The Tell me tool: The development and feasibility of a tool for person‐centred infertility care

Abstract Background An important—and often missing—element of person‐centred care is the inclusion of individual patients' values and preferences. This is challenging but especially important for high‐burden fertility treatments. We describe the development of a clinical tool that aims to facilitate the delivery of person‐centred fertility care by giving insight into the patients' values and preferences. Methods We developed the Tell me tool following the three principles of user‐centred design: (1) early and continual focus on users; (2) iterative design; (3) measurement of user behaviour. Accordingly, our methods consisted of three phases: (1) conducting semi‐structured interviews with 18 couples undergoing fertility treatment, followed by a consensus meeting with relevant stakeholders; (2) performing seven iterative improvement rounds; (3) testing the feasibility of the tool in 10 couples. Results The Tell me tool consists of a ranking assignment of 13 themes and two open‐ended questions. These themes relate to the couples' wellbeing and experience of the treatment, such as mental health and shared decision making. The open‐ended questions ask them to write down what matters most to them. The field test showed variation between the individual patients' answers. The tool proved to highlight what is important to the individual patient and gives insight into patients' personal contexts. Conclusions We developed a tool that gives insight into the values and preferences of the individual patient. The tool seems feasible for facilitating person‐centred fertility care. Patient or Public Contribution The tool was developed with a user‐centred design that strongly involved patients.


| INTRODUCTION
In the last decades, we have seen a growing trend toward personcentred healthcare. 1 Person-centred care has several advantages. It can improve health outcomes, patient's wellbeing, the patientclinician relationship, patients' experiences with care and it can lower medical costs. [2][3][4][5][6][7][8][9] Patients with a chronic disease or a condition associated with a heavy burden of treatment can especially benefit from personcentred care. 10 A burdensome treatment, both physically and emotionally, is in vitro fertilization with intracytoplasmic sperm injection (ICSI), for which semen needs to be surgically retrieved through percutaneous epididymal sperm aspiration (PESA) or testicular sperm extraction (TESE). This treatment involves both partners, includes frequent and often emotional visits to the clinic and requires close, multidisciplinary collaboration.
Current literature defines several themes that are important to infertile patients, such as effectiveness, time and genetic parentage. 11,12 However, these studies take the approach of patientcentred care. Although many similarities exist between person-and patient-centred care (both include aspects such as empathy, shared decision-making, communication and relationships) the main difference is that patient-centred care aims for a functional life while person-centred care is broader and aims for a meaningful life. 1 Patients receiving infertility treatment might benefit from a personcentred approach because the outcome of this treatment and possibly stopping the treatment relate to their meaningfulness of life. 13 Living a life without biological children or without children at all might force couples to redefine meaning in life.
Despite many initiatives, person-centred care remains hard to accomplish because many elements are involved, such as communication between patients and clinicians, coordinated care and the individualized context of the patient. 1 One component is adequate incorporation of patients' preferences into healthcare decisions. 14 However, this appears to be a tough nut to crack. Many clinicians believe that they already integrate patient preferences into their recommendations, 15,16 and as Mulley et al. 15 put it: 'a preference misdiagnosis generally goes unnoticed'.
Misdiagnosis of preferences impedes person-centred care delivery. As communication is a dyadic concept involving efforts from both the patient and the physician, 17 strategies targeted at both groups could help to improve person-centred care. First, the clinician needs to get acquainted with the patient and his/her preferences. 18 Second, patients should be able to voice their values and preferences.
However, it is not easy for patients to engage in their care. 19 Patients need to be empowered to participate in the consultation; 20,21 moreover, they need time to construct an informed preference.
Preparation in formulating preferences in advance could encourage patient engagement during the consultation. 21,22 A tool could facilitate both patients and clinicians in: (1) supporting the patient to form and voice their preferences and (2) supporting the clinician to correctly estimate these preferences to deliver personcentred care. Tools that facilitate infertile patients to think and speak up about what is important to them in their fertility treatment and life are particularly promising because studies have shown that clinicians underestimate the importance of person-centred care and tend to assume that the couple's only goal is to become pregnant. 16,23 A recent review showed that interventions for patients, their families and practitioners could improve patient-centredness of care. 24 For example, a tool that was developed for hospitalized patients showed a positive effect on patient participation. 25,26 A review focusing on shared decision-making, which is an aspect of person-centred care, concluded that patients who use decision aids feel clearer about their values. 27 An existing theoretical framework defines several themes that are important to infertile patients, 12 but this framework does not provide an intervention that can be used in clinical practice and does not use a person-centred viewpoint. To our knowledge, no tools exist for facilitating a person-centred approach for both patients and clinicians in complex fertility treatment. Therefore, we aimed to develop a tool, the 'Tell me tool' for couples in need of PESA/TESE-ICSI treatment, that clarifies individual patients' values and preferences, facilitates patients to voice these and clinicians to understand them.
This study describes the development of a person-centred tool, using an iterative design and evaluates the usability of the tool in practice.

