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Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

Objective

Qualitative research among patients with systemic lupus erythematosus (SLE) can identify aspects of the disease relevant to clinical research and practice. A phenomenological, mixed-method approach was used to investigate these disease-driven health issues.

Methods

A convenience sample of patients with SLE from Los Angeles County, California was recruited from a private, community-based rheumatology practice for participation in focus groups and interviews. Semistructured discussions explored disease manifestations and impact. A self-administered questionnaire evaluated the occurrence and importance of disease issues previously identified from literature. Patient health issues were identified through convergence using 1) qualitative analysis of focus group transcripts and 2) quantitative analysis of the questionnaire. Patients were also asked about their ability to accurately recall disease experiences.

Results

Focus group participants (n = 23) had a mean age of 43 years and a mean disease duration of 8 years; 19 (83%) were women and 14 (61%) were white. The most frequent health issues identified by focus group transcript analysis were pain (83%), fatigue (61%), work or school impairment (48%), skin manifestations (43%), and skin sensitivity (43%). Questionnaire findings were similar: the most frequent health issues were inability to do previous activities (87%), fatigue (87%), pain (87%), and work or school impairment (83%). Most interviewed patients (7 of 10) reported an ability to accurately recall disease issues between 24 hours and 7 days.

Conclusion

SLE patients reported signs and symptoms that could significantly impact their functioning in daily life. Treatments that substantially improve these disease manifestations would offer considerable benefit to patients, treating physicians, and general society.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown cause that is often cyclical, sometimes progressive, and believed to be related to chronic inflammation (1–7). SLE is heterogeneous in manifestations and carries a significant mortality risk (1, 2, 6, 8–10). Organ system pathologies associated with the condition, particularly pulmonary, cardiovascular, and renal involvement, are well-established prognostic indicators for accelerated morbidity (2, 6, 8, 9). Although American College of Rheumatology (ACR) disease activity indices and biomarkers assist with SLE diagnosis and treatment, there continues to be debate about clinical subtypes (6, 7, 11).

No curative therapy currently exists for SLE, making chronic disease management the operating clinical paradigm (12–16). Many SLE symptoms and related functional impairments are difficult or impossible to measure through laboratory or physician assessments (14, 17). The health perceptions of SLE patients can markedly differ from a clinician's, possibly due to the heterogeneous nature of SLE as well as differences in which health issues are important (18, 19). Consequently, patient questionnaires asking about various aspects of health-related quality of life (HRQOL) have been used in SLE studies (14, 20–22).

The objective of this study was to determine the key SLE health issues from the patient perspective. An HRQOL questionnaire in SLE should address the key, disease-driven health issues identified by patients (18, 19, 20–26). This investigation into disease-specific content included: 1) a literature review of SLE HRQOL issues, 2) conducting qualitative and quantitative research on HRQOL issues among SLE patients, and 3) summarizing the findings from these data sources.

PATIENTS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

Multiple modes of investigation based on a phenomenological approach guided by the health impact model of Wilson and Cleary (27) were used to explore the life experiences of SLE patients: narrative review of disease-based HRQOL literature, patient focus groups, and face-to-face interviews. A health issue identification survey or endorsement questionnaire was also administered. This mix of methods increased the likelihood of identifying all relevant health issues and also validated critical health issues derived from any one method through confirmation (28, 29).

The study proceeded in 3 steps. In step 1, a narrative literature review was conducted to identify existing information on the burden of disease. The narrative literature review focused on identifying themes from various lupus studies capturing HRQOL information, which supported the creation of a patient questionnaire for use in step 2, comprising items inquiring about disease issues already documented.

In step 2, a convenience, purposeful sample of English-speaking patients meeting the ACR criteria for SLE (30) was recruited by study physicians (RR, MS, MW) from a private, community-based rheumatology practice located in Los Angeles County, California. Qualitative and quantitative methods were used to capture the patient perception of disease impact through 2 focus group discussions and a patient endorsement questionnaire (29, 31–36). In step 3, face-to-face interviews with SLE patients meeting the same entry criteria as the focus groups further explored the disease experience and the timeframe for reliably recalling health status. Finally, all of the information was integrated to create this summary report (Figure 1). Institutional Review Board approval was gained, all patients provided informed consent, and their data were anonymized for analysis.

