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Acceptability and perceived barriers and facilitators to creating a national research register to enable ’direct to patient’ enrolment into research: the Scottish Health Research Register (SHARE)

Acceptability and perceived barriers and facilitators to creating a national research register to... Background: Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. Methods: We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. Results: The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. Conclusions: This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers. Keywords: Research register, Recruitment, Randomised controlled trial, Qualitative * Correspondence: a.m.grant@dundee.ac.uk Population Health Sciences, Medical Research Institute, University of Dundee, The Mackenzie Building, KirstySemple Way, Dundee DD2 4BF, Scotland Full list of author information is available at the end of the article © 2013 Grant et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Grant et al. BMC Health Services Research 2013, 13:422 Page 2 of 15 http://www.biomedcentral.com/1472-6963/13/422 Background Institute [12]. The Diabetes Research Register in Scotland Between 30-50% of all randomised controlled trials fail has already shown that response rates are likely to be to recruit a sufficient number of participants [1]. In a higher, significantly faster and with fewer screen failures speech on 5th December 2011, the United Kingdom’s amongst patients who have previously considered and (UK) Prime Minister proposed two main changes to the expressed interest in participation and whose electronic use of data collected in the National Health Service records (EHRs) are used to identify their suitability for (NHS) in an attempt to address this issue [2]. Firstly, he studies, than the general population [13]. advocated a public consultation on changing the NHS Given the increasing adoption of EHR systems in constitution to enable all patient data to be “automatic- the UK, we believe there is a considerable opportunity ally included in clinical research” with an opt-out for to use the data within EHRs to identify people for re- those who did not wish to participate; and secondly, a search projects though the risks of doing so need to mechanism to provide researchers access to NHS re- be addressed [14-16]. The proposed model was de- cords to identify and directly contact patients who might veloped following national discussions with a range of qualify for clinical trials. There is now a widely accepted key stakeholders, including the British Medical As- realisation that the ability to conduct clinical research is sociation (BMA), research charities, patient repre- threatened in the UK. Similar concerns are also being sentative groups, the pharmaceutical industry and the expressed in many other countries [3,4]. Scottish Government [17]. Instead of self-reported Other strategies to improve recruitment of participants health data, we proposed using clinical data in med- to trials have recently been assessed in a Cochrane re- ical records and linked information in laboratory and view, but with the exception of telephone reminders and administrative databases across Scotland [18]. opt-out strategies, most were found to be of limited value [5]. An alternative approach is the creation of a A national research register - proposed process model register of patients who have expressed a general interest Briefly, the technology now exists to extract data from to participate in research. Such an approach may entail various EHRs (primary care, dental, hospital records registrants volunteering information about their health and many more) and link this information via the pa- or patients giving permission for research teams to tient’s CHI number. Data linkage makes it possible to search their electronic health records (EHRs) to assess identify patients who may be eligible for studies based whether they met the eligibility criteria for studies. If so, on data held in their EHRs. The proposed register they could then be informed about relevant studies and model only holds registration and contact preference offered the chance to participate. Volunteer research data on patients; when linked to eHealth records it en- registers already exist, varying in terms of disease [6,7], ables the identification of potentially eligible patients study type [8], and location such as the pioneering ‘Vol- for studies Figure 1. unteer for Vanderbilt’ system [9]. Registrants are notified Patients either register via the website or completing electronically when they are a possible match to a pro- their details on a form for secure entry by register staff. posed research project and they then make the decision In doing so, they are providing consent for to their EHRs regarding the release of their contact information. The to be securely searched within the NHS to assess Vanderbilt approach is now being adopted nationally in whether they met the eligibility criteria for studies which the United States of America (USA) as part of the new have NHS ethical and governance approval. US Research Match program, which comprises a con- Researchers contact the register administrators with sortium of institutions under the aegis of the National their inclusion and exclusion criteria, and if all the ap- Institutes of Health (NIH) [10]. These registers ensure propriate approvals were in place, an electronic search is that personal information is protected until volunteers carried out to identify eligible patients. Patients are in- authorize the release of their contact information to a formed by register staff about relevant studies and of- specific study. MediGuard is another system which pro- fered the chance to participate and if interested respond vides a free medication monitoring service and enables directly to the researcher. its 2.5 million registrants to be contacted directly about research for which they may be eligible [11]. In Scotland, the unique Community Health Index (CHI) has allowed Aim deterministic record linkage of health data since the In the context of developing the system specification, we 1970s. This has enabled the development of exceptional sought to explore the acceptability and feasibility of the data resources and long tradition of excellence in eHealth national research register model to patients, clinicians, informatics research recognized by a leading role in the healthcare management staff and researchers to under- UK’s network of health eResearch centres funded by stand their perspectives on key facilitators and barriers the MRC and a consortium of other funders: the Farr to engagement. Grant et al. BMC Health Services Research 2013, 13:422 Page 3 of 15 http://www.biomedcentral.com/1472-6963/13/422 Figure 1 (See legend on next page.) Grant et al. BMC Health Services Research 2013, 13:422 Page 4 of 15 http://www.biomedcentral.com/1472-6963/13/422 (See figure on previous page.) Figure 1 An example of how a research study enquiry will be processed by the proposed research register. An enquiry will be received and checked by register staff for eligibility. Once eligibility is determined search criteria will be generated and a search will be run on all relevant databases for matching Community Health Index (CHI) numbers. These databases will include the Scottish Morbidity Records (SMR), GP records and laboratory data to name a few. This search will generate a list of research interested patients with eligibility criteria for the study in question. The register staff will check if any of these people have recently been contacted about another study. If available the patient will be contacted and willingness to participate will be explored. If they say no the register will be updated and if they say yes, the researchers will be given the patients contact information and the register will be updated. Methods with experience in data-linkage and recruitment to Focus groups and semi-structured interviews were clinical studies. conducted between February and June 2011 with pa- tients, general practice staff from NHS Tayside and Data generation NHS Lothian and academic researchers from the local The focus groups and interviews sought to establish if University. Focus groups were chosen for patients as the proposed model was acceptable to key stakeholders the concept of a research register would be novel and and to gain an understanding of their perspectives on focus groups present an efficient way to demonstrate how the register should operate and be advertised; to in- new ideas, allow people to use the responses of others form the design, development, operationalisation and as a starting point, and are especially helpful in under- promotion of a national research register. standing nuances of attitudes, beliefs, or opinions. In- Prior to every focus group and interview, the facilitator terviews were considered more efficient for health gave a short presentation as to the current problems service staff that have difficulty attending focus with patient recruitment to research and how a national groups. This study was approved by the Tayside Com- research register was expected to work, including infor- mittee on Medical Research Ethics B, (reference num- mation about possible mechanisms for participation and ber: 11/S1402/6) and written informed consent was data extraction and linkage mechanisms. These discus- obtained from all participants. sions were further facilitated by a topic guide as an aide memoire, audio-recorded and transcribed verbatim. The Sampling and recruitment topic guides and presentations were modified between Research interested general practices in two Scottish focus groups and interviews. Focus groups with patients health boards were identified via the Scottish Primary and researchers lasted approximately an hour. Focus Care Research Network [19]. groups with patients were held in local health centres General practices: General practitioners (GPs) and and with researchers within the University department. practice managers from 10 practices were invited to take Telephone interviews with GPs and practice managers part in telephone semi-structured interviews. This was a lasted for approximately half an hour. purposive, convenience sample to gain perspectives from clinically active GPs who act as data controllers. Data analysis Focus groups and interviews were conducted by two so- Patients cial science researchers (AG & DN) and the focus We aimed to recruit a maximum variation sample of groups were supported by a rapporteur responsible for ages, rurality, sex and deprivation, via the participating writing notes and capturing key points. All the audio- general practices. 732 patients from five practices were recordings were transcribed verbatim. The transcripts invited to attend focus groups by their general practice were read and re-read by three of the researchers inde- on behalf of the research team. No reminder letters were pendently (DN, JU & AG). An initial coding frame was sent. developed inductively from the interviews, and disagree- In addition, focus groups were organised with admin- ments were discussed and resolved. This was then sys- istrative members of staff from the local hospital and tematically applied to all transcripts. Themes were university to gain a wider patient perspective. organised under related concepts derived from the topic A focus group was also held with members of the local guide and thematic analysis. The data was explored for Public Patient Partnership group (PPG). negative cases [20,21]. Research staff Health service researchers and data analysts from the Results/findings University of Dundee were invited to take part in a A total of 17 general practitioners and practice managers focus group. Participants were purposively selected were interviewed, 37 people took part in seven patient Grant et al. BMC Health Services Research 2013, 13:422 Page 5 of 15 http://www.biomedcentral.com/1472-6963/13/422 focus groups and 10 health service researchers took part “…I’m here to find out a little bit more about it, I don’t in another focus group. know enough at the moment. And I also think pre- authorising people to access my data might be an issue. I don’t know what sort of studies you’re doing” (Male, Patient perspectives of a national research register patient focus group 3, PPG). The following findings are from the seven focus groups held with patients. Although most patients perceived the register to be for the ‘common good’, those who said they were likely to register indicated that their rationale for registering Acceptability of a research register would be primarily personal with the hope of future The focus group discussions were generally positive to- health gains for themselves or their family, so would be wards the concept of a research register. Participants in interested in contributing to research in areas of concern the patient focus groups could understand the aims and to them. rationale for the register and made reference to the ben- efits as being for the ‘common good’ and to advance “…I’ve got arthritis in my spine and if there’s something research: new or something that can help wi the pain I have, which is not constant then I’d be willing to try anything “….. I mean it’s a better system than it is at the present, cause when it’s bad, it’s bad.” (Female, patient focus because you are going to get 100% response that way or group 1.). near enough and the present system is that the GPs put out things on spec to people that may want to join this Some participants did provide a more altruistic ration- thing and they may get a very low return” (Male, ale for registering. patient focus group 3, PPG). “…I’ve been, had quite a few things done under the NHS And: the past two or three years so I’m quite happy to put things back” (Male, patient focus group 3, PPG). “..the great advantage of a system like this is that if I was a researcher dealing with a rare disease and I Our data show that the concept of a research register wanted to get together everybody in the country, or is acceptable to patients who volunteer for research via perhaps all five of them for instance to do some trial on invitation from their GP practice. We do not suggest them, I could identify these people” (Male, patient focus that all patient groups would be likely to enroll with a group 2). research register but these findings suggest that a re- search register is likely to recruit patients who wish to There was a willingness to participate in the register, give a ‘gift’ to society or who wish to contribute for per- with the vast majority of the patient participants indicat- sonal gain. Doubts have been expressed about the ability ing they would be likely to join the national research of biobanks to deliver on ‘promises’ [22]. It is not the register, in principle: intention of a national research register to make any claims about enrolment and participation in research “Well I think it’s a good thing to get involved in leading to improvements in health care prevention, diag- (referring to a national research register), I just felt that nosis or treatment regimens which may give patients I wanted to do it and…quite happy….to see what false hope. happens now, as you say I can withdraw if I’m unhappy, if I’m happy I’ll just stay in….” (Female, What would expedite confidence to facilitate recruitment patient focus group 4). to a national research register? The participants of the patient focus groups identified a And: number of conditions which they felt should be met in the design of a national research register and website to “…research register seems like a great idea, why has encourage confidence and facilitate recruitment: nobody done it before?” (Female, patient focus group 6) Information about the kind of personal data extracted from The remaining participants felt they required more in- patient records formation about how the research register would oper- Some participants wanted more information about the ate, including recruitment and management processes nature of personal data which would be extracted from (these issues are addressed below). patient records. They had reservations about more Grant et al. BMC Health Services Research 2013, 13:422 Page 6 of 15 http://www.biomedcentral.com/1472-6963/13/422 sensitive information being accessed as the quote below records sit? Because I would like my records to be illustrates: available throughout the country, I don’tcareonce they’re on the internet and a doctor here can call “Yeah and what would be, the factual information that them up, but I’m totally surprised how if you goes into this Register, you know in terms of actually the move from one practice to another your records factual information that goes there, for instance thinking can’t now electronically move easily.” (Male, patient about mental health and thinking about, you know focus group 1) things, or disclosure or sexual abuse or, all these kind of things …” (Female, patient focus group 4). And Some focus group participants expressed the view that “Does Alex Salmond’s (Scotland’s first minister) that people might not wish to participate in studies department and does Shona Robinson from Dundee, as about sensitive issues. Designers of the research register health minister in Scotland, are they not already also considered that people may not be aware or may looking at these figures and data?”