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J R Soc Med. Aug 1, 2008; 101(8): 416–422.
PMCID: PMC2500238

The patient's experience of being a human subject

Summary

Objective

To explore the patient's experience of clinical research with a view to improving its conduct.

Design

Qualitative analysis of focus groups, semi-structured telephone interviews and questionnaires undertaken with subjects of clinical research.

Subjects

265 patients enrolled in two therapeutic and four non-therapeutic clinical studies were invited to take part. 95 agreed; 32 took part in focus groups, 34 in telephone interviews and 29 returned a questionnaire. Response rate (36%).

Results

Most patients are channeled into research by the health care professionals treating them. Benefits of taking part were seen as: extra care; increased surveillance; obtaining expert information; and being able to help others. Participants also had criticisms which included lack of information about research findings, problems in making sense of adverse events, insufficient attention to their comfort and ‘unscientific’ aspects of particular studies.

Conclusion

Participation in clinical research is not entirely altruistic. Patients expected reciprocity in their on-going relationship with the researcher. Therefore to help ensure that patients continue to support clinical research, we suggest that: time should be allowed for providing information; greater attention should be paid to physical comfort; opportunities should be provided for involvement in research design, in the excitement of research and for giving feedback on the findings; and contact between patients taking part in the same study should be facilitated. By investing in the idea of scientific progress through research, some subjects are able to transform their suffering into hope for the future.

‘Being pumped with poison is risky but it was handled well and it worked …’

Introduction

Patient involvement in clinical research is now firmly on the agenda, with patients contributing to the design of studies, undertaking research themselves1 and planning the research agenda.2 The barriers to, and benefits of, participation in clinical trials have been explored in two systematic reviews,3,4 but there are few studies5 which shed light on the patient's experience of being a research subject. In this study we explore what can be learnt from the participants so as to improve the conduct of clinical research.

Subjects and methods

All principal investigators undertaking clinical research at a large teaching hospital were invited to volunteer studies where recruitment had been completed in the last year. In all, 60 studies were volunteered from some 15 investigators. Studies where fewer than ten subjects were enrolled or surviving were excluded. Six were then selected to provide a range of different types of studies – therapeutic and non-therapeutic, studies for both life threatening and chronic conditions. Details of the studies selected and response rates are shown in Table 1.

Table 1
The clinical studies and response rates

Research ethics committee approval was obtained. Potential participants were informed that the directorate undertaking the work was separate from clinical services and that information would only be fed back to participating clinicians in an anonymized form.

The initial plan was for focus groups using the following topic guide to be the only method of data collection:

  • ‘how did participants become involved in the research?’;
  • ‘what are their views on the of benefits of participation?’;
  • ‘what could have been done better?’

But attendance at the first two groups was poor. Information volunteered by those who did not attend indicated a number of participants would have liked to give their views but were prevented from doing so because of poor health or professional commitments. It was decided, therefore, to amend the protocol to allow patients a choice of ways of responding: by attending a focus group, through a telephone interview or by completing a questionnaire – all using the same topic guide. In all, 95 out of a possible 265 research subjects participated, a response rate of 36%. The focus groups were tape-recorded and transcribed. In telephone interviews notes were taken. Summarizing content analysis6 was used to reduce the material in such a way that the essential contents relating to the conduct of the clinical research were preserved. Material with similar content, for example the subject referring to obtaining information from researchers, was then linked. Themes or categories were then produced from the linked content inductively and tested through independent analysis of data by two researchers.

Results

The referral process

Participants were usually made aware of the potential research by the nurses or doctors in the hospital providing care, but occasionally the process was not well handled. Three patients believed that they were referred for help with their condition, but when they arrived this was delivered within the framework of a medical research project. This could cause particular problems where patients being recruited to studies might have a life-threatening illness. If consultants had failed to raise this possibility earlier, it could be through the consent process that patients learnt for the first time that they were potentially very ill:

‘I was given an information sheet to read while waiting to go in to the theatre for the first bronchoscopy, headed ‘‘For patients with suspected lung cancer’’. This does not seem an appropriate time to be given this …’ (Q S4)

Although participants in five studies were first made aware of the research by the team providing their care, one study was somewhat different. Through support groups, websites and the like, the story of Botox as an experimental treatment for incontinence appeared to have reached a fairly wide public audience. This publicity led to some patients actively seeking out a referral to a study which employed this technique.

