Understanding the impact of non-alcoholic steatohepatitis with metabolic comorbidities on adults: a real-world qualitative study

Figures & data

Table 1. Study inclusion and exclusion criteria.

Inclusion criteria

Exclusion criteria

Confirmed or suspected diagnosis of fibrosis stage F1, F2, or F3^31 NASH as determined within the past 2 years by either biopsy or transient elastography (FibroScan) or an ultrasound Adults ≥18 years of age BMI ≥27 kg/m^2 and ≤50 kg/m^2 At least one of the following comorbidities: T2D, hypertension, or dyslipidemia Able to read, speak, and understand English Willing and able to provide written informed consent Willing and able to be audio-recorded for a virtual (webcam or telephone) one-on-one interview lasting approximately 60 minutes

Liver disease from causes other than NASH: alcohol consumption (>14 drinks/week for females, >21 drinks/week for males), alcoholic liver disease, viral/mumps hepatitis, HIV/AIDS, Wilson disease, autoimmune/chronic toxic hepatitis, Gaucher disease, lysosomal acid lipase deficiency, or primary biliary cholangitis Liver cirrhosis Prior bariatric surgery Liver transplant Participation in a clinical trial for NASH Visual or hearing problems, mental illness, or cognitive impairments that might have interfered with the ability to participate in the study

BMI body mass index, HIV/AIDS human immunodeficiency virus/acquired immunodeficiency syndrome, NASH non-alcoholic steatohepatitis, T2D type 2 diabetes.

Table 2. Participants’ sociodemographic and clinical characteristics.

Variable	Total (N = 20)
Age, years, mean (SD)	42.4 (15.6)
Gender, n (%)
Male	9 (45.0)
Female	10 (50.0)
Non-binary	1 (5.0)
Ethnicity, n (%)
Hispanic or Latino	9 (45.0)
Non-Hispanic or Latino	11 (55.0)
Race, n (%)
White	15 (75.0)
Asian	2 (10.0)
American Indian or Alaska Native	1 (5.0)
Hispanic	2 (10.0)
Level of education, n (%)
High school	4 (20.0)
College or higher and technical/vocational	16 (80.0)
NASH diagnosis, n (%)
FibroScan	11 (55.0)
Liver Biopsy	9 (45.0)
Fibrosis stage, n (%)
F1	3 (15.0)
F2	9 (45.0)
F3	8 (40.0)
Time since diagnosis, days, mean (SD)	127.8 (114.2)
BMI, kg/m^2, mean (SD)	36.4 (6.5)
Comorbidities, n (%)^a^,b
T2D	11 (55.0)
Hypertension	11 (55.0)
Dyslipidemia	10 (50.0)

BMI body mass index, n number of participants, N total number of participants, NASH non-alcoholic steatohepatitis, SD standard deviation, T2D, type 2 diabetes.

^a Comorbidities based on the three conditions for participant eligibility; this did not represent all possible diagnoses or conditions that participants may have experienced.

^b Responses were not mutually exclusive.

Table 3. Summary of key and frequently endorsed NASH symptoms with example quotes from study participants.

