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“I Will Do It If It Will Help Others:” Motivations Among Patients Taking Part in Qualitative Studies in Palliative Care
Vol. 35 No. 4 April 2008
Journal of Pain and Symptom Management
347
Original Article
‘‘I Will Do It If It Will Help Others:’’ Motivations Among Patients Taking Part in Qualitative Studies in Palliative Care Marjolein Gysels, MA, PhD, Cathy Shipman, BA (Hons), MA, and Irene J. Higginson, BMBS, FFPHM, PhD, FRCP Palliative Care, Policy and Rehabilitation (M.G., C.S., I.J.H.), King’s College London School of Medicine at Guy’s, King’s College and St. Thomas’ Hospitals, London, United Kingdom, and Barcelona Centre for International Health (CRESIB) (M.G.), University of Barcelona, Barcelona, Spain
Abstract The aim of this study was to explore patients’ and carers’ preferences and expectations regarding their contribution to research in palliative care through the use of qualitative interviews. Data were collected in the context of two studies exploring the experiences of care of palliative care patients and carers. Both studies recorded the recruitment process, numbers of patients or carers accepting and declining, and the circumstances of interviews. Participants were asked about their motivation to participate in research. The data were analyzed by labeling patients’ reflections on their motivations for participating in these studies and identifying themes. Analysis of the recruitment process revealed differential patterns in decline and acceptance of interviews by patients with different conditions and across settings. Among cancer patients, 21/51 declined; the proportion with other conditions that declined was small, and was 0/10 for patients with motor neuron disease. Motivation to participate in the studies was related to (1) altruism, (2) gratitude and concerns about care, (3) the need to have somebody to talk to, and (4) the need for information or access to services. Palliative care patients and carers were capable of deciding whether to participate in interviews and negotiating how they wanted this to happen. This strengthens the argument for patients’ autonomy in deciding whether to participate in research. Patients and carers have different motivations for participation, reflecting the heterogeneity of the palliative care population. This suggests a need for ethics committees to reconsider their views and widen their perspectives on the involvement of palliative care patients and carers in research. J Pain Symptom Manage 2008;35:347e355. Ó 2008 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Recruitment for research, motivations, expectations, qualitative interview, palliative care
This research was made possible through funding from The Cicely Saunders Foundation (TCSF). Address correspondence to: Marjolein Gysels, MA, PhD, Palliative Care, Policy and Rehabilitation, King’s College London, Weston Education Centre, Cutcombe Road, London SE5 9RJ, United Kingdom. E-mail: [email protected] Accepted for publication: May 8, 2007. Ó 2008 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved.
Introduction Views differ as to whether patients who have a serious illness and are near the end of life should be involved in research. It has been argued that they are vulnerable and should be protected because research could be distressing, intrusive, and time-consuming and that 0885-3924/08/$esee front matter doi:10.1016/j.jpainsymman.2007.05.012
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it may divert them from more important priorities.1 Indeed, de Raeve proposed that patients with palliative care needs should never be asked to participate in any research, whatever the design.2 Raudonis et al. argued that research with palliative care patients is not appropriate as they are a ‘‘captive audience,’’3 and patients who rely heavily on health professionals for essential care might fear that the care they receive could be compromised when they give a negative account of services. However, there may be a danger that protecting patients from research also denies them the opportunity to make independent decisions.4 Indeed some studies found that patients were happy to be involved in research.1,5,6 It has been documented that recruitment of patients with advanced disease for research is difficult. A study on patients and staff attitudes toward research in a specialist palliative care unit reported that patients’ limited physical and emotional reserves often influenced trial participation.7,8 In another study, the reasons for taking part in research included the chance of being treated by a specialist and the chance to benefit humanity.9 However, little is known about how patients and their families perceive the risks and benefits of research participation, or what their motives are for participating.1 Judgments are often based on a priori assumptions of vulnerability rather than on evidence of what is actually harmful. We need empirical data on these issues to decide whether and what type of research is appropriate and acceptable10 and to support ethics committees in making appropriate decisions.11 Therefore, we explored the views of patients and their carers about participation in research interviews while conducting two studies. The aim was to explore patients’ and carers’ preferences and expectations regarding their contributions to research, making use of qualitative interviews.10 We documented the process of recruitment and interview and gathered evidence on responses to the invitations for an interview.
Methods Data were collected in the context of two qualitative studies exploring the experiences of involvement in research of palliative care
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patients and their carers. One study (Experience of Breathlessness Study or EBS) took a comparative approach toward patients suffering from breathlessness, with different conditions, in different care settings. The other study (Experience of Cancer Study or ECS) specifically focused on cancer patients. Both studies explored issues regarding recruitment and interviewing among these patients, and the data were combined for the present analysis. Both studies took place in a large London teaching hospital and were concurrent (between July 2005 and March 2006). All patients included in the study signed informed consent. The sample was purposive. Within the limits of our time and means, we decided to target the types of participants shown in Table 1. Demographic data and clinical information about patients was retrieved from patients’ records (electronic and paper files), or specialist databases (Medinet), which recorded details of patients with respiratory problems. Patients’ letters also were used for this purpose. We used semistructured, open-ended interviews. They were exploratory in the sense that they allowed respondents to touch on any topic relevant to them, but a topic guide was used to ensure that all the necessary topics were covered as much as possible. The ECS study also included some closed questions. The interviews lasted between 40 and 150 minutes, and all were tape recorded and transcribed verbatim, except for two where the recorder broke down, but these were reconstructed immediately after the interview. A notebook was used to record field notes during the interviews or when events happened that were inappropriate to tape record. The recruitment process was recorded, as were the number of patients or carers accepting or declining and the reasons given for declining participation in the study. The circumstances in which the interviews took place were described. The interviews ended with questions to patients and carers about their motivation to participate in research. First, the numbers of patients and carers accepting and declining were compared. Then the data on reasons for decline and motivations were analyzed by labeling them and identifying themes, which were linked back to the numbers of those accepting and declining involvement.