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Figure 1. Multimodal method of health-related quality of life (HRQOL) research.

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Step 1: literature review.

Literature published from January 1990 to February 2005 was identified from PubMed using the following search terms: lupus, erythematosus, systemic, cutaneous, quality of life, disability, survey, questionnaire, signs, symptoms, functioning, and epidemiology. Publications were reviewed for content based on the following criteria: 1) disease relevance (SLE, cutaneous lupus erythematosus, or discoid lupus erythematosus), 2) availability of primary, population-based data (excluding letters, editorials, reviews, or case studies), 3) availability of HRQOL data (symptoms, functioning, disease manifestations, patient symptoms), 4) treatment-targeted study design (etiologic in intent, not supportive care), and 5) comparative in nature (requiring analytical contrast with other patient groups).

Patient endorsement questionnaire.

This questionnaire was developed through HRQOL literature review. Authors had to identify the issue as notable, although statistical significance was not required. Health issues were collapsed when dealing with identical or similar concerns and eliminated when redundant. Questionnaire items were constructed to inquire about the health issue using key word descriptors from the selected literature. Patients were asked about the occurrence of lupus-driven health issues (yes/no), and if occurring, the importance of the issue, using an importance scale ranging from 0 (not at all important) to 5 (extremely important).

Step 2: focus groups.

Ambulatory patients from a community-based rheumatology practice were identified by their attending physician (RR) and recruited for one of two 90-minute focus groups. Eligibility criteria were: 1) SLE (meeting at least 4 of the 11 ACR criteria) (30), 2) at least 18 years of age, 3) English speaking, and 4) providing informed consent. Sample size was based on qualitative research considerations (28, 34). Sociodemographic and clinical information was collected using a case report form and supplemental patient questionnaire.

An experienced moderator (SR) conducted all of the focus groups. Coverage of key research questions was ensured through open-ended questions using a standardized, semistructured format and a focus group guide: 1) what are the disease-based signs and symptoms, 2) how do they impact daily life, and 3) what are their frequency, duration, and intensity. The endorsement questionnaire was administered at the conclusion of the focus groups to reduce suggestion bias. This ensured the greatest likelihood of identifying new health issues while also providing another means of sharing information for less assertive or vocal members of the focus group.

Step 3: face-to-face interviews.

Additional SLE patients meeting the same inclusion criteria were recruited from the same rheumatology practice for face-to-face 60-minute interviews following a semistructured format with a trained interviewer (SR). Interviews explored 1) health issues that had previously been identified by the focus groups, 2) additional disease-driven health issues that may exist, 3) examples of how these issues affected their lives, and 4) their perception of an accurate recall period. Focus group and interview patients were paid $100 US dollars for their participation.

Analysis plan.

Identified literature underwent full-text review, reporting citation, year, study type, disease population and size, geographic location, and major HRQOL findings. Focus group sessions and face-to-face interviews were recorded, transcribed, and reviewed for errors. Key word in context and word count analysis documented the frequency of disease issues. All of the transcripts were independently reviewed and agreement was reached on 1) the list of health issues that were identified through open coding, 2) relevant passages from the transcripts, 3) contextual descriptors of the issue and its relationship to other factors (axial coding), and 4) the categorization of these issues into higher-order themes or domains (29, 35, 36).

In this report, health issues were aggregating into higher-order domains. Pain included severe headache or migraine, joint pain or aches (often caused by swelling), muscle pain or aches (sometimes described as “flu-like symptoms”), or generalized body pain. Fatigue included self-described fatigue, tiredness, exhaustion, or lack of energy or stamina. Skin sensitivity incorporated reactions to sunlight, artificial light, heat, or touch (often associated), while skin manifestations combined malar, facial, or body rash, hives, lesions, or discoid lupus. Physical functioning included any activity requiring bodily movement and action, while social functioning incorporated activity with children or grandchildren (parenting or grandparenting), domestic partner (including sexuality), or friends. Impaired work life addressed absenteeism, reduced productivity, job loss, and difficulty finding or holding a job. Depressed mood was based on patient comments referring to a long-term, low-mood state.

