Digital Therapeutics in the NHS: the Rise of Digital Therapies & The

Digital Therapeutics in the NHS: The rise of digital therapies & the evidence that proves they work

In partnership with

#DHLCOLLABORATE digitalhealth.london #Digitaltherapeutics DigitalHealth.London

Contents

04 Fear over pragmatism? Have we reached the tipping point for evidence and digital therapies?

07 DigitalHealth.London: a pan-London partnership

08 The UK could become a leader in digital health by rolling out a turnkey solution for Digital Therapeutics research

10 Infographic: the digital medicine cabinet is coming of age

12 The balancing act of Digital Therapeutics: how should the NHS bring global innovation in the clinical validation of apps home?

14 Let’s move on from the evidence challenge to explaining what good looks like

16 Evidence is crucial but context can be king in ensuring innovation spread

18 How real world data could be used to generate evidence for digital health

02 Digital Therapeutics in the NHS

Foreword

The past decade has seen rapid development and adoption of technologies that change the way we live in many areas of day to day life. Digital and connected technologies continue to stake their claim in the health and care industries. In the last few years we have seen the rise of a new type of health technology product — one that promises measurable health outcomes: Digital Therapeutics.

It’s clear that Digital Therapeutics holds Our health and care sector continues great promise to enhance patient care, to face difficult challenges. We need to create treatment efficiencies, and ensure universal access to any benefits improve clinical outcomes. However, delivered via innovation through the NHS, the complexities of our current research preventing the system from being left and development system, coupled with amidst a vibrant and growing consumer the costs associated with running robust market. Furthermore, we must make it William Smart clinical trial and studies, has historically easier for providers, commissioners and Chief Information Officer curtailed the development of a validated patients to leverage and benefit from the NHS suite of digital interventions that could rich health information these technologies confidently be adopted or prescribed can deliver. by healthcare providers. Fortunately, the emerging body of evidence suggests a So, I invite you, our NHS colleagues and positive and fertile landscape to start to industry to be part of the conversation on encourage in earnest the use of Digital the future of Digital Therapeutics. Let us Therapeutics in conjunction with existing engage with digital health companies from and more traditional therapeutic options. around the world with best in class clinical evidence and learn what the current At this year’s annual DigitalHealth.London/ evidence is telling us right now about Collaborate event, which is being hosted in clinical effectiveness. As a collective, let collaboration with NHS England, IQVIA and us commit to taking the steps to ensuring The Digital Therapeutics Alliance, we will evidence does get into real-world clinical explore the process for getting the most practice for Digital Therapeutics. out of proven digital therapeutic solutions, focussing on the evidence base, what we Let us continue to embrace new know right now, what good looks like, and technologies like these, which present how this should be informing how we make new opportunities for our health and care decisions around which digital solutions to system, improving the lives of our patients adopt and use. and citizens.

03 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

Fear over pragmatism? Have we reached the tipping point for evidence and digital therapies?

DigitalHealth.London Amy Galea, Deputy Director, Transforming Firstly, what are ‘Digital Therapeutics’ – Health Systems, NHS England, recently here’s a definition: have been debating stated at the HIMSS executive leadership the growing value of summit, that currently seven pence in every “Digital Therapeutics are something pound is being spent on chronic condition that is digital or software by nature, that Digital Therapeutics in management. Despite 70% of funds going engages a patient, and by virtue of the the United Kingdom and towards this, it is not necessarily reflected mechanics of the software can by itself or in the health outcomes being achieved. in combination with something else lead engaging with many Ruth Robertson, The King’s Fund, showed to clinical outcomes,” says Eddie Martucci, stakeholders both inside how the increased demand for health care CEO, Akili Interactive Labs. services is having a negative impact on and outside of the NHS. the quality of care being delivered. Martucci goes on to say, “there are The July 2017 Healthcare System various forms and approaches that Performance Rankings, published by Digital Therapeutics take, whether that be The Commonwealth Fund, ranks the digitally-enabled drug delivery, software- UK first for care process and equity, driven behaviour modification or disease but 10th (out of 11 countries) for health management, or stand-alone digital care outcomes. products that directly activate physiology to achieve outcomes.” There are many contributing factors driving the quality of health outcomes. We at DigitalHealth.London have been But one emerging question that is debating the growing value of Digital gaining traction and profile is, canDigital Therapeutics in the United Kingdom and Therapeutics play a role in improving engaging with many stakeholders both health outcomes, and what is the inside and outside of the NHS on its evidence to suggest they can? potential to improve patient experience and impact clinical outcomes.

Some examples of digital therapeutic innovations that you may have come across include: Akili; Quit Genius; Omada Health; Pear Therapeutics, Propeller Health, myCOPD, WellDoc, Voluntis; Yinka Makinde Programme Director Sleepio; Vida Health; Oviva; Changing DigitalHealth.London Health; OurPath, and more besides.

04 Digital Therapeutics in the NHS

A recent report on 571 published efficacy Recently, three of our UK grown studies and 234 randomised controlled innovators; OurPath; Oviva and Changing trials of the quantitative value of digital Health (current and previous DigitalHealth. health apps and connected devices on London Accelerator companies) delivered important metrics like weight loss, blood impressive outcomes following a four sugar control, depression scales, and month real world evidence trial led by hospitalisations, concluded that the vast Dr Tony Willis, Clinical Lead for Diabetes, majority of these efficacy studies have North West London Collaboration of CCGs shown statistically significant benefits on where more than 400 Type-2 diabetes health outcomes. patients from 18 GP practices in North West London were offered one of the The July 2017 Healthcare Few of these published clinical studies three digital therapeutic interventions. and results however, had been generated System Performance by digital therapeutic innovations But what is the quantitative value of digital Rankings ranks the developed outside the UK. I believe there health? Do apps and connected devices UK first for care process is a reason for this. In the UK we currently really improve patient outcomes? Will and equity, but 10th for have four challenges affecting the prolific digital health create cost savings that the generation of clinical evidence to support NHS can count on? And most importantly, health care outcomes digital clinical interventions: what is growing body of ‘evidence’ that currently exists – whether randomised 1 Lack of clear standards defining what controlled trials or real-world evidence? good looks like – so that innovators These questions and others are the focus know the bar to aim for of the debate at this years’ DigitalHealth. 2 Insufficient trial sites to conduct the London/Collaborate 2018 Summit. clinical studies 3 Borrowed (from life sciences clinical Thank you for attending this important trials) infrastructure, rigid approaches event. This year DigitalHealth.London is and a legacy culture that drives up a delighted to host its 2018 Collaborate cost of conducting clinical studies that Summit in partnership with NHS England, is out of reach for the average digital IQVIA and The Digital Therapeutics health innovator Alliance. This Summit is aimed at a 4 Poor visibility of and access to national and international audience. the growing body ‘evidence’ that currently exists – whether randomised controlled trials or real-world evidence

