The three lay members (representing both genders) and four researchers all agreed to take part and were interviewed. The duration of the interviews ranged from 10 to 45 min. Verbatim quotes are used to illustrate themes.
Recruitment of lay observers
Recruitment of lay observers was reported to be challenging. The patient and clinical engagement group originally suggested that additional lay members could be recruited from among existing registered hospital volunteers at the two trusts at which observations were to be carried out. However, the volunteer manager at one of the trusts reported that existing volunteers already had their own roles at the hospitals and did not have extra capacity, and at the second trust, there was little interest in response to an advertisement to existing volunteers.
I probably thought it would be a lot easier. I think when we first met in our initial meetings we were discussing that we needed lay people, I thought it would be quite easy because I knew we had volunteer… kind of hub, …I thought it would be quite easy … And then I guess I was surprised that [name of volunteer manager] couldn’t really kind of magic up someone quite quickly who would be keen to do that kind of thing. (Researcher 3)
Following this, recruitment was based on using existing contacts who had been involved in other patient and public involvement activities and two further lay members were recruited. Three of five members of the expanded patient and clinical engagement group conducted observations and a fourth expressed an interest and registered as a volunteer but was then not able to commit the time to carrying out observations due to changes in personal circumstances
Previous experience of patient and public involvement
The lay observers and researchers all reported previous experience of being involved in research as lay people. One of the researchers had previous experience of lay people being involved as part of an ethics committee, and the other three had experience of lay people having a consultative role on study steering groups. The previous experience of the lay observers ranged from being a participant in a focus group to having a patient and public involvement consultative role on several research steering groups.
From both the researchers’ and lay observers’ perspectives, previous involvement in research had been much more limited than in the current project.
I think there are projects we wanted to involve lay people but they’d never – they’ve not been involved to any significant extent. It’s kind of like, “Oh we’ve got to put in this grant application, it’s got patient involvement as one of the criteria, we’d better try and do something” rather than really thinking the way we did in this project about how the lay observers were actually going to contribute to the project. It was more about ticking a box to get the grant application. (Researcher 2)
Well, very often when patients, patient reps are involved in research projects and initiatives and programmes they are basically consulted. Consultation can cover many things, can cover reading patient information, patient leaflets, reading such proposal in some cases adding in fact the dimension that the researchers may not have seen. It’s basically looking at something which has been already thought about, already at a stage of more or less the design has started and just asking the patients to have a look at it and express their views. (Lay observer 2).
Other experiences lay observers brought to the project
The three lay observers reported different experiences that they were able to bring to the project; one had been a patient herself in hospital many times with multiple chronic conditions, one had experience of communication management and the third had experience working a physiotherapist and in educational environments in the past.
Benefits of including lay observations
Positive experience for lay observers and their role in research
All three lay observers described conducting the observations as an enjoyable and interesting experience. One of the lay observers also expressed the view that the lay observers had an equal relationship with the researchers. Three of the researchers identified benefits to the research that subsequently resulted from these positive experiences. Two of these researchers expressed the view that being involved in the data collection had resulted in increased lay observers’ motivation and involvement with the project. The third was of the opinion that having the lay people play such an integral part in the research may also benefit any other research projects they were involved in, as they would have an increased understanding of the research process.
The bottom line is, as I say, I really enjoyed it and I found it really interesting and quite eye opening. I think it’s a really valuable experience. (Lay observer 1)
It was at corporate level playing field there is no differences basically a group of people who want to produce some improvement in a particular service area, healthcare and who want to join forces and a very co-operative way and the relationship between the healthcare professionals and the patient representatives is really excellent. (Lay observer 3)
It has… probably contributed to how involved that they’ll be later in the project and discussing our findings and their findings … has meant that their involvement isn’t token. It’s probably increased their motivation and interest as well so that will be useful. (Researcher 2)
Different perspectives
The two researchers who were most involved in conducting the observations and working with the lay observers were of the opinion that the lay observers had greatly contributed to the research findings by bringing different perspectives to those of the researchers; all three lay observers also expressed this view. While the researchers reported being focused on discussions related to medication, the lay observers brought a wider perspective of general communication and engagement management and the impact that this may have on medication-related discussions between healthcare professionals and patients.
