Database ResourcesFinal Project

Database Demonstrations2/9/2010

Outline

• Obtaining and paying for data management help

• Assignment 4/Final Project

• CT Syndesmosis Database – Simon Knops

• SurveyMonkey

• HCG and Ectopic Pregnancy

• Course Evaluation

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

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.

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

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)

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.

CTSI DMU

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.

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.

Final ProjectPart B

Write a one-page data management section for your research study protocol or a one-page description of your current research study database.

Final ProjectPart 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.

Final Project Part BStudy Description

What is your study?  ("The [CUTE ACRONYM] study is a [DESIGN] study of the associations between [PREDICTOR] and [OUTCOME] in [STUDY POPULATION]").

Final Project Part BGeneral Database Description

Platform? 

Access? Filemaker Pro? QuesGen? REDCap? SurveyMonkey? Other?

Tables and Relationships?

Optionally, include a relationships diagram.

Final Project Part BData 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?)

Final Project Part BError Checking and Data ValidationHow 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.)

Final Project Part BAnalysis/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? 

Final Project Part BSecurity/Confidentiality

How will you protect your subjects' identifying data?

(You are not allowed to keep identifying data on your laptop or USB drive.)

Final Project Part BAdministration/Back up

How will you ensure that you don't lose your data file in a computer crash or if a water pipe leaks?

Answering these questions is an essential part of doing a clinical

research study.

Final Project Part B

Extra Credit: Include a budget or cost estimate for data management.

Example: CT Evaluation of the Tibiofibular Syndesmosis

SurveyMonkey Demo

• Enter Robert’s exam

SurveyMonkey Advantages

• Nice looking forms

• Simple to create

• Hosted

• Inexpensive

• Great for surveys

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

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

Example: β-hCG and the Likelihood of Ectopic Pregnancy

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.

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)

Course Evaluation