STANDOUT MPE Version 1.0

• Research type

  Research Study

• Full title

  Standardising Outcomes in Malignant Pleural Effusion Interventional Trials - The STANDOUT MPE study

• IRAS ID

  354309

• Contact name

  Alice Milne

• Contact email

  alice.milne@bristol.ac.uk

• Sponsor organisation

  University of Bristol

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Doctors and patients need to have evidence from clinical trials so that they can make the right treatment choices together. However, Malignant Pleural Effusion (MPE) trial results cannot be easily compared because they do not all measure the same information or ‘outcomes’ (e.g. pain.) This is because there is no agreement on which outcomes are the most important to patients with MPE, doctors and researchers. My study aims to address this by creating a core outcome set (COS).

  To achieve this, the research will answer three questions:
  1) ‘What’ outcomes of MPE care are important to patients and healthcare professionals?
  Patients with MPE and their carers will be invited to participate in qualitative interviews. Healthcare professionals will be invited to take part in focus groups. These outcomes will be added to those found in the literature to generate a long list.

  2) ‘Which’ outcomes should be collected in all future MPE trials?
  This list will be used to develop a survey. The survey will be initially tested to ensure that it is easy to complete and understand. The online survey will then be sent out to a wide range of patients, researchers and MPE healthcare professionals including international experts. Survey participants will be asked to rate the importance of each outcome on a scale of 1 -9. The outcomes of critical importance for research will then be voted on in a face-to-face meeting to create a final MPE COS.

  3) ‘How’ should information be measured in future MPE trials?
  All applicable patient reported outcome measures (PROMS), e.g questionnaires, applicable to the COS will be collated from the literature. Patients will be invited to take part in focus groups to review these measures for relevance and usability. This will help to ensure greater recognition of patient-focused outcomes in future MPE research
  

• REC name

  Wales REC 6

• REC reference

  25/WA/0186

• Date of REC Opinion

  12 Jun 2025

• REC opinion

  Favourable Opinion