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Settings Outpatient clinic
Types of Participants
Age
Gender
Recruitment Strategy
Carers Patients Patient Interviewed; Carer Interviewed Declines Separate/Joint Declines
Patients with cancer
Range: 52e67 8 women Median: 68 22 men
CNS outpatient clinic: 8 Physiotherapists at pulmonary rehabilitation classes: 2
30
21
Patients with COPD
Range: 52e75 9 women Median: 69 5 men
Consultants at respiratory outpatient clinics: 2 CNS ward rounds and clinics: 9 ‘Breathe Easy’ meetings: 3
14
Patients with cardiac failure
Range: 61e80 3 women Median: 69 7 men
CN from outpatient clinics: 7 Consultants at respiratory outpatient clinics: 3
10
MND patients
Range: 24e77 1 woman CNS from inpatient wards: 3 and outpatient clinic:7 9 men
Community Patients with severe COPDa
Range: 52e78 2 women Written invitation sent by GP practice: 36 Median: 70 2 men
Patients needing palliative care Range: 64e79 5 women Consultant and CNS of palliative care team by 3 men home visits: 8 COPD ¼ chronic obstructive pulmonary disease; NE ¼ Not eligible. a This group was not included into the analysis as there was no further information on why they refused.
10
7J
2
2
2S/ 4 J
1 1 NE
3
3S
1 NE
9S
1 missed
/
/
1S/1 J
2
/
4
32
8
3
Motivation for Research Participation in Palliative Care
Table 1 Patterns of Acceptance and Decline Across Different Conditions
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The study obtained ethics approval by the Local Research Ethics Committee and the relevant R&D committees of the hospital where the studies took place and the community of Lambeth and Southwark. A patient and carer coding system ensured confidentiality throughout the study. Before recruitment, it was important to negotiate access to patients and clinics with health care professionals in the different sectors. The EBS made contact with the people caring for patients suffering from breathlessness, that is, nurses, physicians, physiotherapists, and coordinators of the centers. The researcher explained the nature of the study and asked the health professionals if they would be willing to assist with recruitment. In this process of familiarization, health professionals requested the researcher to give presentations at meetings or seminars that were held in the departments where the researcher planned to work. The function of these meetings was to convince staff of the relevance of the study. Most questions focused on the methods used, the eligibility criteria of patients and verification of ethics approval. The qualitative design raised concerns among practitioners about the practical relevance of the study, and, therefore, its justification. However, their commitment to improve care and their unfamiliarity with qualitative research led them to eventually give their support. Similarly, the researcher undertaking the second study approached and approved the process of contact and interview with clinical teams, and principally the clinical nurse specialists for lung and colorectal patients at the hospital.
Results In total, we conducted 108 interviews. In the EBS, we conducted a total of 85 interviews, including 56 patients and 25 carers. We did four repeat interviews, with one patient and two carers. In the ECS, we conducted 23 interviews, 20 with patients and three with carers. Four repeat interviews were undertaken (see Table 1).
Patients’ and Carers’ Responses During the process of recruitment for the study, various patterns of acceptance and
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decline of participation were identified from the responses of patients with different conditions and across different settings (see Table 1). Among cancer patients, 21/51 declined, whereas the proportion declining among those with other conditions was small, for example, 0/10 for motor neuron disease (MND) patients. The palliative care patients who declined all had a cancer diagnosis.
What Were the Reasons for Declining an Interview? The reasons recorded for declining to take part in a research interview were as follows (Table 2): (1) in four cases, we received an outright negative answer to our invitation for interview (objection to interview); (2) 12 refusals were due to being too ill, confused, having moved from home to hospice, or to not perceiving themselves as eligible for the study (external circumstances); (3) two carers were protective toward their patients and asked not to approach the patient for an interview as they thought it would harm them (gatekeeping by carer); (4) five patients were ‘‘silent declines,’’ who could not be contacted for the interview (we suspected from the outset that these patients were not completely convinced that they wanted to take part in the study from their hesitant responses; they did make appointments, but later either had an excuse for not participating, simply did not turn up for the occasion, or changed their mind at the last moment); (5) one patient felt improved and wanted to put the recent experience of hospital care behind him; and (6) in six cases, patients did not give a reason for declining an interview. When carers declined to be interviewed in their own right, this was reported to be largely a matter of personality. They were mostly approached via the patient, who then explained after having asked the carer that he or she was too ‘‘shy.’’ Few patients, therefore, objected to participation in a research interview, or to their main carer being contacted. Refusals were largely due to external circumstances. We found that this was especially the case for the cancer patients and their carers, as we often met shortly after they had been informed about their diagnosis and were coping with difficult issues such as the impact of bad news or important decisions about treatment and care.
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Table 2 Reasons for Declining a Research Interview Type of Patient
Reason Patient Declined
Reason Carer Declined/NE
Outpatients COPD
Too ill (1) Did not answer phone (1)
Did not want to talk (1) 1 NE, did not speak English
Cancer
Too ill (2) Did not want to be interviewed (2) Died (1) Gatekeeping by wife (2) Denies breathlessness (4) Confused (2) Went into hospice (1) No reason given (6) Wanted to put episode behind him (1)
Shyness (1) ‘‘Just doesn’t want to’’ (1)
Heart failure
Wanted to be invited by letter, but no reply (1) Does ‘‘not feel up to it’’ (1) Not home for appointment (1)
Husband suffers from schizophrenia (1)
MND
No declines
Missed 1 carer, had to be at work
Palliative care in the community
Not at home for appointment (1) Thinks interview might hurt her (1) Too ill (1)
Husband is told to be shy (1) No reason given (1)
COPD in community
28 of 32 did not reply to written information 1 phoned to stress he did not want to take part
COPD ¼ chronic obstructive pulmonary disease; NE ¼ Not eligible.
Cancer patients declined substantially more often than the other patient groups due to having other priorities, and the distress that the diagnosis had brought them. The contrast with the MND patient group suggests the influence of disease-specific experiences. The latter patients had a rare disease with a far more uncertain prognosis, scant information sources, fewer treatment options, and fewer opportunities to participate in research. The silent refusals occurred in all disease categories. These signify that recruitment is a social process, where patients and carers who are confronted with the question to take part in an interview do not always have decisive responses but need to consider what participation involves for them. It is possible that meeting the researcher face-to-face, or being introduced by the doctor or nurse responsible for one’s care, is a factor that leads patients to initially accept the interview, as they want to please them. Having accepted participation makes declining afterward even more difficult, so further contact is avoided. A few patients in the ECS study voiced potential concerns about the content of the interview, not wanting to have to talk about declining health. It is possible that some patients refused an interview for this reason.
