Join us at the Global Clinical Trials Connect 2018, 25-26 April, London

Global Clinical Trials Connect

On Thursday the 26th April 2018 we’ll be presenting on Mobile First Clinical Trial Design at the Global Clinical Trials Connect 2018 Conference in London.

Overview

“The Global Clinical Trials Connect 2018 conference focuses on introducing pioneer technology, developing better patient engagement and collaborating strategies in clinical trials. With the right commitment and attention to detail, contract research organizations (CROs) and pharmaceutical companies can drive collaboration with greater efficiency.

The global pharmaceutical industry has seen a downturn in recent years because of the challenges and cost associated with pharmaceutical development, procrastination in drug development, etc. Clinical trials field is also faced with such challenges. Cases of failures, cost and delay are high. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry. Due to complex clinical trials and bygone data standardization methods, we need algorithms and lucrative strategies that will enhance the clinical trials outcomes. There are vast data collected across clinical trial process, the standardization of these data will turn into an opportunity for companies to trap the information and raise clinical trial design, patient recruitment, monitoring insights and augment decision-making”

Key Topics:

Partnership & Collaboration – Sponsors, CROs, Sites and External Vendors
Outsourcing strategies and models
Patient centric clinical trials
Real World Clinical Trial Strategies
Electronic Clinical Outcome Assessment and Electronic Patient Reported Outcome
Clinical Technology and Driving Innovation
M-Health, Wearable and Consumer Technology
Artificial Intelligence Technology in Clinical trials
Patient Recruitment and Site selection
Keeping the Patients Informed After the Trial – Post-Clinical Trial closed communities
How to future proof your clinical operations
Data Quality & Technology
Big-Data and IoT in Clinical Trials
Clinical Data Strategy & Analytics
Implementing Risk Based Monitoring
Streamlining R&D and lower costs in clinical trials
Adaptive Trial Model
Clinical Trial Auditing
ResearchKit & Mobile First Clinical Trial Design

Speakers include:

Sam Adamson, Business Development Manager, Australia, NZ & USA, GreenLight Clinical outsourcing & Clinical Trials.

Aji Barot, Business Development Director, HealthUnlocked

Kate Chapman, Director, Clinical Technology Consultants (Former Associate Director, Interactive Response Technology Services, Shire Pharmaceuticals)

Lucy Clossick Thomson, Director Clinical Operations Strategy, AstraZeneca

Sarah Cooper, Business Development Manager, NIHR Clinical Research Network

Emma D’Arcy-Sutcliffe, Director, Patient Engagement and Innovation, NexGen Healthcare Communications

David Doherty, cofounder, 3G Doctor

Rita Fitzpatrick, General Manager, ESMS Global

Kylie Gyertson, Head of CCTU, UCLH

Oleksandr Karpenko MD MBA, Managing Director, Olexacon

Disa Lee Choun, Director Head, Data Acquisition, UCB

Nancy Meyerson-Hess, Associate Partner, admedicum Business for Patients (Chair)

Gjon Mirdita, Head of Site Management, Key Markets, R&D Solutions, NEMEA & CESE, IQVIA

Sheuli Porkess, Deputy Chief Scientific Officer, ABPI

Nawab Qizilbash, Clinical Epidemiologist & Head, OXON Epidemiology

Michael Ramcharan, Managing Director, Reumat Consulting

Belle Roels, Head of Clinical Operations UK and Ireland, GSK

Tom Ruane, Global Head of Patient Recruitment, Parexel

Victor Sastre, Senior MSL, Coordinator of the MSL Working Group AMIFE

Nico Schönig, Senior Data Analyst Global Clinical Operations, Boehringer Ingelheim

Vasil Todorov, Clinical Program Leader, GSK

Mike Tremblay, Founder & CSO, Volv global

Max Woolley, R&D Manager, Pre-Clinical Lead, Drug Delivery, Device Design & Development, Renishaw

Get in touch via the comments if you’ll be in London and would like to meet up. Refresh this page on Friday April 27th 2018 for my slides and a video of the talk. In the meantime you might like to watch a presentation I gave a couple of years ago on the topic of “What would happen if we took a Mobile First approach when designing Clinical Trials”:

Slides:

Video coming soon…

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NHS Digital is doing sterling work to undermine trust in the NHS

