The Relationship between Student self –efficacy and Ability in Reading and Writing

OERE-Summary-Writing-Guide_Checklist3 abbott2018

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Research Summary Checklist

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Tip: Ensure summary is relevant and useful to your target audience
It is important to have a clear understanding of your target audience before you begin writing a
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This summary writing checklist was developed by the OERE (http://oere.oise.utoronto.ca/) in order to increase the
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(2007) (see references below). For more information, please contact Shasta Carr-Harris at
shasta.carr.harris@utoronto.ca or via twitter @ShastaCH

http://oere.oise.utoronto.ca/

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https://twitter.com/ShastaCH

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Headline

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“Are girls really better readers?”

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“The Relationship between Student Self-Efficacy and Ability in Reading and Writing”

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are both critical pieces of information as they suggest how “generalizable” the findings from
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Provide a few examples whenever possible.

Instead of:
The researchers found that a majority of teachers had a positive view of the after school
literacy program.

Be specific:
The researchers found that the majority of teachers surveyed (35 out of 40) had a
positive view of the after school literacy program. Specifically, teachers reported that it
was easy to deliver as it did not require a lot of pre-planning or extra resources.

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The nature of the results will determine the layout of this section. For a study with 3 or more
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Identify who would be interested in the findings from this study (remember to focus on
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The research could help practitioners:

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o Know which stakeholder can or should be consulted when addressing
issues/problems;

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o Understand the programs/policies/practices that can be used to address

issues/problems and in which context different programs/policies/practices are
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(Adapted from Nutley, Walter, Davies, 2007)

Instrumental use: research has a direct impact on policy and/or practice decisions (Amara,
Ouimet, Landry, 2004).

The research may help practitioners take action to:

o Learn and implement evidence-based methods;

o Implement organizational programs/policies/practices based on research
evidence that can be used to address issues/problems;

o Consult with stakeholders to develop policies/programs/practices founded in

research evidence;

o Provide staff training that help practitioners learn evidence-based methods;

o Etc…

What you need to know (3-4 sentences):

This section is a very brief overview of the summary – what the study is about and an overview
of the findings. This section can be put into a highlighted box on the top right hand side of the
first page, so that practitioners can quickly decide whether this research summary will be useful
to them.

Example:

This study examined the factors that impact a young person’s decision to pursue
university education in Canada. The researchers found that family income and level of
parental education were important factors. The researchers also found an increasing
gender gap between male and female participation, with more young women attending
university than young men.

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Things to include:

1 sentence description of the study;

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Original research article

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References

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About this summary

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Page 7

References

Amara, N., Ouimet, M., & Landry, R. (2004). New evidence on instrumental, conceptual,
and symbolic utilization of university research in government agencies. Science
Communication, 26(1), 75-106.

Nutley, S. M., Walter, I., & Davies, H. T. (2007). Using evidence: How research can inform public

services. The Policy Press.

British Journal of Anaesthesia, 120(1):

146

e155 (2018)

doi: 10.1016/j.bja.2017.08.002

Advance Access Publication Date: 23 November 2017

Quality and Safety

Q U A L I T Y A N D S A F E T Y

The surgical safety checklist and patient outcomes

after surgery: a prospective observational cohort

study, systematic review and meta-analysis

T.E.F. Abbott1, T. Ahmad1, M.K. Phull2, A.J. Fowler3, R. Hewson2,

B.M. Biccard4, M.S. Chew5, M. Gillies6 and R.M. Pearse1,*, for the
International Surgical Outcomes Study (ISOS) groupa

1William Harvey Research Institute, Queen Mary University of London, London EC1M 6BQ, UK, 2The Royal

London Hospital, Barts Health NHS Trust, London E1 1BB, UK, 3Guys and St. Thomas’s NHS Foundation

Trust, London SE1 7EH, UK, 4Department of Anaesthesia and Perioperative Medicine, Groote Schuur

Hospital, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa, 5Department of

Anaesthesia and Intensive Care, Faculty of Medicine and Health Sciences, Link€oping University, 58185

Link€oping, Sweden and 6Department of Anaesthesia, Critical Care and Pain Medicine, University of

Edinburgh, Edinburgh EH48 3DF, UK

*Corresponding author. E-mail: r.pearse@qmul.ac.uk.

a Complete details for the collab authors are available in Supplementary data.

Abstract

Background: The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians
continue to debate the clinical effectiveness of this tool.

Methods: Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international obser-
vational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published

literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the

secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear

model was used to test associations. To further contextualise these findings, we included the results from the ISOS

cohort in a meta-

analysis.

Results are reported as odds ratios (OR) with 95% confidence intervals.

Results: We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%)
patients exposed to the checklist, whilst 7508 (16.8%) sustained �1 postoperative complications and 207 (0.5%) died
before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32e0.77);

P<0.01], but no difference in complication rates [OR 1.02 (0.88e1.19); P¼0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated

with both reduced postoperative mortality [OR 0.75 (0.62e0.92); P<0.01; I2¼87%] and reduced complication rates [OR 0.73 (0.61e0.88); P<0.01; I2¼89%). Conclusions: Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider

quality of care in hospitals where checklist use is routine.

