The Intervention to Improve Quality of life for African American lupus patients Project: Incorporating the element of choice to improve disease self-management and quality of life: A Randomized Controlled Study

Abstract

Background:

The Intervention to Improve Quality of life for African American lupus patients (IQAN) Project is a three armed randomized, wait list-controlled trial focused on providing a variety of self-management tools to participants. We focus on African American individuals with lupus due to the increased morbidity and mortality in this population.

Purpose:

To examine whether a unique ‘a-la-carte’ self-management program improved quality of life, decreased depression, and reduced perceived and biological indicators of stress in African American lupus patients.

Methods:

Individualized intervention plans (IIP’s) offered 1–4 options, including a mail-delivered arthritis kit, message board, support group, and enrollment in a self-management program. A ‘set menu’ control condition included a standardized chronic disease self-management program only, and a control condition was usual care (UC). Validated measures of stress, depression, and quality of life were collected in all patients before and after intervention activities. To evaluate changes between baseline and post-intervention, compact scores were compared across groups, using two-sample t-tests.

Results:

Improvements were observed in areas of stress management and pain management (p=0.05). The frequency of managing pain by applying positive techniques increased in the intervention group (p=0.08), but the other two groups did not display such improvements. An increasing trend persisted in the intervention group in the frequency of applying stress management techniques (p=0.02) and decreasing trends in activity limitation were observed in both the intervention and set-menu control groups.

Conclusions:

Better self-management outcomes were observed when participants were able to dictate the content or pace of the intervention program. This suggests that self-selection of program components has the potential to improve disparate trends in quality of life, disease activity and stress among African American lupus patients, which could impact future research and policy decisions.

BACKGROUND:

Lupus disease experience in African Americans

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with acute periodic flare-ups of symptoms impacting any organ system and resulting in potentially life-threatening complications.^{1, 2} Unpredictability is a hallmark of living with SLE which has profound implications on patient experiences such as difficulty maintaining relationships and managing one’s condition.³

SLE disproportionately affects nonwhites,⁴ and a number of studies have shown that African Americans are at increased risk for morbidity and mortality from SLE, with a more sudden onset and a quicker progression of the disease.⁵ In these studies, SLE occurrence was three to four times higher among African American than white women, and more severe disease activity are more commonly observed in African Americans.^{6, 7} Other significant complications of treatment include weight gain, osteoporosis, osteonecrosis, accelerated atherosclerosis, and retinal damage.^{1, 2, 8} These side effects and complications can lead to significant functional and emotional challenges. Patients often experience a high degree of psychological symptoms, including anxiety, depression, mood disorders, and decreased health-related quality of life.^{9, 10} In addition to managing disease-specific stressors, it has been suggested that African Americans are exposed to a unique set of risk factors that lead to a pattern of cumulative disadvantage over time. High rates of unemployment, poverty, violent crime, incarceration, and homicide among African American adults reflect this accumulation of disadvantage at multiple transition points during their development and across the life course.^11–15 Additional stressors include deprivation of resources and facilities, differential exposure to health risks in the physical environment because of economically disadvantaged neighborhoods and poor quality housing, higher costs of goods and services in deprived areas, as well as roles of social networks and social capital, which often give rise to peer pressure against academic achievement and in support of crime and substance use.^13–15 Presence of any of these risk factors is a strong predictor of SLE risk and disease outcome.¹¹ Due to the exposure of African Americans to a unique trajectory of stressors throughout the life course, it is critical to address modifiable risk factors for SLE that may be further exacerbated by this trend in an effort to improve health status and reduce health disparities in this high-risk group.

Evidenced based prevention programs

A large body of evidence has shown that health-promoting programs in stress management have been successful in helping people improve their health practices and related health conditions, especially when it comes to chronic disease management.^16–18 Scientific literature suggests that therapeutic interventions be proposed to reduce psychological distress, improve quality of life and possibly moderate the evolution of chronic and unpredictable diseases like SLE.⁵ Cognitive-behavioral stress management (CBSM) techniques have resulted in short-term improvement in pain, psychological function, and perceived physical function among persons with SLE.¹⁹ Additionally, psychoeducation²⁰ and graded aerobic exercise²¹ have been shown to be useful in the management of fatigue. Programs designed to reduce stress levels of chronically ill patients have also included support therapy, lifestyle interventions incorporating elements of yoga or other similar disciplines, and mini-sessions on depression, adaptive coping strategies, and body image.^{19, 22, 23} Although there is no generally accepted self-management program available for SLE, two programs that have been shown to be successful in improving health outcomes in patients with arthritis are the Arthritis Self-Management Program (ASMP) and the generic Chronic Disease Self-Management Program (CDSMP). Each program incorporates six weeks of peer led sessions ranging in disease-specific and more general self-help content. Arthritis self-management education delivered by small-group, home study, computer, and internet modalities have demonstrated significant improvements in health distress, self-reported global health, and activity limitation, with trends toward improvement in self-efficacy and mental stress management.^{12, 19, 24–28}

