World Patient Safety Day

September 17, 2020

Tablets

It’s patient safety day. If you go to twitter and look at the hashtag #WorldPatientSafetyDay there’s lots of interesting and valuable material that can be used to make healthcare a safer place for both patients and healthcare staff.

But there is one easy small thing you can do to have huge impact.

This year make a commitment to spend 5 minutes on one thing that adds to global patient safety.

You can definitely do it if you are a health professional.

You might be able to do it if you are a patient or a carer, but I hope you don’t need to.

You can report a suspected adverse reaction (side effect) to your country’s regulatory system.

We don’t know much about the real-world safety of new drugs and vaccines when they first come to market. We can predict what might happen from the studies that got the drug or vaccine licensed, but when they are used in the wider population new side effects might become apparent. Sometimes even mild side effects may be indicative of a more serious issue in other patients.

Therefore every report of suspected adverse drug reactions that regulators receives adds a little knowledge. That knowledge accumulates. And over time that aggregation of data can give a signal of possible harm. And that helps regulators keep us all safe by focusing where they need to look.

So if you take a medicine or a vaccine this year, please let regulators know if you suffer a side effect.

You probably won’t.

You might even think the side effect is from something else. But you only have to suspect, not be sure. And each one helps other patients by ensuring we know a drug or vaccine is safe, or alternatively allowing us to find a problem that can be prevented in others.

If you are a health professional, just reporting one of the many suspected adverse drug reactions you see a year will make you better than average reporter.

And it will take you 5 minutes.

Once a year.

Photograph: Photo by James Yarema

Science Fictions

August 10, 2020

Pro-Science Rally, Washington DC, 2017

About 15 years ago the skeptic movement on the internet was in full throat, pushing back against anti-vaccine activists, homeopaths, and poor science reporting in the media. Before social media, this network of blogs focused on quackery, framed as an issue outside of science itself. Alongside quacks, the media was seen as particular problem, with journalists making unfounded claims about scientific papers. If you were lucky, they might put a caveat in paragraph 19 of a news report.

But what if the problem isn’t with media reporting, but the science itself?

Science Fictions is a new book by Stuart Ritchie, a psychologist and researcher, which makes this claim. Described in his twitter bio as a ‘startled hedgehog’, like the hedgehog in Isaiah Berlin’s Fox and the Hedgehog, he has focused on one important thing.

Incentives.

In some ways Science Fictions follows on from Ben Goldacre’s excellent Bad Science, and his later book Bad Pharma. When covering the same, or similar cases, of bad science Ritchie keeps the focus on the incentive structures surrounding science, rather than the individual issues themselves.

The book consists of three main parts. Firstly, how science ought to work and its value, and inevitably the replication crisis in psychology. It then takes on the some of the main faults in science: fraud, bias, negligence, and hype. Finally, it deals with the perverse incentives that create the climate which allow the flaws in science to flourish, with some suggestions for fixing them.

Goldacre argued in Bad Pharma that the total contribution of fraud to in the medical literature was marginal when compared to the ‘routine, sophisticated and - more than anything - plausibly deniable everyday methodological distortions.’ Ritchie makes a stronger case that fraud has a more insidious effect on science as a whole, damaging careers, diverting scare resources into fruitless areas and investigations, and poisoning the scientific record (as retracted papers continue to be unwittingly cited despite being retracted). His gathering of some of the worse cases, and the fact much may remain undetected, gives it a greater weight than when you read about them as isolated cases in the news. However, again this is dwarfed by the other issues in science such as multiple forms of bias, clear negligence (some of which are genuinely shocking failures), and hype (scientists are as guilty as the media).

The discussion of these issues is clear, easy to read, and would be an excellent primer for anyone about to take an undergraduate science degree, or for that matter someone about to undertake a PhD. I imagine scientists may be familiar with controversies in their own areas, but not the wider picture he describes. However, the last chapter on the incentives that drive science suggests another group of readers.

the scientific incentive system engenders an obsession not just with certain kinds of papers, but with publication itself. The system incentivises scientists not to practise science, but simply to meet its own perverse demands. These incentives are at the root of so many of the dubious practices that undermine our research.

Ritchie, Stuart. Science Fictions (p. 177). Random House. Kindle Edition.

