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Keywords:

  • Systemic lupus erythematosus;
  • International Classification of Functioning, Disability and Health;
  • Patient perspective

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

Objective

To explore the array of concepts important to patients with chronic systemic lupus erythematosus (SLE) and to compare these with instruments assessing disease activity, damage, and health status.

Methods

We conducted a qualitative focus-group study of patients with SLE concerning their problems in daily functioning. The group sessions were tape recorded, transcribed, and divided into meaning units. The concepts contained in these meaning units were extracted and linked to the International Classification of Functioning, Disability and Health (ICF). We then compared the concepts from the focus groups with those concepts covered by SLE activity scores, the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), and the Short Form 36 Health Survey (SF-36).

Results

A total of 92 concepts emerged from 5 focus groups; of these, 28 related to body functions and structures, 24 to activities and participation, and 25 to environmental factors. Two concepts were linked to the health condition itself and 6 to personal factors. Seven were not covered by the ICF. Of the 28 concepts regarding body functions and structures, 24 (86%) were covered by the combination of activity scores and the SDI. The SF-36 also addressed 3 of these concepts and contained 9 (38%) of 24 concepts in activities and participation.

Conclusion

Although the combination of SLE activity scores, SDI, and SF-36, as suggested for SLE studies, well covers body functions and structures and includes a significant portion of problems regarding activities and participation, neither environmental nor personal factors are covered at all.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

The World Health Organization's International Classification of Functioning, Disability and Health (ICF) (1) is a tool used to better characterize the full array of problems a patient faces when affected with disease (2–4). Specifying these problems is a particular challenge in a disease such as systemic lupus erythematosus (SLE) because of the wide variety of organ systems involved and its variable activity and severity.

SLE is a prototypical autoimmune disease with an incidence and prevalence varying considerably in different countries (5, 6). The burden of the disease is elevated among nonwhite racial groups. There is a trend toward higher incidence and prevalence of SLE in Europe and Australia compared with the US. In Europe, the highest prevalence was reported in Sweden, Iceland, and Spain (7). Patients with SLE commonly experience combinations of various organ symptoms, which often include joints, skin, kidney, or central nervous system (CNS) disease, but can also affect essentially all other organ systems (8, 9). SLE also varies in disease activity, from life-threatening conditions, where patients are hospitalized and often need intensive care, to rather mild but chronic problems, which may still impair functions of daily living. Whereas patients may not even be conscious during the acute phases of life-threatening disease, it is the chronic disease problems that have a long-term impact on functioning and quality of life. Therefore, a broader understanding of functioning and limitations in activities and restriction in societal participation will prove essential (10–12).

To incorporate this comprehensive understanding of functioning into the assessment and management of chronic diseases, ICF-based tools, such as ICF core sets, have been developed for patients with various chronic conditions (4). ICF core sets are short lists of ICF categories that are typically relevant and important for individuals with a certain health condition. For SLE, such an ICF core set is currently being developed (13). In this process it is of utmost importance to ensure comprehensive understanding of the concepts important to patients with SLE.

Whereas ICF core sets determine the relevant and typical problems of patients with a particular health condition, instruments assess the amount of impairment, limitation, or restriction in a certain area. For SLE clinical trials, Outcome Measures in Rheumatology Clinical Trials (OMERACT) IV recommended measuring disease activity and damage, health status, and adverse events (14). The most commonly used specific instruments in SLE are activity scores (15), such as (in alphabetical order) the British Islands Lupus Assessment Group index (BILAG) (16), the European Consensus Lupus Activity Measure (ECLAM) (17), the SLE Index Score (SIS) (18), the Systemic Lupus Activity Measure (SLAM) (19), and the SLE Disease Activity Index (SLEDAI) (20), with local difference with regard to preference. However, all of these scores correlate well with each other and have been found to be feasible and reliable (15, 17). There is one well-established SLE damage index, the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (ACR) Damage Index (SDI) (21). For measurement of health status in patients with SLE (14, 22), the Short Form 36 Health Survey (SF-36) (23) has been used in several studies (10, 12, 24–26). Some studies have used the Health Assessment Questionnaire (HAQ) (27), although this may be mainly relevant for patients with symptoms of arthritis (22).