Barriers to participation

Despite the apparent need for help with multiple illness-related problems and evidence that some of these problems can be ameliorated with cognitive-behavioral interventions without adverse effect, several studies have emphasized the need to design interventions that address barriers to participation and curtail noncompliance, particularly for African American patients,^29–32 these patients often experience anxiety and poor patient-provider interactions leading to a lack of trust, poor adherence to therapeutic regimens, and failure to keep scheduled appointments.³³

Additionally, arthritis self-management education has reached a limited number of people, despite recommendations from numerous national agencies that self-management education complement medical care,^{10, 20} and many vulnerable populations like African Americans have not been included in study samples even though they experience more severe manifestations of the disease.^{6, 22} Compliance is also a persistent problem in standardized programs. One study reported that less than 50% of a closed eligible population participated, even when internet and small-group programs were offered repeatedly over many years,³⁴ suggesting that interventions may not be reaching the largest portion of lupus cases. Self-selection of program components had not been explored as an approach to improve such trends, but better self-management outcomes have been documented when participants are able to choose/dictate the content and/or pace of the respective treatment/intervention program.^{17, 35–37} The promise of self-selection in this population, coupled with the known unpredictability of SLE on the patient experiences, suggests that further research on how this mode of self-management may improve patient outcomes is warranted.

METHODS:

Study Aims

This study examined whether a culturally sensitive educational intervention that includes self-selection of program components would lead to improved quality of life and health status among African American patients with lupus.

Recruitment

Participants were recruited from an ongoing SLE Clinical Database Project based at a southeastern medical school, as specified in the protocol paper.³⁸ All patients invited to participate were African American lupus patients who resided in areas where self-management programs were offered and who were free of CNS/neuropsychiatric lupus and dementia. All patients met at least four components of the American College of Rheumatology (ACR) criteria for SLE.³⁹ This study complies with the Helsinki Declaration and was approved by the Institutional Review Board of the main institution.

Study design

The study was a three armed randomized, wait list-controlled trial that compared a unique patient-centered ‘a-la-carte’ self-management program that offered participants a variety of modes of interaction from which they could choose as many or few as they wish (IQAN intervention) with a ‘set menu’ control group who were offered a standardized chronic disease self-management program only, and a control group of participants who received usual care (UC). Each participant in the intervention arm created an individualized intervention plan (IIP) that included 1–4 options: mail-delivered arthritis kit, addition and access to a listserv, participation in a support group, and enrollment in local self-management program(s). For the ‘set-menu’ and control arms, participants were allowed the choice to join any intervention element (e.g., listerv, participation in support group, mail-delivered arthritis kit etc.) after one year.

The mail-delivered Arthritis Self-Management Tool Kit contained: 1) a “Self-Test” to help participants determine how arthritis affects their lives and self-tailor the use of the Tool Kit; 2) information sheets related to working with their doctor and health care systems, exercise, medications, healthy eating, fatigue and pain management, finding community resources, and dealing with emotions; 3) information sheets on key process components of the ASMP, including action planning, problem solving, decision making, and individualization of program components; 4) the Arthritis Helpbook;⁴⁰ 5) audio relaxation and exercise compact discs (CDs); and 6) an audio CD of the information contained in information sheets.

A project listserv was established to link all intervention participants and facilitate exchange of coping strategies, pose questions, and share preferred educational resources or any other information relative to their everyday and disease-specific experiences and/or participation in the project. Interested participants were provided with a URL, from which they were able to subscribe to the listserv. Once subscribed, they were able to post and receive messages, managed by a listserv moderator. Participants had the option to unsubscribe at any time.

