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