BCIS PCI DATA COLLECTION AND VALIDATION: HOW TO AND GUIDANCE DOCUMENTS
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Current dataset and csv file specification (5.6.5 01-05-2019)
Import system and rules for BCIS-NICOR 2018 Version 07-06-2018
16th May 2019
To all database PCI operators, database contacts and database software providers
Dear colleagues,
I have updated the PCI dataset libraries, to try to capture more recent changes to our armamentarium. These are ONLY library updates, and affect only 4 libraries. There is no change to the overall structure of the database.
We would hope that most centres will be able to update their library options rapidly, but would hope that all will have done this by the next 6 months at the latest.
The dataset is now named: ‘PCI_Dataset_Standard 5_6_5 version 1-05-2019’ and can be downloaded as an excel file from:
The changes are summarised below:
5.09 ECG ischaemia
The following have been added:
3.17 Drug eluting stents
The following have been added:
3.19 Diagnostic device(s) used during procedure
Will now be used for any device that assesses a coronary stenosis and requires hyperaemia to be induced. It has been re-named:
The following have been added:
3.20 Procedural device:
Will now be used for the legacy device and so be renamed
Will now be used for both Finecross and ANY other microcather and so has been renamed:
The following have been added:
Please note that where options have been re-named, the previous and new names will both be accepted
There is no change to the underlying structure of the dataset.
The only thing you need to do is to update your library drop down lists.
4th August 2016
Dataset Version 5.6.5 (August 2016)
Sent to all commercial DB vendors and all Database audit contact and PCI database clinical leads:
I have updated the BCIS PCI dataset. The ‘change history’ tab in the spreadsheet gives the details. They are as follows:
1. A text clarification
2. Clarification of an endpoint definition
3. Minor additions to three of the libraries as:
Library update: 3.17 Drug eluting stent – Addition 46. Orsiro (Biotronik)
Library update: 3.21 Athero-thrombus removal device(s) used – Addition: 13. QXT extraction catheter
Library update: 5.10 Drug therapy PreOp – Addition: 10. Cangrelor
There is no change to the underlying structure of the dataset.
The only thing you need to do is to update your library drop down lists.
30th October 2014
Sent to all All commercial DB vendors and All Database audit contacts
Dataset Version 5.6.2 To be collected from 1st December 2014
Addition to the library of Drug Eluting Stent names only. No change to the database structure.
29th October 2013
Sent to: All commercial DB vendors, All UK PCI operators, All Database audit contacts
Dataset version 5.6.1 To be collected from 1st January 2014
I am always reluctant to change our dataset, but unfortunately there are compelling reasons to make some small changes. There are 11 additional fields (6.01 to 6.11) and additional options to an existing field.
Eleven additional fields:
6.01: PCI indication for stent thrombosis. It has previously been impossible to identify these cases as they could fall under several options available in the ‘Indication for PCI’ field. This new field will allow us to track this particular indication for PCI for the first time.
6.02: As we move towards international standardisation of definitions, we felt it important to have uniform reporting of bleeding complications. This field aligns us to the Bleeding Academic Research Consortium (BARC) definitions.
6.03 to 6.11: Out Of Hospital Cardiac Arrest. We have only been able to infer this specific patient presentation by using the field ‘need for pre-procedural ventilation’. As out of hospital arrest carries its own very specific high risk features we felt it critical to try to capture some key features of patients presenting in this way for PCI. I hope that the data items selected provide the correct balance between essential detail without too burdensome data entry.
Update to existing fields:
3.24 Circulatory support. New LV support device potion have been added to include: Impella, Lucas device, Autopulse and ECMO
What you need to do
1. The commercial suppliers of PCI databases are all being informed of these modifications so that their systems can be upgraded to remain compliant with the BCIS – NICOR audit collection. I recommend you contact then to make sure changes can be effected in time.
2. The Lotus Notes database will be updated in the near future.
3. If you are using my PCI database (in access), then I will shortly be providing a method to allow you to update your database to a newer version that will incorporate all these changes
Best wishes
Peter Ludman
BCIS audit lead
3 September 2013
Sent to all BCIS members and database contacts
Diagnostic Interventional Procedures
The use of FFR, IVUS and OCT (and OFDI etc) when no PCI ensues will be described as an ‘Interventional Diagnostic Procedure’.
An Interventional Diagnostic Procedure is therefore defined as invasive coronary angiography with the use of adjunctive invasive diagnostic equipment such that a coronary device approaches, probes or crosses one or more coronary lesions (including – but not limited to – a pressure wire, intravascular ultrasound and swept laser imaging), before the intention to treat by mechanical revascularisation has been decided. Interventional diagnostic cases should be performed by interventional cardiologists in intervention capable centres.
The definition of a PCI will remain unchanged as:
“A percutaneous coronary intervention (PCI) is deemed to have taken place if any coronary device approaches, probes or crosses one or more coronary lesions, with the intention of performing a coronary intervention. Usually this device will be a guide wire. The only exception to this will be patients who have an adverse cardiac event (during an attempted PCI) that necessitates procedure termination prior to the introduction of a coronary device. This rare type of case will also be defined as a PCI and therefore this will classify as a complication.”
