Recruiting patients to studies was described as the ‘bread and butter work’ by Melanie, and this was the case for many nurses, midwives and allied health professionals (NMAHPs) in research delivery roles*. Recruitment usually involved several steps: identifying eligible patients, approaching them, discussing the study, and consenting them to take part in the study.
Identifying eligible patients
Identifying eligible patients for recruitment into a study was done in many different ways, including:
- screening hospital records and patient databases (online and/or paper-based);
- going onto clinics and wards, and in response to Accident and Emergency (A&E) Department admission alerts;
- being informed by clinical staff* (clinicians, nurses, midwives) of any patients they come across who might be eligible;
- attending multidisciplinary team (MDT) meetings;
- attending NHS-run information sessions/programmes (for newly diagnosed patients, for example);
- attending other illness-related support groups;
- via social media; and
- hosting stands at public events (e.g. regional festivals).
In some teams, the screening for eligible patients was carried out by the research NMAHPs themselves. Other times, there were people employed as data managers/support who did these tasks.
Many studies involved identifying and recruiting patients from healthcare settings, such as hospitals and GP clinics. This could be challenging in terms of fitting around other clinical activities and finding appropriate spaces to talk to eligible patients. Some research NMAHPs emphasised the importance of being confident when approaching potential participants and having a strong grasp of what the study entailed. Sarah, a research midwife, said it was important ‘to be really, really confident about your eligibility criteria, and to understand a bit about the patient that you’re going to see, and where they’ve come from today’.
The recruiting/screening arrangements were usually documented in the study protocol but, if recruitment was a struggle, it was sometimes possible to try new approaches. Sandra recalled a study where ‘recruitment was very poor and so I contacted a research nurse from another [site]’ who recommended attending multidisciplinary team (MDT) meetings to flag potential participants: ‘so then I started going to some of the MDT meetings for that study and that did yield a better increase’.
Some studies did not permit looking for potential participants outside of NHS settings; as such, non-NHS support groups, social media and public events. These were not common avenues used in the clinical research studies by most of the people we spoke to. Libby felt there was sometimes a lot of unnecessary ‘red tape’ around recruitment.
Identifying potential participants in some settings, such as care homes and hospices, could have extra challenges. Gavin had led* a randomised controlled trial about fall-prevention which required a two-step approach to recruitment: firstly seeking approval from care homes to approach residents and then from individual residents. Carrying out research in these different settings also required NMAHPs to adapt in various ways, for example there could be different practices and paces of working involved.
Whilst it could be a successful strategy to enlist clinical non-research staff in helping identify potential participants that they had cared for and to seek their advice on how best to approach, some research NMAHPs found gatekeeping was an issue. This meant that some individuals blocked access to potential participants, usually by telling the research NMAHP that they ‘shouldn’t’ or ‘couldn’t’ approach the patient about a study. Helen saw it as paternalistic and worried it compromised equal access to study opportunities: ‘[a patient might ask] ‘Why didn’t I get access to that study?’ ‘Because we were told [by clinical staff] that we couldn’t come and see you because you’d be too upset”.
In the context of paediatric intensive care studies, Julie felt it was helpful to talk to ward staff about patient suitability. Communication within the research team was important too.
Telling patients about the study
Once potential participants were identified, the next step was usually to contact them and tell them about the studies. There were a number of ways research NMAHPs did this:
- going to meet the patient before, during or just after an already-scheduled appointment (for example, whilst the patient was in the waiting room);
- sending out postal invites (sometimes a few lines about study opportunities were added to an appointment letter); and
- telephoning the patient (sometimes to set up a visit to the patient’s home or to arrange for the patient to come into the GP clinic or hospital).
In approaching patients, the aim was to give them more information about the study and see if they were interested in taking part. Sometimes patients had to be seen by consultants and receive a diagnosis or other information before a research NMAHP could approach them, as was the case in a heart study James worked on.
Conversations to introduce studies to eligible patients usually had to fit around their other clinical appointments, which could make the discussions disjointed. Layla had a study in which she approached patients waiting for antenatal appointments and found she often lost the opportunity to finish speaking to them: ‘what often happens as well is we’ll start the recruitment process and then they get called into their scan. So you have to wait for them to finish. I’ve had a few who, by the time they’ve finished their scan, are just like ‘nah, not going to’, and they don’t come back’.
A vital part of the research NMAHP role is supporting patients to make an informed decision about whether to take part in a research study or not. This included telling potential participants if and when they would need to have follow-up visits, what activities (e.g. interventions, tests) would be involved, and any possible disadvantages and risks. Helen, a lead research nurse, said that discussing any health/travel insurance implications was important too. As Libby explained of one study she recruited to, ‘[if] someone is going to commit to you [to go into a study] for two and a half to three years, the very least you can do is give them time and information and support to make that decision’. The amount of time patients had to decide whether or not to participate varied. Some studies were very time-sensitive (for example, within a window of a few hours of a medical event such as arriving to hospital with chest pains), whilst others had more flexibility.
As a general rule, Sandra said research NMAHPs should use ‘simple, clear, plain language as much as possible’. Many recognised it was important to tailor the way they communicated to help patients understand. Some people had approaches they used for particular studies or groups of patients, including children and young people. Tabitha ‘pared it down’ when explaining the technology being used in an antenatal study she recruited for, as she felt ‘it would have been really inappropriate’ to explain ‘everything behind it’.