These data underscore the need to be sensitive to the cues patients are giving to ensure that we fully understand whether they really want to take part or not. We should, at least, give them sufficient time to consider a request for an interview and be prepared to accept their decline, even if this is expressed indirectly. One example illustrates this particularly well. When contacting a woman with breast cancer, referred to us by the community palliative care team, and having asked her willingness to be interviewed, the following took place: She expressed her willingness to take part in the study but immediately qualified this by telling the researcher that she did not want to speak about her ‘‘problems.’’ The researcher was puzzled by her answer and asked her what she exactly meant by this. She explained she could tell anything about her breathlessness but that she did not want to speak about her cancer and started crying after having pronounced the word cancer. The researcher reassured her that it wasn’t necessary to speak about her illness and that the study was interested in people’s experiences with care. After this, she made an appointment with the researcher to meet her later that week at her home. When the
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researcher arrived at the address given, there was nobody there. The researcher waited outside for about 40 minutes, considering that she could have been delayed. A few days later the researcher phoned again to check she had been at the right address. The woman apologized, telling the researcher she had been unable to be there for the appointment. When the researcher asked if she still wanted to be interviewed, she agreed to another appointment. At the next visit, again nobody was home. It is not always clear whether patients do not want to participate or whether they are prevented from doing so by external circumstances. Twice, when an interview for a chronic obstructive pulmonary disease (COPD) patient had been arranged, the patient had been admitted to hospital. It is always important, however, to err on the side of caution, and if unwillingness to take part is suspected, the patient is not subjected to further contact. Other patients or carers had particular wishes about the interview and determined whether the carer should be present or not, or whether home was the best place or the researcher’s office.
What Were the Motivations for Accepting an Interview? There were four main motivations reported for accepting the interview: 1) Altruism: It is striking that all patients with MND gave this as the motivation to accept an interview. A positive answer followed our question immediately and without hesitation from both patient and carer. Some explained that they had made a conscious decision to take part in any research on MND from the moment they had been given the diagnosis. They expressed their wish to contribute to anything that would raise greater awareness and knowledge about this rare disease, so that more could be done to save people from what they had to go through. Some spoke about the invasive tests they had undergone previously, the times they went in wheelchairs to the high streets of the towns where they lived to collect money for the MND association, their enrollment in clinical trials or their appearance on television to inform the public. They found that an interview was the least they could do.
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Altruism was also mentioned by other groups, either in the form of ‘‘to help others’’ (patients or carers) or ‘‘to help you’’ (the researcher), the latter being the result of the process of recruitment through meeting faceto-face with patients. Altruism also could appear in the form of wanting to contribute to science, especially among patients with cancer. This may be because of their awareness, through the media, of progress in cancer research. Replies such as the following were given: ‘‘build up knowledge step by step’’ and ‘‘it’s gonna help somewhere down the line.’’ A few times the need for health care to focus on other than medical areas was seen as important. 2) To have somebody to talk to: One important finding for the group of COPD patients was that they had least access to the services that were available to people with some other conditions. There is also lack of awareness of the disability that COPD causes for patients, as these families tend to only get into contact with health professionals at their next check up in hospital or in the emergency department in case of an acute exacerbation. These patients appreciated someone who could listen to their story. The interview was often a welcome opportunity to talk with an interested outsider about the problems and uncertainties faced and the misunderstandings that had arisen with health professionals. Where patients suffered disability arising from their illness, the interview was experienced as a way of bringing relief from their daily isolation. It offered an occasion to vent frustrations, which could result in the narration of true life stories taking place over several hours. After the interview, patients often expressed their thanks for having been able to make sense of their experiences and said that they should have had this opportunity much earlier. We found that the opportunity to talk was also the main reason that people caring for a patient with COPD and heart failure agreed to do the interview. These carers often spoke extensively about the problems the patients had to go through and had to be guided and redirected to topics that concerned themselves. When talking to someone was a motivation to accept an interview, they meant talking about the patient and the consequences of illness. When prompted to think about their role
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as carers, they recognized their need for support, and this was often lacking for people caring for patients with COPD and heart failure. Interviews could also relieve the boredom of spending time in hospital, when patients felt well enough to participate. 3) To use it as a sounding board for commenting on services received: Patients agreed to the interview because they saw it as a way to impact on the way services worked. Some also wanted the opportunity to complain about an aspect of care that they felt had been poor. Although a small number indicated that they had made a formal complaint, others commented that they felt they had no other way of making their feelings heard. On the other hand, some people wanted to express their gratitude for the excellent care they had experienced and saw it as their duty to give something back. 4) To seek information or access to services: COPD patients have little information and their search for care is often very frustrating. Among this group of patients, we received many questions about their condition and options for care. One man we visited was registered at his physician’s practice as a patient with severe COPD. He said he had only seen a doctor recently to ask about his breathing problems and that the doctor had not told him what was wrong with him. His sister, who was present, said that he had been anxiously looking forward to the interview, hoping to find out more about his condition. An elderly woman with COPD described the problem of mobility that her breathing caused. The reason given for participation in the interview was her hope to increase her chances to get access to a taxi service. These motivations can also operate together. We found evidence of this in two interviews. In one interview, a patient said that she participated out of altruism when answering our questions, whereas later on she said she had accepted to take part in the interview in the hope it would contribute to getting access to the taxi service (as described above). In another interview, altruism was mentioned, as well as the carer’s need to talk to someone.
