Rationale for participation in venous leg ulcer clinical research: Patient interview study

Abstract

Recruitment to wound care clinical trials is challenging and a better understanding of patient decisions to participate has the potential to influence recruitment success. We conducted 31 semi‐structured telephone interviews of patients who participated in the Aspirin in Venous Leg Ulcer (ASPiVLU) randomised controlled trail (RCT) or ASPiVLU cohort study. Data were coded and analysed using thematic analysis. We identified four key themes: (a) “I participated to help others”; (b) “I participated in research to thank those who cared for me”; (c) “I participated to receive better care”; and (d) “I participated to have a say on what works.” These themes became basic elements for the Rationale for Research Participation Framework that we have developed to improve the participant recruitment process for clinical trials in wound care.

1. INTRODUCTION

Venous Leg Ulcers (VLUs) occur in a result of venous insufficiency ¹ and comprise one of the most common chronic wounds in Australia ² and globally. ³ , ⁴ , ⁵ Incidence of VLUs is projected to increase due to the aging population and increased prevalence of diabetes, obesity and chronic vascular insufficiency. ¹ , ⁶ As a result, health related quality of life, ⁷ , ⁸ and economic burden on health systems will continue to be impacted. ⁵ , ⁹ , ¹⁰ , ¹¹ , ¹² , ¹³ , ¹⁴ Implementation of evidence‐based VLU management has been shown to optimise wound healing outcomes, improve quality of life, and reduce costs. ¹⁵ In efforts to optimise VLU management The Australian and New Zealand Practice Guideline for Prevention and Management of Venous Leg Ulcers was developed and disseminated in 2011, ¹⁶ although recent evidence suggests Australian VLU patients continue to receive suboptimal care, ¹⁷ , ¹⁸ , ¹⁹ i.e. delayed VLU diagnosis ²⁰ and delayed referral to specialist wound clinics. ²¹ Suboptimal management of people with VLUs prolongs healing outcomes and contributes to VLU recurrence. ²² , ²³ , ²⁴

Compression application, subject to absence of arterial insufficiency, is best practice evidence‐based recommendation for VLU management. ²⁵ Compression adherence is a common barrier to evidence‐based VLU management from patients' perspective, ²⁶ , ²⁷ although the rationale and understanding of compression therapy adherence is poorly understood by patients. ²⁸ , ²⁹ Evidence of effective interventions to improve compression adherence is limited ³⁰ and there is a need for better quality clinical trials to address these gaps. ³¹ A large number of participants need to be recruited in the Randomised Controlled Trials (RCTs) to ensure that high quality research is carried out. ³² , ³³ Study‐related, patient‐related, clinician‐related, and health system‐related factors may influence participation in wound research. ³⁴ Patients with VLUs are often elderly, may have limited cognitive ability and mobility constraints or frailty, all of which can impact on patient research participation. ³⁵ , ³⁶ Moreover, additional “pre‐screening” approaches applied by health professionals may limit the generalizability of the study findings. ³⁷

We conducted a qualitative study, nested within the Aspirin in Venous Leg Ulcer (ASPiVLU) study. ³⁸ The aim of this nested qualitative study was to elicit patient experiences in participating in the ASPiVLU study. One of the nested study objectives was to elicit participants' reasoning regarding their decision to participate in a clinical trial to inform study recruitment strategies in future research projects. Qualitative paradigm in general is a suitable approach to investigate patients' experiences of health and illness and qualitative methodology—semi‐structured interviews—were the most appropriate method to answer the research question. ³⁹ Moreover, we had a slower than anticipated recruitment rate to the ASPiVLU study, ³⁵ and nested qualitative studies are commonly used alongside clinical trials for explanatory and exploratory purposes. ⁴⁰

