Of the 17 registers approached, we were able to conduct interviews with representatives from six disease registers. We were unable to secure interviews with the remaining 11 registers approached. An overview of the history, aims and organisations involved in each register is presented in Table 1. Since completing the interviews, the IBD Registry announced in January 2024 that is closing; the Royal College of Physicians will act as interim steward for safeguarding the data but no data processing will take place (18-20).
Table 1 History and current aims of the sampled registers
Register
|
History/Development
|
Current aims
|
Organisations involved
|
Funding
|
British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) (21)
|
Launched in 2001, when anti-TNF therapies were first rolled out across the NHS. All UK consultant rheumatologists who prescribed anti-TNF, and other targeted therapies, were recommended to enrol patients by the British Society of Rheumatology to monitor the safety profile of these drugs.
|
To monitor the long-term safety of biological and other targeted therapies used to treat rheumatoid arthritis.
|
- British Society for Rheumatology
- The Biologic Studies Group at The University of Manchester
- Pharmaceutical Industry
|
- British Society for Rheumatology, which receives funding from pharmaceutical companies.
|
Complex regional pain syndrome (CRPS) UK Registry (22)
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Established in 2008 by a network of clinicians, therapists and researchers with an interest in CRPS (CRPS UK Clinical & Research Network). There was interest to explore how best to capture a population suffering from CRPS and facilitate epidemiology studies and clinical trials.
|
To raise awareness and understanding of Complex Regional Pain Syndrome amongst health professionals, patients, and the public.
|
- CRPS UK Clinical & Research Network
- Cambridge University Hospitals NHS Foundation Trust
- Royal United Hospitals Bath NHS Foundation Trust
|
- Not directly funded; built funding into research studies to cover cost of an administrator.
|
Inflammatory Bowel Disease (IBD) Registry (23)
|
Formed in 2012 by a group of consultant gastroenterologists to help provide a better picture of IBD in the UK.
The IBD Registry officially launched as an independent not-for-profit in 2018.
Announced its closure in January 2024.
|
To improve treatment and care for people with IBD, and support research.
|
- Royal College of Physicians
- British Society of Gastroenterology
- Crohn’s & Colitis UK
|
- Variety of sources including grants from both public institutions and commercial entities.
|
UK Juvenile-onset Systemic Lupus Erythematosus (JSLE) Cohort Study and Repository (24)
|
In 2006 a group of paediatric rheumatologists, nephrologists and other specialists formed the UK JSLE Study Group.
The Group established the UK JSLE Cohort Study and Repository in 2006 to facilitate research.
|
To improve both patient care and improve understanding of the disease.
Develop a comprehensive research programme to investigate the clinical characteristics and immunopathology of JSLE.
|
- UK JSLE Study Group
- Alder Hey Children’s Hospital and University of Liverpool
- Lupus UK
|
|
Multiple sclerosis (MS) Register (25)
|
Launched in 2011 by the Population Data Science team at Swansea University Medical School to capture real world data about people living with MS in the UK. Initially aimed to provide a better estimate of the number of people suffering from MS in the UK.
|
Build the evidence needed to campaign for fair policies and improved healthcare.
Build a clearer picture of the true impact MS has on people’s lives.
Be a resource for people with MS to track, store, access and then share their own data with their healthcare provider.
|
- Swansea University Medical School
- MS Society
- Currently in process of linking with registers in US, France, Switzerland & Sweden.
|
|
UK Renal Registry (UKRR) (26)
|
Established in 1995 by the Renal Association to improve the care of patients with end-stage kidney disease. Originally limited to people on kidney replacement therapy. Has expanded to include cases of acute kidney disease.
|
To record and analyse longitudinal health data about children and adults with kidney disease in the UK for audit, quality improvement and research purposes.
|
- British Renal Association
- UK Kidney Association
|
- Capitation fee per patient on renal replacement therapy paid by the NHS.
