Let’s Do Something

Today’s #Blogtober isn’t about anything that I’m doing with regards to academic life; it’s more important than that. I got back from Birmingham today and I’ve just caught up with freelance projects, still got a new pin to design for a Science On A Postcard client, but I’m sat in my office with the snuggliest of jumpers, the most delicious smelling candle I’ve ever known, and a huge mug of tea – it’s not all bad.

I had fully intended on giving today’s blog post a miss because I just have too much other stuff to do, but instead I’m posting something super quickly that I hope can make a difference to some.

This afternoon my local foodbank posted this on Facebook:

Just take a minute to think about that, every single day in a city with a population of 228,800 residents, 170 people are going to one foodbank – I’m not sure exactly how many foodbanks there are across the city, I know of at least 5. The shelves at CFINE are just about empty, and they are seriously struggling to meet demand.

Image may contain: indoor
People within our communities are hungry. If you can afford to donate something – whether it’s cash, a few tins of soup or a tube of toothpaste, please, please do.
I’ve just donated some money to CFINE, if you have a few pounds to spare I urge you to do the same. Not sure where to start? Find your local foodbank here.
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Prioritising the Research Agenda for Trial Retention – Birmingham, 23rd October 2018

I’ve been in Birmingham today for the final consensus meeting of the PRioRiTy II project, so I thought I’d write a quick blog post before dinner so that you can find out a bit more about the process of research prioritisation.

Image credit: Prof Shaun Treweek

I’ve spoken on this blog before about the first PRioRiTy project, which was a prioritisation of questions around trial recruitment. That project took the same shape, though I’ve been more heavily involved in PRioRiTy II because it’s led by Dr Katie Gillies, who was one of my PhD supervisors; she’s now one of my line managers and she’s fantastic to work with. Katie was a participant in the consensus meeting for PRioRiTy, and as soon as she came back from that meeting (almost 2 years ago!), she set to work on PRioRiTy II – she moves fast because she is a complete trial methods nerd, just like me (I’ve found my people!).

So, I said she moves fast, but you might ask why it’s taken 2 years to get here. As with anything in research the process is not as simple as it looks. This prioritisation exercise was not simply a group of people getting together in a room today and deciding what we thought was most important; the process has involved many, many more people than just those in the room, and is based on the method that the James Lind Alliance (JLA) use for priority setting partnerships. The JLA method is designed to take into account the views and opinions of all stakeholders that have an interest in a specific research area. For us, that meant: trialists, methodologists, ethics committee members, researchers, patients, funders, clinicians and more, but the JLA method has been used for lots of prioritisation activities and the people involved are tailored each time to fit with the aims of the project.

We had a wonderful graphic illustrator with us today, and she captured the ‘story so far’ brilliantly in the image below. Before today we had a survey, followed by a huge amount of data analysis and question searching within the responses from that initial survey, an interim prioritisation process (some of you might have been involved with this because I posted about it here), and then came this face to face consensus meeting – so today was the culmination of a lot of views, opinions, time and effort.

A snapshot of a graphic illustration from the PRioRiTy II consensus meeting showing the story so far.

Below are a few photographs from the day – lots of serious faces, extensive discussion, and some compromises needing to be made too.

The kick off – Katherine Cowan (Senior Advisor to the JLA) did an excellent job chairing the workshop, keeping us all to time and making sure that everyone’s voice was heard within the discussions.

Image credit: Prof Shaun Treweek

In the first session of group work attendees shared their 3 most and 3 least important questions from the list of 21 that we had supplied them with in advance. From the initial survey responses we had 27 questions, which were then narrowed down to 21 questions during the interim prioritisation.

The second session of group work saw the beginning of the ranking process! Coloured tablecloths were used to distinguish questions that were most important (green), least important (red), and somewhere in the middle (yellow). This allowed participants to discuss the ranking of their group as a whole (i.e. based on the feedback from the first group session), and then physically move the questions into a more defined ranking position after discussion.

The final session – questions were laid on the floor so that the entire group could see the ranking. Katherine then went through each question in turn to ensure that the group could reach a consensus; harder than you might think!

Image credit: Trial Forge

We won’t be sharing the top 10 questions around trial retention just yet though; tomorrow we have our final Steering Group meeting (let me know if you’d like to see a blog post about what a Steering Group does within a research project!) where we will go through the top 20 questions and make sure that all the wording is clear.

We then plan on unveiling the top 10 at the Society of Clinical Trials meeting in New Orleans next May. If you’ve been reading the blog for a while you might remember that I went to the Society for Clinical Trials meeting earlier this year when it was in Portland. It’s a brilliant conference that enables trialists from around the world to meet each year to share their work. After that we also plan to do some more conference dissemination at the International Clinical Trials Methodology conference, which takes place in Brighton next October. Keep an eye out for future blog posts too – I’ll be posting the final top 10 when they’re released!

Image credit: Prof Jane Daniels

Monday Media: Episode 2, 22nd October 2018

Last week’s Media Monday blog post seemed to go down pretty well, so I’m bringing it back today. As I said last week, it might not turn out to be a weekly occurrence; selfishly though, I think it’s a good post for me to write – it forces me to take a step away from my own research and read about what others are doing.

Letter: Comprehensive literature search for animal studies may have saved STRIDER trial

This is an important letter, and one that I wish had seen earlier – it was published last week and usually I see BMJ opinion pieces doing the rounds on Twitter, but this didn’t crop up.

The letter discusses the recent announcement that the STRIDER (sildenafil therapy in dismal prognosis early onset fetal growth restriction) trial has been halted after 11 babies died. An interim review of the trial data showed that lung complications were more common in the babies born to women assigned to take sildenafil (also known as viagra) than those that were assigned to the placebo. The main focus of this piece is not the early closure of the STRIDER trial, but the fact that the trial ever went ahead in the first place. The authors, Prof Michael Symonds and Prof Helen Budge, argue that a more comprehensive literature search during the trial planning stages could have prevented the infant deaths. One study that was published in 2009 demonstrated ‘adverse effects of sildenafil including hypotension, reduced fetal oxygen supply, and further fetal growth reduction. It concluded that sildenafil “should be used with caution in [intrauterine growth retardation] because of its detrimental effects on uteroplacental perfusion and on the fetus.”‘ Why that study was omitted in the rationale for the STRIDER trial is unclear; this reinforces the need for up to date, comprehensive systematic reviews to be conducted before a trial begins.

This response to the letter makes some important points too: Isn’t it the right time for librarians to officially join clinical trial teams?

Publishing:  BioMed Central journals launch new pre-print platform

BioMed Central has launched a pilot pre-print platform that gives researchers the option to share their work in a citeable way at the point of manuscript submission. The peer review process will still go ahead as normal, but the manuscript will be publicly accessible for those submitting to BMC Anesthesiology, BMC Neurology, BMC Opthalmology and Trials. If the manuscript is ultimately rejected, all information corresponding to the journal will be removed, but the article itself will remade available online along with any revisions that have been submitted too. Personally I think this is a fantastic step forward in the world of publishing, and I am glad to see efforts being made to reduce the time between manuscript submission and dissemination. Find out more about In Review, here.

In a blog post later this week I will be doing a ‘publication explainer’ for a manuscript that we’ve just submitted to Trials, which is now available on the In Review platform, so I’ll talk a bit more about it then.

Opinion: How one pharmaceutical company is reinventing the clinical trial
Janssen Logo. (PRNewsFoto/Janssen Research & Development, LLC)

This piece is written by Andreas Koester, MD; the Vice President and Global Head of Janssen Clinical Innovation. The company that the title is referring to is Janssen Clinical Innovation, which is part of Janssen Research & Development LLC, and therefore the information held within it should be read with that in mind.

