Clinical data - toward a single dataset supporting Research, Service Delivery and Performance Management

We were lucky enough last month to discuss with the Finance Director of a major London healthcare service, the use of enterprise data, from clinical to financial, to support performance management - and were struck by the extent to which the processes which support performance management analytics mirror those which support clinical research.

We were put in mind of our conversations earlier this year with Oracle and other vendors whose healthcare data warehouse platforms and attendant applications were being demonstrated as solutions to both research and performance measurement problems - this in turn called to mind the comments we had heard from data experts coming into healthcare from other industries who could not understand why information of all kinds pertinent to the administration of healthcare, from genomic analyses to staff costs, were not seen as belonging to a single and vitally important information asset.

The concerns of this London hospital in getting a handle on their data were strikingly similar to those of the research institutes we have spoken with - and indeed what they describe as performance management is really research by another name - when they correlate outcomes with treatment modalities and different packages of care, they are using their Business Intelligence architecture in many ways like a clinical research engine but with the addition of financial data .

Their core issue is data quality - they currently have four main clinical IT systems - one for each borough subsumed into their organisation. Trying to use these to derive information even at the level of 'number of patient encounters' has not been straightforward. Although they didn't go into it, we should imagine that supporting those clinical systems must be an array of systems capturing e.g. pathology, radiology, cytology data at a more granular level.

In addition, their financial data resides in three ledgers each with different coding - a 'consolidation nightmare' was how they described the move to a single ledger; painful but essential as they attempt to get a grip on expenditure.

The introduction of Service Line Reporting of income and expenditure (in order to assess profit by service) is driving their data validation and data quality improvement - but their clinical operations requirement to deliver an integrated service, developing 'packages of care' rather than looking at individual activities related to the same condition in isolation, is also dependent on quality and timely data - both financial and clinical performance management require the facility to benchmark accurately.

Touching on other IT issues their organisation faces, they mentioned that the mobile workforce are not well supported by technology - "it's still a surprise that no-one has developed a good mobile working solution for healthcare in the UK". Their words, not ours! They did suggest complications which we hadn't thought of hitherto, coming from a tertiary care background as we do, for example nurses on home visits may not be able to work online, thus need data stored locally to upload later which means on-device storage of personal identifiable data. We can't believe that is still an issue from a technological perspective, however, we can imagine that risk-aversion in respect of personal data in the healthcare industry is dampening demand for solutions - anyone care to offer a more informed opinion?All comments welcome!

We were really interested to hear how they addressed the development of their Business Intelligence capabilities - developing KPIs to meet significant and varied requirements from different commissioners. Their previous dashboards had been provided by NHS London - their goal at that time had been to ensure compliance with standards and regulations but as they have matured they now have to develop their own dashboards to meet more complex internally-driven reporting requirements. To do this, they have their own Performance and Information team who work on data collation and aggregation - creating Performance Packs - which provide detail by Service line under headings such as Operations, Quality, Finance, Workforce etc. supported by detailed analysis across the board from hard to soft data.

The capacity to present a performance summary across directorates has led to internal competition which is already leading to performance improvements. Their next steps?

the P&I teams are looking to automate the production of their performance packs and to create an overall dashboard for the organisation, leading in turn to a Balanced Scorecard.

Having realised that their previous KPIs and the systems which provided the data were inadequate, they embarked on a redesign of their processes by, and in this order!:

• Defining the goals / purpose / vision of the organisation


• Asking what information they need to support the delivery of these


• Asking what KPIs would adequately measure their delivery


• Then developing the systems which support the provision of the answers to the above

They are no longer looking simply at meeting regulatory reporting requirements - but at using their data internally to drive their performance - they are setting up data quality fora - having an external data quality audit and linking their output data to their income - and beginning to realise the benefits of placing data at the heart of the organisation.

Clinical Practice Research Datalink courts potential users

We received on Friday our invitation to the Clinical Practice Research Datalink (CPRD) Users Meeting that will be held at the MHRA offices in London on 24th May 2012, consisting of a series of short presentations by representatives of CPRD and external partner organisations to give "further insight, and an opportunity for input, into the current and future aims of CPRD."

The background we have covered severally before (see here and here): "CPRD is the new English NHS observational data and interventional research service, jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). It combines the piloting work of the Research Capabilities Programme (RCP) and the existing General Practice Research Database (GPRD)."

CPRD services are designed to maximise the way anonymised NHS clinical data can be linked to enable many types of observational research and deliver research outputs that are beneficial to improving and safeguarding public health. CPRD will act to provide services to a wide range of researchers and the aim of the Users Meeting will be to ensure that its plans meet the needs of the broad cross section of researchers in academia, the NHS and commercial companies both in the UK and globally.