Symptom concept	Participants endorsing symptom n/N (%)	Example quote
Key symptoms
Fatigued/ tired	15/20 (75.0)	“Yes. I constantly feel fatigued and I just haven’t gotten enough sleep, no matter what I do. I’ll wake up and it feels like all my muscles just wore out. Like I’ve gone and run a mile but I haven’t done anything.” NB_19_F2 “Just without energy. I don’t necessarily have to be functioning, like doing something to feel tired. I can just basically feel tired without doing anything.” F_53_F2
Weakness/ lethargy/ decreased level of energy	14/20 (70.0)	“Yes, lethargic overall. Like, a giant weight is setting on me.” M_54_F2 “For me it just feels like when I wake up for the day, I’ve got a lot less energy to do things in my day before I have to just sit around and do nothing. I don’t know if you’ve ever heard of spoon theory where it’s like each task you do requires a certain number of spoons and you only have so many in a day. It feels like that number went from like 20, and now I’ve got like 10.” NB_19_F2
Bloated/ swollen	13/20 (65.0)	“All the bloated or swollen feeling, it feels like somebody’s put a air hose to my stomach and just let it fill my stomach up. It really is an uncomfortable feeling.” F_47_F3 “It just makes you feel like you’re just extended, like your stomach is extended more. And just uncomfortable. It doesn’t actually hurt, hurt.” F_53_F3
Nauseous/ queasy	8/20 (40.0)	“I wake up early in the morning to go to work…leaving my house to the entrance of where I live I'm already sick to my stomach, so I have to pull over, I’m gagging. Sometimes I throw up…But it’s an intensive gag to where your chest feels like it’s going to explode and your head is exploding.” F_35_F1
Problems focusing/ concentrating	7/20 (35.0)	“During work there will be meetings that are important on a major system update or upgrade we’ll be doing or meeting with a vendor for the first time and it’ll be 20 minutes into the conversation and I’ll realize I’ve been thinking about X, Y and Z and not anything about what I need to focus on.” M_28_F1 “Sometimes I’ll ask my husband the same question like four times because I’ll sit there and think, well I’m not really sure if I asked him that or not…And then sometimes he’ll tell me stuff and it’s like I don’t have a clue that he told me.” F_53_F3
Pruritus/ itching	5/20 (25.0)	“It’s just uncomfortable because you’re already having trouble sleeping, so you get really itchy and you’re like, “Oh my God, I can’t stop scratching. But I have to lay on my hands and just not think about it, and it’s still hard because you’re like, ‘I can’t go to sleep, but I’m tired’.” F_35_F1 “It’s like a bunch of, I would say bugs crawling on you, but it’s not that. I just want to grab something and start scratching because it just itches.” F_63_F2
Frequently endorsed symptoms
Overweight	14/19 (73.7)	“I’ve gained a lot of weight from having NASH because I’m not able to go out and exercise. And it’s hard for me to eat so I’ve gained a lot of weight because my body is kind of in starvation mode. So a lot of my clothes already aren’t fitting.” NB_19_F2 “It’s just that my weight is like, you know, slowly creeping up more.” M_41_F2
Abdominal discomfort	13/19 (68.4)	“Abdominal discomfort, I usually feel that when I come in to see the doctor and she examines my abdomen or she palpates it, then I would feel discomfort.” F_27_F1 “It’s very uncomfortable. It hurts. It’s like you need to let your pants out. It just feels like there’s pressure there.” F_47_F3
Discomfort (general)	10/18 (55.6)	“It’s like a whole-body ache, basically. I think it’s like where you’re so fatigued and tired that you don’t want to do anything, but it just makes your body so sore. So I would say that it is related to NASH.” F_35_F1
Dry mouth	10/19 (52.6)	“It can get a little uncomfortable because you’re in the middle of a conversation, or just walking, and your throat just turns into a cotton ball, so I always have water with me. I think I drink like 12 bottles of water a day or more.” F_35_F1 “Well, I drink a lot of water, so it’s like constantly-but at night I wake up, and I’m very parched.” F_64_F3
Abdominal pain	9/20 (45.0)	“Yeah, it’s on the upper… right below the breast and below the rib. It starts like a dull pain, and then it turns more into almost like a cramp, but it’s not a cramp.” F_35_F1 “I used to get severe abdominal pain and I didn’t know why. Then they later told me I did have the NASH…I want to say it’s almost like a knot in my stomach.” F_53_F2
Pain (general)	9/20 (45.0)	“Pain would extend up from my back, and when I walked, when I tried to lean down to get something on the floor, I had pain…it’s in the back on the liver. I had so much pain that I couldn’t even jump…And walk and exercise. I couldn’t do nothing because of the pain…It limited me a lot.” M_44_F3 “I mean I know it’s not like an organ pain or anything like that. I just know that somehow it is directly related to this because the pain and the suffering that I feel is immediately- it’s felt immediately like I work out.” M_41_F2
Daytime tiredness	8/18 (44.4)	“So daytime tiredness to me is like, you’re going about your day and you’re like, oh I need a nap.” NB_19_F2
Shortness of breath	7/19 (36.8)	“I was feeling shortness of breath and I was – when I had my blood pressure that was high. I thought it was like something psychological or something, but I didn’t know it was about that.” F_46_F3 “…it’s mostly just been being out of, you know, being short of breath. But I think that’s just, hey, you don’t exercise and you’re overweight.” M_28_F1
Sleep problems	6/17 (35.3)	“Yes, I have those [sleep problems]. My doctor actually prescribed something for me to sleep because I would wake up in the middle of the night, my mind’s going wide open. But I never thought of it as being NASH.” F_47_F3 “So it [back pain] could be really painful, especially throughout the day. Sometimes it can hurt to lay down. I definitely don’t get any sleep, so it’s really challenging to go about your day when you’re working.” F_35_F1
Constipation	7/20 (35.0)	“It’s usually just kind of the general pressure and discomfort needing to go and not being able to go and then finally going and then not feeling as if bowel movement is complete.” F_29_F2
Decreased strength	7/20 (35.0)	INTERVIEWER: “Decreased strength?” PARTICIPANT: “It’s like low energy?” INTERVIEWER: “Is that how you think of it?” PARTICIPANT: “Like when you have like low energy?” INTERVIEWER: “Is that what decreased strength means to you?” PARTICIPANT: “Mm-hm.” F_46_F3
Heartburn	6/19 (31.6)	“Yes, I have had quite a bit of heartburn. My gastro doctor actually put me on a higher dose of the generic Prilosec, and of course told me that I needed to watch what I eat…and I was like, But I didn’t eat anything that would have triggered it.” F_47_F3 “I have acid reflux, so could be associated with that, I don’t know.” F_64_F3
Malaise or generally feeling bad	6/19 (31.6)	“Yes. I feel bad more days than I feel good, but I don’t know if that is contributed to the NASH or… like I say, it would make sense.” F_47_F3 “You feel so bad like you don’t want to do anything. You just want to sleep, but you can’t sleep. It’s hard to get motivated to do the things that you know you need to do.” F_35_F1
Muscle cramps	5/19 (26.3)	“I do have some muscle cramps in my legs, usually at nighttime.” F_71_F3 “I do have a lot of leg cramps.” F_64_F3
Other symptoms^a	15/20 (75.0)	“Yeah. I’ll wake up in the middle of the night and my pillow will actually be saturated with sweat and, I mean, I won’t really feel discomfort or anything. I’ll just notice that I’ve gotten to a little period of sweatiness.” M_54_F2 “I’ve always been kind of prone to headaches. I have light sensitivity issues…it’s causing high levels of stress so I’ve been getting stress headaches more frequently because of this condition.” NB_19_F2