Health issue significance was determined by its 1) frequency in the literature, focus group discussions, or face-to-face interviews, 2) frequency of endorsement on the patient questionnaire, and 3) importance ranking from the questionnaire. No a priori assumptions were made about theoretical saturation, since comparing results across patient samples and methods was fundamental to the study design. An external reviewer confirmed the coding of qualitative text and the reporting of quantitative results (29, 35, 36). Standard descriptive statistics were used to analyze the endorsement questionnaire data using the SAS statistical package, version 9.1 (SAS Institute, Cary, NC). Quantitative comparison was limited to notable trends, as statistical significance was not sought.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

Step 1: literature review results.

The PubMed search produced 1,895 studies of interest; 797 publications were accepted for narrative analysis after full-text review and 102 met all of the inclusion criteria. Of these 102, 53 were primarily HRQOL in content, 15 were neuropsychiatric, and 34 were studies administering HRQOL questionnaires. The most frequent reasons for publication exclusion were 1) lacking HRQOL measures, 2) not meeting publication type criteria, and 3) being a supportive care study (see Supplementary Appendix A, available in the online version of this article at http://www3.interscience.wiley.com/journal/77005015/home).

Approximately 50% of the selected studies were conducted in North America (n = 29 [37%] in the US, n = 16 [20%] in Canada); 61% (n = 48) were cross-sectional. The 31 longitudinal studies had observation periods ranging from 4 weeks to 10 years and included 2 randomized controlled trials. There was 1 meta-analysis of 8 studies and 5 reports on lupus focus groups. The most frequently used HRQOL questionnaires were the Short Form 36 or Short Form 20 Health Surveys. Patient global assessments, the Fatigue Severity Scale, and the Rheumatology Attitudes Index were less common.

The top 5 health issues emerging from the literature review were fatigue, energy, or vitality (n = 8); depression (n = 7); pain (n = 4); helplessness (n = 4); and inability to cope with the disease (n = 4). Impaired concentration (n = 3), impaired work life (n = 3), anxiety or distress (n = 3), and impaired personal relationships (n = 2) were also noted. Many other HRQOL issues, such as uncertainty or unpredictability of the disease, body image, recreational impairment, forgetfulness, and reduced sexuality, appeared in one source each (data not shown). Six domains of interest were identified: symptoms, physical functioning, social functioning, cognitive functioning, emotional health, and aspirations (life goals and spiritual needs).

Step 2: focus group results.

Focus group participants (n = 23) had a mean age of 43 years, had a mean disease duration of 8 years, were 83% women, and were 61% white (n = 14) and 13% Hispanic (n = 3). Skin manifestations were observed in 70% of patients and 17% had current renal involvement. Almost all of the participants (96%) reported concurrent lupus medication use; 12 (52%) of 23 reported using 2 or more concomitant medications. There was clinical and demographic variation across the focus groups; patients in focus group 2 also had more comorbidities (Table 1).

Table 1. Characteristics of the focus group participants*
 Focus group 1 (n = 12)Focus group 2 (n = 11)Total (n = 23)
  • *

    Values are the number (percentage) unless otherwise indicated. Unique medication and disease counts are at the specified categorical level. Percentage totals may not equal 100% due to rounding or overlapping counts.

  • Includes those patients with malar, facial, or body rashes, hives, lesions, or discoid lupus.

  • When identified by brand name, prednisone was the most frequent corticosteroid and hydroxychloroquine was the most frequent antimalarial medication. Other reported medications were anti-migraine (n = 1), angiotensin-converting enzyme inhibitor (n = 1), and blood thinner (n = 1).

  • §

    Other reported comorbidities were Devic disease (n = 1), diabetes mellitus (n = 1), Raynaud's phenomenon (n = 1), and pericarditis (n = 1).