The ASPiVLU study is a randomised double‐blind multicentre placebo‐controlled clinical trial ³⁸ (ASPiVLU RCT) that investigated whether a daily 300‐mg oral dose of aspirin as an adjunct to compression therapy improved time to VLU healing. Patients that were ineligible, or did not want to participate in the ASPiVLU RCT were invited to participate in a parallel cohort study (ASPiVLU cohort) that investigated rates of ulcer healing at 12 and 24 weeks following baseline visit to identify which factors impacted on time to healing and recurrence if the target VLU was healed. Participants were recruited from six outpatient wound clinics in Victoria, New South Wales, Queensland, or Tasmania (Australia). Community dwelling adult participants identified from hospital outpatient wound clinics and clinically diagnosed with a VLU present for 6+ weeks were eligible. We conducted semi‐structured telephone interviews with ASPiVLU RCT and cohort participants who had a current or past VLU.

2. MATERIALS AND METHODS

We conducted 31 semi‐structured telephone interviews between October 2019 and December 2019. The ASPiVLU RCT and the ASPiVLU cohort participants, who expressed interest in participation in further studies were contacted by two members of the research team (LT and CR). The qualitative study was explained and interviews were set up with the participants. Prior to the interview, researchers read the participant information explanatory statement to each participant and recorded their verbal consent to participate.

The interview guide (supplementary file) designed by VT and CW consisted of various open‐ended questions related to five pre‐identified themes: (a) study participation, including risks and benefits, information on VLU management received before and at the time of the study, patient experiences from VLU diagnosis to participation in clinical trial; (b) issues related to compression treatment adherence; (c) VLU healing; (d) patient‐professional communication; and (e) health literacy. Telephone interviews were conducted by researchers, LT and CR, at health service teleconference room booked at the time that was convenient to participants. The mean interviewing time was 35 minutes, ranging from 12 to 87 minutes. The participants were reimbursed for their participation with a $25 Coles Myer gift‐card. All interviews were audio recorded. The audio files were transcribed, using professional transcription services—Triple A Transcription, Australia. All transcripts were compared with the voice files by CR and VT to ensure data quality. Corrections were made where inconsistencies between the voice file and transcript were identified. The transcripts were not sent back to the participants for verification.

We conducted data analysis concurrently with data collection, using NVivo 12 software for qualitative data management. Recruitment was guided by data saturation, which was reached on the 25th interview, while the remaining few voice files were still in transcription services. We transferred our voice files to transcription services in batches of five‐six. Given there were no specific frameworks developed to understand people's experiences of research participation, we also guided our recruitment by the principle of information power ⁴¹ and aimed to get adequate sample size for developing a framework. Thematic analysis ⁴² was applied as a method of data analysis. Data were analysed, using three levels coding. All repeated concepts and ideas were tagged as codes. ⁴³ Transcripts from the first three interviews were coded by CR. Individual codes and the developed coding framework were discussed with CW and VT, who also read transcripts and provided comments. The developed framework was used for coding the remaining interview transcripts, all additional codes were developed by CR after discussion with VT. Codes related to patients' rationale for participation were allocated in the main themes and sub‐themes.

3. ETHICAL CONSIDERATIONS

The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in approval by the Monash University Human Research Ethics Committee.

4. RESULTS

We developed four themes, demonstrating the reasons patients decided to participate: (a) I participated to help others; (b) I participated in research to thank those who cared for me; (c) I participated to receive better VLU care; and (d) I participated to have a say on what works.

4.1. Participant characteristics

Thirty‐one participants were included in this study, 16 females and 15 males. Twenty‐one (68%) participants were aged 65 years and older. The mean age of the participants was 69.54 years, ranging from 39 to 89. Twenty‐four participants were recruited from the ASPiVLU cohort study and seven were recruited from the ASPiVLU RCT. Five participants revealed they previously had a hospital admission related to VLU; and 12 were prescribed antibiotic treatment due to secondary wound infection. At the time of data collection, 13/31 participants had a VLU. A detailed summary of the participant characteristics is provided in Table 1.

TABLE 1.