The consent process

Four subjects in two studies, the chemotherapy trial for ovarian cancer and the diagnostic audiology, were unaware that they were part of a research study, even though they had signed consent forms. But the majority of participants clearly recalled that they had actively ‘signed up’ for research. ‘Signing up’ symbolized a significant change in the relationship with the clinician:

‘I have to sign every time. I have always understood why they are doing it, why it is important and what signing means. To agree gives a sense of involvement which is very good.’ (I S6)

Some supplemented information from the patient information sheet with what they could find out by their own efforts:

‘I did some research and the internet … joined Ovacom and looked up different papers …’(FG 1 S2)

The written information given during the consent process had considerable importance. It was often carefully preserved to be referred to when things happened that they did not understand. Failure to provide information sheets which were easily understood by lay people wascriticized:

‘I have no idea what that research was about. The only word I understood [of the information sheet] was ‘hearing’’ (I S5)

The majority of participants felt the study was portrayed accurately in the information given at the outset. But four said they were taken by surprise, for example, by the amount of lung tissue taken in the brochoscopy study, and the number of injections into the bladder wall in the Botox study.

‘I thought there would be just one … but it finished up with 38’ (FG S6).

What are the benefits of taking part in research?

Participants felt they had gained from their involvement in research in following ways: effective treatment, increased surveillance, obtaining information from experts and through the excitement and hope of science.

Effective treatment

Clearly, in the two drug trials therapeutic advance was a possibility. In the Botox study, from the investigator's point of view, the treatment of incontinence was a side effect of the aim of investigating the mechanism of action of the drug. But over half of the respondents described the benefits of the Botox injections in terms of successful treatment – ‘amazing’ (I S6) and ‘life changing’ (I S6).

Increased surveillance

Even involvement in ‘non-therapeutic’ studies, such as fluorescence bronchoscopy or MRI study of MS, was construed as having therapeutic benefits. In the bronchoscopy study, patients saw a chance that treatment would be more effective if the cancer was ‘caught early’. Being ‘kept an eye on’ by knowledgeable staff and the ‘extra care; twice the care’ (FG S4) provided was particularly a comfort for those with life-threatening conditions:

‘I thought that because it was a trial I would be more closely monitored. The diagnosis comes as a shock, if you can be monitored it gives you reassurance.’ (FG S2)

Where special arrangements had been made to offer support to research subjects, this was appreciated, as was continuity of care.

Obtaining information

The opportunity to obtain information appears to be one of the great benefits of research participation. For the studies of diagnostic methods (S3 and S4) this meant privileged access to information about how the disease had affected their bodies:

‘Initially I got the chance to speak to the researchers conducting the research. They showed me the scans and explained things to me, how the research was progressing … GP said you are getting a free brain scan every three monthsGetting information from the horse's mouth about your condition.’ (I S3)

But participants in all studies saw participation as an opportunity to question knowledgeable professionals about a broad range of issues, for example organ donation, or whether it would be worthwhile for the GP to prescribe the latest drug.

Investing in scientific progress

In the imaging study of MS in particular, contact with active researchers whom participants saw as being at the forefront of discovery linked their illness with the powerful narrative of scientific progress:

‘Fantastic machine. Let me look at the scan. Very expensive. They are excited about what they do and it comes across.’ (FG S3)

Investing in the research project also meant investing in clinical researcher. In the focus groups for four of the studies, respondents spontaneously spoke of the key research doctor with passionate enthusiasm, for example, ‘he is the best’.7

And science offers hope

‘I feel that the doctor at the … hospital feels that they are getting somewhere, and that's very exciting.’ (I S3)

What could have been done better?

For all studies, thirty-nine individual respondents (62%) and all of the eight focus groups identified issues for improvement. These are considered under three headings: participants' discomfort; study methods; and lack of information about the findings.

Discomfort

Many respondents were quite disabled or unwell, but nonetheless made consistent efforts over long periods to take part in these research projects. They identified a range of inconveniences, such as very short notice for overnight admission, and discomforts, such as ‘five to six hours in a scanner four times a year’ and anaesthetic sprays to nose. But were often tolerant of them, particularly where they felt they were treated with respect. That is ‘as a human being and not just a number on a tick sheet’ (Q S3). Some descriptions could suggest that discomfort or even suffering was expected when participating in this kind of research. It was ‘par for the course’ (FG S4).

