Composite outcome measures in high-impact critical care randomised controlled trials: a systematic review.

BACKGROUND: The use of composite outcome measures (COM) in clinical trials is increasing. Whilst their use is associated with benefits, several limitations have been highlighted and there is limited literature exploring their use within critical care. The primary aim of this study was to evaluate the use of COM in high-impact critical care trials, and compare study parameters (including sample size, statistical significance, and consistency of effect estimates) in trials using composite versus non-composite outcomes. METHODS: A systematic review of 16 high-impact journals was conducted. Randomised controlled trials published between 2012 and 2022 reporting a patient important outcome and involving critical care patients, were included. RESULTS: 8271 trials were screened, and 194 included. 39.1% of all trials used a COM and this increased over time. Of those using a COM, only 52.6% explicitly described the outcome as composite. The median number of components was 2 (IQR 2-3). Trials using a COM recruited fewer participants (409 (198.8-851.5) vs 584 (300-1566, p = 0.004), and their use was not associated with increased rates of statistical significance (19.7% vs 17.8%, p = 0.380). Predicted effect sizes were overestimated in all but 6 trials. For studies using a COM the effect estimates were consistent across all components in 43.4% of trials. 93% of COM included components that were not patient important. CONCLUSIONS: COM are increasingly used in critical care trials; however effect estimates are frequently inconsistent across COM components confounding outcome interpretations. The use of COM was associated with smaller sample sizes, and no increased likelihood of statistically significant results. Many of the limitations inherent to the use of COM are relevant to critical care research.

Competency Assessment in Focused Cardiac Ultrasound-Can the Use of Sequential Testing Help Tailor Training Requirements?

Varying numbers of scans are required by different professional bodies before focused cardiac ultrasound (FCU) competence is assumed. It has been suggested that innovation in the assessment of FCU competence is needed and that competency assessment needs to be more individualized. We report our experience of how the use of sequential testing may help personalize the assessment of FCU competence. DESIGN: This was a planned exploratory reanalysis of previously prospectively collected data. FCU was performed sequentially by an intensive care trainee and expert on the same patient. Assessment of left ventricular (LV) function by the trainee and expert was compared. Sequential testing methods were used in the analysis of this data to see if they could be used to help in the assessment of competence. Each trainee had completed a 38-hour teaching program and a logbook of 30 scans prior to enrollment. SETTING: Tertiary Australian not for profit private academic hospital. MEASUREMENTS AND MAIN RESULTS: Two hundred seventy paired echocardiograms were completed by seven trainees. For trainees to achieve greater than 90% accuracy in correctly assessing LV function when compared with an expert, a variable number of scans were required. This ranged from 13 to 25 (95% CI, 13-25) scans. Over the study period, the ability to correctly identify LV function was maintained, and it appeared there was no degradation in skill. CONCLUSIONS: Using the Sequential Probability Ratio Test demonstrates a variable number of scans were required to show greater than 90% accuracy in the assessment of LV function. As such, the use of sequential testing could help individualize competency assessments in FCU. Additionally, our data suggests that over a 6-month period, echocardiographic skill is maintained without any formal teaching or feedback. Further work assessing the utility of this method based on larger samples is required.

Laparoscopic appendicectomy in pregnancy: a systematic review of the published evidence.

UNLABELLED: Surgical intervention for acute appendicitis during pregnancy carries significant risk to both mother and foetus. The safety of Laparoscopic Appendicectomy in pregnancy has been a matter of debate among clinicians. We have critically reviewed the available published evidence in regards with this debate. CONCLUSION: There is no strong current evidence as to the preferred modality of appendicectomy; open or laparoscopic, during pregnancy from the prospect of foetal or maternal safety. However, low grade evidence shows that laparoscopic appendicectomy during pregnancy might be associated with higher rates of foetal loss.