Fibromyalgia Fatigue: Development of a Conceptual Model based on Qualitative Patient Interviews

Transcription

1 Fibromyalgia Fatigue: Development of a Conceptual Model based on Qualitative Patient Interviews Louise Humphrey, Mapi Values Rob Arbuckle, Mapi Values Philip Mease, Seattle Rheumatology Associates David Williams, University of Michigan Bente Danneskiold-Samsoe, Copenhagen University Hospital Claire Gilbert, Pfizer The Background Fibromyalgia (FM) is a chronic disorder characterised by widespread pain and tenderness Prevalence estimates in adults range from % in North America and the EU (1-7) 2 1

2 The Background In addition to pain, FM symptoms can include: fatigue sleep disorders headaches memory or concentration problems mood disturbances, and stiffness FM can have considerable impact on FM patients daily lives (8) 3 The Background There is growing consensus amongst patients and experts that fatigue is a key symptom for FM and an important domain to measure in clinical trials (8-12) Delphi Panel Study (13;14) OMERACT Research (15) 4 2

3 The Challenge Like pain, the measurement of fatigue relies on patient report Existing fatigue measures such as the MFI and the MAF have been used extensively in FM clinical trials (16;17) But current fatigue measures have not been validated in an FM population 5 The Challenge Thus, in-depth, qualitative research is needed that focuses on exploring the experience of FM fatigue 6 3

4 Research Aims To conduct in-depth interviews to support the development of an FM fatigue conceptual model This model could be used to support the selection or development of PROs for FM fatigue 7 Sampling 40 FM patients recruited 20 from the US 10 from Germany 10 from France A multi-national, cross-cultural sample was used to increase the likelihood that findings could be generalised across cultures and languages 8 4

5 Sampling Key Inclusion Criteria 1. At least 18 years of age 2. Must meet the American College of Rheumatology (ACR 18 ) criteria for FM 3. Must be willing and able to participate in a 90-minute interview Key Exclusion Criteria Any significant physical or psychiatric co-morbidity (including other severe pain) that might interfere with their experience of, or ability to talk about, FM. Of note, participants were not required to experience fatigue they were only required to have a diagnosis of FM 9 Interview Method A semi-structured qualitative discussion guide was developed Part 1: Initial open-ended questions to avoid biased discussion of the topics of interest Tell me about your experience of having fibromyalgia? Picture/collage task Animal analogy Part 2: Direct questioning used only if topics of interest did not arise in Part

6 Demographic Characteristics Sample Demographics (Patient Reported) Age (years) Mean Median Min, Max US (n=20) ,69 Germany (n=10) ,58 France (n=10) ,58 Total (n=40) ,69 11 Demographic Characteristics Sample Demographics (Patient Reported) % (n) Gender Male Female US (n=20) 25 (5) 75 (15) Germany (n=10) 50 (5) 50 (5) France (n=10) 20 (2) 80 (8) Total (n=40) 30 (12) 70 (28) 12 6

7 Demographic Characteristics Sample Demographics (Patient Reported) % (n) Ethnicity Hispanic Caucasian African American Asian Oriental or Pacific Islander Other US (n=20) 0 (0) 80 (16) 10 (2) 0 (0) 10 (2) Germany (n=10) 0 90 (9) (1) France (n=10)* Total (n=40)* (25) 6.7 (2) (2) *Ethnicity data not collected in France as deemed inappropriate to ask for this information so total for ethnicity n=30 13 Clinical Characteristics Patient Reported FM Symptom Severity: 0-10 Numerical Rating Scale (NRS) US (n=20) Germany (n=10) France (n=10) Total (n=40) 0-10 NRS Pain Fatigue Difficulty Concentrating Difficulty Doing Daily Activities 14 7

