scholarly journals P157 Patient-reported disease activity in a large sample of ulcerative colitis patients using social media-delivered questionnaires

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S216-S217
Author(s):  
M T Abreu ◽  
F Cataldi ◽  
K Van Horn ◽  
L B Herbert ◽  
M Fridman ◽  
...  

Abstract Background Medical therapy for inflammatory bowel disease (IBD) should have dual goals of improving symptoms and mucosal healing. Patient-reported outcomes (PROs) used for approval of ulcerative colitis (UC) treatments include number of bowel movements and bloody stools.[1] Recent research highlights the discordance between PROs and mucosal healing.[2] The aim of this analysis is to understand patient perspectives on UC symptoms and disease burden based on a cross-sectional survey of UC patients. We hypothesised that UC patients experience disease activity despite treatment and that current PROs fail to capture the full impact of disease activity on patients’ lives. Methods The IBD In America survey recruited patients via InflammatoryBowelDisease.net and associated social platforms in 2019. Patients self-reported an IBD diagnosis, were 18+, lived in U.S., and participated without monetary incentive. Survey questions addressed diagnosis, symptoms, QoL, treatment, demographics, etc. Survey terms were based on how patients discuss UC in the IBD online community. Remission was defined as ‘significant reduction of symptoms without an actual cure.’ Flare was defined as ‘temporary intensification of symptoms.’ Patients were categorised by disease activity based on number of flares and remission status during the past year. Results Of 487 patients diagnosed with UC, mean age was 45.6 (SD 16.0); 85% were female; 89% moderate to severe; 78% diagnosed in past 5 years; and 51% taking 5ASAs, 37% biologics/JAKs, and 23% immunomodulators. Despite treatment, 46% experienced 15+ symptom days in the past month. Fatigue/low energy was most frequent complaint (86%) followed by urgency to move bowels (80%), abdominal pain/cramps (76%), joint pain/inflammation (67%), and bloating (66%). Daily pain was experienced by 32%; even patients in remission with no flares experienced pain at least once a month (55%). Difficulty completing daily tasks was reported by 37%, and 27% felt their UC was not controlled despite efforts to manage it. Only 7% reported being in remission with no flares (past year) and no symptoms (past month). Conclusion Most UC patients experience frequent symptoms and flares while on treatment. The most common and bothersome symptoms are not taken into account in PROs nor addressed with current treatment. A more holistic approach to patient disease is needed. Reference

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S381-S382
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
S Pundir ◽  
...  

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine how strong patient reported outcomes, clinical scores and symptoms correlate with endoscopy for assessment of disease activity in UC patients. Methods 171 patients were included prospectively and consecutively (age: 49 (IQR: 38-61) years, duration 12 (4-19)years, 79 females (46.2%), 57.3% extensive disease, 42.7% on biologicals) at the time of the colonoscopy. The 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI), Mayo endoscopic subscore (MES), Baron and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores were calculated. C reactive Protein (CRP) and fecal calprotectin (FCAL) was available in 83 and 45.6% of patients. 17.0% had clinical flare, treatment was escalated in 14.6% of patients. Sensitivity, specificity, PPV and NPV values were calculated, ROC analysis and K-statistics were performed. Results Rectal bleeding (RBS), stool frequency (SF) subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission were similarly associated to mucosal healing defined by MES (0 or ≤1) or Baron (0 or ≤1) scores (Table 1). PRO2 (AUCMES0/Baron0: 0.770/0.740, AUCMES0-1/Baron0-1: 0.868/0.858), SF (AUCMES0/Baron0:0.751/0.724, AUCMES0-1/Baron0-1:0842/0.820), RBS (AUCMES0/Baron0: 0.718/0.698, AUCMES0-1/Baron0-1: 0.814/0.845) partial Mayo (AUCMES0/Baron0: 0.823/0.788, AUCMES0-1/Baron0-1: 0.927/0.902) and SCCAI (AUCMES0/Baron0: 0.767/0.752, AUCMES0-1/Baron0-1:0.888/0.867) were similarly associated with mucosal healing in a ROC analysis. There was a strict association between MES 0 and Baron 0 (k=0.917) and UCEIS <4 and MES 0-1 (k=0.813), while moderate to fair agreement between UCEIS <4 and MES 0 (K=0.471) or Baron 0 (K=0.414)/Baron 0-1 (K=0.353), and between MES 0-1 and Baron 0-1 (K= 0.350) scores. Agreement between CRP and clinical remission or endoscopic healing (MES/Baron) was poor (K~0.2), while agreement between FCAL (>100 or >250) and RBS-PRO2 remission (K>100 or >250: 0.44-0.60) or pMAYO (K>100 or >250: 0.41-0.59) or MES/Baron 0 was moderate to good (K>100:0.53-0.52 and K>250:0.57-0.53). Conclusion We found no difference across accuracy of RBS, SF, PRO2, partial Mayo and SCCAI in predicting endoscopic healing. A strong association was found with high PPV for MES/Baron ≤1 and high NPV for MES/Baron 0. FCAL, but not CRP was associated to clinical and endoscopic remission.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S657-S657
Author(s):  
M Cañas ◽  
F Mesonero ◽  
I Rodriguez-Lago ◽  
C Savini ◽  
R Saldaña ◽  
...  

