Establishing high-level evidence for the safety and efficacy of medical devices and systems

I have recently been made aware of an excellent publication jointly by the Royal Academy of Engineering and the Academy of Medical Sciences entitled Establishing high-level evidence for the safety and efficacy of medical devices and systems, so this post is to reach out to those like me who were previously unaware.

It is a major step forward in applying engineering methodology to evaluating the effectiveness of medical devices & systems and, even more important, ensuring their ongoing safety.  Those of us who have participated in a substantial randomised control trial such as the Whole System Demonstrator (see earlier post today) will take great interest at what follows the quote: “For pharmaceutical innovation, the randomised controlled trial is the acknowledged gold standard for creating a body of high-quality evidence. But designing clinical trials to establish the evidence for medical devices has proven more problematic.”

(Included in the paper is the observation  that the ultimate health improvement device when you leave an aeroplane that is in the air – the parachute – has never been proven by an RCT.)

Finally just to return to an earlier comment, the report makes the point that because medical devices can be changed far more often than the composition of a drug, the importance of appropriate safety monitoring is absolutely critical, an issue that is becoming increasingly relevant as penetration of telehealth (in particular) and telecare increases.  Whilst  we might choose to ignore the different nature of medical devices when assessing a trial, we cannot ignore the different nature of medical devices when designing and putting in place appropriate safety systems.

Telehealth Soapbox: Time to bid farewell to the WSD?

TTA Contributing Editor Charles Lowe asks whether it is now time to stop looking back to the UK’s pioneering Whole Systems Demonstrator (WSD) programme.

As the person who led the bid for Whole System Demonstrator status for LB Newham back in 2006/7, this is my case that it’s time now to bid farewell to the programme, as soon as is possible.

Why?  This was a great programme that came up with some encouraging results for telehealth, and taught us a huge amount about how best to implement telehealth and telecare.  However the echoes from that long gone time are increasingly providing ammunition for the naysayers, when in reality the world is now a totally different place.  The technology is unrecognisable from that that we considered when bidding for the WSD in 2006; it is far more efficacious and far cheaper; and it can be deployed much faster & for many more conditions, opening up many possibilities not available to us when we won in 2007.  We now know much more about how to implement the technology too: in particular it delivers greatest benefit when a part of an overall programme for improving care and not, as the WSD randomised control trial (RCT) treated it, as a simple intervention, like most drugs.  In retrospect therefore there were significant weaknesses in the way the trial was run.

The continuing drip-feed of WSD results is sadly resulting in (more…)

Hospitals can benefit from telemonitoring (US)

As someone who has spent a huge amount of time attempting to persuade acute trusts in the UK that telehealth is in their interests (with, I’m glad to say, a modicum of success more recently) it is good to see this paper entitled  in the July 2013 edition of the Journal of Telemedicine & e-Health (freely accessible).  The key finding is (more…)

In changing behavior, ‘wanna’ works better than ‘hafta’

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/07/carrot-cake01.jpg” thumb_width=”150″ /]The proliferation of apps, tracking programs and devices that promise to change your life through Quantifying Yourself and lead you to the New Jerusalem of fitness and health is fascinating in number and variety. Yet why do some apps and programs do their job of changing behavior–and others, equally well-intentioned, do not? It’s all about ‘wanna’ vs. ‘hafta.’  Tracking your caloric consumption quickly turns into a ‘hafta’ drag for most (MyFitnessPal), but if you plug into a lively online community (Fitocracy), make the app easy to use and the changes gradual, plus forgive a few lapses, the same activity can start feeling rewarding and ‘wanna’. It’s all about personal autonomy, reward and control. It may be carrots rather than carrot cake, but you’re doing the choosing. Must reading for those working to develop corporate wellness programs, sticky apps and engage users. Why Behavior Change Apps Fail To Change Behavior (TechCrunch) Hat tip to reader Sandeep Pulim, MD via LinkedIn.

Related: Our April discussion of employee wellness programs, Employee wellness: Carrot? Stick? Or something else?

An example of simplification helping to increase positive behavior–and perhaps outcomes–is the recent study of the Center for Connected Health’s BP Connect program. Mobile users took their blood pressure more often than the telephone hub/device users; these older users (median age 61!) found the mobile version both easier and more convenient in portability. Overall BP scores went down moderately. Connected Health Study Finds Mobile Health Improves Patient Engagement (HIT Consultant)

New telecare and telehealth purchasing framework to stitch up the UK market for four years

As flagged up in TTA last October, [start here and follow the links back] The Eastern Shires Purchasing Organisation (ESPO) has now issued a tender for a telehealth and telecare systems framework agreement. It will run for four years and comprises three ‘lots’:

  1. A single online shop for products (and possibly services): “products included in the catalogue can be updated, increased or revised at any time in response to innovations in the market place and evolving client needs”
  2. Managed service provision: “a list of proven, specialist suppliers who are able to undertake this for [service commissioners]. This may include some or all of: service user assessment, equipment supply, service monitoring, and response…we intend to restrict the number of suppliers…to approximately 6[Emphasis ours]
  3. Consultancy services: “a list of suitably experienced consultants who are able to provide specialist advice to commissioners on the topics of telecare and telehealth”

Editorial comment

The EU and UK laws on tendering for supplies and services are extremely burdensome on suppliers and commissioners alike but (more…)

June Telecare LIN newsletter published (UK)

In a content-packed edition of this newsletter one 6-page item stands out for special attention. It’s Mike Clark’s ‘summary’ of telehealth, called Telehealth, how are we doing? which begins on page 17. Mike turns his laser-like attention on the UK’s telehealth issues including those arising from the WSD programme results and orders them into an easy-to-read logical sequence and draws some measured conclusions. It’s a pity it is not available as a standalone report for wider circulation. June Telecare LIN newsletter (PDF) plus separate news item list supplement (PDF)

One of the links in the newsletter is to the Department of Health’s 2013-14 Corporate Plan which includes a list of its achievements for 2012-13. Search it as much as you like for any telehealth-related keywords, you will not find any. It looks like DH has brushed it off its hands and moved on. Which, given its recent toxic-touch history may not be a bad thing.

