gms | German Medical Science

Background/research question: Core outcome sets (COSs) are “agreed standardised sets of outcomes […] that should be measured and reported in all trials for a specific clinical area” [1] to improve the quality of clinical research. The Outcomes for Pressure Ulcer Trials (OUTPUTs) project aims to develop a COS for trials evaluating strategies to prevent pressure ulcers (PUs) [2]. A first project step was to identify and summarise outcomesmeasured inexisting trials as well asadditionally relevant patient-reported outcomes (PROs).

Methods/Material: A scoping review was conducted [3], involving searches in10 databases. Following studies targeting adult patients in any healthcare setting were eligible: (i) clinical trials or systematic reviews on the efficacy/effectiveness or full economic evaluations of PU prevention strategies, or (ii) studies of any type or systematic reviews on PU prevention-related PROs. The data extraction included: type of study, research setting and population, type of PU prevention strategy researched, and each outcome measured. Extracted outcome data were descriptively summarised and thematically synthesised into preliminary core domains and sub-domains [1].

Results: Out of 7,876 references retrieved, appr. 400 references were assessed as being eligible. Data extraction is still ongoing and will be completed by the end of 2017. At the congress, quantitative findings and the preliminary set of core domains and sub-domains will be presented.

Conclusions: We expect the results will represent a valuable basis for a successive Delphi study to build consensus on the core outcome domains and sub-domains. In addition, we have noted some methodological challenges due to thepreventative nature of PU prevention strategies. Since this COS project is the first addressing the prevention of a potential health problem instead of the treatment of a confirmed disease, our experiences will add important knowledge to future COS development.