This article was published in STAT News in September, but I’ve only just seen it now and thought it worth drawing attention to. The piece rightly highlights how common issues with participant recruitment to clinical trials are, as well as the problem of ensu

ring that those participants remain in the trial right to the end. It then goes on to describe several projects that Janssen Clinical Innovation are running, that all aim to improve trial design in some way. Described in the main body of the article are three projects;

  1. The mHealth Screening to Prevent Strokes study – a collaboration between Janssen, Scripps Translational Science Institute, Aetna, and iRhythm Technologies, that aims to ‘bring the trial to the patient’ by incorporating wearable devices for data collection.
  2. The Global Trial Community – an initiative that allows patients to have access to some of their data during trials in a way that does not compromise the integrity of the research. This aims to ’empower patients by giving them what they want: their health data’.
  3. The Integrated Smart Trial & Engagement Platform – a digital technology platform that works to combat many of the administrative and logistical challenges that are common within the lifetime of clinical trials. The platform, called iSTEP for short, uses scanners to track when medication kits arrive and are returned, sends patients customised information like dosing instructions and tutorial videos, and includes electronic drug labels that are tailored to the patient’s preferred language. The aim of the platform is to ‘use technology to enable more efficient clinical trials’.

Now, I’m the type of person that wants evidence of the difference that these new initiatives and platforms make – it could be that Janssen is spending huge amounts of money implementing all of these changes, but participant recruitment and retention is still not improving. That said, Janssen are a huge pharmaceutical company with funding behind them that allows this sort of ‘try it and see’ approach; in the academic world that would never work, we don’t have the resources for it. I’ll be watching these developments closely over the coming years, hopefully they will be rigorously evaluated at some point!

Inspiring People: Wendy Mitchell

Another post late in the day… this Blogtober thing is no joke! I feel like I’ve been busy all day, and yet it’s currently 9.45pm and I’m only just getting to writing today’s post.. Anyway, it’s been over a week since I’ve written an ‘Inspiring People’ post, and today is the turn of Wendy Mitchell.
Wendy was diagnosed with young onset dementia in 2014 at the age of 58, and after being shocked at the lack of awareness of the condition, she set up her blog; Which me am I today?

Picture: Lorne Campbell / Guzelian
Wendy Mitchell of York, North Yorkshire, who was diagnosed with early onset Alzheimer’s at the aged of 58. She is pictured with her daughters Gemma (left) and Sarah.
Why does Wendy Mitchell inspire me?

After Wendy was diagnosed with dementia, she was forced to retire early from her job as a non-clinical team leader in the NHS; people didn’t know what to say or how to modify her role so that she could continue to work – even those that had extensive clinical experience (she worked in the NHS for goodness sake!). That in itself is both shocking and upsetting, and I say that as someone who has limited experience with dementia. Older members of my family have had it, but I’ve never been a carer for someone with the disease, and I’ve been distanced from those individuals by physical location rather than emotion. It’s difficult to say what you’d do if you were diagnosed with dementia; surely no one really knows until it happens to them. That said, I don’t think I’d deal with it very well. Honestly I can only just visualise myself doing everything that Wendy does now, as a healthy 26 year old, but I can’t imagine deciding to start a blog, contributing to support groups, travelling around the country to be involved with research projects, and giving talks to student nurses having been diagnosed with dementia.

I read and reviewed Wendy’s book, Somebody I Used To Know, in March this year, and her work continues to inspire people as she spreads knowledge and awareness of life with dementia; last month Wendy’s words featured in The New York Times, yes, the actual New York Times.

One day I would love to write a book, and I would be stunned if I was ever able to write for The New York Times; but Wendy demonstrates that these things are possible. She raised her two daughters, she had a brilliant job within the UK’s health service, and then life threw her a curve ball. Instead of collapsing and admitting defeat, Wendy make a new career for herself. She is an author, a public speaker, an ambassador for the Alzheimer’s Society, and an active research partner. She has found her own way through Alzheimer’s disease, compiling her own tips and tricks to help her live with the condition in an independent and comfortable way. She shares these tips so that others can continue to maintain their independence too – see the video below that she filmed for the Alzheimer’s Society.

Find out more

If you’d like to find out more about what Wendy is up to, I would recommend that you follow her blog and Twitter page. I’d also recommend reading her book, which you can get here (it’s currently reduced to £11.49 so grab it whilst you can!).

