Objective: Disparity within the use of measurement instruments in clinical research can result in reporting bias, unreliable reporting and a limited quality of evidence that is produced, thus hindering effective treatment comparisons. The principle aim of this study is the creation of a core measurement set, in which recommendations can be made regarding measurement instruments that can be used to enable standardised outcome reporting.
Method: A systematic review of the literature will be performed to identify all measurement instruments used in studies relevant to fistulising perianal Crohn's disease. All measurement tools that are identified will be evaluated for their measurement properties using the COSMIN (Consensus-based standards for the selection of health status measurement instruments) checklist.
A modified-Delphi consensus will be undertaken to identify which measurement instruments should be included in the final core measurement set. This process will include key stakeholders, including patients, surgeons, gastroenterologists and radiologists with experience in the management of fistulising pCD. If no suitable measurement instrument is identified for any of the core outcomes, further work will be undertaken with key stakeholders to develop and validate a new, appropriate tool.
Conclusion: Although pCD is a challenging disease pathology to manage for both patients and clinicians alike, there is progress in the innovation and development of novel treatment modalities for this condition. Creation of a core measurement set will reduce heterogeneity within outcome reporting, resulting in more clinically applicable treatment comparisons, and ultimately, improved care for patients with pCD.
Miss Shivani Joshi, Mr Phil Tozer, Professor Ailsa Hart, Mr Kapil Sahnan, Professor Angus Mcnair, Dr Philip Lung, Miss Nusrat Iqbal, Dr Luke Hanna,
Principal investigator: Mr Phil Tozer
Disease Category: Gastroenterology
Disease Name: Perianal Crohn's disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Drug, Surgery
- Clinical experts
- Consumers (patients)
- Methodologists
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
Phase 1 will involve a systematic review of the literature to identify all measurement instruments used in studies relevant to fistulising perianal Crohn’s disease (pCD). Measurement instruments will be evaluated as to their methodological quality.
Phase 2 will involve a modified-Delphi consensus. This will decide which measurement instruments will be included in the final core measurement set. This process will include key stakeholders, including patients, surgeons, gastroenterologists and radiologists with experience in the management of fistulising pCD. If no suitable measurement instrument is identified for any of the core outcomes, further work will be undertaken with key stakeholders to develop and validate a new, appropriate tool.