ICVR InVASC PAOD. PAOD Core Data Set Survey_Behrendt.pdf · The oracle of Delphi (Δελφοί) Pythia, priestess of the temple of Apollo at Delphi Lycurgus of Sparta (maybe consulting

ICVR

InVASC PAOD 15 NOV 2016 – NEW YORK

Peripheral artery disease (PAD)

Closure devices

♂ ♀ Risk factors

Approaches

Diagnostic

Devices and grafts

Multiple lesions

Location

Anatomic informations

Events

Patient-related Outcome

~ 171 basic parameters

Aim of InVASC PAOD

(Basic) minimal

dataset for

PAD registries

Individual

registry

dataset

Consensus

Vascular research and quality

improvement

Solutions to find a consensus

> 20 international experts on peripheral artery disease and registry work

Telephone conferences? Cisco WebEx Meetings? Mail? Facebook/Twitter? Chat?

Skype? Local meetings? Survey? …just create a list and wait for objections?

Different time zones, limited time,

large scope of decisions (items)

Highly complex!

The oracle of Delphi (Δελφοί)

Pythia, priestess of the

temple of

Apollo at Delphi

Lycurgus of Sparta

(maybe consulting

in vascular matters)

World Cultural Heritage

Delphi (Greek): Seat of the oracle

DELPHI METHOD

„The Use of Expertes for the Estimation

of Bombing Requirements“ (Nov 1951)

DELPHI METHOD

Group

faciliator

Expert 1

Circulating series of questionnaires

Expert 2

Expert 3

Expert 4

Expert n

yes

no

Maybe…

Structured feedback with comments

General sense

of consensus

yes • Anonymous

• Structured

questionnaire

• Experts

• Repeated rounds

• Group decision

„Holders“

„Swingers“

167 to 360

A-bombs

First Delphi: Items

Logistics and infrastructure

Socio-demographics

General medical condition

Assessment of medical cond.

Specific risk factors

Best medical treatment (BMT)

General technical procedures

Endovascular revascularization

Open revascularization

Procedure related events

Outcome

• 11 groups of questions

• 171 items • Which items should be

included in a minimal

dataset?

• (Definition of items was no

aim of this Delphi!)

„Should registries collect any kind of informations

on platelet inhibitor?“ Yes or No?

Next Delphi: „How exactly shoud

registries collect these informations (e.g.

at discharge, dual vs. single)?“

First Delphi: Items

Expert 1

Expert 2

Expert 3

Expert 4

Expert n

23 experts

Server

4 6

13

3 5

2 3

10

Relative

consensus

No

consensus

4.39

3.52

1 No importance

2 Low importance

2.0 – 3.9 unclear

4 High importance

5 Very high importance

anonymous!

First Delphi: Items


Socio-demographics









Outcome

Mode of admission (e.g. emergent vs. elective)

Date of procedure

Date of discharge

Hospital capacity / volume / teaching status

Discharge destination

Special discipline responsible for hospital treatment

Date of administration

Intensive care unit LOS

Date of procedure is highly important in order to match and validate against claims data. Dates needed to calculate LOS: LOS could be supplied as integer. The mode of hospital admission is not as important as the mode of operation. ICU not very common for PAOD treatment. LOS (proc to dc) correlates well with MAE so important. Hospital size, etc doesn't need to be added to each form, but rather known for that hospital.

First Delphi: Items


Socio-demographics









Outcome

Age

Sex / Gender

Functional status

Nursing status

Income

Race and ethnicy

Health insurance status

Housing

Education

Migration background

Occupation

In Sweden it is illegal to register race and ethnicity. Health insurance status is different in different countries, it may be difficult to create a variable for that. There is evidence, however, that ethnicity has significant impact on morbidity and the individual risk profile of the patient, […].

