Infectious Disease ยท Medical Literature
The use of patient-reported outcome questionnaires in patients with post-COVID-19 condition: a systematic review and meta-analysis.
Abstract
Post-COVID-19 condition (PCC) is a complication of acute COVID-19, which often presents with a variety of symptoms. It can also impact individuals' overall well-being, capacity to carry out daily activities, engage in physical exercise, maintain employment, and their general quality of life. Therefore, this review aimed to examine the role of patient-reported outcome measures (PROMs) questionnaires in assessing patients with PCC through prevalence of abnormal tests. We searched three databases. Two reviewers independently screened articles using Laser Al and extracted relevant data using a piloted Google Sheets. We performed a meta-analysis using OpenMeta and RevManWeb and conducted a subgroup analysis based on the setting of the patients during their acute COVID-19 infection. We assessed the risk of bias using a modified ROBINS-I tool and the certainty using the Grading of Recommendations Assessment, Development, and Evaluation approach. No studies reported diagnostic test accuracy measures for questionnaires in PCC. However, 23 comparative studies reported on the prevalence of abnormal questionnaire results in patients with PCC. Outcomes showed that patients with PCC have higher abnormal results than controls, regardless of their setting during acute COVID-19 infection. The overall certainty of the evidence was low due to the high risk of bias, indirectness, and imprecision. This review sheds light on the importance of testing PROMs in patients with PCC using these questionnaires and the need for further testing their validity in this condition.
Clinical relevance
Post-COVID-19 condition (PCC) is a multisystemic complication of acute COVID-19 that impairs well-being, physical function, occupational capacity, and quality of life across a broad patient population. Despite widespread clinical use, the diagnostic test accuracy of patient-reported outcome measures (PROMs) for PCC has never been formally validated, representing a critical evidence gap for frontline practitioners. As PCC prevalence remains substantial globally, clinicians urgently need standardized, validated tools to objectively assess symptom burden and functional impairment in this population.
Key findings
1. No studies identified in this systematic review reported formal diagnostic test accuracy measures (e.g., sensitivity, specificity, AUC) for any PROM questionnaire used in PCC, highlighting a fundamental gap in the evidence base. 2. Twenty-three comparative studies reported on the prevalence of abnormal questionnaire results, providing the sole quantitative basis for meta-analytic synthesis. 3. Patients with PCC demonstrated consistently higher rates of abnormal PROM results compared to controls, a finding that held regardless of whether the index acute COVID-19 infection was managed in an inpatient or outpatient setting. 4. Subgroup analysis stratified by acute COVID-19 care setting (hospitalized vs. non-hospitalized) did not attenuate the signal of elevated abnormal PROM prevalence in PCC patients, suggesting the burden of PCC-related dysfunction spans disease severity strata. 5. Overall certainty of evidence was graded LOW per GRADE methodology, driven by high risk of bias (assessed via modified ROBINS-I tool), indirectness, and imprecision across included studies. 6. No numerical effect sizes, confidence intervals, or p-values were reported in the abstract, precluding extraction of specific quantitative estimates; this limitation is noted per the absence of that data in the source material.
Practice implications
Clinicians should routinely administer validated PROM questionnaires to patients with suspected PCC to capture the full spectrum of symptom burden and functional impairment, recognizing that abnormal results are consistently more prevalent in this population than in controls regardless of initial disease severity. However, given the low certainty of evidence and the absence of validated diagnostic accuracy data, PROM results should currently be interpreted as adjunctive clinical tools rather than definitive diagnostic instruments for PCC. Future research must prioritize prospective validation studies that establish sensitivity, specificity, and optimal cut-off scores for PROMs in PCC before these instruments can be formally incorporated into diagnostic algorithms or treatment-response monitoring protocols.