PSYCHOLOGICAL DISTRESS OVER 12 MONTHS POST-DIAGNOSIS IN A NATIONAL EARLY INFLAMMATORY ARTHRITIS COHORT

BackgroundIn inflammatory arthritis patients, the concomitant decline of their mental wellbeing is an increasing concern[1,2]. It is important to not only describe the trajectory of psychological distress in early disease stages, but also understand which clinical outcome measures are most associated with these changes.ObjectivesUsing data from the National Early Inflammatory Arthritis Audit (NEIAA), we assessed trends in psychological wellbeing over 12 months after initial diagnosis and mapped these against clinical outcomes to identify significant associations.MethodsNEIAA collects data from patients referred with suspected early inflammatory arthritis in rheumatology services in England and Wales. We used data provided by 20,472 patients eligible for follow-up (diagnosis of inflammatory arthritis) between May 1st, 2018, and April 1st, 2022. Data items included baseline demographics e.g., age and gender, and clinical variables e.g., rheumatic disease comorbidity index (RDCI), DAS28, and patient reported outcomes.Psychological distress was measured by the sum score of Patient Health Questionnaire Anxiety and Depression Screener (PHQ4ADS). Using mixed effects regression models, we analysed the co-variability of PHQ4ADS with demographic factors and clinical outcomes over 12 months. Time was included as a dummy-coded covariant.ResultsThe analysis included 36% of patients (7,378 out of 20,472) who completed the baseline patient outcome survey. In this cohort, PHQ4ADS scores decreased from a baseline average of 4.7 (CI: [4.6, 4.8]) to 2.62 (CI: [2.5, 2.8]) at 12 months post-diagnosis. The proportion of patients screening positive decreased from 50.0% (CI: [48.9, 51.1]) at baseline to 23.8% (CI: [21.8, 25.9]) at 12 months.At baseline, psychological distress correlated significantly with age, gender, ethnicity, RDCI, prior depression diagnosis, and baseline DAS28 (Figure 1). No significant correlations were found between psychological distress and working diagnosis, seropositivity, or the assessment being recorded after the start of the COVID-19 pandemic. Younger ages were nonlinearly associated with higher distress levels (coefficient per decade: -0.006;p<0.001;CI: [-0.009, -0.003]) (Figure 1a). Distress levels in females were higher than that of males (coefficient: 0.5;p<0.001;CI: [0.4, 0.7]) (Figure 1b). White patients reported lower PHQ4ADS scores compared to non-white patients (coefficient: -0.7;p<0.001;CI: [-1.0, -0.4]) (Figure 1c). Higher distress levels were also associated with higher RDCI (coefficient: 0.2;p<0.001;CI: [0.1, 0.3]) and prior diagnosis of depression (coefficient: 1.8;p<0.001;CI: [1.5, 2.2]) (Figure 1d, 1e). Furthermore, higher baseline DAS28 scores correlated with more severe psychological distress (coefficient: 0.8;p<0.001;CI: [0.7, 0.8]) (Figure 1f).By 12-months, psychological distress decreased significantly overall, which correlated significantly with ethnicity (coefficient: 0.8;p=0.005;CI: [0.3, 1.4]) and baseline DAS28 (coefficient: -0.5;p<0.001;CI: [-0.6, -0.4]). Compared to white patients, the reduction was significantly greater for non-white patients, but the level of distress was no longer different at 12 months (Figure 1c). While those with higher baseline DAS28 showed a greater reduction in psychological distress, the distress levels remained higher at 12 months (Figure 1f).Figure 1.Changes in psychological distress correlated with age, gender, ethnicity, RDCI, prior depression diagnosis, and baseline DAS28.[Figure omitted. See PDF]ConclusionIn this early inflammatory arthritis cohort, mental health burden was high. Age, gender, ethnicity, RDCI, prior depression diagnosis and baseline DAS28 significantly correlated with psychological distress at baseline. Supporting mental health should be a focus of clinical care for this population and it may be beneficial to use an approach that is culturally valid for non-white patients and accounts for multimorbidity.References[1]Euesden, J, et al. Psychosomatic medicine 79.6 (2017): 638.[2]Lwin, MN, et al. Rheumatology and therapy 7.3 (2020): 457-471.AcknowledgementsThe authors would like to thank the Healthcare Quality Improvement Partnership (HQIP) as the commisioner of NEIAA, British Society for Rheumatology as the audit providers, Net Solving as the audit platform developers, and the Wellcome Trust (ST12406) for funding to support L.Z..Disclosure of InterestsLucy Zhao: None declared, James Galloway Speakers bureau: Has received honoraria from AbbVie Celgene, Chugai, Gillead, Janssen, Eli Lilly, Pfizer, Roche, and UCB, Jo Ledingham: None declared, Sarah Gallagher: None declared, Neena Garnavos: None declared, Paul Amlani-Hatcher: None declared, Nicky Wilson: None declared, Lewis Carpenter Consultant of: Statistical consultancy for Pfizer, Kirsty Bannister: None declared, Sam Norton Speakers bureau: Has received honoraria from Janssen and Pfizer.

IMPAIRED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES: A CROSS-SECTIONAL ANALYSIS FROM AN INTERNATIONAL E-SURVEY