n number of participants, N total number of participants, NASH non-alcoholic steatohepatitis.

Note: The participant code is provided next to each quote for easy identification. It includes the gender (female, F; male, M; non-binary, NB), age, and fibrosis stage (F1, F2, or F3): Gender_Age_Fibrosis stage.

Note: Key symptoms refer to those identified from the targeted literature review; frequently endorsed symptoms refer to those reported by five or more participants.

^a Other symptoms endorsed by less than five participants included: headache (n = 4/20; 20.0%); joint pain (n = 4/20; 20.0%); brain fog (n = 3/20; 15.0%); diarrhea (n = 3/20; 15%); dizziness (n = 3/20; 15.0%); memory problems (n = 3/19; 15.7%); frequent urination (n = 2/20; 10.0%); burning feeling in stomach (n = 1/20; 5.0%); chest pain (n = 1/20; 5.0%); feeling bruised under ribs (n = 1/20; 5.0%); sweatiness at night (n = 1/20; 5.0%); skin discoloration/jaundice (n = 1/20; 5.0%); and vomiting (n = 1/20; 5.0%).

Figure 1. Average severity ratings for key and frequently endorsed NASH symptoms. n number of participants, NASH non-alcoholic steatohepatitis. Note: Key symptoms refer to those identified from the targeted literature review; frequently endorsed symptoms refer to those reported by five or more participants. Participants were asked to rank symptom severity on a scale of 1 to 10 (1 = not severe; 10 = extremely severe).

Figure 2. Average bother ratings for key and frequently endorsed NASH symptoms. n number of participants, NASH non-alcoholic steatohepatitis. Note: Key symptoms refer to those identified from the targeted literature review; frequently endorsed symptoms refer to those reported by five or more participants. Bother rating categories were low (1-3), moderate (4-6), or high (7-10).

Table 4. Topmost bothersome NASH symptoms and impacts.