When considering content validity and relevance of outcomes, it is extremely important to include the patient perspective because personal values for outcomes vary between and among patients and professionals (28–32). Qualitative methodology (31, 33–38) provides the possibility to explore the perspective of those who experience the disease (the patient perspective) (28–32) and to include this perspective in the assessment of the disease (14, 39, 40). A possible approach is to examine whether the concepts important to patients with a disease or health condition are covered by certain instruments (41).

It appears to be important to determine the degree to which concepts derived from patients are covered by the tools recommended for clinical trials. Therefore, the goal of this study was to explore the range of concepts important to patients with chronic SLE, and to compare these concepts with those addressed by the specific instruments used for SLE trials. The specific goals were 1) to explore in a qualitative focus group study which ICF categories are relevant and important from the perspective of patients; 2) to determine which concepts important to patients are covered by selected commonly used instruments assessing disease activity, damage, and health status; 3) to identify issues important to patients that are currently not addressed using these instruments; and 4) to make first recommendations for the further development and modification of instruments integrating the patient perspective.

PATIENTS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

We conducted a qualitative study based on focus groups of patients with SLE.

Participants.

Patients from the rheumatology department of the Medical University of Vienna who fulfilled ≥4 of the ACR criteria for SLE (42–44) were eligible for participation in the study. All participants were fully informed about the study procedures and gave their written and oral informed consent in accordance with the 1996 Declaration of Helsinki. The study was approved by the local ethics committee.

Sample size.

To obtain the required level of rich, meaningful, and in-depth data, qualitative research typically uses small sample sizes with a diverse range of participants. Individual experience, which can express variations of a given phenomenon and potentially raise new and unexpected issues, is more important than numbers and frequencies (33, 45, 46). Thus, the selection of the participants is a crucial issue. In the present study, sampling of patients followed the maximum variation strategy (33, 47) based on the following criteria: disease duration, involvement of organ systems, age group, and professional status. If a patient who was asked about participation in the present study agreed to participate, we looked in our clinical SLE patient database for another patient with at least 2 criteria, of the above-described criteria, that were different from the previous patient who was already included in the study. Furthermore, for the next patient to be asked, we looked again for a patient who was different from the previous participants in at least 2 criteria. Initially, we planned to include 20 patients in 5 focus groups.

Interviews.

All focus groups were chaired by the same moderator (TAS) aided by 1 or 2 assistants responsible for the observation of the group and the recording of data. Each focus group meeting was tape recorded and transcribed verbatim. At the beginning of each session, a short introduction as to the purpose of the study was given to all patients in lay terms. Five open-ended questions were formulated around functioning in daily life based on the ICF model (Figure 1): patients were asked 1) which SLE-related problems of their body functions they were experiencing, 2) which body structures were involved, 3) which limitations of activities and restrictions in participation were significant to them, and 4) which environmental factors and 5) which personal factors were barriers or facilitators for them.

thumbnail image

Figure 1. The International Classification of Functioning, Disability and Health (ICF) model and the concepts in each component. The model shows the relationship between the ICF components body functions and body structures, activities and participation, and the contextual factors: environmental factors and personal factors. Each component consists of chapters, which then consist of categories. Numbers in the shaded circles indicate the number of concepts from the focus groups in each component. Bold numbers in the boxes indicate the number of concepts covered by the instruments in each component. Three concepts in the component body functions and structures covered by the Short Form 36 Health Survey (SF-36) overlap with the activity scores. We report the results for body functions and structures together because patients did not differentiate between the function and the structure of an organ system as indicated in the ICF. Seven concepts were not covered by the ICF. In contrast to published experience (32, 41, 50) and to what we expected, the systemic lupus erythematosus (SLE) patients in our study were likely to come up with much more of the body functions and structure problems, whereas other ICF domains were less important. SLICC = Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index.