BackgroundComprehensive and large-scale assessment of health-related quality of life in patients with idiopathic inflammatory myopathies (IIMs) worldwide is lacking. The second COVID-19 vaccination in autoimmune disease (COVAD-2) study [1] is an international, multicentre, self-reported e-survey assessing several aspects of COVID-19 infection and vaccination as well as validated patient-reported outcome measures (PROMs) to outline patient experience in various autoimmune diseases (AIDs), with a particular focus on IIMs.ObjectivesTo investigate physical and mental health in a global cohort of IIM patients compared to those with non-IIM autoimmune inflammatory rheumatic diseases (AIRDs), non-rheumatic AIDs (NRAIDs), and those without AIDs (controls), using Patient-Reported Outcome Measurement Information System (PROMIS) global health data obtained from the COVAD-2 survey.MethodsDemographics, AID diagnoses, comorbidities, disease activity, treatments, and PROMs were extracted from the COVAD-2 database. The primary outcomes were PROMIS Global Physical Health (GPH) and Global Mental Health (GMH) scores. Secondary outcomes included PROMIS physical function short form-10a (PROMIS PF-10a), pain visual analogue scale (VAS), and PROMIS Fatigue-4a scores. Each outcome was compared between IIMs, non-IIM AIRDs, NRAIDs, and controls. Factors affecting GPH and GMH scores in IIMs were identified using multivariable regression analysis.ResultsA total of 10,502 complete responses from 1582 IIMs, 4700 non-IIM AIRDs, 545 NRAIDs, and 3675 controls, which accrued as of May 2022, were analysed. Patients with IIMs were older [59±14 (IIMs) vs. 48±14 (non-IIM AIRDs) vs. 45±14 (NRAIDs) vs. 40±14 (controls) years, p<0.001] and more likely to be Caucasian [82.7% (IIMs) vs. 53.2% (non-IIM AIRDs) vs. 62.4% (NRAIDs) vs. 34.5% (controls), p<0.001]. Among IIMs, dermatomyositis (DM) and juvenile DM were the most common (31.4%), followed by inclusion body myositis (IBM) (24.9%). Patients with IIMs were more likely to have comorbidities [68.1% (IIMs) vs. 45.7% (non-IIM AIRDs) vs. 45.1% (NRAIDs) vs. 26.3% (controls), p<0.001] including mental disorders [33.4% (IIMs) vs. 28.2% (non-IIM AIRDs) vs. 28.4% (NRAIDs) vs. 17.9% (controls), p<0.001].GPH median scores were lower in IIMs compared to NRAIDs or controls [13 (interquartile range 10–15) IIMs vs. 13 (11–15) non-IIM AIRDs vs. 15 (13–17) NRAIDs vs. 17 (15–18) controls, p<0.001] and PROMIS PF-10a median scores were the lowest in IIMs [34 (25–43) IIMs vs. 40 (34–46) non-IIM AIRDs vs. 47 (40–50) NRAIDs vs. 49 (45–50) controls, p<0.001]. GMH median scores were lower in AIDs including IIMs compared to controls [13 (10–15) IIMs vs. 13 (10–15) non-IIM AIRDs vs. 13 (11–16) NRAIDs vs. 15 (13–17) controls, p<0.001]. Pain VAS median scores were higher in AIDs compared to controls [3 (1–5) IIMs vs. 4 (2–6) non-IIM AIRDs vs. 2 (0–4) NRAIDs vs. 0 (0–2) controls, p<0.001]. Of note, PROMIS Fatigue-4a median scores were the highest in IIMs [11 (8–14) IIMs vs. 8 (10–14) non-IIM AIRDs vs. 9 (7–13) NRAIDs vs. 7 (4–10) controls, p<0.001].Multivariable regression analysis in IIMs identified older age, male sex, IBM, comorbidities including hypertension and diabetes, active disease, glucocorticoid use, increased pain and fatigue as the independent factors for lower GPH scores, whereas coexistence of interstitial lung disease, mental disorders including anxiety disorder and depression, active disease, increased pain and fatigue were the independent factors for lower GMH scores.ConclusionBoth physical and mental health are significantly impaired in patients with IIMs compared to those with non-IIM AIDs or those without AIDs. Our results call for greater attention to patient-reported experience and comorbidities including mental disorders to provide targeted approaches and optimise global well-being in patients with IIMs.Reference[1]Fazal ZZ, Sen P, Joshi M, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int. 2022;42:2151–58.AcknowledgementsThe authors a e grateful to all respondents for completing the questionnaire. The authors also thank The Myositis Association, Myositis India, Myositis UK, the Myositis Global Network, Cure JM, Cure IBM, Sjögren's India Foundation, EULAR PARE for their contribution to the dissemination of the survey. Finally, the authors wish to thank all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsAkira Yoshida: None declared, Yuan Li: None declared, Vahed Maroufy: None declared, Masataka Kuwana Speakers bureau: Boehringer Ingelheim, Ono Pharmaceuticals, AbbVie, Janssen, Astellas, Bayer, Asahi Kasei Pharma, Chugai, Eisai, Mitsubishi Tanabe, Nippon Shinyaku, Pfizer, Consultant of: Corbus, Mochida, Grant/research support from: Boehringer Ingelheim, Ono Pharmaceuticals, Naveen Ravichandran: None declared, Ashima Makol Consultant of: Boehringer-Ingelheim, Parikshit Sen: None declared, James B. Lilleker: None declared, Vishwesh Agarwal: None declared, Sinan Kardes: None declared, Jessica Day Grant/research support from: CSL Limited, Marcin Milchert: None declared, Mrudula Joshi: None declared, Tamer A Gheita: None declared, Babur Salim: None declared, Tsvetelina Velikova: None declared, Abraham Edgar Gracia-Ramos: None declared, Ioannis Parodis Grant/research support from: Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche, Elena Nikiphorou Speakers bureau: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly, Consultant of: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly, Grant/research support from: Pfizer, Eli Lilly, Ai Lyn Tan Speakers bureau: AbbVie, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Arvind Nune: None declared, Lorenzo Cavagna: None declared, Miguel A Saavedra Consultant of: AbbVie, GlaxoSmithKline, Samuel Katsuyuki Shinjo: None declared, Nelly Ziade Speakers bureau: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Consultant of: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Grant/research support from: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Johannes Knitza: None declared, Oliver Distler Speakers bureau: AbbVie, Amgen, Bayer, Boehringer Ingelheim, Janssen, Medscape, Novartis, Consultant of: 4P-Pharma, AbbVie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi, Topadur, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Kymera, Mitsubishi Tanabe, Novartis, Roche, Hector Chinoy Grant/research support from: Eli Lilly, UCB, Vikas Agarwal: None declared, Rohit Aggarwal Consultant of: Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, EMD Serono, Kezar, Pfizer, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim (BI), Corbus, Janssen, Kyverna, Roivant, Merck, Galapagos, Actigraph, Abbvie, Scipher, Horizontal Therapeutics, Teva, Biogen, Beigene, ANI Pharmaceutical, Nuvig, Capella, CabalettaBio, Grant/research support from: Bristol Myers-Squibb, Pfizer, Mallinckrodt, Janssen, Q32, EMD Serono, Boehringer Ingelheim, Latika Gupta: None declared.

REDUCED HEALTH-RELATED QUALITY OF LIFE USING PROMIS IN PATIENTS WITH SYSTEMIC SCLEROSIS: A CROSS-SECTIONAL ANALYSIS FROM THE INTERNATIONAL COVAD-2 E-SURVEY

