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      Long-term Consequences of COVID-19 and the Pandemic: Protocol for a Web-Based, Longitudinal Observational Study (DEFEAT)

      research-article
      1 , 2 , , DrPH 3 , , DrPhil 3 , 1 , 3 , 4 , 4 , 1 , 1 , 5 , , Prof Dr 4 , 6 , , Prof Dr med 1 , 7 , , Dr med 3 , , PD Dr med 1 , 7 , , Prof Dr med 1 ,
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      SARS-CoV-2, COVID-19, long COVID, post–COVID-19, long haulers, pandemic, long-term effects, symptoms, long-term, risk factors, Germany, population study, quality of life, social participation, engagement

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          Abstract

          Background

          With population-wide vaccination availability, the global COVID-19 pandemic entered a new phase. Despite vaccination status, some people who were infected with SARS-CoV-2 experience long-term symptoms.

          Objective

          In this study, we aim to characterize the long-term effects of SARS-CoV-2 infection and the pandemic. We also aim to build symptom clusters and determine risk factors for developing long COVID symptoms. Furthermore, we assess social participation and health-related quality of life in patients with long COVID and in the general population during a global pandemic.

          Methods

          With a mixed-methods, web-based approach, we aim to recruit 2000 people in Germany who are older than 18 years and can provide informed consent. In the quantitative arm of the study, we identify symptoms of and predictive factors for long COVID manifestations with cluster analysis and assess social participation during the pandemic with standardized questionnaires. The qualitative arm of the study uses individual interviews and focus group discussions to better understand the illness experience of persons who experience long COVID.

          Results

          Recruitment started in September 2021. Up until July 2022, we recruited approximately 4500 participants via our web-based database.

          Conclusions

          This study aims to build an innovative, patient-centered, web-based research platform appropriate for the pandemic by minimizing physical contact between study personnel and participants. All study activities are designed to better understand the long COVID syndrome, social participation during the pandemic, and the illness experiences of persons affected by long COVID.

          Trial Registration

          German Clinical Trial Registry DRKS00026007; https://tinyurl.com/yh282fkt

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/38718

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          Most cited references17

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          Attributes and predictors of long COVID

          Reports of long-lasting coronavirus disease 2019 (COVID-19) symptoms, the so-called 'long COVID', are rising but little is known about prevalence, risk factors or whether it is possible to predict a protracted course early in the disease. We analyzed data from 4,182 incident cases of COVID-19 in which individuals self-reported their symptoms prospectively in the COVID Symptom Study app1. A total of 558 (13.3%) participants reported symptoms lasting ≥28 days, 189 (4.5%) for ≥8 weeks and 95 (2.3%) for ≥12 weeks. Long COVID was characterized by symptoms of fatigue, headache, dyspnea and anosmia and was more likely with increasing age and body mass index and female sex. Experiencing more than five symptoms during the first week of illness was associated with long COVID (odds ratio = 3.53 (2.76-4.50)). A simple model to distinguish between short COVID and long COVID at 7 days (total sample size, n = 2,149) showed an area under the curve of the receiver operating characteristic curve of 76%, with replication in an independent sample of 2,472 individuals who were positive for severe acute respiratory syndrome coronavirus 2. This model could be used to identify individuals at risk of long COVID for trials of prevention or treatment and to plan education and rehabilitation services.
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            A clinical case definition of post-COVID-19 condition by a Delphi consensus

            People with COVID-19 might have sustained postinfection sequelae. Known by a variety of names, including long COVID or long-haul COVID, and listed in the ICD-10 classification as post-COVID-19 condition since September, 2020, this occurrence is variable in its expression and its impact. The absence of a globally standardised and agreed-upon definition hampers progress in characterisation of its epidemiology and the development of candidate treatments. In a WHO-led Delphi process, we engaged with an international panel of 265 patients, clinicians, researchers, and WHO staff to develop a consensus definition for this condition. 14 domains and 45 items were evaluated in two rounds of the Delphi process to create a final consensus definition for adults: post-COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset, with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include, but are not limited to, fatigue, shortness of breath, and cognitive dysfunction, and generally have an impact on everyday functioning. Symptoms might be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms might also fluctuate or relapse over time. A separate definition might be applicable for children. Although the consensus definition is likely to change as knowledge increases, this common framework provides a foundation for ongoing and future studies of epidemiology, risk factors, clinical characteristics, and therapy.
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              More than 50 long-term effects of COVID-19: a systematic review and meta-analysis