Age, mean ± SD years44 ± 1342 ± 1543 ± 13
Women8 (67)11 (100)19 (83)
Ethnicity/race   
 White9 (75)5 (45)14 (61)
 Black1 (8)1 (9)2 (9)
 Hispanic1 (8)2 (18)3 (13)
 Asian0 (0)2 (18)2 (9)
 Other1 (8)1 (9)2 (9)
Disease duration, mean ± SD years7 ± 710 ± 78 ± 7
Current renal involvement4 (33)0 (0)4 (17)
Current skin manifestations6 (50)10 (91)16 (70)
Current medication   
 Antimalarial9 (75)9 (82)18 (78)
 Corticosteroid4 (33)7 (63)11 (48)
 Antiinflammatory1 (8)3 (27)4 (17)
 Immunosuppressant2 (17)1 (9)3 (13)
 Antidepressant1 (8)1 (9)2 (9)
 Combination opioid0 (0)2 (18)2 (9)
 Other0 (0)3 (27)3 (13)
Comorbidities§   
 Anemia1 (8)3 (27)4 (17)
 Blood hypercoagulation0 (0)2 (18)2 (9)
 Costochondritis0 (0)2 (18)2 (9)
 Other1 (8)3 (27)4 (17)

The 5 most frequent signs and symptoms that emerged from the transcript analysis were pain (83%; predominantly joint pain), fatigue (61%), skin manifestations (43%; malar, facial, or body rash), skin sensitivity (43%), and alopecia (39%). When patients referred to fatigue, they often did so using the term “fatigue,” but also described it as tiredness, lack of energy, lack of endurance or stamina, or extreme exhaustion: “For me, the fatigue is the biggest one [disease manifestation] because it makes me feel real tired …,” “The fatigue is just so bad. I was taking naps all the time … coffee wasn't doing it … I didn't have the energy to walk my dog,” “… and the fatigue, that does affect your social life. After work, you just don't want to do anything,” “… when you have joint pain, I think that leads to the fatigue because your body is just fighting this pain so much that … you just wear out.”

Leading areas of functional impairment identified by these patients consisted of work (57%), recreation (30%), and walking (22%) (Table 2). Domestic partner and parenting roles were also compromised: 25% (n = 3) and 36% (n = 4) in focus groups 1 and 2, respectively (data not shown): “… the hard part is that I have a 5-year old and a 2-year old … it's hard to say, ‘dad can’t go to the beach' or ‘dad can’t go out in the sun' because they don't understand …,” “… probably the biggest impact … was really in … my relationship with my husband. It was really hard to be touched …,” “This is a weird disease. It definitely was something that made or broke some relationships.”

Table 2. Top systemic lupus erythematosus health issues from the focus groups
 Focus group 1 (n = 12), no. (%)Focus group 2 (n = 11), no. (%)Total (n = 23), no. (%)
  • *

    Includes absenteeism, reduced productivity, cutting back on hours, disease-driven sick days, disease-driven job loss or disability, and difficulty finding or holding a job.

  • Includes activity restrictions with children or grandchildren (parenting or grandparenting), domestic partner (including sexual difficulties), or friends.

Pain9 (75)10 (91)19 (83)
Fatigue7 (58)7 (64)14 (61)
Impaired work life*7 (58)6 (55)13 (57)
Skin manifestations3 (25)7 (64)10 (43)
Skin sensitivity3 (25)6 (55)9 (39)
Hair loss3 (25)6 (55)9 (39)
Impaired social functioning3 (25)6 (55)9 (39)
Impaired recreation2 (17)5 (45)7 (30)
Sleeping problems4 (33)2 (18)6 (26)
Impaired walking3 (25)2 (18)5 (22)
Impaired driving3 (25)1 (1)4 (17)
Mood swings 4 (36)4 (17)
Depressed mood 4 (36)4 (17)

Joint pain, fatigue (or pronounced, persistent tiredness), and severe headaches (or migraines) were identified by 17 (74%) of the 23 SLE patients as initial disease manifestations occurring before SLE treatment. Poor emotional health, defined as depression, hopelessness, or mood swings, was reported by 7 patients (30%); they were frequently taking antidepressant medication. Some participants referred to their depressed mood as arising from persistent, severe pain. Others attributed sleeping difficulties to unexpected and pronounced pain: “I hurt all over, terrible … just constantly … hurting … and being very grumpy and depressed…. The arthritis is what was severe to the extent that I needed help dressing, getting out of bed … all that adds to the depression,” “… you wake up with back pain or joint pain so you don't get a good night's sleep as you would like …,” “The joint pain, I was dealing with that, but once I started feeling like I had flu symptoms … I couldn't sleep….”