BackgroundThe second COVID-19 vaccination in autoimmune disease (COVAD-2) study [1] is an international, multicentre, self-reported e-survey designed to evaluate several facets covering COVID-19 infection and vaccination as well as validated patient-reported outcome measures (PROMs) in a variety of autoimmune diseases (AIDs), including systemic sclerosis (SSc). Detailed assessment of the health-related quality of life (HRQOL) and its drivers in patients with SSc is lacking.ObjectivesTo assess physical and mental health in a global cohort of SSc patients in comparison with non-SSc autoimmune inflammatory rheumatic diseases (AIRDs), non-rheumatic AIDs (NRAIDs), and those without AIDs (controls) using Patient-Reported Outcome Measurement Information System (PROMIS) global health data from the COVAD-2 survey.MethodsThe COVAD-2 database was used to extract demographics, AID diagnosis, comorbidities, disease activity, current therapies, and PROMs. PROMIS global physical health (GPH), global mental health (GMH) scores, PROMIS physical function short form-10a (PROMIS PF-10a), pain visual analogue scale (VAS), and PROMIS Fatigue-4a scores were compared between SSc, non-SSc AIRDs, NRAIDs, and controls. Outcomes were also compared between diffuse cutaneous SSc (dcSSc) vs limited cutaneous SSc (lcSSc). Multivariable regression analysis was performed to identify factors influencing GPH and GMH scores in SSc.ResultsA total of 10,502 complete responses from 276 SSc, 6006 non-SSc AIRDs, 545 NRAIDs, and 3675 controls as of May 2022 were included in the analysis. Respondents with SSc were older [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 55 (14) vs. 51 (15) vs. 45 (14) vs. 40 (14) years old, mean (SD), p < 0.001]. Among patients with SSc, 129 (47%) had dcSSc and 147 (53%) had lcSSc. SSc patients reported a significantly higher prevalence of ILD [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 30.4% vs. 5.5% vs. 1.5% vs. 0.2%, p < 0.001], and treatment with MMF [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 26.4% vs. 9.5% vs. 1.1% vs. 0%, p < 0.001].Patients with SSc had lower GPH and PROMIS PF-10a scores [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 13 (11–15) vs. 13 (11–15) vs. 15 (13–17) vs. 17 (15–18), median (IQR), p < 0.001;39 (33–46) vs. 39 (32–45) vs. 47 (40–50) vs. 49 (45–50), p < 0.001, respectively] and higher Pain VAS and PROMIS Fatigue-4a scores compared to those with NRAIDs or controls [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 3 (2–5) vs. 3 (1–6) vs. 2 (0–4) vs. 0 (0–2), p < 0.001;11 (8–14) vs. 11 (8–14) vs. 9 (7–13) vs. 7 (4–10), p < 0.001, respectively]. Patients with AIDs including SSc had lower GMH scores compared to controls [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 12.5 (10–15) vs. 13 (10–15) vs. 13 (11–16) vs. 15 (13–17), p < 0.001].Among SSc patients, GPH, GMH, and PROMIS PF-10a scores were lower in dcSSc compared to lcSSc [dcSSc vs. lcSSc: 12 (10–14) vs. 14 (11–15), p < 0.001;12 (10-14) vs. 13 (10-15), p<0.001;38 (30–43) vs. 41 (34–47), p < 0.001, respectively]. Pain VAS and PROMIS Fatigue-4a scores were higher in dcSSc compared to lcSSc [4 (2–6) vs. 3 (1–5), p < 0.001;12 (8–15) vs. 9 (8–13), p < 0.001, respectively].The independent factors for lower GPH scores in SSc were older age, Asian ethnicity, glucocorticoid use, and higher pain and fatigue scales, while mental health disorders and higher pain and fatigue scales were independently associated with lower GMH scores.ConclusionIn a global cohort, patient-reported physical and mental health were significantly worse in patients with SSc in comparison to those with non-SSc AIDs and without AIDs. Our findings support the critical need for more attention to patient's subjective experiences including pain and fatigue to improve the HRQOL in patients with SSc.Reference[1]Fazal ZZ, Sen P, Joshi M, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int. 2022;42: 2151–58.Acknowledgements:NIL.Disclosure of InterestsKeina Yomono: None declared, Yuan Li: None dec ared, Vahed Maroufy: None declared, Naveen Ravichandran: None declared, Akira Yoshida: None declared, Kshitij Jagtap: None declared, Tsvetelina Velikova Speakers bureau: Pfizer and AstraZeneca, Parikshit Sen: None declared, Lorenzo Cavagna: None declared, Vishwesh Agarwal: None declared, Johannes Knitza: None declared, Ashima Makol: None declared, Dey Dzifa: None declared, Carlos Enrique Toro Gutierrez: None declared, Tulika Chatterjee: None declared, Aarat Patel: None declared, Rohit Aggarwal Consultant of: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio, Grant/research support from: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio, Latika Gupta: None declared, Masataka Kuwana Speakers bureau: Abbvie, Asahi-Kasei, Astellas, Boehringer-Ingelheim, Chugai, Eisai, MBL, Mochida, Nippon Shinyaku, Ono Pharmaceuticals, Tanabe-Mitsubishi, Consultant of: Astra Zeneka, Boehringer-Ingelheim, Chugai, Corbus, GSK, Horizon, Tanabe-Mitsubishi, Grant/research support from: Boehringer-Ingelheim, Vikas Agarwal: None declared.

EVALUATION OF PATIENT SATISFACTION WITH REMOTE SELF-INJECTION TRAINING: A SINGLE-CENTRE PATIENT-REPORTED SURVEY

BackgroundSubcutaneous self-injection of methotrexate (SC MTX) is used for the treatment of several inflammatory diseases. All newly initiated patients should be educated and trained in the proper injection technique by their healthcare provider (HCP), with the first injection performed under medical supervision. This training has typically been conducted during face-to-face consultations, however since the start of the COVID-19 pandemic it has been necessary to conduct training remotely due to the cancellation of clinics.ObjectivesTo understand patient-reported experiences and satisfaction with remote SC MTX self-injection training.MethodsA cross-sectional electronic survey was administered between 11 October 2022 and 30 November 2022 to patients at Southern Health and Social Care Trust who had recently been trained via telephone or video conference [VC] on how to self-inject methotrexate using a pre-filled, auto-injector pen. Patients were aged ≥18 with a range of arthritis types, including rheumatoid, psoriatic, polyarticular juvenile idiopathic and chronic reactive inflammatory arthritis. Remote training was delivered by the patient's nurse as per routine practice (independently of this survey). Patients were sent a patient information pack (PIP) prior to the training consultation. During the training, the nurse discussed the process of injecting with the auto-injector pen before virtually supervising the first injection.The survey consisted of 14 questions;topics included experiences and satisfaction with preparation for the HCP appointment, the training consultation itself and post-training experiences and preferences. The responses were analysed descriptively on an item-by-item basis.ResultsIn total 73 patients completed the survey;77% (n=56/73) were female, and 96% (n=70/73) had no prior experience with a SC MTX auto-injector pen. The training was completed by telephone for 92% (n=67/73) of patients and by VC for 8% (n=6/73). 99% (n=72/73) received a PIP in advance of their training consultation and 92% (n=67/73) received this by post. 67% (n=49/73) of patients strongly agreed and 26% (n=19/73) agreed that they felt prepared for the training after receiving the PIP;78% (n=57/73) of patients strongly agreed and 22% (n=16/73) agreed that it was easy to read and understand, whilst 52% (n=38/73) strongly agreed and 32% (n=23/73) agreed that the PIP was helpful and did not require additional instructions before the appointment. 84% (n=61/73) took 15 minutes or less to complete the training with their HCP. None of the participants felt confused or did not understand the training instructions from their HCP, 78% (n=57/73) strongly agreed and 19% (n=14/73) agreed that the remote training was helpful and made them feel more confident to use the injector pen on their own and 97% (n=71/73) did not need to contact their HCP for more training or advice following their appointment. When asked about the main advantages of remote training, 32% (n=23/73) agreed it was more convenient, 25% (n=18/73) agreed that it was time saving and 30% (n=22/73) agreed that not having to attend the hospital was beneficial. 85% (n=62/73) strongly agreed and 14% (n=10/73) agreed that they were satisfied with the remote training provided and 82% (n=60/73) strongly agreed and 18% (n=13/73) agreed that they would recommend the remote training to another patient.ConclusionThese findings provide new insight into patients' experiences with self-injection training when delivered remotely by their HCP. The patient information pack and training consultation were well received as most patients found it helpful, convenient and time saving.References:NIL.AcknowledgementsThis survey was funded by Nordic Pharma. Medical writing support was provided by Angie Bonsu of Open Health and funded by Nordic Pharma.Disclosure of InterestsShannon McCourt Grant/research support from: Nordic Pharma, Mano Andiappan Employee of: Open Health who were paid by Nordic Pharma to support the work described in the .

