MID-EPIC_D
Minimally Important Differences and recommendations for use in clinical practice for the German version of EPIC-26
With 65,200 new cases in 2018, prostate cancer is the most common type of cancer in men in Germany (Robert Koch Institute, GeKiD, ed. Cancer in Germany 2013/2014. 9th edition; 2017). With a relative 10-year survival rate of 91%, the chances of survival are relatively good compared to most other cancers. However, the symptoms and functional limitations of the disease and its treatment are very severe in many cases. In particular, physical functional limitations such as erectile dysfunction and urinary incontinence as a result of surgical treatment or gastrointestinal limitations as a result of radiotherapy persist long after prostate cancer treatment.
The "Expanded prostate cancer index composite 26" [EPIC-26], a questionnaire for recording patient information (Patient-Reported Outcome [PRO]), has become established for mapping symptoms and functional limitations in clinical studies and increasingly also in clinical routine. In the prostate cancer centres certified by the German Cancer Society (DKG), the use of the instrument is a certification requirement and is used to compare the quality of results of the clinics.
The clinical relevance of differences between PROs in the course of treatment or between patients can be described by means of "minimally important differences" (MID). With the help of MIDs, doctors and patients can, for example, assess more quickly whether a patient-specific deterioration between two points in time is clinically relevant and therefore requires further treatment.
MIDs have already been determined for the English version of the EPIC-26. However, MIDs can vary widely by population, translation and context and depend on the methodology used to derive them. They are therefore not transferable to patients in other countries without prior verification. Despite the high relevance for care and science, no MIDs are yet available for the German version of the EPIC-26. Firstly, this makes it difficult to make a meaningful comparison of clinics that treat prostate cancer with regard to the quality of outcomes. Secondly, MIDs are required for planning (sample size planning etc.) and interpretation of studies on PROs. And thirdly - and most importantly for everyday care - MIDs are required for the interpretation of EPIC-26 in clinical practice and are essential for decision-making and communication aids. For PROs to be used in everyday care to support treatment decisions, MIDs are needed to assess when changes in PROs are large enough that intervention should be considered.
The project, which is funded by German Cancer Aid, has two objectives:
1st: To statistically determine MIDs for the German version of EPIC-26 based on data from certified cancer centres (inclusion of at least 2,100 patients planned) and on data from the survey infrastructure currently in place in over 100 certified prostate cancer centres (subproject 1).
2nd: To develop recommendations for dealing with EPIC-26 together with patients, relatives and all care groups involved, taking into account the MIDs determined for treatment planning (subproject 2).
The results of the study will be made available to caregivers and organised self-help groups in the form of fact sheets and prompt sheets and conceptualised for the existing digital application.