Because I am far less knowledgeable about medication and prescribing than the investigators I was working with, I concentrated much more on the human relationship between the inpatient, the patient in the bed and the consultant … when it was a consultant led ward round, or the pharmacist on a pharmacist ward round or the nurse/nursing student on a nurse ward round, the interaction, the body language, the relationship, the physical interaction, physical location and placement [of] the healthcare professional in relation to the patient in the bed. (Lay observer 2)
I felt the lay observers were picking up more about the overall conversation, about how the patient was involved, and not specific to medication-related issues, it was more of a general “how’s the patient being involved in decision making and in the conversation”, that kind of thing. So they definitely brought a different perspective, so it was really positive, it’s a really positive thing and it almost made me reflect how I was looking at the situation as well. (Researcher 1)
Secondary analysis of the IMPRESS data demonstrated that there were additional codes added to the coding framework specifically as a result of the lay observers’ involvement. These comprised length of consultation, consultation structure, communication style, the level of engagement of the patient and the lay perception of the patient situation. The secondary analysis also suggested that lay observers of different backgrounds brought different perspectives. For example, the lay observer who had a background in communication and customer management brought a fresh perspective on the effect that the consultation structure and communication style of the healthcare professional team might have on patient involvement in medication decisions and the lay observer who had his/her own experience as an inpatient documented observations based on empathy with the inpatients’ perspectives.
Overall, interviews and secondary analysis suggested that combining the lay and researcher perspectives together gave a richer output than either could have given alone (Fig. 1). For example, the researchers reported observing that some discussions about medication that happen on doctors’ ward rounds did not involve the patient. The lay observers noted that ward round consultations were structured so that there was a ‘technical phase’ where the healthcare professional discussed the patient, in which the patient was about ‘as involved as a coffee pot’ followed by a ‘summary phase’ to the patient (coded as consultation structure). Taking the lay and researcher perspectives together, it became clear that discussions about medicines did not involve patients when they took place in the ‘technical’ phase and were then not included in the summary to the patient.
Impact on study design
Finally, the process of making arrangements with potential lay observers also shaped the overall direction of the project. One of the potential lay observers suggested that he would particularly like to observe rounds where carers would be present, and so the research team took the decision to carry out some observations of evening drug administration rounds, which coincided with visiting hours to the ward.
Challenges
Registration of lay observers as hospital volunteers
As noted above, lay observers needed to be registered as hospital volunteers in order to obtain a DBS check and to ensure that they were covered by appropriate indemnity insurance. Both lay and researcher interviewees reported considerable difficulty in this registration process. Interview data suggested that this was due to data collection being a different role to that typically carried out by hospital volunteers, and existing processes were not easily adaptable to this new role. The problems presented varied between the two trusts and with different lay observers. Interviews suggested that some of the lay observers had been quite upset by the process.
Well, the experience at [name of hospital 1] was okay, a trifle lengthy. The experience at [hospital 2] I thought was absolutely appalling. (Lay observer 2, discussing registration process)
It seemed to me that nobody seemed to know how to do it. They didn’t fall within the typical hospital volunteer profile, because they weren’t able to commit to doing so many hours a week in the hospital shop, or whatever it is that they're used to doing, and they were being recruited for a specific project. Nobody really knew how to deal with that, and it felt a bit like we were being passed from pillar to post, in terms of how we do it. It just took … a lot of effort and time. I think both for researchers and for the patients. I think it was a big commitment for everybody to try and make it happen. I think we all had to be quite motivated, otherwise it would have been very easy to just say, “You know what? This isn't worth the aggro”. (Researcher 4)
Similarly, when lay volunteers were asked about the training, all three lay observers found the volunteer training provided by the trusts to be long-winded or patronising. One of the researchers reported that there had also been delays in obtaining hospital identity cards for the lay observers. No unmet training needs were identified by the lay observers although the researchers identified a need for further training in research and information governance (see the next section).
Differing paradigms of information and research governance and codes of practice
Interview data suggested that lay observers without any previous experience as healthcare professionals may have had a different paradigm of information and research governance to the researchers. A common theme emerging from the interviews was the responsibility that researchers felt for ensuring information and research governance procedures were followed. In addition, one of the researchers reported that the healthcare professionals being observed had had similar concerns.
