We performed a mixed methods user-centered development and evaluation study informed by principles of integrated knowledge translation. Integrated knowledge translation is an approach to collaborative research in which researchers and knowledge users work together to identify a problem, conduct research as equal partners to address that problem, and coproduce research products that aim to impact health service delivery [17]. We selected this approach to increase the likelihood that our end PtDAs would be relevant, useable, and used for patients and health care professionals in Canada [17]. The need for a PtDA was identified through engagement with health care professionals. In 2017, they highlighted the need for patients to be supported in choosing between procedural care—which historically represented more than 90% of abortions in Canada [18]—and the newly available medication option [19,20]. This need was reaffirmed in 2022 by the Canadian federal health agency, Health Canada, which circulated a request for proposals to generate “evidence-based, culturally-relevant information aimed at supporting people in their reproductive decision-making and in accessing abortion services as needed” [21].

We operationalized integrated knowledge translation principles in a user-centered design process. User-centered design “grounds the characteristics of an innovation in information about the individuals who use that innovation, with a goal of maximizing ‘usability in context’” [22]. In PtDA development, user-centered design involves iteratively understanding users, developing and refining a prototype, and observing user interaction with the prototype [23,24]. Like integrated knowledge translation, this approach is predicated on the assumption that involving users throughout the process increases the relevance of the PtDA and the likelihood of successful implementation [24].

Our design process included the following steps (Figure 1): identification of evidence about abortion patients’ decisional needs and the attributes of medication and procedural abortion that matter most from a patient perspective; development of a paper-based prototype; usability testing via think-aloud interviews with potential end users; refinement of the PtDA prototype into an interactive website; usability testing via a survey with potential end users and abortion health care professionals; and final revisions before launching the PtDA for real-world testing. Our systematic process was informed by user-centered methods for PtDA development [23,24], guidance from the IPDAS collaboration [25-27], and the Standards for Universal Reporting of Patient Decision Aid Evaluation checklist [10].

Our multidisciplinary team included experts in shared decision-making (SM and LT), a PhD student in patient-oriented knowledge translation (KJW), experts in integrated knowledge translation with health care professionals and policy makers (WVN and SM), clinical experts in abortion counseling and care (WVN and MB), a medical undergraduate student (RS), a research project coordinator (AW), and family medicine residents (KD-L, CMB, NC, and JS) who had an interest in abortion care. Additionally, a panel of experts external to the development process reviewed the PtDA for clinical accuracy following each revision of the prototype. These experts included coauthors of the national Society for Obstetricians and Gynaecologists of Canada (SOGC) clinical practice guidelines for abortion care in Canada. They were invited to this project because of their knowledge of first-trimester abortion care as well as their ability to support the implementation of the PtDA in guidelines and routine clinical practice.

The research was approved by the University of British Columbia Children’s and Women’s Research Ethics Board (H16-01006) and the Nova Scotia Health Research Ethics Board (1027637). In each round of testing, participants received a CAD $20 (US $14.75) Amazon gift card by email for their participation.

We identified the decisional needs of people seeking early abortion care using a 2018 systematic review of reasons for choosing an abortion method [28], an additional search that identified 1 study conducted in Canada following the 2017 availability of mifepristone/misoprostol medication abortion [29], and the SOGC clinical practice guidelines [2,3]. The review identified several key factors that matter most for patient choice of early abortion method: perceived simplicity and “naturalness,” fear of complication or bleeding, fear of anesthesia or surgery, timing of the procedure, and chance of sedation. The additional Canadian study found that the time required to complete the abortion and side effects were important factors. According to the SOGC clinical practice guidelines, the key information that should be communicated to the patient are gestational age limits and the risk of complications with increasing gestational age [2,3]. The guidelines also indicate that wait times, travel times, and cost considerations may be important in a person’s choice of abortion method and should be addressed [2,3].

We compiled a long list of attributes for our expert panel and then consolidated and refined the attribute list through each stage of the prototype evaluation. For evidence of how these factors differed for medication and procedural abortion, we drew primarily from the SOGC clinical practice guidelines for abortion [2,3]. For cost considerations, we described the range of federal, provincial, and population-specific programs that provide free coverage of abortion care for people in Canada.

