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100 Publications visible to you, out of a total of 100
Implementing an automated monitoring process in a digital, longitudinal observational cohort study

Abstract (Expand)

BACKGROUND: Clinical data collection requires correct and complete data sets in order to perform correct statistical analysis and draw valid conclusions. While in randomized clinical trials much effort … concentrates on data monitoring, this is rarely the case in observational studies- due to high numbers of cases and often-restricted resources. We have developed a valid and cost-effective monitoring tool, which can substantially contribute to an increased data quality in observational research. METHODS: An automated digital monitoring system for cohort studies developed by the German Rheumatism Research Centre (DRFZ) was tested within the disease register RABBIT-SpA, a longitudinal observational study including patients with axial spondyloarthritis and psoriatic arthritis. Physicians and patients complete electronic case report forms (eCRF) twice a year for up to 10 years. Automatic plausibility checks were implemented to verify all data after entry into the eCRF. To identify conflicts that cannot be found by this approach, all possible conflicts were compiled into a catalog. This "conflict catalog" was used to create queries, which are displayed as part of the eCRF. The proportion of queried eCRFs and responses were analyzed by descriptive methods. For the analysis of responses, the type of conflict was assigned to either a single conflict only (affecting individual items) or a conflict that required the entire eCRF to be queried. RESULTS: Data from 1883 patients was analyzed. A total of n = 3145 eCRFs submitted between baseline (T0) and T3 (12 months) had conflicts (40-64%). Fifty-six to 100% of the queries regarding eCRFs that were completely missing were answered. A mean of 1.4 to 2.4 single conflicts occurred per eCRF, of which 59-69% were answered. The most common missing values were CRP, ESR, Schober’s test, data on systemic glucocorticoid therapy, and presence of enthesitis. CONCLUSION: Providing high data quality in large observational cohort studies is a major challenge, which requires careful monitoring. An automated monitoring process was successfully implemented and well accepted by the study centers. Two thirds of the queries were answered with new data. While conventional manual monitoring is resource-intensive and may itself create new sources of errors, automated processes are a convenient way to augment data quality.

Authors: L. Lindner, A. Weiss, A. Reich, S. Kindler, F. Behrens, J. Braun, J. Listing, G. Schett, J. Sieper, A. Strangfeld, A. C. Regierer

Date Published: 2021

Publication Type: Journal

EULAR recommendations for a core data set for pregnancy registries in rheumatology

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BACKGROUND AND OBJECTIVE: There is an urgent need for robust data on the trajectories and outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD). In particular when rare outcomes … or rare diseases are to be investigated, collaborative approaches are required. However, joint data analyses are often limited by the heterogeneity of the different data sources.To facilitate future research collaboration, a European League Against Rheumatism (EULAR) Task Force defined a core data set with a minimum of items to be collected by pregnancy registries in rheumatology covering the period of pregnancy and the 28-day neonatal phase in women with any underlying IRD. METHODS: A stepwise process included a two-round Delphi survey and a face-to-face meeting to achieve consensus about relevant items. RESULTS: A total of 64 multidisciplinary stakeholders from 14 different countries participated in the two rounds of the Delphi process. During the following face-to-face meeting of the EULAR Task Force, consensus was reached on 51 main items covering ’maternal information’, ’pregnancy’ and ’treatment’. Generic instruments for assessment are recommended for every item. Furthermore, for the five most frequent IRDs rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, disease-specific laboratory markers and disease activity measurements are proposed. CONCLUSION: This is the first consensus-based core data set for prospective pregnancy registries in rheumatology. Its purpose is to stimulate and facilitate multinational collaborations that aim to increase the knowledge about pregnancy course and safety of treatment in women with IRDs during pregnancy.

Authors: Y. Meissner, R. Fischer-Betz, L. Andreoli, N. Costedoat-Chalumeau, D. De Cock, Rjem Dolhain, F. Forger, D. Goll, A. Molto, C. Nelson-Piercy, R. Ozdemir, L. Raio, S. C. Rodriguez-Garcia, S. Sciascia, M. Wallenius, A. Zbinden, A. Zink, A. Strangfeld

Date Published: 2021

Publication Type: Journal

Pregnancy in women with psoriatic arthritis: A systematic literature review of disease activity and adverse pregnancy outcomes

Abstract (Expand)