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“The Home Office is displaying a blatant disregard for the trusted and vital GP-patient relationship, and its casual approach to confidential patient data risks alienating highly vulnerable patients…  …It is treating GP patient data like the Yellow Pages, and we are calling on NHS Digital to take urgent measures to suspend the agreement that is allowing them to do so…   …The scale of the examples we’re hearing about are becoming increasingly alarming – and if all are true, paint a terrible picture”

Professor Helen Stokes-Lampard, Chair of the Royal College of GPs

“The BMA has been vocal in its opposition to this data sharing arrangement between NHS Digital, the Home Office and the Department of Health and Social Care, which risks undermining the very foundation of the doctor-patient relationship…    …We therefore welcome this report, which echoes many of our key concerns over the ill-thought out and potentially destructive agreement that NHS Digital is yet to resolve…   …As stated by the committee, most immigration offences clearly do not meet the high public interest threshold for releasing confidential data, which according to NHS England, the GMC and even NHS Digital’s own guidance, should be reserved for cases which involve ‘serious’ crime…  …Doctors were being asked to “effectively act as an enforcer for the Home Office…   …If the bond of trust between doctor and patient is broken, it risks not only the health of that individual, but can also have serious public health implications if people suffering from infectious conditions avoid seeking medical treatment…   …use of the data sets a dangerous precedent that opens up the possibility of patients’ data being passed on not just in immigration cases, but for other non-health-related purposes”

Dr John Chisholm, Chair, Medical Ethics Committee, BMA

“We will consider the Health Select Committee’s report carefully and will take into account any new evidence as it becomes available, but we have been through a rigorous process to assess the release of demographic data to the Home Office…   …This has established that there is a legal basis for the release and has assured us that it is in the public interest to share limited demographic data in very specific circumstances.”

Sarah Wilkinson, chief executive at NHS Digital

mHealth Insights

It’s horrific to see new private only pay clinics springing up in areas of the UK where poverty is the highest and it’s because immigration offenders have realised that the supposedly ‘confidential’ NHS GP and Hospital records relating to them and their families are being used to shop them to the Home Office.

Of course there are a million other more effective ways to trace immigrants (they are mostly young and have mobile phones that are accurately identifiable by location or they are being homed/employed by citizens who have mobiles and all of this monitoring can be easily done by the Home Office) so I think it’s clear the NHS is doing this because it thinks they’ve concluded that there is a short term economic benefit.

It should be clear that it is vastly cheaper to give every immigration offender free NHS care than it is to try and care for them when they get really sick and turn up with a false identity in a hospital. By sharing details (that include Patients’ names, date of birth, address) the NHS is driving growth in criminal gangs who are stealing citizens identities and this is putting Patients (and the Professionals trying to care for them) at much greater risk of making very expensive mistakes (treating a Patient based on completely inaccurate information in their NHS Record).

No individual Doctor is going to speak out, refuse or complain against the Home Office because they will probably just turn their investigation to the ‘non-compliant’ Doctor so please support the British Medical Association and Royal College of GPs call for a suspension of a memorandum between the Home Office and NHS which has given them access to data that is undermining the ethical principles underpinning confidentiality and the determination to act in the best interests of Patients.

Please share and write to your MP and ask them to back calls to abolish the MOA

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Related posts: 

Daily Telegraph: “NHS 111 enquiries will be handled by robots within two years, leaked report suggests”

Google apologises for paying ad revenue to rape apologists & racists but says nothing to the 1.6 Million NHS Patients who didn’t consent to sharing their Hospital records

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American Medical Association launches a Healthcare Interoperability & Innovation Challenge with Google

In a rather bizarre turn around just when the US is just waking up to the huge privacy implications of sharing their sensitive medical information with companies like Facebook & Google (who then seemingly think it’s perfectly ok to sell it onto any advertisers who pay them) the American Medical Association has “announced the AMA Health Care Interoperability and Innovation Challenge sponsored by Google to inspire novel examples of mobile health technology—such as wearable devices and applications—that effectively monitor and share medical data between patients and physicians to improve the management of chronic diseases”.

mHealth Insights

“The AMA is working to unleash a new era of patient care through its Integrated Health Model Initiative (IHMI) by pioneering a common data model for organizing and sharing meaningful health data like patient goal, state and functioning, and assembling an unprecedented collaborative effort across health care and technology stakeholders” said AMA President David O. Barbe, M.D., M.H.A.”

This is an incredible turn around as the AMA CEO has been pointing fingers at mHealth and making claims it’s little more than modern day snake oil.

