Cohort 1 included seven Indigenous women living with RA aged 37–61 years, and cohort 2 included nine Indigenous women with RA aged 28–69 years. None of the participants were in the process of changing their RA therapy during the study period, their disease duration ranged from 4 months to 30 years, and they had been exposed to either disease-modifying antirheumatic drugs (DMARDs) only (n = 4), DMARDs and biologics (n = 4), or no RA medication (n = 1). Participants self-identified as First Nations, Plains Cree, or Indigenous.
Cohort 1 Input Informing Initial Modifications
Cohort 1 suggested the following modifications to the existing Early RA PtDA: (1) clarify medication names and routes of administration, (2) include Indigenous traditional healing practice options, (3) provide information on formulary coverage for Indigenous patients, (4) simplify text, and (5) include Indigenous images and use colors aligned with Canadian Indigenous community representation. The participants also suggested (6) incorporating evidence from Indigenous population or patient studies about medications and their effects and (7) providing translation of key words into Indigenous languages . Based on these recommendations, TLF and VU modified the original decision aid, although the suggestions to include Indigenous-specific data in the decision aid could not be applied, due to lack of availability of this evidence, and it was decided that translation into Indigenous languages would occur prior to dissemination to specific communities. Table 1 summarizes the initial edits made.
Cohort 2 Verifications and Additional Modifications
The second cohort of participants affirmed alignment with the changes made to the original decision aid and suggested further adaptations to be made, outlined in Table 2, which we substantiate with the participants’ quotations in the following subsections.
Layout, Legibility, and Clarity
Participants acknowledged that the formatting of the decision aid and the flow of information was “clear and pretty thorough” (cohort 2, participant [P] 9). The pictures and different sections of the decision aid advanced its clarity and enabled understanding. As stated by a participant, “Like, even picture-wise, it helps one to understand it and whatnot. And with – you know, like, different pinpoints that are right here … it really helps. Like, it really breaks it down” (cohort 2, P4). Another mentioned, “The sections explain what the title is about, and I found it very organized” (cohort 2, P6). Participants noted that the language and wording used in the decision aid were simplified and concise, making the tool easy to read: “It's user-friendly … it kind of breaks it down into layman's terms, because it's, like – you're not giving too much, like, higher medical terminology that's really hard to understand for the regular person, so it's – yeah, I think – and it's pretty neutral. I think it's okay” (cohort 2, P2).
Nonetheless, as much as they found the decision aid to be organized and clear, most participants indicated that the text used in the tool was not very legible. A participant stated, “[E]verything's good. It's just the words that are tiny” (P4) and another noted, “It's pretty clear if I really, you know, focus on it” (cohort 2, P9). Thus, a participant suggested, “Maybe a little bigger [text]” (cohort 2, P3), and another suggested bolding or unbolding some text to increase legibility of text. For example, a participant stated, “I'm just wondering, like, if the side effects have to be bolded, or should we bold, like, the medication itself?” (cohort 2, P2).
Traditional Care and Healing Practices
Participants appreciated including Indigenous traditional healing practices as adjuncts to treatment in the decision aid, as one participant stated, “Well, I like how you put in you can talk to an elder and engage in traditional ceremonies. That's nice … I really like that. You never see anything that puts traditional therapy or talk to an elder” (cohort 2, P3). Additional changes were suggested, particularly including holistic care components tailored to the population. A participant indicated, “[I]n Blackfoot, because that's where I'm from, there's a difference. So if I'm going to go get doctored, I would go to a healer … An elder would be somebody who would, you know, not necessarily have those rights … it would have made more, like, an impact if it, you know, talk with a traditional healer or knowledge keeper” (cohort 2, P8).
Formulary Coverage for Non-status First Nations Patients
Participants affirmed the value of including the information regarding Non-Insured Health Benefits (NIHB) in the decision aid. As stated, “I really like how you put ‘All drugs are covered by Non-Insured Health Benefits.’ That's really good … that's good that that's in there” (cohort 2, P2). However, a participant raised a concern on providing clarity on coverage of medications for non-status Indigenous patients, noting, ‘So when it says "Non-Insured Health Benefits," what does that mean?… Okay, what if you're still First Nations and don't have that?... Because I'm First Nations and don't have status’ (cohort 2, P3). Based on this feedback, additional information regarding formulary coverage for non-status First Nations patients was added.
Indigenous Imagery and Colors
Participants generally appreciated the eagle feather image that was included in the DMARDs section of the modified decision aid. Nonetheless, they mentioned the need to include more images that Indigenous patients using the tool will relate to. A participant stated, “So maybe put, like…, some medicine wheels on there, or, like – you've got a feather on there already. Anything that relates to, like, healing and positivity and – you know, something happy that First Nations could relate to so that it's, like – a healing type of an image or thing” (cohort 2, P2). Another suggested, “A watermark that's Indigenous … A watermark would be nice … I would put either the medicine wheel … or a feather … a smudge bowl … with sweetgrass” (cohort 2, P8). Participants acknowledged the value of using colors aligned with Canadian Indigenous community representation in the decision aid. Although there was a general impression that the decision aid was colorful, two participants expressed the need to include more Indigenous-specific colors. A participant stated, “The color is nice, but I think if you try and use our four colors, because when you look at – our colors are universal, right? So, when I see a document, I don't even look at the words, but I see the colors, I automatically focus on it … Yeah. And so that'll say to me, my mind, okay, this has something to do with my people … White, yellow, black, and red” (cohort 2, P8).
Lifestyle and RA Care
Participants commented on information related to lifestyle factors that influence arthritis care and management. Two participants were interested in viewing more information on diet and the use of alcohol in arthritis. One participant stated, ‘But I would like, to know, how – the use of drugs and alcohol … What's that word? Predisposes you even more to it, right? … So, some kind of side wording, like, "The use of drugs and alcohol will…”’ (cohort 2, P8). The same participant went on to state that, “[B]ecause now that I'm older and I'm now paying attention to my health and to my diet, that's the biggest thing for me, is to connect my diet with the inflammation” (cohort 2, P8). Another participant suggested, “[A]dd more to … the lifestyle” (cohort 2, P4).
Potential Use of the Indigenous Adaptation of the Early RA PtDA
Participants viewed the decision aid as a talking guide that would drive discussions with their doctor and advance communication and relationship building with health practitioners. Three participants indicated, “[B]ecause it's information” (cohort 2, P7), “[I]f I were to read it, there's still bound to be question so…” (cohort 2, P4), and “I'd rather, you know, a [physician] tell me....walk through it with me” (cohort 2, P9). The decision aid was generally viewed as an informative tool that could be displayed at the doctor’s office and referred to before, during, and after clinic appointments. As stated, “It looks like it belongs in a doctor's office. Like, in the waiting room, or when you're in the – if you're in their actual office where they have other stuff hanging up. They always have some health stuff hanging up … or in a magazine or something” (cohort 2, P3). In addition, participants conveyed being empowered and validated by hearing and including the voices of First Nations' people in developing health decision tools. For example, in the words of a participant, “It's about time we get a say in what's going on with our First Nations” (cohort 2, P5). Another expressed “Relief, … because I'm informed, because this reinforces my knowledge thus far, I have more confidence” (cohort 2, P8).
Finalization of the Adaptation of a PtDA for RA Treatment for Use with Indigenous Patients
Following data review, the research team made final revisions to address the additional recommendations and other changes that were not operationalized in the initial modification. This was presented to the First Nations person with lived experience of RA engaged in the study for final review and approval. The final version of the Indigenous Adaptation of the Early RA PtDA is presented in Fig. 1.