EFIC PAIN OUT project: Optimizing management of perioperative pain in Europe

Kick off meeting in the Italian Network – 19th April, 2018

SIAARTI (Italian Society of Anaesthesia), Viale dell'Università, Rome

Topics to discuss:

Mostly issues related to methodology &

administration; not scientific or medical

1. Background of PAIN OUT

2. Aims of the EFIC project

3. Quiz review

4. Dummy cases

5. Where to find useful information in the

website & finances

6. Project schedule – in Italy and overall.

Frustration worldwide regarding poor outcomes and wide

variability in management of perioperative pain

Fields in medicine facing

insufficient management of

disease developed a mechanism

for standardized collection of data

[1], creating a database [2],

feeding back data to clinicians

[3] or researchers [4] or

administrators [5] to use for

Quality Improvement & research.

This is called a REGISTRY

Observational studies; un-controlled

pre- post - not Randomized

Controlled

Can seek for associations between

variables; not correlations

[2]

[1]

[3]

[4]

[5]

Feedback &

Benchmarking

in perioperative PAIN…

National, German

Established in 2003

Funding: German Ministry of Health

~200 sites contributed ~ 500,000

patient datasets

International

Established 2009 – 2012

Funding: European Commission

~70 sites contributed ~ 60,000

datasets

Post-Operative

Pain Registry Research

Clinicians, researchers,

hospital administrators,

policy makers can use the data to

further knowledge about

management of perioperatiive pain

and pain-related patient reported

outcomes.

Immediate feedback &

benchmarking is given to

clinicians online.

Used for Quality Improvement.

THE ROUTINE

MODULE

Evolution of the current project

Setting

up

version 4.

13 hospitals in 1

national network

*

How is the data collected? Using 2 questionnaires

(1) Patient reported Outcomes

Filled in by the patient

In the patient‘s native language

~ 5 - 10 minutes to fill in

(2) Process data Demographics: gender & age,

comorbidities; type of anaesthesia;

preoperative analgesics.

Abstracted from patient‘s record by a

surveyor

~ 10 minutes to fill in

Can be filled in directly to web-based

server (depends on availability of Wifi

connection). To get patient‘s perspective

Languages of the patient questionnaire

Additional translations added, when necessary

Patient outcomes questionnaire:13 questions, 4 domains & 2 extra questions

Intensity of pain

Interference with activities

Interference with affect

Adverse effects

Perception of care

Patient outcomes questionnaire [cont]

Perception of care

Use or receipt of

non-pharmacological

interventions

Experience of

chronic pain before

admission to hospital

The 2 extra questions:

Include which patients?

1. On the first post-operative day (*)

2. Of consenting age and over

3. Gave oral or written consent (depends on requirements of

local ethics committee).

(*) methodology is available for assessing outcomes in patients using email

–> ambulatory patients can be assessed after discharge.

Which surgical specialities?

General surgery

Trauma and orthopaedic surgery

Obstetrics & gynaecology

Neurosurgery

Plastic surgery

Thoracic surgery

Vascular surgery

Ambulatory surgery

Ear, nose and throat

Eye surgery

Most of the

data is from

these

disciplines

Include the relatively minor surgical procedures;

exclude the very minor procedures.

KEEP the relatively

minor procedures

Exclude the very minor

procedures, eg biopsies;

trans-uretheral clearance of

bladder -> minor pain,

limited information to learn

from about outcomes and

treatment processes.

Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM,

Kalkman CJ, Meissner W.

Pain intensity on the first day after surgery: a prospective cohort

study comparing 179 surgical procedures.

Anesthesiology. 2013 Apr;118(4):934-44.

And which procedures ?

The surveyor inputs the data into the

web-based software

patient code Patient code

(anonymous)

Site code

(access by password)

Items from

questionnaire

Data about general surgery from 36 different wards, internationally

Outcome assessed ‚worst pain since surgery‘.

X axis - each ‚box and whisker‘ plot represents summarized data from one

ward.

Y- axis - pain scale, 0 (=‚no pain‘) – 10 (‚worst pain imaginable‘)

Average scores of ward on the left indicate low pain scores;

on the right – scores are high.

Own site is identified; others anonymous.

Online feedback: worst pain

• Sites with datasets >20

• Nausea

• Female

Online feedback: side effects

Here filtered for:

The EFIC project consists

of a pre – post – study:

Months 1- 6

• Kick off meeting

• Collect BASELINE data from

patients in (1) - 2 wards \ hospital &

analyze it;

• Mid project workshop to discuss

findings and propose 1-3 quality

improvement (QI) measures.

Months 7 - 12

• Discuss QI measures with your local

multi-disciplinary working group &

consent on 1-2 measures;

• Obtain ethics approval (if necessary)

• Start implementing the QI measures.

Months 13 - 22 • Carry out another

round of data

collection in the

1-2 wards = POST-

IMPLEMENTATION

• Analyze findings &

prepare for summary

workshop.

Months 23 /24

Workshop summarizing

findings & planning next

steps within hospital &

network.

There is leeway with regards to duration of the phases, however, all hospitals

in the network will progress together from one phase to another.

Administrative phase contract; ethics; training surveyors

( = SOPs & quiz & practice datasets)

What are ‘quality improvement measures’ for the second phase of the project?