Participant characteristics (n = 31)

Participant characteristics	Number and percentage	Participant characteristics	Number and percentage
Gender		Employment status
Male	16 (52%)	Retired	24 (77%)
Female	15 (48%)	Working full‐time > 30 h per week	3 (10%)
Age		Working part‐time < 30 h per week	1 (3%)
<45	2 (6%)	Self‐employed	0
45‐54	2 (6%)	Long‐term disability (specify) a	1 (3%)
55‐64	6 (19%)	No response	1 (3%)
65‐74	12 (39%)	Not working	1 (3%)
75‐84	5 (16%)	Self‐rated health
85+	4 (13%)	Excellent/very good	4 (13%)
Education		Good	19 (61%)
High school	19 (61%)	Poor	7 (23%)
College/bachelor's degree	8 (26%)	Worse than poor	0
Postgraduate degree	4 (13%)	No response	1 (3%)
Prefer not to answer	0

^aNot specified.

4.2. “I participated to help others”

Altruism was a strong motivator for participants. Eighteen participants perceived involvement may improve the care of someone else who suffered with a VLU. Participants understood that the research process was necessary for advancing medical knowledge:

Q: What made you decide to participate? What made you say yes?

A: Well, I just wanted to participate. She [the research nurse] explained to us that they wanted to do a study in that [in VLU management] and asked if I would like to participate, and I said I would, if there's any way I can help. [P05].

They believed that their participation in research might improve the way VLU patients are treated in the future, regardless of whether they saw any direct benefit to themselves:

Well, it was partly because it [research participation] might provide some assistance to future treatment of other people. [P24].

and

It's more what are the benefits for the whole community. If it's something that can improve conditions for somebody, I'd do it, even if it's not me. [P26].

4.3. “I participated in research to thank those who cared for me”

The participants appreciated the way they were treated at the specialist wound clinic and pleased with the care they have received. They viewed research participation as one of the ways to thank health professionals for the quality of care they have received.

Well, I wasn't doing anything before and I was struggling. And then when I went to the [name of the wound clinic] clinic and I ended up getting tubigrips and all this sort of stuff, everything came together really good and I'm very, very happy. [P06].

and

I'm incredibly grateful about the treatment we got at the clinic, it was fantastic. And the keenness of everybody to make sure you got over it was wonderful. [P26].

Participants said that the wound clinic professionals had time to invest in them and were very knowledgeable and this established trust between the participants and their treating team:

I have confidence in them. [P31].

and

Well, I'll go back to my treatment… the nurse that dressed my wound… I felt confident in what she was doing. I could see she was experienced, very experienced in what she was doing; she knew what she was doing. [P27].

Participants felt that through participating in the trials and other research projects conducted in the wound clinic, they would be repaying health professionals that helped them to manage their VLU:

Well, I usually agree to things like that [research participation] because I've had a lot of health problems, and I've been looked after very well. So, I think it's right. I should be doing things too. [P22].

and

Q: And what made you decide to say yes?

A: Well, the hospital [staff] has been really good to me, so I do not mind trying to help them out and also, make it better for other people with the same thing. [P14].

4.4. “I participated to receive better VLU care”

Four participants were driven to engage in the ASPiVLU RCT to receive better or innovative treatment because they felt they had exhausted all other treatment options. After many failed attempts to heal, P25 reported being desperate to try anything new that may result in VLU healing:

Q: And what motivated you, or what do you think might have been a reason to do it

A: Well I thought maybe it would help

Q: Help what?

A: My ulcer healed, because it [research] was ulcer related… and I was desperate to try anything. And I knew if it was the placebo, it would not do any harm. [P25].

Others reported they believed involvement in a clinical trial may result in finding a better method of treatment that facilitates faster VLU healing time:

I agreed because I thought it might be able to speed up my recovery from the ulcers that I've got on my lower legs, that's why I participated in it, so hopefully some findings come out as to why the ulcers take a very long time to heal. [P29].

While only four participants initially became involved in a clinical trial for their own personal gain, many participants acknowledged various benefits from research participation. Some of these benefits included wound improvement and/or healing, enhanced knowledge of VLU care, more frequent appointments and better quality of care.