As Steven Pinker noted in Enlightenment Now, science is under attack from both the right and left of politics, and where it intersects with religion, humanities, and the arts. Yet science is possibly the greatest achievement of the human race. Science, and the application of reason, is the best way we have to try to understand the universe we live in, and even to defeat a tiny virus which has turned the world upside down (Ritchie’s book includes discussion of preprint culture in a time of Covid, unexpected given the book publication process).

Science Fictions is clearly written by someone who loves science, and while it could be seen as a condemnation of science, it is not. Science is a process that includes humans and all their fallibilities. Ritchie’s concern with the incentives that lead to poor decisions around statistics, the lack of openness of data, the culture of publications, the metrics that drive academic success, and how grant money is allocated is about strengthening the core tenets of science, rather than a destructive assault on science as a concept.

This is why, while I would recommend the book to undergraduate or graduate students, this book should be read by leaders in science, by those running funding bodies, by those involved in senior managerial positions, and also by politicians who can have a system wide influence on incentive structures. It’s not enough for individual scientists to push back against perverse incentives. Although Ritchie provides sound advice that all should follow, some of the incentives themselves also have to change. That requires either a long wait as a new generation of researchers battle through the existing system, or a top down examination from those who can effect system wide change now. The strength of his argument suggests the latter is needed. Whether that is possible during a period of unprecedented pressures on Universities is another question.

Photograph: Photo by Vlad Tchompalov

Ten Steps to Safety

July 31, 2020

Trapani Pharmacy, Sicily

Back in October of last year, I was in Sicily attending an international forum on improving patient safety. It seems a long time ago. Flying to Palermo. Sitting in a room with new people, talking. Shaking hands. Ordinary activities that seem risky propositions now.

However, the plan that arose at the meeting is more relevant than ever, as the debate on the safety of drugs for treating Covid-19 continues and the monitoring of the safety of potential vaccines will be under increased scrutiny.

The delegates came from varied backgrounds, with sometimes clashing perspectives. At times, it was hard to see how a consensus would be obtained, but an open debate did eventually lead to agreement on some core recommendations. As with most things, the clash of opposing viewpoints did strengthen those finally agreed on.1

  1. Raise public and professional awareness of the harms from medicines and devices.
  2. Shift the culture within regulatory and health care management systems from one of secrecy to one of transparency.
  3. Enforce existing effective regulations, revise ineffective ones, and implement effective regulations in those areas lacking appropriate regulatory infrastructure.
  4. Transfer from industry to healthcare systems the responsibility for providing information and support to healthcare providers on the use of medicines and devices.
  5. Encourage and enable prescription and use of medicines and devices that are appropriate and tailored to the needs of individual patients.
  6. Facilitate access to all relevant data.
  7. Recognize case reports, including those written by patients, as a valid and important form of evidence of harms.
  8. Improve baseline and continuing education of all stakeholders, including healthcare professionals, policymakers, and the public.
  9. Recognize the importance of patients and carers, as well as healthcare professionals, in studying all aspects of therapy.
  10. Establish and continuously develop effective communication with patients and other relevant stakeholders about the potential benefits and harms of interventions to improve the basis for shared decision making about treatments.

As we move closer to having a potentially useful vaccine, the issues of transparency and openness with the public become more important. Ensuring that known harms, and benefits, are communicated honestly with the public will be crucial to obtaining public trust. Clearly communicating how safety will be monitored to find any unknown harms, and the reporting lines for suspected adverse effects, will be equally important. The days of telling people something is “safe” is long gone. Such a strategy will merely give those seeking to spread misinformation an opportunity to exploit.

You can read more about this from Uppsala Reports and from the 4Es Website. There is also a podcast from the BMJ, which covers the meeting.

In other news, I will shortly be starting a new twice monthly newsletter on drug safety issues. Many of these will touch on the recommendations from the 4Es forum. You can sign up here.

Photograph: Pharmacy, Trapani, Sicily by Anthony Cox

  1. 4Es Forum: Improving the detection, analysis, and reporting of harms in medicines and devices - statement from the 2019 4Es Forum (Exploring, Enhancing, Empowering in Erice)LINK to PDF 

Recreational running and NSAIDs

July 05, 2020

Paris Marathon

A couple of years ago we published a short paper on the use of Non Steroidal Anti-Inflammatory Drugs (NSAIDs) in runners, cyclists, and triathletes.1 There was high usage of oral NSAIDs (70%), particularly in runners and triathletes.