05 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

The title of the event is: ‘Digital Joshi, Digital Health and AI Clinical Lead, and Therapeutics in the NHS: The rise of backs the need for clear standards defining digital therapies & the evidence that what good looks like, so that innovators proves they work’ and offers senior know the bar to aim for. Through a multi stakeholders in the NHS insight into stakeholder steering and working group, the evidence that exists right now, the group aims to deliver a set of NICE supporting the clinical effectiveness endorsed guidance for digital innovation, of digital therapies. It aims to provide for commissioners and innovators. delegates with the opportunity to see real examples of innovations and interrogate We are optimistic that by engaging the evidence, and to start to co-produce Recently, three of our in more activity like this, led by the a toolkit for commissioning and adopting UK grown innovators; ‘pioneers’ in our system who will drive the digital therapies with confidence. OurPath; Oviva and transformation needed for a sustainable Changing Health delivered health and care system, we can help We are fortunate to have an excellent line to deliver better clinical outcomes and up of speakers and panellists including impressive outcomes improve patient experience. Jonathan Sheffield (CEO, NIHR CRN); following a four month real Will Smart (CIO, NHSE); Simon Dixon word evidence trial My question to those of you reading (Head of Digital Strategy, PHE); Dr Axel this today, whether you are a patient or Heitmueller (MD, Imperial College Health clinician, a commissioner, policy maker or Partners); Dr Mark Kelsey (Clinical Chair, an innovator, what is the tipping point to NHS Southampton City CCG), Sarah make this mainstream? If a vast majority Haywood (CEO, MedCity); and Mark of the 571 efficacy studies reviewed have Campbell (Deputy Programme Director, shown statistically significant benefits for NICE). The event is chaired by Dr Mark health outcomes in 5 key therapy areas: Davies, GP & Non-Executive Director, BMJ. diabetes prevention, diabetes, asthma, cardiac and pulmonary rehabilitation, then Innovations (and their founders) on stage what is the checklist of ‘must haves’ to will be Akili; myCOPD, WellDoc, Voluntis; support the proactive commissioning and Sleepio all evidence based Digital adoption of these digital therapies in the Therapeutics innovations. years to come?

A very important stream of work recently Join the #digitaltherapeutics kicked off at NHS England, led by Dr Indra conversation with #DHLCollaborate

06 Digital Therapeutics in the NHS

DigitalHealth.London: a pan-London partnership

Meet our founding partners

The Health Innovation Network UCLPartners is a leading Imperial College Health Partners acts as a catalyst of change academic health science is a partnership organisation – identifying, adopting and partnership that brings together bringing together NHS providers spreading innovation across the people and organisations of healthcare services, clinical health and care system in south to transform the health and commissioning groups and London, based on a culture of wellbeing of the population. leading universities across partnership and collaboration Working in partnership and at North West London. We are the with our healthcare, research pace, its members from the designated Academic Health and industry partners. We are NHS and higher education Science Network (AHSN) for the Academic Health Science support the healthcare system North West London. Together we Network (AHSN) for South serving over six million people in aspire to create a health system London. Speeding up the best in parts of London, Hertfordshire, where what we know is what health and care, together. Bedfordshire and Essex. we do, unleashing the power of collaboration, experimentation hin-southlondon.org uclpartners.com and innovation in healthcare. @HINSouthLondon @uclpartners imperialcollegehealthpartners.com @Ldn_ICHP

DigitalHealth.London is also strongly supported by the three Academic Health Science Centres MedCity is a not-for-profit NHS England’s mission is to (AHSCs), and the organisation that works across the provide health and high quality Cambridge-London-Oxford cluster care for all, now and for future Mayor of London supporting the establishment generations. We are committed of business partnerships and to putting patients at the heart collaborations across the region. of everything we do, promoting We work with academic, clinical transparency and accountability of and research centres within the our work and ensuring the most south east of England. We provide efficient, fair and inclusive use free assistance with introductions, of taxpayer resources. Central advice and connections for to our role is the commissioning industry, academics and investors of health services. We empower looking for partners, infrastructure and support clinical leaders at and expertise. Our goal is to every level of the NHS, to make facilitate and support collaboration genuinely informed decisions and across all parts of the sector to provide high quality services. turn life science innovations into commercial products and services. england.nhs.uk @NHSEngland medcityhq.com @MedCityHQ

07 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

If Digital Therapeutics companies could conduct their studies better, faster, and cheaper in the UK than elsewhere, the benefits to the health and wealth of the nation would be significant. Improving the UK’s Digital Therapeutics research infrastructure would position the nation The UK could become for more investment in research and downstream commercial activity; UK startups would become more competitive, a leader in digital health and more world leaders in Digital Therapeutics would want to set up operations in the UK. However, to realise by rolling out a turnkey solution these clinical and economic benefits, the leading apps that drive this value would for Digital Therapeutics research likely need to be studied in NHS patients prior to their broad adoption.

The research needs of the Digital As a preview to the DigitalHealth.London/Collaborate Therapeutics industry are – at the 2018 Summit: Digital Therapeutics in the NHS (London, highest level – fairly uniform and well understood. To be sustainably successful, UK; April 24, 2018), the authors outline how the Digital Therapeutics developers of all kinds need an efficient means of proving UK could become a leader in the emerging Digital their effectiveness, safety and cost- Therapeutics industry by creating the world’s first effectiveness relative to the standard of care in a setting that very closely turnkey Digital Therapeutics research platform. resembles real world practice. In fact, most industry participants would agree that the main problem with current infrastructure is not necessarily ‘quality;’ Digital Therapeutics are patient health In many ways, the UK is in a position to it’s the excessive time and cost of today’s applications and connected devices that grow and catch up with the market leaders studies together with the struggle to have proven clinical benefits, as well as, in the Digital Therapeutics industry. To date, transition seamlessly from research to appropriate regulatory clearances and only 8% of published app effectiveness real world practice. distribution pathways to serve their intended studies have taken place in the UK.3 In use. Recent reporting by the IQVIA Institute 2017, $USD 14.2 billion was invested in has identified a large, growing number of digital health startups globally, but only such apps with the potential to save billions $USD 426 million (3%) was invested in in unnecessary healthcare costs.1 This value UK digital health startups.4 drives strong industry growth projections, with some forecasting that Digital Therapeutics sales will expand to $USD 9.4 billion worldwide by 2025.2

Figure 1: The UK’s global position in digital health

Global VC Investment in Digital Health Global Digital Health Efficacy Study Publications

3% 8%

Brian Clancy Nelia Padilla Co-Lead & Associate Vice President & Director, AppScript, Global Services Lead, 97% 92% IQVIA Digital Health, IQVIA

UK Other

08 Digital Therapeutics in the NHS

A turnkey solution for ‘Bench’ of qualified independent Digital Therapeutics research research teams

The UK has an opportunity to provide the A list of academic and private sector world’s first turnkey solution for Digital teams with expertise in the management Therapeutics research. Key features of such and analysis of pseudonymised a solution should include the following: data should be available to prepare manuscripts that meet high quality

publication standards, such as the WHO’s Simplified application & setup ‘mERA’ checklist5