8 Patient Experience of Fibromyalgia Tell me about your experience of FM (n=40) Pain Fatigue Sleep Problems Mobility Problems Difficulty getting up in the morning Well, it s painful, it s tiring, exhausting even. It s yeah, it controls your entire life. Well, my fibromyalgia, for the most part, consists of fatigue, overall muscle aches, very sore spots beyond the muscle aches, and then problems sleeping from the pain. US = German = French = Patient Experience of Fibromyalgia Picture/Collage Task (n=40) Pain-related concepts (n=18, 45%) Fatigue/tiredness (n=10, 25%) This reminded me of how I get up, not feeling rested and in pain. And this one is me after a day, just wiped, completely wiped. I don t feel like I m up to my full potential, I feel like everything seems to be a heavier load than it should be And the fatigue makes you feel that way, too. It s like something is weighing you down, keeping you from doing something. 16 8

9 Patient Experience of Fibromyalgia Animal Task (n=38) I don't know, the sloth for example!... Because I'm sluggish no matter what I'm doing, that's it! I would probably choose a tortoise, because it makes such slow progress and always has to lug its shell around with it like a big burden. My mind went to something like a hippopotamus or something slow-moving and big and heavy. A walrus because they re just dragging their bodies around when they re on land. Interviewer: What symptoms are you thinking about when you talk about that or what is it that you re thinking about? Patient: The fatigue. 17 Patient Experience of Fibromyalgia Animal Task (n=38) Concept US (n=20) Germany (n=10) France (n=10) Total (n=40) Fatigue or Tiredness 12 Sloth, Elephant, Cat, Hippopotamus, Walrus, Rhinoceros Tortoise 2 6 Turtle, Sloth Parasite, Monkey, Crocodile 20 Pain-Related Porcupine, Lion, Dog Mouse, Wolf, Lion, Turtle, Armadillo, Lizard Turtle, Spider, Monkey, Bull Sneaky or Unpredictable 3 Wolf, Snake 3 Cat, Panther, Lizard, Armadillo, Pole Cat

10 Conceptual Model of FM Fatigue Overwhelming feeling of tiredness Not relieved by resting or sleeping Not proportional to effort exerted Feeling of weakness/heaviness Difficult to get motivated Difficulty doing the things they want to do or having to do things more slowly Difficult to concentrate, think or remember things Frequency Fatigue Descriptors Severity Varies from day to day, unpredictable Lack of energy, Exhaustion, Heavy body, Muscle fatigue, Low motivation, Tiredness, Fatigue Primarily in terms of impact on difficulty performing day to day tasks 19 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted N of subjects who talked about each fatigue characteristic Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping Having to do things more slowly you can t think and you can t hear, and everything s grey

11 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted N of subjects who talked about each fatigue characteristic Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping Having to do things more slowly whereas in this case you ve done nothing, you shouldn t feel tired, but you do, you re weary, completely lethargic. 21 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted N of subjects who talked about each fatigue characteristic Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping Having to do things more slowly...so you are too tired to go shopping, for example 22 11

12 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping Yes, well, the N of subjects who talked about each fatigue characteristic lack 20of enthusiasm which I have, that I have to overcome to motivate myself into doing something. Having to do things more slowly 23 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping N of subjects who talked about each fatigue characteristic Your whole body feels really heavy, like I was saying about the cement suit thing. I just feel like there s a real heaviness to it. Having to do things more slowly 24 12

13 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping N of subjects who talked about each fatigue characteristic You re that tired, it s this big oppressive it s like a blanket and it wraps you up...it s overwhelming Having to do things more slowly 25 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping N of subjects who talked about each fatigue characteristic I could sleep 20 hours and still be tired. That is terrible. Having to do things more slowly 26 13

14 Findings to support the Conceptual Model US = German = French = Difficult to concentrate, think or remember things Not proportional to effort exerted Difficulty doing the things they want to do Difficult to get motivated Feeling of weakness or heaviness Overwhelming feeling of tiredness Not relieved by resting or sleeping N of subjects who talked about each fatigue characteristic Because I'm sluggish no matter what I'm doing, that's it! I need more time doing things now that took me 5 minutes before! Having to do things more slowly 27 What terms do US FM patients use to describe their fatigue experience? TIRED/ TIREDNESS n=20 FATIGUE n=20 Just very tired, and just really no energy, energy level very low GET TIRED EASILY n=