Discussion The process of recruitment and interviewing used within these studies suggests some of the
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organizational, methodological, and ethical issues that need consideration when conducting similar research with palliative care patients. Researchers need to carefully think through a study’s design and set time aside specifically dedicated to evaluation of the research sites so that access can be negotiated, issues of gatekeeping be detected, and alternative sites considered. This is also the time for discussions with health practitioners to convince them of the relevance of the methods of enquiry. Qualitative researchers should be prepared to give presentations in the department in which the study will take place to educate others about the contribution that qualitative methods can make to better understanding health care needs. Deciding on recruitment strategies with health practitioners is part of the process of enabling researchers to be sensitive to patients’ experiences and preferences when inviting them to an interview. Documenting the recruitment process of these projects revealed that most palliative care patients and carers were capable of deciding whether to participate in interviews and negotiating the circumstances in which they wanted this to happen. It demonstrates that patients and carers enter into studies with particular expectations, and when these get fulfilled, the experience of having participated can be very satisfying. From this perspective, the extreme position of arguing that palliative care patients should never be asked to take part in research is not justified.2 Simply because patients are nearing the end of life is not a valid reason to exclude them from research. To do so implies that they also will be denied the benefits of participating in research studies and having their voices heard. The literature on research with a palliative care population reflects concerns about balancing optimal conditions for undertaking successful research with the commitment to conduct research in an ethically appropriate way. Attempts to maximize recruitment have focused on realistic entry criteria, early screening, swift referrals, and simple information provision.7 Ethical principles center around concepts of self-determination, patient beneficence, justice, and confidentiality.12 The significance of the findings in these studies affects both these endeavors, and the findings are important considerations for enhancing
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recruitment to research studies while respecting the patients’ wishes. This is especially salient in the group of the ‘‘silent decliners,’’ for whom the challenge is to help vulnerable people to overcome fears of participating in research while avoiding any possibility of coercion. The differences we found in motivations to take part in a research interview reflect the heterogeneity of the palliative care population. We distinguished varying patterns in decline and acceptance of interviews across different conditions. For some, differences in their experiences of health care and expectations of research related to their specific conditions. Cancer patients declined more often than other patient groups, which could have been related to the timing of the request for participation, which is something that needs to be explored further. An awareness of patients’ motivation to participate could enable researchers to adjust strategies to enhance recruitment into studies. This could enable researchers to be more responsive to patients’ expectations, to make the experience of participating a worthwhile contribution. The use of a screening tool has been proposed before13 and evaluated13,14 for its feasibility to identify willing patients in a palliative care setting to take part in research studies. A tool incorporating a small number of targeted questions could be a possible way to identify and respond to motivations, expectations and potential concerns. The finding of those participants who agreed to take part in the research so that they could have their voices heard, or could have someone to talk to, highlights the needs of patients and caregivers to have means of being heard outside of research. It reflects perhaps a loneliness and isolation around the illness experience and the need for more information.
Limitations and Strengths of This Study We need to recognize some limitations in the methods we used to obtain these findings. The data could be challenged with the objection that some responses reflect social acceptability, rather than genuine patients’ responses. Politeness may have led some patients to decline participation in the study with answers such as ‘‘not feeling up to it,’’ rather than expressing doubts about the value of the study or concerns about
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what it might involve. However, the qualitative methodology used made it possible to check the intentions shaping these responses. The declines recorded not only represent the responses given to questions but were confirmed by observations, conversations with patients’ health care professionals, and contextual information obtained by interaction with participants. Additionally, we verified the qualitative information gained by looking at the internal consistency of the interviews. This triangulation approach makes us confident that the given responses represent patients’ intentions. Such robust checks involving triangulation are less possible with standardized questions in a quantitative study design. Future research could develop this triangulation approach further by using a mixed methods approach, combining quantitative and qualitative methods. Further research should be undertaken to gain a broader understanding of the variations in patient acceptance or refusal to be involved in research, exploring demographic characteristics in a systematic way. Insight into the motivations of disadvantaged populations, such as ethnic minorities or the elderly, about participation in research could inform about ways to enhance access to them. Additionally, views and motivations may change as disease progresses and a longitudinal study using interviews at different time points could shed light on factors that determine this.
Conclusions In this study, we explored the experiences and perceptions of palliative care patients and their carers related to involvement in qualitative research. Documenting the recruitment process revealed differential patterns in decline and acceptance of interviews by patients with different conditions and across different settings. Patients and carers were capable of deciding whether to participate in interviews and negotiating the circumstances in which they wanted this to happen. This suggests that the argument concerning the unethical nature of research with palliative care patients is unacceptable. It strengthens our position that research should respect patients’
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autonomy and enable their voices to be heard when they choose to participate. Patients enter into studies with specific expectations. Differences in motivations to participate in studies reflected the heterogeneity of the palliative care population. This suggests that the supervisory role of ethics committees, the criteria they apply to judge ethically sound research in these patient groups, and the measures they prescribe to protect those who opt to take part in research studies should take account of such heterogeneity and right to autonomy. It indicates that supplementary regulations for an alleged vulnerable population are not necessarily appropriate and that the careful weighing of interests and concerns is more relevant to enable the inclusion of user voices in this patient group. Ethics committees need to be equipped with the expertise of experienced researchers in this area and should function collaboratively with researchers, health care professionals, and patients alike to develop a protocol to inform judgments made on behalf of this patient group. Ethics committees are often more familiar with the rigor of quantitative research and sometimes need education about the standing and rigor of qualitative research, as well as to the importance of research with the palliative care population. Researchers in palliative care could make use of a screening tool embedded in patients’ clinical care, which would include probes for patients’ concerns and motivations. Awareness of issues and challenges specific to certain conditions could be used to enhance patient recruitment, and consequently, to monitor adherence by adjusting research protocols so that patients perceive them as relevant. At the same time, such a tool could improve the quality of the research process as researchers could use this information to undertake studies that appropriately reflect patients’ views and are consistent with their interests.
Acknowledgments The authors thank the Cicely Saunders Foundation (TCSF) whose funding made this research possible. They would also like to thank CRUK for its support to the ECS study, and in particular to thank Alison Richardson,
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Matthew Hotopf, Scott Murray, Peter Speck, Marilyn Kendall, Jonathan Koffman, and Richard Harding, who provided advice for this study.