“The winning ideas will demonstrate how the applicant uses patient-generated health data in meaningful ways to have maximum impact on improving physician workflow, improving clinical outcomes, and reducing cost in the health care system. The three best ideas that are submitted to the Challenge by June 7, 2018 will be selected to share $50,000 in credits for Google Cloud”

What a bizarre set of zero-actual-cost prizes. Google is highly profitable and is generating over $100,000,000,000 in annual revenues so why are the prizes being given to promising start ups being paid in ‘monopoly’ money?

I have no doubt the AMA shopped this collaboration opportunity around with Apple, Facebook, Microsoft and Amazon and in deciding to work with Google they didn’t agree to be paid for the collaboration with Google Cloud Credits (I doubt most of the executives at the AMA even know what they are).

“assembling an unprecedented collaborative effort across health care and technology stakeholder”

I’m very cynical as it’s very unlikely the AMA hasn’t seen what Apple are doing with Health Records so it just looks like Apple either refused to pay the AMA any money because their focus is on what helps Patients rather than what gets reimbursement (and so they’re going to stubbornly refuse to be positive about their ground breaking work) or this is a last ditch attempt to help steer Patient record control towards Google’s ‘freemium’ ad funded business model on the proviso that the AMA have a seat at the table.

Doesn’t sound promising for the AMA when you consider this along with Google’s track record of taking Medical Records of Patients without consent (aka theft).

FULL PRESS RELEASE: 

CHICAGO – The American Medical Association (AMA) today announced the AMA Health Care Interoperability and Innovation Challenge sponsored by Google to inspire novel examples of mobile health technology—such as wearable devices and applications—that effectively monitor and share medical data between patients and physicians to improve the management of chronic diseases.

“The AMA is working to unleash a new era of patient care through its Integrated Health Model Initiative (IHMI) by pioneering a common data model for organizing and sharing meaningful health data like patient goal, state and functioning, and assembling an unprecedented collaborative effort across health care and technology stakeholders” said AMA President David O. Barbe, M.D., M.H.A. “The Challenge we’re announcing today is an extension of the AMA’s work and will explore possible uses of mobile health technology to provide patients and physicians with a rich stream of medical data that is important for improving care and long-term wellness.”

The Challenge invites the health and technology sectors to present solutions that demonstrate how patient-generated data is captured by mobile health monitoring technology, transferred to a medical practice, and transformed into accessible and actionable information for the patient and physician to improve health outcomes.

Specifically, entrants are asked to present ideas on how to:

  • Import (or transfer) patient-generated health data from a mobile device or a mobile application into one or more phases of clinical care. Examples of phases: Assessment of current condition, risk stratification, goal definition (both patient and physician), treatment plan, intervention(s), recording of observed outcomes, re-assessment.
  • Extract (or transfer) data from one or more phases of the clinical care and send it back into a mobile application or mobile device so patients can view, track and ultimately act upon the information relative to their goals or share it with other physicians.

The winning ideas will demonstrate how the applicant uses patient-generated health data in meaningful ways to have maximum impact on improving physician workflow, improving clinical outcomes, and reducing cost in the health care system. The three best ideas that are submitted to the Challenge by June 7, 2018 will be selected to share $50,000 in credits for Google Cloud.

To learn more about the AMA Health Care Interoperability and Innovation Challenge sponsored by Google, go to: https://ama-ihmi.org/googlechallenge

# # #

Media Contact:
Robert J. Mills
AMA Media & Editorial
Phone: (312) 464-5970
Email: robert.mills@ama-assn.org

About the American Medical Association
The American Medical Association is the premier national organization providing timely, essential resources to empower physicians, residents and medical students to succeed at every phase of their medical lives. Physicians have entrusted the AMA to advance the art and science of medicine and the betterment of public health on behalf of patients for more than 170 years. For more information, visit ama-assn.org.

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Privacy & Patient access to Healthcare Record information

Imagine how Patients would cross examine healthcare provider organisations that don’t provide Patients with access to Health Records:

“(PATIENT) Would you be comfortable sharing with me the name of the conditions you have diagnosed me with and the results and treatments you have provided to me?

(HEALTHCARE PROVIDER) …um…  er no.

(PATIENT) If you shared my info with anyone else or messaged any colleagues would you share with me the name of these people/companies?

(HEALTHCARE PROVIDER) …no I would choose not to do that.

(PATIENT) I think that might be what this is all about. Your right to withhold information relating to my care. The limits of your rights and how much I’m having to give away in order to ‘get healthcare services that I am ultimately paying for’. The question I want answered is what information is the healthcare system collecting on me, who are they sending it to and whether they’ve ever asked me in advance for my permission to do that? Is that a fair thing for a user of healthcare services to expect?” 

