Development of a patient decision aid for patients with breast cancer who consider immediate breast reconstruction after mastectomy

Abstract Purpose The aim of this study was to develop a patient decision aid (pDA) that could support patients with breast cancer (BC) in making an informed decision about breast reconstruction (BR) after mastectomy. Methods The development included four stages: (i) Establishment of a multidisciplinary team; (ii) Needs assessment consisting of semi‐structured interviews in patients and a survey among healthcare professionals (HCPs); (iii) Creation of content, design and technical system; and (iv) Acceptability and usability testing using a think‐aloud approach in patients and interviews among HCPs and representatives of the Dutch Breast Cancer Patient Organization. Results From the needs assessment, three themes were identified: Challenging period to make a decision, Diverse motivations for a personal decision and Information needed to make a decision about BR. HCPs valued the development of a pDA, especially to prepare patients for consultation. The pDA that was developed contained three parts: first, a consultation sheet for oncological breast surgeons to introduce the choice; second, an online tool including an overview of reconstructive options, the pros and cons of each option, information on the consequences of each option for daily life, exercises to clarify personal values and patient stories; and third, a summary sheet with patients’ values, preferences and questions to help inform and guide the discussion between the patient and her plastic surgeon. The pDA was perceived to be informative, helpful and easy to use by patients and HCPs. Conclusion Consistent with information needs, a pDA was developed to support patients with BC who consider immediate BR in making an informed decision together with their plastic surgeon. Patient or Public Contribution Patients participated in the needs assessment and in acceptability and usability testing.


| INTRODUCTION
Patients undergoing mastectomy as a treatment for breast cancer (BC) or to reduce their increased risk of BC often have a choice of whether or not to undergo breast reconstruction (BR). Undergoing BR after mastectomy can be beneficial for patients' quality of life and psychosocial functioning. [1][2][3][4][5] However, there are also disadvantages of having BR, such as an increased risk for complications. 6,7 Most patients who consider BR also have to make choices regarding the timing (i.e., immediate or delayed) and the type (i.e., implant-based or autologous) of surgery.
The decision for BR largely depends on patients' values and preferences. 8,9 For preference-sensitive decisions such as this, shared decision-making is increasingly advocated as the preferred approach. 10,11 Shared decision-making is a patient-centred approach in which physicians and patients collaborate and share information about the best available evidence and patient preferences and values to reach a health decision. 10,12,13 In this approach, physicians are considered experts about the medical evidence and patients are considered experts about what matters most to them. 14 Previous studies have suggested that there remains an unmet need for support in the context of decision-making about BR after TER STEGE ET AL. | 233 mastectomy since both knowledge and decisional preparedness are low among patients deciding about BR. [15][16][17] Moreover, another study found that less than half (43%) of the participants made a high-quality decision regarding BR, defined as having knowledge of important BR facts and undergoing treatment in accordance with one's personal preferences. 18 Furthermore, previous studies found that a substantial number of women (37% up to 47%) experienced some level of decisional regret after undergoing BR. [19][20][21] With a median time period between diagnosis and surgery of 5 weeks, patients often have limited time to decide about immediate BR. 22 Previous studies have highlighted the importance of high-quality, realistic preoperative information and decisional support to enable patients to make a longterm satisfying decision about BR. 19,20,[23][24][25][26][27][28] Patient decision aids (pDAs) may be beneficial for patients who are facing the decision regarding BR. PDAs are tools that, as adjuncts to counselling, aim to support shared decision-making. PDAs explicitly state the decision, consist of evidence-based information about the options and their pros and cons and clarify patients' personal values. 29 Across a variety of health-related decisions, pDAs have been found to reduce decisional conflict, increase knowledge and increase insight into personal values related to the decision. 30,31 Worldwide, a limited number of pDAs are available for patients considering BR. 32,33 Whilst studies showed promising results regarding their effectiveness, 32,33 no evidence-based pDA is available for patients considering BR in the Netherlands.
Therefore, the aim of this study was to develop an online pDA that could support patients in making an informed decision about BR after mastectomy together with their plastic surgeon. As part of the development of this pDA, we aimed to assess the information needs of both patients and healthcare professionals (HCPs) and to test the acceptability and usability of the pDA.

| METHODS
The development was guided by International Patients Decision Aids Standards (IPDAS) criteria for developing a high-quality pDA. 34 The development was performed in partnership with ZorgKeuzeLab, a Dutch company specialized in the development and implementation of pDAs. The development consisted of four stages, briefly described in the protocol of the trial to evaluate the pDA 35    porting Information Appendix S1 for the complete interview script).
Interviews were audio-recorded, transcribed verbatim and coded by two independent researchers (J. A. t. S. and D. R.) using thematic analysis. 36 Consensus about the coding scheme was reached in two consecutive meetings. Data were stored and coded in NVivo 10 (QSR International Pty Ltd.).   38 The online infrastructure was built as an extension of an existing platform of pDAs (https://zorgkeuzelab.nl/keuzehulpen).

| Stage 4: Acceptability and usability testing
The acceptability and usability of the developed pDA was assessed in patients who previously considered undergoing BR after mastectomy, HCPs involved in decision-making about BR and representatives of the Dutch Breast Cancer Patient Organization (Borstkankervereniging Nederland). In patients, we used a 'think-aloud approach', in which they were invited to literally think aloud whilst using the pDA. 39 This is a common method for testing ICT tools including pDAs, [40][41][42] and enables to get an impression of how patients perceive of and use the pDA. Each session finished with a short interview to evaluate the pDA (see Supporting Information Appendix S2 for the script). A total of eight patients who participated in the needs assessment and agreed to be contacted for acceptability and usability testing were invited. This procedure was per-

| Needs assessment
Seventeen patients (85%) and 33 HCPs (83%) participated in the needs assessment. Background characteristics of both groups are provided in Table 1.

| Patients
Thematic analysis yielded three themes reflecting patients' most important experiences with, and information needs regarding, their BR decision (see Table 2 for illustrating quotes).