Other articles I’d recommend reading:

Wendy Mitchell’s 5 tips for supporting somebody with dementia
I had Alzheimer’s. But I wasn’t ready to retire. (The New York Times article that I mentioned earlier)
I have dementia and I take part in research: Here’s why
Dear Diary, I know I can live well with dementia
Dear Diary, I want to talk about public perception of dementia
Don’t call us sufferers – it makes us lose all hope

The Phrase “I’m Not a Scientist” and Why You Might Be Wrong

The phrase ‘I’m not a Scientist’ has made its way into the vernacular of politicians, particularly those that are members of the Republican party in the US. When asked about climate change or the age of the Earth, politicians such as John Boehner, Rick Scott, Marco Rubio, Bobby Jindal, and Mitch McConnell, have all used their perceived lack of scientific professional background as a way to wriggle out of questions that they don’t want to answer.

The phrase was singled out by Barack Obama during his 2015 State of the Union address, saying:
“I’ve heard some folks try to dodge the evidence [of global climate change] by saying they’re not scientists; that we don’t have enough information to act. Well, I’m not a scientist, either. But you know what, I know a lot of really good scientists at NASA, and at NOAA, and at our major universities. And the best scientists in the world are all telling us that our activities are changing the climate, and if we don’t act forcefully, we’ll continue to see rising oceans, longer, hotter heat waves, dangerous droughts and floods, and massive disruptions that can trigger greater migration and conflict and hunger around the globe.”

Whilst I agree with Obama that we need to be listening to scientists that have weighed up the evidence on subjects like climate change, I don’t agree with his immediate dismissal of him being a scientist.

This phrase ‘I’m not a scientist’ cropped up much closer to home whilst I was at Peterborough STEM Festival last weekend. As people were looking through the item’s I’d taken with me for the Science On A Postcard stall, people were looking for pin badges that they felt described them or their future goals. A young boy of around 6 asked his Dad to buy him an ‘Engineer’ pin as he told me in intricate detail how a steam engine worked, and a young girl of around 8 used her pocket money to buy herself a ‘Science Communicator’ pin because she liked talking to her Grandparents about science and by her rationale that meant that she was a science communicator. As well as making my heart do warm fuzzy feelings, these interactions made me realise just how open children are – the contrast was stark when compared with the children’s parents who were saying things like, ‘Oh there isn’t one for me, I’m not a scientist’. These were parents that were clearly engaged with science in some way; they were at an event held in a conference centre on the outskirts of Peterborough on a Saturday morning. Whether that was because their children wanted to be there, they wanted their children to be there, or if they actually wanted to learn something themselves; there was clearly an interest in science there.

Whist lots of people are not scientists by trade, I would argue that everyone is a scientist in some way. Science is a mindset, a way of thinking, rather than simply a job title.

If you type ‘what is science?’ into Google, you get about 2,750,000,000 results. Now, I haven’t been through every single one of these results for obvious reasons, but after clicking my way through the first few pages it’s pretty clear that there isn’t one definition that the world has reached consensus on. The UK’s Science Council define science as “the pursuit and application of knowledge and understanding of the natural and social world following a systematic methodology based on evidence.” In reality, the word science comes from the Latin ‘scientia’, simply meaning ‘knowledge’. To me, that means that if you are interested in expanding your knowledge, then you are a scientist. Whether that’s asking why your voice sounds different in your own head than it does on a recording, wondering how your car manages to run out of anti-freeze on the first day that it snows out of the entire year, or pondering why you can never find the end of a rainbow.
You might choose to focus your questions on society and how humans interact – in which case you’re a social scientist, maybe you’re more into figuring out why every house plant you own dies despite your best efforts – you’re a botanist or plant scientist, perhaps you’re like me and you want to know how people make decisions about taking part in trials and why they do or don’t stay in them – you’re a trials methodologist.

If you’ve ever asked a question, you’re a scientist, and the incessant use of the phrase ‘I’m not a scientist’ achieves nothing other than to give politicians a get out when they’re asked to give answers that may split their potential supporters.

Publication Explainer: Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

This is the third in my ‘Publication Explainer’ series, read the first and second here and here. As I have said previously, these explainers are a place for me to answer some of the most common questions I’ve been asked by the people around me (usually my boyfriend, friends, or colleagues that haven’t been involved with the project).