Editorial decision: August 21, 2017; Accepted: September 18, 2017

For Permissions, please email: permissions@elsevier.com

146

mailto:r.pearse@qmul.ac.uk

https://doi.org/10.1016/j.bja.2017.08.002

mailto:permissions@elsevier.com

The surgical safety checklist and patient outcomes after surgery – 147

Key words: cohort studies; operative/mortality; postoperative care/methods; postoperative care/statistics and numerical
data; surgery; surgical procedures

Editor’s key points

� The surgical safety checklist is being promoted as an
effective tool to enhance patient safety

� This study provides outcome data from a large and
diverse collection of hospitals from around the world

� Surgical safety checklist use was associated with a
lower incidence of postoperative mortality, but not of

postoperative complications

� A pooled analysis of previous studies found that
checklist use was associated with a lower incidence of

both postoperative complications and death

More than 310 million surgical procedures are carried out

worldwide every year.1 Estimates of morbidity and mortality

vary.2e4 However, recent data suggest that approximately 75

million patients will experience a postoperative complication,

leading to two million deaths each year.5,6 An important cause

of avoidable harm is healthcare acquired illness or injury. In

the UK, perioperative adverse events account for one in six

patient safety incidents,7 and as many as half are potentially

avoidable.8 Preventable adverse events are costly in both hu-

man and financial terms. The UK Department of Health esti-

mates that iatrogenic harm costs the National Health Service

more than £1 billion each year,9 and other developed countries

are likely to be exposed to similar costs.

Checklists are a simple and reproducible way to stan-

dardize selected aspects of patient care. The World Health

Organisation (WHO) surgical safety checklist is the most

widely used surgical checklist, comprising 19 items in three

domains: before induction of anaesthesia, before surgical

incision, and before the patient leaves the operating theatre.

Actions include checks for a variety of items including patient

identity, introducing all team members, and antibiotic pro-

phylaxis.10 Since its inception, the checklist has been adopted

in >4000 hospitals worldwide,11 and is now considered a sur-
rogate marker for quality of patient care.12 However, there is

only limited evidence of any effect of checklist use on health

outcomes.12 A previous meta-analysis reported insufficient

high-quality evidence to draw robust conclusions, but there

have been further studies since this publication.12,13 Mean-

while, the clinical effectiveness of the surgical safety checklist

remains unclear and some clinicians object to its use.14,15

In the recent International Surgical Outcomes Study (ISOS)

we collected prospective data describing surgical safety

checklist use, along with patient outcomes following elective

in-patient surgery in 27 countries.6 Given the apparent wide-

spread and growing use of the surgical safety checklist and the

need for further evidence, we performed a prospective anal-

ysis of the effects of checklist exposure on postoperative pa-

tient outcomes. To contextualise the results of this analysis

and to describe the current evidence for this intervention, we

included these findings in a systematic review and meta-

analysis of the published literature.

Methods

This was a pre-planned secondary analysis of prospectively

collected data as part of ISOS. To complement this, we con-

ducted a systematic review of the existing literature and a

meta-analysis, in which we included the results of ISOS

analysis.

ISOS analysis: design, setting, and participants

ISOS was a 7-day international cohort study, the main results

of which have been reported previously.6 In the UK, the study

was approved by the Yorkshire and Humber Research Ethics

Committee (Reference: 13/YH/0371). In other countries, regu-

latory requirements varied with some requiring research

ethics approval and some requiring only data governance

approval. The inclusion criteria were all adult patients (age

�18 years) undergoing elective surgery with a planned over-
night stay in hospital. Each participating country selected a

single data collection week between April 2014 and August

2014. Patients undergoing emergency surgery, day-case sur-

gery, or radiological procedures were excluded. During the 1-

week study period, data were collected for consecutive pa-

tients until hospital discharge, using standardized paper case

record forms. Data included baseline demographic informa-

tion, details of the surgical procedure, postoperative care, and

in-hospital postoperative clinical outcomes. The use of the

surgical safety checklist was collected by study investigators

at each site as part of the core dataset. Data were censored at

30 days following surgery for patients who remained in hos-

pital. Data were anonymized and entered onto a purpose-built

secure internet database, which included automated checks

for plausibility, consistency, and completeness.

ISOS analysis: outcome measures

The primary outcome measure for the analysis of the ISOS

cohort was in-hospital mortality. The secondary outcome

measure was the presence of any postoperative in-hospital

complication assessed according to predefined criteria.6,16 A

patient with any of the following complications was deemed

to have met the secondary outcome: surgical site infection,

body cavity infection, pneumonia, urinary tract infection,

bloodstream infection, myocardial infarction, arrhythmia,

pulmonary oedema, pulmonary embolism, stroke, cardiac

arrest, gastro-intestinal bleed, acute kidney injury, post-

operative bleed, acute respiratory distress syndrome, anasto-

motic leak, or other un-categorized complications. The

severity of complications was graded as mild, moderate, or

severe.16

ISOS analysis: statistical methods

Data were included for hospitals returning valid data for �20
participants, and countries with at least 10 participating hos-

pitals. We dichotomized the sample according to the presence

Table 1 Baseline patient characteristics of patients included in the analysis of the prospective observational cohort (International
Surgical Outcomes Study). Data are presented as n (%) for categorical variables and as mean with standard deviation (SD) or median
with interquartile range (IQR) for continuous variables. Univariable association with exposure to surgical safety checklist presented as
odds ratios (OR) with 95% confidence interval (95% CI) and P-value. ASA, American Society of Anesthesiologists physical status score;
COPD, chronic obstructive pulmonary disease