(Male, patient focus have forgotten their health care record contains sensitive group 2) information and access to certain information could make registrants vulnerable. Based on these observations All participants were informed of the research ethics, sensitive information would not be accessed by re- governance and legal frameworks within which re- searchers without explicit patient consent. On occasions search teams and the operators of the research register where researchers might want access to information are accountable. Patients were reassured by this and such as mental or sexual health they would only be pro- felt this information should be made available on the vided with anonymised data within the strict ethics and register website, along with how particular studies were governance rules and regulations which are in place to approved or included in the register: protect vulnerable patients in accordance with the pro- portionate governance arrangements of the Scottish ”…I understand, I understand, I am a lot more Health Informatics Programme (SHIP) [23]. enlightened”, (male) “That information should be made available for people” Concerns about data security (female) (Patient focus group 2). All participants wanted reassurance their data was to be handled securely. Participants recruited via the local And University and NHS hospital were already informed of some of the governance and legislative issues involved in “One of the things I’d like to see is that there was a sign handling confidential patient data. off on adequate training on all the legislative requirements for holding people’s data…you know if “… if you don’t think your data’s secure then it's really, you’re going to minimise risk then everybody has to really going to, to put a lot of people off, you know, it know absolutely where the legislation lies..” (Female, just takes one slip up in that department and that’s just patient focus group 1). going to completely put people off from signing up” (Female, patient focus group 6). Although participants were concerned about the sen- sitivity of some data and the security of all data and And were reassured by governance and legislative controls it was difficult to ascertain their views about these issues “..reassurance…it would just be few hands and eyes … so in relation to data extraction and linkage. Specific con- it's not being passed around” (Male, patient focus group cerns were not raised and questions were not clearly 6). responded too. Whereas, participants recruited via general practices Reassurance about levels of commitment involved in the assumed the electronic transfer information within the register NHS was already taking place and some assumed politi- Despite understanding the rationale behind the register cians had access: and being willing to register participants were ambiva- lent about making open-ended commitments. Some par- “…I don’t mind where my data goes…I just wondered ticipants argued that registrants may not always be able when and where and who was doing this. Was it to contribute to research or only to studies with minimal Scottish Government or the NHS and where do your involvement. Grant et al. BMC Health Services Research 2013, 13:422 Page 7 of 15 http://www.biomedcentral.com/1472-6963/13/422 “I suppose I don’t yet understand how much of my time, more intensive participation. Suggestions by researchers what people would be asking me - would it be lots of designing the register to resolve this issue have centred projects?” (Female, patient focus group 6) on a maximum of three invitations per year. This section has raised some important concerns And around sensitive information, data security and levels of involvement. These concerns raise the issue of who “Yeah, I suppose it just depends what’s like going on in should be in control of a national research register. your life at the time, you know how busy you are with other things.” (Female, patient focus group 5) Patient perceptions of how a national research register should operate Or The focus groups also set out to understand patient per- ceptions of how a national research register should oper- “…probably ones that take up the least of your time, ate, exploring issues such as ownership and control of 'cause if you've to keep going to the surgery or go the registers and the involvement of pharmaceutical somewhere to do things, if you get a questionnaire in the companies. post, I'd quite happily fill that in and post it back” (Female, patient focus group 1) Who should host a national research register? All participants placed trust in Universities and the NHS During the focus group discussions participants were as potential organisations to host a national research asked how often they thought registrants should be register, indicating they would prefer public ownership. contacted to participate in research studies. “…but government, Universities, charities, I would’nae “..I don’t know perhaps if I was being asked to do have a problem if they were behind it but I think the something every week I might think that’s a bit much, drug companies, I would step back from that” (Female, but if it was may be once every six months I would patient focus group 6). think that was alright, once a year, that’s alright…it just depends… (Female, patient focus group 3, PPG) Within these public organisations patients would pre- fer access to their data to be controlled: There was no consensus about frequency of contact because the research studies which will hopefully utilise “I would like, like as little people as possible, you know I a research register will have differing levels of involve- don’t want every NHS staff to be able to access it, I ment. Participants felt reassured that they could have would want core (national register proposed name) options to refuse to participate in a study which would registered people, you know not even researcher, I be easy to complete and not time consuming and oppor- wouldn’t want them to be able to access it, I would tunities to withdraw if their circumstances change. want them to be able to go to somebody who was in charge of the database to be able to give them the “I mean sometimes you go into these things thinking information out, I wouldn’t want a lot.” (Female, patient that’s fine….it’s only an hour a month or whatever but focus group 5) sometimes life doesn’t give you that opportunity” (Female, patient focus group 2). It was important for the patient focus group partici- pants that a national research register was to be publi- Of more concern was that participation in one study cally owned and controlled by public servants. One of may prevent them from taking part in another: the main reasons these participants gave for an intention to register was for the common good, so they perceived “…if you’re taking part in a longitudinal study, as I the register to be a public service and that benefits have done in the past, and it’s just a question of, it’s just should be publically based. a kind of questionnaire about my diet and that kind of thing, would that prevent me from taking part in something else?” (Female, patient focus group 3) Access to a national research register Discussions about the register primarily focused on This raises questions about how participation in a na- the implicit assumption that access would be by med- tional register may be ethically monitored. Some studies ical personnel and academics and research scientists may involve participation in a ‘one-off’ interview or employed by Universities. Participants had particular questionnaire study whereas other studies may require concerns about access by insurance companies largely Grant et al. BMC Health Services Research 2013, 13:422 Page 8 of 15 http://www.biomedcentral.com/1472-6963/13/422 because it was felt they could use this information to research study they will be informed of the funding refuse to pay out on insurance claims. body. This is likely to result in the register requiring a larger number of registrants for commercial than pub- “I’m not sure if anyone’s investigated the potential lically funded studies. implications of anyone with a life insurance policy joining something like this and whether that voids, The promotion of a national research register invalidates or causes any effect on their insurance given There was a general feeling across all the focus groups that they can be particularly funny when it comes to that a national research register would require both local claims later in life…” (Male, patient focus group 4) and national promotion as a public good. They perceived that the register’s success would depend upon public Participants had polarised views towards the poten- awareness, and on highlighting the benefits of taking tial involvement of pharmaceutical companies. They part in research and the contribution to society. In the perceived involvement to be in the funding of the regis- general practice recruited focus groups this topic was ter or in the funding of particular studies recruiting returned to more than once. through the register. The majority felt the involvement of pharmaceutical companies in the infrastructure of “…personally I think this register should be sold as the the register would put them off registering whereas benefit to all of us from birth to death…but I believe others felt the involvement of these companies would that if you start it now you have to catch the attention help investment. of the young kids to have this evolve through 50 years…” (Male, patient focus group 2). “I can see how that would attract the pharmaceutical companies to invest (in the register) if there was this They favoured promotion by a range of media: spin off effect….an economic benefit” (Male, patient focus group 2). “Well it depends if I had the budget or if I had other mechanisms, if budget was no object the television’s And obviously a great mechanism” (Female, patient focus group 4). “I would be slightly more concerned if they went out wider commercially, say Glaxo-Klein or whatever got And data as part of the research register” (Male, patient focus group 1). Concern was focused on how ethical “…it would be something that could be advertised to pharmaceutical companies would be “…drugs everyone, like say on the television or you would hear it company… they always have a vested interest in the on the radio so you know that it’s not something, you outcome don’t they really?” (Female, patient focus know secretive about, a secret project, it’s about group 3, PPG) something that everybody could join in.” (Female, patient focus group 5) For some involvement of pharmaceutical companies in finding research was a necessary evil: “…the drug com- Or panies are just trying to make money, and yes of course they are, it’s all about money in the end of the day but if “I guess information leaflets through you know the door they don’t find the research for some of these the less in- I guess, you know that would get to the (health board teresting or less topical things then they, there will not be named) population…I’m not so keen on emails but research into those things…we need to get funding from certainly something through the mail is always good or, drug companies anyway, if they’re the ones with the you know posters up around the hospital or in the GP money.” (Female, patient focus group 3, PPG) surgery…” (Female, patient focus group 6) The involvement of pharmaceutical companies was controversial and investment by pharmaceutical com- There was consensus among all participants, if pa- panies in the infrastructure of the register is likely to tients were to be written to and invited to participate in influence registration. A large part of making wider the research register this should be by their general health benefits a reality, such as those desired by the practitioner (GP): focus group participants (improvements in prevention, diagnosis, and treatment), will require the funding of “I do think it (a letter) would be better coming from pharmaceutical companies. This concern has ensured their GP” (female) that when patients are invited to participate in a “GP, Yeah” (female) Grant et al. BMC Health Services Research 2013, 13:422 Page 9 of 15 http://www.biomedcentral.com/1472-6963/13/422 “…I think in terms of response people would prefer their Acceptability of a research register GP because it’s someone that they know, trust in….you’d All GPs and practice managers interviewed could under- just treat it like every other thing and probably just stand the rationale for a national research register, were discard it.” (female) (Patient focus group 1) aware of recruitment issues and were in favour of a re- search register, in principle. There was however a lack of agreement amongst pa- tient focus group participants as to the best way to pro- “..in principle it sounds like a good idea, I mean mote a national research register. Some participants obviously research is very important and it's difficult to were strongly in favour of invitations coming from get people for research.” (Female GP interview 5) their GP. As recruitment to research via general prac- tices is increasingly becoming more difficult with the Security and confidentiality of patient data additional pressures on GP time, these findings suggest Of primary concern to all GPs and some practice man- a range of media would be appropriate to appeal to agers was the security and confidentiality of patient data cross sections of society. within a national research register. “I think being reassured about the security of the patient Invitations to join research study data would be sort of, you know 1A on the, on the list of Participants were asked how they thought registrants things that we need to, to be absolutely 100% eh should be invited to participate in research studies and reassured by before we could … agree to getting there was agreement invitations should initially come involved.” (Male GP interview 6) from the research register: And “Well, I think if initially you’ve signed up to this through a letter from your GP….I, to get the invitation for the “I mean from our point of view confidentiality is one study, that’s when I think it should come from SHARE of the kind of absolute … youneedtobesocareful (research register)”( Female, patient focus group 6). about if you're giving letters about patients, there's no third party references and secure e-mails and all And that - so you're thinking “where do we stand with the law?”