Patient‐initiated recruitment for clinical research: Evaluation of an outpatient letter research statement

Abstract Background UK Hospital Trusts are charged with increasing patients’ research awareness and willingness to take part in research. This includes implementing strategies to encourage patient‐initiated enquiries about participation. Objectives To evaluate the impact of a research statement inserted in outpatient letters in one clinical service, and to derive suggestions on potential steps towards increasing patient‐initiated recruitment. Setting A medical outpatient clinic of a research‐active hospital trust, serving an inner‐city multi‐ethnic population across two boroughs. Methods Pre‐intervention and post‐intervention questionnaires were administered face‐to‐face to new patients. Questionnaires included closed questions and one open comments section. Data were analysed for frequencies, with thematic coding of open‐ended responses. Results The response rates were 87% for the pre‐intervention survey and 92% for the post‐intervention survey. In the post‐intervention survey, 85% of patients did not notice the research statement in the letter. More than half found the statement “a little unclear,” whilst one‐third considered it “clear.” Three‐quarters of respondents perceived the statement to be “a little helpful.” Only one person enquired about participating in clinical research having read the statement in the outpatient letter. Conclusion The analysis suggests that simple, single‐solution approaches such as including research statements in outpatient letters are unlikely to be sufficient to significantly facilitate patient‐initiated recruitment. Recruitment efforts need to take into consideration the diversity of patient constituencies including the reasons they seek health care, and how patients can meaningfully access information (research literacy).


| INTRODUCTION
Since the 1990s, a greater role of patients in clinical research in the United Kingdom (UK) has been advocated, with patients positioned as "consumers" and "service users," rather than as "research subjects." 1,2 At the same time, the UK's National Institute of Health Research (NIHR) has sought to encourage greater participation of patients in clinical research conducted in the National Health Service (NHS). Long-standing concerns about shortcomings in participant recruitment to clinical trials and other types of health research have been widely reported. A Cochrane review that included 45 trials, reported that "it is likely that less than 50% [of clinical studies] meet their target [in patient recruitment], or meet their target without extending the length of the trial." 3 The authors suggest that recruitment may be viewed as problematic by clinical research stakeholders, outlining three main concerns: At the scientific level, "underpowered" studies may report as statistically non-significant results which are nonetheless clinically relevant; ethically, participants in "underpowered" studies have been exposed to interventions with uncertain benefit but the effectiveness of the intervention remains uncertain; and on economic grounds, they underline that greater costs may be incurred if "underpowered" studies need to be extended to arrive at statistically significant results. These three concerns provide a framework within which to understand why stakeholders consider greater numbers of participants as vital to the efficiency and efficacy of clinical research .
Patient recruitment into clinical research is subject to three core considerations: approach (how to reach sufficient numbers of participants), eligibility and retention. To increase recruitment, the NIHR has proposed that UK health organizations develop a "research culture," focused on delivering innovation in research and care provision, 4 which encourages patients to proactively seek involvement in clinical research. The clinical research network aims to support the development of such a "research culture" by "providing NHS Trusts with additional funding to cover the cost of research nurses and other clinical research delivery staff, who identify and approach patients about relevant research opportunities." 5 Not only does this work aim at recruiting patients, but even more so at encouraging patients to voluntarily and of their own accord come forward to enquire about, and subsequently participate in clinical research.
However, the NIHR's mystery shopper campaign conducted at 82 hospital sites in England in 2012, found that very little information on clinical research is made available to patients at point of care, 5 evidencing concern about difficulties with recruitment to NHS research.
Subsequently, the NIHR devised an annual patient engagement campaign, until recently called "OK to Ask" (https://www.nihr.ac.uk/ patients-and-public/documents/OK-to-ask-report.pdf), and since 2017 entitled "I am Research" (https://www.nihr.ac.uk/news-andevents/support-our-campaigns/i-am-research/), to raise awareness of opportunities for patient participation in research. Such efforts are premised on expectations that patient-initiated recruitment can significantly increase participation numbers and reach also those patients that may not be included in hospital-based patient recruitment drives. The NIHR's "OK to ask" campaign (2013-16) had positioned patient participation in clinical trials as a right, and the campaign was framed in terms of empowerment to ask about clinical research and potential participation in it. The recent shift to "I am Research" frames research participation as both a right and an obligation, a way to "give back" to the health-care system to help improve care whilst benefitting on various levels including generating a sense of community, becoming more informed about illness, gaining access to latest treatments and gaining a feeling of more control over their illness.
The messages of "I am Research" dually frame patient participation in terms of reciprocity for health-care provision based on equity or solidarity whilst calling upon the imagined patient's more economic reasoning of cost-benefit.

