Marjon Borgert

79 A flowchart for building evidence-based care bundles Table 2. Process steps to design evidence-based care bundles Process steps Reported methods of the IHI Additional reported methods Step 1. Identify problems or risks in a speci c patient population or intervention that contributes to great harm and/or high costs. Systematic reviews 2,10,19,20,23,29,33 Adverse Event Trigger Tool. 2 Analysing own clinical patient data 18,21,30 ; Root Cause Analyses 11 ; Failure Mode Evaluation and Analysis (FMEA) 26 Step 2. The identi ed care problems or risks should be clearly de ned. Comprehensive literature search strategy 2 No additional methods reported Step 3. Conduct a literature search to collect relevant evidence for the problems or risks and to nd related elements. Collect evidence from the international electronic databases and from the distillation from (inter)national clinical guidelines 2,19,20,23,26-28,32,33 No additional methods reported Step 4. Select potential relevant and feasible elements from the literature search. Select those elements that were described in the literature and were associated with the identi ed problem 2,10,18,19-33 or from local or (inter)national clinical guidelines 10,21,29 Selected elements by analysing the medication errors 30 Step 5. Select a nal set of maximally ve elements Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to evaluate the quality of the evidence of the elements. 19,24,32 Weighing and scoring technique to select the most suitable, reliable or most appropriate key elements 10,29,32 ; Root Cause Analyses 11 ; FMEA 26 ; Through discussion sessions or consensus meetings with experts or hospital sta . 19,23,25,27 Step 6. Create the care bundle in draft form. Create the bundle in draft form and check if the IHI bundle requirements are met. 2,22,24 No additional methods reported Step 7. Pilot test the care bundle in order to assess the reliability. The pilot should be performed in a small sample of patients to identify (potential) risks or barriers for implementation. It is important to monitor the performance of all bundle elements to identify potential problems or risks and to evaluate if the care bundle is feasible, comprehensive, e ective and easy to use 2,25,27,28 No additional methods reported