BCIS will plan to report operator’s total numbers of ‘PCI procedures’ and, separately, total numbers of ‘Interventional Diagnostic Procedures’
In order to do this all ‘Interventional Diagnostic procedures’ should now be entered into the BCIS database. To distinguish these from PCI procedures, the following rules need to be applied:
For an ‘Interventional Diagnostic Procedure’:
Total number of lesions attempted (field 3.11) must = 0
and Total number of vessels attempted (field 3.10) must =0
and ‘Diagnostic device(s) used during procedure (field 3.19) should include one of the interventional diagnostic procedures described
Vessels attempted (field 3.09) should be left empty
(Any adverse in-hospital outcomes should be recorded in the same way as for a PCI procedure)
It is suggested that recording all ‘Interventional Diagnostic Procedures’ should start from Jan 2014, but those wishing to add data retrospectively can do so, and it may be possible to include this in the 2013 data reports to be produced in 2014.
Peter Ludman
April 2013
Sent to: All commercial DB vendors, All BCIS members, All Database audit contacts
Dear all
Dataset version 5.5.6 to 5.5.7: To be applied by 1st June 2013
No structural change to the database.
The only changes are to update of some of the menu items in the volatile fields, and some clarification of descriptors.
1. Volatile fields
The following additions have been made to the list:
3.17 Drug based stents
| 31 | Synergy (Boston Scientific) |
| 32 | Promus premier (Boston Scientific) |
| 33 | Biofreedom (Biosensors) |
| 34 | Combo (Orbus) |
| 35 | Mguard (InspireMD) |
| 36 | Xience Pro (Abbott) |
| 37 | Absorb BVS (Abbott) |
2. Dataset clarification
Minor changes to clarify the meaning of items:
5.09 ECG Ischaemia. Option 3 ‘on perfusion scan’. This should also be selected for other stress imaging such as stress echo and stress cardiac magnetic resonance imaging.
3.19 Diagnostic device(s) used during procedure. Option 6 relabelled ‘OCT (Optical Coherence Tomography) or similar’. This should be selected for all similar laser swept intracoronary imaging techniques such as optical frequency domain imaging (OFDI).
Attached files:
1. A full history of the dataset changes are documented (Dataset version history)
2. A complete spreadsheet of the new version 5.5.7
(The csv file specification is unchanged)
All these will also be available on the BCIS web site
What you need to do
1. The commercial vendors of databases are all being informed of these modifications.
2. The Lotus Notes database will be updated to include these shortly.
3. If you are using my PCI database, then these changes can be added to the lists by going to the ‘default settings / field lists / database admin’ button on the main switchboard, and then selecting each list to be update in turn and typing in the additions.
Best wishes
Peter Ludman
BCIS Audit Lead
peter.ludman@uhb.nhs.uk
October 2012
Import system and rules for BCIS-CCAD 2012 version
The logical and internal validation rules used by NICOR to check for data consistency during all data uploads can be found here.
Peter Ludman
BCIS Audit Lead
peter.ludman@uhb.nhs.uk
Risk Adjusted Funnel Plots and Delays Report
December 2008
The risk adjusted outcome cummulative funnel plot generator for PCI is now ready to be used. The report works in the same way as the generation of aggregate data reports, and the time delays reports generator. Via the Lotus Notes program in BCIS section, look under the list of reports on the left of the page. Click on ‘ Funnel Plot’. Work your way through the steps, which represent a series of choices regarding the variables and parameters you would like to use to analyse your data .
The report will generate an analysis in the form of a password protected excel spreadsheet. The predicted and observed MACCE are listed for each PCI procedure using your reported CCAD data and the NQWIP model. A cummulative funnel plot is generated with 2 and 3 sigma lines. You will find an explanation of this plot in the last few slides (number 156 to 177) of my BCIS audit presentation of 2007 data at BCIS Audit Returns 2007.
The latest version of the delays report generator for PCI is now ready to be used. The report works in the same way as the generation of aggregate data reports. Via the Lotus Notes program in BCIS section, look under the list of reports on the left of the page. Click on ‘Delay reports v.6’ This will bring up the following dialogue (please see attachment for dialogue).
Work your way through the 7 steps, which represent a series of choices regarding the variables and parameters you would like to use to analyse your data.
The report will generate an analysis in the form of a password protected excel spreadsheet. The worksheets include a measure of your data completeness for the key fields, and explanation of how each field is calculated, and overall analysis of various time intervals in the treatment of patients being treated for acute coronary syndromes. The report will aslo create statistical process control charts allowing you to see (for example) each individual door to balloon time delay for each patient treated for STEMI. These charts can be split to look at night versus day time delays.
I hope you find this is helpful. If you spot any errors in our programming please do not hesitate to contact me.
Peter Ludman
BCIS Audit Lead