1. Interagency Registry for Mechanically Assisted Circulatory Support Web-Based Reporting What can you get from the Database?
Friday March 3, 2017

2. Intermacs Products: What Can You Get From The Database
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

3. Web Based Reporting – Reports Page

4. Intermacs Products: What Can You Get From The Database
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

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?
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
Calendar Quarter
Report Coverage Stop Date
Report Distribution Deadline Q1
March 31st
June 30th Q2
September 30th Q3
December 31st Q4

7. Data Quality Report

8. Intermacs Products: What Can You Get From The Database
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

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
Calendar Quarter
Report Coverage Stop Date
Report Distribution Deadline Q1
March 31st
June 30th Q2
September 30th Q3
December 31st Q4

11. Quality Assurance Report
Only primary prospective 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
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

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
Row Labels
Count of Internal Form Status
Incomplete
456
Validated
1174
Grand Total
1630

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
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

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 Follow-up Device
Intermacs DCC Merge
Follow-up
Dataset
Device
Dataset
Events
Dataset

28. What is contained in a research dataset?
Patient Dataset
Device Dataset
Follow-up Dataset
Events 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
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

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
Demographic Form
Pre-Implant Form
Implant
Form
Interactive Cohort Selection
Multiple Types of Comparisons
Descriptive Statistics
Bar Charts
Instant Download

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
Data Quality Report
Quality Assurance Report
Live Data Download
Site Datasets (SAS)
Research Datasets
Customized Cohort Reports
Outcome Analytics
Patient Informatics
I. Accessing Your Data
Examining/Validating your data ü
Compliance Rates
Electronic copies of your data
II. Patient Management Tools
Clinical timeline
Clinical measures across time
III. Patient Selection and Outcomes
Quality Assurance Report
Cohort (subset) report
Benchmarking ü 
IV. Quality Initiatives
Joint Commission
Internal Initiatives
V. Using Intermacs for Your Research
Within your site
Across Intermacs

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

48. Questions contact
Devin Koehl
(205)