References 1. Emanuel EJ, Fairclough DL, Wolfe P, Emanuel LL. Talking with terminally ill patients and their caregivers about death, dying, and bereavement: is it stressful? Is it helpful? Arch Intern Med 2004;164:1999e2004. 2. de Raeve L. Ethical issues in palliative care research. Palliat Med 1994;8:298e305. 3. Raudonis BM. Ethical considerations in qualitative research with hospice patients. Qual Health Res 1992;2:238e249. 4. Mount BM, Cohen R, MacDonald N, Bruera E, Dudgeon DJ. Ethical issues in palliative care research revisited. Palliat Med 1995;9:165e166. 5. Henderson M, Addington-Hall JM, Hotopf M. The willingness of palliative care patients to participate in research. J Pain Symptom Manage 2005;29: 116e118. 6. Ross C, Cornbleet M. Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med 2003;17:491e497. 7. Jordhoy MS, Kaasa S, Fayers P, et al. Challenges in palliative care research; recruitment, attrition and compliance: experience from a randomized controlled trial. Palliat Med 1999;13:299e310. 8. Rinck GC, van den Bos GA, Kleijnen J, et al. Methodologic issues in effectiveness research on palliative cancer care: a systematic review. J Clin Oncol 1997;15:1697e1707. 9. Slevin ML, Stubbs L, Plant HJ, et al. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ 1990;300:1458e1460. 10. Addington-Hall JM. Research sensitivities to palliative care patients. Eur J Cancer Care 2002;11: 220e224. 11. Stevens T, Wilde D, Paz S, et al. Palliative care research protocols: a special case for ethical review? Palliat Med 2003;17:482e490. 12. Steinke EE. Research ethics, informed consent, and participant recruitment. Clin Nurse Spec 2004; 18:88e95. 13. Crowley R, Casarett D. Patients’ willingness to participate in symptom-related and disease-modifying research: results of a research screening initiative in a palliative care clinic. Cancer 2003;97: 2327e2333. 14. Casarett D, Kassner CT, Kutner JS. Recruiting for research in hospice: feasibility of a research screening protocol. J Palliat Med 2004;7:854e860.
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Original Article
‘‘I Will Do It If It Will Help Others:’’ Motivations Among Patients Taking Part in Qualitative Studies in Palliative Care Marjolein Gysels, MA, PhD, Cathy Shipman, BA (Hons), MA, and Irene J. Higginson, BMBS, FFPHM, PhD, FRCP Palliative Care, Policy and Rehabilitation (M.G., C.S., I.J.H.), King’s College London School of Medicine at Guy’s, King’s College and St. Thomas’ Hospitals, London, United Kingdom, and Barcelona Centre for International Health (CRESIB) (M.G.), University of Barcelona, Barcelona, Spain
Abstract The aim of this study was to explore patients’ and carers’ preferences and expectations regarding their contribution to research in palliative care through the use of qualitative interviews. Data were collected in the context of two studies exploring the experiences of care of palliative care patients and carers. Both studies recorded the recruitment process, numbers of patients or carers accepting and declining, and the circumstances of interviews. Participants were asked about their motivation to participate in research. The data were analyzed by labeling patients’ reflections on their motivations for participating in these studies and identifying themes. Analysis of the recruitment process revealed differential patterns in decline and acceptance of interviews by patients with different conditions and across settings. Among cancer patients, 21/51 declined; the proportion with other conditions that declined was small, and was 0/10 for patients with motor neuron disease. Motivation to participate in the studies was related to (1) altruism, (2) gratitude and concerns about care, (3) the need to have somebody to talk to, and (4) the need for information or access to services. Palliative care patients and carers were capable of deciding whether to participate in interviews and negotiating how they wanted this to happen. This strengthens the argument for patients’ autonomy in deciding whether to participate in research. Patients and carers have different motivations for participation, reflecting the heterogeneity of the palliative care population. This suggests a need for ethics committees to reconsider their views and widen their perspectives on the involvement of palliative care patients and carers in research. J Pain Symptom Manage 2008;35:347e355. Ó 2008 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Recruitment for research, motivations, expectations, qualitative interview, palliative care
This research was made possible through funding from The Cicely Saunders Foundation (TCSF). Address correspondence to: Marjolein Gysels, MA, PhD, Palliative Care, Policy and Rehabilitation, King’s College London, Weston Education Centre, Cutcombe Road, London SE5 9RJ, United Kingdom. E-mail: [email protected] Accepted for publication: May 8, 2007. Ó 2008 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved.
Introduction Views differ as to whether patients who have a serious illness and are near the end of life should be involved in research. It has been argued that they are vulnerable and should be protected because research could be distressing, intrusive, and time-consuming and that 0885-3924/08/$esee front matter doi:10.1016/j.jpainsymman.2007.05.012
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it may divert them from more important priorities.1 Indeed, de Raeve proposed that patients with palliative care needs should never be asked to participate in any research, whatever the design.2 Raudonis et al. argued that research with palliative care patients is not appropriate as they are a ‘‘captive audience,’’3 and patients who rely heavily on health professionals for essential care might fear that the care they receive could be compromised when they give a negative account of services. However, there may be a danger that protecting patients from research also denies them the opportunity to make independent decisions.4 Indeed some studies found that patients were happy to be involved in research.1,5,6 It has been documented that recruitment of patients with advanced disease for research is difficult. A study on patients and staff attitudes toward research in a specialist palliative care unit reported that patients’ limited physical and emotional reserves often influenced trial participation.7,8 In another study, the reasons for taking part in research included the chance of being treated by a specialist and the chance to benefit humanity.9 However, little is known about how patients and their families perceive the risks and benefits of research participation, or what their motives are for participating.1 Judgments are often based on a priori assumptions of vulnerability rather than on evidence of what is actually harmful. We need empirical data on these issues to decide whether and what type of research is appropriate and acceptable10 and to support ethics committees in making appropriate decisions.11 Therefore, we explored the views of patients and their carers about participation in research interviews while conducting two studies. The aim was to explore patients’ and carers’ preferences and expectations regarding their contributions to research, making use of qualitative interviews.10 We documented the process of recruitment and interview and gathered evidence on responses to the invitations for an interview.
Methods Data were collected in the context of two qualitative studies exploring the experiences of involvement in research of palliative care
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patients and their carers. One study (Experience of Breathlessness Study or EBS) took a comparative approach toward patients suffering from breathlessness, with different conditions, in different care settings. The other study (Experience of Cancer Study or ECS) specifically focused on cancer patients. Both studies explored issues regarding recruitment and interviewing among these patients, and the data were combined for the present analysis. Both studies took place in a large London teaching hospital and were concurrent (between July 2005 and March 2006). All patients included in the study signed informed consent. The sample was purposive. Within the limits of our time and means, we decided to target the types of participants shown in Table 1. Demographic data and clinical information about patients was retrieved from patients’ records (electronic and paper files), or specialist databases (Medinet), which recorded details of patients with respiratory problems. Patients’ letters also were used for this purpose. We used semistructured, open-ended interviews. They were exploratory in the sense that they allowed respondents to touch on any topic relevant to them, but a topic guide was used to ensure that all the necessary topics were covered as much as possible. The ECS study also included some closed questions. The interviews lasted between 40 and 150 minutes, and all were tape recorded and transcribed verbatim, except for two where the recorder broke down, but these were reconstructed immediately after the interview. A notebook was used to record field notes during the interviews or when events happened that were inappropriate to tape record. The recruitment process was recorded, as were the number of patients or carers accepting or declining and the reasons given for declining participation in the study. The circumstances in which the interviews took place were described. The interviews ended with questions to patients and carers about their motivation to participate in research. First, the numbers of patients and carers accepting and declining were compared. Then the data on reasons for decline and motivations were analyzed by labeling them and identifying themes, which were linked back to the numbers of those accepting and declining involvement.
