Abstract
Objective
Although women with rheumatic and musculoskeletal diseases (RMDs) are at an elevated risk for adverse pregnancy and perinatal outcomes, some report that they lack access to resources that support informed reproductive decision‐making. We developed MyVoice:Rheum, a web‐based decision aid to support women with RMDs in reproductive decision‐making. We conducted a pilot trial to assess feasibility and acceptability of MyVoice:Rheum and to assess its preliminary effectiveness compared to a freely available online pamphlet about reproductive and RMDs.
Methods
Using a parallel‐arm randomized pilot trial design, we assigned women aged 18 to 44 years with RMDs in a 3:1 ratio to receive either MyVoice:Rheum or the control pamphlet immediately before a rheumatology clinical encounter. Quantitative and qualitative measures of feasibility, acceptability, and usability were assessed among MyVoice:Rheum users. We evaluated the preliminary effectiveness of MyVoice:Rheum in prompting family planning discussions as compared to pamphlet users, as well as its effects on users’ reproductive knowledge and/or communication self‐efficacy with rheumatologists.
Results
We enrolled MyVoice:Rheum users (n = 31) and controls (n = 9) in the pilot study. MyVoice:Rheum users scored the tool as feasible, acceptable, and easy to use. Approximately 61% of MyVoice:Rheum users and 44% of controls had family planning discussions with their rheumatologists. MyVoice:Rheum users demonstrated increases in self‐efficacy and knowledge scores after the intervention.
Conclusion
In pilot testing, MyVoice:Rheum was feasible, acceptable, and usable to women with RMDs. Preliminary findings suggest that MyVoice:Rheum may increase family planning discussions in the rheumatology context and augment patients’ reproductive knowledge and self‐efficacy; these findings should be confirmed in a future full‐scale study.
INTRODUCTION
One of the most important decisions that a pregnancy‐capable person with a rheumatic and musculoskeletal disease (RMD) can make is if and when they want to conceive a pregnancy. 1 Women with RMDs can experience safe and healthy pregnancies; overall, however, they have an elevated risk of adverse reproductive outcomes, including maternal and fetal death, severe maternal morbidity, preterm birth, and inadvertent fetal exposure to teratogenic disease‐modifying antirheumatic drugs (DMARDs). 1 , 2 To optimize decision‐making around pregnancy timing and other aspects of sexual and reproductive health (SRH), individuals with RMDs ideally have knowledge about how their disease might interact with their reproductive health; understand the full range of their options; are armed with decisional power, self‐efficacy, and autonomy; and are able to access the health services that are needed to actualize their preferences. 3
Critical gaps in knowledge, educational resources, and inadequate provision of family planning counseling by clinicians, however, may prevent some people with RMDs from making informed decisions around pregnancy or contribute to high‐risk behaviors that may undermine healthy outcomes. 3 , 4 For example, some women with RMDs indicate key gaps in knowledge that might increase their risk for pregnancies that are undesired and/or ill‐timed, particularly around the safety and efficacy of contraception and the potential teratogenicity of DMARDs that they are prescribed. 5 , 6 In addition, some women with RMDs feel that their information priorities are not addressed in the rheumatology context. 7 , 8 Misalignment between patients’ information needs and the provision of family planning care by rheumatologists may also undermine informed decision‐making; for example, in one study, women with diverse RMDs preferred for their rheumatologist to initiate family planning care, but separate studies have found that rheumatologists generally prefer for patients to initiate family planning discussions. 7 , 9
Decision aids (DAs) may help to support family planning care in the rheumatology context. DAs are more interactive than traditional tools, such as pamphlets, and may stimulate cognitive processes that help people to better contextualize information and make higher‐quality decisions. DAs are a direct source of information for patients, which may independently enhance their health knowledge, self‐efficacy, and decision‐making capacity. 10 , 11 Many DAs also support shared decision‐making between patients and providers, resulting in treatment plans that people may be more likely to follow and are more aligned with their preferences. 10 , 11 , 12
Our team developed MyVoice:Rheum, which is, to our knowledge, the first reproductive decision aid for women with diverse RMDs to provide evidence‐based information about genetics and heritability of RMDs, contraception options and safety and efficacy, fertility, pregnancy planning and management, medication safety during pregnancy and lactation, and parenting—information priorities identified by patients in our foundational work. 4 , 5 , 7 , 8 The current article describes our development process and results of a pilot trial to evaluate its feasibility and acceptability.
METHODS
Overview
MyVoice:Rheum is a web‐based, patient‐facing decision aid with content that is generally applicable to patients with diverse RMDs and has additional disease‐specific content about systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myositis, vasculitis, Sjögren disease, or spondyloarthritis (Supplementary Materials). Content reflected information priorities identified in our published qualitative and quantitative studies involving nearly 300 reproductive‐age female patients. 4 , 7 , 8 Evidence‐based information was abstracted from the American College of Rheumatology (ACR) Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases (co‐authored, in part, by several members of our team). 13 Our development process was informed by human‐centered design principles that promote equity and patient‐centeredness in digital health development. 14 MyVoice:Rheum content is presented at a seventh grade reading level, congruent with suggested best practices for online educational materials. 15 , 16
Development process
The MyVoice:Rheum developers are members of the FemTech Collaborative at the University of Pittsburgh. 14 FemTech investigators have developed and are in various stages of testing reproductive health digital tools that support a variety of reproductive decisions across diverse health conditions and patient populations. 17 , 18 , 19 MyVoice:Rheum developers have expertise in reproductive rheumatology, women's health and obstetrics and gynecology, pharmacology and medication decision‐making, pediatric chronic medical conditions, and user‐centered design.
