Impact case study database

The Antibiotic Review Kit (ARK)-Hospital Programme has provided the research-based evidence to develop a set of four interventions promoting and supporting hospital health professionals’ adherence to the Department of Health ‘review & revise’ guidance, outcomes of which are described below. This contribution was recognised by Deputy Director of Public Health England (PHE), Healthcare Associated Infections and AMR, Dr Susan Hopkins:

“The approach that ARK has developed to making finalised antibiotic prescribing decisions of “stop unless you can justify continue” incorporated in digital prescribing […] supported by prescriber education around antibiotic “review and revise” decisions […], supports the delivery of Dame Sally [Davies]’s vision [i.e. for a digital AB prescribing in hospitals]”. [ S1]

In June 2015, Dr Diane Ashiru-Oredope at PHE directly referred to Prof Llewelyn’s research [ R1] in her expert commentary in the NICE ‘Eyes on Evidence’ newsletter, which contextualises key new evidence that could signal a change in clinical practice. The research was specifically used to highlight the need for implementing and monitoring the ‘focus’ element of NHS ‘Start smart then focus’ to reduce unnecessary use of AB in NHS Trusts [ S2]. In addition, the detailed overview of the AMR-CQUIN evaluation [ R2] directly underpinned the conclusions of PHE’s English Surveillance Programme on Antimicrobial Use and Resistance 2017 report, i.e. to explore changes in AB prescribing in acute Trusts, and develop resources and tools for hospital engagement with the AMR-CQUIN [ S1, S3].

In a proposal put forward to the AMR Programme Board in December 2019, co-authored with Prof Llewelyn, Dr Susan Hopkins and Dr Keith Ridge (NHS England Chief Pharmaceutical Officer) used the findings of the ARK-Hospital Programme to recommend the roll-out of the ARK interventions across all NHS Trusts in England [ S1 & S4]. This request was made in addition to the agreed decision by the AMR Programme Board in September 2019 for feedback letters addressed to acute Trusts CEOs, to include the requirements to use the ARK interventions as support for the ‘Start smart then focus’ initiative [ S1 & S4].

Several factors led to Dr Hopkins and Dr Ridge’s recommendation to the AMR Programme Board [ S1 & S4]:

• the significant demand from ARK participating Trusts for national leadership to sustain the remarkable impact of the ARK interventions at their Trusts

• the ARK interventions directly addressing the UK AMR Strategy in relation to workforce development, by educating prescribers and non-prescribers involved in AB use about safe effective AB prescribing in hospitals, and how to put ‘Start smart then focus’ into practice

• its support of the relevant NICE Guidance (NICE NG15, Antimicrobial stewardship: systems and processes for effective antimicrobial medicine use) and Quality Statements (NICE QS121 Antimicrobial stewardship) for secondary care.

The COVID-19 situation has delayed the decision of the AMR Board in response to this application, but Dr Hopkins has confirmed (January 2021) that “work is continuing to ensure this is implemented over the next 12 months.” [ S1].

By clarifying the conditions of the initial prescription, the ARK decision aid toolkit gave the reviewing team (often different from the team initiating the AB treatment) increased confidence in their decision to stop or continue the AB course at the 24-72 hours review point. The success of the toolkit’s implementation is illustrated by the feedback provided by participating NHS sites to the [text removed for publication] [ S5].

In light of this overwhelming support, [text removed for publication] the ARK decision aid toolkit into its existing e-Prescribing system managed by WellSky, who control 60% of the pharmacy secondary care marketplace for medicines management e-platforms [ S6]. Key elements of the research – the timing of data recording, their nature, auditing and reporting requirements – informed the majority of the new system design and operation, which now supports the ARK-informed behavioural shift from “continue unless there is evidence to stop” to “stop unless there is evidence to continue” [ S6]. The updated system will be provided free of charge in all 50 large NHS Trusts currently using the WellSky e-Prescribing system [ S6]. WellSky anticipates that the remaining 40% of the pharmacy secondary market will likely soon engage with their system in one form or another, notably due to the predicted NHS mandate to follow the ARK principles in terms of AB prescribing [ S6].

Between April 2017 and July 2019, a total of 7,444 Healthcare Professionals (HCPs) involved in AB use completed the online module at the 40 participating NHS sites [ S7]. Out of the 40 sites, 8 (i.e. 5% of all acute Trusts) have now included the ARK online module in their e-learning platform, demonstrating their sustained commitment to this element of the ARK interventions as part of their standard practice [ S8]. Since May 2019, the ARK brief online training module is provided free of charge to the NHS via two main platforms: the e-learning platform of NHS Health Education England and the British Society for Antibiotic Chemotherapy (BSAC). A total of 8,596 individuals completed the module between May 2019 and November 2020 [ S8]. Feedback comments demonstrate the key role played by the course in increasing HCPs’ knowledge about good AB stewardship and enabling them to re-think their current AB prescribing practice: “Evidence based, sensible, useful. Will change my practice” and “The course has increased my knowledge regarding antibiotic prescribing. It has equipped me to monitor antibiotic use in the patients I care for” [ S8]. Dr Neil Powell, Consultant Antimicrobial Stewardship at the Royal Cornwall Hospital, and one of the ARK trial Champions, acknowledges that the online module is one of the main elements in the ARK interventions for promoting good AMR Stewardship to all HCPs involved in AB prescribing [ S9]. As of November 2020, the module online package has been incorporated in 31 healthcare organisations’ e-learning platforms, including 1 NHS Trust in Wales, 2 NHS Trusts in Northern Ireland, and 10 in Zambia, with the University Teaching Hospital in Zambia and the Ministry of Health among others [ S8].

