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 |