I guess one of the things is as well, you almost feel as though you’re responsible for them up on the wards so from a professionalism … perspective, it’s almost you’re on the line as well because they represent you because they’re with you. (Researcher 3)
Sometimes it would be initiated by the healthcare professional [being observed] to say, “Oh well are these lay observers allowed to be here … they would check that they had gone through the right means. And one consultant [senior doctor] said … “Have you got all the appropriate things to say you’re meant to be here?” Another consultant on another round said to us, “Oh we have really sensitive patients here, so I’d presume that you’re going to respect confidentiality”. So I … just wanted to reassure them yes they’ve gone through the .... appropriate checks. (Researcher 1)
The researchers involved in the observations reported that confidentiality and general code of practice were respected although they had had some minor concerns at times. However, these researchers also expressed concern the lay observers may sometimes have recorded data based on interactions with patients who had not consented to be included. The researchers had subsequently discussed how to approach this and excluded from analysis any data that may have been obtained from patients who had not consented. The interview data suggested that the lay observers did not share these concerns. In most cases where lay observers may have recorded data based on observation of patients who had not consented, they did not recall this at the time of interview, although the researchers reported that the lay observers’ observation notes suggested that they had been aware of it at the time. However, in one case, a lay observer did recall recording data from a patient who had not given consent; he or she had taken a more holistic view and expressed the opinion that collecting data from interesting cases, potentially of great value in informing future practice, overrode the requirement to obtain informed consent. The researchers ensured that data were discarded and excluded from analysis if they were not certain that informed consent had been given. These data suggest that while lay observers were aware of research governance procedures, they may have taken a more fluid or individual approach to their application, whereas the researchers felt bound to adhere strictly to the protocol approved by the ethics committee.
Timing
Lay involvement in data collection was suggested after ethics approval had initially been obtained for the IMPRESS study and very shortly before observations were due to start. This resulted in the need to submit a request for a substantial amendment to the ethics committee. Coupled with the delays in the registration process, this meant that the lay observers were not able to be involved in observations at the very start of the study. One of researchers expressed the view that if the lay observers had been involved with the earlier observations, these may have further informed her own later observations.
If we hadn’t had all the delays in getting them involved and we could have got them all registered earlier and they could have started their observations a bit earlier, I think it would have benefited the project because when I was doing the analysis of the project I did feel like some of the things they found were really interesting and I could have used it for my future observations …but… because it took so long to get their work through, that wasn’t really possible. (Researcher 2)
Workload for researchers
While the researchers involved were very positive towards the lay observations, those involved in organising them also reported that it had increased their workload. This was due to the requirement for the researchers to invite consent from additional patients for the additional lay observations, orientate the lay observers to the ward and be available on the ward while they were doing their observations. There was also additional work related to the registration process and training. Coordinating observations was more complicated as the researchers had to find a time which was suitable for the healthcare professional being observed, the lay observer and the researcher supporting the lay observation. However, the lay observers and researchers noted that this process had run smoothly, and the researchers expressed the view that the value added to the research made the extra time worthwhile. However, they were of the view that this time would need to be taken account of in planning future lay involvement of this type.
With regards to when each lay observer came on to do their observations, orientating them to the wards, showing them the toilet, the facilities, and all that kind of thing, the introduction, that did take a while, but that can’t really be avoided. (Researcher 1)
There’s also logistical challenges about, scheduling observations on the wards is quite challenging, in terms of trying to link up with the healthcare professionals, and when it is a good day and a bad day on the ward? You can turn up and find that the consultant on that day isn’t happy for an observer to be there. Then, when we’ve also got to think about coordinating with lay observers, and according to our protocol, we always want to have one of the professional observers around on the ward at the same time. So it adds an additional logistical complexity to what is already logistically challenging in some ways. (Researcher 4)
Recruiting a representative group of lay observers
One of the researchers discussed the difficulties of recruiting a diverse group of lay observers. They reported that ideally they would have liked to recruit a diverse and more representative group of the public to carry out the observations. However, as noted above, recruitment had to rely on using personal contacts. All lay observers were over 55 and of a similar ethnic group. Some effort was made to widen the range of lay observers by approaching support groups for diseases likely to be found in younger disease groups, asking hospital consultants specialising in those diseases if they knew patients who may be interested and by asking university students. However, none of these approaches were successful.
Despite a lack of diversity in relation to age and ethnic group, one of the researchers was of the view that diversity in relation to different backgrounds and experiences of the lay observers greatly contributed to the quality of the data.
Another researcher raised the issue of ‘how “lay” is lay?’, suggesting that if lay people get involved in many research projects they may cease to become truly ‘lay’ and become more like healthcare professionals and less representative of the general public. The researcher who expressed this view did not think that this was the case in this particular study but that it was something to consider for future work. It should also be noted that one of our lay observers had had past experience as a physiotherapist.