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Settings Outpatient clinic
Types of Participants
Age
Gender
Recruitment Strategy
Carers Patients Patient Interviewed; Carer Interviewed Declines Separate/Joint Declines
Patients with cancer
Range: 52e67 8 women Median: 68 22 men
CNS outpatient clinic: 8 Physiotherapists at pulmonary rehabilitation classes: 2
30
21
Patients with COPD
Range: 52e75 9 women Median: 69 5 men
Consultants at respiratory outpatient clinics: 2 CNS ward rounds and clinics: 9 ‘Breathe Easy’ meetings: 3
14
Patients with cardiac failure
Range: 61e80 3 women Median: 69 7 men
CN from outpatient clinics: 7 Consultants at respiratory outpatient clinics: 3
10
MND patients
Range: 24e77 1 woman CNS from inpatient wards: 3 and outpatient clinic:7 9 men
Community Patients with severe COPDa
Range: 52e78 2 women Written invitation sent by GP practice: 36 Median: 70 2 men
Patients needing palliative care Range: 64e79 5 women Consultant and CNS of palliative care team by 3 men home visits: 8 COPD ¼ chronic obstructive pulmonary disease; NE ¼ Not eligible. a This group was not included into the analysis as there was no further information on why they refused.
10
7J
2
2
2S/ 4 J
1 1 NE
3
3S
1 NE
9S
1 missed
/
/
1S/1 J
2
/
4
32
8
3
Motivation for Research Participation in Palliative Care
Table 1 Patterns of Acceptance and Decline Across Different Conditions
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The study obtained ethics approval by the Local Research Ethics Committee and the relevant R&D committees of the hospital where the studies took place and the community of Lambeth and Southwark. A patient and carer coding system ensured confidentiality throughout the study. Before recruitment, it was important to negotiate access to patients and clinics with health care professionals in the different sectors. The EBS made contact with the people caring for patients suffering from breathlessness, that is, nurses, physicians, physiotherapists, and coordinators of the centers. The researcher explained the nature of the study and asked the health professionals if they would be willing to assist with recruitment. In this process of familiarization, health professionals requested the researcher to give presentations at meetings or seminars that were held in the departments where the researcher planned to work. The function of these meetings was to convince staff of the relevance of the study. Most questions focused on the methods used, the eligibility criteria of patients and verification of ethics approval. The qualitative design raised concerns among practitioners about the practical relevance of the study, and, therefore, its justification. However, their commitment to improve care and their unfamiliarity with qualitative research led them to eventually give their support. Similarly, the researcher undertaking the second study approached and approved the process of contact and interview with clinical teams, and principally the clinical nurse specialists for lung and colorectal patients at the hospital.
Results In total, we conducted 108 interviews. In the EBS, we conducted a total of 85 interviews, including 56 patients and 25 carers. We did four repeat interviews, with one patient and two carers. In the ECS, we conducted 23 interviews, 20 with patients and three with carers. Four repeat interviews were undertaken (see Table 1).
Patients’ and Carers’ Responses During the process of recruitment for the study, various patterns of acceptance and
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decline of participation were identified from the responses of patients with different conditions and across different settings (see Table 1). Among cancer patients, 21/51 declined, whereas the proportion declining among those with other conditions was small, for example, 0/10 for motor neuron disease (MND) patients. The palliative care patients who declined all had a cancer diagnosis.
What Were the Reasons for Declining an Interview? The reasons recorded for declining to take part in a research interview were as follows (Table 2): (1) in four cases, we received an outright negative answer to our invitation for interview (objection to interview); (2) 12 refusals were due to being too ill, confused, having moved from home to hospice, or to not perceiving themselves as eligible for the study (external circumstances); (3) two carers were protective toward their patients and asked not to approach the patient for an interview as they thought it would harm them (gatekeeping by carer); (4) five patients were ‘‘silent declines,’’ who could not be contacted for the interview (we suspected from the outset that these patients were not completely convinced that they wanted to take part in the study from their hesitant responses; they did make appointments, but later either had an excuse for not participating, simply did not turn up for the occasion, or changed their mind at the last moment); (5) one patient felt improved and wanted to put the recent experience of hospital care behind him; and (6) in six cases, patients did not give a reason for declining an interview. When carers declined to be interviewed in their own right, this was reported to be largely a matter of personality. They were mostly approached via the patient, who then explained after having asked the carer that he or she was too ‘‘shy.’’ Few patients, therefore, objected to participation in a research interview, or to their main carer being contacted. Refusals were largely due to external circumstances. We found that this was especially the case for the cancer patients and their carers, as we often met shortly after they had been informed about their diagnosis and were coping with difficult issues such as the impact of bad news or important decisions about treatment and care.
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Table 2 Reasons for Declining a Research Interview Type of Patient
Reason Patient Declined
Reason Carer Declined/NE
Outpatients COPD
Too ill (1) Did not answer phone (1)
Did not want to talk (1) 1 NE, did not speak English
Cancer
Too ill (2) Did not want to be interviewed (2) Died (1) Gatekeeping by wife (2) Denies breathlessness (4) Confused (2) Went into hospice (1) No reason given (6) Wanted to put episode behind him (1)
Shyness (1) ‘‘Just doesn’t want to’’ (1)
Heart failure
Wanted to be invited by letter, but no reply (1) Does ‘‘not feel up to it’’ (1) Not home for appointment (1)
Husband suffers from schizophrenia (1)
MND
No declines
Missed 1 carer, had to be at work
Palliative care in the community
Not at home for appointment (1) Thinks interview might hurt her (1) Too ill (1)
Husband is told to be shy (1) No reason given (1)
COPD in community
28 of 32 did not reply to written information 1 phoned to stress he did not want to take part
COPD ¼ chronic obstructive pulmonary disease; NE ¼ Not eligible.