… I, I guess you'd have to set it up in such a “That would be fine for me, cause I know that I’ve way that the patient was fully aware of what they signed up for that so I would, you know, you would were signing up to including what data would be expect something to come through at some point” (Male, accessed and how it would be accessed and with patient focus group 2). whom it would be shared.” (Female GP Interview 1) There was a real sense in the patient focus groups And that a national research register should be perceived and promoted as a public good, which should be in “I'm not an IT expert but it just feels like the more public ownership and operated by public servants. people there are who have access potentially to The involvement of pharmaceutical companies was patients’ records, themorechancethere is that contentious, with some participants perceiving their there’ll be, it, confidential information leaked and I involvement in funding research studies as a ‘neces- mean I know there was an episode fairly recently in sary evil’. The appeal of the register as a public good Fife where somebody was accessing the Emergency was thought to be important for inclusion in any ad- Care Summary that wasn’t supposedto be, andyou vertising, highlighting registration as contributing to know there'salwaysthatpotential” (Female GP the good of society. interview 5) Perspective of practice managers and general As the Caldicott Guardians of all patient data held in practitioners of a national research register the GP electronic patient record, it is perhaps not sur- The general practitioners and practice managers in- prising that GPs were concerned with data security and terviewed were generally in favour of a national re- confidentiality. Caldicott guardians are responsible for search register; they however expressed concerns the safe use and handling of identifiable patient infor- over the security and confidentiality of personal pa- mation. This suggests GPs will require assurances about tient data and the impact a register would have on the security of the register, including accountability and their workload. transparency mechanisms. Grant et al. BMC Health Services Research 2013, 13:422 Page 10 of 15 http://www.biomedcentral.com/1472-6963/13/422 The first two quotes illustrate the range of views held mobiles so often…. we also have a high turnover of by GPs regarding ownership and consent for use of pri- patients as well, so you might find that by the time you mary care data. Views were polarised with the first quote get in touch with somebody they’ve left or moved..” illustrating that some GPs perceive they would have veto (Female practice manager 4) as to whether patient’s data was extracted and the sec- ond quote illustrates that GPs perceived consent was en- These findings raise important issues for a national tirely at the patient’s discretion. This raises interesting research register as to who has veto over the use of questions for the research register, such as “who is the primary care data and whether GPs will be required to custodian of the data?” and “can GPs veto access to pa- screen lists of patients for eligibility. The register will tients’ records once a patient has registered?” rely on primary care data to provide up-to-date con- tact information and to provide longitudinal data on Impact on workload patients as these are the only health care records to The impact on workload was a key concern for the ma- hold information on a patient from cradle to grave. We jority of GPs and practice managers interviewed. They expect GPs to consider whether they agree to the use had two primary concerns in this regard, firstly the im- of the data held in their records on a study by study pact of patient queries about register or research stud- basis taking into account the patients’ expressed ies, in particular, if letters were to be sent to patients wishes to be contacted for studies in which they are on practice headed note paper. Secondly, GPs were potentially eligible. These findings show GPs are an concerned they would be involved in screening their important group of people to have on board with the patients to ensure they are eligible to take part in stud- register and promotion of the research may need to ex- ies. Currently in the UK, GPs screen lists of patients tend beyond patients. who meet research study eligibility criteria. Despite be- ing concerned about workload from screening patients Health service researchers’ perspectives of a national they saw this as a necessary evil, to protect both pa- research register tients and researchers. The following findings are from one focus group with 10 health service researchers, data analysts and an IT “…workload attached with people contacting the manager from across primary and secondary care surgery for advice on “should I get involved in this based research. research project or not?”…but yeah potentially that’s used up a GP appointment to do that, and that’s, that Benefit of a research register seems a bit of a, a lost opportunity… 'cause yeah, a Researchers were supportive of the initiative seeing a na- patient may be inappropriate for one study but tional research register as having the potential to over- appropriate for another study, the same patient and come their problem of accessing and recruiting patients not having a feel for that because often we're obviously and offering the advantage of more rapid access to a more aware of what’s happenedinpatientssortof wider pool of patients. personally circumstances month to month and you know a patient that was suitable for a research projects “..you can only contact them through their GPs, for last week may not be this week if they're, you know just specific studies, whereas this would be a much wider had their partner, em has died or eh, something else opportunity.” (Male clinical researcher, research focus going on their life or some other new medical condition group) coming along,” (Male GP interview 6) And And “Well, I’m sure the benefits for patients is more that “… I mean the work of screening that list, I guess that in you’re giving them more opportunities to take part in itself might be a considerable job..” (Female GP, research. There are a group of patients who object to the interview 5) GP being the gate-keeper and feel that they should be asked rather than the GP deciding whether they should Practice managers were concerned about the need to be asked is the main benefit” (Female health services ensure that information in patient records was up-to-date. researcher, research focus group). “…the telephone numbers of the patients constantly Although supportive of a national research register, re- change and it's really even hard for us to keep updated searchers raised some issues they felt needed to be with their telephone numbers 'cause they change their addressed to ensure the functionality of a register: Grant et al. BMC Health Services Research 2013, 13:422 Page 11 of 15 http://www.biomedcentral.com/1472-6963/13/422 Concern a national register may not be representative There’s examples over the last fifteen months were Some researchers raised concerns GPs may be able to patients were approached through various registers and block patient involvement in the register by refusing ac- they’d died.” (Male data analyst, research focus group) cess to patient’s personal data or by not giving permis- sion for the data-extraction to take place from their And clinical system: “If someone has said I’m happy to be contacted and “It has to be through the GP so if their GP doesn’t want some researcher contacts him unfortunately after he’s to be involved, you can be losing a great amount of died, it’s not acceptable….you need to make sure that patients that may be willing to take part in this you didn’t do it again” (Male health services researcher, research and it is because their GP is gatekeeping” research focus group). (Female health service researcher, research focus group). And And “That comes back to the idea that maybe this does need….at least the request to participate does need to be “…you will have a two-tier system whereby you would routed via the GP, even if it’s electronically to establish have presumably a very large cohort of patients who that they’re still alive and what conditions they have had agreed and whose GPs had agreed to make the and then you approached them” (Male health services data available and then perhaps a much smaller sub- researcher, research focus group). group of people who had agreed and for one reason or another the GPs felt they didn’t want to share the GPs record when a patient is deceased and the register data..” (Male clinical researcher, research focus group). can also be linked to the Scottish General Registrar Of- fice (GRO), the research register will extract data from This also raised the issue about whether GPs can veto GP practice systems nightly so the information used by patients’ participation in the research register. the research register will be the most up-to-date and the Others were concerned that only the middle classes chances of a deceased patient being identified are min- would register: imal. There are other reasons for which GPs screen patient lists, such as a close family member recently “Is there a danger…that you’re only going to get these passing away. very middle class people so all the trials end up being done on people who have not really got anything wrong Discussion with them?” (Male health services researcher, research There was clear support for the concept of a research focus group) register to facilitate recruitment to research studies from patients, practitioners and researchers. Although sup- This is a common problem in research, in particular portive, some patients and GPs require assurances about with studies which use opt-in models. An important data security and accountability. Without these assur- issue for some studies hoping to use the register will be ances in place researchers were concerned the register the representativeness of registrants. It is therefore may not be representative and/or GPs may be able to intended that targeted advertising and social networking veto patient’s participation in the register. will attract patients from a wide range of groups in Scotland has a public sector health service covering society. the entire population, and using a single patient identi- fier for all health records. This offers a unique opportun- Measures are required to ensure eligibility of patients ity, with cradle to grave records on the whole population Researchers expressed concern about contacting de- in a range of EHRs (primary care, hospital, dental, pre- ceased patients and would like to see some measures in scribing, laboratory, screening and immunisation re- place to protect against this in the national research cords). There was general agreement that these records register: should be used for the public good, an assumption by patients that at some levels this was already being done, “I take it one of the benefits we’re looking for is to and no questions were asked about the technical ability prevent what’s happened in the past, people making to data link, extract or search the records of those on contact with patients who have been deceased since and the register. the accuracy…..what’s the lag between the register being For the patient groups in our study the motivation for updated and someone actually being approached. participation in a national research register was largely Grant et al. BMC Health Services Research 2013, 13:422 Page 12 of 15 http://www.biomedcentral.com/1472-6963/13/422 self-interest although some were happy to volunteer be able to influence uptake or access to data at three without any expectation of direct benefit to them. Any stages of the research register process: 1) registration; 2) promotion of a national register must be careful not to data access; and 3) utilisation. As a result it is important give patients false hope and to promote participant al- to address the concerns raised by GPs about the impact truism. For those who chose to give a ‘gift’ to society it is on their workload and provide reassurances regarding important to ensure their data appropriately cared for, accountability and market a national research register to ensuring data confidentiality and security. health professionals as well as patients. Patients would like to see a public body, operated by Patients desired a range of media to promote a na- public servants in control of a national research register. tional register, emphasising this is a venture which is not This implies high levels of institutional trust for these suited to a ‘one size fits all’ approach. Given the diversity organisations [24]. Their lack of questioning of the data of research studies which are likely to use the research linkage and extraction technology can be viewed as register and levels of contribution required from each, implied trust of NHS staff, researchers and the NHS IT the register must be able to attract a number of regis- infrastructure. Although, some participants sought re- trants from different societal groups to be able to offer a assurance about how secure and confidential their per- comprehensive service, which caters to the needs of all sonal data would be implying levels of conditional trust. research studies. However, lack of trust or conditional trust does not mean distrust [25]. Unsurprisingly, there were differing Strengths and limitations of the study levels of trust, highlighting for some members of society, These findings have highlighted a number of important trust in the register will not be voluntarily given and ac- issues for the key stakeholders in a national research countability information, reassurance and evidence of register. A strength of this research is its timing, successful operations will be required. For those groups allowing these findings to inform the design and devel- who give their trust this should be highly valued. opment of a national research register and contribute to Patients favoured an approach which focuses on the a wider debate and national programme of research and social good and public nature of this research, leading development of EHRs [28]. participants, by a majority, to reject the notion of invest- This study was only conducted within two health ment by pharmaceutical companies in the register infra- boards in Scotland to gain an understanding if a re- structure. Whereas views were polarised over use of the search register was acceptable to patients, health profes- register for commercial gain by making it available to re- sionals and researchers. Unfortunately, we had a low search studies funded by pharmaceutical companies. response rate to invitations to participate in the patient This issue may have been different in other healthcare focus groups. This may be a reflection of a lack of inter- systems where private providers predominate. However, est or may be due to the fact no reminder letters were the issue of ownership and control of personal data sent and patients were only invited once. The views of when it is to be exploited for commercial gain has arisen policy commissioners were not explored. As in any in many different healthcare systems [26,27]. Legal deci- study, we had to make choices in our study design to sions on this vary, but for a voluntary register based on balance ideal recruitment figures with feasibility and re- trust to be successful, complete transparency will be re- source constraints. Only one focus group was held with quired. When current ethical and legal restrictions were health services researchers and those recruited had ex- described to patients in our study this seemed to re- tensive experience in data-linkage and large database assure people, however more detailed exploration of studies. As a result their views may not be representative what is likely to be acceptable to the wider Scottish pub- of all health services researchers working with a range of lic is required. The development of a national register methodologies. Likewise, the GPs and practice managers needs to be within an accepted legal, ethical and govern- had previously taken part in research and their views ance framework. may not be representative of their professional groups. As the Caldicott Guardians and custodians of patient’s Although two thirds