The specific topics that will be covered on the day include:

• Pragmatic and Phase III - IV clinical trials
• Multidimensional data quality
• Hospital prescribing data
• Models for linkage
• Disease and patient group data marts

The day will provide "several opportunities for potential users to raise and discuss their priorities and requirements" to ensure CPRD meets researchers' needs.

It is possible that we won't be able to attend ourself so if any of our readers are planning on going along, let us know and we'll get in touch to see if you want to post some feedback on these pages!

Clinical Practice Research Datalink is finally here - or is it?

The new Clinical Practice Research Datalink about which we have blogged much in the past has finally arrived (http://www.cprd.com/intro.asp) amid a certain amount of fanfare - see this from Pharma Times, this from PMLive and this from GP magazine.

 You may notice that the GPRD pages now redirect to this site and to a certain extent, this is largely a rebranding exercise at the moment. Behind the scenes a team at the DoH are trying to ensure that major data sources are willing and able to engage with this initiative but the speed at which they come online remains to be seen. We'll fill you in further on plans for a researchers data-catalogue interface as this project advances - and if CPRD are not offering that just yet, perhaps the MRC are - we'll get you up to date with the MRC's Data Support Service before the week is out.

Allied health professionals (AHP) Qality Improvement (QIPP) toolkits

Courtesy of the King's Fund:

The Department of Health has identified potential savings and the opportunity to provide better care by involving more AHPs in patient care. This series of online tools aims to help the NHS identify how therapists can intervene at different stages of a patient's condition to improve patient care whilst saving on costs. This first set of toolkits covers how AHPs can help to improve care for stroke; oral nutritional support; musculoskeletal care; cancer; and diabetes.

• Toolkits
• Department of Health - press release

General Practice data for research

We have just read, courtesy of eHealth Insider that "the NHS Information Centre is on the verge of having all GP clinical systems suppliers signed up to the General Practice Extraction Service. Emis, Microtest, iSoft and INPS have signed up to extract and communicate data to the NHS IC, and TPP expects to have a contract signed within weeks."


For more information on the General Practice Extraction Service (GPES), see the NHS IC GPES page which currently only mentions the contract with EMIS and whilst it describes the value of GP data, does not allude to its use for research but only in commissioning despite asserting that "GP patient records are the most complete record of a patient's health within the NHS. They comprise a wealth of information about patient care, the prevalence of diseases and treatments given."

So where does this leave services like GPRD, THIN and QRESEARCH. Well, we know that GPES won't be fully up and running for another year at least, and that GPRD will become the CPRD  (Clinical Practice Research Datalink) if all goes to plan. In the interim, as per this from the Health Protection Agency, GPRD and QRESEARCH will still be providing primary care data for research, but what will the landscape look like by the end of 2013?

Patients' views on participating in medical research - Part 2: Engagement and Participation

Our last post here began our summary of recent work on patients' attitudes to participating in medical research - part of our primer on the current state of play in clinical research in the UK selecting choice elements from recent reports; check out the footnotes for interesting sources to follow up. We include in this a look at the influence of media coverage of issues pertaining to data security on patients' attitudes and behaviour.

As always, let us know what you think - if there are more recent / complete / credible studies out there which draw different conclusions, let us know!

Engagement and participation

The UK has a long history of public support for health research, as evidenced by the large number of participants in clinical trials and population studies (For example, the UK Collaborative Trial of Ovarian Cancer Screening and UK Biobank have recruited their targets of 200,000 and 500,000 individuals (respectively) with minimal objection to the use of their healthcare data) and the generous contributions to medical research charities such as Cancer Research UK and the British Heart Foundation.[1]

Public engagement initiatives in relation to specific issues, such as the use of patient data, generally show that research is warmly supported. The attitudes of over 1,000 adults towards participating in health research were examined in the Wellcome Trust Monitor survey. Seventy-one per cent of participants indicated that they would be willing to give blood or tissue samples for research and 62% were willing to test a new treatment for a disease from which they were suffering.[2]

Evidence from two national research studies demonstrates that a small number of patients complain about receiving direct invitations to participate in research. The UK Collaborative Trial of Ovarian Screening is one of the largest ever randomised controlled trials, covering 13 NHS Trusts in England, Wales and Northern Ireland, with successful recruitment of more than 200,000 women. Of the 1.2 million women invited to participate in the study only 32 complained about being contacted. UK Biobank reported from its integrated pilot phase that approximately 1 person from 1,000 invitations indicated that they did not want to participate because of concerns that their contact details had been provided to UK Biobank by the NHS.[3]

There are a large number of organisations working to improve patient and public engagement with health research, including (but not limited to) UK Clinical Research Collaboration (UKCRC), INVOLVE, regulators themselves, the medical Royal Colleges, research charities and disease specific patient groups working to help the public understand the role and importance of research as an integral part of the care system. 

