Reduction in medical error rates when
implementing a 48h EWTD-compliant rota
for junior doctors in the UK:
a single-blind intervention study
FP Cappuccio1,3, A Bakewell1, FM Taggart1, G Ward1, C Ji1, JP Sullivan2,
M Edmunds3, R Pounder4, CP Landrigan1,2, SW Lockley1,2, E Peile1
on behalf of the Warwick EWTD Working Group
1Sleep,
Health & Society Programme, Clinical Sciences Research Institute, Warwick Medical School, Coventry, UK;
Work Hours Health & Safety Group, Harvard Medical School, Brigham and Women’s Hospital and
Children’s Hospital, Boston, MA, USA;
3University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK;
4Royal College of Physicians, London, UK
2Harvard
Background (1)
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1993 EWTD: limiting the maximum required working hours to 48/wk (average
over up to 6 mo) to protect employees’ health and safety and improve patient
safety
1998: adopted into UK law through the Working Time Regulations
Extension up to 12 yrs before full implementation
2003 European Court ruling: resting and sleeping time during duty in hospital
should be considered as working time
Aug 2005: Changes affecting medical profession phased over 5 years (junior doctors’
six-monthly average weekly working hours reduced from 72 to 54)
The New Deal: BMA negotiations with DoH to improve lives of junior doctors –
key feature to reduce extended working hours and ensure adequate rest was built
in rotas
Aug 2009: EWTD-compliant rotas must be in place
Background (2)
2004: UK Multidisciplinary Working Group of the Royal College of Physicians
established to:
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develop practical advice for junior doctors working night shifts
guide those designing rotas for junior doctors
2006 Recommendations of the UK EWTD WP of the RCP
i.
ii.
iii.
iv.
v.
Rotas involving seven consecutive 13h night shifts may increase risks to patients and staff, and
should be avoided
Number of night shifts in succession should be limited to a maximum of four, and their length
reduced
Encouraged to testing of three 9h shifts to cover 24h to achieve improved health, safety, teaching
and supervision, and efficiency.
Using an evidence-based approach, hospitals should implement optimal 48h rotas by 2009
A ‘cell’ of 10 junior doctors is necessary for any post that provides 24h cover, plus specialty work and
training
Need to implement EWTD competes with demands to
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–
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maintain medical cover at all times
provide safe and effective healthcare to patients
ensure doctors access educational and training opportunities
ensure safety and quality of life of doctors
Background (3)
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Considerable controversy
– Concerns raised about
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• Doctors’ and patients’ lives at risk (BMJ 2005;330:1404)
• Reduced time available for training, with negative impact on clinical experience and
quality of care (BMJ 2007;334:777. BMJ 2008;336:345. Clin Med 2008;8:126-7)
Without exceptions, assertions based on opinions, anecdotes or non validated
questionnaires
(Occup Environ Med 2007;64:733-8. Ann R Coll Surg Engl 2008;90:60-3 and 68-70. BMA 2008)
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Evidence
– Studies in the US show that a reduction in total hours worked in a week and in
the duration of each shift results in
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More sleep (i.e. less fatigue)
Fewer attentional failure
Fewer serious medical errors
Fewer car crashes when doctors’ driving home after a shift
Fewer sharp injuries
(NEJM 2004;351:1829-37 and 1838-48. NEJM 2005;352:125-34. JAMA 2006;296:1055-62. PLoS Med 2006;3:e487)
No objective evidence in the UK and Europe
Aims of our study
• To study the effects of implementing an EWTD-compliant 48h
week rota on
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Patients’ safety
Doctors’ work-sleep patterns
Quality of life and well-being
Quality of handover
• Comparing the effects of an EWTD compliant 9h shift system
versus a traditional rota for junior doctors at UHCW
Methods (1) - Study period and design
• 7th May – 31st July 2007 (12 weeks)
– MTAS time!!!
