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Table 3 Primary outcome switching between the registry and report

From: Transparency and reporting characteristics of COVID-19 randomized controlled trials

Outcome switch

Example

N = 104 (%)

Added primary outcome(s)

Registry:

1. Time to clinical improvement

Report:

1. Death

2. Time to clinical improvement

9 (9%)

Removed primary outcome(s)

Registry:

1. Time and rate of temperature return to normal

2. Time and rate of improvement of respiratory symptoms and signs

3. Time and rate of change to negative COVID-19 nucleic acid test

4. Rate of mild/moderate type to severe type, rate of severe type to critical type

Report:

1. Rate of nucleic acid negativity conversion of SARS-CoV-2

2. Negativity conversion time

19 (18%)

Added and removed primary outcome(s)

Registry:

1. Hospitalization days

2. Need for mechanical ventilation

3. Condition of discharge (death or recovery)

Report:

1. Improvement in the rate of ICU admissions

2. Intubation/mechanical ventilation

3. Mortality 28 days

16 (15%)

Changed primary outcome(s)

Registry:

1. Time to improvement

Report:

2. Clinical status

39 (38%)

Time frame or metric different

Registry:

1. Change in clinical status of subjects at day 7

Report:

2. Change in clinical status of subjects at day 15

21 (20%)a

  1. Percentages may not add up to 100% due to rounding
  2. aTwelve additional trials comprised both, changes in time frames or metrics, as well as added, removed, or changed primary outcome(s). Those trials were counted only a single time within the added, removed, or changed outcome switching domain