Article Text

Original research
Clarifying misbeliefs about hydroxychloroquine (HCQ): developing the HCQ benefits versus harm decision aid (HCQ-SAFE) per low health literacy standards
  1. Shivani Garg1,
  2. Sancia Ferguson1,
  3. Betty Chewning2,
  4. Shelby Gomez2,
  5. Jon Keevil3 and
  6. Christie Bartels1
  1. 1Department of Medicine, Division of Rheumatology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA
  2. 2Department of Pharmacy, School of Pharmacy, Madison, Wisconsin, USA
  3. 3Madison, Wisconsin, USA
  1. Correspondence to Dr Shivani Garg; sgarg{at}


Background Up to 83% of patients with SLE stop taking hydroxychloroquine (HCQ) within the first year due to knowledge gaps regarding the survival benefits of HCQ versus inflated fears of rare toxicity. Thus, there is a need for a shared decision-making tool that highlights HCQ’s significant benefits versus rare harms to improve patients’ understanding and align treatments with their values. The objective of this study was to describe development and piloting of a decision aid (HCQ-SAFE) to facilitate HCQ adherence, and safe, effective use by engaging patients in therapeutic decision-making.

Methods HCQ-SAFE was developed via a collaborative process involving patients, clinicians, implementation scientists and health literacy experts. The initial prototype was informed by Agency for Healthcare Research and Quality (AHRQ) low literacy principles and key themes about HCQ use from six prior patient and clinician focus groups, with iterative expert and stakeholder feedback to deliver a final prototype. We implemented HCQ-SAFE in four clinics to examine usability and feasibility on Likert scales (0–7) and net promoter score (0%–100%).

Results The final HCQ-SAFE shared decision-making laminated tool organises data using pictograms showing how HCQ use reduces risk of organ damage, early death and blood clots versus low risk of eye toxicity.

HCQ-SAFE was reviewed in all eligible patient visits (n=40) across four clinics on an average of ~8 min, including 25% non-English-speaking patients. All patients scored 100% on the knowledge post-test; no decisional conflicts were noted after using HCQ-SAFE. HCQ-SAFE garnered high clinician and patient satisfaction with 100% likelihood to recommend to peers.

Conclusions HCQ-SAFE is a stakeholder-informed feasible shared decision-making tool that enhances communication and can potentially improve knowledge, clarify misbeliefs and engage patients in treatment decisions, including those with limited English proficiency.

  • patient care team
  • outcome assessment, health care
  • lupus erythematosus, systemic
  • qualitative research
  • therapeutics

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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What is already known on this topic

  • Decision aids, designed using low health literacy guidelines, can increase patient’s participation in decision-making and improve adherence and outcomes, even in populations that are risk averse or less engaged in care; however, no benefits versus harm decision aids are available for hydroxychloroquine (HCQ)—the pivotal therapy in lupus.

What this study adds

  • This study delivers a stakeholder-informed feasible decision aid for HCQ (HCQ-SAFE) using a collaborative process.

  • Our decision aid (HCQ-SAFE) facilitated shared decision-making by supporting a conversation on significant benefits versus harms with HCQ use in lupus to align treatment decisions with patients’ values and preferences.

How this study might affect research, practice or policy

  • Use of HCQ-SAFE in clinics could foster more patient-centred care and enhance shared decision-making for all patients with lupus, including those with limited proficiency in English, and target the alarmingly high HCQ non-adherence.

  • Future studies will aim to test the effectiveness of HCQ-SAFE in improving adherence and resolving decisional conflicts need to be tested in larger cohorts, particularly in populations with low health literacy, and across diverse clinical settings.


