We are looking for feedback on the #NIHRoktoask campaign from patients, researchers, everyone…. Please help and RT.

We are the only country which runs a public awareness campaign across our national health system to encourage people to participate in clinical research – NIHR ‘OK to ask’.  We’ve been doing it for three years on the trot to coincide with International Clinical Trials Day (ICTD) in May.  Now we want your views on how this year’s campaign went and what we should do next.

It doesn’t matter if you are a local organiser for the ‘OK to ask’ campaign, a patient or carer who took part in an event, a researcher or clinician who helped out.  We want to hear from you. And if you need a little reminder of what happened here’s a ‘storify’ of the year’s events.

But even if you have never heard of the National Institute for Health Research (NIHR) (let alone ‘OK to ask’) before, we’d still like to get your views.  For what you tell us will be used to:

  • produce a report about the ‘OK to ask’ campaign in 2015 this year which will be made publicly available on NIHR’s website and through our networks.
  • think about and plan our public awareness work about research for the future.

You can complete the online survey by clicking on the link here.

And there’re plenty of time to also send on to your friends and colleagues because the survey is open until Friday 11th September 2015 to respond.

Thanks in advance for your help.

Best wishes as ever,

Simon Denegri
NIHR National Director for Patients and the Public in Research
Simon.Denegri@nihr.ac.uk

A word in your ear about organ donation

A word in your ear….

Worrying news indeed from the NHS Blood and Transplant authority. Yesterday they reported the first fall in a decade in the number of people donating organs after death. Also, a decline in the number of live organ donors.

Wales is about to change its rules from December 2015 to one where everybody is presumed to have given their consent to organ donation while giving them the right to opt-out.

Doctors there hope that it will solve the perennial issue of not having enough donors to match those needing a transplant. 1200 people died in the UK last year while waiting for an organ donation. Many charities including the British Heart Foundation support the move.

Altruism is a fragile tenet of our society at the best of times. For most of my adult life it seems to have come under sustained attack from all directions – political, economic, social. It has just about held its own in health care. But even here it now seems under constant threat.

However, in few areas other than organ donation is the impact of self-interest – well intentioned and deeply held though it may be – so immediate and profound for the life and wellbeing of another. To those people on waiting lists it must seem perverse that in over 100 cases the wishes of the deceased to donate their organs were overridden by their families.

I hope that the NHS Blood and Transplant Authority figures are just a blip. Greater public awareness, professional training and the like will all help. Yet voluntarism in itself is a shaky foundation for altruism. Codification, ground rules have an important part to play.

A move towards presumed consent for organ donation across the UK can not come too soon. Sadly, for some, it is already too late.

Please sign up to become an organ donor:
https://www.organdonation.nhs.uk/about-donation/

Good manners in research #researchetiquette

They say good manners can take you a long way in life. My first Chair at the Association of Medical Research Charities (AMRC), the wonderful Dame Bridget Ogilvie, used to swear by them (that doesn’t sound quite right doesn’t it?). She taught me how important they can be in bringing people with you – even your stoutest opponents. How effective they can be in confronting the poor behaviours of others. Indeed, I often think they are one of the most under-rated transferable skills that we should be teaching young people when they enter the workforce.

This time last week I took part in the annual summer training camp that the National Institute for Health Research (NIHR) runs for its trainees – post doctorate researchers. The theme of this year’s camp was communications. I had to deliver masterclass on ‘developing a good communications plan.’

The time-pressed researcher must wonder if there can be any more they can fit into their day such are the demands on them. As one cheeky young wag tweeted after my session ‘now we have to tweet and blog and go on speaking tours.’

Well, um, yes I do actually. Good communication is fundamental to excellent research. And isn’t it true in research as in many other aspects of life that when issues or problems arise, poor
communications is not far away?

Communications need not be as labour intensive as we think. Sometimes it’s purely a case of good etiquette. This was brought home to at a couple of recent dementia events. The first hosted by the award winning Lancashire NHS Foundation Trust Dementia Nurses Team. The second, a regular meeting of the Lay Champions Group that has helped develop the Join Dementia Research register.

At both these meetings, people with dementia and their carers talked about the things that can be dispiriting and sometimes downright rude from a research volunteer’s perspective. For me they all come down to good manners.

Researchers not responding to people who express an interest in participating in their study. Poor communication during research with long gaps where people hear nothing (or not being told this will be the case for good reasons). Not responding to emails or questions. Not being able to put a face to a name. Not being thanked. Never hearing what happened with the research. Not recognising that participants are also patients who will need encouragement and motivation sometimes to stay with a trial. Lack of basic information being provided. Email addresses that don’t work, phones that don’t get answered.

Our researchers and their colleagues should also have the right to expect to be able to do their job and be treated with courtesy and respect by patients, carers and families. To be thanked. For the difficulty of their task to be acknowledged in the level of our own commitment and responsiveness to being a participant.

There is no doubt that surveys by the UK Clinical Research Facilities (UKCRF) network as well as many others have shown that most people’s experience of being in research is a good one. But we should always be looking to improve and there seems enormous scope to get these simple things right.