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Qualitative data analysis.

Qualitative data analysis followed the method of meaning condensation (33). In the first step, the transcribed interviews were read through by the first author to gain an overview of the collected data. In the second step, the data were divided into meaning units. A meaning unit was defined as a specific unit of text, either a few words or a few sentences with a common theme (46). In the third step, the subconcepts contained in the meaning units were identified. A meaning unit could contain more than 1 subconcept. An example is the meaning unit “recently, ‘Lupey,’ as I call him [the disease] fondly, has become a part of myself, he leaves me alone for the time being, but I will never be able to kill him, this is clear to me now because of the constantly changing symptoms,” in which we identified the subconcepts “own attitudes towards SLE/personalized as Lupey” and “constantly changing symptoms.” In the fourth step, subconcepts were organized and grouped according to their meaning to yield more comprehensive concepts. A concept was defined as a separate meaningful entity distinct from other concepts, while several subconcepts shared the attributes of the concept and were therefore subordinate to this concept (33). In the above-described example, the subconcept “constantly changing symptoms” was subordinated to the concept “course of the disease.”

Linking concepts from the focus groups to the ICF.

We linked each concept obtained in the focus groups to the appropriate ICF category according to published linking rules (48, 49) that have been used in qualitative studies (31, 32, 41, 50). According to these linking rules, each concept is linked to the most precise ICF category. If a concept was not contained in the ICF classification, this concept was assigned as “not covered,” such as the concept “loss of time” in our study.

Procedure to check whether or not a concept was covered by an instrument.

Every concept obtained from the patient focus groups was examined to determine if it was covered by the instruments recommended by OMERACT IV for use in SLE studies (14). To this end, we used the ICF as the frame of reference.

To determine whether a concept was covered by any of the commonly used SLE activity scores, the BILAG (16), ECLAM (17), SIS (18), SLAM (19) or SLEDAI (20), the SDI (21), or the SF-36 (23), we obtained the ICF categories contained in the activity scores and SF-36 from previous linking analyses (13, 51) or linked them anew (SDI) and matched them to the linked categories from the focus groups. Thus, we could determine which concepts were covered and not covered, respectively. An example is the concept “pain” from the focus groups, which was linked to the ICF category b280 sensation of pain. Items from the BILAG, ECLAM, SIS, SLAM, and SF-36 have been linked to the ICF category b280 sensation of pain (13, 51). Therefore, we considered the concept “pain” from the focus groups to be covered in BILAG, ECLAM, SIS, SLAM, and SF-36, but not in the SLEDAI or SDI.

Rigor and accuracy of the analysis.

To ensure the validity of the qualitative analysis and the linking to the ICF performed by the first author, the following procedures were performed. First, identification of the subconcepts and concepts in the complete transcribed text of the focus groups was examined by a second health professional (MM). In case of disagreement, both options were discussed and additional concepts were included.

Second, all concepts were independently linked to the ICF by a third health professional also trained in linking concepts to the ICF (MC). The degree of agreement between the 2 investigators in linking concepts to the ICF was calculated using the kappa statistic (52). Kappa values generally range from 0 to 1, where 1 indicates perfect agreement and 0 indicates no additional agreement beyond what is expected by chance alone. Kappa coefficients >0.61 are regarded as moderate to good (53). This analysis was performed using SPSS 12.0.1 software (SPSS, Chicago, IL).

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

Participants and focus groups.

A total of 20 female patients and 1 male patient with SLE participated in this qualitative study. Of the 21 participants, 14 (66%) were white-collar workers, 2 (10%) were blue-collar workers, 2 (10%) were retired, 1 (5%) was without a job, 1 (5%) was a student, and 1 (5%) was a homemaker. Characteristics of the participating patients are presented in Table 1.

