care for people with serious mental illness. Investment in these service forms a major part of this Long Term Plan” [C p.69]. The recognition of ADM as being part of a modern mental health system forms a critical part of how the NHS can deliver on Government’s commitment to give people more control over their mental health treatment [B6].

King’s supported an early implementor of advance choice documents in the context of the Mental Health Act. Our work has led to the approval of the UK’s first ACD clinic/workshop for service users at the South London and Maudsley NHS Foundation Trust, supported by the Trust’s CEO David Bradley [D]. This initiative has allow King’s researchers to evaluate the success of early implementation, and to provide a model for other trusts in the future.

King’s researchers inform Bipolar UK’s strategy on providing advance choice documents.

The charity Bipolar UK has been a committed partner with King’s during our ACD work and subsequent advocacy for inclusion of ADM in MHA reform, and a survey of over 900 Bipolar UK subscribers found overwhelming support for ADM (7) [E1]. King’s researcher Gergel drafted instructions and a proforma for making an ACD, which is now freely available on Bipolar UK’s website so that visitors to the site can articulate their own advanced choices [E2, E3].

King’s research informed the work of artist Beth Hopkins to raise public awareness about ADM. In 2019, service user artist Beth Hopkins was commissioned by the Bethlem Gallery to explore ADM for people with bipolar, and created work using King’s research. COVID-19 has delayed a planned exhibition to examine notions of autonomy, which will be open to the general public [F1, F2].

Mental health charities, patients and carers welcome the ADM recommendations of the IRMHA. The Chief Executive of the leading UK mental health charity, Mind – which supports hundreds of thousands of people through its services, and up to 18,000,000 more a year through its website resources – recognises that the changes to the MHA informed by King’s research are beneficial to the people that his charity supports. He said “we are pleased to see that many of our concerns – and those of the people we represent and have supported to feed into the review – have been heard. The recommendations to strengthen people’s rights, empower them to question decisions about their care, choose their treatment and involve friends and family have the potential to make a real difference to those who are in an extremely vulnerable situation” [G1]. One carer bears witness to the impact on individuals: following a previous episode of psychosis in his partner during which inappropriate discharge arrangements had been made, an advance directive was drawn up. He says of a subsequent episode, “we are extremely grateful that this document was adhered to when necessary during her hospital stay. This allowed us to continue communicating through her period of psychosis and to avoid a repeat of the damage to our relationship with the previous admission had caused” [H1].

Against a backdrop of escalating opioid use and overdose deaths, King’s research has built on our 2014 case study to improve THN implementation and availability by developing a more user-friendly and acceptable nasal spray. Our research into the role of training in the effectiveness of THN has underpinned changes in policies and practices in the UK, the US and globally, and increased the availability of naloxone, saving lives worldwide in 23 countries which now have documented THN programmes [A].

King’s research drove and informed commercial development of naloxone in the form of a nasal spray. Based on the strength of King’s research ( 5), Mundipharma decided to test and develop nasal spray forms of naloxone. King’s researchers contributed to the design of trials and collaborative research ( 7) that formed the evidence base for the regulatory approval of the resulting product, Nyxoid, across Europe and Australia. Nyxoid is progressively being introduced into public policy and clinical practice [B1, B2, B3].

King’s research led to UK policies recommending THN, and its implementation.