Cancer patients declined substantially more often than the other patient groups due to having other priorities, and the distress that the diagnosis had brought them. The contrast with the MND patient group suggests the influence of disease-specific experiences. The latter patients had a rare disease with a far more uncertain prognosis, scant information sources, fewer treatment options, and fewer opportunities to participate in research. The silent refusals occurred in all disease categories. These signify that recruitment is a social process, where patients and carers who are confronted with the question to take part in an interview do not always have decisive responses but need to consider what participation involves for them. It is possible that meeting the researcher face-to-face, or being introduced by the doctor or nurse responsible for one’s care, is a factor that leads patients to initially accept the interview, as they want to please them. Having accepted participation makes declining afterward even more difficult, so further contact is avoided. A few patients in the ECS study voiced potential concerns about the content of the interview, not wanting to have to talk about declining health. It is possible that some patients refused an interview for this reason.
These data underscore the need to be sensitive to the cues patients are giving to ensure that we fully understand whether they really want to take part or not. We should, at least, give them sufficient time to consider a request for an interview and be prepared to accept their decline, even if this is expressed indirectly. One example illustrates this particularly well. When contacting a woman with breast cancer, referred to us by the community palliative care team, and having asked her willingness to be interviewed, the following took place: She expressed her willingness to take part in the study but immediately qualified this by telling the researcher that she did not want to speak about her ‘‘problems.’’ The researcher was puzzled by her answer and asked her what she exactly meant by this. She explained she could tell anything about her breathlessness but that she did not want to speak about her cancer and started crying after having pronounced the word cancer. The researcher reassured her that it wasn’t necessary to speak about her illness and that the study was interested in people’s experiences with care. After this, she made an appointment with the researcher to meet her later that week at her home. When the
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researcher arrived at the address given, there was nobody there. The researcher waited outside for about 40 minutes, considering that she could have been delayed. A few days later the researcher phoned again to check she had been at the right address. The woman apologized, telling the researcher she had been unable to be there for the appointment. When the researcher asked if she still wanted to be interviewed, she agreed to another appointment. At the next visit, again nobody was home. It is not always clear whether patients do not want to participate or whether they are prevented from doing so by external circumstances. Twice, when an interview for a chronic obstructive pulmonary disease (COPD) patient had been arranged, the patient had been admitted to hospital. It is always important, however, to err on the side of caution, and if unwillingness to take part is suspected, the patient is not subjected to further contact. Other patients or carers had particular wishes about the interview and determined whether the carer should be present or not, or whether home was the best place or the researcher’s office.
What Were the Motivations for Accepting an Interview? There were four main motivations reported for accepting the interview: 1) Altruism: It is striking that all patients with MND gave this as the motivation to accept an interview. A positive answer followed our question immediately and without hesitation from both patient and carer. Some explained that they had made a conscious decision to take part in any research on MND from the moment they had been given the diagnosis. They expressed their wish to contribute to anything that would raise greater awareness and knowledge about this rare disease, so that more could be done to save people from what they had to go through. Some spoke about the invasive tests they had undergone previously, the times they went in wheelchairs to the high streets of the towns where they lived to collect money for the MND association, their enrollment in clinical trials or their appearance on television to inform the public. They found that an interview was the least they could do.
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Altruism was also mentioned by other groups, either in the form of ‘‘to help others’’ (patients or carers) or ‘‘to help you’’ (the researcher), the latter being the result of the process of recruitment through meeting faceto-face with patients. Altruism also could appear in the form of wanting to contribute to science, especially among patients with cancer. This may be because of their awareness, through the media, of progress in cancer research. Replies such as the following were given: ‘‘build up knowledge step by step’’ and ‘‘it’s gonna help somewhere down the line.’’ A few times the need for health care to focus on other than medical areas was seen as important. 2) To have somebody to talk to: One important finding for the group of COPD patients was that they had least access to the services that were available to people with some other conditions. There is also lack of awareness of the disability that COPD causes for patients, as these families tend to only get into contact with health professionals at their next check up in hospital or in the emergency department in case of an acute exacerbation. These patients appreciated someone who could listen to their story. The interview was often a welcome opportunity to talk with an interested outsider about the problems and uncertainties faced and the misunderstandings that had arisen with health professionals. Where patients suffered disability arising from their illness, the interview was experienced as a way of bringing relief from their daily isolation. It offered an occasion to vent frustrations, which could result in the narration of true life stories taking place over several hours. After the interview, patients often expressed their thanks for having been able to make sense of their experiences and said that they should have had this opportunity much earlier. We found that the opportunity to talk was also the main reason that people caring for a patient with COPD and heart failure agreed to do the interview. These carers often spoke extensively about the problems the patients had to go through and had to be guided and redirected to topics that concerned themselves. When talking to someone was a motivation to accept an interview, they meant talking about the patient and the consequences of illness. When prompted to think about their role
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as carers, they recognized their need for support, and this was often lacking for people caring for patients with COPD and heart failure. Interviews could also relieve the boredom of spending time in hospital, when patients felt well enough to participate. 3) To use it as a sounding board for commenting on services received: Patients agreed to the interview because they saw it as a way to impact on the way services worked. Some also wanted the opportunity to complain about an aspect of care that they felt had been poor. Although a small number indicated that they had made a formal complaint, others commented that they felt they had no other way of making their feelings heard. On the other hand, some people wanted to express their gratitude for the excellent care they had experienced and saw it as their duty to give something back. 4) To seek information or access to services: COPD patients have little information and their search for care is often very frustrating. Among this group of patients, we received many questions about their condition and options for care. One man we visited was registered at his physician’s practice as a patient with severe COPD. He said he had only seen a doctor recently to ask about his breathing problems and that the doctor had not told him what was wrong with him. His sister, who was present, said that he had been anxiously looking forward to the interview, hoping to find out more about his condition. An elderly woman with COPD described the problem of mobility that her breathing caused. The reason given for participation in the interview was her hope to increase her chances to get access to a taxi service. These motivations can also operate together. We found evidence of this in two interviews. In one interview, a patient said that she participated out of altruism when answering our questions, whereas later on she said she had accepted to take part in the interview in the hope it would contribute to getting access to the taxi service (as described above). In another interview, altruism was mentioned, as well as the carer’s need to talk to someone.