Because—and I see it when we do the ethics committee, you know, you get a couple of new lay members and after a few years they all of a sudden are starting to talk all the jargon … . So, say for example, we had a couple of new lay members join us about three months ago and it’s actually really refreshing to hear what they’re saying on the applications … because I guess they haven’t been jaded by previous applications. So if you translate that then to a study, if you’ve got lay members who are involved a lot in lots of different research procedures, they will be almost experienced lay people. (Researcher 3)
Other challenges experienced by lay observers
Lay observers reported experiencing some challenges during the observations themselves, which were similar to those experienced by researchers when they carried out their observations. These included time spent hanging around due to not all patients consenting, ward rounds being rescheduled at the last minute, difficulties in remaining a passive observer when those being observed wanted to include the observer in conversation and the rounds observed only representing a snapshot of the patient’s full care.
Well sometimes the elderly patient in some cases [wanted] me to participate in the kind of discussion they were having, let’s say with the pharmacist or even a doctor, they wanted to call on me for more or less agree or disagree with what they were saying, hoping that perhaps because of my age I would know better than a young person what they were trying to say. … So the only challenge I had in some cases, not at all obviously was to keep very very mute, silent, control any body language except for being smiling obviously and not appear gruff or judgemental or anything, but to be really kind of statue in that sense. (Lay observer 2)
One of the researchers reported that a challenge specifically affecting lay observers was that local policy stated that they were not allowed to go into single bed rooms where infection control procedures were in place. This meant that they were more limited than the healthcare professional researchers who were allowed to enter these rooms provided they took appropriate infection control precautions.
Lessons for future studies
Interviewees were asked about their view of lay involvement in conducting future research. All lay observers and researchers were positive about lay involvement in the future. Alongside this, both a lay observer and researcher expressed the view that while lay involvement in data collection had worked well in this context, this may not applicable to all types of studies. Both the lay observer and researcher were of the opinion that in this study, lay involvement in data collection was particularly relevant because the study focused on interactions between patients and healthcare professionals. However, there may be less of a place for lay involvement in observations of inter-professional issues which do not directly involve patients.
Well, I guess what we’re interested in, in this particular project, is about interactions between healthcare professionals, hospital patients, medicines. So the interactions with people is a key part of that. I could imagine that there would be many other studies where we’re actually interested in, I don’t know, interactions between pharmacists and doctors, which is perhaps slightly less relevant to get a public view on that, if those are interactions and communications that don’t really happen in front of the patient anyway. (Researcher 4)
In some projects actually the patient perhaps has to be limited to a consultative role, when the project is really aimed at healthcare professionals for them to introduce quality improvement programme[s]. (Lay observer 3)
Another recurring theme with regard to future projects was the need for proper planning in terms of lay involvement. This was both in terms of specific projects and overall coordination of patient and public involvement at hospital trusts. For future studies, it was suggested that it would be important to plan any lay involvement in data collection at an earlier stage so that resource could be allocated and the paperwork put in place in time. The majority of lay and researcher interviewees felt that improvement was also needed to streamline the registration and training processes. Suggestions included collaboration with the volunteer coordinating centre much further in advance for future projects, finding out whether it was possible to fast track DBS applications and completing all necessary procedures on one occasion rather than asking the lay observers to return on a large number of occasions.
How could my experience be improved for the future? Well, not having to go through all the inductions. (Lay observer 3)
The issue also arose as to how much training to give lay observers. The two researchers specifically involved in the observations were of the view that the role of the lay observers was to bring their own perspective and that while they wanted to provide training on research governance and ethical procedures, they had not wanted to provide much training on what to observe and record during the observations. A third researcher expressed uncertainty about the right level of training to include.
So I think if they were concentrating too hard on just like trying to find out – or just pick out the bits about medication or treatment, I think it might have meant that they were distracted. So I think it was probably a good thing actually that we just kind of left it up to them to just record what they felt they needed to record. (Researcher 1)
You could almost give them a whole training programme on how to find your way around a hospital, a ward, what communication structures, what theoretical framework filled that, to practically nothing, and then there’s a whole continuum in between.. I suppose what I don’t have a sense of is, where is the right place on that continuum for them and for the study? I think that something that, going forwards, we’ll probably need to have a better sense of, is to how much of that background information and training is needed to do the right job? (Researcher 4)
As noted above, the lay observers’ recollection was of the mandatory training provided by the trust rather than the more specific training the researchers had provided. However, the lay observers did report feeling supported by the researchers working with them.
And the investigators explained everything very clearly to the lay observers and basically facilitated the whole process extremely well. (Lay observer 2)