Hydroxychloroquine (HCQ) is the cornerstone of SLE or lupus treatment and is recommended in all patients without contraindications. HCQ use is associated with lower rates of lupus flare, less accrued organ damage, lower rates of cardiovascular disease and thrombotic events and prolonged survival in patients with SLE.1–5 However, >50% of patients self-discontinue HCQ by 9 months, and 33% do not refill HCQ after an index prescription.6 7 High non-adherence results in 30% higher lupus hospitalisations (OR 1.30, 95% CI 1.18 to 1.44), 36% higher risk of kidney failure (OR 1.36, 95% CI 1.12 to 1.64), while HCQ use is associated with 54% reduction in mortality (OR 0.46, 95% CI 0.38 to 0.57).5 8–11

In our prior qualitative studies and those of others, patients reported inflated fears of rare eye toxicity and a lack of understanding regarding HCQ’s role in lupus as the top two reasons for prematurely stopping HCQ.12–17 Patients elaborated that due to hurried provider discussions during SLE visits,16 18 they received incomplete information about HCQ’s role in SLE and often resorted to the internet for medication information.14 16 19 20 Reviewing such non-validated resources often amplified their pre-existing fears of side effects and rare toxicity which led to premature self-discontinuation of HCQ.13–16 Moreover, >80% of patients in our stakeholder study reported that they ‘did not know that HCQ could improve survival and protect organs in lupus’, and they ‘might have continued HCQ if they were told about the benefits’.16

Treatment of lupus is complex, especially for young patients who are committed to take lifelong HCQ, which carries some harm, although low (<1% in 10 years), of eye toxicity. Many patients find this decision difficult, necessitating clear patient-clinician communication for shared decision-making.21 22 Moreover, patients with lower education, limited health literacy or proficiency in English have higher risk aversion and may be less engaged in their care contributing to poor outcomes and disparities.23 Decision aids, designed using low health literacy guidelines, can increase patient’s participation in decision-making and improve adherence and outcomes, even in populations that are risk averse or less engaged in care.22 24–28 However, no such decision aids are available for HCQ—the pivotal therapy in lupus.

Thus, we aimed to develop a benefit versus harm shared decision-making tool for HCQ to engage patients in therapy decisions and facilitate adherence and safe, effective use of HCQ. Our tool development process was based on prior successful efforts in designing decision aid tools for patients with diabetes, rheumatoid arthritis and osteoporosis, which have been shown to enhance knowledge and patient involvement in treatment decisions.22 24 25 The objectives of this study were to: (a) develop a decision aid, HCQ-SAFE, which highlights benefits versus harms with HCQ using Agency for Healthcare Research and Quality (AHRQ) low health literacy guidelines for tool development to convey key patient-reported and clinician-reported themes on HCQ use from our prior qualitative study;16 (b) field test HCQ-SAFE to deliver the final version for pilot testing; (c) pilot the implementation of HCQ-SAFE across four clinics during 40 consecutive visits to examine feasibility and usability of HCQ-SAFE during lupus visits.

Materials and methods

Team and settings

To collaboratively design the HCQ-SAFE decision aid, we convened a diverse group of individuals with expertise in lupus (9 clinicians and 11 patients), decision aid and patient education materials research (JK, BC), design (SGa, JK, SF, CB), health literacy (SF, BC) and implementation science (CB, BC). Consolidated Criteria for Reporting Qualitative Research was used to design this study.29

Decision aid (HCQ-SAFE) development process

The initial prototype of our HCQ-SAFE was informed by (figure 1): (a) the design of the prior decision aid tools for rheumatoid arthritis, diabetes, osteoporosis;22 24–28 (b) key themes regarding HCQ use from our six prior patient-advisory and clinician-advisory board meetings (eg, information gaps, misinformation and assumption, barriers, emotions, etc)16 and (c) AHRQ low health literacy tool development guidelines (eg, using plain language, using larger font and icons, eighth grade reading level). Additionally, we gathered evidence from published research studies and reviews on the impact of HCQ across four risk domains, organ damage, death, blood clot, eye toxicity in lupus.1 4 5 30–35 Data from published and validated resources were compiled in pictograms to show declines in organ damage, death and blood clot risk with HCQ use over time in lupus versus low risk of harms.

Figure 1

A collaborative and iterative process to develop HCQ-SAFE, a benefits versus harm decision aid. *SLE, health literacy, dissemination and implementation (D&I) experts. AHRQ, Agency for Healthcare Research and Quality; HCQ, hydroxychloroquine; Mtgs, meetings.