Patients n (%) Checklist use (%) Did not use checklist (%) OR (95% CI) P-value

n ¼ 44 814 n ¼ 40 245 n ¼ 4538 e e
Age, median (IQR) 57 (43e69) 57 (43e69) 56 (41e68) 1.04 (0.87e1.23) 0.70
Male, n (%) 20 458 (45.7) 18 317 (45.5) 2125 (46.8) 0.95 (0.89e1.01) 0.13
Females, n (%) 24 351 (54.3) 21 927 (54.5) 2413 (53.2) 1.05 (0.98e1.13) 0.13
Present smoker, n (%) 7931 (17.8) 6942 (17.3) 965 (12.2) 1.04 (0.89e1.22) 0.64
ASA physical status n (%)
I 11 227 (25.1) 9973 (24.8) 1246 (27.5) 0.97 (0.81e1.16) 0.72
II 22 265 (49.8) 20 300 (50.5) 1956 (43.2) 1.08 (0.94e1.24) 0.28
III 10 193 (22.8) 8991 (22.4) 1194 (26.4) 1.06 (0.92e1.23) 0.41
IV 1038 (2.3) 908 (2.3) 130 (2.9) 0.90 (0.66e1.23) 0.51
Grade of surgery, n (%)
Minor 8411 (18.8) 7448 (18.5) 960 (21.2) 0.69 (0.63e0.77) <0.01 Intermediate 20 203 (45.1) 18 051 (44.9) 2137 (47.1) 0.93 (0.86e1.01) 0.11 Major 16 175 (36.1) 14 732 (36.6) 1438 (31.7) 1.54 (1.39e1.72) <0.01 Surgical specialty, n (%) Orthopaedic 9459 (21.1) 8683 (21.6) 771 (17.0) 1.18 (1.01e1.39) 0.04 Breast 1538 (3.4) 1393 (3.5) 145 (3.2) 0.86 (0.63e1.18) 0.34 Obstetrics and gynaecology 5674 (12.7) 5123 (12.7) 547 (12.1) 0.92 (0.75e1.12) 0.40 Urology and kidney 4871 (10.9) 4299 (10.7) 570 (12.6) 0.92 (0.76e1.11) 0.37 Upper gastrointestinal 1986 (4.4) 1776 (4.4) 208 (4.6) 1.31 (0.99e1.73) 0.06 Lower gastrointestinal 3073 (6.9) 2711 (6.7) 360 (7.9) 1.06 (0.84e1.33) 0.63 Hepato-biliary 2282 (5.1) 1959 (4.9) 322 (7.1) 1.18 (0.91e1.53) 0.22 Vascular 1599 (3.6) 1436 (3.6) 161 (3.6) 1.17 (0.85e1.61) 0.32 Head and neck 6510 (14.5) 5913 (14.7) 592 (13.1) 0.88 (0.74e1.03) 0.11 Plastic or cutaneous 1670 (3.7) 1386 (3.5) 284 (6.3) 1.01 (0.78e1.31) 0.94 Cardiac 1716 (3.8) 1557 (3.9) 159 (3.5) 0.54 (0.39e0.75) <0.01 Thoracic (lung and other) 1157 (2.6) 1086 (2.7) 69 (1.5) 1.44 (0.95e2.18) 0.08 Other 3270 (7.3) 2919 (7.3) 350 (7.7) 0.88 (0.72e1.09) 0.24 Laparoscopic surgery, n (%) 7087 (15.8) 6472 (16.1) 610 (13.5) 1.37 (1.10e1.69) <0.01 Comorbid disorder, n (%) Coronary artery disease 4588 (10.3) 3952 (9.8) 632 (14.0) 1.17 (0.94e1.46) 0.16 Heart failure 1882 (4.2) 1594 (4.0) 287 (6.3) 0.93 (0.70e1.25) 0.65 Diabetes mellitus 5171 (11.6) 4596 (11.4) 571 (12.6) 0.85 (0.70e1.03) 0.10 Cirrhosis 342 (0.8) 311 (0.8) 31 (0.7) 1.15 (0.56e2.37) 0.70 Metastatic cancer 1706 (3.8) 1547 (3.9) 159 (3.5) 0.90 (0.67e1.21) 0.48 Stroke 1492 (3.3) 1333 (3.3) 158 (3.5) 1.00 (0.72e1.39) 0.99 COPD 4094 (9.2) 3790 (9.4) 303 (6.7) 1.07 (0.85e1.35) 0.55 Other 3269 (7.3) 16 552 (41.2) 2042 (45.1) 1.00 (0.87e1.16) 0.95 Had a complication 7508 (16.8) 6734 (16.7) 768 (16.9) 1.04 (0.87e1.23) 0.70 In-hospital mortality 207 (0.5) 163 (0.4) 44 (1.0) 0.79 (0.36e1.73) 0.55

148 – Abbott et al.

