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Promise & limitations of surgical checklists:How can we effectively use them to improve
the quality of surgical care?
Shawn J. Rangel, MD, MSCE & J. William Sparks, MD
Northeast Regional Patient Safety & Quality Improvement Conference
February 5th, 2011
• Review evidence supporting surgical safety checklists
• Attitudes toward the safety checklist at (CHB survey)
• Strategies for improving checklist utilization & relevance
• Next steps: IT, custom checklists & beyond…
Outline of today’s discussion
London, UK EURO EMRO
WPRO I
SEARO
AFRO
PAHO I
Amman, JordanToronto, Canada
New Delhi, India
Manila, Philippines
Ifakara, Tanzania
WPRO II
Auckland, NZ
PAHO II
Seattle, USA
8 Evaluation Sites
Methods
• 1 to 4 operating rooms targeted at each site
• 18-item checklist implemented (sign-in, time-out, sign-off)
• Pre-post intervention study design (general surgery cases)
• Primary outcome measure: aggregate 30-day major complication rate (NSQIP* defined)
*National Surgical Quality Improvement Project
Results: impact on morbidity & mortality(3 month comparison periods)
Baseline Checklist P value
Cases 3,733 3,955 -
Death 1.5% 0.8% 0.003
Any complication 11.0% 7.0% <0.001
Surgical site infection 6.2% 3.4% <0.001
Unplanned Reoperation 2.4% 1.8% 0.047
Limitations of the study
• Unknown influence of the Hawthorne effect
• Unable to prove causality (non-randomized design)
• Effect size may be exaggerated (developing nations)
• Only one of the eight centers was in the U.S.
• Pediatric patients not included in analysis
Methods
•SURPASS implemented at 6 tertiary-care hospitals
•Pre-post intervention study design (3 month periods)
•12 adverse event categories audited
•Outcomes compared with five “control” hospitals
Results: impact on morbidity & mortality(3 month comparison periods)
Baseline(n=3,760)
Checklist(n=3,820)
P value
Mortality 1.5% 0.8% -
Any complication 15.4% 10.6% <0.001
Complications/100 cases 27.3% 16.7% <0.001
Use of the checklist was associated with a significant reduction in complication rates for 10 of the 12 (82%) event categories in the study
Pediatric Safe Surgery Collaborative
• Children’s Hospital Boston Shawn J. Rangel (Study PI) Beth K. Norton (Co-study PI) Jessica Baxter
• Texas children’s Hospital Thomas Luerssen (site PI) Carrie Smith-Bruce
• Riley Children’s Hospital Fred Rescorla (Co-site PI) Charles Leys (Co-site PI) Margo Regas
• Denver Children’s Hospital Tammy Woolley (Site PI) Jenae Nieman
• Children’s Healthcare Atlanta Kurt Heiss (Site PI) Kawana Mitchell
• Children’s National Med Center Kurt Newman (Co-site PI) Rahul Shah (Co-site PI) Andrea Ewing-Thomas
• Children’s Hospital of Philadelphia Peter Mattei (Site PI) Lisa Czyzewski
Collaborative process
• Identification & recruitment of checklist champions
• Development of site-specific checklist
• Plan for piloting on small scale
• Obtaining buy-in from hospital leadership & peers
• Full implementation OR-wide
• Develop internal plan for auditing compliance
General study design
• Seven hospitals included as “checklist” implementers
• All inpatient procedures from 7 surgical services included
Cardiac, General, Neuro, Ortho, Plastics, Oto & Urology
• Pre-post intervention comparison design (9 months)
• Primary endpoint: Aggregate 30-day adverse event rate
• PHIS database used to identify events
• Results compared against seven control hospitals
Patient characteristics (demographics)
Checklist hospitals (n=7) Control Hospitals (n=7)
Pre-intervention(n=19,867)
Post-intervention(n=18,850)
Pre-intervention(n=15,616)
Post-intervention(n=15,298)
Age (mean years) 6.9 7.1 7.2 7.4
Sex (% male) 55.3 54.2 56.5 56.6
Insurance status : Government (%) Private (%) Other (%)
62.524.812.7
63.224.612.2
50.239
10.8
53.939.77.3
Race/ethnicity: African American(%) Hispanic (%)
20.216.9
18.517.5
10.623.3
10.826
Case Mix Index 6.1 6.1 5.5 5.5
Acuity of procedure(% emergent) 15.6 18.9 18.8 19.6
MORTALITY RR of death with checklist utilization: 0.73 (95%CI: 0.57-0.93)
Inci
den
ce (
%)
p=0.758
p=0.018
MORTALITY (emergent procedures)RR of death with checklist utilization: 0.58 (95%CI: 0.36-0.95)
Inci
den
ce (
%)
p=0.724
p=0.029
MORTALITY (ICU admissions)RR of death with checklist utilization: 0.57 (95%CI: 0.40-0.82)
Inci
den
ce (
%)
p=0.731p=0.002
Limitations of the study
• Unknown influence of the Hawthorne effect
• Unable to prove causality (non-randomized design)
• Reliance on administrative data for outcomes analysis
• Variation/degree of checklist compliance unknown
What can be concluded from the available data?
USE OF A SURGICAL SAFETY CHECKLIST
CAN SAVE LIVES !!!!!!
So then, how do people feel about using a surgical safety checklist?
--CHB Checklist Survey--
• Multidisciplinary targeting (3-headed monster!)
• Assess attitudes towards the checklist
• Gain insight on CHB’s current safety culture
• Obtain feedback for improving checklist utility
Have you witnessed an error or complication prevented by the checklist?
(response=yes)
Pro
port
ion
of
resp
onde
rs (
%)
Chi2, p=0.048
Has the checklist improved efficiency?(response=yes)
Pro
port
ion
of r
esp
ond
ers
(%
)
Chi2, p=0.110
Would I want the checklist used for my child?(response=yes)
Pro
port
ion
of r
espo
nder
s (%
)
Chi2, p=0.122
Content adequacy of current checklist?P
ropo
rtio
n of
res
pond
ers
(%)
Chi2, p=0.987
Chi2, p=0.987
Chi2, p=0.987
So, is everyone in love with the checklist??
“This checklist is bullsh&! and just reinforces the
Betty Crocker approach to medicine !!”
“This is probably the most important surgical safety
intervention we could ever implement !!”
“This is stupid- we do this all the time anyway”
“This is stupid- the checklist does not apply to my cases”
• Blood products available?
• Imaging reviewed?
• Special equipment available?
• DVT prophylaxis considered?
• IV access adequate?
Root causes of “checklist fatigue”
So then, how can we improve the effectiveness of our checklist?
• Implementation of forcing cues into work flow
• Incorporation of a more effective auditing system
• Transition to a “quality”-centered checklist paradigm
• Development of customized checklists
Change in the checklist paradigm: transitioning from “safety” to “quality”
Surgical Quality
Value-based
Efficient
Effective
Safe
Take home lessons….
• EFFECTIVE use of surgical checklists CAN SAVE LIVES!
• Checklist MUST be team-based and emphasize communication!
• Checklists HAVE to be developed with input from ALL stakeholders
• Leadership ABSOLUTELY has to be on board!