- UK Kidney Association
|
All registers we examined include individuals who had received a clinical diagnosis, see Table 2. In addition, the JSLE cohort study includes children presenting at rheumatology clinics who do not yet meet the criteria for a lupus diagnosis to gain insight into whether, and who, goes on to develop lupus. Across the registers examined, participants are either recruited when attending a specialist service (BSRBR-RA, JSLE, UKRR, CRPS), register themselves directly (IBD) or are recruited via both routes (MS); the CRPS Registry is no longer recruiting participants. The registers range in size from 618 patients enrolled in the CRPS Registry to 500,000 with acute kidney injury in the UKRR. Most datasets capture clinical data gathered during routine appointments with specialists. The exception is the CRPS, in which data is only collected through an annual self-reported questionnaire. Only the MS Register is currently routinely collecting data on patient-reported outcome measures (PROMs).
Table 2 Recruitment and data collection summary
Register
|
Eligibility criteria
|
Recruitment strategy
|
Consent
|
No. participants
|
Data collected
|
Linkage
|
|
Patients attending specialist services
|
BSRBR-RA (21, 27)
|
- Aged 16 yrs or over.
- Clinical diagnosis of rheumatoid arthritis.
- Starting eligible biologic treatment.
|
- Recruited from all NHS trusts that have a Rheumatology department when starting a new biological treatment either during visit to department or via an outreach consent.
- Requirement to recruit all eligible patients initially mandated by NICE, and now recommended by the British Society for Rheumatology.
- On the NIHR UK CRN Portfolio, means Centres in England have access to UK CRN nurse support/infrastructure support to cover recruitment of participants.
|
- Written informed consent to:
- complete follow-up questionnaires about health;
- for NHS hospital medical records to be shared with the study team;
- for their NHS number to be shared with other national healthcare databases;
- be contacted for other studies; and
- pseudonymised data being shared with pharmaceutical companies.
|
- 30,000 patients from 100+ rheumatology clinics across the UK.
- Followed until withdraw from study or death.
|
- Rheumatology department; data captured at baseline, then every 6 months for three years then once a year.
- Patient diaries & questionnaires (until 2019, when register moved to an electronic system, currently on hold).
- During COVID-19 developed an ePROMs tool to ensure data captured while not being seen routinely face to face (not currently linked to BSRBR-RA).
- NICE mandated between (2003-2008) that all English patients on biologic drugs must have data submitted to the register.
|
- Collect NHS number to enable linkage with datasets held by NHS Digital e.g. cancer and death outcomes, Hospital Episode Statistics (HES).
- Previously linked to Public Health England’s Myocardial Ischaemia National Audit Project (MINAP).
- Exploring feasibility of linking to the juvenile idiopathic arthritis (JIA) register.
|
CRPS (22)
|
- Any age attending one of the approved NHS sites.
- Meet the diagnostic criteria developed by the CRPS UK Network (as there is not official diagnosis for CRPS), based on presenting symptoms and signs.
|
- Approved staff from each of the 10 approved NHS sites were responsible for recruiting patients.
- Since December 2020 no longer recruiting new participants.
|
- Written informed consent to provide personal contact details so can be contacted for:
- contacted for follow-up; and
- other studies.
|
- 618 patients from 10 centres in England, Northern Ireland and the Republic of Ireland.
- No defined endpoint.
|
- Baseline data collected by consenting clinician.
- Annual patient questionnaire.
|
|
JSLE (24)
|
- Aged 18 yrs or under.
- Receiving care in a rheumatology clinic in England.
Two groups:
- Meet international diagnostic criteria for lupus.
- Do not yet meet criteria for a lupus diagnosis (“potentially evolving”).
|
- Recruited from the 23 children’s rheumatology clinics across England.
|
|
- 846 children in England and Scotland (no contributing centres yet listed for Wales and Northern Ireland)
- Followed until discharged from care.
|
- Rheumatology department captures data at diagnosis and each subsequent visit.
- Annual assessment, which includes blood and urine specimens.
|
- Link to registers held by University of Manchester biologics.
|
UKRR (26, 28-31)
|
- All patients being care for by hospital kidney centres with chronic kidney disease, patients receiving dialysis and patients with a kidney transplant in England, Northern Ireland, Scotland and Wales.
