1. Competitive Grant Program: Year 2 Meeting 2

2. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Data Quality Assurance Luohua Jiang Ann Johnson CC Biostatisticians HH DATA COORDINATOR TRAINING Workshop

3. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 A demonstration project Indian health programs could compete for funding A collaborative process to plan, develop, and implement a set of activities in the area of cardiovascular disease risk reduction in individuals with diabetes Overview of Healthy Heart Project

4. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 To determine whether the programs are able to successfully implement the activities (process evaluation), lessons learned in these diverse programs and communities the impact of these activities on the participants and the programs (outcomes evaluation). Goals of CGP Evaluation

5. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Why Conduct Evaluation? Improve practice by encouraging providers and programs to reflect on their progress Grantees will be able to document their accomplishments, as well as to convey problems Demonstrate to Congress the value of programs In the best of scenarios, may lead to increased funding of such efforts, which could potentially benefit thousands of Native people in the future.

6. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 is responsible for Create and distribute evaluation materials Coordinate and supervise data collection Manage and analyze data Develop mechanisms for Quality Assurance Develop and complete reports Data Core of CGP CC

7. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Quality Assurance (QA) are all those planned and systematic actions that are established to ensure the project is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice and the applicable regulatory requirements. Concept of Quality Assurance

8. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Concept of Quality Assurance Is not the responsibility of an independent quality assurance group. Begins with top management’s commitment to appropriate infrastructure and resources. Is the responsibility of everyone involved in the project.

9. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 The Institute of Medicine defines quality data as data that supports conclusions and interpretations equivalent to those derived from theoretical “error-free” data. Definition of Quality Data

10. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Best Practices to Assure Data Quality Include as few steps as possible in the data collection and handling processes Focus on error prevention Focus on process monitoring Should not focus on inspecting quality at the final stage

11. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Procedures Developed by the CC to Assure Data Quality Double Data Entry Completeness Check Range Check Consistency Check Data Audit

12. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Double Data Entry Two Data entry people Each data entry person will enter the data independently The values of data entered by the two people will be compared to prevent data entry error

13. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Completeness Check Have all the fields in the Baseline Assessment of Core Elements form been filled? If not, ☞ CC HH data coordinator Jeanne Amos will contact the data coordinator for that participant to ▪ check the reason of incompleteness ▪ ask him/her to complete the form if applicable

14. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Completeness Check Have all the fields in the Participant Baseline Questionnaire been filled? If not, ☞ CC data entry people will treat the questions not answered as missing data.

15. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Range Check Is the value of data beyond its possible range? Example : Is it possible a participant’s weight is more than 1000 lbs? Ranges.doc

16. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Range Check If any out-of-range value spotted, ☞ CC HH data coordinator Jeanne Amos will contact the data coordinator for that participant to ▪ confirm the validity of that value ▪ correct the value if it is found to be in error

17. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Consistency Check Does the value of one field contradict the value of another field? Example : Topic/MeasureStatus 1. Gender● Male ○ Female 41.History of Diabetes while pregnant? ●Yes ○No

18. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Consistency Check If any inconsistency found, ☞ CC HH data coordinator Jeanne Amos will contact the data coordinator for that participant to ▪ resolve the contradiction

19. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Data Audit The CC computer programmers will randomly select some forms and check the accuracy of data entry. CC HH data coordinator Jeanne Amos will perform similar data audits during her site visits.

20. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 How Can You Help? Get familiar with the Assessment of Core Elements Forms. Make sure the NDPID #, site # and Participant ID # are filled out correctly on the top of each form/questionnaire. Be aware of possible out-of-range values and inconsistencies.

21. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 How Can You Help? - An excellent and real Example The weight of a participant was 272 lbs on his BACE form His weight was 231 lbs at the first class and he said he never weighed as much as 272 lbs in his life His case manager/data coordinator spotted this inconsistency and contacted Dr. Mandelin immediately, and cc’d Alisa Katai.

22. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 How Can You Help? Data Quality Assurance is the responsibility of everyone involved in the project. The staff of the CC really appreciate all your help. We are all working hard toward the same goal – The success of the Healthy Heart Project!

23. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program: Year 2 Meeting 2 Data Quality Assurance Q & A