CE interviews
In June and July 2014, 41 patients with SLE completed CE interviews. Of these, 33 patients had a clinical record of steroid use in the previous year and completed interview questions about their experiences with steroids. The majority were female (97%), 50% were Caucasian, and 31% were African American; 19 patients were currently receiving steroids, with a mean (standard deviation) dose of 8.7 (5.35) mg/day (
n = 18). The majority (82%) of patients were currently receiving concomitant medication, of which hydroxychloroquine was the most common (67%). Mean time since diagnosis was approximately 88 months (
n = 17). Rheumatologists reported that approximately half (
n = 17) of patients had moderate SLE and one patient had severe SLE. In the majority of cases, patients reported that it was the decision of the rheumatologist to initiate steroids (82%) and three patients (18%) stated that they made the decision jointly with their rheumatologist. The most common reason for initiating steroids was to treat an SLE flare (Table
1).
Table 1
Demographics and baseline clinical characteristics
Gender, % (n) |
Male | 3 (1) |
Female | 97 (32) |
Mean age (SD), years | 47.0 (11.13) |
Age range, years | 24–71 |
Ethnicity, % (n/N) |
Caucasian | 50 (16/32) |
African American | 31 (10/32) |
Asian | 3 (1/32) |
Latino/Hispanic | 13 (4/32) |
Other | 3 (1/32) |
SLE severity during 6 months prior to baseline, % (n) |
Mild | 45 (15) |
Moderate | 52 (17) |
Severe | 3 (1) |
Mean SELENA-SLEDAI (SD) (n = 30) | 6.8 (3.36) |
Mean SLICC (SD) (n = 18) | 5.8 (1.54) |
Current SLE treatment, %b (n) |
Hydroxychloroquine | 67 (22) |
Belimumab | 18 (6) |
NSAIDs | 15 (5) |
Methotrexate | 12 (4) |
Currently receiving steroids, % (n) | 58 (19) |
Average steroid dose of current users (n = 18), mg/day | 8.7 ± 5.35 (range: 4–20) |
Mean (min, max) duration of steroid use (n = 23), months | 41.7 (0.2, 144) |
Reasons for initiating steroid use, % (n/N) |
To treat an SLE flare | 26 (5/19) |
To control swelling (hands or other body parts) | 16 (3/19) |
To treat joint pain and stiffness | 16 (3/19) |
To treat autoimmune thrombocytopenia/low platelet count | 16 (3/19) |
The concepts mentioned with high frequency during the CE interviews are shown in Table
2. The most commonly reported side effects (≥10% of patients) were weight gain (67%), swelling/moon face (36%), mood swings/feelings of rage (21%), and difficulty sleeping (12%). Of patients currently taking steroids, 53% reported that they were not currently experiencing any side effects.
Table 2
Concepts discussed during CE interviews
Before receiving steroids |
Potential side effects discussed | 71 (12/17) |
Had expectations of the side effects | 59 (10/17) |
Perceived advantages of taking steroids |
It would be effective | 31 (5/16) |
Would have more energy | 25 (4/16) |
Would have less joint pain | 25 (4/16) |
Perceived disadvantages of taking steroids |
Weight gain | 56 (9/16) |
Potential long-term side effects eg, kidney problems and bone loss | 38 (6/16) |
After receiving steroids: side effects |
Expectations about side effects did not match experienceb
| 50 (8/16) |
Most commonly reported side effects (reported by ≥10% of patients) |
Weight gain | 67 (22/33) |
Swelling/moon face | 36 (12/33) |
Mood swings/feelings of rage | 21 (7/33) |
Difficulty sleeping | 12 (4/33) |
Most bothersome side effects |
Weight gain | 64 (14/22) |
Sleeplessness | 14 (3/22) |
After receiving steroids: dosage |
Have received a higher dose than they typically/currently take | 85 (22/26) |
Have received a lower dose than they typically/currently take | 38 (10/26) |
Stopped or changed dose without consulting physician | 30 (8/27) |
Satisfaction with steroid treatment |
Overall satisfied with steroids | 75 (12/16) |
Would be happy if treatment regimen did not include steroids | 67 (12/18) |
When asked how taking steroids made them feel (n = 19), in general, patients reported symptom improvement and increased energy. For example, one patient stated, “I just felt like, you know like how you would feel on a really good day, you know you had the best night’s sleep and everything is going right, you’re having a great day and you have all the energy you need, the sun is shining. That’s what it was like.” However, the negative impacts of steroids were also described, for example, “The prednisone really helped the symptoms, but it made me feel sicker. Like you know the flares went away, but then I was overweight and bloated and you know my joints were swollen from the water. So I felt sicker even though I wasn’t having like you know massive flares.”
When asked to put into one sentence their feelings about steroids (n = 16), many patients reported mixed feelings; steroids improved their SLE symptoms, but at the cost of experiencing side effects. For example, patients responded, “I think they’re a two-edged sword because on one hand they help you and on the other hand they hurt you” and “I have a love/hate relationship with them.” Overall, 75% of patients were satisfied with steroid treatment, while 67% of patients would be happy if they no longer needed to take steroids.
Development of the SSQ
Based on analysis of the CE transcripts, a draft version of the SSQ was developed. Two rheumatologists then made minor revisions to the SSQ. For example, for consistency, items about side effects and benefits were revised to use the same response options. Additionally, a new item was added to assess the highest dose of steroids ever received and another item was added to enquire about feeling nervous or anxious.
The resulting draft questionnaire contained 51 items, which assessed steroid dose and duration (4 items), impact of steroids in general (18 items), benefits of steroids (8 items), work/productivity (3 items), side effects (10 items), emotions (7 items), and overall satisfaction (1 item).