In alignment with other decision support tools created by the FemTech Collaborative, the developmental framework for MyVoice:Rheum was informed by Self‐Determination Theory, which, when used in health care contexts, suggests that patients whose needs are met in three key domains—“autonomy” (volition, choice), “competence” (knowledge and self‐efficacy), and “relatedness” (feeling respected by and having self‐efficacy, or confidence, to communicate with health care providers)—may adopt behaviors that support better health outcomes. 20 MyVoice:Rheum was developed to support competence through knowledge generation based on guidelines‐concordant information content. 13
We adhered to the International Patient Decision Aid Standards, an evidence‐based framework for the development of DAs, as follows: (1) including a scoping and design process that elicited patient needs and preferences, (2) developing a prototype (eg, wireframes), (3) peer review with stakeholders (eg, beta testing and cognitive interviews with patient partners and/or end‐users), and (4) field testing in real‐world settings to assess whether the DA is acceptable and understandable. 21
During MyVoice:Rheum development and testing, women with systemic lupus erythematosus (n = 2) and undifferentiated connective tissue disease (n = 1) were engaged as patient partners, meeting individually and collectively to advise the study team on content, features, and design elements of page wireframes. Once the wireframes were incorporated into a digital prototype, additional patients with rheumatoid arthritis (n = 5), psoriatic arthritis or spondyloarthritis (n = 4), and Sjögren disease (n = 1) participated in one‐on‐one cognitive interviews with the study team, “thinking aloud” as they provided real‐time feedback about content, usability, and technical errors while navigating the tool. In response to their feedback, we enhanced readability and navigability throughout MyVoice:Rheum, and deleted a planned information module for family members or partners, as patients strongly preferred a tool that supported their autonomy to make their own reproductive decisions.
User experience
MyVoice:Rheum users are first directed to an introductory page, which indicates that the tool is not a replacement for physicians’ recommendations. Next, users are directed to select their RMD(s) from a menu and complete a brief series of interactive questions that indicate their current conceptualizations around pregnancy. The tool generates a list of suggested information modules based on these initial responses, although the user may choose to navigate any module (Supplementary Materials). Deliberation cues encourage users to reflect on their thoughts and questions, which they are encouraged to record on a digital notepad. Interactive reflection exercises are autonomy‐supportive and encourage patients to make reproductive decisions that are concordant with their values and preferences. However, users are not required to finalize a pregnancy or reproductive decision; rather, the objective is to shape women's cognitive and affective processes so they consider their RMDs and DMARDs along with other priorities when making reproductive decisions and engage their rheumatologists in shared decision‐making around family planning.
To build relatedness with rheumatologists, users are prompted to share a summary sheet that details any questions they generated while navigating the tool, summarizes the content they perused, and provides sample questions to stimulate family planning conversations during the rheumatology visit. This summary sheet can be printed or emailed to the user.
Pilot study design
We conducted a pilot trial with a parallel‐arm randomized controlled study design to evaluate the feasibility and acceptability of MyVoice:Rheum among reproductive‐age women with RMDs 22 and to inform study procedures for a future full‐scale hybrid implementation‐effectiveness trial. We included a control arm, a paper‐based copy of a publicly available online webpage from the ACR about reproductive health, to prepare processes for the future trial and to provide all study participants with guidelines‐concordant information about SRH. Because our developmental framework was informed by Self‐Determination Theory, we assessed MyVoice:Rheum's preliminary effectiveness in prompting family planning discussions between users and their rheumatologists (relatedness) compared to pamphlet users. We also assessed the preliminary effects of MyVoice:Rheum on patients’ reproductive knowledge and their self‐efficacy to communicate their priorities and preferences (competence).
Inclusion criteria included (1) female sex at birth, (2) aged 18 to 44 years, (3) ability to read and speak English, and (4) receipt of rheumatology care from one of three outpatient clinics affiliated with a large hospital system in western Pennsylvania. In the context of the COVID‐19 pandemic, when onsite recruitment for clinical research studies was suspended, we chose to limit recruitment to individuals diagnosed with systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myositis, Sjögren disease, or overlap syndromes of these diseases (eg, mixed connective tissue disease); our institution features patient registries for these RMDs, composed of patients who have consented to being contacted about new studies, which we felt would support our recruitment efforts. Potentially eligible participants with an upcoming in‐person or virtual rheumatology clinic visit within 12 weeks were also identified via (1) the University of Pittsburgh's Pitt Plus Me online community research registry and (2) a review of patient lists associated with the three participating rheumatology clinics.
We randomly assigned MyVoice:Rheum users with a 3:1 allocation ratio of MyVoice:Rheum to controls to obtain more user feedback about our newly developed decision aid. 23 Individuals were contacted via phone, email, or text and appraised of the study; if interested in participating, they provided informed consent. Participants were compensated $40 for completing the study visit, an additional $20 for completing a qualitative interview three months after the intervention (MyVoice:Rheum arm only), and $10 for parking (in‐clinic participants) or data usage or minutes (telemedicine participants).
Study procedures
Participants were randomly assigned to the intervention or control groups using a sealed envelope approach 24 ; research coordinator OMS created the randomization list, assigned the envelopes, and had access to the final allocation list. All participants were contacted 48 hours before their next in‐person or telemedicine rheumatology appointment to confirm if they planned to engage in study activities in person or remotely. The study procedures are detailed in the Supplementary Materials. Briefly, participants were asked to present one hour before their in‐person appointment or remotely via phone or an interactive online platform (Zoom Video Communications) on the day before their telemedicine visit. During this study session, participants completed surveys and scales, answered demographic questions, and navigated through the MyVoice:Rheum decision aid or the control pamphlet. Research staff members remained on the telephone or online platform with each participant who completed the study procedures remotely; at in‐person study visits, research staff were accessible in the clinic to answer questions or provide support. MyVoice:Rheum and pamphlet users were given up to 25 minutes to navigate through the tool, as the tool was designed to be part of the clinical encounter and usable within a time frame in which a person might be expected to wait to be seen by their clinician.
MyVoice:Rheum participants were encouraged to share their summary sheets with their rheumatologists but were not required to do so. Participants were also informed that they were not required to discuss family planning during their visits. Within 24 hours of the rheumatology visit, all participants completed another series of measures and engaged with research staff in a 15‐minute debriefing interview. To adhere with COVID‐19 precautions that limited research activities in the clinic, these interviews were conducted via telephone at a location of each participant's choosing. MyVoice:Rheum participants participated in another brief qualitative telephone interview three months after the intervention.