The commonalities of many Digital Therapeutics create the opportunity for a ‘templated’ approach to developing Ability to transition intermediately to study protocols, drafting ethics review use in ‘monitored’ routine care applications, and matching promising studies to potential funding sources. While research can be improved, perhaps an even larger issue for Digital Therapeutics companies is the need to Pre-contracted ‘Digital Therapeutics achieve scale. It would make sense to use a common infrastructure for research and Research Network’ routine care to enable seamless transitions. It generally takes years for Digital The required ‘investment’ to make the Therapeutics companies to find and above a reality is not in new technology set up appropriate legal agreements as the technology exists already. The Improving the UK’s with suitable research sites. The ability required investment to become a world Digital Therapeutics to ‘plug in’ immediately to a network of leader in Digital Therapeutics is in appropriate sites would be priceless for research infrastructure collaboration across the public, academic, the industry. would position the nation and industrial sectors. A consensus is needed around new processes for giving for more investment in research and downstream the UK’s Digital Therapeutics industry a App prescribing platform & 3rd party common sense boost. commercial activity research apps

Studies should minimise the work required of clinicians and patients. Significant efficiency can be realised by providing healthcare professionals with the ability prescribe study apps from their EMR, by providing patients the ability to eConsent to study terms, and by providing qualified researchers with a single source of collated EMR, app, and other data to analyse.

Figure 2: A turnkey Digital Therapeutics research platform

Pre-contracted 2 ‘Digital Therapeutics Research Network’

1 5 1 IQVIA Institute. The Growing Value of Digital Health in the United Kingdom. 7 November 2017. 2 Grand View Research. Digital Therapeutics Market by Application. July 2017. Simplified study 3 4 Ability to transition application & setup immediately to use in 3 IQVIA AppScript Clinical Evidence Database. ‘monitored’ routine Data on File. 13 March, 2018. care 4 Marc Sluijs. DigitalHealth.Network Deals App prescribing Bench of qualified Database. 15 March 2018. platform & 3rd party independent research 5 S. Agarwal. Guidelines for reporting of research apps teams to produce health interventions using mobile phones: high quality research mobile health (mHealth) evidence reporting publications and assessment (mERA) checklist. BMJ 2016;352:i1174. 17 March 2016

09 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

The balancing act of Digital Therapeutics: how should the NHS bring global innovation in the clinical validation of apps home?

Ahead of the Digital Therapeutics in the NHS summit (London, UK; April 24, 2018), this article examines the need for evidence of the value of Digital Therapeutics within the NHS.

All participants in health care systems An IQVIA Institute for Human Data stand to benefit from the contributions Science analysis suggests that if the of digital health – to improve outcomes, NHS used digital health apps in five increase patient convenience and patient populations where they have reduce costs – yet much work remains reduced utilisation of acute care to be done to move digital health into (diabetes prevention, diabetes, asthma, the mainstream. An evidence-based cardiac rehabilitation and pulmonary and deliberative approach is needed to rehabilitation), this would save £170 million build evidence of value, balancing any per year and improve health outcomes. excessive hype or enthusiasm. If this level of cost saving – amounting to 1.1% – is extrapolated to total NHS expenditure, total cost savings of around £2 billion per year could be realised.

Figure 1: cost savings associated with using 5 clinically validated apps across 5 initial indications

9 £170mn 5 24 Key Assumptions 103 • Use of 5 curated apps used in 5 underlying studies suggesting acute care utilisation benefits

• Delivery to each target patient for the given use case (but not necessarily used by patient) 28 • No ‘spill over’ benefits to other conditions (i.e. no reduced healthcare utilisation for stroke based on improved blood sugar Brian Clancy Murray Aitken control in diabetics Co-Lead & Associate Executive Director, Director, AppScript, IQVIA Institute for IQVIA Human Data Science Diabetes Diabetes Asthma Pulmonary Cardiac TOTAL Prevention Rehab (COPD) Rehab (MI)

Other Intervention Costs Reduced GP Visits Reduced Emergency Reduced A&E Costs Reduced Prescription Costs Hospitalisation Costs

Source: IQVIA AppScript Essentials Value Model, Aug 2017 Report: The Growing Value of Digital Health in the United Kingdom, IQVIA Institute for Human Data Science, Nov 2017

10 Digital Therapeutics in the NHS

While analyses of the digital health including the ability to book mobile app landscape published by the IMS Institute video appointments.2 There remains for Healthcare Informatics in 2013 and scope to build enthusiasm from the UK 2015 found evidence to be scarce and the payer and provider sides, based on the value of digital health difficult to measure, availability of tools and evidence, to this has now changed. The benefits to transform the way care is delivered and patients are becoming far clearer. value is provided to patients in this highly cost-effective manner. Worldwide, over 318,000 health apps and 340 consumer wearable devices Possible approaches for the NHS to exist. Clinical evidence of app efficacy resolve the fundamental tension between comprises at least 571 studies, including the extensive clinical proof for digital 234 randomised controlled trials and 20 health apps outside of the NHS, and the meta-analyses. High-quality apps — those lack of evidence from within the health with characteristics such as high patient service, include: ratings, frequent updates, connectivity to sensors, endorsements, and promising 1 Do nothing: start from scratch by clinical evidence — now exist for each waiting for local startups and global major type of health care use. digital therapeutic leaders to sponsor studies within the current NHS Yet, only around 8% of studies of app infrastructure efficacy to date have taken place in the 2 Bridge the gap: seek out global NHS, based on research from the IQVIA digital therapeutic leaders, connecting Institute. One reason may be the relatively them to promising study opportunities, low level of venture capital investment in and enabling generation of local, UK digital health companies, which stands real-world evidence at only 3% of the global total, based on 3 Improve study efficiency: introduce research from DigitalHealth.Network. a new infrastructure for enabling Another may be the fact that some digital Digital Therapeutics research to occur health entrepreneurs report that NHS better, faster, and cheaper in the UK clinical commissioning groups either do than elsewhere. not require or will not allow publication of results from pilot studies they sponsor. This Since the first option – simply waiting poses a problem because institutions such – would delay the benefits of digital as NICE typically prefer to base decisions health to the NHS, the most promising on clinical evidence of value in the NHS. solution is likely the combination of the second and third options. The NHS can The US has seen much progress in proactively engage global leaders with developing evidence through both expertise in evidence generation, while also observational and randomised trials, encouraging development of new platforms enabling practical assessment of app to dramatically lower the cost and speed the quality from both patient and provider recruitment for local clinical studies. Timely perspectives. Progress is also being made action would enable the NHS to realise the in the UK, where the NHS Apps Library benefits of clinically proven digital health (https://apps.beta.nhs.uk) lists 46 apps apps – namely Digital Therapeutics – and that have successfully navigated the new make the NHS a world leader in this exciting Digital Assessment Questions (DAQs) to and rapidly evolving sector. secure an endorsement as ‘trusted apps’ for use by patients and clinicians. Promising steps include publication of privacy and security guidelines (in the form of the DAQs), programmes such as the NHS England Innovation and Technology Tariff to address patient access, efforts to align digital health programmes with providers’ incentive structure, and interoperability initiatives to integrate apps into the 1 Accenture Consulting. Patients physician workflow. want a healthy dose of digital. 2016. Available from www.accenture. com/ t00010101T000000Z__w__/gb-en/_ Patients in the UK are expressing interest acnmedia/PDF-27/Accenture-Patient- in mobile health, with one survey finding Engagement-Survey- Infographic-UK.pdf 1 2 Now Healthcare Group. UK patients that 36% of patients use health apps, demand access to digital health apps and a second survey showing that 97% of through NHS choices. 2017 Feb 7. Available 100 UK adults wanted the NHS to provide from: http://www.nowhealthcaregroup. com/2017/02/07/uk-patients-demand- access to digital health technologies, access- digital-health-apps-nhs-choices/