First Delphi: Items


Socio-demographics









Outcome

Existence of gangrene

Acute limb ischemia (ALI)

Existence of Ulcers

Existence of restpain

Existence of infection

Rutherford classification

Fontaine classification

WIfI-Score

Walking distance

Wound deepness

Angiosome

Texas classification

Target vessel better instead of ANGIOSOME; WIFI would cover wound depth favor classifying claudicants by a few defined categories based on distance and/or time walking; best to include data elements to calculate wifi, then don't need to ask for score; RAPID has new classification for Rutherford that includes claudication distance, and variables to calculate wifi; Rutherford classification replaces the 3 first questions

First Delphi: Items


Socio-demographics









Outcome

Genuine vessel or graft

Ankle-Brachial-Index (ABI)

Exact location of all lesions (even untreated)

Length of stenosis

Pretreatment of lesion

TASC classification

Grade of stenosis

Outflow quantification

Toe pressure

Exact location of treated lesions

Inflow quantification

Invasive digital subtraction angiography (DSA)

Laboratory findings (e.g. cholesterol, HDL, platelet count, haemoglobin)

Duplex ultrasound

Contrast enhanced CT-angiography (SCTA)

Contrast enhanced MR-angiography (MRA)

Transcutaneous oxygen measurement (TcP O2)

Oscillographics

Laboratory finding would be a luxury to have with GFR and LDL; the difficulty with imaging pre Rx is that it is hard to capture info with sufficient detail to have it be useful; TASC can be a good overall estimation of the anatomical lesion, we need not know how that was established. It may become very tough, however, to register both TASC and WIfI, Most of these are important at a patient level but not on a registry where too many fields lead to non-compliance with data entry; Does pretreatment of lesions signify previous intervention? If so, this should be registered.; How do you intend quantify inflow and outflow?; The methodology of toe pressure measurements is very variable, no gold standard. many units do not use that;

First Delphi: Items


Socio-demographics









Outcome

Diabetes type 1

Diabetes type 2

Renal function

Current smoking

Coronary artery disease (CAD)

Dialysis

Ever smoked

History of amputation

Open wound or wound infection

History of acute limb ischemia

Congestive heart failure (CHF)

Myocardial infarction (MI)

History of vascular procedures

Chronic obstructive pulmonary disease (COPD)

History of stroke or TIA

Hypertension

Atrial fibrillation or flutter (AF)

Weight, height, Body-Mass-Index

ASA-Grade (Risk score: American Society of Anesthesiologists)

Hyperlipidemia

Pacemaker, defibrillator, orthopedic endoprosthesis or other artificial material

Open wound and infection contained in Wifi; Hyperlipidemia is difficult, since many are treated with statins and you do not know if they have hyperlipidemia or not; I would prefer to make one variable of MI, CAD or CHF as "heart risk", Diabetes typ 1 or 2: yes or no; Hypertension is difficult, since on one hand we know that most patients have it, on the other hand we do not know if for instance beta-blockers were prescribed for HT or heart disease.

First Delphi: Items


Socio-demographics









Outcome

Aspirine

P2Y12 / Clopidogres

Vitamine K antagonists

New oral anticoagulants

Other platelet inhibitors

Lipid-lowering agents

High dose heparine (not procedural)

Low dose heparine (not procedural)

Cilostazol

Beta-blockers

ACE-inhibitors or sartanes

PGE1 infusions

Naftidrofuryl oxalat

Pentoxifylline

Inositol nicotinate

lipid lowering need to separate statin from others; suggestion to make groups; Ticogrelor should also be included. It is also possible to simplify into the following: AK and or platelet inhibition, and depending on what answer divide inte warfarin/NOAC and single/dual/ticagrelor

First Delphi: Items


Socio-demographics









Outcome

Side of intervention

Intraprocedural heparine

Pre-treatment of lesion

Special discipline performing the procedure

Principal anaesthesia technique

Level of residency supervision

Operation time

Additional anaesthesia technique

First Delphi: Items


Socio-demographics









Outcome

Type of main endovascular procedure

Hybride procedure

Treatment aborted or incomplete

Patency

Acute conversion to open surgery

Thrombolysis

Mechanical thrombectomy

Stent device

Type of used devices

PTA device

Atherectomy device

Access site and approach

Distal protection device

Embolic protection device

Closure device

Completion angiography performed

Access guidance

Chronic total occlusion (CTO) device

Detailed device information

Instructions for Use (IFU) followed

Dose-area product (DAP) / Radiation dosage

Use of duplex ultrasound (access)