Will be selected based on weakness(es) detected during the baseline assessment;

Each network will choose if they want to join other networks and employ similar measures – will allow for analysis and evaluation across the networks.

OR

employ unique measures.

Examples of QI measures employed so far:

1. Teaching nurses and physicians about management;

2. Wound infiltration at the end of surgery.

How do we propose to carry out the project?

Which structures?

We have a ‘titanic task’?

Email written

by a network

leader towards

the end of the

second phase

of the project

in her network.

Emphasizing that in

order to implement

any type of change

in management of

patient care, related

to pain, there is

need to set up

structures within

each hospital which

will facilitate

collaboration and

coordination

between the

different disciplines

of providers caring

for patients

undergoing surgery.

National networks in

Belgium, France, Ireland, Italy, Netherlands, Serbia, Spain, Switzerland

In each

hospital

X 8

Chairs: Winfried Meissner & Elon Eisenberg

Anesthetists: Narinder Rawal

Nurses: Rianne van Boekel

Surgeons: ?

Research & Coordination: Ruth Zaslansky

Vacant posts: surgeon X2

Winfried Meissner – Coordinator

Marcus Komann - IT

Claudia Weinmann – administration

Ruth Zaslansky - Research &

Coordination

Roles of the Principal Investigator (PI)

In each hospital o

Setting up the multi-disciplinary Working Group (WG) in your hospital

The WG will help lead the project within the hospital

What is the charge of the WG ? WG members will communicate to their colleagues in participating wards:

(1) project goals; (2) project stages; (3) findings from the baseline and post-intervention phases; (4) gain their involvement and assistance in implementing the intervention.

Long term: earn commitment of colleagues to implement and disseminate practices that aim to improve management of pain.

The working group will consist of (this is a suggestion; the composition of the WG is left to your discretion): Principal investigator – leader of the team

Will communicate & coordinate activities with the Director of Surgery & Head Nurse & hospital administration

Surveyors

Surgeon (s) from the participating wards

Ward Nurse(s)

Pharmacist

Additional team member(s)?

Combined efforts in each hospital AND within the

network might facilitate the titanic task of changing

1-2 practices in your hospital during this project.

&

&

Publication policy (*)

1. We have setup a publication board which is specific to the project,

composed of members from EFIC Task Force AND the network leaders.

Its charge? Coordinate publications within the networks.

2. Publications planned for the project

Primary publications X 2

Each network will lead publications of interest to network members

Proposals will be submitted to the publication board; once consented, the

data will be sent to the prospective authors.

Each network will be responsible for the statistical analysis of the studies

they lead.

(*) A major motivation for joining the project;

an issue addressed by many when considering to join the project

Training

To collect data in PAIN OUT – every person needs

to complete ALL 3 phases of the training.

There is a learning curve associated with the process of

collecting data

Expect ~ 20 – 30 minutes per patient

Less & good quality is better than a large amount of poorly

collected data !

Training surveyors

Aim ? Obtain quality data which can be used for

quality improvement & publications

Quality of data ?

(1) Little missing data: As much as is possible, data is entered for each

variable, for each patient. Up to 5% data loss for each variable is regarded as inconsequential for data analysis and concerns about

bias’ (Graham JW. Missing data analysis: making it work in the real world. Annu Rev Psychol. 2009 60,549–76).

(2) Data is accurate: e.g. doses are correct.

1.3% 5.4% ! 23% 67% 95% Missings:

QUIZ Review

Dummy Cases

The cases are not necessarily clinically accurate;

they are meant to illustrate issues related to data

collection and / or input into the web-based mask

Generally, first review of SOPs and quiz

Where to find useful information in the website & finances ?

www.pain-out.eu

Scroll down to:

Select:

1.

2.

3.

EFIC PAIN OUT project: Network in Italy

Important dates:

Kick off meeting: 19 April 2018

Ethics ?

Quizzes & 10-15 practice datasets by end of July.

Baseline data collection to begin in September.

Mid project workshop: approximately 6 months later

Month of

project Month Activity

~ - 6 – 0

January 2018 Administrative preparations for joining the project.

Surveyors from each hospital will submit a quiz AND 10-15 practice

datasets AND they will be assessed AND corrected, as necessary

19th April Kick off meeting

1 – 6 ??

• Surveyors collect BASELINE DATA

• PIs carry out descriptive analysis of the findings (assisted

by the network leader, PAIN OUT).

January 2019 Mid-term workshop

7 - 10 February - May

Staff discuss options for quality improvement measures with

the local working groups; carry out the necessary preparations

for implementing the measures

11 -17 June – December POST INTERVENTION DATA COLLECTION.

18 - 22 January – April - May Analysis of findings and preparations for the summary

workshop.

23 or 24 May Summary workshop

Proposed schedule for the network in Italy

Proposed schedule for all networks

1. Networks joining in a staggered way

Spain, Netherlands, Serbia, France,

Switzerland -> collecting baseline data

Italy, Ireland, Belgium still to start

2. Aim that ALL baseline data is collected by the end

of 2018 -> first primary paper

Include chart ?

Review of training process

If you were asked to train a surveyor – of the activities

you’ve been involved in so far, what would you

Keep ?

Change ?

When in doubt, when you have queries or

suggestions contact:

Claudia Wienmann / Ruth Zaslansky /

Thank you – for a successful and beneficial project !