- Expanded to include acute kidney injury in primary & secondary care in England & cases of advanced chronic kidney disease in secondary care, not on kidney replacement therapy, in England & Wales.
|
- All NHS renal centres are required to submit data for patients meeting inclusion criteria, as set out in the NHS Renal Service Specification (A06). The Chief Executive of each trust is responsible for adhering to this contract.
|
- Under Section 251 of the NHS Act 2006, data can be collected without consent for auditing purposes.
- Exempt from the National Data Opt-out programme; means patients cannot opt-out of sharing their data but can opt-out of sharing their identifiable data; this data cannot be linked to any other dataset.
- Patients can consent to being approached to participate in research.
|
- Approx. 70,000 on kidney replacement therapy.
- 500,000 with acute kidney injury.
- Covers 71 adult & 13 paediatric renal centres in hospitals across England, Wales and Northern Ireland1.
- Followed until death.
|
- Renal centres must report data four times a year. Ongoing warehousing project (UK Renal Data Collaborative) aims to provide data in real time.
- Hospital laboratories.
- NHS England’s renal clinical reference group requires all centres to submit to the register.
|
- Collect NHS number to enable linkage e.g. with NHS Blood and Transplant, UK Health Security Agency data.
|
Patients sign up directly
|
|
|
|
IBD (32)
|
- Adults (although plans to expand to children & young people).
- Confirmed diagnosis of Crohn’s disease, ulcerative colitis, IBD unclassified or another type of IBD.
- Living in the UK
|
- Self-sign up through an online form on the IBD Registry website. Must provide their NHS number and date of birth.
|
- Patients consent to having their medical records shared with the register.
- Due to a change in consent procedure in 2022 Registry consists of two datasets:
- Original dataset supplied by NHS Digital, only available as anonymised data.
- Unanonymised data held on own data platform.
|
- Over 85,000 records from 103 partner NHS hospitals in the UK (not including the Channel Islands and Isle of Man).
- Followed until withdraw from study or death.
|
- Gastroenterology unit captures data at each visit.
- Participants consent to being sent questionnaires, although not currently routinely done.
|
- Original dataset stripped of identifiers so linkage not possible.
- Unanonymised data contains NHS number and date of birth ability to link medical records with register data.
|
|
Both
|
MS (33)
|
- Aged 16 yrs or over.
- Confirmed diagnosis of MS.
- Living in the UK.
- To provide clinical data must be receiving treated from one of the NHS centres associated with the register.
|
Two routes:
- Neurologists in large NHS hospital treatment centres associated with register invite patients to participate when they are diagnosed.
- Individuals sign up directly through the website to participate in questionnaires.
|
- Patients consent to having their medical records shared with the register.
- Individuals who sign up to both elements can consent to have their clinical data and questionnaire data linked, and for their questionnaire results to be shared with their clinician.
|
- Between 10,000-20,000.
- Est. 5,500 engaged at each time point.
- Covers the UK, but no NHS partners recorded yet in Scotland.
- No defined endpoint.
|
- MS clinical sites complete an electronic case report file every 6 months to a year.
- 6-mothly patient questionnaires
|
- Link to routine NHS data via SAIL Databank.
- Provide a data linkage services so researchers can link their own data to the register.
|
TABLE NOTES: 1 Scotland has its own Renal Registry (the Scottish Renal Registry), which is merged annually to provide coverage for the whole of the UK, NICE= National Institute for Health and Care Excellence
We identified four key themes that were reported to have enabled or hindered the ability to sustain a disease register. These were: (1) the need to anticipate how data will be used and how this might change over time; (2) unstable funding sources posing a threat to registers’ sustainability; (3) strategies to reduce the burden of primary data collection; and (4) the need to build patients’ and clinicians’ buy-in.
