Digital Health: tensions between hype and reality

There are many articles predicting an amazing future for digital technologies for healthcare: wearables, implantables, wirelessly enabled to gather vital signs information and collate it for future sensemaking, by the individual, clinicians and population health researchers. Two examples that have recently come to my attention are a video by the American Psychiatry Association and a report by Deloitte. The possibilities are truly transformational.

Meanwhile, I recently visited a friend who has Type II diabetes. On his floor, half hidden by a table, I spotted what I thought was a pen lid. It turned out to be the top of his new lancing kit. Although he had been doing blood glucose checks daily for well over a decade, he hadn't done one for over two weeks. Not just because he'd lost an essential part of the equipment, but because he'd been prescribed the new tool and hadn't been able to work out how to use it. So losing part of it wasn't a big deal: it was useless to him anyway. He told me that when he'd reported his difficulties to his clinician, he'd... been prescribed a second issue of exactly the same equipment. So now he has three sets of equipment: the original (AccuChek) lancing device and blood glucose meter, which he has used successfully for many years, but which he can't use now because he doesn't have spare consumables; and two lancing devices and meters (from a different manufacturer), with plenty of spare consumables, which he can't use because he finds the lancing device too difficult to use. And in trying to work out with him what the problem was, we managed to break one of them. Good thing he's got a spare!

If we think it's just isolated individuals who struggle, it's not: a recent report from Forbes reports similar issues at scale: poor usability of electronic health records and patient portals that are making work less efficient and effective rather than more.

So on the one hand we have the excitement of future possibilities that are gradually becoming reality for many people, and on the other hand we have the lived experiences of individuals. And for some people, change is not necessarily good. The real challenge is to design a future that can benefit all, not just the most technology-savvy in society.

Mind the gap: the gulfs between idealised and real practice

I've given several talks and written short articles about the gap between idealised and real practice in the use of medical devices. But to date I've blurred the distinctions between concerns from a development perspective and those from a procurement and use perspective.

Developers have to make assumptions about how their devices will be used, and to design and test (and build safety cases, etc.) on that basis. Their obligation (and challenge) is to make the assumptions as accurate as possible for their target market segment. And to make the assumptions as explicit as possible, particularly for subsequent purchasing and use. This is easier said than done: I write as someone who signed an agreement on Tuesday to do a pile of work on our car, most of which was required but part of which was not; how the unnecessary work got onto the job sheet I do not know, but because I'd signed for it, I had to pay for it. Ouch! If I can accidentally sign for a little bit of unnecessary work on the car, how much easier is it for a purchasing officer to sign off for unnecessary features, or slightly inappropriate features, on a medical device? [Rhetorical question.]

Developers have to work for generic market segments, whether those are defined by the technological infrastructure within which the device sits, the contexts and purposes for which the device will be used, the level of training of its users, or all of the above. One device probably can't address all needs, however desirable 'consistency' might be.

In contrast, a device in use has to fit a particular infrastructure, context, purpose, user capability... So there are many knowns where previously there were unknowns. And maybe the device fits well, and maybe it doesn't. And if it doesn't, then something needs to change. Maybe it was the wrong device (and needs to be replaced or modified); maybe it's the infrastructure or context that needs to be changed; maybe the users need to be trained differently / better.

When there are gaps (i.e., when technology doesn't fit properly), people find workarounds. We are so ingenious! Some of the workarounds are mostly positive (such as appropriating a tool to do something it wasn't designed for, but for which it serves perfectly well); some introduce real vulnerabilities into the system (by violating safety features to achieve a short-term goal). When gaps aren't even recognised, we can't even think about them or how to design to bridge them. We need to be alert to the gaps between design and use.

When reasoning and action don't match: Intentionality and safety

My team have been discussing the nature of “resilient” behavior, the basic idea being that people develop strategies for anticipating and avoiding possible errors, and creating conditions that enable them to recover seamlessly from disturbances. One of the examples that is used repeatedly is leaving one’s umbrella by the door as a reminder to take it when going out in case of rain. Of course, getting wet doesn’t seriously compromise safety for most people, but let’s let that pass: its unpleasant. This presupposes that people are able to recognize vulnerabilities and identify appropriate strategies to address them. Two recent incidents have made me rethink some of the presuppositions.

On Tuesday, I met up with a friend. She had left her wallet at work. It had been such a hot day that she had taken it out of her back pocket and put it somewhere safe (which was, of course, well hidden). She recognized that she was likely to forget it, and thought of ways to remind herself: leaving a note with her car keys, for instance. But she didn’t act on this intention. So she had done the learning and reflection, but it still didn’t work for her because she didn’t follow through with action.