UK Government approval for THN was confirmed in 2015, with nasal naloxone added in 2019 [C1], referencing for advice an open letter describing King’s THN research on the necessity for training [C2]. The development of Public Health England (PHE) clinical national guidelines (AKA the Orange Guidelines), featuring King’s research on THN ( 5) and chaired by King’s researcher Strang, influenced Government decision making [C3]. In England 95% of local authorities now provide THN and 40,033 THN kits were dispensed in community settings in 2017/18 [C4]. In Northern Ireland the Public Health Agency’s THN programme supplied 1,332 kits in 2018/19 [C5]. In Scotland, 8,379 THN kits were distributed in the year 2017/18 [C6]. In Wales 4,120 THN kits were issued in 2017/2018 [C7]. Based on King’s research, pilot schemes were launched in 2020 to train police officers to administer naloxone in North Wales, Durham and West Midlands. The North Wales Police and Crime Commissioner said: “The research carried out by King’s College London on the effectiveness of naloxone in saving lives of those experiencing an overdose contributed to the vision of piloting officers carrying naloxone in North Wales.” Police officers on the pilot have already saved lives [C8]. The chair of the expert sub-committee of the Advisory Council on the Misuse of Drugs which is examining THN, and makes recommendations to the UK government, cites King’s research ( 3,4) as shaping its understanding of the potential for further public benefit from the expansion of THN in the UK [C5].

King’s research informed US policy on THN for overdoses of prescription opioids.

In 2017 alone, an estimated 47,600 people died from opioid overdose in the US. King’s researchers have been influential in the development of US policy to address this widespread problem. Professor Keith Humphreys, previously Senior Policy Advisor for the Obama administration, included naloxone in the 2010 US Drug Strategy [D1], which paved the way for a host of subsequent policies widening the availability of THN. For example, in 2016 the US Surgeon General endorsed THN [D2, D1], and in 2018, Congress passed the SUPPORT Act (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act) [D3, D1]. In 2016 Humphreys ‘used Professor Strang’s work extensively in working with Congress on the CARA Act (Comprehensive Addiction and Recovery Act 2016), which expanded naloxone even further, allocating over $180 million to provide naloxone to individuals taking prescribed or illicit opioids and their families’ [D1, D4]. Nasal and injectable THN kits are now provided to PWUOs in the US, and co-prescribed with opioids for medical treatment. King’s research has resulted in naloxone being used by police officers, homeless shelter workers, firefighters, prison staff, as well as opioid users and their families. Naloxone prescriptions more than doubled from 270,000 to 576,000 from 2017 to 2018 [D5], and in 2019, 94% of Syringe Service Programs in the US implemented overdose education and naloxone distribution compared to 55% in 2013 [D6].

King’s research influenced global THN policies. King’s researchers advocated for and contributed to the first-ever guidelines from the WHO on the ‘Community Management of Opioid Overdose’ (2014) [E1, E2]. The guidelines draw heavily on King’s research ( 2,3) to call for increased availability of THN and training. In 2016 King’s research underpinned a declaration from the United Nations General Assembly calling for national policies to include THN [E3, E2], leading to widespread uptake [A]. King’s research directly contributed to the UNODC Stop Overdose Safely 90-90-90 S-O-S initiative [E4,E2]. King’s researchers also co-designed and co-delivered UNODC strategy for the implementation and evaluation of THN provision at national and regional levels in countries that either produce heroin or are located along the trade routes for heroin to Western Europe. Anja Busse, UNODC, says King’s researchers: “have been invaluable contributors to UNODC's development of training materials, international training events in countries including Kyrgyzstan, Kazakhstan, Tajikistan, and regional training events in Iran which was also for Afghanistan and neighbouring countries… [these] underpin the development of Take-Home Naloxone provision in these countries which did not formerly have expertise in the public benefit of Take Home Naloxone” [E2]. As of August 2020, this initiative has delivered training to 16,000 potential witnesses of opioid overdose in Kazahkstan, Kyrgystan, Tajikstan and Ukraine and provided THN kits to 40,000 people as part of a study [E5].

The European Monitoring Centre for Drugs and Drug Addiction provides the European Union with evidence on European drug problems. King’s researchers authored its 2016 guide on best practices on THN [E6], where King’s research is featured ( 2,3,5), and the King’s Bradford Hill review ( 1) informs the Centre’s guidance on naloxone [E7]. King’s research has impacted policy decisions nationally in Europe. For example, King’s research supported the National Centre for Addiction Research in Norway in advocating for THN provision, leading to the launch in 2014 of a National Overdose Prevention Strategy distributing about 8,000 THN kits in the first four years. A 95% survival rate was recorded in about 600 uses of THN on overdose victims in the first 2.5 years [E8].