“Start with the end in mind": need to anticipate how data will be used and how this might change over time
One of the key lessons was the need to be “really clear what your goals are” from the outset, otherwise registers risk turning into a "basket collecting data on all sorts of things with no specific question in the end that you can answer [...] can have lots of questions, but unless the questions are clear you can't be sure you're collecting the right data to answer them" (JLSE). The registers we examined were predominantly developed by clinicians and consequently, at least initially, the focus was on the data needed to support clinical knowledge. The patient voice had been largely absent from the agenda setting process, but all interviewees considered that this reflected the norms at the time the registers were established. Interviewees discussed ongoing initiatives to increase patient engagement and involvement.
“[Y]ou need to involve patients and the families, if it's involving children, and that needs to be done in a very meaningful way. So not just a tick box at the end of the day, but really starting by speaking in meaningful ways to a cross-section and a representative, you know group of patients and families, and the public at large […]. So, you need to hear what the views of are around the questions that you've got, and listen to the questions that they have that they want you to answer as well” (JLSE)
Linked to the need to broaden the scope and include a more diverse set of stakeholders, interviewees from the IBD and JSLE registers discussed the need to consider which stakeholders should be represented on the board or any steering committee and the value of including individuals from the different areas that the register touches on.
“The big reflection that's going on at the moment by the board themselves is, actually are we the best people? Should we have a more representative board. […] So, there is a piece of work on going to say, do we have the best board to govern what we do?” (IBD)
Before undertaking any data collection, a number of interviewees highlighted the need to ensure there is a deep understanding of the wider data landscape. Interviewees from the CRPS and JLSE registers stressed that this understanding needed to extend beyond England to the rest of the UK to facilitate harmonisation of efforts initially within the UK but then internationally. One mechanism to support this was having representatives with knowledge of the wider data landscape on the steering committee.
“[England is] only a drop in the world's landscape […] so you need to be compliant with fields and elements that would be collected at first and foremost by devolved nation equivalents, because all the other nations will be wanting to do the same thing. But I would also urge internationally, and that takes you into the realms of how you're collecting data, and what are the data sets you use and standardisation of data sets. […] the more your proposed study can plug into it, then can become a central part of an international, and add to or even lead initiatives rather than being isolated in an island that no one else can connect to, even within the UK.” (JLSE)
Data collection was deemed to be both costly and burdensome (see below). Consequently, we were told that registers should be seeking to draw on existing data collections wherever possible. All of the registers, except the CRPS, have the ability to link to other datasets; although a number of interviewees commented they had experienced considerable delays in access to data from NHS Digital (now part of NHS England). Alongside linkage, the MS register is exploring more innovative methods, such as machine learning, to extract data from existing sources.
“[W]e try to apply natural language processing techniques to outpatient and inpatient letters, so we can harvest a lot of the details that we want from our population for those consented people, and that’s explicit in our consent form too” (MS)
The data management system where the register is housed was reported to play a critical role in the feasibility to undertake linkage. The interviewee from the MS Register discussed the value of storing the register in a trusted data environment. In the case of the MS Register, data are held in a Secure eResearch Platform (SeRP) at Swansea University housed within Wales’s SAIL (Secure Anonymised Information Linkage) Databank, which hosts a variety of linkable routine health datasets and other disease registers (33-35).
“[T]he fact is, you know, all the right like security standards […] you've got the right governance in place, you've got the right method of accessing data in place, you've got the right screening to make sure that only the correct things go out […] we’re not hanging on to all of this silo data to ourselves” (MS)
Other registers, such as UKRR and IBD Registry have developed in-house capacity to store and manage data. The IBD Registry moved from being held by NHS Digital to in-house in 2022. When the register was started it was seen to be beneficial to use NHS Digital to provide a “secure trusted name”, but the data shared was anonymous which was reported to limit what could be achieved. The decision to move in-house was taken to give them “more speed and flexibility” and the data now comes with identifiers. At the end of March 2024 the IBD Registry was transferred to the Royal College of Physicians, who is acting as an interim steward while the register finds a new home (18).
Developing a register and its governance structures was reported to be a time-consuming process. However, investing resources upfront was considered a worthwhile investment to reduce the likelihood of having to make changes later.