Staying up at night with telemedicine (and telehealth)

Our readers have many things which keep them up at night, including that extra taco, but René Quashie of leading healthcare/life sciences law firm Epstein Becker Green adds a few more to the list. While muddling telemedicine (remote consults) with telehealth (vital signs tracking and monitoring), he outlines the legal pitfalls (and consequences) that both are facing: non-compliance with state prescribing and licensure laws (physical examination requirements); lack of highly developed protocols and guidelines (liability exposure); lack of greater coverage and reimbursement by payers (low credibility=low/no pay); HIPAA compliance in privacy and security (lack of protection against unauthorized data access). However, how many of these have already experienced accomodation by state regulators, or have started to modify to follow regulations?  Awake yet? This is only Part 1. Things That Should Keep the Telehealth Community Awake at Night (Part 1) (TechHealth Perspectives/EBG blog) Hat tip to reader Ellen Fink-Samnick of Ellen’s Ethical Lens.

Telehealth makes front page in UK newspaper

Rather to many people’s surprise the popular Daily Express newspaper featured a telehealth story on its front page on Wednesday. It appears to be an extension of the UK’s media’s current interest in the woes of hospital emergency departments and the simplistic ‘blame the GPs’ theme that has been fuelled by recent comments from the Secretary of State for Health. However, the article is positive about telehealth blood pressure monitoring: DIY test will save your life: gadget sends blood pressure results direct to your GP (online version). Interestingly, the article contains no reference to the 3ML initiative. One wag Tweeted “Oh no! I’m rubbish at DIY. I’ll surely fail the test”. Here’s a link to a picture of the front page so that readers can gauge the weight that the item received.

text4baby: positive study results (US)

Results from a year-long evaluation provide evidence that text4baby benefits users. text4baby is a free mobile health information service of the National Healthy Mothers, Healthy Babies Coalition (HMHB) that provides pregnant women and new mothers with health and safety information via text message. The content includes messages about immunization, nutrition, birth defect prevention, safe sleep, etc. A survey developed by researchers from the National Latino Research Center (NLRC) at California State University San Marcos and the University of California San Diego, with support from the Alliance Healthcare Foundation, was administered to 631 text4baby users in San Diego. Findings indicate that text4baby is increasing users’ health knowledge, facilitating interaction with health providers, reminding them of their appointments and immunizations, and improving access to health services. More information and link to the study results. Heads-up thanks to Bob Pyke.

Med-e-Tel 2013 presentations available

Copies of the presentations at Med-e-Tel 2013 (10-12 April 2013) are now available. Click on the ‘full presentation’ links to access the presentations. The Med-e-Tel Knowledge Resource Center also still contains the presentations from previous events (2002-2012). You can access the Resource Center here.

The Med-e-Tel 2013 proceedings, published as Global Telemedicine and eHealth Updates – Knowledge Resources, Vol. 6, 2013 (610 pages) are now also available for purchase. It contains 133 short papers of presentations that were submitted for the Med-e-Tel 2013 conference program. To order a copy contact info@medetel.eu.

Gloucestershire telehealth: PCT oversold; GPs undersold (UK)

A news item from the BBC (link below) takes the shine off the story of the Gloucestershire ‘big roll out’ of telehealth as it is generally presented (3ML PDF).

Dr Tim Macmorland, a GP in Churchdown, said the systems were ineffective. “I think it’s been handled poorly. It was rolled out to GPs without discussing anything about the system before it was implemented…We already knew it was working in the heart failure service, [see item here, paragraph 5. Ed.] but then we were asked to find patients who had these other chronic diseases for whom the system might work as well, and I don’t think it has to be honest, it’s been an absolute waste of money.”

For many years suppliers – and we – have been calling for an end to small scale pilots and for going straight for mainstream adoption. However, we may be seeing that in reality this is not possible, at least not with the approaches tried so far. Perhaps the ‘not invented here’ effect is stronger than we all supposed and telehealth adoption will only be achieved one doctor at a time.

BBC item: Gloucestershire health monitors investment a ‘waste of money’.

Wales: telehealth research participants sought

The Institute of Rural Health and Aberdeen University are to research the effect of technology on patients interactions with their home carers, and are seeking input from patients using telehealth in the Powys and Betsi Cadwaladr health board areas. Recruitment is open until the end of June and seeks patients aged 60-79 years, who are visited by a nurse or other professional carer at least once a week and are using some sort of telehealth technology to help them to manage chronic pain or another medical condition. ‘Technology’ might include the use of internet forums, phone ‘apps’, or Skype links to carers. For further information please contact Sophie Corbett at the IRH on 01686 629480. (Info via Dispensing Doctors’ Association)

Telehealth gives patients the chance to take more control over their care

More often than not Professor Stanton Newman has been the bearer of bad tidings…the Whole Systems Demonstrator Program (WSD) hasn’t delivered the hoped-for, definitive, glowing results and he has had to see them used for telehealth-bashing by some doctors and the GP press. In an article in the GP online magazine Pulse Today, he gets the chance to bust a few myths and to reaffirm his belief that there are good reasons why GPs should consider telehealth positively. Telehealth gives patients the chance to take more control over their care. (Requires free sign up to view if you have not done previously. Worth doing.) His comments are apt in view of the remote care monitoring directed enhanced service (DES) conditions (PDF) recently published by the Department of Health. Heads-up thanks to Mike Clark.