OpenPrescribing and DataLab Papers
It has been a busy month for paper publication at The DataLab. We have written a brief description of the most recent papers below. Please sharewith colleagues and [get in touch(mailto:[email protected])if you have any relevant observations! Remember you can read all our academic papers related to OpenPrescribing on our research page.
Methotrexate Prescribing Safety – New paper in BJGP
This week the British Journal of General Practice published our latest paper on unsafe prescribing of methotrexate. We found that the prevalence of unsafe methotrexate prescribing (10mg tablets) has reduced but remains common, with substantial variation between practices and CCGs. In the paper we also discuss recommendations for better strategies around implementation.
OpenSAFELY is a new secure analytics platform for electronic health records in the NHS, created to deliver urgent results during the global COVID-19 emergency. OpenSAFELY is a collaboration between the DataLab, the EHR group at London School of Hygiene and Tropical Medicine and TPP who produce SystmOne. OpenSAFELY is now successfully delivering analyses across more than 24 million patients’ full pseudonymised primary care NHS records. The first analysis from OpenSAFELY is Factors associated with COVID-19-related hospital death in the linked electronic health records of 17 million adult NHS patients with more answers to important questions expected shortly.
Most people share their end of year roundup during late December when everyone is too full of cake to read. Now you’re back in the saddle, here’s our roundup of everything the DataLab threw out into the world over the previous 12 months!
OpenPrescribing.net went from strength to strength, with over 135,000 unique users last year. We now have over 80 measures of prescribing safety, efficacy and cost-effectiveness and have been working on new types of measures and alerts to identify “outlier” prescribing, such as with zuclopenthixol. In 2019 we also: launched new dashboards and bespoke alerts for every single primary care network (PCN), sustainability and transformation partnership (STP), and NHS region; upgraded the Analyse page to support more organisations with bespoke medicines queries; and developed tools to help solve the problem of Ghost Branded Generics which cost the NHS an extra £11.6million per annum but has massively reduced during 2019.
PCN Dashboards Now Live!
We have now launched our long-awaited Primary Care Networks (PCNs) dashboard, made possible thanks to the the membership list being published by NHS England last week.
We have PCN prescribing dashboards for every single NHS PCN and their member general practices. (Don’t know your PCN’s name? You can find it on your practice dashboard). This allows anyone to explore NHS prescribing patterns in their PCN and how this compares to others across England – supporting safer, more efficient prescribing.
Last week, the Commons Science and Technology Select Committee convened an inquiry following-up their previous clinical trials transparency efforts. The Select Committee has been very active in the trials transparency space over the past two years. Earlier this year they sent letters to every public university and NHS trust in the UK that sponsors clinical trials on the EU register. These letters reminded sponsors of their trial reporting responsibilities and provided them with reporting performance figures based on data from our EU TrialsTracker.
New Paper in BMJ
Our newest paper is now out in the BMJ! Here we show huge variation in adoption of warranted changes in prescribing behaviour, using some exciting new openly available change detection methods.
We now have over 80 measures!
This month we have launched a range of new measures. As always, measures are prioritised on your dashboard by potential for improvement so you can quickly and easily spot where your organisation is an outlier. You can also sort by potential savings or group measures by clinical condition.
New Feature! Measures linked to Analyse page
Following many requests from users, we have created links from our measures to the corresponding search on the Analyse page. This is particularly useful if you want to see multiple practices or CCGs on one chart, view the results on a map, or see exactly which products are included in the measure.
You will notice this is not yet available for all of our measures (which now number close to 100), due to the complex way some measures are constructed. This currently affects just 12 of our standard measures and 4 of the Low-Priority prescribing measures, and we hope to keep increasing the options in the coming months.
New Feature! DM+D browser
This week we have launched a new browser for the NHS Dictionary of Medicines and Devices, better known as dm+d. dm+d is the standard dictionary for the medicines and devices used across the NHS. At last count there were over 150,000 packs of medicines and devices described. You can read more about the dm+d in this detailed blog.