11 The rise of digital therapies & the evidence that proves they work Growing evidence Growing evidence Not Not nts abl THEnts DIGITAL abl THE DIGITAL me Clin e q me Clin e q 860 nt 860 ica u nt PACESETTERS Compellingica u NumbersPACESETTERS Compelling Numbers 571 571 oi ) l aoi ) l a Clinical Clinical trials globally Clinical p eClinicald trials globally ev plit ed ev lit p ed ipd eyd Digital Therapiesid y could save Digital Therapies could save a ne a ene e - mostly USA is h - mostly USA is h n n evidence studies evidence studiesd rc d rc c c - as far as Africa l ea - as far as Africa l ea e e a es a es ti r ti r n re n re million pa million pa 244 244o Autism o Autism e e £170 £170 Randomised Randomisedt (m t (m (with Diabetes, Asthma, Cardiac (with Diabetes, Asthma, Cardiac 80% o 80% Anxietyo Anxiety control studies contP rol studies P & Pulmonary rehab) & Pulmonary rehab) of top 26 apps Dermatalogicalof top 26 apps Dermatalogical MS MS have observational have observational Depression Oracle Health Depression Oracle Health 20 20 million saved million saved Meta analysis study demostrating Meta analysisSchizophrenia/study demostrating Schizophrenia/ £131 £131 clinical efficacy Bipolar clinical efficacy Bipolar from Diabetes alone from Diabetes alone studies studies

Measures of app quality Measures of appExercise quality Diabetes Exercise Diabetes £2 billion £2 billion Professional Pain management Professional Pain management If applied system wide If applied system wide Clinical Clinical WellDoc WellDoc Ratings and formulary Ratings and formulary Study outcomes Study outcomes inclusions inclusions The Beneﬁts The Beneﬁts

Smoking Smoking Developer Developer cessation cessation Patient Alzheimers Patient Alzheimers FEWER Emergency FEWER Emergency Techniques Techniques Insomnia Healthy Insomnia Healthy Feedback and use Feedback and use MyCOPD HospitalisationsMyCOPD Hospitalisations and updates and updates eating eating A&E visits A&E visits Endorsement Functional Endorsement Functional Stroke COPDStroke COPD GP visits GP visits Institutions Full assessment Institutions Full assessment Prescriptions Prescriptions Cardiac Cardiac Interventions Interventions The Shift HealariumThe Shiftrehab AsthmaHealarium rehabPropellor Asthma Propellor 24 Health24 Patients Health Patients Patient condition Patient conditiontotal total e e Conﬁdence Conﬁdence management managementGood evidenc Good evidenc Mental health, heart and Mental health, heart and Compliance Compliance circulatory conditions, circulatory conditions, Convenience Convenience nervous system disorders nervous system disorders MORE MORE and muscularskeletal. and muscularskeletal. Outcomes Outcomes 48% 48%1 2 Symptom 3 1 4 Condition2 Symptom 5 3 4 Condition 5 Wellness Wellness spotting Diagnosis Monitoringspotting TreatmentDiagnosis Monitoring Treatment & Prevention & Prevention Wellness Wellness & Monitoring & Management& Monitoring & Management management apps down 13% management apps down 13%

REFERENCE: The Growing Value of Digital Health in the United KingdomREFERENCE: Evidence The andGrowing the Healthcare Value of Digital System Health (November in the 2017)United IQVIA Kingdom Institute Evidence for Human and the Data Healthcare Science System (November 2017) IQVIA Institute for Human Data Science Growing evidence Growing evidence Not Not nts abl THEnts DIGITAL abl THE DIGITAL me Clin e q me Clin e q 860 nt 860 ica u nt PACESETTERS Compellingica u NumbersPACESETTERS Compelling Numbers 571 571 oi ) l aoi ) l a Clinical Clinical trials globally Clinical p eClinicald trials globally ev plit ed ev lit p ed ipd eyd Digital Therapiesid y could save Digital Therapies could save a ne a ene e - mostly USA is h - mostly USA is h n n evidence studies evidence studiesd rc d rc c c - as far as Africa l ea - as far as Africa l ea e e a es a es ti r ti r n re n re million pa million pa 244 244o Autism o Autism e e £170 £170 Randomised Randomisedt (m t (m (with Diabetes, Asthma, Cardiac (with Diabetes, Asthma, Cardiac 80% o 80% Anxietyo Anxiety control studies contP rol studies P & Pulmonary rehab) & Pulmonary rehab) of top 26 apps Dermatalogicalof top 26 apps Dermatalogical MS MS have observational have observational Depression Oracle Health Depression Oracle Health 20 20 million saved million saved Meta analysis study demostrating Meta analysisSchizophrenia/study demostrating Schizophrenia/ £131 £131 clinical efficacy Bipolar clinical efficacy Bipolar from Diabetes alone from Diabetes alone studies studies

we need to understand how these technologies can be used to change care pathways and significantly reduce cost across the system by working closely with healthcare systems such as the NHS.

He is not a lone voice, the DigitalHealth. London programme, nearly three years ago, with their collaborative partners, including the heads of London’s academic health science networks (AHSNs), identified three areas that needed to be at the heart of the programme’s work: evidence, evidence, evidence.

As documented in a report published by BSI, DigitalHealth.London and MedCity Let’s move on from in 2017, the issue is not the lack of guidance, but making the large amount of published guidance out there relevant the evidence challenge and accessible to innovators. The report noted the evidence themes that stakeholders such NICE, MHRA, HRA, to explaining what good SMEs, AHSNs, NIHR, considered relevant to the deployment of digital health looks like technologies, and at which point of the innovation journey these would need to be demonstrated.

Have you ever woken up from a recurring dream? We have made some positive steps in Your mind claws at the images of the dream and this space, last year NICE produced a sample of health app briefings, half asleep you try to guide them to the conclusion reporting on the evidence generated you desire, but the more you try to guide your by medical technologies and their effectiveness in healthcare systems. Last thoughts, the more conscious you become. year, DigitalHealth.London published a blog on the work that the evidence workstream was undertaking to simplify the landscape and remove the barriers for faster innovation development. Since then, the work has moved forward and it is clear that in order to make these ambitious changes, we need a system- wide approach with organisations Eventually you wake with a feeling of working collaboratively at national and something just beyond your reach, and regional level and including government you lie there pondering, if only you could and industry. fall into that dream again you might just reach a fitting end. When we think of Work is underway across organisations evidence in digital health and innovation to offer a tangible set of standards and we are often left with this feeling. Is clarity guidance that takes into account what the Neelam Patel Dr Indra Joshi Chief Operating Digital Health and on standards for evidence in digital innovative technology is, the risk it entails Officer, MedCity AI Clinical Lead, health and innovation still a blur in our and accordingly what level of evidence NHS England imagination or are we at the point that we would be suitable for a commissioner are now visualising this dream and starting to be confident that is has reached the to realise it? required mark.