The unpredictability of symptom onset and the appearance of a seemingly healthy body could produce frustration and anger: “We all look like we are fairly normal, healthy people, and in that way it's very frustrating,” “… you couldn't explain what's wrong with you, and you're tired of people saying ‘what’s wrong,' ‘how come you’re not doing this or that?'”

Some patients reported social isolation resulting from feeling misunderstood and being tired of explaining their health situation: “Isolation, friendships, relationships, even family, because you don't want to talk about it because there is a sense of shame … and something is wrong and people don't understand, and so it's isolating sometimes …,” “I just want to be alone sometimes with so much pain,” “I also had problems with being isolated. I was talking to people less when I had a lot of joint pain.”

Hair loss and facial manifestations of the disease, such as scarring or pimply rash, were especially damaging to the psychological health of the female participants. These disease characteristics created difficulties in social activities and personal relationships: “You know, with hair loss, with any of the facial things, that's really a tough thing to deal with, your personal identity and self-esteem, those sort of things that I think has kept me from doing some projects or interviewing for certain things …,” “I was going to be 28, single, and bald…. As a woman, not so handsome … I would be in the shower and I would be sobbing and my hair would be falling out,” “Embarrassment, definitely, because of the scarring. It's really awful and some people … I don't think they mean to, but, ‘what is that?’, ‘what is that on your face?’, or ‘what happened to you?’, and it's a little frustrating having to explain, you don't feel like it.”

Endorsement questionnaire.

The initial list of SLE health issues totaled 498 and was categorized into 20 health themes, based on keywords and intrinsic conceptual association. Two review rounds produced an endorsement questionnaire of 116 items that inquired about signs and symptoms, physical functioning, mental health, social roles, and impairment in activities of daily living (see Supplementary Appendix B, available in the online version of this article at http://www3.interscience.wiley.com/journal/77005015/home). The most frequent health issues identified by more than half of the patients as lupus driven were: 1) pain (87%), 2) fatigue (87%), 3) inability to do previously possible activities (87%), 4) inability to work or go to school (83%), and 5) impairment in playing sports or other recreational activities (83%). The mean scores for the top 5 most important health issues were: 1) 4.5 for pain, 2) 4.5 for embarrassment or self-consciousness from skin condition, 3) 4.3 for parenting children, 4) 4.2 for fatigue, and 5) 4.1 for sunlight sensitivity. Pain and fatigue were among the most frequent and most important health issues. Patients also endorsed cutaneous manifestations in frequency and importance (Table 3).

Table 3. Top disease-driven health issues from the endorsement questionnaire, frequency versus importance*
Health issueMost frequent (yes/no), %Most important, mean ± SD
  • *

    Including only health issues and associated impairments reported by focus group participants to be related to the disease and not those reflecting treatment, side effects, or the health care system. Response rate of >50% was required for inclusion (denominator = 23).

  • Both most frequent and most important.

Having pain874.5 ± 0.7
Feeling fatigued874.2 ± 1.1
Needing to rest more87 
Feeling sad because unable to do things that once did873.9 ± 0.9
Having painful joints834.4 ± 0.8
Working or going to school834.0 ± 1.1
Playing sports or other recreational activities834.0 ± 0.8
Feeling sad about the impact of lupus on my life78 
Being sensitive to sunlight784.1 ± 1.2
Worried about being in the sun784.1 ± 1.2
Sleepy or drowsy78 
Gripping or opening things78 
Having problems thinking clearly774.1 ± 1.0
Doing household chores74 
Worried about performing at work or school744.0 ± 1.0
Having mood changes744.1 ± 0.9
Having problems falling asleep74 
Having night sleep that is restless or disturbed74 
Feeling embarrassed or self-conscious because of my skin 4.5 ± 0.9
Worried about parenting children 4.3 ± 1.0
Having headaches 4.2 ± 1.0
Sore, painful, or stinging skin 4.0 ± 1.2
Worried about how lupus affects relationships 3.9 ± 1.0
Having a career or getting an education 3.9 ± 1.2
Having a skin rash 3.9 ± 1.6

Face-to-face interviews.

Interviewed patients (n = 10) had a mean age of 42 years and a mean disease duration of 7 years, 80% were women, 6 were white, and 3 were black. One patient mentioned chills and severe sweating as an additional health issue. One focus group participant had mentioned “sweating all night” as one of the early disease manifestations and 2 had mentioned flu-like symptoms, which may include chills. Interviewee testimonials on living with SLE were similar to those from the focus groups: “Sometimes I have difficulty walking, and I can't move without having support or sometimes someone there to … hold onto, to get from one place to another,” “… usually when I need help from people is to carry something because … it hurts … not to hold me or something but to help me … sometimes certain door knobs are hard to [handle] because the joints …,” “Like when the laundry room, when I had to go downstairs 6 flights, if someone was there to do it, I would have sent them to do it. Because it was really hard,” “… one of the biggest ways that lupus has affected me is that it limits the kind of work I can do,” “I can study, I can read things over and over again, I can even write them down but nothing sticks as far as I'm concerned …”

Interviewed patients also described lack of energy, tiredness, and fatigue inter-changeably, and linked them to the inability to engage in desired household or recreational activities. Seven of the 10 participants considered either 7 days or 2 weeks (14 days) to be an appropriate period for accurately recalling SLE health issues. Six of those 7 expressed a clear preference for 7 days. While 2 patients agreed that a recall period of 24 hours was the most accurate when remembering their health, many thought that this recall period would not accurately reflect their SLE experience due to variability in disease activity over relatively short periods of time: “… I think that's [7-day recall] a good timeframe. Longer than that, I think you would have to—with me now, it would be kind of hard to recall. I'd have to get significant events to make me help remember further back, but I think 7 days is an actual good amount of days … I don't think you would get a wide scope … over a 24-hour. It might just be nothing really happening in that 24 hours…. You might say 10 days, but 2 weeks is a bit much,” “… I think 7 days is fine…. Because if you try to go over a whole month [4 weeks], I mean, basically you would have to do what I do, is start trying to remember and document things on a piece of paper, but within 7 days that's something that one can recall. To be totally honest with you, my short-term memory isn't as good. What I need to do is write everything down…. For me, yes. Two weeks, I think it'll be too long,” “… for me, the experience of the last 7 days actually makes sense because sometimes the flare-ups that I've had, I don't recall them lasting any long lengthy months and dragging into months. I think that some of the things that do are maybe fatigue, but actual painful discomfort usually is within 7 days…. No [7 days is not too far back] …,” “Yes [memory would be clearer with 24-hour recall]…. Probably 7 days [if given the choice between 1 week vs. 2 weeks vs. 4 weeks].”

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

SLE patients in this study were from a community-based setting and had mild to moderate disease. Consequently, these data may provide a more “real-world” assessment of SLE health issues from the patient perspective, in contrast to other studies conducted in more severely ill populations or in subjects from therapeutic clinical trials. Patients identified pain, fatigue, skin sensitivity, cutaneous manifestations, cognition, mental health, functional impairment, and role restrictions as significant disease-related issues. The signs and symptoms of SLE impacted household responsibilities, parenting roles, recreational activities, work performance, and scholastic achievement.

There was concordance in the identified SLE health issues across data sources in this study. Endorsement questionnaire results regarding the most frequent disabilities caused by SLE were also consistent with those reported by Katz et al (37). A similar group of health issues has recently been found when creating lupus-specific HRQOL questionnaires or conducting SLE epidemiology studies (24–26, 38, 39). Patient health questionnaires that cover these issues are important indicators of disease activity and impact.

Several patients commented on the progressive, disease-driven decline in activities of daily living over time, especially regarding family, social or recreational events, and career. The worsening physical and psychological impact of SLE created a downward spiral, exacerbated by its unpredictable course. Female participants in this study articulated clear linkages between their mental health and their body image, sexuality, and capacity to care for dependents. The negative impact of skin manifestations, skin sensitivity, and hair loss (alopecia) on self-esteem, body image, and mental health has previously been reported in this population. Items addressing these issues have appeared in recent HRQOL questionnaires specifically developed for patients with SLE (24–26, 38, 39). No major difference emerged between patients reporting skin manifestations and those who did not when rating the occurrence or importance of lupus issues, except for those issues directly associated with cutaneous symptoms.