Media view – data protection

The influential role of mass media has important implications for the formation of public opinion and consequently public behaviour and the actions of policy makers. The most significant impact on attitudes towards the storage, transmission and use of personal data in healthcare is made by coverage of breaches of regulations and guidelines.

Though many of the stories do not relate to data used in research per se, their impact contributes to patients’ concerns about any use of personal medical data.

Storage and transmission of data are key to research, many large datasets (for example the national disease registries) inducting data from a variety of sources and releasing data for research to geographically dispersed users. A key aspect of the conduct of research is the ease with which those researchers can receive the data. The choice of transmission method is not driven solely by actual risk analysis: while an encrypted DVD has a high level of innate security, public perception of sensitive information being moved around on DVDs, memory sticks and laptops is an important consideration. In fact it was a major issue identified in the UK Ministry of Justice's report on Data Sharing, 2008.[4]

A recent article from eWeekeurope.co.uk backs up perception with data under the inflammatory headline “A Freedom of Information request by… Software AG has revealed that most public sector bodies have no idea about secure data transfer.”[5] The article cites recent examples of the loss of sensitive information by public bodies: “A couple of years ago, Her Majesty’s Revenue and Customs (HMRC) lost a number of CDs containing private information on thousands of people. But there have been many more recent examples. Last July the UK Ministry of Defence admitted it had lost an entire server from a secure building – as well as 1.7 million individuals’ personal data. In November the UK Rural Payments Agency (RPA) lost backup tapes containing the payment and banking details of 100,000 farmers in the United Kingdom. And only last month an NHS worker in the secure mental health unit of a Scottish hospital was suspended, after he lost a USB stick containing patients’ medical records. The USB stick apprently contained unencrypted sensitive information – including the criminal histories of some violent patients at the Tryst Park unit at Bellsdyke psychiatric hospital. The stick was later found by a 12-year-old boy in the car park of an Asda supermarket.”

The NHS was recently (April 2010) revealed by the Information Commissioner’s Office (ICO) to be responsible for the highest number of serious data breaches of any UK organisation since the end of 2007. David Smith, deputy commissioner at the ICO told the Infosec security conference the NHS had highlighted 287 breaches to it in the period, accounting for more than 30% of the total number reported.[6] Most of the breaches were the result of stolen data or hardware, followed by 82 cases of lost data or hardware. Richard Vautrey, the deputy chair of the British Medical Association's GPs committee thinks the number of breaches reflect the size and complexity of the NHS (the UK's largest employer with 1.7m staff) as well as its culture of openness.[7] Whilst comments in the BBC’s coverage mention in mitigation that the public sector’s culture of reporting all breaches contrasted with the private sector’s behaviour, these do little to lessen the impact of the headline: “NHS worst for data breaches.”

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[1] The Academy of Medical Sciences: A new pathway for the regulation and governance of health research

[2] Ibid.

[3] Ibid.

[4] Ministry of Justice: Data Sharing Review, 2008 [Richard Thomas, Information Commissioner; Dr Mark Walport]

[5] http://www.eweekeurope.co.uk/news/public-sector-clueless-on-secure-data-transfer-7635

[6] http://www.bbc.co.uk/news/10089066

[7] Ibid.

Patients' views on participating in medical research - Part 1: Attitudes

While we are still working on our 'Funders' Policies on data sharing' article we decided to post here a summary of recent work on patients' attitudes to participating in medical research - again, a primer on the current state of play in clinical research in the UK selecting choice elements from recent reports; check out the footnotes for interesting sources to follow up. Part 2 will cover Engagement and Participation and will be followed by a piece on medics' attitudes to research. As always, let us know what you think - if there are more recent / complete / credible studies out there which draw different conclusions, let us know!

We also came across a tweet today from Simon Denegri linking via his blog to an NIHR site containing video testimonials of the experiences of patients, nurses and doctors taking part in or working on clinical trials which is worth a look too. Apologies for the bizarre formatting of the bullet-points below!

Attitudes

The following bullet points are extracted from the text of the report “The Use of Personal Health Information in Medical Research General Public Consultation” which presents the the findings of a programme of research carried out among the general public by Ipsos MORI on behalf of the Medical Research Council (MRC) published in July 2007 with the aim of “Identifying public concerns and misconceptions surrounding the secondary use of personal health information for medical research.”

In summary they found that there was low public awareness of medical research, that the public were in general supportive of research when informed about it and when they felt in control of their data – but continue to have reservations about privacy:

·         “The advantages of medical research are seen by the public to far outweigh the disadvantages. Seven in ten feel the merits of research outweigh the disadvantages, compared to only 6% who say the opposite.”

·         The qualitative phase of this consultation showed that there was little public awareness and understanding of medical research (and thus the use of secondary health information for medical research purposes), who undertakes it and to what ends.

·         “The workshops indicate that, if the public is informed about what medical research entails, they are generally positive towards it. Communications are key to building public trust… Key to effective communication on the subject is the need to keep terminology simple.”