15 What terms do US FM patients use to describe their fatigue experience? TIRED/ TIREDNESS n=20 FATIGUE n=20 GET TIRED EASILY n=17 And I m just very fatigued. Take my shower, get myself ready, go to work. And at work I just still can t wake up. I just don t feel like I m fully awake. I m very not sleepy so much but just tired. 29 What terms do US FM patients use to describe their fatigue experience? TIRED/ TIREDNESS n=20 FATIGUE n=20 GET TIRED EASILY n=17 And it s an effort to do anything and over time it s like, I don t know, you just get so tired it s like why even bother to do anything 30 15

16 What terms do German FM patients use to describe their fatigue experience? NO ENERGY/LACK OF ENERGY n=8 TIRED/TIREDNESS n=9 SHATTERED n=5 In the mornings I have problems getting out. It takes so long for me to get going and summon up some energy. 31 What terms do German FM patients use to describe their fatigue experience? NO ENERGY/LACK OF ENERGY n=8 TIRED/TIREDNESS n=9 SHATTERED n=5 I can t perform as well as I would like to and that I can t give as much attention to things as I would like to. For example, I would like to read books but I real problems because I get tired so quickly after a couple of pages

17 What terms do German FM patients use to describe their fatigue experience? NO ENERGY/LACK OF ENERGY n=8 TIRED/TIREDNESS n=9 SHATTERED n=5 the bad days are really bad, it is almost impossible to describe. It is simply that I lie in bed, really ill, feeling totally worn out and shattered. 33 What terms do French FM patients use to describe their fatigue experience? FEELING DRAINED n=4 I'll be fifty-seven years old next month, so before I handled things a lot better, and now I feel really drained! GET TIRED EASILY n=4 WORN OUT n=

18 What terms do French FM patients use to describe their fatigue experience? FEELING DRAINED n=4 GET TIRED EASILY n=4 WORN OUT n=6 Walking is a huge effort you see! It's a challenge for me I mean I practically almost have to go beyond myself! I truly feel handicapped in this respect I mean it's a handicap for me 35 What terms do French FM patients use to describe their fatigue experience? FEELING DRAINED n=4 GET TIRED EASILY n=4 WORN OUT n=6 Well, it s the wear, wear, wear, wear, wear! I m so worn down; I ve pushed myself so much, tried so hard and been so worn down 36 18

19 Most common terms used to describe fatigue experience in all 3 countries Tired/ tiredness n=32 Get tired easily n=25 Feeling weak n=11 No energy/ lack of energy n=25 Worn out n=12 TERMS USED BY PATIENTS TO DESCRIBE FATIGUE EXPERIENCE Overwhelming feeling of tiredness n=17 Exhaustion n=13 Fatigue n=20 Tired despite rest n=15 Feeling drained n=11 37 Analysis of Country Differences Fatigue was frequently and spontaneously reported in all 3 countries US participants the most, followed by the German sample, and least by the French participants All model concepts were mentioned in all 3 countries Thus supporting concepts of FM fatigue being relevant to all country samples 38 19

20 FM Fatigue Pain is the primary symptom of FM but Fatigue/tiredness is an important symptom which has considerable impact on patients lives Fatigue/tiredness was not an inclusion criterion, yet all participants reported experiencing it 39 Implications for Future Research How should we measure fatigue? Different people use different terms to describe the same thing: energy: mental vs. physical fatigue? Language differences A direct translation for the word fatigue does not appear to exist in German or French 40 20

21 Implications for Future Research How should we measure fatigue? Nevertheless, consistently fatigue/tiredness was described as being worse than normal tiredness and referred to using characteristics in the model A possible solution? Develop items that ask about the different characteristics of fatigue/tiredness and use the different patient descriptors in the wording of those items Fatigue: A multi- or uni-dimensional concept? 41 Overall Summary Fatigue/tiredness is an important symptom for FM (in addition to pain) Many terms are used when describing the experience of fatigue/tiredness FM fatigue/tiredness is worse than normal tiredness The conceptual model captures the elements of FM fatigue/tiredness that distinguish it from normal tiredness 42 21

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