“I think of it [the register] like the honeycomb. Hasn't got honey in it, but it took ages to build the honeycomb and get the information governance around it and get all these trusts to sign up" (IBD)
Where changes were made, some were seen as unavoidable. For example, a number of registers were paper based when originally set up and have either moved or are in the process of moving to an electronic system. Other changes were seen as being more avoidable. For example, the original patient consents and data sharing permissions obtained were highlighted as placing limitations on what can be done with the data. Interviewees from the IBD discussed the inherent tension between wanting to be highly specific around how data would be used, and by whom, to foster trust and transparency, and the desire to be able to adapt systems over time. Interviewees urged that in setting up any new register it would be vital to try to anticipate the different ways in which data needs might evolve over time and build in mechanisms that allow for some flexibility in data use.
“I guess making any wording that you do, or any permissions that you get as broad as possible, so that when your scope changes slightly, which it will, the consent you gained originally still covers what you're trying to do now because we've been tripped up by that just a couple of times where we thought that in a patient information leaflet oh, we'd be, you know we're giving them lots of information[…]. But then, of course, when we changed that meant that all of the consents weren't valid anymore. So, it's just thinking how you can give enough information to them without pinning yourself down […]. We've got ethics approval for research database as opposed to specific studies. So, someone could come to us and apply for our data, and we could say, yes we're happy for you to have that and do that research.” (IBD)
"It costs a lot to fund a good register”: unstable funding posing a threat to sustainability
Interviewees told us that both establishing and maintaining a disease register are expensive and that costs can rapidly escalate. Costs extend beyond “databases and technical people, but it's almost as much in comms and engagement and reassurance and public work” (IBD). Securing long term funding was therefore cited as one of the most challenging aspects to maintaining a register. The CRPS Registry has stopped recruiting patients, although continues to collect data on existing participants, because of a lack of funds. The register has survived through the commitment of the community of interested clinicians and researchers and "a wing and a prayer and a nice piece of cake. It seriously is at that level".
Initially the CRPS hoped the pharmaceutical industry would provide some funding but in “2012 the entire pharma industry in the UK decided it was not going to fund nor research pain anymore, and that was a massive blow [...] but these things go around in circles, and perhaps there is a bit more interest nowadays than there was. But subjected to these kind of trends [...] they’re either flavour of the month or no one’s going to touch them with a barge pole”. In contrast, the BSRBR-RA has been fully funded by the pharmaceutical industry since its inception in 2001 via the British Society of Rheumatology. This has proved a stable source of funding as the pharmaceutical industry is required by regulatory agencies to undertake post-market surveillance of new drugs prescribed for rheumatoid arthritis. Funding is currently in place until 2028, with further funding dependent on new products to treat rheumatoid arthritis being developed. Other registers have also found commercial opportunities to raise funds, for example, the IBD and MS registers undertake commissioned research for both public and private organisations.
Where data are used commercially, there is a need to build trust and transparency with patients and patient representatives. The interviewees from IBD argued that “you cannot be open enough” with patient groups. IBD is seeking to strengthen the role of its patient advisory group “all the way through the organisation”. In the case of the BSRBR-RA, the British Society of Rheumatology acts as an intermediary between the research team and the pharmaceutical companies providing the funding (36), although the interviewees considered that attitudes towards the pharmaceutical industry were changing.
“[P]eople felt that academic research had to be separate from anything to do with the pharmaceutical industry. So BSR [British Society of Rheumatology] were kind of that sort of buffer between the two. You know, we're the independent scientific research group, and there's the pharma who are given the funding, but it's coming via the BSR, and the pharma have no play on the research that's coming out, and I think that was that was really important at the time. I don't think that's the case now. I think that there's very much more close links between pharma and Academia, and I think that's widely accepted now. So, in that sense, you probably don't need an umbrella of organization like the BSR. But I do think it's still incredibly useful, whether it be a patient focused group, or whether it be a clinical focused group, or whether it be both, to get buy in." (BSRBR-RA)
Charities devoted to the diseases in question were also cited as key sources of funding. Interviewees perceived that these organisations were incentivised to fund registers as they raise the profile of the condition, and the data provide an important advocacy tool for new treatments and to improve the care of the individuals they represent.