·         The quantitative phase of the research showed that “Just over a third (34%) cannot think of any associations with the phrase personal health information, which indicates fairly low awareness for the MRC to address.”

·         “Perceptions of who, or which organisations people feel would hold personal health information focus mainly around the health service [GPs, hospital doctors and the NHS]. Medical researchers (working in any capacity) are mentioned by less than 1% of the general public.”

·         “If the public feels in control of their information and its potential uses, then they are likely to be more inclined to allow their personal health information to be used for medical research purposes…The qualitative research shows that the main public concerns are over organisations sharing this information, particularly for commercial gain…. Medical researchers working in the public sector i.e. for Government and universities (both trusted by 11%) are more trusted than their counterparts working for private companies (4%). The private sector features prominently among the least trusted organisations where personal health information is concerned.”

·         “While most see the benefit of personal health information being used for medical research purposes, the very same people can hold reservations over the implications for privacy…. The most common reason for being unlikely or certain not to allow personal health information to be used for medical research purposes is concern over privacy (28%).”

·         “The two key pillars of anonymity and consent feature highly in the debate over what information should be available, to whom, and in what circumstances. These two themes are central to building trust.”

·         “The vast majority (87%) trust GPs to have access to their personal health information, and over half trust other health professionals – such as consultants or hospital doctors (59%).”

·         The public needs “a human face to reassure them and discuss the issues around consent and confidentiality with them. Health professionals in general, and GPs in particular, are the most trusted to perform this role. For many, the GP’s surgery is the most frequent point of contact on health issues and it would seem sensible to use this as one location for dissemination of information about personal health information for medical research purposes.”[1]

The Academy of Medical Sciences presented a review of public engagement on the use of patient data, summarising several reports thus:

·         NHS Connecting for Health – Using patient information in the NHS (2009).98 This report found that the 96 participants were generally happy for their data to be used in research as long as anonymity was ensured and they were approached by someone they knew and trusted, such as their GP.

·         Royal Academy of Engineering –Young people’s views on the development and use of Electronic Patient Records (201099) Of 3,000 young people surveyed, most were not against the idea of anonymised data being used in medical research; 50% said that they would want to be asked for consent each time researchers used their anonymous record.

·         New Economics Foundation - Exploring public views on personal electronic health records (October 2010100) Surveyed 6000 people and found: that 57% of adults and 67% of young people were enthusiastic about the benefits of switching to digital patient records; and that patient consent would be essential for using identifiable data for research.

·         Wellcome Trust/University of Surrey – Public Attitudes to Research Governance (2006). Based on interviews and focus groups with 89 people; the report found participants were willing to provide personal data for biomedical research providing its use had been explained to them. Concerns remained over whether promises of anonymity and security could be fully relied on.

·         MRC/Ipsos MORI - The Use of Personal Health Information in Medical Research (2007). Interviewed a sample of 2,106 UK adults and found that 69% were ‘likely’ to allow the data to be used for health research purposes

·         Academy of Medical Sciences - Personal data for public good: using health information in medical research (2006). Consulted with a wide range of patient representatives and found research using personal data was strongly supported. Public engagement was identified as one of the most important tasks in developing future arrangements for appropriate governance for the use of health information in health research.[2]

Another 2007 report, a survey of literature covering public and professional attitudes to privacy of healthcare data commissioned by the General Medical Council and conducted by Cambridge Health Informatics, came to the following conclusions:

·         Assessment of public attitudes is dependent on how the topic is framed. People will express concerns if questioned about ‘concerns’, but will readily trade these ‘concerns’ for health  or other benefits, even altruistic ones.

·         ‘Real world’ choices can be very different (and constrained) from those offered in opinion surveys where costs and trade-offs may not appear.

·         Public attitudes are not uniform and the surveys suggest that they are often either ill-informed or unformed (or sometimes formed during an investigation or discussion).

·         Attitudes among the public vary from the completely unconcerned to a small proportion of the public that has strong views on privacy, either from a sense of a ‘right to privacy’ or because of some sensitive episode in the past that they wish to protect. The majority of the public seem to rely on trust in clinicians and the healthcare system.

·         It is clear that the public (and to some degree the professions) are unclear on the potential roles of medical records in modern healthcare.

·         The public would like a choice in the use of their records, but there is little hard evidence about what arrangement of choices the public would generally prefer – or whether there are radically different opinions on this.

·         The public appear to be becoming more comfortable with computer technology, which may reduce fears over privacy, but with increasing expectations over security and choice about access to their records.[3]

Of note these authors contend that “Generally much of healthcare policy in relation to the privacy of healthcare data has been based on historic ethical and legal considerations together with financial practicalities rather than on an evidence-base of what individuals would want or expect.  This has been, in part, been due to a perceived lack of understanding by the public at large (and many professionals too) of how medical records are actually used and shared within the healthcare system as a whole: this perception means that they have rarely been asked in any formal consultative way.”

