1. Database Resources Final Project Database Demonstrations 2/9/2010

2. Outline Obtaining and paying for data management help Assignment 4/Final Project CT Syndesmosis Database – Simon Knops SurveyMonkey HCG and Ectopic Pregnancy Course Evaluation

3. Where to store your data On your laptop or USB drive only if de-identified* On the PSG terminal server that you have been using for this class (available to TICR students and K scholars) MyResearch account with OAAIS REDCap SOM IT QuesGen or another vendor that has been reviewed by UCSF IT Security *HIPAA Privacy Rule covered in next two slides

4. HIPAA Privacy Rule Patient identifying information must be secure and available only to authorized personnel with auditing of all accesses Patient identifying data include dates such as date of visit, date of surgery, etc.

5. 1. Name 2. Address (all geographic subdivisions smaller than state) 3. All elements (except years) of dates related to an individual (birth date, admission date, date of death and exact age if over 89) 4. Telephone numbers 5. FAX number 6. E-mail address 7. Social Security number 8. Medical record number 9. Health plan beneficiary number 10. Account number 11. Certificate/license number 12. Any vehicle or other device serial number 13. Device identifiers or serial numbers 14. Web URL 15. Internet Protocol (IP) address numbers 16. Finger or voice prints 17. Photographic images

6. Where to get data management help CTSI Data Management Unit –(ctsi.ucsf.edu/BREAD/) –? Cost Outside consultants --Typically $100-$150/hour Outsource data management to –PSG –QuesGen –Others (? SOM IT)

7. Before seeking help with data management Search the internet and ask other researchers for already developed data collection forms. Draft your data collection form. Test your data collection form with dummy subjects and, even better, with real (de-identified) study subjects. Enter your test data into a data table with rows corresponding to subjects and columns corresponding to data elements. (Use Excel, Access, Stata, or even Word.) Create or at least think about a data dictionary. Decide who will collect the data, and when/how the data will be collected.

8. CTSI DMU

9. Final Project Due 3/9/10, send to ucsfdbclass@yahoo.com Example of Parts A and B of the final assignment are posted on the course website.

10. Final Project Part A Send in a copy of your research study database. Populate your database, preferably with real, de-identified data, but test data are acceptable. We will work with you to arrange a way for us to review your database.

11. Final Project Part B Write a one-page data management section for your research study protocol or a one- page description of your current research study database.

12. Final Project Part B – One-page data management protocol At the beginning of your assignment, for the readers, briefly describe your study, including design, predictors, outcomes, target population, and sample size. (1 or 2 sentences). Elements of a data management protocol or database description: General description of database (possibly including a relationships diagram*) Data collection and entry Error checking and data validation Analysis/Reporting (e.g., export to Stata) Security/confidentiality Administration/Back up Extra Credit: Include a budget or cost estimate for data management.

13. Final Project Part B Study Description What is your study? ("The [CUTE ACRONYM] study is a [DESIGN] study of the associations between [PREDICTOR] and [OUTCOME] in [STUDY POPULATION]").

14. Final Project Part B General Database Description Platform? Access? Filemaker Pro? QuesGen? REDCap? SurveyMonkey? Other? Tables and Relationships? Optionally, include a relationships diagram.

15. Final Project Part B Data Collection and Entry What data points are you collecting? (Helps to have an actual data collection form mocked up in Word or a screen shot from Access.) Who will collect the data? You? RAs? MDs? Maybe the study subjects will enter the data themselves. How will the data be collected? Written onto a paper form and then transcribed into a computer file? Entered directly into the computer? (If it's going to be transcribed, will you be doing that? Will you hire somebody? Or will you enlist some med students?)

16. Final Project Part B Error Checking and Data Validation How will you validate the data for correctness and monitor the data collection effort? (Usually you have some range checks on individual variables and you periodically query for outliers that are nonetheless within the allowed range.)

17. Final Project Part B Analysis/Reporting How will you meet the funding agency’s reporting requirements? You should periodically analyze the data, not only to look for problems, but also to see where the study is headed. How will you do this?

18. Final Project Part B Security/Confidentiality How will you protect your subjects' identifying data? (You are not allowed to keep identifying data on your laptop or USB drive.)

19. Final Project Part B Administration/Back up How will you ensure that you don't lose your data file in a computer crash or if a water pipe leaks?

20. Answering these questions is an essential part of doing a clinical research study.

21. Final Project Part B Extra Credit: Include a budget or cost estimate for data management.

22. Example: CT Evaluation of the Tibiofibular Syndesmosis

23. SurveyMonkey Demo Enter Robert’s exam

24. SurveyMonkey Advantages Nice looking forms Simple to create Hosted Inexpensive Great for surveys

25. SurveyMonkey Disadvantages Market-research oriented, not medical Flat file (very difficult to do multiple surveys on one subject) No audit trail Limited user roles, security Not designed for PHI/HIPAA compliance Limited skip logic

26. SurveyMonkey Disadvantages Can’t upload data –Cannot import Baby2007.xls file as in Lab 2 –Have to key data in No subject or exam list Have to browse through the surveys to find the one you want. No calculations e.g., BMI

27. Example: β-hCG and the Likelihood of Ectopic Pregnancy

28. Study Description Cross-sectional study and record review comparing the β-hCG distributions in women with ectopic pregnancies, abnormal intrauterine pregnancies, and normal intrauterine pregnancies presenting to the SFGH emergency department with abdominal pain or vaginal bleeding and a positive urine pregnancy test.

29. Study Database The study used a simple Access database with a single dynamic table that had one row per patient. The principal fields were the complaint (pain, bleeding, or both), the β-hCG level, and the final determination as to the pregnancy type. (PreVUEFinalDEIdentified.mdb)

30. Course Evaluation