PICOTS Clinical research element | Document/measure | Analysis/report |
---|---|---|
Patient population | ∙ Measure changes to participant demographic and clinical characteristics ∙ Measure changes to access/attitudes (i.e., Coronavirus Impact Scale) ∙ Evaluate COVID-related methods for electronic phenotyping | ∙ Compare characteristics over time periods (i.e., pre and post March 2020) ∙ Compare characteristics over time periods defined by local COVID status or impacts on research conduct |
Intervention of interest | ∙ Document modifications to ensure the safety of patients and providers ∙ Document/measure changes to the methods to communicate and deliver intervention ∙ Document/measure changes to any components or mechanisms associated with intervention | ∙ Compare engagement in intervention components over time periods ∙ Consider modification to primary analysis to adjust (stratify) for COVID phases ∙ Consider sensitivity analyses that restrict to periods of time based on COVID status ∙ Consider subgroup (interaction) analysis of heterogeneity of treatment effect (HTE) across COVID time periods ∙ Consider time-specific mediation analysis to evaluate putative mechanisms across COVID time periods |
Comparison intervention | ∙ Document modifications to ensure the safety of patients and providers ∙ Measure trends in concomitant care over time | ∙ Compare engagement in comparison (usual care) over time periods ∙ Clarify the estimand of interest—typically the average treatment effect that averages over explicit patient and time characteristics while potentially controlling certain factors ∙ Consider subgroup (interaction) analysis of HTE across COVID time periods ∙ Report the consequence of COVID impacts that are specific to the study design (i.e., parallel randomized trials will be impacted differently from crossover or stepped-wedge designs) |
Outcome(s) | ∙ Document/measure changes in the way that clinical assessments and patient-reported outcomes are obtained ∙ Measure the impact of COVID-related distress on patient-reported outcomes | ∙ Report the psychometric properties of any modified measures ∙ Consider analysis of subgroups based on patient-reported characteristics at baseline that are predictive of outcomes or COVID susceptibility ∙ Describe temporal trends in patient-reported outcomes ∙ Evaluate patterns and correlates of missing data over time to assess differential non-response |
Timing | ∙ Document COVID status at the regional level over time ∙ Document COVID status at the clinic level over time ∙ Measure participant-level impact of COVID over time ∙ Consider evaluation of participant outcomes at longer (shorter) lags to determine potential impacts on response trajectories | ∙ Consider effect modification with proximal measures of COVID impact (patient level, clinic level) ∙ Describe longitudinal trajectories in patient outcomes across treatment groups and across COVID time periods |
Setting | ∙ Document the research setting (modality) for both intervention delivery and participant assessment | ∙ Describe differences in intervention, comparison, and concomitant care across specific research settings ∙ Describe differences in outcomes across research settings |