Discussion The process of recruitment and interviewing used within these studies suggests some of the
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organizational, methodological, and ethical issues that need consideration when conducting similar research with palliative care patients. Researchers need to carefully think through a study’s design and set time aside specifically dedicated to evaluation of the research sites so that access can be negotiated, issues of gatekeeping be detected, and alternative sites considered. This is also the time for discussions with health practitioners to convince them of the relevance of the methods of enquiry. Qualitative researchers should be prepared to give presentations in the department in which the study will take place to educate others about the contribution that qualitative methods can make to better understanding health care needs. Deciding on recruitment strategies with health practitioners is part of the process of enabling researchers to be sensitive to patients’ experiences and preferences when inviting them to an interview. Documenting the recruitment process of these projects revealed that most palliative care patients and carers were capable of deciding whether to participate in interviews and negotiating the circumstances in which they wanted this to happen. It demonstrates that patients and carers enter into studies with particular expectations, and when these get fulfilled, the experience of having participated can be very satisfying. From this perspective, the extreme position of arguing that palliative care patients should never be asked to take part in research is not justified.2 Simply because patients are nearing the end of life is not a valid reason to exclude them from research. To do so implies that they also will be denied the benefits of participating in research studies and having their voices heard. The literature on research with a palliative care population reflects concerns about balancing optimal conditions for undertaking successful research with the commitment to conduct research in an ethically appropriate way. Attempts to maximize recruitment have focused on realistic entry criteria, early screening, swift referrals, and simple information provision.7 Ethical principles center around concepts of self-determination, patient beneficence, justice, and confidentiality.12 The significance of the findings in these studies affects both these endeavors, and the findings are important considerations for enhancing
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recruitment to research studies while respecting the patients’ wishes. This is especially salient in the group of the ‘‘silent decliners,’’ for whom the challenge is to help vulnerable people to overcome fears of participating in research while avoiding any possibility of coercion. The differences we found in motivations to take part in a research interview reflect the heterogeneity of the palliative care population. We distinguished varying patterns in decline and acceptance of interviews across different conditions. For some, differences in their experiences of health care and expectations of research related to their specific conditions. Cancer patients declined more often than other patient groups, which could have been related to the timing of the request for participation, which is something that needs to be explored further. An awareness of patients’ motivation to participate could enable researchers to adjust strategies to enhance recruitment into studies. This could enable researchers to be more responsive to patients’ expectations, to make the experience of participating a worthwhile contribution. The use of a screening tool has been proposed before13 and evaluated13,14 for its feasibility to identify willing patients in a palliative care setting to take part in research studies. A tool incorporating a small number of targeted questions could be a possible way to identify and respond to motivations, expectations and potential concerns. The finding of those participants who agreed to take part in the research so that they could have their voices heard, or could have someone to talk to, highlights the needs of patients and caregivers to have means of being heard outside of research. It reflects perhaps a loneliness and isolation around the illness experience and the need for more information.
Limitations and Strengths of This Study We need to recognize some limitations in the methods we used to obtain these findings. The data could be challenged with the objection that some responses reflect social acceptability, rather than genuine patients’ responses. Politeness may have led some patients to decline participation in the study with answers such as ‘‘not feeling up to it,’’ rather than expressing doubts about the value of the study or concerns about
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what it might involve. However, the qualitative methodology used made it possible to check the intentions shaping these responses. The declines recorded not only represent the responses given to questions but were confirmed by observations, conversations with patients’ health care professionals, and contextual information obtained by interaction with participants. Additionally, we verified the qualitative information gained by looking at the internal consistency of the interviews. This triangulation approach makes us confident that the given responses represent patients’ intentions. Such robust checks involving triangulation are less possible with standardized questions in a quantitative study design. Future research could develop this triangulation approach further by using a mixed methods approach, combining quantitative and qualitative methods. Further research should be undertaken to gain a broader understanding of the variations in patient acceptance or refusal to be involved in research, exploring demographic characteristics in a systematic way. Insight into the motivations of disadvantaged populations, such as ethnic minorities or the elderly, about participation in research could inform about ways to enhance access to them. Additionally, views and motivations may change as disease progresses and a longitudinal study using interviews at different time points could shed light on factors that determine this.
Conclusions In this study, we explored the experiences and perceptions of palliative care patients and their carers related to involvement in qualitative research. Documenting the recruitment process revealed differential patterns in decline and acceptance of interviews by patients with different conditions and across different settings. Patients and carers were capable of deciding whether to participate in interviews and negotiating the circumstances in which they wanted this to happen. This suggests that the argument concerning the unethical nature of research with palliative care patients is unacceptable. It strengthens our position that research should respect patients’
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autonomy and enable their voices to be heard when they choose to participate. Patients enter into studies with specific expectations. Differences in motivations to participate in studies reflected the heterogeneity of the palliative care population. This suggests that the supervisory role of ethics committees, the criteria they apply to judge ethically sound research in these patient groups, and the measures they prescribe to protect those who opt to take part in research studies should take account of such heterogeneity and right to autonomy. It indicates that supplementary regulations for an alleged vulnerable population are not necessarily appropriate and that the careful weighing of interests and concerns is more relevant to enable the inclusion of user voices in this patient group. Ethics committees need to be equipped with the expertise of experienced researchers in this area and should function collaboratively with researchers, health care professionals, and patients alike to develop a protocol to inform judgments made on behalf of this patient group. Ethics committees are often more familiar with the rigor of quantitative research and sometimes need education about the standing and rigor of qualitative research, as well as to the importance of research with the palliative care population. Researchers in palliative care could make use of a screening tool embedded in patients’ clinical care, which would include probes for patients’ concerns and motivations. Awareness of issues and challenges specific to certain conditions could be used to enhance patient recruitment, and consequently, to monitor adherence by adjusting research protocols so that patients perceive them as relevant. At the same time, such a tool could improve the quality of the research process as researchers could use this information to undertake studies that appropriately reflect patients’ views and are consistent with their interests.
Acknowledgments The authors thank the Cicely Saunders Foundation (TCSF) whose funding made this research possible. They would also like to thank CRUK for its support to the ECS study, and in particular to thank Alison Richardson,
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Matthew Hotopf, Scott Murray, Peter Speck, Marilyn Kendall, Jonathan Koffman, and Richard Harding, who provided advice for this study.
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