Related Posts

Join us at the mHealth for Paediatricians Course (led by Prof S Lingam, a Consultant Paediatrician who has for 30+ years been sharing medical notes with Patients) (April 2018).

The NHS doesn’t trust Patients with access to their own Medical Records but has provided strangers with access to the records of 26 Million Patients… (March 2018)

Apple’s Health Records App: A Ripple or a Roar? (March 2018)

Cancer Charities: experts in personal data sharing just not yet in ways that help us better understand Cancer Care (April 2017)

Google apologises for paying ad revenue to rape apologists & racists but says nothing to the 1.6 Million NHS Patients who didn’t consent to sharing their Hospital records (March 2017)

With your access to the internet & my medical degree imagine how we could work together? (Dec 2015)

Dr Eric Topol’s “The Patient Will See You Now: The Future of Medicine is in Your Hands” now available (Jan 2015)

Has your Hospital replaced error prone paper based Observation Systems with mHealth Apps? (2014)

Of all the horrible things that happened the worse was the lack of access to information…  (2013)

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Online GP services: The way forward or caveat emptor?

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Dr Ray Walley in the Medical Independent, 5th April 2018.

mHealth Insights

“We live in a world of rapid advancements in technology but with all the benefits, there are some dangers, as we have seen in relation to the current controversy on the harvesting of personal data.”

The thing I find incredible about hearing this from Doctors is that most Irish Doctors and HSE are already facilitating this. Despite probably the ‘biggest success’ of their €800M eHealth Ireland project (that I’ve been critical of since it’s inception as it was clearly building on obsolete tech) being the HealthMail.ie service they’re still not using email properly (regularly sending emails with all recipients listed) and routinely sending out highly sensitive and confidential Patient information to medics who use email services like Google, Yahoo and Hotmail (which collect and sell on information contained within these “strictly confidential” emails).

“The delivery and provision of healthcare has changed apace with technology, bringing many benefits to patients, and doctors have embraced such advances. Advances in technology can assist with GP learning and enable patients, but we must be careful in ensuring that all the technology does not undermine or damage patient care or health outcomes. In an unregulated environment, there can be real dangers.  The recent proliferation of online GP services is not just a matter of concern to doctors but also, as the evidence is gathered, to health regulators. We must learn from the mistakes that are happening in other jurisdictions and not rush to adopt models that may, in the longer term, be damaging to patients and undermine population health”

I don’t think online GP services do operate in an unregulated environment. Perhaps regulations aren’t being enforced but that’s not the same thing.

“The UK Care Quality Commission recently reviewed online prescribing by such companies and medical practitioners working for them. Such concern has it caused that leading news outlets in the UK reported on their findings.  Some of their comments included: “Safety is where we found the greatest concerns… In February 2018, we found that 43 per cent of the providers were not providing safe care according to the relevant regulations. Their specific concerns included:   Inappropriate prescribing of antibiotics and prescribing high volumes of opioid-based medicines without talking to the patient’s registered GP.   Unsatisfactory approaches to safeguarding children and those who may not have the mental capacity to understand or consent to a consultation.   Not collecting patient information or sharing information.   Inappropriate prescribing of medicines for long-term conditions”

As many critical articles about “Online GP services” do this one also didn’t take long to start mixing them up with “Online Prescription services”.  These are very different things and this would be a great place for regulators to act. In the meantime GPs shouldn’t be using confusion to cast stones at colleagues who have had the courage to move beyond the 2000 year old office visit only model of care.

I think the simple short answer is to only let people who are actual online GPs call themselves online GPs.

One really odd thing I notice about the CQC is that GPs are forever quoting it’s reviews to make their arguments despite the fact the organisations abilities to conduct reviewS have been widely deemed useless (and dangerous) by GPs in the UK.

“Another UK study found that online-based systems were contributing to inappropriate referrals to emergency departments. A recent study in regard to electronic alternatives to face-to-face consultations with GPs published in the British Journal of General Practice showed that such access did not help to alleviate workload pressures of GPs, nor did it improve access for patients. The Royal College of General Practitioners followed up this study with cautionary advice for its members, indicating that if practices chose to provide online and telephone consultations, then it should be only as part of the practice service and that GPs should continue to provide face-to-face consultations, patient safety being paramount in any clinical consultation”

I’ve covered the reasons for this finding extensively on this blog over the years. The NHS has worked hard to undermine GPs with the +£100M pa they keep pumping into their success failed triage services (branded NHS ReDirect, NHS 111, etc). The simple fact is online based communications should avail of clinically validated tools so that Patients Primary Care needs can be handled by their GPs because triaging isn’t the easy bit where you can cut corners it should be done by the most experienced Clinicians and their time used efficiently by letting Patients help and supporting them with the provision of Patient History Taking tools.