BACKGROUND: There is limited robust evidence on the course of pregnancy and its outcomes in women with psoriatic arthritis (PsA) on which to base recommendations for the management of these patients. … OBJECTIVE: The primary objective was to review available data on (I) disease activity during pregnancy and on (II) adverse pregnancy outcomes (APO) in women with PsA. Secondly, neonatal outcomes and treatment of the rheumatic disease were investigated. METHODS: Systematic literature search within the databases Pubmed and Embase until 30 Nov 2020 was performed. Additionally, reference lists of included studies and of review articles revealed by the search were screened. All full text articles identified and published in English language were systematically evaluated by two reviewers. All studies that reported on one of the primary outcomes and included at least five pregnancies in women with PsA were considered. RESULTS: The review of 734 search results revealed 13 eligible publications reporting on a total of 2,332 pregnancies in women with PsA. Nine studies reported on PsA activity and showed an increase or worsening of disease activity after delivery compared to the pregnancy period. APOs were reported by nine studies. Adjusted analyses of APOs did not show an increased risk for gestational diabetes, small for gestational age and low birth weight in PsA patients in relation to the respective comparator groups. However, there were signals for a higher pre-eclampsia, elective caesarean section and preterm birth risk in PsA pregnancies. Meta-analysis was not performed due to study heterogeneity. DISCUSSION: This review showed a postpartum deterioration of disease activity in women with PsA and no risk elevation for gestational diabetes, small for gestational age and low birth weight. A higher risk for pre-eclampsia, elective caesarean section and preterm birth in PsA pregnancies cannot be ruled out. Differences in the studies investigated limit overall summary statements on disease activity and APOs in women with PsA. Harmonization of study approaches, instruments and outcome reporting is crucial to ensure informed counselling of patients with PsA before, during and after pregnancy that is based on robust data. PROSPERO REGISTRATION NUMBER: CRD42020162242.

Authors: Y. Meissner, T. Rudi, R. Fischer-Betz, A. Strangfeld

Date Published: 2021

Publication Type: Journal

[Insights into pregnancy and breastfeeding in inflammatory rheumatic diseases through observational data]

Abstract (Expand)

Information on pregnancy and breastfeeding in women with chronic inflammatory rheumatic diseases is relevant for a successful pregnancy and also for maternal and child health. In general, pregnant and … breastfeeding women are excluded from randomized clinical trials and therefore evidence for clinical care and counselling has to be generated from observational studies. In the past decades, various data collections have been established for this purpose in addition to the existing spontaneous reporting systems initiated by drug authorities, with the aim of monitoring the teratogenic risk of a drug. Health insurance claims data, electronic health records and Scandinavian registers are also increasingly being used for research on pregnancy-associated events; however, all these data sources lack the inclusion of the maternal disease, especially with respect to its inflammatory component. Established cohort studies, biologics and disease registries record disease activity but are not designed for pregnancy-specific questions. Pregnancy registries and studies in rheumatology close this gap. In order to be able to make a better assessment of the possibilities and limitations of existing data sources on pregnancy and lactation, they are presented in detail in the following review including their respective advantages and disadvantages and examples from rheumatology are given. In addition, existing collaborations as well as studies for investigating the influence of paternal rheumatic disease are highlighted.

Authors: Y. Meissner, A. Strangfeld

Date Published: 2021

Publication Type: Journal

TNFi is associated with positive outcome, but JAKi and rituximab are associated with negative outcome of SARS-CoV-2 infection in patients with RMD

Abstract (Expand)