CD interviews and questionnaire refinement
To assess the content and clarity of the draft questionnaire, 13 patients with mild to moderate SLE completed CD interviews; 7/13 were currently treated with steroids and the other 6/13 had taken steroids within the past year. Interviews focused on questions that could have been challenging. For example, the question, did you experience reduced or less muscle pain or achiness?’ was debriefed, as it was thought that the term ‘achiness’ may have been difficult to understand.
All patients asked (n = 12) were able to accurately paraphrase the instructions on the SSQ and none (n = 10) had any suggestions for revisions.
The first four items in the SSQ ask about steroid dose and duration of treatment. Although all patients asked (n = 9) felt that it was easy to remember their current dose, 50% (5/10) of patients asked thought it was difficult to remember their highest dose.
Eighteen items ask patients about their general experience of steroids, including the benefits and side effects of steroids and the impacts of steroids on their daily life 75% of patients reported that it was easy to think about this. Fourteen items refer to specific benefits and side effects of taking steroids. When asked how easy or difficult it was to know if they were experiencing a side effect or benefit due to taking steroids or something else, 70% (n = 7/10) thought it was easy for most questions. Three patients thought that for more than one question it was difficult to know if the side effect was due to steroids; these included questions assessing energy level, mood, memory, daily activities, leisure activities, and desire to be intimate. For example, one patient responded: “But, you know, when it comes to like my energy level I don’t know if that’s the steroids or the Lupus. The memory, I don’t know if that’s really with the two of them, or one of them, or…you know, some of them I don’t really know if it’s the steroids, the Lupus, or another medication that I might be on.” Of patients who reported swelling or ‘moon face’, mood swings or feelings of rage, and weight gain, the majority (≥75%) reported that these occurred while on higher doses of steroids than while on their current dose. Some patients with mild SLE felt that some items were not relevant to them because they had not experienced them. For example, two patients reported having no difficulty sleeping and one patient reported not experiencing an increased appetite, feeling nervous/agitated, having a loss of memory, or being unable to concentrate.
When asked what time frame they considered when answering the questions on side effects, 71% of patients (n = 5/7) thought about the past 7 days, while 29% (n = 2/7) thought about the time since they first started taking steroids or in general. These results supported using a 7-day recall period for questions regarding steroid benefits and side effects in the second draft of the questionnaire. This time frame was also selected as it was considered to be short enough for patients to accurately recall their experiences, but long enough to ensure that a representative picture would be captured.
Seven items covered the range of emotions experienced in the last 7 days; most patients (n = 5/8) did not think there were any missing items. One patient suggested adding an item on feeling helpless or incapacitated, one suggested an item about feeling anxious, and one suggested an item about feeling stressed. As these items were suggested by a small number of patients, they were not added to the questionnaire.
Overall, respondent feedback was that the draft SSQ was comprehensive, clear, and relevant.
Based on the CD interviews, minor modifications were made to the SSQ to improve the clarity, including adding examples of side effects to the questions regarding short- and long-term side effects.
Minor changes were also made to the SSQ based on the translatability assessment. For example, the wording of the instructions “You may have been taking steroids for a short period of time or on and off for many years” was modified to “You may have been taking steroids for a short period of time, a long period of time, or you may have started and stopped steroids many times”, as the term “on and off” is difficult to translate into Japanese and German.
The refined SSQ contains 50 items; sample questions are shown in Table
3. Questions regarding the general impact of steroids do not specify a recall period and typically provide five response options, for example, much better, somewhat better, the same, somewhat worse, much worse. The majority of questions regarding the benefits and side effects of steroids use an 11-point numeric rating scale ranging from 0 (absent/did not have) to 10 (worst imaginable).
Table 3
Concepts included in the refined SSQ and sample questions
Steroid dose/duration (4) | What dose of steroids are you currently taking for lupus? | ______mg/day OR ______mg ________(insert frequency, such as every day) OR _______ mg as needed OR □ I am not sure of my current dose |
General impact of steroids (baseline burden; 19) | In general, since you began taking steroids: |
Do you feel that steroids have made your lupus symptoms…? | a) Much better b) Somewhat better c) The same d) Somewhat worse e) Much worse |
How much of the time have you worried about short-term side effects of steroids (weight gain, mood changes, etc.)? | a) None of the time b) A little bit of the time c) Some of the time d) Most of the time e) All of the time |
Benefits of steroids (7) | While taking steroids for lupus in the past 7 days, to what degree did you experience joint pain? | 0 Absent/Did not have | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 Worst imaginable |
Work/productivity (3) | While taking steroids for lupus in the past 7 days, to what degree did you experience improved productivity at work? | a) Not at all b) A little c) Somewhat d) Quite a bit e) Very much |
Side effects (10) | While taking steroids for lupus in the past 7 days, to what degree did you experience increased appetite? | 0 Absent/Did not have | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 Worst imaginable |
Emotions (6) | While taking steroids for lupus in the past 7 days, how much of the time did you feel aggressive? | a) None of the time b) A little bit of the time c) Some of the time d) Most of the time e) All of the time |
While taking steroids for lupus in the past 7 days, how much of the time did you feel self-confident? | a) None of the time b) A little bit of the time c) Some of the time d) Most of the time e) All of the time |
Overall satisfaction (1) | Overall, how satisfied have you been with how well steroids control your lupus symptoms? | a) Very satisfied b) Satisfied c) Neither satisfied nor dissatisfied d) Dissatisfied e) Very dissatisfied |