Participants interested in a support group were referred to the “Lupus: Listening and Learning Group,” a Charleston-based support group affiliated with the Lupus Foundation of America (LFA). One to two LFA-trained facilitators implemented the group. Notices were placed in community papers, on radio stations, and public access events calendars, as well as rheumatology offices and on emerging social networking platforms like Facebook. Additional outreach activities, such as presence at community health fairs and networking with local churches and community-based organizations were used to invite additional support group participants. The meeting format includes a specific discussion topic or an informative presentation such as by a medical or counseling professional, pharmacist, or lupus researcher. This program is followed by time within the group for further interaction and support among attendees.

The Chronic Disease Self-Management Program is a 2-hour workshop given weekly for six weeks in a variety of community settings, such as senior centers, churches, libraries, and hospitals. People with different chronic health problems attend in a group format and support one another in making positive changes in their health. Workshops are facilitated by two trained leaders, one or both of whom are non-health professionals with a chronic disease themselves. Topics covered include: 1) techniques to deal with problems such as pain, fatigue, frustration and isolation; 2) appropriate exercise for maintaining and improving strength, flexibility, and endurance; 3) appropriate use of medications; 4) communicating effectively with family, friends, and health professionals; 5) healthy eating; and 6) making informed treatment decisions. Classes are highly participative, and mutual support builds the participants’ confidence in their ability to manage their health and maintain active and fulfilling lives.

Assessments

Mailed assessments included validated measures of self-reported disease activity, coping, stress, depression, and quality of life, collected in all patients in each condition before and after intervention activities. The Systemic Lupus Activity Questionnaire (SLAQ) ⁴¹ asks a single Patient Global Assessment (PGA) question about presence and severity of lupus activity over the past month, questions on 24 specific symptoms of disease activity and a single Numerical Rating Scale (NRS) asking the patient to rate disease activity on a scale of 0–10 over the past three months. Coping was assessed by the Arthritis Self-Efficacy Scale pain and other symptoms sub-scale ⁴², which consists of 11 items designed to measure confidence in one’s ability to manage the pain, fatigue, frustration, and other aspects of disease.¹⁹ Stress was measured using the perceived stress scale (PSS), which is a 4-item scale that assesses the degree to which the respondent finds situations stressful.⁴³ Responses range from “0” (never) to “4” (very often) and questions ask about the frequency of feelings related to events in the previous month. The Cronbach alpha value is 0.69 and scores are highly correlated with stress, depression and anxiety. Depression was measured by the PHQ-9, a brief questionnaire that scores each of the 9 DSM-IV criteria for depression as “0” (not at all) to “3” (nearly every day). PHQ-9 score > or =10 have a sensitivity of 88% and a specificity of 88% for major depression.⁴⁴ A modified version of the PHQ-9 that does not include the last question about suicidality was used, making it the PHQ-8. Quality of Life was measured using the LUP-QOL, which incorporates the Medical Outcomes Study (MOS) Short Form 36 Health Survey (SF-36) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), both reliable and valid instruments that are frequently used in quality of life studies of persons with lupus.^{45, 46} Additionally, Stanford Patient Education Research Center Questionnaires assessing medical outcomes such as hospital visits, illness intrusiveness, and use of stress management techniques.⁴⁷ Study assessments were completed at baseline, 6 months, 12 months, 18 months, and a final evaluation at 24 months using mailed questionnaires.

Participants remained blinded to group allocation until after completion of baseline assessments. The only members of the research team who was aware of randomization assignment was the Research Coordinator, and the statistical analyst in charge of randomization. Randomization occurred at the patient level, and the following steps were taken to minimize contamination among the conditions of the study: 1) patients in the intervention and control arms were instructed not to share intervention materials with family members, friends, or other clinic patients; 2) patients were given instructions not to disclose their treatment assignment to their assessment interviewers.

Each IIP was reviewed on a quarterly basis, at which time participants were invited to change and/or add options to their plan. In addition to quarterly review of their IIP, intervention participants received biweekly follow up calls to gauge their progress, comfort, adherence, and any adverse events. In addition to enrollment in a local CDSMP, participants in the set menu control arm received monthly follow up calls to gauge their progress and comfort. Set menu controls completed post-intervention follow-up evaluations bi-annually. Participants in the control arm did not receive follow-up calls, but did complete post-intervention follow-up evaluations on the same schedule as set menu controls. At their second post-intervention follow-up evaluation (after one year), set menu controls and controls were invited to create their own IIP with the same options that were originally extended to intervention participants. All participants then received monthly follow up calls. Each year of the study was considered one wave.

