Involving people with type 2 diabetes in facilitating participation in a cardiovascular screening programme

Abstract Background Knowledge is lacking about how to increase uptake among people with type 2 diabetes (T2D) invited to preventive initiatives like cardiovascular screening. Aim To explore how to improve participation of people with T2D in cardiovascular screening using patient and public involvement (PPI). Methods Patient and public involvement was included in a qualitative research design. From April to October 2019, we invited 40‐ to 60‐year‐old people with T2D (n = 17) to individual consultative meetings, using an interviewing approach. Before the interviews, participants were asked to read a proposed invitation letter to be used in a cardiovascular screening programme. Inductive content analysis was undertaken. Results Participants considered cardiovascular screening important and beneficial from both a personal and social perspective. We found that the relational interaction between the person with T2D and the health‐care professional was key to participation and that nudging captured through the design of the screening programme and the wording of the invitation letter was requested. Conclusion In preventive initiatives perceived as meaningful by the invitee, a focus on recruitment is crucial to facilitate participation. This study contributed with knowledge about how to promote participation by involving health‐care professionals in recruitment initiatives and through nudging. This knowledge may assist researchers, policymakers and ethicists' understanding and assessment of the ethical appropriateness and public acceptability of nudging in cardiovascular screening. Patient or public contribution By consulting 17 people with T2D, we are now in a position to suggest how a screening initiative should be altered because tools to improve uptake have been identified.


| BACKG ROU N D
Knowledge is lacking about how to achieve high participation rates among people with type 2 diabetes (T2D) invited to preventive initiatives like cardiovascular screening. According to the WHO, the screening threshold for participation rates should exceed 70% to ensure screening effectiveness. 1 However, in the pilot study of the DIAbetic CArdioVAscular Screening and intervention trial (DIACAVAS) targeting people with T2D, the participation rate was only 41%. The DIACAVAS trial was designed to identify unprotected subclinical cardiovascular diseases (CVD) among 40-to 60-year-old people with T2D in Denmark in order to offer them individualized treatment. 2 Overall, the low DIACAVAS uptake indicates that it did not meet the invitees' needs and preferences. Thus, the DIACAVAS investigators decided to strengthen recruitment by involving patients before conducting a large-scale trial. 2 In line with DIACAVAS, non-participation in population-based cardiovascular screening and health check have also been found to be associated with diabetes. 3,4 Patient and public involvement (PPI) is an acknowledged approach to improve the quality and relevance of health-care research.
It refers to 'research being carried out "with" or "by" members of the public rather than "to," "about" or "for" them'. 5 PPI has been found beneficial in several ways. A systematic review and meta-analysis by Crocker et al 6 found that PPI interventions increased participant recruitment by 16% on average. Additionally, the likelihood of participation was three times higher when PPI interventions were conducted after having consulted people with lived experience of the condition being studied compared with people not having the targeted condition. Moreover, PPI was shown to be beneficial by improving the study design, study materials and the readability of patient information, 7,8 and by incorporating research objectives relevant to the study population. [8][9][10] Therefore, the aim of this study was to explore how to improve participation in a cardiovascular screening programme among people with T2D by use of PPI.

| ME THODS
We employed PPI in a qualitative research design using an interviewing approach. We consulted people with T2D by conducting individual, elaborating one-off meetings to get their views on how to enhance uptake in a proposed cardiovascular screening programme.
Using an interviewing approach allowed us to elaborate on the participants' perspectives and hereby understand experiences related to their expressed preferences for facilitating participation and what they felt would challenge participation. To guide the consultation, we used a semi-structured interview guide and interviews were recorded to ensure all details were kept for the future analysis. 5,11 The aim was to use any feedback to re-thinking a cardiovascular screening initiative DIACAVAS.

| Context
Participants were recruited from two general practices and two diabetes outpatient clinics in three of the five Danish Regions (the Central Denmark Region, the Region of Southern Denmark and the North Denmark Region). Prior to the study, staff group information meetings were offered.
Data for this PPI study were collected in the setting within which the participants were being monitored for their T2D and recruited for this study.