of Scottish general practices are re- cradle-to-grave health record it is advantageous if a na- search active (Alison Hinds, Scottish Primary Care Re- tional research register has the backing of general practi- search Network, personal communication). There was tioners. Researchers participating in this study were clear enthusiasm among the patients we spoke to, but concerned GPs would be able to veto a patient’s consent these people were to some extent self-selecting and to take part in the register. GPs are not in a position to younger people in particular were under-represented. veto patients consent to take part in a national research Previous research has suggested that younger people are register, but GPs have total control over access to data concerned about allowing access to their personal infor- held in their clinical systems, and will be able, to some mation [29]. It is not clear if the general public would be extent, to influence volunteer uptake. It is likely GPs will so altruistic; many of these people were recruited via Grant et al. BMC Health Services Research 2013, 13:422 Page 13 of 15 http://www.biomedcentral.com/1472-6963/13/422 general practice and may place high levels of trust within Since this research study was completed a ministerial the NHS and public institutions. However, we believe announcement has been made by the Scottish Health seventeen interviews with professionals, seven focus Minister that the register has been adopted by NHS groups with patients and one focus group with health Research Scotland (NRS) and branded SHARE (Scot- services researchers provided a sufficient level of evi- tish Health Research Register) [18,38]. The national re- dence for an explorative study of this nature. searcher register will operatethrough theexisting infrastructure and operating procedures of the Scottish Health Informatics Programme [18]. There has been Comparison with other studies extensive development and pilot work carried out by Although a national research register is a novel con- the Health Informatics Centre at the University of cept the acceptability of disease specific registries has Dundee since the completion of this work and the been shown [6,7,30]. The acceptability and knowledge SHARE process has been influenced by these findings. of ethical and legal governance regulations was im- portant, concern about privacy, security and consent Conclusions could stifle a national research register [31,32] and Providing suitable safeguards are in place, patients, studies which seek representative samples [33]. As health service staff and researchers have a favourable others have found, patients had concerns about the view of the potential benefits of a national register frequency of requests to participate, the extent of com- held within thepublicsectortoidentifypeoplewho mitment required, and who the sponsors potentially are potentially eligible and willing to participate in may be within disease specific registers [33]. Patients health related research. UK Government policies are placed high levels of trust in GPs and the NHS, encouraging greater use of the data in EHRs to en- confirming other studies [34]. For patients, their trust courage more rapid progress with clinical research, was tempered by a concern to know more about the though consent cannot be assumed [39,40]. The Nuffield practicalities of the process. Patients and health practi- Council on Bioethics Working Group has recommended tioners wanted greater clarity on nature of recruitment that the patients’ right to opt-out of a database sys- and data management processes as a basis for this tem at any time should be recognised; that the pa- trust, mirroring the findings of others [30,35,36]. tients should be asked explicitly to consent to the Recruitment to clinical studies is a major concern for sharing of their records outside of the primary care all healthcare researchers [5]. There is also evidence that environment; and that organisations responsible for many people would like to participate in medical re- sharing EHRs engage more effectively with patients search if they knew of suitable projects. This has been to identify what forms of data sharing are accepted as demonstrated in the United States by Mediguard and legitimate [41]. Research Match [10,11]. Abbreviations GP: General practitioner; NHS: National health service; EHR: Electronic health Implications for future research record; NIH: National institute for health; UK: United Kingdom; USA: United States of America; BMA: British medical association; IT: Information These findings have raised a number of important design technology; NRS: National research Scotland; SHARE: Scottish health research and operationalization issues but also highlighted issues register. which will require further public engagement. Competing interests This study did not explore the views of patients to- The authors have an interest in encouraging more effective and efficient wards the secondary use of their data. Further re- recruitment to clinical trials and other methodologically rigorous research. search is required to establish how patients perceive They have no direct financial interest in the existence of a research register. their consent to a national research register and asso- Authors’ contributions ciated research studies. Establishing patient views to- FS conceived and AG designed the study. AG, DN and JU analysed the data. wards the secondary use of their personal data was AG and FS drafted the manuscript and AG is guarantor. All authors helped interpret the results and commented on drafts of the manuscript. All authors beyond the scope of this study however, the concern read and approved the final manuscript. by patients about the security and confidentiality of their data raises this as an issue for further consider- Acknowledgements Laura Wilkie, Marie Pitkethly, and Rebecca Skillen for help in conducting the ation [37]. focus groups and to Shaun Treweek for contributing to research register Participants in the patient focus groups rarely men- development ideas and Fergus Daly for commenting on drafts of this tioned concerns about sensitive data such as sexual or manuscript. mental health unless probed. Researchers were concer- Funding ned about contacting deceased patients. More detailed This work was supported in part by a grant from Scotland’s Chief Scientist exploration about the handling of sensitive information Office (CZG/2/509) and additional support from NHS Tayside and NHS within a national research register is required. Lothian. The funding sources had no role in the design, conduct, or Grant et al. BMC Health Services Research 2013, 13:422 Page 14 of 15 http://www.biomedcentral.com/1472-6963/13/422 reporting of the study or in the decision to submit the manuscript for secondary care in England: final qualitative results from publication. AS is supported by a Harkness Fellowship in Health Care Policy prospective national evaluation in “early adopter” hospitals. and Practice from The Commonwealth Fund, a private independent Br Med J 2011, 343:d6054. foundation based in New York City. The views presented here are those of 16. The privacy of our medical records is being sold off. http://www.theguardian. the author and not necessarily those of The Commonwealth Fund, its com/commentisfree/2012/aug/28/code-practice-medical-data-vulnerable? directors, officers, or staff. CMP=twt_gu. 17. Sullivan F, Treweek S, Grant A, Daly F, Nicolson D, McKinstry B, Hanley J, Author details Ure J, Sheikh A: Improving recruitment to clinical trials with a register Population Health Sciences, Medical Research Institute, University of Dundee, of a million patients who agree to the use of their clinical records for The Mackenzie Building, KirstySemple Way, Dundee DD2 4BF, Scotland. Centre the research in the Scottish Health Research Register (SHARE). for Inflammation Research, Queens Medical Research Institute, 47 Little, France, 4Trials 2011(12 Suppl. 1):A115. Crescent, Edinburgh, EH16 4TJ, Scotland. Centre for Health and Population 18. ScottisH Informatics Programme. http://www.scot-ship.ac.uk/ Accessed 13th Sciences, Hull York Medical School, University of Hull, Hertford Building, November 2012. Cottingham Road, Hull HU6 7RX, England. NHS Lothian Research and 19. Scottish Primary Care Research Network. http://www.sspc.ac.uk/spcrnaboutus- Development, Queens Medical Research Institute, 47 Little France Crescent, item Accessed 12th November 2012. Edinburgh, EH16 4TJ, Scotland. eHealth Research Group, Centre for Population 20. Barbour R: Introducing Qualitative Research. London: Sage Publications Ltd; 2008. Health Sciences, The University of Edinburgh, Medical School, Teviot Place, 21. Silverman D: Interpreting Qualitaitve Data. 3rd edition. London: Sage Edinburgh EH8 9AG, Scotland. Division of General Internal Medicine and Publications Ltd; 2006. Primary Care, Brigham and Women’s Hospital/Harvard Medical School, 1620 22. Barbour V: UK Biobank: a project in search of a protocol. The Lancet 2003, Tremont Street, 3rd Floor, Boston, MA 02120-1613, USA. 361:1734–1738. 23. Laurie G, Sethi N: Information Governance of Use of Health-Related Data in Received: 29 May 2013 Accepted: 27 September 2013 Medical Research in Scotland: Towards a Good Governance Framework. Published: 18 October 2013 Edinburgh: University of Edinburgh; 2013. http://www.scot-ship.ac.uk/sites/ default/files/Reports/Working_Paper_2.pdf. 24. Entwistle V, Quick O: Trustinthe contextofpatient safety References problems. Journal of Health Organization & Management 2006, 1. McDonald A, Knight R, Campbell M, Entwistle V, Grant A, Cook J, Elbourne 20(5):397–416. D, Francis D, Garcia J, Roberts I, et al: What influences recruitment to 25. Brownlie J: Conceptualising trust and health. In Researching Trust randomised controlled trials? A review of trials funded by two UK and Health. Edited by Brownlie J, Greene A, Howson A. London: funding agencies. Trials 2006, 7(1):9. Routledge; 2008. 2. Vogel E: U.K. to Open Health Records as E.U. Considers Restrictions. 26. Prins C: When personal data, behavior and virtual identities become and Science 2011, 334:1483–1484. commodity: would a property rights approach matter? SCRIPTed 2006, 3. Probstfield RL, Frye RL: Strategies for recruitment and retention of 270(3):4. participants in clinical trials. J Am Med Assoc 2011, 306:1798–1799. 27. Haddow G, Laurie G, Cunningham-Burley S, Hunter K: Tackling community 4. A new pathway for the regulation and governance of health research. http:// concerns about commercialisation and genetic research: a modest www.acmedsci.ac.uk/p47prid88.html Accessed 8th November 2012. interdisciplinary proposal. Soc Sci Med 2007, 64:272–282. 5. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrom M, Johansen M, Taskila 28. Medical Research Council: New Centres put Health Records at Heart of UK TK, Sullivan F, Wilson S, Jackson C, et al: Strategies to improve recruitment Medical Research, Volume 7th. 2012. http://www.mrc.ac.uk/ to randomised controlled trials. Cochrane Database Syst Rev 2010(4):Art. Newspublications/News/MRC008799. No.: MR000013. 29. Carlisle J, Shickle G, Cork M, et al: Concerns over confidentiality may deter 6. Barrett G, Cassell JA, Peacock JL, Coleman MP: National survey of British adolescents from consulting their doctors. A qualitative exploration. public’s views on use of identifiable medical data by the National Cancer J Med Ethics 2006, 32:133–137. Registry. Br Med J 2006, 332(7549):1068–1072. 30. Baird W, Jackson R, Ford H, Evangelou N, Busby M, Bull P, Zajicek J: Holding 7. Morris AD, Boyle DI, MacAlpine R, Emslie-Smith A, Jung RT, Newton RW, personal information in a disease-specific register: the perspectives of MacDonald TM: The diabetes audit and research in Tayside Scotland people with multiple sclerosis and professionals on consent and access. (darts) study: electronic record linkage to create a diabetes register. J Med Ethics 2009, 35:92–96. Br Med J 1997, 315(7107):524–528. 31. Ingelfinger JR, Drazen JM: Registry research and medical privacy. 8. Pressler T, Yen P-Y, Ding J, Liu J, Embi P, Payne PR: Computational N Engl J Med 2004, 350(14):1452–1453. challenges and human factors influencing the design and use of clinical 32. Peto J, Fletcher O, Gilham C: Data protection, informed consent, and research participant eligibility pre-screening tools. BMC Med Inform Decis research. Br Med J 2004, 328(7447):1029–1030. Mak 2012, 12(1):47. 33. Clinton-McHarg T, Carey M, Sanson-Fisher R, Tracey E: Recruitment of 9. Harris PA, Lane L, Biaggioni I: Clinical research subject recruitment: the representative samples for low incidence cancer populations: do Volunteer for Vanderbilt Research Program. J Am Med Assoc 2005, registries deliver? BMC Med Res Methodol 2011, 11(1):5. 12:608–613. 34. Willison DJ, Schwartz L, Abelson J, Charles C, Swinton M, Northrup D, 10. Harris PA, Scott KW, Lebo L, Hassan N, Lightner C, Pullney J: Thabane L: Alternatives to project-specific consent for access to personal ResearchMatch: a national registry to recruit volunteers for clinical information for health research: what is the opinion of the Canadian research. Acad Med 2012, 87(1):66–73. public. J Am Med Assoc 2007, 14:706–712. 11. Mediguard.org. www.mediguard.org Accessed 8th November 2012. 35. Robling MR, Hood K, Houston H, Pill R, Fay J, Evans HM: Public attitudes 12. £20 million for new health informatics research institute. http://www.mrc.ac. towards the use of primary care patient record data in medical uk/Newspublications/News/MRC009207. research without consent: a qualitative study. JMed Ethics 2004, 13. Scottish Diabetes Research Portfolio November 2010 – October 2011. http:// 30(1):104–109. www.sdrn.org.uk/sites/default/files/sdrpreport_2011.pdf Accessed 12th 36. Summary of responses to the consultation on the additional uses of patient November 2012. data. http://collections.europarchive.org/tna/20100509080731/http://www. 14. Robertson A, Cresswell K, Takian A, Petrakaki D, Crowe S, Cornford T, Barber dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/ N, Avery A, Fernando B, Jacklin A, et al: Implementation and adoption of digitalasset/dh_110715.pdf Accessed 8th November 2012. nationwide electronic health records in secondary care in England: 37. Souhami R: Governance of research that uses identifiable personal data. qualitative analysis of interim results from a prospective national Br Med J 2006, 333(7563):315–316. evaluation. Br Med J 2010, 341:c.4564. 38. Scotland to host clinical trials register. 15. Sheikh A, Cornford T, Barber N, Avery A, Takian A, Lichtner V, Petrakaki D, Crowe S, Marsden K, Robertson A, et al: Implementation 39. Robling MR, Hood K, Houston H, Pill R, Fay J, Evans NM: Public attitudes and adoption of nationwide electronic health records in towards the use of primary care patient record data in medical Grant et al. BMC Health Services Research 2013, 13:422 Page 15 of 15 http://www.biomedcentral.com/1472-6963/13/422 research without consent: a qualitative study. JMed Ethics 2004, 30:104–109. 40. Summary of responses to the consultation of the additional uses of patient data. Accessed 12th November 2012. 41. Medical profiling and online medicine: the ethics of ‘personalised healthcare’ in the consumer age. http://www.nuffieldbioethics.org/personalised-healthcare- 0 Accessed 8th November 2012. doi:10.1186/1472-6963-13-422 Cite this article as: Grant et al.: Acceptability and perceived barriers and facilitators to creating a national research register to enable ’direct to patient’ enrolment into research: the Scottish Health Research Register (SHARE). BMC Health Services Research 2013 13:422. 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Acceptability and perceived barriers and facilitators to creating a national research register to enable ’direct to patient’ enrolment into research: the Scottish Health Research Register (SHARE)

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Springer Journals
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Copyright © 2013 by Grant et al.; licensee BioMed Central Ltd.