Input was garnered through three steps: (1) a team of experts including design, health literacy, lupus, implementation science and decision aid research, and four patient advocates participated in the initial tool development and their feedback on design, content, readability, colour scheme, layout, wording were incorporated to inform subsequent prototypes; (2) 11 patients did a focus group review and 9 healthcare advisors completed an online survey; (3) 40 patients pilot tested the final version during routine visits.

Field testing

Once a prototype was approved by the expert team, that version was field tested by lupus experts, clinicians and patients (n=20, 11 patients and 9 clinicians). Briefly, patients selected to participate in the focus group were recruited for our prior study.16 In that study, we purposefully recruited for representative patients from two racially and socioeconomically diverse Wisconsin cities: Madison and Milwaukee. We recruited a broadly representative group of 11 patients from different age groups. We sought to include at least one male member, at least 50% of members with severe lupus defined as ≥1 vital organ involvement, and at least 30% with low health literacy or social challenges. All 11 patients were invited and agreed to participate in the focus group meeting for this study. The patient group reviewed the decision aid during a 90 min online focus group meeting followed by in-depth 1:1 interviews with each patient advisor by a non-Principal investigator (PI) team member (SGo) to obtain feedback. During the 1:1 interview, an a priori list of eight questions was used to obtain feedback regarding content, ease of understanding harm versus benefits with HCQ use, likelihood to use or recommend and other comments. Next, healthcare advisors from two diverse academic centres (University of Wisconsin-Madison and Medical College of Wisconsin) reviewed HCQ-SAFE via an online survey. After reviewing the decision aid, they completed an online survey that included an a priori list of questions regarding content, ease of understanding and likelihood to use or recommend. We analysed surveys completed by the healthcare advisors and transcripts from 1:1 interviews with patient advisors to revise the decision aid. The revised version was then circulated with our expert panel and field testing panel for review, edits and endorsement. Using an iterative editing process, the final version of HCQ-SAFE was developed which was endorsed by all stakeholders. The research team met with designers to develop a laminated tool for pilot testing.

Pilot test to establish feasibility and usability

The final version of HCQ-SAFE, endorsed by all stakeholders, was implemented across three university hospital-based clinics (lupus, lupus nephritis and rheumatology) and one community-based rheumatology clinic. Data from 40 unique consecutive lupus visits assessed feasibility and usability. During clinic visits, clinicians (pharmacists, pharmacy students or doctors) reviewed the decision aid tool with patients with lupus who had no contraindication to HCQ use. At the end of the visit, patients completed a three-item self-knowledge test to gauge basic understanding of benefits versus low harm of HCQ in lupus (online supplemental file 1) and a Likert scale (0–7, extremely unlikely through extremely likely) to report their likelihood to recommend HCQ-SAFE to peers. Additionally, patients completed a four-item decisional conflict scale (SURE, scores 0–3=residual conflicts, 4=no conflicts) to assess any residual decisional conflicts after using HCQ-SAFE.36 Residual decisional conflicts are defined as patient’s uncertainty about which course of action to take when choice among competing options involves risk, harm or challenge to personal values even after reviewing medical information with healthcare team.36 No patient identifiers were collected. Only group-level data, such as patient’s preferred language, gender, whether lupus was involving ≥1 vital organs (yes/no), were collected on the form. Likewise, at the end of the clinic visit, clinicians completed a four-item paper survey including one-item question to report usefulness of HCQ-SAFE (yes or no), one-item Likert scale (0–7, extremely unlikely through extremely likely) to report their likelihood to recommend to peers and reported the time spent to review the tool and their role in the clinic (MD, pharmacist or pharmacy student). In this paper survey, there was an optional section for clinicians to add free-text comments regarding the tool, workflow, barriers or facilitators and clinical experience. Using survey results, we examined usability and feasibility of using HCQ-SAFE during visits.

Supplemental material

Usability/Impact of the tool

Usability/Impact of the tool was measured by calculating patient-reported knowledge/understanding of benefits versus harm of HCQ in SLE after using HCQ-SAFE. Each item in the self-knowledge test was scored as 1 for correct answer and 0 for incorrect answer with a maximum score of 3. An average score of correct responses per patient visit was calculated. Next, using the standard scoring for residual decisional conflict, we reported residual decisional conflict (defined as a postscore of ≤3; 4=no conflict). Finally, we calculated the average Likert score and a net promoter score (NPS) for patients and clinicians to measure users’ likelihood to recommend HCQ-SAFE to peers. To assess NPS, ‘extremely or very likely’ were included as promoters and ‘extremely or very unlikely’ as detractors; NPS=%promoters–%detractors (≥80%=high likelihood to recommend to peers).