“These findings should not be ignored in Ireland and health regulators need to take notice. The bedrock of patient care in general practice is continuity and that is something that must be protected at all costs. All the medical evidence points to the positive link between continuity of care with a GP and better health outcomes for patients. There is a proven link between the provision of a personal GP and reduced hospital admissions, better mortality rates and more equitable delivery of healthcare across socio-economic groups”

I agree with this but it’s 2018 and a general practice clinic like Dr Ray Walley’s that has no website and is closed most of the time isn’t providing what most citizens of Ireland would consider to be continuity of care. What are people supposed to do to get continuity of care? Send a tweet to their GP?

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“The GP is at the centre of healthcare provision: Of the 25 million patient consultations in general practice, 90 per cent are dealt with by the GP without the need to refer to another service. This deeply personal relationship is reflected in a high level of patient satisfaction. The value that patients put on their GP, accompanied by a low rate of referral, is only possible where the GP has a long-standing relationship with the patient, access to a patient’s previous records, including attendance at the practice and out-of-hours service, referrals to secondary care, medication, a complete history of that patient and all the factors driving healthcare needs”

The GP was at the centre of healthcare provision but convenience is now a quality measure and Patients and Carers in Ireland are nearly all now carrying around supercomputers through which they’re able to Google their symptoms, Google their medications, Google their Doctors, read about their treatments, watch free videos about their conditions, etc.

Oh and because the world’s biggest corporation is betting the farm on it very soon they’ll be able to download their electronic medical records to their mobile…

“Sláintecare and the Health Service Capacity Review both cite the importance of general practice and the need to deliver more services through general practice. However, in the absence of any support or resources by the State, the potential for better patient outcomes is in danger. As Ireland grapples with the appropriate funding and provision of general practice, there is a race to the bottom to replace the existing GP model with alternative models that, although dressed-up as general practice to distract from their lack of long-term detailed analysis, are not general practice”

I think the simple short answer is to only let people who are actual online GPs call themselves online GPs.

“What we are now seeing is a commercially-driven shift from patients having a relationship with their GP, being partners with their GP in managing their health and wellbeing, to accessing healthcare on a pay-as-you-go basis. While there is of course a benefit in GPs using video consultations with their own patients in certain circumstances, this is not what the models being promoted are offering. In fact, it is the exact opposite. Healthcare in Ireland is fast becoming a commodity that is being driven by market forces, not by medical evidence or in the pursuit of quality patient care”

I think this has already pretty much happened in the USA where 100s of millions of VC debt have driven the growth of phone call services that have undermined the last few GPs.

I’m sure there is no political will in Ireland to stop major tech companies like Google undermining GPs by offering their Patients free video chats 24×7 so it’s really key that Irish GPs take the initiative and start providing online services to their Patients and we’re working with a few GP practices in Ireland now to bring in a successful service that’s already been deployed at scale in the NHS:

It’s interesting that Dr Ray Walley now states “While there is of course a benefit in GPs using video consultations with their own patients in certain circumstances” because in his own practice it seems he doesn’t even have a website and no means for Patients to discover whether they have the ‘certain circumstances’ for which a video consultation would be helpful.

“The ‘Uber-like’ apps that offer a so-called GP service emphasise access and speed, but there is no continuity of care and it is not a GP service. It is a service of convenience and from evidence to date, we can now see it has the potential to lead to inappropriate prescribing and safety issues. The doctors providing the system may be trained GPs, will likely make more money and have a less stressful career, but what they will provide will not be general practice”

Sounds like a simple trade description issue. If you’re not an actual online GP you’re not allowed to call yourself one. Call on the ICGP and NAGP to suspend any GPs contravening this for dishonest conduct. Nothing stops Dr Walley reporting them himself.