This post focusses on the paper below: Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)? Read the full paper here.

What is a SWAT?

A SWAT is a Study Within A Trial – i.e. a self-contained research study that is taking place within a clinical trial. Usually SWATs focus on a methodological aspect of a trial, e.g. evaluation of: an intervention that is designed to improve the recruitment of participants to trials; an intervention that is designed to keep participants engaged with the trial (i.e. retention of participants); or an intervention that is designed to find out more about the way that data is collected (e.g. online versus paper). Often

Why are you trying to encourage people to do SWATs?

It is important that we encourage people to do SWATs because they are so often underpowered. Statisticians can calculate the sample size needed for the results to enable us to see a difference between the two interventions; if we hit that target sample size (i.e. recruit enough participants) then the result is less likely to be down to pure chance. As sample size calculations are done for the host trial, and not the SWAT, it’s likely that the SWAT will be ‘underpowered’ – meaning that the effect that we see in the results may not be a real effect; it could be down to chance. That’s ok though, because SWATs are designed to enable the data from them to be pooled with the same SWATs that have been done in other host studies.

What are you aiming to do in this paper?

This paper is the result of a huge amount of discussion, much of which started at a face to face event that was held in Aberdeen last year, the group of authors on this papers is pretty big, and that reflects everyone that took part in that event and the discussions that came after it. As a group, we are very conscious that SWATs are one of the most obvious (and arguably, easiest) ways for us to improve the way that trials are designed and conducted; so it’s important that we encourage people to do them. It is not realistic to think that trial methodologists can do all of the SWATs that we need; there just isn’t enough of us, and we need trialists to help us. By writing and publishing this piece of guidance, we aimed to produce a one-stop paper where people could go to find out what a SWAT is easily.

Within the last few days, we’ve submitted ‘Trial Forge Guidance 2: How to decide if a further Study Within A Trial (SWAT) is needed’ to the same journal, Trials. Trials journal is currently taking part in a pilot along with a number of other journals that fall under the BioMed Central umbrella, when authors submit their papers for publication they have the option of publishing a pre-print of their work. This pre-print edition is published online within about a week, meaning that the peer review process can run along side, but the research is being disseminated more more quickly. Once that pre-print is available, I’ll share it on the blog so you can read that too 🙂

Knowing When to Take a Break

If you’ve been following my Blogtober posts, you might have noticed that I missed a day yesterday. I just did not have the time to get a blog post written and uploaded.
I had planned to do it on Tuesday night, but I ended up getting caught up with some freelance work and then packaging and sorting my shop orders took way longer than I thought it would. Yesterday just seemed to go by in a blur; in the morning I was doing a viva for an MSci student that I’ve been supervising whilst she’s been away on placement all year. After that I had a Mandarin Chinese lesson (I’ll talk more about this in another blog post – it’s so much fun!), and then by the time I got back to my desk, sorted out my inbox, and did the urgent things on my to do list it was almost 6pm and my tummy was doing the ‘leave work now and feed me’ grumbles. Predictably, last night also went at super speed and before I knew it it was 11pm.

I had thought of staying up and working on getting a blog post up before midnight because the thought of missing 1 day in the middle of the month was driving me mad, but after more than 30 seconds’ thought and a yawn that was so big it probably could have broken my jaw, I decided against it.

Today has also gone by in a blur, so I’m here after 6pm thinking ‘oh crap, what do I blog about today?’ – and I think that in itself is interesting. I blog to share my research, to draw attention to subjects that I care about, and to try to encourage people to engage with health services research. If I’m exhausted and pushed for time, it’s very unlikely that I’ll achieve any of those things; knowing when to take a break is important.

So, with that in mind, I am going to take tonight easy. I am going to read my book (I’m currently reading Ghost Wall by Sarah Moss and really enjoying it so far), I might write a blog post later on, and I’m going to get an early night.

I’ll be back tomorrow with a blog post that I haven’t felt pressured or felt rushed to write. I’m planning on doing a ‘publication explainer’ post talking about embedded studies, what they are and why we need more of them.

Have a lovely evening 🙂