Earlier this year we noticed a disturbing trend among UK trials registered on the EUCTR. The amount of newly approved and registered trials on the EUCTR dropped drastically following the 2016 Brexit vote. The chart from that blog post (from May 2019) is included below.
When we reached out to the MHRA to ask about this, they stated that there was actually no decline in UK trials post-Brexit but rather administrative delays that kept trials from appearing on the public-facing EUCTR website. They noted this issue was being addressed and updates would be completed by the end of Q2 2019.
New low-priority measures approved
Yesterday (27 June), NHS England completed its consultation on an additional proposed set of products being considered for a recommendation against regular use in primary care. Therefore, on the site we have now included these new items in the set of low-priority measures. The newly added products include bath and shower emollients, higher cost insulin pen needles and dronedarone. See how your practice or CCG is performing on these measures here, or navigate to the Low Priority measures from your favourite organisation’s dashboard.
Varied implementation of UTI prescribing guidelines
One of our recent papers, published in the Journal of Antimicrobial Chemotherapy, highlighted variability in the speed at which different CCGs switched from prescribing trimethoprim to nitrofurantoin (as recommended by PHE for uncomplicated UTI).
It appears that the practices which changed the most were in CCGs that had taken some action to promote the new guidelines, such as a change in formulary. What are the implications? Read more on this in our blog and you can of course see any region’s performance on this measure on OpenPrescribing.
We recently noticed a very dramatic drop in the number of UK clinical trials post-Brexit on the EU Clinical Trials Register (which would be a catastrophe for British science) and wrote to MHRA to get their view. It turns out that the drop is largely due to bad data management: this is worrying, but not the same thing as a drop in the number of UK clinical trials.
The Short Story
We’ve been conducting research on trends in clinical trials globally with one very striking recent finding: examining clinical trials on medicinal products, using the EU Clinical Trials Register (EUCTR), the number of trials with a competent authority decision from the UK has fallen dramatically. As you can see on the graph below: from a long-term trend of around 150 new trials per quarter, after 2016 there is a rapid drop to fewer than 50, and now fewer than 10.
It’s been a busy start to the year for the FDAAA TrialsTracker! As the FDAAA TrialsTracker celebrates its 1 year anniversary, we now show over 1000 trials currently overdue to report under the FDA Amendments Act of 2007 (some background on our tracker and the FDAAA 2007 here). Additionally, we estimate that the FDA could have collected over $2 billion in fines if they were enforcing these requirements. To date, we have no evidence they have issued even a single dollar in fines. But along with the bad comes the good. Over the past year we’ve also heard from many trial sponsors and other organisations and individuals who are using our TrialsTrackers to ensure trials are reported on time and in accordance with the law.
As you know, here at the DataLab we are working on the RetractoBot project to reduce the number of cited retracted papers.
Citations of retracted RCTs are particularly dangerous because such trials provide strong and unbiased evidence of treatment’s safety and efficacy (hierarchy of evidence). Moreover, results of RCTs are often pooled in systematic reviews and meta-analyses, which are used to synthesise the available evidence on a given subject or to justify clinical guidelines.
Nearly all trials of medicinal products conducted in Europe since 2004 are required to post their results directly onto the EU trials register within one year of completion. Since September, our EU TrialsTracker has monitored all clinical trials in the EU to check whether they are compliant. Recently we produced a specific report on data on trial reporting at UK Universities: the House of Commons Science and Technology Committee is currently using this data to alert Universities and monitor their current reporting performance.
Our EU TrialsTracker has been live for 4 months providing data on who is and isn’t meeting EU trial reporting guidelines. The tracker reached a major milestone last week when our data was used by the House of Commons Science and Technology Committee to inform UK Universities of their current reporting performance and remind them of their ethical and legal obligations to report their sponsored trials.
Following-up on the October 2018 report on clinical trials transparency, the chair of the House of Commons Science and Technology Committee, Norman Lamb MP, has sent letters to 41 universities with trials registered on the EU Clinical Trials Register (EUCTR).
