Kelly Gavighan, MPH, on Patient-Reported Outcomes from ArthritisPower

Kelly Gavighan, MPH, discusses the research she presented at EULAR 2022 on changes in patient-reported outcome scores among patients with rheumatic diseases during the COVID-19 pandemic and how they reflect the impact of the pandemic on physical, mental, and emotional health.

Kelly Gavighan, MPH, is the director of data management and analytics for the Global Healthy Living Foundation.

TRANSCRIPT:

Welcome to this podcast from the Rheumatology and Arthritis Learning Network. Today, we're joined by Kelly Gavigan, the Director of Data Management and Analytics for the Global Healthy Living Foundation. She's going to discuss an abstract she presented at EULAR on changes in patient reported outcome scores during the COVID-19 pandemic, drawing on data from the ArthritisPower registry.

RALN:  What was the purpose of your study?

Kelly Gavigan: COVID-19 is of particular concern for people living with autoimmune and rheumatic diseases, they are at an increased risk of infection. As a result, many patients have continued to adhere to strict social distancing protocols that has created this heightened sense of isolation. We wanted to better understand if symptoms among people with autoimmune and rheumatic disease in our ArthritisPower research registry were impacted throughout the COVID-19 pandemic. We actually previously conducted and reported on an analysis of the patient-reported outcome data from ArthritisPower between January 2020 and April 2021 at the American College of Rheumatology Convergence in the fall of 2021. But then we conducted a follow-up analysis between May and December 2021, which is the area of focus for this particular abstract.

Interviewer: Did you learn anything new or different in this follow-up? Did you see changes from the previous study?

Kelly Gavigan: Certainly. We found that first, we had over 2,200 people participate and can provide over 50,000 PRO scores during the total study period, of which about 8,400 were contributed between May and December 2021. It was a good portion of the assessments that were contributed during that time period. It's similar to the other analysis. We found that participants' mental and social health assessment scores fluctuated throughout the time. They worsened over those 8 months of 2021. But we found that they fluctuated in a manner that corresponded with major events during the COVID-19 pandemic. After vaccines became widely available throughout the US, scores for anger and social isolation declined. Those assessments improved. However, by July, social isolation scores worsened, actually. We noticed that this actually corresponded with the emergence of the delta variant in the US. And then from July to August to September, social isolation decreased, as well as anger and anxiety.

Again, this seems to correspond with the possibility of a third vaccine dose that became available for people with compromised immunity. We really did see this fluctuation, these highs and these lows, with what was happening in the US pertaining to COVID-19. And then certainly by the end of 2021, in December, with the emergence of the omicron variant, we again saw an uptick in anger and anxiety and isolation. Interestingly, although similar to this or the initial analysis, these scores for pain interference, fatigue, sleep disturbance, these physical health scores, didn't actually significantly worsen during this time. We noticed that they improved in the summer months between May and August, but they didn't change greater than even a half standard deviation during that time. These physical health scores actually maintained. They stayed pretty steady throughout the pandemic. It was really the mental and emotional health and social support that really fluctuated during this time.

RALN:  How much change did you see among patients on those scores for a mental health and social support? Was it a dramatic change from one point to another?

Kelly Gavigan: Yes, these changes were significant, and we weren't only just looking at statistical significance. We were also looking at changes by standard deviation. These assessments that we were using are PROMIS assessments. They're scored on a T-score scale. And so 1 standard deviation is a difference of 10 points, so half a standard deviation is a difference of 5. We noticed that during this time, the mental health assessments and the social-emotional health assessments, depending on the month, would change by at least half a standard deviation. Which not was not only significant, but we found that it was clinically meaningful as well.

RALN: Explain what you mean by clinically meaningful in that context.

Kelly Gavigan: I'm not a rheumatologist, so I certainly don't want to speak too much to the clinical side of this. When we mean clinically significant, we mean that there's a notable change in the patient. Sometimes there might be statistical significance, but the change can be very slight. But this  clinical significance means that there is a notable change that the patient themselves are experiencing.

Interviewer: You noted that there weren't significant changes in scores for fatigue and sleep disturbance. Did you see anything in regard to whether some of these patients were less likely to, for instance, exercise as they needed to? Were they more concerned about leaving their home to do things like that?

Kelly Gavigan: Sure. I don't want to speculate, but I can say that between the results that we presented at ACR that covered January of 2020 to April of 2021, encompassing a whole summer and more, we noticed that the physical health assessments didn't change during that time. However, from May 2021 to December 2021, after the vaccines were rolled out more widely in the US, we saw that physical health assessments like physical function, pain, sleep disturbance, that they did improve during those summer months. It's speculation to say whether or not the people who experienced those improvements in their physical health scores were more active or exercised more. But we certainly did see an improvement in their physical health that corresponded with summer months.

RALN:  What does this mean in the context of a rheumatology practice? We're not really out of the woods entirely with this pandemic, as we keep hearing. What suggestions do you think a clinician could pull from your results here to help them help their patients as the pandemic continues?

Kelly Gavigan:  As you said, we're more than 2 years into the COVID-19 pandemic, and it's still ongoing. I think it's not surprising to most people that people's mental and emotional health continue to be impacted by the pandemic, by new virus variants, increases in prevalence of COVID-19 in the population. While it is encouraging to see that the participants' rheumatic disease, as indicated by their physical health scores, wasn't worsening during this time, it's incredibly important to highlight that these mental health concerns and social support for rheumatic disease patients deserve attention by their providers and by their caregivers, just to ensure comprehensive care. We encourage, for the care of rheumatology and autoimmune patients, that the care doesn't just stop at the physical health, that the care really is comprehensive, and it encompasses mental health and social support and emotional wellbeing.

RALN: For the rheumatologist who's caring for these patients, even as the pandemic goes on, what do they need to be most conscious of when they're talking to their patients and they're physically doing fine? How can they determine if these patients are doing okay on the mental aspect?

Kelly Gavigan: I think that ArthritisPower is honestly a great resource. It's a resource that many patients are aware of but I think that more providers, clinicians, can take advantage of in terms of being able to see how their patients are doing over time in between their office visits. During those 3 to 6 months between visits, how are their symptoms faring? That includes the physical health symptoms, as well as the mental and emotional health symptoms.

RALN: Are there follow-up studies ongoing?

Kelly Gavigan: The study has now encompassed 23 months of the pandemic. That might not be enough time to understand the impact that declines in mental health and emotional health actually have on physical health. I think that future research could really benefit from studying the long-term physical impact that the pandemic has had on mental and been emotional health.

RALN: Well, thank you very much for taking time to talk with us today. It's very interesting, and we hope to follow up with you again sometime.

Kelly Gavigan: Yes, absolutely. Thank you so much for having me.