Based on patient comments, questions regarding the level of tiredness, energy, and stamina are the most relevant when assessing fatigue. Fatigue was linked to a sense of endurance, particularly the ability to conduct household or work place tasks. Consequently, fatigue questions in an HRQOL questionnaire should also assess endurance or stamina, such as being able to “do things” or “get things done.” Pain and painful joints were also frequently described as inhibiting restful sleep. Consequently, sleepiness or troubled sleep may partly be a consequence of pain. Since a lack of good sleep obviously contributes to tiredness, an indirect relationship may exist between pain and fatigue, with poor sleep acting as an intermediary factor.

While all of the patients in the face-to-face interviews agreed that a recall period of 24 hours was the most accurate, many indicated concern with this time period because of the variation in disease activity over short periods of time. A 24-hour recall period would not accurately capture their disease course. Patient health questionnaires using a 7-day recall period may be optimal in this population, but this requires confirmation by a larger study.

Several limitations to this research must be noted. In the narrative review, 57% of the selected studies came from North America. The patient sample size was small, came from a limited geographic area, and consisted of all English-speaking SLE patients from a single rheumatology practice who agreed to participate. Therefore, the external validity of these findings could be limited. Recent work conducted among SLE patients in another multiethnic US cohort as well as European studies found similar health concerns, however (24, 25, 38–41). Additionally, the literature review included information about SLE patients from around the world, as well as several ethnicities within the US. The consistency of major health issues found among SLE patients suggests that these HRQOL issues may be global in nature.

Results from this study suggest that effective treatment could improve many aspects of life for SLE patients, particularly restoring patients to full functionality at home and work (39, 42). Future medicinal development should go beyond signs and symptoms and include functioning as important treatment end points. HRQOL questionnaires in SLE should encompass symptoms and functionality to capture the full impact of disease or treatment on the patient.

AUTHOR CONTRIBUTIONS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be submitted for publication. Mr. Robinson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study conception and design. Robinson, Aguilar, Schoenwetter, Dubois, Russak, Ramsey-Goldman, Revicki, Rapaport, Renahan, Ress, Wallace, Weisman.

Acquisition of data. Robinson, Aguilar, Schoenwetter, Dubois, Russak, Navarra, Rapaport, Ress, Wallace, Weisman.

Analysis and interpretation of data. Robinson, Aguilar, Schoenwetter, Dubois, Russak, Ramsey-Goldman, Hsu, Revicki, Cella, Rapaport, Wallace, Weisman.

ROLE OF THE STUDY SPONSOR

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

Centocor Ortho Biotech Inc., a subsidiary of Johnson & Johnson, sponsored this study. Several authors, including the corresponding author, who contributed to the design and conduct of the study, are employees of Johnson & Johnson. All authors reviewed and approved the manuscript content before submission and jointly agreed to submit the final version of the manuscript. Publication of this study was contingent upon approval from Centocor Ortho Biotech Inc.

Acknowledgements

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

We want to thank the lupus patients who participated in the focus groups and interviews, many of whom did so explicitly to help fellow patients. The present research greatly benefited from the contributions of Debra Eisenberg, PhD, Richard Hector, PhD, Robert Nordyke, PhD, Hsing-Ting Yu, PhD, and supporting Cerner research staff. Jay Getsy, MD, was key to the conception and realization of this study. The editorial and operational support of Robert Achenbach, Jennifer Han, Kirsten Schuck, and Patti Shirey of Centocor Ortho Biotech Inc. (formerly Centocor, Inc.), Medical Publications Group was indispensable.

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  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information
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Supporting Information

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. ROLE OF THE STUDY SPONSOR
  9. Acknowledgements
  10. REFERENCES
  11. Supporting Information

Additional Supporting Information may be found in the online version of this article.

FilenameFormatSizeDescription
ACR_20077_sm_AppendixA.doc48KSUPPLEMENTARY APPENDIX A: LITERATURE REVIEW LIST
ACR_20077_sm_AppendixB.doc173KSUPPLEMENTARY APPENDIX B: SLE PATIENT ENDORSEMENT QUESTIONNAIRE

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