They also contend, however, that “Establishing public concerns about the privacy of health data poses problems because, from the few surveys that have been performed, it appears that only a small proportion of the public have a strong opinion and fewer still have an understanding of the complex issues that need to be weighed up when arriving at an opinion.”[4]

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[1] Ipsos MORI on behalf of the Medical Research Council: The Use of Personal Health Information in Medical Research General Public Consultation [2007]

[2] Ibid. Full citations for these reports are:

UK Clinical Research Collaboration (2010). Attitudes and awareness amongst General Practioners (GPs) and

patients about the use of patient data in research – a study by the UK Clinical Research Collaboration Board

Sub-Group on Public Awareness. UCKRC, London.

NHS Connecting for Health (2009). Using patient information in the NHS.

http://www.connectingforhealth.nhs.uk/engagement/public/consultations/hsreport.pdf

Royal Academy of Engineering (2010).Privacy and prejudice: young people’s views on the development and

use of electronic patient records.

http://www.raeng.org.uk/news/publications/list/reports/Privacy_and_Prejudice_EPR_views.pdf

New Economics Foundation (2010). Who sees what? Exploring public views on personal electronic health

records.

http://www.neweconomics.org/sites/neweconomics.org/files/Who_Sees_What.pdf

Wellcome Trust/University of Surrey (2006) Public attitudes to research governance: a qualitative study in a

deliberative context.

http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document

/wtx038443.pdf

Medical Research Council/Ipsos MORI (2007). The use of personal health information in medical research.

http://www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILE&dID=10983&dDocName=MRC003810&allowI

nterrupt=1

Academy of Medical Sciences (2006). Personal data for public good: using health information in medical

research. http://www.acmedsci.ac.uk/download.php?file=/images/publication/Personal.pdf

[3] Cambridge Health Informatics report for the General Medical Council: Public and Professional attitudes to privacy of healthcare data - A Survey of the Literature; http://www.gmc-uk.org/GMC_Privacy_Attitudes_Final_Report_with_Addendum.pdf_27007284.pdf

[4] Cambridge Health Informatics report for the General Medical Council: Public and Professional attitudes to privacy of healthcare data - A Survey of the Literature; http://www.gmc-uk.org/GMC_Privacy_Attitudes_Final_Report_with_Addendum.pdf_27007284.pdf

Research Capability Programme's Health Research Support Service - UCL report on the Pilot's effectiveness in Primary Care

Happy New Year and apologies for our lack of recent posts - we're back with some interesting stuff in the pipeline on data integration platforms for service delivery and research (Oracle, Orion, OpenClinica, IBM, Cerner etc.) coming tomorrow.

For now, we should direct you to University College London's report on the "Health Research Support Service Pilot in Primary Care: facilitators and barriers to successful implementation at a national level" - an independent evaluation.

The report contains good feedback from key stakeholders including many patients from the GP practices involved in the Primary Care part of the Pilot. If you're not aware of the aims and status of the National Institute for Health Research's Research Capability Programme and the Pilot Health Research Support Service, check out our links to them and our notes on the Clinical Practice Research Datalink which will take the service forward.

Amongst the key observations from the UCL report were:

On the sample group:

"There were only two practices involved in the pilot and these were strong research practices.  This means the practice staff were used to dealing with research projects and the patients were aware of research, even if they had not previously taken part in it.  Moreover the patients who participated were self-selected and were generally older and educated to a high level.  It may be more difficult to engage both staff and patients in non-research practices."

On patient attitudes:

"There was widespread support for the concept of the HRSS.  The vast majority of patients stated that they felt the HRSS was a good idea and a number highlighted potential benefits that they felt the HRSS would bring about. 'Giving something back’ to the NHS emerged as an important motivation for participating in the HRSS pilot in primary care.  The majority of patients who participated in this evaluation were happy for their GP practice to share their patient data with the HRSS pilot in primary care."

On the programme's communications efforts:

"Levels of understanding about the detail of the HRSS varied and very few people had a good understanding.  One patient who opted out of the HRSS stated that she would have opted in if she had had clearer, more detailed information about the HRSS pilot in primary care."

Cancer Research UK unites with global research groups (IRCI and EORTC) to fight rare cancers

We missed this press release from Cancer Research UK last week - the only other place we've seen it publicly is on ecancermedicalscience in their Insider News section:


Cancer Research UK will ... join forces with international research groups from the UK, Europe and the US to launch an initiative to boost the development of new treatments for patients with rare cancers. The announcement will be made by Dr Harpal Kumar, chief executive of Cancer Research UK, at the 2011 World Cancer Leaders’ Summit taking place today in Dublin.