Our pilot study did not include a provider‐facing intervention. However, one month before the commencement of the study, we apprised rheumatologists at the three clinics via email about the study and the possibility that some MyVoice:Rheum users might bring a summary sheet to their appointments. Rheumatologists were advised that the summary sheet should be treated as any other educational resource that a patient might bring to their appointment. Rheumatologists were also not required to discuss family planning at the visit, as we wished to provide patients and clinicians the flexibility to discuss other priorities during the visit. Finally, rheumatologists were provided with an online link to the freely available ACR Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. 13
The REDCap web application was used for data collection (UL1‐TR‐001857). The University of Pittsburgh Institutional Review Board approved this study (STUDY20060240).
Measures
Quantitative
We collected baseline information about participants’ demographic and personal characteristics. Questions about contraception use, reproductive histories, and health care utilization were adapted from the National Survey of Growth. 25 The Desire to Avoid Pregnancy scale was used to assess patients’ preferences around a future pregnancy. 26
Feasibility, usability, and acceptability of MyVoice:Rheum were assessed using qualitative and quantitative measures. The validated Intervention Appropriateness Measure (IAM) and Acceptability of Intervention Measure (AIM) consist of Likert scales 27 ranging from 1 to 5, for which higher scores indicate more positive responses. No cutoffs of acceptability are available for the AIM and IAM. However, when averaged, the scores tend to skew positively with a limited range, which may obscure scores that might be deemed lower than acceptable. 28 Thus, in addition to calculating means and standard deviations for AIM and IAM scores, we assigned an a priori feasibility threshold of ≥3.5 of 5 for both measures, the same threshold used for another decision aid developed in the FemTech Collaborative. 17 Usability was assessed via summary scores from the System Usability Scale (SUS), 27 , 29 which consists of a 10‐item Likert scale with scores ranging from 0 to 100; we set a threshold of scores >80.3 as “A” or excellent and 68 to 80.3 as “B” or very good, consistent with standard rating for the SUS. To assess users’ perceived value of MyVoice:Rheum, we developed a four‐item Likert scale with responses ranging from 1 to 5 (1: strongly disagree; 5: strongly agree). Scales and scoring systems are provided in the Supplementary Materials.
Our pilot study was designed to inform a future full‐scale trial by providing preliminary data (eg, means, SDs) in the control arm for purposes of sample size calculation. Pilot studies are not designed to test hypotheses 30 , 31 ; because we were not powered to assess differences between the intervention and control group or within‐group differences, our analyses are primarily descriptive. However, we preliminarily assessed the effectiveness of MyVoice:Rheum in prompting family planning discussions by documenting the incidence in which these discussions occurred across the study arms. 32 We also evaluated self‐efficacy and knowledge scores within each arm before and after the intervention. Self‐reported efficacy in communicating with providers was assessed using a modified version of the validated five‐item Perceived Efficacy in Patient‐Provider Interactions (PEPPI) scale. 33 Rheumatology‐specific reproductive health knowledge was assessed via ReproKnow, a measure developed and preliminarily validated by our team that covers domains of contraception safety and efficacy, pregnancy management, preconception planning, medication safety, fertility; a priori, a two‐part question on breastfeeding was not included because previous validation testing indicated that a large percentage of patients did not complete both parts of the question. Therefore, in this nine‐item version of ReproKnow, an adjusted score of nine indicated the highest level of reproductive knowledge. 6 Among MyVoice:Rheum users only, reproductive knowledge was assessed again three months after the intervention.
Qualitative
We used a deductive qualitative approach, which uses predefined concepts from previous research or theory to facilitate a focused exploration of the data. 34 Drawing from quality metrics proposed by the Ottawa Decision Support Framework as well as findings from studies involving other FemTech Collaborative DAs, we organized our semistructured interview guide and codebook by the following domains of interest: tool/pamphlet feasibility and acceptability, family planning discussed at rheumatology visit (yes or no), barriers and facilitators to discussing family planning at the rheumatology visit, ideal time points and contexts to use the tool and pamphlet, and suggested modifications to the tool and pamphlet. 5 , 17 , 18 , 19 , 35 , 36 All participants engaged in interviews after the rheumatology encounter; MyVoice:Rheum users were also interviewed three months after the intervention. Interviews were audio‐recorded and transcribed verbatim, with redaction of participant and physician identifiers. OMS, a research coordinator with experience in qualitative research, conducted all of the interviews.
Analysis
Quantitative
Quantitative measures of demographics, feasibility, and acceptability were assessed via descriptive statistics. Comparisons between the number of family planning visits between MyVoice:Rheum users and controls were assessed using Fischer's exact text for categorical measures. Among MyVoice:Rheum users and controls, we conducted paired comparisons before and after intervention for self‐efficacy and reproductive health knowledge measures, using McNemar's test for proportions and the Wilcoxon signed rank test for means. Calculations were performed using Stata 17.0.
Qualitative
Qualitative interview transcripts were entered into NVivo software, and reviewed by LEP, an experienced qualitative analyst and sociologist. LEP developed a preliminary codebook, which was reviewed by the principal investigator (MBT) for clarity and completeness. LEP and GL, a trained research assistant, independently coded the transcripts. 37 Coders initially used a deductive approach to coding, but also noted any new themes that emerged from the data. Coders discussed similarities and differences in coding, reconciled differences as needed with MBT, created new codes, and applied the final codebook to the transcripts. We report on findings most relevant to tool and pamphlet evaluation and feedback.