Abstract Background Self-medication, when agreed with the treating physician, is an essential component of self-care. We describe the associated factors and the reasons related to the practice of self-medication with steroids, aminosalcylates (AS) or analgesics in patients with ulcerative colitis (UC) in Spain. Methods Information was anonymoulsy provided by patients through a web-based cross-sectional survey developed by 3 inflammatory bowel disease (IBD) experts from the Spanish working group on IBD (GETECCU), one nurse from the Spanish nursing working group on IBD (GETEII) and two patients from the Spanish confederation of associations of patients with IBD (ACCU). Participants voluntarily answered to the survey based on their own experiences from February to April 2019. Reasons for self-medication are described as frequencies and associated factors through logistic regression models. Results A total of 546 patients (61% women, mean age 40 years old) responded. Of these, 36 (7%) patients self-medicated with corticosteroids, and was associated with higher number of UC self-reported flares during the past year [OR 7 (95% CI: 1–32), p < 0.001] and follow-up by a general gastroenterologist instead of in an IBD unit [OR 0.08 (0.01–0.5), p = 0.007]. Self-medication with AS was reported by 90 patients (16%) [oral 20 (22%) and topic 70 (78%)], and was associated with treatment with topical AS [OR 3 (95% CI: 2–4), p < 0.001]. Finally, 320 patients (59%) self-medicated with analgesics and this was associated with female gender [OR 2 (95% CI: 1–3), p < 0.001], need of intravenous (IV) biological therapy [OR 3 (95% CI: 2–5) p < 0.001] and emergency room visits within the past year [OR 3 (95% CI: 2–4), p < 0.001]. The main reasons for self-medication were ‘need for quick relief of symptoms’, ‘fear of worsening’ and, for AS, ‘agreed with the doctor’ (Table 1). Conclusion Self-medication in UC is not a common practice, but most of the times it is not agreed with the treating physician. Self-medication with analgesics was more frequent, probably reflecting a need of self-care. Female sex, number of flares, IV treatment, and need of emergency room care were factors associated to self-medication. This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.


2021 ◽  
Author(s):  
Rianne Brouwer ◽  
Peter M. ten Klooster ◽  
Joost B. Masselink ◽  
Harald E. Vonkeman

Abstract Objectives Only few observational studies have investigated the actual effectiveness of switching to biosimilars in daily clinical practice in unselected patients. The objective of this study was to examine the maintenance of effect and safety after a hospital-wide switch for economic reasons from adalimumab originator Humira® to biosimilar Amgevita® in real-world rheumatoid arthritis (RA) patients and patient satisfaction with the switch. Methods A single centre retrospective observational study of RA patients on the course of their disease activity (DAS28, ESR and CRP), health-related quality of life (SF-36) and functional disability (HAQ-DI) before and up to one year after the switch, supplemented with a cross-sectional survey on satisfaction and experienced side effects approximately 18 months after the switch. Treatment outcomes were analysed with linear mixed modelling and generalized estimation equations. Results On November 1st 2018, 239 rheumatology patients switched to the adalimumab biosimilar. Of 52 RA patients who met the inclusion criteria sufficient data were available. Disease activity levels, the proportion of patients in remission (DAS28 < 2.6), and SF-36 and HAQ-DI scores did not significantly change from before the switch. 38 of the 52 analysed patients returned the questionnaire. Overall, patients were satisfied with the switch. Three patients (7.9%) stopped the biosimilar due to side effects. Conclusion Switching to the adalimumab biosimilar did not result in increased disease activity or worse patient-reported outcomes over an observation period of 9 to 12 months. Also, there was no apparent evidence of increased side effects. Patients themselves were mostly satisfied with the switching experience.