“Government must take action and ensure that a meaningful and evidence-based general practice service is provided to patients, with the required support and investment from the State. General practitioners are not Luddites by any measure and technology has a place, as long as it enhances patient care, not undermines it. The advice has to be caveat emptor”

Sadly the government has little no interest in properly supporting GPs, there’s an abundance of evidence that the office visit only consult model can be very dangerous (and we know that self-harm is the largest killer among 15 to 24-year-olds in Ireland), so buyer beware doesn’t apply because if you provide a service in 2018 and have no website and offer no means for a Patient to engage with you electronically they’re going to go somewhere else for advice.

*** UPDATE 15 April 2018 ***

Classic example of how an organisation like the RCGP is unaware that it is helping peddle misuse of the term ‘online GP’ by sharing news articles that use the term inappropriately:

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Going beyond killer apps: building a better mHealth evidence base

mHealth Insights

 

“mHealth relates to the provision of health-related services via a mobile device. It comprises multidimensional elements including provider, patient and administrative applications. Applications include consumer education and behaviour change, wearable sensors and point-of-care diagnostics, disease and population registries, electronic health records, decision support, provider tools (communication, workflow management, professional education) and healthcare management (human resources, financial monitoring, supply chain logistics)”

I see a lot of shortcomings in this definition and think the authors would’ve done better if they’d gone with the definition I proposed when I coined the term eg. in 2010.

“Although mHealth has potential to strengthen health systems worldwide, the evidence base is immature, and consequently, the opportunities to advance knowledge remain limited. Mobile devices and apps have become essential tools for disruptive change in many industries, but thus far, this has not happened in healthcare. Here, we discuss five interrelated reasons as to why mHealth has under delivered and highlight challenges and opportunities for mHealth researchers”

I think this is a popular myth held by researchers. In the real world (as I wrote here in 2009) successful mHealth applications are already commonplace across the world.

“The myth of the ‘killer app’. Disruptors often rely on a ‘killer app’—a highly popular application that users will consider indispensable for their needs. At last count, there were nearly 260 000 health apps on the market, but most downloads are never opened and consistent use is extremely rare. Further, these apps are often disease siloed, focus mainly on behaviour change, gloss over privacy issues and are not integrated into any overarching healthcare structure. Such apps struggle to achieve large-scale adoption because of their failure to address the needs of diverse stakeholders”

We’ve noted this happening time and again before (eg. “Majority of mHealth apps fail to engage patients”, NIH funded researchers spend $270 on misleadingly labelled iPhone apps & conclude that apps offered for ‘EDUCATIONAL USE ONLY’ can’t be relied on for ‘PROPER MEDICAL ADVICE’The Impact of mHealth Interventions: Systematic Review of Systematic Reviews, etc) and it’s a classic case of the researchers being failed by their imaginations. The reality should be obvious: it’s now cheaper to distribute high quality life saving medical information than it is to distribute water to most of the citizens living on this planet. The killer app is probably the baked in life saving potential that mobile connectivity offers.

“Most apps are consumer facing, whereas healthcare systems tend to be provider facing. This important distinction may explain why the ‘killer app’ approach is not the correct mindset. The diversity of users and the inability to address their varied problems results in user fickleness and ready abandonment of new technologies”

It’s odd to think that a group of researchers in 2018 feel their audiences need to be made aware that ‘most apps are consumer facing’. I know lots of researchers still get confused by all this but I’d of thought anyone reading the BMJ in 2018 is aware that the app stores have created an unprecedentedly low barrier to entry and that this means there are millions of cookie cutter apps some made by students having fun trying something out and posting it for it to be downloaded a few times (and probably never for real world use by an actual Patient/Carer).

The neat distinction between ‘consumer’ and ‘healthcare provider’ facing is also fast disappearing eg. see Apple Health Record.

“When tools are not connected to systems and human support, they are unlikely to be effective. Consequently, moving beyond a single solution focus towards a ‘health ecosystem’ approach is needed”

This hope of joining everything up before joining anything up is why in 2018 your dog has more joined up care than that provided by £multibillion teaching Hospitals to your sick child.

“Neglecting user perspectives and preferences. Related to the killer app mythology is the tendency to over engineer solutions before having an opportunity to fully understand user needs, contextual factors and the size and specifics of the problem that needs addressing. The Greentree consensus outlines nine principles for digital development, emphasising frequent and in-depth user engagement in all phases of the development process. It stresses the importance of understanding the ecosystem, designing for scale and sustainability, addressing privacy, using open standards and taking a data-driven approach”

This is such a dated concept and is only held by people who haven’t yet learnt how to use an app store. Who is making smartphone apps and neglects user perspectives and preferences??? Don’t the authors realise that apps all have public ratings posted by actual users and that developers are prioritising this feedback or getting fired in quick order?

