The inspirational imperative

“Inspirational” and its derivatives has replaced “passionate” as a CV-staple. “Inspirational” has also become a clickbait-staple. My Twitter feed seems to sag under the burden of just so many “inspirational” and “inspiring” links. “Inspiration”, “inspiring”, “inspirational” – all join “disruptive”, “revolutionary”, “transformational” in the Overused Lexicon.

Recently a video circulated online (OK, “went viral”) of a woman with terminal illness being interviewed by Ryan Tubridy on The Late Late Show. While her own determination to live every moment is entirely admirable, I do wonder if the cult of Inspiration can put pressure on people in this situation (and many others) to Be An Inspiration. Winston Churchill’s battles with the “black dog” of depression are often held up as inspiring – look what he achieved despite his depression! – but this can be demoralising – look what he achieved despite his depression, so why can’t I? Cue guilty spiral…

Currently Sir Bradley Wiggins is facing serious questions about his use of Therapeutic Use Exemptions. Cycling seems a sport that, even more than others, is bound up with a culture of Being Inspirational (perhaps this is because cycling does seem to small-i inspire many adults to take up the bike themselves, in a way watching professional football, for example, doesn’t) . One of the reasons Lance Armstrong got away with his drug cheating was the Inspirational Story he was able to wrap himself in, and a natural reluctance on the part of many to burst an Inspirational bubble.

Much of the discourse online about eHealth can take a similarly  Inspirational Above All turn. Perhaps this is another example of how the can-do, market-focused, startup culture of tech conflicts with the more restrained, evidence-focused, small-c conservative world of healthcare.

 

 

“The Wild West of Health” care: mental health Apps, evidence, and clinical credibility

We read and hear much about the promise of mobile health. Crucial in the acceptance of mobile health by the clinical community is clinical credibility. And now, clinical credibility is synonymous with evidence, and just “evidence” but reliable, solid evidence. I’ve blogged before about studies of the quality of mental health smartphone apps. I missed this piece from Nature which, slightly predictably, is titled “Mental Health: There’s an app for that.” (isn’t “there’s an App for that a little 2011-ish though?) It begins by surveying the immense range of mental health-focused apps out there:

 

Type ‘depression’ into the Apple App Store and a list of at least a hundred programs will pop up on the screen. There are apps that diagnose depression (Depression Test), track moods (Optimism) and help people to “think more positive” (Affirmations!). There’s Depression Cure Hypnosis (“The #1 Depression Cure Hypnosis App in the App Store”), Gratitude Journal (“the easiest and most effective way to rewire your brain in just five minutes a day”), and dozens more. And that’s just for depression. There are apps pitched at people struggling with anxiety, schizophrenia, post-traumatic stress disorder (PTSD), eating disorders and addiction.

The article also has a snazzy  infographic illustrating both the lack of mental health services and the size of the market:

The meat of the article, however, focuses on the lack of evidence and evaluation of these apps. There is a cultural narrative which states that Technology = Good and Efficient, Healthcare = Bad and Broken and which can give the invocation of Tech the status of a godterm, pre-empting critical thought. The Nature piece, however, starkly illustrates the evidence gap:

But the technology is moving a lot faster than the science. Although there is some evidence that empirically based, well-designed mental-health apps can improve outcomes for patients, the vast majority remain unstudied. They may or may not be effective, and some may even be harmful. Scientists and health officials are now beginning to investigate their potential benefits and pitfalls more thoroughly, but there is still a lot left to learn and little guidance for consumers.

“If you type in ‘depression’, its hard to know if the apps that you get back are high quality, if they work, if they’re even safe to use,” says John Torous, a psychiatrist at Harvard Medical School in Boston, Massachusetts, who chairs the American Psychiatric Association’s Smartphone App Evaluation Task Force. “Right now it almost feels like the Wild West of health care.”