2019 ◽  
Vol 47 (3) ◽  
pp. 333-340 ◽  
Author(s):  
Taysir G. Mahmoud ◽  
Jie Huang ◽  
Michelle Frits ◽  
Christine Iannaccone ◽  
Vivian Bykerk ◽  
...  

Objective.Describe strategies used to manage rheumatoid arthritis (RA) flares that contribute to a successful postflare outcome.Methods.Data were collected from the BRASS registry, including clinical and patient-reported outcomes, and a survey with a Likert scale assessing postflare symptoms (better, unchanged, or worse). A logistic regression analysis adjusting for age, sex, flare number in the past 6 months, flare pain severity, home management, clinical consultation, and medication change was performed to evaluate factors influencing flare outcome.Results.Of 503 participants, 185 reported at least 1 flare that had resolved in the past 6 months, with median (interquartile range) 28-joint count Disease Activity Score based on C-reactive protein 3 score 2.1 (1.7–2.8). Compared with RA symptoms before the flare, 22 (12%) patients felt worse, 125 (68%) were unchanged, and 38 (20%) felt better. To manage flares, 72% of patients used home-based remedies, 23% sought clinical consultation, and 56% made medication change. Of 103 patients who changed medication, 70% did so without seeking clinical advice. Making a medication change (OR 3.48, 95% CI 1.68–7.21) and having lower flare pain (OR 0.83, 95% CI 0.71–0.97) were associated with better flare outcome.Conclusion.Flares occur frequently even in patients with low disease activity. Independent of home-based or clinically guided care, making a medication change and having less severe pain during a flare were associated with better flare outcomes. Of interest, the decision to change medications was frequently made without clinical advice. Future studies might address how best to intervene when patients experience flares and whether patient-initiated medication changes have adverse outcomes.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S613-S614
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
W Afif ◽  
...  

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine how strong patient reported outcomes, clinical scores and symptoms correlate with endoscopy for assessment of disease activity in UC patients. Methods One hundred and thirty-six patients were included prospectively (age: 48 (IQR: 38–61) years, duration 12 (4–19) years, 63 females, 53.7% extensive disease, 40.4% on biologicals) at the time of the colonoscopy. The 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI), Mayo endoscopic subscore (MES), Baron and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores were calculated. C reactive Protein (CRP) and fecal calprotectin (FCAL) was available in 58.1 and 33.8% of patients. 20.7% had clinical flare, treatment was escalated in 17.8% of patients. Sensitivity, specificity, PPV and NPV values were calculated, ROC analysis and K-statistics were performed. Results Rectal bleeding(RBS), stool frequency(SF) subscore of 0, or total PRO2 remission(RBS0 and SF≤1), partial MAYO(≤2) and SCCAI(≤2.5) remission were similarly associated to mucosal healing defined by MES(0 or ≤1) or Baron (0 or ≤1) scores (Table 1). PRO2 remission (AUCMES0/Baron0:0.747/0.715, AUCMES0-1/Baron0-1:0.867/0.863), SF AUCMES0/Baron0:0.731/0.703, AUCMES0-1/Baron0-1:0851/0.839), RBS(AUCMES0/Baron0:0.708/0.685, AUCMES0-1/Baron0-1:0.828/0.835) partial Mayo (AUCMES0/Baron0:0.792/0.755, AUCMES0-1/Baron0-1:0.917/0.903) and SCCAI (AUCMES0/Baron0:0.738/0.724, AUCMES0-1/Baron0-1:0.908/0.880) were similarly associated with mucosal healing in a ROC analysis. There was a string association between MES and Baron (k=0.798), while moderate agreement between UCEIS and MES (K=0.451) or Baron (K=0.499) scores. Agreement between CRP and clinical remission or endoscopic healing (MES/Baron) was poor (K~0.2), while agreement between FCAL (&gt;100 or &gt;250) and RBS-PRO2 remission (K&gt;250:0.56–0.61) or MES/Baron 0 was moderate to good(K&gt;100:0.54-0.53 and K&gt;250:0.50–0.54) Conclusion We found no difference across accuracy of RBS, SF, PRO2, partial Mayo and SCCAI in predicting endoscopic healing. A strong association was found with high PPV for MES/Baron ≤1 and high NPV for MES/Baron 0. FCAL, but not CRP was associated to clinical and endoscopic remission.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 617.1-617
Author(s):  
H. Wohland ◽  
N. Leuchten ◽  
M. Aringer

