Structured, expert-informed selection and harmonization of patient-reported outcome measures (PROMs) in a German multicenter network: the post-COVID syndrome use case.

BACKGROUND

Patient-reported outcome measures (PROMs) provide subjective information on symptoms, functional ability or quality of life. In post-COVID syndrome (PCS), lacking clear diagnostic criteria or biomarkers, PROMs enable a differentiated assessment of disease course and treatment effects. Within a multicenter research project (EMOPROM LCN), a structured selection process for PROMs was conducted to reach consensus on a validated PROMs battery for PCS, suitable for studies and clinical care, and transferable to other complex conditions.

METHODS

An interdisciplinary committee identified key symptoms/syndromes and constructs (e.g., fatigue, depression, post-exertional malaise) and selected PROMs through a structured, expert-based consensus process considering psychometric properties, clinical relevance, feasibility, time efficiency and applicability within the German healthcare context. The questionnaires were organized into thematic domains and compiled into a modular test battery.

RESULTS

The following 13 questionnaires were included in the final PROMs battery: Post-COVID Syndrome Score (PCS-Score), Post-COVID Functional Status Scale (PCFS), Fatigue Scale for Motor and Cognitive Functions (FSMC), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Scale 7 (GAD-7), DePaul Symptom Questionnaire - Post-exertional malaise (DSQ-PEM), Insomnia Severity Index (ISI), Somatic Symptom Scale-8 (SSS-8), Somatic Symptom Disorder - B Criteria Scale (SSD-12), EuroQoL Five-Dimension Five-Level Questionnaire (EQ-5D-5L), Pain Disability Index (PDI), Primary Care PTSD Screen for DSM-5 (PC-PTSD-5), PROMIS v2.0 Cognitive Function Short Form 6.

CONCLUSION

The battery offers a selection of validated, time-efficient, and mostly free assessment tools, particularly valuable in specialized care. For routine practice, targeted partial use is recommended. The structured EMOPROM LCN selection process illustrates how clinically relevant, validated and patient-centered assessment instruments can be harmonized for multicenter research and care. PROMs hold considerable potential for improving the quality of care in post-infectious syndromes.