Subject
Medicine & Public Health; Public Health; Health Administration; Health Informatics; Nursing Management/Nursing Research
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1472-6963
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10.1186/1472-6963-13-422
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24139174
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Abstract

Background: Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. Methods: We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. Results: The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. Conclusions: This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers. Keywords: Research register, Recruitment, Randomised controlled trial, Qualitative * Correspondence: a.m.grant@dundee.ac.uk Population Health Sciences, Medical Research Institute, University of Dundee, The Mackenzie Building, KirstySemple Way, Dundee DD2 4BF, Scotland Full list of author information is available at the end of the article © 2013 Grant et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Grant et al. BMC Health Services Research 2013, 13:422 Page 2 of 15 http://www.biomedcentral.com/1472-6963/13/422 Background Institute [12]. The Diabetes Research Register in Scotland Between 30-50% of all randomised controlled trials fail has already shown that response rates are likely to be to recruit a sufficient number of participants [1]. In a higher, significantly faster and with fewer screen failures speech on 5th December 2011, the United Kingdom’s amongst patients who have previously considered and (UK) Prime Minister proposed two main changes to the expressed interest in participation and whose electronic use of data collected in the National Health Service records (EHRs) are used to identify their suitability for (NHS) in an attempt to address this issue [2]. Firstly, he studies, than the general population [13]. advocated a public consultation on changing the NHS Given the increasing adoption of EHR systems in constitution to enable all patient data to be “automatic- the UK, we believe there is a considerable opportunity ally included in clinical research” with an opt-out for to use the data within EHRs to identify people for re- those who did not wish to participate; and secondly, a search projects though the risks of doing so need to mechanism to provide researchers access to NHS re- be addressed [14-16]. The proposed model was de- cords to identify and directly contact patients who might veloped following national discussions with a range of qualify for clinical trials. There is now a widely accepted key stakeholders, including the British Medical As- realisation that the ability to conduct clinical research is sociation (BMA), research charities, patient repre- threatened in the UK. Similar concerns are also being sentative groups, the pharmaceutical industry and the expressed in many other countries [3,4]. Scottish Government [17]. Instead of self-reported Other strategies to improve recruitment of participants health data, we proposed using clinical data in med- to trials have recently been assessed in a Cochrane re- ical records and linked information in laboratory and view, but with the exception of telephone reminders and administrative databases across Scotland [18]. opt-out strategies, most were found to be of limited value [5]. An alternative approach is the creation of a A national research register - proposed process model register of patients who have expressed a general interest Briefly, the technology now exists to extract data from to participate in research. Such an approach may entail various EHRs (primary care, dental, hospital records registrants volunteering information about their health and many more) and link this information via the pa- or patients giving permission for research teams to tient’s CHI number. Data linkage makes it possible to search their electronic health records (EHRs) to assess identify patients who may be eligible for studies based whether they met the eligibility criteria for studies. If so, on data held in their EHRs. The proposed register they could then be informed about relevant studies and model only holds registration and contact preference offered the chance to participate. Volunteer research data on patients; when linked to eHealth records it en- registers already exist, varying in terms of disease [6,7], ables the identification of potentially eligible patients study type [8], and location such as the pioneering ‘Vol- for studies Figure 1. unteer for Vanderbilt’ system [9]. Registrants are notified Patients either register via the website or completing electronically when they are a possible match to a pro- their details on a form for secure entry by register staff. posed research project and they then make the decision In doing so, they are providing consent for to their EHRs regarding the release of their contact information. The to be securely searched within the NHS to assess Vanderbilt approach is now being adopted nationally in whether they met the eligibility criteria for studies which the United States of America (USA) as part of the new have NHS ethical and governance approval. US Research Match program, which comprises a con- Researchers contact the register administrators with sortium of institutions under the aegis of the National their inclusion and exclusion criteria, and if all the ap- Institutes of Health (NIH) [10]. These registers ensure propriate approvals were in place, an electronic search is that personal information is protected until volunteers carried out to identify eligible patients. Patients are in- authorize the release of their contact information to a formed by register staff about relevant studies and of- specific study. MediGuard is another system which pro- fered the chance to participate and if interested respond vides a free medication monitoring service and enables directly to the researcher. its 2.5 million registrants to be contacted directly about research for which they may be eligible [11]. In Scotland, the unique Community Health Index (CHI) has allowed Aim deterministic record linkage of health data since the In the context of developing the system specification, we 1970s. This has enabled the development of exceptional sought to explore the acceptability and feasibility of the data resources and long tradition of excellence in eHealth national research register model to patients, clinicians, informatics research recognized by a leading role in the healthcare management staff and researchers to under- UK’s network of health eResearch centres funded by stand their perspectives on key facilitators and barriers the MRC and a consortium of other funders: the Farr to engagement. Grant et al. BMC Health Services Research 2013, 13:422 Page 3 of 15 http://www.biomedcentral.com/1472-6963/13/422 Figure 1 (See legend on next page.) Grant et al. BMC Health Services Research 2013, 13:422 Page 4 of 15 http://www.biomedcentral.com/1472-6963/13/422 (See figure on previous page.) Figure 1 An example of how a research study enquiry will be processed by the proposed research register. An enquiry will be received and checked by register staff for eligibility. Once eligibility is determined search criteria will be generated and a search will be run on all relevant databases for matching Community Health Index (CHI) numbers. These databases will include the Scottish Morbidity Records (SMR), GP records and laboratory data to name a few. This search will generate a list of research interested patients with eligibility criteria for the study in question. The register staff will check if any of these people have recently been contacted about another study. If available the patient will be contacted and willingness to participate will be explored. If they say no the register will be updated and if they say yes, the researchers will be given the patients contact information and the register will be updated. Methods with experience in data-linkage and recruitment to Focus groups and semi-structured interviews were clinical studies. conducted between February and June 2011 with pa- tients, general practice staff from NHS Tayside and Data generation NHS Lothian and academic researchers from the local The focus groups and interviews sought to establish if University. Focus groups were chosen for patients as the proposed model was acceptable to key stakeholders the concept of a research register would be novel and and to gain an understanding of their perspectives on focus groups present an efficient way to demonstrate how the register should operate and be advertised; to in- new ideas, allow people to use the responses of others form the design, development, operationalisation and as a starting point, and are especially helpful in under- promotion of a national research register. standing nuances of attitudes, beliefs, or opinions. In- Prior to every focus group and interview, the facilitator terviews were considered more efficient for health gave a short presentation as to the current problems service staff that have difficulty attending focus with patient recruitment to research and how a national groups. This study was approved by the Tayside Com- research register was expected to work, including infor- mittee on Medical Research Ethics B, (reference num- mation about possible mechanisms for participation and ber: 11/S1402/6) and written informed consent was data extraction and linkage mechanisms. These discus- obtained from all participants. sions were further facilitated by a topic guide as an aide memoire, audio-recorded and transcribed verbatim. The Sampling and recruitment topic guides and presentations were modified between Research interested general practices in two Scottish focus groups and interviews. Focus groups with patients health boards were identified via the Scottish Primary and researchers lasted approximately an hour. Focus Care Research Network [19]. groups with patients were held in local health centres General practices: General practitioners (GPs) and and with researchers within the University department. practice managers from 10 practices were invited to take Telephone interviews with GPs and practice managers part in telephone semi-structured interviews. This was a lasted for approximately half an hour. purposive, convenience sample to gain perspectives from clinically active GPs who act as data controllers. Data analysis Focus groups and interviews were conducted by two so- Patients cial science researchers (AG & DN) and the focus We aimed to recruit a maximum variation sample of groups were supported by a rapporteur responsible for ages, rurality, sex and deprivation, via the participating writing notes and capturing key points. All the audio- general practices. 732 patients from five practices were recordings were transcribed verbatim. The transcripts invited to attend focus groups by their general practice were read and re-read by three of the researchers inde- on behalf of the research team. No reminder letters were pendently (DN, JU & AG). An initial coding frame was sent. developed inductively from the interviews, and disagree- In addition, focus groups were organised with admin- ments were discussed and resolved. This was then sys- istrative members of staff from the local hospital and tematically applied to all transcripts. Themes were university to gain a wider patient perspective. organised under related concepts derived from the topic A focus group was also held with members of the local guide and thematic analysis. The data was explored for Public Patient Partnership group (PPG). negative cases [20,21]. Research staff Health service researchers and data analysts from the Results/findings University of Dundee were invited to take part in a A total of 17 general practitioners and practice managers focus group. Participants were purposively selected were interviewed, 37 people took part in seven patient Grant et al. BMC Health Services Research 2013, 13:422 Page 5 of 15 http://www.biomedcentral.com/1472-6963/13/422 focus groups and 10 health service researchers took part “…I’m here to find out a little bit more about it, I don’t in another focus group. know enough at the moment. And I also think pre- authorising people to access my data might be an issue. I don’t know what sort of studies you’re doing” (Male, Patient perspectives of a national research register patient focus group 3, PPG). The following findings are from the seven focus groups held with patients. Although most patients perceived the register to be for the ‘common good’, those who said they were likely to register indicated that their rationale for registering Acceptability of a research register would be primarily personal with the hope of future The focus group discussions were generally positive to- health gains for themselves or their family, so would be wards the concept of a research register. Participants in interested in contributing to research in areas of concern the patient focus groups could understand the aims and to them. rationale for the register and made reference to the ben- efits as being for the ‘common good’ and to advance “…I’ve got arthritis in my spine and if there’s something research: new or something that can help wi the pain I have, which is not constant then I’d be willing to try anything “….. I mean it’s a better system than it is at the present, cause when it’s bad, it’s bad.” (Female, patient focus because you are going to get 100% response that way or group 1.). near enough and the present system is that the GPs put out things on spec to people that may want to join this Some participants did provide a more altruistic ration- thing and they may get a very low return” (Male, ale for registering. patient focus group 3, PPG). “…I’ve been, had quite a few things done under the NHS And: the past two or three years so I’m quite happy to put things back” (Male, patient focus group 3, PPG). “..the great advantage of a system like this is that if I was a researcher dealing with a rare disease and I Our data show that the concept of a research register wanted to get together everybody in the country, or is acceptable to patients who volunteer for research via perhaps all five of them for instance to do some trial on invitation from their GP practice. We do not suggest them, I could identify these people” (Male, patient focus that all patient groups would be likely to enroll with a group 2). research register but these findings suggest that a re- search register is likely to recruit patients who wish to There was a willingness to participate in the register, give a ‘gift’ to society or who wish to contribute for per- with the vast majority of the patient participants indicat- sonal gain. Doubts have been expressed about the ability ing they would be likely to join the national research of biobanks to deliver on ‘promises’ [22]. It is not the register, in principle: intention of a national research register to make any claims about enrolment and participation in research “Well I think it’s a good thing to get involved in leading to improvements in health care prevention, diag- (referring to a national research register), I just felt that nosis or treatment regimens which may give patients I wanted to do it and…quite happy….to see what false hope. happens now, as you say I can withdraw if I’m unhappy, if I’m happy I’ll just stay in….” (Female, What would expedite confidence to facilitate recruitment patient focus group 4). to a national research register? The participants of the patient focus groups identified a And: number of conditions which they felt should be met in the design of a national research register and website to “…research register seems like a great idea, why has encourage confidence and facilitate recruitment: nobody done it before?” (Female, patient focus group 6) Information about the kind of personal data extracted from The remaining participants felt they required more in- patient records formation about how the research register would oper- Some participants wanted more information about the ate, including recruitment and management processes nature of personal data which would be extracted from (these issues are addressed below). patient records. They had reservations about more Grant et al. BMC Health Services Research 2013, 13:422 Page 6 of 15 http://www.biomedcentral.com/1472-6963/13/422 sensitive information being accessed as the quote below records sit? Because I would like my records to be illustrates: available throughout the country, I don’tcareonce they’re on the internet and a doctor here can call “Yeah and what would be, the factual information that them up, but I’m totally surprised how if you goes into this Register, you know in terms of actually the move from one practice to another your records factual information that goes there, for instance thinking can’t now electronically move easily.” (Male, patient about mental health and thinking about, you know focus group 1) things, or disclosure or sexual abuse or, all these kind of things …” (Female, patient focus group 4). And Some focus group participants expressed the view that “Does Alex Salmond’s (Scotland’s first minister) that people might not wish to participate in studies department and does Shona Robinson from Dundee, as about sensitive issues. Designers of the research register health minister in Scotland, are they not already also considered that people may not be aware or may looking at these figures and data?”