• 12-week single-blind intervention trial
– Intervention group (9h shift system=48h/wk)
– Traditional Group (traditional shift system=56h/wk)
• Intervention group (n=9)
– CDU and Endocrinology
• Traditional group (n=10)
– Respiratory and Care of the Elderly
• Rota adjustment after 6 weeks
(to increase day-time cover and extend night shift from 9h to a max of 11h)
Methods (2): examples of junior doctor work and sleep patterns
Day of week
Subject #1
12:00
18:00
M
T
W
T
F
S
S
M
T
W
T
F
S
S
Subject #2
Day of week
Clock time (h)
6:00
Subject #3
Clock time (h)
6:00
12:00
18:00
6:00
12:00
18:00
M
T
W
T
F
S
S
M
T
W
T
F
S
S
6:00
12:00
18:00
Subject #4
M
T
W
T
F
S
S
M
T
W
T
F
S
S
M
T
W
T
F
S
S
M
T
W
T
F
S
S
Traditional 56-h rota
Intervention 48-h rota
Self-reported sleep times () and work hours () are shown for four
junior doctors while working
on either a 56-hour schedule (Subjects 1 and 2, left panels) or a 48hour schedule (Subjects 3 and 4, right panels).
Methods (3)
• Retrospective manual case note review
 Random selection
 916 case notes out of 1677 admissions (55%)
 Episode of care >24 hours
 Institute for Healthcare Improvement Global Trigger Tool
Trigger words e.g. confusion, warfarin, hypotension
 Clinical Adverse Event forms
 Incident identified - descriptive information collected
 Incidents submitted to physician review (2 or 3)
 Reviewers blind to allocated rota
 Error classification
 Error type
• Statistical analysis
 Error rate per 1,000 patient-days
 Intervention effect by intention-to-treat analysis
 Hazard ratios
Methods (4) - Incidents detected
Preventable Adverse Event
On warfarin, INR not monitored  bled
Intercepted Potential Adverse Event
Prescribed contraindicated drugs (pharmacy note)
Non-intercepted Potential Adverse Event
Drug allergy not recorded on prescription chart (but not prescribed during
stay)
Minor error
Blood tests not repeated as planned (but improved)
Results (2) - Distribution of scheduled weekly work hours across
12 weeks by group
52.411.2 vs 43.27.7 h/week; p<0.001
Percentage of Scheduled Work Weeks
50
48 hr
56 hr
40
30
25%
>58h
20
2%
>58h
10
0
<28
28<38
38<48
48<58
58<68
Duration of Scheduled Work Week (hr)
10 56 hr rotas x 12 weeks
9 48 hr rotas x 12 weeks
100
68<78
Range: 26 to 60 h/week
Range: 30 to 77 h/week
Percentage of Scheduled Work
Percentage of Scheduled Work
30
20
10
0
60
40
Results (3) – Distribution of work
shift duration
20
Scheduled
(n=19)
<28
28<38
38<48 work
48<58
58<68
68<78
0
Duration
of Scheduled
Work Week
9.0 0.8
h [3.0 to 11.0;
n=5](hr)
vs
10
56
hr
rotas
x
12
weeks
9.91.8 h [4.5 to 12.5; n=4]
9 48 hr rotas x 12 weeks
48 hr
56 hr
60
25%
>12h
40
Nil
>12h
0
p<0.001
48 hr
56 hr
80
60
40
20
0
<10
10<12
>12
<10
Duration of Scheduled Work Shift (hr)
633 56 hr shifts, 520 48 hr shifts
10<12
>12
Duration of Self-Reported Work Shift (hr)
134 56 hr shifts, 114 48 hr shifts
100
80
Percentage of Self-Reported Work Shifts
Percentage of Scheduled Work Shifts
9.20.8 h [5.5 to 11.5] vs
100
80
20
Self-reported
work (n=9)
<10
10<12
>12
Duration of Scheduled Work Shift (hr)
9.91.9 h [3.0 to 13.0]
633 56 hr shifts, 520 48 hr shifts
p<0.001
100
d Work Shifts
48 hr
56 hr
80
48 hr
56 hr
Results (4) - Comparison of average duration of sleep after
each shift type during the two rotas
Intervention rota
Traditional rota
7.260.36h*
6.750.40h
8.68h
6.93h
6.28h
5.69h
*p=0.095 vs traditional
Results (5) - Wards’ characteristics
Age
P<0.001
100
90
Hospital stay
P<0.001
35
70
30
60
Length on Study
25
40
P<0.001
20
25
15
Elderly (C)
Respiratory (C)
Endocrine (I)
20
10
5
Clinical Decisions
Unit (I)
Ward
15
0
Elderly (C)
Days
50
Days
Years
80
10
Respiratory (C)
Endocrine (I)
Clinical Decisions Unit
(I)
Ward
5
0
Elderly (C)
Respiratory (C)
Endocrine (I)
Ward
Clinical Decisions Unit
(I)
Results (6) - Characteristics of patients and episodes
Traditional
Intervention
p-value
Respiratory
Endocrinology
Admissions (n)
248