Feasibility was determined by measuring percentage of eligible visits using HCQ-SAFE, per cent completed by a non-MD (eg, pharmacist, pharmacy student) and average time spent to review HCQ-SAFE during visits.


HCQ-SAFE decision aid development process

Content. The content was derived from evidence-based reviews and informed by the key themes identified during our prior qualitative study. In that study, we identified eight themes regarding HCQ use with ‘incomplete information’, ‘long-term concerns with HCQ use’ and ‘unclear role of HCQ in lupus’ as the top three themes. Additionally, striking quotes such as, “I was unaware that HCQ improves survival and prevents blood clots in lupus” helped the research team identify four key risk domains for the decision aid: (1) organ damage; (2) death; (3) blood clot; (4) eye toxicity and other side effects/concerns. We then performed an extensive review of the literature and guidelines to identify landmark studies that examined the declines in the risk categories of interest in HCQ users versus non-users.1 4 5 30–35 Using published data and event rates, we developed parallel pictograms highlighting the differential risk of organ damage in lupus with or without HCQ use over time (27 out of 100 in HCQ users vs 73 out of 100 in HCQ non-users, figure 2). Additionally, the risk of eye toxicity with HCQ use was included in the pictogram so that patients could understand the significant benefits of HCQ use in lupus versus the rare eye toxicity harm (1 out of 100 in <10 years of HCQ use, figure 2).

Figure 2

HCQ-SAFE decision aid pictogram of SLE organ damage risk and how the risk reduces with hydroxychloroquine (HCQ) use.

Similarly, we created pictograms to show declines in early deaths (17/100 vs 5/100 in HCQ non-users vs users; figure 3), and blood clots with HCQ use over time (30/100 vs 5/100 in HCQ non-users vs users; figure 4). A separate pictogram highlighting the low risk of eye toxicity with HCQ use for two time periods was developed: 2 cases out of 100 at >10 years and 20 cases out of 100 after >20 years of use (figure 5). Finally, data on other concerns for stopping HCQ such as pregnancy, liver or kidney disease, cost, interactions were also summarised in an interactive table format in the initial prototyped decision aid (figure 5).

Figure 3

HCQ-SAFE decision aid pictogram of early deaths in SLE and how the risk reduces with hydroxychloroquine (HCQ) use.

Figure 4

HCQ-SAFE decision aid pictogram of the risk of blood clots in SLE and how the risk reduces with hydroxychloroquine (HCQ) use.

Figure 5

HCQ-SAFE decision aid pictogram of the risk of eye toxicity with hydroxychloroquine (HCQ) use over 10 and 20 years of use, and considerations to enhance adherence and address barriers. GI, gastrointestinal.

Readability and design. The team decided a priori to use an interactive and easy to use format developed by colleagues at the Mayo Clinic and Dr Keevil.24 26–28 The colour scheme was suggested by our design and decision aid experts. Additionally, we followed low literacy principles from AHRQ such as using more illustrations, using simple language, using natural frequencies (eg, 1 out 100) instead of percentages and font size ≥14 points to guide our tool design use. A team of health literacy experts and implementation scientists reviewed the tool to ensure that low health literacy principles were followed in this prototype.

Format and wording. Our initial prototype was a paper tool which consisted of six pages for six domains of interests: death, organ damage, blood clots, eye toxicity, side effects and special considerations with HCQ use. In the next prototype, we combined several additional risks (eye toxicity, side effects and special considerations) into one page to reduce redundancy and maintain focus on the most important issues. Following low literacy principles, we used gender-neutral illustrations and icons, simplified text to eighth grade reading level, large font size and added colours to generate contrast for better understanding.