The Health Research Authority (HRA) is currently taking forward work on the next version of the Research Governance Framework – the ‘how to’ bible for research and researchers. A public consultation is due later this year. Perhaps there should be a section on research etiquette?

Have a good weekend and remember…..mind your manners.

Public get new tool to report problems with medicines @MHRAgovuk #medicineuse #adversereactions

Last year the Yellow Card Scheme by which health professionals and patients can report problems with their medicines celebrated its 50th Anniversary.  A conference organised by the regulator which runs the scheme – the Medicines and Healthcare Products Regulatory Agency (MHRA) – was one of the highlights of my year.  Not so much for what it told us about the present-day.  But for what it told us about new ways in which we might be able to work with patients and the public in the future to highlight problems with their medicines.

Now, one of the new tools previewed at that conference, has had its public launch.  The Yellow Card ‘app’ can be used by people on their phone or ipad to report side effects of medicines or review information published by MHRA on medicines.   You can download the app from the iTunesiTunes App Store App Store and Google Play for your IOS or Android device.

The Yellow Card Scheme is a great innovation.  Raising awareness of its existence and encouraging people to use it has been a perennial issue. Providing people with new ways to access it won’t solve the problem in itself but will undoubtedly help in this digital age.

The full news release from MHRA is worh publishing in full in my view because it gives a bit of history to the Yellow Card Scheme but, more importantly, details the key features on the new app.

I should add that I am a member of the General Advisory Board of the WEB-RADR project mentioned below.

A Yellow Card smartphone app has been launched today for people to report problems with medicines.

Yellow Card smartphone app on ipad

It’s a system borne from one of the biggest healthcare scandals of our time to protect public health.

Fifty years on from its inception, the Yellow Card Scheme is moving into the digital age through a free-access mobile app that was launched today (14 July) by Life Sciences Minister, Mr George Freeman MP.
The Yellow Card Scheme was introduced by Sir Derrick Dunlop, Chair of the Committee on the Safety of Drugs, in the wake of the Thalidomide disaster in 1964. The aim was to monitor the safety of UK medicines and act as an early warning system to identify potential side-effects and adverse reactions.
The Medicines and Healthcare products Regulatory Agency (MHRA), which runs the scheme, collates and reviews reports of suspected adverse drug reactions on all licensed and unlicensed medicines and vaccines.  It includes those issued on prescription as well as those bought over the counter from a pharmacist or supermarket.

Yellow Cards are used alongside other scientific safety information to help MHRA make changes, if necessary, to the warnings given to people taking a medicine or vaccine, or to the way they are used, to minimise potential risks.
The new Yellow Card smartphone app supplements an existing one-stop website and is the only app that allows patients, carers and healthcare professionals to report side effects directly to the Yellow Card Scheme to help MHRA ensure they are acceptably safe for patients.
Users can select specific medicines or vaccines to track and receive news and alerts about them.
The app has been created in collaboration with the Innovative Medicines Initiative WEB-RADR project, a large-scale public-private partnership between the European Commission, national regulatory authorities, academia, small and medium sized enterprises and the European Federation of Pharmaceutical Industry Associations (EFPIA) that aims to boost biopharmaceutical innovation.
The key features can be used by patients, carers and healthcare professionals and:
provide a convenient alternative to using paper Yellow Card forms or the Yellow Card website
the app is free to use for everyone on iOS and Android

is easy to use for reporting side effects directly to the Yellow Card Scheme

enables users to:

create a ‘watch list’ of medications to receive official news and alerts on

view numbers of Yellow Cards received by MHRA for medicines of interest

see immediate response that shows Yellow Card has been accepted

submit updates to Yellow Cards already submitted

view previous Yellow Cards submitted through the app

Mick Foy, Group Manager for MHRA’s Vigilance and Risk Management of medicines division said: ‘The contribution of patients, careers and healthcare professionals alike in reporting suspected side effects to the Yellow Card Scheme is vital. The evidence helps MHRA detect safety issues and take the necessary action to keep the public safe.

Moving Yellow Card onto a mobile app is a logical progression in this digital age, allowing us to build on the existing website to improve user engagement. It offers some good functionality to access further safety information, and it will continue to evolve over the course of the WEB-RADR project based on user feedback.

Life Sciences Minister George Freeman MP commented:  The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years and the launch of this new mobile app brings it into the 21st century.  By making the scheme accessible to researchers, healthcare professionals and millions of patients, it will not only improve the safety of reporting but ultimately better protect people’s health and support research in the NHS.

You can download the app from the iTunes App Store and Google Play for your IOS or Android device.
Background
The Medicines and Healthcare Products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The agency consists of three centres: MHRA, the Clinical Practice Research Datalink (CPRD), and the National Institute for Biological Standards and Control (NIBSC)

The Vigilance and Risk Management of Medicines Division of MHRA is responsible for monitoring the safety of all medicines on the UK market. The Commission on Human Medicines is responsible for the Yellow Card Scheme, which is run on the Commission’s behalf by MHRA.

