Table 3. Methodological Recommendations for Future Studies of Persistent COVID-19 Symptoms.
Category | Recommendations |
---|---|
Study population | Report underlying comorbidities (based on WHO56 and CDC57 guidelines), including hypertension, type 2 diabetes, obesity, chronic kidney disease, cancer, compromised immunity, COPD, heart conditions, and smoking |
Report prevalence of symptoms before COVID-19 infection | |
Report severity of COVID-19 illness: asymptomatic or mild, moderate, severe, and critical using standard COVID-19 symptom severity scales (eg, WHO56) | |
Report patient care settings, including inpatient (ICU/non-ICU), outpatient, and individuals not seeking treatment | |
Use patient flowchart similar to STROBE diagram58 reporting the number of patients eligible, excluded, and lost to follow-up (with reasons) | |
Include a comparable cohort of individuals without COVID-19 for comparison | |
Recruitment strategy | Recruit patients consecutively and indicate reasons for any nonconsecutive enrollees |
Follow-up | Define time zero, with universal reporting of time from initial diagnosis or first symptom onset |
Report mean length of follow-up, including SD and range | |
Measure and report outcomes longitudinally at fixed intervals (at least monthly) | |
Exposure measurement | Report COVID-19 diagnosis based on PCR test or test of equivalent specificity |
Provide name of specific confirmatory test, along with its sensitivity and specificity | |
Outcomes of interest | Refer to established core outcome sets (eg, COMET Initiative59 or WHO COVID-19 Working Group60) to identify relevant symptoms and outcome definitions for a disease category |
Outcome measurement | Report methods of collecting outcome information (eg, phone vs in-person); passive methods (eg, EHR) discouraged for symptoms unlikely to require specific treatment or be passively reported (eg, fatigue and neurocognitive outcomes) |
Include operational definitions for each measured symptom | |
Report severity of symptoms (mild, moderate, severe, and/or critical) | |
Report number of symptoms experienced by each patient | |
Use validated instruments to measure symptoms when available (eg, Chalder Fatigue Scale or Fatigue Severity Scale to measure fatigue, 36-Item Short Form Survey or EuroQol questionnaires to measure quality of life) (Table 1) | |
Include questionnaire used to measure symptoms (when applicable) in supplementary material | |
Results | Stratify symptom frequency and severity by baseline severity of COVID-19 infection and/or patient care setting and patient characteristics (eg, age, comorbidities, and race/ethnicity) |
Abbreviations: CDC, Centers for Disease Control and Prevention; COMET, Core Outcome Measures in Effectiveness Trials; COPD, chronic obstructive pulmonary disease; EHR, electronic health record; ICU, intensive care unit; PCR, polymerase chain reaction; WHO, World Health Organization.