Take-Home Naloxone saves lives. King’s research continues to demonstrate the effectiveness and feasibility of THN as a public health intervention, whilst advocating for increased provision and training to ensure that THN is available in the community to save lives. In Northern Ireland alone THN was administered 240 times in 2018-19 and was successful in reversing an opioid overdose in over 90% of cases. As Michael Owen, Lead for Drugs and Alcohol at Northern Ireland’s Public Health Agency said: “each overdose reversal is an occasion when a person could have died, but didn’t” [F1]. First-hand accounts from those who have been trained to use THN demonstrate its powerful impact. A PWUO who had saved the life of his friend with THN said “I’ve administered naloxone once to a friend of mine who was minutes away from death…gasping for air and barely breathing…and within a minute she was sitting up and talking. It was that simple and that quick” [F2]. The development of the more acceptable nasal spray coupled with THN training have together empowered a broader range of witnesses to receive training and administer THN. The British Red Cross deliver such training to PWUO, their friends and families. One of their delegates said “just knowing and saving someone’s life, it’s better than any drug in the world you know, any drug in the world” [F3]. These changes in THN availability and use could not have happened without King’s research identifying the barriers to use, improving the product, providing the evidence to increase uptake, and influencing policy across the world.

The collaboration between King’s researchers and local partners, each bringing complementary skills and experience, has led to improved mental health outcomes for people in Zimbabwe and beyond. Its research showing that the Friendship Bench grass roots initiative benefits community mental health has led to changes in national and international policy and guidelines, and has underpinned funding applications to enable widespread implementation of the Friendship Bench, benefitting tens of thousands of people.

King’s research has led to changes in national policy and guidelines in Zimbabwe, which now recommends the Friendship Bench in its mental health strategy. The evidence of the Friendship Bench’s effectiveness (1-4) has led to the intervention being included in its 2019 national mental health strategy. The National Strategic Plan for Mental Health Services 2019-2023, commits to “Improving mental health awareness and community empowerment”, through adoption of the Friendship Bench as a Ministry of Health program [A1, A2, A3].

Also, for the one in eight Zimbabwean adults living with HIV and twice as likely to suffer with depression as those without, King’s researchers have made the case for the adoption of Friendship Bench into HIV policy, by working with the Organisation for Public Health Interventions and Development (OPHID). This non-governmental organisation (NGO) develops and implements approaches to strengthen the provision of quality HIV prevention, care and treatment services, and supports over half a million Zimbabweans with HIV. OPHID held a briefing workshop on HIV and mental health for the Zimbabwean Ministry of Health and Child Care (MOHCC) in March 2020, and recommended Friendship Bench as an existing, evidence based intervention which could be scaled up across Zimbabwe, based on King’s research (6). As a result, the MOHCC set up a Technical Working Group for the integration of mental health into HIV care; it committed to develop a pathway to improve referrals for HIV mental health care and to scale up/strengthen existing tools, including Friendship Bench being written into the care pathway for those with HIV [A4]. The first MOHCC mental health/HIV Technical Working Group meeting was delayed because of the pandemic but met on December 17 2020 [A5] to report on implementation of the recommendations.

King’s research supports substantial funding which has allowed the scale up of the Friendship Bench in Zimbabwe. The strong evidence base for the efficacy of Friendship Bench generated by King’s and collaborators (1,2,3,4,5), has enabled successful international funding applications to scale up the implementation of the Friendship Bench [B1, B2, B3]. For example, Grand Challenges Canada’s award of $US 852,000 in 2016 enabled Friendship Benches to reach a further 14,000 people with investment in 33 clinics in Zimbabwe [B4, B5, B6].

The Friendship Bench has empowered healthcare lay workers to deliver therapy in their own communities outside of clinical settings. King’s finding that 9 out of 10 lay health workers feel competent to deliver the intervention after the course of training, even with no previous experience (2), has underpinned the continued development of tools to train lay health workers in their local communities to deliver the Friendship Bench intervention, with training available in both English and Shona [C1]. Also 120 members of the public were trained in 2019, working towards a goal making Friendship Bench accessible to all in Zimbabwe who may need it [A2].

