Data Management for Health Sciences Research

1
Data Management for Health Sciences Research

• Now More than Ever--
• SIR is the Best Option
• Howard Andrews
• Data Coordinating Center
• Columbia University School of Public Health
• New York State Psychiatric Institute

2
SIR Traditional AdvantagesI Facilitating
Structural Integrity of Data

• Case-structured SIR database option
• Appropriate for virtually every health research
  project because person (or family) is the case
• Each record in each table must be owned by a
  case
• No New Cases option on data entry screens
• In conjunction with case-structured option, can
  be used to enforce registration requirements
• Eliminates orphan records
• Sir Tables offer easy access to information that
  is not case-structured

3
SIR Traditional AdvantagesII Enhanced Variable
Attributes

• Variable labels
• No less valuable with 8 character variable names
• Value labels
• Still a significant lack in all major relational
  data management software systems other than SIR
• Missing value assignment (up to 3 per variable)
• Reduces analytic error effort by statisticians
• All variable attributes are directly associated
  with each variable, both in database creation
  output
• WRITE SCHEMA generates a codebook containing
  all information required by investigators
  statisticians

4
SIR Traditional AdvantagesIII Interface with
Stat Packages

• Procedural Query Language (PQL) facilitates
• extraction of database variables
• creation of new variables
• structuring of information
• SPSS, SAS, Stata files generated by a single
  command
• All variable attributes recognized by the stat
  package are ported seamlessly by SIR
• Eliminates need to rebuild variable labels, value
  labels and missing value assignments in the stat
  package
• Ensures that statistical system files are
  self-documenting

5
Policy shifts in medical research

• Increased scrutiny of database management plans
• Proposals without adequate DBM plans are rejected
• Funding of multi-site projects and research
  centers
• Individual projects (R01s) benefit by center
  association
• Emphasis on cost, efficiency, productivity
• Emphasis on professional, dedicated DBM staff
• A need now widely recognized in the research
  community
• Databases often serve project management as well
  as data management functions,e.g., scheduling of
  followup examinations
• Greatly increased regulatory oversight of data
• HIPAA Regulations / IRBs / DSMBs / PSMBs/Data
  Sharing

6
The Internet Factor

• Facilitates geographically dispersed data entry
  and access
• Puts a premium on data security
• Reinforces reliance on trained professionals and
  continuity of effort
• Requires close cooperation between IT and data
  management experts

7
What is the impact of these trends on management
of research data?

• Data coordinating centers are emerging growing
• institutional and private sector
• Shift from DBM by researcher to external center
  puts a premium on efficiency a focus on cost
• Use of sophisticated data management software is
  becoming the rule rather than the exception
• Increasing demand for building systems in which
  input output is under end-user control
• data entry by research staff rather than data
  center staff
• direct access to by investigators and
  statisticians

8
SIR is well positioned to take advantage of these
trends

• SIR research database management systems with
  user-friendly entry and data access interfaces
  can be set up quickly and efficiently
• Tony Reardon, Advanced Training
• Traditional SIR advantages for research are
  enhanced in a competitive situation
• SIR increases productivity of individual
  researchers
• Data coordinating centers using SIR can run more
  efficiently and attract more research clients

9
What is the SIR community doing to take advantage
?

• Extending SIRs reach VPN / Secure web access
• custom interfaces connected to SIR database
  engine
• Citrixmakes the full range of SIRs integrated
  systems available over the internet
• Improving user access
• Enhanced menuing options in SIR (David Baxter)
• Automatic updates of reports statistical files
• Direct user access to complex data systems
• DVQuery by DataVisor (Tom Shriver)
• Supporting multiple-project data management by
  Data Centers, e.g. DVSchema by DataVisor

10
What else ?

• The new version, SIR X/S Tony Reardon
• Data Transfer/ODBC
• John Lemon/Jon Johnson
• Training a new generation of SIR users
• Dave Doulton, Tony Reardon, Tom Shriver
• John Lemon
• Heartbase update
• Nick Gawrit
• And much more!