| Contextual framework
In Denmark, equal access to health services for all residents is a health-care cornerstone. The health-care system offers publicly financed preventive, primary care and hospital services. All registered Danish residents receive a health insurance card provided by the Danish public authorities. Reimbursement of medicine carries some co-payment depending on the individuals' annual use of prescription medication. 12 In 2019, the maximum co-payment for reimbursement medicine was DDK 4110 per year (552,45 euro). 13 A total of 98% of the Danish population is listed with a general practitioner (GP). 14 GPs coordinate medical care for the majority of people with T2D, whereas a minor share of these patients are followed in outpatient clinics.
All Danish residents have a personal digital mailbox provided by the Danish public authorities. 15 Using the digital mailbox is an easy and well-known strategy to reach the majority of the Danish population in a safe, secure and inexpensive manner. In 2019, only 4.2% of 35-to 64-year-old Danes living in the region where the DIACAVAS was offered did not receive digital post due to language difficulties and disabilities, for instance. 15

| Sampling strategy
Eligible participants were identified by purposive sampling of 40-to 60-year-old men and women with T2D from diabetes care settings.
The inclusion criteria were being diagnosed with T2D without limitations due to diabetes duration, ability to speak Nordic languages or English and willingness to participate in the study. This approach was taken as people with lived experience of the condition being studied were considered experience-based experts. 16 A total of 24 patients K E Y W O R D S cardiovascular disease, codes of ethics, patient and public involvement, screening, type 2 diabetes were invited, 17 (70.8%) of whom accepted to participate. Busyness was the main reason stated for declining to participate in the study.
Participants were recruited face-to-face either by their treatment provider or by the first author. The interviews were scheduled so as to fit the participants' availability.

| Data collection
Interviews were conducted using an interview guide based on the scope of PPI (Table 1). We pilot-tested the interview guide by conducting two interviews with participants meeting the study inclusion criteria. No changes to the interview guide were needed. Therefore, these interviews were included in the final PPI study.
Data were collected from April to October 2019 by the first author. Data collection was continued until the sample met the inclusion criteria and the authors deemed that further data would not add to the analysis. 17 Prior to the interview, the participants were asked to read and make notes to a proposed invitation letter for cardiovascular screening. An English version of the invitation is available in the supporting information. The invitation consisted of an invitation letter (Appendix S1) and some participant information (Appendix S2). When the participants read the invitation, the interviewer left the room so that they could read it undisturbed and at their own pace. Once the participants had finished reading the invitation, including making notes, they asked the interviewer to re-enter. The time taken to read and make notes to the invitation letter ranged from 14 to 22 minutes. Subsequently, interviews were conducted.
The interviews were audiotaped and transcribed verbatim by a research assistant. The length of the interviews was 8-17 minutes, excluding the time needed to obtain informed consent. Notes were made after the interview relating to, for example important unrecorded statements and the interview setting.

| Data analysis
We conducted an interpretive, inductive content analysis following the recommendations by Elo and Kyngas. 17 The first author performed the analysis by first reading and then rereading the transcribed interviews to get an impression of the data. Next, units of analysis related to the research question were identified and coded by using an open coding approach. Subsequently, coded contents were compared in terms of similarities and differences to determine coded contents that could be synthesized into subcategories. This abstraction process was an iterative process moving back and forth between raw data, coded contents and subcategories. Then subcategories were grouped together based on similarities in contents into main categories. Finally, these categories and subcategories were discussed with the research team until consensus was achieved on both interpretations of data and sufficient data abstraction, but also to ensure credibility of findings. 17 In this analysis, we used the software program NVivo, version 12 Pro (QRS International Pty Ltd), as a structural tool to underpin the analysis.