Field testing

The characteristics of patients and healthcare advisors participating in decision aid development are reported in table 1. Patient focus group members (n=11) were 55% of black race, 27% had low health literacy (table 1). Among healthcare advisors, 78% were women, 33% of black race and Hispanic ethnicity and 78% had >5 years of experience in lupus (table 1). Key themes, subcategories and illustrative quotes from the analysis of surveys and interviews completed for field testing are shown in table 2.

Table 1

Patient and healthcare advisors’ characteristics (n=20)

Table 2

Themes highlighting patients and healthcare advisors’ suggestions regarding HCQ-SAFE

Overall, healthcare advisors (n=9) reported high likelihood to use the decision aid during clinic visits and reported that the content was easy to understand. Additionally, they agreed with the domains of interests in our decision aid, and did not suggest including other domains. Two physicians were concerned regarding the use of numbers instead of percentages as they reported that interpreting numbers could prolong the length of the visit. They recommended that discussions using the HCQ decision aid could be tailored to sections based on individual patient’s concerns to save time. All healthcare advisors (n=9) unanimously agreed that using a laminated version of the paper tool would be most feasible in different clinics, while most (80%) also supported the use of an online web-based version. All healthcare advisors liked the colour scheme and content of the decision aid.

All 11 patient advisors reported an extremely high likelihood to use the decision aid and recommend the tool to peers. They reported that the decision aid tool was easy to understand and the language was simple and clear. One patient advisor suggested adding a definition for organ and adding details on eye testing. All patient advisors commented that the use of numbers, text and figures added to the clarity and comprehensibility of the tool. They recommended that the sequence of risk domains be changed and that organ damage be listed as the first risk domain instead of early death. Additionally, they liked the colour scheme with contrasting colours highlighting the benefits of HCQ. Specifically, patients unanimously agreed that the ‘avoid damage’ category highlighted in a different colour, helped them appreciate the impact of HCQ in protecting organs, preventing early deaths and blood clots. Nine patient advisors preferred using a paper format and recommended that the decision aid tool be reviewed with their healthcare team during their clinic visits. A majority of patient advisors reported that after reviewing HCQ-SAFE they had a better understanding of the benefits of HCQ in lupus in reducing blood clots, protecting organs and preventing deaths, which motivated them to continue HCQ (n=9; 81%).

Final prototype and workflow

Several changes were made to the final prototype in response to the feedback from patient and healthcare advisors, for example, a definition was added for organ, the sequence of risk domains was changed to organ damage, death, blood clot and side effects. The final prototype was then shared with our experts and patient and healthcare advisors for endorsement and approval. All stakeholders approved the final prototype and agreed to use a laminated version of the paper tool for the pilot (figures 2–5). Additionally, patient and healthcare advisors gave feedback to inform workflow for implementation in clinics. The final workflow (figure 6) for clinical implementation had six steps including clinicians reviewing the significant declines in organ damage, death, blood clots with HCQ use compared with rare increase in eye toxicity. Clinicians could choose to spend more or less time on certain domains based on individual patient concerns. At the end of the visit, patients and clinicians completed a postintervention paper survey. All six steps were needed to complete the intervention, although tailoring allowed spending more or less time on given domains.

Figure 6

Workflow showing the implementation of HCQ-SAFE during SLE visits in our pilot. HCQ, hydroxychloroquine.

Pilot testing

The tool was piloted with 40 patients across 4 clinics (3 university-based rheumatology or lupus clinics and 1 community-based rheumatology clinic; table 3). Key patient characteristics included: 75% of patients below age 50 years, 85% were women, 50% were of non-white race or Hispanic ethnicity and 25% had low proficiency in English (table 3).

Table 3

Pilot testing of HCQ decision aid (HCQ-SAFE), n=40

Usability/Impact of the tool

After reviewing HCQ-SAFE, all patients scored 100% (the number of correct answers/the total number of questions) on the self-knowledge test about the benefits versus harms of HCQ in SLE (average score=3; maximum score=3, n=40/40). Patients reported no residual decisional conflicts (average score 4 for 100% visits; 4=no decisional conflict; 3 or below=residual decision conflict) after reviewing HCQ-SAFE. Finally, patients and clinicians reported a high average Likert score of 6.7 and 6.9 (maximum score 7), and the NPS was 100% for both clinicians and patients (table 3).