The International Rare Cancers Initiative (IRCI) has been established by Cancer Research UK and the National Institute for Health Research Cancer Research Network (NCRN) in the UK, the National Cancer Institute (NCI) in the US, and the European Organisation for Research and Treatment of Cancer (EORTC).

The initiative will design and fund clinical trials of treatments for rare cancers – defined as those which occur in approximately fewer than two cases per 100,000 people. There are limited treatment options for patients suffering with these cancers and there is an urgent need to develop new therapies.

Initially the IRCI will focus on designing clinical trials for five cancer types: salivary gland cancer, small bowel adenocarcinoma, gynaecological sarcoma, ocular melanoma (melanoma of the eye) and penile cancer.

Helene Craddock, 37, a nurse in the intensive care unit at Bristol Children’s Hospital, was diagnosed with cancer of the salivary glands at the age of 19. She said: “Being told you have cancer is a very difficult thing to come to terms with.  You have a lot of questions, which is normal, but having a rare cancer means the answers are not always there. “I am very thankful to say that although I had extensive surgery, and continue to be followed up, I am currently very well.

“There is a huge need to look into these rarer cancers, and I sincerely hope that this new research will lead to improvements in understanding, diagnosing and treating these cancers, and ultimately give us all more hope for our futures.”

The first clinical trial developed as a result of the IRCI, a study for patients with a type of gynaecological cancer called uterine leiomyosarcoma, has recently received approval from both the NCI and Cancer Research UK.  Nine further studies are currently being developed through the initiative. The partner organisations will provide the funding that will enable patients in their countries to take part in the studies.

In addition, it is hoped that studies for other rare cancer types will be developed through the IRCI, including studies in anaplastic thyroid cancer, fibrolamellar hepatoma, thymoma and metastatic/relapsed anal cancer.

Dr Harpal Kumar, chief executive of Cancer Research UK, said: “This initiative is an exciting opportunity for some of the top clinicians in the world to work together to develop and run trials for rare cancers. We hope this will lead to new and more promising treatments for those patients who today have a very limited set of options.

“This is an urgent need. New treatments for rare cancer types are few and far between – these essential clinical trials are the first step in helping these cancer patients. International collaboration is critical to share knowledge and expertise in this area – it will help speed up and improve the design of these trials. We hope this initiative will increase survival from these diseases.”

Professor Matt Seymour, director of the NCRN, said: "Although each rare cancer may affect only a small number of patients, for those people it is critical that we find the best treatments. And combined, rare cancers affect thousands of UK patients every year.

“But research has lagged behind common cancers, partly because rare cancers have not been a priority for drug companies and funders, and partly because it is difficult to organise large-scale trials in diseases only affecting a few patients in any one region.

"Over the past decade, Cancer Research UK and the NCRN have led the world in making cancer research part of routine treatment in every hospital: over 46,000 UK patients took part in NCRN trials last year. We are confident that by bringing together experts from around the worldwe can do ground-breaking research, even in these rare diseases."

Ted Trimble, director of NCI's Center for Global Health, said: “This initiative will allow us to perform trials for cancers so rare that none of us could have managed it on our own.  Working together like this allows us to reduce the cost of trials for each partner organisation, to speed development and conduct of rare cancer clinical trials, and to harness worldwide expertise in these rare conditions.”

Denis Lacombe, EORTC headquarters director, said: “The low numbers of patients with rare tumours brings an urgent need for international cooperation of experts with complementary skills and knowledge to find new ways to treat these diseases.

“This International Rare Cancers Initiative will allow cancer doctors to recruit patients for one large and effective trial, instead of several smaller trials whose results might be inconclusive.

“EORTC embraces this initiative. Rare tumors are a priority at EORTC, which has carried out landmark trials that have changed standard of care for rare cancers such as glioma and sarcoma.

“Patients and public health are at the center of the EORTC mission, and this initiative fits perfectly into the EORTC scientific agenda.”

Notes: 

The following eight rare cancers currently form the core activities of the IRCI.  The names of the lead clinicians for each rare cancer have been listed:

Head and Neck cancer specifically;

Salivary gland cancer 

Leads: Dr Kevin Harrington (UK), Dr Alan Ho (US), Dr Lisa Licitra (EORTC)

Anaplastic thyroid cancer

Leads: Dr Laura Moss (UK), Dr Keith Bible (US), Professor Martin Schlumberger (EORTC)

Small bowel adenocarcinoma

Leads: Dr Richard Wilson (UK), Dr Rob McWilliams (US), Dr Arnaud Roth (EORTC)

Gynaecological sarcoma

Leads: Dr Helen Hatcher (UK) Dr Martee Hensley (US), Professor Jean-Yves Blay (EORTC)

Fibrolamellar hepatocellular carcinoma

Leads: Dr Tim Meyer (UK), Dr Marcio Malogolowkin (US), Dr Michel Ducreux (EORTC)