              COVID-19 can involve persistence, sequelae, and other medical complications that last weeks to months after initial recovery. This systematic review and meta-analysis aims to identify studies assessing the long-term effects of COVID-19. LitCOVID and Embase were searched to identify articles with original data published before the 1st of January 2021, with a minimum of 100 patients. For effects reported in two or more studies, meta-analyses using a random-effects model were performed using the MetaXL software to estimate the pooled prevalence with 95% CI. PRISMA guidelines were followed. A total of 18,251 publications were identified, of which 15 met the inclusion criteria. The prevalence of 55 long-term effects was estimated, 21 meta-analyses were performed, and 47,910 patients were included (age 17–87 years). The included studies defined long-COVID as ranging from 14 to 110 days post-viral infection. It was estimated that 80% of the infected patients with SARS-CoV-2 developed one or more long-term symptoms. The five most common symptoms were fatigue (58%), headache (44%), attention disorder (27%), hair loss (25%), and dyspnea (24%). Multi-disciplinary teams are crucial to developing preventive measures, rehabilitation techniques, and clinical management strategies with whole-patient perspectives designed to address long COVID-19 care.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                October 2022
                26 October 2022
                26 October 2022
                : 11
                : 10
                : e38718
                Affiliations
                [1 ] Department for Rheumatology and Immunology Hannover Medical School Hannover Germany
                [2 ] Deans' Office, Curricular Development Hannover Medical School Hannover Germany
                [3 ] Department of General Practice University Medical Center Göttingen Göttingen Germany
                [4 ] Department of Computer Science Ostfalia University of Applied Sciences Wolfenbüttel Germany
                [5 ] Department of Otolaryngology Hannover Medical School Hannover Germany
                [6 ] Biostatistics Research Group Helholtz Center for Infection Research Braunschweig Germany
                [7 ] German Center for Infection Research Partner site Hannover-Braunschweig Germany
                Author notes
                Corresponding Author: Sandra Steffens steffens.sandra@ 123456mh-hannover.de
                Author information
                https://orcid.org/0000-0001-8546-0548
                https://orcid.org/0000-0002-3937-5956
                https://orcid.org/0000-0002-8497-6515
                https://orcid.org/0000-0001-7367-9286
                https://orcid.org/0000-0002-3564-4725
                https://orcid.org/0000-0002-9713-4595
                https://orcid.org/0000-0003-2741-5989
                https://orcid.org/0000-0002-0029-8455
                https://orcid.org/0000-0002-6495-2583
                https://orcid.org/0000-0003-3482-3470
                https://orcid.org/0000-0001-9613-182X
                https://orcid.org/0000-0003-3111-621X
                https://orcid.org/0000-0002-9496-9423
                https://orcid.org/0000-0001-7129-100X
                https://orcid.org/0000-0002-7478-3920
                Article
                v11i10e38718
                10.2196/38718
                9611102
                36108134
                42e4ff39-1833-4d95-bbad-b563fd4f74a1
                ©Marie Mikuteit, Stephanie Heinemann, Sascha Roder, Jacqueline Niewolik, Dominik Schröder, Kai Vahldiek, Sandra Klawitter, Anne Cossmann, Torsten Bergemann, Chantal Degen, Frank Klawonn, Georg Martin Norbert Behrens, Frank Müller, Alexandra Dopfer-Jablonka, Sandra Steffens. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.10.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 21 April 2022
                : 21 July 2022
                : 12 August 2022
                : 18 August 2022
                Categories
                Protocol
                Protocol

                sars-cov-2,covid-19,long covid,post–covid-19,long haulers,pandemic,long-term effects,symptoms,long-term,risk factors,germany,population study,quality of life,social participation,engagement

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