Background

Pleural infection is a condition associated with high morbidity and mortality. The inconsistency in outcome measures reported in pleural infection clinical trials makes it difficult to compare treatments. No review currently exists exploring reported outcome measures in interventional pleural infection randomised controlled trials (RCTs).

Aims

The primary aim was to describe the primary outcomes measured in adult pleural infection treatment RCTs. The secondary aims were to report on the breadth and frequency of outcomes used and the domains of these outcomes.

Methods

Bibliographic databases were searched from inception to 31 August 2022 to find RCTs reporting on treatment of pleural infection. Data was reviewed on primary and secondary outcome measures and the outcomes were categorised into domains.

Results

Twenty-two RCTs were identified and their reported outcomes were recorded. Of these, eight did not state a primary outcome and only two trials had the same primary outcome (length of hospital stay). Several trials stated treatment failure or success as the primary outcome but defined these using different parameters. Mortality rate, radiological improvement and surgical intervention were among the primary outcomes stated. One study used a patient reported outcome measure (PROM) as their primary outcome.

Conclusions

This review demonstrates the inconsistency of measured outcomes in interventional pleural infection RCTs. We have identified limited reporting of PROMs and an emphasis on clinical and/or radiological outcomes. The heterogeneity demonstrates a lack of consensus in the measured outcomes and highlights the need for core outcome set development in pleural infection treatment RCTs.