RESULTS
Sample characteristics
Fifty‐five patients initially consented to participate in the study, of whom 10 were lost to follow up. Forty‐five patients were randomized to a study arm. Five patients did not present to their clinic appointments. Forty patients completed the study, among whom 31 patients were randomized to the MyVoice:Rheum intervention and 9 were randomized to the control arm. Figure 1 includes additional details about participation. Participant characteristics are presented in Table 1. The most common RMD diagnoses were systemic lupus erythematosus, rheumatoid arthritis, and myositis. Most participants identified as heterosexual, and nearly half of all participants were married. More than half of participants had at least a college degree. More than 40% of participants identified their rheumatologist as their main health provider. Most participants had never been pregnant, and approximately 10% had a diagnosis of infertility. More than two‐thirds of participants used a method of contraception.
Figure 1.
Recruitment and retention.
Table 1.
Demographic and personal characteristics*
| Intervention (N = 31) | Control (N = 9) | |
|---|---|---|
| Age, mean (SD), yr | 33.7 (7.2) | 29.7 (5.5) |
| Race, N (%) | ||
| Black | 3 (9.7) | 1 (11.1) |
| Asian | 0 (0.0) | 1 (11.1) |
| White | 27 (87.1) | 7 (77.8) |
| Other | 1 (3.2) | 0 (0.0) |
| Ethnicity, N (%) | ||
| Hispanic or Latino | 3 (9.7) | 0 (0.0) |
| Sexual orientation, N (%) | ||
| Heterosexual or straight | 27 (87.1) | 7 (77.8) |
| Homosexual, gay, or lesbian | 1 (3.2) | 0 (0.0) |
| Bisexual | 2 (6.5) | 0 (0.0) |
| Asexual | 1 (3.2) | 0 (0.0) |
| Other | 0 (0.0) | 2 (22.2) |
| Education, N (%) | ||
| Some high school, high school degree, or GED | 1 (3.2) | 1 (11.1) |
| Some college or associate's degree | 7 (22.6) | 2 (22.2) |
| College degree | 8 (25.8) | 5 (55.6) |
| Professional or graduate degree | 15 (48.4) | 1 (11.1) |
| Relationship status, N (%) | ||
| Single | 11 (35.5) | 3 (33.3) |
| Married | 15 (48.4) | 4 (44.4) |
| Living with a partner | 4 (12.9) | 2 (22.2) |
| No response | 1 (3.2) | 0 (0.0) |
| Rheumatic disease diagnosis, N (%) a | ||
| Rheumatoid arthritis | 7 (22.6) | 2 (22.2) |
| Scleroderma/systemic sclerosis | 4 (12.9) | 1 11.1) |
| Systemic lupus erythematosus | 7 (22.6) | 4 (44.4) |
| Myositis | 5 (16.1) | 0 (0.0) |
| Sjögren disease | 2 (6.45) | 0 (0.0) |
| Overlap syndrome | 6 (19.4) | 2 (22.2) |
| Administration of medication with potential or known fetotoxicity, N (%) b | ||
| Yes | 12 (38.7) | 5 (55.6) |
| No | 19 (61.3) | 4 (44.4) |
| Main health care provider, self‐reported, | ||
| Primary care provider | 20 (64.5) | 4 (44.4) |
| Rheumatologist | 10 (32.3) | 5 (55.6) |
| Other subspecialist | 1 (3.2) | 0 (0.0) |
| Ever been pregnant, N (%) | ||
| Yes | 10 (32.3) | 4 (44.5) |
| No | 21 (67.7) | 5 (55.6) |
| Currently using a birth control method, N (%) | ||
| Yes | 19 (61.3) | 6 (66.7) |
| No | 10 (32.3) | 2 (22.2) |
| Prefer not to answer | 2 (6.45) | 1 (11.1) |
| Current method of birth control, N (%) c | ||
| Long‐acting reversible contraception | 13 (41.9) | 5 (55.6) |
| Moderately effective contraception | 12 (38.7) | 1 (11.1) |
| Low‐efficacy contraception | 4 (12.9) | 1 (11.1) |
GED, General Educational Development.
Overlap syndromes include more than one rheumatic disease diagnosed in a single individual (eg, mixed connective tissue disease, rheumatoid arthritis and Sjögren disease, systemic sclerosis and myositis).
Medications with potential or known fetotoxicity include methotrexate, mycophenolate/mycophenolic acid, leflunomide, cyclophosphamide, thalidomide; this categorization was abstracted from the American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases.
Participants could indicate use of more than one birth control method. Long‐acting reversible contraception methods include intrauterine devices and subdermal implants. Moderately effective contraception methods include oral contraceptive pills, contraceptive patches, vaginal rings, and the depot medroxyprogesterone acetate shot. Low‐efficacy contraceptive methods include barrier methods and withdrawal.
Quantitative outcomes
MyVoice:Rheum was rated as feasible, acceptable, and usable by study participants (Table 2). The minimum threshold score of 3.5 for the AIM was met or exceeded by 96.8% of MyVoice:Rheum users, with an average score of 4.46 (SD 0.58). The minimum threshold score of 3.5 for the IAM was met or exceeded by 96.8% of users, with an average score of 4.47 (SD 0.60). SUS scores were rated in the range of excellent (mean 83.2 [SD 15.4]). Users agreed that MyVoice:Rheum was valuable, with a mean score of 4.12 (SD 0.73).
Table 2.