Explaining certain concepts could be challenging, such as randomisation (when patients are randomly allocated to one option of several options within a study) and placebos (when patients are given a ‘dummy’ treatment). Although most research NMAHPs found it helpful to describe the randomisation process as being a computer-based one, Rachel X thought this sounded ‘very impersonal’. Barbara also struggled with this: ‘it is a good metaphor, if you will, to say, ‘It’s rolling a dice’. However, when you’re talking about people’s health and survivability of a condition, that’s a pretty cold and calculating, callous way of expressing things’. With studies that have a control arm (when the treatment or care for one group of participants does not change as part of the study), Christine felt it was important to make these participants ‘feel equally as valued, that one’s not any more valuable than the other, because we need both sides of the coin to tell us what is best’.
Many research NMAHPs talked about how important it was to convey that taking part in research was a voluntary and separate activity to the ‘normal’ clinical care that a patient would receive. Opportunities for patients to ask questions were important and many people said that, if they didn’t know the answer, they would try to find out. As Dawn explained, ‘if they ask questions that I haven’t got the answer for‚ then I would suggest coming back to see the consultant or I’ll get the consultant to come and speak to them’.
Pressures to recruit to ‘time and target’ were described as a major source of stress. For some, this pressure came from PIs (Principal Investigators) and study centres. Others, such as Layla, felt there was ‘pressure that I put on myself’. Many expressed concern about funding being suspended or future study opportunities being lost because of recruitment difficulties. This was particularly a concern for those employed by the Clinical Research Network (where funding was based on ‘activity units’) and those who were running commercial studies. In general, the focus on high recruitment numbers could make research NMAHPs feel uncomfortable and, as Ginny said, like they were doing a ‘sales job’. Libby felt it was crucial to keep ‘sight of why we’re doing the research and who it’s for, and the fact that the human beings behind it are the important people, not the numbers on the page’.
The reasons why recruitment was difficult varied across studies. Research NMAHPs sometimes asked for advice and shared tips with those at other study sites. This could be very helpful if the suggestions to boost recruitment could be put into place. Whilst some factors for recruitment difficulties were unpredictable, it was frustrating for those research NMAHPs who felt the targets had been unrealistic from the start and that there was nothing they could do to increase it. Sometimes this was because the recruitment targets were higher than eligible patients seen, other times the likely consent rates of patients had been significantly overestimated.
When recruitment for a study was a struggle, Sandra found it useful to get advice from research nurses at another site.
Many people highlighted that, despite pressures to recruit, it is important patients feel able to say ‘no’ to study participation. They valued that part of their research NMAHP role was to support patients to make decisions for themselves, including whether to enrol or stay in studies. Although a patient might be eligible, there could be many other life circumstances and factors to consider. Helen suggested that, although research NMAHPs shouldn’t ask patients ‘why they declined unless they offer it, ‚Äö√Ñ¬∂if you get an inkling that they don’t really understand but they’ve just declined it then it’s worth exploring a little bit more with no pressure, just to make sure that they have got the right idea [about the study]’.
If a patient is willing to enrol in a study, they will then usually go through a consent process before they can take part. This often involved patients reading and signing paper documents, and their records being updated to say that there are on a study. In one of the studies Layla recruited to, participants had a sticker put on their maternity notes. Participants enrolled in brain surgery research wore wristbands at the hospital where Jisha worked.
For some studies and in some places, research NMAHPs took consent from patients. In other circumstances, and particularly for CTIMP (Clinical Trials of an Investigational Medicinal Product) studies, consent was taken by consultants. Most research NMAHPs had attended training [specifically for taking consent in research. Julie thought that often ‘people [who design/timeline research plans] underestimate the amount of time it takes to consent a study’, but emphasised it was important ‘to do these things properly’.
Paul described a study where it was possible to use ‘non-witness consent’ (when the researcher is not present when a consent document is signed): ‘I can identify them in MDT [Multidisciplinary Team meetings], the clinical nurse specialist gives them a brief overview at their next appointment, then I ring them and we discuss the trial. If they’re happy, I send them a pack out with a consent form and demographics form [to complete and return]’.
Different models of consent
Patients are not always able to give consent themselves and relatives or carers might give consent on their behalf (for example, for studies involving newborn babies and unconscious patients). Graham and Imogen talked about research studies in emergency settings, and how different models of consent were often used. Some of the brain surgery studies Jisha worked on also allowed professional consent if patients were incapable of making the decision themselves (e.g. if unconscious). With elderly participants at risk of dementia, it was sometimes necessary to assess cognitive decline and re-consent at each follow-up visit.
Imogen described some studies in emergency medicine with different approaches to consent.
Graham described how consent tended to work in paramedic studies.
*The people interviewed for this website were mostly research NMAHPs (i.e. those employed in a research delivery role). However, we also interviewed some NMAHP researchers (i.e. those leading research as independent researchers). The latter group included people who were undertaking or had completed academic research qualifications, such as PhDs, and many had previously been in (or continued to also be in) research delivery roles. For more information about the distinctions between these roles and the sample of NMAHPs interviewed for this project, please see the Introduction section.
*Many research NMAHPs and NMAHP researchers felt strongly that they continued to be clinical within their research roles. As such, the wording of ‘research’ NMAHPs/staff and ‘clinical’ NMAHPs/staff can be problematic for implying that research is not also clinical activity. Where the wording ‘clinical staff’ is used on the website, we mean for this refer to non-research clinical staff (i.e. those who are not currently employed to carry out research or enrolled to pursue research through an academic qualification).