My partner occasionally forgets to lock the retractable roof on our car. I have never made this mistake, but wasn’t sure why until I compared his behavior with mine. It turns out he is more relaxed than I am, and waits while the roof closes before taking the next step, which is often to close the windows, take the keys out of the lock and get out of the car. I, in contrast, am impatient. I can’t wait to lock the roof as it closes, so as the roof is coming over, my arm is going up ready to lock it. So I never forget (famous last words!): the action is automatised. The important point in relation to resilience is that I didn’t develop this behavior in order to keep the car safe or secure: I developed it because I assumed that the roof needed to be secured and I wanted it to happen as quickly as possible. So it is not intentional, in terms of safety, and yet it has the effect of making the system safer.

So what keeps the system safe(r) is not necessarily what people learn or reflect on, but what they act on. This is, of course, only one aspect of the problem; when major disturbances happen, it’s almost certainly more important to consider people’s competencies and knowledge (and how they acquired them). To (approximately) quote a London Underground controller: “We’re paid for what we know, not what we do”. Ultimately, it's what people do that matters in terms of safety; sometimes that can be clearly traced to what they know and sometime it can't.

"How to avoid mistakes in surgery": a summary and commentary

I've just returned from the US, and my one "must see" catch-up TV programme was "How to avoid mistakes in surgery" (now available on youtube). It's great to see human error in healthcare getting such prominent billing, and being dealt with in such an informative way. This is a very quick synopsis (of the parts I particularly noted).

The programme uses the case of Elaine Bromiley as the starting point and motivation for being concerned about human error in healthcare. The narrator, Kevin Fong, draws on experience from other domains including aviation, firefighting and formula one pit-stops to propose ways to make surgery and anaesthesia safer. Themes that emerge include:

• the importance of training, and the value of simulation suites (simlabs) for setting up challenging scenarios for practice. This is consistent with the literature on naturalistic decision making, though the programme focuses particularly on the importance of situational awareness (seeing the bigger picture).

• the value of checklists for ensuring that basic safety checks have been completed. This is based on the work of Atul Gawande, and is gaining recognition in UK hospitals. It is claimed that checklists help to change power relationships, particularly in the operating theatre. I don't know whether there is evidence to support this claim, but it is intuitively appealing. Certainly, it is important in operating theatres, just as it has been recognised as being important in aviation

• the criticality of handovers from the operating theatre to the intensive care unit. This is where the learning from F1 pitstops comes in. It's about having a system and clear roles and someone who's in charge. For me, the way that much of the essential technology gets piled on the bed around the patient raised a particular question: isn't there a better way to do this?

• dealing with extreme situations that are outside anything that has been trained for or anticipated. The example that was used for this was the Hudson River plane incident; ironically, on Thursday afternoon, about the time this programme first broadcast, Pete Doyle and I were discussing this incident as an example that isn't really that extreme, because the pilot has been explicitly trained in all the elements of the situation, though not in the particular combination of them that occurred that day. There is a spectrum of resilient behaviour, and this is an example of well executed behaviour, but it's not clear to me that it is really "extreme". The programme refers to the need to build a robust, resilient safety system. Who can disagree with this? It advocates an approach of "standardise until you have to improvise". This is true, but this could miss an important element: standardisation, done badly, reduces the professional expertise and skill of the individual, and it is essential to enhance that expertise if the individual is to be able to improvise effectively. I suspect that clinicians resist checklists precisely because it seems to reduce their professional expertise, when in fact it should be liberating them to develop their expertise at the "edges", to deal better with the extreme situations. But of course that demands that clinical professional development includes opportunities and challenges to develop that expertise. That is a challenge!

The programme finishes with a call to learn from mistakes, to have a positive attitude to errors. Captain Chesley 'Sully' Sullenberger talks about "lessons bought with blood", and about the "moral failure of forgetting these mistakes and having to re-learn them". `On the basis of our research to date, and of discussions with others in the US and Canada studying incident reporting and learning from mistakes, this remains a challenge for healthcare.

Ethics and informed consent: is "informed" always best?

I am in the US, visiting some of the leading research groups studying human factors, patient safety and interactive technologies. This feels like "coming home": not in the sense that I feel more at home in the US than the UK (I don't), but in that these groups care about the same things that we do – namely, the design, deployment and use of interactive medical devices. Talking about this feels like a constant uphill struggle in the UK, where mundane devices such as infusion pumps are effectively "invisible".

One of the issues that has exercised me today is the question of whether it is always ethical to obtain informed consent from the patients who are receiving drugs via infusion devices. The group I'm working with here in Boston have IRB (Institutional Review Board, aka Ethics Board) clearance to just obtain informed consent from the lead nurse on the ward where they are studying the use of devices. Not even from all the nurses, never mind the patients. In one of our studies, we were only allowed to observe a nurse programming a device in the middle of the night if we had obtained permission to observe from the patient before they had fallen asleep (which could have been several hours earlier). Even though we were not gathering any patient data or disturbing the patient in any way. In fact, we were probably disturbing the patient more by obtaining informed consent from them than we would have been just observing the programming of the pump without their explicit knowledge.