There isn’t an absolute lack of evidence, but there are issues with  much of the evidence that is out there:

Much of the research has been limited to pilot studies, and randomized trials tend to be small and unreplicated. Many studies have been conducted by the apps’ own developers, rather than by independent researchers. Placebo-controlled trials are rare, raising the possibility that a ‘digital placebo effect’ may explain some of the positive outcomes that researchers have documented, says Torous. “We know that people have very strong relationships with their smartphones,” and receiving messages and advice through a familiar, personal device may be enough to make some people feel better, he explains.

And even saying that (and, in passing, I would note that in branch of medical practice, a placebo effect is something to be harnessed, not denigrated – but in evaluation and study, rigorously minimising it is crucial) there is a considerable lack of evidence:

But the bare fact is that most apps haven’t been tested at all. A 2013 review⁸ identified more than 1,500 depression-related apps in commercial app stores but just 32 published research papers on the subject. In another study published that year⁹, Australian researchers applied even more stringent criteria, searching the scientific literature for papers that assessed how commercially available apps affected mental-health symptoms or disorders. They found eight papers on five different apps.

The same year, the NHS launched a library of “safe and trusted” health apps that included 14 devoted to treating depression or anxiety. But when two researchers took a close look at these apps last year, they found that only 4 of the 14 provided any evidence to support their claims¹⁰. Simon Leigh, a health economist at Lifecode Solutions in Liverpool, UK, who conducted the analysis, says he wasn’t shocked by the finding because efficacy research is costly and may mean that app developers have less to spend on marketing their products.

Like any healthcare intervention, an App can have adverse effects:

When a team of Australian researchers reviewed 82 commercially available smartphone apps for people with bipolar disorder¹², they found that some presented information that was “critically wrong”. One, called iBipolar, advised people in the middle of a manic episode to drink hard liquor to help them to sleep, and another, called What is Biopolar Disorder, suggested that bipolar disorder could be contagious. Neither app seems to be available any more.

And even more fundamentally, in some situations the App concept itself and the close relationship with gamification can backfire:

Even well-intentioned apps can produce unpredictable outcomes. Take Promillekoll, a smartphone app created by Sweden’s government-owned liquor retailer, designed to help curb risky drinking. While out at a pub or a party, users enter each drink they consume and the app spits out an approximate blood-alcohol concentration.

When Swedish researchers tested the app on college students, they found that men who were randomly assigned to use the app ended up drinking more frequently than before, although their total alcohol consumption did not increase. “We can only speculate that app users may have felt more confident that they could rely on the app to reduce negative effects of drinking and therefore felt able to drink more often,” the researchers wrote in their 2014 paper¹³.

It’s also possible, the scientists say, that the app spurred male students to turn drinking into a game. “I think that these apps are kind of playthings,” says Anne Berman, a clinical psychologist at the Karolinska Institute in Stockholm and one of the study’s authors. There are other risks too. In early trials of ClinTouch, researchers found that the symptom-monitoring app actually exacerbated symptoms for a small number of patients with psychotic disorders, says John Ainsworth at the University of Manchester, who helped to develop the app. “We need to very carefully manage the initial phases of somebody using this kind of technology and make sure they’re well monitored,” he says.

I am very glad to read that one of the mHealth apps which is a model of evidence based practice is one that I have both used and recommended myself – Sleepio:

One digital health company that has earned praise from experts is Big Health, co-founded by Colin Espie, a sleep scientist at the University of Oxford, UK, and entrepreneur Peter Hames. The London-based company’s first product is Sleepio, a digital treatment for insomnia that can be accessed online or as a smartphone app. The app teaches users a variety of evidence-based strategies for tackling insomnia, including techniques for managing anxious and intrusive thoughts, boosting relaxation, and establishing a sleep-friendly environment and routine.