VASCULITIS DISEASE ACTIVITY SCORES BEFORE AND DURING THE COVID-19 PANDEMIC: A COMPARISON OF FACE-TO-FACE CLINICIAN SCORING AND PROMS COLLECTED USING REMOTE MONITORING IN A SINGLE-CENTRE COHORT

BackgroundDuring the COVID-19 pandemic, asynchronous consultations were introduced for patients with vasculitis. To assess disease activity without of face-to-face clinical reviews and blood testing, patients submitted patient reported outcome measures (PROMs) via electronic survey forms, which were subsequently triaged by clinicians.Objectives1. To investigate how patients' vasculitis disease activity was affected by the COVID-19 pandemic through retrospective comparison of clinician-assessed scores recorded pre-pandemic with intra-pandemic self-reported patient reported outcome measures (PROMs) and disease scores submitted by patients remotely.2. To assess patients' clinical outcomes, including allocation of follow-up and further management/treatment escalation during this period.3. To validate self-reported BVAS scores against an existing PROM.MethodsThis is a retrospectively study of patients with a known diagnosis of vasculitis under the care of the Nuffield Orthopaedic Centre, Oxford. For the purposes of this study, we included patients with all vasculitis diagnoses.Clinician-reported scores (Bristol Vasculitis Activity score v.3, BVAS) were recorded during in-person clinics pre-pandemic (defined as 01/01/2019-31/12/2019) [1].Patients' self-reported BVAS (SR-BVAS) and AAV-PRO (ANCA-associated vasculitis patient-reported outcomes) scores were submitted by patients via electronic forms containing the requisite questionnaires sent out during-pandemic (defined as 01/12/2020-31/03/22) [2].SR-BVAS has not been validated but was collected to allow clinical comparison to disease activity scores completed by clinicians. Response were stored and analysed in a secure database. Score comparison was performed using Wilcoxon Sign Rank testing. Clinical outcome data was collected from the local Electronic Patient Record. Data analysis was performed in Microsoft Excel and R (version 4.2.1).ResultsWe noted a significantly higher overall level of patient-reported disease activity during the pandemic than was recorded in clinics prior. In the total cohort of all vasculitis patients for whom we had data, the median BVAS increased from 2 pre-pandemic (N = 335, range 0-21) to 6 intra-pandemic (N = 143, range 0-42) (p <0.001). The overall proportion of patients with severe/active disease (defined as BVAS ≥4) increased from 27% to 36% during the pandemic period.In a smaller cohort of 64 patients for whom we had paired pre- and during-pandemic scores, increased disease activity was reported (p<0.01). Notably, the number with a BVAS consistent with severe disease increased from 7 (11%) to 19 (30%).There was a significant positive correlation between SR-BVAS and AAV-PRO (r=0.61, p< 0.001) submitted by patients during-pandemic;however, at low BVAS (≤3), the AAV-PRO ranged widely (28-87)Follow-up data was available for all 64 patients in this cohort: 8/19 (42%) with a during-pandemic SR-BVAS ≥4 were seen in clinic within 3 months (telemedicine or face-to-face).ConclusionPatients reported worsening of vasculitis disease activity during the COVID-19 pandemic. This may be attributable to impacts on well-being or access to healthcare services. We note that disease activity scores in vasculitis may be limited in their ability to capture the whole picture disease activity in the absence of clinical assessment [3]. 42% of patients with self-reported high disease activity were seen within 3 months. There was a significant positive correlation between AAV-PRO and SR-BVAS, suggesting it has some use as a PROM.References[1]Mukhtyar C, Lee R, Brown D, Carruthers D, Dasgupta B, Dubey S, et al.. Ann Rheum Dis. 2009 Dec;68(12):1827–32.[2]Malley T, Jackman J, Manderson S, Saldana Pena L, Evans E, Barrett J, et al. Ann Rheum Dis. 2021 Jun 1;80(Suppl 1):289.[3]Luqmani RA. Nephrology Dialysis Transplantation. 2015 Apr 1;30(suppl_1):i76–82.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

IMPROVING THE UPTAKE OF ELECTRONIC PATIENT REPORTED OUTCOME MEASURES IN A SPECIALISED AXIAL SPONDYLOARTHROPATHY CLINIC

BackgroundSheffield Teaching Hospitals (STH), UK, has a specialised axial spondyloarthropathy (axSpa) clinic run by a rheumatology consultant and physiotherapist with special interest in this area. BASDAI and BASFI patient reported outcome measures are used to assess disease activity and response to treatment, in line with national guidelines. STH has invested in MyPathway (MP), an electronic patient messaging system used for patient information, appointments and electronic patient reported outcome measures (ePROMs). The data can also be viewed at a system level on a clinician dashboard. Prior to 2020 the uptake of ePROMs was low in the axSpa clinic. The move primarily to telephone consultations in March 2020, due to the COVID-19 pandemic, created an opportunity for increasing the use of MP for ePROMs collection to enable improved remote monitoring of patients with axSpa.ObjectivesThis quality improvement project aimed to increase the use of electronic BASDAI and BASFI (ePROMs) in the axSpa clinic.MethodsA multi-pronged approach has been taken since March 2020 to increase ePROMs completion and improve their use. Each appointment was used as an opportunity to discuss and recruit patients to MP. Clinicians invited each patient to join MP and sent them a link after their appointment. QR codes were then added to all rheumatology patient letters encouraging patients to register. A pathway was set up that automatically sent a prompt to patients registered on MP to complete their BASDAI and BASFI questionnaires prior to clinic appointments. Clinicians began logging into MP to view scores during appointments to provide patients with real-time feedback.A mixed methods approach was used to assess the uptake of ePROMs over time. We tracked MP registration rates and BASDAI completion rates as the key outcome measures, using a run chart to assess special cause variation. We undertook a patient focus group to explore attitudes towards ePROMs, key barriers and opportunities for further improvement.ResultsThe total number of axSpa patients seen in the specialised clinic (named LADAS) who have registered with MP has increased from 56 (35.9%) in January 2019 to 200 (58.9%) in September 2022. There has been an improvement in the BASDAI completion rate, with 80% of patients completing more than one BASDAI in 2022, compared to 24% in 2019, as illustrated on a run chart (Figure 1). Patients can complete BASDAI forms sent to them in a previous month, therefore the completion rate some months exceeds 100%.In a dedicated focus group, patients reported that ePROMs were generally more convenient, and provided a useful record to refer back to. This could be further improved by development of a graph function to view scores over-time and the ability for patients to complete a questionnaire between appointments when they feel their disease is more active. A key theme for improving the use of ePROMs was the need for more discussion about their utility and around individual patient's scores. There is concern that the BASDAI and BASFI scores are arbitrary and lack nuance, and that the importance of these scores at an individual patient level is not clear. This may be rectified by more discussion with clinicians in appointments, to add meaning to these scores. There was also concern that sleep and other generic health measures are not covered in the BASDAI or BASFI. The EQ-5D, a generic questionnaire, is also sent to axSpa patients, but there seems to be a lack of patient awareness regarding it. There is an appetite to improve and standardise the amount of patient information accessible on MP, for example disease information and links to patient support groups.ConclusionThere has been a clear improvement in the completion of ePROMs in the dedicated axSpa clinic at STH, over the last three years. Patient feedback has highlighted key areas for further improvement to maximise the potential of ePROMs, including more discussion around PROM scores to increase understanding and add individual patient meaning and nuance.Figure 1.AcknowledgementsI have no acknowledgements to declare.Disclosure of InterestsJudith Jade: None declared, Zoe Cox: None declared, Emily Fox: None declared, Rachel Tattersall Speakers bureau: honoraria as speaker for Abbvie, Lisa Dunkley Speakers bureau: honoraria as speaker/ teaching for UCB/ Abbvie/ Pfizer.

