Strengths and limitations
SECONDARY, BLIND
The methodology of the study using an intervention group vs. a control group in a RCT design is a strength in order to avoid systematic errors and the intervention and the control group were not clinically different from each other in the descriptive baseline characteristics, possible differences were present for outcomes measures at baseline, however the sensitivity analysis showed this only impacted the result of a single secondary outcome. Due to COVID-19, the inclusion period was disrupted, and the patient inclusion rate was lower than expected. Thus, the study ended up being underpowered (control group n = 35; intervention group n = 33) for assessing the effect of the family-focused intervention on the AFEQT score. Furthermore the 11 point change on the AFEQT used in the sample size calculation could have been reduced to 5 [The generalisability of the study findings is limited due to the COVID-19 pandemic, resulting in patient receiving. intervention/standard care as early as intended, thereby impacting the effect of the intervention. Additionally, the pandemic probably affected the mental and physical well-being of the participating patients and their families. However, we expect that the negative effects of COVID- 19 have equally affected the intervention and control group. Because the intervention potentially allowed participants to only undergo one session in total there is a possibility that different participants received different amount of the intervention, which could introduce bias in the results. Furthermore, the intervention was delivered in the course of a year. The nurses might have improved their family-focused nursing skills during the trial, reducing the effect at the beginning of the trial, checked during the intervention this was not revealed as a problem. It was not possible to blind clinicians due to the nature of the intervention. Therefore, the open-label design of the study may have biased the results in favour of the intervention because the follow-up visit was conducted by the first author who also recruited patients and their family members. It was a strength in this study that all FNTCs were recorded digitally and 19 recordings were validated by the first author to confirm that the components of the intervention were delivered as intended and that the FNTCs were individualised and met families’ needs. An additional strength is that nurses delivering the family-focused intervention received the same skills training within a theoretical and practical, certified post-graduate training programme (Linné University, Sweden) with experienced teachers and examinations to conclude the course. Furthermore, both nurses were actively involved in the planning and development of the intervention, which enhanced ownership to the intervention. Given the complex nature of this trial and the mentioned limitations, our findings should be considered preliminary and should be interpreted with caution. The fact that patients in the intervention group in this sample had lower scores at baseline could indicate a positive effect of the intervention even though the study was underpowered. Therefore, results warrant examination in a higher-powered study. Furthermore, it could be relevant to broaden a future study to also measure the effect on the family members as well as the patient, which also could support knowledge of the effect of a family-focused approach.