| Researcher characteristics and reflexivity
The first author who conducted the interviews and analysis was not involved in the DIACAVAS, but has experience with cardiovascular screening in terms of designing, implementing and evaluating such initiatives. The research group consisted of multidisciplinary experts  We recruited from different regions to ensure the anonymity of recruited study participants as well as the participating outpatient clinics and general practices.

| RE SULTS
In the analysis, we found that the participants viewed cardiovascular screening to be an important initiative both from a personal and social perspective with a view to preventing diabetes-related cardiovascular disease and thereby reducing the costs associated with diabetes complications. Therefore, they suggested clarifying the relevance of the initiative for the invitees by using relational interaction and nudging. This led us to formulate two main categories conceptualized as follows: 'making screening relevant through relation' and 'participation by nudging'. Selected baseline characteristics from the structured interviews are listed in Table 2.

| Making screening relevant through relation
We found that it was pivotal to establish a relation between the invitee and the sender of the invitation to make cardiovascular screening personally relevant. The wording of the invitation did not only present specific content, but also established a specific and inexpedient relationship. Using medical terminology created an impersonal professional distance to the recipient:

| Participation by nudging
In our analysis and interpretation, we found that the participants requested support to become attentive to the person-centred relevance of participation. They suggested using nudging in the screening invitation and the screening programme to facilitate participation.

| A nudging screening invitation
Overall, the participants found that the invitation was too extensive. Another participant suggested linking to additional information: If you want to read more about some things, then you can click on to another document (Participant 1).
We found it important for the participants to be attentive to the benefits of participating in order for them to find that screening was personally relevant. Therefore, in our interpretation, the invitation needed to nudge attention towards the personalized benefits of participating, thereby also facilitating an informed decision about participation as ethically and legally required.
An eye-catching invitation with illustrations was also suggested in order to nudge the invitees' attention: The invitation is not inspiring … the text is compre- In this way, illustrations may also underpin achieving informed consent. In this way, the invitees' needs and preferences for a readable invitation might be set aside in order to shield the researchers from legal issues. But, overall, we found an easy-to-read invitation to be preferable in order to build awareness about the relevance of participating and to allow invitees to make an informed decision.
We found that the articulation and wording of cardiovascular In this manner, a screening invitation that includes a pre-booking might be considered as compulsory and therefore limit the invitees' self-determination and autonomy.
We found that the scheduling of the screening appointments needed to fit into the invitees' everyday lives in order to nudge them towards participation: If it is scheduled during working hours, you have to take a day off or a half day. I am very convinced that people will decline for that reason … because you would much rather spend a day off with your family In contrast, offering screening in the afternoon and evening may be a barrier for those prioritizing their family: The period offered is not practical ( But cardiovascular screening was also perceived as beneficial from a social perspective: I really mean that it should be mandatory! Because of the consequences, when people get this (CVD) it will be a lot more expensive for the society as opposed to tackling the issue early on (Participant 16).
Based on these statements, we interpret that cardiovascular screening is considered beneficial, and therefore participants suggested using nudging towards participation. Notably, the participants did not mention whether the DIACAVAS is effective or not, even though the invitation emphasized that the purpose of DIACAVAS was to establish whether a screening offer reduces the cardiovascular risk.
Finally, Figure 1 provides an overview of the identified encouraging and challenging factors relating to screening participation. We found interpersonal variation in what was considered as encouraging and challenging factors suggesting that a person-centred invitation approach may be appropriate. As such, involving the usual treatment providers in recruiting is necessary.

| D ISCUSS I ON
In this study, we obtained important feedback from people with T2D and established that relational aspects and nudging are considered essential in facilitating uptake in a cardiovascular prevention initiative. In the following, we discuss the possible effects of our findings.