4.4.1. “My wound has improved”

Seven participants believed that their involvement in a clinical trial led to better wound care and thus improved wound healing.

Q: Did you think it did help at all, being in the study, at this stage?

A: I think it did. I do not know if I was part of the placebo group or the Aspro group, I'm not too sure, but the target area that we were looking at is now healed completely, so obviously that's a good thing. [P29].

One participant distinguished that their wound clinic's involvement in research in general demonstrated an investment into following best practice care. They believed this led to improved wound care:

I feel that I benefited very much from the treatment that I got. Compared to the treatment that I got at the doctor's clinic and the nurses here. And I'm not saying that in an awful way, but the different treatment, the different way the ulcer was treated. And that's obviously come about because research is being done to find a way and I've benefited from it. [P01].

Other participants explained that as part of participation in research either in ASPiVLU RCT or cohort study they had more frequent and timely appointments at the wound clinic, which they viewed as improved quality of care that facilitated faster healing.

The benefits were, probably, seeing someone every couple of weeks… [it] was obviously a good thing, because sometimes there is a time delay between appointments at [regular visits to the clinic], where sometimes you might not be seen for six weeks or eight weeks, but in that time, ulcers do break down. I just think I received treatment more often because I was part of that group, and I think that's obviously helped in healing the target area. [P29].

Twelve participants reported that participation in research made no difference to their VLU, and they had ulcers that were not yet healed:

Q: Did you see any difference in your treatment prior to that study or after?

A: Oh, there's been a lot of different treatments because nothing seems to work. They've been trying a lot of things. Yeah, no one thing that's absolutely been great, otherwise it would be gone by now. [P07].

4.4.2. “My knowledge has improved”

Another perceived benefit was the participants' enhanced knowledge of their VLU and options for treatment. Many participants explained they rely solely on medical professionals as a means of procuring health information, and do not use other sources of information:

Q: Would you ever look up information on the Internet?

A: No, I do not actually, no. I rely on what the doctors tell me. [P31].

Involvement in wound research provided a good opportunity for participants to access information about the VLU care. One participant said this was the key benefit of their participation.

Q: And do you think that it all helped improve the treatment you got at the clinic?

A: Well it certainly helped me understand what was happening, and I think that's important. [P26].

and

Q: And do you think that sort of helped, being part of the research?

A: I was more knowledgeable of the condition… I had a choice of treatments; I had guidance with the treatments. So, it was being better informed to make choices. [P17].

Some participants became very invested in the study, wishing to know the outcome of the study and whether they had been prescribed a placebo:

Q: Is there anything else that you have thought of throughout that that I did not ask that you wanted to add in?

A: Yeah, I wanted to know whether I was on the real tablet or…

Q: That's a million dollar, I cannot answer that actually.

A: Well it was a blind study so I was on the aspirin or the placebo, that's what I want to know. [P23].

4.5. “I participated to have a say on what works” (from a patient perspective)

One of the reasons for participation was participants' desire to provide a feedback on the effectiveness of a particular therapy:

I also have a feeling that at times you have got to be proactive, and there have been occasions where I've had to say to them, what you are recommending will not work, and I know it will not work because we have tried it before and it has not worked… I take the view that I have to accept some responsibility to what's being done [research]. [P27].

Some participants felt that they are better positioned to provide suggestions because they have the first‐hand “in your body” experience of what particular therapy may or may not work.

Yeah. When it's happening in your body, you do know some feelings that aren't good, and the feelings that you recognise from the past of having infection ‐ it [a particular treatment approach] may not be working, or your skin's not reacting too well to a certain dressing ‐ so, you can tell them. [P31].

One of the participants had particular interest in the communication diaries that were provided at the commencement of the ASPiVLU RCT; and participants had been asked to log any changes to their wellbeing throughout the trial period. This participant diligently kept a record of any changes that he noticed, and developed a spreadsheet of treatments he had trialled before, as well as, his symptoms and signs of improvement. This participant felt as though his experience was validated, he was thus able to influence the care that he received and contribute to research.