“[T]hey continue to fund [the register] because I think beyond the intrinsic value, because we're expensive, [...] it's producing good research, you know, at the end of the day you put money in you want papers out. They're in higher quality journals, and they have more impact to the MS Society, so they can justify their investment." (MS)
Beyond direct sources of funding, several interviewees discussed the value of access to NIHR Clinical Research Network (CRN) support gained through their inclusion on the NIHR CRN Portfolio. This provides additional funding to support participating sites with recruitment and follow-up of patients, although not all registers have been able to secure this funding.
“We got CRN support, and you know that is a hugely important thing […] if it is adopted then the infrastructure that’s in place in every NHS or an NHS setting will be additive to the research costs [..] it has to plug into NIHR as much as you can” (JSLE)
To reduce costs, interviewees highlighted the need to have a good understanding of the wider data landscape: “I'm always looking for reuse and partnering rather than let's build it all again” (IBD). Where primary data collection was necessary interviewees discussed the need to limit the amount of data collected to avoid escalating costs.
“You need to keep the dataset manageable so that you have good quality and complete data”: strategies to reduce the burden of primary data collection
Tied to the financial costs of data collection, interviewees were also conscious of the burden data collection can place on both clinicians and patients. Where data collection was overly onerous, it was reported to harm the quality and completeness of the data. The pandemic and NHS staff shortages were perceived to have further reduced the ability to collect data.
"[T]he NHS is so stretched, and I would say that that is one of the themes in terms of data quality, when we send back our queries and our summaries, it's getting trickier to get people to actually have the time to look at those queries" (UKRR)
Interviewees discussed a number of strategies taken to reduce the amount of primary data collected, in particular moving to linkage to reduce pressure on sites.
"There's only so much you can ask nurses and doctors to do without giving them any recompense. So, we need to be really sort of aware of what we're asking, how much we're putting on the sites, and because they have so little time. So, it's so hard, and we're trying to move more to linkage rather than putting the pressure on the sites. And we've tried to strip down the questions that we're asking the sites as well." (BSRBR-RA)
A number of the registers have streamlined the data items to a core set of measures, working with clinicians to build a consensus on what is most important to understand from a care point of view. In doing so, they have aimed to integrate data requests into routine care.
“[T]he data collection is integrated into standard care, so that required a huge amount of engagement with clinicians across different specialities […] therefore you need to ensure that you have a very active engagement programme” (JSLE)
Interviewees from some registers pointed to challenges that the lack of a standardised IT system across the NHS posed to data collection. To reduce the burden on clinicians, the MS and IBD registers have developed “system-agnostic” tools. However, interviewees reported that data are submitted in different formats. As a result, a lot of data cleaning and validating is required before data can be uploaded to the register. The UKRR employs a dedicated in-house team. While this was noted to save clinicians’ time and facilitate buy-in, it generates extra costs for the register.
“It would be tool-agnostic, was the phrase, because every trust has a different system […] There, wasn't a one size fits all. It would be system-agnostic. Here is a tool. If you want to use the tool. If you already got your tool, you could upload to us from your tool.” (IBD)
The IT system was also reported to limit the flexibility to change the data collected.
"[H]ave a well-established and published change management process, so that you, aren't adding data items willy nilly because it's difficult for centres to, if they're relying on a renal system supplier, then there's all the work that goes into adding data items on to the system, then, having it mapped within the hospital, and then making sure that people know that they're supposed to be recording that data and all those sorts of things.” (UKRR)
Registers were seen to reduce the burden on patients by acting as a central resource, “a one-stop shop [...] [patients] don’t have to be putting their information everywhere all of the time” (MS). Where data are lacking, many registers have developed mechanisms to expand the data collected either through data linkage or by approaching participants to participate in additional data collection. For example, during the COVID pandemic the BSRBR-RA, IBD, MS and UKRR registers all expanded data collection to capture the impacts of COVID-19. The ability to be able to either collect more data or contact participants is dependent on prior consent being sought.
