Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial

BACKGROUND: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations. METHODS: The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization. RESULTS: In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI − 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI − 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes. CONCLUSION: The offer to use the SPIN-HAND Program did not improve hand function. Low offer uptake, program access, and minimal usage among those who accessed the program limited our ability to determine if using the program would improve function. To improve engagement, the program could be tested in a group format or as a resource to support care provided by a physical or occupational therapist. TRIAL REGISTRATION: NCT03419208. Registered on February 1, 2018

Patterns of patient-reported symptoms and association with sociodemographic and systemic sclerosis disease characteristics: a scleroderma Patient-centered Intervention Network (SPIN) Cohort cross-sectional study

Background: Systemic sclerosis is a heterogenous disease in which little is known about patterns of patient-reported symptom clusters. We aimed to identify classes of individuals with similar anxiety, depression, fatigue, sleep disturbance, and pain symptoms and to evaluate associated sociodemographic and disease-related characteristics. Methods: This multi-centre cross-sectional study used baseline data from Scleroderma Patient-centered Intervention Network Cohort participants enrolled from 2014 to 2020. Eligible participants completed the PROMIS-29 v2.0 measure. Latent profile analysis was used to identify homogeneous classes of participants based on patterns of anxiety, depression, fatigue, sleep disturbance, and pain scores. Sociodemographic and disease-related characteristics were compared across classes. Findings: Among 2212 participants, we identified five classes, including four classes with “Low” (565 participants, 26%), “Normal” (651 participants, 29%), “High” (569 participants, 26%), or “Very High” (193 participants, 9%) symptom levels across all symptoms. Participants in a fifth class, “High Fatigue/Sleep/Pain and Low Anxiety/Depression” (234 participants, 11%) had similar levels of fatigue, sleep disturbance, and pain as in the “High” class but low anxiety and depression symptoms. There were significant and substantive trends in sociodemographic characteristics (age, education, race or ethnicity, marital or partner status) and increasing disease severity (diffuse disease, tendon friction rubs, joint contractures, gastrointestinal symptoms) across severity-based classes. Disease severity and sociodemographic characteristics of “High Fatigue/Sleep/Pain and Low Anxiety/Depression” class participants were similar to the “High” severity class. Interpretation: Most people with systemic sclerosis can be classified by levels of patient-reported symptoms, which are consistent across symptoms and highly associated with sociodemographic and disease-related variables, except for one group which reports low mental health symptoms despite high levels of other symptoms and substantial disease burden. Studies are needed to better understand resilience in systemic sclerosis and to identify and facilitate implementation of cognitive and behavioural strategies to improve coping and overall quality of life. Funding: National Institute of Nursing Research (F31NR019007), Canadian Institutes of Health Research, Arthritis Society Canada, the Lady Davis Institute for Medical Research, the Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland

Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients

Objective: Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.Methods: The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score >= 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via video-conference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.Ethics and dissemination: The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak

AB1767-HPR DOCUMENT SEARCH IN LARGE RHEUMATOLOGY DATABASES: ADVANCED KEYWORD QUERIES TO SELECT HOMOGENEOUS PHENOTYPES

International audienceBackground Natural language processing tools are powerful for mining rheumatology databases, extracting patient information directly from clinical notes. However, these algorithms come with a high computational cost and are often not applicable at the scale of very large databases in the temporality of clinical practice. Objectives The objective of our study is the automatic detection of clinical documents of interest for a specific clinical question, with low computational cost, to be applied on a database of millions of documents. These sets of documents of interest constitute a pre-screening to allow the development of more complex algorithms. Methods The task was considered as an information retrieval task in French clinical texts. Two different methods were compared. For the first method, we used several state-of-the-art document vector representations: TF-IDF, doc2vec, docBERT and tested if the closest documents are relevant. The second method consists in building a powerful query expansion from a key term entered, its French synonyms from the UMLS and the synonyms found by similarity with the embeddings of the CODER algorithm. These methods are developed and evaluated on a set of 8 and on 20 phenotypes respectively (e.g. “pericarditis in lupus”, etc.). Our database corresponds to 2 million documents from a cohort of patients suffering from four autoimmune diseases: systemic lupus erythematosus, scleroderma, antiphospholipid syndrome, and Takayasu’s disease, coming from the AP-HP’s data warehouse. Results Our experience does not support the vector representation model of clinical notes for searching similar patients. However, searching with an advanced synonym search method can lead to very good results without additional burden for the clinician: we achieved a precision (or positive predictive value) of 0.93 [0.90; 0.96] evaluated manually by a physician and a recall (or sensitivity) of 0.78 [0.71; 0.85] evaluated on the basis of the ICD10 codes of the retrieved patients. Conclusion We propose a new advanced keyword search method with automatic synonym search with very good accuracy and recall performance. References [1]Alison Callahan, Vladimir Polony, José D Posada, Juan M Banda, Saurabh Gombar, Nigam H Shah, ACE: the Advanced Cohort Engine for searching longitudinal patient records, Journal of the American Medical Informatics Association , Volume 28, Issue 7, July 2021, Pages 1468–1479, [2]Yuan, Zheng, et al. “CODER: Knowledge-infused cross-lingual medical term embedding for term normalization.” Journal of biomedical informatics 126 (2022): 103983 [3]Gérardin C, Mageau A, Mékinian A, Tannier X, Carrat F, Construction of Cohorts of Similar Patients From Automatic Extraction of Medical Concepts: Phenotype Extraction Study, JMIR Med Inform 2022;10(12):e42379 Table 1. Accuracy and recall results for 13 over 20 queries. Query Accuracy (on 50 manually-annotated document per query) Recall (comparison with respective CIM10) Number of corresponding documents 1 “Rheumatoid Arthritis” 0.98 0.73 15189 2 “Takayasu” 1 0.94 2459 3 “Pericarditis in lupus” 0.92 0.93 7490 4 “Kidney transplantation” 0.92 0.98 10716 5 “Autoimmune hepatitis” 0.8 0.85 2797 6 “Dermatomyositis” 1.0 0.77 3510 7 “Idiopathic thrombocytopenic purpura” 0.98 0.81 3749 8 “Acute kidney injury” 0.86 0.81 15775 9 “Raynaud syndrome” 0.98 0.98 31900 10 “HIV” 0.90 0.98 43582 11 “Scleroderma” 1.0 0.92 24199 12 “Diabetes” 0.96 0.96 51224 13 … “Stroke” … 0.64 0.63 28162 Overall 0.93 [0.90; 0.96] 0.78 [0.71; 0.85] Figure 1. Overview of the two methods of searching for documents in our data warehouse. Method 1 is document oriented and method 2 is keyword oriented. Acknowledgements The authors would like to thank the AP-HP data warehouse, which provided the data and the computing power to carry out this study under good conditions. We would like to thank all the medical colleges, including internal medicine, rheumatology, dermatology, nephrology, pneumology, hepato-gastroenterology, hematology, endocrinology, gynecology, infectiology, cardiology, oncology, emergency and intensive care units, that gave their agreements for the use of the clinical data. Disclosure of Interests None Declared