(Male, patient focus have forgotten their health care record contains sensitive group 2) information and access to certain information could make registrants vulnerable. Based on these observations All participants were informed of the research ethics, sensitive information would not be accessed by re- governance and legal frameworks within which re- searchers without explicit patient consent. On occasions search teams and the operators of the research register where researchers might want access to information are accountable. Patients were reassured by this and such as mental or sexual health they would only be pro- felt this information should be made available on the vided with anonymised data within the strict ethics and register website, along with how particular studies were governance rules and regulations which are in place to approved or included in the register: protect vulnerable patients in accordance with the pro- portionate governance arrangements of the Scottish ”…I understand, I understand, I am a lot more Health Informatics Programme (SHIP) [23]. enlightened”, (male) “That information should be made available for people” Concerns about data security (female) (Patient focus group 2). All participants wanted reassurance their data was to be handled securely. Participants recruited via the local And University and NHS hospital were already informed of some of the governance and legislative issues involved in “One of the things I’d like to see is that there was a sign handling confidential patient data. off on adequate training on all the legislative requirements for holding people’s data…you know if “… if you don’t think your data’s secure then it's really, you’re going to minimise risk then everybody has to really going to, to put a lot of people off, you know, it know absolutely where the legislation lies..” (Female, just takes one slip up in that department and that’s just patient focus group 1). going to completely put people off from signing up” (Female, patient focus group 6). Although participants were concerned about the sen- sitivity of some data and the security of all data and And were reassured by governance and legislative controls it was difficult to ascertain their views about these issues “..reassurance…it would just be few hands and eyes … so in relation to data extraction and linkage. Specific con- it's not being passed around” (Male, patient focus group cerns were not raised and questions were not clearly 6). responded too. Whereas, participants recruited via general practices Reassurance about levels of commitment involved in the assumed the electronic transfer information within the register NHS was already taking place and some assumed politi- Despite understanding the rationale behind the register cians had access: and being willing to register participants were ambiva- lent about making open-ended commitments. Some par- “…I don’t mind where my data goes…I just wondered ticipants argued that registrants may not always be able when and where and who was doing this. Was it to contribute to research or only to studies with minimal Scottish Government or the NHS and where do your involvement. Grant et al. BMC Health Services Research 2013, 13:422 Page 7 of 15 http://www.biomedcentral.com/1472-6963/13/422 “I suppose I don’t yet understand how much of my time, more intensive participation. Suggestions by researchers what people would be asking me - would it be lots of designing the register to resolve this issue have centred projects?” (Female, patient focus group 6) on a maximum of three invitations per year. This section has raised some important concerns And around sensitive information, data security and levels of involvement. These concerns raise the issue of who “Yeah, I suppose it just depends what’s like going on in should be in control of a national research register. your life at the time, you know how busy you are with other things.” (Female, patient focus group 5) Patient perceptions of how a national research register should operate Or The focus groups also set out to understand patient per- ceptions of how a national research register should oper- “…probably ones that take up the least of your time, ate, exploring issues such as ownership and control of 'cause if you've to keep going to the surgery or go the registers and the involvement of pharmaceutical somewhere to do things, if you get a questionnaire in the companies. post, I'd quite happily fill that in and post it back” (Female, patient focus group 1) Who should host a national research register? All participants placed trust in Universities and the NHS During the focus group discussions participants were as potential organisations to host a national research asked how often they thought registrants should be register, indicating they would prefer public ownership. contacted to participate in research studies. “…but government, Universities, charities, I would’nae “..I don’t know perhaps if I was being asked to do have a problem if they were behind it but I think the something every week I might think that’s a bit much, drug companies, I would step back from that” (Female, but if it was may be once every six months I would patient focus group 6). think that was alright, once a year, that’s alright…it just depends… (Female, patient focus group 3, PPG) Within these public organisations patients would pre- fer access to their data to be controlled: There was no consensus about frequency of contact because the research studies which will hopefully utilise “I would like, like as little people as possible, you know I a research register will have differing levels of involve- don’t want every NHS staff to be able to access it, I ment. Participants felt reassured that they could have would want core (national register proposed name) options to refuse to participate in a study which would registered people, you know not even researcher, I be easy to complete and not time consuming and oppor- wouldn’t want them to be able to access it, I would tunities to withdraw if their circumstances change. want them to be able to go to somebody who was in charge of the database to be able to give them the “I mean sometimes you go into these things thinking information out, I wouldn’t want a lot.” (Female, patient that’s fine….it’s only an hour a month or whatever but focus group 5) sometimes life doesn’t give you that opportunity” (Female, patient focus group 2). It was important for the patient focus group partici- pants that a national research register was to be publi- Of more concern was that participation in one study cally owned and controlled by public servants. One of may prevent them from taking part in another: the main reasons these participants gave for an intention to register was for the common good, so they perceived “…if you’re taking part in a longitudinal study, as I the register to be a public service and that benefits have done in the past, and it’s just a question of, it’s just should be publically based. a kind of questionnaire about my diet and that kind of thing, would that prevent me from taking part in something else?” (Female, patient focus group 3) Access to a national research register Discussions about the register primarily focused on This raises questions about how participation in a na- the implicit assumption that access would be by med- tional register may be ethically monitored. Some studies ical personnel and academics and research scientists may involve participation in a ‘one-off’ interview or employed by Universities. Participants had particular questionnaire study whereas other studies may require concerns about access by insurance companies largely Grant et al. BMC Health Services Research 2013, 13:422 Page 8 of 15 http://www.biomedcentral.com/1472-6963/13/422 because it was felt they could use this information to research study they will be informed of the funding refuse to pay out on insurance claims. body. This is likely to result in the register requiring a larger number of registrants for commercial than pub- “I’m not sure if anyone’s investigated the potential lically funded studies. implications of anyone with a life insurance policy joining something like this and whether that voids, The promotion of a national research register invalidates or causes any effect on their insurance given There was a general feeling across all the focus groups that they can be particularly funny when it comes to that a national research register would require both local claims later in life…” (Male, patient focus group 4) and national promotion as a public good. They perceived that the register’s success would depend upon public Participants had polarised views towards the poten- awareness, and on highlighting the benefits of taking tial involvement of pharmaceutical companies. They part in research and the contribution to society. In the perceived involvement to be in the funding of the regis- general practice recruited focus groups this topic was ter or in the funding of particular studies recruiting returned to more than once. through the register. The majority felt the involvement of pharmaceutical companies in the infrastructure of “…personally I think this register should be sold as the the register would put them off registering whereas benefit to all of us from birth to death…but I believe others felt the involvement of these companies would that if you start it now you have to catch the attention help investment. of the young kids to have this evolve through 50 years…” (Male, patient focus group 2). “I can see how that would attract the pharmaceutical companies to invest (in the register) if there was this They favoured promotion by a range of media: spin off effect….an economic benefit” (Male, patient focus group 2). “Well it depends if I had the budget or if I had other mechanisms, if budget was no object the television’s And obviously a great mechanism” (Female, patient focus group 4). “I would be slightly more concerned if they went out wider commercially, say Glaxo-Klein or whatever got And data as part of the research register” (Male, patient focus group 1). Concern was focused on how ethical “…it would be something that could be advertised to pharmaceutical companies would be “…drugs everyone, like say on the television or you would hear it company… they always have a vested interest in the on the radio so you know that it’s not something, you outcome don’t they really?” (Female, patient focus know secretive about, a secret project, it’s about group 3, PPG) something that everybody could join in.” (Female, patient focus group 5) For some involvement of pharmaceutical companies in finding research was a necessary evil: “…the drug com- Or panies are just trying to make money, and yes of course they are, it’s all about money in the end of the day but if “I guess information leaflets through you know the door they don’t find the research for some of these the less in- I guess, you know that would get to the (health board teresting or less topical things then they, there will not be named) population…I’m not so keen on emails but research into those things…we need to get funding from certainly something through the mail is always good or, drug companies anyway, if they’re the ones with the you know posters up around the hospital or in the GP money.” (Female, patient focus group 3, PPG) surgery…” (Female, patient focus group 6) The involvement of pharmaceutical companies was controversial and investment by pharmaceutical com- There was consensus among all participants, if pa- panies in the infrastructure of the register is likely to tients were to be written to and invited to participate in influence registration. A large part of making wider the research register this should be by their general health benefits a reality, such as those desired by the practitioner (GP): focus group participants (improvements in prevention, diagnosis, and treatment), will require the funding of “I do think it (a letter) would be better coming from pharmaceutical companies. This concern has ensured their GP” (female) that when patients are invited to participate in a “GP, Yeah” (female) Grant et al. BMC Health Services Research 2013, 13:422 Page 9 of 15 http://www.biomedcentral.com/1472-6963/13/422 “…I think in terms of response people would prefer their Acceptability of a research register GP because it’s someone that they know, trust in….you’d All GPs and practice managers interviewed could under- just treat it like every other thing and probably just stand the rationale for a national research register, were discard it.” (female) (Patient focus group 1) aware of recruitment issues and were in favour of a re- search register, in principle. There was however a lack of agreement amongst pa- tient focus group participants as to the best way to pro- “..in principle it sounds like a good idea, I mean mote a national research register. Some participants obviously research is very important and it's difficult to were strongly in favour of invitations coming from get people for research.” (Female GP interview 5) their GP. As recruitment to research via general prac- tices is increasingly becoming more difficult with the Security and confidentiality of patient data additional pressures on GP time, these findings suggest Of primary concern to all GPs and some practice man- a range of media would be appropriate to appeal to agers was the security and confidentiality of patient data cross sections of society. within a national research register. “I think being reassured about the security of the patient Invitations to join research study data would be sort of, you know 1A on the, on the list of Participants were asked how they thought registrants things that we need to, to be absolutely 100% eh should be invited to participate in research studies and reassured by before we could … agree to getting there was agreement invitations should initially come involved.” (Male GP interview 6) from the research register: And “Well, I think if initially you’ve signed up to this through a letter from your GP….I, to get the invitation for the “I mean from our point of view confidentiality is one study, that’s when I think it should come from SHARE of the kind of absolute … youneedtobesocareful (research register)”( Female, patient focus group 6). about if you're giving letters about patients, there's no third party references and secure e-mails and all And that - so you're thinking “where do we stand with the law?”