International seven day cohort study of

standards of care and clinical outcomes

for non-cardiac surgery

European Surgical Outcomes Study

(EuSOS)

EuSOS Objectives of talk

• Describe current data on surgical outcome

• Explain why we need better data for Europe

• Describe study design and methods

• Explain data collection

• Provide contact details

• 234 million major surgical procedures worldwide

• 4,000 procedures per 100,000 population overall

• 11,000 procedures per 100,000 in high income countries

80% of surgical deaths are from the high-risk population

Pearse et al. Crit Care 2006; 10: R81.

Overall Standard High-risk0

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Size Mortality

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Poor outcomes from high-risk surgery are hidden

by large numbers of low risk cases

Pearse et al. Crit Care; 2006; 10 R81.

Standard risk High risk p

n 3,603,803 513,924 -

Age (years) 54 (38-69) 75 (63-83) <0.0001

Emergencies (%) 769,371 (21.3%) 454,924 (88.5%) <0.0001

Hospital stay (days) 3 (1-6) 16 (9-29) <0.0001

Mortality (%) 15,038 (0.42%) 63,340 (12.3%) <0.0001

Estimated annual figures for European

high-risk surgical population

• 21 million in-patient general procedures

• 2.6 million high-risk procedures

• 1.3 million patients develop complications

• 315,000 deaths

Weiser T. Lancet 2008; 372: 139–44

Ghaferi A. N Engl J Med 2009; 361: 1368-75

Pearse R. Crit Care 2006; 10: R81

Surgical complications decrease

long-term survival

Khuri et al. Ann Surg 2005; 242: 326–343

Surgical mortality varies widely in USA

Ghaferi A. N Engl J Med 2009; 361: 1368-75.

Poor quality of surgical outcome data

• Inaccurate healthcare systems data

• Specialty society data on limited subsets

• Mostly retrospective analyses

• Too much focus on elective surgery

• No comparative data across Europe

• Hospital mortality rate

• Duration of hospital stay

• Standard of peri-operative care

• Do standards of care differ across Europe?

• Does mortality differ across Europe?

• What determines admission to critical care after surgery?

EuSOS: for in-patient non-cardiac surgery, what is the…

• Observational seven day cohort study

• Follow-up to hospital discharge

• Basic dataset for all adult non-cardiac surgery

• Follow-up for clinical outcomes (inc crit care)

• Web-site entry of anonymous patient data

EuSOS: Study design

EuSOS: Inclusion criteria

All adult patients undergoing

in-patient non-cardiac surgery during

the seven day study period

Start: 09:00 4th April 2011

Finish: 08:59 11th April 2011

EuSOS: Exclusion criteria

• No planned overnight hospital stay

• Neurosurgery

• Obstetrics

• Cardiac surgery (thoracic surgery is included)

EuSOS: Data collection

• Data set as small as possible......!

• Hospital data form: describing size, case mix, etc

• Operating room form: describing all patients

• Critical Care form: only for admissions to critical care– NB defined as a unit which can routinely ventilate overnight

• Internet based entry from paper case records

EuSOS: Data set

• Age

• Gender

• ASA grade

• Co-morbid disease

• Procedure category

• Urgency

• Duration

• Anaesthetic technique

• Cardiac output monitoring

• Seniority of medical staff

• Recovery stay (hours)

• Critical care stay

• Ventilation within 24 hours

• Data for SAPS III & SOFA

• Inotrope / vasopressor use

• Duration of hospital stay

• In-hospital mortality

Outcome measures

• Primary:– In-hospital mortality

• Secondary:– Duration of hospital stay– Duration of critical care stay

EuSOS: Study sites

• So far, over 300 hospitals in 30 nations

• Geographical Europe (EU and non-EU nations)

• National co-ordinators in each nation

• Local co-ordinators in each hospital

EuSOS: Risks of failure

• Enough hospitals to represent national practice

• Poor data capture (completion of data forms)

• Poor data return (internet data entry)

EuSOS: Opportunities

• Provide powerful data to improve patient care

• International benchmark for each hospital

• Formation of international research group

• Public recognition for every investigator

• Data sharing for future research

EuSOS: Steering committee

• Rupert Pearse (chief investigator) UK

• Peter Bauer (statistician) Austria

• Philipp Metnitz Austria

• Rui Moreno Portugal

• Paolo Pelosi Italy

• Andy Rhodes UK

• Claudia Spies Germany

• Benoit Vallet France

• Jean-Louis Vincent Belgium

info@eusos.esicm.org

http://eusos.esicm.org

EuSOS:

Information