In a recent publication by the New The dream at the edge of our fingertips will Statesman, John Bell writes that the key become a reality. We will see innovators challenge is obtaining sufficiently robust knowing the steps and standards they evidence of how innovative technologies need to follow in order to properly test work in the real world, he goes on to their technology and generate evidence say that for them to be implemented that is relevant and evaluated consistently effectively and to lead to genuine cost to support payer decision-making. We will savings from the adoption of innovation see evidence that is generated through

14 Digital Therapeutics in the NHS

trials, pilots and evaluations based on failures, it also requires a shift in culture We will see across the Real World Data (RWD), both positive and mindset to enable this collaborative healthcare landscape and negative, that is disseminated and approach. The fact that stakeholders available for shared learning and faster and such as NHS England, NHS Digital, NICE, informed clinicians more consistent adoption, and lastly we BSI, Innovate UK, MedCity, DigitalHealth. having easy access to will see across the healthcare landscape London and AHSNs are engaging in this the right evidence-based informed clinicians having easy access topic together is a huge step forward. technology tailored to their to the right evidence-based technology tailored to their patient’s needs and By designing the solutions that solve a patient’s needs users providing real world data to ensure problem and collect the needed data sets ongoing surveillance of the technology and that impact healthcare outcomes, we are its safety and efficacy. one step closer to producing solutions needed by the healthcare system. The With technology changing at a fast pace, dream may yet end in way we desire. can we ever be definitive in setting evidence standards for digital health you may ask? Defining standards and guidance must be a process that is adaptive and agile. It requires connectivity between organisations and innovators to monitor and learn from successes and

15 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

Sleepio

Evidence is crucial but context can be king in Sleepio ensuring innovation spread

How can a ‘great innovation’ become a ‘great innovation that achieves widespread adoption’? Laura Boyd shares learnings from the NHS Innovation Accelerator.

Introduction Now in its third year and supporting The role of evidence is rightly a crucial 36 Fellows, a breadth of innovations factor in convincing decision makers to are represented on the NIA, including adopt an innovation. Purchasers need to patient safety devices, models of care, IT be assured of the impact and true costs platforms and apps. Learning from Fellows’ before committing public funds. Likewise, experiences, as real-world case studies, patients and clinicians are unlikely to adopt offers insight into what can help make a something that does not have a proven, great innovation achieve wide take-up beneficial impact. across the NHS.

However, our experience from the NHS The challenge for many of the Fellows Innovation Accelerator (NIA) has found that on the NIA with ‘new’ digital innovations, adopters often require different types of is the lack of established frameworks as evidence, dependent on innovation ‘type’ to what evidence is required to make the and application. A host of other factors in case, particularly in comparison to the addition to the evidence will also impact more established thresholds set out for decision-making. pharmaceuticals.

About the NHS Innovation Accelerator For Digital Therapeutics, unsurprisingly Laura Boyd The NIA selects mature innovations the bar is set high, particularly when National Programme Lead, with evidence demonstrating better accepted evidence-based approaches like NHS Innovation Accelerator patient outcomes and at lower cost, led medication or face-to-face interventions, by a Fellow committed to sharing their are replaced by remote digital innovations. learnings. An NHS England initiative Adopters need to be confident that the delivered in partnership with the country’s technology meets the needs of patients 15 academic health science networks and clinicians, and delivers value for the (AHSNs) and hosted at UCLPartners, public purse. Evidence is a tool that helps Fellows receive tailored support to help people decide to invest public money and/ them spread their innovations to benefit a or time in implementing an innovation. greater number of patients and clinicians. Every decision requires the weighing An independent evaluation of the first year up of significant opportunity costs when of the NIA identified the positive impact of resources are extremely limited and this national initiative, as well as the factors demands are high. that enable an innovation to spread.

16 Digital Therapeutics in the NHS

Digital therapeutics on the NIA include: myCOPD Sleepio: a digital sleep improvement programme which teaches users cognitive and behavioural techniques (CBT) via a virtual sleep professor and his narcoleptic dog, Pavlov. myCOPD: a patient self-management system for chronic obstructive pulmonary disease that also includes online pulmonary rehabilitation (PR). Oviva Diabetes Support: a structured education and behavioural change programme for adults with type two diabetes, including 1:1 coaching from a dietitian that can achieve diabetes remission and is as effective as high- cost medications in achieving the right level of hba1c.

Each of the NIA innovations are selected to join the programme based on their evidence base, which puts them in a strong position to be rolled out nationally. Evidence gathering does not stop once selected onto the NIA, as decision makers often have different concerns and requirements depending on the context in which they are operating. Additionally, context will also influence what other conditions will need to be in place to support adoption. Evidence alone is often not enough For Sleepio, a focus on building national For example, evidence of effectiveness for to initiate adoption advocates to act as champions, coupled Oviva Diabetes Support, enables stand-out Our learning from the NIA has shown that with a rigorous academic approach to in a busy market, given the number of online evidence alone, no matter how extensive building the evidence base, coincided structured education services on offer. and weighty, is rarely sufficient to enable with a general national interest in the adoption. In parallel, a wealth of other impact of sleep on mental health. Patient The initial application for Sleepio was to factors – taking into account local and advocates have also had a powerful address insomnia and the team successfully national policy context – influence the impact, starting with co-founder Peter built the evidence to demonstrate its positive speed and ease of which innovations Hames whose personal experience of impact. Sleepio’s evidence base includes six are adopted. insomnia and frustration with repeatedly randomised control trials (RCTs), more than being offered sleeping pills when existing 20 peer-reviewed papers and over 30 years For example, recognising local preferences evidence highlighted the beneficial effects of clinical psychology expertise to deliver vary, myCOPD offers a blended approach. of CBT, led him to create Sleepio. Team online CBT. However, the team identified Trusts which prefer to offer face-to-face members at Sleepio have since become as the growing evidence between sleep and PR can do so, and adapt myCOPD to passionate as Peter is about the impact of metal health, and – with NHS partners – support its COPD population. Additionally, sleep on mental health, enabling them to has demonstrated the effectiveness of commissioners requested the service be enthuse other advocates on their behalf. CBT interventions – including Sleepio – in adapted for other disease areas so that addressing mental health, including its they could easily purchase a package of Evidence is crucial. Equally, the rigour of impact on reducing early signs of psychosis. care for a number of conditions, including evidence that speaks to the needs of the diabetes and asthma, which myCOPD adopter cannot be underestimated. But For myCOPD, part of the solution has now created. As a further enabler, to ensure that a great innovation – Digital provides online pulmonary rehabilitation the national endorsement provided Therapeutics included – achieves take-up, (PR) replacing the face-to-face group- through myCOPD being accepted onto context is king. Innovators must appreciate based classes generally used. It saw the the Innovation and Technology Tariff (ITT) and adapt to context, and consider the importance of an RCT demonstrating that means that CCGs are reimbursed for wide-ranging factors that support decision not only could myCOPD deliver PR online, adopting this innovation, removing at least makers to say yes. This will ultimately turn a but that it delivered better outcomes for one potential barrier of finance. myCOPD great innovation into a great innovation that patients and at reduce cost to the system. has now achieved widespread take-up achieves widespread adoption. This evidence provides adopters with the across England. confidence and assurance of moving to a new way of delivering care.

