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3 BACKGROUND  5 Participation of Patients and Other Stakeholders  6 METHODS  13 Choice of Study Design  13 Study Cohort  16 Study Setting  19 Intervention and Choice of Comparators  19 Follow-Up  19 Study Outcomes  20 Data Collection and Sources  22 Analytical and Statistical Approaches  25 Conduct of the Study and Final Study Protocol  28 RESULTS  30 Baseline Parent Characteristics (Prior to Receiving Enhanced Report)  38 Aim 3 Primary Outcomes: Report Access and Satisfaction  41 Report Utilization and Impact on Information Asymmetry  43 Aim 3 Secondary Outcomes and Adverse Events  45 Unanticipated Findings Affecting Report Access  45 Report Utilization and Impact on Information Asymmetry  43 DISCUSSION  47 CONCLUSION  57 REFERENCES  58 APPENDIX  62

Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients