Strengths and limitations
a reduced number
CRITICAL ILLNESS
Our complex intervention (ICU follow-up clinic) was developed in a participatory multi-stakeholder process. This enabled us to consider as many different perspectives as possible. The intervention was subsequently implemented in an RCT and the entire concept was tested for feasibility. The external evaluation as well as the (initially blinded) outcomes assessment further improved the quality of the here presented concept and study. This should be also considered in the large-scale trial in order to evaluate the effectiveness of the ICU follow-up clinic. In this study, we were not able to identify the exact healthcare trajectories of each participant after the ICU stay and we did not gather data on healthcare use before their critical illness. Therefore, no comparison on healthcare use before/after critical illness was possible. Even in light of COVID-19, we were able to restart and manage the study, however with a reduced number of participants. Statistical testing regarding the RCT’s primary outcome was not intended per our study protocol [