| Relational interaction is essential in facilitating participation
Overall, we found that a relationship between the patient and the health-care provider was essential in making the invitee perceive the screening as personally relevant. If people with T2D are to participate, screenings must be meaningful to them, and this may be achieved by building on a previously established relationship.
According to a narrative review and synthesis by Kitson and colleagues, 20 the relationship between patients and treatment providers is a core element of patient-centred care across health-care disciplines. Patient-centred care involves, for example having and maintaining a genuine relationship, having a cohesive team of treatment providers and creating a setting in which knowledge is shared and flows freely between patient and treatment providers. 20 Moreover, a relationship is based on a moral commitment by the treatment providers to care for patients. 21 Accordingly, a systematic review by Harrington and colleagues found that reinforcing patient-doctor communication was beneficial for recall of information, participation and adherence to recommendations, long-term changes in health status and lifestyle as well as for patient participation preferences in medical consultations. 22 Communication may hence facilitate shared decision making that involves eliciting the individual's preferences. 23 Therefore, we argue that a relationship-centred approach is important when treatment providers encourage participation in screening because the encouragement to participate will then be based on the individuals' preferences. In Denmark, citizens are affiliated with a specific general practice. This allows for continuance in diabetes care, among others, but also provides the foundation for the establishment of a relationship between patient and GP that includes knowledge about the individual patient.
In screening, personalized prompts from health professionals have been found to be particularly effective in enhancing participation. In a randomized controlled trial among invitees to the NHS Health Check for CVD, Gidlow et al 24 found that the uptake increased significantly from 30.9% to 47.6% among those invited by a phone call from the practice staff compared with receiving a standard invitation letter. Moreover, in an analysis of recorded invitation approaches (n = 12 048) in 30 general practices, Cook and colleagues found that the overall uptake of face-to-face invitation was 71.9% compared with 43% by telephone invitation and 29.5% by written invitation. 25 This is in line with our finding that personal encouragement to participate based on a trusted relationship with the invitee is important in ensuring that the screening invitation is considered personally relevant. Similarly, a recent systematic review by Brewster and colleagues found that non-participation in diabetes outpatient settings was related to impersonal relationships with treatment providers. 26 Therefore, we suggest that invitees may be more attentive to a personalized invitation if its sender is a wellknown health-care professional, for example the family's GP.
Interestingly, we found that people with T2D did not view health professionals with higher academic degrees to be a signifi-

| Nudging as a strategy for participation in screening
To our knowledge, this is the first study illuminating that invitees suggest the use of nudging in cardiovascular screening prospectively. Recently, nudging has been defined as 'an umbrella term for F I G U R E 1 Encouraging and challenging factors involved in determining if a screening invitation is accepted deliberate and predictable methods of changing people's behaviour by modifying the cues in the physical and/or social context in which they act. It uses these cues to activate non-conscious thought processes involved in human decision-making. Nudging implies that none of the choices should be difficult to avoid, made mandatory, incentivized economically or socially, and made significantly more costly in terms of time or trouble' (page 3). 28 We found that the participants advocated use of nudging in the design of the invitation and the screening programme.
We found that the participants considered their personalized Disquieting, we found that invitees might ignore their own needs for a readable invitation, thinking that the invitation is meant to protect the research team from litigation. Thus, the legal and moral requirements guiding the drafting of study information may not always lead to an informed decision as intended in research and outlined in the Declaration of Helsinki and by the Council for International Organizations of Medical Sciences. 34,35 Moreover, an invitation to a screening needs to be understandable. 36,37 These concerns need to be addressed in future research. We argue that the identified encouraging and challenging factors relating to participation may also impact the invitees' ability to make an informed decision when facing a screening invitation.
In the invitation tested here, the wording used to describe cardiovascular risk was found to be important for the acceptability of nudging invitees towards participation. However, the preferences of the risk description were contradictory as they ranged from soft to hard word wording. Consequently, the description of the cardiovascular risk might need to be worded softly in order to minimize harm, as also emphasized in the screening criteria outlined by the health authorities. 36,37 A pre-scheduled appointment is known to increase participation in screening for breast cancer. 38 Similarly, we found that our participants recommended offering a pre-scheduled appointment, although concern was expressed about the risk of violating the invitees' autonomy. However, legally, a screening invitation must stress that participation is optional and that whether the invitation is accepted or not is without consequences for the invitees' current treatment. Thus, pre-scheduling seems an acceptable intervention that is in accordance with the definition of nudging as the choices are neither difficult to avoid nor made mandatory. In cardiovascular population-based screening, pre-scheduling has produced a 74% uptake. 39,40 In a later publication, one of these studies has reported the specific uptake for invitees with diabetes and found diabetes to be significantly associated with non-participation. 3