Additional approach (e.g. Nitro)

Informations about sheath used

Informations about guidewire used

First Delphi: Items


Socio-demographics









Outcome

Hybride procedure

Type of main open procedure

Distal anastomosis

Patency

Re-intervention of bypass

Type and location of vein graft

Type of used prosthetic grafts

Proximal anastomosis

Treatment aborted or incomplete

Acute conversion to endovascular procedure

Existence of infection

Access site and approach

Completion angiography performed

Blood loss

Instructions for Use (IFU) followed

Diathermia or ligature used for cut down

Type of surgical suture material

First Delphi: Items


Socio-demographics









Outcome

Death (MACE) Major amputation (MALE) Reoperation or reintervention Reintervention open surgery Stent or graft thrombosis Myocardial infarction (MACE) Wound infection or graft infection Stroke or TIA (MACE) Acute renal replacement therapy Reintervention endovascular Acute limb ischemia / Lower extremity ischemia Minor amputation (MALE) Distal embolisation Compartment syndrome Bleeding (Pseudo)Aneurysm Dissection Device fracture or rupture Perforation Nerve injury Lung embolism Lymphfistula or seroma AV-fistula Deep venous thrombosis (DVT) Pneumonia Transfusion Gastro-intestinal compliactions Lymphedema Delirium

First Delphi: Items


Socio-demographics









Outcome

Limb salvage

Patency

MACE

Reintervention

MALE

Quality of life

Ankle-Brachial-Index (ABI)

Infection

Rehospitalization

Destination at discharge

Walking distance

First Delphi: Items


Socio-demographics









Outcome

Mode of admission, date of procedure, age, sex, functional status, existence

of gangrene or ulcers or restpain (acute limb ischemia), existence of

infection, genuine vessel or graft, Ankle-Brachial-Index, diabetes 1 or 2, renal

function, current/former smoking, CAD, dialysis, history of amputation, history

of open wound or wound infection, history of ALI, CHF, myocardial infarction,

history of vascular procedures, COPD, history of stroke or TIA, hypertension,

aspirine, P2Y12, VKA, NOAC, other platelet inhibitors, lipid-lowering agents,

side of intervention,

If ER: type of main procedure, hybride procedure, treatment aborted or

incomplete, patency, acute conversion to open surgery, thrombolysis,

mechanical thrombectomy, stent device, type of used devices, PTA device,

atherectomy device,

IF OR: hybride procedure, type of main procedure, distal anastomosis,

patency, reintervention of bypass, type and location of vein graft, type of

used prosthetic grafts, proximal anastomosis, treatment aborted or

incomplete, acute conversion to ER,

death, minor/major amputation, reoperation, stent or graft thrombosis,

myocardial infarction, wound infection/graft infection, stroke/TIA, acute renal

replacement therapy, ALI, distal embolisation, compartment, bleeding

Limb salvage, patency, MACE, reintervention, MALE, QoL, ABI, infection

~79 items

Suggestion


Socio-demographics









Outcome

Mode of admission (e.g. emergent vs. elective)

Date of procedure

Date of discharge

Hospital capacity / volume / teaching status

Discharge destination

Special discipline responsible for hospital treatment

Date of administration

Intensive care unit LOS

If 2-times > 4.0, consensus is achieved

If 2-times < 2.0, consensus is achieved

include

exclude

Proceed to next round

Documents

ICVR InVASC PAOD. PAOD Core Data Set Survey_Behrendt.pdf · The oracle of Delphi (Δελφοί) Pythia, priestess of the temple of Apollo at Delphi Lycurgus of Sparta (maybe consulting