The Friendship Bench has had a positive impact on communities. Thanks to the collaboration between King’s and local partners developing the Friendship Bench, CMDs are reduced. 112 Friendship Benches have now provided therapy to over 63,000 people in areas which previously had little access to primary health care [B2, B3, D1]. Patients who visited a Friendship Bench and received the intervention from healthcare lay workers see a reduction in symptoms of depression and anxiety [A2], and Friendship Bench users report learning to seek support from their families and being able to return to work [D2].

The Friendship Bench benefits young people. CMDs often begin in adolescence. Friendship Bench research facilitated funding to trial and implement iterations of the intervention to reach young people aged 16-19, known as YouFB [A2, B2, B3]. YouFB has been implemented in over 26 sites, with King’s researchers as co-investigators on evaluation of strategies for scaling up [E1]. UniFB has also been launched to support university students [A2].

The impact of the Friendship Bench is now being felt beyond Zimbabwe, across the globe

The intervention has now been implemented by local primary health care services across Zimbabwe and elsewhere in Africa, including Kenya, Malawi and Zanzibar [B2, B3]. This simple, effective intervention has captured imaginations across the world [F1].

The Friendship Bench intervention has been recognised in the WHO Sustainable Development Goals (SDG) (Good health and Well-being) 2019 action plan where it is listed as SDG 3.4 as an example of an evidence-based innovation which could be scaled up globally to improve mental health care [F2]. In addition, the Joint United Nations Programme on HIV/AIDS (UNAIDS) recommended Friendship Bench at its 2018 meeting as an effective intervention [F3]. The World Innovation Summit for Health (WISH), featured Friendship Bench as a case study which improves depression and increases adherence to HIV medication, in its 2018 Depression and Anxiety Forum [F4].

Beyond it’s implementation in Zimbabwe, the low-cost, low-resource nature of the intervention, coupled with its strong evidence base, has been used to engage some of the most marginalised people in treatment, such as those living on the streets in New York. This is a rare example of an initiative with impact in a low-income country being brought to a high-income country [F5]. The Friendship Bench even made an appearance at the 2018 World Economic Forum in Davos, where it attracted visits from UK Secretary of State for Health Matt Hancock [F6], and the Duke and Duchess of Cambridge [F7].

King’s research has informed high level policy on military mental health. Since the REF2014 case study that described the early post-deployment interventions influenced by King’s research, our work has been used extensively to inform Government policy on the mental health and wellbeing of serving and ex-serving personnel and their families. It has further informed the charity sector in terms of their advocacy and service provision. The key Government strategy, Defence People Mental Health and Wellbeing Strategy 2017-2022 [A1] was influenced by King’s research over several years [A2]. The 350 plus papers from the King’s cohort study (e.g. 1, 2) collectively comprise the majority of evidence used to support top level policy making by the UK Ministry of Defence on military mental health and wellbeing [A3, A4].

In 2014/2015 the House of Commons Defence Select Committee (HCDC) scrutinised the way that Government strategies uphold the military covenant in relation to those injured, mentally or physically, as a result of military service. The resulting HCDC report: Armed Forces Covenant: Military Casualties was informed by King’s research into the long-term mental health trajectories of military personnel. King’s researchers gave oral and written evidence [A5]. The Committee concluded that whilst the UK provides world-class care to injured serving personnel, there was concern about the support provided for those developing or living with longer-term physical, mental and neurological conditions. This was one of five HCDC sessions on various topics where King’s researchers were invited to give evidence.

The Parliamentary Office of Science and Technology (POST) produced a POSTnote [A6] based on the conclusions of the 2014/15 HCDC report indicating that the needs of military personnel who may be suffering long term conditions should be addressed. This cited King’s research 35 times, and informed policy makers of trends and mental health needs in the military population.