17 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

How real world data could be used to generate evidence for digital health

We can be fairly confident that the majority of people reading this article own a smart phone and that it now forms a core component of their lifestyle. According to the Office of Life Sciences, 70% of our UK population were using smart phones in 20151 and this figure has already substantially increased.

We use our phones to navigate our manage chronic obstructive pulmonary way around the country. They enable disease (COPD), to help us stop smoking, us to keep in touch daily with the lives to help us lose weight and to track of people we care about, select the pregnancy. And the sector is expected to best restaurants and order takeaways. expand significantly with CAGR of 35%2 And increasingly they enable us to between 2014 and 2018. communicate with communities of people, Jess Henderson we have never, and will never, meet. Our NHS Digital has now also developed Innovation Delivery Lead, lifestyles have changed substantially since an evidence-based NHS apps library in Imperial College Health the introduction of the smart phone, and recognition that the market is saturated Partners a large proportion of us are now highly with digital health apps and we need dependent on these gadgets. to be utilising the best ones. This is particularly important given that there The NHS, now in its 70th year, has finally are now more than 260,000 apps in the started to realise the importance and digital health market and less than 1% of value attached to the digital health market. these have an evidence base. There is an understanding that society has evolved, and is both information rich and To support this growing market, information hungry. The doctor – patient academic health science networks relationship is gradually starting to shift (AHSNs) have formed collaborations to from a paternalistic one to a partnership ensure that the best digital innovations model, as patients live longer and start are supported to be brought to market, to accumulate more long term conditions an example being the formation of which they need to monitor themselves, DigitalHealth.London in partnership at home. with MedCity. However whilst these organisations provide a level of guidance We have apps for everything. Don’t know around what is good and what isn’t, 1 Digital Health in the UK – An Industry Study which NHS service to use? There is an the universal feedback from users and for the Office of Life Sciences Sept 2015 2 Digital Health in the UK – An Industry Study app for that. In fact there is a broad church developers is that there is still a lack of for the Office of Life Sciences Sept 2015 of digital health apps, including apps to evidence base in this fast-paced market.

18 Digital Therapeutics in the NHS

The digital health market is different Regulatory approval: The regulatory Discover enables researchers to access from the rest of the health market. system has not kept up with digital the anonymised WSIC data set for Everyone is in the game of developing health, so the sector is currently not research purposes, and a number of apps, ranging from entrepreneurial as well regulated as – for example offerings are available: clinicians sitting in their clinic trying – pharmaceutical products. This study feasibility to solve a problem, to savvy patients also means that market access and consent to contact for study recruitment spotting a gap in the market to help reimbursement can be challenging, retrospective studies improve the management of their particularly for those products with a real world evidence and condition. And developers range from tiny limited evidence base. Whilst efforts observational studies digital tech start ups, to large established have been made with the NHS investigator matching organisations such as big pharma. Digital Apps Library, there is perhaps support for study design not the rigour and level of approval analytical capability to interpret It’s great that so many individuals and provided by NICE endorsement for results from studies organisations can easily get involved with other interventions. The regulatory publication writing improving patient’s lives. But again, how environment is however catching up can we know what works? What is the in America with the FDA issuing new Discover is also developing a ‘Discover impact and where is the evidence base? guidance and legislation around digital Digital Test Bed’ capability to enable Digital health is still a young industry and health appraisal and requirements for emerging digital products to be tested it does need someone to hold its hand to a Real World Evidence base, and it is nimbly, helping to generate a compelling ensure high value innovations get into the questionable as to how long it will take value story to support prescribing and hands of patients rapidly. for NICE to follow suit. reimbursement.

We can quantify the challenges currently Real World Evidence (RWE) can help meet Discover brings value to the digital health facing the digital health market: the challenges above. RWE studies are market through its: Time: The digital market is fast paced. in vogue and they should be. It is great Unparalleled linked data set of A traditional randomised control trial when an intervention works on the perfect 2.2 million North West London residents (RCT) process can take decades. These patient, but what about the rest of us? RWE Volunteers who want to hear more about apps will be redundant in this time, even studies utilise existing healthcare data sets research which is relevant to them if they generate a fabulous evidence alongside reported data, to understand Engaged researchers base, something better will likely be how an intervention may impact on patient Pace developed in that time. In addition, use of the system, allowing all stakeholders Affordability the way apps are developed is very involved to understand the broader value Digital and start-up expertise and different from other technologies, as of a product. advisory services they have a ‘sprint cycle’ approach. Money: It costs money to develop an However, RWE studies can be challenging There is a gap in the market in supporting evidence base. How does a digital tech when NHS data is fragmented. There digital tech to generate the evidence that entrepreneur access funding to enable this? is nothing national about our data set, their product will generate good patient Study design: Apps are not medicines. conversely it thrives in its localised outcomes. The Discover Digital Test Bed They can help to improve care, but they cottage industries of hospitals, GP can close that gap. Let’s get smart about don’t represent the same level of risk. practices, community services, mental using real world evidence to enable As mentioned above, a traditional RCT health services and social care. This is the digital health to cement its place in the will not suffice. There needs to be a set up in most places, but not all. NHS marketplace. new range of evaluation measures: – User acceptance – do people like it? North West London is one leading area Do they use it? which has collaborated and set up strong – Impact – does it actually help governance and information sharing to the condition? enable the sharing of data for direct care – Value – what is the value to society? and secondary uses. Whole Systems Does it help patients with self-care Integrated Care (WSIC) is a database and reduce the primary care burden? containing the coded data of 2.3 million Does it help keep people out of A&E North West London residents, drawing by reducing exacerbations? Does it from data sets across primary, secondary, To hear more about Discover please contact help the user feel informed about mental health, community and social [email protected] their condition? care. This data is linked and allows us to Study delivery: Finding patients to understand full patient pathways across You can also read more about participate in studies can be challenging our community. Policy drivers such as Discover on our website: and can add significant delays to the the Life Sciences Industrial Strategy and www.registerfordiscover.org.uk process. Correspondingly, it can also the NHS Constitution all support the use be hard to find a clinical investigator of this data for research purposes, and to run a digital health study particularly North West London has now set up the where the entrepreneur may not have governance and infrastructure to enable a strong network. this, and the platform is called Discover.

19 The rise of digital therapies & the evidence that proves they work DigitalHealth.London

Q How does DigitalHealth.London help to build London’s digital health ecosystem?