Q: You mentioned that you had to fill out a communication diary. Was that something that you initiated or that they asked you to do?

A: They gave it to me the first time; and I started to handwrite it. And I thought: “This is useless, there's not enough room there. I'll start putting my own together in a spreadsheet.” And I turned it into landscape [format] instead of portrait; …the prior one did not have enough room in it. [P23].

This same ambition was shared among other participants. Participant 12 described the main benefit of research participation was in having an opportunity to vocalise some of their experiences: Well, there is lots of things you don't know, and you can only tell by asking people if it [a particular health intervention] was a success or not and what influence has it had in their lifestyle. [P12].

5. DISCUSSION

We asked participants to share their experience of participation in the ASPiVLU RCT and cohort study, including their reasoning to participate. Greater proportion of the interviewed participants had reported having VLUs for many years and provided valuable context for understanding their motivators to participate. Most participants reported VLU treatment needed to be improved, and believed that their participation in research would aid in better outcomes for future VLU patients. This motivator is consistent theme across the literature on research participation. ⁴⁴ , ⁴⁵ Participants reported they also felt a rewarding sense of “doing good” and repaying health professionals who had helped them to heal. However, appealing to altruism may not be a sufficient recruitment approach, and researchers should outline benefits, such as health education on wound management, an opportunity to provide feedback on treatment, and improved health access when participating in clinical trials. ⁴⁶

Getting access to up to date innovative treatment formed the participants' rationale for engaging in the ASPiVLU studies. Our study demonstrated the level of participant understanding the benefits and risks related to research participation varied. A few participants did not remember the nature of research, while others had a clear understanding of the aim of the study, the randomisation process, and differences in VLU management for the intervention and control groups. No participants discussed risks and complications related to research participation, although a few reported the lack of the VLU improvement. This was an important finding, as past studies reported participants are inadequately informed about the benefits of participation in clinical trials and have unrealistic expectations that involvement in research will improve their health, ⁴⁷ , ⁴⁸ and disliked the randomisation process. ⁴⁹ , ⁵⁰

Participants identified benefits to involvement in research study, including receiving better wound care, improving knowledge base, more frequent and comprehensive appointments, and improved communication with healthcare professionals/researchers. Ultimately, these benefits led them to continue with their involvement in research. Although VLU time to healing or reduction in ulcer size may have occurred as a result of research protocol adherence and more frequent appointments as part of research participation, the participants valued the opportunity to strengthen patient‐professional relationships and felt they were listened to by researchers. Improved patient‐professional communication, in‐turn, may have improved quality of care and patients' well‐being. ⁵¹

One key element of improved patient‐professional communication was the verbal advice and written health information participants were given by researchers and research nurses. Participants trusted healthcare professionals more than any other source of health information. Considering the lack of wound‐related information for patients in general, ⁵² , ⁵³ all information on VLU management provided to patients as part of research participation was valued by research participants as they acknowledged this improved their understanding of VLU healing and future prevention and care, which they considered as part of research‐related quality care.

In line with the other studies, ⁵⁴ the ASPiVLU study participants reported they valued the opportunity to ask researchers questions and to gain knowledge as a result of research participation. Although provision of health information may not enhance study recruitment, improved communication and researchers' availability to answer questions may lead to greater participant engagement and reduced drop‐out. ⁵⁵

Participant health issues are often described as a barriers to participation in research. ³⁵ In our study, people with non‐healing VLUs and the desire to get better care were the patient‐related facilitators to study participation. Health professionals frequently assume that a particular patient may not want to participate in research because of health issues and, therefore, may not inform patients (potential participants) about existing trials. ³⁵ , ³⁷ , ⁵⁶ Known as gatekeeping, ⁵⁶ this type of health professionals' behaviour has been reported as a barrier to participant recruitment. ³⁴ , ³⁵ In order to make wound care evidence‐based, greater quality evidence needs to be generated ⁵⁷ and translated in wound care, ²⁰ to optimise quality evidence and patient involvement. ⁶ Research participation is one way to involve consumers in health care research to ensure the consumer voice is present to inform health policy through patient advisory groups, and patient representation on research advisory committees. ⁵⁸ , ⁵⁹