We recently discussed the design of a planned study of possible errors with infusion devices with patient representatives. Feedback we got from one of them was: "patients and relatives need to have complete confidence in the staff and equipment, almost blind faith in many instances." There are times when ensuring that patients are fully informed is less important than giving them reassurance. The same is true for all of us when we have no control over the situation.

On the flight on the way here, there was an area of turbulence where we all had to fasten our seatbelts. That's fine. What was less fine what the announcement from the pilot that we shouldn't be unduly worried about this (the implication being that we should be a little bit worried): as a passenger in seat 27F, what use was it for me to worry? No idea! It made the flight less comfortable for me, to no obvious benefit (to me or anyone else).

Similarly with patients: if we accept that studying the use of medical devices has potential long-term benefits, we also need to review how we engage patients in the study. Does obtaining informed consent give them benefits or whatever-is-the-opposite? Maybe there are times where the principle of "blind faith" should dominate.

When context really matters: entertainment, safety ... or neither?

Yesterday, Mark Handley drew my attention to a video of the recent evacuation of an All Nippon Airways Boeing 787 due to a battery problem: "Here's a video from inside the plane:  The inflight entertainment system has clearly just rebooted, and about half the screens are displaying the message "Please Wait" in large comforting letters. Maybe not the most appropriate message when you want people to evacuate quickly!"

Fortunately, it seems that passengers ignored the message asking them to wait, and did indeed evacuate instead. But did they do so as quickly as they might have done otherwise? We'll never know. They will have had many other sources of information available at the time, of which the most powerful were probably other people's behaviour and the appearance of the evacuation slides. The digital and physical contexts were providing different cues to action.

Brad Karp observed that : "Presumably when you activate the slides, you either want to kill the entertainment system or have it display "EVACUATE!"

Alan Cooper, in "The inmates are running the asylum", discusses many examples of interaction design. One he explores is the challenge of designing good in-flight entertainment systems. For example, he points out that the computer scientist's tendency to deal with only three numbers (0, 1, infinity) is inappropriate when choosing a maximum number of films to make available on a flight, and that choosing a reasonable (finite) number makes possible attractive interaction options that don't scale well to infinity. He also argues that the entertainment system needs two different interfaces: one for the passenger and a different one for the crew who need to manage it. But if you watch the video, you will see that half the screens on the plane are showing a reboot sequence. Who designed this as an interface for passengers? If the system developers don't even think to replace a basic reboot sequence by something more engaging or informative, what chance of them thinking about the bigger picture of how the entertainment system might be situated within, and interact with, the broader avionics system?

In-flight entertainment systems don't seem to be considered as part of the safety system of the aircraft. Surely, they should be. But that requires a broader "systems" perspective when designing, to give passengers more contextually relevant information that situates the digital more appropriately within the physical context.

Happy (entertaining, safe) flying!

An accident: lots of factors, no blame

At one level, this is a story that has been told many times already, and yet this particular rendering of it is haunting me. I don't know all the details (and never will), so parts of the following are speculation, but the story is my best understanding of what happened, and it highlights some of the challenges in trying to make sense of human error and system design.

The air ambulance made a tricky descent. Although the incident took place near a local hospital, the casualty was badly injured and needed specialist treatment, so was flown to a major trauma centre. Hopefully, he will live.

What happened? The man fell, probably about 10 metres, as he was being lowered from the top of a climbing wall. It seems that he had put his climbing harness on backwards and tied the rope on to a gear loop (which is not designed to hold much weight) rather than tying it in correctly (through the waist loop and leg loop, which were behind him). Apparently, as he let the rope take his weight to be lowered off from the climb, the gear loop gave way.

I can only guess that both the climber and his partner were new to climbing, since apparently neither of them knew how to put the harness on correctly, and also that there was no-one else on the wall at the time (since climbers generally look out for each other and point out unsafe practices). But so many things must have aligned for the accident to happen: both climbers must have signed a declaration that they were experienced and recognised the risks; the harness in question had a gear loop at the centre of the back that they could mistake for a rope attachment point... but that loop wasn't strong enough to take the climber's weight; someone had supplied that harness to the climber without either providing clear instructions on how to put it on or checking that he knew...

So many factors: the climber and his partner apparently believed they were more expert than they actually were; the harness supplier (whether that was a vendor or a friend) didn't check that the climber knew how to use the equipment; there weren't other more expert climbers around to notice the error; the design of the harness had a usability vulnerability (a central loop that actually wasn't rated for a high load and could be mistaken for a rope attachment point); the wall's policy allowed people to self-certify as experienced without checking. Was anyone to blame? Surely not: this wasn't "an accident waiting to happen". But the system clearly wasn't as resilient as it might have been because when all these factors lined up, a young man had to be airlifted to hospital. I wish him well, and hope he makes a full recovery.

The wall has learnt from the incident and changed its admissions policy; hopefully, there will be other learning from it too to further reduce the likelihood of any similar incident occurring in the future. Safety is improved through learning, not through blaming.