Post-acute infection syndrome U09.9 R53.0 R53.1 R53.9 G93.3 G93.39 G93.31
Conditions
Interventions
Group 1: Work packages Systematic literature review - In order to obtain an overview of the current state of research, a systematic literature review on symptom complexes, diagnostic criteria and pati
Sponsors
Abteilung Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Work package: Expert panel • Experts with recognized leadership in their discipline from Germany. This includes general practitioners, physicians in specialized centers for adults with post-acute infection syndromes, and patients with PAIS who also have a medical or other healthcare background. • Potential conflicts of interest will be disclosed. Work package Systematic literature review - not applicable Work package Qualitative survey • Adult (aged 18 or over) • Written consent to participate in the study • Sufficient knowledge of German to answer the questions • For patients, additionally: symptoms with onset in temporal association with clinical infection, symptoms persistent for at least 3 months Work package Quantitative analysis of post-COVID outpatient data • Inclusion of patients who have presented to the post-COVID outpatient clinic since October 2022 Work package Primary care study Validation/usability General practitioners - General practitioner with health insurance approval in Germany Patients - Adults (age = 18 years) - Written consent to participate in the study - Referral by a primary care physician for fatigue and exhaustion syndromes or (suspected) PAIS, as indicated by the presence of a code (R53, G93, U09) in the practice information system - Completion of guideline-based basic differential diagnosis for fatigue or post-COVID syndrome Work package Advisory board Affected persons ? Adult patients with PAIS, both with post-COVID syndrome and with symptoms following other infections (e.g., Epstein-Barr virus infection), both with and without a diagnosis of ME/CFS.
Exclusion criteria
Exclusion criteria: Work package: Expert panel • Are under the age of 18; • Have functional limitations so severe that they consider participation impossible; • Do not have sufficient knowledge of German Work package: Systematic literature review -Not applicable Work package: Qualitative survey ? Are under the age of 18 ? Persons with cognitive impairments that severely limit their ability to answer questions, ? Insufficient knowledge of German, as well as persons who do not give their written consent. Work package Quantitative analysis of post-COVID outpatient data -Not applicable Work package Primary care study Validation/usability General practitioners - General practice with health insurance approval in Germany Exclusion criteria for general practitioners - None Patients - Acute illness requiring immediate treatment - Pregnancy and/or breastfeeding - Cognitive or other limitations that make it impossible to complete the questionnaire (e.g., dementia, visual impairment, insufficient language skills) - Conditions that preclude a timely in-person telemedicine consultation with a specialist (e.g., unwillingness and/or inability to use telemedicine) Work package Advisory board Affected persons ? Age < 18 years; ? Persons with such severe functional limitations that they consider participation to be unfeasible; ? Insufficient knowledge of German; ? Lack of capacity to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Work package Expert panel – Rating of the selection of symptoms, diagnostic criteria, and outcomes from work packages (scoping reviews, qualitative survey, quantitative analysis of post-COVID outpatient data), resulting in a tool Work packages Systematic literature review – Creation of an overview of existing literature Work package Qualitative survey – Conducting 9–17 interviews per target group Work package Quantitative analysis of post-COVID outpatient data - Summary of reported symptoms in symptom clusters Work package Primary care study Validation/usability - Determination of diagnostic quality (sensitivity and specificity) with regard to the reference standard “expert diagnosis” Work package Advisory board of affected persons - Documentation of feedback and integration into the project process | — |
Secondary
| Measure | Time frame |
|---|---|
| Work package Expert panel - not applicable Work packages Systematic literature review - not applicable Work package Qualitative survey - practical number of patients and stakeholders Work package Quantitative analysis of post-COVID outpatient data - analysis of correlations, identification of subpopulations, and verification of test quality using the first version of the instrument Work package Primary care study Validation/usability – Determination of the factorial structure of the questionnaire, clinical subtypes, reliability (internal consistency), criterion and construct validity in comparison with other questionnaires. Determination of sensitivity to changes and a threshold for clinically relevant changes. Determination of usability in general practice. Work package: Advisory board of affected persons – not applicable | — |
Countries
Germany
Contacts
Public ContactKathrin Sesterheim
Abteilung Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg
Outcome results
None listed