233
Patients (n)
244
230
71 (27)
71 (31)
0.14
10 (9)
9 (13)
0.37
7 (7)
7 (10)
0.61
Death Rate - n (%)
34 (13.7)
38 (16.3)
0.43
Death Rate (age adj.) - n (%)
34 (14.2)
38 (15.8)
0.62
Age (years) - median (IQR)
Patient-days in hospital - median
(IQR)
Patient-days on study ward
median (IQR)
Results (7) -Adverse events and error rates between
Traditional and Intervention rotas
Traditional
Intervention
Respiratory
Endocrinology
Patient-days
2,315
2,467
Preventable Adverse Events
n (rate*)
5 (2.2)
4 (1.6)
HR: 0.63 (0.42 to 0.94)
16 (6.9)
3 (1.2)
Intercepted Potential Adverse
Events n (rate)
HR: 0.16 (0.05 to 0.57)
Non-Intercepted Potential Adverse
Events n (rate)
Minor Errors
n (rate)
Overall
n (rate)
Rate reduction
% (95% C.I.)†
p
-27.3
(-85.1 to 249)
0.68
-82.6
(-97.7 to -38.5)
0.002
56 (24.2)
41 (16.6)
-31.4
(-55.2 to 4.6)
0.067
18 (7.8)
20 (8.1)
3.8
(-52.2 to 91.0)
0.90
95 (41.0)
68 (27.6)
-32.7
(-52.9 to -10.4)
0.006
HR: 0.62 (0.45 to 0.84)
†:
rate reduction = (rate of Endocrine – rate of Respiratory) * 100 / rate of Respiratory.
*: rate is expressed as Number (per 1000 patient-days)
Results (8) – Qualitative analysis
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Workload issues and Perception of Patient Safety
– Reduced day-time cover with potential for delay in investigations and
treatments
– Lack of time for team interaction
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Learning opportunities
– Drs in intervention felt educational opportunities were compromised
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Rest and Sleep
– Pro: less tired and performing better
– Con: felt performing worse due to higher workload, though less tired
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Quality of Life
– Shifts at night and w/end impact negatively (irrespective of rotas)
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Handover
– Few concerns about quality
– Several comments about number and timing (potential for missing things)
Summary
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First intervention study in the UK and Europe on the effects of a 48h/wk EWTDcompliant rota on patient care, as assessed objectively from medical error rates
The results show that
– 33% fewer medical errors occurred on the 48h/wk intervention rota
– the new rota dramatically reduced the proportion of long work weeks
– the experimental sequence facilitated sleep by providing opportunity for a
long recovery sleep after the evening shift prior to starting the first night
shift
– implementation of a 48h work week can be accomplished without adverse
effects of patients’ safety
Limitations
– Only tested in medical wards (generalisability > controlled studies needed)
– Comparability of wards (case-mix and likelihood of medical errors)
– Not designed to assess the impact on educational opportunities (need for
validated educational outcomes)
Conclusions
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Patient care can be safely provided on a 2009 EWTD-compliant rota
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Although our findings may not be directly applicable to all specialties,
they do not indicate that a reduction in work hours inevitably leads to a
reduction in the quality of patient care
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There is a need for a wider re-engineering of shift systems and hospital
processes to ensure that the safety gains for patients cared for by less
tired doctors are not compromised by difficulties in managing the
routine daytime workload
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Evidence-based policy decisions must be made for work hours in the
same way as evidence-based medicine is used for clinical decisions
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Concerns remain regarding reduced educational opportunities. More
objective research is needed around these areas