Background:Fatigue is among the top complaints of patients with systemic lupus erythematosus (SLE), but only in part associated with SLE disease activity. Physical activity can help to reduce fatigue and should therefore be recommended to SLE patients. Vice versa, fatigue may arguably lead to reduced physical activity.Objectives:To investigate the extent of physical activity and the perception of fatigue and sleep quality in patients with SLE.Methods:Starting in February 2019, SLE patients were invited to participate in a cross-sectional survey study of fatigue and physical exercise during their routine outpatient clinic visits. Participants filled out a ten-page paper questionnaire focused on physical activity. To evaluate fatigue, we primarily used a 10 cm visual analogue scale (0-100 mm, with 100 meaning most fatigued), but also the FACIT fatigue score (range 0-52). Sleep quality was estimated using grades from 1 (excellent) to 6 (extremely poor).Results:93 SLE patients took part in the study. All patients fulfilled the European League Against Rheumatism/ American College of Rheumatology (EULAR/ACR) 2019 classification criteria for SLE. 91% of the patients were female. Their mean (SD) age was 45.5 (14.3) years and their mean disease duration 12.1 (9.4) years. The mean BMI was 25.2 (5.6). Of all patients, 7.5% had a diagnosis of (secondary) fibromyalgia. The mean fatigue VAS was 32 (27) mm and the mean FACIT fatigue score 35.7 (10.3). As expected, fatigue by VAS and FACIT was correlated (Spearman r=-0.61, p<0.0001). The mean SLEDAI was 1 (1) with a range of 0 to 6. Median glucocorticoid doses were 2 mg prednisolone equivalent, with a range from 0 to 10 mg.Out of 66 patients in payed jobs, 64 (97%) reported details on their working space. One person (2%) worked in a predominanty standing position, 37 (58%) worked in essentially sedentary jobs and 26 (40%) were in positions where they were mildly physically active in part. The mean fatigue VAS was 31 (24) mm for patients with partly active jobs and 27 (30) mm for those in sedentary jobs. Sleep was graded 2.9 (0.9) by those with active and 3.1 (1.3) by those with sedentary jobs.Half of the patients (51%) reported more than one physical recreational activity. 44 (47%) were walking and for five persons (5%) this was the only form of activity. Cycling was reported by 19 patients (20%), 18 of whom also practiced other activities. For transport, 52 (56%) in part chose active modes, such as walking and cycling. Patients who reported any of the above activities showed a mean fatigue VAS of 28 (25) mm, compared to 36 (28) mm in the patient group without a reported activity. Sleep quality was very similar: 3.1 (1.2) and 3.2 (1.1) for more active and more passive patients, respectively.65 (70%) patients regularly practiced sports. Of these, 39 (60%) practiced one kind of sport, 15 (23%) two, 7 (11%) three, and 2 (3%) each four and five kinds of sports. Fatigue VAS of patients practicing sports was 27 (25) mm versus 43 (28) in those who did not (p=0.0075). Sleep quality was 2.9 (1.1) in the sports cohort and 3.5 (1.1) in the no-sports cohort (p=0.0244).Conclusion:A majority of SLE patients in remission or low to moderate disease activity regularly practiced sports, and those doing so reported lesser fatigue and better sleep quality. The absolute values on the fatigue VAS were in a moderate range that made fatigue as the main cause of not performing sports rather unlikely for most patients.Disclosure of Interests:Helena Wohland: None declared, Nicolai Leuchten Speakers bureau: AbbVie, Janssen, Novartis, Roche, UCB, Consultant of: AbbVie, Janssen, Novartis, Roche, Martin Aringer Speakers bureau: AbbVie, Astra Zeneca, BMS, Boehringer Ingelheim, Chugai, Gilead, GSK, HEXAL, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Astra Zeneca, BMS, Boehringer Ingelheim, GSK, Lilly, MSD, Roche, Sanofi, UCB