King’s research underpinned the Defence People Mental Health and Wellbeing Strategy 2017-2022 [A1] which set the scene for Government policy on mental health and wellbeing. Of the 31 peer-reviewed academic papers used to support the strategy, 27 were produced by King’s. The Strategy covers all aspects of military mental health, including help-seeking, stigma, deployment mental health, Reserve Forces mental health, child and family health, trauma risk management and the effect of “overstretch”. All these recommendations were underpinned by King’s research [A2, A3, A4]. The Strategy also led to the establishment of the Office of Veterans Affairs (OVA) within the Cabinet Office [A7, A8], which continues to support the ongoing King’s Military Cohort, now renamed the Legacy Cohort, since most of its members have now left the Armed Forces. It remains the most trusted source of data on health and wellbeing of veterans of the conflicts in Iraq and Afghanistan, and was recently accessed for a rapid investigation into how COVID-19 has affected military veterans [A9]. Wessely now sits on the new Veterans’ Board formed in 2020 which oversees the provision of services to military personnel and veterans, and the health and wellbeing of military families [A10].

King’s research has informed advocacy by groups representing military personnel.

Several military charities have benefited from King’s research ensuring an evidence-base both for their advocacy and for the services they provide. For example: the Royal British Legion’s response to NHS England’s consultation on “Developing mental health services for veterans in England” [B1] is informed by the research which they commissioned King’s to carry out [B2]. Also, the Forces in Mind Trust (FiMT) Policy Statement on Health [B3] is influenced by King’s research into stigma and the barriers to help-seeking [B4].

King’s research has reduced stigma around military mental health. King’s research (e.g. 2) has reduced harmful stigmatising views of military personnel, veterans and their families, and has, as the NHSE Director responsible for the Armed Forces services explained, “helped counter the sometimes negative impact of the stereotype of veterans as being ‘mad, bad and sad’” [C].

King’s research provided evidence leading to improvements and investment in a new initiative providing NHS mental health services for military personnel. By demonstrating the extent of mental health needs within the military, and the barriers to seeking help in this population, King’s research led to NHS England (NHSE) committing to developing services dedicated to veteran mental health and an annual increase in funding for these services [A8]. The research informed the consultation that began this process and the subsequent action plan in 2016 [e.g.B1]. Finally, our research informed the formation of the Transition, Intervention, Liaison Service (TILS) in 2017 [C]. TILS supports military personnel through their discharge from military service and into their life as a veteran, linking the MoD, NHS and community-based care to reduce the barriers to help-seeking. The service supports specific stages of the veteran experience: transitioning towards being discharged from service, at which stage support is co-ordinated with the MoD; intervention by NHS complex treatment services for those found to need them at pre-discharge assessment, and liaison within community-based care, for long term support specifically designed for veterans without complex treatment needs [e.g. D]. King’s research (2) has also enabled focus on a specific area of concern – the increased rate of violent offending in those exposed to combat, and the suggested key targets for intervention – mental health and substance misuse.

King’s research has informed Government policy on the health of service families.

In 2019 the Secretary of State for Defence asked Andrew Selous MP to conduct an independent review to consider the diverse needs of service families, assess whether the current support offer is meeting these needs, and make recommendations accordingly, resulting in the Living in Our Shoes report [E1, E2]. King’s research (e.g. 5) underpins Chapter 6 of this report and its Recommendation 74 to promote better mental health and wellbeing for the whole family.

King’s research has enabled evidence-based decisions across diverse policy areas.

King’s work on post-deployment mental health screening (6) shaped the UK’s decision to not implement this intervention on the basis that it was not effective [A2]. Also, our research (7) finding that PTSD rates were no higher in deployed female military personnel informed the Ministry of Defence policy decision to lift the ban on women in Ground Close Combat roles in 2016 [F1, A2]. This research also informed the preparation of the minor additional support services needed to support the potential elevation in help-seeking from women.