Feasibility, acceptability, and usability scores for MyVoice:Rheum users (N = 31)*
| Feasibility, acceptability, and usability measures | Mean (SD) |
|---|---|
| Acceptability of Intervention Measure | |
| I approve of the pamphlet/MyVoice. | 4.68 (0.48) |
| The pamphlet/MyVoice is appealing to me. | 4.42 (0.76) |
| I like the pamphlet/MyVoice. | 4.52 (0.63) |
| I would use the pamphlet/MyVoice again. | 4.23 (0.92) |
| Overall acceptability | 4.46 (0.58) |
| Intervention Appropriateness Measure | |
| The pamphlet/MyVoice seems appropriate for women like me. | 4.39 (0.67) |
| The pamphlet/MyVoice seems suitable for women like me. | 4.48 (0.57) |
| The pamphlet/MyVoice seems applicable to women like me. | 4.52 (0.63) |
| The pamphlet/MyVoice seems like a good match for women like me. | 4.48 (0.68) |
| Overall appropriateness | 4.47 (0.60) |
| Perceived value | |
| The pamphlet/MyVoice prepared me to have a discussion with my rheumatologist about my reproductive health. | 3.94 (0.81) |
| The pamphlet/MyVoice helped me learn more about reproductive health. | 4.23 (0.96) |
| The pamphlet/MyVoice: helped me make decisions related to my reproductive goals (parenthood, pregnancy, or choice of birth control). | 3.61 (1.23) |
| The pamphlet/MyVoice is a valuable tool for women with diseases like mine. | 4.71 (0.53) |
| Overall value | 4.12 (0.73) |
| System Usability Scale | |
| System Usability Scale score a | 83.2 (15.4) |
Values for measures of acceptability, appropriateness, and value ranged from 1 (completely disagree) to 5 (completely agree).
Based on a nine‐item System Usability Scale. Values range from 0 to 100.
In debriefing interviews after the clinic visit, 61.3% of MyVoice:Rheum users (n = 19) indicated that they had discussed any aspects of family planning with their rheumatologists during their clinic visits, whereas 44.4% of control participants (n = 4) indicated family planning discussions occurred during their visits (P = 0.46). The most common reasons why family planning discussions were not discussed included (1) competing priorities during visit, (2) lack of relevance to the patient (eg, male partner infertility), (3) the perception that the physician was rushed, and/or (4) rheumatologist or obstetrician gynecologist had previously addressed family planning. All participants who had a family planning discussion with their rheumatologist indicated that MyVoice:Rheum or the pamphlet had influenced their interest in discussing family planning at their visit.
Among MyVoice:Rheum users, self‐efficacy scores on the PEPPI scale rose from a pretest mean of 3.47 (SD 1.19) to a posttest mean of 4.07 (SD 0.82) (mean difference 0.59 [SD 0.91]; P = 0.001) (Table 3). Among controls, PEPPI scores rose from a pretest mean of 3.73 (SD 0.92) to 3.98 (SD 0.98) (mean difference 0.24 [SD 0.43]; P = 0.16). The overall reproductive knowledge scores on ReproKnow rose among MyVoice:Rheum users from a pretest mean of 6.23 (SD 2.11) to a posttest mean of 8.03 (SD 1.58), with a mean difference of 1.90 (SD 1.92; P = 0.0003). Among controls, ReproKnow scores rose from a pretest mean of 5.44 (SD 2.74) to a posttest mean of 7.11 (SD 2.50), with a mean difference of 2.11 (SD 1.17; P = 0.008) (Table 4).
Table 3.
Self‐efficacy scores before and after intervention for MyVoice:Rheum users and controls (Perceived Efficacy in Patient‐Physician Interactions) a
| Thinking about your personal reproductive goals or plans, how confident are you in your ability to | MyVoice:Rheum users (n = 31) | Controls (n = 9) | ||||
|---|---|---|---|---|---|---|
| Mean (SD) | P value | Mean (SD) | P value | |||
| Previsit | Postvisit | Previsit | Postvisit | |||
| Know what questions to ask a doctor? | 3.74 (1.41) | 4.48 (0.72) | 0.0004 | 3.89 (1.17) | 3.89 (1.27) | 0.99 |
| Get a doctor to answer all your questions? | 3.42 (1.31) | 3.94 (1.09) | 0.002 | 3.67 (1.00) | 4.11 (0.78) | 0.31 |
| Make the most of your visit with the doctor? | 3.65 (1.33) | 4.13 (0.85) | 0.046 | 3.67 (1.00) | 4.11 (1.05) | 0.25 |
| Get a doctor to take your chief health concerns seriously? | 3.45 (1.46) | 3.90 (1.19) | 0.11 | 3.78 (1.20) | 4.00 (1.32) | 0.50 |
| Get a doctor to do something about your chief health concerns? | 3.30 (1.26) | 3.90 (0.88) | 0.003 | 3.67 (1.22) | 3.78 (1.30) | 0.99 |
| Overall self‐efficacy regarding clinical care a | 3.47 (1.19) | 4.07 (0.82) | 0.001 | 3.73 (0.92) | 3.98 (0.98) | 0.16 |
Based on the five‐item Perceived Efficacy in Patient‐Provider Interactions (PEPPI) scale. Scores range from 0 to 5.
Table 4.
Overall reproductive knowledge scores on ReproKnow between MyVoice:Rheum users and controls (ReproKnow scale)
| Knowledge domains | MyVoice:Rheum, pre‐ and postvisit (n = 31) | Controls, pre‐ and postvisit (n = 9) | ||||
|---|---|---|---|---|---|---|
| Previsit | Postvisit | P value | Previsit | Postvisit | P value | |
| Heredity, n (%) correct answers | 24 (77.4) | 26 (83.9) | – | 6 (66.7) | 6 (66.7) | – |
| Fetal risk, n (%) correct answers | 14 (45.2) | 20 (64.5) | – | 1 (11.1) | 8 (89.0) | – |
| Fertility, n (%) correct answers | 12 (38.7) | 25 (80.7) | – | 2 (22.2) | 6 (66.7) | – |
| Contraception safety, n (%) correct answers | 24 (77.4) | 30 (96.8) | – | 6 (66.7) | 7 (77.8) | – |
| Contraception efficacy, n (%) correct answers | 26 (83.9) | 27 (87.1) | – | 7 (77.9) | 7 (77.8) | – |
| Prepregnancy planning, n (%) correct answers | 22 (71.0) | 30 (96.8) | – | 7 (77.9) | 8 (89.0) | – |
| Pregnancy management, n (%) correct answers | 24 (77.4) | 25 (80.6) | – | 7 (77.9) | 8 (89.0) | – |
| Pregnancy management, n (%) correct answers | 18 (58.1) | 28 (90.3) | – | 7 (77.9) | 8 (89.0) | – |
| Fetal outcomes, n (%) correct answers | 10 (32.3) | 22 (71.0) | – | 2 (22.2) | 6 (66.7) | – |
| Overall reproductive health knowledge, mean (SD) | 6.23 (2.11) | 8.03 (SD 1.58) | 0.0003 | 5.44 (2.74) | 7.11 (2.50) | 0.008 |
Note: Based on nine‐item ReproKnow scale. Values range from 0 to 9.
