Changes in the Swiss Federal Health Insurance Act will introduce systematic outcome assessment in dietetics in Switzerland. Currently, dietitians define outcomes assessed individually per patient, which is important for client-centered care but makes the analysis of aggregated outcome data difficult. This project aims to develop a core outcome set for medical nutrition therapy in irritable bowel syndrome (IBS) as a proof of concept to solve the problem of heterogenous data and to enable the development of further dietetic practice specific core outcome sets for other indications in a second phase.
ContributorsSandra Jent, Bern University of Applied Sciences, Sandra.jent@bfh.ch
Natalie Bez, Bern University of Applied Sciences
Prof. Dr. med. Dr. phil. Gerhard Rogler (Supervisor), University Hospital Zurich
Disease Category: Gastroenterology
Disease Name: Irritable bowel syndrome (IBS)
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Diet and nutrition
- Clinical experts
- Consumers (patients)
- Policy makers
- Regulatory agency representatives
- Researchers
- Service providers
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Delphi process
- Literature review
The study protocol is defined based on the COMET handbook and publications from the COSMIN initiative. The scope of the project was defined as follows:
– Health condition: IBS and food intolerances with IBS-like symptoms. Justification: IBS is the main focus of this core outcome set. However, in real-life settings, diagnostics may not always be as strict as in efficacy randomized controlled trials, and symptoms of some food intolerances may considerably overlap with IBS symptoms.
– Target population: adults. Justification: Rome IV criteria and guidelines differ between children and adults as may outcome assessment.
– Interventions: evidence-based medical nutrition therapy interventions implemented with the sup-port of a dietitian. Justification: This core outcome set focuses on medical nutrition therapies as it is developed for dietitians and their needs may differ, e.g. from drug interventions.
– Setting: routine medical nutrition therapy of outpatients, ambulatory care. Justification: Inpatient setting needs may differ from outpatient care needs.
The project will define what outcomes to include in the core outcome set and how to measure them. The goal is to work with four stakeholder groups ((1) dietitians, (2) health service users, (3) gastroenterologists and (4) policymakers, regulators and health insurance representatives) with participants from Germany, Austria and Switzerland to avoid language issues. Fifty to one hundred participants per panel should be included, maybe less for the fourth panel. The consensus process will include two Delphi parts (part 1: what outcomes and part 2: how to measure them) with two rounds each. For part 1, a list of outcomes will be developed based on studies included in a systematic review on the low FODMAP diet (one dietetic intervention in IBS) currently conducted by our research group and qualitative studies on needs of IBS patients. These outcomes will be rated on a 9-point scale (1-3 not important, 7-9 important). Consensus will be defined as at least 70% rating an out-come as important with maximally 15% of participants rating the same outcome as not important. The Delphi questionnaire will also include a question on how many outcomes can be applied in dietetic practice.
For part 2, outcome measurement instruments for each outcome included in the core outcome set will be searched and evaluated. This evaluation will include three parts: (1) the methodological quality of the studies validating outcome measurement instruments, (2) the quality of the outcome measurement instrument itself and (3) the feasibility of using the outcome measurement instrument. Based on this, the questionnaire for a second Delphi process will be developed. In this pro-cess, only panels one to three ((1) dietitians, (2) health service users, (3) gastroenterologists) will be included.