or absence of surgical safety checklist use and presented

baseline demographic and clinical characteristics. The out-

comes were considered as binary categorical variables. In the

primary analysis, we assessed for associations between

exposure to a surgical safety checklist and postoperative

mortality, compared to no exposure to a surgical safety

checklist, before and after adjustment for potential con-

founding factors. For the adjusted analysis, we used a hierar-

chical two-level generalized linear model, with patients at the

first level and hospitals at the second level; a three-level model

with countries at the third level did not converge. We included

the following pre-specified covariates to adjust for potential

confounding factors: age, gender, current smoker, American

Society of Anesthesiologists physical status score, grade of

surgery, surgical procedure category, and presence of co-

morbid disease (coronary artery disease, heart failure, dia-

betes mellitus, chronic obstructive pulmonary disease/

asthma, cirrhosis, metastatic cancer, stroke, and other un-

specified chronic disease). These covariates were selected

for clinical plausibility and evidence of association with

the exposure or outcomes in previous epidemiological

research.4,17e19 The results are presented as odds ratios (OR)

with 95% confidence intervals (CI) and associated Wald P-

values. The primary analysis was repeated for in-hospital

complications as the secondary outcome measure, consid-

ered as a binary categorical variable using a three-level

generalized linear model, with patients at the first level, hos-

pitals at the second, and countries at the third level. Normally

distributed continuous variables are presented as mean with

standard deviation (SD), and non-normally distributed

continuous variables are presented as median with inter-

quartile range (IQR), and proportions are presented as n (%).

We used STATA version 14 (StataCorp LP, College Station, TX,

USA) for the statistical analysis.

Table 2 Results of the primary and secondary analyses of the prospective International Surgical Outcomes Study (ISOS) cohort.
Summary of two separate statistical models, where the dependent variables were either mortality or any postoperative complication
(excluding mortality). Generalized linear models, with results presented as odds ratios with 95% confidence intervals and P-values. All
variables were binary categorical unless otherwise stated, where exposure to a variable was compared to non-exposure. ASA physical
status and grade of surgery categorical variables where the reference was the average effect across the whole cohort. ASA, American
Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease

Any complication P-value Mortality P-value

Age (yr) 1.01 (1.00e1.01) <0.01 1.03 (1.02e1.04) <0.01 Male 1.05 (1.02e1.08) <0.01 1.03 (0.89e1.21) 0.67 Female 0.95 (0.93e0.98) <0.01 0.97 (0.83e1.13) 0.67 Present smoker 0.99 (0.92e1.07) 0.84 1.61 (1.12e2.31) 0.01 ASA physical status I 0.54 (0.49e0.58) <0.01 0.09 (0.02e0.39) <0.01 II 0.71 (0.67e0.75) <0.01 0.69 (0.39e1.22) 0.20 III 1.21 (1.14e1.29) <0.01 2.20 (1.29e3.76) <0.01 IV 2.17 (1.92e2.46) <0.01 7.54 (4.18e13.63) <0.01 Grade of surgery Minor 0.52 (0.49e0.56) <0.01 0.63 (0.43e0.93) 0.02 Intermediate 0.91 (0.87e0.96) <0.01 0.92 (0.71e1.21) 0.55 Major 2.10 (2.00e2.20) <0.01 1.72 (1.34e2.22) <0.01 Surgical specialty Orthopaedic 0.89 (0.83e0.96) <0.01 0.64 (0.41e0.98) 0.04 Breast 0.59 (0.49e0.70) <0.01 0.65 (0.17e2.42) 0.52 Obstetrics and gynaecology 0.77 (0.69e0.85) <0.01 0.80 (0.36e1.76) 0.57 Urology and kidney 0.83 (0.76e0.91) <0.01 0.48 (0.26e0.89) 0.02 Upper Gastrointestinal 1.37 (1.23e1.53) <0.01 2.79 (1.85e4.22) <0.01 Lower gastrointestinal 1.48 (1.34e1.62) <0.01 1.90 (1.27e2.84) <0.01 Hepatobiliary 0.97 (0.86e1.10) 0.67 1.61 (0.93e2.78) 0.09 Vascular 1.05 (0.93e1.19) 0.42 0.96 (0.56e1.64) 0.87 Head and neck 0.67 (0.62e0.74) <0.01 0.63 (0.36e1.11) 0.11 Plastic or cutaneous 1.01 (0.88e1.17) 0.85 0.94 (0.39e2.23) 0.88 Cardiac 2.49 (2.20e2.80) <0.01 1.47 (0.95e2.28) 0.09 Thoracic (lung and other) 1.25 (1.08e1.45) <0.01 1.19 (0.63e2.26) 0.59 Other 0.68 (0.60e0.77) <0.01 0.76 (0.37e1.58) 0.46 Comorbid disorder Coronary artery disease 1.04 (0.95e1.13) 0.44 0.99 (0.70e1.40) 0.96 Heart failure 1.28 (1.13e1.44) <0.01 1.59 (1.08e2.32) 0.02 Diabetes mellitus 1.10 (1.01e1.19) 0.02 1.24 (0.89e1.73) 0.20 Cirrhosis 1.45 (1.11e1.88) <0.01 2.77 (1.34e5.72) <0.01 Metastatic cancer 1.45 (1.28e1.64) <0.01 3.41 (2.25e5.19) <0.01 Stroke 1.16 (1.01e1.32) 0.03 2.79 (1.88e4.14) <0.01 COPD 1.13 (1.04e1.24) <0.01 1.13 (0.78e1.64) 0.52 Other 1.23 (1.15e1.31) <0.01 1.47 (1.07e2.01) 0.02 Exposure to checklist 1.02 (0.88e1.19) 0.75 0.49 (0.32e0.77) <0.01

The surgical safety checklist and patient outcomes after surgery – 149

ISOS analysis: sensitivity analyses

We were interested to assess whether countries with high

checklist usage, as a proportion of the total number of patients

(i.e. checklist compliance), were more likely to have lower risk

of in-hospital mortality or postoperative complications. We

calculated checklist compliance by country as the proportion

of patients in each country that were exposed to the checklist.

