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Data Management for Health Sciences Research

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. SIR: Traditional Advantages 1. Facilitating Structural Integrity of Data.

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Data Management for Health Sciences Research

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  1. Data Management forHealth 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 Advantages1. 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 Advantages2. 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 Advantages3. Interface with Statistics 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 (R01’s) 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. Technology Shifts – Internet, Mobility Factors • Internet 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 • Multiuser update, ODBC, PDA update, citrix, replication

  7. Trends in the 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 data by investigators and statisticians

  8. SIRis 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 • 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’ • Procedural language • Seamless stats package interfaces • Total management solution • Consistent Upgrade Path (22 years worth)

  9. An Application - Heartbase Regulated by: • American College of Cardiology • Society of Thoracic Surgeons • Anthem • Oryx (JCAHO) • CCORP • Get with the Guidelines • Leapfrog

  10. Another - Metropolitan New York Registry (MNYR)of Breast and Ovarian Cancer Families • Funded by the National Cancer Institute at the Mailman School of Public Health, Columbia Uni. • Largest family breast cancer database in the world. • Participates in the Cooperative Family Registry of Breast & Colon Cancer • 12 Sites (6 Breast, 6 Colon) • International (USA, Canada, Australia) • Data from all sites merged in the central CFR registry • Family History Info about many People & Families • Questionnaire Data • Bio-specimen Samples and Associated Data • Genetic Test Results • Detailed Pathology Information on Tumor Specimens

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