‘Not too bad. After 10 injections I thought this isn't so nice, then after that point it became quite bearable … No it was OK … I am fairly good with pain.’ (I S6)

Others had suggestions about things that that would have helped. Patients with multiple myeloma whose spines were affected by the disease found the chairs in the outpatients clinic very uncomfortable (FG1 S1). MRI scans were considered to be an unpleasant experience – an experience which participants suggested might be better managed with more effective ear protection and a comforting hot drink afterwards (FG1 S3). The effort and cost of repeated, sometimes long, trips to London was a concern, particularly as costs were not reimbursed for all studies.

How to make sense of, and deal with, ‘adverse effects’ was a topic of conversation in all focus groups apart from the diagnostic audiology study. Patients were particularly concerned where they felt doctors had not accepted their view that the symptoms were caused by the drug or research procedures. The Thalidomide focus group discussed at length the difficulty of knowing whether ‘tingles in limbs’, and ‘feet swelling like a balloon’ could be attributed to the experimental drug as ‘everything gets attributed to the drug’ (FG S1). Seven of the 38 individual respondents in the Botox study reported long-term adverse effects. Subjects thought that the procedure gave them infections. Two had experienced leg weakness and spasms in their muscles. The latter was attributed to the injections, not the drug. Similarly a patient in the chemotherapy trial remarked:

‘Worst effects constipation and furry mouth. Dreadfully sore toes...lost sensitivity in my fingertips. Can't turn over single sheets of paper … joints is something you put up with. Not sure if the blackouts are an effect of the chemo.’ (FG 1 S2)

Study methods

Ten respondents made spontaneous criticisms of the study methods, with two finding the tests and methods ‘unscientific’. Functional assessments and questionnaires in particular were criticized:

‘We have a form to fill in about frequency and urgency and all that … given three categories to tick. But it wasn't clear between when the feeling started and when you did something about it. Slightly misleading, possibly for them as well, that they weren't getting the information they wanted.’ (I S6)

‘Change the exercises … The contrast between hi-tech (machines) to these tedious tests … not sophisticated …’ (FG 2 S3)

Others questioned the reliability of tests used in conjunction with MRI scans. Sometimes the tests were conducted before the scans, other times afterwards, when subjects suggested tiredness would influence the test result. Concern was also expressed when lack of long term follow up meant that later consequences of interventions could not be known by the investigators.

Lack of information about findings

Participants in studies wanted more feedback both on their own ‘test’ results and on the study's findings in general. ‘I asked for results but never got them.’ (Q S5) Participants wanted ‘to have been given information if it was of any benefit and any conclusions’ (Q S3) and ‘I would like to know if they have discovered anything new, in understandable language’ (FG S3). They asked researchers ‘to take people seriously as persons and let them know what was found out’ (Q S5). Also, a handful of participants in all studies were frustrated that they did not know basic details such as the timescale of the study or numbers to be recruited.

Discussion and lessons for researchers

The principal findings

Despite the discomforts of research, even those who were involved in non-therapeutic studies felt they had benefited. In particular, for participants who invested hope in scientific advance, the opportunity to get information from experts who were perceived to be at the forefront of such advances was particularly valued. There were criticisms when their experience did not match up with their expectations of scientific method. In particular, research subjects were in some cases critical of the validity of questionnaires or tests which aimed to capture their experience of their own bodies. Similarly, there was disappointment when the expectation of sharing in the findings was not fulfilled.

Research may be part of the therapeutic plan for patients. But a seamless progression from care to research can cause patients to misunderstand where the plan is leading, particularly when consent is also seen as a process rather than an event. Participants can slip so easily from care into research that they had difficulty in identifying boundaries between the two. As research suggests that some patients may not recollect key aspects of what they have been told,8,9 it is not difficult to understand how patients can unwittingly become involved in research.

Strengths and weaknesses of the study

The study was unusual in giving respondents a choice of route of response, enabling the depth of data gained from focus groups to be supplemented by the privacy and ease of telephone interviews and self-completion questionnaires. But despite the use of three different methods, the response rate was fairly low. This rate is acceptable given that the qualitative method used aims to provide descriptive overview of the lived experience of sample of patients which can be used both to inform more detailed future studies and to improve experience for patients in this under researched area.