We noted that the intervention was completed during all 40 consecutive visits (100% completion rate) with 40% discussions led by a physician and 60% of the discussions led by a pharmacist or a pharmacy student during the clinic visits. Finally, we calculated an average of 7.6 min were spent to complete the intervention (all six steps) during clinic visits. During 36% of visits the tool was reviewed in ≤5 min. We noted that reviewing the tool during visits with patients with limited proficiency in English took additional time (8.5 min using an interpreter).

Additional clinician comments

Three clinicians suggested that using an online web-based version of HCQ-SAFE could be easier. Additionally, clinicians suggested translating HCQ-SAFE in different languages could reduce time commitment and increase patients’ understanding further. Moreover, giving a paper copy in preferred language to the patients after visits could be beneficial to review the decision aid at home. For busier clinical settings with limited resources and those clinics without pharmacy support, clinicians recommended to consider training other staff members, such as nurses, to review HCQ-SAFE with patients. Finally, in paper survey completed at the end of the clinic visit by clinicians reviewing HCQ-SAFE, clinicians documented patient scenario examples (n=10 out of 40) in the comment section to highlight how reviewing HCQ-SAFE during visits had helped clarify misbeliefs and improve patients’ understanding to resume HCQ after stopping for a non-specific reasons (such as blurry vision) validating our approach.


We created HCQ-SAFE, a feasible shared decision-making tool using a collaborative process with patient and clinician input at every step and incorporated health literacy and implementation science expertise. HCQ-SAFE received high patient and clinician satisfaction scores, 100% NPS and required <8 min to review during clinic visits. HCQ-SAFE could potentially improve knowledge and engage patients in treatment decisions. Moreover, the ‘simple graphics (patient 8)’ of HCQ-SAFE enhanced physician-patient discussions and provided visual cues to patients to understand benefits versus low harm of HCQ and motivate them to continue HCQ.

People with high or residual decisional conflicts are more likely to delay treatment decisions or change their mind and stop taking a treatment.37 Shared decision-making using decision aids could help such patients by increasing their knowledge, reducing worry and ensuring that the treatment aligns with their preferences and values.22 Therefore, we specifically examined residual decisional conflict scores in our pilot study. No residual decisional conflicts were reported by patients after reviewing HCQ-SAFE. Moreover, in our pilot, clinicians reported that several conflicts or patient concerns that led to prior discontinuation of HCQ were addressed after systematically reviewing the significant benefits of HCQ in lupus versus rare harms using the decision aid. These findings support future testing of HCQ-SAFE for effective shared decision-making and changes in adherence in a large-scale trial.

Decision aids, such as HCQ-SAFE, informed by low literacy and patient engagement principles are needed to facilitate shared decision-making with populations who are less engaged in their care and have higher risk aversion due to barriers in communication like literacy and language. In our pilot, we noted that all patients, including patients with limited proficiency in English (25%), scored highly on the postpilot self-knowledge test (average score=3, maximum score=3). Moreover, these patients reported no residual decisional conflicts after reviewing HCQ-SAFE. HCQ-SAFE could improve the quality of the decision making by increasing patient’s knowledge, clarifying misbeliefs and resolving decision conflicts even in patients with limited proficiency in English. However, we did not have a pretest score to quantify change in scores after reviewing the decision aid and examine the impact of HCQ-SAFE on decision conflicts, which needs to be examined in a future study.

Clinician satisfaction and high feasibility are needed to ensure adoption and sustainable use for future implementation efforts. The results of our pilot across four clinics demonstrated promise for future use and dissemination. We noted that the decision aid was used in 100% of consecutive eligible unique patient visits showing a high uptake in diverse clinical settings (academic vs subspecialty vs community-based rheumatology clinics) and by different clinicians (physicians vs pharmacist vs pharmacy students). Both clinicians and patients reported high satisfaction and a high likelihood to recommend the tool to peers (NPS=100%). Finally, clinicians during the postpilot survey reported that an average of 7.6 min spent to review HCQ-SAFE during visits was acceptable. However, they also recommended to test other effective strategies such as training nurses and using HCQ-SAFE in patient’s preferred language during visits to reduce physician’s time commitment and ensure better uptake in busy clinics. We will be testing the effectiveness of these strategies in a future dissemination and implementation study.