A We match innovations with NHS need, and support them to navigate the UK health environment. The programme is uniquely positioned to provide in- depth knowledge of the NHS and the wider UK health and care sector. In practice we deliver this vision through Q&A with supporting both innovators and our NHS stakeholders to develop: 1) Insight & awareness; 2) Capability and 3) Yinka Makinde Connections. For Insight & Awareness, we run open Masterclasses. Last year we hosted eight for industry attended Programme Director, by circa 360 innovators, covering procurement, interoperability, digital health safety, data, analytics, GDPR DigitalHealth.London and health economics. For the NHS we ran three in partnership with the NHS London Leadership Academy providing insight to 130 NHS stakeholders into the application of the Internet of Things (IoT) in healthcare; Big Data, and Q Why was DigitalHealth.London leadership. For Capability, we recently set up? launched the NHS Digital Pioneer Fellowship, which supports 25 NHS A DigitalHealth.London was set up just leaders to deliver impact through over 2 years ago with the purpose of digital transformation within their host accelerating the pace of adoption of organisations and across populations. Yinka Makinde Programme Director digital health innovations to address For industry, we build navigation DigitalHealth.London areas of need across the health and capability through mentorship (Free care sector. What this means in practice 1-to-1 Innovation Surgeries) and through is that our team spends a lot of time the DigitalHealth.London Accelerator We help innovators to interfacing with innovators- largely programme. Finally, Connections - we SMEs, but increasingly life science have given NHS stakeholders insight navigate the complex companies exploring digital innovation. into some of the digital health solutions health and care landscape We help innovators to navigate the in the marketplace through providing in London and match those complex health and care landscape a platform for 40 companies (last with the most compelling [in London] and match those with the year) to pitch to a captive audience. most compelling value propositions, At a trust or CCG level, we have been value propositions, to demand that has been expressed involved with match-making digital to demand that has by the [healthcare] system. As we solutions to NHS need. DigitalHealth. been expressed by the are born out of the three London London also supports system wide transformation, which includes NHS AHSNs (together with MedCity), we healthcare system are duty bound to ensure we are stakeholders at different stages in their serving the needs of our providers implementation and adoption journeys. and commissioners , both in terms of For example, we are currently working assisting them in accessing what’s in with NHS Improvement and the 15 the market place (we do this through Academic Health Science Networks curating the best of breed shortlists of to support provider organisations in innovation to look at), but also in terms taking advantage of digital technology of building the in-house capability in the area of Outpatients. Building on required to achieve adoption and the momentum of the pan-London spread of digital innovations. workshop, ‘Channel shift to digital outpatients’, in October 2017, two projects are now underway, with regional workshops taking place across England and outpatients collaboratives in London.

20 Digital Therapeutics in the NHS

We helped them to identify three such Q DigitalHealth.London has been Q How is DigitalHealth.London solutions: OurPath, Changing Health at the center of the debate on supporting innovators to become and Oviva. Since then the clinical the growing value of Digital clinically validated? lead in the geography has gone on to Therapeutics in the United successfully roll out these solutions Kingdom and engaging with A Across our ecosystem we are able and conduct observational studies which have generated some very many stakeholders both inside to convene our partners in order to positive outcomes. and outside of the NHS. offer different approaches that suit the What are your key findings? needs of the individual company at a particular point in their journey. We offer an Accelerator programme (which Q A DigitalHealth.London, MedCity and Now that DigitalHealth.London has the British Standards Institute (BSI) is led by Health Innovation Network) brought together a large number have been focusing on viewing the to promising digital health innovators of stakeholders to debate this landscape from an SME’s viewpoint meeting a clear system need, that have topic, at the Digital Therapeutics in already proven their concept but are and asking the questions; ‘What is the NHS Summit, what next? the right level and type of evidence seeking support in increasing adoption and scale of their technology across and how should companies generate A Over the course of the next year, we the health and care sector. Often one it?’ Our work has involved working will continue to work closely with of the barriers to adoption is their with multiple stakeholders to answer our colleagues at NHS England, scarcity of a robust evidence case. We the above questions. We hosted a NICE, PHE, NIHR, and BSI (too many assist them in finding and formalising On 12th July 2017 a Digital Health acronyms), to forge this work forward. research partnerships with academic Technology and Evidence Stakeholder By the end of this financial year, institutions. We have facilitated circa workshop which brought together we need to see some significant 15 partnerships so far, with more in the key experts along the innovation progress having been made in 1) the the pipeline. The recent launch of the development pathway, as well as delivery of a set of standards that sets four new regional AHSN Digital Health SMEs, to outline what evidence is the bar for developers to reach in Accelerators, set up in collaboration considered a priority and also to terms of efficiency and effectiveness with DigitalHealth.London, means that share knowledge on what exists and safety; 2) the launch of tools more national support can be given already. Participants included Policy to drive better transparency and to accelerating clinical validation for Makers; Regulators and Statutory access to the evidence (real world SMEs. There are other programmes Bodies; Research Infrastructure; and randomised controlled trials), operated by our founding partners NHS and Academia; Customer that exists out there already. This that can further support innovators in Facing Organisations; Small-Medium will enable commissioners to better this regard. Collaborate to Innovate Enterprises. The initial hypothesis compare and contrast innovations, run by MedCity. The NHS Innovation of there being a lack of guidance and make informed decisions. Accelerator, run by UCLPartners. generating the right evidence to test DigitalHealth.London has a seat at the Imperial College Health Partners digital technologies is not strictly table of these discussions, and will offers a bespoke package of expertise true. The workshop found that many play a pivotal role in consolidating its tailored to those innovators that are resources exist, however they are not position as a convener and connector looking to build both their evidence linked or referenced clearly between of stakeholders. Linking together case, and their economic value case. the responsible stakeholder groups. the streams of work being led on In addition, it is not easy for innovators the industry side by MedCity, British to gauge what type of evidence is Standards Institute and DigitalHealth. considered a priority to stakeholders Q Can DigitalHealth.London support London, with the strands of work at particular points in the development the NHS to find clinically validated being led by NICE and NHS England, pathway. The impact is a slower digital health solutions, more easily? on the commissioner side. I also see innovation development. our role, in providing a channel to A Yes we can. The IQVIA report showed access this guidance once available, that the UK was lagging behind in to ensure the guidance is delivered terms of producing clinically validated in an accessible way (language and digital health solutions, however format), and to help with curation. through the rigorous processes we undertake to find good companies to join our accelerators, we do have an in-depth insight into the innovations We offer a bespoke in the market place, and particularly the ones that are close to gaining that package of expertise level of clinical credibility. Examples tailored to those of this would include the support we innovators that are provided to the North West London looking to build both their Collaboration of CCGs last year when they were looking for digital diabetes evidence case, but also solutions to support their local diabetes economic value case self -care agenda.