Penile cancer

Leads: Dr Steve Nicholson (UK), Dr Curtis Pettaway (US), Dr Christine Theodore (EORTC)

Ocular melanoma

Dr Ernie Marshall (UK), Dr Richard Carvajal (US), Professor Poulam Patel (EORTC)

Thymoma

Professor Mike Lind (UK), Professor Frank Detterbeck, Dr Sanjay Popat

Metaplastic/relapsed anal cancer

Dr Rob Glynne-Jones (UK), Dr Al Benson (US), Professor Dirk Arnold

Consultation on building an e-health research infrastructure for cancer

The National Cancer Intelligence Network (NCIN) posted a consultation document on their site last week to coincide with the beginning of the National Cancer Research Institute's annual conference.

It's worth reading this in conjunction with the Department of Health document describing the new Clinical Practice Research Datalink which we blogged about a few days ago as the consultation seeks to co-ordinate its proposals with the infrastructure developments proposed by the CPRD.

In overview (taken from the Executive Summary - these are expanded upon in the main body of the document) the proposals are:

Proposal 1: A safe haven facility to enable research access to potentially identifiable data from the English cancer registration service in a secure, controlled environment. All outputs removed from the safe haven would be checked against anonymity criteria before release.

Proposal 2: A linkage service to allow combination of different datasets for use in research.

Researchers with the appropriate consent could receive data from the cancer registration service to supplement a study dataset. Other researchers could receive access to the de‐identified product of linking one or more existing datasets to cancer registry data.

Proposal 3: A notification service for new cancer diagnoses and other events.

Investigators could register study participants (with their consent) with the cancer registration service and allow them to be regularly informed of new diagnoses and other events.

Proposal 4: A hosting service for study data. This would provide investigators with a secure environment in which to store and analyse their study data together with routinely collected information from the cancer registration service.

Proposal 5: Support for the planning and recruitment of studies.

This would involve mechanisms for estimating trial feasibility and the likely recruitment rates of different centres, and for notifying clinical teams when patients are eligible for a particular study or clinical trial. (Potentially a joint project with the NIHR Cancer Research Network (NCRN) and others).

Proposal 6: A research support service. This would advise users on the availability of data, the requirements for access, and would manage requests and provide access.

Proposal 7: Guidance on guidance on permissions for data access and linkage.  

This would involve providing investigators with guidance on consent wording for using record linkage and notification services. (Potentially joint projects with NRES and NIGB and others).

King's Fund blog added to our blog-roll

Just added the King’s Fund blog to our blog-roll – see down there on the left? The King’s Fund, with a long and noteworthy history, produce research aimed at shaping policy, developing effective practice and supporting the goals of forward-looking individuals and care-providing organisations.

In their words, they “aim to exercise influence at all levels – from national policy-makers, to frontline staff delivering care in hospitals and in the community”.

Their current projects are looking at increasing NHS productivity, shaping the future of health and social care at a time of change, strengthening leadership, improving patient experience, integrating the provision of services which combine to effect long-term care and supporting the changes required to deliver the Information Revolution.

If you have an interest in healthcare policy and innovations to drive productivity, their blog is well worth checking out.

National Cancer Research Institute's 2011 Conference

In case you are not already following on Twitter (#NCRI2011) or the blog (http://scienceblog.cancerresearchuk.org/) the NCRI conference is in full swing in Liverpool. Unfortunately we're not able to attend this year but we'll be looking out for choice updates to collate and talking to some of our colleagues about the highlights as it progresses.

eCancermedicalscience.com are blogging about it already and quite fulsomely: http://ecancermedicalscience.com/blog.asp?postId=171

Best wishes to all involved.

NIHR / NOCRI Information Systems Workshop - Part 2 - FP7 TRANSFoRm: Translational Medicine and Patient Safety in Europe

Next up, after Mike Denis, in the first session was Prof. Brendan Delaney (Guy's and St Thomas' Charity Chair in Primary Care Research, King's College London) talking about the TRANSFoRM project under FP7 – for the uninitiated, “'Framework programmes' (FPs) have been the main financial tools through which the European Union supports research and development activities covering almost all scientific disciplines.”

The project is looking to develop infrastructure supporting research and diagnostic decision support in primary care – and in the UK is working with GPRD (the primary care data-source). 

Prof. Delaney referred to the well worth reading report from the US Institute of Medicine of the National Academies DigitalInfrastructure for the Learning Health System: The Foundation for ContinuousImprovement in Health and Health Care - Workshop Series Summary 

 

Prof. Delaney’s big statement was that “Research is in crisis!”, his verdict on the recent reports (we will find the link!) on caBIG was that the lesson to be taken is, “Don’t build massive infrastructure projects! They just grow and grow and create wealth for consultants.” Interestingly, other speakers noted that they were using at least one caBIG tool in the development of their own infrastructures.