The main strength of the present work is that it was an interactive process integrating the needs of different stakeholders in lupus care (including nurses, rheumatologists, pharmacists and patients) at every step to inform tool and workflow development. Using patient-stakeholder and healthcare-stakeholder informed themes and low literacy guidelines improves comprehensibility and aligns with the needs of the individuals who will be using this tool during clinic visits. However, we do acknowledge limitations. First, our tool is currently only available in English language and in a paper format. Using a translated version of tool could improve shared decision-making in the populations with language barriers. Second, developing an interactive web-based electronic version could increase uptake, especially for telehealth and help regularly update the tool with new information. Third, only pharmacist, pharmacy students and physicians used the tool in our pilot test. Physicians could have time constrains in busy practices and most clinics are still not supported by a pharmacist. Thus, testing other effective ways to review HCQ-SAFE in clinics is needed, and we will examine these in our future studies. Fourth, HCQ-SAFE was tested across four clinics of a single large health facility and no pretest results were available to compare change or improvement in patient’s knowledge and decisional conflict scores after reviewing HCQ-SAFE. Thus, the effectiveness of HCQ-SAFE in improving adherence and resolving decisional conflicts need to be tested in larger cohorts and across diverse clinical settings. Moreover, in our study, only three patients had low health literacy during field testing and only 25% of patients who participated in the pilot had limited proficiency in English. Additionally, in-depth cognitive interviews to gauge understanding were not done in this study. Thus, larger prospective studies are required to test the effectiveness of this tool in improving knowledge and clarifying misbeliefs in such populations using in-depth cognitive interviews. Finally, in our prior stakeholder study,16 patients had reported a lack of understanding regarding long-term role of HCQ in lupus and inflated fears of rare eye toxicity as the top two reasons for prematurely stopping HCQ. Thus, our team of experts including patient advocates selected four long-term risk domains including organ damage, death, blood clot, eye toxicity. However, we agree with the reviewer that preventing flares with HCQ use is an important risk domain as well. Thus, we drafted an initial version of this risk domain (online supplemental file 2).38 In our forthcoming longitudinal study, we will work with designers and advisors to modify a final version of this additional flare risk domain. Additionally, in that longitudinal study, we will discuss how to add this additional risk domain during clinic discussions and balance time commitment and the amount of information provided to the patients.

Supplemental material

To summarise, we developed a stakeholder-informed feasible benefits versus harm decision aid for HCQ (HCQ-SAFE) using a collaborative process and evidence-informed design. Our decision aid facilitated shared decision-making by supporting a conversation on benefits versus harms with HCQ use in lupus to align treatment decisions with patients’ values and preferences. Use of HCQ-SAFE in clinics could foster more patient-centred care and enhance shared decision-making for patients with lupus and target the alarmingly high HCQ non-adherence.

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

Ethics statements

Patient consent for publication

Ethics approval

Given the study focused on process, quality improvement and tool development, the study received an exemption from the Institutional Review Board of the University of Wisconsin, Madison (IRB# 2020-0979 and quality improvement project exemption). Participants gave informed consent to participate in the study before taking part.


Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.


  • Contributors All authors (SGa, SGo, SF, CB, BC, JK) critically reviewed the study proposal. SGa, SGo, SF, BC, JK and CB were involved in collecting or supervising data collection, and analysing data. All authors participated in review of analysed data and summarising findings. All authors reviewed and approved the final version of the manuscript. SGa is responsible for the overall content as the guarantor.

  • Funding This research was supported by a pilot award from the University of Wisconsin-Madison, Institute for Clinical and Translational Research (UW ICTR) and from a KL-2 grant sponsored by the University of Wisconsin-Madison, Institute for Clinical and Translational Research (UW ICTR). Additional support was provided by the National Institutes of Health-National Center for Advancing Translational Sciences through a Clinical and Translational Science Award (1UL1TR002373 and MSN267532) to UW ICTR.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the ‘Materials and methods’ section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.