21 The rise of digital therapies & the evidence that proves they work A North West London pilot study of digital [P277]behaviour A North change West pr ogrammesLondon pilot for study patients of digital with behaviourType 2 Diabetes change programmes for patients with Type 2 Diabetes [Wayne Smith1, Abeer Itrakjy2, Aran Porter2,Tony Willis2, Andi Orlowski1], [WayneImperial Smith College1, Abeer Health Itrakjy Partners2, Aran (ICHP) Porter1, NWL2,Tony Clinical Willis2 ,Commissioning Andi Orlowski1], G roups2 Imperial College Health Partners (ICHP)1, NWL Clinical Commissioning Groups2

Patient activation measure (PAM) Summary PAM is a validated patient-reported measure of skills and confidence in managing health, which is associated 1 • We evaluated three smartphone-based digital behaviour change with clinical outcomes and healthcare costs. Most patients (51%) were PAM level 3 before enrolment programmes lasting 8 to 12 weeks for patients with Type 2 Diabetes (Figure 1). Patients at this PAM level typically know key facts about their health and strive for best practice (T2DM): Changing Health, OurPath and Oviva Diabetes Support. behaviours based on specific goals. • All programmes resulted in mean improvements in clinical indicators Figure 1: Distribution of PAM level at baseline for NWL pilot study population relevant to T2DM (weight, body mass index [BMI], glycated haemoglobin

[HbA1c], blood pressure, and medication use). 80 • Of 118 patients 19% were not on metformin post programmes. This may

have been due to improvement in clinical outcomes such as HbA1c. 60 • Patient feedback on all three digital behaviour programmes was generally

positive, although access to a compatible smartphone was a barrier for 40 Frequency some.

• Completion rates appeared to be much higher for the digital behaviour 20 change programmes than for face-to-face diabetes structured education

at participating practices. 0 1 2 3 4 • Within the limitations of this pilot, results support the wider use of PAM level smartphone apps for delivering structured diabetes education. • This evaluation was not a direct comparative analysis between the Clinical outcomes three programmes. Figures 1: change in HbA1c Figures 2: change in BMI

Ch_Health Ch_Health Background

In North West London (NWL), approximately 129,000 people are diagnosed with OurPath OurPath Type 2 diabetes mellitus (T2DM). They spend, on average, around three hours with a healthcare professional annually and manage their condition themselves

for the remaining 8,757 hours. Smartphones are increasingly becoming a tool Oviva Oviva used to manage lives and there are many apps and digital programmes available

to support people with diabetes to self-care. -10 -8 -6 -4 -2 0 -1.5 -1 -.5 0 Mean change in HbA1c (mmol/mol) Mean change in BMI (kg/m2)

Aim Figures 1 and 2 are descriptive figures and do not make inferences on the differences between programmes. Across the study population, there was a mean negative change (i.e. a reduction) in all clinical indicators To test whether the use of a digital behaviour change programme can lead to measured after the programme compared with baseline levels (Table 2). Median HbA1c, BMI and systolic blood positive health benefits for people with T2DM. pressure (SBP) was significantly lower after the programme compared with pre-enrolment levels, based on a Wilcoxon signed-rank test. Changes in clinical indicators during the programme showed low correlation with Methods PAM or IMD and not significant (p>0.05). Table 2: Mean change in clinical indicators after participation in the NWL pilot study population Three digital behaviour change programmes were rolled out to 430 patients Variable Number of observations Mean change Std. Dev. with T2DM across 18 GP Practices in NWL between March and August 2017. Programmes offered structured diabetes education and lifestyle tracking (e.g. diet Weight change (kg) 140 -2.5 4.7 and fitness) mainly through smartphone app, with remote support from a trained BMI change (kg/m²) 112 -0.99 1.8 behaviour change coach or diabetes educator. Programmes lasted between 8 weeks (Oviva) and 12 weeks (Changing Health and OurPath), with ongoing HbA1c change (mmol/mol) 160 -6.9 14.6 access to the smartphone apps and educational resources after completion. SBP change (mmHg) 151 -3 15

Non-identifiable demographic and clinical data (age, ethnicity, index of multiple DBP change (mmHg) 151 -2 10 deprivation [IMD], weight, BMI, HbA1c, blood pressure, and medication use) were extracted from patients’ medical records before and after participation. The Patient Activation Measure (PAM) was collected at baseline and completion. The preliminary data suggested that there were some differences in the various outcomes between programmes. Data on uptake, engagement, completion, usability and patient experience were Due to limitations in data, for example, length of follow up and additional confounding factors, this study does not recorded as part of the programme. Qualitative feedback was obtained through make any direct comparisons between programmes. Further analysis would be needed in the longer term. patient focus groups and email surveys. According to prescription data extracted from medical records, 23 patients discontinued metformin while taking part in the programme. Reductions in HbA1c, weight and blood pressure for these patients indicate they may Results have been able to discontinue metformin because clinical indicators improved during the programme.

Data were available for 295 patients. Mean age was 57 years (range, 32 to Patient feedback 89) and ethnicity for most participants (79%) was non-white. Where available, Patient feedback on all three digital behaviour programmes was generally positive: completion rates of the digital programmes in this pilot (Table 1) were much • The Net Promoter Score (NPS), which measures the likelihood of recommending a service to family, friends or higher than for face-to-face diabetes structured education (<6.3% completion colleagues, was positive for Changing Health and OurPath. Oviva participants did not complete NPS, but most for DESMOND, DAFNE and X-PERT) at participating practices. said they would recommend the programme to family and friends. Table 1: Uptake and completion data for the NWL pilot programmes • Most patients said they had experienced a benefit from taking part in the programme (in some cases describing it as “life changing”). Programme Uptake on referrals Completion • Some patients reported improvements in their general wellbeing and motivation, and others said that they had Changing Health 83/167 (50%) individuals No data available avoided needing to start medication by taking part. downloaded the app The main negative comments from patients related to technical problems with the smartphone app or a connected OurPath 133/186 (72%) of referred 70/133 (53%) had patients enrolled completion data available device, or incompatibility with (or not owning) a smartphone. A few patients, particularly those who were already well-informed about diabetes, did not feel the digital behaviour change programme or smartphone app were Oviva 88/120 (73%) of referred 82% completed the programme patients enrolled useful for them.

Demographics available for 119 pts

Ethnicity Frequency Percent Conclusions Asian 27 23 Overall, high completion rates coupled with positive change in clinical indicators in this pilot suggest for Black 32 27 digital behaviour change programmes may be an effective alternative to face-to-face programmes. Mixed 19 16 Patients may prefer digital programmes because of their easy access, flexibility and integration of Other 16 13 educational resources and support through a single medium (i.e. a smartphone app). White 25 21 Within the limitations of this pilot, results support the wider use of smartphone apps for delivering structured diabetes education within the NHS. TOTAL 119 A block contract provider payment system and low completion rates for face to face programmes may be an inefficient way of procuring structured education services. An alternative provider payment system References along with digital health programmes (such as above) which suits individual patient needs should be

1. Hibbard JH and Gilburt H. Supporting people to manage their health: An introduction to patient activation. The King’s Fund (2014); considered. 2. Ellins J, Coulter A. How engaged are people with their healthcare? Findings of a national telephone survey (2005). Available from: http://www.picker.org/wp-content/uploads/2014/10/How-engaged-are-people-in-their-health-care-....pdf [Accessed February 2018]

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