… I, I guess you'd have to set it up in such a “That would be fine for me, cause I know that I’ve way that the patient was fully aware of what they signed up for that so I would, you know, you would were signing up to including what data would be expect something to come through at some point” (Male, accessed and how it would be accessed and with patient focus group 2). whom it would be shared.” (Female GP Interview 1) There was a real sense in the patient focus groups And that a national research register should be perceived and promoted as a public good, which should be in “I'm not an IT expert but it just feels like the more public ownership and operated by public servants. people there are who have access potentially to The involvement of pharmaceutical companies was patients’ records, themorechancethere is that contentious, with some participants perceiving their there’ll be, it, confidential information leaked and I involvement in funding research studies as a ‘neces- mean I know there was an episode fairly recently in sary evil’. The appeal of the register as a public good Fife where somebody was accessing the Emergency was thought to be important for inclusion in any ad- Care Summary that wasn’t supposedto be, andyou vertising, highlighting registration as contributing to know there'salwaysthatpotential” (Female GP the good of society. interview 5) Perspective of practice managers and general As the Caldicott Guardians of all patient data held in practitioners of a national research register the GP electronic patient record, it is perhaps not sur- The general practitioners and practice managers in- prising that GPs were concerned with data security and terviewed were generally in favour of a national re- confidentiality. Caldicott guardians are responsible for search register; they however expressed concerns the safe use and handling of identifiable patient infor- over the security and confidentiality of personal pa- mation. This suggests GPs will require assurances about tient data and the impact a register would have on the security of the register, including accountability and their workload. transparency mechanisms. Grant et al. BMC Health Services Research 2013, 13:422 Page 10 of 15 http://www.biomedcentral.com/1472-6963/13/422 The first two quotes illustrate the range of views held mobiles so often…. we also have a high turnover of by GPs regarding ownership and consent for use of pri- patients as well, so you might find that by the time you mary care data. Views were polarised with the first quote get in touch with somebody they’ve left or moved..” illustrating that some GPs perceive they would have veto (Female practice manager 4) as to whether patient’s data was extracted and the sec- ond quote illustrates that GPs perceived consent was en- These findings raise important issues for a national tirely at the patient’s discretion. This raises interesting research register as to who has veto over the use of questions for the research register, such as “who is the primary care data and whether GPs will be required to custodian of the data?” and “can GPs veto access to pa- screen lists of patients for eligibility. The register will tients’ records once a patient has registered?” rely on primary care data to provide up-to-date con- tact information and to provide longitudinal data on Impact on workload patients as these are the only health care records to The impact on workload was a key concern for the ma- hold information on a patient from cradle to grave. We jority of GPs and practice managers interviewed. They expect GPs to consider whether they agree to the use had two primary concerns in this regard, firstly the im- of the data held in their records on a study by study pact of patient queries about register or research stud- basis taking into account the patients’ expressed ies, in particular, if letters were to be sent to patients wishes to be contacted for studies in which they are on practice headed note paper. Secondly, GPs were potentially eligible. These findings show GPs are an concerned they would be involved in screening their important group of people to have on board with the patients to ensure they are eligible to take part in stud- register and promotion of the research may need to ex- ies. Currently in the UK, GPs screen lists of patients tend beyond patients. who meet research study eligibility criteria. Despite be- ing concerned about workload from screening patients Health service researchers’ perspectives of a national they saw this as a necessary evil, to protect both pa- research register tients and researchers. The following findings are from one focus group with 10 health service researchers, data analysts and an IT “…workload attached with people contacting the manager from across primary and secondary care surgery for advice on “should I get involved in this based research. research project or not?”…but yeah potentially that’s used up a GP appointment to do that, and that’s, that Benefit of a research register seems a bit of a, a lost opportunity… 'cause yeah, a Researchers were supportive of the initiative seeing a na- patient may be inappropriate for one study but tional research register as having the potential to over- appropriate for another study, the same patient and come their problem of accessing and recruiting patients not having a feel for that because often we're obviously and offering the advantage of more rapid access to a more aware of what’s happenedinpatientssortof wider pool of patients. personally circumstances month to month and you know a patient that was suitable for a research projects “..you can only contact them through their GPs, for last week may not be this week if they're, you know just specific studies, whereas this would be a much wider had their partner, em has died or eh, something else opportunity.” (Male clinical researcher, research focus going on their life or some other new medical condition group) coming along,” (Male GP interview 6) And And “Well, I’m sure the benefits for patients is more that “… I mean the work of screening that list, I guess that in you’re giving them more opportunities to take part in itself might be a considerable job..” (Female GP, research. There are a group of patients who object to the interview 5) GP being the gate-keeper and feel that they should be asked rather than the GP deciding whether they should Practice managers were concerned about the need to be asked is the main benefit” (Female health services ensure that information in patient records was up-to-date. researcher, research focus group). “…the telephone numbers of the patients constantly Although supportive of a national research register, re- change and it's really even hard for us to keep updated searchers raised some issues they felt needed to be with their telephone numbers 'cause they change their addressed to ensure the functionality of a register: Grant et al. BMC Health Services Research 2013, 13:422 Page 11 of 15 http://www.biomedcentral.com/1472-6963/13/422 Concern a national register may not be representative There’s examples over the last fifteen months were Some researchers raised concerns GPs may be able to patients were approached through various registers and block patient involvement in the register by refusing ac- they’d died.” (Male data analyst, research focus group) cess to patient’s personal data or by not giving permis- sion for the data-extraction to take place from their And clinical system: “If someone has said I’m happy to be contacted and “It has to be through the GP so if their GP doesn’t want some researcher contacts him unfortunately after he’s to be involved, you can be losing a great amount of died, it’s not acceptable….you need to make sure that patients that may be willing to take part in this you didn’t do it again” (Male health services researcher, research and it is because their GP is gatekeeping” research focus group). (Female health service researcher, research focus group). And And “That comes back to the idea that maybe this does need….at least the request to participate does need to be “…you will have a two-tier system whereby you would routed via the GP, even if it’s electronically to establish have presumably a very large cohort of patients who that they’re still alive and what conditions they have had agreed and whose GPs had agreed to make the and then you approached them” (Male health services data available and then perhaps a much smaller sub- researcher, research focus group). group of people who had agreed and for one reason or another the GPs felt they didn’t want to share the GPs record when a patient is deceased and the register data..” (Male clinical researcher, research focus group). can also be linked to the Scottish General Registrar Of- fice (GRO), the research register will extract data from This also raised the issue about whether GPs can veto GP practice systems nightly so the information used by patients’ participation in the research register. the research register will be the most up-to-date and the Others were concerned that only the middle classes chances of a deceased patient being identified are min- would register: imal. There are other reasons for which GPs screen patient lists, such as a close family member recently “Is there a danger…that you’re only going to get these passing away. very middle class people so all the trials end up being done on people who have not really got anything wrong Discussion with them?” (Male health services researcher, research There was clear support for the concept of a research focus group) register to facilitate recruitment to research studies from patients, practitioners and researchers. Although sup- This is a common problem in research, in particular portive, some patients and GPs require assurances about with studies which use opt-in models. An important data security and accountability. Without these assur- issue for some studies hoping to use the register will be ances in place researchers were concerned the register the representativeness of registrants. It is therefore may not be representative and/or GPs may be able to intended that targeted advertising and social networking veto patient’s participation in the register. will attract patients from a wide range of groups in Scotland has a public sector health service covering society. the entire population, and using a single patient identi- fier for all health records. This offers a unique opportun- Measures are required to ensure eligibility of patients ity, with cradle to grave records on the whole population Researchers expressed concern about contacting de- in a range of EHRs (primary care, hospital, dental, pre- ceased patients and would like to see some measures in scribing, laboratory, screening and immunisation re- place to protect against this in the national research cords). There was general agreement that these records register: should be used for the public good, an assumption by patients that at some levels this was already being done, “I take it one of the benefits we’re looking for is to and no questions were asked about the technical ability prevent what’s happened in the past, people making to data link, extract or search the records of those on contact with patients who have been deceased since and the register. the accuracy…..what’s the lag between the register being For the patient groups in our study the motivation for updated and someone actually being approached. participation in a national research register was largely Grant et al. BMC Health Services Research 2013, 13:422 Page 12 of 15 http://www.biomedcentral.com/1472-6963/13/422 self-interest although some were happy to volunteer be able to influence uptake or access to data at three without any expectation of direct benefit to them. Any stages of the research register process: 1) registration; 2) promotion of a national register must be careful not to data access; and 3) utilisation. As a result it is important give patients false hope and to promote participant al- to address the concerns raised by GPs about the impact truism. For those who chose to give a ‘gift’ to society it is on their workload and provide reassurances regarding important to ensure their data appropriately cared for, accountability and market a national research register to ensuring data confidentiality and security. health professionals as well as patients. Patients would like to see a public body, operated by Patients desired a range of media to promote a na- public servants in control of a national research register. tional register, emphasising this is a venture which is not This implies high levels of institutional trust for these suited to a ‘one size fits all’ approach. Given the diversity organisations [24]. Their lack of questioning of the data of research studies which are likely to use the research linkage and extraction technology can be viewed as register and levels of contribution required from each, implied trust of NHS staff, researchers and the NHS IT the register must be able to attract a number of regis- infrastructure. Although, some participants sought re- trants from different societal groups to be able to offer a assurance about how secure and confidential their per- comprehensive service, which caters to the needs of all sonal data would be implying levels of conditional trust. research studies. However, lack of trust or conditional trust does not mean distrust [25]. Unsurprisingly, there were differing Strengths and limitations of the study levels of trust, highlighting for some members of society, These findings have highlighted a number of important trust in the register will not be voluntarily given and ac- issues for the key stakeholders in a national research countability information, reassurance and evidence of register. A strength of this research is its timing, successful operations will be required. For those groups allowing these findings to inform the design and devel- who give their trust this should be highly valued. opment of a national research register and contribute to Patients favoured an approach which focuses on the a wider debate and national programme of research and social good and public nature of this research, leading development of EHRs [28]. participants, by a majority, to reject the notion of invest- This study was only conducted within two health ment by pharmaceutical companies in the register infra- boards in Scotland to gain an understanding if a re- structure. Whereas views were polarised over use of the search register was acceptable to patients, health profes- register for commercial gain by making it available to re- sionals and researchers. Unfortunately, we had a low search studies funded by pharmaceutical companies. response rate to invitations to participate in the patient This issue may have been different in other healthcare focus groups. This may be a reflection of a lack of inter- systems where private providers predominate. However, est or may be due to the fact no reminder letters were the issue of ownership and control of personal data sent and patients were only invited once. The views of when it is to be exploited for commercial gain has arisen policy commissioners were not explored. As in any in many different healthcare systems [26,27]. Legal deci- study, we had to make choices in our study design to sions on this vary, but for a voluntary register based on balance ideal recruitment figures with feasibility and re- trust to be successful, complete transparency will be re- source constraints. Only one focus group was held with quired. When current ethical and legal restrictions were health services researchers and those recruited had ex- described to patients in our study this seemed to re- tensive experience in data-linkage and large database assure people, however more detailed exploration of studies. As a result their views may not be representative what is likely to be acceptable to the wider Scottish pub- of all health services researchers working with a range of lic is required. The development of a national register