The Yellow Card Scheme is MHRA’s system of monitoring the safety of medicines in the UK and it acts as an early warning system to identify new and strengthen existing safety information about medicines. Yellow Cards are used alongside other scientific safety information to help MHRA to take action, if necessary, to make changes to the warnings given to people taking a medicine or review the way the medicine is used to maximise benefit and minimise the risk to the patient.

Yellow Cards are processed rapidly, according to tight timelines set out in legislation, in order to ensure that data from the reports are available in for analysis as quickly as possible for inclusion in the single detection process.

The Yellow Card Scheme has been in existence for five decades. Despite its limitations, which are common to all spontaneous reporting schemes, it has a proven track record in the identification of previously unrecognised safety hazards. The Scheme has undergone continual evaluation and development over the years, and this will continue to fulfil its central role in the UK pharmacovigilance in the changing climate in which it operates. At the same time it will continue to adhere to the key principles defined by Sir Derrick Dunlop at the inception of the scheme: spontaneity and speed, confidentiality and above all the commitment of health professionals and patients to report their suspicions in the interest of protecting public health.

Too much of a good cause…our lives are being slowly but surely ‘donorised’ by charities and fundraisers

I do not envy the task of charity fundraisers.  They will know that finance is the perennial worry of their Board of Trustees senior managers.  Without a steady stream of money coming in the work of the charity will become unviable. Those who it aims to help will be left without support. The pressure is on.

It’s not the generosity of the public that’s the issue.  Far from it.  It’s the intensely competitive environment in which charities are now having to raise funds.  An environment, it should be said, that has been buffeted by the harsh winds of austerity in recent years.

But some charities have clearly over-stepped the mark in making their ‘ask’ of the public.  First there was the death of poppy seller Olive Cooke.  Bombarded by demands for donations from good causes, her passing has become symbolic of charity excess. This despite the family stating many times they do not hold charities responsible. 

Since then, we have had undercover investigations by the Daily Mail and a steady stream of negative media articles highlighting bad practice. It is the perfect storm from which the charity sector is understandably reeling. 

On Saturday, the Prime Minister said ‘enough is enough’ and announced new laws as part of the Charities Bill going through parliament to tighten up fundraising regulation. Sir Stuart Etherington, CEO of NCVO, has been asked to lead a review.  Which is a shame. I think the matter is serious enough to warrant an outsider chairing the inquiry and lending it some independence.  That said, most of the charity statements I have seen have welcomed the move.

For what it is worth, last week our household received two charity bags for unwanted clothes and five letters from charities asking for donations.  On Thursday I went to the cinema and, for the third time running, the  trailers included a charity ‘ad.’  For a short while, a charity billboard marked one of the exits of the A21.  Not to mention my commute to London in which tube escalators and platforms are peppered with adverts and slogans; mostly about charity marathons, bike rides and other pursuits.

None of this is in itself bad or wrong.  You might argue it is not even that excessive.  But, whereas once upon a time we used to worry about the corporatisation of modern living, it now feels as if every day and everything we do can be ‘donorised’ by charities.

Charities need to get on top of this before it becomes their equivalent of the MPs expenses scandal or the banking crisis.   They can’t feign surprise as this issue has been slowly burning away for some time now.  Only a few weeks ago the Charity Commission published survey findings on public attitudes to the Commission and to charities which showed people inside and outside the sector want better regulation of their operations including fundraising.

Charities will no doubt want to keep a system that is predominantly about self-regulation. Or simply strengthen some of the existing measures in place. So, as the Prime Minister suggested, one possible tightening of current regulation is to legislate to ensure charities and the professional fundraisers who raise money on their behalf have written agreements in place. 

Personally, I don’t think this goes far enough. Charity bosses increasingly argue that running a charity is now akin to running a business. So perhaps we should apply the same sort of carrot and stick regulatory principles that exist in other sectors. How about fines for professional fundraisers and their charity clients who harass donors. It could be £s per person who complains or received unwanted calls or letters.  This money could then be given to the Charity Commission or distributed to other charities or projects. 

It’s been a sorry few months for charities. They need to heed the warnings. Or the public may one day decide that they have had too much of  a good cause and stop donating entirely. To the detriment of our society.

Have a good day.

More on mobile technology and health research…. #ResearchKit and @OfficialNIHR photo competition on theme of diversity and equality

Interesting news from the US last night that a number of pharmaceutical companies – GSK and PurduePharma being the ones cited – are now looking into the use of Apple’s new ‘ResearchKit’ app in clinical research.

‘ResearchKit’ was launched in March this year with many saying it would be a game-changer in medical research.  My understanding is that the significance of this latest move is that – up until now – those using ResearchKit have been not-for-profit organisations.

This particular report from ‘appleinsider’ also suggests there are rumours that some thought is being given to ResearchKit’s application to DNA Testing.  This slightly more detailed report from Buzzfeed says that, so far, ResearchKit has been used by a range of not-for-profits to sign-up 75,000 participants to research.  Amazing if true.

And in other news……

I encourage you to visit the National Institute for Health Research (NIHR) website.  It’s better than ever with a steady flow of news now being put on it.  In particular I wanted to highlight NIHR’s second photo competition which is open to all.  I am really pleased that this year’s theme is ‘diversity and equality.’  Closing date is: 23 August 2015. More details here.