Finally, our finding that some patients participated in the clinical trial “to have a say on what works” reflects patient's need for empowerment, that is; taking an active role within the decision‐making relationship with researchers and/or health service providers and an active role in the care process, including the quality of care. ⁶⁰ This finding also reflects the transformational change in patient‐professional relationship in Australia and globally, where patients are enabled to provide a substantial contribution to all aspects of health service activities, including health research, where consumers become equal partners. ⁵⁹ , ⁶¹ , ⁶² , ⁶³ This finding has the potential to improve research recruitment by accentuating partnership and power‐sharing in health research, which constitutes consumer empowerment. ⁶³

5.1. The Rationale for Research Participation Framework

Based on the Dennis' ⁶⁴ conceptualization of research participants experiences, we have developed the Rationale for Research Participation Framework (Figure 1). Conceptualising research participant experiences, Dennis ⁶⁴ identified three different approaches, including cost–benefit, relational and the critical consciousness‐raising approach. The cost–benefit approach is the most frequently used approach to explain the participant rationale for participation; it reflects participants' understanding of risks and benefits of participation and their altruistic motives, such as benefits to other people. In our study, it aligns well with the “I participated to receive better VLU care” and “I participated to help others” themes, and “My wound has improved” subtheme. However, the risk–benefit would be a more appropriate concept than cost–benefit. The relational approach, as described by Dennis, ⁶⁴ reflects the relationship between the researchers and the participants and aligns with our theme “I participated in research to thank those who cared for me,” which is more about the reciprocity in health professional/researcher‐participant relationships. The critical consciousness‐raising approach reflects on the participant self‐reflection and new ways of thinking; it aligns well with our sub‐theme “My knowledge has improved.” Although our theme “I participated to have a say on what works” can be attributed to either relational in terms of the participant's equal power with a researcher or risk–benefit in terms of personal contribution as a benefit, we decided to develop a separate, consumer perspective approach, which better reflects the motivation to participate as a consumer right to reflect on a particular service.

FIGURE 1.

The Rationale for Research Participation Framework (developed using Dennis' ⁶⁴ conceptualizations of research participant experiences)

5.2. Strength and limitations

Although patient‐related barriers to research participation have been reported we found a paucity of high quality studies that report on patient recruitment facilitators. ³⁴ Better understanding of patients' reasoning regarding the decision to participate may enhance understanding of recruitment facilitators. A limitation identified earlier was that ASPiVLU RCT and cohort participants had participated in VLU research in specialist wound clinics, and their views may not reflect the views of people who did not wish to participate or those participants treated in another setting.

6. CONCLUSION

We analysed patients' experiences of research participation in ASPiVLU study to identify their rationale in study participation; and identified four key themes: (a) “I participated to help others”; (b) “I participated in research to thank those who cared for me”; (c) “I participated to receive better care”; and (d) “I participated to have a say on what works.” These themes were discussed in light of Dennis' ⁶⁴ conceptualization approaches to research participants' experiences, and became basic elements of the Rationale for Research Participation Framework. This framework has the potential to improve the participant recruitment process for clinical trials in wound care and could be applied in other research fields, subject to testing and further development.

AUTHOR CONTRIBUTIONS

Carolina D. Weller and Victoria Team: study proposal; Catelyn Richards and Louise Turnour: conducted the interviews. Catelyn Richards: coded the interview transcripts. All authors: data analysis and article writing. Victoria Team: Rationale for Research Participation Framework. The final version was approved by all authors.

CONFLICT OF INTERESTS

The authors declare that the research was conducted in the absence of any personal, professional, commercial and financial relationships that could be construed as a potential conflict of interest.

Supporting information

Appendix S1 Supporting Information

Weller CD, Richards C, Turnour L, Team V. Rationale for participation in venous leg ulcer clinical research: Patient interview study. Int Wound J. 2020;17:1624–1633. 10.1111/iwj.13438