Symptom	Participants endorsing symptom, n/N (%)	Participants selecting symptom among top three most bothersome, n (%)
Most bothersome symptom
Fatigued/ tired	15/20 (75.0)	11/15 (73.3)
Nauseous/ queasy	8/20 (40.0)	5/8 (62.5)
Abdominal discomfort	13/19 (68.4)	5/13 (38.5)
Bloated/ swollen	13/20 (65.0)	5/13 (38.5)
Overweight	14/19 (73.7)	4/14 (28.6)
Weakness/ lethargy/ decreased energy levels	14/20 (70.0)	4/14 (28.6)
Most bothersome impact
Psychological/ emotional	14/20 (70.0)	11/14 (78.6)
Physical	14/20 (70.0)	6/14 (42.9)
Daily activity	13/20 (65.0)	5/13 (38.5)
Diet	13/19 (68.4)	4/13 (30.8)
Relationship/ social interaction	11/19 (57.9)	10/11 (90.9)
Economic burden	11/20 (55.0)	5/11 (45.5)
Work productivity	8/18 (44.4)	3/8 (37.5)
Depression	8/20 (40.0)	3/8 (37.5)

n number of participants, N total number of participants, NASH non-alcoholic steatohepatitis.

Table 5. Summary of the impact of NASH with example quotes from study participants.