We ranked countries by compliance and divided the sample

into four similarly sized quartiles, with quartile one repre-

senting lowest compliance and quartile four representing

highest compliance. We repeated the primary analysis using

quartiles of checklist compliance as the exposure of interest,

using a deviation contrast where the mean compliance for the

whole cohort was treated as the reference category. Secondly,

to identify whether a relationship between checklist use and

postoperative complications or mortality differed according to

income status of the country of origin, we stratified the sample

by country income status (high income or low and middle

income), according to the World Bank definition and repeated

the analysis.20

Evidence synthesis: systematic review and meta-
analysis

We undertook a systematic review and meta-analysis of the

published literature describing the effects of surgical safety

checklist use on patient outcomes, including the results of the

ISOS study. We prospectively registered the systematic review

with PROSPERO (2016:CRD42016039878). The primary outcome

was mortality, which we expected to be the most frequently

reported outcome measure. The secondary outcome was

postoperative complications. Definitions of complications for

included studies are presented in Supplementary Table 1. We

searched MEDLINE, The Cochrane Library, EMBASE, and

CINAHL for the years 2009e2017 using Healthcare Database

Advanced Search (hdas.nice.org.uk). We scanned the bibliog-

raphies of included studies and consulted experts to identify

studies that were missed by the search. Full details of the

search strategy are provided in Supplementary Table 2. We

extracted records to Mendeley (London, UK) to sort and

remove duplicates. Two investigators (M.P. and A.F.) inde-

pendently reviewed each record by title and abstract. Papers

Table 3 Compliance with surgical safety checklist by country and postoperative outcomes. Summary of two separate statistical
models, where the dependent variables were either mortality or any postoperative complication (excluding mortality). Generalized
linear models, with results presented as odds ratios with 95% confidence intervals and P-values. All variables were binary categorical
unless otherwise stated, where exposure to the variable was compared to non-exposure. Checklist compliance, ASA score and grade of
surgery categorical variables where the reference was the average effect across the whole cohort. ASA, American Society of Anes-
thesiologists; COPD, chronic obstructive pulmonary disease

Any complication P-value Mortality P-value

Age (yr) 1.01 (1.00e1.01) <0.01 1.03 (1.02e1.05) <0.01 Male 1.05 (1.02e1.08) <0.01 1.05 (0.90e1.22) 0.58 Female 0.95 (0.93e0.98) <0.01 0.96 (0.82e1.12) 0.58 Present smoker 0.99 (0.92e1.07) 0.84 1.58 (1.10e2.27) 0.01 ASA physical status I 0.54 (0.49e0.58) <0.01 0.09 (0.02e0.40) <0.01 II 0.71 (0.67e0.75) <0.01 0.72 (0.41e1.26) 0.25 III 1.21 (1.14e1.29) <0.01 2.21 (1.29e3.78) <0.01 IV 2.17 (1.92e2.46) <0.01 7.02 (3.87e12.74) <0.01 Grade of surgery Minor 0.52 (0.49e0.56) <0.01 0.64 (0.43e0.94) 0.02 Intermediate 0.91 (0.87e0.96) <0.01 0.91 (0.70e1.19) 0.5 Major 2.10 (2.00e2.20) <0.01 1.72 (1.33e2.22) <0.01 Surgical specialty Orthopaedic 0.89 (0.83e0.96) <0.01 0.65 (0.42e0.99) 0.05 Breast 0.59 (0.49e0.70) <0.01 0.64 (0.17e2.40) 0.51 Obstetrics and gynaecology 0.77 (0.69e0.85) <0.01 0.83 (0.37e1.84) 0.65 Urology and kidney 0.83 (0.76e0.91) <0.01 0.49 (0.26e0.91) 0.02 Upper gastrointestinal 1.37 (1.23e1.53) <0.01 2.69 (1.78e4.08) <0.01 Lower gastrointestinal 1.48 (1.35e1.62) <0.01 1.89 (1.26e2.83) <0.01 Hepatobiliary 0.98 (0.86e1.10) 0.69 1.49 (0.86e2.58) 0.16 Vascular 1.05 (0.93e1.19) 0.45 0.97 (0.57e1.66) 0.92 Head and neck 0.67 (0.62e0.73) <0.01 0.62 (0.35e1.10) 0.11 Plastic or cutaneous 1.01 (0.88e1.17) 0.88 0.95 (0.40e2.26) 0.91 Cardiac 2.49 (2.20e2.81) <0.01 1.60 (1.03e2.49) 0.04 Thoracic (lung and other) 1.25 (1.08e1.45) <0.01 1.15 (0.61e2.19) 0.66 Other 0.68 (0.60e0.77) <0.01 0.74 (0.36e1.54) 0.43 Comorbid disorder Coronary artery disease 1.03 (0.94e0.13) 0.48 0.98 (0.69e1.39) 0.91 Heart failure 1.27 (1.13e1.44) <0.01 1.47 (1.00e2.16) 0.05 Diabetes mellitus 1.10 (1.01e1.19) 0.03 1.26 (0.90e1.75) 0.18 Cirrhosis 1.45 (1.11e1.88) <0.01 2.72 (1.31e5.63) <0.01 Metastatic cancer 1.45 (1.28e1.64) <0.01 3.41 (2.24e5.19) <0.01 Stroke 1.15 (1.01e1.32) 0.03 2.80 (1.88e4.16) <0.01 COPD 1.13 (1.04e1.24) <0.01 1.18 (0.81e1.72) 0.38 Other 1.22 (1.15e1.31) <0.01 1.42 (1.03e1.94) 0.03 Checklist compliance Quartile 1 (low) 1.07 (0.94e1.23) 0.32 1.80 (1.34e2.41) <0.01 Quartile 2 (medium) 1.17 (1.00e1.36) 0.04 1.02 (0.73e1.41) 0.93 Quartile 3 (high) 0.87 (0.75e1.02) 0.09 0.90 (0.61e1.32) 0.58 Quartile 4 (very high) 0.92 (0.81e1.03) 0.15 0.61 (0.45e0.83) <0.01