Our EU TrialsTracker has now been live for four months. As of 10 January 2019, we have identified 8,062 trials registered in Europe that are unambiguously due to report results under EU guidelines; a total of 4,323 (53.6%) trials have reported results to the registry. We have also seen some institutions – for example Kings College London – improve their trial reporting performance dramatically and rapidly.
In our third full year of existence we produced even more exciting outputs and continued to grow. We welcomed Lydia Berry, back from maternity leave; Dave Evans, Consultant Programmer, who joined the OpenPrescribing technical team; and Brian MacKenna, an Honorary Research Fellow Pharmacist and member of the NHS England Medicines and Diagnostics Policy Unit. We also welcomed Darren Smyth, a UK and European Patent Attorney – our work so far includes our pregabalin papers (here and here), and he has also contributed to our EUCTR work.
Earlier this week, the Media, Freedom & Information Access Clinic at Yale Law School filed a lawsuit against the heads of the Department of Health and Human Services, the NIH, and the FDA over their interpretation and implementation of trial reporting provisions in the FDA Amendments Act of 2007 (FDAAA 2007). The lawsuit was filed on behalf of Charles Seife, a journalist and NYU professor, and Dr. Peter Lurie, President of the Center for Science in the Public Interest.
New “do not prescribe” measures on OpenPrescribing.net
At OpenPrescribing we pride ourselves on developing our tools in response to the needs of our users. Last week NHS England announced a new “Do Not Prescribe” list for consultation. Within an hour we made graphs showing every GP practice’s prescribing of these items. You can drill down to CCG level, and then practice level.
All England Dashboard - A New Feature on OpenPrescribing.net
At OpenPrescribing we pride ourselves on developing our tools in response to the needs of our users. OpenPrescribing is being increasingly used at national organisations and we have had many requests for an All England dashboard. This month we launched the first version of the All England dashboard and blogged about it here.
The EU TrialsTracker, which provides the results reporting status of every trial on the EU Clinical Trials Registry, launched last week alongside a paper in the BMJ. We already shared some of the media coverage from the launch of the tracker and comments from Norman Lamb MP, Chair of the House of Commons Science and Technology Committee and Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance and Committees at EMA.
Earlier this year we launched our FDAAA TrialsTracker, providing a live look at whether individual sponsors and trialists are meeting their responsibility to report the results of clinical trials on ClinicalTrials.gov. Now we have launched the EU TrialsTracker. This new tracker shows the results status for every trial on the EU Clinical Trials Registry (EUCTR). We are launching the tracker alongside a paper in the BMJ providing a detailed overview of our methods, an analysis of the factors associated with non-reporting and a discussion of the data issues that make assessing compliance difficult on EUCTR.
Now that we’ve launched our FDAAA TrialsTracker, we plan on occasionally taking a closer look at some of the trials that go unreported. Our first blog was about a trial examining 2 drug combinations for managing pain during labor (NCT01846221).
So why do we think this specific trial is due to report? While we go through how we established our criteria and set up our database in detail in our preprint paper on Biorxiv, we wanted to walk you through exactly what fields matter on ClinicalTrials.gov and how we used them to build our tracker. We think we were able to do this well, but are open to feedback and will amend our paper and methods as necessary.
When you produce online tools from data, you often get useful feedback that helps you improve the outputs. (Send us feedback any time!). Additionally, when you use data, you learn about interesting glitches in it, some of which can be entirely undocumented. Here we share one example of helpful feedback, and how we used it to improve our tool.
First some background. Trial reporting is a huge problem in medicine: the results of clinical trials are routinely withheld from doctors, researchers, and patients. We think all trials should be reported. The WHO agrees. A US law called the FDA Amendments Act requires some trials to report their results on ClinicalTrials.gov: this law has many loopholes, but it’s an important start. Since the results reporting requirements of FDAAA came into full force, our FDAAA TrialsTracker has been identifying the individual trials that have breached it. You can read our paper on how the tool works: we also blogged about our methods for identifying overdue trials. Staff in universities who manage trial reporting are already telling us that they find our tool useful.