Prof. Delaney’s work on TRANSForM encompasses a data quality tool, data linkage functionality (browsing, selection, extraction) and semantic mediation – the latter facilitating the transformation of Electronic Health Records (EHRs) into research quality data (EHRs with tabs for CRFs which partially pre-populate and can ultimately be signed-off online).

This last facility is at the heart of the work, using reference ontologies, controlled vocabularies etc. to interpret the EHRs.

The first year’s deliverables (including the privacy framework, security framework and provenance framework – together creating the governance framework) are already available on the website: http://137.73.82.45/Home.html

We’d be interested to know the relative ease of navigation of the regulatory landscape for each of the involved nations.... and will the deliverables form the semantic mediation be published?

This is the abstract for Prof. Delaney’s talk:

“TRANSFoRm is an EU FP7 project that aims to develop and test a digital infrastructure for the 'learning healthcare system'. Specifically we are working to develop capacity within primary care electronic health records to manage research workflow (recruitment and follow up), data collection and record linkage, and to develop diagnostic decision support using a common infrastructure.

NIHR / NOCRI Information Systems Workshop - Part 1

With apologies for the delay in getting this to you, here comes the first of our updates on last Monday's NIHR Office for Clinical Research Infrastructure (NOCRI) Information Systems Workshop!

The workshop was held at Guy's Hospital and the introductory remarks began with a welcome from Professor Simon Lovestone, who is, in addition to being the Director of the Mental Health Biomedical Research Centre at South London and Maudsley & King's College London, Director of Research at King's Health Partners Academic Health Sciences Centre.He was followed by Mark Samuels (MD, NOCRI) and Peter Knight who is now Deputy Director of R&D and Head of Research Information and Intelligence at the Department of Health.

Session 1 - Chair: Prof. Peter Parker, Cancer Theme Lead, NIHR BRC at Guy's and St. Thomas' NHS Foundation Trust & King's College London.

We've blogged twice before about Mike Denis's presentation covering South London and Maudsley NHS Foundation Trust's (SLaM) Clinical Records Interactive Search (CRIS) system - Mike was up first in the first session after the introductory messages and talked on the Vision for Translational Informatics at SLaM.

He talked to two themes in relation to SLaM's creation of a Personal Health Record, the first being the technical aspects (including deep pseudonymisation - meaning that it extends into the free-text within records) and the second being the social aspect that puts the patient in the driving seat of the process but also aims to link Patient Reported Outcomes to research.

An interesting aspect of the technical discussion was the use of intelligent agents to provide automated analysis and predictive analysis - which chimed with Prof. Michael Luck's comments later in the day on the use of computer sicence agents in medical informatics - of which more later.

Mike emphasised the scalability of the approach, the potential to implement it across multiple centres and carry out data linkage inter-organisationally.

Here's the abstract provided for Mike's talk:

“Within SLAM, we have sought to focus on a relatively fine-grain model of clinical informatics, building the Clinical Records Interactive Search (CRIS) system which provides researchers access to full but anonymised data on a large mental health NHS provider covering a 1.2m population catchment area and containing over 180,000 case records. Key areas for resource development which will be outlined include the routine collection of consent for researcher contact, informative data linkage with internal (biological) and external (health and social) data resources, and adding depth to the dataset through natural language processing, shared health records and patient reported outcomes. We believe that these developments, coupled with advances in nested trial designs and electronic health records (EHR) feedback loops will help move the current focus of EHR and 'case register' research in our field from an observational to translational footing.”

Department of Health Ideascale - Health-related Apps

It's been a while since we checked out the DoH Ideascale site where the Department invited suggestions for healthcare related applications - the call for submissions is now over and the top rated suggestions are:

Moodscope - measuring your state of mind (and alerting friends)  (604 likes, 48 dislikes)

HealthUnlocked - the social network for patients (310 likes, 4 dislikes)

FoodWiz.co - the app for people with food allergies. (283 likes, 16 dislikes)

Reducing Post Traumatic Stress Disorder after sexual assault  (264 likes, 34 dislikes)

We were shocked to discover that our app garnered 0 votes - well at least we can say no-one disliked it! It was:

Pregnancy app "Conception to birth support"

How about a pregnancy app giving "conception to birth" support, with information by month on symptoms, syncing with your calendar to pop-up reminders about GP and midwife appointments, tests and how to prepare for them (e.g. Glucose Tolerance Test) and enabling you to search across multiple forums for similar experiences (e.g. "26 weeks leg cramps") - plus links to NHS choices for maternity services in your area (pre-natal ward visits, user feedback on services)...

It doesn't seem vastly different to others which have been 'liked' in some degree - such as

You and Your Pregnancy

A step by step guide through each day of your pregnancy


So where did we go wrong? Anyhow, some great ideas on there and well worth using the search to see what's there relating to your area of interest.