| Study design
We aimed to develop an instrument that would support patients in forming and voicing their preferences and clinicians in correctly understanding these preferences to deliver person-centred care. We were inspired by the literature on goal setting and patient empowerment [28][29][30][31][32] and wanted the tool to help patients construct their preferences by providing a list of 'goals' that could be important to them. These goals could then be discussed with their clinician.
We developed the tool using a user-centred development approach that includes feedback from both patients and clinicians as the most important stakeholders. 33 A user-centred design was originally used for the development of interactive software technologies in fields outside healthcare. 34 Yet such a concept could also facilitate the design of healthcare interventions. 33,35 We used this approach following the three principles of user-centred design: (1) early and continual focus on target users; (2) measurement of user behaviour; (3) iterative design. 36,37 In our setting, patients and clinicians were the target users of the intended tool. For that reason, they were involved from the very beginning of the development process. Accordingly, our methods consisted of three phases: (1) developing a draft of the tool; (2) improving the tool in iterative improvement cycles; (3) testing the usability of the tool.

| Setting
This study focused on infertile couples of which the man had been diagnosed with azoospermia, which required a PESA/TESE-ICSI treatment. Because this is the most burdensome of fertility treatments and involves treating both the man and the woman, discussing person-centred care aspects might be very important for these pa-  We interviewed until we achieved data saturation. For confirmation purposes, we conducted two more interviews. Interviews were audio-recorded and transcribed verbatim. E. V. and E. S. independently coded the transcripts using an inductive thematic analysis in Atlas.ti. 44 In this approach, the analysis was data-driven and themes were constructed without a pre-existing frame. Codes were compared, and when they differed, we discussed until we reached a consensus, if necessary with a third person (W. N.). All codes were grouped into categories derived from the data through constant comparison and review.

| Phase II: Iterative improvement cycles
Following the second and third principles of user-centred development (i.e., measurement of user behaviour and iterative design), the Tell me tool went through several iterative improvement cycles. In these cycles, user experiences and approaches to fill in the tool were measured using the think-aloud method. 45 We asked couples to complete the tool while telling out loud what they were thinking. The completed tools and results were discussed with the physicians and subsequently, the expert team adapted the tool into a new version ( Figure 2). We concluded the improvement cycles when no more considerable issues emerged.

| Phase III: Field test
During Phase III, the tool was introduced into daily practice. For optimal implementation, we discussed the distribution, processing and use of the tool in the aforementioned consensus meeting and the improvement cycles. We held educational meetings with all The clinicians preferred to read the tool before the consultation instead of receiving the tool from the patient during the consultation.
Also, due to time constraints, both the clinician and the patient expected that only one or two themes could be discussed during the consultation. The remarks were taken into account for using the tool in daily practice (Phase III).

| Phase II: Iterative improvement cycles
In total, 23 PESA/TESE-ICSI couples and several nurses, nurse practitioners and physicians working at the Department of Obstetrics and Gynecology during this study were consulted in the improvement cycles. We adjusted the tool seven times until no more considerable issues emerged.
Regarding the content of the tool, couples found it confusing that the tools for men and women sometimes differed in themes. We, therefore, decided to use the same themes for both genders. Some  The field test aimed to give insight into the user experiences of patients. Based on the input from both the consensus meeting and the improvement cycles, the tool was used as follows: PESA/TESE-ICSI patients, scheduled for intake, received the tool by mail together with their registration forms to ensure limited administrative time. This also met the patients' preference to complete the tool on paper.
Next, patients returned the completed tool and the registration forms to the secretary, who added them to their medical records. In addition, E. V. wrote a summary of the patient's tool in the treatment overview. In doing so it would be easier to find for all clinicians, should they wish to read the summary before the consultation. Both men and women rated the importance of all the themes highly, as can be seen in Table 1  We have to go through this together. (Woman, age 32) We want to become pregnant, but our health should not suffer from this. (Man, age 34) Information in easy language. Taking the time for a good explanation and for understanding the next steps.
(Woman, age 30) Next to comments on their themes, several patients mentioned a personality trait and/or their (care) experiences from the past.
I have an optimistic personality. In the past years I have conquered several setbacks and experienced that I can beat them on my own, which has made me stronger.
Therefore, I believe that we can handle this treatment.  The elicitation of patients' preferences is an important step in the process of shared decision-making, 46 which is essential to delivering person-centred care. 1,31 In general, it is known that clinicians' knowledge of patients' preferences enhances person-centred care.
Since the tool is developed to support patients and clinicians in communicating about patient's values and preferences and subsequently enable person-centred care, we will discuss the potential of the tool through the concept of clinician-patient communication. Mean score on what requires extra attention, 10 points were distributed over top four (Steps 2 and 3 in Figure 4A,B). c Number of times a theme received the highest score from a patient on requiring extra attention (Step 3 in Figure 4A,B); patients could distribute 10 points freely and some patients gave two items an equally highest score.
genuinely interested in their patients' values and preferences.
Therefore, the tool could not only help patients to form their preferences but also empower patients to voice them during the con-  16 Our results were in line with another study that assessed family-building aspects in infertile couples. It was reported that a close and satisfying relationship with one's partner was the highest priority for couples. 51

| Strengths and limitations
The user-centred design was the greatest strength of our study. We used this method for developing the content, layout and use of the Lastly, for the development of similar interventions, we recommend using a user-centred design. Especially the iterative feedback cycles in which we were able to try out different versions of the tool (language, questions, explanation, lay-out), have helped us improve the tool. These approaches could enhance delivering personcentred care.

| Conclusion
The Tell me tool appears to be feasible for facilitating the delivery of person-centred fertility care since the tool gives a reflection of the patients' values and preferences, and there is variation between the individual patients' answers. The user-centred design was an important element in developing the Tell me tool since the feedback of end-users heavily influenced the content, layout and use of the tool.
Future research is necessary to confirm the effect of the tool for person-centeredness fertility care.