Core Outcome set in Anti-refLux InTerventIONs :
The COALITION Study

Background

There is no clear consensus on which anti-reflux intervention is the best.Defining success after treatment is problematic; increasingly patient quality of life measures are being recognised as the most accurate measures of success but there is no consensus on what outcomes should be measured after anti-reflux interventions. 

Aims

1) To determine the most important outcomes after anti-reflux intervention to patients and clinicians
2) To reach agreement between patients and clinicians on a Core Outcome Set, to be measured and reported as a minimum in all future anti-reflux intervention trials

Methods

Part 1 -
Systematic review of outcomes reported in trials of anti-reflux interventions

1)  Systematic literature search
2) Data extraction
3) Formation of a long list of reported outcomes and map to outcome domains

 

Part 2 -
Exploring anti-reflux intervention outcome measures that are important to patients

1) Identification and recruitment of patients
2) Semi-structured interviews
3) Data analysis and mapping to outcome domains

 

Part 3 - 
Delphi consensus survey

1) Recruitment of patients and health care professionals
2) Survey (Round 1): Outcomes from systematic review and semi-structured patient interviews presented and ranked for importance
3) Results analysed by stakeholder group and feedback to participants with whole group results. 
4) Survey (Round 2): Outcomes ranked again for importance (aiming for further consensus) 
5) Results analysed by stakeholder group

 

Part 4 -
Consensus meeting to finalise the
Core Outcome Set