Challenging period to make a decision
Patients with BC experienced the trajectory as a rollercoaster in which they were overwhelmed by emotions after a sudden diagnosis of BC.
They had difficulties processing the large amount of information that they received. Some patients felt sick due to neoadjuvant systemic therapy and did not feel like themselves at the time of making their decision.
Other patients highlighted the short period of time between diagnosis and surgery in which they had to make a decision, and the importance of TER STEGE ET AL. | 235 taking adequate time to make a decision. Although many patients perceived having the option of BR as something positive, their highest priority at that time was to be cured from cancer, and aesthetics were less important. In contrast, women who considered undergoing BR after prophylactic mastectomy were not suddenly confronted with a diagnosis, did not feel sick and felt that they had sufficient time to become informed about BR and to make a decision. They stressed the importance of planning surgery at the right moment in their lives and of taking time to optimally prepare for surgery.

Diverse motivations for a personal decision
Patients emphasized the importance of identifying their personal values to make a decision about BR. Although most patients had an immediate preference for or against undergoing BR, some patients had difficulties in making a decision. Patients' reasons for their BR decision were diverse (see Table 3 for an overview of the reasons). The reasons for undergoing immediate BR included the desire to improve body image and appearance, and the reasons against undergoing immediate BR included having no interest in undergoing BR and the desire for faster recovery and avoiding increased risk for complications. The reasons for deciding on undergoing implant-based BR included having no option for autologous BR and the desire for a shorter duration of surgery and faster recovery, and the reasons for autologous BR included the desire for more natural outcomes and avoiding the use of foreign materials. Although it was important to feel supported by their partner and relatives in making their decision, most patients emphasized that the decision had been made by themselves.    Table 5 for a detailed description of each module 35 Table 6. Participants were positive about the look and feel of the pDA.

| Acceptability and usability testing
Information was perceived as well structured and understandable. T A B L E 4 Results of needs assessment in healthcare professionals (N = 33)

A. Current information about breast reconstruction and satisfaction with information
Main resource for information about breast reconstruction for patients a While most participants appreciated the amount of information, some participants felt that it was too much. HCPs considered the pDA valuable for their patients, to prepare for consultation and to increase patient empowerment. Some HCPs expected that the pDA could also be helpful for themselves in supporting patients in decision-making.
The most important changes made to the pDA are listed below (a detailed overview of changes is provided in Supporting Information Appendix S5): • Text was shortened where possible; • Information about immediate BR and its pros and cons was adjusted to more accurately reflect the situation in which a tissueexpander is used (e.g. 'You wake up with a reconstructed breast' was changed to 'You will not wake up flat'); • The burden of recovery from autologous BR was emphasized, and information about recovery from surgery was expanded to include anticipated restrictions in daily life. Based on the patient's treatment options selected on the consultation sheet by their oncological breast surgeon during the clinical encounter, patients tailor the pDA to their situation (i.e., whether or not the patient is eligible for nipple-sparing surgery, whether or not radiotherapy is or might be necessary following surgery and whether or not the patient is eligible for breast-conserving surgery). Based on these treatment options, specific information is shown or rephrased.

Considerations
With value clarification exercises, patients are actively encouraged to weigh the options of immediate breast reconstruction versus no immediate breast reconstruction. Furthermore, patients are invited to indicate their preference for or against immediate breast reconstruction and for the type of breast reconstruction. There is space to note questions for the plastic surgeon.

Patient Stories
Six short stories of patients who previously underwent mastectomy with or without breast reconstruction. The stories illustrate the experiences of these patients with decision-making and the impact of their decision on their daily lives.

Summary
A summary sheet (A4 format) including the patient's personal considerations, preferences and questions for the plastic surgeon. The sheet can be saved as PDF and printed. Patients are encouraged to discuss the summary sheet with their plastic surgeon.
a Information is rephrased dependent on whether or not the patient is eligible for nipple-sparing surgery.
b Section briefly describes reconstruction options after breast-conserving surgery. Only shown if the patient is eligible for breast-conserving surgery.
c Only shown if adjuvant radiotherapy is indicated.
T A B L E 6 Background characteristics of participants in acceptability and usability testing (N = 20) Only a limited number of studies investigated the attitudes and preferences regarding shared decision-making in BR from the perspective of HCPs. 26,27,52 The positive attitudes of HCPs towards active patient involvement and usage of the pDA were comparable to the findings of these studies. 26,27,52 In developing a pDA, it is challenging to determine the appropriate amount of information. In our needs assessment, patients reported that they felt overwhelmed by the amount of information that they had to process at the time of decision-making about BR.
Therefore, we wanted to provide patients with sufficient information, without (further) overwhelming them. Individuals have different preferences in terms of the amount of information they wish to obtain when faced with a cancer-related health threat, as some patients prefer higher levels of details than others. 53 This emphasizes the importance of the possibility for patients to tailor the amount of information in tools like a pDA. 53 In our pDA, patients were free to select the information they wanted to read and skip parts they did not want to read. Furthermore, we felt that we reached an appro- The strength of this study was the rigorous development process, which included all relevant stakeholders from the beginning. It resulted in a pDA that incorporated information needs of both patients and HCPs and complied with international criteria for a highquality pDA. According to an independent group of researchers, 81% of all IPDAS criteria were fulfilled in our pDA. 54 To investigate the pDA's impact on the decision-making process and the decision quality, a multicentre randomized-controlled trial is currently underway comparing use of the pDA to usual care including a widely available information leaflet. 35,55