In the first NHS Trust to implement the ARK interventions, the Brighton and Sussex NHS Hospital Trust, AB stop rates (i.e. decisions to safely discontinue the initial AB prescription following its review at 72 hours) increased from 9% to 36% in hospitalised patients without any harmful effect [ R5]. The Trust management adopted the interventions across the whole organisation following which AB consumption fell quarter on quarter for two years. In North Middlesex University Hospital – one of the 40 implementing sites and 6^th highest consumer of AB out of the 153 NHS Acute Trusts – compliance with 72-hour reviews went from 63% at the start of ARK interventions implementation in May 2019 to 90% at the end of the 12-week evaluation [ S10]. Stop rates at 72 hours rose from 10% to 20% within the same period. The Trust has projected savings of £35,000/year in drugs costs alone just through the increase in stop rates [ S10]. Similarly, the stop rate at the Royal Cornwall Hospital went from 5-9% at the start of the ARK interventions implementation to 20% at the end of the 12-week period. This rate steadily increased to 24% in November 2019 [ S9]. For both Trusts, the ARK audit tools and feedback sessions were key in driving this change in AB prescribing by HCPs, as it allowed them to assess in real time the effectiveness of the interventions and thus provide targeted support where required. This view is best illustrated in a quote from one of the ARK Champions at another participating NHS site:

“[ARK] was a helpful tool and resources to enable us to do what we needed to do, in terms of antimicrobial stewardship. It’s the activities that we wanted and needed to do, but ARK provided us with a framework for that.” [ S11]

Across the 39 other acute NHS Trusts that implemented ARK, AB stop rates increased by a median of 8% and up to 25% depending on how robustly the interventions were implemented. The participating Trusts have extended use of the ARK interventions beyond Acute Medicine and into clinical areas such as surgery, and to other Trust sites not involved in the original evaluation [ S1].

In its survey study of World Antibiotic Awareness Campaigns (WAAC), the WHO – referring to Prof Llewelyn’s BMJ analysis [ R4] – acknowledges:

“The validity and usefulness of the ‘Complete the course’ message has, for instance, been questioned, since antibiotics are often prescribed unnecessarily and for too long, and the evidence for the impact of duration of treatment on AMR is weak.” [ S12]

Given these concerns, since 2017, the WHO has eliminated this message from WAA Week [ S12]. The ARK findings, and successful implementation in all 40 participating sites, were especially fitting for the 2020 PHE World Antimicrobial Awareness Week and European Antibiotic Awareness Day in England, which focussed on avoiding inappropriate AB prescribing while working together to prevent serious infections – including COVID-19 [ S1]. As a result, in its set of suggested actions to healthcare professionals, PHE recommended to “visit the Antibiotic Review Kit (ARK) website to engage with a range of resources designed to help all healthcare professionals to reduce antibiotic overuse in hospitals” [ S13].

1. National Podoconiosis Prevention, Control and Elimination Policy: Ethiopia & Rwanda

Information from studies conducted by staff at the CGHR has shaped policy in two countries in East Africa – Ethiopia and Rwanda. The route to impact is via Neglected Tropical Disease (NTD) Masterplans, which each endemic country is required to draw up to receive donations for Mass Drug Administration (community-wide preventive therapy). Due to the co-productive nature of the research conducted in each country, CGHR members provided research-based evidence as part of the development and writing of the Masterplans, thus ensuring the rapid implementation of their research findings.

1.1 Ethiopia – evidence-based national NTD Masterplan and healthcare programmes

LF/Podo integrated mapping. In Ethiopia, evidence from CGHR research on podo informed the first edition of the country NTD Masterplan 2013-2015 (Deribe K. et al., Parasit. Vectors, 2012), and the need for a nationwide mapping of the disease. At subsequent national NTD review meetings, Deribe and Davey presented CGHR findings on podo mapping [ R1] and estimation of the disease burden [ R2], which in turn informed the Ethiopia NTD Masterplan second edition 2015/16-2019/20 [ S1]. As a result, the country met two milestones for podo elimination [ S1] by 2016: (1) completion of podo mapping and identification of endemic districts [ S2, R1], and (2) burden assessment in 58 (16%) of the districts [ S2].