TESTING A NEW FATIGUE CHECKLIST IN SLE PATIENTS FOR EVERYDAY CLINICAL PRACTICE - AN INTERIM ANALYSIS

BackgroundFatigue is a difficult subject for both physicians and patients. It is barely addressed during consultations and can therefore burden patient-physician-relations. To improve communication regarding fatigue, we developed a checklist that includes suggestions for evaluating possible causes for fatigue. In this analysis, we describe our study population and report first results 3 and 6 months after using the checklist.ObjectivesThe aims of our study are to validate the use of our newly developed fatigue checklist and to demonstrate that addressing fatigue in daily clinical practice and offering possible interventions can improve fatigue.MethodsWe recruited n=110 SLE patients with fatigue from our university hospital-based lupus reference centre in Duesseldorf. Fatigue was measured using the FSS (Fatigue Severity Scale). Our checklist included signs of depression and anxiety using the PHQ-4 (Patient Health Questionnaire), BMI (body mass index), physical activity, anemia, hypothyroidism and vitamin D deficiency. For each applicable cause, we listed possible interventions for free selection by the treating physician, such as replacement therapy (vitamin D, vitamin B12, iron, folic acid, erythropoietin), physical activity programs and psychosomatic consultations that were discussed with the patients. We re-evaluated our patients after 3 (T1) and 6 months (T2).ResultsBaseline characteristics of patients are summarized in Table 1.Table 1.BMI=body mass index, TSH=thyroidea stimulating hormone, PHQ4=patient health questionnaire (cut-off >3 points), HAQ=health assessment questionnaire, IMET= Index for measuring restrictions on social participation (higher scores point towards more restrictions on social participation), FSS=fatigue severity scale (≥4 points equal severe fatigue)N = 110n (%)Mean (SD)Age (years)49.0 (12.34)Female sex99.0 (90.0)BMI (kg/m2)25.9 (5.55)Disease duration (years)19.1 (10.05)TSH (µIU/ml)1.5 (1.05)25-OH-Vitamin D (ng/ml)39.5 (15.35)Haemoglobin (g/dl)13.0 (1.64)Sports activities>4h/week6.0 (5.5)2-4h/week18.0 (16.4)1-2h/week16.0 (14.5)<1h/week28.0 (25.5)No sport42.0 (38.2)Depression (PHQ4 score)2.3 (1.63)Anxiety (PHQ4 score)2.0 (1.71)Functional status (HAQ score)0.8 (0.49)Participation (IMET score)2.8 (2.31)Fatigue (FSS score)5.3 (1.35)After 3 and 6 months, we re-evaluated 83 patients and saw a significant reduction in fatigue measured by the FSS score (T1: mean difference estimate 0.367 and p-value <0.001;T2: mean difference estimate 0.305;p-value <0.005).Figure 1.Comparing FSS-Scores from T0, T1 and T2[Figure omitted. See PDF]ConclusionThe preliminary analysis of our study shows for the first time that incorporation of a checklist procedure into the management of patients with fatigue may improve short-term outcome after 3 and 6 months of observation. The improvement of symptoms documented in our study occurred even though the suggested exercise program and psychosomatic counseling sessions were not available for use during the current observation period because of the COVID-19 pandemic. At present, the mechanisms behind the observed effect remain unclear. Our ongoing analysis will clarify whether an additional effect on fatigue will occur after all suggested interventions resulting from the use of the checklist have been executed. Finally, it will demonstrate whether the incorporation of our checklist into routine clinical practice is capable to reduce fatigue over a prolonged time period.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

RECOMMENDATIONS ON HANDLING MEDICINE SHORTAGE: LEARNING FROM HYDROXYCHLOROQUINE 2020 CRISIS FOR SLE PATIENTS

BackgroundEarly 2020, short supply of hydroxychloroquine sulfate (HCQ) – then claimed as effective for treatment of COVID-19 in several countries - raised significant concerns for those who use HCQ for chronic diseases including SLE. In April 2020, Lupus Europe launched a survey to quantify the access gap, as well as the anxiety expressed by patients confronted with this outage. 2422 patients responded with an average level of anxiety about access to HcQ of 6.45 on a maximum of 10. After supply issues were resolved, a follow up survey (Aug-Sept 2020 – 1854 answers) showed a significantly reduced anxiety of 4.15. A second follow up survey (Nov 2021 -Feb 2022 - 2255 answers) showed a further reduction to 3.54. Importantly, a core group of 6.2-13.7% of patients remains extremely anxious (scoring 9 or 10) about supply of their medication, substantially more than in Portugal (3.5%) and Finland (0%), where supply remained fair at the heat of the crisis.ObjectivesTo provide consensus on how communication should be conducted to minimize the impact of medicine shortages on patient anxiety.MethodsThe Patient Advisory Network (PAN) of Lupus Europe established an extensive list of potential elements of a more effective communication on shortages, that could help reduce patient anxiety. 20 statements were derived from those elements and proposed to PAN members and Lupus Europe member organisations. 101 answers were collected from 17 countries. For each country, the individual ratings of all participants were averaged to assign an individual vote for each country on each statement. Consensus amongst the 17 countries was then considered as obtained if 14 or more of the 17 countries agreed or strongly agreed with statements.Results9 out of the 20 statements reached consensus:1. Lupus specialists should (a) clarify alternative medication existing and its difference versus current treatments, (b) clarify appropriate emergency procedures and (c) clarify to the patients how to handle a short supply.2. Specialists and Hospitals should establish alternative supply mechanisms to guarantee minimum availability.3. pharmaceutical industry should (a) provide all information to all stakeholders and (b) help create emergency supply routes to ensure that no patient is left without his/her medication for a sustained period of time.4. National authorities should help patients with demonstrated need have priority access to limited supply quantities through a simple process.5. Hospitals should communicate (by email or postal mail) information on the shortage, how to handle it and how to access emergency supply routes. The same number agreed with Health authorities performing that same communication.6. pharmaceutical industry should avoid diverting products from one country to another if that would reduce supply below normal consumption level.7. Patient organisations should stop the rumors that can quickly spread though social media.8. pharmacists should be better equipped in terms of data (on the reasons and clear timelines for resolution as well as alternatives or recommendations for patients facing shortages)9. GP's should clarify alternative medication and appropriate emergency procedures.ConclusionShortages of medicine create an anxiety that can be long lasting. Even when supply is re-established, the fear remains. For this reason, establishing an effective communication system is necessary to reassure patients when short term shortages are taking place, and is key to avoid fast spreading anxiety relating to this concern. In this process, patient associations, physicians, industries and all the stakeholders should be involved.Reference[1]Cornet A, Andersen J, Tani C, Mosca M. Hydroxychloroquine availability during COVID-19 crisis and its effect on patient anxiety. Lupus Sci Med. 2021 Apr;doi: 10.1136/lupus-2021-000496Acknowledgements:NIL.Disclosure of InterestsNone Declared.

