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Putting the Pieces Together for Research: Analyzing SAS Research Datasets at the 10th Annual Meeting

Learn how to analyze SAS research datasets for statistical analyses at the 10th Annual Meeting. Understand the differences between live form downloads and research datasets. Gain insights into the content and potential analyses of research datasets.

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Putting the Pieces Together for Research: Analyzing SAS Research Datasets at the 10th Annual Meeting

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  1. 10th Annual Meeting: Friday, March 11th – Products for the Sites Quarterly Site (SAS) Datasets “Research Datasets” Susan Myers Director, Data Management & Quality Control

  2. Relevant Financial RelationshipDisclosure Statement Intermacs 10th Annual Meeting: Session I Intermacs Products for the Sites: SAS Research Datasets Susan L. Myers, Director of Data Mgt I will not discuss off label use and/or investigational use of the following devices: The following relevant financial relationships exist related to my role in this session: None

  3. Putting the Pieces together for Research At your Hospital • Analytical Team • Statistician • Data Manager • Hypotheses/Aims • (What is your research question?)

  4. Putting the Pieces together for Research So, what are the differences between the LIVE form downloads and “Research datasets”? • Live Form Downloads • Real Time • Live Data • Each form is independent • Exact data entered • Site (SAS) Research datasets • Quarterly • Analytical ‘ready’ data • Links all forms into 4 research datasets • Contains derived intervals and indicators • Integrity checks • Built-in ‘30 day’ data entry allowance • Recodes (e.g. ‘Other’ text boxes reviewed) • Completed/Validated forms

  5. Putting the Pieces together for Research “Research Datasets” All Forms “Live” Patient Dataset Intermacs DCC MERGES Device Dataset Follow-up Dataset Events Dataset

  6. What is contained in a ‘research dataset’? 1 record per “patient” (contains demographics, primary implant information, overall outcomes) 1 record per “implant operation” per patient (contains demographics, ALL implant information, outcomes for a single implant) 1 record per “follow-up visit” per implant operation per patient (contains follow-up visit information, e.g. labs, hemodynamics, etc) 1 record per “adverse event” per implant operation per patient (contains adverse event information, e.g. date of occurrence, information based on Intermacs AE definition)

  7. Quarterly Site (SAS) Datasets “Research Datasets” Examples of statistical analyses that can be performed with your site’s SAS research datasets • Overall survival • Survival by Device type • Time to First DLI by era • Risk Factor analyses: Death Model

  8. Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Overall Survival Months post implant % Survival 3 91% 6 88% 12 78% 24 55% 36 39% % Survival Event: death on device (censored at transplant, recovery, exchange) Months post implant

  9. Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Survival by Device Type TAH, n=3, deaths=0 P (overall) = .36 LVAD, n=85, deaths= 27 % Survival Bi-VAD, n=12, deaths= 4 Event: death on device (censored at transplant, recovery, exchange) Months post implant

  10. Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Time to First Driveline Infection by Era 2010-2012, n=34, events=3 % Freedom from DLI Era at 1 year post implant 2006-2009 63% 2010-2012 88% 2013-2015 78% 2013-2015, n=47, events=12 2006-2009, n=19, events=4 % Freedom of Driveline Infection P (overall) = .08 2006-2009 vs. 2010-2012 p= .07 2006-2009 vs. 2013-2015 p= .97 2010-2012 vs. 2013-2015 p= .03 Event: time to first driveline infection according to era Months post implant

  11. Quarterly Site (SAS) Datasets “Research Datasets” Hospital X: implants June 2006 – December 2015, n=100 patients Multivariable Hazard analyses for death

  12. Only the Site Administrator at your Hospital can download your Site SAS Research Datasets! Reports

  13. Information Security Agreement when Downloading Intermacs data

  14. IntermacsSite Datasets (SAS) • What materials does your Site Administrator receive with your Research Site Datasets? Research Datasets: • Patient Dataset: This file contains one record per patient at your site • Device Dataset: this file contains one record per implanted device at your site • Follow-up Dataset: this file contains all follow-up visits for each implant operation/patient at your site • Events Dataset: this file contains all adverse events for each implant operation/patient at your site • Text files: The DCC provides the 4 research datasets (patient, device, follow-up and events) as text delimited files Documentation: • Intermacs Standard Formats (2016-02-01).sas • Printable Forms v4.0 2014 10 06 (a folder of pdf files) • Annotated Printable Forms v3.0 (a folder of pdf files) • Intermacs Users Guide v4.0 2015 06 18 – Data Dictionary.docx

  15. If you need assistance with using your site’s SAS Research Datasets please contact: John Pennington Data Analyst jkpennington@uab.edu

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