Qualitative Outcomes
Table 5 includes representative themes and quotations from interviews with MyVoice:Rheum and control users. MyVoice:Rheum users felt that (1) the tool was feasible, informative, usable, and customizable; (2) the tool prepared them to initiate and engage in family planning conversations with their rheumatologists; (3) the tool should be provided for patients to review immediately before the rheumatology encounter, around the time of the initially RMD diagnosis and periodically afterwards; (4) family planning conversations that occurred at the rheumatology visit were facilitated by respectful and trusting relationships with the rheumatologist; and (5) they could suggest modifications to MyVoice:Rheum to include tools directed toward clinicians to facilitate patient‐centered care. Control participants also felt that the pamphlet was informative, although some users felt it was difficult to contextualize to their particular health condition.
Table 5.
Representative qualitative responses from MyVoice:Rheum and/or control users.
| Pt response | |
|---|---|
| MyVoice:Rheum theme: MyVoice:Rheum was informative, feasible and easy‐to‐use, and customizable to the user. | |
| Rheum user | Pt 1 (40 years old, overlap syndrome): “I thought that the material was presented in a logical and thoughtful way.” |
| Pt 2 (27 years old, myositis): “One thing I really liked about [MyVoice:Rheum] was that it was, like, general autoimmune, but they also had a few points where, like, you could list what autoimmune condition you had.” | |
| Pt 2 (27 years old, myositis): “I'm in a weird position where I'm, like, I'm not really thinking about all of these [family planning] things. Yes, maybe, but it is helpful to think about in terms of like a lot of that stuff I didn't even know. So now if I were to think about it, I would know kind of what I wanted to ask or think about.” | |
| Pt 3 (32 years old, SLE): “It helped me like, kind of review things with myself.” | |
| Pt 5 (29 years old, SLE): “I liked that it covered very specific topics, and that you could choose those topics that you wanted to go over.” | |
| Pt 7 (40 years old, RA): “It was pretty user friendly, very easy to navigate, it wasn't like it was complex or very difficult to understand.” | |
| Pt 18 (42 years old, overlap syndrome): “It gave me a little bit more insight on like what other people deal with fertility, with autoimmune diseases.… I was able to remember more about certain conditions like preeclampsia or different risk factors or different precautions I need to take.” | |
| Pt 22 (32 years old, Sjögren disease): “I'm not someone who has ever been pregnant. That's why I feel like I'm like a great candidate for the tool.” | |
| Pt 23 (42 years old, RA): “I'm not very tech savvy. But I mean, even I could figure it out.” | |
| Pt 27 (20 years old, RA): “I feel more informed for sure.” | |
| Pt 30 (20 years old, RA): “I was aware of all of the methods that it had mentioned, like birth control methods, but I didn't know much about how RA or any other autoimmune disease affects pregnancy or any of that. So it was very helpful to learn. You know, what it means for me and my life.” | |
| Pt 35 (37 years old, overlap syndrome): “It was really nice just to get some information.” | |
| Pt 39 (38 years old, overlap syndrome): “I think there were some possible side effects of certain birth controls that I wasn't aware of, like interaction type things. There was one that I had never even heard of, which was the implant.” | |
| Control user | Pt 4 (21 years old, SLE): “Just to know those options for myself, were really helpful.” |
| Pt 8 (33 years old, overlap syndrome): “I thought it was informative, especially with the list of medications.” | |
| Pt 16 (31 years old, SLE): “It's not like a glossy thing you'd pick up if it was just like in a little brochure holder in the office. It's not necessarily something you'd like, gravitate to in a waiting room. But if it were handed directly to you, there's a lot of good information there.” | |
| PT 19 (20 years old, SLE): “It was concise, and it summarized a lot of the findings that I had found online.” | |
| Pt 20 (23 years old, SLE): “It took a couple tries to kind of like read through everything and make sure I was absorbing all the information.” | |
| Pt 24 (23 years old, SLE): “I thought it was super educational, but it was kind of hard to digest.” | |
| Pt 28 (38 years old, RA): “I do think that because there are so many autoimmune diseases, that it is vague, but it gives, it gives the start to open up the conversation with your doctor.” | |
| Pt 32 (31 years old, systemic sclerosis): “It almost seems a little dry though, just like the solid blocks of text, so it wasn't as engaging in some of the other things that I'd looked up online.” | |
| MyVoice:Rheum theme: MyVoice:Rheum helped users to feel comfortable to feel prepared to initiate and engage in family planning conversations with their rheumatologists. | |
| Rheum users | Pt 22 (32 years old, Sjögren disease): “I appreciated the time to be able to look over that [MyVoice:Rheum] ahead of my appointment, because it gave me the opportunity to like, think about things put together, like my questions. And then I was able to bring some of that up during my appointment.… It was definitely better to have the opportunity to look over it ahead of time, and then, like, bring my takeaways and questions into my appointment with him.” |
| Pt 23 (42 years old, RA): “I don't wanna say that [I sounded] smarter, but at least I knew what I was talking about.” | |
| Pt 26 (33 years old, overlap syndrome): “It was helpful to have like this, you know, kind of background information going into my appointment.” | |
| Pt 39 (38 years old, overlap syndrome): “I don't know what questions to ask…so it helps like to direct a conversation and make you feel more comfortable asking because you have a little bit of a background, which gives you confidence.” | |
| MyVoice:Rheum theme: preferred setting for using MyVoice:Rheum | |
| Rheum users | Pt 2 (27 years old, myositis): “When I was first diagnosed, I would have been overwhelmed because I like didn't really know what it was going to look like for me and how the disease is going to progress.… I don't think I would have liked needing to think about [parenting] at that time.” |