methodologies. Likewise, the GPs and practice managers needs to be within an accepted legal, ethical and govern- had previously taken part in research and their views ance framework. may not be representative of their professional groups. As the Caldicott Guardians and custodians of patient’s Although two thirds of Scottish general practices are re- cradle-to-grave health record it is advantageous if a na- search active (Alison Hinds, Scottish Primary Care Re- tional research register has the backing of general practi- search Network, personal communication). There was tioners. Researchers participating in this study were clear enthusiasm among the patients we spoke to, but concerned GPs would be able to veto a patient’s consent these people were to some extent self-selecting and to take part in the register. GPs are not in a position to younger people in particular were under-represented. veto patients consent to take part in a national research Previous research has suggested that younger people are register, but GPs have total control over access to data concerned about allowing access to their personal infor- held in their clinical systems, and will be able, to some mation [29]. It is not clear if the general public would be extent, to influence volunteer uptake. It is likely GPs will so altruistic; many of these people were recruited via Grant et al. BMC Health Services Research 2013, 13:422 Page 13 of 15 http://www.biomedcentral.com/1472-6963/13/422 general practice and may place high levels of trust within Since this research study was completed a ministerial the NHS and public institutions. However, we believe announcement has been made by the Scottish Health seventeen interviews with professionals, seven focus Minister that the register has been adopted by NHS groups with patients and one focus group with health Research Scotland (NRS) and branded SHARE (Scot- services researchers provided a sufficient level of evi- tish Health Research Register) [18,38]. The national re- dence for an explorative study of this nature. searcher register will operatethrough theexisting infrastructure and operating procedures of the Scottish Health Informatics Programme [18]. There has been Comparison with other studies extensive development and pilot work carried out by Although a national research register is a novel con- the Health Informatics Centre at the University of cept the acceptability of disease specific registries has Dundee since the completion of this work and the been shown [6,7,30]. The acceptability and knowledge SHARE process has been influenced by these findings. of ethical and legal governance regulations was im- portant, concern about privacy, security and consent Conclusions could stifle a national research register [31,32] and Providing suitable safeguards are in place, patients, studies which seek representative samples [33]. As health service staff and researchers have a favourable others have found, patients had concerns about the view of the potential benefits of a national register frequency of requests to participate, the extent of com- held within thepublicsectortoidentifypeoplewho mitment required, and who the sponsors potentially are potentially eligible and willing to participate in may be within disease specific registers [33]. Patients health related research. UK Government policies are placed high levels of trust in GPs and the NHS, encouraging greater use of the data in EHRs to en- confirming other studies [34]. For patients, their trust courage more rapid progress with clinical research, was tempered by a concern to know more about the though consent cannot be assumed [39,40]. The Nuffield practicalities of the process. Patients and health practi- Council on Bioethics Working Group has recommended tioners wanted greater clarity on nature of recruitment that the patients’ right to opt-out of a database sys- and data management processes as a basis for this tem at any time should be recognised; that the pa- trust, mirroring the findings of others [30,35,36]. tients should be asked explicitly to consent to the Recruitment to clinical studies is a major concern for sharing of their records outside of the primary care all healthcare researchers [5]. There is also evidence that environment; and that organisations responsible for many people would like to participate in medical re- sharing EHRs engage more effectively with patients search if they knew of suitable projects. This has been to identify what forms of data sharing are accepted as demonstrated in the United States by Mediguard and legitimate [41]. Research Match [10,11]. Abbreviations GP: General practitioner; NHS: National health service; EHR: Electronic health Implications for future research record; NIH: National institute for health; UK: United Kingdom; USA: United States of America; BMA: British medical association; IT: Information These findings have raised a number of important design technology; NRS: National research Scotland; SHARE: Scottish health research and operationalization issues but also highlighted issues register. which will require further public engagement. Competing interests This study did not explore the views of patients to- The authors have an interest in encouraging more effective and efficient wards the secondary use of their data. Further re- recruitment to clinical trials and other methodologically rigorous research. search is required to establish how patients perceive They have no direct financial interest in the existence of a research register. their consent to a national research register and asso- Authors’ contributions ciated research studies. Establishing patient views to- FS conceived and AG designed the study. AG, DN and JU analysed the data. wards the secondary use of their personal data was AG and FS drafted the manuscript and AG is guarantor. All authors helped interpret the results and commented on drafts of the manuscript. All authors beyond the scope of this study however, the concern read and approved the final manuscript. by patients about the security and confidentiality of their data raises this as an issue for further consider- Acknowledgements Laura Wilkie, Marie Pitkethly, and Rebecca Skillen for help in conducting the ation [37]. focus groups and to Shaun Treweek for contributing to research register Participants in the patient focus groups rarely men- development ideas and Fergus Daly for commenting on drafts of this tioned concerns about sensitive data such as sexual or manuscript. mental health unless probed. Researchers were concer- Funding ned about contacting deceased patients. More detailed This work was supported in part by a grant from Scotland’s Chief Scientist exploration about the handling of sensitive information Office (CZG/2/509) and additional support from NHS Tayside and NHS within a national research register is required. Lothian. The funding sources had no role in the design, conduct, or Grant et al. BMC Health Services Research 2013, 13:422 Page 14 of 15 http://www.biomedcentral.com/1472-6963/13/422 reporting of the study or in the decision to submit the manuscript for secondary care in England: final qualitative results from publication. AS is supported by a Harkness Fellowship in Health Care Policy prospective national evaluation in “early adopter” hospitals. and Practice from The Commonwealth Fund, a private independent Br Med J 2011, 343:d6054. foundation based in New York City. The views presented here are those of 16. The privacy of our medical records is being sold off. http://www.theguardian. the author and not necessarily those of The Commonwealth Fund, its com/commentisfree/2012/aug/28/code-practice-medical-data-vulnerable? directors, officers, or staff. CMP=twt_gu. 17. Sullivan F, Treweek S, Grant A, Daly F, Nicolson D, McKinstry B, Hanley J, Author details Ure J, Sheikh A: Improving recruitment to clinical trials with a register Population Health Sciences, Medical Research Institute, University of Dundee, of a million patients who agree to the use of their clinical records for The Mackenzie Building, KirstySemple Way, Dundee DD2 4BF, Scotland. Centre the research in the Scottish Health Research Register (SHARE). for Inflammation Research, Queens Medical Research Institute, 47 Little, France, 4Trials 2011(12 Suppl. 1):A115. Crescent, Edinburgh, EH16 4TJ, Scotland. Centre for Health and Population 18. ScottisH Informatics Programme. http://www.scot-ship.ac.uk/ Accessed 13th Sciences, Hull York Medical School, University of Hull, Hertford Building, November 2012. Cottingham Road, Hull HU6 7RX, England. NHS Lothian Research and 19. Scottish Primary Care Research Network. http://www.sspc.ac.uk/spcrnaboutus- Development, Queens Medical Research Institute, 47 Little France Crescent, item Accessed 12th November 2012. Edinburgh, EH16 4TJ, Scotland. eHealth Research Group, Centre for Population 20. Barbour R: Introducing Qualitative Research. London: Sage Publications Ltd; 2008. Health Sciences, The University of Edinburgh, Medical School, Teviot Place, 21. Silverman D: Interpreting Qualitaitve Data. 3rd edition. London: Sage Edinburgh EH8 9AG, Scotland. Division of General Internal Medicine and Publications Ltd; 2006. Primary Care, Brigham and Women’s Hospital/Harvard Medical School, 1620 22. Barbour V: UK Biobank: a project in search of a protocol. The Lancet 2003, Tremont Street, 3rd Floor, Boston, MA 02120-1613, USA. 361:1734–1738. 23. Laurie G, Sethi N: Information Governance of Use of Health-Related Data in Received: 29 May 2013 Accepted: 27 September 2013 Medical Research in Scotland: Towards a Good Governance Framework. Published: 18 October 2013 Edinburgh: University of Edinburgh; 2013. http://www.scot-ship.ac.uk/sites/ default/files/Reports/Working_Paper_2.pdf. 24. Entwistle V, Quick O: Trustinthe contextofpatient safety References problems. Journal of Health Organization & Management 2006, 1. McDonald A, Knight R, Campbell M, Entwistle V, Grant A, Cook J, Elbourne 20(5):397–416. D, Francis D, Garcia J, Roberts I, et al: What influences recruitment to 25. Brownlie J: Conceptualising trust and health. In Researching Trust randomised controlled trials? A review of trials funded by two UK and Health. Edited by Brownlie J, Greene A, Howson A. London: funding agencies. Trials 2006, 7(1):9. Routledge; 2008. 2. Vogel E: U.K. to Open Health Records as E.U. Considers Restrictions. 26. Prins C: When personal data, behavior and virtual identities become and Science 2011, 334:1483–1484. commodity: would a property rights approach matter? SCRIPTed 2006, 3. Probstfield RL, Frye RL: Strategies for recruitment and retention of 270(3):4. participants in clinical trials. J Am Med Assoc 2011, 306:1798–1799. 27. Haddow G, Laurie G, Cunningham-Burley S, Hunter K: Tackling community 4. A new pathway for the regulation and governance of health research. http:// concerns about commercialisation and genetic research: a modest www.acmedsci.ac.uk/p47prid88.html Accessed 8th November 2012. interdisciplinary proposal. Soc Sci Med 2007, 64:272–282. 5. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrom M, Johansen M, Taskila 28. Medical Research Council: New Centres put Health Records at Heart of UK TK, Sullivan F, Wilson S, Jackson C, et al: Strategies to improve recruitment Medical Research, Volume 7th. 2012. http://www.mrc.ac.uk/ to randomised controlled trials. Cochrane Database Syst Rev 2010(4):Art. Newspublications/News/MRC008799. No.: MR000013. 29. Carlisle J, Shickle G, Cork M, et al: Concerns over confidentiality may deter 6. Barrett G, Cassell JA, Peacock JL, Coleman MP: National survey of British adolescents from consulting their doctors. A qualitative exploration. public’s views on use of identifiable medical data by the National Cancer J Med Ethics 2006, 32:133–137. Registry. Br Med J 2006, 332(7549):1068–1072. 30. Baird W, Jackson R, Ford H, Evangelou N, Busby M, Bull P, Zajicek J: Holding 7. Morris AD, Boyle DI, MacAlpine R, Emslie-Smith A, Jung RT, Newton RW, personal information in a disease-specific register: the perspectives of MacDonald TM: The diabetes audit and research in Tayside Scotland people with multiple sclerosis and professionals on consent and access. (darts) study: electronic record linkage to create a diabetes register. J Med Ethics 2009, 35:92–96. Br Med J 1997, 315(7107):524–528. 31. Ingelfinger JR, Drazen JM: Registry research and medical privacy. 8. Pressler T, Yen P-Y, Ding J, Liu J, Embi P, Payne PR: Computational N Engl J Med 2004, 350(14):1452–1453. challenges and human factors influencing the design and use of clinical 32. Peto J, Fletcher O, Gilham C: Data protection, informed consent, and research participant eligibility pre-screening tools. BMC Med Inform Decis research. Br Med J 2004, 328(7447):1029–1030. Mak 2012, 12(1):47. 33. Clinton-McHarg T, Carey M, Sanson-Fisher R, Tracey E: Recruitment of 9. Harris PA, Lane L, Biaggioni I: Clinical research subject recruitment: the representative samples for low incidence cancer populations: do Volunteer for Vanderbilt Research Program. J Am Med Assoc 2005, registries deliver? BMC Med Res Methodol 2011, 11(1):5. 12:608–613. 34. Willison DJ, Schwartz L, Abelson J, Charles C, Swinton M, Northrup D, 10. Harris PA, Scott KW, Lebo L, Hassan N, Lightner C, Pullney J: Thabane L: Alternatives to project-specific consent for access to personal ResearchMatch: a national registry to recruit volunteers for clinical information for health research: what is the opinion of the Canadian research. Acad Med 2012, 87(1):66–73. public. J Am Med Assoc 2007, 14:706–712. 11. Mediguard.org. www.mediguard.org Accessed 8th November 2012. 35. Robling MR, Hood K, Houston H, Pill R, Fay J, Evans HM: Public attitudes 12. £20 million for new health informatics research institute. http://www.mrc.ac. towards the use of primary care patient record data in medical uk/Newspublications/News/MRC009207. research without consent: a qualitative study. JMed Ethics 2004, 13. Scottish Diabetes Research Portfolio November 2010 – October 2011. http:// 30(1):104–109. www.sdrn.org.uk/sites/default/files/sdrpreport_2011.pdf Accessed 12th 36. Summary of responses to the consultation on the additional uses of patient November 2012. data. http://collections.europarchive.org/tna/20100509080731/http://www. 14. Robertson A, Cresswell K, Takian A, Petrakaki D, Crowe S, Cornford T, Barber dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/ N, Avery A, Fernando B, Jacklin A, et al: Implementation and adoption of digitalasset/dh_110715.pdf Accessed 8th November 2012. nationwide electronic health records in secondary care in England: 37. Souhami R: Governance of research that uses identifiable personal data. qualitative analysis of interim results from a prospective national Br Med J 2006, 333(7563):315–316. evaluation. Br Med J 2010, 341:c.4564. 38. Scotland to host clinical trials register. 15. Sheikh A, Cornford T, Barber N, Avery A, Takian A, Lichtner V, Petrakaki D, Crowe S, Marsden K, Robertson A, et al: Implementation 39. Robling MR, Hood K, Houston H, Pill R, Fay J, Evans NM: Public attitudes and adoption of nationwide electronic health records in towards the use of primary care patient record data in medical Grant et al. BMC Health Services Research 2013, 13:422 Page 15 of 15 http://www.biomedcentral.com/1472-6963/13/422 research without consent: a qualitative study. JMed Ethics 2004, 30:104–109. 40. Summary of responses to the consultation of the additional uses of patient data. Accessed 12th November 2012. 41. Medical profiling and online medicine: the ethics of ‘personalised healthcare’ in the consumer age. http://www.nuffieldbioethics.org/personalised-healthcare- 0 Accessed 8th November 2012. doi:10.1186/1472-6963-13-422 Cite this article as: Grant et al.: Acceptability and perceived barriers and facilitators to creating a national research register to enable ’direct to patient’ enrolment into research: the Scottish Health Research Register (SHARE). BMC Health Services Research 2013 13:422. 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