150 – Abbott et al.

identified as potentially relevant were reviewed in full. Papers

were selected for inclusion if they described the use of the

WHO surgical safety checklist in adult patients (>18 years)
undergoing surgery, and reported either complications or

mortality as postoperative outcomes. We did not include

studies where the surgical safety checklist was tested with

another intervention or where the checklist was modified.21

Differences in opinion were resolved through discussion and

referred to a third investigator (M.G.). Data were extracted

from the selected papers by two independent investigators

(M.P. and A.F.) to a pre-formatted Excel worksheet (Microsoft,

Redmond, WA, USA). The meta-analysis was conducted using

Review Manager Version 5.3 (Cochrane Collaboration, Copen-

hagen, Denmark). Risk of bias was assessed using the

Cochrane tool for randomized controlled trials, the National

Institutes of Health ‘quality assessment of before-and-after

studies’ tool for before and after studies, and the Newcastle

Ottawa Scale for other non-randomized studies.22e24 Between

study heterogeneity was assessed with c2 test and I2 test using
P<0.1 as the pre-defined threshold for statistical significance. A random effects model was used for all analyses. Results are

presented as OR with 95% CI, associated P-values, and forest

plots.

Results

Surgical safety checklist use in the ISOS cohort

We included 44 814 ISOS participants from 497 hospitals in 27

countries in this analysis (Supplementary Fig. 1). Eight coun-

tries, with 134 participating hospitals, were classed as low- or

middle-income nations.20 Participating hospitals had a me-

dian of 550 (329e850) beds and 21 (10e38) critical care unit

beds. Some 40 245/44 814 (89.8%) patients were exposed to the

surgical safety checklist, 7508/44 814 (16.8%) sustained at least

c
a
rd

ia
c

s
u
rg
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ry

;
O
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,
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m
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s

M
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li
ty

C
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m
p
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s

N
Y

Y
Y

Y
N

Y
N
N
Y
Y
Y
Y
Y
Y
Y
Y
N
Y
Y

The surgical safety checklist and patient outcomes after surgery – 151

one postoperative complication, and 207/44 814 (0.5%) died

before hospital discharge (Table 1). The results of regression

models for surgical safety checklist exposure against post-

operative mortality or complications in the ISOS cohort are

shown in Table 2. In the unadjusted analysis, exposure to the

surgical safety checklist was associated with a reduction in

mortality [OR 0.42 (0.33e0.58); P<0.01], which remained sta- tistically significant after adjustment for confounding factors

[OR 0.49 (0.32e0.77); P<0.01]. Exposure to the checklist was not associated with a reduction in the incidence of postoperative

complications in either the unadjusted [OR 0.99 (0.91e1.07);

P¼0.74] or the adjusted analyses [OR 1.02 (0.88e1.19); P¼0.75].

a
ly
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4
5
3
8

4
0
2
4
5

Sensitivity analyses of the ISOS cohort

When countries were ranked by compliance with the check-

list, the mean compliance in the lowest and highest quartiles

were 62.5% and 98.7%, respectively (Supplementary Table 3).

Low checklist use at a national level (quartile 1) was associated

with increased mortality [OR 1.80 (1.34e2.41); P<0.01] and high checklist use at a national level (quartile 4) was associated

with reduced mortality [OR 0.61 (0.45e0.83); P<0.01] (Table 3), with the whole cohort as the reference category. National

rates of checklist use (quartile 1 and quartile 4) were not

associated with any effects on postoperative complication

rates. When we stratified the sample by income status of the

participating country and repeated the primary analysis, the

findings remained similar (Supplementary Tables 4 and 5). To

further explore the absence of association between checklist

use and reduced incidence of postoperative complications, we

conducted a post hoc sensitivity analysis to see if checklist use

was associated with reductions in the incidences of specific

severities of complications (either mild or moderate or severe).

However, we did not identify any such associations

(Supplementary Table 6).