| CASE STUDY
This case study took place in one medical outpatient department of an academic hospital trust, serving two inner-city two boroughs, tertiary referrals from a larger geographical area. The local population is characterized by high levels of ethnic diversity: in one borough, Black Africans and Caribbeans make up one-quarter of the population, whilst in the other, this proportion is 31% of the total. There are wide variations in socio-economic status, with these boroughs ranking as the 22nd and 41st most deprived in England. The Trust is highly research active, consistently ranking very highly in NIHR research league tables in terms of studies and patients recruited to research. It is also active in promoting research to patients, taking part in annual Clinical Trials information days, including information about research on its website and in its patient and public engagement strategy, and supporting a number of condition-specific patient and public involvement (in research) groups.
The Trust responded positively to the "OK to ask" campaign's recommendation to include a statement on research in each patient admission letter and one clinical department agreed to pilot the statement in letters for outpatients attending a medical clinic for the first time following referral from a general practitioner. We have previously reported on this process, highlight the resource intensive nature of its implementation. 6 The statement wording was devised by Trust staff and had considerable input from lay members with experience of patient and public involvement and of research participation. The purpose of the statement was to raise patient awareness of the Trust as, not only as a health-care provider, but also a research centre, and to encourage patients to ask about research, with a view to increasing patient-initiated recruitment. The final wording was adopted as follows: Our hospitals are involved in developing new treatments and better care. If you would like to take part in a research study or want to know more about taking part, please speak to the doctor or nurse caring for you. If you are asked to take part in a research study, we will explain it to you in detail. If you decide not to take part, this will not affect your treatment in any way.
On 24 October 2014, the piloting of the initiative began when the statement above was inserted into the outpatient letter template for patients attending their first appointment (Supplementary Appendix S1). This paper analyses findings of an evaluation of this pilot scheme, which aimed to understand if and to what degree the research statement in the admission letter impacted on patient awareness of, and patient-initiated recruitment to, the research activities of the Trust. The analysis focuses on patient perceptions of the pilot statement and discusses outcomes and implications of the pilot test for facilitating patient-driven recruitment to clinical research. The paper then discusses these findings within the context of the NIHR's patient engagement and recruitment.  3 minutes to administer, the post-intervention survey around 5 minutes.

Pre
Both were deliberately short to encourage a high response rate. No identifying patient data were collected. Ethics committee approval was not required as the survey was NHS pre-assessed to fall within the category of "service evaluation" (http://www.hra.nhs.uk/research-community/ before-you-apply/determine-whether-your-study-is-research/).

| Data analysis
Survey responses were tabulated and analysed for frequencies. Openended comments were recorded verbatim and coded to facilitate grouping into broader categories. At this stage, findings were presented to two local patient and public involvement groups, with discussion on interpretation of the results and their implications.

| Survey results
In total, 453 patients were approached to take part in the two sur-

| Impact of the research statement
This section focuses on results from the survey designed to assess the impact of the statement (post-intervention).

| Notice
Only 15% of participants indicated that they noticed the letter statement; 85% said they did not. In the Open Comments section of the survey, patients suggested that they did not notice the statement because they had used the letter to primarily learn about the time and date of their appointment, or because they had lost the letter or disposed of it once they had noted the details for their appointment.

| Clarity
When participants read the statement, the majority (56%) found its content "a little unclear", whilst 7% perceived it to be "very unclear". A third (33%) of patients felt that the statement was "clear," and only a minority of 4% found it "very clear". In their Open Comments, two patients expressed difficulty understanding the statement, suggesting, respectively, that it was "too wordy" and "too long".

| Helpfulness
The statement was considered to be of "little help" for encouraging research participation by 76% of participants, only a minority found it helpful. Some participants reported through the Open Comments that they had noticed the statement and were interested in taking part, but had not asked about research because they forgot to ask, or they were concerned they would "waste" time in their clinical appointment, which they felt was already short.
The pre-intervention survey provides baseline data on the propensity of patients in this clinic to ask about taking part in research.   them, with 29% undecided. 8 A Korean survey found that 25% of randomly selected members of the public would be willing to participate in a future trial, 9 with the same proportion reported from a German study of the general public. 10 Patient populations report higher levels of willingness to participate. In a 2006 survey of 400 outpatients at a general internal medicine practice at a tertiary care academic medical centre in the United States, 68% showed "interest" in participating in clinical trials. 11 The UK National Cancer Experience Survey reported that 95% of patients who had research discussed with them were happy to have been asked and 53% of those with whom research was not discussed would have been happy to have been asked. 7 Moorcraft et al 12 report that most patients in a specialist cancer hospital were happy to be approached about research participation, and 88 % of those approached during the study period consented to take part in a clinical trial. 12 However, they note that "patients who have just started their first treatment for cancer are less likely to participate in cancer

| DISCUSSION
research and it appears that as time increases from diagnosis, patients are more positive about engaging with research" (2016:8).
The Cochrane review by Treweek and colleagues, 3 cited in the Introduction to this paper, seeks to quantify the effects of strategies to improve recruitment of participants to randomized controlled trials.
They report that promising approaches include telephone reminders; requiring potential participants to opt-out of being contacted by the trial team regarding taking part in a trial, rather than them having to opt-in; and open designs. These recruitment strategies presuppose prior identification and access to patients who represent eligible potential trial participants and require considerable time investment by the trial team who will also be busy fulfilling other roles in the research process. As such, it is likely that such strategies can only meaningfully increase patient participation with groups that are easy to access by trial teams. This body of work shows that potential trial participants come from very diverse constituencies and that there are both structural (social and research institutional) as well as personal barriers to participation.
These efforts, at least in part, can provide the means to compensate for an increasing methodological formalism in recruiting patients which threatens to substitute substantive concern with the reasons why certain populations may be hard to recruit into clinical research. 25  and an addresser. The research statement in the letter aims to address not just any public but an "active," "attentive" public who understands the context and rationale for the statement to be able to act upon it and has an interest in doing so. To be attentive, the patient audience needs to "have a special incentive for assessing the common content The findings from this case study lead us to suggest that perhaps the UK health-care system-particularly the relationship between care provision and clinical research-remains black-boxed to a large part of the patient population and does not reproduce the attentive audience imagined by the NIHR and its institutional executors as potential research participants. To be able to reach as many different patients as possible and to "activate" these towards patient-initiated recruitment, the broad concept of patient may need to be disaggregated so that specific audiences can be addressed.

| CONCLUSION
Our results suggest that simple, single-solution approaches to increas- Therefore, there is an ongoing need to develop the health-care system's approach to patients: patients are not one homogenous public, but are diverse publics that need to be addressed as specific audiences along a broad continuum of different priorities and needs, values and perceptions.