Deviations from the initial study protocol and its implications
SECONDARY
The initially planned sample size of 100 participants had to be reduced due to the impacts of the COVID-19 pandemic. However, the final sample size followed recommendations for pilot trials if the effect size is unknown but expected to be small [Second, participants did not attend the planned self-help groups, so we were not able to actively assess acceptability or feasibility of this intervention component. Perhaps not attending the groups reflects a form of non-acceptance of this component.Third, a network of health care professionals could not be implemented due to the impact of the pandemic; cross-sector collaboration for follow-up care could not be assessed.Fourth, our SAP was already geared towards a large-scale study. Therefore, parts of it could not be implemented e.g., regarding the data analysis no intention-to-treat approach could be followed to analyse the effect of the ICU follow-up clinic on HRQOL as primary outcome and the secondary outcomes due to the small sample size and the nature of the conducted feasibility study. In addition, a sensitivity analysis was not suitable with regard to this data basis.