King’s research has had far-reaching impacts on perinatal mental health, including practice guidelines, their implementation, funding of new services and establishment of such services through training. Based on King’s body of research in this area, King’s researchers developed a comprehensive pathway to impact by engaging with policy makers. Howard chaired NICE CG192 guideline panel, wrote a chapter for the Chief Medical Officer public health reports and compiled a highly influential The Lancet series of three reviews on perinatal mental health ( 1, 5). These and other avenues described below ensured King’s research findings catalysed a transformation of services for women with perinatal mental disorders in the UK and beyond.

King’s research directly influenced UK and international maternity and mental health services guidelines. King’s evidence on the diversity, complexity and extent of morbidity in women with perinatal mental disorders, with over 20 individual citations (e.g. 2, 3, 4), informed detailed recommendations on comprehensive assessment in NICE guidance CG192 (2014), Antenatal and postnatal mental health: clinical management and service guidance [A].

Professional organisations cited King’s research as an evidence-base for recommendations to their members. The Royal College of Psychiatrists referred to King’s research ( 1) in their CR197 Report on Perinatal Mental Health Services which made recommendations on service provision [B1]. The Chief Medical Officer’s 2014 report - The Health of the 51%: Women, included a chapter on perinatal mental health which cited King’s research ( 1,5) to inform recommendations [B2]. King’s findings ( 11) led to the removal of anxiety screening questions from the NHS Maternity Minimum Dataset, which is used for local and national monitoring, commissioning and addressing health inequalities [B3, B4].

Internationally King’s research ( 1) informed the World Psychiatry Association (WPA) position statement [B5]. King’s research into perinatal suicide ( 8) was cited in guidance for US maternity professionals [B6] and King’s research on outcomes for the fetus and child ( 5) was cited in Australian and New Zealand mood disorder guidelines [B7].

King’s research influenced significant increases in funding for new NHS perinatal mental health services. King’s research on the prevalence ( 1), impact ( 5, 8) and cost ( 6) of perinatal disorders defined the urgent need for increased service provision. King’s research ( 1) was a key contribution to a report in 2014 commissioned by the Maternal Mental Health Alliance (MMHA), a consortium of more than 80 charities, as part of their awareness-raising campaign Everyone’s Business [C1]. MMHA also commissioned the Centre for Mental Health to conduct an independent review of the health economic case for further investment [C2] which cited King’s research extensively (including 2, 3, 4) and led on to £365 million funding for new NHS perinatal mental health services.

King’s research informed and refined implementation guidelines into UK clinical practice.

To fulfil this funding commitment, the NCCMH was then commissioned by NHSE to develop new perinatal mental health services and training, in the form of implementation guidance and NICE concordant care pathways [D]. Professor Howard was National Clinical Advisor (2014-5) informing the development of these, based on insights from King’s research (e.g. 5, 8), and the guidelines widely cite (including 1, 5 and 8) King’s research, leading to the implementation of care pathways concordant with NICE guidelines. King’s recent reviews and primary research on the prevalence of disorders and interventions (e.g. 1, 7) are also cited.

King’s research resulted in many thousands more women supported through perinatal mental health services. This investment and development in services led to 30,000 more women receiving perinatal mental health interventions in line with NICE guidance (2016-21) [B4], and a planned further 24,000 women receiving NICE-concordant care to 2025, as described in the NHS Long-Term Plan (which cites ref 7 on evidence of the high prevalence of maternal mental disorders) [E1]. NICE showcases this progression of evidence from these reports which led to government investment in perinatal services [E2]. This implementation continues to be evaluated by King’s researchers, supporting shared learning and the delivery of high quality services, and identifying changes of focus as needed [B4].

KCL research underpinned resources to help women in the UK with perinatal mental illness

King’s research laid the foundation for the development of the KCL self-help guide for antenatal depression which became available through the Increased Access to Psychological Therapies services [F1]. The workbook was requested by 134 services nationally, estimated to have impacted more than 5,000 women per year (a perinatal specifier was only recently added to routine data collection). One practitioner’s feedback by email was “Fantastic...really helpful for the women.” [F2].