T
a
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le

4
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-a
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it
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in
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rb

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a
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3
4

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/a
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v
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K
le
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a
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4
4

Y
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R
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tr
o
s
p
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IS
O
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G
ro

u
p

N
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P
ro
s
p
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c
ti
v
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c
o
h
o
rt

Systematic review and meta-analysis

Searches identified 3732 records. After removal of duplicates,

3554 abstracts were screened, 41 full-texts were reviewed, and

11 studies (including ISOS) were selected for inclusion

(Supplementary Fig. 2). Five studies included in previous sys-

tematic reviews were excluded because they did not meet our

inclusion criteria.12,13 A summary of the articles included is

provided in Table 4. A total of 419 799 patients were included in

the meta-analysis for mortality. Some 2624/230 929 (1.1%) of

patients exposed to the checklist died, compared to 2466/188

870 (1.3%) not exposed to the checklist. In the random effects

meta-analysis, checklist exposure was associated with

reduced mortality [OR 0.75 (0.62e0.92); P<0.01; I2¼87%] (Fig. 1). The definition of mortality was ‘in-hospital’ in two studies, in-

hospital restricted to 30 days in five studies, and in-hospital

restricted to 60 days in one study. In contrast, 12 054/161 858

(7.4%) of patients exposed to the checklist developed post-

operative complications, compared to 6043/123 329 (4.9%) of

patients not exposed to the checklist. In the random effects

meta-analysis, checklist exposure was associated with a

reduced incidence of postoperative complications [OR 0.73

(0.61e0.88); P<0.01; I2¼89%] (Fig. 2). The meta-analysis is weighted according to effect size and the two biggest studies,

which account for 38.2% of patients showed no difference in

complication rates between exposed and unexposed patients.

The risk of bias was low in all included studies

(Supplementary Table 7) and visual assessment of funnel plots

Fig 1. Forest plot for meta-analysis of exposure to surgical safety checklist and relative risk of postoperative mortality.

Fig 2. Forest plot for meta-analysis of exposure to surgical safety checklist and relative risk of postoperative complications.

152 – Abbott et al.

demonstrated no evidence of publication bias. Compliance

with checklist use was variable across studies with no pattern

of changing use over time (Supplementary Table 8). To account

for the possibility that some studies in the meta-analysis

included patients exposed to a modified checklist, we

repeated the meta-analysis including five studies of modified

surgical safety checklists that were excluded from the primary

meta-analysis.25e29 Our findings remained similar for both

mortality [OR 0.77 (0.64e0.91]; P<0.01; I2¼83%] and complica- tions [OR 0.71 (0.60e0.84); P<0.01, I2¼92%].

Discussion

The principal finding of this research was that patients

exposed to a surgical safety checklist had a lower incidence of

postoperative complications and death when compared to

patients who were not exposed to a checklist. These findings

may reflect a higher quality of care in hospitals where check-

list use is routine. While the data included in the meta-

analyses are primarily observational, this study adds to the

overall understanding of the surgical safety checklist, indi-

cating that checklists are widely used internationally, but that

in most healthcare settings it is not possible to randomly

assign patients to checklist use because of existing widespread

implementation. Therefore, in the absence of data from ran-

domized trials, our analyses may represent the highest

currently attainable level of evidence describing the effects of

surgical safety checklist use. Future randomized trials may not

be possible, but further research should be standardized for

individual compliance with the checklist. The findings of the

ISOS analysis, where checklist exposure was associated with

reduced mortality but not complications, contrasted with the

results of the meta-analysis. This is counterintuitive, but not

uncommon among meta-analyses, where the results of an

individual study may contrast with the overall weighted effect.

The results of this meta-analysis suggest that across a range of

studies at many hospitals, checklist use is associated with

fewer postoperative complications and deaths. However, it is

unlikely that it will ever be possible to prove the causality of

improved patient outcomes associated with checklist use.

Previous studies in mostly high-income countries have

demonstrated associations between checklist use and reduced

morbidity and mortality. The European Surgical Outcomes

Study, conducted in 426 European hospitals, suggested that

checklist exposure was associated with a 19% reduction in the

relative risk of in-hospital mortality, while a single centre

retrospective cohort study in Chile identified a 27% reduction

in mortality.14,30 However, there is less evidence to support

checklist use in low or middle-income countries.28 Our anal-

ysis of the ISOS is the largest study of which we are aware, to

include data from both low-, middle-/high-income countries.

Our results are therefore more widely generalizable and indi-

cate a need for research and quality improvement to ensure

safe and effective patient care in low- and middle-income

countries. Examples may include rapid response systems

and early warning scores.31e33 The largest study to evaluate

the surgical safety checklist to date was a cohort study of an

implementation project performed in acute care hospitals in

Canada.34 In contrast to our results, the authors did not

identify any benefit associated with checklist use, when

comparing the 3 months before and after implementation in

>200 000 patients. This may be attributable in part to pre-
existing high-quality care at these hospitals. We included

this study in our meta-analysis, which may explain, in part,

The surgical safety checklist and patient outcomes after surgery – 153

the smaller effect estimates than observed in a previous sys-

tematic review.12 Similarly, the findings of the ISOS analysis

contrast with the results of our meta-analysis, which identi-

fied a reduction in postoperative complications associated

with checklist exposure. This might be explained by the high

compliance with checklist use in the ISOS cohort (nine out of

10 patients), making it harder to detect a difference in out-

comes between exposed and non-exposed patients. Alterna-

tively, it may be attributable to bias or heterogeneity between

studies included in the meta-analysis (Supplementary

Table 6).

This work has several strengths. This was a prospective

analysis of the ISOS cohort and a prospective meta-analysis.