| Pt 3 (30 years old, SLE): “I personally like to have the time to spend at home, you know, you can go through a section, take a break, or you know, really just have that quiet space to read through it. I don't know that I'd have that much love going through (MyVoice:Rheum) with my doctor, just because it's a lot of information. And you know, I guess I get a little bit nervous whenever I go to the doctor sometimes. So I don't know that I'm as clear as I had hoped, personally.” | |
| Pt 22 (32 years old, Sjögren disease): “I think with some of the general information, like, you know, as a woman, as soon as I got diagnosed, I think that's like one of your first thoughts…” | |
| Pt 29 (20 years old, SLE): “I liked that I got to do [MyVoice:Rheum] at home. I also like that it was before an appointment.… I think doing it may cause me to have like a little bit of anxiety. And then there may be some pressure for me to answer things in a way.” | |
| Pt 35 (37 years old, overlap syndrome): “I think when you first get I know, like when I first got diagnosed, I think people tend to go the Internet. But that's a terrifying thing. Because you learn a lot of horrible things.… I think having a tool like that, right at diagnosis, would be super helpful. You know, having legit information come from credible sources is huge, like huge huge.” | |
| Pt 39 (38 years old, overlap syndrome): “If I had that tool, you know 10 years ago [when diagnosed], it would have been a huge difference to me. So I think it's really helpful for people who were just, you know, coming to that stage…when I was first diagnosed with lupus, basically, they gave me a very vague, ‘if you ever want to have kids, you better hurry up and do it. Now. It's going to be high risk, don't plan on having kids.…’ And I was devastated.… It like messed me up for a long time.” | |
| Pt 39 (38 years old, overlap syndrome): “It's definitely a pro to be able to do it, like, on your own time. Since…you might not be able to like focus on it as much when you’re rushing to an appointment or something. And plus, they’re already really long appointments and you don't really want to spend more time there. And then the only con would be maybe if you forgot some of the questions, but you know, being able to write them down and print them out basically gets rid of that problem.” | |
| MyVoice:Rheum theme: Family planning conversations were facilitated by respectful and trusting relationships with the rheumatologist, whereas rushed visits were a barrier to family planning conversations at the visit. | |
| Rheum users | Pt 35 (37 years old, overlap syndrome): “I actually like truly trust his [rheumatologist's] opinion. But I know not everybody, you know…feels like that. So for some people, [MyVoice:Rheum] might be like a better option. I think it really depends on what your relationship with your doctor is.” |
| Pt 39 (38 years old, overlap syndrome): “[Tool would be helpful for] I guess people who don't have a good relationship with their doctor or between doctors, and they’re unsure about stuff.” | |
| MyVoice:Rheum users recommended adding modules for patients and/or family members and providing resources for rheumatologists. | |
| Rheum users | Pt 6 (30 years old, overlap syndrome): “I think there should be a better way for that tool to be used by the practitioner and make them more comfortable. Because again, this [rheumatologist] that I saw is the first male and I thought, I don't know if I would be comfortable talking to him about [reproductive health]…it would be great if there was like a physician side to it. So train them how to, you know, make the patient more comfortable.” |
| Pt 35 (37 years old, overlap syndrome): “I wouldn't have hated if there was maybe even like a few links to like, you know, maybe like recent medical journal articles…” | |
Abbreviations: *Pt, participant; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus.
Three‐month outcomes
Most MyVoice:Rheum users engaged in interviews three months following the intervention (n = 30). Some MyVoice:Rheum users indicated the receipt of family planning services after the intervention, including (1) initiation of a new birth control method (n = 7), (2) counseling about birth control or pregnancy planning from a clinician (n = 4), and/or (3) a clinic visit or medical test related to birth control or pregnancy planning (n = 3). Reproductive knowledge scores remained significantly higher than preintervention scores (preintervention mean 5.77 [SD 1.76] vs postintervention mean 7.27 [SD 1.17], mean difference 1.50 [SD 1.93]; P = 0.0008).
DISCUSSION
We developed MyVoice:Rheum, a digital, patient‐facing family planning decision aid, to help reproductive‐age women with rheumatic diseases learn about how their diseases and medications might affect a pregnancy, to deliberate and make informed choices about pregnancy and contraception, and to facilitate family planning discussions and care with rheumatologists at their clinic visits. In pilot testing, MyVoice:Rheum was feasible, usable, and acceptable to users. These promising preliminary data suggest that MyVoice:Rheum might be a valuable tool in prompting family planning counseling and care for female patients with RMDs.
Our team developed MyVoice:Rheum as part of a broader effort to develop a comprehensive new model of SRH in rheumatology, building on initiatives such as the ACR's Reproductive Health Initiative and Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. 38 A core component of rheumatology‐integrated SRH care is the development of educational resources that support patients’ informed decision‐making around family formation, provide clarity about the range of their reproductive options, and address their reproductive needs in the health care context. Our developmental approach and early pilot evaluation were patient‐centered, as our primary objective was to develop a tool that was highly feasible and acceptable to patients. Our results indicate that MyVoice:Rheum users found the content to be understandable, relevant to their informational and decisional needs, and highly navigable. In preliminary effectiveness testing, we found that MyVoice:Rheum users demonstrated increases in self‐efficacy and knowledge after their clinic visits; in addition, three months after the intervention, nearly one‐quarter of MyVoice:Rheum users reported having additional family planning encounters with clinicians. In future work, we plan to confirm these preliminary findings and study the extent to which MyVoice:Rheum reduces decision conflict, enhances decision quality, and contributes to healthier and goals‐concordant reproductive outcomes.