INTRODUCTION: Several risk factors for severe COVID-19 specific for patients with inflammatory rheumatic and musculoskeletal diseases (RMDs) have been identified so far. Evidence regarding the influence … of different RMD treatments on outcomes of SARS-CoV-2 infection is still poor. METHODS: Data from the German COVID-19-RMD registry collected between 30 March 2020 and 9 April 2021 were analysed. Ordinal outcome of COVID-19 severity was defined: (1) not hospitalised, (2) hospitalised/not invasively ventilated and (3) invasively ventilated/deceased. Independent associations between demographic and disease features and outcome of COVID-19 were estimated by multivariable ordinal logistic regression using proportional odds model. RESULTS: 2274 patients were included. 83 (3.6%) patients died. Age, male sex, cardiovascular disease, hypertension, chronic lung diseases and chronic kidney disease were independently associated with worse outcome of SARS-CoV-2 infection. Compared with rheumatoid arthritis, patients with psoriatic arthritis showed a better outcome. Disease activity and glucocorticoids were associated with worse outcome. Compared with methotrexate (MTX), TNF inhibitors (TNFi) showed a significant association with better outcome of SARS-CoV-2 infection (OR 0.6, 95% CI0.4 to 0.9). Immunosuppressants (mycophenolate mofetil, azathioprine, cyclophosphamide and ciclosporin) (OR 2.2, 95% CI 1.3 to 3.9), Janus kinase inhibitor (JAKi) (OR 1.8, 95% CI 1.1 to 2.7) and rituximab (OR 5.4, 95% CI 3.3 to 8.8) were independently associated with worse outcome. CONCLUSION: General risk factors for severity of COVID-19 play a similar role in patients with RMDs as in the normal population. Influence of disease activity on COVID-19 outcome is of great importance as patients with high disease activity-even without glucocorticoids-have a worse outcome. Patients on TNFi show a better outcome of SARS-CoV-2 infection than patients on MTX. Immunosuppressants, rituximab and JAKi are associated with more severe course.

Authors: A. C. Regierer, R. Hasseli, M. Schafer, B. F. Hoyer, A. Krause, H. M. Lorenz, A. Pfeil, J. Richter, T. Schmeiser, H. Schulze-Koops, A. Strangfeld, R. E. Voll, C. Specker, U. Mueller-Ladner

Date Published: 2021

Publication Type: Journal

Mobile Responsive App-A Useful Additional Tool for Data Collection in the German Pregnancy Register Rhekiss?

Abstract (Expand)

Background: The German pregnancy register Rhekiss is designed as a nationwide, web-based longitudinal observational cohort established in 2015. The register follows women with inflammatory rheumatic … disease prospectively from child wish or early pregnancy until 2 years post-partum. Information on clinical and laboratory parameters, drug treatment, and (adverse) pregnancy outcomes are documented in pre-specified intervals. Physicians and patients report data for the same time periods via separated accounts and forms into a web-based application (app). As data entry on mobile devices might improve response rates of patients, a responsive app as a further convenient documentation option was developed. Methods: The Rhekiss-app is available for self-reported data retrieval since August 2017 from the App stores. For the current analysis, Rhekiss register data were used from the start of the register until 30 September 2020. The analyses were performed for forms containing information on devices. Outcome parameters were compared for mobile and desktop users for the quantity and quality of filled forms. Results: In total, 5,048 forms were received and submitted by 966 patients. About 57% of forms were sent from mobile devices with the highest numbers in patients with child wishes (63%). Users of mobile devices were slightly younger and often had less high-education level (62 vs. 79%) compared with desktop users. The proportion of forms submitted via mobile devices increased steadily from 48% in the fourth quarter of 2018 to 64% in the third quarter of 2020. The proportion of forms received before and after the Rhekiss-app implementation increased with the highest increase of 12% for forms filled at time point 12 months post-partum. Mobile users submitted significantly more forms than desktop users (2.9 vs. 2.1), data sent via desktops were more often complete (88 vs. 86%). Conclusion: The responsive app is a valuable additional tool for data collection and is well-accepted by patients as indicated by its increasing use in Rhekiss. Apart from desktop/browser developments, the technological adoptions within observational cohorts and registries should take smartphone requirements and developments into account, especially when patient-reported data in young, mobile patients are collected, bearing in mind that data quality could be compromised and concepts for improving data quality should be implemented.

Authors: J. G. Richter, A. Weiss, C. Bungartz, R. Fischer-Betz, A. Zink, M. Schneider, A. Strangfeld

Date Published: 2021

Publication Type: Journal

Updated recommendations of the German Society for Rheumatology for the care of patients with inflammatory rheumatic diseases in the context of the SARS-CoV-2/COVID-19 pandemic, including recommendations for COVID-19 vaccination

Abstract

Not specified

Authors: C. Specker, P. Aries, J. Braun, G. Burmester, R. Fischer-Betz, R. Hasseli, J. Holle, B. F. Hoyer, C. Iking-Konert, A. Krause, K. Kruger, M. Krusche, J. Leipe, H. M. Lorenz, F. Moosig, R. Schmale-Grede, M. Schneider, A. Strangfeld, R. Voll, A. Voormann, U. Wagner, H. Schulze-Koops

Date Published: 2021

Publication Type: Journal

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