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Friday March 3, 2017

Interagency Registry for Mechanically Assisted Circulatory Support Web-Based Reporting What can you get from the Database?. Friday March 3, 2017. Intermacs Products: What Can You Get From The Database. Web Based Reporting – Reports Page. Intermacs Products: What Can You Get From The Database.

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Friday March 3, 2017

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  1. Interagency Registry for Mechanically Assisted Circulatory SupportWeb-Based ReportingWhat can you get from the Database? Friday March 3, 2017

  2. Intermacs Products: What Can You Get From The Database

  3. Web Based Reporting – Reports Page

  4. Intermacs Products: What Can You Get From The Database

  5. Data Quality Report • The Purpose of the Data Quality Report is to provide each hospital an up to date snapshot of key data they have entered into Intermacs and to provide lists of inconsistencies and improbable values that occur in the data. • The data in this report are based on implants entered into the Intermacs web-based data application • The Data Quality Report contains information from ALL INTERMACS patients at your institution. This includes patients receiving primary, subsequent, retrospective devices, and pediatric patients that were entered prior to the launch of Pedimacs. • For patients who have transferred away from your institution, only information prior to the transfer is listed. Information from patients that have transferred to your institution are included in this report.

  6. Who receives the Data Quality Report? • Who receives the data quality report? • Site Administrators • When do I receive the Data Quality Report? • Quarterly • Where is this report located? • A part of the quarterly report zip packet downloadable from the filed delivery tab

  7. Data Quality Report

  8. Intermacs Products: What Can You Get From The Database

  9. Quality Assurance Report • The Purpose of the Quality Assurance Report is to facilitate the refinement of patient selection to maximize outcomes with current and new device options. • Identify predictors of good outcomes as well as risk factors for adverse events after device implantation. Develop consensus best practice guidelines to improve clinical management by reducing short and long term complications of MCSD therapy. • The Quality Assurance Report contains information from your site compared to the overall Intermacs experience. To facilitate this comparison only primary prospective patients are analyzed. • Exclusion reasons from the QA report include; Retrospective patients (implanted prior to site activation), Patients whose first implant in Intermacs is not their primary implant, Patients only receiving an RVAD, or Pediatric patients entered into Intermacs prior to the launch of Pedimacs. Transfer patients and their subsequent experience are analyzed in the report for the site that implanted the primary implant.

  10. Who receives the Quality Assurance Report? • Who receives the data quality report? • Site Administrators • When do I receive the Quality Assurance Report? • Quarterly • Where is this report located? • A part of the quarterly report zip packet downloadable from the filed delivery tab

  11. Quality Assurance Report • Only primaryprospective patients are included if facilitate valid comparisons across sites • The list below are reasons why a patient from your site is excluded from the Quality Assurance Report (QA). • Retrospective patients • Patients with a prior history of MCS (LVAD,RVAD,TAH) • Pediatric patients • Patients that have transferred to your site • Patients with missing implant dates.

  12. New Exhibits in QA Reporting • Most Recent Year Report - The “Recent Year” version of Quality Assurance report focuses on a contemporary cohort of patients by limiting the report to patients receiving primary prospective implants within the last complete calendar year. You will receive this report if you have enrolled a patient with a primary prospective implant within the coverage window for the report. • Time to First AE • Device Malfunction and/or Thrombus • Infection • Neurological Dysfunction • New Features Planned for 2017 • Quality of life supplemental report

  13. QoL Supplement Report • Quality of life committee is designing a QoL specific report to highlight EQ5D and KCCQ change over time and compare site data to the overall Intermacs experience

  14. Intermacs Products: What Can You Get From The Database

  15. Form Download • The Intermacs Form Download is a tool that allows sites to download all data they have entered into the Web-Based Data Entry System. • The Form Download is broken down by each individual form. The Form Download follows the Web-Based Data Entry Screen

  16. Intermacs Live Form Download Goal • Allow sites to download any data they enter into the Web-Based Data Entry by form in Excel format • Allow sites to see an instantaneous update from data entered in the Web-Based Data Entry to each downloaded form

  17. Downloading Each Form

  18. Demographics Form – 1 Record Per Patient

  19. The Top Three Rows of the Form Download • Report Title • Report Description • Site downloading the report

  20. Implant Form

  21. Major Infection Form

  22. Excel Charts from the Form Download Implant Year (2015) by Device Type Implant Year (2016) by Device Type

  23. Drive Line Infection By Year Number of Infections Year

  24. Electronic Copies of your Data • All of the forms are available for you to download to your secure server or desktop.

  25. Intermacs Products: What Can You Get From The Database

  26. What are the SAS Datasets? • Live Data Download • Real Time • Live Data • Each form is independent • Exact data entered • Site (SAS) Research Datasets • 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

  27. SAS Datasets • Four SAS datasets Patient Dataset Intermacs DCC Merge Follow-up Dataset Device Dataset Events Dataset

  28. 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)

  29. What can you generate with SAS datasets? • Some examples of analysis from the research sas datasets • Overall survival • Survival by device type • Time to first drive line infection by era • Risk Factor analyses: Death Model

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

  31. Intermacs Products: What Can You Get From The Database

  32. Cohort Comparison Reports • The Cohort Comparison tool entails the creation and delivery of reports that describe the user-defined cohorts. After the user has selected the criteria for the cohort, they may select “cohort report” and print a PDF report of their selection • The user-defined cohorts may be compared: • A single cohort selection from a site • Between the site’s own patients based on subgroups (cohort # 1 and cohort # 2) • Between the site’s own patients (cohort # 1) and an equivalent overall Intermacs (cohort # 2)

  33. Explore User Selected Groups Interactive Cohort Selection Demographic Form • Multiple Types of Comparisons • Descriptive Statistics • Bar Charts • Instant Download Pre-Implant Form Implant Form

  34. Cohort Comparison Report Screen

  35. Key Cohort Parameters • Interactive Cohort Selection • Real time display of cohort size • Selection parameters • All vs Primary MCSD Patients • All Patients – Includes Patient’s who have previous MCSD and patients whose first device was entered into Intermacs • Primary MCSD – Patients with no prior MCSD before being entered into Intermacs • Implant Date Range • Gender • Race • Age Range • Intermacs Patient Profile Level • Device Strategy • Device Type • Flow Type

  36. Cohort Parameters • After selecting the type of cohort report you would like to compare, you may check or check the different filters. As you click, the numbers will change instantaneously.

  37. Downloading your Report

  38. Example 1: Single Cohort

  39. Example 2: Subgroups Within Your Site (Males vs. Females)

  40. Example 3: Comparing your cohort to overall Intermacs (LVAD Patients)

  41. Intermacs Products: What Can You Get From The Database

  42. Clinical Summary • Provide coordinators with an easy to read summary on all clinical characteristics for a single patient • Key information in the Intermacs Web-Based Data Entry condensed into a few summary pages • Contains charts and other helpful features to see changes in lab vales over time • Expected Launch Date: July 2017

  43. Clinical Summary – De-identifed Example

  44. Clinical Summary

  45. Clinical Summary

  46. Charts from Lab Values

  47. Intermacs Website www.intermacs.org/reports

  48. Questions contact • Devin Koehl • devinkoehl@uabmc.edu • (205) 934-0109

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