Our goal was to produce an interactive, web-based PtDA that would be widely accessible to people seeking an abortion in Canada by leveraging the widespread use of digital health information, especially among reproductive-aged people [30]. Our first prototype was based on a previously identified paper-based question-and-answer comparison grid that presented evidence-based information about the medication and procedural options [9,31]. We calculated readability by inputting the plain text of the paper-based prototype into a Simple Measure of Gobbledygook (SMOG) Index calculator [32].

We made 2 intentional deviations from common practices in PtDA development [33]. First, we did not include an “opt-out” or “do nothing” option, which would describe the natural course of pregnancy. We chose to exclude this option to ensure clarity for users regarding the decision point; specifically, our decision point of interest was the method of abortion, not the choice to terminate or continue a pregnancy. Second, we characterized attributes of the options as key points rather than positive and negative features to avoid imposing value judgments onto subjective features (eg, having the abortion take place at home may be beneficial for some people but may be a deterrent for others).

We first conducted usability testing involving think-aloud interviews with patient participants to assess the paper-based prototype. Inclusion criteria included people aged 18-49 years assigned-female-at-birth who resided in Canada and could speak and read English. In January 2020, we recruited participants for the first round of think-aloud interviews [34] via email and poster advertising circulated to (1) a network of parent research advisors who were convened to guide a broader program of research about pregnancy and childbirth in British Columbia, Canada, and (2) a clinic providing surgical abortion care in Nova Scotia, Canada, as well as snowball sampling with participants. We purposively sought to advertise this study with these populations to ensure variation in age, ethnicity, level of education, parity, and abortion experience. Interested individuals reviewed this study information form and provided consent to participate, before scheduling an interview. The interviewer asked participants to think aloud as they navigated the prototype, for example describing what they liked or disliked, missing information, or lack of clarity. The interviewer noted the participant’s feedback on a copy of the prototype during the interview. Finally, the participant responded to questions adapted from the System Usability Scale [35], a measure designed to collect subjective ratings of a product’s usability, and completed a brief demographic questionnaire. The interviews were conducted via videoconferencing and were audio recorded. We deidentified the qualitative data and assigned each participant a unique identifier. Then, the interviewer listened to the recording and revised their field notes with additional information including relevant quotes.

For the analysis of think-aloud interviews, we used inductive content analysis to describe the usability and acceptability of different elements of the PtDA [36]. Further, 3 family medicine residents (KD-L, CMB, and NC) under guidance from a senior coauthor (SM) completed open coding to develop a list of initial categories, which we grouped under higher-order headings. We then organized these results in a table to illustrate usability issues (categories), illustrative participant quotes, and modifications to make. We then used the results of interviews to adapt the prototype into a web-based format, which we tested via further think-aloud interviews and a survey with people capable of becoming pregnant and health care professionals involved with abortion care.

For the web-based format, we used DecideApp PtDA open-source software, which provides a sustainable solution to the problems of low quality and high maintenance costs faced by web-based PtDAs by allowing developers to host, maintain, and update their tools at no cost. This software has been user-tested and can be accessed by phone, tablet, or computer [37,38]. It organizes a PtDA into 6 sections: Introduction, About Me, My Values, My Choice, Review, and Next Steps. In the My Values section, an interactive values clarification exercise allows users to rank and make trade-offs between attributes of the options. The final pages provide an opportunity for users to make a choice, complete a knowledge self-assessment, and consider the next steps to access their chosen method.

From July to August 2020, we recruited patient and health care professional participants using Twitter and the email list of the Canadian Abortion Providers Support platform, respectively. Participants received an email with a link to the PtDA and were redirected to the survey once they had navigated through the PtDA. As above, inclusion criteria included people aged 18-49 years assigned as female-at-birth who resided in Canada. Among health care professionals, we included eligible prescribers who may not have previously engaged in abortion care (family physicians, residents, nurse practitioners, and midwives), and allied health professionals and stakeholders who provide or support abortion care, who practiced in Canada. All participants had to speak and read English.

