Quality Assurance (QA) Cumulative and Recent Report
Data Quality (DQ) Report
Who can obtain the quarterly statistical reports?
The Site Administrator (SA) is the only person who can view and download the report. If the SA cannot view the site reports or SAS datasets zip files then please contact Maceo Cleggett at email@example.com.
Where can I find the quarterly statistical reports and how do I download them?
Log in to the Web Based Data Entry system (WBDE) and then click the “Files” tab at the top of the dashboard. Click your site reports and SAS datasets zip files to download. See “WBDE System File Delivery Instructions” for more details.
What do I do if I’ve never signed into the WBDE?
You will need to complete the self-enrollment process. Please contact use at firstname.lastname@example.org.
What do I do if I’ve forgotten my WBDE log in username or password and now locked out of my account?
Contact email@example.com for help with your login.
How do I get my 8 digit passcode or why is my passcode not working?
If you need your 8 digit password or any assistance accessing your site’s reports, please contact Maceo Cleggett at firstname.lastname@example.org.
How can I get an older quarter’s statistical site report?
Site reports from previous quarters are available on request. Please contact Maceo Cleggett at email@example.com.
How are duplicate entries or data entry mistakes, etc., removed?
If you are having trouble editing or removing data that was entered by mistake (duplicate or incorrect information) contact us at firstname.lastname@example.org.
When are the reports distributed?
|Calendar Quarter||Data Entry Deadline||Coverage Stop Date||Distribution Date|
|Q1||April 30th||March 31st||June 30th|
|Q2||July 31st||June 30th||September 30th|
|Q3||October 31st||September 30th||December 31st|
|Q4||January 31st||December 31st||March 31st|
How long are my reports and datasets available online on the WBDE?
Your site reports and dataset are available online for 90 days
Quality Assurance (QA) Cumulative and Recent Report
What is the coverage period?
The “Cumulative” version of the Quality Assurance report includes Intermacs web-based data entry application data of all primary prospective patients implanted by your site thru the report coverage stop date for each quarter, as seen in the Quarterly Report Schedule above. Patient enrollment in Intermacs began on June 23, 2006 and retrospective entry of patients with implants after March 1, 2006 was allowed. Your institution may have joined Intermacs at a later date and therefore your patient enrollment may have begun at a later date. This report is restricted to your patients who were implanted after your enrollment date and received a primary implant.
The “Recent Year” version of the Quality Assurance report focuses on a contemporary cohort of patients. This report includes patients implanted in the most recent completed calendar year (2015) and any patients implanted in the current calendar year (2016).
What patients are included in the Quality Assurance (QA) Report?
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.
Why are some patients excluded from the QA Site Report?
Exclusion reasons from the QA report include:
a. Retrospective patients (implanted prior to site activation)
b. Patients whose first implant in Intermacs is not their primary implant
c. Form Status = Incomplete and Pending
d. Pediatric patients entered into Intermacs prior to the launch of Pedimacs
e. Patient with missing Implant Dates
f. If patients have had a previous cardiac operation (LVAD, RVAD, TAH)
g. If patient has had a Clinical Event and Intervention this hospitalization (Pre-implant) (LVAD, RVAD, TAH)
h. If patient has Interventions within 48 hours of implant (LVAD, RVAD, TAH)
How are the transfer patients handled in the QA report?
Transfer patients and their subsequent experience are analyzed in the report for the site that implanted the primary implant.
How are the transplant patients and recovery patients accounted for in the survival graphs?
The post implant graphs show percentage of survival over time with the qualifying event being death. The patient is censored at transplant and recovery. This simply means that on the date of transplant or recovery, the patient is no longer included in the total number of patients from which the percentage of surviving patients is derived. So, if you have 75 patients that are alive, and one of them is transplanted, from the day of transplant and afterward, the patient no longer exists in respect to this data calculation. The total number of surviving patients is now 74 (instead of 75). There are several graphs showing post-implant survival and both transplanted and recovery patients are all accounted for in the same way on each graph.
How are the Adverse Events (AEs) handled on transfer patients?
AE’s are calculated from the implanting site. Once patient has transferred, the AE rates are excluded.
How are the Adverse Event rates calculated?
Rates are a special type of comparison in which the ratio of two numbers is calculated. Rate are used when the ratio includes numbers with different units (example: miles per hour, or events per patient-months). In Intermacs the ratio is between the observed number of adverse events and the total amount of time patients have been supported on a device. A rate is not a percentage, it is a proportion obtained by dividing the number of events by the amount of patient follow-up time. This proportion can be scaled to compare the amount of events observed from groups that have different amounts of patient follow-up (example: your site and Intermacs overall).
Adverse Event Rate (events per 100 patient months) = (number of events) / (patient time at risk (months)) * 100
EXAMPLE FROM 2015 Q3 QA REPORTS
Overall, Intermacs has followed 15,323 primary prospective patients for a total of 249,786 patient months at risk. The time at risk can be divided into early and late follow-up time using a three month cut point. Intermacs has a total of 41,189 months of early follow-up time and 208,597 months of late follow-up time. There were 8,138 early bleeding events (within 3 months of implant) and 6,820 late bleeding events (after 3 months of implant)
Early Bleeding Adverse Event Rate = 8,138 / 41,189 * 100 = 19.76
Late Bleeding Adverse Event Rate = 6,820 / 208,597 * 100 = 3.27
How are the 30 Day Readmission percentages calculated?
% with 30 day Readmission = (Patients with 30 day Readmission) / (Patients Discharged Alive on Device (n)) * 100
Patients Discharged Alive on Device (n) = number of patients discharged alive and on a device from a primary device implant hospitalization. This is the first hospitalization discharge recorded in Intermacs. A specific patient will have only one primary prospective implant hospitalization and will only be counted in this measure 1 time, even if they have subsequent implants after their initial hospitalization. If a patient has subsequent devices implanted during their first hospitalization in Intermacs and is discharged with a device in place they will be included.
Patients with 30 day Readmission = number of patients from the denominator that were rehospitalized for any reason within 30 days of the 1st time they were discharged alive with a device in place.
Can the DCC perform custom analysis related to my QA reporting?
STS Intermacs has developed a process to field small scale custom analysis requests through a mechanism called a Minor Data Request (MDR). MDRs are formally submitted through the STS website and the analytics are performed by the STS Intermacs Data Coordinating Center (DCC). There are two types of MDRs:
- Minor Data Requests for Quality Improvement
- Minor Data Requests for Research purposes, most often used for the development of a formal research proposal
Note that MDR data is not intended for publication, and an MDR only allows for 4 hours of DCC analytic time. Follow this link for more information on formally submitting Minor Data Requests through STS.
Once the DCC receives a request, we are given 4 weeks to return it, but we can usually get it back much sooner.
Data Quality (DQ) Report
How are the transfer patients handled in the DQ report?
Only information prior to the transfer is listed for patients who have transferred away from your site. Information from patients that have transferred to your site are included in this report.
What happens if there are changes made to the WBDE before a report is distributed?
Changes made to the WBDE after the report cutoff date will not be made in the report. These changes will be included in the subsequent report.
Where would I find the Intermacs Operation ID number?
This is the device ID number located on the patient summary (Device ID, Event ID, and Operation ID are all the same).
I have already verified that this data is entered correctly. Why does it keep showing up on my report?
Some data are listed for you to verify that it is correct (i.e., subsequent device check).