THE PATIENT-PERSPECTIVE AND FEASIBILITY OF HOME FINGER PRICK TESTING TO COMPLEMENT AND FACILITATE LARGE SCALE DIGITAL DATA COLLECTION

BackgroundPrevious studies have shown that using a finger prick as the primary method for blood withdrawal is an efficient way to collect blood samples remotely, and data on blood levels from a finger prick are directly comparable to that obtained by a venepuncture. During the COVID-19 pandemic, we therefore complemented our large digital research platform with serum collection via a home finger prick testing in order to collect samples without the need of visits to a hospital. This repeatedly enabled us to rapidly answer new and relevant clinical research questions about COVID-19, thereby showing the potential of the finger prick for research purposes. However, the use of finger pricks in a research or clinical practice setting is still uncommon, and not yet tested on a large scale. In addition, there is limited data on peoples' willingness and ability to successfully use the finger prick at home, especially in patients with inflammatory rheumatic diseases (iRD) who may have impaired hand function.ObjectivesTo investigate the feasibility of finger prick testing in combination with a digital research platform by evaluating the success rate and patients' perspective towards the use of the finger prick.MethodsData were collected from an ongoing prospective cohort study including patients with iRD from the Amsterdam Rheumatology & immunology Center and healthy controls. Serum samples were collected up to eight times during follow-up via blood withdrawal by venepuncture at the local research institute or via a finger prick that could be performed at home. For the latter option, participants were instructed to collect three drops of blood, which would yield approximately 40-80 µL of serum after clotting. All study participants were questioned about their preference for a particular sampling method for individual healthcare and for scientific research. Participants who received a finger prick test before June 26, 2021, were asked to complete a digital evaluation questionnaire of the finger prick after their attempt. The finger prick was defined as failed when less than 10 µL of serum could be recovered from the collection device, or if no sample was returned to the laboratory and participants indicated in the questionnaires that they did not succeed in collecting the required amount of serum.ResultsA total of 3080 patients with iRD and 1102 healthy controls were included in the study. Of these, 2135 (69%) patients and 899 (82%) controls attempted to execute at least one finger prick, and 1439 (67%) patients and 712 (21%) controls executed multiple finger pricks. The first finger prick was successfully done by 92% (CI 90 – 93) of iRD patients, 94% (CI 92 – 95) of healthy controls, 93% (CI: 92 – 94) of all participants aged 70 years or younger, and 89% (CI 86 – 92) of all participants aged above 70 years (Table 1). Sex did not impact these success rates. Repeated failure occurred in 11 of 1439 (0.8%) patients and 4 of 712 (0.6%) controls. The two most common reasons for perceived failure of the finger prick were related to insufficient blood yield when applying the finger prick. Finally, both patients and controls were less willing to perform a finger prick for individual healthcare compared to scientific research;31% of patients and 61% of controls were willing to perform a finger prick for scientific research compared to 19% of patients and 39% of controls for healthcare. The most important reason for this was lower confidence in the execution and laboratory measurements when blood was drawn via a venepuncture compared to a finger prick.ConclusionIn this study, we demonstrated that the vast majority of participants, among which elderly and patients of whom hand function may be impaired by an underlying rheumatic disease, were able to successfully draw the required amount of blood for serological analyses. This shows that the finger prick testing is suitable for a high-throughput implementation to monitor patients remotely, which will likely contribute to improving the efficiency and cost-effectiveness of b th healthcare and scientific research.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

Measuring symptom burden in patients with cancer during a pandemic: the MD Anderson symptom inventory for COVID-19 (MDASI-COVID).

BACKGROUND: Symptom expression in SARS-CoV-2 infection (COVID-19) may affect patients already symptomatic with cancer. Patient-reported outcomes (PROs) can describe symptom burden during the acute and postacute stages of COVID-19 and support risk stratification for levels of care. At the start of the COVID-19 pandemic, our purpose was to rapidly develop, launch through an electronic patient portal, and provide initial validation for a PRO measure of COVID-19 symptom burden in patients with cancer. METHODS: We conducted a CDC/WHO web-based scan for COVID-19 symptoms and a relevance review of symptoms by an expert panel of clinicians treating cancer patients with COVID-19 to create a provisional MD Anderson Symptom Inventory for COVID-19 (MDASI-COVID). English-speaking adults with cancer who tested positive for COVID-19 participated in the psychometric testing phase. Patients completed longitudinal assessments of the MDASI-COVID and the EuroQOL 5 Dimensions 5 Levels (EQ-5D-5L) utility index and visual analog scale, which were presented through an electronic health record patient portal. To test the validity of the MDASI-COVID to distinguish between known groups of patients, we hypothesized that patients hospitalized, including having a hospitalization extended, for COVID-19 versus those not hospitalized would experience higher symptom burden. Correlation of mean symptom severity and interference scores with relevant EQ-5D-5L scores tested concurrent validity. The reliability of the MDASI-COVID was evaluated by calculating Cronbach alpha coefficients and test-retest reliability was evaluated by calculating Pearson correlation coefficients between the initial assessment and a second assessment no more than 14 days later. RESULTS: The web-based scan found 31 COVID-19-related symptoms; rankings of a 14-clinician expert panel reduced this list to 11 COVID-specific items to be added to the core MDASI. Time from literature scan start in March 2020 to instrument launch in May 2020 was 2 months. Psychometric analysis established the MDASI-COVID's reliability, known-group validity, and concurrent validity. CONCLUSIONS: We were able to rapidly develop and electronically launch a PRO measure of COVID-19 symptom burden in patients with cancer. Additional research is needed to confirm the content domain and predictive validity of the MDASI-COVID and define the symptom burden trajectory of COVID-19.