The survey included 3 sections: usability, implementation, and participant characteristics. The usability section consisted of the System Usability Scale [35], and purpose-built questions about what participants liked and disliked about the PtDA. The implementation section included open- and close-ended questions about how the PtDA compares to other resources and when it could be implemented in the care pathway. Patient participants also completed the Control Preference Scale, a validated measure used to determine their preferred role in decision-making (active, collaborative, or passive) [39]. Data on participant characteristics included gender, abortion experience (patient participants), and abortion practice (health care professional participants). We deidentified the qualitative data and assigned each participant a unique identifier. For the analysis of survey data, we characterized close-ended responses using descriptive statistics, and, following the analysis procedures described in Step 2 in the Methods section, used inductive content analysis of open-ended responses to generate categories associated with usability and implementation [36]. In 2021, we made minor revisions to the website based on the results of usability testing and published the PtDA for use in routine clinical care.

In the following sections, we outline the results of the development process including the results of the think-aloud interviews and survey, as well as the final decision aid prototype.

Our initial prototype, a paper-based question-and-answer comparison grid, presented evidence-based information comparing medication and procedural abortion. The first version of the prototype also included a second medication abortion regimen involving off-label use of methotrexate, however, we removed this option following a review by the clinical expert panel who advised us that there is very infrequent use of this regimen in Canada in comparison to the gold standard medication abortion option, mifepristone. Other changes at this stage involved clarifying the scope of practice (health care professionals other than gynecologists can perform a procedural abortion), abortion practice (gestational age limit and how the medication is taken), the abortion experience (what to expect in terms of bleeding), and risk (removing information about second- and third-trimester abortion). The updated prototype was finalized by a scientist (SM) and trainee (KJW) with expertise in PtDA development. The prototype (see Multimedia Appendix 1) was ultimately 4 pages long and described 18 attributes of each option framed as Frequently Asked Questions, including abortion eligibility (How far along in pregnancy can I be?), duration (How long does it take?), and side effects (How much will I bleed?). The SMOG grade level was 8.4.

We designed a web-based, interactive PtDA for the choice of method of abortion in early pregnancy [42], taking a user-centered approach that involved usability testing with 36 patients and 25 health care professionals. Both patient and health care professional participants indicated that the PtDA had good usability and would be a valuable resource for decision-making. This PtDA fills a critical need to support the autonomy of patients and shared decision-making with their health care professional related to the preference-sensitive choice of method of abortion.

A 2017 systematic review and environmental scan found that existing PtDAs for the method of abortion are of suboptimal quality [9]. Of the 50 PtDAs identified, all but one were created without expertise in decision aid design (eg, abortion services, reproductive health organizations, and consumer health information organizations); however, the development process for this UK-based pamphlet-style PtDA was not reported. The remaining PtDAs were noninteractive websites, smartphone apps, and PDFs that were not tested with users. The authors found that the information about methods of abortion was presented in a disorganized, inconsistent, and unequal way. Subsequent work has found that existing PtDAs emphasize medical (versus social, emotional, and practical) attributes, do not include values clarification, and can be biased to persuade users of a certain method [13].

To address some of the challenges identified in the literature, we systematically structured and designed elements of the PtDA following newly proposed IPDAS criteria (eg, showing positive and negative features with equal detail) [33]. We included an explicit values-clarification exercise, which a recent meta-analysis found to decrease decisional conflict and values-incongruent choices [43].

We based the decision aid on comprehensive and up-to-date scientific evidence related to the effectiveness and safety of medication abortion and procedural abortion; however, less evidence was available for nonmedical attributes. For example, many existing PtDAs incorrectly frame privacy as a “factual advantage” of medication abortion [13]. To address this, we included privacy in the About Me section as something that means “different things to different people.” Similarly, evidence suggests that patients who do not feel appropriately informed about the pain associated with their method of abortion are less satisfied with their choice [44,45]; and the degree of pain experienced varies across options and among individuals. Following the suggestion of patient participants to include stories and recognizing that evidence for the inclusion of narratives in PtDAs is emerging [46], we elected to develop brief first-person qualitative descriptions of the pain experience. The inclusion of narratives in PtDAs may be effective in supporting patients to avoid surprise and regret, to minimize affective forecasting errors, and to “visualize” their health condition or treatment experience [46]. Guided by the narrative immersion model, our goal was to provide a “real-world preview” of the pain experience [47].

