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. 2020 Jul 6;12(4):399–411. doi: 10.1080/19466315.2020.1779122

Table 4.

Attributes of pandemic-related missing data.

Missing endpoint measurement
  • Assessment missing due to a participant’s premature discontinuation from the study overall for pandemic-related reasons;

  • Assessment missing due to missed study visits/procedures while a participant remains in the study (intermittent missing data);

  • Assessment delayed (out-of-window) and deemed unusable for an analysis;

  • A composite score (e.g., ACR20 in rheumatoid arthritis) cannot be calculated because some components are missing;

  • Assessment deemed to be influenced by pandemic-related factors and deemed unusable for a particular analysis because the interpretability of the results may be impacted (e.g., in assessments of quality of life, activity/functional scales, healthcare utilization, etc.);

  • Recorded data cannot be properly verified or adjudicated due to COVID-19-related factors and deemed to be unreliable for analysis;

  • Assessment performed after an intercurrent event intended to be handled with a hypothetical strategy and collected data are deemed unusable for this estimand.

Assessment accessibility
  • Site (facilities or staff) unavailable to perform study-related assessments;

  • Site/assessment procedure available but participant is unable/unwilling to get assessment done due to personal pandemic-related reasons.

Participant’s COVID-19 infection condition
  • Participant positive for COVID-19 and alive;

  • Participant deceased due to COVID-19;

  • Participant without a known COVID-19 infection.

Participant’s COVID-19 concomitant treatment(s)
  • Participants treated for COVID-19 (pharmacologically, oxygen, etc.);

  • Hospitalized, not in intensive care;

  • Admitted to intensive care.

   

NOTE: Row 1 summarizes reasons of missing data, rows 2–4 summarize related conditions that contribute to those reasons.