The Relationship between Internet Patient Satisfaction Ratings and COVID-19 Outcomes.

Our prior research showed that patient experience-as reported by Google, Yelp, and the Hospital Consumer Assessment of Healthcare Providers and Systems survey-is associated with health outcomes. Upon learning that COVID-19 mortality rates differed among U.S. geographic areas, we sought to determine if COVID-19 outcomes were associated with patient experience. We reviewed daily, U.S.-county-level-accrued COVID-19 infections and deaths during the first year of the pandemic using each locality's mean online patient review rating, correcting for county-level demographic factors. We found doctor star ratings were significantly associated with COVID-19 outcomes. We estimated the absolute risk reduction (ARR) and relative risk reduction (RRR) for each outcome by comparing the real-world-observed outcomes, observed with the mean star rating, to the outcomes predicted by our model with a 0.3 unit higher average star rating. Geographic areas with higher patient satisfaction online review ratings in our models had substantially better COVID-19 outcomes. Our models predict that, had medical practices nationwide maintained a 4-star average online review rating-a 0.3-star increase above the current national average-the U.S may have experienced a nearly 11% lower COVID-19 infection rate and a nearly 17% lower death rate among those infected.

Comparative evaluation using PRO of an algorithm of one-stage immediate alloplastic breast reconstruction versus two-stage reconstruction.

BACKGROUND: One-stage direct-to-implant (DTI) immediate breast reconstruction has proven to be an oncologically safe technique, but there are some conditions that do not allow its performance. The introduction of new surgical techniques and the recent COVID-19 pandemic have pushed us to introduce a breast reconstruction algorithm in our clinical practice. This allows a one-stage immediate reconstruction for all patients, regardless of their anatomical characteristics, the type of implants used, and the need for postoperative radiotherapy. METHODS: A total of 40 patients were recruited and divided into two cohorts, 20 patients underwent immediate one-stage breast reconstruction in the period between October 2019 and January 2021, and 20 patients completed the two-stage reconstructive process in the period prior to October 2019. During the follow-up at 6 months, all patients who had completed the reconstructive process filled out the Breast-Q Reconstruction Module Pre and Postoperative scales questionnaire. The outcomes of the questionnaires were compared between the two cohorts, and statistical analysis was carried out using SPSS Statistics 20 (IBM Corporation, Armonk, NY, USA). RESULTS: The analysis of patient-reported outcomes showed that patients from the one-stage group reported better outcomes in all items evaluated. We did not find statistically significant differences concerning the rate of complications and length of hospital stay between the two groups. CONCLUSIONS: The analysis of the results shows that the outcomes reported by patients who completed breast reconstruction according to our algorithm are statistically better than those with the two-stage technique.

Patient perspectives and narratives

An understanding of telerheumatology is incomplete without considering the perspective of people who are living with rheumatic conditions and their experience using telehealth for the management of their disease. Notably, all but one of the authors of this chapter are patients themselves, individuals diagnosed in childhood or adulthood and living daily with inflammatory arthritis. This chapter first defines what is meant by the term "patient perspective" as it concerns access to, expectations of, and use of telerheumatology. The advantages and disadvantages of telerheumatology from patients' point of view are described, including previous research reporting collective patient satisfaction with telerheumatology. An overview of patient preparation needed for telerheumatology is also offered along with resources that rheumatologists may refer to when helping their patients plan for telemedicine visits. The chapter concludes with patient narratives of telerheumatology encounters during the COVID-19 pandemic. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022. All rights reserved.

General population reference values for the Functional Assessment of Cancer Therapy-Lung and PROMIS-29.

BACKGROUND: Therapeutic advances in lung cancer have turned attention toward patient-reported outcome measures (PROMs) as important clinical outcomes. The Functional Assessment of Cancer Therapy-Lung (FACT-L) is a common endpoint in lung cancer trials. This study calculated FACT-L reference values for the United States (US) general population. METHODS: Adults from the US general population (N = 2001) were surveyed between September 2020 and November 2020. Surveys contained 126 questions, including the FACT-L [36 items; FACT-G and four subscales (Physical Well-Being [PWB], Social Well-Being [SWB], Emotional Well-Being [EWB], and Functional Well-Being [FWB]) and the Lung Cancer Subscale (LCS), and a Trial Outcome Index (TOI)]. Reference values for each FACT-L scale were calculated with means for the total sample and separately for participants with: no comorbidities, COVID-19 as only comorbidity, no COVID-19. RESULTS: In the total sample, the reference scores were as follows: PWB = 23.1; SWB = 16.8; EWB = 18.5; FWB = 17.6; FACT-G = 76.0; LCS = 23.0, TOI = 63.7, and FACT-L Total = 99.0. Scores were lower for those reporting a prior diagnosis of COVID-19, especially for SWB (15.7) and FWB (15.3). SWB scores were lower than previous references values. CONCLUSIONS: These data provide US general adult population reference value set for FACT-L. While some of the subscale results were lower than those found in the reference data for other PROMs, these data were obtained in a more contemporaneous time frame juxtaposed with the COVID-19 pandemic and may represent a new peri-pandemic norm. Thus, these reference values will be useful for future clinical research.

Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and 2 surveys.

OBJECTIVES: Disease flares in the post COVID-19 vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). METHODS: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022 respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history, and vaccination details.Flares of IIMs were defined as a. patient self-reported, b. immunosuppression (IS) denoted, c. clinical sign directed, and d. with >7.9-point MCID worsening of PROMISPF10a score. Risk factors of flares were analyzed using regression models. RESULTS: Of 15165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians), and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7%, and 19.6% patients by definitions a-d respectively with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR:1.2; 95%CI:1.03-1.6, p = 0.025) were prone to flares, while those receiving Rituximab (OR:0.3; 95%CI:0.1-0.7, p = 0.010) and Azathioprine (OR:0.3, 95%CI:0.1-0.8, p = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in immunosuppression. Asthma (OR: 1.62; 95%CI: 1.05-2.50, p = 0.028) and higher pain VAS (OR: 1.19; 95%CI: 1.11-1.27, p < 0.001) were associated with disparity between self-reported and IS-denoted flares. CONCLUSION: A diagnosis of IIMs confers an equal risk of flares in the post COVID-19 vaccination period to AIRDs, with active disease, female gender, and comorbidities conferring a higher risk. Disparity between patient and physician reported outcomes represents a future avenue for exploration.

Assessing the Predictive Power of Frailty and Life-Space Mobility on Patient-Reported Outcomes of Disability in Older Adults with Low Back Pain.