Table 1. Patient characteristics*
CharacteristicValue
  • *

    Values are the percentage unless otherwise indicated. A total of 21 patients participated in 5 focus groups. The participants were recruited according to maximum variation strategy based on the following criteria: disease duration, involvement of organ systems, age group, professional status, and educational status. Most patients had renal involvement, followed by skin involvement and blood abnormalities. ACR = American College of Rheumatology.

Age, mean ± SD (range) years39.7 ± 10.8 (26–66)
Sex, no.
 Female20
 Male1
Disease duration, mean ± SD  (range) years13.0 ± 9.8 (2–30)
ACR criteria
 Malar rash67
 Discoid rash5
 Photosensitivity33
 Oral ulcers19
 Arthritis48
 Serositis5
 Renal disorder89
 Neurologic disorder14
 Hematologic disorder76
 Immunologic disorder81
 Antinuclear antibodies100

We conducted 5 focus groups. The mean ± SD duration of the focus group sessions was 78 ± 11 minutes. The transcribed data resulted in 2,113 lines of text.

Concepts and subconcepts identified in the qualitative analysis.

In 521 meaning units in the transcribed data of the focus groups, we identified 211 subconcepts that were then grouped and assigned to 1 of 92 concepts (presented in Table 2 in the far left column).

Table 2. Concepts important to patients with SLE related to body functions and structures, activities and participation, and environmental factors*
Concepts derived from the focus groupsICF categoriesBILAGECLAMSISSLAMSLEDAISDISF-36
  • *

    Dots represent the concepts covered by any of 5 SLE activity scores. Every concept from the focus groups was linked to the most precise ICF category using the same linking rules that have been developed to link health status measures (48, 49) and concepts from qualitative studies of rheumatoid arthritis and psoriatic arthritis patients to the ICF (31, 32, 41). SLE = systemic lupus erythematosus; ICF = International Classification of Functioning, Disability and Health; BILAG = British Islands Lupus Assessment Group index; ECLAM = European Consensus Lupus Activity Measure; SIS = SLE Index Score; SLAM = Systemic Lupus Activity Measure; SLEDAI = SLE Disease Activity Index; SDI = Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Index; SF-36 = Short Form 36 Health Survey.

  • A concept related to the health condition, such as “course of the disease,” was linked to “health condition” (HC). Concepts that were linked to the not-yet developed ICF component personal factors were coded with PF. Concepts found to be not covered by the ICF were coded NC. To differentiate between activities and participation, we chose the approach of partial overlap of ICF chapters within this component to be either activities or participation or both (1). In the component activities and participation, concepts marked with either A or P relate only to activities or participation, respectively; concepts marked with both A and P relate to both activities and participation.