“It also emphasises the need for multidisciplinary collaborations. Although researchers are often the subject matter experts, non-health specialists such as human factors engineers, human computer interaction specialists, anthropologists and ethicists can provide strong methodological frameworks for understanding user perspectives at all stages of the development, implementation, evaluation cycle”

This is  a classic misconception. In my opinion researchers are far from the subject matter experts and the basic flaws in this paper stand testament to that. The real subject matter experts are carers who just intrinsically know that ‘here’s my number’ is one of the most caring things you can say to a Patient.

“By not taking a user-centred approach, we risk over engineering solutions. The most promising use of mHealth to date has not been smartphone apps, but basic functions such as short messaging service or voice calls to address specific issues such as medication adherence and promoting smoking cessation”

This could only ever be written by someone who has never been involved in producing a mHealth app/service.

How are sms and voice calls to ‘address specific issues such as medication adherence and promoting smoking cessation’ still considered ‘promising’? Aren’t these already common and widespread eg. in 2012 Walgreens were generating more than $300M a month in revenue from their medication adherence/reordering app.

I think it’s important to realise native functions of mobiles now all start first as features/apps and the mobile brands get to enormous data sets that show their popularity/use/value in order to make the decision to make them native ‘basic functions’. A good example of how futuristic smartphone apps can quickly become ‘basic functions’ can be seen by studying Apple Health Record. Only weeks ago that wasn’t even imaginable to most and many very senior Doctors still can’t believe it!

“Apps are not pills. Researchers tend to lack a good understanding of how developers operate. Two commonly used industry standards include Waterfall and Agile development. Waterfall is a stepwise process whereby developers iteratively revise their software at each stage of the product development cycle based on target audience feedback. It may be particularly appropriate for large-scale system development. Agile design takes an incremental rather than sequential approach. Initial prototypes are usually simple and each development effort is completed in short sprint cycles with increasing maturity at each cycle. It is particularly useful when there is not a clear idea what might work. Whichever approach is used, initial deployments are unlikely to work perfectly. The interim goal should be a ‘good enough’ prototype, known in industry as the minimum viable product. These approaches highlight differing developer and researcher perspectives. The developer’s outlook is plastic, continually updating and refining a product to create novel solutions and stay ahead of the competition. By contrast, a researcher’s outlook is more static where interventions are viewed as pills—specific agents that are developed and tested in isolation of other factors. These differences in perspective are often disregarded. Understanding the developer’s approach can help research teams to get apps in front of users quickly, fail early and build from the lessons learnt. This approach can also avoid expensive ‘scope creep’ later in the development cycle when the app is more mature and user testing reveals a major redesign is needed”

I find this quite a bizarre piece of editorial. Why would anyone think developers must choose between 2 completely different approaches? Isn’t everyone aware that all the major pharma brands now have beyond the pill strategies?

“Rigid approaches to evaluate evolving technologies. While we strongly support the need for evaluations with randomised controlled trials (RCTs), there are several considerations in applying this design in mHealth. First, traditional RCT designs reflect ‘the static view’ described above—assuming an intervention is ‘fixed’ and external factors are standardised or adjusted for to avoid introducing a bias. This is anathema to software development where iteration, bug fixes and new releases as user experience grows are the norm—‘the perpetual beta’. The key consideration here is that we test principles rather than fixed apps”

I agree with this but sadly a lot of key decision makers in the Healthcare industry don’t even understand it eg. until recently the EU and major pharma brands were actually sponsoring a printed directory of mHealth apps!

MyHealthApps Directory

“A third and unexplored area is postmarketing surveillance mechanisms to safeguard against unintended consequences derived from mHealth-related activities”

I don’t think this is unexplored at all. What’s unexplored greatly is the potential for mHealth apps to support post marketing surveillance of medicines (something I’m currently working on with a leading vaccine brand).