Healthcare programmes – the Preventing Podo Project (PPP). In 2014, Davey and colleagues were successful in securing a UK Big Lottery Fund grant for an implementation project coordinated by the Ethiopian National Podoconiosis Action Network (NaPAN) – an NGO bringing together researchers, policy makers, clinicians, and representatives of all groups offering care to patients with podo in Ethiopia. The PPP was a three-year implementation project (2014-2017, GBP499,078 award + in-kind/financial support, total GBP2,214,745), aiming to extend small-scale interventions of podo case management in the three regions of Ethiopia most affected by podo [ R1]. The successful project application was based on the CGHR research on the social [ R4] and mental health impact of podo [ R5]. The project contributed to the capacity building of 370 government health professionals and 182 health extension workers trained in podo morbidity management [ S2], with 67% expressing confidence in their ability to provide podo care [ S3]. As a result, 68,181 podo patients (around 5% of the national total) who would otherwise not have had access to treatment, were treated for podo and 115,653 individuals in podo endemic districts were educated on the disease through 1,150 community events, 55 district workshops, and 16 rounds of national radio campaigns [ S3]. A network of 18 patient-led groups was also established for a more sustainable and accessible community-based approach to podo [ S3]. Finally, the PPP was instrumental in catalysing [text removed for publication] [ S2].

Development of the LF/Podo Morbidity Management and Disability Prevention (MMDP) guidelines. Davey and Deribe contributed to the development of the LF/Podo MMDP guidelines [ S4] via NaPAN, using CGHR data on the mental health impact of podo [ R5]. These research findings enabled advocacy for psychological and socioeconomic support to complement medical and surgical care, which ensured full reintegration of patients into their communities [ S4]. These findings helped to define the patient counselling element of the care package, alongside medical care. As of February 2016, the guidelines were used to train a total of 300 health care workers and full coverage of the MMDP guidelines had been achieved in 87% of endemic districts, leading to the treatment of 153,250 people [ S2].

Lymphoedema Management Package. The GoLBeT trial provided the research-based evidence for a simple treatment intervention on which to base national policy. It showed that a simple, inexpensive care package was effective in reducing the frequency and duration of acute lymphoedema attacks resulting in increased work productivity and quality of life [ R6]. In March 2019, the results of the trial were presented at workshops held to draft the third National Masterplan alongside CGHR research on podo burden assessment [ R2]. The GoLBeT care package is set to be incorporated in the next five-year Ethiopian NTD Masterplan (2020-2025) [ S5] and has been used by the [text removed for publication] [ S8].

1.2 CGHR-led podo research contribution to Rwanda NTD Strategic Plans

In Rwanda, the CGHR research [ R3] has been described as “an impressive and substantial undertaking […] reaching more than 1:10 Rwandans” and resulting in 282 community health workers being trained to identify podo cases [ S6]. The findings contributed to advocacy for podo interventions in the 2017-2020 NTD Strategic Plan [ S7a] and CGHR staff advised on the podo elimination plan. In 2018, the study results were presented internally within the Rwanda Ministry of Health and underpinned the podo section of the 2019-2024 NTD Strategic Plan, which sets the strategies to reduce the burden of the disease by 2024 [ S7b, S8]. Amongst these initiatives are the training of health professionals, establishment of 10 podo treatment centres in the most affected districts, and education of the population to the importance of foot hygiene and shoe-wearing. Through Foot work, CGHR secured a three-year (2020-2023) implementation award funded by the IZUMI Foundation to support the government in this first step [ S8]. [text removed for publication]. The CGHR IZUMI award is critical for Rwanda’s government to implement the podo-specific initiatives laid out in its NTD Strategic Plan, due to limited internal resources available to tackle this disease.

2. Global Advocacy on podo elimination

CGHR research on podo prevalence and distribution mapping in Ethiopia and Rwanda has been pivotal for disease advocacy. In 2010, Davey was invited to give a presentation to the WHO Neglected Tropical Diseases department about podo which, until then, was not one of the diseases considered by the department. As a result of this presentation, the WHO NTD department integrated podo under its “other neglected tropical conditions”. This recognition by the WHO catalysed significant changes to policy development within Ethiopia. Through this recognition, the country was able to include podo in their 2013-2015 NTD Master Plan and mobilise essential resources (such as the network of district-level NTD-leads) to control the disease [ S9].

In 2018, the WHO NTD department put together a pictorial training guide on neglected tropical diseases of the skin for district health workers, to support capacity building in the diagnosis and treatment of NTDs. Davey and colleagues’ research informed the podo section of the WHO training guide [ S10] which has since been converted into an interactive new mobile phone app [ S11]. Dr Jose Postigo, Medical Officer, Skin NTDs team, WHO Department of Control of NTD, at the announcement of the app’s launch in July 2020, explained its significance as follows:

“This software application will quickly allow health care workers and the public to get information about a specific disease – such as its clinical features, management and geographical distribution – and also provide a list of potential diagnosis.” [ S11]

In July 2020, Davey and colleagues, [text removed for publication], put together a series of user-friendly slides on podo for district health workers training on the disease. This includes the latest GoLBeT care package [ S12].