Data Analysis

Primary analyses represent a one-between subjects (intervention versus control and intervention versus set menu control) and one-within or repeated factor (pre, post, and follow up assessments) crossed factorial design, with multiple dependent outcome measures (disease activity and damage, perceived indicators of stress, and quality of life). The multivariate approaches to repeated measures were used to test for pre-post-follow up changes between the intervention group and the control groups in order to provide a more comprehensive description of longitudinal patterns for each dependent variable. P < 0.05 was used to indicate statistical significance and data from all randomized participants were analyzed. Multiple imputations were used to estimate missing data from dropouts and participants who did not complete follow up evaluations.

Basic descriptive statistics such as means, ranges, and standard deviations were calculated and tabulated for quantitative data using SAS (SAS Institute, Cary, North Carolina). The Z test and Student’s t test were used for continuous variables satisfying normality assumption, and the Mann Whitney U test and Kruskal-Wallis Test were applied for variables which cannot satisfy the normal assumption. All statistical comparison tests were made at 95% significant level.

RESULTS:

Recruitment and Implementation

Figure 1 presents overall study data, including enrolled participants and explanations for loss to follow-up. Of the 153 participants who were enrolled and randomized, 125 completed the study and were included in the analytical sample. Those who did not complete the study included twenty-eight lost to follow-up because of withdrawn consent (24 participants) or adverse events (4 participants). The four adverse events were unrelated participant deaths.

Figure 1. Overall Study Status.

Flow diagram of participants, from recruitment to completion of the study.

Table 1 presents more detailed baseline and demographic characteristics of participants, including the number of participants included in each of the three study arms: control, set menu, and intervention. Of the 153 enrolled participants, six were male and 149 were female. The average age among groups was similar, with means of 39.2 years in the control group, 40.58 years in the set menu group, and 40.46 years in the intervention group. The most common clinical features of SLE present at baseline included arthritis (78%), immune disorder (68%), malar rash (48%), photosensitivity (45%), renal disorder (44%), heme disorder (44%), oral/nasal ulcers (38%), serositis (38%), and discoid rash (22%). Of the 130 participants who had symptoms at baseline, 95% were ANA positive. Regarding insurance status, 38% had private insurance, 30% Medicaid, 34% Medicare, 5% uninsured, and 2% unknown. Currently employed participants represented 38% of the study sample, with another 32% disabled, 12% student, 9% unemployed, 5% homemaker, and 4% retired. Regarding education, 35% of participants completed high-school, 22% completed college, 22% had post-graduate degrees, and 2% completed grade school.

Table 1:

Demographic and Key Baseline Characteristics by Treatment Group

	Control (N=52)		Set Menu (N=47)		Intervention (N=54)		Total (N=153)
Characteristics	N*	(%)**	N*	(%)**	N*	(%)**	N*	(%)**
Gender (N=153)
M	5		0		1		6	4%
F	47		47		53		147	96%
Age (N=130)
Mean	39.2		40.58		40.46
Maximum	63		60		75
Minimum	15		16		11
Clinical Features (N=130)
Malar rash	20	15%	17	13%	25	19%	62	48%
Discoid rash	10	8%	10	8%	9	7%	29	22%
Photosensitivity	15	12%	21	16%	23	18%	59	45%
Oral/Nasal Ulcers	16	12%	13	10%	21	16%	50	38%
Arthritis	28	22%	30	23%	43	33%	101	78%
Serositis	12	9%	13	10%	25	19%	50	38%
Renal disorder	20	15%	16	12%	21	16%	57	44%
Heme disorder	14	11%	18	14%	25	19%	57	44%
Immune disorder	29	22%	25	19%	34	26%	88	68%
ANA Positivity	43	33%	34	26%	46	35%	123	95%
Risk Factors (N=130)
Insurance Status	16	12%	16	12%	18	14%	50	38%
Private	14	11%	12	9%	13	10%	39	30%
Medicaid	16	12%	10	8%	18	14%	44	34%
Medicare	2	2%	2	2%	2	2%	6	5%
Uninsured	1	1%	2	2%	0	0%	3	2%
Unknown
Employment
Currently working	13	10%	11	8%	22	17%	46	35%
Retired	0	0%	3	2%	2	2%	5	4%
Homemaker	3	2%	3	2%	0	0%	6	5%
Student	7	5%	4	3%	5	4%	16	12%
Disabled	15	12%	13	10%	14	11%	42	32%
Unemployed	5	4%	5	4%	2	2%	12	9%
Education
Post-graduate	7	5%	7	5%	14	11%	28	22%
College	11	8%	12	9%	6	5%	29	22%
Grade school	1	1%	1	1%	1	1%	3	2%
High school	14	11%	12	9%	19	15%	45	35%