Before putting Sleepio to the test, Espie insisted on creating a placebo version of the app, which had the same look and feel as the real app, but led users through a set of sham visualization exercises with no known clinical benefits. In a randomized trial, published in 2012, Espie and his colleagues found that insomniacs using Sleepio reported greater gains in sleep efficiency — the percentage of time someone is asleep, out of the total time he or she spends in bed — and slightly larger improvements in daytime functioning than those using the placebo app¹⁵. In a follow-up 2014 paper¹⁶, they reported that Sleepio also reduced the racing, intrusive thoughts that can often interfere with sleep.

The Sleepio team is currently recruiting participants for a large, international trial and has provided vouchers for the app to several groups of independent researchers so that patients who enrol in their studies can access Sleepio for free.

This is extremely heartening – and as stated above, clinical credibility is key in the success of any eHealth / mHealth approach. And what does clinical credibility really mean? That something works, and works well.

 

 

Evidence based medicine and evidence based policy

There was a fair bit of media coverage of the finding that teenage-pregnancy-prevention programmes using simulated babies are associated with an increased rather than decreased teenage pregnancy rate. Some of the media discussion focused on the role of evidence in public policy.

Via Twitter, I came across this article on evidence-based policy by Howard White in The Independent

Evidence-based medicine has transformed medical practice. TheCochrane Library has published more than 6,000 studies summarising high quality evidence for health interventions. Notable cases include breast screening, which used to be recommended for women from the age of 40 until the evidence showed that the number of false positives recorded was in fact doing more harm than good. The risks from unnecessary surgery were greater than the often small benefits from early treatment forbreast cancer.

Hormone replacement therapy (HRT) is another example. It was routinely used to reduce heart disease, but then became far less common when evidence showed adverse effects. There is now a more nuanced understanding of which women will benefit from HRT and which will not.

Prior to Cochrane, doctors based their advice on out-of-date knowledge, personal experience and the influence of drug reps. Today, doctors have access to evidence-based guidelines. Decisions on what the NHS can and should fund are informed by the advice of the National Institute for Health Clinical Excellence after a review of the evidence.

So why can’t we do the same for social and economic policy?

For those who are interested, I engaged (or am engaging) in a twitter exchange on this with Howard White, whose replies have been very gracious. As in so many of these exchanges I suspect that we agree on more than we disagree on (and possibly agree on everything with a difference in emphasis)

Of course policy should be based on evidence, where available. This not only seems extremely reasonable and  rational – it is eminently reasonable and rational. I also write as an admirer of the Cochrane Collaboration.

However, I always feel a sense of caution when clinical concepts are introduced into political discourse. The best definitions of EBM always include the word “judicious”, as here

“Evidence-based medicine is the conscientious explicit and judicious use of current best evidence in making decisions about the care of individual patients.”

Judicious is key – judgment and reflection are required. Does this body of evidence apply to my patient, this individual person in front of me, or does it not? As I wrote on another point:

it is one thing to have an evidence base for a specific therapy in medical practice, quite another for a specific intervention in society itself.

My review of Helen Pearson’s The Life Project is still to be published, when it does I will perhaps write a little more on “evidence-based policy”, a concept which began to enjoy great vogue in the 1990s.What Pearson’s book shows, however, is that the devil can cite evidence for his own purpose; “evidence” can be wielded with agendas.

Obviously the Campbell Collaboration aims to address this, by being transparent about the evidence used and the methodology used to synthesise it.

A further point is that evidence-based policy tends to presuppose consensus on the ends of policy  – and emphasise technocratic means of getting there. Thereby the focus on specific interventions, rather than any wider sense of not merely social goals but of social meaning. Of course, this very much in keeping with a time in which we are all supposed to be beyond “grand narratives” – which is of course itself a “grand narrative.” I would suggest that many recent events in politics around the world are best understood as testing this notion to destruction.

Bringing it all back to a question I asked a while ago about the best kind of evidence for health informatics innovations, perhaps what this illustrates is that the way we do evidence now tends to be to focus on specific interventions and, as far as possible, measure their effects as specific interventions and without reference to an overall system. Indeed, this is obviously necessary for assessing therapies and treatments. But is it necessarily missing something when it comes to a system?