Given our conceptual framing in Self‐Determination Theory, our team's pilot study also preliminarily explored whether the MyVoice:Rheum tool could empower patients to overcome certain barriers to family planning care identified in our foundational work, such as discomfort felt by some patients around initiating family planning conversations during their clinic visits. 7 , 8 In our pilot study, more than 61% of MyVoice:Rheum users engaged in family planning conversations with their rheumatologists as compared to 44% of controls. These findings suggest that our patient‐directed tool may augment family planning care receipt independent of a physician‐directed intervention. This finding is especially noteworthy because rheumatologists in previous studies have indicated structural and interpersonal barriers to family planning care (eg, a preference for patients to initiate family planning conversations if relevant to them), and a number of physician‐directed interventions have demonstrated poor uptake and sustainability in diverse clinical settings. 39 , 40
MyVoice:Rheum users expressed preferences about when they would like to be presented with the decision aid. A number of patients mentioned that they would have valued using MyVoice:Rheum early after their RMD diagnoses. Users overwhelmingly valued the opportunity to review the decision aid before the rheumatology visit, particularly at home when they had more flexibility to review the material; this allowed them to contextualize information and formulate questions to ask during their visits. Patients wanted to review MyVoice:Rheum at least on an annual basis, as their reproductive goals could change over time. In the future, we plan to examine whether MyVoice:Rheum is also feasible and acceptable when used in contexts outside of rheumatology (eg, obstetrics and gynecology, primary care, or asynchronously with a clinical visit).
Although we focused on the patient experience in our initial pilot testing, our qualitative interviews highlighted the critical role of rheumatologists in facilitating family planning care. For example, MyVoice:Rheum users who trusted their rheumatologist felt confident in initiating and engaging in family planning conversations, as compared to users who felt distrustful of their rheumatologist or perceived that their visits were rushed. All MyVoice:Rheum users indicated that their rheumatologist was amenable to discussing family planning when prompted; however, in future work, we plan to evaluate rheumatologists’ impressions about the impact of the tool on the clinical encounter. Although not explicitly studied herein, we also plan to study the quality of rheumatologists’ family planning care, which may impact patients’ perceptions that their reproductive needs have been met. 32 Some rheumatologists do not receive formalized training in how to provide family planning care, 41 and several participants in our pilot trial saw value in developing a companion intervention to enhance rheumatologists’ communication around SRH. Although MyVoice:Rheum was not designed to overcome all of the challenges to integrating SRH into the rheumatology clinical context, our team has previously proposed strategies to help rheumatologists to build the knowledge, skills, and resources to provide patient‐centered SRH care. 3
Our study has limitations. Concordant with best practices of pilot trials, our primary objective was to assess feasibility and acceptability rather than effectiveness outcomes; the small sample size precluded our ability to assess meaningful differences between MyVoice:Rheum and the pamphlet. 30 , 42 We did not explicitly evaluate the association of patient–clinician gender discordance with patients’ receipt of family planning counseling, although several patients expressed that they felt less discussing family planning with male versus female clinicians. In addition, we assessed the number of family planning discussions as a preliminary effectiveness measure in our pilot study. Rheumatologists were apprised of the study via email one month before study onset, standard practice for research in our division, which could have increased the likelihood that they engaged in family planning discussions with patients, and therefore may have increased the overall number of family planning discussions occurring in both study arms. However, because our focus was not the overall number of family planning discussions but rather the preliminary difference in the number of discussions between the study arms, we were less concerned that this was a major limitation of our pilot findings.
The MyVoice:Rheum decision aid also has limitations. Although MyVoice:Rheum was developed for patients with childbearing capacity, we acknowledge that male patients with RMDs may also benefit from family planning decision support. 43 Future work must evaluate the tool's impact among women of color and/or gender‐diverse individuals, subgroups that have been historically marginalized from patient‐centered health care and may particularly benefit from a tool that supports informed decision‐making. 14 Finally, we acknowledge that not all people have the autonomy to make values‐concordant reproductive decisions, and the personal and health policy contexts in which people live may also affect the range of decisions they are able to make for themselves and their families. 44 , 45 , 46
In summary, we developed MyVoice:Rheum to support women with RMDs in making informed reproductive choices and to prompt reproductive health conversations between patients and rheumatologists. MyVoice:Rheum appears to have the potential to facilitate family planning care in the rheumatology context, and we plan to confirm our preliminary findings in a future full‐scale effectiveness implementation trial.
AUTHOR CONTRIBUTIONS
All authors contributed to at least one of the following manuscript preparation roles: conceptualization AND/OR methodology, software, investigation, formal analysis, data curation, visualization, and validation AND drafting or reviewing/editing the final draft. As corresponding author, Dr Birru Talabi confirms that all authors have provided the final approval of the version to be published, and takes responsibility for the affirmations regarding article submission (eg, not under consideration by another journal), the integrity of the data presented, and the statements regarding compliance with institutional review board/Declaration of Helsinki requirements.
Supporting information
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ACKNOWLEDGMENTS
We are very appreciative of the contributions of patient stakeholders to the development and testing of MyVoice:Rheum.
ClinicalTrials.gov Identifier: NCT04879745.
Dr Birru Talabi's work is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant K23‐AR‐075067).
1Mehret Birru Talabi, MD, PhD: University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; 2Megan E. B. Clowse, MD, MPH: Duke University, Durham, North Carolina; 3Kaleab Abebe, PhD, Traci M. Kazmerski, MD, MPH, Catherine Wright, MPH, Leslie E. Pierce, MS, Olivia M. Stransky, MPH, Sonya Borrero, MD, MS: University of Pittsburgh, Pittsburgh, Pennsylvania; 4Susan J. Blalock, PhD: University of North Carolina Eshelman School of Pharmacy, Chapel Hill; 5Lisa S. Callegari, MD, MPH: University of Washington School of Medicine, Seattle; 6Raelynn O'Leary, MDes, Ashley Deal, MDes: Carnegie Mellon University, Pittsburgh, Pennsylvania; 7Goutham Lakkaraju, BA, Swetha Jasti, BA: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Additional supplementary information cited in this article can be found online in the Supporting Information section (https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr2.11791).
Author disclosures are available at https://onlinelibrary.wiley.com/doi/10.1002/acr2.11791.
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