Course of the diseaseHC       
Mismatch between laboratory results and subjective symptomsHC       
Experience of positive aspects of the disease (challenge, different way of experiencing life)PF       
Learning to handle the disease and being in controlPF       
Own attitudes towards
 SLE (personalized)PF       
 DrugsPF       
 Other peoplePF       
 ProfessionalsPF       
Loss of timeNC       
Took a long time until diagnosisNC       
Giving up career plansNC       
Thoughts about heredity transmissionNC       
Experience of giving birth to a child is different because of the higher riskNC       
Anxiety of partner and familyNC       
Employers' policiesNC       
Body image and appearanceb1801       
Self-confidenceb1266       
Gaining/losing weightb530     
Fatigue, weakness, and need for restb130, b4552  
Fever, chillsb550  
Emotional functionsb152
Memory and attention functionsb144, b140 
Painb280 
Sleepingb134      
(Central) nervous systems1, b1 
Skins810, b8 
Hairs840, b8  
Eyess220, b210   
Vesselss4101, s4102, s4103, b415 
Bloodb430  
Immune systemb435, s420  
Peritoneums540    
Lungs4301, b440  
Cardiovascular systems410–s430, b410–b420      
Hearts4100, b410    
Kidneyss6100, b610, b545 
Swelling of body partsb545      
Jointss7701, b710, b715 
Back/spines7600      
Muscle powerb730   
Sensations in fingersb780   
Inflammation and stiffnessb7800       
Reproductive functionsb640–b670      
Focusing attention while completing a taskd160 (A)       
Inability to manage the workloadd230 (A)      
Mental and physical stressd2401 (A)       
Lifting and carryingd430 (A + P)      
Functions of hand and arm and fine motor functionsd445, d440 (A + P)       
Turning and twistingd4453 (A + P)      
Holding and lifting a cupd4401, d4300 (A + P)      
Walking including stairs and runningd450, d4551 (A + P)      
Lying in bed, getting up, and standing upd4100, d4104, d4150 (A + P)       
Driving a card4751 (A + P)       
Using public transportationd4702 (A + P)       
Dressingd540 (A + P)      
Shoppingd6200 (A + P)       
Preparing mealsd630 (A + P)       
Doing houseworkd640 (A + P)      
Shaking handsd7105 (P)       
Intimate relationshipsd770 (P)       
Leisure activitiesd920 (P)      
Appointments with friendsd9205 (P)       
Going on holiday (especially in a hot climate)d920 (P), e225       
Sportsd9201 (P)      
Paid work and occupational imbalanced850 (P)      
Schoold820 (P)       
Working on a computerd810 (P), e135       
Drugse1101       
Food and nutritione1100       
Assistive products and devices in daily lifee1151       
Access to buildingse150       
Loss of incomee1650       
Climate and sune225       
Support of
 Partnere310       
 Familye310, e315       
 Professionalse355, e360       
 Specialized professionals for SLEe355       
 Assistant for houseworke340       
 Self-help groupse325       
Wrong treatment through uninformed professionalse355       
Attitudes of
 Partnere410       
 Familye410, e415       
 Friendse420       
 Colleaguese425       
 Other peoplee445       
 Other childrene4       
 Informed and uninformed peoplee4       
 Professionalse450, e455       
 Societye460       
Policies of institutions and authoritiese5802, e5       
Policies of insurance companiese5802       
Institutions of the health care system: working together of specialists in hospitalse580       

Agreement between the investigators.

The kappa statistic for agreement between the 2 investigators in linking the concepts to the ICF was 0.74 (P < 0.0001). Thus, the kappa coefficient exceeded 0.61, which has been regarded as moderate to good.

Linking of the concepts to the ICF.

The concepts are presented in Table 2 according to the model of the ICF: 28 concepts were linked to ICF categories in the component body functions and structures, 24 concepts were linked to ICF categories in the component activities and participation, and 25 concepts were linked to ICF categories in the component environmental factors. The concepts “experience of positive aspects of the disease (challenge, different ways of experiencing life)” and “learning to handle the disease and being in control” were linked to the not-yet developed ICF component personal factors. The ICF covers attitudes of others such as family members, friends, or society as environmental factors, but not the attitudes of the individual with the disease. Therefore, we linked the concepts “own attitudes towards SLE, drugs, other people, and professionals” to personal factors.

It is very interesting that some participants personalized the disease in a homunculus-like fashion and regarded this SLE homunculus as a part of their own person, as best illustrated by the already-cited statement, “recently, ‘Lupey,’ as I call him [the disease] fondly, has become a part of myself.” Others reported that they had deliberately avoided integrating this SLE homunculus into their lives: “I have accepted the diagnosis now, but I don't let this disease dominate me, ‘he’ is here, I care for ‘him,’ but ‘he’ is no longer the most important part of my life…this is my attitude, it depends a lot on one's attitude towards the disease.”