We have now repeated this in recreational runners who attend ParkrunUK.2 We found 80% of runners used NSAIDs. Runners who participate in longer event were more likely to use NSAIDs during events. You can read more at the open access paper, or in this complimentary piece at The Conversation.

Photograph: Start of the Paris Marathon 2011,  Av. des Champs-Élysées, by Anthony Cox

  1. Rudgard WE, Hirsch CA, Cox AR. Amateur Endurance Athletes’ use of non-steroidal anti-inflammatory drugs: a cross sectional survey. International Journal of Pharmacy Practice. 2019;27:105-107 :https://doi.org/10.1111/ijpp.12469 LINK 

  2. Rosenbloom CJ, Morley FL, Ahmed I, Cox AR. Oral non-steroidal anti-inflammatory drug use in recreational runners participating in Parkrun UK: Prevalence of use and awareness of risk. International Journal of Pharmacy Practice 2020; doi:10.1111/ijpp.12646 

Shifting to online teaching, shouldn't mean being remote

May 04, 2020

Empty Examination desks

Covid-19 brought a hard stop to face-to-face teaching at Universities. The normal interaction between students and academics disappeared over the space of a week, as the black mirror of technology slid between them. Lectures, small group teaching, tutorials, laboratory sessions all gone. The entire University sector pivoted to remote teaching. After the great retreat to the virtual learning environments, the digital refugees looked around with fresh eyes at the tools lying around. What should we do with these?

If my own experience is anything, a great deal of hard work was done at short notice to make the best experience possible for students. However, it is fair to say that skills in teaching online are unevenly distributed across the sector, from Universities to individual lecturer level. Students’ experience, even with the best online materials provided would also have been mixed. Evidence shows that the multitasking digital native (homo zappiëns) is a myth.1

Aside from the more general disruption and anxiety added to our lives these past weeks, for both teachers and learners, this abrupt change in provision of teaching was not easy. Students still value the everyday face-to-face interaction with other students and academic staff. Replicating this for potentially 18 months while social distancing measures are in place will be a key challenge.

Finding new on-line tools for teaching and innovation is the new Pokemon game for academics. I’ve become enamoured with Perusall myself. However, there are dangers in trying to innovate2 in the face of a complete system change. Here are some of the thoughts I’ve been having about online learning during this change.

Make it coherent - Building a coherant course identity is more important than ever. No one wants their course to be “corporate”, but presenting a programme of study that fits together is more important than ever.

Less is more - The temptation to innovate with new tools is huge, but bombarding students with new tools in a random way will not improve the student experience. Use what you have well. Bring in new things in a consistent controlled way using pilots.

Build a community - As well as using our virtual learning environments for teaching and learning, we need to learn how to use them to build a sense of shared community of learning.

Don’t focus on the tool - Tools don’t replace human connection. How do we get through the black mirror to reach someone? How do we dissolve the screen in the higher education context?

Current students have the peer support they have built up over months and years, and established relationships with academics. They have networks. They have trust. This will have to built from scratch in less than ideal circumstance with new students. Remote teaching seems the wrong term.

If we focus being authentic in our interactions and use digital tools with empathy we can improve our chances of making those connections that matter in teaching. We need to be anything but remote.

Photograph: “Empty Desks” by Anthony Cox. Attribution-NoDerivs 2.0 Generic (CC BY-ND 2.0)

  1. Kirschner PA, De Bruyckere P. The myths of the digital native and the multitasker. Teaching and Teacher Education 2017;67:135-145 doi.org/10.1016/j.tate.2017.06.001 

  2. If your definition of innovation includes effectiveness then relax. This is about the pro-innovation bias that occassionally blinds people to potential weaknesses or lack of evidence in their innovation. Witness, the attempt to leverage new forms of social media into teaching with hardly any evidence or thought about downsides (such as the creepy treehouse effect, when teachers try to use the networks students use for friendships for education). I haven’t seen someone attempt to use Tiktok for teaching, but it can’t be far away. It goes without saying, that not all effective ways to teach are innovative. Some things have been around for a long time precisely because they work.