^*N- number of participants with particular characteristic;

^**% of total number of participants enrolled

Table 2 breaks down the individual intervention plans (IIPs) by study arm and wave. In the control group, participants in waves I and II received no intervention, while in waves III-V, 2 participants received a mailed arthritis toolkit, one received the toolkit and attended a support group, and one received the toolkit along with enrollment in a self-management program. In the set menu control group during wave I, 7 participants received a mailed arthritis toolkit while thirty-four were enrolled in a self-management program. In wave II, 28 participants in the set menu control group were enrolled in a self-management program while one was enrolled in the self-management program and attended a support group, and six others were enrolled the self-management program and received the mailed arthritis toolkit. In waves III-V, 5 participants in the set menu control group were enrolled in a self-management program, 1 received a message board intervention, 2 received a mailed arthritis kit/self-management program combination, 1 received a support group/mailed arthritis kit/message board combination, 1 received a support group/arthritis kit/self-management program combination, and 1 received a mailed arthritis kit/self-management program/message board combination. In the intervention group, one participant in wave I chose only the support group option, one chose only the message board option, and sixteen others chose only to receive a mailed arthritis toolkit. The rest of the intervention group participants in wave I chose a combination of therapies.

Table 2:

Individual Intervention Plans (IIP’s)

	WAVE I			WAVE II			WAVE III/IV/V
Intervention Combinations	C	SM	I	C	SM	I	C	SM	I	Total
Support Group (SG)			1			1				2
Mailed Arthritis Toolkit (MAT)		7	16			14	2		2	41
Self Management Prog (SMP)		34			28	2		5	4	73
Message Board (MB)			1			1		1	1	4
SG + MAT			2			2				4
SG + SMP			2		1	3	1		1	8
SG + MB									2	2
MAT + SMP			4		6	5	1	2	4	22
MAT + MB			3			4			3	10
SG + MAT + SMP			2			2		1	1	6
SG + MAT+ MB			1			1		1		3
MAT + SMP + MB			1			1		1		3
SG + MAT + SMP + MB			3			3			2	8

C-Control; SM-Set Menu; I-Intervention

Health behaviors

Stress management

Indications of stress management included the ability to manage and control both the emotional and physical symptoms of the disease. These factors were assessed by self-report of thinking positively or applying positive measures, controlling fatigue, helping oneself to feel better, and the overall management of pain or a specific system. The frequency of stress management behaviors in the intervention group increased in the first three waves and then decreased in wave IV (p=0.061; Figure 2a). The average increase of the frequency of doing stress management from baseline to wave V was 1.44 in the intervention group (p=0.037). There was no significant difference among groups in all the five waves.

Figure 2. Health Outcomes by Treatment Group. Outcomes for control, set menu, and intervention participants.

Bars on the x-axes indicate waves of the project for each study condition, and y-axes indicate range of values for mental stress management or relaxation techniques (2a), impact of physical health status on work (2b), average fatigue rating (2c), and number of visits to the physician (2d). Roman numerals refer to wave number (year of study).

Health Status

Depression

There were no statistically significant differences in feelings of depression among the three groups, across the duration of the study.

Interference of lupus with day-to-day activities

The set menu control group showed a decreasing trend in interference of lupus with day-to-day activities from wave I to wave IV (p=0.006). There were no significant differences in the other two groups.

Activity limitation

With respect to vigorous activities, the proportion of patients reporting being ‘limited a lot’ by their health status decreased from 83.33% in Wave I to 64.71% in Wave IV and then increased to 76.47% in the last wave. Similar trends were observed for moderate activities.

Impact of physical and emotional health status

For this scale, a lower score indicates a greater impact of physical health status on work. Figure 2b shows that the intervention group experienced a decrease in the impact of physical health status on work, with a change in average score from 10.33 at baseline to 12.76 in Wave V (p=0.065). The set-menu control group also had a significant decrease in the impact of physical health status on work, with a change in average score from 9.30 at baseline to 12.62 in Wave V (p=0.048). Compact scores for the impact of emotional problems on accomplishments were not significantly different among the three groups for the five waves.