“We have NHS ethics to ask, you know, staff and patients and people with MS. This is flexible enough that we can put additional instruments as is required and we have in the past. It’s one of the services we offer for other researchers of MS and other conditions” (MS)
“We recognise that there needs to be a carrot”: maintaining patients’ and clinicians’ buy-in
Building and maintaining buy-in was reported to be challenging. For example, NHS hospitals are required to submit data to both the BSRBR-RA and the UKRR; for the BSRBR-RA, “NICE actually mandated that all patients on these new biologic drugs should be registered and followed within this system. So we got really good buy in from the rheumatology community” while participation in the UKRR is specified in the NHS Renal Service Specification (A06) and the chief executive of each Hospital Trust is responsible for ensuring data are recorded accurately on local IT systems and all required data are uploaded electronically to the UKRR (30). . However, in both cases, this has proved impossible to enforce and the BSRBR-RA in 2008/2009 “decided not to mandate it anymore, and after that it was the British Society for Rheumatology that then put their recommendations in place that all patients should be registered on these drugs in the study”. Interviewees linked this to the lack of a financial mechanism to make this happen.
“So [NHS Renal Service Specification (A06)] sets out that renal centres must be able to send 100% of our dataset to us in electronic format. […] the problem I feel is that because […] not being part of the NHS, because we’re completely independent, but I think historically it’s been a problem because we don’t have any teeth. It hasn’t been enforced, it’s not like CQUINs [NHS Commissioning for Quality and Innovation incentive payments] where there is finance associated with whether you return the data. So, moving forward with the data warehousing and out new dataset we’re pretty sure that it is going to be mandated by NHS England. So, we’re just waiting for that to come out which will make life easier” (UKRR)
In the absence of financial remuneration, interviewees across registers recognised the need to provide other incentives to foster buy-in. The involvement of a network of interested clinicians was seen as one mechanism to develop “social buy-in and some sort of moral or ethical driver”, while being able to demonstrate the impact data are having on the understanding of the condition, clinical practice and patient care was another. All registers publish routine insights and provide access to the data to support academic research.
“[W]e have strong buy in. I mean we don't provide the centres with any payments or any reimbursement for all of this data. but you know that there's so many decisions are made based on the data that clinical decisions are made based on the data that's come out of the register.” (BRSRB-RA)
However, the timeliness of the data was reported to limit the value to day-to-day decision making in clinical settings. To better support clinical decision making and provide more timely assessment of patient care, the UKRR is currently supporting renal centres to transition from the existing system, in which data are submitted on a quarterly basis, to receive daily updates from renal centres submitted via the UK Renal Data Collaboration (28, 37, 38).
“When the registry was originally set up nothing like it had existed before, so the publication of an annual report was incredibly useful for comparison and audit but now things have moved on. And actually, by the time we’ve collected the data and published the data is, you know, two years old and people want data now” (UKRR)
Improving access to the data was also seen as important to support patient engagement. Both the UKRR and the MS Register provide patient participants with access to their data to help them to monitor their conditions themselves. The MS Register interviewees discussed anecdotal evidence that patients were sharing results with their clinicians during consultations.
“[W]e do something quite unusual. We actually give them data back. So, as you answer these PRO's [patient-reported outcome measures] that I've told you about. We actually give them a graph and say you're here and last time you were there, and we all look at our steps and stuff these days, so the thinking was you can monitor your MS […] they can show [their doctor] on the screen or we can send [their doctor] the link […] so we hope in the longer term this will boost participation too. [...] As well as saying oh by the way your data has gone to three publications this year, and these are them, which I’m not sure most people care about, I think it gives you a good feeling at the back end to actually you say this is for improving research in people with MS and yeah my data did make a difference there.” (MS)
Patients’ willingness to participate was also linked to the knowledge of the individual undertaking recruitment and the need for material that clearly articulates the benefits of participating. The involvement of charities and disease organisations was also reported to foster buy-in.
“[I]f you want to get buy in from the hospitals and the doctors that you're approaching, I think it's been really helpful for us to have the British Society for Rheumatology to help us with that because obviously all the doctors and now the nurses as well […] So the buy in from the community really comes with that kind of umbrella organization.” (BSRB-RA)