All participants in this study were suffering from serious illnesses and under the care of the hospital undertaking the research. Not only did this mean that the authors felt it inadvisable to pursue non-respondents for fear of jeopardizing their relationship with the hospital, but these factors may have meant that participants found it difficult to be critical of clinical researchers on whom they depended for care. The sample is likely to be over-represented by subjects committed to medical research. Nevertheless two respondents with serious concerns about the conduct of the research did respond. Both chose to be interviewed, rather than respond in other ways.

The picture might be different where conditions were of less significance to potential subjects and where the researchers were independent of the institution providing the care. Similarly, the location of the research – in a tertiary centre – means that the study does not necessarily reflect the experience of research subjects in primary care or local hospital settings.

Implications for clinicians and policy makers

As others have noted, research subjects should not be characterized as passive.7 Participants greatly valued the opportunity this study presented for contact with others who are part of the same research. All focus groups said that they were very pleased to meet one another to share their experiences about a range of matters, not all of them directly relevant to the research. They exchanged contact details and planned to keep in touch. For many, it was the first time they were able to meet others also undergoing the sometimes demanding requirements of the research process. Such meetings enabled them to create a coherent story about their illness and its relationship with the research study. Feelings of isolation and fear of the unknown could be shared. This was perhaps particularly valued where the condition also carried stigma or fear, as in urinary incontinence, cancer and MS, or in the case of the Thalidomide trial where patients were taking a drug with a notorious history. Therefore such contact, either face-to-face or using electronic communication, may improve retention when used as a regular part of studies.

In taking part in research, the subject's role changes from seeing him or herself as a recipient of care to one making an active contribution towards both the research clinician's work, and to their own and others' welfare. Patients will put themselves to considerable inconvenience where they feel their contribution is respected and reciprocated. Reciprocity can take many forms, including taking the time to provide information and advice or close attention to the subjects' physical comfort. From their comments about research methods it was interesting to see how intellectually engaged patients were. Many respondents felt they had a real stake in the research they were involved with, and wanted to be treated as partners in the project. Others have argued that the involvement of patients in study design will improve the acceptability of questionnaires and other tests of functioning.1 Partnership suggests a share in the excitement of research, with access to the findings in a understandable form, perhaps through meetings as well as on paper or electronically, and interim news for long-term studies. A lack of feedback can render meaningless a process which was once full of hope.

A further issue is that processes of care and research can sometimes be so closely woven together that patients become confused between the two. Participants in the Botox study expected treatment with long-term follow up. Participants enrolled in two other studies ‘forgot’, they had been involved in research. In these latter studies, the research procedure did not vary markedly from normal diagnosis or treatment. One involved hearing tests after a stroke, the other the administration of an investigational drug through an intravenous infusion, rather than by mouth from a container labeled ‘investigational medicinal product’. Where patients are unaware they are part of a drug trial it is likely that this will have significant implications for the reporting of adverse events. Patients may not connect events with a drug if they are not aware they are part of or have been part of a trial. In such studies, the consent process requires special attention by the investigator.

This research was undertaken as part of a commitment to improving the patient experience. However it also proved valuable as a method of monitoring the conduct of studies, raising issues which are difficult to identify by other means. Indeed, a full review of one such study was undertaken as a result of concerns raised by participants.

Unanswered questions and future research

While altruism is usually considered to be one of the main motivations for involvement in research,3 this study suggests that participants often expected more immediate returns. Some calculated that there could be therapeutic benefits. Most expected, and indeed received, other benefits such as information from the on-going relationship with a clinician researcher. Thus further investigation of the nature of this relationship may help to improve the conduct of future studies and increase patients' support for the scientific enterprise. Future research could usefully ask direct questions about subjects' views on the methods used for the medical research. It is important to appreciate that for those with long-term illness, suffering can be understood as a fundamental loss of self.10 For some, to engage in the idea of scientific progress through medical research can transform suffering into something more meaningful. Part of the lost self may be restored by investing in this ‘political economy of hope’.11 The views of those who choose not to participate either in clinical research or in this study and who may be skeptical of the value of an engagement with science would also be enlightening.

Footnotes

DECLARATIONS —

Competing interests None declared

Funding None

Ethical approval Not applicable

Guarantor SK

Contributorship SK designed the project, undertook part of the fieldwork and drafted the final paper for publication. SL designed and undertook the fieldwork, analyzed the data and prepared an initial report. MC organized and undertook fieldwork. AT provided advice about lessons for researchers and edited the final paper

Acknowledgements

None

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