Pain, Fatigue, and Memory conditions

Regarding pain and its interference with daily life, the mean score in the intervention group first decreased from 6.20 at baseline to 4.59 in wave four, and then increased to 6.76 in the last wave, while scores in control and set menu control groups first increased and then decreased. However, these findings did not reach statistical significance in across the three groups. Scores comparing feelings of fatigue over the last 4 weeks were not significantly different across the five waves for the intervention and control groups (Figure 2c). There were score decreases from 23.74 at baseline to 17.23 in wave V (p=0.054) for the set-menu group. There were no significant differences in memory problems across the five waves for the three groups. Depression scores ranged from 4.74 at baseline to 2.38 in wave V in the set-menu control group but this difference did not reach statistical significance (p=0.051).

Overall impact on life and Lupus flare and disease activity

There were no significant differences in the overall impact of lupus on life across the five waves for the three groups. In the set-menu control group, disease activity scores ranged from 5.32 at baseline to 3.46 at wave V but this difference did not reach statistical significance (p=0.098).

Health Care Utilization

Figure 2d shows that the number of times participants reported visiting a physician in the past six months decreased significantly across the duration (i.e., from wave I to wave V) of the study for the intervention group (p=0.015). No significant differences were observed in the other two groups. There were no significant differences in the number of times going to the emergency room in the past 6 months among the five waves for the set-menu control and intervention groups. There were no significant differences in the number of nights spent in the hospital in the past 6 months across the five waves for each group, and no significant improvements were observed across the five waves for each group with regard to communication with physicians (i.e., preparation and how frequently participants talked with physicians about their problems).

DISCUSSION

This study successfully collected data from 153 enrollees and followed 125 of those enrollees through completion. We found that participants in the intervention group (able to build individualized intervention plan) reported higher frequency of stress management techniques, decreased impact of physical health status on work, reduction in disease activity, and decreased health care utilization. Decreased impact of physical health status on work was also observed in the set-menu group (chronic disease self-management program only). Our findings are consistent with those from studies of similar design. Researchers collecting qualitative data on the perceptions of chronic diseases self-management programs among African American women with SLE concluded that relaxation and stress management were perceived as highly valuable in the management of their disease.⁴⁸ Additionally, a review of clinical outcomes and adherence in adults with mental health interventions found that patients who received their preferred treatment options had higher rates of compliance and lower rates of dropout.⁴⁹

The two main limitations of the study were participant recruitment and completion of self-report assessments. Upon initiation of the trial, we encountered a higher-than-expected rate of patient refusal for study participation. To mitigate these recruitment challenges, expanded recruitment strategies included posting study information to Craig’s List, asking lupus foundation affiliates to include study details in their newsletters, and posting flyers in local rheumatologist offices. Return of baseline forms also required numerous follow up calls and repeat mailings, prompting strategies to increase response. Similarly, other studies relying on patient survey responses for evidentiary data suffered low response rates. An intervention evaluating weight management program in an integrated healthcare setting reported challenges with reliance of self-reported data and high rates of non-response to follow-up assessments.⁵⁰ For the last phase of the study, staff were dedicated solely to more rigorously solicit participant response, and questions were added to follow-up tools to assess barriers to participation, in an effort to inform future research efforts.

CONCLUSIONS:

Better self-management outcomes were observed when participants were able to dictate the content or pace of the intervention program. Positive findings included a significant reduction in disease activity in the intervention group, compared with other groups, over the entire follow-up period. This suggests that self-selection of program components has the potential to improve disparate trends in quality of life, disease activity and stress among African American lupus patients, which could impact future research and policy decisions. Moreover, the self-selection of intervention materials may better align with the lived experience of diseases such as SLE which have a fluctuating and unpredictable disease course.³

Since low response rates could have impacted our resulting analytical sample and corresponding findings, it will be important to test whether observations can be replicated on a larger scale. Further confirmation of this approach where patient preference and choice are included in the design as a viable model for the reduction of adverse disease outcomes could have very far-reaching implications, particularly in groups that have been harder to reach, but appear to be responsive to interventions that provide more autonomy.

Data availability:

De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author.