“What are the priorities of those who pay for mHealth technologies? Public and commercial payers of health services play a central role in determining whether mHealth can be adopted at scale. Innovation in the business model is just as important as the apps themselves in promoting disruption. Greater attention to business model specifics may stimulate different research questions. From a researcher’s perspective, the priority is to demonstrate clinical effectiveness. This contrasts with the payer’s perspective which is broader and includes factors such as reduced administrative burden, improved workflows, greater patient and provider engagement and improved quality of care and outcomes at lower costs. The macroeconomic environment is also key to driving particular business models. While profits may be greater in high-income countries, the largest mHealth market in terms of user numbers will be in emerging economies. Just as the pharmaceutical industry tends to be segmented into low volume, high margin products for rich countries and high volume, cheaper products for poorer countries, mHealth markets are likely to evolve differently depending on the payer, provider and consumer environment. It is therefore important that the research community generate evidence on effective business models as much as effective apps”

This is why I think Apple is taking such a positive direction in it’s unique approach as a tech company to not be focused on what helps the Patient rather than what gets you reimbursement. I really hope Apple can make a product that’s great for Patients and can earn their trust because if they achieve that ambition they will once again change the world and I have every confidence that the business model will take care of itself (and will indeed dwarf their current annual revenues of ++$200B).

“Conclusion. Although some may be disillusioned by the lack of ‘blockbuster’ mHealth trials, we are optimistic that the evidence base for mHealth will grow substantially in coming years. Particular challenges remain, especially in low-income and middle-income country settings where literacy, health literacy, unavailability of smartphones and limited access to reliable data connectivity all pose adoption challenges. However, these factors are improving rapidly, and the opportunities for future growth are substantial. With increasing knowledge of what works and what the challenges are, we will arrive at a more nuanced understanding of the role of mHealth in improving health and healthcare”

Last week I presented to the medical students at UCD Medical School in Dublin. At this world leading medical school the future Doctors were being trained for a career that no longer exists using tools that are relics of a by gone era.

No doubt we could research every avenue (‘Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials’?) but we really don’t need to wish for ‘blockbuster’ mHealth trials we need to move beyond the 2,000 year old office visit only model of care and stop expecting medics to do the impossible because the Born Mobile generation wouldn’t actually believe that a Doctor would be allowed to work without at least a connected smartphone loaded with quality medical content.

“Competing interests: None declared”

I understand this is a challenging area but even a cursory appreciation of the George Institute’s work and it’s clear the organisation has several heavily vested commercial interests in this area eg. the George Institute has a ‘China Centre of mHealth Innovation’ that was set up with corporate sponsorship from Qualcomm to “improve community health care in China through the study of affordable, sustainable mHealth interventions, which target the nation’s leading causes of premature death and disability, while supporting the central government’s deepened commitment to health care reform” and it clearly benefits from a paper that in summary calls for more need for the work of researchers.

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mHealth for Paediatricians Course

mHealth for Paediatricians

We’ve had a request to produce a new module of the mHealth for Healthcare Professionals course (that we originally developed for the Healthcare Informatics Society) for Paediatricians and would like you to contribute, attend the meeting and suggest topics we should include.

It is a great honour for us to have Professor Sam Lingam MD (Hons) FRCPCH FRCP (Glas) DCH DRCOG, Consultant in Paediatrics and Adolescent Medicine & Medical Director of the Harley Street Paediatric Chambers, as Chair of the meeting.  An incredibly caring and experienced Paediatrician who has for 30+ years been sharing medical notes with Patients he will also be launching his new mHealth tool that enables Parents/Carers to share a high quality Paediatric Long Term Condition and Allergy History using their mobile at the meeting.

Below is a draft overview/schedule that will be updated as the event develops. The course will be live streamed and video recorded and the date for the meeting is provisionally set for Wednesday the 25th April 2018.

Overview of the opportunities and issues

Why mHealth has created a need to update clinical practice.

Challenges being encountered.

Deep dive into mHealth best practice

Giving your child a Mobile: when? why? how?

Sharing medical records and communicating with Parents/Carers

Vaccine Safety

Medication Safety

Mobiles give us superpowers: what are the opportunities to empower Patients with disabilities

Future Opportunities

Apple Health Record: Patients sharing their Medical Records with Doctors

ResearchKit: imagine the potential if every Patient could contribute to medical research

Note 1: The 1 hour CPD accredited course will be followed by a 1 hour CPD accredited course that trains Paediatricians to work with Patients/Carers who have used Prof Lingam’s Paediatric LTC & Allergy Questionnaire App and to use the Template for Paediatricians app with their Patients.

Note 2: The venue for the meeting is provisionally confirmed and has a capacity of just 100 delegates so we’ll be oversubscribed (Prof Lingam runs a monthly CPD meeting that is live streamed from the British Medical Association House that has a capacity of 200 and that’s regularly oversubscribed) so if you’d like to register to attend the meeting or livestream please get in touch via the comments below or by emailing David Doherty (david_doherty@3gdoctor.com) with your details.

 

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