King’s research has contributed to the pregnancy charity, Tommy’s, widely-used pregnancy information resources (30,000 page views per month) and the pregnancy planning tool for the general population including information on common mental health problems (9,000 monthly unique users) [F3, F4].

King’s research has improved health professionals’ understanding of perinatal mental health. King’s research underpins the Building Capacity in Perinatal Psychiatry programme. This is training delivered by the Royal College of Psychiatrists, and commissioned by Health Education England, to perinatal psychiatrists leading the new services set up under NHS England funding, and has trained almost 500 psychiatrists and other mental health professionals [G1]. The Maternal Mental Health Alliance reports [C1, C2] which were underpinned by King’s research (see above), were the key resource for the development of the Royal College of General Practitioners Perinatal Mental Health Toolkit, a widely-accessed free online educational resource for all health practitioners [G2]. Internationally, taken together with the WPA Position Statement [B5], the guidance for US maternity professionals [B6], and the Australian and New Zealand mood disorder guidelines [B7], these activities will have reached tens of thousands of health professionals internationally.

King’s research has had widespread coverage in the media raising public awareness.

With the continuing barriers to women voicing their experiences of perinatal mental illness it is important to raise awareness about the commonplace existence of mental health problems in this group and the available support. King’s research has been covered widely in the UK media, including television (e.g. BBC News), Radio (e.g. BBC Radio 4) [H1] and print (e.g. Daily Mail, Huffington Post) [H2], allowing its messages and implications to be communicated directly to women themselves with the aim of enabling them to seek the help they need.

King’s research has underpinned UK policy changes, resulting in better recognition of the needs of trafficked people, and better mental health support for this extremely vulnerable group. King’s has demonstrated the value of research to inform policy, healthcare standards and professional training in this area. Alongside this we have raised awareness to ensure all these changes are supported by a shift in the public visibility of this hitherto hidden group.

King’s research influenced UK policy on the mental health needs of trafficked people. King’s research (1) fed into the Department of Health’s (DOH) 2015 consultation on charging visitors to the UK for NHS care, leading to an amendment to legislation (regulation 6), so that healthcare charges incurred by a patient prior to being identified as a potentially trafficked person would be refunded [A1, A2]. Also in 2015, King’s PROTECT research (1, 4, 5) was cited in a joint statement from the Department of Health and NHS England (NHSE) to health services on Anti-Slavery Day **[A3]. ** In 2016, King’s researchers presented findings on trafficked people’s contact with health services (2,5) to the Parliamentary Under Secretary of State for Public Health and Innovation [A4, A5], and to the All Party Parliamentary Group on Human Trafficking and Modern Slavery [A6]. King’s researchers were then requested by Baroness Butler-Sloss to author a briefing paper with the Helen Bamber Foundation (HBF) on the mental health difficulties experienced by trafficked people and the impact on their ability to provide testimony [A7]. Featuring King’s research (2,4), this work was cited by the Work and Pensions Committee in their 2017 inquiry into Victims of Modern Slavery as evidence for the physical and mental health problems experienced by trafficked people [A8, A9].

King’s research has also supported The Human Trafficking Foundation (HTF), an organisation which grew out of the All-Party Parliamentary Group on Human Trafficking and Modern Slavery, which aims to shape human trafficking policy and legislation by equipping policy makers and statutory agencies with evidence. King’s work (1) underpinned an improvement in the HTF’s 2018 Trafficking Survivor Care Standards [A10, A11], developed to ensure that all professionals working with trafficked people provide high quality, evidence backed and consistent care, as they are entitled under law. The Home Office have committed to incorporate these standards into its Modern Slavery Victim Care Contract as part of the National Referral Mechanism, the system by which potentially trafficked people are identified and signposted to services and support, confirmed by Parliamentary Under Secretary of State for the Home Department, Victoria Atkins, in a parliamentary debate in March 2019 [A12].