ISOS is one of the largest prospective international cohort

studies of surgical outcomes conducted to date, and in

contrast to many other studies, includes data from low-,

middle-, and high-income countries.6 Because of the large

number of patients enrolled, we were able to adjust the anal-

ysis for a variety of potential confounding factors. However, as

with any epidemiological study, we must acknowledge the

potential influence of unmeasured confounding. The meta-

analysis included more than 10 times as many patients as

the previous largest evidence synthesis, and the risk of bias

was lower than in previous work.12,13 Our study also has

several weaknesses. The ISOS investigators hoped to include a

mix of hospitals from each country. However, it is impossible

to say whether the results are representative of practice in any

one country. This is particularly pertinent to low- and middle-

income countries, where there was a bias towards university

hospitals and away from smaller district hospitals. In general,

we would expect hospitals that participate in research to offer

a better standard of care, since research active hospitals tend

to have superior clinical outcomes.35 There is likely to be

heterogeneity of surgical and perioperative care and admin-

istrative procedures across hospitals included in the ISOS

study, which may influence the results. For example, hospitals

in some countries may discharge patients at an earlier stage of

the postoperative pathway than others, which may influence

the rates of recorded in-hospital complications. This is further

illustrated by the variation in compliance with the checklist at

a country level, where three-quarters of countries used the

checklist in >89% of cases, in contrast to a wide variation in
checklist use among countries in the lowest quartile (27e85%).

However, checklist complianceesimilar to the heterogeneity

of surgical care within and between countriese is unlikely to

be uniform across countries and the ISOS sample may not be

representative of country-wide practice. Furthermore, we did

collect data on individual components of the checklist, so it is

possible that some sections were completed more frequently

than others. The meta-analysis did not include studies of staff

training on the use of the surgical safety checklist and we did

not differentiate between different types of complications in

the analysis. The literature describing the checklist describes a

variety of methodologies including randomized trials, pro-

spective and retrospective cohort studies, implementation

studies, and natural trials. We performed a wide-ranging

systematic review and meta-analysis to reflect the breadth

of available knowledge. However, while we were able to in-

crease the precision of our effect size estimates compared to

previous studies, the population samples of included studies

may be different, and this is reflected in the between study

heterogeneity. An alternative approach is to undertake a

meta-analysis based on one methodology only, for example

randomized trials. This approach has been helpful, but is

limited by the number of available studies and therefore pa-

tients.13 Given the inclusion of three large studies in the meta-

analysis, there is the potential that the results may be skewed

towards findings of these studies. We were unable to adjust for

potential improvements in perioperative care over time or

differences in compliance with the checklist between or

within included studies.1,36,37 While several studies have re-

ported compliance rates greater than 90%, the findings of the

included studies do not suggest any trend to improved adop-

tion of the checklist over time.

Conclusions

We have provided evidence to show that patients exposed to a

surgical safety checklist experience better postoperative out-

comes. However, it remains uncertain whether these associ-

ations are a direct causal effect, or if this simply reflects wider

quality of care in hospitals where checklist use is routine.

Authors’ contributions

Study design/plan: T.E.F.A., R.P.

Study draft: T.E.F.A., T.A., A.F., M.G., R.P.

Patient recruitment and data collection: members of the ISOS

study group (see supplementary file).

Analysis of ISOS data: T.A., T.E.F.A.

Systematic review: A.F., M.P., M.G.

Meta-analysis: A.F., T.E.F.A., M.G.

Writing paper: T.E.F.A., A.F., R.P.

Revised paper: all authors.

Acknowledgements

The ISOS study was funded through an unrestricted research

grant from Nestle Health Sciences. T.E.F.A. is supported by a

Medical Research Council/British Journal of Anaesthesia clin-

ical research training fellowship. B.B. is funded by a National

Research Foundation rating grant and an MRC (SA) self-

initiated research grant. M.G. is a Chief Scientist Office (Scot-

land) NHS Research Scheme Clinician. R.P. is a UK National

Institute for Health Research Professor.

Declaration of interest

R.P. holds research grants, and has given lectures and/or per-

formed consultancy work for Nestle Health Sciences, BBraun,

Medtronic, Glaxo SmithKline, and Edwards Lifesciences, and is

a member of the Associate Editorial Board of the British Jour-

nal of Anaesthesia. M.S.C. has received unrestricted research

grants, and has given lectures and/or performed consultancy

work for Thermofisher Scientific, Pulsion Medical Systems,

and Edwards Lifesciences, and is a member of the Associate

Editorial Board of the European Journal of Anaesthesiology. All

other authors declare they have no conflicts of interest.

Supplementary data

Supplementary data related to this article can be found at

https://doi.org/10.1016/j.bja.2017.08.002.

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154 – Abbott et al.

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Handling editor: P.S. Myles

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The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic revi …
Editor’s key points

Methods
ISOS analysis: design, setting, and participants
ISOS analysis: outcome measures
ISOS analysis: statistical methods
ISOS analysis: sensitivity analyses
Evidence synthesis: systematic review and meta-analysis
Results
Surgical safety checklist use in the ISOS cohort
Sensitivity analyses of the ISOS cohort
Systematic review and meta-analysis
Discussion
Conclusions
Authors’ contributions
Acknowledgements
Declaration of interest
Supplementary data
References

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