Impact And Sub-impact	Participants Endorsing Symptom n/N (%)	Example Quote
Physical impact	14/20 (70.0)	“It’s just like I have to…it’s not as easy as it was before. I have to be careful because my back, my knees. I don’t know, I thought it was age, like I cannot do things like I used to do. I just have to be careful when lifting heavy things, bending. I thought it was normal.” F_46_F3
Vitality (i.e. energy level)	5/14 (35.7)	“It’s just most of… I would say most of the day I feel tired. I don’t have the energy to do anything, so I can’t really do house chores after work. Or even on my days off, sometimes I’ll just be in bed the whole day, so I don’t get do a lot.” F_27_F1
Limited/ reduced exercise	4/14 (28.6)	“I cannot do exercise…And walk and exercise, this exercise bicycle, and I couldn’t do that.” M_44_F3
Difficulty lifting or carrying heavy objects	2/14 (14.3)	“I cannot…carry heavy boxes. And carry cement or something. Cement bags. That’s too heavy for me. Cement bags are too heavy.” M_44_F3
Trouble bending, lifting, or stooping	2/14 (14.3)	“Pain would extend up from my back, and when I walked, when I tried to lean down to get something on the floor, I had pain.” M_44_F3
Trouble walking two or more blocks	2/14 (14.3)	“Walking is difficult…Sometimes even just walking around my house.” NB_19_F2
Sports	1/14 (7.1)	“Before I was diagnosed I was actually in a sword fighting club on my college campus. I have not been able to participate anymore. One, because I don’t have the physical ability to as at the moment. But two, there’s also the fear of during sparring if I get hit the wrong way with my liver being inflamed, is it possible I could get. Hit the wrong way and possibly not be able to recover?” NB_19_F2
Trouble climbing two flights of stairs	1/14 (7.1)	“It’s just hard, very difficult to move around, like, say, when you go up on a flight of stairs, if there’s a little short of breath when you get up there, you can’t even run on the treadmill without being … wounded … however you say.” F_27_F1
Psychological/ emotional impact	14/20 (70.0)	“Yeah, it’s very frustrating and it’s very depressing. It makes you feel kind of less than a person. Not pulling your weight on everything.” F_53_F3
Sadness/low mood	2/14 (14.3)	“I think it’s because you know that the things that you typically did before you can’t, so you get sad, you get angry, you get unencouraged because you’re like, I’m so tired, and I know that I wasn’t tired before. I was active, and now I can’t be as active as I was because I have no energy.” F_35_F1
Anxiety	1/14 (7.1)	“I don’t know. I think maybe probably anxiety… not the sense of throw up, I think that’s probably because of my anxiety because of other things.” M_20_F2
Feel irritable	1/14 (7.1)	“…it’s irritating but not – I live with it. That’s what I do.” F_63_F2
Frustrated	1/14 (7.1)	“The frustration of that, if that’s one. Because I get frustrated because I can’t do what I want to do because of it.” F_63_F2
Have mood swings	1/14 (7.1)	INTERVIEWER: How have NASH symptoms affected your daily life? PARTICIPANT: Mood swings.” F_63_F2
Other: stress (n = 1); worry (n = 2); self-esteem (n = 3)	4/14 (28.6)	“But at the same time, with the constantly being nauseous, it’s causing high levels of stress so I’ve been getting stress headaches more frequently because of this condition.” NB_19_F2 “It worries me, so it’s worrisome, it’s bothersome, you don’t know like what’s going to happen. Am I going to advance into full blown cirrhosis? Am I going to have like metabolic or hepatic encephalopathy? Do I need to take lactulose forever and a day so that I can get them on the level. You know these kinds of things, it bothers my mind.” M_41_F2
Dietary impact	13/19 (68.4)	“…it’s having to peel the skin off my chicken or cut the fat off a good, juicy steak. You know. Oh, yeah. I miss them tastes.” M_54_F2
Bothered by diet limitations	2/13 (15.4)	“It’s a little, I guess, sometimes challenging because the diet and the health changes and the habits that you have to change to try to stop it from continuing to harden, like weight management. Changing your whole lifestyle and diet basically around your illness is kind of challenging because some people are on a set budget for groceries or whatever, and it’s just a little bit tricky because you have to balance everything all over again.” F_35_F1
Unable to eat as much as you would like	1/13 (7.7)	“Like I’m trying to eat less. Talking about quantity, less. And avoiding fried food, eating more vegetables.” F_46_F3
Daily activity impact	13/20 (65.0)	“Yes. If I have an active day before then the following day I’m not going to be active unless I have to be active…. Babysitting sometimes. I make myself do that, but it’s definitely hard. Outdoor activity stuff, helping with my husband do stuff.” F_53_F3
Household chores	8/13 (61.5)	“I mean, just this past year doing anything more active has gotten me tired, you know, doing the vacuum cleaning, running around loading the dishwashers and whatever.” F_71_F3
Day-to-day usual activities	3/13 (23.1)	“To shopping, I don’t know if you who doesn’t like to shop, at least for groceries, you know? You don’t want to get up, and when you, you’re just like, “Can I send my kid in to get it?” F_35_F1
Leisure activities	3/13 (23.1)	“So it’s really disruptive because you can’t do the things that you once enjoyed. It’s hard to get motivated to do it.” F_35_F1
Personal care	2/13 (15.4)	“When I have the headaches then I cannot touch my head or even comb my hair. It’s painful.” F_46_F3
Relationship/ social participation impact	11/19 (57.9)	“ Yes, I don’t have the energy to go out and be social. And then there’s times where I’m so tired and just don’t feel like moving to where I don’t want to see people…Or even have people over.” M_54_F2
Family/children	3/11 (27.3)	“I think when I gave notice when I talked about my situation at first that I have NASH with, for example, with my friends or my family members, I think they treat me more differently, a little, the fact that I used to be. Yeah.” M_20_F2
Partner/spouse/ dating	3/11 (27.3)	“They’ve definitely affected my daily life. I haven’t been able to work as much, so financially it’s put me in a really bad spot…And I really like going and getting coffee with my partner but when you’re broke, you can’t really go out and get coffee either.” NB_19_F2
Friends	2/11 (18.2)	“And I like spending time with my small group of friends. And having a decreased level of energy prevents me from really doing any of those things.” NB_19_F2
Social participation	1/11 (9.1)	“Yes, because, you know, drinking is a very social activity. My family does a lot. Friends of the family do it a lot. And obviously it’s not something I can participate in on a regular basis, due to my condition.” F_29_F2
Economic and burden impact	11/20 (55.0)	“…it does definitely have an economic impact, especially in stuff like insurance and co-pays, because you’re paying, you know, another co-pay, another pharmacy bill, another procedure bill for something else yet again.” F_29_F2
Financial burden	2/11 (18.2)	“I was told, “You need to stay away from carbs, stay away from red meats, go more on a lean diet like the Mediterranean diet.” All things good are expensive, really expensive. It goes from, “Let me spend $150 on groceries for the week,” to now we’re spending $300 a week. It can put a stressor in your pocket…It’s a little hard because you go from limiting your budget to certain things to now I need to expand it.” F_35_F1
Disability	1/11 (9.1)	INTERVIEWER: Are there any impacts to your work productivity as a result of NASH? PARTICIPANT: “I guess, yes. I am on disability.” F_63_F2
Healthcare utilization	1/11 (9.1)	INTERVIEWER: Any physical impacts? PARTICIPANT: “Outside of biopsies to check the progression of the NASH? No.” F_29_F2
Work absenteeism	1/11 (9.1)	PARTICIPANT: “I’m constantly dealing with diarrhea and vomiting every time I eat. And it affects my ability to work…” INTERVIEWER: Have you had to call out of work? PARTICIPANT: “A lot…Probably for about 50% of my shifts.” NB_19_F2
Other (school disruption, reduced work hours)	1/11 (9.1)	“It’s [fatigue] definitely more severe if I’ve had to do something the day before. I work a part time job but I’ve had my hours reduced because of all the medical issues I’ve been having.” NB_19_F2