The concepts “course of the disease” and “mismatch between laboratory results and subjective symptoms” were linked to the health condition. These 2 concepts included flares, symptoms appearing or disappearing suddenly, constantly changing symptoms, symptoms changing from one part of the body to another part, and feeling well then. The concepts “loss of time,” “took a long time until diagnosis,” “giving up career plans,” “experience of giving birth to a child is different because of the higher risk,” “thoughts about hereditary transmission,” “anxiety of partner and family,” and “employer's policies” were found to be not covered by the ICF.

Instrumental coverage of concepts derived from the focus groups.

The number of concepts in each component of the ICF is presented in Figure 1, as well as the number of concepts covered by the activity scores, the SDI score, and the SF-36. The SF-36 covers 3 concepts of the component body functions and structures that are also covered by the activity scores (overlap).

The concepts and their representation in the instruments are shown in Table 2. Of the 92 concepts, the majority (62%) were found to be not covered by any of the suggested instruments. However, there were important differences between the components (Table 2). Of the 28 concepts in the component body functions and structures, 24 (86%) were covered by disease activity and/or the SDI, with considerable overlap. In addition, the SF-36 also included 3 concepts from this component, all of which were also covered by the activity scores. In addition, however, the SF-36 covered 9 (38%) of 24 concepts of the component activities and participation.

As expected, environmental factors were not at all covered in any of the selected instruments. However, several environmental factors apparently were very important for SLE patients, in particular, support and attitudes of other persons. An example is the following meaning unit: “I remember when I went somewhere on summer holidays, … and I had all these spots and pimples on my skin, on nearly every part of the body. Then it bothered me when other people turned around and looked, … It is so easy in society, you will be labeled, as if someone said: look at her, she has got AIDS [acquired immunodeficiency syndrome].”

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

This focus-group study, in the process of developing an ICF core set for SLE, is the first qualitative attempt to comprehensively explore the perspective of patients with SLE. In addition, we used the newly gained information to assess the extent to which standard instruments used in today's SLE clinical trials cover the spectrum of problems.

The patients with SLE in our focus groups, however, verbalized an amazingly high number of concepts belonging to the physical domain body functions and structures. This is in line with the report of a quantitative survey about the unmet needs of persons with SLE (54), where essentially all but one unmet need of patients with SLE would link to body functions and structures. For the concepts on body functions and structures derived from the focus groups, it is reassuring that these were largely covered by the commonly used SLE activity indices, as well as by the SDI. Indeed, some concepts, which were related to damage but not directly related to disease activity, were appropriately picked up by the damage index only, thus largely completing the picture (Table 2).

However, at least 2 important concepts in the component body functions and structures are not covered by any of the instruments, namely, body image and appearance and self-confidence. Because the skin problems (structure and functions of the skin) covered in every SLE activity score may commonly affect both, these concepts should probably be examined, given statements in several focus groups. One rather drastic example is the following meaning unit: “They said ‘tomato-face’ [because of the red face] to me–it was a joke, but it affected my self-confidence. I also had no hair at that time because of the chemotherapy; I had to wear a cap on the head.” We therefore think that in clinical practice and research, for the subset of patients with SLE with skin disease, an instrument for assessing the consequences of skin (and perhaps mucosal) involvement would be helpful. Although this has not been formally investigated, it is possible that the more general Dermatology Life Quality Index (55) might suit this role.

Despite this limitation, body structures and functions are fairly well covered. In contrast, for the other ICF components, the conventional instruments were much less successful. The SF-36 still covered almost 40% of the 20 concepts with regards to activity and participation, and thus proved a useful tool. However, several important concepts are not covered. It is here that questionnaires targeting more specific problems relevant to patients with SLE in clinical practice, such as the HAQ focusing on functioning of patients with arthritis (27), the fatigue severity scale, and depression scales, may find their relevant places. All of these have appropriately been used in some clinical studies (14, 22).

Finally, not unexpectedly, there is a total lack of representation of environmental and personal factors, both of which are very important to patients with SLE. It appears that there is a need for assessing the environmental factors pertinent to patients with SLE. By developing the ICF core set for SLE, we may get closer to this target even though the ICF core set is not an instrument, because it should be a solid base on which the actual instrument for such assessments could be modeled.