In addition to integrating user perspectives on the optimal tone, content, and format of the PtDA, user testing provided evidence to inform the future implementation of the PtDA. A clear barrier to the completion of the PtDA during the clinical encounter from the health care professional perspective was its length, supporting the finding of a recent rapid realist review, which theorized that health care professionals are less likely to use long or otherwise complex PtDAs that are difficult to integrate into routine practice [48]. However, 46 out of 50 (92%) participants endorsed the use of the PtDA by the patient alone before the initial consultation, which was aligned with the patient participant’s preference to take an active role in making the final decision about their method of abortion as well as the best practice of early, pre-encounter distribution of PtDAs [48].

A unique feature of this PtDA was that it resulted from a broader program of integrated knowledge translation designed to support access to medication abortion once mifepristone became available in Canada in 2017. Guided by the principle that including knowledge users in research yields results that are more relevant and useful [49], we developed the PtDA in response to a knowledge user need, involved health care professional users as partners in our research process, including as coauthors, and integrated feedback from the expert panel. This parallels a theory of PtDA implementation that proposes that early involvement of health care professionals in PtDA development “creates a sense of ownership, increases buy-in, helps to legitimize content, and ensures the PtDA (content and delivery) is consistent with current practice” thereby increasing the likelihood of PtDA integration into routine clinical settings [48].

Viewed through an integrated knowledge translation lens, our findings point toward future areas of work to support access to abortion in Canada. Several patient participants indicated a need for tools to identify health care professionals who offer abortion care. Some shared that their primary health care professionals did not offer medication abortion despite it being within their scope of practice, and instead referred them to an abortion clinic for methods of counseling and care. We addressed this challenge in the PtDA by including links to available resources, such as confidential phone lines that link patients to health care professionals in their region. On the website we also indicated that patient users could ask their primary care providers whether they provide abortion care; however, we acknowledge that this may place the patient in a vulnerable position if their health care professional is uncomfortable with, or unable to, provide this service for any reason. Future work should investigate opportunities to shorten the pathway to this time-sensitive care, including how to support patients who use the decision aid to act on their informed preference for the method of abortion. This work may involve developing a tool for patients to talk to their primary care provider about prescribing medication abortion.

Several factors affect the interpretation of our work. Although potential patient users participated in the iterative development process, the patient perspective was not represented in a formal advisory panel in the same way that the health care professional experts were. Participant characteristics collected for the think-aloud interviews demonstrated that our patient sample did not include people with lower education attainment, for whom the grade level and length of the PtDA could present a barrier [50]. Any transfer of the PtDA to jurisdictions outside Canada must consider how legal, regulatory, and other contextual factors affect the choice of the method of abortion. Since this study was completed, we have explored additional strategies to address these concerns, including additional user testing with people from equity-deserving groups, drop-down menus to adjust the level of detail, further plain language editing, and videos illustrating core content. Since the focus of this study was usability, we did not assess PtDA effectiveness, including impact on knowledge, decisional conflict, choice predisposition and decision, or concordance; however, a randomized controlled trial currently underway will measure the impact of the PtDA on these outcomes in a clinical setting. Finally, our integrated knowledge translation approach added to the robustness of our study by ensuring that health care professionals and patients were equal partners in the research process. One impact of this partnered approach is that our team has received funding support from Health Canada to implement the website on a national scale for people across Canada considering their abortion options [51].

The PtDA provides people choosing a method of early abortion and their health care professionals with a resource to understand methods of abortion available in the Canadian context and support to make a values-aligned choice. We designed the PtDA using a systematic approach that included both patient and health care professional participants to help ensure its relevance and usability. Our future work will seek to evaluate the implementation of the PtDA in clinical settings, create alternate formats to enhance accessibility, and develop a sustainable update policy. We will also continue to advance access to abortion care in Canada with our broader integrated knowledge translation program of research.