n number of participants, NASH non-alcoholic steatohepatitis.

Note: The participant code is provided next to each quote for easy identification. It includes the gender (female, F; male, M; non-binary, NB), age, and fibrosis stage (F1, F2, or F3): Gender_Age_Fibrosis stage.

Participants may endorse more than one concept, and only the most relevant sub-impacts of each impact of NASH are presented; as such, the total number of participants endorsing a sub-impact may not add up to the total number endorsing an impact of NASH.

Table 6. Participant descriptions of a good and bad day with NASH.

Description Theme	Total n/N (%)	Example Quotes
Good Day
Lack of symptoms	7/20 (35.0)	“I mean, a good day would be no symptoms, obviously, but I guess with symptoms, it’s mild, it’s manageable, it doesn’t directly impact my ability to function.” M_35_F2
Able to carry out daily activities (e.g. household chores, shopping)	5/20 (25.0)	“A good day is going is like Saturday I went Christmas shopping. I had a good day Saturday. We have ATVs, and we ride those. A good day is going and actually feeling like going riding, just being motivated, doing things.” F_47_F3
Full of energy	3/20 (15.0)	“A good day is not getting tired throughout the day, being able to get things done around the house and actually have the energy to leave the house.” M_54_F2
Able to get work done	3/20 (15.0)	“A good day is I get most if not all of the things I planned to do done, and I’m able to relax at the end of the night so that way the pain that I’m feeling, especially in my back, can have a chance to dissipate.” NB_19_F2
No changes	2/20 (10.0)	“I don’t know what a good day or a bad day because I still feel the same as I always did.” M_53_F2
Bad Day
Experience symptoms	12/20 (60.0)	“I would say just the feeling overall tiredness or no energy, or I’ll… very bad bloating, the discomfort. I would say that that’s the main one.” F_27_F1 “A bad day is I’m not able to get most of the things I planned to do in my day done because I’m in too much pain, I don’t have the energy, or because I’m in and out of the bathroom.” NB_19_F2
Sedentary (e.g. not able to go out, stay in bed)	3/20 (15.0)	“A bad day with NASH, I absolutely won’t go to the store. I can’t get out and walk around. I’ll drive into the store if they want some things.” F_35_F1
Not able to do household chores	2/20 (10.0)	“That I cannot exercise or do my chores.” M_44_F3
Cognition/emotional (e.g. self-esteem, lack of focus)	2/20 (10.0)	“That sense of low self-esteem, and it becomes a little bit more difficult to think that it’s not that big of an issue. It becomes a bit more difficult to understand that I have this. It’s not a normal thing, like a normal day in the past.” M_20_F2
No changes	2/20 (10.0)	“I couldn’t answer that because I, like I said, I wouldn’t have even noticed that I had it. So, I don’t know.” M_53_F2

ATV all-terrain vehicle, n number of participants, NASH non-alcoholic steatohepatitis.

Note: The participant code is provided next to each quote for easy identification. It includes the gender (female, F; male, M; non-binary, NB), age, and fibrosis stage (F1, F2, or F3): Gender_Age_Fibrosis stage.

Figure 3. Conceptual model of NASH: participants’ perceptions of NASH clinical signs, symptoms, impact, and unmet treatment needs. F fibrosis stage, GI gastrointestinal, n number of participants, NASH non-alcoholic steatohepatitis. Note: Concepts listed within grey boxes were identified from the targeted literature review; concepts listed within blue (symptoms) and green (impacts) boxes were identified from both the targeted literature review and qualitative interviews.

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Data availability statement

The data that support the findings of this study are available from the corresponding author, SS, upon reasonable request.