Because functioning is understood in the ICF as the umbrella concept covering body functions and structures, and activities and participation, not in the form of a fixed state but rather as the result of a dynamic interaction between the health condition, the environment, and the person, environmental and personal factors may play an important role in assessing functioning. This is reflected in several instruments, such as the HAQ, which covers environmental factors (56) or specific instruments assessing the impact of environmental factors, for example, the use of assistive devices on functioning in daily life (57).

In this regard, it is interesting that, in the focus groups, each environmental factor could have both positive and negative aspects, even for one and the same participant. Examples were medications, which both control the disease and have side effects, and the patient's partner, who cares for the patient but is also overprotective or affected with fear and anxiety. To some degree, such ambiguity of environmental factors is reflected in the ICF, in that an environmental factor can be classified either as facilitator or barrier. However, a factor still cannot be classified as both facilitator and barrier in one and the same patient, although it may be an important aspect in clinical practice of health professionals to take the possible ambiguity of environmental factors into account.

The size and number of focus groups is a critical detail of such a study. At an average, 4–5 individuals participated in the focus groups, because many patients who had agreed to participate and had given their written informed consent did not arrive for the group meeting. We thought that a maximum number of 7 individuals in one group would have been too high for this study, given that many patients with SLE told longer individual stories, when compared with patients with rheumatoid arthritis or psoriatic arthritis in similar focus groups (41,32). However, this may also cause bias. We could not exclude that patients with SLE who did not arrive for the group meeting would more likely be those with involvement of the CNS or other vital organs and those with frequent flares. Therefore, to better capture such problems, we performed one focus group meeting in the rheumatology ward in our hospital, and specifically invited inpatients to participate. Although the overall increase in concepts was minimal, this approach indeed added several CNS-related concepts. This unconventional approach was therefore consistent with the maximum variation strategy in our sample.

Other than this focus group, we have not undertaken any attempts to include acutely ill patients with SLE. Although this is a limitation of the study to some degree, it appeared acceptable in view of both feasibility issues and added value: there can never be focus groups with several severely sick patients with SLE in an intensive care ward, and such periods are very limited, as compared with the overall time span in which patients live and cope with their SLE. Finally, if memory of such dramatic events is an important issue, such memories should still come up in the focus groups.

In conclusion, body functions and structures is the ICF component that covers most of the concepts important to patients with SLE. The high number of concepts regarding body functions and structures suggest that these are of particular importance for patients with SLE. Overall, SLE activity scores and the SDI cover these concepts remarkably well, whereas the SF-36 addresses a considerable number of the concepts in activity and participation, and may be supported by problem-specific questionnaires, such as the HAQ, or depression scales. In contrast, environmental factors, which likewise obviously play an important role, are not covered by any of the instruments. An appropriate instrument should be developed.

AUTHOR CONTRIBUTIONS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

Dr. Stamm 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 design. Stamm, Stucki, Aringer.

Acquisition of data. Stamm, Bauernfeind, Mathis.

Analysis and interpretation of data. Stamm, Coenen, Feierl, Machold, Aringer.

Manuscript preparation. Stamm, Bauernfeind, Coenen, Feierl, Mathis, Stucki, Smolen, Machold, Aringer.

Statistical analysis. Stamm, Coenen.

Acknowledgements

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES

We thank Herta Resch from the Department of Rheumatology of the Medical University of Vienna, Austria, for her excellent transcriptions of the focus groups.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. PATIENTS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. AUTHOR CONTRIBUTIONS
  8. Acknowledgements
  9. REFERENCES
  • 1
    World Health Organization. ICF: International Classification of Functioning, Disability and Health. Geneva: World Health Organization; 2001.
  • 2
    Stucki G, Grimby G. Applying the ICF in medicine. J Rehabil Med 2004; 44 Suppl: 56.
  • 3
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