| Ethical aspects of nudging in screening
We found that the participants advocated using nudging in cardio-

| Discussion of method
We used PPI in recognition of the low uptake in the DIACAVAS pilot study. This study contributed with important information about the relevance of offering cardiovascular screening and how to facilitate participation in forthcoming preventive initiatives. However, it may be favourable to also incorporate PPI in re-thinking process of the DIACAVAS study and to invite people with T2D to become members of advisory or management groups, for instance 42 ; an initiative which is in line with one of our key findings; the relational component.
We performed qualitative research interviews which rely on an active process in which the interviewer and interviewee produce knowledge through their relation within a certain context. 43 We used individual interviews to gain profound and personal insights 8 and to ensure that each participant was active and felt free to share their views. 44,45 Interviews are preferable when the research question aims to explore the interviewee's perspective of a phenomenon rather than generating generalizable understandings from large groups of people. 46 Moreover, interviews is a recommended approach in PPI. 11 Alternatively, workshops may be favourable as they allow participants to inspire each other and engage in discussions based on their personal experiences, attitudes and ideas. Workshops may also be a suitable manner to prioritize new initiatives facilitating participation. 47 The analytical approach was based on content analysis, the purpose of which is to provide knowledge and new insights about a complex phenomenon while also providing a practical guide to action. 17,48 The study participants were characterized by wide socioeconomic variation from secondary-level to tertiary-level education and their working status varied from being outside the labour market (retired, unemployed) to being employed or self-employed. However, people of a non-Western origin were not represented. Given the limitations related to the demographic characteristics of the participants, it would be interesting to explore possible ethnic differences, which is a potential area for future research.
Our findings may be disease-specific as people with diabetes may have special preferences for nudging due to the severity of the diabetes diagnosis.

| CON CLUS ION
Support for cardiovascular screening among people with T2D appears to be widespread. To enhance the uptake in such initiatives, focussing on recruitment is essential. To facilitate participation, we found that people with T2D emphasized the relation with their usual health-care professionals. Therefore, any screening offer should be provided in collaboration with these health-care professionals. Moreover, nudging was advocated to facilitate participation, particularly in relation to the screening set-up and invitation. Furthermore, the written invitation needs to be prepared thoroughly and in collaboration with the invitees to ensure that the text is easy to read and understand.
Overall, this study contributed with knowledge on how to promote participation by involving health professionals and using nudging in accordance with the preferences of people with T2D. This knowledge is valuable for researchers, policymakers and ethicists as it enhances our understanding and assessment of the ethical appropriateness and public approval of nudging in cardiovascular screening.
Finally, participation is a general concern, not only in relation to cardiovascular prevention. Our findings might be applicable to other preventive services targeting people with T2D.

ACK N OWLED G EM ENTS
Thanks to the general practices and outpatient clinics for assisting with the recruitment of study participants. Additionally, we are indebted to the participants for generously sharing their views and experiences, which will inform decision making on how to design an initiative aiming to prevent CVDs.

CO N FLI C T O F I NTE R E S T
The authors declare that there are no conflicts of interest.

AUTH O R CO NTR I B UTI O N S
MD, AD and JS designed the study. MD collected field data, conducted the analysis and drafted this manuscript. All authors contributed with constructive criticism during the design of the study, analysis of the data and preparation of the manuscript. All authors have read and approved the final manuscript.

DATA AVA I L A B I L I T Y S TAT E M E N T
The entire transcribed interviews used in this study are not publicly available. But minor anonymized parts are available from the corresponding author upon a reasonable request. This is to protect and maintain participants' anonymity and confidentiality.