2021 ◽  
Author(s):  
April N Naegeli ◽  
Theresa Hunter ◽  
Yan Dong ◽  
Ben Hoskin ◽  
Chloe Middleton-Dalby ◽  
...  

Abstract Background Understanding ulcerative colitis (UC) disease activity assessed via the full, modified or partial Mayo Score may help clinicians apply results from clinical trials to practice and facilitate interpretation of recent and older studies. Methods Mayo Score variables were assessed in a cross-sectional study of 2608 UC patients. Results Permutations of Mayo Scores were highly correlated, and models predicting the omitted variable from each permutation demonstrated significant agreement between predicted and observed values. Conclusions Partial/modified Mayo Scores may be used to predict endoscopic and Physician's Global Assessment scores, and serve as proxies for the full Mayo Score in clinical practice/trials.


Author(s):  
Yoshito Nishimura ◽  
Tomoko Miyoshi ◽  
Hideharu Hagiya ◽  
Yoshinori Kosaki ◽  
Fumio Otsuka

The coronavirus disease 2019 (COVID-19) global pandemic has drastically changed how we live and work. Amid the prolonged pandemic, burnout of the frontline healthcare professionals has become a significant concern. We conducted a cross-sectional survey study to provide data about the relationship between the COVID-19 pandemic and the prevalence of burnout in healthcare professionals in Japan. Healthcare workers in a single Japanese national university hospital participated in the survey, including basic demographics, whether a participant engaged in care of COVID-19 patients in the past 2 weeks and the Maslach Burnout Inventory. Of those, 25.4% fully answered the survey; 33.3% were doctors and 63.6% were nurses, and 36.3% engaged in care of COVID-19 patients in the past 2 weeks. Compared to those belonging to General Medicine, those in Emergency Intensive Care Unit were at higher risk of burnout (odds ratio (OR), 6.7; 95% CI, 1.1–42.1; p = 0.031). Of those who engaged in care of COVID-19 patients, 50% reported burnout while 6.1% did not (OR 8.5, 95% CI; 1.3–54.1; p = 0.014). The burnout of healthcare workers is a significant concern amid the pandemic, which needs to be addressed for sustainable healthcare delivery.


Author(s):  
Hasan Saeed Alamri ◽  
Wesam F. Mousa ◽  
Abdullah Algarni ◽  
Shehata F. Megahid ◽  
Ali Al Bshabshe ◽  
...  

Background: This study aims to investigate the mental health of COVID-19 patients in Saudi Arabia. Method: A cross-sectional study was carried out targeting confirmed cases of COVID-19 in Saudi Arabia. Due to travel and time constraints as well as the accessibility of patients, cases were included from East Jeddah Hospital, King Abdulaziz Hospital, and the Oncology Center in Jeddah. The data were collected using a predesigned self-administered questionnaire. The questionnaire addressed COVID-19 cases, personal data, medical history, smoking, traveling abroad, and work-related conditions. Additionally, data regarding contact level with COVID-19 cases were considered. The mental health statuses of the patients were assessed using a validated Arabic version of the Hospital Anxiety and Depression (HAD) scale. The study included 261 COVID-19 patients whose ages ranged from 18 to 65 years. Results: The survey findings revealed that 13% of COVID-19 patients had a borderline level of anxiety, 26.8% were considered anxiety cases, while 60.2% were normal. The findings also revealed that 29.9% had a borderline level of depression, 18.4% were considered depression cases, while 51.7% were normal. Conclusions: This study concluded that COVID-19 patients experience anxiety and depression, and as the COVID-19 epidemic continues to spread, the results of the study are particularly useful in developing a strategy to psychologically support COVID-19 patients.


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