Aim: The aim of this paper is to focus on the findings and problems of an RCT to establish the effect of raising intraperitoneal pressure (IPP) through wearing an abdominal binder and breathing exercises to delay the reaccumulation of malignant ascites following drainage. A brief overview of the study will be presented as well as addressing the key issue that arose from it: What are useful outcome measures in palliative care?
Method: Interventions to raise IPP were tested by placing a pressure transducer into the peritoneal cavity of 10 women undergoing drainage of their ascites. Three breathing exercises and an abdominal binder were found which significantly raised IPP. An RCT was conducted comparing wearing the abdominal binder and carryout breathing exercises with a control group who received no intervention. Sixteen women were randomised. The primary endpoint was time to re-accumulation of ascites, which was going to be analysed by comparing the mean time to drainage. Results The study was stopped early because most patients entering were too unwell to complete the study. The outcome measure was unrealistic as it took too long to reach it. However, many women welcomed the intervention and found wearing the abdominal binder made them more comfortable.
Conclusions: The impact of this study is that an outcome that enables patients to evaluate their care or the use of concepts such as comfort may be more useful in determining the effectiveness of this palliative intervention. Developing comfort as an outcome measure requires further qualitative exploration before the study can be repeated in a larger group. Findings highlight the complexity of conducting an RCT in palliative care and suggest that qualitative research is needed before planning future evaluations of the intervention.