King’s research informed UK health guidance to support victims of modern slavery. King’s PROTECT research (1,2,4,5,6) is featured in Public Health England’s guidance on supporting victims of modern slavery in healthcare settings [B1]. King’s research (5) also informed DOH guidance for health staff on identifying and supporting victims of modern slavery [B2], which led to NHSE guidance on safeguarding victims of modern slavery [B3] and has helped inform a nationally disseminated video produced by NHSE to educate healthcare professionals about modern day slavery [B4].

King’s research has informed guidance and training within the healthcare professions and beyond to better meet the needs of trafficked people. King’s evidence that NHS services are important points of contact for trafficked people and potential routes to identify and support this voiceless and vulnerable group (5,6), alongside King’s research identifying the necessity to address the skills gap to meet their complex needs (2, 6), led to the provision of specialist training for healthcare professionals in this area, and informed the development of national training guidelines [C1, C2].

King’s PROTECT research (1) was cited by the Independent Anti-Slavery Commissioner in letters to several Royal Colleges including: Emergency Medicine; Obstetricians and Gynaecologists; Paediatrics and Child Health; Psychiatrists; Surgeons. The letter urged Colleges “in the strongest possible terms to include reference to Modern Slavery Human Trafficking (MSHT) and exploitation within curriculum for trainee[s] ” [C3].

King’s research informed the Royal College of Nurses on advising their members/trainees to identify and respond to suspected cases of trafficking. King’s research (2,5,6) was the basis for a set of guidelines produced by the Royal College of Nurses for nurses and midwives. This has evolved over the years and is now entitled the Modern Slavery and Trafficking Guidance [C4]. Since publication, 10,000 print copies have been distributed and at least 2,000 copies downloaded [C5], plus it is recommended in a list of resources in the Home Office’s Modern Slavery Unit [C6]. At the request of the Royal College of Midwives and on the basis of King’s research demonstrating the contact of trafficked women with maternity services (3), King’s researchers developed an iLearn module for midwives on responding to human trafficking and modern slavery to be launched in 2021 [C7]. Healthcare professionals are also trained via the VITA network, commissioned by NHS trusts to provide training on health responses to modern slavery, and using King’s work (5) to inform the content and delivery of their training [C8,C9]. King’s research has helped caseworkers, advocates and legal advisers to advocate for trafficked people. This includes gaining access to specialist post-trafficking healthcare support services, and supporting successful applications for leave to remain, positively impacting the physical safety and psychological wellbeing of survivors. King’s research has also been used to support survivors’ asylum and immigration claims, and has been cited within medico-legal reports [C10].

King’s research has informed international policy development. King’s research (5,6) has been cited by the World Health Organization in its submission to the Committee on Elimination of Discrimination Against Women (CEDAW), which is elaborating a General Recommendation on trafficking of women and girls in the context of global migration [D1].

King’s research underpinned the recognition of the unique mental health needs of trafficked people in international diagnostic classifications. Due in a large part to King’s research into the complex and severe mental health problems of trafficked people (2) and the need to recognise their experiences in diagnosis and care, codes for abuse from experiences of trafficking were introduced in the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), and these were differentiated from other forms of abuse [E1, E2]. ICD-10 is the global standard guidance for making all clinical diagnoses. The trafficking codes went live in 2019, and this recognition of the harm caused to trafficked people has enabled healthcare professionals to track provision of healthcare to survivors of trafficking and build global data sets; and demonstrated the human and economic costs associated with this criminal activity.

King’s research has increased public awareness and engagement with human trafficking.

King’s has increased awareness of the mental health impacts of human trafficking, with national and local media coverage of research [e.g. F1]. A collaboration with Syrian artist Sara Shamma culminating in a 2020 exhibition exemplifying HBF’s mission to “bear witness to the suffering of survivors and fight for their rights” resulted in coverage in more than 30 national and international media outlets [e.g. F2]. As public attitudes go hand-in-hand with policy, these have widened the inroads King’s research has made into changing the political, legal and health landscape to address the needs of this hitherto invisible group.