Marjon Borgert

67 A flowchart for building evidence-based care bundles independently. Studies were included in the analyses in case a description was given of the methodologies used on how to develop care bundles on ICUs for adult patients. Consensus was reached by discussion and a third author was involved in case of disagreement. Data extraction We extracted the following data from the identi ed studies: author, publication year, research design, setting, type of care bundle, methods used to develop the care bundle. Data extraction was independently performed by two authors (M.B.,D.D.). In case of discrepancies, consensus was reached by discussion. A third author was involved in case of disagreement. Quality assessment Given the diversity in study designs of the selected articles, we used two di erent tools for assessing the quality of the studies. For studies that primarily described the development of a care bundle, we used the Appraisal of Guidelines, REsearch and Evaluation II (AGREE II) instrument. 12,13 This instrument is designed for assessing the process of guideline development and howwell this process is described. 13 To categorize the study quality we used the following cut-o points: excellent: (90-100); good (70-89); fair (50-69; poor (≤49). 13 The checklist of Downs and Black was used for studies that primarily assessed clinical outcomes by using non-randomized study designs. 14 Checklist item number 27 about sample size calculation was simpli ed to a score of 0 (no sample size calculation) or 1 (sample size calculation reported). The following cut-o points have been reported to categorize studies by quality: excellent (26–28); good (20–25); fair (15–19) and poor (≤ 14). 15,16 Quality assessments were conducted by two reviewers independently. Disagreement between the reviewers was resolved through discussion. A third reviewer was involved in case of disagreement. Flowchart Based on the IHI methods as well as on the results of the systematic review we built a comprehensive owchart for designing new care bundles. The owchart contains the main process steps that should be followed. Each step contains methods that can be used for that particular part of the bundle design process. The development of the owchart will be explained in the next paragraphs.