BACKGROUND: Frailty and decreased life-space mobility are known as risk factors to develop physical limitations leading to disability in older adults with low back pain (LBP). This cross sectional study aimed to investigate the prevalence and predictive power of frailty and life-space mobility on patient-reported outcomes of disability in older adults with LBP. METHODS: The sample comprised 165 older adults with LBP who visited two tertiary care hospitals between December 2021 and February 2022. The participants responded to structured standard questionnaires. Data were analyzed using descriptive statistics and robust logistic regression. RESULTS: More than two-thirds of participants were classified as non-frail (26.67%) or pre-frail (66.67%). Mobility restrictions and minimal to severe disability were identified. Controlling other variables, frailty (OR = 1.74, 95% CI: 1.14-2.64) and restricted life-space mobility (OR = 0.42, 95% CI: 0.26-0.67) were significantly associated with disability. Integrating frailty with life-space mobility evaluations demonstrated the highest predictive power for disability-related LBP (AUC = 0.89, 95% CI: 0.84-0.93). CONCLUSION: Frailty and restricted life-space mobility significantly predicted disability in older adults with LBP. Healthcare professionals should recognize the critical importance of integrating patient-reported outcomes with screening for frailty and life-space mobility limitation to optimize care or tract symptom progression.

Perceived COVID-19 pandemic impact and protective factors predicting patient-reported depression and anxiety in individuals living with cancer.

BACKGROUND: The COVID-19 pandemic presents a unique, amplified threat to those living with a cancer diagnosis, but personal factors may play a role in how this affects well-being. This cross-sectional study (1) describes the impacts of COVID-19 on cancer patients' lives, and (2) explores the extent to which specific impacts of COVID-19 and noted protective factors, hope and resilience, predict two crucial patient-reported outcomes, depression and anxiety, after controlling for relevant sociodemographic and clinical factors. METHODS: 520 cancer patients and survivors in the U.S. completed an online survey during the first year of the pandemic and answered questions about COVID-19 areas of impact, psychological well-being, hope, and resilience. Hierarchical regression analyses were used to analyze the unique impact of each group of variables on patient-reported levels of depression and anxiety during the pandemic. RESULTS: Participants strongly endorsed COVID-19 impact across several areas of life, especially social activity, well-being, and ability to acquire basic essentials. Regression models explained a substantial amount of variance in patient-reported depression (R2 = .50, p < .001) and anxiety (R2 = .44, p < .001), revealing COVID-19 financial impact as a significant predictor of depression (ß = 0.07), and COVID-19 family impact as a significant predictor of anxiety (ß = 0.14), even after controlling for the effects of relevant sociodemographic and clinical variables. Additionally, resilience and hope were the largest predictors of both depression (ß = - 0.19 and - 0.37, respectively) and anxiety (ß = - 0.18 and - 0.29), suggesting that they account for unique variance in patient-reported mental health during the COVID-19 pandemic and might serve as important protective factors. CONCLUSIONS: The current results add to existing literature documenting the significant effect of COVID-19 on those living with cancer. COVID-19 impact, including financial and family well-being, as well as positive psychological constructs, hope and resilience, play a crucial role in levels of patient-reported depression and anxiety during the pandemic. As COVID-19 continues to evolve, health care providers should routinely assess psychological well-being and needs related to COVID-19 financial and family impact in an effort to appropriately align individuals with resources and support, and consider how hope and resilience can be fostered to serve as psychological buffers during this time.

Factors Associated With Long COVID Symptoms in an Online Cohort Study.

Background: Few prospective studies of Long COVID risk factors have been conducted. The purpose of this study was to determine whether sociodemographic factors, lifestyle, or medical history preceding COVID-19 or characteristics of acute severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are associated with Long COVID. Methods: In March 26, 2020, the COVID-19 Citizen Science study, an online cohort study, began enrolling participants with longitudinal assessment of symptoms before, during, and after SARS-CoV-2 infection. Adult participants who reported a positive SARS-CoV-2 test result before April 4, 2022 were surveyed for Long COVID symptoms. The primary outcome was at least 1 prevalent Long COVID symptom greater than 1 month after acute infection. Exposures of interest included age, sex, race/ethnicity, education, employment, socioeconomic status/financial insecurity, self-reported medical history, vaccination status, variant wave, number of acute symptoms, pre-COVID depression, anxiety, alcohol and drug use, sleep, and exercise. Results: Of 13 305 participants who reported a SARS-CoV-2 positive test, 1480 (11.1%) responded. Respondents' mean age was 53 and 1017 (69%) were female. Four hundred seventy-six (32.2%) participants reported Long COVID symptoms at a median 360 days after infection. In multivariable models, number of acute symptoms (odds ratio [OR], 1.30 per symptom; 95% confidence interval [CI], 1.20-1.40), lower socioeconomic status/financial insecurity (OR, 1.62; 95% CI, 1.02-2.63), preinfection depression (OR, 1.08; 95% CI, 1.01-1.16), and earlier variants (OR = 0.37 for Omicron compared with ancestral strain; 95% CI, 0.15-0.90) were associated with Long COVID symptoms. Conclusions: Variant wave, severity of acute infection, lower socioeconomic status, and pre-existing depression are associated with Long COVID symptoms.

Feasibility and first results of the 'Trials-within-Cohorts' (TwiCs) design in patients undergoing radiotherapy for lung cancer.

Background: 'Trials-within-Cohorts' (TwiCs), previously known as 'cohort multiple randomized controlled trials' is a pragmatic trial design, supporting an efficient and representative recruitment of patients for (future) trials. To our knowledge, the 'COhort for Lung cancer Outcome Reporting and trial inclusion' (COLOR) is the first TwiCs in lung cancer patients. In this study we aimed to assess the feasibility and first year results of COLOR.Material and Methods: All patients diagnosed with lung cancer referred to the Radiotherapy department were eligible to participate in the ongoing prospective COLOR study. At inclusion, written informed consent was requested for use of patient data, participation in patient-reported outcomes (PROs), and willingness to participate in (future) trials. Feasibility was studied by assessing participation and comparing baseline PROs to EORTC reference values. First-year results of PROs at baseline and 3 months after inclusion were evaluated separately for stereotactic body radiotherapy (SBRT) and conventional radiotherapy patients.Results: Of the 338 eligible patients between July 2020 and July 2021, 169 (50%) participated. Among these, 127 (75%) gave informed consent to PROs participation and 110 (65%) were willing to participate in (future) trials. The inclusion percentage dropped from 77% to 33% when the information procedure was switched from in-person to by phone (due to COVID-19 pandemic measures). Baseline PROs for physical and cognitive functioning were comparable in COLOR patients compared to the EORTC reference values. No significant changes in PROs were observed 3 months after inclusion, except for a slight increase in pain scores in the SBRT group (n = 97).Conclusions: The TwiCs-design appears feasible in lung cancer patients with fair participation rates (although negatively impacted by the COVID-19 pandemic). With a planned expansion to other centers, the COLOR-study is expected to enable multiple (randomized) evaluations of experimental interventions with important advantages for recruitment, generalizability, and long-term outcome data collection.